The Issue The issue in this proceeding is whether the application of Catholic Hospice, Inc., to establish a hospice program in District 10 meets the statutory and rule criteria for approval.
Findings Of Fact 1. Catholic Hospice, Inc. (Catholic Hospice) is the preliminarily approved applicant for Certificate of Need (CON) Number 9333, to expand hospice services, currently provided in Dade County, into adjacent Broward County, Florida. 2. The Agency for Health Care Administration (AHCA) is the department authorized to administer the Florida CON program for health care facilities and services. 3. Catholic Hospice applied for CON Number 9333 to initiate services in Eroward County, which is designated AHCA, District 10, for the July 2001, planning horizon. As the parties stipulated prior to the final hearing, AHCA published zero as the numeric need for an additional hospice program in Broward County. At the time the CON application was submitted, Catholic Hospice asserted that its proposal would meet an unmet need for hospice care for the Hispanic and Haitian populations, in particular, and the growing multi-ethnic population in Broward County, in general. Catholic Hospice also initially indicated that its program would increase access to hospice care by eliminating financial, language, religious, and cultural barriers. At the hearing, Catholic Hospice presented evidence to support its intention to improve access for the Hispanic population by overcoming language and cultural barriers, and its assertion that the existing hospice programs are not consistently and aggressively reaching Hispanics. 4. Catholic Hospice is a partnership established in 1988 by the Archdiocese of Miami, St. Francis Medical and Health Care Services, and Mercy Hospital. The governing body is a 15-member Board of Directors with five directors from each of the three member organizations. The Board is ethnically diverse and includes three directors who are native Spanish language speakers. Catholic Hospice serves people of various religions, having, within the last year and a half, established the L'Chaim Jewish Hospice Program. 5. Catholic Hospice has steadily increased the proportion of care it gives to Hispanics in Dade County. In 1989, approximately 30% of Catholic Hospice patients were Hispanic. By 1999, Catholic Hospice served 740 Hispanic patients out of a total of 1157. By 2000, the number and proportion of Hispanic patients increased to 841 out of a total of 1228. Currently, over 60% of Catholic Hospice's patients are Hispanics, while 55% of the total populaticn of Dade County is Hispanic. Existing Hospice Programs and Services 6. The existing hospice providers in Broward County are vitas Healthcare Corporation (Vitas), Hospice Care of Broward County, Inc. (Hospice Care of Broward), Hospice by the Sea, Inc. (HBTS), and Hospice of the Gold Coast. All of the existing hospices have elected to qualify for and to obtain accreditation from the Joint Commission for Accreditation of Health Care Organizations. 7. Vitas is the successor to the organization known as Hospice of Miami, established in 1978. Vitas is a for-profit organization, having been established prior to the enactment of the Florida law which currently requires hospices to be not-for- profit corporations. ‘Currently, Vitas operates twenty separately licensed programs in seven states with an average daily census of 5,400 patients. In 1999, Vitas admitted 5,921 patients in Broward County and 4,382 in Dade County. It is the largest provider of hospice care in the United States, and in Broward and Dade Counties. In Broward County, Vitas cared for 180 Hispanic patients in 1998, 238 in 1999, and 206 through November 15, 2000. Approximately 3.3 to 4% of its total number of Broward County patients are Hispanic. 8. Hospice Care of Broward operates in both Dade and Broward Counties, with offices in both Fort Lauderdale and Miami. The main business office is the one in Fort Lauderdale with close to 180 employees as compared to a staff of 50 in the Miami office. The Miami and Fort Lauderdale operations share the same board of directors, executive director, development director, finance director, and clinical director of operations. 9. Hospice Care of Broward cares for patients in their homes, in hospitals or nursing homes, and in its own 5-bed residence in Fort Lauderdale. Approximately half of their Dade County patients and 2% of their Broward County patients are Hispanic. In 1999, Hospice Care of Broward admitted a total of 999 patients in Broward County and 172 in Dade County. 10. HBTS, established in 1979, is a not-for-profit corporation, which serves both AHCA District 9, for Palm Beach County and AHCA District 10, for Broward County. It operates a 30-bed inpatient center in Palm Beach and, by contract, provides care at various hospitals, including Hollywood Medical Center, Holy Cross Hospital, Cleveland Clinic Hospital and North Ridge Hospital. 11. In Broward County, HBTS served five Hispanic patients out of a total of 287, in 1998; 7 out of 415 in 1999; and 15 out of 641 in 2000, or almost 2.4%. 12. Hospice of the Gold Coast is a relatively small operation, serving approximately 200 patients a year, primarily at the North Broward Hospital District facilities. Its office located in the northeastern area of the County, which has a relatively small Hispanic population. As a result, Hispanic utilization of Hospice of the Gold Coast was estimated at 2% by one expert. 13. In general, hospice care is provided to terminally ill patients who are certified by a medical doctor as having a prognosis of death within six months. The care is, therefore, palliative, that is, to provide comfort to the dying patient, not curative. The patient and family members are treated as a unit by an interdisciplinary team which includes doctors, nurses, home health aides, chaplains, social workers, and counselors. Hospice services are gaining in acceptance and utilization in the United States. It is considered cost effective and is, therefore, subject to reimbursement by Medicare, Medicaid and private insurances. Many hospice services to relatives and the community, however, including camps for bereaved children, are funded by charitable donations to the programs. 14. In its CON application, Catholic Hospice describe two cases in which hospice patients in Broward expressed a preference for its care. One doctor who testified by deposition for Catholic Hospice said he supports the application because there is no real advocate for Hispanics in Broward County. He complained of discriminatory practices in county hospital emergency rooms. He also expressed frustration that the existing hospices are not supporting his clinic, but admitted that he is not familiar with referrals to hospices. When his hospital patients need hospice, the social service departments handle referrals. He refers his other potential hospice patients to their churches. See Catholic Hospice Exhibit 20. Demographic Data 15. Approximately 80% of all hospice patients are over 65 years old. Hospice patients, obviously, are those whose deaths 10 are not unexpected, that is, not the victims of homicides, suicides or fatal motor vehicle accidents. Hospice services were traditionally provided largely to terminally-ill cancer patients, who still make-up the majority of patients statewide. 16. Catholic Hospice's expert noted that, particularly after some Dade County communities were destroyed by Hurricane Andrew, the trend of Hispanic migration into Broward County has been increasing. The projected increase in the Broward Hispanic population, from 2000 to 2005, is 45,900 for people under age 65 and 7,000 for people 65 and over. 17. The total Hispanic population of Broward County, is approximately 205,000 people out of a total of 1.5 million, or an estimated 12.6 to 13.4%. It is projected to increase to 15.6% by 2005. By comparison, Hispanics are approximately 55% of the population in Dade County. In Broward, Hispanics are more heavily concentrated in south central and southwestern areas of the County. One of Catholic Hospice’s offices is located in the northern Dade County area of Miami Lakes, conveniently near the southern areas of Broward County. Broward County residents are included in the staff and volunteers working in that office. The other office is in Kendall. Consistent with the concentration of the population, the largest number of Hispanics discharged from a Broward County hospital come from Memorial Hospital West. il 18. Catholic Hospice took the position that hospice care for Hispanics in Broward County should be provided within two or three percentage points of that which the group represents in the total population. The fact that the Broward providers serve from two to 4% Hispanic patients is, according to Catholic Hospice, indicative of underservice to the group. 19. Catholic Hospice's health planning expert conceded, however, that a better analysis than Hispanic population as a percentage of the total, would take into consideration more specific demographic data, including age, death rates by ethnicity, and causes of death. 20. Hispanics over 65 were 8.7% of the total Hispanic population in Broward County, 3.4% were over 75 years old. By comparison, over 20% of the total Broward County population is over 65, and over 10% over 75. Catholic Hospice offered its Dade County service, where 60% of its patients are Hispanics, as an example of its ability to achieve better results serving Hispanics in Broward County. In Dade County, however, the pool of potential patients is larger, with smaller differences between ethnic groups. Hispanics over 65 are 14.4% of the total population, almost identical to the 14.6% the non-Hispanic and total Dade populations over age 65. 21. Differences in age cohorts in the population are, as expected, reflected in differences in death rates. In 1998, 12 there were 641 Hispanic deaths in Broward County. of these, 383 were in the 65 and over age group, and 258 were under 65 years old. For 1999, there were 718 Hispanic deaths, of which 455 were 65 and over, and 261 were under 65. In the larger and older Hispanic population of Dade County, there were 9,220 Hispanic deaths, in 1999. 22. Hispanics in Broward County have a lower number of deaths per thousand, which is consistent with the relative youth of the group, as compared to the total population. In 1998, Hispanics accounted for 3.64 deaths per thousand, while there were 10.71 deaths per thousand in the total population of Broward County. In 1999, the Hispanic rate was 3.83 per thousand, as compared to 10.89 per thousand for the total population. When death rates are adjusted to exclude as causes accidents, suicides, and homicides, the Broward Hispanic death rates for 1998 and 1999 were 3.8 and 4%, respectively. 23. The analysis of the Hispanic population by age, death rates, and causes of death indicates that the current level hospice services, ranging between 2% for lower volume providers to 4% for Vitas, is the appropriate, expected level. 24. The level of hospice care which Catholic Hospice deemed appropriate is virtually impossible to reach considering the reality of the causes of death. Using Catholic Hospice's expert health planner's expectation that nine percent of all 13 Hispanics who died in Broward County should have hospice care, then 680 of 718 deaths in 1999, would have had to have been admitted to hospice. Numeric Need 25. Due to the demographic make-up and the level of care provided by the existing four hospice programs in District 10, AHCA published a zero numeric need for additional programs. AHCA publishes a need for a new hospice program when its formula demonstrates that the number of additional patients who would elect hospice care equals or exceeds 350 patients over and above the current volume of hospice admissions. 26. The formula, in Rule 59C-1.0355(4) (a), Florida Administrative Code, for projecting additional hospice deaths, uses actual three-year resident deaths in four groups of people, those with and without cancer, who are both over and under age 65. 27. When the formula was applied to the Broward County data, the result was 5,947 projected hospice patients for the July 2001, planning horizon. When compared to the actual volume, in 1999, of 7,550 patients served by the four existing hospice programs, the number of projected additional patients is a negative 1,603. The negative number is based on the statewide hospice experience and indicates that the hospices in Broward 14 County, in 1999, served 1,603 more people than they were expected to serve two years later. Penetration Rate, Accessibility and Availability 28. Although not used in the formula, the negative need calculation is, in part, a function of what the health planners described as the hospice use rate or hospice penetration rate. All of the expert health planners who testified agreed that the hospice penetration rate is the single most significant factor in determining the extent of the existing hospice utilization. The total number of hospice deaths divided by the total number of deaths during the same time period in the same planning area gives that planning area's penetration rate. 29. In Florida, the statewide hospice penetration rate for is 33.5%. In Broward County, District 10, the rate is 46.6%, the highest in the State. By contrast, the national average is approximately 29%. For adjacent District 11, which includes Dade County, the penetration rate is 30.7%. 30. For Hispanics in Broward County, the hospice penetration rate was 37.3% in 1999. In Dade County, the Hispanic hospice penetration rate was 28.2% in 1999, indicating greater opportunities for growth in Dade. In general, the data indicates that Hispanics in Broward are utilizing hospice care more than Hispanics in Dade County, and more than the total population of Florida. 15 31. The adequacy of access to hospice care in terms of geographical coverage has been considered. In Broward, with a total of 1,211 square miles and four hospices, each one averages 303 square miles. The smallest geographical area for hospices in Florida was 280 square miles for the one hospice operating in Pinellas County. The statewide average, however, is 1,083 square miles for each hospice in Florida. There are no apparent geographical limitations on access to hospice care in Broward County. 32. As the parties stipulated, accessibility in terms of timeliness is not at issue. There is no indication that hospice referrals do not get a response within 48 hours, a special circumstance, specified in Rule 59C-1.0355(4) (d)3., Florida Administrative Code. Spanish Language Material and Spanish-Speaking Staff 33. Catholic Hospice conceded that the existing Broward County hospices provide appropriate printed material, forms, and promotional information in Spanish. But, Catholic Hospice argued that it has the ability to reach out to and serve Hispanic patients better than any of the other existing providers based on its experience and staff. Catholic Hospice noted that the percentages of Hispanics to total Dade County patients it serves is higher, ranging between 61 to 67% than Vitas' to 35 to 40%, even though in absolute numbers Vitas 16 served twice as many Hispanics, in Dade County in 1999, as did Catholic Hospice. 34. Spanish-speaking staff is inadequate to serve Spanish- speaking patients, according to Catholic Hospice, unless every member of the hospice interdisciplinary team speaks Spanish. In response to discovery requesting numbers of fluent Spanish speakers on staff in Broward County, HBTS reported three full- time equivalent (FTE) employees. Each FTE represents a 40-hour work week. 35. Hospice Care of Broward reported that it employs, in Broward, three nurses, one home health aide, two chaplains, but no social workers or bereavement counselors who speak Spanish. Although that was considered inadequate by Catholic Hospice's expert, Hospice Care of Broward noted its ability to use Spanish-speaking staff from its Dade office. Catholic Hospice also indicated its intention to use its staff from Dade, if needed, as well as some of its current staff members and volunteers in Dade who actually reside in Broward County. 36. Vitas employed three chaplains, six registered nurses, three doctors, three home health aides, a secretary, a case worker, six pool staff and various others, for a total of 42 Spanish speakers in Broward County. Vitas was considered inadequately staffed by Catholic Hospice's expert for not having a Spanish-speaking social worker, although its chaplains and not 17 just social workers provide bereavement counseling. At the time, Vitas' census of Hispanic patients included seven in three different nursing homes, and 29 patients at home. 37. Catholic Hospice listed the names of 69 Spanish- speaking employees, who staff Catholic Hospices current operations in Dade County. Catholic Hospice's expert testified that, with 69 Spanish-speaking staff members, it adequately met the needs of 840 Hispanic patients. It must be concluded, logically, that Vitas, with 42 Spanish-speaking staff members, also had an adequate number to serve 238 Broward County Hispanic admissions in 1999. Including all of Catholic Hospice's administrators and excluding all but apparently fluent Spanish- speaking staff, the ratio of staff to Hispanic admissions is 9.9 to one for Catholic and 5.7 to one for Vitas. 38. All of the hospices rely on volunteers to help provide care to patients and their relatives. They also rely on relatives to serve as translators, if necessary. In addition, some hospice employees who are not fluent in the language do speak and understand some Spanish. Staffing 39. The staffing and related expenses, included in Catholic Hospice's financial projections, were criticized as inadequate. An expert for Vitas testified that $80,000 rather than $50,000 is appropriate for an hospice administrator; that 18 $18.99 an hour, Catholic Hospice's second year projection, is more appropriate for the first year than the first year projection of $17.78 an hour, or $37,000 a year, which was proposed for the first year for a registered nurse; that, although starting salaries are $16,000, or $7.69 an hour for nurses' aides, Catholic Hospice should expect to pay a minimum of $8.50 an hour in Broward County; that $35,000 a year is unreasonable for a patient care manager, a position typically filled by a registered nurse; and that $37,000 rather than $32,000 is more reasonable for a licensed clinical social worker. 40. The Vitas' expert also testified that 7.6 not 6 FTEs for registered nurses are needed, and more than one FTE for a social worker for the entire County for the first year. The proposal to hire one bereavement counselor, and one volunteer coordinator in the second year, but none in the first was also criticized as an underestimate of staffing needs, considering an average daily census of 30 patients in the first year, and 50 patients in the second. 41. Catholic Hospice used its experience and ratios established by national associations to project staffing needs. The projections are reasonable in providing, for example, one nurse for every ten patients and one home health aide for every eight patients. The nursing shortage, which all parties concede 19 exists in South Florida will likely increase the time and expense for Catholic Hospice to recruit its staff. Some health care facilities also find it necessary to provide signing bonuses, which Catholic Hospice has not proposed to do. At the time of the hearing, Catholic Hospice needed more staff and was participating in a jobs fair in Dade County. 42. In terms of its own operations, Catholic Hospice could also use and benefit from economies of scale, by using some of its existing staff and volunteers in Broward County. Its per unit costs would decrease primarily from sharing administrative staff, in much the sawe way as Hospice Care of Broward operates in both counties. For this reason, the criticism of Catholic Hospice that its propesed staffing and salaries are adequate is rejected, even though its work papers showed more staff than its CON application. Financial Feasibility 43. Catholic Hospice expects to serve 220 patients in the first year and 400 in the second. The average length of stay for each hospice patient in Broward County was around 40 days For Catholic Hospice, in Dade County, it was 48.9 days in 1999. When patient days are calculated from admissions with an average of 48.9 days, the results are 10,219 for the first year, and 19,574 for the second year. Catholic Hospice's application uses 10,905 patient days for the first year, and 25,520 for the 20 second year. It appears that utilization is overestimated by 700 admission in the first year and 6000 in the second year. To reach the second year projection of 400 admissions, the average length of stay would have to be 63.8 days. 44. One expert quantified the effect on projected revenues as a result of Catholic Hospice's overstatement of utilization by patient days. The conclusion was that projected revenues would decrease by $136,000 in the first year, and $1,063.881, in the second year. When Medicare rate increases approved by Congress are considered, the projected revenue decreases are approximately $65,000 in the first year, and that adds back $123,000, to the expected decrease of $1,063,881, increasing it to about a $900,000 reduction in revenues for the second year. 45. The analysis of revenues as compared to patient days was flawed having not reflected a proportionate reduction in variable expenses. Vita's expert's assumed that expenses should not be reduced because: Catholic Hospice had underestimated staffing and salaries. The finding that staffing and salaries are adequate means that, although Catholic Hospice overestimated revenues, the exact amount cannot be determined. The evidence that revenues and utilization are overestimated means that Catholic Hospice failed to prove that its proposal is financially feasible. The assumption is made that revenues are sufficient to‘cover projected start-up costs of $69,493. 21 46. Catholic Hospice's expert criticized the use of average length of stay to determine patient days. That approach is more reasonable than that used by Catholic Hospice which relied on its start-up experience in Dade County in 1989, to guess what Broward patient days might be in 2002 and 2003. When Catholic Hospice started, its average lengths of stay were 21.17 days in 1989, and 32.1 days in 1990. 47. Additional factors which cast doubt on the likelihood of Catholic Hospice achieving its projected utilization and revenues are the pattern of referral sources in Broward County and the level of charity care. Physicians referred approximately 43% of all hospice patients in Broward County, while approximately 24% came from hospitals in 1999. It will take Catholic Hospice longer to establish referral relationships with a number of different physicians. Lower revenues are also reasonably expected with higher percentages of charity care. Historically, in Dade County, charity care has accounted for -23% of Catholic Hospice's services, but it projected 3.5% for Broward County. 48. The CON application submitted to AHCA was incomplete, having omitted key information necessary for AHCA to determine financial feasibility, including the following: (1) failure to distinguish between Broward and Dade operations in sufficient detail for an evaluation of Broward separately, 22 although payer mix assumptions for each were different ; (2) inadequate breakdown of admission by payer type; (3) no provision for dietetic and nutritional counseling; (4) no specific allocation of FTEs for a medical director; (S) no details of a staff recruitment and retention plan; and (6) a material discrepancy of $3 million, given the projected year two net profit of $39,100, between revenues on one schedule as compared to the notes to the same schedule. Impact on Existing Providers 49. The existing providers presented evidence related to the potential impact on their admissions, revenues, and staffing, if Catholic Hospice begins operating in the Broward County market. They need to maintain or increase their censuses to have some leverage for contract negotiations, and to provide charity care and unreimbursed services, such as bereavement services. Catholic Hospice maintained that it would not adversely affect existing providers, citing the experience in Dade County when Hospice Care of Broward began operations in 1998. The situations are distinguishable. From 1997 to 1999, for example, hospice admissions increased 16.7% in Broward and 35.3% in Dade County. Dade County started with a lower-than- average hospice penetration rate in 1998. Most importantly, 23 AHCA published a numeric need for an additional hospice which led to the approval of the Hospice Care of Broward CON. 50. Although Vitas' market share in Dade County increased during the time that Hospice Care of Broward began operations there, the smaller hospices, Hospice Care of South Florida and Catholic Hospice lost market shares. Similarly, recent increases in the market share of HBTS in Broward County have adversely affected Hospice Care of Broward, but not Hospice of the Gold Coast, which has the affiliation with a hospital district, or Vitas. Based on these experiences, it is reasonable to expect that the smaller providers will experience a disproportionately greater adverse impact from the entry of Catholic Hospice into the Broward County market. 51. Assuming that: Catholic Hospice achieves it projection of 220 patients in its first year of operations in Broward County and 400 in the second year, then it will adversely affect all of the existing providers, at least to the extent of limiting their potential growth. 52. Using the total number of projected hospice patients for 2002 and 2003, and allocating all incremental admissions to Catholic Hospice first, the result is that 61 cases for 2002, and 120 for 2003, are available for Catholic Hospice. That leaves an additional 159 admissions for the first year and 280 24 for the second year, waich must come from patients who would have otherwise used the existing hospices. 53. When proportional losses of cases to Catholic Hospice are assumed with static market shares, the expected impact in terms of lost admissions are 5 and 8 from Hospice of the Gold Coast, 11 and 20 from HBTS, 21 and 37 from Hospice Care of Broward, and 121 and 215 from Vitas, in years one and two, respectively. 54. If the assumption is made that the market shares will change, following established trends, then projected losses will increase most (to 16 in 2002 and 29 in 2003) for the hospice which has been expanding most rapidly, HBTS. More consistent providers, in terms of volume, would have lower projected losses, for example, 15 and 26 admissions in years one and two, respectively, for Hospice Care of Broward County. 55. Of the three scenarios presented, the most reasonable assumptions are that proportional losses of the type which occurred in Dade County would also occur in Broward, and that market share trends would continue. If that happens, then the smaller providers would lose more potential patients, up to 91 and 165 from HBTS, 87 and 158 from Hospice Care of Broward, and 27 and 49 from Hospice of the Gold Coast, in years one and two, respectively. For Hospice Care of Broward, the loss of 158 is 25 significant when compared to total volume of approximately 1000 patients. 56. The market share analyses could be criticized for relying on projected population growth, but not factoring in an increase in the penetration rate. In fact, the penetration rate in Broward, as high as it is, has been increasing, but in relatively small increments, from 45.8% in 1993 to 46.6% in 1999. The .8% increase is considered approximately flat, particularly having followed a 7% decline in the Broward hospice penetration rate from 45.8% in 1993 to 38.6% in 1994. The fluctuations in the penetration rate and the decline in deaths from cancer and AIDs support the reasonableness of the assumption of a static penetration rate in the market share analysis. 57. Only HBTS presented evidence on the financial impact of the projected losses, ranging from a low of $61,554 for 20 lost admissions to a high of $507,464 for the more reasonable assumption of 165 lost admissions. The magnitude of the detrimental impact, put in context, is significant given HBTS' losses from operations of $1.8 million in 1999, and $1 million in 2000, which had to be offset by charitable contributions and income from investments. 58. In addition to lower operating revenues from patient care reimbursements, HBTS also projected losses from charitable 26 contributions. In 1993, HBTS received $629 in charitable donation for each hospice patient admitted, from bequests, memorials, tributes, holiday remembrances from families and friends. Contributions from these sources are directly related to the care given to individual patients and, therefore, to the total number of patients. At HBTS, over 64% of its total charitable contributions are in the combined categories of tributes and bequests. The adverse financial impact on HBTS including reduced charitable contributions, is $74,149 for 20 cases and up to $611,301 for 165 cases. 59. WVitas received referrals from Holy Cross Hospital, a Catholic facility in Broward County which would be expected to enter an agreement with Catholic Hospice. Vitas also runs a bereavement group for Spanish speakers at Holy Cross Hospital. Holy Cross Hospital is listed, in the CON application, as the likely source of a contract for services with Catholic Hospice. In a three-month period, Vitas received 30 referrals resulting in 25 hospice admissions from Holy Cross Hospital. In Dade County, Vitas receives virtually no referrals from Mercy Hospital, which is also a Catholic institution and one of the Catholic Hospice partners. Therefore, despite the projected disproportionate impact in the market, to Vitas' advantage, if all other things were comparable to the Dade County experience, because of the institutional relationships between Catholic 27 Hospice and Holy Cross Hospital, Vitas' is reasonably expected to be adversely affected. It is impossible to determine if projected losses are significant in terms of the total Vitas operation, since it provides over three-fourths of all hospice care in Broward and returned approximately $10 million in revenues in 1999, to its corporate operations. There is also no evidence that more competition with Vitas will enhance services or reduce costs. 60. Expert witnesses acknowledged a severe nursing shortage in South Florida, approaching crisis proportions. The existing providers are always recruiting and never fully staffed. The kind of care required of hospice nurses, the pressure of dealing with dying patients, the need for them to be on call rather than working only on scheduled shifts, the preference for oncology nurses, and the need for bilingual nurses further limits the available pool. The shortage has increased since 1998, when Hospice Care of Broward expanded into Dade County. Hospices are also not free to attract nurses by raising rates to pay increasingly higher salaries, but must resort to other incentives which increase recruiting costs. Hospice patient care is usually reimbursed on a per diem basis, regardless of actual costs, at rates set by the Medicaid and Medicare programs. The existing hospices reasonably expect an adverse impact on their staffing, recruiting time and costs, 28 particularly for nurses and home health aides, if Catholic Hospice enters the market in Broward County and succeeds in staffing its project as proposed. Agency Action and Rules 61. The Chief of the Bureau of Health Facility Regulation for AHCA, who is also an expert in health planning, testified that the review process in this case was the same as for most CONs. Within AHCA, however, the initial recommendation was to deny the application because of insufficient data to support the allegation of a lack of access for the Hispanic population. 62. The decision to approve CON Number 9333 was made because AHCA Secretary, "Ruben King-Shaw indicated that he felt that it was a policy priority at the highest level of the current administration, both within the Agency and I would say at the level of the Governor, to promote culturally sensitive access to end of life care. And that he referenced a presentation that I believe that he had heard Secretary Brookes (phonetic) of the Department of Health make a day or two prior to our meeting where he said that Dr. Brookes was one of the best speakers that he had ever seen on the issue of culturally sensitive health care and barriers to -- cultural barriers to health care." Transcript, p. 955-956. 63. In addition to the statutory review criteria for CONs, AHCA relied on Rule 59C-1.030, Florida Administrative Code, which lists general criteria for evaluation of CON applications, 29 and Rule programs. there is included 64. follows: 59C-1.0355, which applies specifically to hospice The need to serve a particular ethnic minority, if evidence that their access to a service is limited, is in the criteria. The most relevant provisions of Rule 59C-1.030 are as (2) Health Care Access Criteria. (a) The need that the population served or to be served has for the health or hospice services proposed to be offered or changed, and the extent to which all residents of the district, and in particular low income persons, racial and ethnic minorities, women, handicapped persons, other underserved groups and the elderly, are likely to have access to those services. (b) The extent to which that need will be met adequately under a proposed reduction, elimination or relocation of a service, under a proposed substantial change in admissions policies or practices, or by alternative arrangements, and the effect of the proposed change on the ability of members of medically underserved groups which have traditionally experienced difficulties in obtaining equal access to health services to obtain needed health care. (c) The contribution of the proposed service in meeting the health needs of members of such medically underserved groups, particularly those needs identified in the applicable local health plan and State health plan as deserving of priority. (d) In determining the extent to which a proposed service will be accessible, the following will be considered: 30 1. The extent to which medically underserved individuals currently use the applicant's services, as a proportion of the medically underserved population in the applicant's proposed service area(s), and the extent to which medically underserved individuals are expected to use the proposed services, if approved; 65. In the absence of numeric need, the special circumstances subsection in Rule 59C-1.0355(4) (d)1., Florida Administrative Code, on which Catholic Hospice relied is as follows: Evidence submitted by the applicant must document one of the following: 1. That a specific terminally ill population is not being served. 66. One expert testified that the provision should be narrowly construed to require a proposal to care for a specific terminal diagnosis, such as AIDS, but AHCA reasonably rejected that interpretation as applied to this case. Care fora particular ethnic group is specifically recognized as a valid consideration in Rule 59C-1.030. 67. AHCA's expert also noted, that under its rules, there is no reason to approve the application of Catholic Hospice if it fails to show that there is an underserved population, in this case, Hispanics in Broward County. The CON was prepared based on a belief that Hispanics are underserved, but without any data on Hispanic utilization. That data is not routinely 31 collected by AHCA and only became available in this case as a result of discovery. AHCA also determined that Catholic Hospice needed to show evidence that the existing providers are not meeting the area's needs. Catholic Hospice failed to show any need for its services in Broward County. In fact, there is affirmative evidence that the Hispanic hospice penetration rate should be what it is, which is approximately the same as the Hispanic death rate, adjusted to exclude unexpected causes of death. Therefore, the application of Catholic Hospice should be denied.
Conclusions For Petitioner Hospice by the Sea, Inc.: Robert A. Weiss, Esquire Karen A. Putnal, Esquire Parker, Hudson, Rainer & Dobbs, LLP 118 North Gadsden Street The Perkins House, Suite 200 Tallahassee, Florida 32301 For Petitioner Vitas Healthcare Corporation: Geoffrey D. Smith, Esquire Steven E. Oole, Esquire Blank, Meenan & Smith, P.A. 204 South Monroe Street Post Office Box 11068 Tallahassee, Florida 32302-3068 For Petitioner Hospice Care of Broward County, Inc.: Stephen A. Ecenia, Esquire R. David Prescott, Esquire Thomas W. Konrad, Esquire Rutledge, Ecenia, Purnell and Hoffman, P.A. 215 South Monroe Street, Suite 420 Post Office Box 551 Tallahassee, Florida 32302-0551 For Respondent Catholic Hospice, Inc.: Theodore E. Mack, Esquire Powell & Mack 803 North Calhoun Street Tallahassee, Florida 32303 For Respondent Agency for Health Care Administration: Richard A. Patterson, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order denying the application of Catholic Hospice for Certificate of Need Number 9333 to establish a hospice program in District lo. DONE AND ENTERED this [3% day of July, 2001, in Tallahassee, Leon County, Florida. Ahicamae rn Yt. ELEANOR M. HUNTER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this /.3r* day of July, 2001. COPIES FURNISHED: Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403 38 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403 Robert A. Weiss, Esquite Karen A. Putnal, Esquire Parker, Hudson, Rainer & Dobbs, LLP 118 North Gadsden Street The Perkins House, Suite 200 Tallahassee, Florida 32301 Geoffrey D. Smith, Esquire Steven E. Oole, Esquire Blank, Meenan & Smith, P.A. 204 South Monroe Street Post Office Box 11068 Tallahassee, Florida 32302-3068 Stephen A. Ecenia, Esquire R. David Prescott, Esquire Thomas W. Konrad, Esquire Rutledge, Ecenia, Purnell and Hoffman, P.A. 215 South Monroe Street, Suite 420 Post Office Box 551 Tallahassee, Florida 22302-0551 Theodore E. Mack, Esquire Powell & Mack 803 North Calhoun Street Tallahassee, Florida 32303 Richard A. Patterson, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403
The Issue Whether Petitioner is entitled to recover certain Medicaid funds paid to Respondent pursuant to section 409.923(1), Florida Statutes, for hospice services Respondent provided through three program locations (Melbourne, Boynton Beach, and Dade) during the audit period between September 1, 2009, and December 31, 2012; and the amount of sanctions, if any, that should be imposed pursuant to Florida Administrative Code Rule 59G-9.070(7)(e).
Findings Of Fact Parties AHCA is the state agency responsible for administering the Florida Medicaid Program. § 409.902, Fla. Stat. (2018). Medicaid is a joint federal and state partnership to provide health care and related services to certain qualified individuals. Vitas is a provider of hospice and end-of-life services in Florida. During the relevant periods, Vitas maintained hospice programs headquartered in Melbourne, Dade, and Boynton Beach, each enrolled as a Medicaid provider with a valid Medicaid provider agreement with AHCA. Hospice Services Hospice is a form of palliative care. However, hospice care is focused upon patients at the end-of-life-stage, while palliative care is for any patient with an advanced illness. Both hospice and palliative care patients are generally among the sickest patients. Hospice is focused upon serving the patient and family to provide symptom management, supportive care, and emotional and spiritual support during this difficult period when the patients are approaching their end-of-life. Hospice care, as with Vitas, uses an interdisciplinary team ("IDT") to provide comfort, symptom management, and support to allow patients and their families to come to terms with the patient's terminal condition, i.e., that the patient is expected to die. Each patient is reviewed in a meeting of the IDT no less than every two weeks. For hospice, a terminally ill patient must choose to elect hospice and to give up seeking curative care and aggressive treatments. At all times relevant to this proceeding, Vitas was authorized to provide hospice services to Medicaid recipients. As an enrolled Medicaid provider, Vitas was subject to federal and state statutes, regulations, rules, policy guidelines, and Medicaid handbooks incorporated by reference into rule, which were in effect during the audit period. Medicaid Hospice Benefit Medicaid recipients are eligible to have their hospice services covered by Medicaid if a physician, using his/her clinical judgment, determines and certifies that the patient is terminally ill with a life expectancy of six months or less if the disease runs its normal course. See 42 C.F.R. §§ 418.3 and 418.22. The Florida Medicaid Hospice Services Coverage and Limitations Handbook, the January 2007 edition ("Handbook"), governs whether a service is medically necessary and meets certification criteria for hospice services. Pages 2 through 4 of the Handbook identify six areas of documentation (often referred to throughout this proceeding as "the six bullet points") for a physician to consider when making a determination regarding a patient's initial certification for hospice eligibility. These include: Terminal diagnosis with life expectancy of six months or less if the terminal illness progresses at its normal course; Serial physician assessments, laboratory, radiological, or other studies; Clinical progression of the terminal disease; Recent impaired nutritional status related to the terminal process; Recent decline in functional status; and Specific documentation that indicates that the recipient has entered an endstage of a chronic disease. The Medicaid hospice provider must provide written certification of eligibility for hospice services for each patient. The Handbook also provides certification of terminal illness requirements as follows: For each period of hospice coverage, the hospice must obtain written certification from a physician indicating that the recipient is terminally ill and has a life expectancy of six months or less if the terminal illness progresses at its normal course. The initial certification must be signed by the medical director of the hospice or a physician member of the hospice team and the recipient's attending physician (if the recipient has an attending physician). For the second and subsequent election periods, the certification is required to be signed by either the hospice medical director or the physician member of the hospice team. Certification is required for each election period. A patient may elect to receive hospice services for one or more of the election periods. The election periods include: an initial 90-day period; a subsequent 90-day period; and subsequent 60-day time periods. The Handbook provides guidance regarding the election periods as follows: The first 90 days of hospice care is considered the initial hospice election period. For the initial period, the hospice must obtain written certification statements from a hospice physician and the recipient's attending physician, if the recipient has an attending physician, no later than two calendar days after the period begins. An exception is if the hospice is unable to obtain written certification, the hospice must obtain verbal certification within two days following initiation of hospice care, with a written certification obtained before billing for hospice care. If these requirements are not met, Medicaid will not reimburse for the days prior to the certification. Instead, reimbursement will begin with the date verbal certification is obtained . . . . For the subsequent election periods, written certification from the hospice medical director or physician member of the interdisciplinary group is required. If written certification is not obtained before the new election period begins, the hospice must obtain a verbal certification statement no later than two calendar days after the first day of each period from the hospice medical director or physician member of the hospice's interdisciplinary group. A written certification must be on file in the recipient's record prior to billing hospice services. Supporting medical documentation must be maintained by the hospice in the recipient's medical record. AHCA's Audit Florida law obligates AHCA to oversee the activities of Florida Medicaid recipients and providers in order to ensure that fraudulent and abusive behavior occur to the minimum extent possible and, when appropriate, to recover overpayments and impose sanctions on providers. § 409.913, Fla. Stat. Among other duties, AHCA is required to conduct (or cause to be conducted) audits to determine possible fraud, abuse, and overpayments in the Medicaid program. § 409.913(2), Fla. Stat. The statutes define "overpayment" as "any amount that is not authorized to be paid by the Medicaid program whether paid as a result of inaccurate or improper cost reporting, improper claiming, unacceptable practices, fraud, abuse, or mistake." § 409.913(1)(e), Fla. Stat. When an overpayment is identified, AHCA is required to recover the overpayment and impose sanctions as appropriate. § 409.913, Fla. Stat. When making a determination that an overpayment has occurred, the agency shall prepare and issue an audit report to the provider showing the calculation of overpayments. § 409.913(21), Fla. Stat. The Department of Health & Human Services, Centers for Medicare and Medicaid Services ("CMS"), contracted with HI to perform an audit of Vitas on AHCA's behalf. HI, in turn, retained a PRO, Advanced Medical Reviews ("AMR") to provide physician reviews of claims during the audit process in order to determine whether an audited claim was eligible for payment. HI is an approved Medicaid Integrity Contractor that is assigned by CMS to Florida and was instructed to perform audits of Florida hospice providers who had been paid with Medicaid funds for the audit period. HI received the Medicaid billing information from AHCA and developed an audit plan in conjunction with AHCA MPI staff. Per Vitas' Medicaid Provider Agreements, Vitas agreed "to comply with local, state, and federal laws, as well as rules, regulations and statements of policy applicable to the Medicaid program, including Medicaid Provider Handbooks issued by AHCA." To that end, Vitas also agreed to maintain its records for at least five years to satisfy all necessary inquiries by AHCA. The stated objective of the audit, as reflected in the FARs, was "to determine whether the recipients met eligibility for hospice services and payments were in accordance with applicable Federal and State Medicaid laws, regulations, and policies." For the purpose of the audit, the recipient files to be reviewed were selected using the following criteria: The recipient was not dually eligible (eligible for both Medicaid and Medicare); and The hospice coverage was greater than or equal to 182 days based on the recipient's first and last date of service within the audit period. In addition, HI excluded recipients who had at least one malignancy (cancer) primary diagnosis and had a date of death less than one year from the first date of service with this provider. HI, in its capacity as an authorized contractor of CMS, contacted Vitas and requested medical files for those 250 recipients who met HI's selection criteria for the audit. HI then forwarded the 250 recipients' medical files to HI nurse claims analysts for initial detailed review. If, after review of Vitas' medical records, the HI claims analyst determined that a recipient was eligible for Medicaid hospice services, the analyst would clear the file and remove it from further consideration. As a result, 63 files were determined to have sufficient documentation to support approval of the claim. If, however, based upon the initial review, the analyst had any questions or concerns about a particular file, he or she would set it aside for later peer review by an independent physician who would make the ultimate determination with regard to hospice eligibility. In this case, 187 recipients' medical records were peer-reviewed by a physician who made a determination concerning whether the medical records supported the recipient's eligibility for Medicaid hospice. Of the 187 files, 118 were determined to be ineligible in whole or part for Medicaid hospice. HI contracts with PROs, which provide physicians to perform the peer review. Initially, HI contracted with AMR to provide peer review services. Section 409.9131(2)(c), provides that a "peer" is "a Florida physician who is, to the maximum extent possible, of the same specialty or sub-specialty, licensed under the same chapter, and in active practice." Often recipients in hospice care see multiple physicians. HI staff, therefore, reviewed the recipients' medical records to determine the names of Respondent's physicians treating the recipients whose medical records were being audited. Thereafter, HI staff obtained the specialty or subspecialty of Respondent's physicians from the Florida Department of Health, Board of Medicine, website. The most common specialties were Internal Medicine and Family Medicine. HI instructed AMR to appoint peers who are: (1) licensed in Florida, (2) in active practice, and (3) to the maximum extent possible have a specialty in Internal Medicine or Family Medicine. In this case, HI, through AMR, initially employed the services of five Florida physicians who reviewed the 187 recipient files at issue. The findings of the peer reviewers were presented in the Draft Audit Reports ("DARs"). Physicians Tania Velez, M.D. (specializing in family medicine), Terese Taylor, M.D. (specializing in family medicine), and Anita Arnold, D.O. (specializing in cardiovascular disease, interventional cardiology, and internal medicine), discontinued providing services as peers following the publication of their opinions in the DARs. These physicians were initially responsible for reviewing 25 recipient files. Todd Eisner, M.D. (specializing in internal medicine and gastroenterology), reviewed and rendered his opinion as to the hospice eligibility of five recipients in the DARs. Ankush Bansal, M.D. (specializing in internal medicine), reviewed the hospice eligibility of 88 recipients. Subsequent to the petitions being filed in this matter, Dr. Bansal opted to no longer participate in this matter. AHCA, therefore, requested HI to have all of Dr. Bansal's cases re- reviewed by another peer physician. AMR could not provide peer physicians who could complete the re-reviews in the desired time frame, so HI sent the re-reviews to another PRO, Network Medical Review ("NMR"). HI gave NMR the same instructions it gave to AMR with respect to how to select peers. HI, through NMR, selected Dr. Kelly Komatz (specializing in pediatrics, and hospice and palliative Care) and Dr. Charles Talakkottur (specializing in internal medicine) to perform the re-reviews of Dr. Bansal's claims. Dr. Komatz reviewed one patient file in dispute. Dr. Talakkottur reviewed 76 recipient files in dispute. Audit Methodology There is no statutory definition of "terminal illness" and no guidelines for the term are provided by rule or in the Handbook. In performing their respective peer reviews, the peer physicians were instructed to use their clinical experience, generally accepted medical standards, and the Handbook. Two peer reviewers with similar experience could review the same record and come to different conclusions as to a terminal diagnosis. The same goes for a determination as to a life expectancy of six months or less. Both are subjective by nature. Similarly, there are no AHCA guidelines to determine when the criteria of serial physician assessments, laboratory, radiological or other studies, have been met. The same is true for what constitutes sufficient documentation of clinical progression of the terminal disease, recent impaired nutritional status, recent decline in functional status, and specific documentation that a recipient has entered the end-stage of a chronic disease. Local Coverage Determinations ("LCDs") are Medicare guidelines that are disease specific and nationally recognized tools used to assist physicians in determining hospice eligibility. Florida does not use LCDs with respect to Medicaid. However, HI developed a document, titled the "Summary Lead Sheet—Medical Review Methodology Documentation/LCD's," which was approved by CMS. This documentation was then provided to AHCA and sent to the claims analysts and initial peer reviewers to perform their review of Medicaid reviews in this audit. To evaluate the likely terminality of a recipient's condition for benefit eligibility, LCDs direct physician reviewers to use certain clinical indicators including: Palliative Performance Scale ("PPS") scores; Functional Assessment Staging ("FAST") scores; Activities of Daily Living ("ADL") scores, which measure the patient's abilities in bathing, dressing, feeding, transferring, continence, and ambulation; Body Mass Index ("BMI"); and New York Heart Association ("NYHA") classifications. The Handbook makes no reference to LCDs or these clinical indicators. Nor does it prohibit their use. In fact, these clinical indicators are part of the "generally accepted standard of medical practice" to be considered in the context of "medical necessity" as defined by sections 409.913 and 409.9131. LCDs are not all-inclusive of all the different conditions for which a person may be eligible for hospice. Resultantly, LCDs are an appropriate tool to use in prognosticating whether a patient has a terminal illness with a life expectancy of six months or less. However, a patient's failure to meet the LCD for a specific disease does not per se disqualify the patient from Medicaid hospice eligibility. The peer reviewers were instructed, "Please do not break up a certification period with partial approved and partial denied dates." Pursuant to this instruction, if a patient meets hospice eligibility for any portion of a certification period, they should be approved for the entire period. None of the doctors involved in this case, from either side, actually examined the patients. All of the doctors conducted essentially a desk audit review of the medical records. Issuance of the DARs and FARs Based upon the peer reviews, DARs were prepared by HI, which identified overpayment of Medicaid claims totaling $6,943,664.74, relating to 118 recipients. The DARs were transmitted to Vitas. Vitas, through its medical directors, provided a response to the DARs. Vitas contested every alleged overpayment and maintained that all recipients in question were eligible for the Medicaid hospice benefit at all times. After receiving Respondent's responses, HI forwarded the responses to AMR so that the AMR peer review physicians could evaluate the responses and amend any of their conclusions, as appropriate. While the peer review physicians agreed with Vitas' responses in certain limited instances, the peer review physicians mostly disagreed, and, as a result, HI prepared the FARs. The FARs were then submitted to, and approved by, CMS. CMS provided the FARs to AHCA with instructions that Florida was responsible for furnishing the FARs to Vitas and initiating any state recovery process needed to collect the overpayment. The FARs prepared by HI contain the determinations of the peer review physicians concerning whether each of the recipients at issue had a terminal diagnosis with a life expectancy of six months or less if their disease progressed at its normal course. The FARs concluded that 92 recipients were ineligible for at least a portion of their stay with a cumulative overpayment of $5,401,615.18. Vitas timely filed three petitions, one for each location, with AHCA's agency clerk. On or about February 6, 2017, AHCA referred the three cases to DOAH. On February 14, 2017, the undersigned entered an Order of Consolidation, and the three cases are now proceeding under DOAH Case number 17-0792MPI. During the course of the underlying proceeding, the parties first stipulated that 67 of the original 92 recipients identified in the FARs were at issue. Throughout the course of these proceedings, however, the parties have moved closer and disputed less ineligibility determinations. As a result, of the original 250 recipients' medical files reviewed, only 61 remain in dispute. AHCA now seeks the revised overpayment of $3,847,755.95, with a corresponding reduction in the fines of $906,715.29 for a grand total of $4,754,471.24. The Experts Due to the nature of the review and "re-review" process, the vast majority of the final hearing was comprised of the testimony of each parties' experts regarding whether particular recipients met the criteria of Medicaid hospice benefit eligibility. For each recipient, an AHCA and a Vitas expert reviewed the medical records and provided an opinion as to whether the six bullet points of the Handbook were satisfied to determine whether the recipient was "terminally ill with a life expectancy of six months or less if the disease runs its normal course." The following physician experts were tendered and accepted for AHCA: Dr. Talakkottur, Dr. Eisner, and Dr. Komatz.1/ The following physician experts were tendered and accepted for Vitas: Dr. Shega and Dr. Vermette. Because the determinations of whether a recipient met the applicable criteria are highly subjective, it is important to distinguish between the relative qualifications of the experts. AHCA's Experts Dr. Talakkottur Dr. Charles Talakkottur was presented by AHCA as an expert in internal medicine. He has maintained an active practice in Florida for over nine years and reviewed and issued his opinion as to the hospice eligibility of 76 recipient files in dispute. Of those 76 recipient files, Dr. Talakkottur initially determined that 59 recipients were ineligible for at least a portion of the period that Vitas billed for hospice Medicaid services. In subsequent reviews, Dr. Talakkottur overturned two more files, leaving 57 recipients ineligible for at least a portion of the Medicaid services billed by Respondent. As discussed above, negotiations continued between the parties during the course of the final hearing. This resulted in Dr. Talakkottur testifying about 48 of the remaining disputed recipients' Medicaid hospice eligibility. Dr. Talakkottur admits patients to hospice from his practice, which requires him to make the type of prognosis determination, such as those at issue in this proceeding. However, Dr. Talakkottur is not now nor ever has been board- certified in hospice and palliative medicine. He has never been a Certified Hospice Medical Director. He has never signed a certification for hospice eligibility nor worked for a hospice. Dr. Talakkottur's practice is named TLC Medical, Aesthetics & Pain Management. The website for his practice shows that he provides Botox, IPL Photofacial, Juvederm/Dermal Fillers, Laser Hair Removal, Medical Marijuana, Medical Services, Medical Weight Loss, Medicare Doctor in Tampa, and Pain Management. Although advertised on his website, Dr. Talakkottur acknowledged he is not certified to provide medical marijuana treatment. Neither Dr. Talakkottur's practice website nor his practice YouTube page advertise hospice or end-of-life care services. Dr. Talakkottur never discussed the Handbook with anyone at AHCA. He did not receive any training from AHCA, CMS, HI, or NMR on how to perform the audit. Dr. Talakkottur was provided certain instructions from NMR on how to perform his reviews. The instructions state, "Please do not break up a certification period with partially approved/partially denied dates (i.e. if certification period is 01/01/2015 through 02/01/2015, and any dates within that period are deemed medically necessary, please approve the entire certification period)." Dr. Talakkottur acknowledged, however, that he did not follow this instruction. Dr. Talakkottur's testimony regarding the many patients he reviewed clarifies that he applied the six bullet points from the Handbook to his reviews of both certification and recertification decisions. However, the six bullet points are prefaced with a paragraph beginning: "Documentation to support the terminal prognosis must accompany the initial certification of terminal illness." In other words, the six bullet points are not applicable to recertification decisions. A patient must still have a prognosis of less than six months to be recertified, but the six bullet points no longer represent the appropriate factors. In fact, the Handbook clarifies that "[f]or subsequent election periods, written certification from the hospice medical director or physician member of the interdisciplinary group is required." In light of this clear distinction, deference to the clinical judgment of the hospice physicians becomes more significant for recertification periods. Dr. Talakkottur did not lend any credence to the "real-time" decisions of the hospice physicians. Instead, Dr. Talakkottur sought out ways to deny coverage and frequently based his decisions on bullet points that the patient was not required to satisfy to support eligibility. Dr. Talakkottur opined that he would not want to consider a patient's severity of comorbidities when prognosticating six months life expectancy or less. He often reviewed patients myopically, considering only the primary diagnosis. By way of explanation, he opined that in his professional opinion taking into account comorbidities was wrong because a condition such as an "ant bite" or a scratch is a comorbidity. In contrast, the other experts in this proceeding convincingly testified that the patient's whole condition should be evaluated in determining the prognosis of life expectancy of six months or less, including the presence and severity of comorbidities. Although Dr. Talakkottur was properly selected as a peer reviewer and qualified as an expert in internal medicine, his testimony was deemed less credible than that of the Vitas medical experts, Dr. Shega and Dr. Vermette. Dr. Eisner Dr. Eisner performed the peer review for 13 recipients, 12 of whom remain in dispute. Dr. Eisner's background is in internal medicine and gastroenterology. He held a board certification in internal medicine between 1993 and 2003. In 1995, Dr. Eisner was board-certified in gastroenterology, a board certification that he continues to maintain. At some point around 2003, the certification standards changed such that Dr. Eisner was no longer required to maintain his board certification in internal medicine in order to remain board- certified in gastroenterology. Since 1995, 100 percent of Dr. Eisner's practice has been focused on gastroenterology. Dr. Eisner routinely makes life expectancy prognostications for his patients. Further, Dr. Eisner also refers patients to hospice on a regular basis. In so doing, Dr. Eisner is called upon to make the type of prognosis determination similar to those at issue in this proceeding. Dr. Eisner does not treat patients for the following specific diseases: diabetes, hypertension, Chronic Obstructive Pulmonary Disease ("COPD"), HIV/AIDS, cerebral degeneration, cerebral vascular disease, cardiovascular disease, malignant neoplasm of the brain, heart disease, dementia, Alzheimer's, adult failure to thrive, or debility. He was only familiar with those diseases as comorbidities to a principal diagnosis related to a gastroenterological disease and does not treat those primary diseases. While cardiology, critical care, geriatric, infectious disease, medical oncology, and pulmonary disease are also subspecialties of internal medicine, Dr. Eisner has not done a fellowship in any subspecialty other than gastroenterology and does not hold himself out as an expert in any internal medicine subspecialty other than gastroenterology. Dr. Eisner did not recall receiving any instructions other than the Handbook but acknowledged he did not read the entire Handbook to perform his review. Dr. Eisner was not aware of what documentation must accompany the initial certification for a terminal disease for Medicaid hospice purposes or what documentation must accompany a subsequent certification for Medicaid hospice purposes. Contrary to the testimony of Dr. Talakkottur, Dr. Eisner acknowledged that the presence and severity of comorbidities should be considered when making a clinical determination of life expectancy of six months or more. Although Dr. Eisner was qualified both as a peer reviewer and an expert in this proceeding, his lack of any recent experience in a practice area other than gastroenterology diminished the weight given to his testimony concerning non- gastroenterology related illnesses and conditions. Dr. Komatz Dr. Komatz re-reviewed the records of one recipient that remains in dispute. Dr. Komatz holds an active Florida medical license and is board-certified in pediatrics and hospice and palliative medicine. She has been board-certified in hospice and palliative medicine since 2010. As part of her practice, Dr. Komatz currently cares for hospice patients, refers patients to hospice, and certifies patients for hospice care. According to Dr. Komatz, when determining the eligibility of a patient for hospice, a practitioner must look at the patient's overall level of function, medications, and needs regarding such things as the use of oxygen and equipment to assist with daily living. The determination is then made taking into account these and other factors regarding the patient's current state. In her professional opinion, it is not uncommon to see a patient who has a prognosis of six months or less actually live for longer than six months. Significantly, Dr. Komatz opined as an expert for AHCA that it is important for a physician to be board-certified in hospice and palliative care in order to be competent to review a hospice record because the hospice training teaches the practitioner more about disease trajectory, the interdisciplinary team and how that works in conjunction with the patient. It also provides experience as to how hospice operates in general. In addition, she noted that the person best able to determine hospice eligibility is someone who has been trained in hospice care and/or practices in that field on a regular basis. Dr. Komatz acknowledged that it is possible that two physicians could review the same medical records and reach different conclusions about the hospice eligibility of a patient. When reviewing the initial certification requirements, Dr. Komatz stated that most hospice beneficiaries forego further laboratory or radiologic studies. She also opined that the condition of hospice patients can plateau or improve due to the hospice care being received. Likewise, it would not be fair to look for a progression of functional decline in a patient if the patient was already at the lowest functional level. She stated that "specific documentation that indicates the recipient has entered an end-stage of a chronic disease" is vague and is merely a summary of the other specific initial certification requirements. Consequently, most of the six bullet points are rarely applicable. Dr. Komatz stated that to be eligible for hospice services, a patient need not meet all the initial certification six bullet points, but instead it is a "totality of circumstances" standard based on the medical record of the patient. Dr. Komatz worked as a subcontractor for NMR. She only communicated with NMR personnel regarding the audit. She had no contact with HI or AHCA. Dr. Komatz was provided the NMR instruction sheet, which instructs reviewers not to break up certification periods to perform her review. Dr. Komatz was qualified both as a peer reviewer and an expert in this case. Due to her regular and direct experience in hospice and palliative care, her testimony, particularly as to prognostication of life expectancy and the practice of hospice and palliative care generally, was given great weight. Vitas' Experts Dr. Shega Dr. Shega was accepted as an expert in hospice and palliative care and geriatric medicine. He is the National Medical Director for Vitas. In that role, he oversees the four regional directors, as well as the medical directors that report to them, and also oversees physician services. Dr. Shega testified regarding the disputed recipients in the Melbourne and Boynton Beach programs. Dr. Shega attended Northwestern University Medical School, performed his residency and internship at the University of Pittsburgh, and performed a two-year academic fellowship in geriatric medicine at the University of Chicago. He is board- certified in geriatrics and hospice and palliative medicine. He is licensed to practice medicine in Florida and Illinois and actively treats hospice patients roughly six to eight weeks per year. Dr. Shega is currently an associate professor of medicine at the University of Central Florida. Prior to that, he has held positions as an associate professor of medicine at the University of Chicago, an assistant professor of medicine at Northwestern, an assistant professor of medicine at the University of Chicago, and an instructor of medicine at the University of Chicago. While at Northwestern, he was the director of its hospice program for several years and also worked in a hospice as a team physician for the University of Chicago. Dr. Shega was part of the University of Chicago leadership committee in geriatrics and palliative medicine where he helped to oversee its clinical operations. He has also served on numerous geriatric and hospice-related committees. Dr. Shega is a member of the American Geriatric Society and the American Academy of Hospice and Palliative Medicine, and through being an associate editor for the "Pain and Aging" section of Pain Medicine, has a membership to the American Pain Society. He currently performs one to two teaching presentations a week across the country and has published over 40 peer-reviewed articles on topics related to hospice and palliative care. Dr. Shega was recently the co-managing editor of a nine-book series that discusses the background of hospice and palliative care, pain management, non-pain symptoms, psychological and social symptoms, pediatric care, and chronic illnesses and end- of-life illnesses, congenital hyperinsulinism ("CHI"), COPD, dementia, renal disease, and neurologic disorders. Dr. Shega was qualified as an expert in this case. Due to his regular and direct experience in hospice and palliative care, his testimony, particularly as to prognostication of life expectancy, and the practice of hospice and palliative care generally, was given great weight. However, the credibility given to Dr. Shega's testimony was tempered by the fact that he is directly employed by Vitas and was involved in overseeing or facilitating Vitas' response to the DARs, wherein Vitas contested every finding and sought reimbursement for every alleged overpayment. Dr. Vermette Dr. Vermette was accepted as an expert in hospice and palliative care, and family medicine. During the final hearing, he testified regarding the disputed recipients in the Dade program. Dr. Vermette is the Vitas Medical Director for the Claims Review Group. In that capacity, his duties are to review charts and perform support and training of other medical directors and physicians throughout the country in how to review charts and documentation. Dr. Vermette attended medical school at the University of Texas, Southwestern Medical School in Dallas. He then attended a three-year residency program in family medicine at the University of Texas Health Science Center in Houston followed by service in the military as a medical doctor, achieving the rank of Major. Dr. Vermette is licensed to practice medicine in a number of states, including Florida. He is board-certified in family medicine and hospice and palliative medicine. He is also certified as a Hospice Medical Director, which is designed to recognize expertise in hospice and palliative medicine. Dr. Vermette is certified as a registered medical auditor. Dr. Vermette has held faculty positions as a clinical instructor at the University of Texas Health Science Center, an associate professor of medicine at the University of Nebraska, a clinical preceptor for Texas A&M University and the University of North Texas, and currently serves as a volunteer faculty member at the Drexel School of Medicine and a voluntary clinical instructor at the Mercy Health System in Philadelphia. Dr. Vermette currently has staff privileges to provide hospice and palliative care medicine at Mercy Fitzgerald Hospital, Mercy Hospital, and Methodist Hospital in Philadelphia. In 1998, Dr. Vermette began referring patients to hospice and following them as their attending physician. In 2009, Dr. Vermette began working part-time for Vitas and routinely followed patients in the inpatient units ("IPUs") in Fort Worth. He would spend two out of every four weeks rounding and seeing hospice patients in the IPU. He then began doing some of the call activities, some home team visits, and participating in interdisciplinary care team meetings. He moved to Philadelphia in 2012 and continued treating Vitas hospice patients. At that time, he also began performing chart reviews for Vitas. Dr. Vermette sought licensure to practice in Florida shortly after Vitas became aware of this audit and that his pursuit of licensure in Florida was intended to facilitate his provision of expert witness services in this case. Dr. Vermette admitted that, even though he is licensed in Florida, he has never treated nor evaluated a single patient in Florida. In fact, the first time that Dr. Vermette read the Handbook was as part of his preparation to testify in this case. Dr. Vermette was qualified as an expert in this case. However, like the testimony of Dr. Shega, the credibility given to Dr. Vermette's testimony was tempered by the fact that he is directly employed by Vitas and was involved in overseeing or facilitating Vitas' response to the DARs, wherein Vitas contested every finding and sought reimbursement for every alleged overpayment. SPECIFIC CLAIMS FOR RECIPIENTS AT ISSUE Patient 2, D.A.2/ Melbourne Recipients Patient D.A. was a 48-year-old female, admitted to hospice on 07/15/09, with a terminal diagnosis of end-stage HIV/AIDS. The claim periods at issue are 09/01/09 to 09/12/09 and 02/15/10 to 05/31/10. D.A. was evaluated face-to-face by Dr. Peterson, the Associate Medical Director for Vitas, on 07/14/09, the day before her admission. Based on his clinical assessment, he determined the patient was hospice appropriate because she had HIV/AIDS, debility, and failure to thrive, with significant recent weight loss, and dysphagia, secondary to esophageal candidiasis.3/ D.A. was admitted to hospice with two active infections, profound weight loss over the previous two- to three-month period (per her self-reporting), peripheral neuropathy, lethargy, and fatigue; she spent most of her time in bed. She had discontinued her antiretroviral HIV-targeted treatment. She was noted to have a BMI of 18 at the time, which is considered severe malnutrition and which negatively impacted her prognosis. On admission, D.A. reported 10 of 10 pain in both legs from her HIV-related peripheral neuropathy. She was described as thin, cachectic (physical wasting with loss of weight and muscle mass due to disease), and had difficulty ambulating. D.A. was also noted to have a medical history of syncope (fainting), urinary tract infections ("UTIs"), and fractures. D.A. was started on medications for the infections, Mycelex for thrush, and Bactrim double-strength for her lung infection. D.A.'s blood work was done on 07/16/09, which showed the patient had a CD4 count of 89. Dr. Shega testified that while her CD4 count was above 25, given D.A.'s clinical status, hospice care was appropriate because the patient was more than likely at end-stage HIV/AIDS. After her July admission, D.A. started gaining weight with the support of the Vitas interdisciplinary team. She had no recurrent refractory infection and the status of her fractures improved as well. D.A.'s clinical status improved such that at the end of the first 90-day period, she no longer could be evaluated with a prognosis of six months or less, and was discharged on 09/12/09. D.A. was readmitted to hospice on 02/15/10 with a diagnosis of end-stage HIV/ADIS. At that time, D.A. was lethargic, weak, had a flat affect and responded with one-word answers. She required assistance with bathing and ambulating, and had a PPS score of 50 percent.4/ On 02/26/10, D.A. was noted to have some secretions and dyspnea (shortness of breath) with exertion. She was believed to have a recurrence of thrush and was started on Mycelex troches. On a 03/02/10 physician visit, the patient was noted to have difficulty swallowing, decreased ability to ambulate, was slightly confused, and displayed white patches on her oral pharynx, suggestive of candidiasis. A subsequent physician evaluation on 03/19/10 noted D.A. was suffering from a severe sore throat, weighed 96 pounds, and had a poor appetite, low blood pressure, and ongoing significant loss of muscle mass. On 05/17/10, D.A. was noted to have a temperature of 99.7, shortness of breath, thrush, and was placed on medication to help with her discomfort. On 05/31/10, a nurse saw D.A. and noted her weight had dropped to 94 pounds, her PPS declined to 40 percent. A hospital bed was ordered because the patient was spending 90 percent of the time in bed, due to fatigue and weakness. Dr. Eisner testified that this patient was not Medicaid hospice eligible because her candidal esophagitis is a treatable condition, it was treated, and her PPS score improved and she gained weight. Further, Dr. Eisner pointed out some likely inaccuracies in the recorded weights of D.A. However, Dr. Eisner provided an opinion regarding this patient outside his expertise as shown by his inability to provide any specific indicators with regard to prognosticating if an HIV/AIDS patient had six months or less to live. AHCA has not met its burden by the greater weight of the evidence that D.A. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 3, D.G. Patient D.G. was a 48-year-old female who was admitted to hospice with a terminal diagnosis of debility unspecified. Debility is a condition similar to "failure to thrive," which usually denotes a patient with poor conditioning due to multiple medical problems. The dates at issue are 09/30/09 to 10/20/09 and 11/12/09 to 12/25/09. D.G. was hospitalized on three occasions within several months of her initial hospice admission. At the second hospital admission on 09/15/09, she experienced respiratory failure requiring intubation and a tracheostomy and was placed on a ventilator, secondary to influenza and pneumonia. She experienced a myocardial infarction (heart attack or "MI"), acute renal failure requiring dialysis, and had multiple infections. She required a percutaneous endoscopic gastrostomy ("PEG") tube for feeding and a dialysis catheter. D.G. was placed in a skilled nursing facility upon the second hospital discharge, but soon signed out against medical advice and refused further dialysis. On 09/23/09, she was readmitted to the hospital with bacteremia, secondary to her dialysis catheter being infected. In addition, she had a UTI and a skin infection on her abdomen. While hospitalized, D.G. displayed an extremely high potassium level, which could trigger ventricular arrhythmia (irregular heartbeat). Her hospital physician deemed her to be hospice appropriate and referred her to hospice. Upon initial evaluation, the admitting nurse was unsure how to most appropriately list D.G.'s terminal diagnosis, as her multiple comorbidities included a left leg amputation above the knee due to severe peripheral vascular disease; ongoing dry gangrene on her right leg and foot; coronary artery disease resulting in a recent heart attack; renal failure requiring dialysis; COPD with recent respiratory failure from pneumonia; and Crohn's disease, requiring multiple surgeries. The terminal diagnosis of debility unspecified was deemed the most appropriate. When admitted to hospice on 09/30/09, Patient D.G. was very ill and in substantial pain, requiring increased pain medication. Shortly after admission, D.G. developed a change in level of consciousness. Patient D.G. suffered a seizure on 10/20/09. Her family revoked hospice care, and D.G. was transferred back to the hospital for more aggressive treatment. On 11/10/09, D.G. again presented to the hospital emergency room ("ER"), this time with abdominal pain and right lower extremity pain, confusion, and a low albumin of 3.0. D.G. was supposed to follow up with hospice, but did not do so. She was found to have a PPS of 40 percent, was disoriented, and was at risk of aspiration. She also had an ongoing ulcer on her right leg from the peripheral vascular disease with gangrene. D.G. returned to the ER the following day, 11/11/09, and at that time, was admitted to the hospital. Upon hospital admission, D.G. had a PPS of 30 percent and a BMI of 23. She was disoriented, lethargic, had shortness of breath at rest or minimal exertion, and had lower extremity edema on the right side with a foot ulcer. She was now on oxygen, two to three liters. On 11/12/09, D.G. was transferred from the hospital to the Vitas IPU for symptom management of uncontrolled pain, agitation, anxiety, and wound care. D.G. was diagnosed with debility and failure to thrive due to the multitude of medical conditions noted above. During the months prior to this second hospice admission, she had undergone serial physician assessments and laboratory and radiologic studies. She had also had multiple admissions to the hospital and ER. Over the course of the second hospice period, D.G. had a PPS of 40 percent, then a PPS score of less than 40 percent, and finally, a PPS score of 30 percent. Dr. Shega testified that a patient's PPS score of 30 or 40 percent is supportive of a prognosis of six months or less, if the illness runs its normal course. After a brief stay in the Vitas IPU, D.G. returned home for care. On 12/04/09, she was dependent in 5 of 6 ADLs. On 12/11/09, her dry gangrene converted to wet gangrene and additional medication was started. She became lethargic and was given antibiotics, but her condition worsened, and she was transferred back to the IPU with a 10 of 10 pain, and low-grade fever. D.G. met specific indicators of "rapid decline and disease progression" from the LCD for debility. She exhibited dependence in more than 3 of 6 ADLs, a PPS below 70 percent, recurrent infections, worsening pressure wounds, increased pain, increased respiratory symptoms, and changes in lucidity. At final hearing, Dr. Eisner testified that D.G. "improved to the point that hospice was revoked on 12/25/09." Dr. Eisner was incorrect, however, because the record reflects D.G. was placed back in hospice IPU on 12/24/09, as she continued to deteriorate, refused evaluation by staff and threatened to call the police if wound care was attempted. The following day, D.G. revoked hospice a second time and went back to the hospital to seek aggressive treatment. Dr. Eisner concluded that D.G. did not meet the standard of six or less months to live; rather, D.G. suffered from a chronic condition, Crohn's Disease. However, this does not account for D.G.'s multitude of significant comorbidities. AHCA has not met its burden by the greater weight of the evidence that D.G. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 6, J.R. Patient J.R. was a 58-year-old male with a terminal diagnosis of end-stage heart failure. The claim period at issue is only one week, 01/24/11 to 01/31/11. During the period at issue, J.R. suffered NYHA Class IV heart failure. Class IV is the worst classification and supportive of hospice appropriateness. J.R. had a PPS of 50 percent and had active symptoms that supported a life expectancy of six months or less if the illness ran its normal course. Dr. Eisner credibly testified that by 01/24/11, J.R. had improved to a point that his life expectancy was greater than six months. J.R.'s disease was no longer progressing to the point of impairment, and his functional capacity had improved. However, AHCA approved benefits for Patient J.R. for the time frame 04/19/10 through 01/23/11. The one-week time frame at issue fell within the last 60-day benefit period approved by AHCA, which began on 12/15/10. According to the instruction provided to the reviewers, this week must be approved. AHCA has not met its burden by the greater weight of the evidence that J.R. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 7, R.A. Patient R.A. was a 59-year-old male with a terminal diagnosis of COPD who was admitted to Respondent's care on 03/21/11. The dates at issue are less than two months, from 03/21/11 to 05/01/11 and 05/04/11 to 05/16/11. R.A. had a medical history of non-small cell lung cancer, which had been treated with chemotherapy and radiation. He also had a history of hypertension, depression, peripheral vascular disease, arthritis, chronic back pain, gastroesophageal reflux, and seizures. The precipitating event leading to his hospice admission was a hospitalization for pneumonia. At the time of discharge from the hospital, the original plan was for R.A. to be discharged to a skilled nursing facility. The hospital had trouble finding a skilled nursing facility willing to take the recipient because of his social problems, so it appears the hospice placement was a placement of convenience as indicated in a physician's visit note dated 03/28/11, where it was noted, "Case manager is involved in the case to help him out and for possible placement. We will continue with the present medications at this point." In fact, R.A. told Vitas' staff that he would like to have an aid to help him with ADLs and his medications until he gets better, and Vitas' staff suggested R.A. should be referred for home care services. R.A. lived alone. Instead, R.A. entered hospice care. The initial certification documentation incorrectly indicated that R.A. had end-stage lung cancer; however, he had previously been diagnosed with lung cancer, which was in remission at the time of his hospice admission. R.A. revoked hospice care to return to the hospital for aggressive treatment of pneumonia. The certification documentation for R.A.'s second admission again incorrectly listed R.A. as having an end-stage diagnosis of lung cancer, despite the recipient telling Respondent that he was negative for cancer during his first admission. Respondent's certifying physician stated there was a new finding of mediastinal lymphadenopathy, a swelling of the lymph glands in the chest areas, which could be consistent with a reoccurrence of his primary process. Dr. Talakkottur, however, explained that R.A.'s lymph glands could have been enlarged for a number of reasons, such as if he had a cold, a blockage of lymph fluid, or pneumonia. Because R.A. had been suffering from bouts with pneumonia, enlarged lymph glands was not conclusive evidence of a reoccurrence of lung cancer. The initial nursing assessment prepared 05/04/11, notes that R.A. had been diagnosed during his last hospitalization with pneumonia and was complaining of cough and congestion. A nurse noted in her assessment that the recipient continued to express his desire to live alone, but she noted he may need a higher level of care. Dr. Talakkottur credibly testified that this recipient did not suffer from a terminal illness; rather, R.A. suffered from a chronic disease-—COPD. He had been diagnosed with COPD five years prior to his first hospice admission. R.A. was sick, but he was not likely to expire within the next six months. He just needed assistance with minor care, housekeeping, and occasionally with ADLs. He was not hospice appropriate and could have been served in a home health setting. The medical records contained in this recipient's file do not support a finding that the Medicaid hospice eligibility standard was met. Based upon the greater weight of evidence in this case, it is determined that this recipient was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $20,467.42.5/ Patient 8, T.F.C. Patient T.F.C. was a 57-year-old female with a terminal diagnosis of malignant neoplasm of the corpus uteri. The dates at issue are 06/16/11 to 02/21/12. T.F.C. was diagnosed on 04/25/11 with high-grade serous adenocarcinoma by her treating oncologist. Her uterus and one of her fallopian tubes were removed due to cancer. After surgery, she was seen as an oncology outpatient during May 2011. On 06/12/11, T.F.C. presented to the ER with low back pain, which was not relieved with morphine. Her computed tomography ("CT") scan revealed severe left-side hydronephrosis, hydroureter, left pelvis and a spiculated soft tissue, whose density measured 3 x 2 centimeters. During the dates at issue, her PPS ranged from 40 to 60 percent, although she required increased pain medication and experienced three infections. She had a series of physician assessments and lab work, both while in the hospital and on outpatient visits. Dr. Shega testified that an oncologist from MD Anderson Cancer Center referred T.F.C. to hospice. There is, however, no file evidence to support this testimony, and it is difficult to understand how Dr. Shega knew this fact to be true. The only certification was that of the written certification prepared by Vitas' physician. Dr. Rebecca Moroose of MD Anderson Cancer Center of Orlando saw T.F.C. on 11/02/11. In her progress note, Dr. Moroose reflected upon the T.F.C's severe left hydronephrosis while hospitalized in June, which was believed to be associated with a mass "suspicious for recurrence." Dr. Moroose further reported that since being on hospice care, T.F.C. had excellent symptom control and that most of her pain was associated with her midline abdominal surgical scar and an associated mass found. Dr. Moroose planned to contact Vitas for clearance to obtain a CT imaging of the abdomen to reassess T.F.C.'s disease. On 11/07/11, a CT of her abdomen and pelvis with contrast, was performed and a comparison made to CT of June 2011. Two masses were discussed and compared to the earlier study. The seroma in the anterior abdominal wall of her vertical midline surgical incision was stable and felt not to represent a malignancy but rather a benign fluid collection. The second mass was much less conspicuous in the current study and represented a significant reduction in size compared to the previous study and was believed to possibly represent fibrotic tissue or residual disease. No clear evidence exists from the hospital records and/or MD Anderson Cancer Center that either mass is a definite recurrence of the disease. T.F.C.'s functional status remained static during her first admission. She was able to feed herself, her BMI was consistent with obesity, she could make her needs known, and when the nursing notes assessed her cognitive function, the recipient was consistently reported to be alert and oriented "times three." T.F.C. often reported her pain as zero, on a scale of zero to ten, and her PPS was between 40 and 60 percent. T.F.C. had no inpatient or continuous care stays while in hospice. T.F.C.'s need for increased pain medication appears to be related to issues she was having with her bladder, including kidney stones. She revoked hospice care on 02/21/12, to go to the hospital, to be treated for pain in her abdomen, which was related to kidney stones. Additionally, while in the hospital, she underwent a procedure to insert a stent to facilitate urination. Although T.F.C. had a history of bladder and UTIs, none of Vitas' recertifications or addenda to the recertifications report the recipient having either a bladder or UTI during the disputed period. Although T.F.C. suffered from a terminal illness, the medical records for this recipient do not support a diagnosis of six months or less if the disease runs its normal course. As Dr. Talakkottur testified, the medical records do not demonstrate a clinical progression of the terminal illness. During the period in dispute, T.F.C.'s condition overall remained static. Based upon the greater weight of evidence in this case, it is determined that this patient was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $36,221.03. Patient 9, A.J. Patient A.J. was a 74-year-old female with end-stage cerebral degeneration, with two recent hospitalizations prior to hospice admission. The dates at issue are 09/01/10 to 04/22/12. Upon admission to Vitas hospice, A.J. had a PPS of 30 percent and was dependent for 6 of 6 ADLs, with a FAST score of 7c. A.J. had an altered level of consciousness and was at high risk of aspiration. A.J. had a history of strokes and transient ischemic attacks ("TIA" or "mini-strokes"), with encephalomalacia in the left frontal and right thalamus, hypertension, coronary artery disease, increased lipids, dementia, psychosis with hallucinations, anemia, diabetes, chronic renal insufficiency, a history of gastrointestinal ("GI") bleed, and peripheral vascular disease. In terms of her functional state at initial certification, A.J. was bedbound, not fully capable of following commands, had sarcopenia (muscle wasting) in all four extremities, was very feeble, lethargic and oriented times zero, which meant she did not know who she was, where she was, or when it was. During the period at issue, A.J.'s PPS remained at 30 percent, she was dependent in 6 of 6 ADLs, her FAST score was always above 7, she was oriented to zero or one, and she was incontinent. A.J. had several infections during this time frame. A FAST score above 7 in a dementia patient is consistent with a terminal prognosis, according to the LCDs. Dr. Talakkottur testified that, in his opinion, A.J.'s condition was chronic, not end-stage. His opinion was based on his evaluation that A.J. did not decline during her stay in hospice. Dr. Shega, with ten years' experience as co-director of the Memory Disorders Clinic at the University of Chicago, strongly disagreed, opining that based on her medical history, including two recent hospitalizations, and the evaluation upon admission, A.J.'s dementia was end-stage. During her hospice stay, she continued to lose weight, had temporal wasting and muscle loss, began to experience contractures, and was sleeping more. Furthermore, citing the medical literature, Dr. Shega opined that A.J.'s health did decline in light of her three infections. Two weeks after her initial admission to hospice, A.J. was placed on continuous care due to nausea and vomiting, with no oral intake for two days. Later that same month, she was admitted to a hospital while remaining on hospice. A.J. met the disease specific criteria from the LCD for dementia and related disorders. As noted above, she had a FAST score of 7c, which indicates she was speaking six words or fewer, was 6 of 6 ADLs, and was incontinent. While A.J.'s time in hospice stay was certainly longer than anticipated, a review of her complete medical history presented a dementia patient with a prognosis of six months or less should the disease run its normal course, and she continued to decline. A.J. clearly met the criteria for admission to hospice for the dates at issue. AHCA has not met its burden by the greater weight of the evidence that A.J. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 10, M.A. Patient M.A. was a 56-year-old male with end-stage liver disease and end-stage COPD. The period in dispute is 10/10/10 to 04/30/11. M.A. had been hospitalized twice just prior to hospice admission, the first for 13 days beginning 08/03/10, with a second admission on 08/30/10. M.A. was hospitalized the second time with chest pain and dyspnea. M.A. remained in the hospital (almost six weeks) until referred to hospice by his hospital physician due to abdominal pain and ascites. Ascites, the accumulation of fluid in the peritoneal cavity, causing abdominal swelling, can occur as a result of liver failure. M.A.'s medical history included end-stage liver cirrhosis, chronic COPD, a history of GI bleed, esophageal varices, portal hypertension, alcohol abuse, diabetes, chronic renal insufficiency, anemia, coronary artery disease, and a left frontal cerebrovascular accident ("CVA" or stroke). In Dr. Talakkottur's opinion, Patient M.A. did not have end-stage liver disease because, in part, there was no report of blood in the stool or of vomiting blood. Although Dr. Talakkottur asserted ascites was not present in this patient, on cross-examination, he acknowledged ascites was noted in January 2011. In fact, M.A. was referred to hospice directly from an extended hospital stay for abdominal pain and ascites. Dr. Talakkottur also testified that M.A. had not been prescribed Lasix or Aldactone for ascites during his hospice stay. Dr. Shega, however, testified to the patient's substantial ascites, despite his being given a very high dose of diuretics, including Aldactone. Contrary to Dr. Talakkottur's testimony, the draft audit report acknowledges M.A. also had ascites on 12/29/10 and in March and April 2011. Dr. Shega opined that although M.A. did not specifically meet the LCDs for end-stage liver disease alone, the fact that he also had end- stage COPD, in combination with his substantial symptom burden, refractory ascites, and encephalopathy with forgetfulness, which worsened over the patient's stay, made the patient appropriate for hospice. M.A. exhibited shortness of breath at rest and with activity and was on 3.5L oxygen per nasal cannula. Over the course of the period at issue, M.A.'s dependency for ADLs generally trended higher, as did his level of pain, while his cognitive status worsened. The recertification signed on 03/24/11 reported cachexia and muscle wasting. While upon admission M.A. could walk a handful of steps by himself, by the end of the period, he was essentially bedbound. M.A.'s health clearly declined over the period at issue. Given his history of recent, lengthy hospitalizations, his numerous comorbidities with significant symptom burden, and his decline in functional status, M.A. clearly met the criteria for admission to hospice for the dates at issue. AHCA has not met its burden by the greater weight of the evidence that M.A. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 11, D.C. Patient D.C. was a 47-year-old female with a terminal diagnosis of adult failure to thrive. The three claim periods at issue are 12/21/10 to 02/10/11; 04/25/12 to 07/16/12; and 10/04/12 to 12/29/12. D.C. had a longstanding diagnosis of refractory Crohn's disease. At the time of her appropriateness evaluation in December 2010, she resided in a nursing home, which would have required a physician's order to agree that the patient was hospice appropriate. She had a PPS of 40 percent, was dependent in 2 of 6 ADLs, weighed 103 pounds, and suffered from alopecia (loss of hair). Her pain level was 7 of 10. Prior to admission to hospice, D.C. had been hospitalized twice in 2010, the first time in March for sepsis and endocarditis, and the second time on 07/30/10, for GI surgery, with complications of three fistulas, which placed her at high risk for infection. D.C.'s comorbidities included protein-calorie malnutrition, ongoing abdominal pain, anemia, reactive airway disease, neuropathy, peptic ulcer, a history of duodenal ulcer and GI bleed, ileostomy, depression, peripheral vascular disease, coronary artery disease, and cellulitis. The patient was very hesitant to eat, as food equaled pain. During the course of her first certification period, D.C.'s medical condition stabilized, and she was discharged on 02/10/11 due to an extended prognosis. Upon D.C.'s second hospice admission, her PPS was 40 percent, she was dependent on 5 of 6 ADLs, with a recent loss of weight and a BMI of 21.6. Her pain was recorded at 7 of 10 and she had developed a stage 2 sacral wound, in addition to two wounds on her abdomen. Her comorbidities remained the same as at the first admission, with the exception of a benign tumor above her heart, which was removed. During the course of her second certification period, Patient D.C.'s medical condition again stabilized and she was discharged on 07/16/12 due to an extended prognosis. Upon admission to hospice the third time, D.C.'s comorbidities remained the same. Her PPS score was 40 percent. In early December 2012, however, D.C. began to develop paranoia, was agitated and anxious, and required continuous care to have her antipsychotic medication titrated. On 12/15/12, D.C. fell and again was placed on continuous care for her paranoia and the fall. On 12/25/12, D.C. was involuntarily committed to the Halifax Hospital psychiatric unit. Her mother requested she be returned to the Halifax ER on 12/29/12 for a worsening altered mental state, at which time she was described as unresponsive. Her family revoked the hospice benefit, and D.C. was transferred to an inpatient hospice house in another program closer to the family's home. Dr. Talakkottur testified Crohn's Disease is a chronic disease and one could live for 20 to 30 years or more. Crohn's Disease is characterized by periods of dormancy or being well- controlled and periods of exacerbation. It should be noted, however, that at the time of the first admission, D.C. had already lived 39 years with the disease. Dr. Shega testified he believed that D.C. was hospice appropriate for each of the three periods in dispute due to her chronic condition, coupled with recent infections and weight loss. However, Dr. Shega admitted that it is common for a person suffering from Crohn's Disease to have weight fluctuations. Moreover, Dr. Shega admitted that many of the weight measurements in D.C.'s medical records were unreliable. D.C. met all applicable criteria for admission to hospice for the first period in dispute. However, as to the second and third periods in dispute, Dr. Talakkottur more credibly testified that D.C.'s medical records did not support an end-stage progression of any kind of disease; rather, she experienced exacerbations of her chronic illness, which she has had for the preceding 39 years prior to her hospice admission. Based upon the greater weight of evidence in this case, it is determined that this recipient was not eligible for Medicaid hospice services during the second and third periods in dispute and that AHCA is entitled to recover an overpayment in an amount to be determined. Patient 12, C.W. Patient C.W. was a 42-year-old male with a history of stroke in 2003 and a terminal diagnosis of end-stage cerebrovascular disease. The dates at issue are 02/17/10 to 01/05/11 and 01/31/11 to 05/23/11. In 2003, seven years prior to his hospice admission, C.W. experienced a stroke. Additionally, since 2006, C.W. had cardiomyopathy, which is a disease of the heart reflective of an ejection fraction ("EF") of 35 percent or less. Dr. Shega opined that although the stroke was in 2003, it "could have left him extremely debilitated." Furthermore, C.W. also suffered from HIV, heart failure, and had been recently hospitalized for the removal of skin lesions in his groin area prior to his first admission. C.W. was discharged from his first admission for extended prognosis. For the second admission, Dr. Shega testified that C.W. had experienced a urinary tract infection ("UTI") precipitating his readmission to hospice. Ultimately, C.W. was discharged for extended prognosis, and Dr. Shega stated C.W. was appropriate for discharge because although C.W. had a couple of acute conditions during this stay, his weight and functional status stabilized, he did not have another infection, and he did not show any other decline. Dr. Talakkottur credibly opined that C.W. experienced issues related to his stroke and cardiomyopathy for quite some time prior to his admission to hospice. Therefore, C.W. had not experienced any change in health to warrant admission to hospice. While C.W. suffered from HIV, Dr. Talakkottur testified his HIV viral load was undetectable, meaning the viruses in his bloodstream were very low. Furthermore, Dr. Talakkottur opined that C.W.'s comorbidity of HIV was of no concern because the recipient also continued to receive his highly active antiretroviral therapy. Dr. Talakkottur further opined with respect to C.W.'s second admission that a UTI is not an indicator of end-stage cerebrovascular disease. C.W. had a Foley catheter, and it is common for recipients with a Foley catheter to develop UTIs. The medical records contained in this patient's file do not support a finding that the Medicaid hospice eligibility standard was met. Based upon the greater weight of evidence in this case, it is determined that C.W. was not eligible for Medicaid hospice services during either period in dispute and that AHCA is entitled to recover an overpayment of $61,721.28. Patient 13, J.M. Patient J.M. was a 59-year-old male with a longstanding history of medical noncompliance with treatment plans and substance abuse, who was admitted with a terminal diagnosis of end-stage COPD after six ER visits or hospitalizations in just over six months. The dates at issue are 03/29/12 to 06/15/12 and 08/31/12 to 12/31/12. J.M.'s PPS upon admission was 50 percent, and he had shortness of breath at rest and exertion. His comorbidities included known fatty liver with history of ascites, CVA times two, UTIs, diabetes type 2, gastritis, hypertension, gastroesophageal reflux disease, heart failure with diastolic dysfunction in left ventricular with amyloidosis, myocardial infarction ("MI" or "heart attack") times two, pulmonary embolism, obesity, and bipolar disorder. J.M. suffered from COPD for many years preceding his hospice admission. He used oxygen on an as-needed basis, preceding and during his hospice stay. J.M. was also a polysubstance abuser. Dr. Talakkottur opined that J.M.'s issues were not the result of a progression of his terminal illness; rather, his decline was associated with his substance abuse. When J.M. was not abusing drugs and was compliant with his medication for his COPD, he had a good quality of life. Conversely, when he abused drugs and was noncompliant with his medication for COPD, he seemed to decline more. Dr. Shega testified that J.M.'s six ER visits/hospitalizations factored into his opinion that the recipient's COPD was end-stage. The nurse completing the Appropriateness Evaluation form noted under hospitalizations that the recipient visits a hospital at least monthly. The recipient tested positive for cocaine during those hospitalizations. The hospital attributed J.M.'s abdominal pain to cocaine use during the latter visit. Dr. Shega testified it was known that J.M. was a controlled substance abuser, particularly cocaine. Although J.M. suffered from a chronic illness, the medical records do not support a diagnosis of six months or less if the disease ran its normal course. Instead, as Dr. Talakkottur testified, the medical records demonstrate J.M. had an issue with medication compliance. For instance, nurses routinely had to remind J.M. to take his nebulizer treatment. However, when he took his medication, he appeared to have no respiratory distress and the intervention was effective. The medical records contained in J.M.'s file do not support a finding that the Medicaid hospice eligibility standard was met. Based upon the greater weight of evidence in this case, it is determined that J.M. was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $31,736.82. Patient 16, M.W. Patient M.W. was a 61-year-old female diagnosed with multiple sclerosis ("MS"). The claim periods at issue are 08/26/11 to 08/14/12 and 12/16/12 to 12/31/12. The patient's comorbidities included multiple basal cancer cell removals, arthritis, a history of gallstones, ileus, depression, osteoporosis, COPD, and glaucoma. MS is a condition that affects the neurological system. There are different kinds of MS, yet the most common type is called relapsing-remitting MS, which affects 80 percent of MS recipients. A patient with relapsing-remitting MS is similar to patients with other chronic illnesses in that a patient will have events or flare-ups that may occur roughly every 12 to 18 months or more. MS affects the quality of life more than it affects the quantity of life. M.W. suffered from MS since she was 34 years old, so she had dealt with the effects of MS for 27 years. Dr. Shega opined that this recipient was hospice eligible because of the recent decline in her functional status and nutritional decline. Dr. Shega stated his recollection was this patient could ambulate prior to her hospice admission. However, he later admitted M.W. was unable to walk for the past three to four years and had used a wheelchair for the past five to six years. Furthermore, on cross-examination, Dr. Shega admitted that the BMI for M.W. was miscalculated, and her BMI was in the normal range (22.8). In contrast, Dr. Talakkottur testified this patient was merely experiencing flare-ups of her chronic condition. Dr. Talakkottur opined that patients with terminal MS experience deteriorating respiratory function, which is evidence of the final decline. Dr. Talakkottur also noted that Respondent's month-to-month reports demonstrated unexplained discrepancies in M.W.'s reported scores for PPS, MMA, and ADLs. Furthermore, the medical records did not demonstrate M.W. had any deterioration in her respiratory function or any other terminal progression. If anything, as Dr. Talakkottur testified, the medical records show improvement for dependence with ADLs and her PPS score remained static. The medical records contained in this recipient's file do not support a finding that the Medicaid hospice eligibility standard was met. Based upon the greater weight of evidence in this case, it is determined that this recipient was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $54,133.32. Patient 17, T.D. Patient T.D. was a 45-year-old female with a terminal diagnosis of end-stage heart disease. The claim period at issue is 04/14/11 to 12/23/11. The patient was diagnosed with NYHA Class IV heart failure as evidenced by shortness of breath at rest, worsening with exertion, and three and a half liters of oxygen via nasal cannula. Her PPS was 50 percent. She requested hospice and was referred to hospice by her primary physician because she required increased support and only wanted palliative treatments. Prior to her admission to hospice, T.D. had multiple encounters requiring physician management and an ER visit on 02/02/11 for a respiratory infection. She also suffered from ischemic cardiomyopathy, had a defibrillator placed in 2008, and suffered from diabetes requiring an insulin pump, peripheral neuropathy, COPD, sleep apnea, arthritis, spinal stenosis, gastroesophageal reflux disease, and history of TIAs. She was on 13 different medications. Dr. Shega opined that the NYHA classification is the predictor most tightly correlated with patient mortality. In this case, while T.D.'s EF changed, her symptom burden did not change. Dr. Talakkottur acknowledged that throughout the claim period at issue, the patient was a Class IV. Dr. Talakkottur testified that in his opinion hospice eligibility was not established, in part because the patient had no jugular venous distention ("JVD") on physical exam. Dr. Shega opined that in hospice care, forced expiratory volume in one second ("FEV1s") are done to characterize the patient's underlying pulmonary status. While outside hospice total volume tests are frequently done to establish a diagnosis, in this case diagnosis had been established and Vitas was prognosticating, not diagnosing. Between 04/29/11 and 11/08/11, T.D. had an abdominal infection requiring antibiotics; she had an episode of thrush; she had a titration of her pain medication due to discomfort; she had another episode of cellulitis in the abdomen; her PPS dropped to 40 percent and her ADLs were 4 of 6; she experienced a respiratory infection requiring antibiotics; she required antibiotics for a vaginal boil; she had an abdominal wound; methadone was prescribed for increased pain; methadone dosage was increased due to swelling; and methadone was again increased because of worsening pain. T.D. was discharged on 12/23/11 for extended prognosis. Dr. Shega testified that while he understood why that call was made, he offered the opinion that the patient still had a prognosis of six months or less. In addition to the reasons set forth above, during the course of the admission period, her PPS went from 50 to 40 percent, back up to 50 percent and, then declined again to 40 percent. She also experienced poor intake and chest pains during this time. T.D. was evaluated as a NYHA Class IV throughout her hospice admission. She had had multiple physician encounters in the months prior to her admission and was referred to hospice by her primary care physician. She continued to have multiple episodes of infection and wounds while in hospice care. For these reasons, this patient met the hospice admission guidelines for the claim period at issue. AHCA has not met its burden by the greater weight of the evidence that T.D. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 18, R.J. Patient R.J. was a 52-year-old male with terminal COPD. The claim dates at issue are 11/18/10 to 01/11/11. Immediately prior to admission to hospice, R.J. had been hospitalized for 12 days (from 11/06/10 to 11/18/10) for COPD exacerbation. He had hypercapnic, hypoxic respiratory failure and was unable to breathe on his own. He was on oxygen and placed on a BiPAP. Upon hospice admission, in addition to having disabling dyspnea at rest, R.J. was poorly responsive to bronchodilators and had an enlarged right atrium. His PPS was 40 percent, a BMI of 20, a very low weight of 114, and was dependent 4 of 6 ADLs. The patient was referred to hospice while in the hospital by his treating physician. His comorbidities included HIV, history of substance and alcohol abuse, arthritis, thrush, and bladder infections. Upon admission, R.J. was prescribed treatment of three liters of oxygen via cannula, continuous. A nebulizer treatment was used, using aerosolized medication to penetrate into the pulmonary system. On 12/03/10, the patient experienced a respiratory rate of 20, had an 8 of 10 abdominal pain, and was noted to be confused and agitated. On 12/09/10, R.J. had a pulmonary function test with an FEV1 of 0.42, which was 18 percent of predicted. An FEV1 less than 30 percent of predicted is associated with a severe airflow obstruction, supportive of a prognosis of six months or less. R.J. continued to have confusion and agitation through 12/14/10, when he was oriented times two. While it was true that R.J. did not suffer a COPD exacerbation or infection during the months at issue, Dr. Shega testified he had declined in respiratory status since admission, noting a second, severely reduced FEV1 to 10 percent. On 12/31/10, R.J. had elevated blood pressure, and continued to exhibit confusion, agitation and cognitive loss. He also continued to have dyspnea with low activity tolerance. R.J. exhibited specific indicators of "progression of end stage pulmonary disease" and "severe chronic lung disease" from the LCD for pulmonary disease. As noted above, he had hospitalizations due to his COPD immediately prior to admission to hospice and an FEV1 of less than 30 percent. His 12-day hospitalization, his poor nutritional status, his comorbidities and decline in respiratory status during the eight weeks at issue all support a finding that Patient R.J. was hospice appropriate during the claim period at issue. AHCA has not met its burden by the greater weight of the evidence that R.J. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 21, W.C. Patient W.C. was a 55-year-old female with congestive heart failure. She had ischemic cardiomyopathy, suggesting poor blood flow in her coronary arteries, impacting how well it pumps. The claim periods at issue are 10/06/11 to 10/25/11 and 11/30/11 to 11/27/12. W.C. was hospitalized for a cardiac catheterization on 08/29/11, and then hospitalized in September 2011 and again on 10/02/11 with heart failure exacerbation, the latter hospital stay being immediately prior to her first admission to hospice. She presented with chest pain and shortness of breath and had a low EF of 20 percent. W.C. also had an extremely low albumin of 2.2 indicating malnutrition, which was a factor in her refractory and recurrent edema. Both the hospitalist and cardiologist who treated W.C. on her most recent hospitalization referred her for hospice care. W.C. previously had cardiac bypass surgery, a history of chronic renal insufficiency, anemia, hypertension, bipolar disorder and was an insulin dependent diabetic. She had a defibrillator implanted twice, but it had to be removed each time due to infection. She also suffered from chronic lung disease. Likely due to her underlying mental health issues, W.C. had a longstanding history of noncompliance with her medication regimen. Despite W.C.'s multiple clinical issues, on 10/11/11 W.C.'s history and physical raised a question whether she was too functional for hospice services. Given her recent clinical history, W.C. was monitored for two weeks to evaluate and her case was forwarded to medical review to determine hospice appropriateness. On 10/16/11, W.C. complained of chest pain, her BMI had declined from 27.2 to 22.5, and she was experiencing edema. W.C. also experienced paroxysmal nocturnal dyspnea, and required three pillows at night for comfort and dyspnea. On 10/25/11, W.C. revoked the hospice benefit to return to the hospital for aggressive treatment for shortness of breath. During that stay she experienced a MI (heart attack), and ongoing ischemic cardiomyopathy with a low EF of 20 percent. W.C. was readmitted to hospice on 11/30/11, following discharge after a five-day hospitalization. Dr. Shega admitted this recipient was a challenge to diagnose for disease progression because she had good days and bad days, and that one of Respondent's physicians, who treated her struggled with whether she was chronic or end-stage. Dr. Talakkottur opined this patient did not appear to be end-stage. W.C. had a normal volume status with sporadic periods of edema (swelling in the legs). W.C. had no heart arrhythmia, no tachycardia (fast heart rate), no hypotension (low blood pressure), and no hemodynamic instability (unstable blood pressure to support normal organ function). If anything, the problems experienced by W.C. were the result of her noncompliance with her medications and not that her disease had reached a terminal state. In fact, when Vitas discharged this patient, they noted that she was noncompliant with her medications. W.C. was independent for ADLs, lived alone, drove herself, and was still active in the community. The medical records contained in W.C.'s file support a finding that the Medicaid hospice eligibility standard was met for the first period but not the second. Based upon the greater weight of evidence in this case, it is determined that this recipient was not eligible for Medicaid hospice services during the second period and that AHCA is entitled to recover an overpayment in an amount to be determined. Patient 22, B.A. Patient B.A. was a 51-year-old female diagnosed with end-stage cerebrovascular disease. The claim periods at issue are 05/01/12 to 09/19/12 and 09/24/12 to 12/31/12. Prior to her admission to hospice, B.A. had two recent hospitalizations due to complications from a stroke suffered in December 2011. A PEG was placed during the second hospitalization on 04/21/12, for dehydration and fever. Over a period of five months, B.A.'s weight declined from 180 to 123 pounds, with a BMI of 20.5. Upon initial admission to hospice, B.A. was thin and frail, lethargic, short of breath with minimal exertion, incontinent, and had a stage one ulcer on her coccyx. B.A. was nonverbal, dependent in 6 of 6 ADLs and had a PPS score of 30. Her comorbidities were severe dementia, diabetes, carotid artery disease, and hypertension. Patient B.A. suffered a change in consciousness (likely seizures) and revoked hospice on 09/19/12 when she was admitted to a hospital. An MRI was conducted in the hospital, which showed diffused cerebral atrophic changes and evidence of decreased blood flow/oxygen to the brain. B.A. was discharged from the hospital and readmitted to hospice on 09/24/12, at which time she was unresponsive, with a PPS of 10, a documented weight of 110, and a FAST score of 7f. Just after her second hospice admission, she had a temperature of 100 on 09/25/12. On 10/10/12, she developed a stage two sacral ulcer. During this second admission period, B.A.'s weight continued to decline and she showed signs of muscle wasting. Dr. Talakkottur's re-review and deposition testimony was that Patient B.A.'s "records did not support progression of end-stage pulmonary disease, as evidenced by increasing visits to the emergency department for pulmonary infections or respiratory failure." As pointed out by Dr. Shega, however, Patient B.A. was never admitted for end-stage pulmonary or respiratory disease, but rather for cerebrovascular disease and cerebral degeneration. Dr. Talakkottur did not offer final hearing testimony regarding Patient B.A. Instead, AHCA offered his deposition testimony. In his deposition, he acknowledged he had not made note of B.A.'s significant weight loss. B.A. met the disease specific criteria from the LCD for dementia and related disorders. As noted above, she had a FAST score of 7c or less, which indicates she was speaking six words or fewer, was dependent in 6 of 6 ADLs, and was incontinent. For the audit periods in question, it is undeniable that Patient B.A.'s prognosis of six months or less was correct, and she was Medicaid hospice eligible during all of the dates at issue. AHCA has not met its burden by the greater weight of the evidence that B.A. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment for either period. Patient 23, E.G.D. Patient E.G.D. was a 70-year-old female diagnosed with adult failure to thrive. The patient was initially admitted to hospice on 01/06/10 and deemed eligible for hospice through 03/23/10. The dates at issue are 03/24/10 to 4/16/10 and 5/20/10 to 12/21/10. On 03/23/10, E.G.D. was noted to weigh 95 pounds, with a BMI of 19.9. She also experienced dysphagia and increased agitation. She had edema on the lower extremities, a PPS of 40 percent, and her ADLs were 11 of 12.6/ Patient E.G.D. had been hospitalized during the prior year with a MI in June 2009. Her comorbidities also included diabetes mellitus, hypertension, advanced Alzheimer's disease, coronary artery disease, ischemic cardiomyopathy, a pacemaker, and recurrent falls. On 04/02/10, while the patient's weight had increased to 95 pounds while on hospice care, her PPS was 40 percent and her FAST score remained at 7b. E.G.D. had impaired communication, was confused, had edema in her periphery, and had an acute UTI requiring antibiotics. Although the patient's weight had increased, her BMI was still under 20. E.G.D. was discharged on 04/16/10 for extended prognosis. She was readmitted to hospice on 05/20/10, after having been hospitalized for an acute heart attack, with hypoxic respiratory failure, resulting in low oxygen and respiratory distress. She had also been diagnosed with pneumonia during her hospital stay and had shortness of breath with minimal exertion making her a NYHA Class III. Due to her recent MI and an injection fraction of 20 percent, upon readmission to hospice, E.G.D. was diagnosed with end-stage heart disease. E.G.D.'s FAST score was 7f, she was 6 of 6 ADLs, had a PPS of 20 percent, and her weight had declined in the preceding month from 99 to 92 pounds. She was nonverbal and continued to be an aspiration risk. Her skin turgor was noted as poor and she was incontinent. Dr. Talakkottur opined that while E.G.D. had suffered a second heart attack, it was an acute event and not a terminal prognosis. He further argued that this patient's condition was chronic because there were no signs of angina, no shortness of breath, and no extended neck veins in a JVD test. In response, Dr. Shega noted that in the plan of care review, E.G.D. exhibited dyspnea at rest, had a FAST score of 7f, had a decreased level of consciousness and was lethargic. In Dr. Shega's opinion, JVD does not define end-stage heart failure. Rather, it just defines whether a patient is having an acute heart failure exacerbation at that time. Furthermore, research has shown that physicians, other than cardiologists, are not necessarily good at assessing JVD. According to Dr. Shega, Dr. Talakkottur also failed to take into account this patient's comorbidities, including end- stage dementia, which was likely a contributing factor to her sleeping 18 to 20 hours a day during her second admission and affecting her prognosis. 215. On 05/25/10, 06/08/10, and 06/22/10, E.G.D.'s cardiovascular condition was NYHA Class IV, with dyspnea at rest. During the benefit period beginning 09/17/10, this patient continued to be described as NYHA Class IV. And, while her weight increased to 110 pounds, she was still sleeping up to 20 hours a day, dependent in all ADLs, and had a PPS of 30 percent. During the last benefit period at issue, Patient E.G.D. continued to be NYHA Class IV, and had worsening edema. By 12/21/10, she was essentially unresponsive and the family revoked hospice to seek aggressive care in the hospital related to decreased appetite and decreased responsiveness. Dr. Talakkottur opined that there was nothing in the record to support a diagnosis of NYHA Class IV or significant symptoms of heart failure. In response, Dr. Shega pointed out those portions of the medical record that supported the fact E.G.D. had NYHA Class IV symptoms. As far as alleged lack of reports of frequent ER visits or hospitalizations, this patient was hospitalized for an acute MI less than a year prior to her initial hospice admission, was hospitalized again for a second heart attack immediately prior to her second hospice admission, and the family revoked hospice on 12/21/10 to readmit her to the hospital at the end of the last benefit period. AHCA has not met its burden by the greater weight of the evidence that E.G.D. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment for either period. Patient 25, M.M. Patient M.M. was a 57-year-old male admitted to hospice with a primary diagnosis of systemic lupus erythematosus ("SLE"). The dates at issue are 02/01/12 to 12/31/12. M.M. was first diagnosed with lupus in 1974, and also had a history of vasculitis, which resulted in several fingers amputated secondary to necrosis. M.M. also suffered from glomerulonephritis, an autoimmune disease that attacks the kidney. Other comorbidities included multiple surgeries on his right knee, a left ankle surgery with ultimate fixation, neuropathy, hypertension, morbid obesity, umbilical hernia, Cushing syndrome, diabetes, and a history of gastric ulcers, hepatic steatosis, sleep apnea, peripheral vascular disease, coronary artery disease, and chronic renal insufficiency. In the six months prior to hospice admission, M.M. had been admitted to the hospital four times: to amputate several fingers; for ileus; for chest pain; and for shortness of breath. M.M.'s primary care physician referred him to Vitas for end-stage SLE. Patient M.M. was initially admitted to hospice on 02/01/12. At that time, his PPS was 30 percent and his pain registered 8 of 10. He also suffered multiple weeping wounds on his lower extremities from edema upon admission and throughout his stay in hospice. His long time primary care physician noted, "in the face of aggressive medical care, the patient's condition continues to deteriorate." Over the claim period at issue, M.M. required multiple increased levels of care for pain management and decline in his overall condition. M.M. required continuous care on 03/14/12 for increased pain; on 09/27/12 for pain and change in level of consciousness; and on 10/27/12 for confusion, agitation, delusion and falls. M.M. required hospice inpatient care on 08/23/12 for shortness of breath and fever; and on 10/01/12 for a fall, nausea, vomiting, and low blood pressure. After a fall, M.M. was taken to the ER in July 2012 for a laceration on his left foot. He required another trip to the ER in December 2012 for a fall. In November 2012, he became severely anemic, requiring three units of blood. On direct, Dr. Talakkottur acknowledged that anemia is one of the symptoms of SLE. In his re-review, Dr. Talakkottur opined that M.M.'s condition overall was static throughout the claim period and questioned whether the patient even had SLE. In response, Dr. Shega noted that M.M.'s primary treating physician's records documented he had SLE. In addition, he noted M.M.'s multiple infections requiring antibiotics, as well was requiring numerous IPU and continuous levels of care during the period at issue. Dr. Talakkottur's re-review acknowledged that Patient M.M.'s functional performance had declined during the hospice stay to a PPS of 30 percent on his last recertification, dated 11/21/12. Dr. Talakkottur also testified that M.M.'s recorded weight was inconsistent and that he was addicted to pain medication. While there are acknowledged weight inconsistencies in the record, it is clear the patient was obese and his weight was not a factor in his prognosis. As to whether M.M. was addicted to pain medication, Dr. Shega opined that this patient was in severe pain and needed multiple titrations of opioid treatment to manage the patient's pain and attempt to improve his quality of life at the end. While he was dependent on pain medication, there was no evidence M.M. was addicted. Patient M.M.'s terminal condition was documented by his primary care physician, as well as by four hospitalizations in the six months prior to hospice admission, the multiple times he was placed in the IPU or on continuous care during hospice care, his ongoing edema with infections, a hospital admission in July 2012, and a trip to the ER in December 2012. M.M.'s extensive, well-documented comorbidities supported a prognosis of six months or less. For the foregoing reasons, Patient M.M. was Medicaid hospice eligible during all of the dates at issue. AHCA has not met its burden by the greater weight of the evidence that M.M. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Boynton Beach Recipients Patient 2, H.P. Patient H.P. was a 51-year-old female admitted to hospice with a terminal diagnosis of end-stage HIV/AIDS. H.P. had two admissions to hospice: 01/03/11 to 05/16/11; and May 2011 to October 3, 2011. The period that is in dispute is the last eleven days of H.P's first admission: 05/05/11 to 05/16/11. H.P. was discharged for extended prognosis. At the time of admission on 01/03/11, H.P. exhibited pain, diarrhea, poor oral intake, a very low CD4 count, and was weak. She had a history of noncompliance with her plan of care, anemia, chronic pain which included neuropathy from her HIV/AIDS, and a history of blood clots to her leg and her lung. This patient also had a history of kidney stones, depression, seizures, insomnia, frequent UTIs, diabetes, and asthma. On 05/05/11, H.P. was transmitted to an IPU and was simultaneously evaluated for extended prognosis and determined that the patient, on that date, had a prognosis that more likely than not, she would live longer than six months. Vitas began working to discharge this patient on 05/05/11, but was unable to make appropriate accommodations for her until 05/16/11. The discharge of H.P. took longer because H.P. had very few financial resources, had HIV/AIDS, and was Haitian with an alien resident card, all of which complicated the placement process. None of H.P.'s family that was contacted by Vitas would accept H.P. in their home, including her daughter, niece, and sister. H.P. also refused to go to a nursing home. Vitas contacted multiple Assisted Living Facilities (ALFs) and made nine attempts to secure placement, but the ALFs were full or refused to accept H.P. Dr. Shega opined that during this time, the patient had a terminal illness with a life expectancy of six months or less if the terminal illness ran its normal course. Dr. Eisner did not know the specific indicators with regard to prognosticating whether an HIV/AIDS patient had six months or less to live despite being offered as an appropriate peer reviewer. The period at issue was during H.P.'s initial 90-day recertification period. According to the audit instructions provided to some peer reviewers, if any day during a certification period was approved by a peer reviewer, then the entire certification period was to be approved. Dr. Eisner claimed he was not provided this document to perform the audit. Drs. Talakkottur and Komatz, however, were provided such instructions. According to the audit instructions, the period at issue is required to be approved. H.P. was Medicaid hospice eligible during all of the dates at issue. AHCA has not met its burden by the greater weight of the evidence that H.P. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 3, G.L. Patient G.L. was a 54-year-old male, admitted to hospice initially with a terminal diagnosis of adult failure to thrive and later, prostate cancer. The claim period at issue is 02/01/2012 to 12/31/2012. Dr. Komatz testified that during the disputed period, G.L.'s medical records demonstrated the recipient was stable on consecutive visits and exams and was not showing progression of his hospice diagnosis. Dr. Komatz testified that G.L.'s PPS score remained consistently at 50 percent, which, to her, showed the patient was stable at that point in time and was not showing further decline. Dr. Komatz's opinion was also based upon the fact that G.L. was independent with respect to his ADLs. Dr. Shega opined that during this time, the patient had a terminal illness with a life expectancy of six months or less if the terminal illness ran its normal course. Although G.L.'s PPS was stagnant at 50 percent, when coupled with G.L.'s increasing pain and other symptoms, cancer literature indicates that G.L.'s life expectancy was six months or less. Dr. Shega testified that it was his belief that Dr. Komatz did not take into account G.L.'s disease progression as indicated by the ever- increasing pain and increasing dosage of oxycodone given to treat the increasing pain. AHCA demonstrated that the medical records regarding this patient's weight were inaccurate. However, the patient's weight appears to have increased or remained relatively stable. Furthermore, Dr. Shega testified that he could not find any documentation to support the proposition that G.L.'s cancer had metastasized or to support that his prostate cancer had metastasized to the pancreas. The medical records contained in G.L.'s file do not support a finding that the Medicaid hospice eligibility standard was met during the disputed period. Based upon the greater weight of evidence in this case, it is determined that G.L. was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $51,686.51. Patient 5, G.R. Patient G.R. was a 41-year-old female admitted to hospice with a terminal diagnosis of debility unspecified. The claim periods at issue are 02/26/10 to 08/19/11 and 09/28/11 to 12/31/12. At 40 days old, G.R. contracted a measles infection, with a high fever, which had essentially left her disabled for her entire life. She had been nonambulatory and nonverbal for many years prior to her entering hospice care. G.R. was initially admitted to Vitas on 02/26/10. At the time of admission, G.R. had a PPS of 20 percent, was dependent in 6 of 6 ADLs, and had a FAST score of 7f. She exhibited muscle wasting and was nonverbal, disoriented, and drowsy. She had shortness of breath at rest, a Stage I ulcer on her foot, and had a PEG tube due to her high risk for aspiration. Just prior to admission, she had a UTI and was hospitalized. However, those hospital records were not provided to support her initial admission. G.R. also had a history of recurrent pneumonia. She presented extremely contracted, stiff, and weak. Dr. Shega admitted that although a physician's note indicated G.R. had been in a steady decline as she had been previously ambulatory and interactive, G.R., in fact, had been nonambulatory for 15 years prior to her hospice admission. During the first disputed period, shortly after admission, G.R. developed cellulitis around the PEG tube site that required antibiotics. Also, during the first admission, she developed pneumonia, a lower respiratory tract infection, and required Levaquin for ten days. G.R. was discharged for extended prognosis on 08/19/11. She was then seen by Dr. Patrick Kavanaugh, a non- Vitas treating physician, who re-referred G.R. back to Vitas hospice because he believed the patient was hospice appropriate. G.R. was readmitted on 09/28/11 with a terminal diagnosis of cerebral degeneration. She had a PPS of 20 percent, was dependent in all ADLs, had a FAST of 7f, was in a fetal position, contracted and unresponsive, was a very high aspiration risk, had difficulty swallowing, and was noted to have increased congestion. She was on Xanax, Tylenol, Benadryl, and nebulizers. During the second admission period, G.R. had skin breakdown on her left and right heels, had problems with congestion and aspiration, had worsening shortness of breath, and became more unresponsive such that by the end of the second period, she could not track people with her eyes. Skin breakdowns are specific indicators of nutritional impairment. Her condition also worsened such that by the end of the second period, G.R.'s secretion treatment had gone from medication only to also requiring manual suction to prevent aspiration. Dr. Talakkottur stated, in his rationale for denying the dates at issue, that G.R.'s skin was intact, which is inaccurate. Dr. Talakkottur also indicated that the patient's aspiration and congestion was chronic, but failed to take into account that those symptoms worsened over G.R.'s second period of hospice care. AHCA has not met its burden by the greater weight of the evidence that G.R. was not eligible for Medicaid hospice services during the second period in dispute, and it is not entitled to recover an overpayment for that period. The medical records contained in G.R.'s file do not support a finding that the Medicaid hospice eligibility standard was met for the first period in dispute. Based upon the greater weight of evidence in this case, it is determined that this recipient was not eligible for Medicaid hospice services for the first disputed period and that AHCA is entitled to recover an overpayment in an amount to be determined. Patient 6, S.B. Patient S.B. was a 30-year-old male admitted to hospice with a terminal diagnosis of cirrhosis of the liver. The claim period at issue is 10/06/11 to 01/03/12. S.B. was admitted directly to hospice from Broward Health Medical Center where he was hospitalized for liver failure and delirium tremens secondary to alcohol use. Liver failure was exhibited by an international normalized ratio ("INR") of 1.52 and an albumin of 2.2, a total bilirubin up to 28.5, ammonia of 86, and elevated liver function tests. S.B. had an altered level of consciousness and was disoriented. S.B. had a PPS initially of 30 percent that increased to 50 percent shortly thereafter with some ADL difficulty. S.B. had encephalopathy, decreased oral intake, and anemia. Both Dr. Talakkottur and Dr. Shega agree that this patient suffered from delirium tremens, which is basically a severe condition associated with alcohol withdrawal. Patients with liver disease often develop ascites. If the patient's condition is severe, a paracentesis procedure can be performed to remove the fluid. While the recipient was in the hospital, a paracentesis was attempted. S.B.'s paracentesis, however, was unsuccessful because there was no fluid to actually remove. Additionally, Dr. Shega admitted there was no evidence of ascites refractory to treatment in the medical records. Patients with liver disease often develop variceal bleeding, which are enlarged blood vessels in the gastrointestinal tract. If left untreated, the enlarged blood vessels can rupture and cause a patient to bleed to death. A patient with variceal bleeding has an increased risk of a poor prognosis and a more limited life expectancy. Dr. Shega admitted he could not recall evidence of variceal bleeding in the medical records for S.B. Dr. Talakkottur credibly testified that soon after S.B.'s acute episode of delirium tremens for alcohol withdrawal, he returned to being alert and oriented times three. In Dr. Talakkottur's opinion, S.B. could have been more appropriately served in an outpatient setting for his delirium tremens, which, in essence, was episodic. The medical records contained in this patient's file do not support a finding that the Medicaid hospice eligibility standard was met during the disputed period. Based upon the greater weight of evidence in this case, it is determined that this recipient was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $40,025.67. Patient 8, J.F. Patient J.F. was a 60-year-old male, admitted to hospice on 04/15/11, with a terminal diagnosis of cerebrovascular disease. The claim period at issue is 04/15/11 to 09/28/12. J.F. suffered a severe stroke and was hospitalized in March 2011, about a month prior to hospice admission. An MRI showed multiple infarcts that resulted in dysphagia, shortness of breath, confusion with disorientation, and poor oral intake. The patient was then readmitted to the hospital for a gallbladder- related acute infection and, at that point, the patient was referred by a hospitalist for evaluation of hospice services. On admission, J.F. had a PPS of 20 percent with comorbidities of diabetes, hypertension, depression, bipolar disorder, increased lipids, atrial fibrillation, and coronary artery disease. J.F. was extremely overweight. J.F.'s terminal diagnosis of cerebrovascular disease was evidenced by the severe stroke, poor functional status, significant dysphagia, and high risk for aspiration that is known to be associated with a poor prognosis, and two recent hospitalizations. A physician assessment indicated the patient was hospice appropriate and referred J.F. to Vitas indicating that the patient had a terminal disease. Upon admission, J.F. was extremely ill and required continuous care until 05/02/11, with recurrent fevers, shortness of breath, cough, and poor oral intake that ultimately resolved. In September 2011, he was noted to be incontinent, dependent in 6 of 6 ADLs, with a FAST score of 7d. J.F. continued to have issues with the shortness of breath and coughing with meals. In October 2011, he had increased weakness and cough, and his family called 911; and J.F. went to the ER where he was found to have severe bradycardia with a pulse of 48. There was concern the patient might be having a heart attack. The ER physician indicated that the chest x-ray showed cardiomegaly, or an enlarged heart, and also noted that the patient had mild heart failure at the time of admission to the hospital. The patient also had low-grade fever and an albumin of 2.6, documenting very poor nutritional status. From November through December 2011, the patient transitioned from the hospital to home on continuous care to further manage his dyspnea and lethargy. During that time, J.F. continued to have difficulty swallowing and had episodes of apnea for 10 to 20 seconds. From January through April 2012, J.F. had severe depression, was emotionally labile and weak, and still had problems coughing. Dr. Shega testified that depression is a complication of stroke and associated with a higher mortality. J.F. was put on an antidepressant, which improved his agitation and aggression, and he became more compliant with the medication regimen, but continued to have dysphagia. J.F. had high blood pressure and, given the labile hypertension, Vitas was concerned that it would precipitate a stroke. J.F.'s prognosis remained six months or less, so his blood pressure medications were continually adjusted. By the end of August 2012, J.F. demonstrated significant improvement by going from dependent for care in 6 of 6 ADLs, which he was the whole stay, to having the ability to feed himself; he also had improvement in dysphagia at that time. Consequently, Patient J.F. was discharged from Vitas for extended prognosis. J.F. met all applicable criteria for admission to hospice for the disputed period. Dr. Talakkottur also acknowledged that J.F. was acutely ill at admission to Vitas, was dependent in 6 of 6 ADLs until he was discharged, was confined to bed and chair and transferred from bed to chair with a Hoyer lift throughout his hospice stay, was incontinent of bladder and bowel throughout his stay, and had a FAST score that did not improve to better than 7a throughout his stay. AHCA has not met its burden by the greater weight of the evidence that J.F. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 10, A.R. Patient A.R. was an 83-year-old female, admitted to hospice on 1/10/11, with a terminal diagnosis of adult failure to thrive. The claim period at issue is 01/10/11 to 07/02/12. Upon admission, Patient A.R. had a recent ER visit in December 2010 at Columbia Hospital for mental status changes and a UTI, she had a PPS of 30 percent, was bedbound, and required assistance with 6 of 6 ADLs. Also at admission, A.R. had two right foot wounds and was disoriented. She was a nursing home resident in Palm Beach. An order was obtained from the physician for a hospice evaluation and services. A.R.'s comorbidities were mixed dementia of Alzheimer's and vascular disease, with history of stroke, hypertension, hip fracture with repair, coronary artery disease, UTI, pneumonia, diabetes, and increased lipids. A.R.'s weight over the previous five to six months, obtained from the medical record, dropped from 117 to 103 pounds (about a 12 percent loss) with a BMI of 20.5, reduced oral intake along with dysphagia and risk for aspiration on a pureed diet. A.R. had unstageable wounds on her heels in April 2011. She continued to lose weight in May 2011 (as of 5/16/11, she had a weight of 97.5 pounds with poor oral intake) and by July 2011, she continued to have a poor appetite and was known to be pocketing her food. Dr. Shega testified this meant her dementia was so severe that she would forget to swallow, which not only impacted her food intake, but also increased her risk of aspiration. Patient A.R.'s weight continued to decline and then, after her weight got to about 95 pounds, multiple interventions were put in place at the end of September to improve her nutritional status, including increasing her resource supplements to three times a day, and increasing her dosage of Remeron, a known appetite stimulant, as well as an antidepressant. A.R.'s weight increased to 102 pounds in December with a fair appetite, but still noted dysphagia and pocketing food. By January 2012, A.R.'s weight increased slightly, then decreased to 100 pounds, before increasing back to 103 pounds. Her weight then decreased to 97 pounds in February 2012, documenting A.R.'s extremely unstable condition. In April 2012, A.R. continued to have dysphagia on a pureed diet and a poor appetite. By June and July 2012, A.R.'s weight stabilized around 100 pounds, and she did not appear to be declining; consequently, she was discharged from Vitas for extended prognosis. Dr. Shega testified that Patient A.R. also had progressive contractures due to her severely debilitated condition. Dr. Shega noted that at each recertification period, A.R.'s prognosis was six months or less if her illness ran its usual course. A.R.'s fluctuating weight, as much as three to five percent per month at times, created a poor prognosis and put her at high risk of death, and she met Medicaid hospice eligibility without having documented ongoing infections or fevers. Dr. Talakkottur acknowledged that, during her entire hospice stay, Patient A.R. was on a pureed diet and required crushed pills due to dysphagia; and as a precaution against aspiration, was dependent in 6 of 6 ADLs, was confined to bed and chair, was incontinent of bladder and bowel, had a FAST level of no better than 7a, and had a PPS never higher than 40 percent. AHCA has not met its burden by the greater weight of the evidence that A.R. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 13, W.G. Patient W.G. was a 61-year-old male, admitted to hospice on 10/19/09, with a terminal diagnosis of end-stage cerebrovascular disease. The claim period at issue is 10/19/09 to 06/12/12. W.G. suffered a stroke in his 50s. Between 07/29/09, and 10/19/09, his nursing home requested he be evaluated for admission to hospice care. Vitas completed two Appropriateness Evaluation forms during this period for W.G. and, on both occasions, Vitas concluded that he was not eligible to receive the hospice benefit because his condition simply was not terminal. Ultimately, on 10/19/09, W.G. was admitted to hospice care with a reported terminal diagnosis of end-stage cerebrovascular disease. Respondent altered his terminal diagnosis to debility on 10/20/09. Dr. Shega opined that W.G. was eligible for hospice services because the patient had an ER visit prior to admission, became wheelchair bound, and had worsening dysphasia requiring an endoscopy. However, Dr. Shega admitted that the hospital visit and the endoscopy procedure both preceded the two Appropriateness Evaluations where Respondent failed to certify W.G. as eligible for hospice care. Moreover, the two Appropriateness Evaluation forms where Respondent declined to certify W.G. as eligible list his PPS score as 40 percent, yet the third Appropriateness Evaluation by which Vitas certified W.G. as eligible for hospice lists his PPS score as 30 percent. Notably, however, the next time W.G.'s PPS score is recorded in Vitas' records, it is back up to 40 percent. In this case, it is clear from W.G.'s medical records that he did not evidence deterioration in his nutritional status, pain control, breathing, or complication of his cardiovascular condition. Although W.G. received continuous care (a higher level of hospice medical attention) on occasion, W.G. returned back to his baseline status after each time of heightened care. Dr. Talakkottur credibly testified that patients who experience a stroke can have residual deficits, i.e., they may not be able to move an entire side of their body or walk, yet they live with the deficits for 20 or 30 years. In Dr. Talakkottur's opinion, W.G. was such a recipient who experienced deficits, yet he did not have a terminal diagnosis with a life expectancy of six months or less to live. Based upon the greater weight of evidence in this case, it is determined that this recipient was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $169,928.96. Patient 14, A.G. Patient A.G. was a 58-year-old male, admitted to hospice on 05/31/12, with a terminal diagnosis of end-stage liver disease. There are two claim periods at issue: 05/31/12 to 08/20/12 and 08/28/12 to 12/31/12. Patient A.G. was hospitalized at Broward Health on 05/18/12 with abdominal pain, imaging documenting cirrhosis with splenomegaly, no ascites, but significant liver dysfunction evidenced by a low platelet count, which supported portal hypertension associated with cirrhosis, elevated ammonia of 127, an INR of 1.4, albumin of 2.6, and a total bilirubin of 1.5. Chronic pancreatitis was also present and the patient had an elevated lipase of 392. A.G. had an altered level of consciousness with lethargy, and was at risk for aspiration. At admission A.G. was oriented times zero and only minimal arousal to painful stimuli. A.G. demonstrated a significant decline in liver function with encephalopathy, and the patient's primary care physician, who knew the patient very well, indicated that he thought A.G. had deteriorated and was hospice appropriate. Dr. Shega further testified that A.G. was Medicaid hospice appropriate at the time of admission to Vitas because the patient's laboratory values indicated severe liver dysfunction, including the INR and the albumin, along with elevated ammonia to corroborate the patient's confused mental status. A.G.'s clinical progression was documented by the primary care provider noting that the disease had taken a turn for the worse. Although the patient's weight was 188, he had an albumin of 2.5, which is very low, and demonstrated a decline in functional status with a PPS of 50 percent and some ADL impairment, which supported Dr. Shega's opinion that the patient had a prognosis of six months or less if the illness ran its normal course. During A.G.'s initial stay in hospice from 05/31/12 to 08/20/12, he had changes in mental status and lethargy indicative of hepatic encephalopathy. He also had dyspnea. Patient A.G. had two continuous care episodes: the first for lethargy and the second for pain and shortness of breath. He also required an IPU stay. Just prior to A.G. coming off service, he had an episode of thrush on 08/07/12 that required treatment with nystatin. Thereafter, A.G. went missing and was subsequently noted to be incarcerated. Being incarcerated does not disqualify a patient from Medicaid hospice eligibility. A.G. was readmitted to Vitas hospice on 08/28/12. Dr. Shega testified that A.G. was Medicaid hospice eligible at that time because he had lost weight from 188 to 180, continued to have abdominal pain rated 8 of 10, had shortness of breath with minimal exertion, had ascites, abdominal distension, and lower extremity edema. From 08/28/12 to 12/31/12, A.G. was dependent in 3 of 6 ADLs, his PPS score decreased to 40 percent, then to 30 percent, he had a poor appetite, and while his weight increased to 185 pounds, he continued to have lethargy, occasionally having shortness of breath with activity. By 12/31/12, his weight had decreased to 170 pounds. Dr. Shega testified that A.G. was eligible for Medicaid hospice services during the second admission period. On 11/17/12, the patient was receiving methadone at ten milligrams every eight hours for pain, which is a high dose, and he continued to need breakthrough medication for pain. A.G. continued to have shortness of breath with activity and continued to have weakness, nausea and vomiting, 3 of 6 ADL dependency, and a PPS of 40 percent. A.G.'s treating physician believed the patient was still hospice appropriate because of the ongoing pain requiring methadone for management, the shortness of breath with oxygen, and the nausea and vomiting which required an inpatient stay. Dr. Talakkottur acknowledged that while A.G. presented with an INR of 1.4 and an albumin of 2.6, a normal INR is 1.1 or below and a normal albumin is 3.5 or above. Consequently, A.G.'s INR and albumin levels were well outside of normal. Dr. Talakkottur also acknowledged A.G. had an altered mental status and lethargy, dysphagia, chronic pancreatitis, and comorbidities of congestive heart failure, COPD, diabetes, cirrhosis, hepatitis C, gallbladder disease, depression, schizophrenia, drug and alcohol abuse, a history of suicide attempts, and needed assistance with bathing and toileting. Dr. Talakkottur agreed that a patient is not disqualified from Medicaid hospice eligibility because of a past incarceration or for being a drug addict. Talakkottur acknowledged that A.G. also had ascites, edema, a PPS score that declined to 40 percent, and required oxygen. AHCA has not met its burden by the greater weight of the evidence that A.G. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 15, L.C. Patient L.C. was a 50-year-old female, admitted to hospice on 09/15/10, with a terminal diagnosis of stomach cancer (malignant neoplasm of the stomach). The four claim periods at issue are 09/15/10 to 10/26/10; 11/07/10 to 02/09/11; 03/11/11 to 03/24/11; and 03/23/12 to 04/05/12. Patient L.C. had a rare type of stomach cancer. Dr. Shega testified that in patients who have a more diffuse disease that is inoperable, the five-year survival rate is about 40 percent with treatment--if they pursue treatment--but the survival rate is unknown if the patient does not pursue treatment because most patients elect to pursue treatment. However, L.C.'s cancer was inoperable, which, by definition, means it was already diffuse. Patient L.C. had chemotherapy treatment on 09/06/10, prior to the first admission, and thereafter elected comfort care over more anti-tumor treatment. At the appropriateness evaluation, her PPS was 50 percent. Her previous weight four to five months prior to the first admission was 160 pounds and her weight at admission was 145 pounds, or a 9.4 percent weight loss. Patient L.C.'s BMI was 23.4. She reported 10 of 10 pain and had presented to the North Broward Medical Center ER with severe pain and was directly admitted to the Vitas IPU from the ER. In addition to pain, Patient L.C. reported poor oral intake and unintentional weight loss. L.C.'s primary care physician signed the oral certification of a prognosis of six months or less and was the attending physician for the patient. The Vitas medical director approved the admission, and given her underlying mental health, recommended a psychology consult and the use of methadone as the long-acting opioid to try to manage her pain. L.C. was seen by her primary oncologist, who referred the patient for hospice services and agreed with the admission. Patient L.C. had a history of Hepatitis C; hypothyroidism; schizoaffective disorder; bipolar disorder; a longstanding history of substance abuse; including crack cocaine; multiple suicide attempts; hypertension; tobacco use; and COPD. During the first period at issue, 09/15/10 to 10/26/10, Patient L.C. developed abdominal symptomatology, including pain, nausea, vomiting, cramping, and had underlying psychological/psychosocial challenges. L.C. was in the IPU for pain control for several days and then transitioned home, continued to have pain and titration of some of the medications, was switched from methadone to a Fentanyl patch due to some concerns in the home with possible diversion and abuse. L.C. then went to the IPU for an extremely high heart rate. Her PPS fluctuated, going as high as 80 percent. However, Dr. Shega testified that studies show that a high PPS score is still supportive of a terminal prognosis in cancer patients not receiving antitumor therapy. On 10/26/10, L.C. revoked services to pursue more aggressive treatment in the hospital, no longer wishing to follow the hospice plan of care. Patient L.C.'s second admission in Vitas hospice began on 11/07/10. Just prior to that, she was in the hospital and then readmitted to hospice service in her home. Her PPS was back down to 50 percent. Her previous weight had been 145 pounds and was now reported to be 130 pounds, with a BMI of 22, or a ten percent weight loss. L.C. reported 10 of 10 pain. While L.C. was in the hospital, she received one treatment with Gleevec, an antitumor treatment, and was then sent back for hospice services. Her case was discussed with her oncologist who agreed with the readmission to hospice. During the second period, 11/07/10 to 02/09/11, Patient L.C. was admitted to the IPU for pain, continued to have cachexia, her weight fluctuated, and she needed more Fentanyl to control her pain. She had substantial symptoms, including weight loss, muscle wasting, pain, shortness of breath with activity, agitation, depression, anxiety, early satiety, and nausea. Although L.C.'s PPS rose to 80 percent, she had a substantial symptom burden and was hospice appropriate. L.C. was discharged from Vitas hospice for not following the plan of care on 02/09/11. Patient L.C. began her third admission in Vitas hospice on 03/11/11, which lasted until 03/24/11. At the time of admission, L.C. was at home, had a PPS of 60 percent, her weight had decreased to 110 pounds, with a BMI of 18, reported 10 of 10 pain, and decreased oral intake. During the third admission, L.C. was admitted to the IPU. After the IPU admission, the patient was home for a very short period of time and came back to the IPU, but, ultimately, was discharged again for not being compliant with the plan of care. L.C. was readmitted to Vitas hospice for the fourth time on 03/23/12, until she was discharged again on 04/05/12, for not following the plan of care. Just prior to this fourth admission to Vitas, L.C. was on Heartland Hospice, and had been hospitalized at Holy Cross Hospital. At that time, when she ultimately revoked services from Heartland and transitioned to Vitas hospice, she had a PPS of 30 percent. Her weight was 110 pounds. A CT scan dated 03/21/12 noted that the patient had a large heterogeneous necrotic mass, which meant the mass was so big it outgrew its blood supply and the tumor cells died. It measured 20.5 by 20.5 by 20 centimeters (which is the size of two grapefruits) in the upper abdomen, compatible with malignancy or metastasis, origin uncertain. The mass encased portions of the stomach. Obstruction could not be excluded. L.C. had lost significant body weight, but her tumor's growth was leaving her weight the same. She also lost significant muscle mass. Dr. Shega testified that he had seen that occur several times in patients with this type of tumor. L.C.'s cancer was metastatic and the Vitas admission nurse noted on 03/22/12 that her treating physician in the hospital found that she had a days to a week prognosis that was very grim. During the brief fourth admission, L.C. had a large symptom burden and struggled while in the Vitas IPU trying to control her pain. Contrary to the opinion expressed by Dr. Talakkottur, the fact that L.C. may have been a drug addict had no bearing on whether she was terminally ill or her prognosis. AHCA has not met its burden by the greater weight of the evidence that L.C. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment for the four periods in dispute. Patient 17, D.D. Patient D.D. was an 84-year-old female initially admitted to hospice with a terminal diagnosis of adult failure to thrive. The three claim periods at issue are 09/27/10 to 03/21/11; 05/20/11 to 12/12/12; and 12/15/12 to 12/31/12. On 09/20/10, D.D. was admitted to the hospital for upper abdominal pain, nausea, vomiting, and was diagnosed with pancreatitis, complicated by a pseudocyst. Pseudocysts are associated as a complication of pancreatitis and associated with a significant mortality, particularly in older adults. Upon her initial admission to hospice, D.D. had a PPS of 30 percent, was dependent in 6 of 6 ADLs, bilateral lower extremity contractures, a weight decrease of 190 to 170 pounds, and an albumin of 2.1, which was consistent with severe protein calorie malnutrition. She also exhibited muscle wasting with a Stage II ulcer on her coccyx/sacrum that was open and draining. She had symptoms of abdominal pain, shortness of breath with exertion, decreased appetite, and bilateral lower extremity edema. She was considered at risk for aspiration, had a history of pneumonia, and had a UTI within the six months preceding admission. Patient D.D. also had a history of dementia, cholelithiasis with increased liver function tests, diabetes, arthritis, osteoporosis, reflux, and hypertension. D.D. was incontinent and confused. D.D. left hospice care on 03/21/11. She was experiencing a life-defining condition of a small bowel obstruction and a UTI that, if not treated at an acute care hospital, would have caused her death. Instead, her family elected to revoke the hospice benefit and pursue aggressive treatment. D.D. returned to Vitas hospice care on 05/20/11. She had again been admitted to the hospital with the small bowel obstruction, secondary to recurrent pancreatitis, along with complications from a COPD exacerbation that required IV steroids, bacteremia that required IV antibiotics, and anemia requiring a blood transfusion. At the second admission date, she had a PPS of 30 percent, was dependent in 6 of 6 ADLs, had contractures, and weighed 150 pounds. Her albumin was noted during her hospital stays at 1.9 to 2.1, again documenting severe protein calorie malnutrition. She had two right leg wounds, was a high risk for aspiration and had a very poor appetite with little oral intake. She had hypotension and was noted to have been in a steady decline for the past year. On 07/26/11, D.D. developed an acute infection that required antibiotics with Keflex. On 12/15/11, D.D. experienced shortness of breath requiring oxygen and pedal bilateral edema at two to three. On 04/09/12, three days after D.D. had a UTI, she experienced difficulty swallowing, profound muscle wasting, and was at grave risk of infection and skin breakdown. Her muscle wasting had progressed to bilateral temporal wasting. The Vitas physician noted that "[t]he patient is only alive today due to the excellent care given by her family as her debilitated state continues to put her at grave risk of infection and skin breakdown." On 07/11/12, D.D. was again seen by a Vitas physician. On this date, it was noted D.D. was becoming weaker with unexplained weight loss. On 08/22/2012, D.D. was seen by a Vitas physician who noted she continued to lose weight, was bedridden, and continued to decline. The patient was eating less, needed total care with ADLs, and had a history of UTIs. The Vitas physician stated: "[t]he patient is getting weaker. I saw the patient because the patient was weaker, and the patient, according to the daughter, is more lethargic all the time." In October 2012, D.D. had intermittent wounds including Stage II wounds on her back and right foot. During that month, the family also requested additional assistance taking care of D.D. at home, which is a service Vitas provides and is required to provide by statute. She then had another wound develop on 11/19/12. On 12/12/12, the family again revoked hospice. At that time D.D. developed a life-defining episode of diverticulitis. She had blood in her stool and was put on IV antibiotics in the hospital. She had an electrocardiogram ("EKG") which showed an atrial arrhythmia. Her hemoglobin was all the way down to 7.2--the normal range is 11 to 12. A hemoglobin of 7.2 is a severe level indicative of needing transfusions to prevent cardiac damage. Without an aggressive level of care, she most likely would have died. D.D. returned to hospice care on 12/15/12. At this time her terminal diagnosis was debility. She continued to be bedbound, contracted, dependent in all of her ADLs, with a PPS of 30 percent. Her albumin drawn from her latest hospitalization was still low at 2.7. She also had slightly worsening dysphagia. AHCA has not met its burden by the greater weight of the evidence that D.D. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment for the periods in dispute. Patient 18, M.S.V. Patient M.S.V. was a 77-year-old female admitted to hospice with a terminal diagnosis of respiratory failure. The three claim periods at issue are 06/28/11 to 08/10/11; 03/22/12 to 05/03/12; and 05/11/12 to 07/03/12. On 05/21/11, M.S.V. was admitted to the hospital with respiratory failure secondary to chronic obstructive pulmonary disease and interstitial lung disease, resulting in a very prolonged ICU stay. She had a tracheostomy and a PEG tube placed at that time. Her albumin was below normal at 2.7. She also had a pH of 7.11, which means her blood level was acidic instead of normal, which put her tissues at increased risk of death, such as heart arrhythmias. She also had a UTI and was on a ventilator. Her carbon dioxide level was 193--normal is 40--and her oxygen level was low at 64. Dr. Shega stated that studies show that when a carbon dioxide level ("PCO2") is over 75, the patient is admitted for acute exacerbations, sent to the ICU, and put on a ventilator, the six-month survival rate is 33 percent. In the months leading up to this hospitalization, M.S.V. had a GI issue that led to her having a colostomy. The colostomy was reversed during that hospital stay. The patient also had a history of tuberculosis, hypertension, and anemia. On 06/29/11, a non-Vitas physician certified M.S.V. had a life expectancy of six months or less. This was her primary care physician and attended the patient while in hospice. Her PPS was 30 percent at admission. A PPS below 70 percent is appropriate for hospice admission according to HI's instructions. During the first dates at issue, M.S.V. was admitted to the IPU and had challenges with secretions and choking and needed suctioning. She also had low-grade fevers during her IPU stay and episodes of tachypnea. She subsequently improved and was discharged for extended prognosis. M.S.V was readmitted to Vitas on 03/22/12. Prior to this, M.S.V. was admitted to the hospital with severe respiratory distress, was in the ICU again, was on a ventilator with a pseudomonas pneumonia that was complicated by a clostridium difficile colitis, a very severe infection of the large colon. On 03/31/12, M.S.V. needed five liters of oxygen on the trach collar, which is a substantial amount of oxygen, continued to have cough, secretions, congestion, and needed to be suctioned three times a day to remove green secretions. On 04/14/12, M.S.V. had confusion, was forgetful, and had dyspnea. She had rhonchi, cough, secretions, congestion with dyspnea, was still on five liters of oxygen, had abnormal lung findings and still required suctioning. She was on continuous care at that time. Continuous care is provided when a hospice patient has substantial skilled needs to manage their symptoms. Therefore, the hospice placed a nurse in the patient's home up to 24 hours a day to manage those symptoms. On 04/16/12, M.S.V. experienced shortness of breath and was very dyspneic with any type of exertion. She had weakness and required assistance with all ADLs. On 05/03/12, M.S.V. revoked hospice care. She had been in the IPU with a severe exacerbation of her respiratory symptoms requiring a seven-day course of Levaquin to help treat the increased secretions. She was also started on Prednisone for COPD exacerbation. She continued to struggle with secretions and near the end of the stay, she was having more lethargy, confusion and congestion. She revoked hospice care to seek aggressive care in the hospital. On 06/19/12, M.S.V. was seen at an acute care hospital and was diagnosed by a non-Vitas physician with end-stage pulmonary fibrosis. M.S.V.'s terminal diagnosis during the third period at issue was end-stage pulmonary fibrosis. On 06/20/12, M.S.V. had a heart rate of 124, which was markedly elevated with 100 being the upper limit of normal. She also had an elevated respiratory rate, was confused, agitated, somnolent, trying to take off her oxygen, and required Thorazine and Ativan to help control her symptoms. She had orthopnea, wheezing, cough, secretions, congestion, diminished breath sounds, required suctioning times four of thick yellow mucus, and was on continuous care and five liters of oxygen. M.S.V. developed respiratory infections during both the second and third claim periods in dispute. On 07/03/12, M.S.V. developed a temperature of 100.5, had agitation, anxiety, shortness of breath, increased congestion and increased lethargy. Her PPS was 30 percent at that time. She also was on Ativan and Thorazine and on eight liters of oxygen. She was congested with rhonchi, wheezes, rales, and dyspnea. She had shortness of breath at rest. She needed suctioning and was started on antibiotics. M.S.V.'s family then revoked hospice care for aggressive treatment. Dr. Talakkottur opined that because M.S.V. did not have increased ER visits, she was not showing evidence of decline. However, M.S.V. was hospitalized three times surrounding the dates at issue, had multiple instances of IPU and continuous care during hospice, and experienced multiple infections. Dr. Talakkottur also did not follow the standard of the Florida Handbook in that he denied a period due to no "significant" deterioration in the patient's condition. This is not a guideline for hospice eligibility--clinical progression of the terminal disease is a guideline. That progression is not required to be "significant" by any metric. AHCA has not met its burden by the greater weight of the evidence that M.S.V. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment for the periods in dispute. Patient 29, R.S. Patient R.S. was a 62-year-old male initially admitted to hospice with a terminal diagnosis of cerebral degeneration. The claim period at issue is 06/21/11 to 07/08/11. During the lead up to the dates at issue, R.S.'s status began to improve and Vitas was undertaking a review to determine if discharge was appropriate. On 06/21/11, R.S. suffered a fracture of the right clavicle while in an assisted living home. Fractures alone are associated with subsequent increased mortality in older adults (over age 60). In older adults, the fracture alters their homeostasis because they have homeostenosis. Any small change in the person's condition can lead to dramatic subsequent outcomes that increase the risk of mortality. The cause of death after the fall is variable, but it is often related to conditions, such as R.S.'s underlying condition. R.S. suffered from comorbidities of dementia, hypertension, paranoid schizophrenia, a history of seizures, benign prostatic hypertrophy of the prostate, a history of dysphagia, history of substance abuse, increased lipids, reflux, and a history of coronary heart disease. R.S. was also confused, nonverbal, and on oxygen. On 06/30/11, R.S. was a fall risk, was supervised at all times, and his mobility had substantially declined. R.S. was on Ativan to treat his anxiety and agitation, which also increased the fall risk and the risk of aspiration. Ativan was a new medication for R.S. prescribed to treat the anxiety and agitation and increased the risk of subsequent aspiration. Dr. Shega testified that agitation is a known manifestation of pain in persons with dementia. Particularly in a nonverbal patient who cannot say it hurts, he/she has to express himself/herself other ways. The American Academy of Neurology Guidelines for care of persons with dementia state that clinicians need to assess patients for pain and that includes agitation and dementia. R.S. was on morphine and Tylenol and then also on the Ativan to help control the agitation; however, all those medications can increase risk of aspiration. On 07/08/2011, R.S. was transferred to the ER for choking. He was in respiratory failure when he arrived and died shortly thereafter. Dr. Shega opined that the cause of death was related to his terminal diagnosis as fractures in patients with advanced dementia often change the trajectory of their illness and dramatically increases their likelihood of dying within six months. Dr. Talakkottur acknowledged that dementia patients can progress to the point that they can no longer swallow. It was undisputed that R.S. died of choking. Dr. Talakkottur inaccurately saw no correlation between R.S.'s fracture and his demise the following month. Dr. Shega's testimony was more credible than that of Dr. Tallakottur. AHCA has not met its burden by the greater weight of the evidence that R.S. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 21, A.D. Patient A.D. was a 63-year-old male admitted to hospice with a terminal diagnosis of adult failure to thrive. The claim periods at issue are 10/21/09 to 03/24/10 and 05/13/10 to 02/28/11. Just prior to hospice admission, A.D. had been hospitalized for heart failure which required a BiPAP. At admission to hospice, A.D. had a PPS of 30 percent, weight that had decreased from 150 to 140 pounds, a BMI of 22.2, shortness of breath at rest and with minimal exertion, lower abdominal pain, weakness, and difficulty ambulating. A.D. had comorbidities of COPD; polysubstance abuse including cocaine; marijuana; alcohol; and tobacco; hypertension; atrial fibrillation; coronary artery disease with stents being placed; gastroesophageal reflux disease; medical noncompliance; increased lipids; and depression. A.D. was certified to have a prognosis for a life expectancy of six months or less if the terminal illness ran its normal course by the independent third-party physician who treated A.D. in the hospital. On 10/22/09, A.D. was noted to have an EF of 15 percent. EF alone is not a predictor of reduced life- expectancy. Dr. Shega noted that it is the relationship between the EF and the patient's symptom burden that predicts increased mortality and hospice appropriateness. Dr. Talakkottur testified that a normal EF is above 55 percent. On 10/23/09, A.D.'s respiratory rate was elevated at 24. He was hypotensive with a blood pressure of 90 over 60, required morphine for pain, was lethargic but arousable, had chest pain, was on oxygen, and was short of breath with exertion. On 12/08/09, A.D. was placed on continuous care. He experienced dizziness when he sat up, which Dr. Shega opined was probably related to the patient's low blood pressure of 80 over 50, consistent with a severe NYHA Class. On 03/24/10, A.D.'s terminal diagnosis was changed to end-stage heart disease. He had chest pains and an extremely low heart rate of 40. A.D. revoked hospice care and was admitted to the acute care hospital with a severe life-defining infection in the defibrillator pocket. An infection of a pacemaker is a rare occurrence. A.D. required a transesophageal echo on 14/15/10. A transesophageal echo is a probe down the patient's esophagus to determine how the heart is functioning. Usually, a transesophageal echo is done when there is concern about endocarditis or infection of the heart valves. On 05/13/10, A.D. was readmitted to Vitas. His EF was again 15 percent and his PPS was 30 percent. He was drowsy, was an aspiration risk, and was NYHA Class IV with chest pain and dyspnea at rest and exertion. Symptoms of heart disease are not just shortness of breath. They also include chest pain, fatigue, weakness, or palpitations. At the second admission, A.D. was again certified to have a prognosis for a life expectancy of six months or less if the terminal illness ran its normal course by the independent third-party hospital physician. He received morphine for shortness of breath and still had shortness of breath with exertion. During the second period at issue, A.D. had a trajectory very consistent with end-stage heart disease with intermittent periods of shortness of breath or chest pain at rest or with minimal exertion. At times, he would show minor improvement in cardiac status, then decline. He did gain weight during this period but continued to exhibit NYHA Class III and Class IV disease status. He became weaker and spent more time in bed. His nutritional status improved, but other parameters fluctuated or remained end-stage, particularly the NYHA Class. He also experienced hypotension. A.D. ultimately passed away in hospice during an approved period. A study done by Joan Lunny published in the Journal of the American Medical Association("JAMA") on heart failure and end-stage lung disease patients showed that the patients have exacerbations, get worse, then improve. They may plateau. They may improve a little, but will then get worse again. This is visually displayed in the HI presentation "The Role and Function of Hospice Reviewers, "which depicts via a line graph the saw- tooth nature of the progression of the diseases. (Vitas Ex. 4). A.D. disease trajectory followed this chart. Dr. Talakkottur stated that A.D. showed no signs of acute cardiac disease at either admission, which is contrary to the medical records showing he had NYHA Class III or IV symptoms at both admissions. Dr. Talakkottur also stated that a low EF was not concerning in this patient because it could rebound in six months. However, as indicated above, A.D.'s EF was at 15 percent on the date of each admission, 10/21/09 and 05/13/10. Dr. Talakkottur also stated that this patient was not terminal as evidenced by a lack of increased utilization of health care, such as ER visits and hospitalizations. However, the patient had been hospitalized just prior to each admission to hospice. AHCA has not met its burden by the greater weight of the evidence that A.D. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment for the periods in dispute. Patient 23, S.V.D. Patient S.V.D. was a 44-year-old female admitted to hospice with a terminal diagnosis of end-stage liver disease with cirrhosis. The claim period at issue is 12/03/10 to 07/30/11. Just prior to hospice admission, S.V.D. had been hospitalized for vaginal bleeding, with a hemoglobin down to 2.5, which caused her to be admitted to the coronary care unit where she had a procedure in the hospital to help mitigate future bleeding, including an ablation and a dilation and curettage. She had an INR of 1.5 and an albumin of 2.1. She was jaundiced and had a bilirubin of 6. The upper range of normal for bilirubin is 1.1. She had a history of encephalopathy and multiple paracentesis. A paracentesis performed 11/29/10 removed five liters of fluid and a subsequent paracentesis on 12/03/10 removed four liters. Dr. Talakkottur opined that J.V.D. was not hospice appropriate because she failed to display signs of a terminal prognosis. Her PPS scores were between 30 and 50 percent, she was alert and oriented on the order of two to three, and she was able to ambulate throughout the period. Moreover, her albumin rose to 3.4, which was an improvement and marker of liver function. She had no recurrent or intractable infections, no respiratory problems, and her nutritional status remained good. However, upon admission, S.V.D. had an extremely elevated ammonia level, progressive malnutrition, and continued to use alcohol. She had a PPS of 40 percent, a BMI of 21.5, muscle wasting, weakness, shortness of breath, and a poor appetite. While the normal range for ammonia is 20 or less, S.V.D.'s ammonia level was 74. A BMI of 22 or less is considered significant nutritional impairment. On 12/03/10, a non-Vitas physician certified that S.V.D. had a life expectancy of six months or less if the terminal illness ran its normal course. On 12/08/10, S.V.D. had an INR of 1.53. This was drawn because S.V.D. needed another paracentesis, which occurred in the Vitas IPU on 12/09/10, and removed 1.5 liters of fluid. During the period at issue, S.V.D. exhibited impaired nutritional status with weight loss and muscle wasting, including bilateral temporal wasting. She also had jaundice, fatigue, periods of confusion, and encephalopathy. On 05/18/11, S.V.D.'s weight had decreased to 104 pounds with continued muscle wasting and bilateral temporal wasting with a poor appetite. She may have been abusing alcohol and was having worsening leg pain, probably from peripheral neuropathy related to alcohol. She had shortness of breath with minimal activity, was sometimes sleepy, alert and oriented, times two, with periods of confusion, which supported a diagnosis of encephalopathy. She required more assistance with ADLs and her PPS was 30 percent. S.V.D. had progression of her disease and was more easily fatigued, lost muscle mass, ascites, decreased appetite and weight loss, was sleeping sometimes for a whole day, and at times was too tired to eat. Dr. Talakkottur testified that S.V.D.'s nutritional status improved. Although her appetite did improve after the dates at issue, during the dates at issue, it was severely compromised. He also stated that he could not find any evidence of a compromised nutritional status. This statement was patently refuted by the record. Dr. Talakkottur argued as a reason for denying eligibility that the patient did not have further paracentesis. However, when the third paracentesis was drawn on 12/09/10, after admission to hospice, the fact that no future paracentesis would be drawn was not known. This is the type of revisionist review that is improper and cannot be used to deny eligibility after the fact. AHCA has not met its burden by the greater weight of the evidence that S.V.D. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 24, S.K. Patient S.K. was an 86-year-old female, admitted to hospice with a terminal diagnosis of end-stage cerebral degeneration. The claim period at issue is just over seven months, from 05/10/12 to 12/31/12. Patient S.K. had two recent hospitalizations to Northwest Medical Center for lower extremity cellulitis on 02/20/12 and on 05/04/12, just prior to admission. The patient had functional decline. In the hospital, her PPS was noted to be 20 percent. She became bedbound within the previous nine months. Before that, she was ambulatory. She had upper and lower contractures. She was described as lethargic with a FAST at that time of 7d. She was dependent in 6 of 6 ADLs, with a weight of 78 pounds and a BMI of 14.2. She had muscle wasting, along with anorexia, incontinence, cachexia, and poor appetite. S.K. also had dysphagia, was on a pureed diet, and was at risk for aspiration. The patient had Stage II pressure wounds to the right hip, right toe, and knee. Patient S.K.'s past medical history included dementia, hypertension, DVT of the right lower extremity, and a pressure ulcer of the right hip. Dr. Shega testified that Patient S.K. met the criteria for Medicaid hospice because she had two recent hospitalizations for infections; progression of her disease; functional decline with wounds; impaired nutritional status; with BMI markedly low at 14.2; a PPS at admission of 20 percent likely related to lethargy; and documentation that nine months prior, the patient essentially became bedbound. All of that documentation together indicated that she went from a chronic illness to end-of-life. Patient S.K.'s non-Vitas attending physician signed the oral certification that concurred the patient had a terminal illness with a life expectancy of six months or less if the illness ran its normal course and authorized Vitas to evaluate and admit the patient to the program. After S.K. was admitted to Vitas hospice, she experienced lethargy and low-grade fevers consistent with likely aspiration that slightly improved, and then she developed thrush in the first benefit period, which impacted her ability to swallow and eat. The thrush was appropriately treated. Thrush only happens in usually severely immunocompromised patients. She would cough when she ate, indicating her high risk of aspiration. In July 2012, S.K. was dependent in all ADLs. Her PPS was 30 percent, her FAST level was 7f, she had a Stage III wound, was nonverbal, was eating 50 to 60 percent of small meals, and had visible weight loss. She was in pain when being moved. She developed a wound on the right foot that had bloody drainage, so she had a hip wound and a foot wound. Her caregiver reported she slept most of the day, stared at the ceiling, and continued to document end-stage cerebral degeneration. S.K.'s hip wound resolved in August 2012. In October 2012, the patient developed another episode of thrush, again documenting her poor status. S.K. had dysphagia and coughed when getting liquids, which meant that when the patient was drinking, she was coughing, which dramatically increased her risk of aspiration because she was having a hard time controlling the texture; and at any time, it could get into her lungs and cause pneumonia or asphyxiation. S.K. was recertified as Medicaid hospice eligible on 10/27/2012. S.K.'s MMA had decreased, she remained bedbound with cachexia and muscle wasting, she was eating about 50 percent, she continued to need to be fed, she was given Percocet for pain as needed, had shortness of breath with oxygen as needed, her wounds had resolved, and she was at very high risk for infection given her bedbound status, severe malnutrition, and inability to care for herself. S.K.'s PPS remained at 30 percent, and she was dependent in 6 of 6 ADLs. Her home health aide visits had to be increased to seven times a week to help support the patient and family. Dr. Talakkottur acknowledged that Patient S.K. remained at a FAST level above 7, a PPS score of 30 percent or below, was incontinent of bladder and bowel, had dysphagia and was bedbound, and was 6 of 6 ADLs during the entirety of the dates at issue. S.K. met the disease specific criteria from the LCD for dementia and related disorders. As noted above, she had a FAST score above 7c, which indicates she was speaking six words or fewer, was 6 of 6 ADLs, and was incontinent. AHCA has not met its burden by the greater weight of the evidence that S.K. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 26, E.E. Patient E.E. was a 59-year-old male, admitted to hospice with a terminal diagnosis of end-stage liver disease. The claim period at issue is 09/01/09 to 04/30/10. E.E. had two hospitalizations for ascites and paracentesis prior to his stay in Vitas hospice. Upon admission, E.E. had a distended abdomen with 8 of 10 pain. E.E.'s skin was slightly jaundiced, he had a very poor appetite, and reportedly had not eaten in three days. The family and patient also reported issues with bloody noses and periodic bloody stool. At that time, the patient had a reported weight loss from 180 to 160 pounds or 11 percent of his body weight. E.E. was dependent in 5 of 6 ADLs, a PPS of 40 percent, dyspnea with rest and exertion, and confusion On 09/02/09, E.E. had two plus edema noted in his feet. As of 09/17/09, Patient E.E. had shortness of breath with activity and at rest. From a cognitive perspective, E.E. was confused at times and forgetful. He had bilateral edema in the extremities, was incontinent, under fall precautions, needed help setting up his food, and had very poor skin turgor with easy bruising indicating challenges with coagulation. Patient E.E. was extremely anxious, needed to be placed on an antibiotic for cellulitis, and was started on Aldactone for worsening edema. As of 11/30/09, while E.E.'s weight from admission in June increased from 160 to 180, his PPS remained at 40 percent, and he was having more pain in the abdomen related to ascites. The abdomen was described as distended. He continued to have confusion, forgetfulness, and agitation at times. E.E. also had lower extremity edema and now shortness of breath. E.E. was now on Lasix in addition to the Aldactone to try to control his edema. He continued to have a poor appetite. He was on lactulose to help manage his encephalopathy, which would not be expected in a 59-year-old without a dementia diagnosis, and he had confusion and forgetfulness; consequently, Dr. Shega concluded that was related to the end-stage liver disease. Dr. Shega testified that Patient E.E. was Medicaid hospice eligible at that time because he had ongoing manifestations of end-stage liver disease with worsening ascites, weight gain from the edema, a poor appetite, and required medication for encephalopathy. In February 2010, E.E.'s long-acting morphine was increased from 30 to 45 every 12 hours, he had pain, confusion and cognitive loss, was incontinent, had difficulty with ADLs, was eating about 25 percent of meals with anorexia, and had additional skin tears on his arms. E.E. had confusion, needed reorientation, and required a bed alarm on the bed because he might get up and fall. E.E. was prescribed an antipsychotic, Risperdal, at one milligram twice a day in March 2010 and had episodes of dyspnea requiring oxygen treatment. His PPS was 40 percent, pulse was 102, and had ongoing pain 8 of 10. He remained agitated with confusion and had aggression for which the antipsychotic was started. His Lasix dose was twice a day to try to manage the edema, and he continued to have intermittent dyspnea, ADL dependency, decreased appetite, easy bruising, and skin tears on both arms. In April 2010, E.E. continued to decline with increased confusion and weakness. He had new skin tears on both arms indicative of poor nutritional status. He had ascites along with his liver being able to be palpated. His weight was 165 pounds. He was lethargic, lying in bed with altered mental status; he remained on the lactulose and diuretics. His skin was jaundiced. Patient E.E. was Medicaid hospice eligible during all of the dates at issue. Dr. Talakkottur acknowledged that in March 2010, Patient E.E. became a fall risk, was dependent in 6 of 6 ADLs, and had periods of aggression and was very confused, which was possibly caused by encephalopathy. Dr. Talakkottur further acknowledged in final hearing that in April 2010, Patient E.E. had severe low back and abdominal pain, was on two liters of oxygen, required assistance with 5 of 6 ADLs, had skin tears, signs of ascites, and jaundiced skin. AHCA has not met its burden by the greater weight of the evidence that E.E. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 28, D.M. Patient D.M. was a 59-year-old male, admitted to hospice with a terminal diagnosis of malignant neoplasm of the prostate. The claim period at issue is just over seven months, from 05/26/12 to 12/31/2012. D.M. was admitted to Vitas on 05/26/12 with a terminal diagnosis of malignant neoplasm of the prostate (cancer). He died on service on 5/07/13. The "Scope" of the audit, as included in the FARs, states, "In addition, HI excluded recipients who had at least one malignancy (cancer) primary diagnosis and had a date of death less than one year from the first date of service with this provider." The undisputed evidence shows that D.M. had a terminal diagnosis of cancer and died less than one year after first receiving hospice care from Vitas. AHCA has the burden to prove compliance with the audit scope. It has not in this case. According to the scope of the audit, this claim must be excluded. Even if the scope of the audit did not preclude disputing this patient's benefits, AHCA failed to show this patient was not eligible. Just prior to admission in May 2012, Patient D.M. sustained a fall for which he had imaging that demonstrated diffuse metastatic blastic lesions and an elevated PSA to 302 nanograms per milliliter. D.M. also had left hydronephrosis, an enlarged bladder secondary to the prostate cancer that required Foley catheter placement. A CT scan demonstrated widespread blastic bony metastasis diagnosed as prostate cancer. The patient had substantial physical disability with a noted PPS of 40 percent, a reported weight loss from 150 to 140 pounds, and a BMI of 20. The patient had 6 of 10 groin pain and bilateral lower extremity edema. D.M.'s non-Vitas physician, Dr. Richard Mastrole, signed the certification attesting that the patient had a prognosis of six months or less if the illness ran its normal course and authorized Vitas to evaluate the patient for hospice services and admit him to the Vitas hospice program (signed and dated on 06/07/2012). D.M. also had a hematology consultation by Dr. David Drew. Dr. Drew noted D.M. developed weight loss of more than 20 pounds, close to 15 percent of his body weight, in the previous four to five months. He also noted that D.M.'s pain was so severe it interfered with his sleeping and eating. Dr. Shega testified that D.M.'s imaging demonstrated the blastic disease (prostate cancer) growing and invading into the bone. Dr. Shega further testified that the patient's alkaline phosphatase was markedly elevated to 600, which demonstrated the cancer was eating into the bone. The blastic lesions suggested that the tumor was actively growing and metabolizing the bone, destroying the bone, which is what was contributing to the pain. Within the bone, there are nerve fibers, and those nerve fibers were being stimulated by the cancer, which was destroying the environment. Dr. Shega testified that patients who have bony metastatic disease are at marked increase risk of subsequent fracture. D.M. was Medicaid hospice eligible at the time of initial certification because he had a terminal diagnosis of metastatic prostate cancer with known bony metastatic lesions that were blastic in nature, and a prognosis of six months or less if the disease ran its normal course. There were serial physician assessments of a hospitalization with all the physicians, including the patient's primary care doctor, documenting the patient had a prognosis of six months or less. D.M. had impaired nutritional status as documented in the appropriateness evaluation and in the medical record in the hospital. He had functional decline demonstrated by a PPS of 40 percent, which is markedly impaired. On 05/25/12, the day prior to admission, Patient D.M. met with the Vitas admission nurse and discussed that he had Stage IV prostate cancer and the Vitas hospice philosophy. The patient stated that he would be seeking aggressive care and would be seeing an oncologist in one to two weeks for chemotherapy and that he might also have an orchiectomy in two to three weeks per the urologist. However, D.M. did not follow through with aggressive care. In June 2012, Patient D.M. suffered a fall. X-rays did not document a fracture, but the fall indicated his overall weakness. In July 2012, Patient D.M. had a Stage I ulcer on the left leg that subsequently healed, but demonstrated that his nutritional status had not improved despite the weight gain. As of 08/10/12, D.M. was distressed and not getting adequate pain relief. He had pain in his pelvis, hips, and back relating to bone metastasis. On exam, palpation of different areas of his body exacerbated the pain; he had edema; and his appetite was declining, although he did not appear to be losing weight (due to the steroid treatment). He was also lethargic. Patient D.M. continued to have worsening pain during his stay in Vitas hospice, requiring more aggressive pain management. He was started on methadone, which is one of the most potent opioid analgesics, which was increased as the patient was on Vitas service. The increased pain and titration of opioids supported that the cancer was progressing and worsening. D.M. met the disease specific criteria from the LCD for cancer. As noted above, he had both metastases and a PPS below 70 percent. AHCA has not met its burden by the greater weight of the evidence that D.M. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 29, R.S. Patient R.S. was a 59-year-old male, admitted to hospice with a terminal diagnosis of debility. The claim periods at issue are 04/20/11 to 05/23/11 and 06/03/11 to 10/16/12. Prior to admission, R.S. was hospitalized for almost three weeks beginning on 03/02/11 for joint pain. At that time, the patient had severe electrolyte abnormalities, hyponatremia, along with a hemoglobin of 7.7. He was a known alcohol abuser and had an EGD that found gastritis in the stomach, along with a duodenal ulcer. He also had a UTI during that hospital stay and pneumonia. The patient was not safe to live independently and was placed in an ALF. Patient R.S. had a recent significant decline in functional status and became totally dependent in ADLs resulting in a PPS of 30 percent. R.S. had a poor appetite and an extremely low albumin level of 2.1. The patient became more confused, forgetful and developed extremity edema. He had a wound on his right foot. R.S. had peripheral vascular disease contributing to his diagnosis of debility, with severe functional disability. His prognosis in part was related to severe functional disability. This patient's comorbidities included dementia, atrial fibrillation, alcohol abuse for over 30 years, and a history of delirium tremens ("DTs"), gout, high blood pressure, COPD, anemia, and depression. R.S.'s primary care, non-Vitas physician, certified the patient for hospice and that the patient's prognosis was six months or less. After admission, R.S. developed a lesion on the outer aspect of the right foot that became necrotic due to poor circulation. Ultimately, R.S. had to be transferred to the IPU for management. Patient R.S. decided that due to the pain, he wanted an amputation and revoked hospice services to receive that amputation. R.S. was readmitted to Vitas hospice on 06/03/11 after his above-the-knee amputation at Columbia Hospital and was quickly thereafter admitted to Vitas' IPU for pain control. At that time, the patient's PPS was 40 percent. R.S. had ongoing 9 of 10 stump pain, which is common after an amputation, but he developed necrosis of the left heel, and he was admitted to the IPU for pain management. R.S. was Medicaid hospice eligible at readmission because he had the same terminal diagnosis of debility with the same clinical manifestations, but now had a left heel ulcer; the patient had just come out of the hospital after a life-defining condition and was referred to hospice services from that hospitalization; and, functionally, the patient had a PPS of 30 percent. Those indicators together demonstrated that Patient R.S. continued to have a prognosis of six months or less if the illness ran its usual and normal course. As of 06/11/11, Patient R.S. continued to have pain and had a new necrotic area on the left heel, cachexia and muscle wasting, a poor appetite, and was increasingly confused at times with increasing dementia. As of 08/20/11, R.S. had ongoing cachexia, muscle wasting, continued pain, progressive dementia, and continued to have the wound on the left heel, which was necrotic, and was having regular wound care and needed to be debrided, which was a systemic manifestation of the peripheral vascular disease. In December 2011, R.S. was noted to have poor skin turgor, was at high risk of developing additional skin breakdown, and his skin temperature was cold due to the peripheral vascular disease. The patient had an open coccyx wound, along with a wound to the left outer knee. The ongoing wounds suggested that the patient's nutritional status had not improved and that he continued to be hospice appropriate. The wound tissue was dead and not healing very well and Santyl, a chemical debrider, was administered to remove the dead tissue, indicating a severe wound. R.S. was steadily declining as evidenced by increased weakness and skin breakdown. In May 2012, R.S. had urinary symptoms along with increased lethargy and forgetfulness. He was started on an antibiotic for UTI. His condition was steadily declining, requiring frequent repositioning in bed and had poor balance. R.S. had an active infection. In his debilitated stated, it was considered a life-defining infection making R.S. hospice appropriate with a prognosis of six months or less if the illness ran its usual and normal course. In July 2012, R.S. needed increased pain medication to help manage his symptoms and was transitioned from morphine to methadone for the neuropathic pain he was experiencing. He remained bedbound, incontinent, and dependent in all ADLs. He had persistent sleepiness throughout the morning and difficulty staying awake, a sign of end-stage disease. He had shortness of breath along with anorexia, anxiety and depression, and a PPS of 30 percent. R.S. continued to have poor blood flow to the leg with decreasing sensation and decreased pulses in the left leg, putting it at very high risk for subsequent skin breakdown and the risk of an additional ulcer was very high. He had decreased breath sounds and scattered rhonchi. R.S. was also complaining of urinary symptoms and was started on another antibiotic for a UTI. As of 08/27/12, R.S. continued to demonstrate severe physical disability, with a fair appetite, poor skin turgor, and a right shoulder wound that was open and draining, consistent with an infection. His right shoulder had a raised area with redness, hard, moderate drainage, and he was started on an antibiotic to treat the infection. Patient R.S. was discharged from Vitas hospice in October 2012. The patient was presented to the Vitas medical director review for a possible extended prognosis. The patient's pain was much better controlled with titration of medications. The patient's weight had increased and his appetite had improved. The patient currently did not have any wounds, and previous wounds had healed. The infection in August 2012 had resolved. Patient R.S. did not need a higher level of care. At that time, the medical director believed that the patient had a prognosis greater than six months if the illness ran its usual course. At final hearing, Dr. Talakkottur acknowledged that R.S., at initial certification, had a history of dementia, was incontinent, required full assistance with ADLs, had a necrotic toe, was bedbound and wheelchair-bound. He revoked hospice on 05/23/11, and shortly thereafter had his necrotic and gangrenous foot amputated above the knee. Dr. Talakkottur further acknowledged that during R.S.'s stay in hospice, he did not have a PPS score above 40 percent, his condition was slowly declining, evidenced by delayed wound healing and increased weakness. R.S. had muscle wasting, severe low back pain, became anorexic, continued to be incontinent of bowel and bladder, was too weak to get out of bed, developed a Stage III decubitus ulcer, and had a UTI and cellulitis. AHCA has not met its burden by the greater weight of the evidence that R.S. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment for the two periods at issue. DADE RECIPIENTS Patient 1, A.B. Patient A.B. was a 34-year-old female admitted to hospice with a terminal diagnosis of end-stage AIDS. The claim periods at issue are 02/12/11 to 07/18/11 and 10/18/11 to 12/30/11. A.B. was hospitalized just prior to hospice admission on 02/04/11 for shortness of breath, cough, weakness, and pneumonia. On admission to hospice, A.B.'s weight had decreased from 189 pounds to 160 pounds in the previous five to six months. She also had a CD4 count of less than four. She was having difficulty chewing and was on a mechanically soft diet. A.B. had a history of several pneumocystis pneumonias, which Dr. Vermette stated is one of the sentinel opportunistic infections that define a patient as having AIDS, instead of HIV, and is a very serious type of pneumonia that is difficult to treat and eradicate. She had a PPS of 40 percent. A.B. had numerous admissions to Vitas continuous care and IPU. She was admitted to continuous care at the time of admission. On 02/17/11, she was admitted to the IPU. She was again placed on continuous care on 02/19/11. She was admitted back to the IPU on 03/23/11 for difficulty breathing and a respiratory infection. A.B. was re-admitted to the IPU on 04/11/11 for pain, and admitted again on 04/21/11 due to vomiting and pain. She was admitted to the IPU on 05/12/11 for abdominal pain and diarrhea. She was again admitted to the IPU for chest pain on 05/19/11. She was placed on continuous care for pain management on 06/10/11. A.B. was again transferred to the IPU on 07/04/11 for vomiting and abdominal cramping. On 05/10/11, A.B.'s weight had decreased to 157 pounds, she was cachectic, had shortness of breath managed with oxygen and bronchodilators, had a PPS of 40 percent, had increased episodes of confusion, agitation and forgetfulness, and was recently treated for oral candiasis. A.B. was discharged on 07/18/11 when arrested. On 10/18/11, A.B. was readmitted to Vitas hospice. Between the two hospice admissions, A.B. was again seen at the Magic Johnson Healthcare Center. In August 2011, her CD4 count was less than six. On 09/19/11, her weight was 151 pounds. She was taking her AIDS and heart medications without improvement and with periods of noncompliance, which are both indicators of worsening prognosis. At admission, A.B. had a PPS of 40 percent, a weight of 150 pounds, was having significant pain, shortness of breath at exertion and rest, ulcers and lesions on both legs, a history of recurrent infections, and had been discontinued for antiretroviral medications. On 10/19/11, A.B.'s attending physician certified her as having a life expectancy of six months or less if her terminal illness ran its normal course. On 11/12/11, A.B. was admitted to the IPU for pain management, at which point her PPS had decreased to 30 percent. On 11/20/11, A.B. was again admitted to the IPU for shortness of breath and chest pain. Her respiratory rate was extremely high at 28 and her pain medications had been changed from Percocet to morphine. On 12/01/11, A.B. had a CD4 count of 20, which was still in the terminal stage. She also had decreased appetite, increased weakness, and a PPS of 40 percent. On 12/30/11, A.B. revoked hospice care to seek surgery for recurrent diarrhea and gastrointestinal issues. Dr. Talakkottur stated as his rationale for denying eligibility that there was a lack of CD4 labs during the first admission, that her PPS remained at 40 percent, that she had no frequent hospitalizations, and that she had no recurrent infections. These statements are all contrary to the evidence. Dr. Talakkottur admitted A.B. had multiple hospitalizations leading up to hospice, serial assessments and lab work in the two years leading up to hospice, ten higher levels of care during her first admission, a CD4 count of less than 4 at admission, a PPS that dropped to 30 percent, and documented recurrent infections (pneumocystis pneumonia and thrush, which are opportunistic infections). At hearing, Dr. Talakkottur relied on the study "Mortality and Well Controlled HIV and the Continuous Antiretroviral Therapy Arms of the SMART and ESPRIT Trials Compared with the General Population" dated 03/27/13, by A.J. Rodger. The study, published after the end of the audit period, was not available to Vitas in 2011 when physicians were making real time prognoses regarding patient A.B. In addition, the patients examined in the study were only those with a CD4 count of greater than or equal to 350. With CD4 counts always at or below 20, A.B.'s condition would exclude her from the parameters of this study. Dr. Talakkottur acknowledged that the lower the CD4 count, the more susceptible a person is to infections and that these infections can increase the risk of morbidity and mortality. He also acknowledged that not taking AIDS medication increases the patient's chances of getting opportunistic infections. Patient A.B. was not compliant with medication. AHCA has not met its burden by the greater weight of the evidence that A.B. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment for the two periods at issue. Patient 4, E.M. Patient E.M. was a 70-year-old male, admitted to hospice with a terminal diagnosis of end-stage COPD. The claim periods at issue are 12/21/11 to 05/13/12 and 05/15/12 to 12/31/12. Patient E.M. was hospitalized on 11/30/11 through to his initial admission to Vitas. He had shortness of breath and a pulse oxygen reading of 88. He responded poorly to treatment with bronchodilators and had a wound on his sacrum. He had a carbon dioxide pressure of 67, which was very high and implied the patient was not able to flush the carbon dioxide out of his lungs because of his disease. He had acidosis in his bloodstream of 7.32. Acidosis in the bloodstream can be extremely life- threatening it if drops below 7.25 or 7.2. An acidosis level of 7.32 shows that despite E.M.'s body's best effort to compensate for the retained carbon dioxide that his lung disease was causing, he was not able to maintain homeostasis. During the 11/30/11 hospital stay, Patient E.M. was placed on BiPAP, which at the time was the most aggressive nonintubation treatment available. He remained on BiPAP for about 22 days, despite efforts to ween him off before being referred to hospice. At the time of discharge from the hospital, E.M. was informed that he did not have many options to improve his condition. E.M. was certified hospice appropriate by his non- Vitas attending physician. He was admitted with evidence of extensive disease as identified above and a BMI of less than 19. At admission, E.M. was placed on continuous care while on eight medications to treat his respiratory symptoms. In January 2012, E.M. lost consciousness and was sent to the ER. On 03/09/12, E.M. had cough, congestion, and secretions, and had to be started on another antibiotic. On 03/15/12, E.M. had a PPS of 40 percent, was short of breath and on oxygen 24 hours a day. He could stand with assistance but could not walk freely. He had a poor appetite and slept day and night, which was evidence of progression as end-stage COPD patients require increased sleep and rest. E.M. had crackles in his lungs which were consistent with end-stage lung disease. He also had apnea during the first benefit period, which is more significant in COPD patients, because there is a chance they never start breathing again. Most COPD patients, who do not die of some other cause, die of acute respiratory arrest. Apnea in an end-stage COPD patient is a significant indicator of a poor prognosis. E.M. revoked hospice care on 05/13/12 and was treated at Baptist Hospital of Miami for intractable shortness of breath. He was discharged from the hospital on 05/15/12 and re-admitted to hospice that same day. At the second admission to hospice on 05/15/12, E.M. had shortness of breath, was coming off the recent hospitalization, had decreased weight from 121 pounds to 109.5 pounds, was chair-bound, had chronic kidney disease, bronchial asthma, and a PPS of 40 percent. He was placed on continuous care on admission. Upon readmission on 05/15/12, E.M. had muscle wasting, was unable to be weighed, had shortness of breath with continuous oxygen usage, and had decreased tolerance to activity and increased weakness. Dr. Talakkottur relied on the Global Initiative for Obstructive Lung Disease ("GOLD") Criteria for COPD for denying eligibility during the periods at issue. However, the GOLD criteria were developed to standardize what treatments are started when in a step-by-step organized fashion for COPD patients. GOLD is designed to treat patients to keep them out of the hospital. Dr. Vermette stated that the GOLD criterion has no relevance to a patient in E.M.'s condition who is already on eight medications, which is far beyond the GOLD criteria. Dr. Talakkottur's reliance on a spirometry test for prognosis is similarly misguided. A spirometry test is helpful to determine treatment and medication. Dr. Vermette stated that once a patient's COPD has progressed to the severity of E.M.'s, spirometry is inconsequential. The six-minute walk test is also irrelevant for a patient who has an illness as advanced as E.M. That test is to determine how many breathing treatments a patient needs and has no impact on prognosticating life expectancy. Dr. Talakkottur believed E.M. should have performed a six-minute walk test to determine the severity of his COPD, despite being unable to walk for six minutes (mainly bed and chair-bound). On 08/13/13, E.M. was forced to sit in a tripod position, trying to actually push air in and out of his lungs, not just with his diaphragm. He also exhibited global muscle atrophy, which meant all the muscles in his body were shriveling. This was evidence of both functional and nutritional impairment. COPD, by definition, is a chronic disease from the time of diagnosis. It does, however, enter an end-stage as evidenced by symptoms such as having shortness of breath at rest, being in and out of the hospital with intractable shortness of breath, being oxygen-dependent, and being on eight medications. E.M. exhibited specific indicators of "progression of end stage pulmonary disease" for the LCD for pulmonary disease. As noted above, he had hospitalizations due to his COPD both immediately prior to admission and during his stay in hospice. AHCA has not met its burden by the greater weight of the evidence that E.M. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment for the two periods at issue. Patient 6, G.O. Patient G.O. was a 90-year-old male admitted to hospice with a terminal diagnosis of end-stage heart disease. The claim period at issue is under three months, from 05/21/12 to 08/18/12. Just prior to being admitted to hospice, G.O. had been hospitalized for multiple complex problems, including sepsis, left lower lobe pneumonia, severe anemia, and had a heart attack while in the hospital. He was referred to and certified for hospice by his attending physician. Dr. Vermette opined that G.O. was terminally ill with a prognosis of six months or less to live and his condition and symptoms were indicative of a NYHA Class IV because he suffered from shortness of breath at rest. NYHA Class III and Class IV patients will present with shortness of breath, chest pain, fatigue or palpations at rest; any of those symptoms occurring at rest would stage a person at Class IV and be considered an indicator of a poor prognosis. However, Vitas's file for G.O. seems to belie a finding that he met the standards for NYHA Class IV or Class III. The Plan of Care Review documents during the disputed timeframe fail to indicate that G.O. ever suffered from shortness of breath at rest--the hallmark for NYHA Class IV. One plan in the disputed timeframe remarks upon the recipient's respiratory system, but all other plans have no comment for the recipient's respiratory status. The plan dated 08/30/12, indicated the recipient had shortness of breath and received oxygen. Not all plans are indicative of the recipient having dyspnea. Those that are checked to indicate the recipient had dyspnea do not all suggest it was with exertion. Not one indicated dyspnea at rest. In the initial nursing note following G.O.'s hospice admission, a nurse assessed the recipient and checked that no problems were identified with the patient's neurosensory, cardiovascular, or respiratory systems. The patient was in no pain. G.O.'s vital signs in the cardiovascular section were reported within normal limits. Subsequent nursing notes reported G.O. having no shortness of breath, having no level of concern with his respiratory status, reporting oxygen was used "as needed" or "PRN" and that G.O. reported no level of concern with his respiratory system. In the cardiovascular system of the same notes, G.O. was reported to have no dyspnea at rest. Many notes were not checked for dyspnea and most reported the recipient had a "0" level of concern with his cardiovascular system. Further, the Appropriateness Evaluation form failed to support the patient being NYHA Class IV. The form notes that the recipient had shortness of breath with minimal exertion and not at rest. The respiratory system section of the evaluation is marked not applicable and the cardiovascular section does not indicate that the patient had dyspnea at rest, but instead noted only that the patient had dyspnea on exertion. Based upon the greater weight of evidence in this case, it is determined that this patient was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $38,253.17. Patient 9, L.B. Patient L.B. was a 70-year-old female, admitted to hospice with a terminal diagnosis of end-stage vascular dementia. The claim period at issue is 11/12/10 to 03/05/12. L.B. had been hospitalized for a stroke just prior to hospice admission. Dr. Talakkottur acknowledged the stroke was severe. At admission, L.B. was on a PEG tube, had quadriparesis, breast cancer, hypertension, and contractures in her lower extremities caused by brain damage. She was total care, 6 of 6 ADLs, and incontinent, with a FAST of 7f. She had a PPS of 30 percent. L.B. also had renal insufficiency, dysphagia, malnutrition, and required oxygen supplementation. Patient L.B.'s FAST score of 7f demonstrated functional impairment, along with quadriparesis and constrictors, which indicated that her disease process was advanced. On 11/15/10, L.B.'s non-Vitas attending physician certified that the patient was appropriate for hospice and had a terminal diagnosis. Dr. Vermette testified that once a dementia patient reaches the equivalent debility of a FAST 7a, has functional decline, and has other significant comorbidities, then the patient is considered to have a terminally ill prognosis. L.B. had those conditions at admission. On 12/29/10, L.B. had an albumin on the lower end of normal at 3.6, had an abnormal lung exam with decreased breath sounds and rhonchi, and had dysphagia. Dr. Vermette testified that abnormal breath sounds and rhonchi in a patient with a PEG tube was a sign the tube feeding was not tolerated and placed the patient at a higher risk of aspiration. On 01/24/11, L.B. had a fever of 100 degrees. Her blood pressure medication was also increased. Dr. Vermette testified that stroke patients have an increased risk of stroke when their blood pressure is high. L.B. remained incontinent during the first certification period. On 02/10/11, L.B. had a PPS of 30 percent, was dependent in 6 of 6 ADLs, had a FAST score between 7d and 7e, had contractures, weakness, high blood pressure, a lesion on her lower lip, and incontinence. Dr. Talakkottur opined that he saw no progression of the terminal illness. He opined the recipient's clinical state was static. Dr. Vermette explained that with these indicators, L.B. would not be able to decline significantly until her actual death, and so it would be expected for her PPS, ADLs, and FAST scores to remain static. Most patients in this condition die of an aspiration or respiratory event at some point in the course of their care. On 04/01/2011, L.B.'s PPS dropped to 20 percent before returning to 30 percent later that month. L.B. also developed a Stage II wound on her right buttock and sacrum, which persisted into May. On 05/09/11, L.B. had mild shortness of breath, had some congestion and excess secretions and was placed on atropine drops, an anticholinergic medicine used to dry up the oral/nasal secretions. Dr. Vermette testified that with dysphagia, the secretions would end up in the patient's lungs and she would have significant respiratory distress. On 06/24/11, L.B. was placed on Pro-Stat because her wounds were not healing with conventional treatment. Her PPS remained 30 percent, her FAST was 7d to 7e, and she still had decreased breath sounds and rhonchi. In August 2011, L.B. had wounds on her great toe and coccyx. On 09/08/11, L.B. was moaning and groaning at times and medicated with morphine for pain and still required ongoing wound care. On 09/24/11, L.B. still had a PPS of 30 percent, was 6 of 6 ADLs, had wounds, and increased secretions. The increased secretions increased L.B.'s risk of aspiration. On 10/27/11, L.B. had a FAST of 7f, was total care, and her PPS was 30 percent. L.B. had increased pain and increased secretions. She also had decreased tolerance to activity and decreased tolerance to being placed in a chair with a Hoyer lift. On 12/20/11, L.B.'s breast mass was increasing, her FAST was 7f and her PPS was 30 percent. She had contractures and chest congestion. Dr. Talakkottur stated a patient like L.B. could live for ten or 20 years. Dr. Vermette opined that L.B. was displaying the signs of the last six months of life if the disease progresses normally--advanced dementia with a FAST in the 7s, a PPS level in the 30s, recurrent problems with secretions, contractures, and wounds. In fact, L.B. did not live ten years but instead died on service at Vitas on 04/24/12. AHCA has not met its burden by the greater weight of the evidence that L.B. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 10, G.S. Patient G.S. was a 74-year-old female admitted to hospice with a terminal diagnosis of end-stage dementia. The claim period at issue is just under seven months, 09/01/09 to 03/26/10. Prior to admission to hospice, G.S. had aspiration pneumonia, a PEG tube, and ongoing dysphagia. In September 2009, G.S. had a PPS of 30 percent, a FAST of 7d, was incontinent, and weighed 107 pounds. She had gastroesophageal reflux disease as a comorbidity. G.S. was dependent in 12 of 12 ADLs, which is the same as 6 of 6, but on a different scale. She had episodes of congestion and cough related to dysphagia, which gave her a higher risk of aspiration, and she also had a recent UTI that required an antibiotic. Patients with dysphagia and gastroesophageal reflux disease who cannot swallow normally and are having liquid food pumped into their stomach have an increased risk for aspiration, making it a significant comorbidity. In October 2009, G.S. developed wounds on her left foot and left elbow. She was bedbound with contractures. Her wounds evidenced poor nutritional and functional status, as well as an increased risk of infection. In November 2009, G.S. remained total care, FAST 7d, and bedbound. She had impaired bed mobility--she could not reposition herself in bed by herself and her wounds had not healed. In January 2010, her left elbow wound was open, her FAST was 7d, she was total care, and she had an episode of vomiting. Dr. Vermette stated that G.S. was at an especially high risk of aspiration because when she vomited she could not lean over the bed or sit up to reposition herself but was forced to lie there and hope someone assisted her before she choked. G.S. began having shortness of breath at rest during January and February 2010. In March 2010, G.S. began tolerating placement in a chair better and her PPS increased to 40 percent. Vitas discharged her for extended prognosis on 03/25/10. Dr. Vermette stated that the patient's PPS and ADLs remained the same throughout the dates at issue, but she also had infections, wounds, and a risk of aspiration that evidenced a terminal prognosis of six months or less. He testified that G.S. was what a terminal dementia patient looks like. Dr. Talakkottur stated that G.S.'s wounds and UTI ultimately healed with appropriate treatment. He did not mention that it took nearly four months for the wounds to heal. Moreover, he could not have known in real time that those wounds would ultimately heal four months after they began. L.B. met the disease specific criteria from the LCD for dementia and related disorders. As noted above, she had a FAST score above 7c, which indicates she was speaking six words or fewer, was total care, and was incontinent. AHCA has not met its burden by the greater weight of the evidence that G.S. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 11, J.A. Patient J.A. was a 64-year-old male, admitted to hospice with a terminal diagnosis of end-stage heart disease. The claim period at issue is under three months, from 06/12/11 to 09/09/11. Prior to admission, J.A. had two significant hospitalizations. He was hospitalized from 05/10/11, to 06/02/11. During that hospitalization, he suffered a heart attack, respiratory failure, aspiration pneumonia, and encephalopathy. He had cardiomyopathy with an EF of ten percent and had congestive heart failure. He had several other comorbidities, including respiratory insufficiency, atrial fibrillation, diabetes, hypomagnesemia, which means low magnesium in the blood, and hypertension. J.A. was readmitted to the hospital on 06/04/11. He was in the hospital from 06/04/11 to 06/12/11, for altered mental status and was admitted directly to hospice from the hospital. At the time of his admission, J.A. was confused, had reduced ambulation, needed assistance with self-care, and had a PPS of 40 percent. He had a heart attack, which required intubation. He had an EF of 15 percent. He was jaundiced and was found to have cirrhosis with end-stage liver disease as a comorbidity. He had a JVD of three centimeters and diminished breath sounds. Dr. Vermette testified that J.A. had a prognosis of six months or less if the disease progressed at its expected rate because he had significant evidence of severe heart disease, multiple hospital admissions, and radiologic evidence of end- stage disease. He had a declining functional status, a PPS of 40 percent, and had just been intubated after a heart attack; consequently, it was very reasonable to assume that he had entered the terminal stage of the disease. Dr. Vermette testified that the prognosis is very limited for patients that have to be intubated and on a ventilator for five days after an acute heart attack, together with the other conditions affecting J.A., including the aspiration pneumonia. During June 2011, J.A. was admitted to the IPU. He continued to have significant symptoms of heart disease and more symptoms related to the liver disease, including encephalopathy. In July 2011, J.A.'s blood pressure became so low that he could not tolerate his medications; and, by August, his blood pressure medications had to be discontinued due his body's lack of tolerance. When Dr. Vermette was asked about plan of care reviews in the records for J.A. and whether those documents were inconsistent with a terminal prognosis of six months or less, Dr. Vermette testified that he focused his attention on the physician notes and nurse notes because those are notes that are being done, for the most part, at the bedside, in the presence of the patient, and the notes were a peer reviewers opinion of the patient at that point in time. In contrast, the plan of care reviews were produced as a result of discussing the case at an IDG meeting, with someone making notes of the comments that various people around the room were saying about the patient, and hoping to capture the discussion. Dr. Vermette pointed out that the plan of care reviews he was asked about contained a lot of information that corroborate J.A.'s terminal prognosis and condition, including shortness of breath on exertion, the extensive heart medications he was on, and dependent in 4 of 6 ADLs, which later worsened to 5 of 6 ADLs. Dr. Vermette testified that the plan of care reviews do not contradict the patient's eligibility for hospice. Dr. Eisner's testimony corroborated Dr. Vermette's that just prior to admission to hospice, J.A. suffered a cardiac event where his heart had stopped beating and he had an EF of 15 percent. Dr. Eisner further acknowledged that during J.A.'s stay in hospice, he lost 30 pounds of body weight, his dependency increased to 5 of 6 ADLs, his PPS score remained 40 percent, he had a decreased appetite and ambulation, had decreased tolerance to activity, had increased weakness, and was incontinent of bowel and bladder. AHCA has not met its burden by the greater weight of the evidence that J.A. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 12, N.D. Patient N.D. was an 87-year-old female, admitted to hospice with a terminal diagnosis of end-stage cerebrovascular disease. The claim period at issue is 11/07/09 to 02/24/12. At the time of admission, N.D. had had a history of strokes and her attending non-Vitas physician referred and certified her as hospice appropriate. N.D. had a history of cerebral vascular disease and extensive dementia as a result. At admission, she had a PPS of 30 percent, was completely bedbound, had a FAST score of 7d, was total care, and incontinent. The Appropriateness Evaluation notes show that N.D. was referred to hospice for weight loss and severe agitation. However, a psychosocial/spiritual note reflects that N.D. had previously been on services and was discharged for extended prognosis, and she was reported to be more confused and depressed according to her family. The Appropriateness Evaluation reported N.D.'s weight as 150 pounds, with a BMI of 25 according to chart and family, and no pressure ulcers or skin lesions. It reported the patient having recurrent infections over the last six months but no further information regarding the infections was included in the space provided on the form. The Appropriateness Evaluation finally indicated that N.D. was hypertensive with no other cardiovascular symptoms and indicated that she had no issues with the following systems: respiratory, genitourinary, gastrointestinal, neurological, HIV disease, debility, or adult failure to thrive. Vitas reported N.D. as having a history of CVA, but failed to reflect the number or dates of such occurrences. Dr. Talakkottur noted that there was no indication as to when the CVA occurred in the Appropriateness Evaluation, and there was nothing marked under the neurological section to reflect how that system had been impaired or to what degree. Under the section entitled stroke/coma, Dr. Talakkottur also noted that none of the pertinent assessments were checked for certifying that diagnosis. A physician, in his addendum to the initial certification, stated N.D. suffered a CVA, was hypertensive, diabetic and had been left weak with a poor caloric intake. However, there is no indication of the severity of her condition or notice as to when the CVA occurred in the physician's addendum. If anything, the file records demonstrate that the condition could have been ongoing for some time. Four years prior to the hospice stay at issue, N.D. was noted to be nonambulatory and bed and wheelchair bound. Dr. Talakkottur shed light on this issue and testified that the N.D.'s CVA or diagnosis of a CVA was recorded back in 2006. These facts and findings are further evidence in support of Dr. Talakkottur's testimony that patients who have strokes oftentimes have a chronic condition and can live for years. This patient's condition essentially remained stagnant. The medical file reflects that N.D. lived three years following her CVA before being admitted to hospice care during the disputed period. In N.D.'s 59 Plan of Care Review documents, her level of impairment was listed as one and two--mild to moderate except for seven occurrences where her gastrointestinal system was reported as a three (severe concern) for constipation (typically not a life-threatening condition). Her level of care and medication were not reported to have changed. While N.D. was reported at times to have dyspnea, the Plan of Care Reviews never reported dyspnea at rest. N.D. did not suffer from non-healing wounds or recurrent infection. The file did not show any recurrent infections, any aspirations, or any instances where the recipient was oriented times zero. Based upon the greater weight of evidence in this case, it is determined that this patient was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $126,209.70. Patient 14, M.G. Patient M.G. was an 83-year-old male, admitted to hospice with a terminal diagnosis of end-stage cerebrovascular disease. The claim period at issue is 09/01/09 to 07/14/10. At the beginning of the dates at issue, M.G. had comorbidities of vascular dementia, hypertension, and a history of aspiration pneumonia. He had a FAST of 7c, was dependent in 5 of 6 ADLs and had a PPS of 40 percent. During the first few weeks, the patient had significant pain, was having some shortness of breath with activity, was using oxygen, continued to have a 40 percent PPS, was bed to chair-bound and totally dependent on ADLs. Just getting from the bed to the chair required assistance. Dr. Vermette testified that the differences between 30 percent and 40 percent PPS in the patient at this point was moot because both of those scores describe a patient who is in a terminal phase of the disease process. The patient had increased weakness and worsening dysphagia. In October and November 2009, Patient M.G. had an episode of respiratory symptoms, a low-grade fever, a high respiratory rate, shortness of breath, rales, and was on oxygen. The patient was having excess secretions, cough and congestion, and began an inpatient level stay to manage those symptoms. According to Dr. Vermette, in a patient with dysphagia, secretions, cough, fever and congestion make up an aspiration event. Anytime food or secretion goes down the trachea and into the lungs, it causes congestion, causes a cough, can cause fever, and can become full-blown pneumonia. It can lead to airway compromise and death; there is no way of predicting when that event is going to happen. Through January 2010, M.G. had a PPS of 40 percent, a low FAST, and required assistance with 6 of 6 ADLs. He had an episode of chest pain, went to the hospital and was evaluated. He was recommended to have a cardiac catheterization, which he/his family refused to do. He did not appear to have had a heart attack, but the hospital believed he was at risk of a heart attack. Although it would have been M.G.'s right to have the catheterization and get that done outside the hospice benefit, he/his family refused, which demonstrated that he/his family recognized that he was not in any condition for an invasive procedure and they just wanted to keep him comfortable rather than pursue aggressive treatment. Through March of 2010, patient M.G. was bedbound, had dysphagia, aphasia, hemiplegia, and was at high risk for aspiration pneumonia and sudden death due to an aspiration attack. He had a FAST of 7d, a PPS of 40 percent, increased weakness, and decreased tolerance to activities. M.G. was not improving. He was, at best, staying the same and, at worst, declining. In May of 2010, M.G. had a PPS of 30 to 40 percent, dependent in 6 of 6 ADLs, incontinence, muscle wasting, and shortness of breath with minimal activity and at rest with chest pain off and on. M.G. qualified as a NYHA Class IV based upon the shortness of breath at rest and chest pain. M.G. had an albumin test in early June that came back in the normal range, at 4.5, which was high for the patient at that point. The patient was discharged in July 2010 for extended prognosis, before the patient was due for the next recertification. During the dates at issue, M.G.'s FAST level never improved to better than 7c, his PPS score never improved to greater than 40 percent and declined in March and June of 2010 to 30 percent, he was dependent for least 5 of 6 ADLs, and he had dysphagia. Dr. Talakkottur testified specifically that a patient with dysphagia is always at risk for aspiration. M.G. met the disease specific criteria from the LCD for dementia and related disorders. AHCA has not met its burden by the greater weight of the evidence that M.G. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 16, T.P. Patient T.P. was a 50-year-old female, admitted to hospice with a terminal diagnosis of advanced AIDS. The claim period at issue is 10/17/11 to 06/12/12. Just prior to her admission to Vitas, T.P. was hospitalized with an admitting diagnosis of advanced AIDS, an altered mental status, noncompliance and polysubstance abuse, and she was cachectic. The non-Vitas attending physician referred and certified the patient to hospice for end-stage AIDS. At initial certification, T.P. was mainly bedbound, had reduced oral intake, was total care, and her PPS was 40 percent. She only weighed 88 pounds, she had a significant amount of pain, rated as 7 of 10 pain after receiving pain medicine. She had comorbidities of cocaine use, kidney infections, latent syphilis, muscle wasting, shortness of breath with minimal exertion, and a UTI in the last six months. Dr. Eisner testified that between the dates of 10/17/11, and 06/12/12, T.P. had a continuous PPS of 40 percent, she was gaining weight, she was performing some of her ADLs and, as such, she was not an appropriate candidate for hospice. The Appropriateness Evaluation simply reported her date of diagnosis in the HIV Disease section but failed to give any other clinical evidence, such as the CD4 count, persistent elevated viral load, opportunistic infections or organ damage that would be related to HIV. The date of diagnosis was reported to be 2010 and the terminal diagnosis was reported to be AIDS. Dr. Eisner opined that T.P.'s condition while hospitalized--bedbound, requiring 100 percent dependence with ADLs, a PPS of 40 percent, dyspnea, lethargic, oriented to one, and incontinence of bowel and bladder--were conditions not related to her underlying HIV disease but instead were related to her drug abuse. Dr. Eisner testified that had it been her underlying end-stage HIV disease, T.P.'s condition would not have gotten better during her hospitalization. Dr. Eisner noted that the hospital did not find infection or organ damage that one would associate with someone who had end-stage AIDS. Laboratory data from while T.P. was in the hospital came back "essentially normal." Upon discharge from the hospital, the recipient was taken to Gramercy Park nursing home. Multiple face-to-face encounters were made between Vitas' physician(s) and T.P. at Gramercy Park nursing home. During many of those visits, she was reported to be alert, oriented, in no acute distress, denying pain except for one occasion, yet she could not rate or describe the pain. T.P. was also reported to ambulate mostly with a wheelchair, to have an adequate appetite, and to require some assistance with ADLs. During face-to-face encounters with Vitas' physician on 03/14/12, and 05/03/12, signs of weakness were noted but otherwise her condition was essentially the same as prior visits. Dr. Vermette agreed that Vitas' file lacked any CD4 count or viral load for this patient. Dr. Vermette nonetheless believed T.P. to be end-stage based upon a very low albumin level of 1.8 taken 10/09/11. T.P.'s albumin, however, was measured again on 04/17/12, and was 3.3, which is within the normal range. Dr. Vermette's opinion that T.P. was end-stage AIDS was also based upon a reported shortness of breath. Plan of Care Reviews, however, failed to report T.P. having dyspnea during the time in dispute. Quite the contrary, the plans often reported she had oxygen available to her on an as needed basis without reporting respiratory distress or shortness of breath. The lack of terminality is also supported by Vitas' signed recertification charts, all of which failed to report a single instance of non-healing wounds, recurrent infections, titrations in pain medications, or dyspnea during the dispute period. Based upon the greater weight of evidence in this case, it is determined that this recipient was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $40,711.85. Patient 17, Z.H. Patient Z.H. was a 63-year-old female admitted to hospice with a terminal diagnosis of end-stage heart disease. The claim period at issue is just over one month, from 09/01/09 to 10/06/09. Dr. Talakkottur testified that in a Plan of Care Review dated 09/12/09, covering the period 08/26/09 to 09/02/09, Z.H.'s PPS was reported as 60 percent, her weight was 85 pounds, and the recipient required assistance with 5 of 6 ADLs. No shortness of breath was indicated. Nursing notes prepared in the months of September (September 3, 10, 15, 22, 25 and 29) all reveal that a nurse assessed and reported no issues or concerns with Z.H.'s bodily systems and observed little to no pain. Little to no issues were reported again for the recipient's neurosensory system. Z.H. was reported oriented times two or three following 09/03/09, and there was but one occurrence on 09/25/09, where the nurse indicated some confusion and agitation but noted the recipient was oriented times two. There was never any indication of a problem or issue with this patient's cardiovascular system. With regard to Z.H.'s need for assistance with ADLs, a nurse reported in all but one note that the recipient required assistance in 3 of 6 (grooming and bathing) ADLs. On 09/10/09, the recipient was reported to require assistance in all ADLs without providing comment or evidence of change in the recipient's organ systems or pain level. Throughout the month of September 2009, oxygen was reported to be available as needed and there was no higher level of care administered to the recipient. Throughout the month of October, nurses similarly reported Z.H.'s condition as they did in September. She was oriented times two, no concerns, issues, or comments regarding the recipient's bodily systems or pain, and required assistance in 3 of 6 ADLs. Dr. Talakkottur testified that the patient did not have a terminal condition. Further, while physicians reported Z.H. to have cardiovascular problems in the recertification documents, there is no chest pain, no edema, no JVD, no dyspnea, no palpations, no arrhythmia, and no syncope reported. As such, Dr. Talakkottur testified he could not classify this patient as having a terminal condition related to heart disease. In support of the patient's eligibility for hospice, Dr. Vermette relied upon Z.H. having a comorbidity of ovarian cancer. Vitas initially admitted Z.H. to hospice with a terminal diagnosis of ovarian cancer. However, shortly after admission, a physician consult reported there was no evidence of metastatic ovarian cancer. Vitas changed Z.H.'s terminal diagnosis to heart disease, but continued to reflect upon the patient having a comorbidity of ovarian cancer in support of her hospice eligibility. On cross, Dr. Vermette testified that he did not review the entire file to determine Z.H.'s clinical status and relied upon the recertification note during the period in dispute. The medical records contained in this file do not support a finding that the Medicaid hospice eligibility standard was met during the disputed period. Based upon the greater weight of evidence in this case, it is determined that Z.H. was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $31,409.54. Patient 18, R.W. Patient R.W. was a 58-year-old male admitted to hospice with a terminal diagnosis of end-stage liver disease caused by alcoholic cirrhosis. The claim period at issue is 11/26/11 to 12/09/12. In the two months preceding the disputed period, R.W. had multiple open wounds on his legs, had evidence of persistent ascites, and had symptoms of hepatic encephalopathy. He also required two episodes of continuous care, one for change in mental status and the other for shortness of breath and anasarca. He suffered a fall the day before recertification for the dates at issue. In November 2011, R.W. was very lethargic, had a poor appetite, a decrease in verbal skills, respiratory distress with a rate of 24, and rhonchi with labored breathing. His ADLs varied between 5 of 6 and 6 of 6 due to his fluctuating encephalopathy. R.W. had comorbidities of cardiac disease, encephalopathy, and COPD. In early December 2011, R.W. had recurrent episodes of shortness of breath at rest and with exertion, which made him a NYHA Class IV. R.W. developed a respiratory infection with a moist productive cough and labored respirations. He was coughing up large amounts of yellow sputum and was placed on nebulizer treatments. He also began having tremors in his hands, known as asterixis, which Dr. Vermette stated was evidence of neurologic dysfunction caused by the ammonia and other toxins built up in the blood because of R.W.'s liver failure. R.W. also had episodes of apnea in December 2011. R.W. had anasarca, facial swelling, and tremors into January 2012, and he developed foul- smelling wounds on his legs. At the end of January 2012 and into February 2012, R.W. was on continuous care for a change in level of consciousness. He was dependent in 6 of 6 ADLs, PPS of 40 percent, and his abdomen was large. He had edema in all extremities and was weak and very lethargic. R.W. was placed on prednisone to help with breathing. In March 2012, R.W. had anasarca and significant lethargy. He spent most of his days slumped over in a wheelchair, and he was on oxygen most of the time. By May 2012, R.W. was on oxygen at three to four liters and exhibited shortness of breath. He developed edema with a swollen scrotal region, which Dr. Vermette stated occurs typically only in significant heart failure and liver failure patients. The time he spent in bed as opposed to a wheelchair had increased, as had his periods of lethargy and his ascites. He remained on lactulose for hepatic encephalopathy. He also had facial edema. In July 2012, R.W. was placed on methadone around the clock and Percocet as needed, especially before dressing changes. He also was no longer able to wheel himself in his wheelchair, which evidenced further functional decline. In September 2012, R.W. was having shortness of breath at rest and with activity, again demonstrating NYHA Class IV, which was evidence of end-stage liver disease according to Dr. Vermette. At the end of September and into early October 2012, R.W. was on continuous care for difficulty breathing, as well as a low-grade fever and change in level of consciousness. He developed respiratory distress, was having periods of apnea and was hypotensive. In the end of November 2012, R.W. was again on continuous care. He was lethargic and confused. His pain medications had increased again and he had diminished consciousness, hepatic encephalopathy, arrhythmia and respiratory distress with a high respiratory rate. He also had muscle wasting. R.W. was again on continuous care on 12/05/12. This was his third hospitalization-equivalent within the last 60 days. He was admitted for respiratory distress and he died on hospice service on 12/09/12. Dr. Talakkottur's rationale for his opinion that Patient R.W. was not Medicaid hospice was that lab work had not been done. However, lab work is rarely done in a hospice setting. Lab work is only done to adjust the patient's plan of care to better address his symptoms and keep him comfortable. Hospices do not take labs just to document a disease. Dr. Talakkottur used a visual aid that contained a list of symptoms that he believed should be present in an end-stage liver patient. Dr. Vermette opined that a patient with terminal cirrhosis of the liver would not have all of those symptoms. Dr. Vermette stated that the list appeared to simply be a list from a textbook of all symptoms that could possibly relate to liver disease of any sort. Most were not useful for prognostication whatsoever. Dr. Talakkottur reasoned that Patient R.W. was not hospice eligible because he did not have refractory ascites. Dr. Vermette stated this patient had ascites recurrently and frequently. Dr. Vermette also testified that in his experience working in and treating hospice patients, that the clear majority of end-stage liver patients on hospice do not receive repeated paracentesis because they do not tolerate them well. R.W. was on medication throughout his stay in hospice for his ascites. As part of Dr. Talakkottur's rationale for denying eligibility, he stated R.W. "did not show any signs of end-stage of his chronic disease." However, the LCD for liver disease specifically states that refractory ascites, alone, is evidence of the disease being end-stage. Dr. Talakkottur also reasoned that this patient was not hospice eligible because he did not have anasarca. Dr. Vermette noted that R.W. had severe edema, including edema of his face and scrotum, which was anasarca. Dr. Talakkottur also reasoned that R.W. was not hospice eligible because he did not have asterixis, which was directly refuted by the record. AHCA has not met its burden by the greater weight of the evidence that R.W. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 19, M.M. Patient M.M. was a 48-year-old male admitted to hospice with a terminal diagnosis of end-stage AIDS. The claim period at issue is just under eight months, 03/30/10 to 11/24/10. M.M. was admitted to an acute care hospital on 03/26/10 just prior to entering hospice with a history of fever, shaking, chills, and sweats, and he had a bacterial infection in his bloodstream of Enterobacter cloacae. He also had an infection in the wounds on his left leg of methicillin-resistant staph aureus ("MRSA"). He was anemic and was positive for cocaine and benzodiazepine. His CD4 count from the prior year was 70. M.M. was admitted directly from the hospital to hospice. At admission to hospice, M.M. was weak, bedbound, had dysphagia, was malnourished, severely immunocompromised, had failed treatment with antiretrovirals, had a PPS of 30 percent, and weighed 145 pounds, which indicated a five-pound loss from prior to admission. He had an ulcer on his left leg. M.M. was homeless, which according to Dr. Vermette impacted the patient's prognosis because he was not receiving adequate meals, shelter, and prior medical care. Dr. Vermette testified that the fact that the patient was homeless did not preclude him from being eligible for Medicaid hospice services, but made delivery of the services more challenging. In April 2010, M.M. was unable to ambulate and fell out of his wheelchair, further damaging the skin on his legs. M.M. did have improvement in his ADLs over the course of his stay in hospice, but he had a respiratory infection in July 2010 which required antibiotics and, by August 2010, had declined and was placed in a nursing home. His ADLs returned to 6 of 6 while in the nursing home. In September 2010, M.M. only had to be in the wheelchair for short intervals; however, he had muscle wasting at that time. On 09/14/10, M.M. was having generalized pain and shortness of breath with activity that required oxygen and occasional bronchodilators. He also had a respiratory infection and was incontinent. In November 2010, M.M. had a CD4 count of 29 from a prior level of 70. Dr. Talakkottur agreed that this lower CD4 count put the patient at higher risk for opportunistic infections. During the dates at issue, M.M.'s PPS increased to 40 percent, but decreased back to 30 by the fall of 2010. Dr. Vermette testified that M.M. had terminal AIDS because he was noted to have advanced HIV illness with wasting by the physician taking care of him in the hospital just prior to hospice admission. M.M. was also seen by an infectious disease expert who stated M.M. had advanced AIDS. M.M. was discharged from the hospital and referred to hospice by his doctors who stated that he had a poor prognosis and was hospice appropriate. Those doctors were not affiliated with Vitas. Dr. Vermette noted that although MRSA is not an opportunistic infection, it is a seriously harmful bacterium that is hard to eradicate even in a healthy patient with a normal immune system. Dr. Talakkottur believed, in part, that M.M. was not hospice appropriate because he did not have opportunistic infections. Dr. Vermette stated that Dr. Talakkottur did not properly take into account that an AIDS patient is usually not going to die from an opportunistic infection, and that most AIDS patients who die from an infection die from a regular infection that is more likely to kill an AIDS patient. M.M had two respiratory infections, a staph infection, and an infection in his blood. Any of those could be life-threatening to a healthy person, much less a person with AIDS. AHCA has not met its burden by the greater weight of the evidence that M.M. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 22, E.D. Patient E.D. was a 64-year-old male admitted to hospice with a terminal diagnosis of adult failure to thrive. The claim period at issue is eight months from 02/23/10 to 11/25/10. E.D. was hospitalized in February of 2010 prior to hospice admission with respiratory failure. He was intubated. He also had renal failure during the hospitalization and was diagnosed with a brain tumor. He was admitted directly from the hospital to Vitas. At admission to hospice, E.D. had a PPS of 20 percent, was 6 of 6 ADLs, had a BMI of 17.7, a Stage III ulcer on his hand, pulmonary edema, hypertension, a brain tumor, a PEG tube, and coronary artery disease. He was taking only minimal sips of fluid and had confusion. E.D.'s brain tumor was measured to be 4.9 by 4.9 centimeters, or about two inches in diameter. Shortly after admission to hospice, E.D. was placed in the IPU due to severe agitation. In March 2010, E.D. had an infection of his central line. He developed blood in his stool and had significant anemia and significant gastrointestinal bleeding with a hemoglobin of 9.6 and hematocrit of 29.6, which would have required a transfusion if E.D. was not in hospice. In May 2010, E.D. was transferred to the IPU unit because of aggressive behavior, including hitting caretakers. He continued to have wounds and significant functional and nutritional decline, as evidenced by a PPS that remained at 40 percent or less and a BMI that remained significantly below 20. In June 2010, E.D. had a low albumin of 2.93. He still had non-healing wounds and required another IPU stay for agitation and combativeness in late July 2010. All nonessential medications were stopped because of side effects, including agitation. He also had a UTI in the end of July. In August 2010, E.D. was having dark discoloration to his right foot, which was evidence of diabetic peripheral vascular disease. Dr. Vermette testified that this was a significant finding of progression of E.D.'s comorbidity of diabetes. In September 2010, E.D. had another UTI requiring antibiotics. In October 2010, E.D. had a respiratory infection with rhonchi, congestion, cough, and he was on respiratory nebulizer treatments. He still had a PEG tube for nutritional supplements. His ambulation was restricted from bed to wheelchair with assistance. He was on dexamethasone for intracranial swelling from the brain tumor and on seizure prophylaxes. In November 2010, E.D. developed respiratory distress with a respiratory rate of 38. He was placed on continuous care, became nonresponsive despite being on continuous care, and ultimately died on hospice care. Dr. Eisner opined that E.D. did not die because of his terminal illness; therefore, Dr. Eisner found E.D. ineligible for Medicaid hospice. Dr. Vermette testified that adult failure to thrive is a diagnosis that was, at the time of E.D.'s admission, one of the four most common diagnoses used in hospice nationwide. It was used for patients who had significant functional impairment, significant nutritional impairment, and was used for a patient who had multiple conditions that could result in his death. It is now called multiple morbidity. Dr. Vermette testified that typically a patient who has concurrent different illnesses is admitted for adult failure to thrive when they meet the criteria. All of E.D.'s comorbidities were part and parcel of the diagnosis of adult failure to thrive. The pneumonia or respiratory failure that he developed right before he died was extremely similar to the event that led to him being admitted to hospice. Dr. Eisner stated that E.D. did not have adult failure to thrive because he gained 12 pounds and, therefore, could not have nutritional impairment. Dr. Vermette testified that E.D.'s weight gain was not inconsistent with the terminal diagnosis and that factors, such as nutritional supplements, beginning to eat a soft diet, and use of the steroid dexamethasone, would cause a weight gain. Dr. Vermette noted that there was no indication that the weight gain coincided with increased muscle mass or strength. More importantly, the fact that the patient gained weight over the course of his stay in hospice could only be known at the end of the hospice stay and during a retrospective review. It could not be known when the initial certification was made on the date the patient was admitted with a BMI of 17. E.D. met the disease specific criteria from the LCD for failure to thrive. As noted above, he had a PPS of 40 percent or less, a BMI less than 22, and was not responding to nutritional support by way of his PEG tube at admission. AHCA has not met its burden by the greater weight of the evidence that M.M. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 23, J.L. Patient J.L. was a 59-year-old female admitted to hospice with a terminal diagnosis of end-stage COPD. The claim period at issue is just over four months, 03/14/11 to 07/27/11. J.L. was admitted to the hospital with an exacerbation of COPD on 03/09/11. She was found to have severe anemia during this stay and was treated by IV with hydration, antibiotics, and blood transfusions. At the time of admission to Vitas, J.L. had shortness of breath at exertion and at rest, was an aspiration risk, and had recurrent infections. Her PPS was 40 percent. She also had AIDS, acute renal failure, and a history of hepatitis. Her BMI was 19.9 and she had a glomerular filtration rate of 25 and an albumin of 2.5. She was immediately admitted to the IPU with shortness of breath, agitation, and altered mental status. In April 2011, J.L. was drinking heavily and was found vomiting after drinking, which put her at a risk of aspiration and affected her longevity. She had bitemporal wasting, which showed significant nutritional decline for a patient this young. Between admission and the end of June, J.L. had multiple hospitalizations for a viral illness, a UTI, and a psychiatric admission--she was hospitalized on 03/25/11, 05/16/11, and 06/17/11. In late June 2011, J.L. showed signs of improvement. She was dependent in 5 of 6 ADLs, but her PPS increased to 60 percent. She was still having shortness of breath, but it was intermittent as opposed to constant. She was still having agitation and gastrointestinal issues. Over the course of the next month, she stabilized enough to be discharged for extended prognosis. Dr. Vermette testified that J.L. followed the sawtooth pattern of decline. J.L. had a serious decline at admission and subsequently improved, but at the time of admission there was no way to know whether that decline was going to be the one that resulted in death or she would have a rebound in condition. When she rebounded enough to no longer support a prognosis of less than six months, she was appropriately discharged. Dr. Eisner noted in his review that J.L. was not hospice eligible because "she improved during her hospice admission." However, her improvement from her severe status exhibited at admission could not be realized until she was appropriately discharged at the end of the dates in dispute. AHCA has not met its burden by the greater weight of the evidence that J.L. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 24, F.F. Patient F.F. was an 84-year-old female, admitted to hospice with a terminal diagnosis of end-stage renal failure. The claim period at issue is just over four months, from 09/01/09 to 01/18/10. F.F. was referred to hospice for progressive decline in function. On her admission date, she was reported awake, alert, and oriented times two to three. In January 2009, a CT scan revealed that F.F. had a large renal cyst suggestive of Myeloma (a cancer of plasma cells in the bone marrow). Vitas admitted F.F. with a terminal diagnosis of end-stage chronic renal disease that had been diagnosed approximately four years earlier (2005). Evidence of F.F.'s renal disease was reported within the Appropriateness Evaluation's genitourinary section. One would therefore assume that Vitas would continue to track the status and/or progression of the disease under that system. Dr. Vermette, however, testified at the final hearing that end- stage renal disease did not produce genitourinary symptoms. End- stage renal disease caused symptoms systematically in other parts of the body because of the fact that the kidney's main function is to eliminate toxic metabolites from the body. When those toxins build up, they produce symptoms elsewhere in the body unrelated to genitourinary review of symptoms. A review of F.F.'s other systems reported in the Plan of Care Reviews suggest no terminal illness or progression of her renal disease. The Plan of Care Reviews reported no respiratory issues at all over the course of the disputed period. F.F. was reported to itch under the integumentary system. F.F. was neurologically sound. At best, she was reported to be forgetful at times, and her symptoms were reported mild from August through mid-October. Afterwards, Vitas failed to make further comment or score an impairment level for F.F.'s neurological system. The same was true for F.F's cardiovascular system except her impairment levels, when recorded between August and mid-October, fluctuated between mild and moderate. The plans reported no edema under cardiovascular. The plans reported F.F.'s musculoskeletal system to have a mild impairment level until 11/03/09, and thereafter, it went to moderate. As for her genitourinary system, there was no impairment level noted throughout the disputed period. Vitas also failed to report any concerns with F.F.'s genitourinary system in any nursing note, including the initial note prepared following admission (March 2009). Most nursing notes were checked that the genitourinary system had been "Assessed, no GU problems identified." The Plan of Care Reviews also fail to report F.F. enduring any pain above a mild impairment level. The only pain medication referred to in the plans is Tylenol 3 and it was used on an as needed basis. When marked in the Plan of Care Reviews, F.F.'s PPS was consistently 50 percent. F.F.'s weight was not always reported, despite the fact that she was ambulatory. However, when it was reported, the Plan of Care Reviews showed a steady increase. At admission she weighed 98 pounds, the first recorded weight in the Plan of Care Reviews was 100 and that was in October, and she was consistently reported to weigh 100 pounds until the latter part of December when her weight increased to 102 pounds and remained as such until the last Plan of Care Review in the disputed period. There were no labs to report F.F.'s albumin in the disputed period; however, labs were taken in October 2011, and it was reported at that time the recipient's albumin was 3.8 and 3.9 on 10/25/11 and 10/26/11. The medical records contained in this patient's file do not support a finding that the Medicaid hospice eligibility standard was met during the disputed period. Based upon the greater weight of evidence in this case, it is determined that F.F. was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $20,545.60. Patient 25, S.C. Patient S.C. was a 43-year-old female, admitted to hospice with a terminal diagnosis of end-stage SLE. The claim periods at issue are 02/02/12 to 02/24/12 and 05/14/12 to 12/31/12. SLE is an autoimmune disease where the body develops antibodies and attacks its own cells, damaging organ tissue all over the body. SLE can cause damage to the heart, to the lungs, to the liver, to the kidneys, and to the brain by damaging the blood vessels, leading to vasculitis. Most patients with SLE die from organ failure. In the time period leading up to the dates at issue, Patient S.C. was hospitalized with a stroke resulting from lupus. At the time of admission, she had a PPS of 30 percent, was drowsy, and required total care. Her family reported she had recently lost nine percent of her body weight. S.C. had significant comorbidities, including tuberculosis meningitis, four previous strokes, atrial fibrillation, and cardiac disease. She was an aspiration risk due to dementia and dysphagia. Her family sought hospice services. Patient S.C. met the criteria in the Florida Handbook at the beginning of the dates at issue because of her recent hospitalization with a stroke; the progression of her disease with multiple organs affected, including the brain, the heart, and immune system; nutritional decline; and significant functional impairment. During the first admission, Patient S.C. was on continuous care for numerous symptoms, including pain and respiratory symptoms. She came off continuous care but then was started on it again on 02/23/12, for agitation. Shortly thereafter, 911 was called, the patient was taken to the hospital, and hospice was revoked for aggressive treatment. At the time of her next admission beginning on 05/14/12, Patient S.C. had just been hospitalized again for altered mental status and possibly another stroke. The physician certification noted the patient was lethargic, had extensive evidence of disease, was bedbound, had reduced intake, required total care, had lost all intelligible vocabulary, was unable to sit independently, unable to smile, and unable to even hold her head up. Dr. Vermette testified that tuberculosis meningitis is a very rare condition. S.C. was exposed to tuberculosis while doing earthquake relief in Haiti about six months prior to her initial admission to hospice, which meant that, based on her status at admission to hospice, she had rapidly declined during those previous six months. With tuberculosis meningitis, instead of lodging in the lungs, it makes its way to the brain and affects the meninges. It is extremely difficult to treat. As of the initial certification on 05/14/12, Patient S.C. had a PPS of 30 percent, had a FAST of 7f, and had shortness of breath with minimal exertion. S.C. had contractures locking her limbs in a flexed position, as well as agitation and dysphagia. Her weight was 105 pounds, an additional 15-pound weight loss from the previous hospice admission three months earlier. S.C. showed evidence of progression of the terminal illness with worsening of the various organs that had been involved with lupus, further nutritional decline, and significant functional impairment. Over the next few months, S.C. continued to decline. She became aggressive and screamed when someone tried to bathe her, she tried to attack and claw nurse's aides, she began to develop skin breakdown on her ankle, and was only eating 30 percent of her pureed diet that had to be fed to her. S.C. was Medicaid hospice appropriate as of the recertification in August 2012. She had a fair appetite, was cachectic, had signs of muscle atrophy, needed total care, and had a PPS of 30 percent. In late August going into September, S.C. had fever and cough, and she was at increased risk of developing aspiration pneumonia. At the next recertification on 10/06/12, S.C. had to be fed, had an increasing appetite, and was eating 50 to 70 percent of her meals, but despite this, she was still very thin and cachectic. S.C. had atrophy of her leg muscles, so she was not able to stand on a scale. She was no longer able to tolerate being in a chair, even with a lift, so she was completely bedbound all the time. S.C. was recertified a final time during the period in dispute on 11/26/12. At that point, S.C. demonstrated functional decline, anorexia and weight loss, dysphagia, cardiac involvement of lupus, and had oral thrush, which further indicated the decline of her immune system and susceptibility to an infection. Following that recertification, S.C. continued to show evidence of significant decline. She developed a lung infection that required bronchodilators in the form of nebulizer treatments and antibiotics and had a fever of 102, which continued until 12/20/12. Whether S.C.'s PPS score was less than 30 percent, or whether it was 20 or 40 percent, did not change her eligibility for Medicaid hospice. Any number of 50 percent or less would have shown functional impairment to meet the expected functional decline. A PPS of 50 percent is generally considered compatible with a prognosis of six months or less in non-cancer hospice diagnoses. Even when a nurse note did not calculate a PPS number, they indicated the patient required total care, was bedbound, or was able to get in a wheelchair only with a Hoyer lift. Consequently, the description of the patient in the notes described the criteria that a physician would use to infer a PPS of 30 or 40 percent at any given time. There was no description of S.C. in the medical records that would lead to a PPS of 50 percent or greater. Dr. Vermette testified that once S.C. began developing cachexia and had a level of terminality to her disease process, she reached a tipping point at which even with good nutrition, she could not gain weight because her body was no longer capable of reversing the process. Where the records showed S.C. did eat 100 percent of her meal, she did not feed it to herself. She needed assistance with eating at those times. She was total care at those points and she was bedbound. Dr. Talakkottur testified that at the second admission, 05/14/12, Patient S.C. had been hospitalized for agitation and nasal bleeding, she had a PPS score of less than 30 percent, she was bedbound and had a FAST level of 7f, and she continued to be dependent in 6 of 6 ADLs. Dr. Talakkottur further testified that patient S.C.'s PPS score never rose above 40 percent, her FAST level never improved to better than 7c, and she was nonambulatory and incontinent during her entire length of stay. AHCA has not met its burden by the greater weight of the evidence that S.C. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 26, D.A. Patient D.A. was a 61-year-old female, admitted to hospice with a terminal diagnosis of end-stage cerebral degeneration. The claim period at issue is 10/17/11 to 12/31/12. At the time of admission, Patient D.A. had end-stage dementia. In addition, she had recurrent UTIs and had been hospitalized a little over a month prior to hospice admission with a serious UTI. D.A. also had hyperglycemia and had a malignant melanoma Stage IV on her leg. A Stage IV melanoma, by definition, means that it is in the bloodstream waiting to settle. D.A.'s secondary conditions due to her dementia included severe cognitive impairment, functional impairment, incontinent of bowel and bladder, FAST of 7d, PPS of 30 percent, bedbound, reduced intake, dysphagia, and dependent in 6 of 6 ADLs. Patient D.A. met the criteria for Medicaid hospice eligibility in the Florida Handbook at the beginning of the dates at issue because of her status at admission and terminal diagnosis, clear evidence that she had reached the terminal stage of her illness, a recent hospitalization, significant functional decline, and significant evidence of nutritional impairment. Dr. Vermette testified that the indicators of end-stage cerebral degeneration include a FAST of 7a or above and secondary or comorbid conditions which are significant and contribute to prognosis. D.A. portrayed these indicators by having a FAST of 7c or above throughout the dates at issue, a known malignancy that has a poor prognosis in general, significant dysphagia which puts the patient at high risk of aspiration--the most common cause of death in dementia patients. She continued to be severely declined, she remained bedbound during the entire period, and she had signs of decline throughout her course of her care. At the beginning of the dates at issue, D.A. had a pressure ulcer to her left foot that eventually resolved. However, she quickly developed another wound on her upper thigh. D.A. developed dyspnea on exertion, such as while trying to roll over in bed and trying to eat, even though she was bedbound. There were very few actions D.A. could perform at that point. Shortness of breath while rolling over or eating was significant and showed an aspect of respiratory involvement in her disease. In December 2011, D.A. developed tremors in her hands, which was a sign of further disease progression of D.A.'s end-stage cerebral degeneration. D.A. also had hydrocephalus, which means that the areas in her brain that are normally filled with fluid had expanded. This was evidence that she lost brain tissue. In May of 2012, D.A. required an IPU stay because of shortness of breath and vomiting, which was life-threatening because of D.A.'s dysphagia and aspiration risk. While she was in the IPU, she weighed 165 pounds, which was a five-pound weight loss. In July 2012, she was coughing more frequently while trying to eat, which was evidence of worsening dysphagia and increased risk of aspiration. In September 2012, she developed another wound on her elbow. In October of 2012, she had developed contractures, so her fingers were curling up on themselves and the pressure of one finger pushing against the skin of another finger caused wounds. This was a sign of further progression of her terminal disease of cerebral degeneration. At the end of the dates at issue, D.A. was in the IPU again for shortness of breath and fever, which could lead to an aspiration pneumonia. She was started on antibiotics during the last few days of December 2012. Dr. Vermette testified that the only improvement in D.A.'s condition during the dates at issue was that, except for the elbow wound that began in October 2012, her numerous wounds did eventually heal, albeit at a delayed pace. However, whether or when a wound resolves cannot be known at the time it occurs. In December 2012, D.A. developed decorticate posturing, which means that D.A.'s brain had declined to the point where her arms were stiffly held out at the sides with the palms up and were immobile. Decorticate posturing is incompatible with having tremors and is a worse decline than tremors. Patient D.A. had aspiration events when she was having shortness of breath, and coughing and choking while eating, even though such events did not end up leading to pneumonia. When asked whether a patient was hospice appropriate that had a PPS score of 30 percent, was bedbound, required assistance with 6 of 6 ADLs, was confused, had reduced intake, was unable to sit up on her own, was not ambulatory, was incontinent of bowel and bladder, and had a history of melanoma, hydrocephalus, diabetes, obesity and arterial hypertension, Dr. Talakkottur would not answer yes or no and was unpersuasive. D.A. met the disease specific criteria from the LCD for dementia and related disorders. As noted above, she had a FAST score of at least 7c, which indicates she was speaking six words or fewer, was dependent in 6 of 6 ADLs, and was incontinent. AHCA has not met its burden by the greater weight of the evidence that D.A. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 28, N.M. Patient N.M. was a 57-year-old female, admitted to hospice with a terminal diagnosis of end-stage heart disease. The claim period at issue is less than one year, from 05/25/11 to 04/06/12. N.M. had a long history of heart disease, as well as stroke. She was admitted to the hospital approximately six months prior to her hospice admission in November 2010 and was diagnosed with cardiogenic shock, as well as coronary artery disease and carotid stenosis. Cardiogenic shock means the heart has such an insult that it becomes stunned for a period of time and the blood pressure rapidly drops. The patient usually ends up on multiple medications in an attempt to keep the blood pressure high enough to stay alive. N.M. was hospitalized again on 05/20/11, approximately five days prior to her hospice admission, for an acute decompensation of congestive heart failure. N.M. was having orthopnea (shortness of breath lying down) and had progressive shortness of breath, but was not a candidate for bypass surgery or other modalities that would have corrected her issues because of her multiple comorbidities. N.M.'s comorbidities included a previous stroke, obesity, diabetes, hypertension, and carotid stenosis. During the 05/20/11, hospitalization, Patient N.M. was found to have an EF of 45 percent, which was between normal and abnormal. She also had a pulmonary artery pressure of 57 with moderate to severe mitral regurgitation. Normal is only 8 to 25, making this finding more significant to her prognosis than the EF. N.M. was referred to and admitted directly to hospice from the hospital. She was unable to do any work, she was mainly sitting and lying, she needed assistance with care, and her weight was 183 with a BMI of 36, which was in the obese range. She had shortness of breath, or dyspnea, at rest and with exertion, NYHA Class IV. She had residual issues from her prior stroke, including muscle weakness on the left side. She was immediately admitted to a higher level of hospice care. Patient N.M. met the criteria for Medicaid hospice eligibility at the beginning of the dates at issue because she had evidence of terminal diagnosis with a life expectancy of six months or less, she had multiple hospitalizations, and she had multiple physician assessments and radiologic assessments. N.M. further had progression of the disease, declining functional status with a PPS of 40 percent. She had gone from chronic heart disease to end-stage heart disease. In August 2011, N.M. had signs of muscle atrophy and wasting, she remained bedbound, and she had a skin abscess in her axilla, or armpit, in the previous month. She remained a NYHA Class IV, and she was on six medications to try to control her cardiac symptoms. N.M. was also on oxygen 24 hours a day and had nitroglycerin tablets for when she had chest pains. Between August and November of 2011, N.M. had another abscess under her arm and she continued to have shortness of breath at rest and was NYHA Class IV. In November 2011, N.M. continued to have an abscess, needed extensive care, and had a PPS of 40 percent. In January 2012, N.M. had yet another skin infection. She required multiple doses of sublingual nitroglycerin and she required oxygen continuously. Her PPS was down to 30 percent. She needed extensive assistance and she had another UTI in addition to the abscess. N.M. had shortness of breath at rest and she became incontinent and was wearing diapers. In February 2012, N.M. was having continuous episodes of chest pain and shortness of breath at rest. In March 2012, she had more episodes of abscesses in her sweat glands and axilla which had become a recurrent infection. She had increased episodes of pain, which required more doses of pain medication. She was having more psychosocial symptoms, anxiety and depression, because of her symptoms related to her end-stage heart disease and medication was started for those symptoms. She continued to be a NYHA Class IV and continued to need oxygen 24 hours a day. N.M. was appropriately recertified for Medicaid hospice at each point in time and had evidence of a prognosis of six months or less at each point in time. On 04/06/12, N.M. had a worsening of her symptoms, and her family called 911. She went to the hospital and revoked hospice and was admitted to the hospital with decompensating symptoms. N.M. did not have any significant improvement during the dates at issue. Even though the EF found on the echocardiogram at the time N.M. revoked hospice showed some improvement, other issues on the echocardiogram showed the patient remained Medicaid hospice eligible, such as pericardial effusion more related to her intrinsic heart disease than to heart failure per se. She also had evidence of valve disease and inoperable multivessel coronary artery disease. Although there were a few nursing notes in N.M.'s records where the orthopnea box was not checked, the nurses frequently noted the patient had dyspnea, and that the patient was bedbound or lying in bed, which is the definition of orthopnea. AHCA has not met its burden by the greater weight of the evidence that N.M. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 29, V.R. Patient V.R. was a 56-year-old female, admitted to hospice with a terminal diagnosis of end-stage cirrhosis of the liver. The claim period at issue is just over seven months, from 04/05/12 to 11/20/12. Rather than being referred to hospice from a hospital admission, V.R. was referred to hospice by her primary care physician. Dr. Eisner testified that V.R.'s liver disease was related to her chronic Hepatitis C. V.R. had suffered from liver disease since 1998. During the disputed period, Dr. Eisner opined that V.R. had a life expectancy of greater than six months because the file did not contain evidence to show her cirrhosis was progressing and her functional status did not change. Although she suffered from ascites, it did not worsen to the point of requiring a paracentesis. Dr. Vermette noted V.R. had a "declining functional status, including a PPS of 40 percent." However, her PPS score was 40 percent on admission and remained static at 40 percent until 09/20/12, when it rose to 50 percent. Dr. Vermette admitted that the most common markers for liver functionality are albumin scores and INR scores, which are assessed through a blood test. Vitas' training document, created by Dr. Shega, states that a patient must have an INR of greater than 1.5 and an albumin score of less than 2.5 AND other evidence of end-stage liver disease, such as ascites or encephalopathy. Dr. Vermette admitted that no blood tests were performed for V.R. during the disputed period. Therefore, V.R. did not have lab values which would lead a physician to conclude she had a life expectancy of less than six months. The medical records contained in this patient's file do not support a finding that the Medicaid hospice eligibility standard was met during the disputed period. Based upon the greater weight of evidence in this case, it is determined that V.R. was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $35,999.98. Patient 30, J.A. Patient J.A. was an 86-year-old male admitted to hospice with a terminal diagnosis of debility unspecified. The claim period at issue is less than one year, from 10/29/09 to 09/29/10. Patient J.A. was transferred to Vitas from a different hospice at the beginning of the dates at issue. The medical director from the prior hospice believed J.A. was still hospice eligible at the time of transfer and noted that J.A. had an increase in healthcare utilization as well as a fall causing a head injury. At admission to Vitas, J.A. had underlying organ systems insufficiency with significant cognitive and nutritional impairment, was dependent in 6 of 6 ADLs, and required maximum assistance in going from bed to chair. He had dysphagia with micro aspirations, end-stage dementia with a FAST greater than 7, lung disease which required nebulizers frequently, coronary artery disease, and his PPS was 40 percent. On 11/02/09, Patient J.A. was on a pureed diet and was using oxygen and bronchodilators for cough, congestion, and agitation. He had a recent respiratory infection requiring antibiotics. His FAST score was 7c, he was dependent in 6 of 6 ADLs, and he had a PPS of 40 percent. He required a Velcro support to keep him from falling out of his wheelchair. By December 2009, J.A. had lost a pound and a half more weight. He had another fall later that month, hit his head, and required a skull X-ray. In January 2010, J.A.'s PPS decreased to 30 percent while his FAST remained in the terminal stage. In April 2010, J.A.'s weight decreased to 123 pounds. He had chest congestion requiring nebulizer treatment, increased weakness, dysphagia, and needed to be fed. In June 2010, J.A. was incoherent in speech and his FAST score was 7c to 7d. His weight was between 122 and 123 pounds, he had decreased tolerance to activity and sitting in a wheelchair, he had increased weakness and confusion, and he remained on a pureed diet due to the risk of aspiration. In August 2010, J.A. had shortness of breath and chest congestion intermittently, increased weakness and agitation, and restlessness. He was dependent in 6 of 6 ADLs, had further decreased tolerance to sitting in a chair and increased mental confusion. On 09/27/10, Patient J.A. developed a sudden change in level of consciousness and respiratory distress. He was placed on continuous care and over the next two days, he had very rapid breathing and respiratory distress with a respiratory rate as high as 42. His skin became mottled as he was getting less oxygen to the tissues. He had apnea spells and ultimately died of respiratory distress on 09/29/10. Dr. Eisner testified that J.A. did not exhibit functional decline over the dates at issue. Dr. Vermette explained that this patient was dependent in 6 of 6 ADLs at admission requiring maximum assistance so there was no way to decline in functional status, although he did exhibit decline in his inability to tolerate just sitting in a chair. Dr. Eisner also stated that J.A.'s weight had been stable at admission at 128 pounds. However, J.A.'s weight declined by ten pounds in the months leading up to admission. AHCA has not met its burden by the greater weight of the evidence that J.A. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 31, A.J.M. Patient A.J.M. was a 77-year-old female admitted to hospice with a terminal diagnosis of end-stage heart disease. The three claim periods at issue total about six months: 03/13/12 to 03/15/12; 03/20/12 to 03/24/12; and 03/30/12 to 09/28/12. A.J.M. had a history of heart disease which required a defibrillator be placed three years prior to admission at Vitas. She was hospitalized in the days leading up to the first claim period with significant heart failure, diastolic dysfunction, and an EF of only 10 percent. She also had severe global hypokinesis of the left ventricle, which means heart tissue had died so the heart beat in an abnormal pattern with less strength than normal. A.J.M. was admitted directly from the hospital to Vitas. On admission on 03/13/12, A.J.M. had a PPS of 30 percent, was bedbound, had reduced intake, was NYHA Class IV, and had leg edema. She also had comorbidities of recurrent pneumonias and dementia. She was dependent in 6 of 6 ADLs. A.J.M. revoked hospice care less than three days after admission on 03/15/12. A.J.M. returned to the hospital on 03/16/12. She presented to the ER with a hypertensive emergency and pulmonary edema. Her EF was 10 percent. She was intubated during this hospitalization and her blood gas was monitored. A.J.M. was immediately readmitted to Vitas hospice from this hospitalization on 03/20/12. At this admission, she had a PPS of 30 percent, was total care, still had reduced intake, had edema in both legs, was short of breath at rest, and had a wound on her sacrum. More history was noted including that the patient had pneumonia and UTIs in the last six months. Given the hospitalization with respiratory failure requiring intubation between the first and second period, this patient's terminal prognosis had worsened since the initial admission to hospice. During the second admission, A.J.M. had chest pains which required nitroglycerin. Vitas was arranging to transfer A.J.M. to the IPU for pain management when her family instead elected to seek aggressive treatment in the hospital and revoked hospice care again on 03/24/12. Patient A.J.M. was again admitted to Vitas directly from a hospitalization on 03/30/12. On admission, A.J.M. had a PPS of 30 percent, shortness of breath, an EF of 10 percent, a FAST score of worse than 7, diabetes, anemia, and dysphagia. A.J.M.'s weight had decreased to 130 pounds and she was experiencing chest pains. In April 2012, A.J.M. required an IPU stay for shortness of breath and had chest pain which was treated with nitroglycerin. A.J.M. received four bursts of defibrillation because she had three episodes of ventricular tachycardia and one episode of ventricular fibrillation, requiring the automatic device to shock her. On 05/06/12, Patient A.J.M. required a stay in the IPU for chest pains. Her respiratory rate was high and she was tachycardic. A.J.M. was in significant distress at this time. On 05/21/12, A.J.M. again required care in the IPU, this time for a change in level of consciousness. She was hypotensive, and as a result, some of her blood pressure medications were withheld. On 06/22/12, A.J.M. again required IPU care due to pain and respiratory distress. Her weight decreased to 122 pounds. On 09/14/12, Patient A.J.M. had significant respiratory and cardiac symptoms, increased weakness, and muscle wasting. On 09/24/12, she again was transferred to the IPU for change in level consciousness and agitation. She was in respiratory distress with a respiratory rate of 26, was becoming more delirious, and experienced more shortness of breath. A.J.M. died on hospice care on 09/28/12. Dr. Vermette opined that each of the IPU stays would have resulted in another hospitalization if A.J.M. had not been on hospice at the time. Dr. Vermette also opined that this patient died of end-stage heart disease or end-stage congestive heart failure with respiratory arrest. Dr. Talakkottur stated A.J.M. was not hospice eligible because she did not have significant respiratory or cardiac symptoms, had no frequent hospitalizations, and had no recurrent infections. These statements are directly contrary to the evidence. A.J.M. was noted to have recurrent UTIs and pneumonia within the six months prior to hospice admission. She had three hospitalizations in March 2012 due to her cardiac and respiratory distress along with five other IPU stays. Dr. Talakkottur also stated that A.J.M.'s nutritional status was not compromised despite a decrease in weight from 175 pounds to 122 pounds from the time of initial admission until the patient's death. AHCA has not met its burden by the greater weight of the evidence that A.J.M. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 33, M.V. Patient M.V. was an 89-year-old female admitted to hospice with a terminal diagnosis of end-stage cardiovascular disease and also exhibited symptoms of end-stage cerebral degeneration. The claim period at issue is 12/14/10 to 03/25/12. On recertification for the period beginning 12/14/10, M.V. had shortness of breath, a PPS of 30 percent, was dependent in 6 of 6 ADLs, a comorbidity of end-stage dementia with a FAST of 7d, and had dysphagia which required a pureed diet, as well as the Thick-It compound added to her fluids. M.V. remained 6 of 6 ADLs during the dates in dispute with a PPS of 30 percent. In April 2011, M.V. suffered a respiratory infection requiring antibiotics. In June 2011, she had visible signs of cachexia and muscle wasting. On 08/12/11, M.V. had a significant infection. Similarly, on 08/25/11, M.V. had congestion, shortness of breath, cough, and secretions, which was consistent with an aspiration event in a patient such as this with severe dementia and dysphagia. On 08/31/11, M.V. required a suction machine to help with the secretions. In October 2011, Patient M.V. became hypotensive and had another upper respiratory infection. M.V. continued to experience brachycardia and hypotension in December 2011. Her FAST score also worsened to 7e. Dr. Talakkottur agreed that this progression of M.V.'s FAST score would be consistent with her comorbidity of Alzheimer's disease. On 03/23/12, Patient M.V. developed acute respiratory distress with a respiratory rate of 24. She had cyanosis and was placed on continuous care for respiratory distress. M.V. died on hospice services on 03/25/12. Dr. Vermette testified that each of M.V.'s episodes of infection where she developed respiratory distress and developed cough, congestion, and required antibiotics were likely aspiration events. As noted from the Mitchell study, an episode of pneumonia in the presence of advanced dementia results in a grave prognosis. Patient M.V. had three episodes of significant respiratory distress, the last one of which ended up killing her, and either of the other two could have done so. Dr. Talakkottur stated this patient was not hospice eligible because she did not have recurrent infections. However, the record shows that M.V. had three respiratory infections within a year. Dr. Talakkottur stated that this patient had a hip fracture but that such an injury would have no impact on her prognosis. This is directly refuted by the credible testimony of Dr. Shega in prior claims. Dr. Talakkottur admitted that the medical record on 03/25/12 immediately preceding M.V.'s death evidenced that M.V.'s life expectancy at that point was less than six months. According to the audit instructions, if any day during a certification period was approved by a peer reviewer, then the entire certification period was to be approved. Dr. Talakkottur agreed that M.V. was hospice appropriate on 03/25/12; accordingly, that entire period must be approved for reason of the instruction alone. AHCA has not met its burden by the greater weight of the evidence that M.V. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 34, L.S.L. Patient L.S.L. was an 85-year-old male admitted to hospice with a terminal diagnosis of end-stage cerebral vascular disease. The claim period at issue is 12/03/10 to 09/28/11. In 2008, L.S.L. suffered a significant stroke. Over time, he became increasingly debilitated. He was hospitalized prior to admission to repair and replace his PEG tube, but was noted by his daughter to have declined since that hospitalization, including that he required a Foley catheter. At the time of admission, he required a PEG tube for his feedings, had developed vascular dementia and was nonverbal. He had problems swallowing and had dysphagia. He had a seizure disorder and was on seizure medications. The medical records indicate that this patient was admitted to hospice for "agitation." Dr. Vermette testified that he thought it was "very likely" that the agitation experienced by L.S.L. was associated with the PEG tube reinsertion and Foley catheter insertion. Dr. Eisner opined that although L.S.L. was sick on presentation, it was the result of his stroke in 2008. He showed no change in his cerebral vascular disease and no progressive decline in his functional or nutritional status. Besides one brief inpatient overnight stay in June of 2011 to service his PEG tube, L.S.L. lived at home with his daughter. His daughter was a nurse who described herself as having experience working around patients like her father. In July 2011, a social worker noted the daughter stated her father was doing well, and he seemed like a chronic patient and had not declined since admission. The medical records show that discharge planning was discussed with L.S.L.'s daughter as early as 06/29/11; however, he was not discharged until 09/28/11, for extended prognosis. The medical records contained in this patient's file do not support a finding that the Medicaid hospice eligibility standard was met during the disputed period. Based upon the greater weight of evidence in this case, it is determined that L.S.L. was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $46,830.90. Patient 35, R.B. Patient R.B. was a 52-year-old male admitted to hospice with a terminal diagnosis of end-stage AIDS. The claim period at issue is just two weeks, from 01/14/11 to 01/28/11. R.B. was admitted to the hospital with pneumonia just prior to his hospice admission. The chest x-ray from that admission was consistent with pneumocystis carinii pneumonia ("PCP"), which is one of the defining opportunistic infections in AIDS patients. Patient R.B. was admitted to hospice directly from that hospitalization. He had a combined CD3 CD4 count of 88. At admission, R.B. had a PPS of 30 percent, was drowsy, was dependent in 6 of 6 ADLs, had weight loss from 125 to 110 pounds in the prior three months, and had a BMI of 18. In addition to AIDS, R.B. had thrush, a history of AIDS wasting, systemic lymphoma, non-small cell lung cancer, and COPD. He was placed in IPU for shortness of breath upon admission to hospice. He was also agitated and restless during that time. R.B. was going to be placed in a nursing home because he was homeless, but when the transfer to the nursing home was scheduled to occur, he became angry and belligerent and revoked hospice care. On the date R.B. revoked, his ADLs had improved to needing assistance with 1 of 6. However, Dr. Vermette stated it is not uncommon for a patient to show improvement in the first weeks after admission to hospice from an acute hospitalization. Dr. Vermette also stated that a combined CD3 CD4 count is very similar to a CD4 count. He stated a combined CD3 CD4 count below 200 would be AIDS-defining. During the dates at issue, R.B. required antipsychotic medications. He was also treated with oxygen and nebulizer treatments every four hours. He required two different narcotics for pain. Dr. Eisner found no evidence of decline during the two weeks R.B. was in hospice. However, this again shows the problematic nature of the retrospective review and does not take into account that at admission, this patient was hospice eligible. AHCA has not met its burden by the greater weight of the evidence that R.B. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment. Patient 36, J.D. Patient J.D. was a 79-year-old male, admitted to hospice with a terminal diagnosis of end-stage heart disease. The claim period at issue is just under six months, from 10/21/10 to 04/18/11. Leading up to and at the beginning of the dates at issue, Patient J.D. had been hospitalized because of gangrene in one of his legs, requiring amputation. He was referred to hospice from that hospitalization. In addition to his obvious peripheral vascular disease and anemia, J.D. had a history of stroke and dementia and a comorbidity of hypertension. He had a PPS of 30 percent, was bedbound, disoriented at times and required total care, had shortness of breath at rest and required frequent oxygen. J.D. was also having episodes of chest pain and having episodes of edema in his lower extremity. J.D. had experienced a MI (heart attack) ten years prior to admission to hospice. At admission the recipient's EF was 45 percent. Notably, J.D. was not suffering from shortness of breath or requiring oxygen after admission to hospice care. Moreover, starting with the nursing assessment on 11/16/10, Dr. Talakkottur noted that the nurses' notes fail to evidence anything of significance for either the cardiovascular or respiratory systems of J.D. which would lead him to believe J.D. had a prognosis of six months or less to live. Dr. Vermette opined that J.D. was hospice eligible because of his recent hospitalization and the progression of his terminal illness, specifically that he was a NYHA Class IV. However, in addition to the nurses' notes discussed during Dr. Talakkottur's testimony, the Plan of Care Reviews failed to report this recipient suffered from dyspnea at any time from admission until 04/12/11. Moreover, Dr. Vermette admitted that Respondent conceded a portion of J.D.'s hospice stay based upon concerns that certain Plan of Care Reviews had been merely photocopied with dates changed. Based upon the greater weight of evidence in this case, it is determined that this recipient was not eligible for Medicaid hospice services and that AHCA is entitled to recover an overpayment of $148,606.85. Patient 38, L.F.P. Patient L.F.P. was an 83-year-old female, admitted to hospice with a terminal diagnosis of end-stage Alzheimer's disease. The claim period at issue is just over four months, from 08/09/12 to 12/31/12. In July 2012, L.F.P. was a FAST of 7c to 7d, dependent in 6 of 6 ADLs, PPS of 30 percent, had muscle wasting, decreased oral intake, was having episodes of agitation, and had a recent UTI. Following that recertification, a week prior to the beginning of the denied period, L.F.P. was placed on continuous care because of a change of mental status with significant lethargy and she was also dehydrated and having shortness of breath. On the first day of the denied period, L.F.P. developed a tremor possibly due to medications. L.F.P. then had improvement since the continuous care began and was more awake and alert. Her altered mental status appeared to be improving. Patient L.F.P. displayed the indicators for end-stage Alzheimer's, such as high FAST score, functional impairment, nutritional impairment, and other comorbidities or secondary symptom burden. Dr. Vermette testified that L.F.P. was appropriate for Medicaid hospice at the beginning of the dates at issue because the factors that were present when the patient was appropriately recertified on 07/08/12 were still present one month later, and indeed the patient had shown a need for significantly more care during those two weeks just prior to the beginning of the denied period. Because the first month of the recertification period was approved, the second month, including the beginning of the denied period, must be approved in accordance with the audit instructions. In August 2012, L.F.P. developed blood in her urine and a UTI, requiring an antibiotic. In September 2012, L.F.P. developed a wound in the sacral region and it was a Stage II, over an inch in diameter in all directions. While a patient does not die specifically from a skin wound of this size, he/she can develop an infection which then can debilitate a patient such as this and lead to sepsis and ultimately death from the infection. More commonly, this type of a wound is a marker of nutritional impairment and a general functional decline. In October 2012, L.F.P. remained FAST 7d and remained bedbound, total care. The prior wound healed in October; however, later in the month and early November, she developed a new wound in that area. L.F.P. developed contractures, her muscles tightened up because of disuse and caused her joints to flex and be locked in that position. L.F.P. began receiving baclofen to help with her contractures. L.F.P. was also at risk for aspiration and was on aspiration precautions, requiring a pureed diet and thickened liquids. In December 2012, Patient L.F.P. had a FAST score of 7d, a PPS of 30 percent, dysphagia requiring a pureed diet with thickened liquids, still had contractures, and she had a sacral wound. Additionally, she had shortness of breath at rest, which was an additional symptom burden and additional organ system involvement in her symptom burden. L.F.P. displayed the indicators of end-stage Alzheimer's disease throughout the dates at issue. Dr. Talakkottur confirmed that throughout the dates at issue, L.F.P. was incontinent of bowel and bladder, her PPS score never ranged above 30 percent, her FAST level was never better than 7d, and she was dependent in 6 of 6 ADLs. AHCA has not met its burden by the greater weight of the evidence that L.F.P. was not eligible for Medicaid hospice services, and it is not entitled to recover an overpayment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order directing VITAS Healthcare Corporation of Florida to repay an overpayment to AHCA the sum of $954,488.60, plus the overpayments to be recalculated for Melbourne Patients 11 and 21, and Boynton Beach Patient 5. The undersigned reserves jurisdiction to the extent AHCA provides the revised sanctions, fines, and costs it is entitled to recover against VITAS and that amount is determined in a later proceeding. DONE AND ENTERED this 28th day of September, 2018, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of September, 2018.
The Issue The issue is whether the Agency for Health Care Administration properly determined that the application of Covenant Hospice, Inc. meets the statutory and rule criteria for a hospice program in Service Area (SA) 2B.
Findings Of Fact Hospice Care Hospice care is a medically coordinated group of services that is designed for people who have a terminal diagnosis with a life expectancy less than six months. Hospice care provides palliative care as opposed to curative care. The patients' and their families' needs are multi-dimensional and include physical, psychological, emotional, spiritual, and financial needs. Hospice care includes physician directed medical care, nursing services, social work services, bereavement counseling, and other ancillary services such as community education. Hospice care is reimbursed by Medicare, Medicaid, Champus/Tri-Care (for military populations), and some commercial insurance programs. For example, under the Medicare reimbursement system, hospices are reimbursed based on an identifiable flat per diem rate for a bundled package of services. Medicare does not reimburse hospices for bereavement services. The Medicare benefit is based on level of care. Routine home care is the basic level of care. Routine home care is provided as long as a hospice can care for a patient in a home-like environment. The second level of care is continuous care, which provides between eight and 24 hours of nursing care per day. The third level of care is inpatient care, which a hospice can provide in a hospital, a skilled nursing unit of a nursing home, or a freestanding hospice inpatient facility operated by a hospice. The fourth and final level of care is respite care. The primary reimbursement agent for hospice care is Medicare, but it is becoming more common for private insurers and health maintenance organizations to provide the benefit. Hospices also provide care to charity patients who have no source of payment and no or insufficient assets or income. Hospice SA 2B Hospice SA 2B comprises eight counties: Franklin, Gadsden, Jefferson, Leon, Liberty, Madison, Taylor, and Wakulla. SA 2B covers 5500 square miles. It has an average of 67 persons per square mile. While Leon County has 345 persons per square mile, Taylor, Franklin, Liberty, Madison and Jefferson Counties all have less than 30 persons per square mile. Liberty County is the least populated county in the state of Florida. Liberty County has a low-income population but is better off economically than some of the other counties in the SA. Madison County has a population of approximately 17,000, with mostly low-to-middle income families. The majority of residents in Madison County have a high school education or less. Like most rural communities, Madison County is resistant to change or "outside intervention." Only two SAs in Florida have fewer projected deaths than SA 2B. Those are SA 2A and SA 7C. The providers in SA 2A and SA 7C serve multiple SAs. The Parties AHCA AHCA is the state agency that is responsible for administering the CON program and laws in Florida. In conjunction with these duties, AHCA reviews applications for new hospice programs pursuant to Sections 400.601, 400.602, 400.609, 400.6095, 408.034, 408.035, 408.036, and 408.043, Florida Statutes, and Rules 59A-2 and 59C-1.0355, Florida Administrative Code. Covenant Covenant, formerly known as Hospice of Northwest Florida, is a not-for-profit community organization that was founded by a committee in 1982. The committee included community leaders and several hospitals in the Pensacola, Florida, area. Covenant began treating its first patients in 1984 and is currently licensed to provide hospice services in SA 1 and SA 2A. The following counties are located in SA 1: Escambia, Santa Rosa, Okaloosa, and Walton. The following counties are located in SA 2A: Holmes, Washington, Jackson, Calhoun, Bay and Gulf. Covenant obtained its first CON for SA 1 and three counties in SA 2A. Covenant later expanded to cover all of SA 2A. In 1994, Hospice of the Emerald Coast (formerly known as Bay Medical Hospice and hereinafter referred to as Emerald Coast) was the dominant provider in SA 2A, but Covenant became the dominant provider within six years after expanding its coverage. Emerald Coast also has expanded its coverage and is licensed now to provide hospice services in SA 1 and SA 2A. Emerald Coast is now gaining market share in SA 1. Covenant is licensed to provide hospice services in 26 southern Alabama counties. However, Covenant currently provides services in only nine or ten Alabama counties. Covenant currently shares its Alabama SAs with five or six other providers and is considering further expansion in Alabama. On average, Covenant serves 429 Florida hospice patients per day. It admits patients and provides service 24 hours a day, seven days a week, without regard to their ability to pay. Covenant's main office and its eight-bed inpatient/residential facility, the Joyce Goldberg Hospice Inpatient Residence, are located in Pensacola, Florida. The room and board residential component of the inpatient facility is not reimbursed by any government agency and most often provides services on a charitable basis. Covenant built the inpatient facility to provide services to the homeless. However, Covenant does not consider patients who present with subjective signs of imminent death to be appropriate for admission to the facility. Covenant performs a financial assessment of patients at the time of their admission to the inpatient facility. If the patient or his or her representative elect not to provide Covenant with financial data, patients and their families understand that the full rate per day for room and board will be charged on a monthly basis at the beginning of each month, even when there is little or no chance that Covenant will ever collect the amount owed. Patients that have the ability to pay for some or all of their treatment at the facility do so on a sliding scale basis. However, the bottom line is that Covenant admits patients to the inpatient/residential facility without regard to their ability to pay. Covenant historically has provided inpatient care to children in one of the area's children's hospitals, Sacred Heart Hospital. Providing inpatient hospice care to children in a special hospital is appropriate from a quality of care perspective. Covenant operates the following Florida branch offices: Okaloosa County at Niceville, Florida; Jackson County at Marianna, Florida, and Bay County at Panama City, Florida. Covenant operates Florida community support centers in Okaloosa County at Crestview, Florida, and in Walton County at Destin, Florida. Volunteers staff Covenant's community support centers. Among other activities, the centers conduct blood drives and provide space and volunteer training for organizations such as the American Cancer Society and various Alzheimers groups. Covenant provides the centers on a charitable basis. Covenant's growth and expansion has focused on serving persons in underserved areas and populations. Its mission is to provide direct care to dying patients, their families and friends, and to provide education to the community. Covenant is the 30th largest hospice in the United States. It serves the largest geographic area in Florida. Covenant's audited finances demonstrate the corporation's growth. In the past five years, Covenant has nearly tripled its number of patient days. Covenant has purchased management software and systems, with a useful life of five years, to facilitate support for a corporation twice its size. It has secured contracts for services with every hospital, nursing home, and assisted living facility in SA 1 and SA 2A. Covenant's vision is to create and foster a corporate culture of excellence. In order to achieve its goals, Covenant has recruited personnel from the for-profit industrial sector. As incentives for achievement of performance goals, Covenant pays bonuses to its top management. It also has a separate staff bonus pool. Covenant made a profit in 2001 despite paying such bonuses out of its operational funds. Covenant has achieved its growth and expansion, in part, by implementing a continuous quality improvement process in which it constantly looks for ways to improve its operations and services. Expansion into SA 2B will improve Covenant's operations by allowing it to spread its fixed overhead costs. Consistent with its objectives, Covenant chose to pursue accreditation from the Joint Commission on Accreditation of Health Care Organizations (JCAHO) four years ago. Covenant became accredited without outside consultation, using its own staff and resources. Since then, JCAHO has re-accredited Covenant, pursuant to a 98 percent survey report with no Type I recommendations. Covenant provides hospice care in a way that ensures sensitivity to cultural diversity and the hospice patient's cultural values. For example, Covenant has informational brochures and material in various foreign languages, including Vietnamese and Spanish. Covenant's policies and procedures comply with all applicable requirements of the U.S. Department of Health and Human Services related to discrimination in the workplace. They are sufficient to ensure confidentiality for any employee with HIV and to ensure protection of all other employees. Covenant provides substantial "unfunded" and "underfunded" programs to the community. Underfunded programs include palliative chemotherapy and palliative radiation therapy. In addition to unfunded community support centers, Covenant provides unfunded bereavement programs in schools and grief-in-the-workplace seminars. Through its physicians and medical teams, Covenant provides unfunded physician care for non-Medicare patients. In fact, Covenant provided approximately $1.5 to $1.7 million in unreimbursed care in the calendar year 2001, and anticipates that it will provide more such care in 2002. Covenant, like all not-for-profit organizations, must raise funds to pay for non-reimbursed expenditures that support charitable services. Covenant has developed a strategic plan to identify ways to measure its success in meeting the needs of underserved populations. As a part of its ongoing strategic planning process, Covenant determined that there was an unmet need for hospice services in SA 2B, the area currently exclusively served by BBH. After receiving requests from physicians for hospice services in SA 2B, Covenant approached BBH to offer assistance and support. Covenant also consulted with its health planner regarding the need for additional hospice services in SA 2B. After AHCA determined that there was a numeric need for an additional hospice in SA 2B, Covenant's chief executive officer (CEO) toured SA 2B to assess the potential for expansion and to look for potential properties. Eventually, Covenant became convinced that there were compelling reasons to apply for a CON in SA 2B because of an unmet need for hospice services. Covenant has strong reserves of ready cash and equivalents, including $2.9 million in cash and over $1 million in investments, to underwrite the SA 2B expansion. Covenant has approximately six times more working capital than BBH. The $84,000 stated in Covenant's application as required expenditures to develop the new program in SA 2B is insignificant compared to the corporation's ability to provide "unlimited funds" for the project. The fact that Covenant has sizable cash and investment reserves despite having to subsidize it SA 2A offices demonstrates its financial power. BBH Community volunteers began organizing BBH in 1981. After its incorporation in 1983 as a not-for-profit community organization, BBH commenced operation under a license that authorized it to provide hospice services only in SA 2B. On average, BBH serves 162 patients per day. BBH's main office is located in Tallahassee, Florida, but it operates the following branch offices and/or community support centers: Franklin County at Carrabelle, Florida; Gadsden County at Quincy, Florida; Jefferson County at Monticello, Florida; Madison County at Madison, Florida; and Taylor County at Perry, Florida. BBH plans to create additional branch offices/community centers in the following locations: Franklin County at Apalachicola, Florida; Gadsden County at Chattahoochee and Havana, Florida; and Wakulla County at Crawfordville, Florida. BBH also operates a 12-bed inpatient facility. The facility, known as The Hospice House is located in Tallahassee, Florida. It usually operates at 80 percent of its capacity. The Hospice House was built using funds raised in a capital funds campaign and $250,000 in community grants. The facility is designed so that family and friends can spend as much time as they can with their loved ones. The facility provides 24-hour care for various reasons, including pain management, respite care, routine residential care as an alternative to continuous care in a patient's home, transition care after leaving a hospital, and care for patients facing imminent death who for personal reasons do not want to die at home. Occasionally, The Hospice House helps local hospitals manage oncology floor bed shortages. BBH has a policy that requires paying patients to pay in advance on a weekly basis because many times patients do not stay at the facility for longer than a week. The rate charged depends on the patient's ability to pay. Frequently, patients stay at the facility for free due to their low-income status. BBH does not bill patients for services that it does not intend to collect. BBH has a 24-member Board of Directors. The Board is comprised of a broad mix of people with backgrounds in law, business, medicine, education, nursing, and insurance. BBH has one or more community advisory councils (CACs) for each county in SA 2B. The CACs hold public meetings in their respective counties each month. The purpose of the CACs is to support BBH's effort to reach out to civic and church groups and to advise BBH on how to gain acceptance in the SAs diverse communities. Like BBH's Board of Directors, the CACs are comprised of a broad group of people who are racially and ethnically diverse. The CACs include local clergy who assists BBH's outreach to the faith-based community. BBH has a minority advisory council (MAC) that supports BBH's outreach efforts in the African-American community. The MAC hosts lunches and dinners at churches and sponsors gospel sings that include education about hospice care. For example, a gospel sing that was conducted at Florida A&M University was preceded by an hour-long seminar on hospice care on National Public Radio. BBH has had an ethics committee since 1994. The purpose of the committee is to educate BBH's staff and the community about ethical issues. The committee routinely reviews BBH's policies and when necessary, reviews particular patient dilemmas. The ethics committee includes a rabbi, a protestant chaplain, a religion professor, a Muslim pharmacist, a social worker, a nurse, and other interested individuals. BBH is a member of the National Hospice and Palliative Care Organization (NHPCO). BBH is accredited by the Community Health Care Accreditation Program, one of the first accreditation programs. AHCA has approved BBH after every licensure survey with no deficiencies. BBH's mission is to provide care and education to terminally ill patients and their families. BBH's mission includes providing emotional support to anyone dealing with grief from loss of a loved one. BBH serves all individuals who meet the clinical criteria for admission to hospice, regardless of their ability to pay. It provides care to indigent patients without concern for financial reimbursement. BBH responds to patient referrals within 24 to 36 hours. BBH does not discriminate against any group on any basis. BBH delivers hospice services with a minimum of administrative costs. Out of the funds raised by BBH through charitable gifts, 86 cents of every dollar goes directly to patient care. BBH does not spend substantial funds on marketing or advertising. BBH has five interdisciplinary teams (IDTs). Each team has a medical director and staff who live in their IDT area. BBH has nurses who live in every county in the SA except Liberty County. The IDTs have separate back-up on-call nurses to provide coverage 24 hours a day, seven days a week. The on-call nurses can provide care to patients within 30 minutes of a call. BBH has a full-time medical director, four part-time IDT associate medical directors, and a part-time associate medical director for its inpatient facility. The associate medical directors meet with the IDTs weekly to review patient care. They also provide advice and education to other providers and physicians in the community. The IDT medical directors provide emergency consultation should an acute situation arise with a patient. In addition to its core services, BBH provides other services to the community and patients that are not reimbursed from any source. These services include grief counseling to adults and children, crisis intervention in schools after a student's death, and the music therapy program. BBH's music therapy program, which is non-reimbursed, is one of only two such programs in Florida that the National Association of Music Therapists has certified as a music therapy site and as a music therapist training site. BBH has the equivalent of five full-time staff members that provide music therapy through out SA 2B as requested by patients or recommended by an IDT. Over 30 percent of BBH's patients receive music therapy. BBH provided over 1,500 hours of music therapy in the six months prior to the hearing. Part of BBH's outreach efforts includes conducting physician education seminars. About 200 out of 320 local physicians in SA 2B periodically refer patients to BBH. BBH provides palliative chemotherapy and radiation treatment on a case-by-case basis. There is no persuasive evidence that BBH has ever denied a physician's recommendation for such services. At times, BBH has reimbursed a local hospital for palliative radiation services for BBH patients. BBH solicits feedback from patients, their families, and their physicians through surveys that are sent out three weeks after patients begin receiving care and again after patients pass away. BBH's committee for quality improvement reviews the results of the surveys on a monthly basis as part of BBH's continuing quality improvement program. Recent results show a high degree of patient and family satisfaction because they are equal to or higher than national palliative care statistics. Physician survey responses show 90 percent or better satisfaction. BBH follows up on any survey response that is less than "very good" from patients or "average" from physicians. Covenant's Application Covenant's Board of Directors duly authorized the filing of Covenant's letter of intent and application. The Executive Committee of Covenant's Board of Directors authorized the filing of the letter of intent on August 27, 2001. Covenant timely filed the letter of intent with AHCA on August 29, 2001. The Board of Directors authorized the filing of the application on August 30, 2001. Covenant filed the application with AHCA on September 4, 2001. After receiving an omissions letter from AHCA, Covenant timely filed its omissions response and complete application along with the appropriate application fee. AHCA has preliminarily approved Covenant's application to establish a new hospice program in SA 2B. AHCA's preliminary approval is subject to the following conditions: (a) Within the first two years of operation, Covenant must open a branch office in Perry, Taylor County, Florida; and (b) Covenant must establish a special non-cancer outreach program to educate the medical community on the effectiveness of hospice care for patients with non-cancer diagnoses. Fixed Need Pool Rule 59C-1.008, Florida Administrative Code, relates to CON application procedures in general. Rule 59C-1.0355, Florida Administrative Code, relates to specifically to hospice programs. Both rules contain provisions that relate to published fixed need pool projections. In this case, Covenant filed its application in response to a published fixed need for an additional hospice program in SA 2B. BBH has challenged that published need in DOAH Case No. 01-4415 CON. A Recommended Order in that case is being issued concurrently with the instant case. Conformance with District Health Plan Preferences Covenant's application is in conformance with the applicable district health plan as required by Section 408.035(1), Florida Statutes, and Rule 59C-1.030(2)(c), Florida Administrative Code. The applicable local health plan preferences are set forth in the District 2 CON Allocation Report, approved October 2000. With respect to the first local health plan preference, Covenant currently provides and commits to providing district-wide services. Covenant will provide the services 24 hours per day, seven days a week, regardless of a patient's ability to pay. As to the second local health plan preference, Covenant currently contracts with and commits to contracting with existing hospitals and nursing homes for the provision of inpatient care. The proposed program does not require the construction of a new facility or the addition of beds. Conformance with Agency Rule Criteria The application conforms to the requirements of Rule 59C-1.0355(3)(a), Florida Administrative Code, which requires hospice programs to comply with the standards for program licensure described in Chapter 400, Part VI, Florida Statutes, and Chapter 58A-2, Florida Administrative Code. Covenant has demonstrated that it meets these statutory and rule requirements. Some of the requirements, including but not limited to "quality of care," are discussed in detail below. The application is in conformance with the five-rule preferences set out in Rule 59C-1.0355(4)(e), Florida Administrative Code. As to rule preference one, Covenant evidences a commitment to serve populations with unmet needs. One such population includes non-cancer patients as discussed below. With respect to the rule preference two, Covenant proposes to provide the inpatient care component of its proposed program through contractual arrangements with existing health care facilities. Covenant does not propose the development of an inpatient facility. The application conforms to rule preference three. Covenant has demonstrated a commitment to serve the homeless, patients with AIDS and patients who do not have primary caregivers at home. Covenant is entitled to credit for rule preference four. Covenant proposes a project in SA 2B, which has eight counties. It intends to establish its main office in Tallahassee, Leon County, Florida, with a branch office in Perry, Taylor County, Florida. Covenant anticipates opening community support centers in Madison County and in Gadsden County during the third year of operation. Covenant has presented persuasive evidence that Madison and Taylor Counties are underserved as discussed below. The application meets the expectations of rule preference five. Covenant is committed to providing services not specifically covered by private insurance, Medicaid, or Medicare. These services include, but are not limited to, chaplain services, support for seriously ill patients not yet appropriate for hospice services, non-health care items such as hot water heaters and telephones that provide quality of life and allow patients to stay at home, bereavement services, and volunteer services. The application is in conformance with Rule 59C-1.0355(5), Florida Administrative Code. Covenant's proposal is consistent with the needs of the community and other criteria contained in local health council plans and the State Health Plan. Rule 59C-1.0355(5), Florida Administrative Code, specifically requires an applicant to provide letters of support from health care organizations, social services organizations, and other entities within the proposed SA that endorse the applicant's development of a hospice program. In order to comply with this provision, Covenant sent approximately 206 letters to individual and entities in SA 2B requesting support of its application. Even though health care providers in SA 2B have limited knowledge about or experience with Covenant, it received the following letters of support: (a) eight letters of support from physicians who practice in SA 2B; (b) three letters of support from hospitals located in SA 2B; (c) 18 letters of support from nursing homes and assisted living facilities located in SA 2B; and (d) six letters of support from other health care professionals and/or residents who live and work in or adjacent to SA 2B. These letters of support are sufficient to show compliance with Rule 59C-1.0355(5), Florida Administrative Code, despite the fact that AHCA received 160 letters of opposition to the proposed project from various individuals and entities in SA 2B. The application is in conformance with Rule 59C-1.0355(6), Florida Administrative Code, because it provides a detailed description of the proposed program. First, proposed staffing for the project will be 9.54 full-time equivalents (FTEs) in the first year of operation and 18.79 FTEs in the second year of operation. The volunteer staff will number about one per patient and will increase from about 15 in the first year to about 35 in the second year. The record contains competent evidence showing how Covenant will recruit and train its staff and volunteers. Second, Covenant expects to obtain patient referrals from hospitals and doctor's offices. Based on Covenant's prior experience in starting new hospice programs, the expected sources of patient referrals are reasonable and appropriate. Third, the application sets forth the projected number of admissions for the first two years, by payer type, by type of terminal illness, and by age groups. Covenant expects Medicare patients to comprise about 80 percent of the admissions. The majority of Covenant's patients will have diagnoses other than cancer, such as heart disease, emphysema, liver disease, and Lou Gehrig's disease. During the first year, Covenant expects to have 27 patients, under 65, and 82 patients, 65 and older. In the second year, Covenant expects to have 56 patients, under 65, and 184 patients, 65 and older. These projected utilizations are reasonable and achievable. Fourth, Covenant has identified the services to be provided by staff and volunteers and those to be provided through contractual arrangements. Covenant plans to provide direct care in the following areas: physician services, nursing services, home health aide services, dietary counseling, social work services, chaplain services, counseling services, and bereavement services. Physical, speech, and occupational therapy services will be provided through contractual arrangements. Fifth, Covenant will provide inpatient services through contractual arrangements with nursing homes and hospitals. Covenant has gained expertise in providing hospice care in nursing homes in its existing SAs. Sixth, the application sets forth provisions for serving persons without primary caregivers at home. Covenant's plan allows patients to be responsible for their own care as long as they are able to do so. When that is no longer possible, Covenant provides the patients with a list of alternatives. Seventh, Covenant will provide bereavement services to its patients before death and to patients' families and friends after death for at least one year. Covenant also provides grief counseling in schools and in the community. Covenant offers grief support to its staff and volunteers. Covenant uses seminars, workshops, and special programs to train and educate its staff, volunteers, and individuals in the community about particular bereavement topics. Next, Covenant will provide extensive community education activities concerning hospice programs. Some of these are discussed in detail below. As indicated above, Covenant has agreed to provide a special non-cancer outreach program to educate the medical community in SA 2B about the effectiveness of hospice care for non-cancer diagnoses. Finally, Covenant's application includes policies for the receipt, acknowledgement, management and utilization of fundraising activities. Covenant expects fundraising to account for 2-3 percent of net revenue for the proposed program. The application does not include specific proposed methods for fundraising activities in SA 2B. However, during the hearing Covenant provided sufficient evidence about its past experiences to support the conclusion that it will be successful in this regard. 80. Rules 59C-1.0355(6)(h) and 59C-1.0355(6)(i), Florida Administrative Code, do not apply here. Covenant does not intend to establish a freestanding inpatient facility in SA 2B. Covenant's proposals, expectations, and projections are reasonable and appropriate as they relate to the factors set forth in Rule 59C-1.0355(6), Florida Administrative Code. Based upon Covenant's experience, the proposed program as described in the application is conservative and achievable. Conformance with Applicable Statutory Criteria As stated above, the proposed project complies with the standards for licensure described in Chapter 400, Part VI, Florida Statutes. Specifically, the application conforms to the requirements of Section 400.606(1), Florida Statutes, because it provides a plan for the delivery of home, residential, and home-like inpatient hospice services to terminally ill persons and their families. Covenant's plan contains, but is not limited to, the following: (a) the estimated average number of terminally ill persons to be served monthly; (b) the geographic area in which hospices services will be available; (c) a listing of services which will be provided, either directly by the applicant or through contractual arrangements with existing providers; (d) provision for the implementation of hospice home care within three months after licensure; (e) the provision of inpatient care in nursing homes and other health care facilities; (f) the number and disciplines of professional staff to be employed; (g) the name and qualifications of potential contractors; (h) a plan for attracting and training volunteers; (i) the projected annual operating cost of the hospice; and a statement of financial resources and personnel available to the applicant to deliver hospice care. Some of these plans are discussed in detail herein. Rule 59C-1.0355(3)(b), Florida Administrative Code, requires an applicant to be in conformance with Sections 408.035 and 408.043(2), Florida Statutes. Covenant meets the standards sets forth in these statutes as indicated below. Section 408.035(1), Florida Statutes, requires consideration of the need for the proposed project in relation to the applicable district health plan. As discussed above, Covenant meets this criterion. Sections 408.035(2) and 408.035(7), Florida Statutes, relate to the need for the proposed project as evidenced by the availability, quality of care, efficiency, accessibility, and extent of utilization of existing health care facilities and health services in the applicant's SA. Covenant meets these statutory criteria for the following reasons: (a) SA 2B is characterized by lack of hospice competition; (b) The proposed project will ensure access to hospice care in the SA's rural communities; (c) Covenant's special non-cancer outreach program will increase utilization for patients with non-cancer diagnoses; (d) With projected admissions of 109 patients in year one, 240 patients in year two, and 305 patients in year three, the proposed project will achieve a 25 percent market share in the third year; and (e) Covenant is Medicare and Medicaid certified and has a history of providing quality of care. Sections 408.035(2) and 408.035(12), Florida Statutes, relate to the applicant's history of providing quality of care and its demonstrated ability to provide such care. Covenant meets these criteria because it has a quality assurance program that provides a comprehensive, centrally coordinated system by which Covenant can conduct an ongoing evaluation of patient care and family services. Covenant's Performance Improvement Plan (PIP) is discussed in detail below. Section 408.035(4), Florida Statutes, relates to whether the applicant will provide services that are not reasonably and economically accessible in adjacent SAs. It is preferable for hospice services to be delivered in patients' homes or in home-like environments. It is undisputed that residents of rural populations often are reluctant to accept hospice services from a local provider. It follows that rural populations would be even more reluctant to seek hospice services in an adjoining SA. Some SA 2B patients from Liberty and Franklin Counties receive hospice services in SA 2A. Additionally, some residents of Madison and Taylor Counties receive hospice services in SA 3A. However, there is no persuasive evidence that a significant number of the underserved patients in the rural populations of SA 2B ever received services in an adjoining county for any one year. To the contrary, the greatest weight of the evidence indicates that for a substantial number of patients in SA 2B, hospice services are not reasonably or economically accessible in adjoining SAs. Section 408.035(5), Florida Statutes, relates to the needs of research and educational facilities in the SA. This criterion does not apply because Covenant's proposed project is not located in a teaching hospital and does not involve research or formal education and training programs for physicians and other health care professionals. Section 408.035(6), Florida Statutes, relates to the applicant's resources, including health personnel, management personnel, and funds for capital and operating expenditures, that are available for project accomplishment and operation. Section 408.035(8), Florida Statutes, relates to the applicant's immediate and long-term financial feasibility. Covenant meets these criteria because it has demonstrated the short-term and long-term financial feasibility of the proposed project. Section 408.035(9), Florida Statutes, relates to whether the proposed project will foster competition to promote quality and cost-effectiveness. Covenant's proposed project will meet this criterion because it will provide the patients of SA 2B a choice of providers. Benefits accrue from competition among hospice providers because hospice utilization is strongly related to awareness and education. Competition creates an environment in which hospices must do more to educate the community, promoting quality of care. Covenant's proposed project also will increase the hospice penetration rate in SA 2B, thereby resulting cost effectiveness and overall savings to the health care system. This is true even though a large majority of patient care is provided by fixed price government payer sources that are not influenced by competition. Section 408.035(10), Florida Statutes, relates to proposed costs and methods of construction associated with the proposed project. This criterion does not apply because the proposed project does not involve any construction. Section 408.035(11), Florida Statutes, relates to the applicant's history of and commitment to providing health services to Medicaid patients and the medically indigent. In 2000, Covenant provided about 7.8 percent of its patient days to Medicaid patients. That same year, Covenant provided approximately $480,000 in non-billable services. In SA 2B, Covenant proposes to provide 10 percent of its patient days to Medicaid patients and 4 percent to charity. The record is clear that Covenant meets this statutory criterion. Section 408.043(2), Florida Statutes, relates to the need for and availability of hospice services in the community. The application is in conformance with the requirements of this statute because there is a need for additional hospice services in SA 2B, especially for non-cancer patients and in rural populations. Additionally, a new hospice program will promote competition. Need for an Additional Hospice Published Fixed Need Pool and Special Circumstances The hospice penetration rate is defined as the ratio of hospice admissions in a SA divided by the number of resident deaths for that SA. Hospice penetration has grown in Florida and the United States in recent years, due primarily to increased awareness among the lay and health care communities. In Florida, overall hospice penetration is currently about 40 percent. Like the rest of the state, Covenant has increased its utilization in the past few years. The licensing of Emerald Coast in SA 1 created a competitive environment with Covenant and resulted in increased admissions and penetration in SA 1. The same result was achieved in SA 2A when Covenant was licensed to serve all of SA 2A in competition with Emerald Coast. In contrast, BBH has been the sole provider in SA 2B, which has experienced a penetration rate gap that has persisted over a seven-year period. For the batching cycle at issue here, SA 2B has one of the lowest penetration rates (29 percent) in the state, ranking 26th out of 27 SAs. In the instant case, AHCA calculated a net numeric need under Rule 59C-1.0355, Florida Administrative Code, of 351, which exceeds the need threshold of 350, and indicates the need for one additional hospice program in SA 2B. The rule's methodology takes into account the demographic differences between SA 2B and the rest of the state. With a projected need of 1,209 patients for the planning horizon at issue here and only 858 BBH admissions for the relevant historical period, BBH would have needed 41 percent more admissions to close the penetration rate gap regardless of the fact that there is only a difference of one between 350 and 351. It is clear that the net numeric need here correlates to the local reality. Special Circumstances Rule 59C-1.0355(4)(d), Florida Administrative Code, identifies the following special circumstances that may merit approval of a new program even if there is no published need. These special circumstances are as follows: (a) that a specific terminally ill population is not being served; (b) that a county or counties within the SA of a licensed hospice program are not being served; and (c) that there are persons referred to hospice programs who are not being admitted within 48 hours (excluding cases where a later admission date has been requested.) AHCA did not review Covenant's application to determine whether a CON should be awarded based on special circumstances. Instead, AHCA gave preliminary approval to the proposed project based on the publication of need. However, AHCA's State Agency Action Report (SAAR) indicates that the agency considered and did not agree with Covenant that Madison and Taylor Counties were "underserved." AHCA also determined that there was a need for educational outreach to non-cancer patients in SA 2B and conditioned the award of the CON on Covenant's provision of that service. During the hearing, Covenant presented persuasive evidence that underserved non-cancer patients and underserved rural populations in SA 2B constitute special circumstances within the meaning of Rule 59C-1.0355(4)(d), Florida Administrative Code. The special circumstances would have warranted approval of Covenant's application in the absence of numeric need. Non-Cancer Patients Care to non-cancer patients has increased dramatically during the past 20 years. Generally, non-cancer patients comprise more than half of all hospice patients. The SA 2B penetration rate of non-cancer patients, under age 65 and age 65 and over, lags behind the overall state penetration rate. This is especially significant because the non-cancer deaths rates are higher in the panhandle of Florida than for the State as a whole. For the batching cycle applicable to this proceeding, the penetration rate gap in SA 2B was most remarkable for elderly non-cancer patients, who make up 69 percent of the net need of 351 patients. The current overall state penetration rate for non-cancer patients, age 65 and older, is 32 percent. In SA 1 and SA 2A, the current overall state penetration rate for non-cancer patients, age 65 and older, is 27.7 percent and 26.6 percent respectively. In SA 2B, the current penetration rate for non-cancer patients, age 65 and older, is 20.1 percent, indicating a gap of 11.9 percent with respect to the state penetration rate. The lack of availability of hospice services in SA 2B nursing homes is another indication of the underserved need of elderly non-cancer patients. Underserved Rural Populations SA 2B is underserved as a whole relative to the rest of the state. All counties in SA 2B, except Jefferson County, had a penetration rate lower than the state average. Comparing the overall penetration rate for SA 2B to the penetration rate for each county in the SA shows that Madison and Taylor counties are significantly underserved. Based upon the most recent data available from the United States, Health Care Finance Administration, there is a 30 percent penetration rate for SA 2B, but for Madison and Taylor counties, it was about 16 percent. For non-cancer diagnoses, the penetration rate was only 8 percent for Madison and Taylor counties, well behind the SA 2B's averages for non-cancer diagnosis. Covenant Hospice Programs Quality of Care Covenant's application is in conformance with the requirements of Rule 59C-1.0355(3)(a), Florida Administrative Code, which provides that the proposed program shall comply with the quality of care standards described in Chapter 400, Part VI, Florida Statutes, and Rule 58A-2, Florida Administrative Code. The best evidence of Covenant's ability to provide quality of care is the finding of no state or federal deficiencies on the three most recent State of Florida compliance surveys. On a yearly basis, Covenant develops a Performance Improvement Plan (PIP) based on its ongoing continuous quality improvement program. The PIP ensures Covenant's ongoing compliance with all state and federal regulations as well as the standards established by JCAHO and NHPCO. Covenant also reviews and updates its corporate and clinical policies and procedures to ensure on-going quality improvement. These policies and procedures are consistent with all state and federal regulations and professional guidelines. The policies and procedures are reasonable and appropriate for all operations, including medical and nursing care. Medical Direction and Medical Quality of Care Covenant's medical director is qualified to take an examination for certification in hospice palliative care. He has completed the American Medical Association's curriculum in Education for Physicians in End-of-Life Care. He is board-certified in geriatrics. In addition to the medical director, Covenant employs physicians as adjunct medical directors and branch office physicians. These doctors provide direct patient care when they make home and nursing home visits. They serve as consultants to IDTs or patients' attending physicians. Covenant's physicians also serve on its quality improvement committee and review records to ensure quality of care. Covenant provides access to physician care for all hospice patients. Physician coverage is available for all patients, 24 hours per day, seven days a week, as appropriate. Covenant physicians follow its clinical procedures manual, which is in conformance with all state and federal regulations and professional guidelines. Covenant provides high quality pharmaceutical services. The policies and procedures related to these services are appropriate to ensure compliance with all state and federal regulations. Partners in Care Program Covenant developed its PIC program in part to ensure appropriate education of its own staff and the community in general. However, the main purpose of the program is to educate and train the staff of nursing homes and other health facility settings. The PIC program promotes continuity and quality of care for patients in such facilities, which house about 47 percent of Covenant's patients. The PIC program is based on a procedures manual known as "The Grey Book." The procedures manual is a toolbox that facility staff can reference at any time. The manual has been instrumental in making the PIC program so successful in addressing the needs of critical patients in extreme pain and discomfort associated with certain terminal illness. Education and Outreach Covenant has a comprehensive education program. It develops an education calendar on a yearly basis and presents extensive educational programs to all applicable audiences. Covenant's education program includes a clinical education program that is designed to ensure high professional competency for nurses, social workers, home health aides, nursing aides, and other health care providers. For example, Covenant's program for nurses requires them to demonstrate "knowledge based competencies" within the first 30 days of employment and on an on-going basis. The competencies are important in achieving high quality of nursing care. Covenant has produced its own comprehensive educational modules on an array of topics. They are "in-depth" courses, not "Hospice 101" or survey courses. They deal with such issues as advanced pain management, advanced symptom management, physiology of dying, ethical issues in the end-of- life care, just to name a few. Many of the advanced training modules are approved by various professional organizations for continuing education credit, including continuing medical education credits. The use of the modules will facilitate hospice utilization and penetration wherever they are used. Another facet of Covenant's education and outreach program is its Patient and Family Handbook that Covenant gives to patients and their families. The handbook provides extensive resources and guidelines to patients and their caregivers. The handbook is clinically appropriate to ensure high quality of care. Covenant's education program also includes extensive and intensive community education. This part of the program increases hospice utilization or penetration by ensuring that the community knows about the availability of hospice services and understands the benefits of those services. Covenant has specific education materials directed to non-cancer diagnoses to ensure access to hospice patients with non-cancer diseases. The materials assist clinicians in determining when a terminally ill non-cancer patient is appropriate for hospice care. They provide the community with knowledge about the availability of hospice care for non-cancer patients. The use of the materials results in greater non- cancer admissions to hospice. In fact, Covenant provides educational programs for physicians to assist them in caring for all types and ages of hospice patients. Referring physicians routinely receive newsletters, written and edited by Covenant's medical staff. At times, Covenant provides one-on-one education of physicians, in-service training, and other modes of education as appropriate. Covenant maintains medical advisory groups in each area office. These groups meet on a regular basis for education and to provide participants input and feedback to Covenant. Covenant has developed educational materials in Spanish and Vietnamese in order to facilitate access to those minority populations. Covenant uses its community support centers to distribute the materials. In contrast, BBH provides far fewer educational opportunities to the community than Covenant. In some months, BBH only provided four or five programs. In other months, none of BBH's programs were provided by trained clinicians. Most of BBH's programs were introductory, not advanced or continuing education level presentations directed to health care professionals. BBH's education programs are insufficient to create adequate public and professional awareness of hospice services in an eight-county area. It appears that BBH has increased the number of programs it presents on a monthly basis after Covenant submitted its application. Rural populations often have religious or conservative belief systems that cause them to be reluctant to accept hospice services. Such barriers to access for hospice services can be overcome by sufficient and appropriate education and outreach to the community and to physicians or other health care providers. Competition of an additional hospice in SA 2B will stimulate additional education and outreach, resulting in higher levels of hospice utilization and penetration rate. Volunteer Program State and federal regulations require a hospice to involve community volunteers in the delivery of hospice services. Hospices use volunteers for a variety of functions including, reading to patients, transportation, housekeeping, and office administrative support. Covenant has developed a comprehensive and high quality volunteer program based upon excellent recruitment and training of volunteers. In an attempt to encourage more patients to remain at home for hospice care, the Escambia County Council on Aging reimburses Covenant for care-giver training and in-home respite care, charged on an hourly basis. Currently, Covenant has over 850 active, trained volunteers. Between 2/3 and 3/4 of Covenant's volunteers come from patient families and friends. Covenant's volunteer training program and manual comply with all state and federal regulations and professional guidelines. Faith in Action Programs Covenant has a special volunteer program referred to as the Faith in Action Program. Covenant developed the program in conjunction with initial Robert Wood Johnson Foundation grant funding. Currently, Covenant provides the service on an unfunded basis. The program sponsors activities to involve faith communities in the care of terminally ill members. Thus, the program enhances access to hospice care by members of the faith communities. Covenant also has established a Faith in Action AIDS Program. The program focuses on the needs of AIDS patients and their families. The educational component of the Faith in Action AIDS program teaches faith communities about the needs of HIV and terminally ill AIDS patients, including children. The Faith in Action AIDS program provides a high level of community service to the AIDS community. It links persons living with HIV to faith communities. It directly addresses many practical needs of individuals with HIV and AIDS. The program was initially grant-funded but is now supported by Covenant as a charitable service. The Faith in Action AIDS program utilizes approximately 75 trained volunteers. Currently the program is based in Pensacola and Escambia Counties and primarily serves those areas. However, Covenant is expanding the program through its SAs. Covenant also has developed a clinical AIDS program as a dedicated hospice program. Covenant provides excellent care and comprehensive services to hospice patients with AIDS and their loved ones through this special program. Chaplain Services Covenant's chaplains function as core members of the IDTs. They provide spiritual care to patients and their families, 24 hours per day, seven days per week. The chaplains are employees of Covenant who receive comprehensive hospice training. This ensures high quality services and proper professional development. For the most part, Covenant's chaplains are ordained ministers with five years of experience and a masters of divinity degree. Covenant's 14 full-time or part-time chaplains are distributed across Covenant's SAs. The program meets state and federal regulations and professional guidelines. Social Work and Bereavement Services Covenant's social work begins at admission with comprehensive assessments of the patients' and their families' needs. Bereavement services focus on the family and loved ones during the terminal illness and after the death of the patient. Both of these services provide extensive education to patients, their families, and the community. Covenant's social work and bereavement programs provide educational seminars and workshops in the community on an unfunded basis. Social workers and bereavement specialists are required to complete competency-based instruction in hospice social work. Covenant's corporate and clinical policies and procedures related to social work and bereavement ensure high quality of care. They meet or exceed all state and federal regulations and professional guidelines. Covenant's social workers are core members of the IDTs. The social worker networks with other members of the team to plan and implement services. They help the patient set and achieve goals. Children's Services Covenant provides children's services through a program that is dedicated to terminally ill children and their families or to children of terminally ill parents or grandparents. The children's program includes unfunded bereavement services even if the bereavement in not associated with a hospice patient. Covenant has been selected to participate in one of eight demonstration projects for children's hospice services known as Program for All Inclusive Care for Children (PAC). The PAC project is a Medicaid waiver program. It will allow hospices to interact with dying children and their families earlier than would be otherwise allowed for enrollment in hospice based upon Medicaid program requirements. Participation in the project is unfunded. Covenant's children's program is comprehensive and provides high quality of care. It meets or exceeds all state and federal regulations and professional guidelines. Competition and Impact of the Proposed Project on the Existing Provider Covenant's application is in conformance with the requirements of Section 408.035(9), Florida Statutes. The proposed project will foster competition and promote quality and cost-effectiveness. The effect of the competition will have a positive impact in the SA and increase hospice penetration, particularly for elderly patients with non-cancer diagnoses and rural populations, due in part to Covenant's comprehensive community education programs. There is no merit to the argument that SA 2B's penetration rates and population size are not sufficient to support two hospices. BBH's own strategic plan shows that its admissions and census will increase even if Covenant is approved. In fact, since AHCA preliminarily approved Covenant's application, BBH has taken numerous steps to increase its referrals and its community outreach and education. These actions show how the mere threat of competition has improved BBH's services. BBH has set a goal of increasing its referrals by 50 percent. Approval of the application will have an adverse impact on BBH only if it does not appropriately respond to the presence of a new provider in the area. Based upon data presented by BBH, its net assets have increased each year. At historical admissions and census levels below that projected by BBH, it actually made money and had an increase in net assets at the end of each year. There is no persuasive evidence that BBH will lose patients days or that its admissions will decrease if Covenant's application is approved. The most credible data indicates that BBH will have at least 970 admissions in year zero, 1,085 admissions in year one, 1,202 admissions in year two, and 1,219 admissions in year three. Covenant will have 0 admissions in year zero, 109 admissions in year one, 240 admission in year two, and 305 admissions in year three. By year three, BBH will still be the dominant provider in SA 2B with 75 percent of the market share. When AHCA approved Emerald Coast for an additional hospice program in SA 1, Covenant undertook certain actions to strengthen its position in the community and to become an even better and more effective provider of hospice services. As a result of these and other actions, the addition of a competitor in SA 1 did not have an adverse impact on Covenant. To the contrary, Covenant grew, increasing its admissions, referrals, fundraising, and volunteer participation. Competition from Emerald Coast brought heightened community awareness about the benefits of hospice services to SA 1. Because Covenant increased community education concurrent with the development of the new hospice program, there was no resulting confusion over the identities of the two programs. Nor did the approval of Hospice of the Emerald Coast erode the economic base of Covenant because Covenant took steps to strengthen its referral base. Emerald Coast did not have an office in Pensacola, or within sixty miles of Pensacola, until approximately May 2002. The admissions and census of Emerald Coast have grown since establishing that office. The change in the competitive environment in SA 1 resulted in increased admissions and penetration in that SA. Covenant increased its admissions and penetration in SA 2A after Covenant AHCA authorized Covenant to serve all of that SA. The same can be expected in SA 2B if AHCA approves Covenant's application to provide hospice services in SA 2B. With Covenant’s approval for an additional hospice service in SA 2B, BBH can and will be expected to do the same kinds of things that Covenant did in SA 1 to preserve market share. All of the things that Covenant can do to increase penetration or obtain market share, BBH can do to preserve market share. These activities include providing education and outreach, developing a referral base, and developing contacts with physicians, hospitals, nursing homes, and other health care facilities. In performing these activities, BBH has a competitive advantage in SA 2B based upon its experience, history, and reputation in the SA. For example, BBH already has contracts with all hospitals and nursing homes in SA 2B. BBH was financially viable at a service volume of 34,404 patient days in 1997, and at a volume of 35,721 patient days in 1999. Big Bend has been financially viable at substantially lower volumes than it will have in the future, even if Covenant is approved and operational in SA 2B. Approval of Covenant will not have an adverse impact on the ability of BBH to recruit and retain sufficient numbers of volunteers in SA 2B. BBH currently does not have difficulty recruiting and retaining sufficient numbers of volunteers, which evidences a substantial pool of volunteers in the SA. In addition, Covenant will draw its volunteers primarily from persons served by it, families and friends of Covenant patients. Covenant is willing to work with BBH cooperatively to ensure training and recruitment of sufficient numbers of volunteers. Approval of Covenant in SA 2B will not have an adverse impact on the ability of BBH to effectively raise funds. In SA 1 and SA 2A, Covenant has tailored its fundraising activities so that they do not conflict with Emerald Coast's efforts to raise funds. Covenant and Emerald Coast continue to grow their fundraising in both SAs. The fundraising pool in any SA is elastic and can be expanded. Hospice in particular opens up a new pool of potential donors. The additional education and community outreach provided by Covenant will increase hospice penetration, thereby increasing the pool of hospice donors. Both hospices can increase the fundraising base by utilizing grant revenue. Covenant is stronger today than it would have been without competition. As friendly competitors, Covenant and BBH will be able to engage in collaborative activities that benefit both hospices, including education and fundraising. Dale Knee, Covenant's CEO, did not always believe that competition would foster such benefits. In 1996, Emerald Coast, located in Panama City, Florida, applied for and was preliminarily approved for a CON in SA 1, which includes the Pensacola home office of Covenant. Mr. Knee testified extensively that the approval and development of another hospice in SA 1 would adversely impact Covenant and would not increase hospice penetration in SA 1. He now holds the opposite view based upon Covenant’s actual experience in a competitive environment. Approval of Covenant in SA 2B will increase access to hospice services. It will have a positive impact on the quality of care in the SA as utilization increases. This is consistent with the prior experience of Covenant. Further, the approval of Covenant will result in substantial cost savings to the health care system generally. Hospice care is more cost effective and less costly than conventional medical care, such as the pursuit of curative or maintenance treatments provided by hospitals, nursing homes, home health agencies, and other settings. The approval of Covenant will result in an overall savings of approximately $1.6 million by Covenant's third year of operation. This is true even through the large majority of patient care is provided from fixed price government payer sources. The approval of Covenant in SA 2B will make "continuous care" available to hospice patients. Continuous care is a required level of care under the Medicare conditions of participation. Continuous care is nursing care in excess of eight hours per day, sufficient to maintain the patient with critical needs at home. BBH currently does not provide continuous care to its patients. Instead, BBH uses home health aides with nurses in attendance for shorter periods of time that is billed to Medicare as routine home care. When a patient needs continuous care to remain at home, BBH places the patient in a hospital or its in-patient facility. Upon approval and initiation of operations, Covenant will make continuous care available to the hospice patients, improving quality of care and continuity of care in SA 2B. Financial Feasibility and Financial Schedules and Projections Schedule 1, Estimated Project Costs. Schedule 1 depicts the estimated project costs for the proposed project. The total estimated project cost is $82,648. The costs are based substantially on the start up experience of Covenant in its Dothan, Alabama, office. The $20,000 in cost proposed for recruitment and training of staff is reasonable and appropriate. The amount includes advertising for staff positions, start-up salaries, rent, utilities, and such expenses for a month of start-up operations. The projections for recruitment and training are consistent with prior start-up experience of Covenant. Covenant provided sufficient costs to hire an office manager for the Tallahassee office 30 days prior to opening. This is a reasonable planning assumption and would be sufficient to provide training and orientation. But this may not be necessary, because Covenant may transfer a manager from an existing office. Prior to initiation of operation, Covenant would need to hire an office manager, a registered nurse, a home health aide, a social worker, an administrative assistant, and a community educator. A medical director would not be necessary initially for the Tallahassee office prior to start-up. Start-up on the Dothan, Alabama, office entailed a different process than starting up a new office in Florida. In Alabama, the office had to become separately licensed by the State of Alabama. The next step in the process was for the office to apply for Medicare certification, which required Covenant to be admitting and treating Medicare eligible patients. This accounts for the fact that Dothan had a longer pre-opening period that is projected for the Tallahassee office. The initial Dothan staff spent a full week at Covenant in orientation. During the next five weeks the Dothan office manager worked in Covenant's Panama City, Florida, awaiting certification for Dothan. The Dothan start-up provides insight to Covenant’s success in initiating hospice start-up such as that proposed for SA 2B. Covenant began in Dothan by educating the medical community and others, particularly in the rural communities, where Covenant encountered a lack of understanding of hospice and some reluctance to acceptance of hospice services. Covenant's program in Dothan has shown a steady increase in census. This is true even though three other hospices serve the same service area. The census of the other three hospices has continued to increase as well, due to increased public awareness of hospice care generally. The $5,000 in Covenant's proposed costs for moveable equipment is reasonable, appropriate, and adequate. Covenant generally relies on donated equipment to meet such needs. Covenant already has on-hand equipment for use in SA 2B. This is consistent with prior start-up experience of Covenant, including the start-up of the Dothan office. Covenant intended the proposed costs for movable equipment in the application to cover incidental items only. The phone system for the Tallahassee office is already in inventory, and no expenditure would be necessary for a phone system. At the time of the application, Covenant had an extensive inventory of donated furniture and other items that could be used in the Tallahassee office. Covenant made a planning assumption that at the time of implementation, sufficient donated items would be on hand to furnish and equip the Tallahassee office. The expectation and assumption that furniture and other furnishing sufficient for the Tallahassee office would be available was reasonable based on the specific prior experience of Covenant. The line item of $5,000 for moveable equipment was placed in the budget as a contingency for incidental items, as needed. Donated equipment is not included in Schedule 1, Line 23, because it is not required to be included. Overall, the amounts projected on Schedule 1 of the application are reasonable and appropriate. They are conservative estimates and sufficient to cover all anticipated and expected costs. Schedule 2, Listing of Capital Projects. Schedule 2 sets out a complete listing of all projected and proposed capital projects planned by Covenant. The schedule completely and accurately depicts all such projects and expenditures that were planned, approved, or under way when Covenant submitted its application. Covenant's audited financial statements and balance sheets indicate that it has sufficient resources to fund the proposed project without adversely affecting Covenant's ability to fund other projects and expenditures. Schedule 3, Source of Funds. Covenant has available cash and other funding sources sufficient to fund the proposed project. There are no other demands on the applicant’s available cash. The information depicted in Schedule 3 is reasonable and appropriate. Schedule 4, Utilization of Existing Beds. Schedule 4 is not applicable to the application of Covenant. Schedule 5, Projected Utilization. The utilization projections set out in Covenant's Schedule 5 are reasonable and appropriate. The projections of patient days projections are obtainable and achievable. Schedule 6, Staffing. The staffing and FTE’s proposed by Covenant on Schedule 6A of the application for the first year and the second year of operations are reasonable and appropriate. The staffing projections are sufficient to ensure quality of care. The projections are consistent with the prior start- up experience of Covenant. They are based on a reliable computer model used by Covenant to staff its operations and administration. The staffing model generally supports staffing ratios for all disciplines, which meet or exceed guidelines established by the NHPCO. The salaries projected also were developed based on the actual experience and mid-range salaries of Covenant. The salaries are sufficient to recruit and retain sufficient numbers of qualified staff at the salary levels indicated in Schedule 6A. Covenant has been able to recruit and retain sufficient numbers of qualified staff, including registered nurses and licensed nurses, in its existing SAs at the salary levels indicated. The proposed nurse salaries are approximately equivalent to salaries paid in SA 1, SA 2A, and SA 2B, including the salaries paid in hospitals. Covenant's ability to recruit and retain nurses at the proposed salary levels is corroborated by the fact that some of the registered nurse salaries are higher in the Pensacola, Florida, metropolitan service area (MSA) than in the Tallahassee, Florida, MSA. Even with higher average salaries in Pensacola than in Tallahassee, Covenant has been able to recruit and retain sufficient numbers of registered nurses at the proposed salary levels. The ability of an organization to recruit and retain sufficient numbers of qualified staff is a function of several factors, including work environment, reputation of the employing organization, satisfaction and morale level of the staff, opportunity for staff development and growth, flexibility and respect of the organization for its staff and, of course, salary and benefits. Many such factors attract nurses and other staff specifically to Covenant. If approved in SA 2B, Covenant will not have a significant adverse impact on the ability of BBH to recruit and retain sufficient numbers of qualified staff. This is true because Covenant does not require that nurses have hospice experience. However, Covenant will recruit from the same pool of nurses and thus compete in its recruiting with hospitals, home health agencies, doctors' offices, and any other organization that employs nurses, including BBH. Any adverse impact on BBH's ability to recruit and retain nurses will be minimal. Further Covenant will recruit its staff across the entire eight-county area that comprises hospice SA 2B. Covenant will fill approximately 3.5 FTEs by the end of the first year. Those numbers are not sufficient to have an adverse impact on BBH's ability to recruit and retain sufficient numbers of staff, including nurses. Nor will Covenant have an adverse impact on the staffing costs in SA 2B by driving up staffing costs. It is undisputed that there is a shortage of nurses nationwide. Covenant will be able to recruit and retain sufficient numbers of skilled staff, including nurses, in SA 2B, notwithstanding that shortage, in part due to the positive work environment that it will provide. Schedules 7A and 8A, Projected Revenues and Expenses. Schedule 7A of the application depicts projected revenue for the proposed project. The starting point for the revenue projections is the utilization and patient day projections for the first two years of operation, set out in Schedule 5 of the application. The revenue projections are based upon an established rate for levels of care and payer source. They are based on obtainable volumes and payer source projections. Covenant used a reliable computer model in making the revenue projections. Covenant also projected revenues in a manner consistent with its experience. The overall revenue projections in Schedule 7A, the assumptions underlying their calculations, and the methodology used in making the projections are reasonable, appropriate, and conservative. Schedule 8A sets forth the projected income and expenses for the proposed project. Covenant used the same computer model discussed above and its experience to project income and expenses. The bottom line is that the project is expected to have a net operating surplus of $23,695 in the second year of operation. The income and expense projections, their underlying assumptions such as inflation factors, and the methodology used in making the calculations are reasonable, appropriate, and consistent with Covenant's experience. They are conservative in that they underestimate income and overestimate expenses. Of particular note is that the proposed non-operating revenues for year one and year two include grant revenues, donations, and fundraising. Additionally, property expenses include the cost of rent. Regarding health insurance costs, Covenant has experienced substantial increases in health care insurance premiums. However, health insurance premiums are a component of benefits, and Covenant’s overall benefit rates are conservative, sufficient, and reasonable. Finally, the projected general and administrative costs and ancillary costs, including contractual costs, are reasonable, appropriate, and conservative. Immediate or short-term financial feasibility is the ability of the applicant to secure the funds necessary to capitalize and operate the proposed project. Schedules 1, 2, and 3 and the audited financial statements of Covenant demonstrate that it has sufficient funds and cash-on-hand to fund the project. The capital projects listed on Schedule 2 do not adversely affect the ability of Covenant to fund the project, nor does the project adversely affect the ability of Covenant to carry out all projects listed on Schedule 2 of the application. Therefore, the project is financially feasible in the short term. Long-term financial feasibility is the ability of the project to reach a break-even point within a reasonable period of time and at a reasonable achievable point in the future. Based upon a review of the reasonableness of the volume and patient day projections, the staffing and income and expense projections, it was established by competent substantial evidence that the proposed project is financially feasible in the long term. It is important to note that the reasonableness of the income and expense projections depicted on Schedule 8A of the application, which result in a second year net operating surplus, are driven by the admissions and patient day projections. Persuasive evidence indicates that Covenant's admissions and patient day projections are reasonable and achievable. Financial feasibility analysis is different for hospices than for other organizations because hospices are not- for-profit entities. They rely to a great extent on grants, donations, and other non-operating revenue to sustain operations. Covenant has an excellent record in regard to fund- raising. It has strong reserves of ready cash and over $1 million in investments. This project would be financially feasible even if it did not show a net profit in the first two years of operation. Covenant has the ability to support the project, and the commitment to do so, such that the program would continue to operate as a viable operating entity.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That AHCA should grant Covenant a CON to establish an additional hospice program in SA 2B. DONE AND ENTERED this 7th day of November, 2002, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 7th day of November, 2002. COPIES FURNISHED: Michael D. Mathis, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308-5403 J. Robert Griffin, Esquire J. Robert Griffin, P.A. 2559 Shiloh Way Tallahassee, Florida 32308 W. David Watkins, Esquire R. L. Caleen, Jr., Esquire Watkins & Caleen, P.A. 1725 Mahan Drive, Suite 201 Post Office Box 15828 Tallahassee, Florida 32317-5828 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
The Issue The issue is whether certificate of need No. 4370 should be issued to the Visiting Nurse Association of Broward County to operate a hospice program, which will include five inpatient beds. STIPULATON CONCERNING APPLICABLE STATUTES The joint stipulation filed by the parties indicates that not all statutory criteria for evaluating certificate of need applications for hospices apply to this case. Section 381.494(6)(c)6, 10, and 11, Florida Statutes, do not apply. Section 400.601, et. seq. Florida Statutes, and Rules 10A- 5.001(1)(j), 10- 5.011(1)(b), and Rule 10A-12.001, et. seq., Florida Administrative Code, apply. There is a dispute over whether Section 381.494(6)(d), Florida Statutes, applies.
Findings Of Fact General Procedural Background The Visiting Nurse Association of Broward County, Inc. Community Hospital (VNA) applied on December 12, 1985, for a certificate of need to operate a hospice program, including five inpatient beds, in Broward County, Florida. A State Agency Action Report was issued by the Department of Health and Rehabilitative Services (HRS) preliminarily approving the application, which was published in Volume 12, No. 21 of the Florida Administrative Weekly on May 23, 1986, at page 1966. Hospice, Inc., Broward County (Hospice) and Hospice Care of Broward County, Inc. (Hospice Care) filed petitions to contest the preliminary approval of the application, and those petitions were consolidated for hearing. Brief Description of the Parties Visiting Nurse Association VNA is a not-for-profit charitable organization established in 1959. It is a Medicare and Medicaid certified home health agency which provides comprehensive home health services to residents of Broward County regardless of age, ability to pay, or payor source. VNA has a somewhat complex corporate structure. The parent corporation is Visiting Nurse Health Services, Inc. This corporation provides management, administrative support and consultative services to its subsidiary corporations which are: The Visiting Nurse Association of Broward County Foundation, Inc., a not-for-profit corporation which raises funds to fulfill VNA's goal of providing health care to the indigent. Visiting Nurse Home Care, Inc., a Florida not-for-profit corporation which provides private duty nursing care, physical therapy and other home health services, including homemaker services and personal care services to non-Medicare patients in Broward County. Visiting Nurse Association of Dade County, a not-for-profit Medicare and Medicaid certified home health agency which provides comprehensive home health services in Dade County. VNA Foundation, a not-for-profit corporation which raises funds for VNA's operations in Dade County. Visiting Home Services, Inc., a licensed home health agency which provides services to non-Medicare patients in Dade County, Florida. VNA is governed by a board made up of community members who serve voluntarily. VNA has provided service to indigents even before inception of the Medicare program. VNA has maintained long term relationships with publicly funded hospitals, with particular emphasis on providing continuity of care to patients and providing alternatives to hospital care. In fulfillment of its mission, VNA has contracted with the North Broward Hospital District to provide a full range of services to indigent Medicaid patients in the northern two-thirds of Broward County, where that District operates three hospitals, North Broward Medical Center, Broward General Medical Center and Imperial Point Medical Center. VNA employs nurses who work with the district hospitals to improve the accessibility of health care to indigents by assisting in planning care for indigents after discharge from the hospital. In 1985 and 1986 VNA served about 2,900 patients each year. VNA also receives referrals from other hospitals in Broward County, including hospitals operated by Humana Corporation; Memorial Hospital, which is operated by the South Broward Hospital District; and Pembroke Pines General Hospital. It receives referrals in Dade County from Jackson Memorial Hospital, the public hospital for Dade County operated by the Public Health Trust, and the Veterans Administration Medical Center. VNA operates special pediatric programs for children whose health care is covered by Medicaid. VNA also had assisted the Public Health Trust to develop in Dade County a comprehensive proposal seeking a grant from the Robert Woods Johnson Foundation for the treatment and prevention of Acquired Immune Deficiency Syndrome. VNA has operated a specialized subunit since 1984 which provides palliative care. This unit is staffed with registered nurses who are experienced in working in hospices, in symptom control for terminally ill patients and in providing supportive therapy for the patients and their families. In 1985 the palliative care unit provided services to about 129 patients; approximately 63 percent were Medicare patients and 10 percent were Medicaid patients. The program's average daily census was approximately 30 patients. In 1986 the palliative care unit provided service to approximately 134 patients; 68 percent Medicare patients and 14 percent Medicaid patients. The number of physicians referring patients to the palliative care unit has increased from fewer than 100 to more than 150 currently. Referring physicians include internists, surgeons, general practitioners and oncologists (physicians specializing in the treatment of cancer). After only three months of operation, the patient census reached 35 patients. The greatest concentration of the palliative care patients reside in the areas near North Broward Medical Center and Broward General Medical Center, which are also the areas with high indigent populations. VNA's palliative care unit will serve patients in Broward County who have physicians who are located in Dade County, and also will serve patients having no family members or others to serve as caretakers. It also has treated a number of terminally ill pediatric patients. The palliative care program is not as diverse a program as a hospice, in that it does not offer inpatient care or bereavement services to the families of the terminally ill, and the palliative care unit's access to funding from the government or third party payors is limited without a certificate of need to operate a hospice program. About 60 percent of the patients currently cared for in the palliative care unit would qualify for hospice services if VNA were authorized to provide those services. About 21 of VNA's home health patients chose to enter a hospice program out of the 263 patients seen during the first few years of operation of the palliative care unit. 2. Hospice, Inc. Hospice, Inc. is authorized to operate in Broward County, and has a 20-bed inpatient unit with an average daily census of 11 patients. About 10 percent of its services are inpatient services. Eleven percent of Hospice, Inc's patients are charity patients; that is, patients who are provided services without charge. Other patients have reimbursement sources which are not adequate to cover the cost of providing care. Hospice, Inc. does not discriminate on the basis of inability to pay. The two different kinds of indigent are those poor to start with and those who become medically indigent because they have paid all of their money to fight their disease. Hospice, Inc. has worked with AIDS patients since the early 1980's and has continually cared for AIDS patients, beginning with Haitian refugees. Hospice, Inc. has been called upon to write the policy and protocols for AIDS care for hospices nationally by the National Hospice Organization and is the only hospice in Florida with a specific contract to provide service to AIDS patients. That contract is with the State of Florida through Jackson Memorial Hospital and the Public Health Trust using State dollars. Hospice, Inc.'s programs in Dade and Broward Counties were selected as demonstration sites by the federal government to demonstrate the efficacy, including cost effectiveness, of hospice services, in a study conducted by the Health Care Financing Administration between 1980 and 1983. 3. Hospice Care Hospice Care is a not-for-profit hospice program licensed in Broward County which operates five inpatient beds. It does not have a parent company and is supported by donations raised in Broward County. It provides an array of nursing, pastoral and spiritual services to its patients and necessary medical care. The program has a Medical Director, Nurses Aides, Licensed Practical Nurses, a Coordinator of Education and Bereavement, a Director of Volunteers, and a Patient Care Coordinator. About 125 volunteers provide emotional support and assistance which a family might need while the patient is in the hospice program; the program offers the family ongoing bereavement support after the patient's death. Hospice Care also offers homemaker services, pharmaceutical services and occupational and physical therapists, at no extra cost to the patient. A pastor or minister provides spiritual assistance to the patient and family on request. Hospice Care accepts AIDS patients (it served approximately 17 in 1986) and provides support for families of those patients. Hospice Care also is developing a program to educate single people about AIDS. As is the case with other hospices, Hospice Care participates with the Robert Woods Johnson Foundation. Hospice Care provides educational materials regarding hospice programs throughout Broward County. Brochures are sent to physicians in Broward County four times a year. A newsletter is distributed quarterly. Hospice Care provides in service educational programs for its registered nurses and seminars for its social workers. Hospice Care accepts patients without regard to the patient's ability to pay, and places a patient in a program within 24 to 48 hours of referral. Hospice Care became Medicaid-certified in January of 1987 and accepts Medicaid patients. During fiscal year 1986, Hospice Care served 227 patients. It could serve additional patients without adding additional staff. During fiscal year 1986 approximately 25 patients treated by Hospice Care were referred to it from North Broward Hospital District hospitals. Based upon referral patterns, Hospice Care would probably lose some patients to VNA if VNA's application is approved. Hospice Care received at least one referral from VNA's palliative care unit last year. Hospice Care refers patients to other hospices in Broward and Palm Beach Counties based on the needs of those patients. 4. Hospice-By-The-Sea Another hospice operating in Broward County is Hospice-By-The-Sea. It has received a certificate of need and operates as a non-profit program. It was Medicare certified in January of 1987. Hospice-By-The-Sea accepts patients from Palm Beach and Broward counties, as it is authorized to do under its certificate of need. Its program is similar to that of Hospice Care and consists of nurses, social workers, clergy, volunteers, homemaker aides, home health aides, a clinical psychologist and a hospice physician. Its nurses receive specific training in the care of terminally ill children. Hospice-By-The-Sea has a bereavement program for family members for a minimum of one year following a patient's death. Hospice-By-The-Sea also offers the services of a dietician, a physical therapist, a speech therapist and an occupational therapist, as well as providing pharmacological and medical supplies and services. Pastoral counselors meet with patients and their families regularly. It has never denied a prospective patient admission to its program for inability to pay. The program accepts AIDS patients and works with the Robert Woods Johnson Foundation. During fiscal year 1986 Hospice-By-The-Sea served 263 patients, and had an average daily census of between 35 and 45 patients. It could increase the number of patients served without the increase in inpatient beds. Hospice-By-The-Sea does not have a waiting list and places new patients in its program within 24 to 48 hours after referral. Hospice-By-The-Sea refers patients to other hospices based upon the patient's need. Since about 1985 Hospice-By-The-Sea has had a program to educate the community about the availability of hospice services. The testimony of Ms. Webb, that the market for hospice services has leveled out, and now is saturated, is not accepted. In the Hospice-By-The-Sea program, inpatient beds play a minor role in its overall program. Only six patients since 1980 have used inpatient services. Volunteers are an important component of the Hospice-By-The-Sea program. About 25 to 30 percent of hospice volunteers reside in Broward County. Hospice-By-The Sea may experience some increase difficulty attracting volunteers if an additional hospice program is approved in Broward County but there is insufficient proof that it would not be able attract an adequate number of volunteers to continue a quality program. Hospice-By-The-Sea receives funds on an annual basis from Palm Beach and Broward county communities. About 30 percent of its fund raising monies comes from Broward County. The approval of the VNA hospice might make it somewhat more difficult for Hospice-By-The-Sea to attract funds. The Hearing Officer is not persuaded that competition for fund raising will result in either Hospice-By-The-Sea or VNA providing less than a quality program. 5. Hospice Of The Gold Coast Hospice Of The Gold Coast is another not-for-profit hospice which holds a certificate of need to serve Palm Beach and Broward counties which is Medicare certified. It has four licensed inpatient beds located at Holy Cross Hospital in Broward County. The hospice is licensed separately from its parent corporation, Gold Coast Home Health Services, a Broward County home health agency. As with the other hospices, the Gold Coast program offers a wide array of services to patients and their families. These include a medical director who serves as the consultant to the patient's primary care physician, who may assume total care for the patient when the primary physician chooses not to provide terminal care. Gold Coast has a team of nurses available 24 hours a day, seven days a week to meet the medical and psychological needs of patients. The nurses provide pain and symptom control, and are trained in providing psychological care to the patient and the patient's family. The Gold Coast home health aides provide personal and respite care to the patient. A psychologist provides counseling services to the patient and the family, while a bereavement specialist works under the direction of the hospice psychologist in a program which can last for a year or longer after the patient's death. Volunteers are trained to work with the terminally ill. Volunteers are an integral part of the hospice team. Gold Coast has 80 active volunteers. Clergymen on Gold Coast staff provide spiritual care to the patient and family. A medical social worker sees each family to be sure that community resources available to the patient and family are obtained. Gold Coast offers homemaker services which are used to maintain the patient's household. Physical therapy services are provided if required by a patient. Hyperalimentation can also be provided if needed. Hyperalimentation is a supplemental feeding done intravenously. The hospice may also provide morphine drips for pain control where required. Gold Coast accepts patients terminally ill from the AIDS virus, and has no policy which would discourage the admission of such patients. It participates in the activities funded to the Robert Woods Johnson Foundation in the southeast Florida area for AIDS patients. During calendar year 1986 Gold Coast received about 26 patient referrals from North Broward Hospital District hospitals. During calendar year 1986 Gold Coast served 304 patients and had an average daily census of between 50 to 55. A substantial number of additional patients could be served without adding additional inpatient beds, for only five percent of the patients served used inpatient beds. About 15 to 20 additional patients could be served without adding additional staff. Gold Coast does not experience a waiting list of patients and serves them within 24 hours after a physician's referral. Gold Coast will refer patients to other hospices in Broward and Palm Beach Counties if those hospices are closer and therefore could better meet the patient's needs. Gold Coast Home Health Agency provides administrative and other support to the Gold Coast hospice. The experience of Gold Coast in admission to its hospice program of those served by the home health agency is that many patients eligible for hospice services do not wish to obtain them. In 1986, of 139 patients the home health agency served with diagnoses which would make them eligible for hospice services, 39 chose the hospice program. Gold Coast makes efforts to educate the community about the availability of hospice services. Methods include lectures given by the hospice's executive director to local nursing college students and to psychology courses on death and dying. Gold Coast also publishes a newsletter distributed throughout the community and participates in health fairs, distributing brochures on hospice care. Factual Findings Concerning Rule Criteria Against Which The Application Must Be Evaluated Rule 10-5.011(1)(j), Florida Administrative Code, contains the rule methodology governing hospice services. It is the same methodology used by the U.S. Office of Management and Budget and other states in determining the appropriate level of hospice care in a community. All parties have stipulated that this methodology shows a need for five additional hospice beds in Broward County. The Broward Regional Health Planning Council calculates a need for 45.8 hospice beds in Broward County. With the current hospice beds of Hospice Care, Hospice-Of The Gold Coast, Hospice, Inc., and Hospice-By-The-Sea, there are 33 beds now licensed. The rule methodology understates the actual need for hospice services. It was developed before the increased number of terminally ill patients as a result of Acquired Immunity Deficiency Syndrome. Twenty percent of all AIDS patients in Florida are Broward County residents. The representatives of Hospice-By-The-Sea, Hospice Care and Hospice Of The Gold Coast all anticipate an increased need for hospice services for AIDS patients in Broward County. The incidence of cancer is substantially higher in Broward County than in Florida generally. Broward County's population is older than the national population. Twelve percent of the population nationwide is over age 65. Almost 24 percent of Broward County's population is over 65. The most current reliable data available demonstrates that the hospice-eligible population exceeds the population now being served. The rule methodology would indicate there should be at least 400 hospice-eligible patients more than are actually being served currently. Unlike rule methodologies for other health services, minimum utilization thresholds do not apply to hospice services. The inpatient component of the hospice program is used for acute care and respite care. The availability of the beds at times of peak demand is more important than the average daily census of inpatient hospice beds filled on a given day. Statutory Criteria For Evaluating The Application Under Section 381.494(6)(c), Florida Statutes. Consistency with the State Health Plan and the Local Health Plan. Section 381.494(6)(c)1., Florida Statutes. The State Health Plan does not address the need for hospice services. The testimony and cross-examination of Kurt Blair, the planning supervisor for the Broward Regional Health Planning Council, establishes that the VNA proposal is not inconsistent with the Local Health Plan. Availability, Utilization, Efficiency, Geographic And Economic Accessibility Of Facilities In The District. Section 381.494(6)(c)2., Florida Statutes. The utilization of hospice services in Broward County is less than the rule methodology would project. The first step of the methodology estimates a hospice eligible population, and that estimate is that between 1,400 and 1,450 people are hospice eligible. Currently, approximately 955 are being provided hospice care. Thus, under the rule methodology there are approximately 400 people in Broward County who are hospice eligible and who may be receptive to hospice services if appropriate additional education were provided. In addition, the second portion of the rule which determines hospice inpatient bed need shows the need for at least the five additional inpatient beds which this application proposes. The rule utilizes the assumption that about 20 percent of hospice patients will be inpatients. In Broward County, only about 10 percent are inpatients. Unlike rule methodologies for other health services, the hospice rule does not use minimum utilization thresholds as a proxy for quality, or for financial viability. The fact that current utilization of inpatient beds is less than the rule would predict does not mean there is not a need for additional programs in Broward County. The reason for the lower inpatient utilization in Broward is not clear but inpatient services are only a portion of the total continuum of services provided by a hospice, so that the lower inpatient utilization cannot be properly thought to show a lack of need. The VNA will operate hospice education for groups that are currently underserved, especially indigents. VNA provides a substantial amount of care to indigents, providing over $740,000 of free care in 1986. Physicians refer a substantial number of indigent patients to VNA for services. VNA's ability to provide care to indigents is enhanced by the array of services that VNA offers through the VNA network. Moreover, the indigent patient population has less awareness of the availability of hospice services, and increased education regarding these services for both patients and their physicians is likely to result in additional persons choosing hospice care. VNA's palliative care unit's physician referral base is highly concentrated in the geographic areas close to the North Broward Hospital and Broward General Medical Center, which are operated by the North Broward Hospital District. An unmet need for hospice services exists in the geographic area served by the North Broward Hospital District, especially in zip code area 33311, which has a high concentration of indigent persons. The VNA hospice would be more accessible because it will accept patients without an identified family member or care giver to assist in the program, while other hospices believe that such patients are not appropriate for hospice care. Other hospices also will not accept a patient whose physician is located in Dade County. When a physician refers a patient to VNA for care, options are discussed with the patient. If the VNA cannot give appropriate care and the patient chooses another community provider, the patient is referred to another provider of care. While other providers do exist in Broward County to serve the unmet need for hospice services in Broward County, VNA's existing relationships with the North Broward Hospital District and physicians serving indigent patients positions it especially well to serve that need. The Ability To Provide Quality Care, Section 381.494(6)(c)3., Florida Statutes. VNA employs several registered nurses with hospice experience who are well qualified to provide a hospice program. Registered nurses are the backbone of the hospice program because they are responsible for pain and symptom control, providing emotional support to patients and families, and education regarding medications. VNA therefore has an existing corps of nursing staff from which the hospice program could begin. Moreover, VNA's palliative care unit provides a quality program which is similar to (though more limited than) a hospice program, which also gives reason to believe it can provide a quality program. The VNA program will also foster a continuity of care because patients have ready access to other VNA programs, and all programs have uniform recordkeeping and assessment techniques. The VNA conducts inter-team conferences to ensure continuity of care between programs. This continuity is helpful because it avoids the dislocations which can occur when a patient and family begin to be served by a different provider after the decision to utilize hospice care has been made. Economies of Scale. Section 381.494(6)(c)5., Florida Statutes. The VNA network will help create an efficient hospice program since management services such as accounting, marketing, billing and collection, and administration are done by the parent organization which spreads the cost of these services across the subsidiaries while avoiding duplication of effort. The placement of the proposed hospice program within the VNA network allows it to benefit from the economies of scale that result from such organization. The presence of VNA community liaisons within the North Broward Hospital District facilities should also increase the efficiency by which VNA can guide patients appropriately into hospice programs earlier which should lower the overall cost of in-hospital care. Availability Of Resources For Project Accomplishment And Operation. Section 381.494(6)(c)8., Florida Statutes. The VNA has been very successful in obtaining grants and other forms of financial assistance from a variety of local, state and federal sources including the Area-wide Agency on Aging and the Community Care For the Elderly Program. The fundraising mechanism for the VNA, the VNA Foundation, raised $31,000 in private contributions in 1986, and it is projected that this amount will increase as a result of implementation of more aggressive fundraising activities. The Visiting Nurse Association movement in the United States has historically been heavily supported by the United Way. The VNA received $273,000 from the Broward County United Way in both 1985 and 1986 and anticipates receiving approximately $300,000 for 1988. Susan Telli, Executive Director of Hospice Care of Broward, acknowledged VNA's strong fundraising capacity. The VNA initially anticipates receiving funds for its hospice program from the United Way and the VNA Foundation. The VNA would be able to handle any unanticipated decrease in revenue or unanticipated increase in expenses through the solicitation of additional charitable contributions or renegotiations of its hospital contract. Financial Feasibility In The Short And Long Terms. Section 381.494(6)(c)9., Florida Statutes. The VNA hospice program is financially feasible in both the short term and long term. The project involves no capital expenditure. Mr. Robert Simione is an expert in health care financial planning and management, and is a principal with Simione and Simione, a certified public accounting firm. Many of the firm's clients are home health agency and hospices. Mr. Simione has extensive experience in the development of hospice programs including budgeting, financial feasibility analysis and financial management. He has recently completed an extensive survey of ten hospices nationwide. Subsequent to VNA's preparation and submission of its hospice certificate of need application, Simione and Simione merged with- the accounting firm of Holstein and Lechner, which therefore had not been involved in either the preparation or submission of the certificate of need application. In November, 1986, after Simione and Simione merged with Holstein and Lechner, the VNA asked Mr. Simione to conduct a feasibility analysis of its proposed hospice program in preparation for both the final hearing and implementation of the program, and to account for extrinsic changes that occurred subsequent to the preparation and submission of the application in October of 1985. The extrinsic changes included an increase in Medicare reimbursement rates for hospice services on or about April 1, 1986, and the availability of Medicaid reimbursement for hospice services in Florida as of January 1, 1987. 1. Patient Census Projections The VNA hospice application, filed with the Department in October of 1985, included a two-year financial projection. The projection was broken into two periods and assumed a projected patient census of 30 for the first six months of operation and 50 thereafter for the next 18 months. Mr. Simione's reliance at final hearing on an anticipated census of 40 during the second period of the analysis (rather than 50) was based on management decisions, and was not intended to reflect the availability of patients or need for hospice services. The proposed patient census in the application is reasonable as a result of the following: The VNA is not starting from "ground zero"; it has systems in place and existing resources and capabilities that would facilitate development of a high quality hospice program. The VNA has experience in implementing its palliative care unit, including community education. The VNA has existing ties and relationships with various charitable and other organizations in Broward County, as well as Dade County. Since 1952, the VNA has historically had large numbers of patient and family contacts throughout Broward County. The VNA has mature relationships with publicly funded entities such as the Public Health Department. Other hospices in Broward County have realized significant patient growth experience during the previous two years. Broward County's morbidity and mortality rates demonstrate demand for hospice services. 2. Outpatient-Inpatient Ratio The VNA hospice certificate of need application, filed with the Department in October of 1985, included financial projections assuming an 80 percent outpatient population and 20 percent inpatient population (80:20 ratio). Projected out-patient to inpatient care ratio of 80:20 reflects a Medicare-imposed ceiling for inpatient care. A 90:10 ratio is more likely in Broward County. The proposed 80:20 ratio is reasonable for planning purposes because: The VNA's existing palliative care unit's statistical experience reflects high inpatient utilization by these patients. The VNA's historical experience with the North Broward Hospital District, as a result of a demonstration project and otherwise, reflects longer hospitalization for Broward patients that come from low income families, often due to their overall poor health status, both nutritionally and physically. The federal government, based on the results of a Medicare demonstration project, has adopted regulations that allow for an 80:20 inpatient hospital ratio for hospice programs. Certificate of need applications recently submitted by other applicants for hospice programs in Broward County utilized an 80:20 ratio. Indeed, Hospice, Inc.'s certificate of need application filed in 1980 projected an outpatient-inpatient ratio of 80:20. The proposed 80:20 ratio had been commonly used by other hospices for financial planning at the time the VNA prepared its certificate of need application. The survey conducted by Mr. Simione revealed that the inpatient utilization component of a participating hospice was as high as 19 percent. 3. Revenue Projections The experience of the palliative care unit supports the VNA's projected payor mix for its hospice program as indicated by the 1986 VNA breakdown by payor source: Medicare 76.8 percent Medicaid 9.0 percent Private Insurance 6.1 percent Private Pay 5.6 percent (sliding scale used) Veteran's Administration 1.2 percent The payor mix projected by Mr. Simione for the VNA hospice is as follows: Medicare 75 percent Medicaid 7 percent Insurance and Private Pay 10 percent Indigent 8 percent Mr. Simione's projections regarding payor mix are not significantly different from those set forth in the VNA certificate of need application, and reflect the availability of Medicaid funding for hospice care. The VNA's projection that ten percent of its projected revenue will be "insurance and private pay" is reasonable because: The amount is supported by VNA's history and the projections of other visiting nurse associations that have recently established hospice programs. An increasing number of private and commercial insurance carriers, including carriers providing coverage in Broward County, are offering hospice benefits. Hospice, Inc. projected that 11 percent of revenue would be "insurance and private pay" in its application for hospice beds in Palm Beach County. As many as 35 percent of Hospice Care of Broward's patients are privately insured for hospice services. Ten percent of Hospice-By-The Sea patient census is composed of private pay patients. The VNA's projections regarding Medicare and Medicaid reimbursement are reasonable in light of the following: As testified by Ella Charland, Executive Director of Hospice Of The Gold Coast, 90 percent of its patients are Medicare reimbursable. Contractual adjustments are not normally considered for projected Medicare revenues since Medicare reimburses hospice on a prospective flat rate. A 2.5 percent Medicare and/or 5 percent Medicaid contractual allowance, if necessary, will not have a significant impact on the financial feasibility of the VNA's proposed hospice program. Use of a wage index of 1.11249 as opposed to 1.1105 in calculating Medicare or Medicaid rates amounts to a difference of .0079 percent of total revenue in Mr. Simione's financial feasibility study. The impact of a .0079 percent discrepancy in calculating Medicare and Medicaid rates for the VNA's proposed hospice program is insignificant. 4. Other Projections The projection of an average length of stay (ALOS) of either 45 or 50 days for a hospice program is consistent with the national average for hospices as stated by the National Hospice Organization and with a survey done by the CPA firm of Simione and Simione. Ambulance costs are not normally a "line item" in a hospice's budget, but if there were any, they would be insignificant in light of its overall operation. The VNA's projection of a .25 full-time equivalent (FTE) for an M.D. Consultant is consistent with projections relied on by other hospices and not violative of any state or federal requirements. The VNA's hospice program does not require an Inpatient RN Coordinator position or a full-time Admissions Assistant since responsibilities inherent in these positions could be assumed by employees budgeted for by the VNA. Impact of VNA Hospice Section 381.494((6)(c)12., Florida Statutes Reverend Westbrook does not believe "...that one single organization could do a good job of caring for all the hospice patients." The VNA will be a positive competitive force vis-a-vis quality, accessibility to indigents, public education, cost effectiveness, and training. Mr. Gates acknowledges that the entry of a new competitor will generally not have a negative effect on existing providers when the new competitor meets unmet needs or provides services the existing providers are not designed to meet. Competition and Regional Monopolies. Section 381.494(3), Florida Statutes. Statutory Intent The only health service for which the Florida statutes explicitly encourage competition and discourage regional monopolies is hospice care. Section 381.494(3), Florida Statutes, encourages competitive forces in the market. The statute provides that the state need methodology should discourage regional monopolies and promote competition. Existing Market Share Hospice, Inc., the largest of all existing hospice competitors in Broward, has captured 60 percent of the Broward County hospice market, and has a market share that is greater than all three existing competitors combined. Hospice Care of Broward retains 16.4 percent of the market share in Broward County. Hospice Gold Coast retains approximately 20.6 percent of the market share in Broward County. Hospice-By-The-Sea retains less than four percent of the market share in Broward County. Hospice, Inc. has obtained certificate of need approval for hospice programs in Broward, Dade and Monroe Counties. Hospice, Inc. is the only hospice in Dade County. Hospice, Inc. has filed a certificate of need application for two hospice beds in Palm Beach County. Hospice, Inc. intends to open and operate additional hospices. HCI, Hospice, Inc.'s management corporation, was capitalized in 1983 for $3.5 million. Venture capitalists who invested in HCI anticipate a reasonable return on their investment. Accordingy, there exists an expectation that profits are to be maximized by HCI, and its related entities, including Hospice, Inc. Hospice, Inc.'s Income Statement dated September 30, 1986, for Hospice, Inc.'s Broward division for fiscal year ending 9/30/85 reflects the following: Total Revenue $1,445,032.28 Total Operating Expenses 1,252,065.18 Division Income $ 192,967.10 Hospice, Inc.'s Income Statement dated September 30, 1986, for Hospice, Inc.'s Broward division fiscal year ending 9/30/86 reflects the following: Total Revenue $2,773,242.48 Total Operating Expenses 2,568,972.14 Division Income $204,270.34 Hospice, Inc. experienced a 92 percent increase in the total revenue from fiscal year ending 9/30/85 to fiscal year ending 9/30/86. In addition to management fees, Hospice, Inc. incurs substantial managerial and administrative costs relating to salaries and wages, director's fees, contract services, and consulting fees.
Recommendation It is RECOMMENDED that a certificate of need be granted to VNA to operate a hospice program in Broward County, which includes five inpatient beds. DONE AND ORDERED this 31st day of December, 1987, at Tallahassee, Florida. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of December, 1987. APPENDIX TO RECOMMENDED ORDER The following are my rulings on the proposed findings of fact submitted by the parties pursuant to Section 120.59(2) Florida Statutes (1985). As a preliminary matter I am constrained to point out that I generally found the testimony of the witnesses for VNA persuasive. While the testimony of the opponents was no doubt sincere, it was colored by undue pessimism about their ability to operate in a more competitive environment but the reasons stated for their fears about licensure of an additional competitor were unpersuasive. While initially the Hearing Officer had some doubt about the financial viability of the project, after a review of the testimony of Mr. Semeoni I am satisfied that the reasons he gave to support his opinion that the project is financially viable and the short and long term, and that the projections found in the application are reasonable, is credible, and should be accepted. In rulings on the proposals filed by VNA and HRS. Rejected as unnecessary. Covered in Finding of Fact 1 Covered in Finding of Fact 21. Covered in Finding of Fact 16. Covered in Finding of Fact 103. Covered in Finding of Fact 112. Rejected as unnecessary. 8-10. Covered in Finding of Fact 2. 11-13. Covered in Finding of Fact 3. Covered in Finding of Fact 4. Covered in Finding of Fact 5. Covered in Finding of Fact 6. Covered in Finding of Fact 7. Covered in Finding of Fact 8. Covered in Finding of Fact 9. 20-22. Covered in Finding of Fact 10. 23. Covered in Finding of Fact 11. 24-27. Covered in Finding of Fact 12. 28-29. Covered in Finding of Fact 13. Covered in Finding of Fact 14. Covered in Finding of Fact 15. Rejected as unnecessary. Covered in Finding of Fact 79. Rejected as subordinate to Finding of Fact 71. Covered in Finding of Fact 84. Rejected as subordinate to Finding of Fact 84. 37-40. Rejected as unnecessary. 41-42. Covered in Finding of Fact 53. 43. Covered in Finding of Fact 54. 44-45. Covered in Finding of Fact 55. 46-49. Covered in Finding of Fact 56. 50-52. Covered in Finding of Fact 57. 53-55. Covered in Finding of Fact 61. 56-57. Rejected as a recitation of testimony not a finding of fact. 58-59. Covered in Finding of Fact 59. 60. Rejected as unnecessary. 61-64. Covered in Finding of Fact 63. 65. Rejected as redundant. 66-67. Covered in Finding of Fact 63. 68-73. Rejected as unnecessary. 74-75. Covered in Finding of Fact 64. 76. Rejected as redundant. 77-80. Covered in Finding of Fact 65. Covered in Finding of Fact 66. Covered in Finding of Fact 60. 83-88. Covered in Finding of Fact 60. 89-91. Rejected as unnecessary. 92-103. Rejected because there are no adequate alternatives to hospice care for persons in need of hospice care. The findings are therefore unnecessary. See Conclusions of Law concerning section 381.494(6)(c)4. 104-105. Rejected as unnecessary. 106. Covered in Findings of Fact 10 and 68. 107-108. Covered in Finding of Fact 69. 109-119. Rejected as unnecessary. 120-122. Covered in Finding of Fact 70. 123-125. Rejected as unnecessary. Covered in Finding of Fact 72. Covered in Finding of Fact 71. Rejected as redundant. Covered in Finding of Fact 79. Covered in Finding of Fact 80. Covered in Finding of Fact 81. Covered in Finding of Fact 82. Rejected as unnecessary. Covered in Finding of Fact 83. 135-136. Covered in Finding of Fact 84. Rejected as cumulative to Finding of Fact 79. Covered in Finding of Fact 85. Covered in Finding of Fact 86. Covered in Finding of Fact 87. Rejected as unnecessary. Covered in Finding of Fact 88. Covered in Finding of Fact 89. Covered in Finding of Fact 90. Covered in Finding of Fact 91. Covered in Finding of Fact 92. Covered in Finding of Fact 93. Covered in Finding of Fact 94. Covered in Finding of Fact 95. Covered in Finding of Fact 96. 151-152. Covered in Finding of Fact 97. Covered in Finding of Fact 98. Covered in Finding of Fact 99. Covered in Finding of Fact 73. Covered in Finding of Fact 74. Covered in Finding of Fact 75. Covered in Finding of Fact 76. Rejected as unnecessary. Covered in Finding of Fact 76. Covered in Finding of Fact 77. Covered in Finding of Fact 78. Covered in Finding of Fact 103. Covered in Finding of Fact 104. Covered in Finding of Fact 105. Covered in Finding of Fact 106. Covered in Finding of Fact 107. Covered in Finding of Fact 108. Covered in Finding of Fact 109. Covered in Finding of Fact 110. Covered in Finding of Fact 111. Covered in Finding of Fact 112. Covered in Finding of Fact 113. Covered in Finding of Fact 114. 175-176. Rejected as unnecessary. Covered in Finding of Fact 115. Covered in Finding of Fact 100. Covered in Finding of Fact 101. Covered in Finding of Fact 102. Rulings on Finding of Fact proposed by Hospice Care of Broward County, Inc. Rejected as inapplicable. Covered in the Conclusions of Law. 3-4. Covered in Finding of Fact 40. 5-6. Rejected as unnecessary. Covered in Finding of Fact 41. Covered in Finding of Fact 42. Covered in Finding of Fact 43. Covered in Finding of Fact 44. Covered in Finding of Fact 45. Covered in Finding of Fact 45. Covered in Finding of Fact 46. Covered in Finding of Fact 47, to the extent necessary. Covered in Finding of Fact 48. Rejected as unnecessary. 17-18. Covered in Finding of Fact 49. Covered in Findings of Fact 50 and 51. Covered in Finding of Fact 52. Rejected because the new hospice, while in competition with hospice of the Gold Coast which necessarily means that its programs would duplicate those of Gold Coast. 22-24. Rejected as unnecessary. Covered in Finding of Fact 30. Covered in Finding of Fact 31. Covered in Finding of Fact 32. Covered in Finding of Fact 33. Covered in Finding of Fact 34. Covered in Finding of Fact 35. Covered in Finding of Fact 36. Covered in Finding of Fact 37. Covered in Finding of Fact 38. Covered in Finding of Fact 39. Rejected as unnecessary. 36-37. Covered in Finding of Fact 21. Covered in Findings of Fact 21, 22, and 23. Covered in Finding of Fact 24. Covered in Finding of Fact 25. Covered in Finding of Fact 26. Covered in Finding of Fact 27. Covered in Finding of Fact 28. Covered in Finding of Fact 29. Rulings on proposed findings of fact from Hospice, Inc. Rejected as unnecessary. Covered in Findings of Fact 2, 16, 21, 40, and 55. Rejected because whether Broward has fewer or more hospices than other counties, HRS service districts or more per person than any county is not relevant, the relevant considerations are those set forth in applicable statutes and rules. Covered in Finding of Fact 54 or rejected as unnecessary. Rejected because I have found the need for an additional hospice program. Rejected for the reasons stated in Finding of Fact Rejected inconsistent with my view of the evidence. Rejected as unnecessary. Rejected for the reasons stated in Finding of Fact Covered in Finding of Fact 49, to the extent necessary. 11-12. Covered in Finding of Fact 27, to the extent necessary. Rejected as argument, not a finding of fact. Rejected as inconsistent with my view of the testimony of Mr. Blair. The local plan does not state that there is a need for a hospice in South Broward, but that if there were two competing applications, preference would be given to the hospice proposing to locate in South Broward, which is not at issue here. Covered in Finding of Fact 60. Rejected as inconsistent with my view of the evidence. Rejected for the reasons given for rejecting finding of fact 3. Rejected as unnecessary. Rejected as unnecessary, the criteria for approving a new hospice is not that existing hospices must have waiting lists. Rejected as unnecessary. To the extent necessary covered in Finding of Fact 87(f). Rejected as unnecessary. To the extent that Broward presents a "not normal" situation, see Findings of Fact 56 and 57. Rejected as unnecessary. Rejected as a recitation of testimony not a finding of fact. Rejected as unnecessary. Covered in Finding of Fact 15. Rejected as recitation of testimony not a finding of fact. Rejected for the reasons stated in Findings of Fact 61 through 67. Rejected as unnecessary because I do not believe that the VNA application should be approved because of unique "high tech" care to be available from it alone. Rejected as unnecessary. To the extent necessary covered in Finding of Fact 17. Covered in Finding of Fact 18. Covered in Finding of Fact 19. 34a. Covered in Finding of Fact 20. Rejected as unnecessary. Rejected as cumulative to the Finding of Fact made in the description of the parties for each of the existing hospices. Rejected as inconsistent with my view of the evidence. Rejected as inconsistent with my view of the evidence. Rejected because hospices may be approved without evidence of "serious problems" seeking admission to hospice programs. Rejected as inconsistent with the evidence which I have credited. See Findings of Fact 73 through 78. Rejected because I do not accept Mr. Nelson's premise that approval of additional hospice means that that a new hospice will have to cut into the existing market share of current hospices. The rule methodology provides reason to believe that there is a substantial pool of unmet need from which patients may be drawn. Rejected as unnecessary. Rejected because I do not share Hospice Care's pessimistic view of the potential loss of revenue it would experience if the VNA hospice were granted. As a general matter, I found the testimony of Mr. Simeone on the reasonableness of the projections in the VNA more persuasive than the criticisms of the application by Reverend Westbrook. No useful purpose will be served by going through a line by line analysis of proposed findings 46 through 92 which generally relate to criticism of the financial projections made by VNA because I have resolved the disputes in favor of VNA's application and against the criticisms of the application raised by Hospice. Inc. The projections of VNA is financially feasible in the long and short terms. See Findings of Fact 79 through 99. COPIES FURNISHED: Howard Hochman, Esquire Gerald M. Cohen, Esquire Wood, Lucksinger & Epstein 200 South Biscayne Boulevard Suite 3700 Miami, Florida 33131-2359 Kenneth Hoffman, Esquire Martha Edenfield, Esquire OERTEL & HOFFMAN, P.A. 2700 Blair Stone Road Post Office Box 6507 Tallahassee, Florida 32314-6507 John Rodriguez, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407 Tallahassee, Florida 32399-0700 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407 Tallahassee, Florida 32399-0700 John Miller, Esquire Acting General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Charles Stampelos, Esquire 215 South Monroe Street Suite 666 Tallahassee, Florida 32301 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 =================================================================
The Issue The issue is whether the Agency for Health Care Administration should approve Petitioner’s application for a Certificate of Need to establish a new hospice program in Service Area 8A.
Findings Of Fact Parties (1) Hope Hope is a not-for-profit corporation and the applicant for the CON at issue in this proceeding, CON 9692. Hope has operated a hospice program in SA 8C since 1981. It is the sole provider of hospice services in SA 8C. SA 8C consists of Lee, Glades, and Hendry Counties. Hope’s SA 8C program is one of the largest hospices in Florida. It had more than 3,200 admissions in calendar year 2003. Hope’s penetration rate in SA 8C has consistently been among the highest rates in Florida. In calendar year 2002, its penetration rate was 54.7 percent, which was the second-highest rate in Florida and well above the statewide average of 43.8 percent. Hope’s penetration rate increased to 58.5 percent over the 12-month period ending June 30, 2004, which was again the second-highest rate in the state and was still well above the statewide average of 49.9 percent. Hope has its main office and several branch offices in Lee County. It also has branch offices in Hendry County (opened in 1996) and in Glades County (opened in 2001). Hope has three “hospice houses” in Lee County in which it provides inpatient and respite care. It has a total of 56 inpatient beds and 20 residential beds in those “hospice houses.” Hope also has contracts for inpatient care at Lehigh Medical Center (in eastern Lee County near the border of Glades and Hendry Counties) and at Hendry Regional Medical Center (in Clewiston). Hope’s SA 8C program is certified by Medicare and Medicaid, and it is accredited by the Community Health Accreditation Program (CHAP). The CHAP accreditation, which runs through 2006, includes citations for excellence in staff education and clinical services. Hope adheres to the guidelines and the standards of practice issued by the National Hospice and Palliative Care Organization (NHPCO), which is the national trade association of hospices. The NHPCO guidelines and standards of practice are not incorporated into any federal or state regulation. Hospices are not required to comply with the guidelines or the standards of practice, and not all do. The NHPCO guidelines advocate the “open access” philosophy by stating that “[h]ospices should structure admission policies that are inclusive and make hospice services available to all who meet eligibility requirements.” The goal of “open access” is to remove or minimize all barriers to accessing hospice care, including barriers associated with the availability of treatments such as palliative chemotherapy and palliative radiation (hereafter "palliative chemo/radiation"). The “open access” philosophy is not yet the standard of practice in the hospice industry. It is an expectation or benchmark that the industry is moving towards. Hope has won several national awards, including the Circle of Life Citation of Honor (2003) and Circle of Life Award (2004) from the American Hospital Association and NHPCO for its “open access” policies and its “innovative program that improves the care of individuals at the end of life and its strategy to make services available to anyone who needs hospice care.” Hope admits all hospice-eligible patients without regard to their ability to pay or their payer status. Hope actively engages in outreach and education activities in SA 8C, both to referral sources and to the community at large. It distributes brochures and newsletters in the community, and its staff members are involved in and make presentations to various community organizations. Hope provides services in SA 8C in addition to the hospice services that it provides to its patients. For example, Hope provides grief counseling to members of the community who have suffered sudden loss, such as the death of a family member in an automobile accident; it provides counseling and support to crime victims; and it operates a camp for terminally-ill children and children who have lost a family member, whether or not the family member was in hospice. A portion of the funding for the community and victim counseling services provided by Hope comes from grants and donations. The remainder of the funding, which is “about $2 million” annually, comes from Hope. Hope is a financially-sound organization. The audited financial statements included in Hope’s CON application reflect that, as of September 30, 2002, Hope had current assets of $13.2 million, including almost $9.65 million in cash and unrestricted investments. As of September 30, 2004, Hope’s current assets had increased to $17 million, but its cash and unrestricted investments had declined to $6.16 million. Hope is a profitable organization. The audited financial statements in Hope’s CON application reflect that it had operating income of $4.65 million in fiscal year 2001 and $3.45 million fiscal year 2002. Its “excess of revenues over expenses” (i.e., net income) was $4.28 million in fiscal year 2001 and $3.13 million in fiscal year 2002. Hope is a successful fundraising organization. The audited financial statements in Hope’s CON application report “cash received from donors” in the amount of $2.7 million in fiscal year 2001 and $2.87 million in fiscal year 2002. Hope’s operating margin has declined every year since 2002, which means that Hope is having to rely more heavily on contributions to subsidize its operations. In fiscal years 2003 and 2004, Hope’s contributions exceeded its operating income, which means that it had negative operating margins in those years. Nevertheless, Hope still had net income of approximately $2.8 million in fiscal year 2004. Hope is aggressively seeking to expand its service area. If its expansion efforts are successful, Hope will more than double the geographic size of its service area and it will triple the number of counties that it serves. Starting in the April 2003 batching cycle (in which CON 9692 was filed), Hope filed CON applications in four successive batching cycles seeking to establish a hospice program in SA 8A. In the same batching cycles, Hope filed successive CON applications seeking to establish a hospice program in SA 8B (Collier County). In the April 2005 batching cycle, Hope filed an application to establish a new hospice program in SA 6B (Polk, Hardee, and Highlands Counties) in response to a published need for one new program in that service area. Hope’s first SA 8B application, CON 9695, was the subject of DOAH Case No. 03-4067CON (hereafter “Hope 8B-I”). The Agency’s final order denying that application is on appeal in Case No. 1D05-2876. Hope’s “follow up” applications in SA 8A and SA 8B were all preliminarily denied by the Agency, and Hope’s challenges to the denial of those applications are pending at DOAH. The record does not reflect the Agency’s action on Hope’s SA 6B application, but Hope states in its PRO (at page 61) that the application was preliminarily approved by the Agency. (2) HSWF HSWF is a not-for-profit corporation established in 1980. HSWF provides hospice services in SA 8A (Charlotte and DeSoto Counties), SA 8D (Sarasota County), and SA 6C (Manatee County), under a single license issued by the Agency. It is the sole provider of hospice services in each of those service areas. HSWF has over 450 employees and 1,800 volunteers. HSWF had a total of 4,552 admissions in its three service areas in calendar year 2002, with 967 (or 21.2 percent) of those admissions coming from SA 8A. HSWF’s average daily census (ADC) was approximately 800 patients as of the time of the final hearing. HSWF has had the authority to provide hospice services in SA 8A since at least October 1993, and it has been the sole provider of hospice services in SA 8A since 1998 when it acquired the competing SA 8A hospice program operated by the Bon Secours organization.1 HSWF has its main office and several branch offices in Sarasota County. It also has branch offices in the other counties that it serves, including Charlotte and DeSoto Counties. In Manatee County, HSWF has a total of 12 hospice inpatient beds in two “hospice houses.” It has CON approval for an additional eight beds at its Bradenton “hospice house.” In Sarasota County, HSWF has a total of 18 hospice inpatient beds in two “hospice houses.” The Venice “hospice house,” which has six hospice inpatient beds is approximately 17 miles from Port Charlotte. In Charlotte County, HSWF has an administrative office and a “hospice house.” At the time of the final hearing, the “hospice house” was a six-bed residential facility, but HSWF had recently received CON approval to expand it to a 12-bed hospice inpatient facility. HSWF is also in the process of constructing a seven-bed residential facility and administrative office in the Charlotte County portion of the city of Englewood. In DeSoto County, HSWF leases office space in Arcadia. It recently purchased land in Arcadia on which it intends to construct an administrative office and an 8-bed “hospice house.” HSWF is certified by Medicare and Medicaid. It is seeking CHAP accreditation. HSWF complies with the staff-to-patient ratios set forth in the NHPCO guidelines. It has begun to embrace the "open access" philosophy, albeit not to the same extent as Hope. HSWF accepts all hospice-eligible patients without regard to their ability to pay or their payer status. HSWF provides services to the community in addition to the hospice services that it provides to its patients. For example, it offers bereavement support groups for members of the community in need of such services; it provides grief counseling to the local schools, when needed; and like Hope, HSWF operates a camp for children who have lost a family member, whether or not the family member was in hospice. HSWF is a financially-sound organization. Its audited financial statements reflect that, as of June 30, 2004, it had current assets of $40.5 million, including approximately $33 million in cash, cash equivalents, and investments. HSWF is a profitable organization. Its audited financial statements reflect that it had operating income of approximately $4.25 million in fiscal year 2002, $3.85 million in fiscal year 2003, and $3.1 million in fiscal year 2004. HSWF was expected to have its first operating loss ever in fiscal year 2005 as a result of the hurricanes that hit southwest Florida in the summer of 2004 and disrupted HSWF’s operations for several months. Hope is a successful fundraising organization. Its audited financial statements reflect that it received “total support” -- i.e., contributions and donations, memorials, and donated facility usage –- of approximately $4.12 million in fiscal year 2002, $4 million in fiscal year 2003, and $3.95 million in fiscal year 2004. HSWF funds the construction of its “hospice houses” and other capital projects through the significant reserve of cash and investments that it has built-up with donations from the community. Its reserves also enable it to absorb operating losses, such as those caused by the recent hurricanes. (3) Agency The Agency is the state agency that administers the CON program. It also licenses and regulates hospices. The Agency’s duties under the CON program include the calculation and publication of a FNP, which identifies the need (or not) for new hospice programs in each Hospice Service Area in the state. The duties also include reviewing and taking final agency action on CON applications for new hospice programs. Application Submittal and Review and Preliminary Agency Action The FNP published by the Agency for the April 2003 batching cycle identified a need for zero new hospice programs in SA 8A. Hope challenged FNP calculations, but it withdrew the challenge at the outset of the final hearing. Hope timely filed a letter of intent and a CON application in the April 2003 batching cycle. Hope’s application, CON 9692, seeks to establish a new hospice program in SA 8A. Hope’s letter of intent and CON application complied with the technical submittal requirements in the applicable statutes and Agency rules. The application was properly accepted for review by the Agency. The Agency comparatively reviewed Hope’s CON 9692 with the CON application filed by Heartland (CON 9693), which also sought to establish a new hospice program in SA 8A. The applications filed by Hope and Heartland were simultaneously, but not comparatively, reviewed with the CON application filed by HSWF (CON 9694) to establish a 12-bed freestanding hospice inpatient facility in SA 8A. The Agency’s review of the CON applications complied with all of the applicable statutes and Agency rules. The Agency’s review culminated in the issuance of a State Agency Action Report (SAAR), which recommended denial of the applications filed by Hope and Heartland and approval of the application filed by HSWF. The Agency published formal notice of its decisions on the CON applications in the September 12, 2003, volume of the Florida Administrative Weekly as required by the statutes and the Agency's rules. Hope and Heartland timely challenged the denial of their respective applications. Hope also challenged the approval of HSWF’s application. Heartland withdrew its challenge to the denial of its application prior to the final hearing, and it did not participate in the hearing in any way. Jurisdiction over Hope’s challenge to the approval of HSWF’s application was relinquished to the Agency through an Order issued in this case on January 4, 2005. The Agency issued CON 9694 to HSWF through a final order dated June 3, 2005. The final order was not appealed. The Agency reaffirmed its opposition to Hope’s application at the final hearing through the testimony of Jeffrey Gregg, the Bureau Chief of the Agency’s CON program. Hospice Care, Generally Hospice care is provided to patients who are at or near the end of their lives. To be eligible for hospice care, the patient must have been diagnosed with a terminal illness from which the patient is expected to die within six months if the disease runs its normal course. Hospice care is considered palliative care rather than curative care. The purpose of palliative care is to provide comfort to the patient rather than to cure the patient. Curative care is inconsistent with the hospice eligibility requirement that the patient's illness be terminal. Hospice care includes a comprehensive range of services provided by physicians, nurses, social workers, chaplains, therapists, and volunteers, to address the psychosocial and spiritual needs of the patient in addition to the physical pain associated with the dying process. Hospice care also includes services provided to the patient’s family, including grief counseling during the dying process and after the patient’s death. Hospice care is collaboratively provided through care teams, or interdisciplinary teams (IDTs), which are composed of individuals in the various disciplines identified above as well as the patient and his or her family. The IDT is responsible for developing and implementing the plan of care for the patient. There are four general types or “levels” of hospice care: routine home care, continuous care, inpatient care, and respite care. More than 80 percent of all hospice care is routine home care, which is provided to the patient where he or she resides (e.g., home, long-term care facility, etc.). Medicare pays a per diem rate to the hospice based upon the level of care being provided. The hospice receives the per diem rate for each patient, whether or not services are provided to the patient on a given day. Medicare-certified providers, such as Hope and HSWF, are required to comply with the Conditions of Participation in the Medicare regulations, 42 CFR Part 418, in order to receive reimbursement from Medicare for the hospice services that they provide to their patients. Hope and HSWF are also required to comply with the state licensure requirements in Part IV of Chapter 400, Florida Statutes, and Florida Administrative Code Rule 58A-2. The Medicare regulations require hospice providers to directly provide certain “core” services, including nursing, social work, and counseling. Other services, such as physician services, therapies, and medications, may be provided through third-parties pursuant to a contract with the hospice. The Medicare regulations make the hospice responsible for all medically necessary care and services related to the patient’s terminal illness once the patient elects the Medicare hospice benefit. Hospices are required to admit hospice-eligible patients without regard to the patient’s ability to pay, and, as stated above, Hope and HSWF each do so. Hospice Service Area 8A Demographics and Penetration Rates There are similarities between SA 8A, served by HSWF, and SA 8C, served by Hope. However, there are also material differences between the two service areas that undercut Hope’s contention that the differences in the penetration rates in the service areas are solely attributable to differences in the management and operation of HSWF and Hope. For example, the population of SA 8A (182,190) is significantly smaller than the population of SA 8C (519,395); SA 8A has a lower projected five-year growth rate (11.3 percent) than does SA 8C (14.4 percent); SA 8A is less densely populated (125 persons per square mile) than is SA 8C (170 persons per square mile), even though SA 8A has considerably less land area (1,457 square miles) than does SA 8C (3,046 square miles); and resident deaths increased at a considerably slower rate in SA 8A (four percent) between 1996 and 2001 than they did in SA 8C (15 percent). These demographic differences explain, at least in part, the lower penetration rates in SA 8A as compared to SA 8C. In 2002, which is the period reflected in the applicable FNP calculations, the overall penetration rate in SA 8A was 40.5 percent. That rate was slightly lower than the statewide average of 43.8 percent, and was significantly lower than Hope’s 54.7 percent penetration rate in SA 8C. The overall penetration rate in SA 8A increased to 47.68 percent in 2003, which was almost the same as the 47.75 percent statewide average, but was still lower Hope’s 55.86 percent penetration rate in SA 8C. The overall penetration rate in SA 8A has continued to increase. For the 12-month period ending June 30, 2004, the overall penetration rate in SA 8A was 53.6 percent, which was higher than the statewide average of 49.9 percent and was only slightly below Hope’s 58.5 percent penetration rate in SA 8C. The number of resident deaths in SA 8A is projected to increase to 2,645 for the 12-month period ending June 30, 2005, which is the planning horizon applicable to this case. That is a 10.7 percent increase over calendar year 2001, when there was a total of 2,389 resident deaths in SA 8A. HSWF’s Existing SA 8A Program HSWF's efforts to develop the SA 8A market began in earnest in July 2000 when HSWF hired its current president and chief executive officer, Marge Maisto. Under Ms. Maisto’s leadership, HSWF implemented a number of initiatives designed to enhance the services provided by HSWF, particularly in SA 8A. First, HSWF undertook efforts to strengthen its medical staff. It hired a Vice President of Medical Affairs to work with the clinical medical director, and it began hiring full-time associate medical directors instead of contracting with physicians on a part-time basis. HSWF now employs eight full-time physicians who are board certified in hospice and palliative care and other specialties. The physicians are members of the IDTs and they participate in the care planning for patients. They also make patient visits, which some of the part-time contract physicians did not do. Three of the physicians -- Drs. Martin, Ray, and Gutherie –- are assigned to SA 8A. They were hired in June 2003. Second, HSWF formed dedicated IDTs to serve patients residing in long-term care (LTC) facilities. The LTC teams began serving patients in August 2003. The planning for the dedicated LTC teams began as early as November 2000, and the decision to form the teams was made in March 2003. HSWF hired a physician, Dr. Tuck, to serve as the “medical director” for the LTC teams in June 2003. HSWF has three dedicated LTC teams, including a team that serves the LTC facilities in Charlotte and DeSoto Counties. The team includes Dr. Tuck, nurses, social workers, certified nurse assistants, chaplains, a volunteer coordinator, and others. The LTC team serving Charlotte and DeSoto Counties had a census of approximately 50 patients at the time of the final hearing. There are approximately 10 LTC facilities in SA 8A, but some of the facilities are still closed as a result of damage caused by the 2004 hurricanes. Third, HSWF implemented an outreach and education program designed to strengthen its relationships with local physicians since they are the primary referral source of hospice patients. The program included the hiring of “physician liaisons,” who are responsible for networking with local physicians. The liaisons’ responsibilities initially included “learning about the physician offices, what their barriers were to referrals and how [HSWF] could better serve them,” but the responsibilities evolved into “provid[ing] education to physicians and their office staff regarding [HSWF’s] scope of services, as well as a better understanding of the hospice concept and mission.” HSWF hired a physician liaison in March 2002 to cover Venice and Port Charlotte. It hired another liaison in November 2002 to cover Charlotte and DeSoto Counties. Fourth, HSWF created Community Advisory Councils in each of the counties that it serves (including Charlotte and DeSoto Counties) to “get closer with the community and receive feedback and guidance from [the community] on how better to serve them, how better to educate the community at large about hospice services . . . .” The creation of the Councils was an element of HSWF’s 2001-04 Strategic Plan, which was prepared in May 2001. Fifth, HSWF developed admission guidelines to memorialize its policies regarding the admission of patients on palliative chemo/radiation or other therapies that, although developed to be curative, can be use to palliate symptoms and improve the patient’s quality of life. Sixth, HSWF sought and received a CON to convert and expand the "hospice house" in Port Charlotte from six-bed residential facility to a 12-bed hospice inpatient facility. The CON application was filed in the same batching cycle as Hope's CON 9692, and the CON was issued in June 2005. Although these initiatives address several of the issues that were identified as “special circumstances” in Hope’s CON application, filed in July 2003, the evidence was not persuasive that the initiatives were undertaken in response to Hope’s application as Hope contends. To the contrary, the evidence establishes that these initiatives were at least in the planning stages prior to the time that Hope filed its CON application for a new SA 8A hospice program, and that the implementation of the initiatives was ongoing at the time Hope filed its application. The implementation of these initiatives contributed to the significant growth in admissions experienced by HSWF in SA 8A between 2000 (when it had 793 admission) and 2003 (when it had 1,172 admissions). Over that period, HSWF’s admissions grew by 5.93 percent between 2000 and 2001, by 15.1 percent between 2001 and 2002, and by 21.2 percent between 2002 and 2003. HSWF provides the full continuum of hospice care in SA 8A, including routine home care, continuous care, inpatient care, and respite care. HSWF has contracts with all of the hospitals in Charlotte and DeSoto Counties, which allow HSWF to provide hospice inpatient services in those hospitals. Its “hospice house” in Venice, which is approximately 17 miles from Port Charlotte, is also available for SA 8A patients in need of hospice inpatient services and, as noted above, HSWF will soon have a 12-bed inpatient facility in Port Charlotte. HSWF offers a full range of ancillary or expressive “therapies” to its patients through its Creative Caring and Connections program. The services include touch, art, music, horticulture, aroma, and pet “therapies.” HSWF also has a training program for clowns. It is the only hospice-affiliated clown program in the country. The clowns visit and entertain hospice patients and their families under the premise that, sometimes, laughter can be the best medicine. HSWF’s clown program is recognized by the world’s largest clowning organization but, unlike massage, art, and music therapies, clown “therapy” is not formally recognized as an expressive therapy by any accrediting body. The expressive “therapies” offered by HSWF are provided to patients in order to reduce anxiety or palliate symptoms. They are delivered as part of the patient’s care plan, typically upon the recommendation of the social worker on the IDT. The “therapies” offered by HSWF are provided by trained volunteers from the community, not certified therapists employed by HSWF. Massage therapy, which is one type of touch therapy offered by HSWF, is provided by licensed massage therapists who are volunteers, not employees of HSWF. HSWF relies heavily on “local clergy” to deliver spiritual care to its patients. It does so because it has found that patients are often more comfortable with their own spiritual advisor with whom they are familiar and have a longstanding relationship. HSWF hired a full-time director of spiritual care in October 2002. It has since hired two additional full-time chaplains and has another who provides services on a contract basis. The chaplain who serves SA 8A was hired in March 2003. The staff chaplains coordinate the spiritual care of the patient and are available to patients 24 hours a day, seven days a week. They visit patients, they perform memorial services, and they coordinate the services provided by the “local clergy.” The hiring of staff chaplains by HSWF predated Hope’s application and, as acknowledged by a former HSWF employee who testified on behalf of Hope at the final hearing, it had nothing to do with the filing of Hope’s application. In “late 2004” or early 2005, HSWF implemented a formal training program for “local clergy” regarding the manner in which end-of-life issues are dealt with by hospice staff. The program had been in the planning stages since October 2002 when HSWF hired a full-time director of spiritual care, but it was not considered to be a priority because clergy are generally familiar with the unique needs of dying patients and their families by virtue of their training in divinity school and/or their experience with their own parishioners. Patient admissions at HSWF are handled by a clinician who is part of a centralized admissions team, rather than by a clinician who is part of the IDT serving the geographic region where the patient is located. This streamlines the admissions process and allows the IDT members to focus on the delivery of patient care. HSWF actively engages in outreach and education efforts to the community at large. It distributes newsletters and other publications throughout Charlotte and DeSoto Counties, it participates in community events in those counties, and its staff members speak to community groups and are involved in community activities. Hope’s Proposed SA 8A Program (1) Generally Hope’s proposed SA 8A hospice program is essentially an expansion of the service area of its existing program into the adjacent SA 8C. The policies and procedures that Hope utilizes in its existing program will be implemented in its proposed SA 8A program. The policies include Hope’s commitment to serving patients and families without regard to caregiver status, homelessness, or HIV/AIDS status, and without regard to their ability to pay. The policies also include Hope’s commitment to “open access,” particularly with respect to patients on palliative chemo/radiation. There have been no changes to Hope’s polices related to palliative chemo/radiation since the time of the final hearing in Hope 8B-I. Hope's procedures include protocols used by its nurses to help them manage the most common pain symptoms found in hospice patients, including anxiety, fatigue, and depression, as well as Hope's detailed protocols for pediatric hospice patients. The protocols are used by Hope's nurses as a guide in the assessment of the patient; the identification of treatment options; the administration of medications, when indicated and pre-authorized by the physician; and the facilitation of the nurse’s communications with the physician and pharmacist about the patient’s condition and course of treatment. At Hope, admissions are handled by a member of the clinical staff who will be caring for the patient, rather than a dedicated admission team. This promotes continuity of care. Hope intends to establish an office in Arcadia to serve DeSoto County and an office in Port Charlotte to serve Charlotte County. The offices will be located in leased space. No new construction is proposed. Hope’s existing offices in Cape Coral and Boca Grande will also be used to provide services in Charlotte County. Those offices are in northern Lee County, close to the southern border of Charlotte County. Hope is not proposing any inpatient hospice beds as part of its proposed SA 8A program. It intends to provide inpatient and respite care through contractual arrangements with existing nursing homes and hospitals in SA 8A and/or through the use of the inpatient beds at its "hospice houses" in Lee County. Hope’s proposed SA 8A hospice program will provide a comprehensive range of hospice services, including physician services, nursing services, home health aide services, social services, chaplain services, and all other services required by the state and federal hospice regulations. Hope provides chaplain services to its patients through its staff of 14 full-time chaplains. It also offers training to “local clergy” regarding bereavement and end-of-life issues. Hope recognizes the importance of the patient’s own spiritual advisor being involved in the patient's plan of care, but it does not rely on "local clergy" as heavily as does HSWF. Hope intends to provide services that are not reimbursed by Medicare or other insurance, such as bereavement services and massage, music, art, and pet therapies. Hope provides those services in its existing SA 8C hospice program. The ancillary or expressive therapies provided by Hope (e.g., art, massage, music, pet) are provided by certified therapists employed by Hope rather than community volunteers. The therapists are members of the IDTs. Hope expects to receive the vast majority of its referrals to its proposed SA 8A hospice program from physicians, which is consistent with its experience in SA 8C. Hope projected in its CON application that approximately 83 percent of the patient days at its proposed SA 8A hospice program will be attributable to Medicare patients, approximately six percent of the patient days will be attributable to Medicaid patients, and approximately two percent of the patient days will be attributable to charity patients. The application states that these figures are based upon Hope’s experience in the adjacent SA 8C, and they are reasonable in light of the demographics of SA 8A. Hope projected in its CON application that the total project costs for its proposed SA 8A hospice program will be $148,450. The largest line-item cost -- $56,941 –- is for “preoperational staffing, recruiting and training.” The projected costs are reasonable. Hope intends to fund the costs of its proposed SA 8A hospice program with cash “on hand and/or from operations." Hope has sufficient financial resources to fund the costs of its proposed SA 8A hospice program along with its other ongoing capital projects and proposed service area expansions. Hope projected in its CON application that it will need 12.17 full-time equivalents (FTEs) to staff its proposed SA 8A hospice program in its first year of operation, and that it will need an additional 7.83 FTEs (for a total of 20 FTEs) in its second year of operation. It was stipulated that the projected staffing levels are reasonable and that Hope will be able to recruit the necessary FTEs at the salaries projected in its CON application. In addition to the FTEs projected in the application, Hope will utilize volunteers to “provide both administrative support and patient support functions.” Hope projects that its proposed SA 8A hospice program will have approximately one volunteer per patient, which equates to approximately 30 volunteers in the first year of operation and 45 volunteers in the second year of operation. Hope has been successful in recruiting and retaining volunteers in SA 8C, and it is reasonable to expect that Hope will be able to recruit and retain sufficient volunteers for its proposed SA 8A hospice program. The payer mix and revenues projected in Schedule 7A of Hope's CON application are reasonable, as are the expenses projected in Schedule 8A of the application. Hope projected that its proposed SA 8A hospice program will generate a net loss from operations of $6,303 in its first year, and that it will generate a net profit from operations of $30,688 in its second year. These projections are reasonable. Hope projected that it will have non-operating revenue of $50,642 and $72,111 in the first and second years of operation, respectively. Those amounts include “donations/memorials and bequests” that Hope expects to receive as well as a net of $10,000 from fundraising. These projections are reasonable. The bottom-line “net profit” projected on Schedule 8A of Hope’s application, which includes the net profit from operations and the non-operating revenues, is $38,959 in the program’s first year of operation and $97,799 in its second year of operation. Those amounts are reasonable. (2) Projected Admissions Hope projected that its proposed SA 8A hospice program will have 167, 238, and 280 admissions in its first three years of operation. By the seventh year of operation, Hope projected that its proposed SA 8A hospice program will have 481 admissions. Those figures represent 15 percent (year 1), 20 percent (year 2), 22 percent (year 3), and 30 percent (year 7) of the projected hospice admissions in SA 8A. Those market shares are at the high end of the range of the market shares achieved by other recent start-up hospice programs that entered into single-provider markets. However, under the circumstances of this case, the market shares projected by Hope are likely somewhat understated. In projecting the total number of hospice admissions in SA 8A, Hope assumed that the overall penetration rate in the service area will increase each year based on its presence in the market. The assumption of an increasing penetration rate is reasonable, but attributing that increase to Hope’s presence in the market is not. Indeed, the evidence reflects that penetration rate in SA 8A has been steadily increasing over the past several years to levels consistent with the rates projected by Hope in its application. Hope’s projected admissions translate into ADCs of 30 patients (year 1), 47.2 patients (year 2), 56.8 patients (year 3), and 97.5 patients (year 7). The ADC figures are based upon a 65.7-day average length of stay (ALOS) in year one, which increases to 74-day ALOS in year seven. The ALOSs and ADCs projected by Hope are consistent with Hope’s experience in SA 8C and are reasonable in light of Hope’s “open access” policies. The methodology used to calculate the projected admissions and the ADCs is reasonable, and Hope will be able to achieve its projected utilization levels. Indeed, as more fully discussed in Part F below, the projected admissions are likely somewhat understated because a component of the market share assumptions made by Hope is too low. Impact on HSWF The number of admissions projected for Hope’s proposed SA 8A hospice program –- 167 (year one), 238 (year two), and 280 (year 3) -- also represent the number of “lost admissions” projected for HSWF because HSWF is currently the sole provider of hospice services in SA 8A. The “lost admissions” projected in Hope’s CON application are likely understated because they were based upon the assumption that Hope will get an equal percentage of the cancer and non-cancer patients that would have otherwise been served by HSWF. Specifically, Hope projected that it will get 15 percent of SA 8A’s cancer patients and 15 percent of the service area’s non-cancer patients in the first year of its program’s operation; 20 percent of each category’s patients in its second year of operation; and 22 percent of each category’s patients in its third year of operation. The assumption that Hope will take an equal number of cancer and non-cancer patients from HSWF each year is not consistent with the evidence regarding Hope’s “open access” philosophy towards palliative chemo/radiation or the testimony of oncologists in SA 8A regarding their intent to refer their patients to Hope rather than HSWF if Hope’s application is approved. Indeed, based upon that evidence and testimony, it is reasonable to expect that Hope will, over a relatively short period of time, have a significantly larger percentage of the cancer patients in SA 8A than will HSWF. On the issue of the percentage of cancer patients that Hope will take from HSWF, the projections of HSWF’s health planner are more reasonable than the projections of Hope’s health planner.2 Specifically, it is not unreasonable to expect that Hope will get 25 percent, 50 percent, and 75 percent of the cancer patients in SA 8A in its first three years of operation. The effect of Hope getting a larger percentage of SA 8A's cancer patients is that its total admissions and, hence, HSWF’s “lost admissions” will more likely be 217, 396, and 545 in Hope’s first three years of operation in SA 8A.3 Those admissions translate into projected market shares for Hope of 19.5 percent, 33.2 percent, and 42.8 percent in its first three years of operation, based upon the total number of admissions projected by Hope’s health planner for SA 8A over that period. Those market shares are reasonable and attainable, even after taking into account HSWF’s status as the incumbent hospice provider with considerable community support. The financial impact of the “lost admissions” on HSWF will be significant, both in terms of the lost patient revenues from the admissions and the lost donations and bequests that HSWF would likely have otherwise received from those patients. The financial impact on HSWF is a factor weighing against approval of Hope’s CON application, but the impact is not so significant that it is an independent basis for denying the application. The financial impact of the admissions that HSWF will “lose” to Hope if Hope’s CON application is approved will be largely offset by the annual savings that HSWF expects to realize from the establishment or expansion of hospice inpatient facilities in SA 8A and its other service areas. Moreover, HSWF has sufficient current assets to absorb the financial impact of Hope’s proposed 8A program while continuing its existing operations in SA 8A at their current levels if it chose to do so. Even though HSWF has the financial strength to continue its existing operations in SA 8A at their current levels notwithstanding Hope’s entry into the SA 8A market, it is unlikely to do so. Indeed, HSWF's chief executive officer testified that HSWF would likely eliminate or scale back certain aspects of its SA 8A program as a result of the patient volume that it would “lose” to Hope. Alleged Special Circumstances Hope identified seven “special circumstances” in its CON application, which, in its view, support the approval of its proposed SA 8A hospice program. Disproportionately High “Unmet Needs” The first special circumstance alleged by Hope in its application is that the “unmet need” in SA 8A, as reflected in the FNP calculation, is disproportionately high. The justification offered by Hope for this special circumstance was statistical data. There was no testimony from physicians or community witnesses related to this special circumstance. Under the hospice CON rule, Florida Administrative Code Rule 59C-1.0355, need for a new hospice program is determined through a FNP calculation in which the hospice admissions from the most recent calendar year (here, 2002) are subtracted from the projected number of hospice admissions over the planning horizon (here, July 2004 through June 2005). The result of that calculation, according to paragraph (4)(a) of the hospice CON rule, is “the projected number of unserved patients who would elect a hospice program.” Hope refers to the result of the calculation as “unmet need.” If the projected number of unserved patients is greater than 350, then the FNP shows a need for a new hospice program. If the projected number of unserved patients is less than 350, then the FNP shows that a new hospice program is not needed. The FNP calculation for the April 2003 batching cycle showed 238 projected unserved patients in SA 8A. Because that figure is less than 350, the end-result of the FNP calculation is a need for zero new hospice programs in SA 8A. The ratio of the projected unserved patients (238) to the actual admissions in SA 8A (967) is 24.6 percent, which is the fourth highest rate of all of the service areas in the state, and, according to Hope, that ratio reflects a disproportionately high level of “unmet need” in SA 8A. This is not a special circumstance. The FNP calculations necessarily include a threshold below which need is presumed not to exist, no matter how close the number of projected unserved patients is to the threshold or how “disproportionate” that number may seem. Hope's contention on this issue is essentially a criticism of the threshold in the FNP calculation because, according to Hope, the “comparatively small size [of SA 8A] has prevented the need formula from calculating an unmet need sufficient to trigger the [350 threshold necessary for a] determination of a numeric need.” The reasonableness of the threshold (in general or for smaller service areas) is not properly at issue in this proceeding and, moreover, the “unmet need” identified by Hope is something that is specifically taken into account in the FNP calculations. Inadequate Lengths of Stay The second special circumstance alleged by Hope in its CON application is that lengths of stay at HSWF are inadequate for quality of care. The critical assumption underlying this contention is that longer lengths of stay are necessarily better than shorter lengths of stay from a quality of care perspective. Longer lengths of stay can be an indicator of the accessibility of hospice care because they tend to reflect that patients are being referred to, and admitted into, hospice earlier in the dying process. Longer lengths of stay are not, however, a reliable indicator of hospice quality of care, which depends more upon the services that the patient is receiving from the hospice than the length of time that the patient is enrolled in hospice. Nursing costs per-patient-day (PPD) is a better indicator of the level of direct patient care being provided by the hospice than is the hospice's ALOS, and, on this point, it is noteworthy that the nursing costs PPD at HSWF exceed the national average for hospices with more than 350 annual admissions whereas the nursing costs PPD at Hope are less than the “national average.”. Another reason that longer lengths of stay are not necessarily a reliable indicator of quality of care is that hospices have a financial incentive to increase length of stay because hospice patients typically require less services in the “middle” portion (i.e., the period between 15 days after admission and 15 days before death) of their stay. The "middle" portion of the patient's stay is more profitable for the hospice because even though it is providing less services to the patient (and, hence, incurring less cost), the per diem rate paid by Medicare remains constant. The ALOS at Hope is among the highest in the state and the nation. Its ALOS was 74 days in 2002, and it is trending upward. The statewide average ALOS in 2002 was 63 days. The ALOS at HSWF in 2002 was 39 days, which is among the lowest in the state. This figure includes all of the counties served by HSWF. The ALOS for the patients served by HSWF in Charlotte was 34.5 days in 2002, and the ALOS for its DeSoto County patients was 35.2 days in 2002. The ALOS for patients served by HSWF in Charlotte in DeSoto Counties has increased. In 2004, the ALOS for patients in Charlotte County was 44.1 days and the ALOS for patients in DeSoto County was 42.1 days. The evidence was not persuasive that the quality of care provided at HSWF in SA 8A was inadequate in 2002 despite its relatively low ALOS, nor was the evidence persuasive that the quality of care provided at HSWF was inadequate in 2004 even though its ALOS at that time was still lower than the ALOS at Hope. To the contrary, the evidence establishes that HSWF provides high quality hospice care. The second special circumstance alleged by Hope was not proven. Inadequate Service to Patients in Need of Palliative Chemo/Radiation The third special circumstance alleged by Hope in its CON application is that patients in SA 8A who are need of palliative chemo/radiation are not being adequately served by HSWF. Palliative chemo/radiation are medical treatments whose goal is symptom reduction and improved quality of life during the dying process. Palliative chemo/radiation is commonly used to reduce the size of the patient’s malignant tumors, which, in turn, relieves pressure exerted by the tumors on other organs and reduces the associated pain. Palliative chemo/radiation is distinguishable from curative chemotherapy and radiation, whose goal is to cure the patient’s cancer and to allow the patient to have a normal life expectancy. As noted above, curative treatments are not appropriate for hospice patients because eligibility for hospice is premised upon the patient having a terminal illness. Palliative chemo/radiation is typically administered by an oncologist, who is a physician who specializes in the treatment of cancer. The treatments are typically administered in the oncologist’s office. The benefits of the treatment (e.g., symptom relief) have to be weighed against the burdens of the treatment (e.g., fatigue, nausea, etc.) for each patient on an ongoing basis over the course of the treatment. Palliative chemo/radiation is expensive, and hospices have a financial incentive not to provide it to their patients because the hospice is not reimbursed for a large part of the high costs associated with the treatment. Patients receiving palliative chemo/radiation constitute only a small percentage of hospice patients. At Hope, for example, the percentage of oncology patients receiving palliative chemo/radiation at the time of their admission was approximately seven percent, and by the seventh week after admission, the percentage of oncology patients receiving palliative chemo/radiation was approximately two percent. HSWF does not, and has never, categorically denied palliative chemo/radiation to its patients. Until October 2003, HSWF did not have a written set of guidelines relating to palliative chemo/radiation. It began the process of developing such guidelines in early 2002 in order to address concerns raised by oncologists in SA 8A. The guidelines, which were “rolled out” in October 2003, describe HSWF’s policies relating to the admission and ongoing evaluation of patients on palliative chemo/radiation and other therapies. Among other things, the guidelines require the treating physician to provide data to the IDT regarding the prognosis, results, and goals of the treatment so that the IDT, in collaboration with the treating physician and the patient, can evaluate the benefits and burdens of the treatment at least every two weeks. HSWF’s guidelines on palliative chemo/radiation are reasonable and appropriate, particularly with respect to the ongoing collaboration they require between the oncologist and the IDT regarding the benefits and burdens of the treatment. Prior to the implementation of the guidelines, there was a perception by some of the oncologists in SA 8A that HSWF would not allow patients to continue to receive palliative chemo/radiation once they were admitted into hospice. As a result of that perception, the oncologists delayed the referral of patients on palliative chemo/radiation to HSWF until the patient’s course of treatment was complete. Since the implementation of the guidelines, that perception has changed. The oncologists who previously delayed referrals of patients on palliative chemo/radiation now find HSWF to be more receptive to admitting those patients, and they testified that they are generally satisfied with the level of collaboration between themselves and HSWF about the patient’s course of treatment. Nevertheless, those oncologists testified that they would likely refer their patients to Hope if its SA 8A program was approved because of the relationship and positive experiences that the Lee County oncologists in their practice group have had with Hope. The level of palliative chemo/radiation provided by HSWF is not insignificant. In fiscal year 2002, for example, HSWF had total expenditures of $124,396 on chemotherapy and total expenditures of $77,026 on radiation. By fiscal year 2004, its total expenditures had increased to $267,871 on chemotherapy and $137,921 on radiation. HSWF spends considerably less on chemotherapy and radiation than does Hope, but that does not mean that HSWF is providing an inadequate level of palliative chemo/radiation in SA 8A. On this point, it is noteworthy that the level of chemotherapy and radiation provided by HSWF is greater than, but not materially out of line with, the national average for hospices with more than 350 annual admissions on both a cost per patient ($/patient) basis and a cost per-patient-day basis ($/PPD). In fiscal year 2002, for example, HSWF spent $26.01/patient (or $0.76/PPD) on chemotherapy and $16.11/patient (or $0.47/PPD) on radiation, and the “national average” was $10.12/patient (or $0.18/PPD) for chemotherapy and $7.27/patient (or $0.14/PPD) for radiation. By contrast, the level of chemotherapy and radiation provided by Hope is materially out of line with the “national average.” In fiscal year 2002, for example, Hope spent $332.33/patient, or $5.32/PPD, on chemotherapy (as compared to the “national average” of $10.12/patient or 0.18/PPD), and $126.06/patient, or $2.02/PPD, on radiation (as compared to the "national average" of $7.27/patient or $0.14/PPD). The total expenditures on chemotherapy and radiation at Hope continues to increase even though, as noted above, patients receiving palliative chemo/radiation are only a small percentage of Hope's patients. Its expenditures in fiscal year 2004 ($3.15 million) were almost three times higher than they were in fiscal year 2001 ($1.19 million). Hope’s “open access” philosophy contributes to its extraordinary level of expenditures on chemotherapy and radiation. Another contributing factor is Hope’s practice of deferring to the oncologist (who has a financial incentive to continue the treatment as long as possible) regarding the benefit/burden evaluation and the decision to continue or not the course of treatment, coupled with the, at best, limited utilization review by Hope of the treatment rendered by the oncologist. In sum, the evidence fails to establish that the level of service provided by HSWF to patients in need of palliative chemo/radiation was inadequate, either at the time of the hearing or at the time Hope filed its application. Moreover, the evidence fails to establish that the model that Hope intends to replicate in SA 8A is appropriate with respect to palliative chemo/radiation and, indeed, the evidence suggests that Hope’s model results in overutilization of such services. The third special circumstance alleged by Hope was not proven, and, even if it had been proven, it would not justify the approval of Hope's application. Inadequate Service to African-Americans The fourth special circumstance alleged by Hope in its CON application is that African-American patients in SA 8A are not being adequately served by HSWF. The justification offered by Hope for this special circumstance was statistical data. There was no testimony from community witnesses related to this special circumstance. African-Americans typically utilize hospice services at a lower rate than the general population and, as a result, it is not unusual for the African-American penetration rate in a service area to be lower than the overall penetration rate in the service area. It is important for hospices to have outreach programs directed to the African-American community. Hope has such programs in SA 8C, as does HSWF in SA 8A. The African American population in SA 8A is relatively small. Only 6.1 percent of the service area’s population was African-American in 2002. In 2001, the penetration rate for African-Americans in SA 8A was 25 percent, which was less than the 32 percent statewide penetration rate for African-Americans and less than the 41 percent penetration rate for African-Americans in Hope’s SA 8C. The lower African-American penetration rate in SA 8A in 2001 is explained, at least in part, by the fact that HSWF did not consistently capture ethnicity in its patient database prior to 2004. Its failure to do so had the effect of understating the penetration rates for African-Americans and other ethnicities. In 2004, the penetration rate for African-Americans in SA 8A was 38.4 percent, which is a more reliable figure and reflects adequate service of African-Americans by HSWF. There is no credible evidence that the increase in the African-American penetration rate is the result of increased outreach efforts by HSWF in response to Hope’s CON application. In sum, the evidence was not persuasive that African- Americans in SA 8A were being inadequately served by HSWF, either at the time Hope filed its application or at the time of the final hearing. The fourth special circumstance alleged by Hope was not proven. Inadequate Service to Elderly Non-cancer Patients The fifth special circumstance alleged by Hope in its CON application is that elderly non-cancer patients in SA 8A are not being adequately served by HSWF. To address this special circumstance, Hope committed in its CON application to "engage in a special Non-Cancer Outreach Program to educate the medical community in [SA] 8A about the effectiveness of hospice care for non-cancer diagnoses." The limited discussion in the CON application (at page 48) relating to this “special circumstance” referred to the “unmet need” shown in the FNP calculations -– i.e., the difference between the projected number of non-cancer patients in the 65+ age cohort (636) and the actual number of patients in that age/disease cohort admitted at HSWF (483) -- and the comparatively low penetration rate for that age/disease cohort in SA 8A (36 percent) as compared to SA 8C (48 percent). The level and/or variance in the penetration rate for non-cancer patients in the 65+ age cohort is not, in and of itself, a special circumstance. Indeed, it is not unusual for hospices to have different penetration rates in each of the age/disease cohorts nor is it unusual for to the penetration rates in an age/disease cohort to differ between service areas. Moreover, it is noteworthy that the statewide penetration rate for non-cancer patients in the 65+ age cohort, as reflected in the “P4” factor in the FNP calculation, was 38.1 percent, which was only slightly above HSWF's 36 percent penetration rate in SA 8A. At the final hearing and in its PRO (at pages 61-71), Hope’s discussion on this “special circumstance” focused primarily on the allegedly inadequate level of service provided by HSWF to its patients in LTC facilities. The LTC facility is required to provide, and is reimbursed by the hospice for providing, “room and board” to hospice patients living in the facility. The hospice is required to provide the nursing and other care related to the patient’s terminal illness, but that does not excuse the LTC facility from providing nursing and other care to the patient to the extent that the care is unrelated to the patient’s terminal illness. HSWF provides "hands-on" nursing care and other required services to its patients in LTC facilities. The "hands-on" care provided by HSWF is less extensive than that provided by Hope to its patients in LTC facilities but, contrary to Hope's contention, the level of care provided by HSWF to its patients in LTC facilities is not inadequate. The care provided by HSWF to its patients in LTC facilities complements the routine care provided by the staff of the LTC facility. It does not duplicate that care. The level of care provided by HSWF to its patients in LTC facilities was enhanced through the establishment of the dedicated LTC teams, which began serving patients in August 2003. Indeed, the LTC facility staff who testified at the hearing regarding perceived deficiencies in the care provided by HSWF acknowledged the improvement in the services provided by HSWF as a result of the dedicated LTC teams. The fifth special circumstance alleged by Hope was not proven. Inadequate Service to Patients in Need of Intensive Hospice Care The sixth special circumstance alleged by Hope in its CON application is that patients in SA 8A who are need of “intensive hospice care” -– i.e., continuous home care and general inpatient care -- are not being adequately served by HSWF. The justification offered by Hope for this special circumstance was statistical data. There was no testimony from physicians or community witnesses related to this special circumstance. The statistics relied on by Hope reflect that, in 2001, only 3.7 percent of the patient days at HSWF’s SA 8A program were attributable to “intensive hospice care,” as compared to 7.5 percent at Hope and “about 6 percent” statewide. The statistics also indicate that only 30 percent of HSWF’s patients in SA 8A received “intensive hospice care” at some point during their stay, as compared to 46 percent of Hope’s patients and 47 percent of hospice patients statewide. Based upon these statistics, Hope asserted in its CON application that “[t]he quality of care received by residents of Service Area 8A is not adequate.” No evidence was presented by Hope regarding patients in need of “intensive hospice care” who were not provided such care by HSWF. Indeed, the more persuasive evidence establishes that “intensive hospice care” is (and has been) available to residents of SA 8A, as needed. Hope’s proposed approach to providing “intensive hospice care” in SA 8A -– i.e., contracting with area hospital and nursing homes and utilizing its “hospice house” in Cape Coral -- is essentially the same as the approach used by HSWF. As a result, approval of Hope's application will not materially enhance access to "intensive hospice care" in SA 8A. Moreover, HSWF recently received a CON to convert its “hospice house” in Port Charlotte to a 12-bed inpatient facility, which will enhance its ability to provide “intensive hospice care” to residents of SA 8A and will further enhance access to “intensive hospice care" in SA 8A. The sixth special circumstance alleged by Hope was not proven. Inadequate Service to DeSoto County The seventh special circumstance alleged by Hope in its CON application is that patients in DeSoto County are not being adequately served by HSWF. DeSoto County is a rural, sparsely populated county. The county’s population was only 35,233 in 2002, and it had only 55 residents per square mile. DeSoto County is an economically disadvantaged county. The median household income, income per capita, percentage of owner-occupied housing, and percentage of college- educated residents in DeSoto County were all lower than the statewide averages in 2002. DeSoto County is racially diverse. The population is 12.7 percent African-American, 26.6 percent Hispanic, and 5.6 percent Native American. DeSoto County is demographically similar to Hendry and Glades Counties, which are rural counties in SA 8C served by Hope. Hospice penetration rates in rural, economically disadvantaged counties (such as DeSoto, Hendry, and Glades Counties) are typically lower than penetration rates in more urban counties. In 2001, HSWF’s penetration rate in DeSoto County was 26.73 percent, which, as expected, is considerably lower than the overall penetration rate in SA 8A. That penetration rate was also lower than the 39.28 percent penetration rate achieved by Hope in Hendry County in 2001. HSWF’s penetration rate in DeSoto County fell to 20.13 percent in 2002, but it increased in 2003 (to 23.59 percent) and 2004 (to 44.74 percent). HSWF’s 23.59 percent penetration rate in DeSoto County in 2003 was slightly higher than Hope’s 22.12 percent penetration rate that year in Glades County, but it was lower than Hope’s 37.29 percent penetration rate that year in Hendry County. The difference in penetration rates achieved by HSWF and Hope in the rural counties of their respective service areas is not material and does not, in and of itself, justify the approval of Hope’s application, particularly since the evidence establishes that HSWF is adequately serving DeSoto County. HSWF had an office in DeSoto County prior to the filing of Hope’s CON application for its proposed SA 8A hospice program, but the office was not staffed until after the application was filed. Before the time that the office was staffed, it was used to store supplies used by staff serving patients in the county. The decision to staff the office was intended by HSWF to “increase visibility in [the DeSoto County] community to counteract the lack of visibility cited in [Hope’s] application.” HSWF established a Community Advisory Council in DeSoto County in June 2002. In the fall of 2003, Hope established a program known as Shepard’s Watch in DeSoto County. The program trains volunteers from the various churches in the county about hospice (and HSWF) so that they are in a position to provide information to persons in the church who are diagnosed with a terminal illness and may be in need of hospice services. The Shepard’s Watch program was recommended by the Community Advisory Council in DeSoto County as a means to educate residents of the county about hospice because it is a faith-based community, and the churches are the “focal point of information sharing” in the community. The program was under development since “the spring of 2003,” prior to the filing of Hope’s CON application. HSWF’s staff and volunteers were active in DeSoto County prior to the filing of Hope’s CON application, but their level of activity increased after the filing of the application. HSWF had an outreach and education program directed to physicians in DeSoto County since at least November 2002. There was not a separate IDT team serving DeSoto until some point in 2003. Prior to that time, DeSoto County was served by an IDT team based in Port Charlotte that also served patients in Charlotte County. The decision to create a separate IDT team for DeSoto County was based upon the increasing census in the area, not the filing of Hope’s CON application. Hope followed a similar approach in serving the rural counties in its service area. Prior to the time that it opened offices in Hendry County (1996) and Glades County (2001), it served those areas with IDT teams based in eastern Lee County. Hope committed in its CON application to "open a branch hospice office in DeSoto County within two years of licensure in [SA] 8A." The office would be in leased space. The physical presence that Hope has proposed for DeSoto County is essentially the same as that which HSWF currently has in the county, and it is less than that which HSWF will likely have in the near future because, as noted above, HSWF recently purchased land for a "hospice house" in Arcadia. In sum, the evidence was not persuasive that patients in DeSoto County were being inadequately served by HSWF at the time that Hope filed its application and, in any event, the evidence establishes that the county is currently being adequately served by HSWF. The seventh special circumstance alleged by Hope was not proven. Statutory and Rule Criteria (1) Statutory Criteria (a) § 408.035(1), (2), and (5), Fla Stat., and § 408.043(2), Fla. Stat. Subsections (1), (2), and (5) of Section 408.035, Florida Statutes, are interrelated and require an evaluation of the “need” for the proposed new hospice program, the availability and accessibility of the existing hospice program, and the extent to which the proposed new program will “enhance access” to hospice care for residents of the service area. Similarly, Section 408.043(2), Florida Statutes, requires consideration of the “need for and availability of hospice services in the community.” There is a presumption that there is no need for a new hospice program in SA 8A based upon the FNP published by the Agency for the April 2003 batching cycle, which identified the need for zero new hospice programs in SA 8A. The hospice services provided by HSWF in SA 8A are available and accessible. HSWF actively engages in education and outreach activities in SA 8A directed to referral sources (e.g., local physicians) and the community at large. HSWF’s penetration rate in SA 8A is a measure of the availability and accessibility of its services. The penetration rate has consistently increased over the past several years, and it now exceeds the statewide average. The ALOS at HSWF in SA 8A, which is another measure of the program's accessibility, has also increased over the past several years. The evidence was not persuasive that that Hope’s proposed SA 8A program would materially “enhance access” to hospice services. Indeed, the initiatives that Hope intends to implement in SA 8A to serve the “unmet need” identified in its application (e.g., establishing a physical presence in DeSoto County, extending its “open access” policy towards palliative chemo/radiation to SA 8A) are, for the most part, already in effect at HSWF. In sum, the evidence fails to establish that there is a “need” for hospice services in SA 8A that is not being met by HSWF so as to warrant the approval of a new hospice program in the service area. As a result, the criteria in Subsections (1), (2), and (5) of Section 408.035, Florida Statutes, and Section 408.043(2), Florida Statutes, weigh against approval of Hope’s CON application. (b) § 408.035(3), Fla. Stat. Section 408.035(3), Florida Statutes, requires consideration of the applicant’s ability to, and record of, providing quality of care. Hope provides high quality hospice care in its CHAP- accredited program in SA 8C, and it is reasonable to expect that its proposed SA 8A hospice program will also provide high quality of care since it is effectively an expansion of Hope's existing program. HSWF provides high quality hospice care at its existing SA 8A program, and the evidence was not persuasive that the quality of care at Hope’s proposed SA 8A hospice program will be materially higher than that currently provided by HSWF. Hope satisfies the criteria in Section 408.035(3), Florida Statutes, but that criteria is given minimal weight because HSWF is (and has been) providing high quality hospice care in SA 8A. (c) § 408.035(4), Fla. Stat. Section 408.035(4), Florida Statutes, requires consideration of the availability of staff, funds, and other resources necessary to establish and operate the proposed hospice program. It was stipulated that the staffing proposed in Hope’s CON application was adequate and that Hope will be able to recruit and retain the staff and volunteers necessary to operate its proposed SA 8A hospice program. Hope has the financial and other resources necessary to expand its current hospice program into SA 8A, and to operate the program as proposed in the CON application. Hope satisfies the criteria in Section 408.035(4), Florida Statutes. (d) § 408.035(6), Fla. Stat. Section 408.035(6), Florida Statutes, requires consideration of the short-term and long-term financial feasibility of the proposed project. Hope’s SA 8A hospice program is financially feasible in the short term. Hope has sufficient financial resources to fund the cost of its proposed SA 8A program along with its other ongoing and proposed projects even though its operating margin has declined over the past several years. Hope’s proposed SA 8A hospice program is financially feasible in the long term. The projections in Hope’s CON application, which are reasonable and attainable, reflect that Hope’s SA 8A program will generate a net profit from operations of $30,688 and a bottom-line net profit of $97,799 in its second year of operation. Hope satisfies the criteria in Section 408.035(6), Florida Statutes. (e) § 408.035(7), Fla. Stat. Section 408.035(7), Florida Statutes, requires consideration of “[t]he extent to which the proposal will foster competition that promotes quality and cost effectiveness.” Hope cites the recent initiatives implemented by HSWF to address the alleged deficiencies in its existing program as evidence that the approval of Hope’s proposed program would foster competition in SA 8A. Those initiatives, according to Hope, are the direct result of the “competitive pressure” exerted on HSWF by the filing of Hope’s CON application. The evidence fails to support that claim. Indeed, as discussed in Part D(2) above, the more persuasive evidence establishes that the initiatives were in the planning stages and/or being implemented prior to the filing of Hope’s application and, therefore, were not a competitive response to Hope’s application. Nevertheless, the establishment of a new hospice in SA 8A will necessarily increase competition for hospice care in the service area because there is currently only one hospice, HSWF, serving the area. The evidence is not persuasive that the competition that would result from the approval of Hope’s application will promote quality or cost effectiveness. Indeed, to the contrary, Hope’s entry into SA 8A will likely result in a dramatic increase in the utilization of costly palliative chemo/radiation services in SA 8A. In any event, fostering competition is not a consideration that is given significant weight in the hospice context. First, hospice care does not lend itself to competition in the traditional sense because its “consumers” are terminally-ill patients and their families. Second, the relative lack of competition among hospices in Florida has allowed the hospices to grow, which, in turn, allows them to provide more unreimbursed services to their patients. The criteria in Section 408.035(7), Florida Statutes, do not materially weigh in favor of the approval of Hope’s application. (f) § 408.035(8), Fla. Stat. Section 408.035(8), Florida Statutes, which requires consideration of the costs and methods of the construction proposed in the CON application, is not applicable because Hope is not proposing any construction as part of its proposed SA 8A hospice program. (g) § 408.035(9), Fla. Stat., and Fla. Admin. Code R. 59C-1.030(2) Section 408.035(9), Florida Statutes, requires consideration of the applicant’s past and proposed commitment to Medicaid patients and the medically indigent. The statutory reference to “the medically indigent” encompasses what are typically referred to as charity patients. Similarly, Florida Administrative Code Rule 59C- 1.030(2) requires consideration of the effect of the proposed project on the ability of low-income persons and other medically underserved groups to access care. Hope did not condition the approval of its CON application on the provision of a minimum level of patient days to Medicaid and/or charity patients. The financial projections in Hope’s CON application assume that six percent of the patient days at its proposed SA 8A hospice program will be attributable to Medicaid patients and that two percent of the patient days will be attributable to charity patients. Those percentages were, according to the CON application, based upon “the experience of the applicant and the proposed service area.” HSWF did not contest that contention, nor did it challenge the sufficiency of Hope’s past or proposed commitments to Medicaid and charity patients. Hope has a history of providing free services for the benefit of the community at-large above and beyond the hospice services provided to its Medicaid and charity patients. Hope satisfies the criteria in Section 408.035(9), Florida Statutes. HSWF provides a significant level of charity care in SA 8A. Over the three-year period of 2002 through 2004, HSWF provided an average of approximately $775,000 (or 2.2 percent of its total revenues) annually in charity care. That figure does not include the value of room and board provided at its residential facilities, which is not reimbursed by Medicare and which amounted to approximately $1.4 million in 2004. HSWF also provides free services to the SA 8A community at-large above and beyond the hospice services that it provides to its Medicaid and charity patients. The evidence was not persuasive that Hope’s proposed SA 8A hospice program is necessary to, or specifically designed to, address deficiencies in the provision of hospice services to the medically indigent in SA 8A by HSWF. As a result, and because hospices are required by law to serve all hospice-eligible patients who request hospice services regardless of their ability to pay, the criteria in Section 408.035(9), Florida Statutes, is given minimal weight. (h) § 408.035(10), Fla. Stat. Section 408.035(10), Florida Statutes, which requires consideration of the applicant’s designation as a Gold Seal Program nursing facility, is not applicable because Hope is not proposing to add nursing home beds. (2) Rule Criteria Fla. Admin. Code R. 59C-1.0355(4)(e) The preferences in Florida Administrative Code Rule 59C-1.0355(4)(e) are primarily used by the Agency in the comparative review of multiple CON applications filed in the same batching cycle for new hospice programs in the same service area. The preferences are less significant where, as here, there is only one application at issue. Florida Administrative Code Rule 59C-1.0355(4)(e)1. gives preference to an applicant who commits to serve “populations with unmet needs.” Hope formally committed on Schedule C of its CON application to open a branch office in DeSoto County and to engage in outreach program to the medical community regarding the effectiveness of hospice care for non-cancer diagnoses. Those commitments were directed to two of the population groups in SA 8A that, according to Hope, have “unmet needs.” Hope contends that the approval of its application will also address the “unmet needs” of African-American patients, patients in need of palliative chemo/radiation, and patients in need of intensive hospice care, through the programs and policies that Hope will bring to SA 8A from SA 8C. Those programs and policies will, according to Hope, increase the utilization of hospice services by those patient groups by as much as 300 percent. As discussed in Part G above, the evidence fails to establish that the needs of those population groups are not being met by HSWF. Accordingly, Hope’s commitment to serve the “unmet needs” of those population groups is given no weight. Florida Administrative Code Rule 59C-1.0355(4)(e)2. gives preference to an applicant who proposes to provide the inpatient component of care through contractual relationships with existing health care facilities unless the applicant demonstrates a more cost-effective alternative. Hope satisfies this preference. It plans to provide inpatient care through contracts with local hospitals, and it will also make its “hospice house” in Cape Coral, which is in northern Lee County less than 10 miles south of Charlotte County, available to patients from SA 8A in need of inpatient or respite care. This preference is given minimal weight because HSWF currently provides inpatient care in a similar manner –- i.e., through contracts with hospitals in Charlotte and DeSoto Counties or in its “hospice house” in Venice -- and it will soon be able to provide inpatient care in its “hospice house” in Port Charlotte, which is in northern Charlotte County in SA 8A. Florida Administrative Code Rule 59C-1.0355(4)(e)3. gives preference to an applicant who commits to serve patients without primary caregivers, the homeless, and patients with AIDS. Hope satisfies this preference. It plans to serve these patients groups in its proposed SA 8A program, as it does in its current SA 8C program. The evidence does not reflect what, if any, special programs HSWF has for these patient groups, but it is noteworthy that Hope did not contend that those groups are not being adequately served by HSWF. Florida Administrative Code Rule 59C-1.0355(4)(e)4. gives preference to an applicant who commits to establish a physical presence in an underserved county within a three-county service area. This preference is not applicable because SA 8A consists of only two counties. Florida Administrative Code Rule 59C-1.0355(4)(e)5. gives preference to an applicant who proposes to provide services not covered by private insurance, Medicaid, or Medicare. Hope satisfies this preference. It plans to provide unreimbursed services (e.g., massage, pet, music, and art therapies; bereavement services to the community at large) as part of its proposed SA 8A program, as it does in its current SA 8C program. HSWF provides similar unreimbursed services as part of its existing SA 8A program, and the evidence was not persuasive that the ancillary or expressive therapies provided by Hope are materially superior to those provided by HSWF even though Hope provides the therapies through certified therapists whereas HSWF provides the therapies through trained volunteers. In sum, Hope’s proposed SA 8A hospice program satisfies the preferences in Florida Administrative Code 59C- 1.0355(4)(e)2., 3., and 5., but the preferences in those subparagraphs are given minimal weight in evaluating whether Hope’s application should be approved because the evidence establishes that HSWF’s existing program is adequately serving SA 8A and already provides essentially the same services as proposed by Hope in its CON application. Fla. Admin. Code R. 59C-1.0355(5) Florida Administrative Code Rule 59C-1.0355(5) requires the applicant to demonstrate that its proposed program is “consistent with the needs of the community” and the criteria in the local health plan. The rule also requires the CON application to include letters of support from “health organizations, social services organizations, and other entities within the proposed service area” that support the applicant’s proposed hospice program. Hope satisfied the criteria in this rule. The parties stipulated that the local health plan preferences are no longer in effect and need not be considered as a result of the 2004 amendments to the CON law, which deleted reference to the local health plan in Section 408.035(1), Florida Statutes. Hope’s proposed program is consistent with the “needs of the community” in that it will offer a comprehensive range of hospice services, but as discussed above, the “needs of the community” are currently being met by HSWF. Hope’s CON application includes letters of support from a number of physicians, nursing homes, social service agencies, religious organizations, and individuals in SA 8A. The application also includes letters of support from individuals and organizations in Hope’s current service area, SA 8C, attesting to quality of care provided by Hope. Fla. Admin. Code R. 59C-1.0355(6) Florida Administrative Code Rule 59C-1.0355(6) requires an applicant for a new hospice program to “provide a detailed program description” in its CON application, which includes the following elements: Proposed staffing, including use of volunteers. Expected sources of patient referrals. Projected number of admissions, by payer type, including Medicare, Medicaid, private insurance, self-pay, and indigent care patients for the first 2 years of operation. Projected number of admissions, by type of terminal illness, for the first 2 years of operation. Projected number of admissions by two age groups, under 65 and 65 or older, for the first 2 years of operation. Identification of the services that will be provided directly by hospice staff and volunteers and those that will be provided through contractual arrangements. Proposed arrangements for providing inpatient care (e.g., construction of a freestanding inpatient hospice facility; contractual arrangements for dedicated or renovated space in hospitals or nursing homes). Proposed number of inpatient beds that will be located in a freestanding inpatient hospice facility, in hospitals, and in nursing homes. Circumstances under which a patient would be admitted to an inpatient bed. Provisions for serving persons without primary caregivers at home. Arrangements for the provision of bereavement services. Proposed community education activities concerning hospice programs. Fundraising activities. Hope’s CON application included a detailed description of its proposed SA 8A program, which addressed each of the elements in Florida Administrative Code Rule 59C- 1.0355(6). Thus, Hope satisfied the criteria in that rule.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Agency issue a final order denying Hope’s application to establish a new hospice program in SA 8A, CON 9692. DONE AND ENTERED this 28th day of December, 2005, in Tallahassee, Leon County, Florida. S T. KENT WETHERELL, II Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of December, 2005.
The Issue Whether the certificate of need (“CON”) applications filed by Cornerstone Hospice & Palliative Care, Inc. (“Cornerstone”); Suncoast Hospice of Hillsborough, LLC (“Suncoast”); and VITAS Healthcare Corporation of Florida (“VITAS”), for a new hospice program in Agency for Health Care Administration (“AHCA” or the “Agency”) Service Area 6A (Hillsborough County), satisfy the applicable statutory and rule review criteria sufficiently to warrant approval, and, if so, which of the three applications, on balance, best meets the applicable criteria for approval.
Findings Of Fact Based upon the credibility of the witnesses and evidence presented at the final hearing, and on the entire record of this proceeding, the following Findings of Fact are made: The Parties AHCA AHCA is designated as the single state agency for the issuance, denial, and revocation of CONs, including exemptions and exceptions in accordance with present and future federal and state statutes. AHCA is also the state health planning agency. See §§ 408.034(1) and 408.036, Fla. Stat. In addition, AHCA is the agency designated as responsible for licensure and deficient practice surveys for health facilities, including hospices. See ch. 408, Part II and § 400.6005-.611, Fla. Stat. Pursuant to Florida Administrative Code Rule 59C-1.0355(4)(a), the Agency established a numeric formula for determining when an additional hospice program is needed in a service area. The Agency's need formula determined a need for one new hospice program in SA 6A in the application cycle at issue. That determination is unchallenged. None of the applicants argued that more than one new hospice program should be approved for Hillsborough in this cycle. Suncoast The Hospice of the Florida Suncoast (“Suncoast Pinellas”) was founded in 1977, and was one of the first hospices in Florida, and in the nation. Although it operates only in Pinellas County, Suncoast Pinellas has grown to become one of the largest nonprofit hospices in the country. Suncoast Pinellas is a subsidiary of Empath Health (“Empath”), which also provides a number of non-hospice services. As discussed further below, Empath is currently undergoing a merger with Stratum Health System (“Stratum”), which operates Tidewell Hospice in Sarasota and Manatee Counties. The Chief Executive Officer (“CEO”) of Empath and Suncoast Pinellas is Rafael Sciullo. Mr. Sciullo was recruited to be CEO of Suncoast Pinellas in 2013, where he has served ever since. When Mr. Sciullo arrived at Suncoast Pinellas, the company operated a human immunodeficiency virus (“HIV”) testing and treatment program, a PACE program, a home health program, and a palliative care program. Mr. Sciullo became concerned that patients in the HIV, PACE, and home health programs were not comfortable hearing the word “hospice,” as those patients did not view themselves as hospice patients. Mr. Sciullo reorganized Suncoast Pinellas by creating Empath in order to alleviate this concern with a more inclusive and mission directed organization. Empath is an administrative services provider that provides support to its affiliates, which include Suncoast Pinellas, Empath Partners in Care (“EPIC”),2 Suncoast PACE, Suncoast Hospice Foundation, and programs for palliative care, pharmacy, durable medical equipment (“DME”), and infusion services. Through its affiliates, Empath already provides several services within Hillsborough, including EPIC HIV services and support, and palliative care. The federal definition of hospice care requires a prognosis of a six- month or less life expectancy. However, Florida’s definition permits patients with a 12-month prognosis. Under its supportive care program, Suncoast Pinellas offers hospice services to patients with a prognosis of six to 12 months. As one of the largest not-for-profit hospices in the nation, Suncoast Pinellas offers specialized programs for veterans, the Jewish population, African Americans, the Hispanic population, and disease groups such as heart failure, Alzheimer’s, and COPD. The applicant entity for the CON is Suncoast Hospice of Hillsborough, LLC. If approved, Suncoast will appear beside Suncoast Pinellas in Empath’s organizational chart, operating as a subsidiary under the Empath Health, Inc., family of companies. Empath has entered into a Memorandum of Understanding with Stratum to merge the two organizations. The merger has not yet been accomplished; the companies are currently in the process of conducting due 2 Empath’s EPIC program provides programs and services to persons impacted by HIV and AIDS throughout the Tampa Bay area. diligence. However, the two companies have already agreed that if the merger is consummated, Mr. Sciullo will serve as the CEO of the merged entity, and will be in charge of both original entities after the merger. According to Mr. Sciullo, the merger will not distract or otherwise serve as an impediment to Suncoast’s plans to implement its new hospice program in Hillsborough. Cornerstone Cornerstone is a 501(c)(3) community-based, not-for-profit entity, founded in 1981 by compassionate nurses in Eustis, Florida, to care for patients during their last days of life. Licensed in 1984, Cornerstone (formerly, Hospice of Lake and Sumter, Inc.) has since grown to serve three hospice service areas (3E, 6B, and 7B) which encompass seven central Florida counties, including Polk County, which is contiguous to Hillsborough. Cornerstone has spent more than 35 years serving tens of thousands of patients and their loved ones in the Central Florida region. As a local, not-for-profit hospice, Cornerstone’s governing body is comprised of leaders from the communities it serves, and its board would be expanded to include new members from Hillsborough. This fosters local accountability to the populations Cornerstone serves. Due to its not-for-profit status, Cornerstone is also legally and ethically bound to benefit its communities, and its earnings are reinvested locally rather than inuring to the benefit of private owners. The Cornerstone Hospice Foundation is an independent, 501(c)(3), nonprofit foundation led by community volunteers. The purpose of the Foundation is to raise money for Cornerstone’s community programs, hospice houses, and for people with no method of paying for hospice. Cornerstone Health Services, LLC, is an affiliated entity which provides non-hospice palliative care services to patients. Cornerstone also includes Care Partners, LLC, which is a consulting and group purchasing organization that provides information and materials to other hospices and group purchasing options. Cornerstone leadership has extensive experience in hospice, including development and expansion of new programs in Florida and elsewhere. Cornerstone has achieved significant growth and expansion within its existing service areas in recent years, led largely by the team that would lead Cornerstone’s expansion into Hillsborough. Cornerstone serves all patients in need regardless of race, creed, color, gender, sexual orientation, national origin, age, disability, military status, marital status, pregnancy, or other protected status. Hospice and palliative care are the only healthcare services Cornerstone provides. This focus assures that Cornerstone is committed to providing high quality care to meet the needs of hospice patients and their families. VITAS VITAS Healthcare Corporation (“VITAS Healthcare”), the corporate parent of VITAS, is the largest provider of end-of-life care in the nation. VITAS Healthcare was initially founded in 1978 in South Florida. At that time, its leaders helped organize bipartisan legislative efforts to establish the state and federal regulatory mechanisms that guide the provision of hospice services today. Upon its inception, VITAS programs in Dade and Broward Counties participated in a federal demonstration project that resulted in the development of model clinical protocols and procedures used by hospice programs across the country. In 2018, VITAS Healthcare served 85,095 patients and maintained an average daily census of 17,743 patients among its 47 hospice programs in 14 states and the District of Columbia. As of 2018, VITAS Healthcare employed 12,176 staff members, including over 4,700 nurses nationwide. VITAS currently serves 46 of Florida’s 67 counties, which covers about 72% of Florida’s population. VITAS serves 16 of AHCA’s 27 hospice service areas under three separate licenses. VITAS successfully operates 34 satellite offices in Florida and provides facility-based care through freestanding inpatient units as well as its contracts with hospitals and nursing homes. In Florida in 2018, VITAS served over 36,000 patients, providing 3.3 million days of care with an average daily census of 9,028 patients. This was no aberration—at the time of the filing of its 6A CON application, VITAS had admitted over 35,000 patients in Florida during 2019. In addition to providing the four required levels of hospice care (see ¶ 35), VITAS also provides a full continuum of palliative and supportive care, and additional unreimbursed services that are beneficial to the hospice population it serves. VITAS has over 40 years of experience as a hospice provider, and has developed comprehensive outreach, education, and staff training programs and resources designed specifically to address the unique needs of a wide range of patient types, communities, and clinical settings. Similarly, VITAS recognizes that the needs of Florida patients vary between service areas, and it has endeavored to provide programs and services tailored to meet the needs of each community. In its Florida programs, VITAS provides complete hospice care, including medications, equipment and supplies, expert nursing care, personal care, housekeeping assistance, emotional counseling, spiritual support, caregiver education and support, grief counseling, dietary, physical, occupational and speech therapy, and volunteer support. VITAS has a long history of providing significant levels of care to all patients without regard to the ability to pay, as well as a demonstrated commitment to underserved populations such as the homeless, veterans, AIDS population, and minorities. VITAS provided almost $7 million in charity care in Florida in 2018, and $7.25 million in 2019 at the time it submitted its CON application. VITAS ensures that anyone who is appropriate for hospice services has the right to access them. VITAS is committed to giving back to the communities it serves through meaningful donations. It accomplishes this goal through VITAS Community Connections, a nonprofit organization, which makes donations and grants to local organizations and families. In 2018, VITAS made over $161,000 in charitable contributions to organizations in Florida. In that same year, VITAS contributed over $700,000 to sponsoring Florida community events. At the time of filing its Hillsborough application, VITAS employed nearly 5,500 persons in Florida, 2,235 of which are nurses. VITAS encourages and assists its nurses in obtaining board certification in hospice and palliative care through training, compensation incentives, and support. Due to VITAS Healthcare’s multi-state operations, VITAS can readily recruit staff to Florida from other markets. VITAS also relies on volunteers in a variety of roles to enhance patient care. In 2018, VITAS used 1,165 active volunteers in Florida, who provided over 145,054 volunteer hours. VITAS is led by an extremely experienced and highly qualified leadership team, many of which have long and successful tenures with the company. Hospice Care Generally Hospice refers both to care provided to terminally ill patients and the entities that provide the care. Hospice care is palliative care. Palliative care relieves or eliminates a patient's pain and suffering and helps patients remain at home. It differs from curative care, which seeks to cure a patient's illness or injury. 42 C.F.R. § 418.24(d); §§ 400.6005 and 400.601(6), Fla. Stat. Hospices provide physical, emotional, psychological, and spiritual comfort and support to patients facing death and to their families. The Medicare and Medicaid programs pay for the vast majority of hospice care. The services those programs require hospices to offer and the services the programs will pay for have become, de facto, the default definition of hospice care, the arbiter of hospice services, and the decider of when a patient is terminally ill. Florida requires a CON to establish a hospice program and regulates hospices through licensure. §§ 400.602 and 408.036(1)(d), Fla. Stat. Florida considers a patient with a life expectancy of one year or less to be terminally ill and eligible for Medicaid payment for hospice care. § 400.601(10), Fla. Stat. To be eligible for Medicare payment for hospice services, a patient must have a life expectancy of six months or less. 42 C.F.R. § 418.20; 42 C.F.R. § 418.22(b)(1). A hospice must provide a continuum of services tailored to the needs and preferences of the patient and the patient’s family delivered by an interdisciplinary team of professionals and volunteers. §§ 400.601(4) and 400.609, Fla. Stat. Hospice programs must provide physical, emotional, psychological, and spiritual support to their patients. A hospice must provide physician care, nursing care, social work services, bereavement counseling, dietary counseling, and spiritual counseling. 42 C.F.R. § 418.64; § 400.609(1)(a), Fla. Stat. In Florida, hospices must also provide, or arrange for, additional services including, but not limited to, “physical therapy, occupational therapy, speech therapy, massage therapy, home health aide services, infusion therapy, provision of medical supplies and durable medical equipment [DME], day care, homemaker and chore services, and funeral services.” § 400.609(1)(b), Fla. Stat. Federal requirements are similar. 42 C.F.R. § 418.70. Hospices are required to provide four levels of care. The levels are routine home care, general inpatient care, crisis care (also called continuous care), and respite care. Since hospice’s goal is to support a patient remaining at home, hospices provide the majority of their services in a patient’s home. Routine home care is the predominant form of hospice care. Routine care is for patients who do not need constant bedside support. A hospice may provide routine care wherever the patient lives. The location could be a residence, a skilled nursing facility (SNF), an assisted living facility (ALF), some other residential facility, or a homeless camp. Continuous care, sometimes called crisis care, may also be provided wherever the patient resides. It is more intense services for a short period of time. Continuous care supports a patient whose pain and symptoms are peaking and need quick management. With continuous care, unlike routine care, a nurse may be at a patient’s bedside 24 hours a day, seven days a week. Continuous care is an option allowing a patient to avoid admission to an inpatient facility. Hospices provide general inpatient care in a hospital, a dedicated nursing unit, or a freestanding hospice inpatient facility. To qualify for inpatient care, a patient must be acutely ill and need immediate assistance and daily monitoring to the extent that they cannot be cared for at home. Hospices must offer around-the-clock skilled nursing coverage for patients receiving general inpatient care. Respite care is caregiver relief. It allows patients to stay in an inpatient setting for up to five days in order to provide caregivers respite. Florida law requires hospices to accept all medically eligible patients. Each hospice must make its services available to all terminally ill persons and their families without regard to age, gender, national origin, sexual orientation, disability, diagnosis, cost of therapy, ability to pay, or life circumstances. A hospice may not impose any value or belief system on its patients or their families, and must respect the values and belief systems of its patients and their families. § 400.6095(1), Fla. Stat. Hospices frequently offer additional, uncompensated services that are not required by Florida licensure laws or federal Medicare requirements. Pre- hospice care and community counseling are two examples. Hospices often establish programs to meet the needs of particular populations, such as the Hispanic, African American, Jewish, veteran, and HIV/AIDS communities. Cornerstone, Suncoast Pinellas, and VITAS provide the hospice services required by state laws and funded by the Medicare benefit. All three providers also offer services beyond those required by, or paid for by, government programs. The Fixed Need Pool and Preliminary Agency Decision Pursuant to its rule-based numeric need methodology, AHCA determined and published a fixed need for one new hospice program in SA 6A, Hillsborough, in the second batching cycle of 2019. Under the Agency's need methodology, numeric need for an additional hospice program exists when the difference between projected hospice admissions and the current admissions in a service area is equal to or greater than 350. In this instance, the difference between projected hospice admissions and current admissions in SA 6A was 863, and therefore a numeric need for an additional hospice program exists in Hillsborough.3 In addition to the three litigant applicants, three other entities filed applications seeking approval for the new program. Those three applications have been deemed abandoned and are not at issue herein. On February 21, 2020, the Agency published its preliminary decision to award the hospice CON to Suncoast, and to deny the remaining applications. Thereafter, Cornerstone and VITAS both filed timely petitions for formal administrative hearing contesting the Agency’s preliminary decision. On April 1, 2020, Suncoast filed a “Cross Petition, Notice of Related Cases and Notice of Appearance” in support of the Agency decision on the competitively reviewed applications. None of the applicants petitioning for 3 According to AHCA’s need methodology, absent a showing of “not normal” circumstances, only one new hospice program may be approved for a SA at a time, regardless of the multiples of 350 “need” that may be shown. Fla. Admin. Code R. 59C-1.0355(4)(c). hearing alleged “special circumstances” or “not normal” circumstances in their application. Service Area 6A: Hillsborough County As can be seen by the map below, Hillsborough is located on the west coast of Florida along Tampa Bay. It includes 1,048 square miles of land area and 24 square miles of inland water area. Hillsborough is home to three incorporated cities: Tampa, Temple Terrace, and Plant City, with Tampa being the largest and serving as the county seat. The county is bordered by Pasco County to the north, Polk County to the east, Manatee County to the south, and Pinellas County to the west. (Source: Google Maps) According to AHCA’s Florida Population Estimates 2010-2030, published February 2015, Hillsborough’s total population as of January 2020 was estimated to be 1,439,041. Hillsborough’s total population is expected to grow to 1,557,830 by January 2025, or 8.25% over that five-year period. In 2020, 14% of Hillsborough’s population was aged 65 and older. According to the 2010 U.S. Census, 35.4% of the county population age 65 and older has a disability, and 17.2% of the county population is below the poverty level, compared to 12.2% statewide. The Hillsborough County Department of Health (“HCDOH”) reports that the county has a diverse mix of residents, with 52% White, 16% African American, 26% Hispanic, and 5% other races. Of the Hillsborough households living below the poverty level, 23.73% are Hispanic/Latino and 31.07% are African American. Nearly 10% of Hillsborough residents report not speaking English “very well.” The most recent U.S. Census indicates that the median income for households in Hillsborough is $54,742, considerably below the national average, with 17.2% reported below poverty level. A larger percentage of the county’s residents (3.3%) received cash assistance than did the state’s residents (2.2%), and a larger percentage (15.7%) received food stamp benefits than is the case for the state overall (14.3%), as reported by HCDOH. Hillsborough is currently served by two hospice providers: Lifepath Hospice (“Lifepath”); and Seasons Hospice and Palliative Care of Tampa, LLC (“Seasons”), a for-profit company. Following approval after an administrative hearing, Seasons was newly licensed to begin operations in Hillsborough in December 2016. Florida’s hospice CON rule prevents need for a new program from being shown for a period of two years following the addition of a new program to a service area. The purpose of the two-year forbearance is to allow new programs to gain a foothold in the market, and to potentially avoid a repeated need determination in future batching cycles. Hospice admissions at Lifepath for the period of July 1, 2018, through June 30, 2019, were 6,195, and for Seasons were 601. The addition of Seasons to the service area was not successful in deterring the need for yet another new program in Hillsborough. The Application Proposals and CON Conditions Suncoast Suncoast recently applied for approval for a hospice program in neighboring Pasco County, but, after a DOAH hearing, that application was denied in favor of another applicant. From that experience, Suncoast determined to better identify local needs before applying for approval in Hillsborough. Upon learning that a fixed need pool would be announced for Hillsborough, Mr. Sciullo directed his team of executives and staff over a series of strategy meetings to conduct an independent community needs assessment of Hillsborough. Mr. Sciullo tasked Kathy Rabon to oversee the development of a community needs assessment of Hillsborough to identify potential needs of Hillsborough residents, based on key informant surveys and other assessment tools. Ms. Rabon has significant experience in conducting feasibility studies for capital projects funded by the Suncoast Hospice Foundation, which she leads. Ms. Rabon began by reviewing existing community needs assessments of the county. Those assessments identified the health needs of Hillsborough’s underserved patients, and identified community leaders that informed the assessments. Ms. Rabon then contacted many of those key informants. At hearing, Ms. Rabon described the process she used to develop a community needs assessment for Hillsborough as follows: Q. When tasked with doing an assessment for Hillsborough's hospice, where did you start? What documents did you first review? A. A community needs assessment can take quite a while when you engage focus groups and need to meet with stakeholders. We didn't have the luxury of a lot of time. We also had the luxury of knowledge that other hospitals in Hillsborough County that are not-for-profit have to periodically do a community needs assessment. So rather than start from a blank piece of paper, I turned to those community needs assessments and I began compiling and gathering as many as I could that I felt were relevant to, A, the geographic boundaries of the entire county, which some did not, but B, also were timely. And I found that the Department of Health had done a very comprehensive community needs assessment in 2015-16 that had been updated in March of 2019 that I felt would provide a lot of good information. * * * I was responsible for identifying need and, if possible, identifying perhaps solutions that could be developed as a result of a partnership or a relationship or an engagement or a future plan that we could put together that would help solve a need in Hillsborough County relative to chronic and advanced illness. In addition to the HCDOH needs assessment and update, Ms. Rabon also obtained quantitative information for her assessment from the following sources: Community Health Improvement Plan 2016- 2020, Florida Department of Health in Hillsborough County, Revised January, 2018; Moffitt Cancer Center Community Health Needs Assessment Report 2016; Florida Hospital Tampa Community Needs Assessment Report 2016; Florida Hospital Carrollwood Community Needs Assessment Report 2016; South Florida Baptist Hospital 2016 Community Needs Assessment Report; Tampa General Hospital; Community Health Needs Assessment 2016; and Community Needs Assessment St. Joseph’s Hospitals Service Area 2016. Ms. Rabon also developed a key informant survey tool to elicit qualitative information regarding the healthcare needs of Hillsborough residents. The survey specifically asked about the strengths and weaknesses of the community for treatment of persons with chronic or advanced illness, and other pressing issues relating to end of life care. Those survey questions included, among others: What is your role, and responsibilities within your organization? What do you consider to be the strengths and assets of the Hillsborough community that can help improve chronic and advanced illness? What do you believe are the three most pressing issues facing those with chronic or advanced illness in Hillsborough County? From your experience, what are the greatest barriers to care for those with chronic or advanced illness? What are the strategies that could be implemented to address these barriers? Once meetings with key informants were complete, and 25 key informant surveys were returned, Ms. Rabon summarized her findings in a final Community Needs Assessment Summary. Ms. Rabon’s findings were consistent with assessments conducted by other organizations, including HCDOH, and local hospitals. The results of the Community Health Needs Assessments, Suncoast Key Informant Surveys, and detailed letters of support, identified the following gaps in end-of-life care for residents of Hillsborough: Need for Disease-Specific Programming: High cardiovascular disease mortality rates (higher than the state average and the highest of the six most populous counties in Florida) and low percentage of patients served by existing hospice providers. Other areas where there appears to be a gap in specific end-of-life programming and a large need in terms of Hillsborough resident deaths include: Alzheimer's Disease and Chronic Lower Respiratory Disease, both of which are in the top 5 leading causes of death in the county. Need for Ethnic Community-Specific Programming Nearly 30 percent of the Hillsborough population is Hispanic, with 19 percent of the county's 65+ population falling into the Hispanic ethnic category. The concentration of 65+ Hispanic residents in Hillsborough is higher than the state average. Surveys and assessments indicate a lack of knowledge in the Hispanic/Latinx[4] community in Hillsborough regarding end-of-life care. Many of these residents speak Spanish at home and/or have limited English proficiency. Hillsborough Hispanic population has low utilization of hospice due to factors including lack of regular physician and medical care, lack of information and cultural barriers. Lack of Available Resources for Homeless and Low-lncome Populations With the 5th largest homeless population in the state, Hillsborough has 1,650 homeless residents as of a Point in Time Count conducted in February 2019. Nearly 60 percent of the area’s homeless population is considered ‘sheltered’, yet there are no resources for end-of-life care for these patients where they live, whether it be an emergency shelter, safe haven or transitional housing. Additionally, 17.2 percent of the Hillsborough population lives below the poverty level and has limited access to coordinated care, including end-of- life services. Largest Veteran Population in Florida Requires Special Programming and Large Number of Resources More than 93,000 veterans currently reside in Hillsborough, with more than one-third over the age of 65. 4 Latinx is a gender-neutral neologism, sometimes used to refer to people of Latin American cultural or ethnic identity in the United States. The ?-x? suffix replaces the ?-o/-a? ending of Latino and Latina that are typical of grammatical gender in Spanish. See “Latinx,” Wikipedia (last visited March 19, 2021). While most hospice programs provide special services for veterans, Suncoast Pinellas has obtained Partner Level 4 certification by We Honor Veterans, a program of the National Hospice and Palliative Care Organization (“NHPCO”) in collaboration with the Department of Veterans Affairs (“VA”). Lack of Specialized Pediatric Hospice Program in the Area Pediatric hospice programming in Hillsborough is limited, as there are no specialized pediatric hospice providers in the county. Hillsborough is home to approximately 338,000 residents ages 0-17 in 2020, and is projected to increase to more than 368,000 by 2025. The pediatric utilization rate of hospice services in Hillsborough is low compared to the general population. For the year ended March 31, 2019, there were only five pediatric patients discharged from the hospital setting to home hospice or an inpatient hospice facility, while 106 pediatric patients died in the hospital. Absence of Continuum of Care Navigation Navigation of the healthcare system was highlighted as a key driver that will bring positive improvements to overall continuum of care in Hillsborough. Hillsborough residents are not accessing hospice services at a rate consistent with the rest of the state, and either access hospice programs very late in the disease process, or not at all. Transportation Challenges for Rural Areas of the County Transportation challenges as a deterrent to seeking medical care, particularly in rural areas of Hillsborough. Approximately one-third of the Hillsborough population is considered “transportation disadvantaged” meaning they are unable to transport themselves due to disability, older age, low income or being a high-risk minor/child. Suncoast retained David Levitt and his firm as its healthcare consultant and primary drafter of its CON application. To develop Suncoast’s application, Mr. Levitt utilized numerous reliable data sources and worked with Suncoast Pinellas’s staff. Mr. Levitt credibly confirmed the need for an additional hospice program in Hillsborough based on reliable healthcare planning data. AHCA’s CON application form, adopted by rule, requires applicants to submit letters of support with their CON applications. Suncoast complied with this requirement and included numerous letters of support from the Hillsborough community. One of the key informants identified by Ms. Rabon was Dr. Douglas Holt of the HCDOH. Dr. Holt agreed to meet with Mr. Sciullo and ultimately agreed to provide a letter of support, which was included with the Suncoast application. Mr. Sciullo also personally met with Dr. Larry Fineman, the regional medical director of HCA West Florida, who provided a letter of support. HCA West Florida hospitals are key referral sources of Suncoast Pinellas’s current hospice admissions. In addition to HCA West Florida, Suncoast Pinellas has an existing relationship with other Hillsborough hospitals: St. Joseph’s, Moffitt Cancer Center and Tampa General Hospital. Suncoast received letters of support from St. Joseph’s and Tampa General. The Agency’s witness, James McLemore, testified that letters from such referral sources were highly persuasive to the Agency, as they indicate the likelihood of successful operations. Suncoast’s witness, Dr. Larry Kay, credibly testified that he obtained letters of support from Dr. Howard Tuch, Director of Palliative Medicine at Tampa General Hospital; Dr. Larry Feinman, Chief Medical Officer at HCA West Florida; and Dr. Harmatz, the Chief Medical Officer at Brandon Regional Hospital, an HCA hospital within HCA West Florida. Those letters were included with the Suncoast application. Suncoast Pinellas currently has working relationships with BayCare, HCA, AdventHealth West Florida, Tampa General, and Moffitt hospital systems. Suncoast submitted letters from BayCare and HCA, which were included with its application. Suncoast received letters specifically related to partnering with Suncoast for inpatient services from St. Joseph’s (BayCare) and Brandon Regional (HCA). Suncoast also received a letter of support related to partnering with Suncoast for inpatient services from the Inn at University Village, a long- term care facility in Hillsborough; and support from a pediatric hospitalist who provides care to terminally ill and medically fragile children at St. Joseph’s Children’s Hospital and Johns Hopkins All Children’s Hospital. Suncoast also received letters of support from numerous community organizations, including Balance Tampa Bay and The AIDS Institute. Also included with the Suncoast application were several letters of support from [Remainder of page intentionally blank] the veterans’ community, including one from the Military Order of the World Wars.5 After considering Ms. Rabon’s Community Needs Assessment, and input from key informants, Suncoast developed programs and plans to meet each of the needs identified above. Suncoast conditioned the approval of its CON on the provision of those services. In all, Suncoast offered 19 conditions in its CON application intended to meet the unique needs of Hillsborough. Condition 1: Development of Disease Specific Programing: Suncoast is committed to providing disease-specific programming in Hillsborough: Empath Cardiac CareConnections, Empath Alzheimer’s CareConnections, and Empath Pulmonary CareConnections. Dr. Larry Kay and Dr. Janet Roman credibly testified that Suncoast will fulfill Condition 1 for disease specific programming. To fulfill Condition 1, Suncoast will provide Empath Cardiac CareConnections in Hillsborough. Dr. Roman designed and currently runs the CardiacCare Connections program in Pinellas County. Dr. Roman is a national expert in developing programs across the continuum of care to assist heart failure patients. Although Suncoast Pinellas has always treated patients with heart failure, since Dr. Roman’s arrival, cardiologists have been referring patients to Suncoast Pinellas earlier than before. Dr. Roman has trained Suncoast Pinellas’s nurses in all advanced heart failure therapies, including IV inotropes, and mechanical circulatory 5 As correctly noted by Cornerstone in its Proposed Recommended Order, letters of support included in the three applications, unless adopted by the sponsoring author at hearing or in sworn deposition received in evidence, are uncorroborated hearsay, and the contents therein may not form the basis of a finding of fact. However, the letters are not being received for the truth of the matters set forth therein, but rather the number and types of support letters included in the applications are relevant generally as a gauge of the level of community support for the proposals. The Hospice of the Fla. Suncoast, Inc. v. AHCA and Seasons Hospice and Palliative Care of Pasco Cty., DOAH Case No. 18-4986 (Fla. DOAH Sept. 5, 2019; Fla. AHCA Oct. 15, 2019) (“In a broad sense, comparison of each applicant's letters of support illuminates the differences between each applicant's engagement with the community.” FOF No. 127.). supports such as left ventricular assist devices (“LVAD”) and artificial hearts. Dr. Roman’s program has been successful at reducing hospital readmissions. Suncoast’s application provided significantly more detail about the operations of its heart program than either Cornerstone or VITAS. Cornerstone and VITAS’s descriptions of their heart programs do not reach the level of specificity of operation as Suncoast’s and are not backed up with a measure of success such as a reduction in readmissions. In furtherance of Condition 1, Suncoast will also offer Empath Alzheimer’s CareConnections. Suncoast Pinellas has already created the foundation for Empath Alzheimer’s CareConnections in Pinellas County, but has not yet been marketing the program under the brand of CareConnections. As part of Empath Alzheimer’s CareConnections, Suncoast will deploy a Music in Caregiving program for Hillsborough hospice patients, including those suffering from Alzheimer’s Disease. Suncoast will also offer Empath Pulmonary CareConnections in Hillsborough. Suncoast Pinellas has already created the foundation for Empath Pulmonary CareConnections in Pinellas County, but has not yet been marketing the program under the brand of CareConnections. Suncoast Pinellas already has several respiratory therapists full time caring for COPD and asthma patients. In Hillsborough, Suncoast plans to engage a pulmonologist as a consultant and to hire dedicated respiratory therapists as volume increases in Hillsborough. Condition 2: Development of Ethnic Community-Specific Programming Suncoast conditioned its CON application on the purchase of a mobile van staffed by a full-time bilingual LPN and a full-time bilingual social worker to discuss advanced care planning and education, and increase access to care to diverse populations. The van will operate eight hours a day, five days a week, and drive to areas in Hillsborough that have a need for the services offered by Suncoast and Empath. This outreach is intended to enhance access to care to diverse communities. The van will spend time at the HCDOH and its satellite clinics, and use Metropolitan Ministries as a resource for identifying additional locations that could benefit. The van will also visit key Latinx community locations within Hillsborough and offer Spanish language assistance. The van will be equipped with telehealth technology capabilities to link the LPN and social worker to the care navigation office to further enhance the care navigation function of the mobile van. The purpose of the mobile outreach van is to build relationships with, and trust in, the community, enhance visibility, and bring care navigation to areas of Hillsborough that may not typically access it. Suncoast Pinellas’s EPIC program has significant experience operating a mobile outreach unit. EPIC currently operates a mobile outreach and testing unit that provides HIV testing and sexually transmitted infection testing in the community. Condition 3: Development of Resources for Homeless and Low-Income Populations Suncoast conditioned its application on the development of resources for homeless and low-income populations. Under this condition, Suncoast will provide up to $25,000 annually for five years to Metropolitan Ministries. Metropolitan Ministries is a leading community-based organization in Hillsborough that serves homeless and low-income individuals. Christine Long, Chief Programs Officer for Metropolitan Ministries, provided a letter of support which was included in Suncoast’s CON application. Condition 4: Development of Specialized Veterans Program Suncoast conditioned its CON application on the development of a specialized veterans program, which includes a dedicated Veterans Professional Relations Liaison to collaborate with the local VA hospital, outpatient clinics, and veterans organizations. Suncoast Pinellas provides a wide range of specialized care for veterans, through its Empath Honors program, including Honor Flight and pinning ceremonies. Additionally, Suncoast Pinellas holds a Level 4 Certification from We Honor Veterans, a national program through the National Hospice and Palliative Care Organization (“NHPCO”) whose mission is to honor military veterans in hospice care. The NHPCO recently added a new Level 5 Partnership, for which Suncoast Pinellas has already applied for its Pinellas hospice program. Suncoast will also pursue a Level 5 Certification in Hillsborough, if awarded the CON. Condition 5: Development of Specialized Pediatric Hospice Program in Hillsborough County Suncoast will also develop a specialized pediatric hospice program in Hillsborough. Dr. Stacy Orloff started the Children’s Hospice Program at Suncoast Pinellas in 1990 and has been with Suncoast Pinellas for 30 years. Dr. Orloff helped draft the first waiver that the State of Florida submitted to CMS for approval to operate a PIC/TFK program. Once the PIC/TFK waiver was approved, Ms. Orloff led Florida’s PIC/TFK steering committee for 12 years. PIC/TFK is a Medicaid waiver program that provides palliative care services for children with a risk of a death event by age 21, and also provides counseling support for family members who lived at the child’s home, such as parents, siblings, and grandparents. A PIC/TFK provider must be a licensed hospice provider in the service area. Suncoast Pinellas has operated a PIC/TFK program in Pinellas since 2004, utilizing a pediatric interdisciplinary team to provide its PIC/TFK services. Suncoast Pinellas’s PIC/TFK program averages a census of approximately 40 children. Combining the PIC/TFK patients with pediatric patients, Suncoast Pinellas’s census averages approximately 50 children. Suncoast Pinellas has already received acknowledgment from Children’s Medical Services to permit it to operate a PIC/TFK program in Hillsborough if awarded the hospice CON. Initially, pediatric patients will be serviced by the Suncoast Pinellas pediatric staff. Suncoast Pinellas currently has sufficient staff availability to service Hillsborough at the commencement of the program. Suncoast anticipates that by the second year, the Hillsborough pediatric program will have a sufficient census to have a staff that serves only Hillsborough. VITAS’s regional Medical Director, Dr. Leyva, acknowledged that a pediatric patient will receive better care from a care team with pediatric expertise than with an adults-only team. Of the three applicants, Suncoast has demonstrated the most experience providing care to pediatric patients.6 In addition, Suncoast Pinellas has longstanding relationships with the local children’s hospitals, St. Joseph’s Children’s Hospital, and Johns Hopkins All Children’s Hospital. Concurrent care is a benefit created as part of the Affordable Care Act that allows children admitted to hospice care to continue to receive their curative care. Although all applicants have proposed providing concurrent care, only Suncoast has proposed a PIC/TFK program. Suncoast is the only applicant currently operating a perinatal loss program and miscarriage at home program. Dr. Orloff credibly confirmed that Suncoast will implement the perinatal loss program if approved in Hillsborough. Condition 6: Development of Continuum of Care Navigation Program Suncoast’s Community Needs Assessment identified that Hillsborough lacks effective access to the full continuum of healthcare services. Suncoast 6 AHCA’s witness, James McLemore, credibly testified that this is an area where Suncoast enjoys an advantage over the other applicants because “Suncoast went with an entire pediatric program.” Pinellas operates an entire care navigation department that can address any inquiry or referral regarding hospice and Empath’s other services, in order to direct that patient to the right care at the right time. All services offered by Empath, including hospice, palliative care, home health, EPIC, and PACE are available to individuals who call the Care Navigation Center. Care Navigation staff can also assist existing patients with questions involving, for example, DME. Suncoast Pinellas’s care navigation center is available 24 hours a day, 7 days a week, 365 days a year. If its application is approved, Suncoast will also offer its Care Navigation Department in Hillsborough. Condition 7: Development of a Program to Address Transportation Challenges for Rural Areas Suncoast has conditioned its application on developing a program to address transportation challenges for rural areas in Hillsborough. As part of this condition, Suncoast will provide up to $25,000 annually in bus vouchers for the first five years to current hospice patients and their families, as well as non-hospice patients. Critics of Suncoast’s plans to offer bus vouchers claimed that Hillsborough’s bus system does not reach all areas within the county. However, Suncoast has also conditioned its application on the provision of funds that may be used to purchase transportation, including ridesharing providers such as Uber. Condition 8: Interdisciplinary Palliative Care Consult Partnerships Suncoast will implement interdisciplinary palliative care partnerships with hospitals, ALFs, and nursing homes located in Hillsborough. Suncoast has already identified potential partnerships, including with Dr. Harmatz at Brandon Regional Medical Center, to launch the program. Condition 9: Dedicated Quality-of-Life Funds for Patients and Families Suncoast is committed to providing quality of life funds as described in Condition 9 in Suncoast’s CON application. Suncoast Pinellas has extensive experience with providing each interdisciplinary team with $1,200 of quality of life funds to be used to facilitate a safe environment for its patients, such as paying rent, getting rid of bedbugs, paying utilities such as electricity for air conditioning, and to power specialized medical equipment. On occasion these funds are also used to provide meaningful patient experiences, similar to the Make-a-Wish programs. Conditions 10 – 13: Development of Advisory Committees and Councils Suncoast has committed to establishing care councils and advisory committees to learn firsthand the needs and concerns of the community. A care council is made up of members from a particular community who provide input regarding the needs of the community. Suncoast Pinellas offers similar councils and committees in Pinellas County. These groups are critical to the success of Suncoast Pinellas’s mission. Condition 14: Development of Open Access Model of Care Suncoast has committed to implementing an open access model of care in Hillsborough. This condition recognizes that while some patients may be receiving complex medical treatments that may lead some to question whether the patient is terminal, those treatments are actually required for palliation and the patient’s comfort. Under this condition, Suncoast promises to admit these patients and provide coverage for their treatments. Condition 15: SAGECare Platinum Level Certification Joy Winheim testified at the final hearing regarding the HIV positive community and the LGBTQ community. Over her many years working with the HIV/AIDS community, Ms. Winheim has built lasting relationships with community partners in the Tampa Bay area, including HCDOH and the Pinellas County Health Department. Empath’s EPIC program has a permanent staff member housed within the HCDOH, and the HCDOH has physicians housed in EPIC’s Tampa office to provide medical care to EPIC’s clients. Ms. Winheim has built lasting relationships with community partners in the Tampa Bay LGBTQ community, including Metropolitan Community Church, an LGBTQ friendly church; the Tampa Bay Gay and Lesbian Chamber of Commerce; and Balance Tampa Bay. SAGE is a national organization dedicated to improving the rights of LGBTQ seniors by providing education and training to businesses and non- profits. The platinum level of SAGECare certification is the highest level and indicates that 80% of an organization’s employees and 100% of its leadership have been trained by SAGE. Leadership training is in the form of a four-hour in-person training. Employee training is in the form of a one-hour training conducted either in person or web-based. All of Empath’s entities are SAGECare certified at the platinum level. Although the platinum level certification requires only 80% of its employees to receive training, Empath Health required that 100% of its employees attend the training. SAGECare certification makes a difference to members of the LGBTQ community choosing a healthcare provider. Suncoast is committed to fulfilling this condition. Condition 16: Jewish Hospice Certification Suncoast Pinellas has a specialized Jewish Hospice Program and holds a Jewish Hospice Certification from the National Institute of Jewish Hospices. Suncoast has conditioned its CON application on achieving this same certification in Hillsborough by the end of year one. Condition 17: Joint Commission Accreditation The Joint Commission on Accreditation of Healthcare Organizations (“Joint Commission”) accreditation is the “gold standard” for hospitals, nursing homes, hospices, and other healthcare providers. Suncoast is currently accredited by the Joint Commission, and if approved, is committed to achieving Joint Commission accreditation for its Hillsborough program. Condition 18: Provision of Value-Added Services Beyond Medicare Hospice Benefit Suncoast has committed to provide its integrative medicine program in Hillsborough. Suncoast Pinellas’s existing integrative medicine program is staffed by an APRN who is also certified in acupuncture. Suncoast Pinellas’s integrative medicine program is a holistic approach for helping patients manage their symptoms with such therapies as acupuncture, Reiki,7 and aromatherapy. Suncoast Pinellas recently established a Wound, Ostomy, and Continence Nurse Program in Pinellas County to provide expertise in end-of- life wounds and incontinence issues in long-term care settings, particularly smaller ALFs that may not have the necessary staffing. Suncoast will also offer this program in Hillsborough. [Remainder of page intentionally blank] 7 Reiki (??, /'re?ki/) is a Japanese form of alternative medicine called energy healing. Reiki practitioners use a technique called palm healing or hands-on healing through which a “universal energy” is said to be transferred through the palms of the practitioner to the patient in order to encourage emotional or physical healing. Condition 19 – Limited Fundraising in Hillsborough County Suncoast has committed to limiting fundraising activities in Hillsborough. Ms. Rabon credibly testified that Suncoast can, and will, fulfill this condition.8 Suncoast’s PACE Program In addition to its conditions, Suncoast’s proposal also includes several other non-hospice services that will be made available in Hillsborough. For example, Suncoast Pinellas operates a PACE program. The PACE program provides everything from medical care to transportation for medical needs and adult daycare services, as well as respite services for caregivers. The overall goal of the PACE program is to reduce unnecessary hospital visits and nursing home placement and keep elderly participants at home. Suncoast Pinellas’s PACE program currently operates at capacity, with 325 participants enrolled. Over the last four years, Suncoast Pinellas PACE has referred 175 people to Suncoast Pinellas. And although there are approximately 14,000 eligible PACE participants in Hillsborough, there is not a PACE provider in the county. In recognition of this unmet need, Suncoast Pinellas is currently in the process of expanding PACE services to residents of Hillsborough. Suncoast’s PACE program distinguishes Suncoast from Cornerstone and VITAS, neither of which currently operates a PACE program in any of their service areas. Suncoast’s Volunteer Program Under the Medicare Conditions of Participation, hospice programs must use volunteers “in an amount that, at a minimum, equals 5 percent of 8 Both Suncoast and Vitas condition their applications on eschewing fundraising activities in SA 6A, apparently in an effort to minimize adverse impact on the two existing providers in the service area. However, neither Lifepath nor Seasons participated as a party to this litigation, or presented evidence at hearing as to revenues received through their fundraising activities. Thus, it is impossible to determine whether the conditions proposed by Suncoast and VITAS would have a material impact on either of the existing providers. the total patient care hours of all paid hospice employees and contract staff.” 42 C.F.R. § 418.78(e). Suncoast Pinellas regularly exceeds that 5% requirement and, in fact, reached 12% in the last fiscal year. Suncoast Pinellas currently has over 1,000 volunteers who support the hospice program by assisting with palliative arts, including Reiki and aromatherapy, Lifetime Legacies, pediatric patients, and transportation. Suncoast Pinellas’s volunteers also assist with Suncoast’s Pet Peace of Mind Program, for which Suncoast Pinellas won the inaugural award for program of the year in 2019. Suncoast is the only applicant that operates a teen volunteer program. Suncoast Pinellas’s teen volunteer program was established in 1994 and was the first of its kind in the entire country. In 1998, it was awarded the Presidential Point of Light award. Suncoast Pinellas’s Volunteer Services Director, Melissa More, regularly consults with hospices across the country on the development of teen volunteer programs. Ninety of Suncoast Pinellas’s 1,000 volunteers currently live in Hillsborough, but travel to Pinellas to volunteer at Suncoast Pinellas. Nine of those volunteers submitted letters of support for Suncoast’s CON application to serve Hillsborough. Doctor Direct Program Suncoast Pinellas’s existing Doctor Direct Program enables physicians in the community and their ancillary referral partners to contact a Suncoast Pinellas physician 24/7, who can answer any questions about a patient they think might be eligible for hospice, and questions related to other Suncoast Pinellas programs. Suncoast will provide its Doctor Direct Program in Hillsborough. Plan for Inpatient Services Suncoast received letters of support from hospitals and a nursing home indicating a willingness to enter into a contract for inpatient services with Suncoast. Suncoast intends to offer both inpatient units and “scatter- bed” arrangements with these providers. Suncoast received letters specifically related to potential partnerships with St. Joseph’s (BayCare) and Brandon Regional (HCA) for the provision of inpatient hospice services. Suncoast also received a letter related to a potential partnership with the Inn at University Village, a long-term care facility in Hillsborough, for the provision of inpatient services. Telehealth Suncoast Pinellas offers telehealth services using CMS and HIPAA- approved software so that patients can keep meaningful connections with their family and friends, regardless of ability to travel. In Hillsborough, Suncoast will provide nurses, social workers, and chaplains with traveling technology for use in the patient’s home to connect with family and friends. Utilizing telehealth in this way will help to minimize emergency room visits and hospitalizations. Suncoast will be prepared to implement its telehealth program in Hillsborough on day one of operation if awarded the CON. Outreach Efforts to Diverse Communities Suncoast is committed to, and has a proven track record of, community outreach efforts to diverse communities. As part of its outreach efforts in Hillsborough, Empath’s Vice President of Access and Inclusion, Karen Davis-Pritchett, met with the Executive Director of the Hispanic Service Council, Maria Pinzon, to discuss the organization’s outreach efforts and gain insight into the Hispanic community in Hillsborough. Ms. Davis- Pritchett learned that the Hispanic community in Hillsborough differs from the Hispanic community in Pinellas, in that Hillsborough has a large and spread out migrant population. Ms. Davis-Pritchett and Ms. Pinzon also discussed the transportation issues facing residents of Hillsborough. To address these transportation issues, Suncoast conditioned its CON application on the purchase and use of a mobile outreach van with bilingual staff to conduct outreach to the Hispanic and other diverse communities. Suncoast also conditioned its application on the provision of vouchers that may be used for buses or ride-sharing services. Ultimately, Suncoast obtained a letter of support from Ms. Pinzon, which was submitted with its CON application. Additionally, Suncoast conditioned its application on recruiting four community partnership specialists, who will conduct outreach to the African American community, the Hispanic community, the Veterans community, and the Jewish community, and six professional liaisons who will conduct outreach to clinical partners in Hillsborough. All of these positions will be dedicated to Hillsborough and be filled by individuals who are connected to these communities, and understand the importance of access to hospice care. Suncoast’s proposal includes a bilingual medical director, Dr. Jerez- Marte, for its Hillsborough program. Dr. Jerez-Marte regularly speaks Spanish with patients and staff, which would be a benefit to Hispanic patients in Hillsborough. Mr. Sciullo credibly testified that Suncoast will offer high quality hospice services in SA 6A, and will fulfill the 19 conditions proposed in its application. Cornerstone Based on its review of data and analytics that Cornerstone relies upon and conducts as part of its ongoing operations in Florida, Cornerstone recognized in the second quarter of 2019, long before AHCA published its need projections, that there was need for an additional hospice program to enhance access to hospice services in Hillsborough. Regardless of the service area, Cornerstone offers quality hospice care through consistent policies, protocols, and programs to ensure that patients are getting the highest quality care possible. Cornerstone will bring all aspects of its existing hospice programs and services to Hillsborough, including all of the programs and services described throughout its application. However, Cornerstone recognizes each service area is different in terms of the needs and access issues patients face, whether based on demographics, geography, infrastructure, a lack of information about hospice, or other factors. When looking to enter a market, Cornerstone conducts a detailed community-oriented needs assessment to determine the specific needs of the community with regard to hospice to best understand how to enhance access to quality hospice services. Cornerstone explores each potential new area to identify the cultural, ethnic, and religious makeup of the community, the current providers of end- of-life care in the community, and the unmet needs and gaps in care, which is critical to understanding where issues may lie. This allows Cornerstone to build and develop an appropriate operational plan to meet the needs identified in a particular market. Cornerstone conducted this type of analysis for its recent successful expansion in Marietta, Georgia, and has had success expanding access to hospice in its existing markets through ongoing similar analyses. Cornerstone conducted an analysis of Hillsborough similar to those it conducts in its existing markets and in expansion efforts outside its existing markets. In its assessment of Hillsborough, Cornerstone relied, in part, on the extensive knowledge of its senior leaders and outreach personnel, many of whom live and previously worked in Hillsborough, with regard to the population characteristics and needs of the Hillsborough area. This experience in the target service area affords Cornerstone’s team a detailed knowledge of the hospice-related needs of the county. Mr. D’Auria, who conducted much of the analytics internally for Cornerstone, also oversaw a team of Cornerstone staff who spent several weeks canvassing Hillsborough at a grassroots level. The Cornerstone team spoke to residents, medical professionals, community leaders, SNFs, ALFs, and hospitals, among others, on the local experience of hospice care, to identify any areas of concern regarding unmet needs or perceived improvements necessary relative to the provision of hospice care by the current providers. Cornerstone’s retained health planning experts, Mr. Roy Brady and Mr. Gene Nelson, further undertook an extensive data-driven analysis of Hillsborough’s health-related needs to explore the access issues and service gaps identified in Cornerstone’s analytics, knowledge of and discussions in the local community, as well as the issues raised in community health needs assessments,9 letters of support, and other resources. Together, the team concluded that quality hospice services are available in Hillsborough County through existing providers LifePath and Seasons Hospice. That care is available to patients of all ages and demographic groups with virtually any end-stage disease process. Yet some patients simply are not accessing hospice services at the expected rate in Hillsborough. For example, Cornerstone’s analyses identified specific unmet community need among particular geographic areas, as well as among persons with a diagnosis other than cancer, particularly those under age 65, persons with end-stage respiratory disease, the Hispanic and African American communities, migrant communities, residents of smaller ALFs, and veterans. Based upon its analysis of the healthcare needs of Hillsborough, Cornerstone included multiple conditions intended to address those needs. In 9 Cornerstone considered the health needs assessments released by Tampa General Hospital and the Moffitt Cancer Center, both published in 2019. Cornerstone also considered the health needs assessment prepared by HCDOH issued on April 1, 2016, as updated, including the March 2019 update. all, Cornerstone proposed 10 conditions in its CON application targeted to meet the hospice needs of Hillsborough: Licensure of the Hospice Program: Cornerstone commits to apply for licensure within 5 days of receipt of the CON to ensure that its service delivery begins as soon as practicable to enhance and expand hospice and community education and bereavement services in SA 6A; Hispanic Outreach: Cornerstone commits to provide two full-time salaried positions for bilingual staff as part of its Community Education Team. These Community Education Team members will be responsible for the development, implementation, coordination and evaluation of programs to increase community knowledge and access to hospice services, particularly designed to reach the Hispanic community in Spanish. Bilingual Volunteers: Cornerstone commits to recruit bilingual volunteers. Patients’ demographic information, including other languages spoken, is already routinely collected so that the most compatible volunteer can be assigned to fill each patient’s visiting request. Offices: Cornerstone commits to establish its first program office in the Brandon area (zip code 33511 or 33584) during the first year of operation. Cornerstone commits to establish a satellite office in the Town & Country area (zip code 33615 or 33634) during the second year of operations. Complimentary Therapies: Cornerstone conditions its application on offering alternative therapies to patients that may include massage therapy, music therapy, play therapy, and holistic (non-drug) pain therapy. These complimentary therapies are not generally considered to be part of the hospice's core services, but are enhancements to the patient’s care which often have a marked impact on the quality of life during their last days. Veterans: Cornerstone commits to providing services tailored to the military veterans in the community. Cornerstone will immediately upon licensure expand its existing We Honor Veterans Level 4 program to serve Hillsborough and will provide the same broad range of programs and services to veterans in Hillsborough as it currently provides in its existing service areas. Bereavement Counseling for Parents: Cornerstone will implement a program in its second year of operation which will provide outreach for bereavement and anticipatory grief counseling for parents of infants who have died. The Tampa area has several hospitals which provide high-level newborn and infant services such as Level III NICU and other programs, consequently there is a higher than average infant mortality rate due to this concentration of high-level services. Cornerstone will work with the local hospitals which provide high-level neonatal intensive care to develop and carry out this program. Cooperation with Local Community Organizations: Cornerstone commits to donate at least $25,000.00 for four years to non-profit community organizations focused upon providing greater healthcare access, disease advocacy groups and professional associations located in SA 6A. These donations will be to assist with their core missions, which foster access to care, and in collaboration with Cornerstone to provide educational content on end-of-life care. Separate Foundation Account: Cornerstone will donate $25,000.00 to a segregated account for SA 6A maintained and controlled by the Cornerstone Hospice Foundation. Additionally, all donations made to Cornerstone or the Foundation from SA 6A, or identified as a gift in honor of a patient served in the 6A program, shall be maintained in this segregated account and only used for the benefit of patients and services in Hillsborough. This account will be used to meet the special needs of patients in Hillsborough which are not covered under the Medicare hospice benefit and cannot be met through insurance, private resources, or community organization services or programs. Continuing Education Programming (CEUs): Cornerstone will commit to extending free CEU in- services to the healthcare community in Hillsborough. Topics will cover a wide range of both required and pertinent subjects and will include information on appropriate conditions and diagnoses for hospice admission, particularly for non-cancer patients. A minimum of 10 in-services will be offered in a variety of healthcare settings during each of the first five years. Additional CEU will be provided on an ongoing basis. In addition to formulating CON conditions, Cornerstone used information gleaned from its community exploration to develop an operational plan detailing the number and type of staff to hire, which programs to offer, and how to tailor its outreach and education to best enhance access to hospice services in Hillsborough to meet the unmet need. Given Cornerstone’s existing outreach to area providers in Hillsborough, such as Moffitt, Tampa General Hospital, and the VA, which already discharge patients to Cornerstone in neighboring service areas, Cornerstone fully expects that it will receive referrals to its hospice from providers throughout Hillsborough upon the initiation of operations in the county. Cornerstone will provide hospice services to those and any other patients throughout Hillsborough from day one. However, when seeking to expand access in new or existing markets, Cornerstone focuses not on taking patients from existing providers but on enhancing access to groups and populations that have been overlooked, or whose needs are not otherwise being met by existing hospices. Cornerstone therefore developed a phased operational plan to focus its outreach and education efforts on areas where there are barriers to access, rather than simply scattering their efforts haphazardly or concentrating on areas that already have a heavy hospice presence. Phase One of Cornerstone’s operational plan will begin immediately upon licensure and continue through the first six months of operation. During this time, Cornerstone will focus outreach and education efforts heavily on the underserved southeast portion of Hillsborough, including Plant City, Valrico, Brandon, Riverview, Mango, and Sun City Center. Phase One includes 68 ALFs, six SNFs, and four hospitals. Almost one-third of the population of Hillsborough resides in this area, and an estimated 28 percent of the residents are Hispanic, and 14 percent are African American. There is also a large, underserved migrant population in this area. Cornerstone conditioned its application on opening an office in Brandon during this initial phase in the first year of operation. Phase Two will expand Cornerstone’s targeted outreach efforts into the southwest quadrant of Hillsborough, including the Apollo Beach, Ruskin, Gibsonton, Progress Village, and Palm River areas. While the population of this phase is smaller than Phase One, the two areas combined make up almost a third of the county’s Hispanic population, and a fourth of the county’s African American population. Phase Three will reach into the broader Tampa area, including towns such as Temple Terrace, Pebble Creek, University, Ybor City, and Carrollwood. This is the largest and most populated of the four phases; however, it is also currently the most hospice-penetrated area of the county as the two existing providers, LifePath and Seasons, each have offices in Phase Three. There is also a hospice house and two hospice inpatient units in the area as well. Because this area already has better hospice visibility and access, and to avoid siphoning patients from existing providers, Cornerstone will focus on this area after Phases One and Two. Cornerstone will ramp up its outreach staffing consistent with the increased area, facilities, and population added during Phase Three. Combined, the first three phases of the operational plan will offer enhanced outreach and education to 90% of the Hillsborough population starting at the beginning of year two operations. Phase Four will encompass the remainder of the county to the west of Tampa in the Town ‘n’ Country area. While this area represents only about 10% of the county’s population, Phase Four has no hospice visibility currently in the form of hospice offices, hospice houses, or hospice inpatient units. Cornerstone has conditioned its application on establishing an office in the Town ‘n’ Country area within project year two to enhance hospice visibility and access in this area of the county. Upon implementation of Phase Four, Cornerstone’s targeted outreach and education will be fully integrated throughout the county. Cornerstone’s application included more than 174 letters of support for its proposal. The letters of support are from a broad range of individuals and facilities located within and outside Hillsborough, including families, SNFs, ALFs, hospitals, vendors, and local charitable organizations, among others. Cornerstone presented testimony from three authors of letters of support, Andrea Kowalski, Eric Luetkemeyer, and Colonel (Ret.) Gary Clark. Ms. Kowalski is an employee benefits coordinator for USI Insurance Representatives in Tampa who works with Cornerstone to build benefits programs for its employees. In addition to authoring her own letter of support, Ms. Kowalski also assisted in gathering approximately 40 additional letters of support for Cornerstone from her colleagues in Hillsborough. Ms. Kowalski strongly supports Cornerstone’s approval and indicated the community would benefit not only from enhanced access to Cornerstone’s excellence and expertise in caring for those with advanced illness, but also from the addition of a highly-regarded employer, which will provide additional options for healthcare workers and financial benefits as Cornerstone reinvests in the community. Mr. Leutkemeyer is the COO for Spectrum Medical Partners (“Spectrum”), the largest privately-held hospitalist group in Florida. Spectrum manages roughly 400 providers across the state, the majority of which (85%) are medical doctors or doctors of osteopathic medicine, either in hospital or post-acute settings, and sees roughly 2,000 patients per day. Spectrum’s footprint includes coverage in Hillsborough for entities such as Simply or Humana with which Spectrum contracts statewide. Spectrum is looking to expand its footprint and services in Hillsborough in the near future. As detailed in his letter, Mr. Luetkemeyer supports Cornerstone’s efforts to establish a hospice program in Hillsborough, indicated a desire to work with Cornerstone in the county if awarded, and believes the community would benefit from the additional resources and quality care that Cornerstone would provide. Colonel Clark, who retired from the United States Air Force in 1993, is co-founder and current Chairman of the Polk County Veterans Council, a volunteer organization of individuals interested in assisting veterans. Colonel Clark is also affiliated with, and participates in, a number of veterans organizations in Hillsborough, including as an adviser to the Mission United Suncoast Chapter in Hillsborough, which primarily assists veterans in transitioning from service to the civilian world. He also serves on the management advisory committee of James A. Haley Veterans’ Hospital in Tampa, which provides a broad spectrum of hospital-based care to area veterans. Colonel Clark has significant experience with Cornerstone through its participation in the Polk County Veterans Council, including on the Council’s committee for the Flight to Honor program, which provides veterans a flight to Washington D.C. to visit war memorials. If a veteran is unable to make the flight, a virtual flight and tour, as well as ceremonies or presentations, are provided by Cornerstone to veterans enrolled in hospice. Cornerstone is heavily involved in the Council’s Flight to Honor program— participating on the committee, recruiting volunteers, working with local schools to gather letters for the veterans on the flights, arranging for orientation prior to the flights, and putting on the virtual flights for those Veterans unable to make the flight due to various disabilities. Colonel Clark is also familiar with Cornerstone’s efforts to support veterans at James A. Haley Veterans’ Hospital in Tampa. Colonel Clark described Cornerstone’s support not only for veterans but for the community overall as “magnificent,” and detailed his support for Cornerstone’s application in a letter of support that is included in Cornerstone’s application. Cornerstone is well-positioned to quickly establish a successful hospice program to enhance access in Hillsborough, and its proposal is a carefully considered, long range plan that would bring its established and proven processes, procedures, and programs to the residents of the county. Cornerstone also posits that its existing presence nearby in Lakeland will enhance its ability to topple barriers to care and serve patients in adjacent SA 6A immediately. For example, Cornerstone has existing relationships with veterans groups that serve both Polk and Hillsborough, and will utilize those relationships to enhance access to the large veteran population in Hillsborough, as highlighted through Cornerstone’s condition to provide services tailored to the veteran community. VITAS VITAS, which operates a hospice program in adjacent SA 6B, proposes to expand into SA 6A under its existing license. This will allow VITAS to begin serving patients quickly without creating an entirely new administrative infrastructure for the opening. Although VITAS provides many of the same core programs in each of its service areas, it also recognizes that each community is different. VITAS performed a qualitative and quantitative assessment that examined the specific needs of Hillsborough regarding hospice care and services. Through its consultants and internal team, VITAS identified several communities, patient types, and clinical settings that are underserved in SA 6A. These include: the African American, Hispanic, and migrant communities, particularly those age 65 and older; impoverished, food insecure and homeless communities; patients with non-cancer diagnoses such as pulmonary disease, cardiac disease, Alzheimer’s Disease, and patients with sepsis; cancer patients in need of palliative care; high acuity patients in need of complex services and those needing admissions during evenings and weekends; patients requiring admission after hours and on weekends; and patients who reside in nursing homes and small ALFs. To understand the hospice needs within Hillsborough, VITAS conducted a two-step review—(1) analyzing data from a wide variety of sources including Medicare, AHCA, Florida Department of Elder Affairs, Florida CHARTS, and demographic and socioeconomic data; and (2) meeting with some healthcare and social service providers in Hillsborough. Key members of VITAS’s leadership team, including Patty Husted, Mark Hayes, and Dr. Shega, conducted an assessment in Hillsborough to identify the unmet need within the community and underserved populations. VITAS’s needs assessment team physically went into Hillsborough to visit nursing homes, ALFs, hospitals, and physicians to determine the unmet need and how to achieve greater access to hospice services for the residents of Hillsborough. VITAS’s team spent a significant amount of time conducting hospice outreach and education in Hillsborough in furtherance of the needs assessment. Specifically, VITAS’s team met with hospitals including H. Lee Moffitt Cancer Center, Baptist Health, BayCare, St. Joseph’s, and Brandon Regional; nursing homes, such as Hudson Manor, Ybor Health and Rehabilitation Center; and physician and nurse practitioner groups. VITAS’s needs assessment team also participated in physician advisory council meetings as part of its needs assessment for Hillsborough. During these meetings, VITAS gained perspective from these local physicians regarding the challenges faced by patients in need of hospice services in SA 6A, as well as insight as to what VITAS could bring from its existing programs to fill the unmet needs. VITAS also drew on the knowledge of the 18 VITAS employees currently living in Hillsborough. To address the needs it identified in SA 6A, VITAS proposes a broad array of programs and services to be offered in Hillsborough which are specifically targeted to increase the availability and accessibility of hospice services for underserved groups and Hillsborough residents more broadly. To demonstrate its commitment, VITAS conditioned its CON application on providing the following 20 programs and services in SA 6A: VITAS Pulmonary Care Program. VITAS Cardiac Care Program. Clinical research and support for caregivers of patients with Alzheimer’s and dementia. VITAS Sepsis Care Program. Veterans programs, including achieving Level 4 commitment to the We Honor Veterans program within the first two years of operation in SA 6A. Bridging-the-Gap Program and Medical/Spiritual Toolkit, which is an outreach and end-of-life education tool for African American and other minority communities. ALF Outreach and CORE Training Program. Palliative care resources and access to complex and high acuity services, including engaging area residents with serious illness in advance care planning and goals of care conversations, as well as offering palliative chemotherapy, inotrope drips and radiation to optimize pain and symptom management as appropriate. Provider clinical education programs for physicians, nurses, chaplains, HHA’s and social workers. Quality and Patient Satisfaction Program, including hiring a full-time Performance Improvement Specialist within the first six months of operation dedicated to supporting quality and performance improvement programs for the 6A hospice program. VITAS staff training and qualification, ensuring the medical director covering SA 6A will be board-certified in hospice and palliative care medicine. Hospice office locations. Deployment of a mobile van to increase access and outreach to rural counties. VITAS will not solicit donations. Outreach and end-of-life education for 6A residents experiencing homelessness, food insecurity, and limited access to healthcare, including advanced care planning for area homeless shelter residents and a partnership to provide a grant for housing and food assistance with a community organization. $5,000 will be distributed during the first two years to the Hispanic Services Coalition or similar qualified organization for promoting academics, healthy communities and engagement of Latinos. Outreach program for underserved residents of SA 6A. Educational grant, to the University of South Florida Foundation including $250,000 for fellowships, scholarships, education and workforce development as well as $20,000 for diversity initiatives. Inpatient hospice house and shelter for natural disasters and hurricanes. Medicaid Managed Care education Services beyond the hospice benefit, including, among others: 24/7 Telecare Program and access to admission on evenings and weekends, including outreach and end-of-life education for residents experiencing poverty, food insecurity, homelessness and/or food insecurity, including nutrition services, advanced care planning for shelter residents, and housing assistance. Hospice Education and Low Literacy (HELLO) Program. Multilingual education materials in several languages including Spanish, Chinese, Korean, Portuguese, Russian, Vietnamese and Creole. CAHPS Ambassador Program to generate interest, awareness and encourage ownership by team members of their team’s performance on CAHPS survey results. Community outreach and education programs. Partnership with a local college for fellowships, scholarships, education and workforce development and diversity initiatives. VITAS’s application contains approximately 50 letters supporting its proposed program, the vast majority of which are from hospitals, nursing homes, ALFs, physicians, and community organizations in Hillsborough County with direct hospice experience. VITAS obtained these letters of support as part of its community-oriented needs assessment, and they attest to the community’s confidence in VITAS’s ability to meet hospice care needs in Hillsborough. Included are letters of support from Cynthia Chavez, Executive Director at Hudson Manor Assisted Living; Brian Pollett, Administrator at Ybor Health and Rehabilitation Center; and Dr. Jorge Alfonso, Regional Chief Medical Officer at Dedicated Senior Medical Center. All three providers expressed a local need to address high acuity patients, including greater access to continuous home care. Statutory and Rule Review Criteria The review criteria are found in sections 408.035, 408.037, and 408.039, and rules 59C-1.008 and 59C-1.0355. (Prehearing Stipulation). Section 408.035(1) - Need for the health care facilities being proposed There are currently two licensed hospice programs in hospice SA 6A, and a need for one additional hospice program, as calculated using the need methodology found in rule 59C-1.0355(4), and published by AHCA, without challenge. AHCA’s need calculation compares reported hospice admissions during the base year with projected admissions in the horizon year and finds need if the difference between base and horizon year admissions exceeds 350, assuming there are no recently-licensed or CON-approved hospice programs in the service area. In this case, AHCA’s calculation revealed a net need of 863 hospice admissions for the January 2021 planning horizon. Each Applicant has put forth a proposal to meet the calculated need for one additional hospice program in Hillsborough. None of the applicants are advocating the approval of more than one new program. Section 408.035(2) – Availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the service district. It is undisputed that quality hospice services are available in Hillsborough today through existing providers LifePath and Seasons, including for patients of all ages and with essentially all end-stage disease processes, as well as for patients of all demographic groups. Relevant data demonstrates discharges to hospice in Hillsborough for a wide range of diagnoses and demographic groups, including African American and Hispanic patients, non-cancer and cancer patients, both over and under age 65; patients with end-stage cardiac disease; end-stage pulmonary disease and dementia, including Alzheimer’s disease, among others. However, despite the availability of quality hospice services, some patients simply are not accessing hospice services at the rate expected in SA 6A, as reflected by low penetration rates and low discharge-to-hospice rates, particularly within certain major disease categories and demographic groups, including Hispanic and African American residents. All three applicants agreed that the underutilization is concentrated among certain patient populations, including demographic groups and disease groups. Generally, all three applicants agreed that the Hispanic, African- American, veteran, and homeless populations are currently underserved in Hillsborough. In addition, Suncoast points to the need for a specialized pediatric hospice program in SA 6A; Cornerstone argues that non-cancer patients younger than age 65 are in need of enhanced access, as are residents of smaller ALF’s; and VITAS asserts that patients with respiratory, sepsis, cardiac, and Alzheimer’s diseases are underserved, as are patients requiring continuous care and high acuity services, such as high-flow oxygen. VITAS’s argument is based largely on a claim that the existing providers are not providing “any measurable continuous care,” as well as hearsay reports from area hospitals indicating a lack of high-acuity services available through existing hospice providers. However, VITAS’s health planning expert conceded that, in fact, existing providers are offering continuous care, and she was unable to quantify any purported dearth of continuous care in Hillsborough as compared to other providers or the statewide average. The record establishes that continuous care is part-and- parcel of the hospice benefit, and there was no evidence presented at final hearing to support the claimed lack of availability of that service from existing providers. Based on the foregoing, the evidence tended to show quality hospice care is available in SA 6A, that it is underutilized, and that the underutilization is driven by accessibility challenges among particular patient groups, and supports AHCA’s determination that another hospice program is needed in Hillsborough. Section 408.035(3) - Ability of the applicant to provide quality ofcare and the applicant’s record of providing quality of care Cornerstone is the only applicant accredited by the Joint Commission, which is a national symbol of quality that reflects its commitment to meeting high quality performance standards. Cornerstone’s Joint Commission accreditation, which was just recertified in 2020, and the accompanying high standards of quality care, will carry over to its new SA 6A program. As a new entity, Suncoast is not Joint Commission accredited, but conditions its application on achieving such accreditation by the end of year two. Suncoast Pinellas is Joint Commission accredited, and indeed, is one of only a handful of hospices nationwide, along with Cornerstone, to hold Joint Commission accreditation and/or certification. While VITAS represents that some affiliated VITAS hospice programs are Joint Commission accredited, VITAS, the applicant here, is not accredited by the Joint Commission, and makes no representation that it will seek or attain such accreditation for its new hospice program in SA 6A. There are two universal metrics codified in federal law that are used as a proxy for assessing the quality of care offered by hospice programs— Hospice Item Set (“HIS”) scores and Consumer Assessment of Healthcare Providers and Systems (“CAHPS”) survey scores. See 42 C.F.R. § 418.312; see also § 400.60501, Fla. Stat. (2020). CAHPS surveys are a subjective metric sent to family members and other caregivers months after a patient's death. The survey asks respondents to provide ratings like: “would definitely recommend,” “would probably recommend,” “would probably not recommend,” and “would definitely not recommend.” It also seeks yes or no responses to statements like: the hospice team “always communicated well,” “always provided timely help,” “always treated the patient with respect,” and “provided the right amount of emotional and spiritual support.” It also asks if the patient always got the help they needed for pain and symptoms, and if “they” received the training they needed. The CAHPS survey was created by CMS in conjunction with the Agency for Healthcare Research and Quality to measure and assess the care experience provided by a hospice. The purpose of the Hospice Compare Website is to allow the public to compare quality scores for CAHPS among different hospice providers. CAHPS scores are one measure of quality that is intended to allow for comparison across hospice programs. Significant time at final hearing was dedicated, through multiple witnesses, to discussing the strengths and weaknesses of CAHPS scores as a measure of quality. Ultimately, the greater weight of the evidence supports that CAHPS scores are an indicator of quality, but are not the only consideration, and suffer from limitations that prohibit drawing distinctions from minor differences in scores. The three applicants’ CAHPS scores are summarized in this chart: (Suncoast Ex. 42, BS p. 12203) While it is true that Suncoast Pinellas’s scores on all CAHPS measures are higher than those of Cornerstone, the slight difference between Suncoast Pinellas and Cornerstone is not significant given the subjective nature of the survey instrument. However, both Suncoast Pinellas and Cornerstone do score significantly higher than VITAS on most measures. Cornerstone’s CAHPS scores meet or exceed state averages on six of the eight measures, are within one to three points of the state average on the remaining two measures, and its average CAHPS score exceeds the state average. As a new entity, Suncoast does not have CAHPS scores. Suncoast Pinellas’s CAHPS scores meet or exceed state averages on six of the eight measures, are within one to two points of the state average on the remaining two measures, and its average CAHPS score exceeds the state average. In contrast, VITAS’s CAHPS scores fall below the state average on all eight metrics, fall five to seven points below the state average on seven of the eight metrics, and its average CAHPS score for all measures combined falls five points below the state average. Cornerstone and Suncoast Pinellas are within one to three points of each other on every CAHPS metric. The difference in scores between Cornerstone and Suncoast Pinellas is not statistically significant or meaningful, particularly given the shortcomings of CAHPS scoring. VITAS’s CAHPS scores are below both Cornerstone and Suncoast Pinellas, falling six and eight points below Cornerstone and Suncoast Pinellas, respectively, on the average of all CAHPS metrics. This difference is meaningful, particularly when viewed in the context of VITAS’s history of substantiated complaints discussed below. HIS scores, which assess documentation of various items, are more a process or compliance measure than a quality measure. Suncoast Pinellas’s HIS scores exceed the state and national average on all metrics, albeit most scores are within two points of the state average. Cornerstone’s HIS scores are on par with state averages on most metrics and meet or exceed the national average on every metric, except Pain Assessment. Cornerstone has worked to substantially improve its Pain Assessment score through better documentation protocols, raising its score from 52.1 to 89.1 in the last few years, and is implementing a new Electronic Records Management system to further improve its scores. VITAS’s HIS scores are on par with state averages on most metrics, and meet or exceed the national average on all metrics except Visits When Death Imminent. VITAS scores 68.4 on Visits When Death Imminent compared to the state and national averages of 83.2 and 82.4, respectively. As measured by the HIS scores, there was no credible, persuasive testimony establishing a meaningful difference among the three applicants. In contrast to CAHPS and HIS scores, the number and substance of complaints substantiated against each applicant by AHCA is a more direct indicator of quality of care. Suncoast has no prior hospice operations history, and therefore no prior substantiated complaints. Suncoast Pinellas has had only three substantiated complaints since 2008, and none since 2013. Cornerstone has only two substantiated complaints since 2008, and only one since Mr. Lee took over as CEO of Cornerstone in late 2012. VITAS has 73 substantiated complaints since 2008, including 10 substantiated complaints in the three years ending November 20, 2019, just prior to submission of the CON application at issue here. Between November 20, 2019, and June 17, 2020, VITAS had five additional substantiated complaints. VITAS’s health planning expert, Ms. Platt, also considered all AHCA survey deficiencies, whether based upon a complaint, life safety survey, or otherwise. Ms. Platt’s analysis demonstrates that VITAS had 80 such surveys with deficiencies since 2012, including 26 between January 2018 and June 2020. VITAS argues that its greater number of substantiated complaints are the consequence of higher patient volumes than Suncoast and Cornerstone. However, even taking into consideration the greater number of patient days provided by VITAS, VITAS had infinitely more surveys with deficiencies in 2019 than Cornerstone, which had zero. And VITAS had five times as many surveys with deficiencies for 2018 and 2019 as Cornerstone. A comparison of VITAS to Suncoast Pinellas yields similar results, with VITAS having significantly more surveys with deficiencies than Suncoast Pinellas, even when taking into consideration the greater number of patient days provided by VITAS. Complaints substantiated against VITAS demonstrate failures in many areas of patient care, including some of the specific aspects of hospice care at which VITAS claims to excel beyond other providers, such as after- hours care, the provision of continuous care, and care to patients wherever they live, including smaller ALFs. For example, a substantiated complaint against VITAS in November 2019 included a finding of “immediate jeopardy”—the most severe level of deficiency possible—for a patient who failed to receive proper care after-hours at end-of-life, resulting in a particularly painful death for the patient, and an excruciating experience for the patient’s daughter who witnessed her mother’s painful death, unaccompanied by hospice personnel. Two additional substantiated complaints from January and February 2020 found deficiencies in VITAS’s care to patients on continuous care, including one where the VITAS nurse had headphones in and was not paying attention when the patient fell. Indeed, VITAS’s own internal review of the substantiated complaint involving the patient who fell confirmed an upward trend in falls among VITAS patients. And, as recently as June 2020, a separate substantiated complaint found that VITAS abandoned a patient on continuous care, requiring the patient to be transferred to the hospital rather than continue to receive care in the “small ALF” where the patient resided. VITAS acknowledged the patients at issue in the substantiated complaints discussed at final hearing did not receive quality hospice care. Those five examples are only a sampling of the complaints substantiated against VITAS, and the others demonstrate similar quality deficiencies. The number of substantiated complaints weighs in favor of Cornerstone and Suncoast, and heavily against VITAS with regard to record of providing quality of care. There is no meaningful difference between Cornerstone and Suncoast in regard to substantiated complaints, and neither is entitled to preference in this regard. On balance, among the three applicants, the quality of care provided by Suncoast and Cornerstone is on equal footing, with both having a distinct advantage over VITAS. Section 408.035(4) - Availability of resources, including health personnel, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation; and Section 408.035(6): The immediate and long-term financial feasibility of the project The parties stipulated that each of the applicants have available funds for capital and operating expenditures in the short term for purposes of project accomplishment and operation. Suncoast demonstrated that it has the resources to accomplish its proposed project. Suncoast provided detailed descriptions of the personnel that would be required to successfully implement its proposed program. Suncoast has reasonably projected the types of staff necessary to operate Suncoast in year 1 and 2 of operation. At hearing, Suncoast witnesses credibly described the roles of the staff contained in Suncoast’s Schedule 6, including the roles of administrator, care team manager, administrative assistant, regional hospice scheduler, business development liaisons, physicians, program director, nurses, hospice aides, respiratory therapists, staff for the mobile van in Condition 2 of its application, community partnership specialists, social workers, patient social team lead, chaplain, volunteer coordinator, and senior staff nurse. Suncoast’s financial expert, Armand Balsano, testified that part of his role in preparing Suncoast’s CON application was working with Suncoast Pinellas’s Chief Financial Officer, Mitch Morel, to develop Suncoast’s financial projections that were included on Schedules 1 through 8 of the application. Mr. Balsano, in collaboration with Mr. Morel, utilized Suncoast Pinellas’s internal financial modeling system to develop the financial schedules and financial narrative for the application. Mr. Balsano credibly testified that financial Schedules 1 through 8 are accurate and reasonable. Suncoast projects admissions of 460 patients for project year one and 701 patients for project year two. Suncoast’s health planner, David Levitt, developed Suncoast’s projected admissions based on experience of other providers entering a market with two existing providers. Suncoast’s projected number of admissions for years one and two are reasonable projections of admissions for a new hospice program in Hillsborough. Suncoast was criticized as having a lackluster record for admissions in its existing Pinellas hospice. While it is true that Suncoast Pinellas’s admissions declined slightly from 2013 to 2014, the overall trend has been one of increasing admissions. For example, based on Medicare claims data, from 2005 to 2019, Suncoast Pinellas’s admissions grew from 4,679 to 6,534.10 Financial feasibility may be proven by demonstrating the expected revenues and expenses upon service initiation, and determining whether a shortfall or excess revenue results. The projection of revenue is not complicated for hospice services. The vast majority of hospice care, more than 90%, is funded by the Medicare Program which pays uniform rates to all hospice providers. Mr. Balsano testified that Suncoast’s projected revenues in Schedule 7 are based on the revenues that are currently realized for the various payer categories, including Medicare, Medicaid, Commercial, and self-pay. Mr. Balsano credibly testified that the assumptions reflected on Schedule 7 of Suncoast’s CON application are reasonable and appropriate. 10 Suggestions by VITAS and Cornerstone that Suncoast’s internal data indicate a history of low utilization or inaccurate reports to AHCA are without merit. Mr. Sciullo credibly testified that the data reported to AHCA is the most accurate admissions data. Mr. Sciullo further credibly testified that the Utilization Trend Reports contained in Cornerstone’s exhibits 82 through 88, relied on by VITAS and Cornerstone, contain duplicate hospice admissions and admissions from non-hospice programs such as Suncoast’s home health program. Mr. Sciullo also credibly testified that the most accurate admissions numbers reported to AHCA are not generated from the Utilization Trend Reports. Rather, the admissions numbers reported to AHCA are produced by Suncoast’s reimbursement department. Mr. Sciullo’s testimony under cross examination demonstrated a confident and credible understanding of the nuances of the Utilization Trend Reports. Additionally, the suggestion that Suncoast would intentionally under-report admissions to AHCA lacks credibility because hospice providers in Florida are incentivized to report higher numbers of admissions. In Year 2, Suncoast projects net operating revenue of $7,138,000, which breaks down to approximately $172 per day of overall net revenue per patient day. Mr. Balsano’s credibly testified that this is a reasonable forecast of net operating revenue. Projected expenses were also reasonably projected by Suncoast. Mr. Balsano testified that Suncoast’s projected income and expenses in Schedule 8A includes salaries and wages, fringe benefits, medical supplies and ancillary services, and approximately 1.5% of inpatient days. Suncoast also included a separate allowance for administrative and overhead cost. Suncoast also allocated $752,000 in management fees to account for “back office services” and other support services that would be provided to the Hillsborough program through the Empath home office. Mr. Balsano arrived at this number by determining that a reasonable assessment would be the cost per patient day of $18, as reflected on Schedule 8 for year two. Mr. Balsano credibly testified that, for a startup program, it is appropriate to include the costs associated with services provided by the corporate office because one must be cognizant of what services are provided locally, and what services will be provided through the corporate office. Mr. Balsano further testified that it would not be reasonable to assume that 100% of the costs associated with corporate services to a new hospice program would be fixed. As Mr. Balsano explained, the variable costs must be accounted for as well. Mr. Balsano credibly testified that Suncoast’s net profit in year two as reflected in Schedule 8A is $615,416. It is found that Suncoast has reasonably projected the revenues and expenses associated with its proposed hospice, and that Suncoast’s proposal is financially feasible in the long term. Cornerstone projected admissions of 448 patients in year one, and 819 patients in year two, for the highest year two admissions of the three applicants. In comparison, Suncoast projected admissions of 460 patients in year one and 701 in year two, while VITAS projected 491 patients in year one and just 593 in year two. Cornerstone’s projected admissions were developed by health planning experts Roy Brady and Gene Nelson based on the experience of recent new hospice programs in the state of Florida, were discussed and confirmed by Cornerstone personnel prior to being finalized, and are a reasonable projection of admissions for years one and two of operations in Hillsborough. Despite the highest anticipated year two admissions, Cornerstone’s projection still fell below the SA 6A service gap of 863 patients and therefore did not, standing alone, establish any greater adverse impact on area providers than Suncoast or VITAS. Cornerstone emphasized its mission as an organization, and intent for this proposal, to expand penetration by resolving unmet need as opposed to capturing patients already served by existing providers. The adverse impact analysis in Cornerstone’s application therefore represents a worst-case scenario by assuming all of its patients otherwise would be served by existing providers, a premise undercut by the substantial published need. Using this approach, Cornerstone anticipated that LifePath would bear the overwhelming burden of its entry into Hillsborough, with a projected adverse impact on LifePath of 408 patients in year one, and 747 in year two. Cornerstone anticipated adverse impact to Seasons of 39 patients for year one, and 72 patients for year two. Even in this worst-case scenario, existing [Remainder of page intentionally blank] providers’ volumes in Cornerstone project years one and two exceed their historical volumes.11 Cornerstone has available health personnel and management personnel for project accomplishment and operation. Cornerstone’s existing staff, as well as its projected incremental staff for the new program, is reflected in schedule 6A of its application. The projected incremental staff shown in schedule 6A is based on established ratios and methodologies Cornerstone uses in its existing hospice programs. The projected incremental staff is all the incremental staff Cornerstone will need to establish the new program in Hillsborough, and combined with its existing personnel, are sufficient to achieve program implementation as proposed in the application. Both Suncoast and VITAS criticized Cornerstone’s financial projections as flawed because they did not present the fully allocated costs of the project. According to Mr. Balsano, Cornerstone’s projected profit margin is unreasonable and, in fact, is “an extreme outlier.” As he explained, Cornerstone’s financial schedules make no allocation of shared service costs for critical services to be provided by the home office. According to Suncoast and VITAS, this omission is unreasonable when viewed in context with Cornerstone’s Schedule 6, which does not allocate any FTEs to back office support services. Not shown are the expenses Cornerstone will incur for finance, billing, revenue cycle, accounts receivable, payroll, human resources, 11 Relative adverse impact on existing hospice programs of competing applicants has been used as a dispositive factor for favoring one applicant over another. See, Hospice of Naples, Inc. v. Ag. for Health Care Admin., DOAH Case No. 07-1264, ¶ 274 (Fla. DOAH Mar. 3, 2008; Fla. AHCA Jan. 22, 2009) (“One factor outweighs all others, however, in favor of VITAS. VITAS's application will have much less impact on HON and its fundraising efforts and in turn on the high-quality services that HON presently provides in Service Area 8B.”). However, as noted here, neither of the existing providers presented evidence as to the relative impact that any of the applicants would potentially have on its existing operations, or whether such impacts would be material. Accordingly, there is no evidentiary basis for providing an advantage to one or another of the applicants based upon consideration of adverse impact. and contract negotiations, among others. Notably, hospice providers include home office costs as part of their Medicare cost reports filed with CMS.12 Because Cornerstone did not allocate home office costs in its application, its profit margins are substantially higher than all other applicants for the October 2019 Batching Cycle. While most applicants fall within the $100,000 – $500,000 range, Cornerstone projected a staggering $4.9 million profit margin. There is nothing in the CON application form or instructions that require that financial projections be presented on a “fully allocated” basis. Notably, in its review of the financial projections, AHCA determined that each applicant’s proposed program appeared to be financially feasible in the long-term. Cornerstone’s financial feasibility analysis included consideration of payer mix, level of service mix, admissions, average lengths of stay, patient days and incremental staffing needs, among others, and focused on the resulting incremental revenues and expenses generated by addition of the new program in Hillsborough. Cornerstone’s projected admissions are reasonable and appropriate for the proposed new program in Hillsborough. Cornerstone’s proposed incremental staff, combined with its existing staff, is sufficient for project accomplishment and operation. Cornerstone’s projected payer mix is based upon consideration of Cornerstone’s own historic experience, the demographics and recent hospice payer characteristics of Hillsborough, and consideration of Cornerstone’s goal to serve the non-cancer under-65 population, which may reduce Medicare 12 In terms of its budgeting process, Cornerstone has one “bucket” for its administrative overhead/home office expenses and then separate buckets for each of its hospice programs. Home office expenses include human resources, IT, compliance, and facility maintenance. Cornerstone does not allocate its home office expenses to each of its hospice programs within its internal books. However, when an audit is performed, the performances of each hospice program and the home office expenses are all included, and the home office expenses are allocated to each of its hospice programs. levels slightly from what they otherwise may be, and is reasonable and appropriate for its proposed hospice program in Hillsborough. Cornerstone’s projected level of service mix and average length of stay are based upon Cornerstone’s historical experience, and are reasonable and appropriate for the proposed hospice program in Hillsborough. Likewise, Cornerstone’s projected revenues as set forth in schedule 7A are based upon the projected volumes, service level mix, payer mix projections, and Medicare service level specific rates, and are a reasonable projection of revenues for the proposed project in Hillsborough. Cornerstone has established the long-term financial feasibility of its proposed SA 6A program. VITAS’s financial projections were prepared through the work of an internal team led by Lou Tamburro, Vice President of Development for VITAS. VITAS reasonably based these projections on the successful opening and ramp up of new hospice programs in Service Areas 1, 3E, 4A, 6B, 7A, 8B, and 9B, and other Florida communities. VITAS has a clear understanding of what startup costs will be, and it was appropriate for VITAS to rely on its past history of success in developing these projections. VITAS projects admissions of 492 patients for project year one and 593 patients for project year two. Mr. Tamburro developed the projected admissions using an internal model based upon VITAS’s prior experience. While Mr. Tamburro is an expert in health finance, not health planning, Ms. Platt reviewed VITAS’s projections and credibly concluded they are reasonable. VITAS proposes to dedicate more resources to SA 6A than the other two applicants in the second year of operations; 74% of that expense is focused on direct patient care, with only 23% associated with administrative and overhead, and 2% property costs. In contrast, Suncoast and Cornerstone only dedicate 54% and 56%, respectively, of their expenses on direct patient care and 41% and 42%, respectively, on administrative and overhead. However, VITAS’s higher direct patient care costs are at least partially explained by the larger number of clinical and ancillary FTE’s associated with the higher levels of continuous care projected by VITAS than either Suncoast or Cornerstone. As would be expected, VITAS also projects to admit a larger number of high acuity patients than Suncoast or Cornerstone. Given VITAS’s vast experience in the start-up and operation of hospice programs, including 16 within Florida, there is no reason to doubt that the VITAS Hillsborough program would be financially feasible in the long term. The following table summarizes the three applications’ financial metrics: Cornerstone Suncoast Vitas Total Project Costs $286,080 $703,005 $1,134,149 Operating Costs Yr.2 $6 million $5.7 million $8.6 million Net Profit Yr.2 $4,972,346[13] $615,416 $154,913 Proj. Admits Yr. 2 819 701 593 Routine Home Care 95.4% 97.5% 94% General Inpatient 3.5% 1.5% 2.5% Continuous Care 0.3% 0.5% 3.5% Respite 0.8% 0.5% 0% Section 408.035(5) The extent to which the proposed services will enhance access to health care for residents of the service district; and Section 408.035(7) The extent to which the proposal will foster competition that promotes quality and cost-effectiveness. Rule 59C-1.0355 and the criteria for determination of need for a new hospice program found within that rule, is predicated upon the notion that, 13 As noted, Cornerstone’s relatively large profit margin is a function of its incremental cost, versus fully allocated cost, financial projections. when need exists, approval of an additional program will foster competition beneficial to potential and prospective hospice patients in the service area. As between the three applicants, Suncoast did the most thorough and extensive analysis of the current needs of the Hillsborough population. This effort was driven by the fact that Suncoast had recently applied for a new hospice program in neighboring Pasco County, and was denied in favor of a competing applicant. In that case, Administrative Law Judge Newton specifically faulted Suncoast for failing to carefully evaluate the hospice needs of Pasco County residents: Suncoast, in effect, proposes a branch operation for Pasco County. Suncoast did not conduct the focused, individualized inquiry into the needs of Pasco County that Seasons did. Nor did it begin developing targeted ways to serve the needs or begin establishing relationships to further that service. The Hospice of the Fla. Suncoast v. Ag. For Health Care Admin., Case No. 18- 4986, ¶ 126 (Fla. DOAH Sept. 5, 2019; Fla. AHCA Oct. 16, 2019). As explained by Mr. Sciullo at hearing, Suncoast took the above criticism to heart, and determined to conduct an exhaustive evaluation of the hospice needs in SA 6A, and to formulate a strategy for addressing those needs. Specifically, Suncoast’s intent was to identify issues and gaps in services facing residents of Hillsborough, and to enable a dialogue with existing community partners and providers in order to create shared solutions. As part of this comprehensive effort, Suncoast met with more than 50 key individuals and organizations, representing a broad range of general and special populations within the county. This effort resulted in the development of collaborative strategies and action plans to fill the gaps and meet the unmet need for additional hospice services in Hillsborough, as reflected in the Suncoast application conditions. In contrast to Suncoast, Cornerstone did not conduct its own needs assessment, but rather relied on the community needs assessments prepared by the HCDOH and two area hospitals. Moreover, rather than reaching out to the Department of Health and to the area hospitals that prepared those assessments to conduct further research or seek their support of its CON application, Cornerstone simply “verified that their documentation was thorough enough.” Cornerstone’s limited outreach effort in Hillsborough is further demonstrated by the letters of support submitted with its CON application. While Suncoast obtained letters of support from the HCDOH and numerous hospitals and community organizations in Hillsborough, Cornerstone failed to obtain a single letter of support from any hospital in Hillsborough. Despite submitting approximately 150 letters of support (many of which were form letters, and letters from Cornerstone employees), Cornerstone failed to obtain any letters from the Hispanic community, the African American community, the HIV community, the migrant community, or organizations that assist the homeless, unlike Suncoast. As Mr. McLemore testified, “a large part” of the review criteria is “hav[ing] the commitment from the organizations in the service area. I think that’s where – a little bit where Cornerstone was a little off base. They did have a bunch of letters of support, but again, they were not specific to the service area.” Mr. McLemore further testified that, rather than a large pile of letters, he was looking for letters “that are definitely from hospitals, nursing homes and civic organizations, healthcare organizations in the area.” Cornerstone’s failure to conduct meaningful and thorough outreach efforts in Hillsborough is also demonstrated by its generic list of CON application conditions. As multiple Cornerstone witnesses acknowledged, the services Cornerstone is proposing to offer in Hillsborough are identical to the services Cornerstone already offers in its existing service areas. Specifically, Cornerstone conditions its application on Hispanic outreach, bilingual volunteers, multiple office locations within a service area, complementary therapies, veterans-specific programming, bereavement counseling for parents, cooperation with local community organizations, a separate foundation account for the specific service area, and continuing education programming, all of which are services that Cornerstone already offers in its existing service areas. Thus, unlike Suncoast, which used the existing community health needs assessments as a starting point for its own comprehensive needs assessment, and proposed conditions that are reflective of the unique needs of Hillsborough, the conditions proposed by Cornerstone are almost identical to the services Cornerstone currently provides elsewhere. Cornerstone’s plan to serve Hillsborough in phases does not immediately address the unmet need for hospice services countywide. Cornerstone will not send its marketing team to facilities and other referral sources in those phased areas until Cornerstone has completed each phase of its plan. Although Cornerstone’s witnesses testified that Cornerstone will not turn away referrals from parts of the county before Cornerstone begins operations in those areas, they also confirmed that Cornerstone will not actively seek referrals from other phased areas until it is ready to move into those areas. Unlike Suncoast, and to a lesser extent VITAS, there is no evidence that Cornerstone conducted a thorough needs assessment of SA 6A before developing its phased implementation plan. Cornerstone simply looked at a map of where existing providers have offices and decided to start elsewhere. Likewise, Cornerstone did not conduct any independent assessment of the needs of the four different geographic areas of its plan to determine whether Cornerstone will be capable of serving all of the county’s residents immediately upon CON approval. Further, Cornerstone did not conduct any review or analysis of comparable start-ups in Florida when preparing its SA 6A CON application. VITAS undertook an analysis of information from a variety of sources, including meetings with various individuals within Hillsborough regarding the perceived gaps in care. Based on this review, VITAS identified a number of patient groups with purported unmet needs: African American and Hispanic populations; migrant workers; patients residing in the eastern and southern parts of the county who are not accessing hospice at the same rate as other parts of the subdistrict; patients with respiratory, sepsis, cardiac, and Alzheimer’s diagnoses; patients requiring continuous care and high acuity services such as Hi-Flow oxygen; patients requiring admission in the evening or on weekends; and patients residing in small, less than 10-bed, ALFs. VITAS proposed a number of solutions to address the purported needs identified in Hillsborough, and largely included those proposed solutions as conditions of its application. However, VITAS failed to identify a specific operational plan for Hillsborough. The purported gaps in care and solutions identified in VITAS’s application for Hillsborough largely mirror those identified in its application for Service Area 2A that was submitted during the same cycle, despite significant differences between the makeups of those two service areas. VITAS’s application included 47 letters of support. Many of the letters are from persons and organizations outside Hillsborough, and even include a letter from one of VITAS’s employees, Kellie Newman, and two letters in support of its 2A application. At hearing, VITAS offered testimony from letter of support authors Mary Donovan and Margaret Duggar. Ms. Donovan lives in Miami and is VP for Caregiver Services, Inc., a nurse staffing agency that contracts with VITAS in other areas of the state and hopes to do so in Hillsborough. Ms. Duggar is the President of MLD & Associates, Inc., located in Tallahassee, which is a management firm that serves as executive staff for a number of entities. Neither of these letters is probative of VITAS’s ability to meet the hospice needs of Hillsborough residents. Ultimately, the applicants all agreed that the unmet need in SA 6A is not purely numeric: it is concentrated among certain patient populations, including Hispanic and migrant communities; non-cancer patients under age 65, including those with dementia, Alzheimer’s, respiratory, and cardiac disease; and lower income groups. Each applicant tailored their proposal to address the perceived, underlying access barriers accordingly. Two primary theories concerning the source of access barriers in Hillsborough developed at final hearing: (a) that access barriers, and hence, unmet need in the service area stem from a lack of access to relevant hospice services through existing providers once a patient has entered hospice care; and (b) that access barriers, and hence, unmet need in Hillsborough, stem from a lack of outreach and education necessary to bring awareness of hospice services to Hillsborough residents so that they access hospice services in the first place. All three applicants proposed to tailor their hospice services and programming to the particular residents of Hillsborough. But Suncoast’s proposal and conditions focused more heavily on outreach and education to bring geographically and culturally-driven awareness of the hospice benefit to patients appropriate for hospice. As noted, Suncoast also did a more comprehensive needs analysis, which allowed Suncoast to focus its CON conditions on those segments of the Hillsborough population most in need of improved access to hospice services. Among the applicants, Suncoast alone proposes to implement a dedicated pediatric hospice program, which is not currently offered in Hillsborough. Dr. Stacy Orloff, accepted as an expert in pediatric hospice care, confirmed in her testimony the following: Suncoast's pediatric hospice program includes a dedicated integrated care team comprised of a fulltime pediatric nurse with more than 25 years’ hospice experience, a pediatric medical director, a full-time licensed social worker, a team assistant, a volunteer coordinator and a pediatric team leader. Additionally, there are part-time staff members including LPNs and CNAs with dedicated pediatric hospice experience. This is an important distinction, as many hospice programs claim to provide pediatric hospice services, but oftentimes they utilize the same care teams that provide care for adult patients. Suncoast's longstanding expertise and network of community partners for its pediatric program will ensure that the proposed pediatric hospice program fits the specific needs of the pediatric patient and family. Suncoast will use a combination of existing staff and PRN assistance until the pediatric caseload is large enough to warrant addition of new team members in Hillsborough County. Suncoast's existing pediatric hospice team has a strong relationship with St. Joseph's Children's Hospital, which it will utilize to expand its network of pediatric providers to increase hospice awareness and utilization in Hillsborough. Suncoast conditions its application on purchasing a $350,000 mobile van, the “Empath Mobile Access to Care,” to conduct mobile outreach activities in Hillsborough for ethnic-specific programming and outreach to homeless. VITAS also conditioned its application on a “Mobile Hospice Education Unit” van, and included photos of similar vans that it operates in other service areas. The Suncoast van will be staffed by a full-time bilingual LPN and a full-time social worker prepared to discuss advanced care planning and education, and will be equipped with telehealth technology capable of linking with the Empath Care Navigation Office. In contrast, VITAS did not explain how its van will be staffed, or whether any of the staff will be clinicians. Indeed, from the photos included in the application, the van appears to be more of a mobile advertisement for VITAS, than it does a tool for hospice education and outreach. VITAS attempted to differentiate its proposal by pointing to disease- specific programming for patients with pulmonary and cardiac conditions, Alzheimer’s, and sepsis. But, Cornerstone and Suncoast are also capable of caring for patients with those conditions. And, specific to sepsis programming—a feature of VITAS’s presentation at final hearing— septicemia is not usually the primary reason a patient enrolls in hospice. Instead, sepsis is a complication of another terminal condition for which a patient is admitted to hospice, and therefore does not represent a need unto itself. VITAS further attempted to differentiate its program by pointing to its comparatively longer average length of stay, arguing that longer average lengths of stay are indicative of greater access and quality. However, this notion was countered by credible testimony that longer lengths of stay, along with a higher percentage of live discharges and higher 30-day readmission rate, may, alternatively, represent targeting of patients unlikely to experience the types of access barriers at which CON is aimed, and may be indicative of lower quality and higher costs. And VITAS’s healthcare planning expert did not conduct an analysis, and offered no opinion, as to the specific cause of VITAS’s comparatively longer length of stay. Taken together, the evidence was inconclusive as to whether longer lengths of stay reflect access enhancements generally, or as applied to VITAS’s proposal. Section 408.035(9) - The applicants’ past and proposed provision of health care services to Medicaid patients and the medically indigent. Rule 59C-1.0355(2)(f) provides that hospice services must be available “to all terminally ill persons and their families without regard to age, gender, . . . cost of therapy, ability to pay, or life circumstances.” Consistent with rule, hospice providers must provide care to Medicaid patients. Medicaid pays essentially the same for hospice care as does Medicare. As such, there is no financial disincentive to accept Medicaid hospice patients. VITAS and Cornerstone both have a history of providing Medicare, Medicaid, and medically-indigent care; Suncoast’s affiliated entity, Suncoast Pinellas, has a similar history, and all three applicants propose to provide care to Medicare, Medicaid, and the medically indigent. While the three applicants project that they will experience different payor mixes for Medicaid and indigent patients, there is no evidence in this record that any of the applicants have discriminated against such patients in the past, or would do so in their Hillsborough program. Cornerstone argues that it is entitled to preference over Suncoast because Cornerstone’s projected percentage of Medicaid and medically indigent admissions (6%) is almost double that of Suncoast (3.3%). However, Cornerstone’s projection is exactly that: a projection of the payor mix it may experience in its new program. Significantly, Cornerstone did not commit to a 6% Medicaid/indigent payor mix within its CON conditions, and therefore that level of Medicaid/indigent admissions is unenforceable. Rather than the applicants’ projected payor mixes, what is significant are plans to reach out to the Medicaid and charity care population to improve their knowledge about, and use of, hospice services. Suncoast’s application presents a specific plan for doing exactly that. All of the applicants have proposed programs for outreach to financially disadvantaged communities within Hillsborough, and none of the applicants are entitled to preference under this criterion. Rule 59C-1.0355(4)(e) – Preferences for a New Hospice Program.Preference shall be given to an applicant who has a commitment to serve populations with unmet needs. Each applicant expressed a commitment to provide hospice services to populations with unmet needs. And to a greater or lesser extent, each applicant conducted an analysis of the specific populations with unmet needs in Hillsborough. No evidence was presented to establish that care for hospice patients with the varying identified conditions or within the various demographic groups is not available in Hillsborough. Rather, the evidence demonstrates that patients are not accessing hospice services, despite their availability to residents of Hillsborough. Among the three applicants, Suncoast best demonstrated a plan for enhancing access to quality hospice care for these populations, as well as a track record of past experience with enhancing access to quality hospice services for these populations. Preference shall be given to an applicant who proposes to provide the inpatient care component of the Hospice program through contractual arrangements. Each of the applicants propose to provide the inpatient care component of the hospice program through contractual arrangements, and presented testimony regarding their ability to do so. Likewise, all three applicants presented letters from entities in Hillsborough regarding their purported willingness to contract for the inpatient care component of the hospice program. However, no applicant presented non-hearsay evidence from any entity within Hillsborough regarding a willingness to contract for the inpatient care component of the hospice program. The applicants are on equal footing in terms of the ability to contract for inpatient care. Notwithstanding its intention to provide the inpatient component of the hospice program through contractual arrangements, VITAS conditioned its application on applying for a CON to construct an inpatient hospice house within the first two years of operation. However, VITAS presented no evidence to establish the need for an additional inpatient hospice house in SA 6A, and no evidence was presented to demonstrate that an inpatient hospice house is a more cost-effective alternative to contracted beds. The proposals by Cornerstone and Suncoast to contract for the inpatient component of the hospice program represent a better use of existing resources than that of VITAS, which will incur the expense of a freestanding hospice house for its proposed program. On balance, this preference weighs equally in favor of Cornerstone and Suncoast, and against VITAS. Preference shall be given to an applicant who has a commitment to serve patients who do not have primary caregivers at home; the homeless; and patients with AIDS. Each applicant presented evidence of a commitment to serve patients who do not have primary caregivers at home; the homeless; and patients with AIDS. However, the programs proposed by Suncoast to address the needs of these populations are more precisely targeted than those of the other applicants, and Suncoast is therefore entitled to preference. Proposals for a Hospice service area comprised of three or more counties. SA 6A is comprised of a single county, Hillsborough. This preference is therefore not applicable in this case. Preference shall be given to an applicant who proposes to provide services that are not specifically covered by private insurance, Medicaid, or Medicare. All three applicants propose to provide services in Hillsborough that are not specifically required or paid for by private insurance, Medicaid, or Medicare. The added services beyond those covered by private insurance, Medicaid, or Medicare as proposed by the applicants differ slightly, but on balance, weigh equally in favor of approval of each applicant. Rule 59C-1.0355(5) – Consistency with Plans. Each of the applicants conducted an analysis of the needs of Hillsborough residents and included evidence within their applications and through testimony at final hearing regarding the consistency of their respective plans with the needs of the community. However, Suncoast’s evaluation of the needs specific to Hillsborough was more thorough, and its application is best targeted at meeting the identified needs. Rule 59C-1.0355(6) – Required Program Description. Each applicant provided a detailed program description in its CON application. The elements of the program descriptions are discussed above in the context of the various statutory and rule criteria. Ultimate Findings Regarding Comparative Review Suncoast conducted the most comprehensive evaluation of the end of life care needs of Hillsborough residents, and developed targeted programs and services to address those needs. Those programs and services are identified as CON conditions, and are enforceable by AHCA. The depth and breadth of Suncoast’s commitments to the residents of Hillsborough exceed those of Cornerstone and VITAS. Unlike the other applicants, Suncoast offers needed programs which are not currently available in Hillsborough, including a dedicated pediatric hospice program, and enhanced transportation options for persons living in rural areas of the county. Suncoast and Cornerstone are comparable in terms of history of providing quality care. VITAS is inferior in this regard, as evidenced by the numerous confirmed deficiencies in recent years. Undoubtedly, VITAS has redoubled its efforts to improve quality in response to the numerous confirmed deficiencies and complaints, but based upon the record in this case, Suncoast and Cornerstone have a better history of providing quality care. Suncoast would be able to commence operations in SA 6A more quickly than Cornerstone or VITAS. It has connections with other healthcare providers in Hillsborough and could easily transition to that adjacent geographic area. All three proposals would enhance access to hospice services in the county, but Suncoast’s program would be the most effective at enhancing access. A careful weighing and balancing of the statutory review criteria and rule preferences favors approval of the Suncoast application, and denial of the Cornerstone and VITAS applications. Upon consideration of all the facts in this case, Suncoast’s application, on balance, is the most appropriate for approval.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered approving Suncoast Hospice of Hillsborough, LLC’s, CON No. 10605 and denying Cornerstone Hospice and Palliative Care, Inc.’s, CON No. 10602 and VITAS Healthcare Corporation of Florida’s, CON No. 10606. DONE AND ENTERED this 26th day of March, 2021, in Tallahassee, Leon County, Florida. COPIES FURNISHED: D. Ty Jackson, Esquire GrayRobinson, P.A. 301 South Bronough Street, Suite 600 Post Office Box 11189 Tallahassee, Florida 32302 Seann M. Frazier, Esquire Parker, Hudson, Rainer & Dobbs, LLP Suite 750 215 South Monroe Street Tallahassee, Florida 32301 Kristen Bond Dobson, Esquire Suite 750 215 South Monroe Street Tallahassee, Florida 32301 Marc Ito, Esquire Parker Hudson Rainer & Dobbs, LLP 215 South Monroe Street, Suite 750 Tallahassee, Florida 32301 S W. DAVID WATKINS Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of March, 2021. Julia Elizabeth Smith, Esquire Agency for Health Care Administration Mail Stop 3 2727 Mahan Drive Tallahassee, Florida 32308 Stephen A. Ecenia, Esquire Rutledge, Ecenia & Purnell, P.A. Suite 202 119 South Monroe Street Tallahassee, Florida 32301 Gabriel F.V. Warren, Esquire Rutledge Ecenia, P.A. 119 South Monroe Street, Suite 202 Post Office Box 551 Tallahassee, Florida 32301 Elina Gonikberg Valentine, Esquire Agency for Health Care Administration Mail Stop 7 2727 Mahan Drive Tallahassee, Florida 32308 Amanda Marci Hessein, Esquire Rutledge Ecenia, P.A. Suite 202 119 South Monroe Street Tallahassee, Florida 32301 Allison Goodson, Esquire GrayRobinson, P.A. Post Office Box 11189 Tallahassee, Florida 32302 Maurice Thomas Boetger, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 James D. Varnado, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Thomas M. Hoeler, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Jonathan L. Rue, Esquire Parker, Hudson, Rainer and Dobbs, LLC Suite 3600 303 Peachtree Street Northeast Atlanta, Georgia 30308 D. Carlton Enfinger, Esquire Agency for Health Care Administration Mail Stop 7 2727 Mahan Drive Tallahassee, Florida 32308 Simone Marstiller, Secretary Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 1 Tallahassee, Florida 32308 Shena L. Grantham, Esquire Agency for Health Care Administration Building 3, Room 3407B 2727 Mahan Drive Tallahassee, Florida 32308
The Issue Whether Florida Administrative Code Rule 59C-1.0355(4)(d)3. is an invalid exercise of delegated legislative authority?
Findings Of Fact Background This is a challenge to the facial validity of the 48-hour rule. It is not a challenge to the 48-hour rule as applied.2 Nonetheless, the following background provides the context that produced the challenge. See also Findings of Fact 14-16. LifePath, Suncoast, and Palm Coast (or related entities), as well as the Agency, are parties in pending proceedings at the Division of Administrative Hearings (DOAH) involving Palm Coast's (or related entities) challenges to the Agency's preliminary determinations to deny CON applications (hospice) filed by Palm Coast (or related entities). These cases have been abated pending the outcome of this proceeding. In each proceeding, Palm Coast (or related entities) contends that a "special circumstance" exists under the 48-hour rule to justify approval of each CON application. Moreover, in support of its position, Palm Coast (or related entities) relies, in part, on data compiled by LifePath and Suncoast. It is the use of this data, in light of the 48-hour rule and interpretation thereof, that caused LifePath and Suncoast to file the rule challenges, notwithstanding that the Agency has not definitively interpreted the 48-hour rule. Parties The Agency administers the CON program for the establishment of hospice services and is also is responsible for the promulgation of rules pertaining to uniform need methodologies, including hospice services. See generally §§ 408.034(3) and (6) and 408.043(2), Fla. Stat.; Ch. 400, Part IV, Fla. Stat. Suncoast is a not-for-profit corporation operating a community-based hospice program providing hospice and other related services in Pinellas County, Florida, Hospice Service Area 5B. Suncoast has provided a broad range of hospice services to residents of Pinellas County since 1977. Suncoast has implemented an electronic medical records system and has developed a proprietary information management software system known as Suncoast Solutions. LifePath is a not-for-profit corporation operating a community-based hospice program providing hospice services in Hillsborough, Polk, Highlands, and Hardee Counties, Hospice Service Areas 6A and 6B. LifePath has provided a broad range of hospice services for the past 25 years. Palm Coast is a not-for-profit corporation currently operating licensed hospice programs in Daytona Beach, Florida, Hospice Service Area 4B and in Dade/Monroe Counties, Hospice Service Area 11. Palm Coast, as well as other related entities such as Odyssey Healthcare of Pinellas County, Inc., e.g., CON application No. 9984 filed in 2007, for Hospice Service Area 5B, has filed several CON applications to provide hospice services. It is also a party in pending proceedings before DOAH, challenging the Agency's preliminary decisions to deny the respective applications. Palm Coast's sole member is Odyssey Healthcare Holding Company, Inc., which is a wholly-owned subsidiary of Odyssey Healthcare, Inc. (Odyssey). (Palm Coast and Odyssey shall be referred to as Palm Coast unless otherwise stated.) Standing Petitioners provide hospice services in Florida and have not applied for a CON to provide hospice services outside their current service areas. In the absence of a numeric need,3 an applicant for a hospice CON is afforded the opportunity to demonstrate a need for a new hospice program by proving "special circumstances." These include circumstances described in the 48-hour rule. The applicant must document that "there are persons referred to hospice programs who are not being admitted within 48 hours (excluding cases where a later admission date has been requested)."4 The parties have cited no law that requires an existing hospice provider to maintain records documenting when a person is referred to a hospice program. Public documents are not available that may otherwise provide information regarding when a person is referred to a hospice program.5 Existing providers do not uniformly maintain data that reflects the length of time between when a person is referred to and later admitted to a hospice program. By rule, existing licensed hospice providers in Florida are required to report admissions data every six months to the Agency. The Agency uses the information to calculate numeric need under the rule methodology. Petitioners keep records indicating, for their record keeping purposes, e.g., when a person contacts the hospice program and when the person is admitted. Petitioners use software to assimilate this type of information. Petitioners also maintain patient records that contain this type of information. However, this information is not specifically gathered and maintained for the purpose of determining when a person is actually "referred" to a hospice program and later "admitted" and whether "persons" are admitted within 48 hours from being referred. During discovery in pending CON proceedings following preliminary agency action, Petitioners produced information, related to this record, to Palm Coast or related entities. Palm Coast or related entities have used this information in their CON applications to justify a "special circumstance" under the 48-hour rule. See generally Pet 6, 17, 17A and PC 75-78. See also T 987-995. It is a fair inference that Palm Coast or related entities have and will use this information in CON application cases pending at DOAH. See generally Palm Coast's February 14, 2008, Request for Judicial Notice, items 1-18. It is the use of the information by Palm Coast or related entities, coupled with Palm Coast's or related entities interpretation of the 48-hour rule that caused Petitioners to file the rule challenges in this proceeding. LifePath and Suncoast are regulated by and subject to the provisions of Rule 59C-1.0355. See generally Pet 30 at 2, item 2. The 48-hour rule is a CON application criterion, a planning standard, that is not implicated unless and until an applicant relies on this provision in its hospice CON application and uses data provided by, e.g., existing providers such as Petitioners. Subject to balancing applicable statutory and rule CON criteria, application of the 48-hour rule may provide an applicant with a ground for approval of its CON application by indicating a need for a new hospice program. This may occur either leading up to the Agency's issuance of its SAAR, see Section 408.039(4)(b), Florida Statutes, stating the Agency's preliminary action to approve a CON application, or ultimately with the entry of a final order following a proceeding conducted pursuant to Section 120.57(1), Florida Statutes. This information may also be considered during a public hearing if the Agency affords one. § 408.039(3)(b), Fla. Stat. Existing hospice providers, such as LifePath and Suncoast, may be substantially affected by the Agency's consideration of this information, especially if the Agency preliminarily concludes (in the SAAR) that a CON application should be approved based in part on application of the 48-hour rule. At that point, existing hospice providers have the right to initiate an administrative hearing upon a showing that its established program will be substantially affected by the issuance of the CON. See § 408.039(5)(c), Fla. Stat. Existing providers may also intervene in ongoing proceedings initiated by a denied applicant. Id. Petitioners have proven that they are substantially affected by the application of the 48-hour rule. Rule 59C-1.035(4) Prior to the Agency's adoption of Rule 59C-1.0355 in 1995, the Agency adopted Rule 59C-1.035, which included, in material part, a numeric need formula. In a prior rule challenge proceeding, it was alleged that Rule 59C-1.035(4) and in particular the numeric need formula was invalid. Paragraph (4)(e) provided: (e) Approval Under Special Circumstances. In the absence of need identified in paragraph (4)(a), the applicant must provide evidence that residents of the proposed service area are being denied access to hospice services. Such evidence must demonstrate that existing hospices are not serving the persons the applicant proposes to serve and are not implementing plans to serve those persons. This evidence shall include at least one of the following: Waiting lists for licensed hospice programs whose service areas include the proposed service area. Evidence that a specifically terminally ill population is not being served. Evidence that a county or counties within the service area of a licensed hospice program are not being served. Rule 59C-1.035(4), including paragraphs (4)(e)1.-3., was determined to be invalid. Catholic Hospice of Broward, Inc. v. Agency for Health Care Administration, Case No. 94-4453RX, 1994 Fla. Div. Admin. Hear. LEXIS 5943 (DOAH Oct. 14, 1994), appeal dismissed, No. 1D94-3742 (Fla. 1st DCA Jan. 26, 1995). However, other than quoting from paragraph (4)(e) because it was included as part of the rule, there was no specific finding or conclusion regarding the validity of paragraphs (4)(e)1.-3. The successor rule, Rule 59C-1.0355(4)(d)1.-3., changed the preface language and substantially retained paragraphs (4)(e)2. and 3., now paragraphs (4)(d)1.-2., but omitted paragraph(4)(e)1. (waiting lists) and added paragraph(4)(d)3. (the 48-hour rule). Rule 59C-1.0355(4)(d)1.-3. Elfie Stamm has been employed by the Agency in different capacities. Material here, Ms. Stamm was the health services and facilities consultant supervisor for CON and budget review from July 1985 through June 1997. Since 1981, Ms. Stamm has had responsibility within the Agency for rule development. In and around 1994 and prior to the former hospice rule being invalidated, a work group was created for the purpose of developing a new hospice rule. Input was requested from the work group. Various hospice providers throughout the state participated in the rule development process. It appears that there was an attempt to replace the waiting list standard in the prior rule with the 48-hour standard. (There had been general objections made to the waiting list standard in this and other Agency rules.) The language for the 48-hour rule apparently came from the work group, rather than from Agency staff, although there is no evidence indicating which person or persons suggested the language. The Agency kept minutes of a meeting conducted on June 30, 1994, to discuss the proposed hospice rule, including the 48-hour rule. The minutes were kept to record any criticisms or comments regarding the proposed hospice rule. The minutes of a rule workshop "only addresses issues where people have concerns and varying opinions." The record does not reveal that any adverse comments were made regarding the 48-hour rule. In 1995, the Agency, adopted Rule 59C-1.0355, including Rule 59C-1.0355(4)(d)1.-3. that provides: (d) Approval Under Special Circumstances. In the absence of numeric need identified in paragraph (4)(a), the applicant must demonstrate that circumstances exist to justify the approval of a new hospice. Evidence submitted by the applicant must document one or more of the following: That a specific terminally ill population is not being served. That a county or counties within the service area of a licensed hospice program are not being served. That there are persons referred to hospice programs who are not being admitted within 48 hours (excluding cases where a later admission date has been requested). The applicant shall indicate the number of such persons.6 The 48-hour rule, in its present iteration at issue in this proceeding, has been a final rule since 1995.7 The Agency's hospice need methodology is set forth in Rule 59C-1.0355(4), which is entitled "Criteria for Determination of Need for a New Hospice Program." Rule 59C-1.0355(4) is comprised of four paragraphs, (4)(a) through (4)(e). Paragraph (4)(a) sets forth the process for the Agency's calculations of a numeric fixed need pool for a new hospice program. Paragraph (4)(b) provides that the calculation of a numeric need under paragraph (4)(a) will not normally result in approval of a new hospice program unless each hospice program in the service area in question has been licensed and operational for at least two years as of three weeks prior to publication of the fixed need pool. Paragraph (4)(c) similarly states that the calculation of a numeric need under paragraph (4)(a) will "not normally" result in approval of a new hospice program for any service area that has an approved but not yet licensed hospice program. Paragraph (4)(d) of the need methodology sets forth the three "special circumstances" quoted above. Paragraph (4)(e) sets forth preferences that may be applicable to a CON application for a new hospice program. The purpose of the 48-hour rule is to establish a standard by which the Agency may determine whether there is a timeliness of access issue that would justify approval of a new hospice program despite a zero fixed need pool calculation. Under the hospice need methodology, "special circumstances" are distinguishable from "not normal" circumstances, in part, because the three "special circumstances" are comprised of three delineated criteria rather than generally referencing what has been characterized as "free form" need arguments. Also, "not normal" circumstances may be presented when the Agency's numeric fixed need pool calculations produces a positive numeric need. Once an applicant demonstrates at least one "special circumstance" in accordance with Rule 59C-1.0355(4)(d)1.-3., the applicant may then raise additional arguments in support of need, which may be generally classified as "not normal" or as additional circumstances. Although the 48-hour rule has existed since 1995, it has rarely been invoked as a basis for demonstrating need by a CON applicant seeking approval of a new hospice program. In this light, the Agency has rarely been called upon to interpret and apply the 48-hour rule. The Agency recently approved a CON application filed in 2003 by Hernando-Pasco Hospice to establish a new hospice program in Citrus County (CON application No. 9678). The application was based, in part, on the 48-hour rule. In its SAAR, the Agency mentions that the applicant presented two letters of support, stating that some admissions to hospice were occurring more than 48 hours after referral. The number of patients was not quantified. There was no challenge to the Agency's preliminary decision. The Agency's decision does not provide any useful guidance with respect to the Agency's interpretation of the 48-hour rule. The Challenges Petitioners allege that the 48-hour rule is an invalid exercise of delegated legislative authority because the terms "referred" and "persons" are impermissibly vague and vest unbridled discretion with the Agency. For example, Petitioners point out that the term "referred" is not defined by statute or rule and contend it is not a term of art within the hospice industry. As a result, Petitioners assert the starting point for the 48-hour period cannot be determined from the face of the rule. Petitioners also contend that the 48-hour rule is arbitrary and capricious because the language, "excluding cases where a later admission date has been requested" (the parenthetical), is the only exception that may be considered when determining whether there has been compliance with the subsection, when, in fact, there are "other facts and circumstances beyond the control of the hospice provider that may result in delay in admission of a hospice patient." Petitioners also contend that the use of a 48-hour time period for assessing the need for a new hospice provider in a service area notwithstanding the Agency calculation of a zero numeric need is arbitrary and capricious. Finally, Petitioners allege that the 48-hour rule contravenes the specific provisions of Section 408.043(2), Florida Statutes, which is one of the laws it implements. Specifically, Petitioners further allege that "[b]ecause of its vagueness, its lack of adequate standards, its vesting of unbridled discretion with the Agency, and its arbitrary and capricious nature [the 48-hour rule] fails to establish any meaningful measure of the 'need for and availability of hospices in the community,' as required by [S]ection 408.043(2), Florida Statutes, and in violation of Section 120.52(8)(c), Florida Statutes (2007)." Joint Prehearing Stipulation at 2-4. The Agency's and Palm Coast's Positions The Agency and Palm Coast contend that Petitioners do not have standing to challenge the 48-hour rule, but otherwise assert that the 48-hour rule is not invalid. In part, Palm Coast and the Agency contend that there is a common and ordinary meaning of the term "referred," which is "that point in time when a specific patient or family member on behalf of a patient or provider contacts a hospice provider seeking to access hospice services. Once a patient, patient family member on behalf of [a] patient, or provider contact [sic] a hospice provider seeking to access services, the 48 hour 'clock' should begin to run." See Joint Prehearing Stipulation at 6; AHCA/Palm Coast PFO at paragraph 79. With respect to the term "persons," Palm Coast and the Agency suggest that whether there are a sufficient number of "persons" that fit within the special circumstance "is a fact-based inquiry, which should be evaluated based on a totality of the circumstances." The Agency and Palm Coast contend that circumstances other than as stated in the parenthetical may be considered. Rule 59C-1.0355(4)(d)3. and Specific Terms Referred The term "referred" is not defined either by AHCA rule, in Chapter 400, Part IV, Florida Statutes, entitled "Hospices," or in Chapter 408, Part I, Florida Statutes, entitled "Health Facility and Services Planning." The terms "referred" or "referral" are not defined in any Agency final order or written policy. No definition of "referred" appears in at least three dictionaries, Webster's New World College Dictionary (4th ed. 2005) at 1203, Webster's II New College Dictionary (1999) at 931, and Webster's Ninth New Collegiate Dictionary (1985) at 989, although "refer" is defined, id. For example, "refer" means, in part "[t]o direct to a source for help or information." Webster's II New College Dictionary (1999) at 931. The term "referral," as a noun, means: "1 a referring or being referred, as for professional service, etc. 2 a person who is referred or directed to another person, an agency, etc." Webster's New World College Dictionary (4th ed. 2005) at 1204. Referral also means: "The practice of sending a patient to another practitioner or specialty program for consultation or service. Such a practice involves a delegation of responsibility for patient care, which should be followed up to ensure satisfactory care." Taber's Cyclopedic Medical Dictionary at 1843 (19th ed.). Pet 18A. Pursuant to the Patient Self-Referral Act of 1992, "'[r]eferral' means any referral of a patient by a health care provider for health care services, including, without limitation: 1. The forwarding of a patient by a health care provider to another health care provider or to an entity which provides or supplies designated health services or any other health care item or service; or 2. The request or establishment of a plan of care by a health care provider, which includes the provision of designated health services or other health care item or service." § 456.053(3)(o)1.-2., Fla. Stat. Essentially, this Act seeks to avoid potential conflicts of interest with respect to referral of patients for health care services. In the absence of any authoritative definition of "referred," it is appropriate to determine whether the word has a definite meaning to the class of persons within the 48-hour rule. It is also appropriate to consider the Agency's interpretation of the 48-hour rule. As noted, hospice services are required to be available to all terminally ill patients and their families. Under the 48-hour rule, a CON applicant has the opportunity to prove that persons are being denied timely access to hospice services after 48 hours elapses from when they have been referred and they have not been admitted, absent some a reasonable justification. The issue is what elements are necessary for a person to be deemed "referred" and are those elements commonly understood well enough to enable the 48-hour rule to withstand a challenge for vagueness. If a person calls a hospice organization and inquires about the availability of hospice services, does this call start the 48-hour period? If the same person calls a hospice organization and states that he or she is the caregiver/surrogate for an elderly parent in need of hospice services, does this call start the 48-hour period? If the same person calls a hospice organization and states that he or she is the caregiver/surrogate of an elderly parent in need of hospice services, that the elderly parent is terminally ill, and further requests hospice services, does this call start the 48-hour period? If the same person calls a hospice organization and states that he or she is the caregiver/surrogate of an elderly parent in need of hospice services, that the elderly parent is terminally ill based on a prognosis by a licensed physician under Chapters 458 or 459, Florida Statutes, and further requests hospice services, does this call start the 48-hour period? Does eligibility for hospice services have a bearing on when a person is referred? If so, what factor(s) constitute eligibility? Petitioners contend the term "referred," as used in the 48-hour rule, can not be defined with any precision; hence the term is vague.8 Petitioners describe "referred" and "referral," for operational purposes, but not with respect to how the term "referred" is used in the 48-hour rule. Agency experts define the term differently, although none suggest the term is vague. Palm Coast offers a definition of "referred" or "referral" as part of its standard of admitting patients within three hours after referral. But, Palm Coast has a more generic and broader definition for the terms when used in the 48-hour rule. It is determined that "referred" can be defined with some precision and is not vague. But, the various positions and thought processes of the parties are described below and help in framing the controversy for resolution. LifePath and Suncoast Over the years, LifePath developed an administrative/operational manual pertaining to policies and procedures. One such policy is the "referral/intake procedure" that is the subject of a two page written policy, PC 55, revised March 2006. LifePath does not have a written definition of the terms inquiry or referral. LifePath does not believe it is reasonable to define referral as the point in time when a patient, a patient family member, or a physician requests hospice services on behalf of a patient. It is too general. In and around March 2006, LifePath considered a referral to occur when a first contact to LifePath was made by a person requesting hospice services. LifePath used the term referred "to anybody requesting services as a referral source." The admissions staff was directed to gather from the referral source, physician, and/or family any information needed to complete the patient record in the Patient Information System, and contact the patient/family on the same day of referral if available to discuss Lifepath hospice services. Sometime after December 2006, and the final hearing that was held in the Marion County hospice case, LifePath began revising its referral and intake procedure. According to LifePath, its process did not change, only its manner of characterizing certain terms, such as referral. At this time, LifePath wanted to track more precisely different occurrences within LifePath's process, including providing a more accurate label for referral as a request for assessment (RFA) rather than a referral. For LifePath, a referral and a RFA are not synonymous. A RFA is the first contact with the hospice program, which enables staff to follow- up with the prospective patient. A referral is a written physician's order for admission. At the same time, it had come to LifePath's attention that hospice providers (Palm Coast) defined referral differently. It became clear to LifePath that "Palm Coast had a very different definition of referral than [LifePath] did at that particular time. [LifePath] wanted to be able to clearly track each event during that time process so that [LifePath] would be able to compare with [Palm Coast's] definition of referral at that time." Stated somewhat differently, LifePath wanted to create a process that would capture several events (e.g., dates and times) consistently and measurable in the intake process rather than comb through paper charts to verify what they were doing. In April 2007, LifePath made several changes and updates to its written policy/procedure manual and software system, including using the term RFA instead of referral. According to the revised April 2007 policy, "Intake means: the initial demographic and patient condition information that is necessary to initiate the process for 'request for assessment.'" PC 56-57. In summary, for LifePath, a RFA for services is different from and precedes a referral. A RFA occurs when a person makes an initial contact with LifePath inquiring about access to hospice services. At this point LifePath has a name and an action to follow up with, and the information is entered into LifePath's system. The intake process begins. A RFA could be made by a physician in the community who orally or in writing requests LifePath to assess a patient for hospice care and/or issues an assess and admit order if appropriate. A call from a physician requesting LifePath to determine whether a person is appropriate for hospice services begins LifePath's RFA process. An RFA could arise when a person calls LifePath and says that their neighbor is really sick and gives LifePath the neighbors name and telephone number. RFA used in the April 2007 policy revision (PC 56) means the same as the term referral as used in the March 2006 policy revision (PC 55), i.e., the same point in time when LifePath received the patient's name and began the intake process and ability to follow up. Again, LifePath's intake process did not change; Lifepath's policies became more specific describing the events that occur during the entire intake process. According to LifePath, LifePath's revised policy of April 2007 is not reflective of LifePath's interpretation of the 48-hour rule. LifePath's revised policy "outlines the process in the organization in which [Lifepath] begin the intake process and how [LifePath follows] up and then certain moments in time within that process that [LifePath tracks] and monitor[s] as an organization." The April 2007 revision was followed by a May 2007 revision. LifePath characterized Palm Coast exhibits 55 through 57 as an "interim pilot process" that has been made permanent without any apparent significant changes. LifePath also perceived Palm Coast as defining referral to mean when a physician issues an admission order. As a result, LifePath began capturing data reflecting that moment in time so that the Agency could compare LifePath's data -- an apples-to-apples approach -- with another provider's data based on a definition that equated referral with a physician's order, but not for the purpose of defining what referred means to LifePath under the 48-hour rule. LifePath now considers a referral to occur when a physician issues an order to admit for the purpose of gathering data that is to be used to compare other providers, not for the purpose of applying the 48-hour rule. An assess and admit order in LifePath's view is not a referral until LifePath assesses the patient, obtains consent of care, determines that the patient is appropriate for hospice services, receives certification, and receives an order to admit the patient at that time. The RFA process is completed when either the patient is admitted to the program or it is determined that the patient cannot be admitted to the program. LifePath will admit a patient in lieu of having an admitting order when LifePath receives a verbal order to admit the patient from a physician. The verbal order for admission is a referral. LifePath admits at least 75 percent of its patients within 48 hours of the RFA. However, LifePath gave several reasons outside of a hospice program's control that would delay admission greater than 48 hours from the RFA. LifePath believes that the Agency's rule is a good rule, but that the language has been taken out of context and used inappropriately. Like LifePath, Suncoast's interest in the 48-hour rule was stimulated when Palm Coast filed two CON applications requesting approval to provide hospice services in Pinellas County and both applications claim a need for an additional hospice program based, in part, on the 48-hour rule. Suncoast was concerned with the manner in which referral was being used by Palm Coast in light of data provided by Suncoast and further believes that the 48-hour rule is being manipulated by Palm Coast. Suncoast uses an elaborate software product that uses terms such as referral. Suncoast does not have a formal policy definition of referral. Suncoast believes that there are differing definitions of referral among hospice programs. Suncoast filed its rule challenge because according to Suncoast the 48-hour rule is nonspecific; because there is no commonly understood definition of referral in the hospice rule or in the Agency that Suncoast and other hospice providers can depend on. Given the lack of a specific definition, Suncoast and others are unable to determine when the 48-hour clock begins. As used in its business and not for the purpose of defining the term in the 48-hour rule, Suncoast defines referral to mean "that first contact with [Suncoast's] program where [Suncoast gets] a name and [Suncoast gets] other information about the client so that [Suncoast] can go see them." This definition is not limited Medicare reimbursed hospice services. Inquiry and referral are the starting points. But, Suncoast states that there is no consistent definition of referral across the hospice industry. Suncoast also views a referral and an admission as "processes," "not really events." Sometimes the process takes a period of weeks to evolve with many variants, e.g., eligibility, consent, etc. Palm Coast In this proceeding, Interrogatories were answered on behalf of Hospice of the Palm Coast - Daytona and by Hospice of the Palm Coast - Waterford at Blue Lagoon with respect to the referral, intake, and admission of patients for hospice services to such facilities. Several terms are defined. "Referral" is an industry term, referring to contact by an individual or entity including but not limited to a patient, family member on behalf of a patient, HCS, POA, guardian, ALF, nursing home, or hospital seeking to access hospice services. "Referred" is an industry term, having a plain and ordinary meaning within the hospice field which generally describes when a patient, patient family member or personal representative, or provider contacts a hospice program seeking to access hospice services. "Intake" [] a general term of art describing the process from referral to admission. Admission is a general term of art describing that point in time when a patient meets all eligibility requirements including clinical requirements for hospice services and is admitted to a hospice program. [Assessment is t]he process by which patients are evaluated regarding clinical appropriateness for hospice services including eligibility requirements as set forth by state regulation, Medicare, Medicaid or other third party payors. [First Contact and initial contact, a]s it relates to referral, intake, and admission of patients, are defined above as referral and referred. For Palm Coast's purposes, a referral occurs when someone, e.g., a physician, discharge planner, family or a friend, contacts the hospice agency seeking hospice services. If the first contact comes from a physician, Palm Coast seeks that physician's approval to admit the patient if the patient is eligible or qualifies for hospice. For Palm Coast, it is typical to obtain a physician's written order for evaluation and admission before the patient is evaluated by the hospice provider. If a physician calls with a referral of a patient, the call goes to the admission coordinator. Calls from patients or family of a hospice patient would be routed into the clinical division. A referral does not include contacting a hospice requesting information where a chemotherapy wig or a hospital bed could be purchased. For Palm Coast, the admissions coordinator determines when an inquiry is an inquiry only or is a referral. The phone call may turn into a referral when the caller is asking for hospice services to be provided or a family member or to a patient who is at their end of life as opposed to a general request for information about hospice services. But, Palm Coast does not have written criteria for use by the admissions coordinator in determining whether a phone call is an inquiry or referral, or when an inquiry becomes a referral. Odyssey also does not have a written definition of referral, although it is a term used in policies and procedures. A referral results when they have a patient's name and a physician's name and someone is calling for hospice services. Ms. Ventre states that order and referral are not interchangeable. A physician's order is not a referral. For the purpose of describing Palm Coast's hospice operations and referring to page four of the "referral process" page within Palm Coast's Admission and Patient/Family Rights Policies, a referral begins when a written physician's order is received by the hospice program. Receipt of a physician's written order and referral are synonymous regarding the three- hour standard. Receipt of a telephone call from a potential patient does not qualify as a referral. It is classified as an inquiry. It is unusual for a patient or a patient's family would make a referral themselves. (Ms. Ventre characterized an inquiry as someone calling for an explanation of hospice services. A phone call could be classified as an inquiry or referral depending on the depth of the call. It may be an inquiry where there is no follow-up.) Palm Coast uses Odysseys service standard providing that all patients are admitted within three hours from a written physician's order to admit -- 24 hours a day, seven days a week. (This three hour standard is one of 14 standards adopted by Palm Coast/Odyssey.) A clinical assessment is performed within this three hour period. For Palm Coast, if it has a written physician's order to admit and if the family is available, Palm Coast believes it can meet the three-hour standard. Palm Coast (and Odyssey) does not track the time between receipt of a physician's order to evaluate and the admission of the patient nor does Odyssey track the time between the receipt of a physician's order to admit and the time the admission of the patient. Palm Coast (and Odyssey) maintains internal mechanisms that are reviewed on a daily basis to evaluate the referral process and if patients are being admitted in a timely fashion. Sometimes the three-hour standard is not met. The most frequent reason is that the patient and/or the family are not available to meet. Another is the time it may take to gather documentation from the referring physician. The Agency Agency experts defined "referred" differently. During the final hearing, Ms. Stamm stated that in order for a person to receive hospice services, the person must be qualified or eligible. Eligibility occurs when a physician certifies that the person has a six months or less (for Medicare) or (pursuant to Florida law) one year or less life expectancy. Ms. Stamm clarified her deposition testimony during the final hearing and stated that a person is referred to a hospice program when a request for hospice services is made to the hospice program by or on behalf of the person, coupled with the physician's written certification. A referral would not occur when, e.g., the person or someone on their behalf simply asks for hospice services without the physician's certification. Ms. Stamm was not aware whether this interpretation reflected the Agency's interpretation. She never thought there was a problem with defining "referred" or that it was an issue, so it was not discussed. Also, Ms. Stamm was not aware of how the Agency has interpreted the 48-hour rule. Mr. Gregg confirmed that there is no written definition of referred, but that it is commonly used in healthcare, i.e., "referral is a mechanism by which a patient is channeled into some specific new or different provider." Having considered his prior deposition testimony, see endnote 9, and in preparation for the final hearing in this proceeding, for Mr. Gregg, the 48 hours starts "[a]t the point of initial contact," "the point when some person representing a potential patient calls a hospice or contacts a hospice and says I believe we have a person who is appropriate for your service." The first contact could be made by a hospital discharge planner or nursing home social worker. Mr. Gregg does not believe that a physician's certification is required to start the 48-hour period or is part of the initial contact.9 Rather, the physician's certification would come at the end of the process, although the "physician is going to be a part of a successful referral." In other words, in order to start the 48-hour period, it would not be necessary for the hospice program to be advised that a patient was terminally ill. The latter determination is required to assess whether "the patient is appropriate and eligible." Generally, Mr. Baehr agrees with Mr. Gregg's view. For Mr. Baehr, there is a transfer of responsibility that occurs when the first contact is made at a point in time when either the patient or a family member or some institution, whether it be an assisted living facility, nursing home, hospital, or a physician, makes a contact with a hospice, and in a sense initiates a process that requires the hospice program to respond and do something so that this process can get underway. Mr. Baehr opines that referral has a common understanding; it is similar to when a patient is provided with a different medical service, whether it be hospice or some other form of healthcare service, from the one they are currently receiving. Mr. Baehr differentiates this scenario from one that occurs when a person merely seeks information about hospice versus someone who is seeking eventual admission to a hospice program. Admitted There is no rule or statute that requires a hospice provider to admit a patient within a certain time period. In Big Bend Hospice, Inc. v. Agency for Health Care Administration, Case No. 01-4415CON, 2002 Fla. Div. Hear. LEXIS 1584 (DOAH Nov. 7, 2002; AHCA April 8, 2003), aff'd, 904 So. 2d 610 (Fla. 1st DCA 2005), a proceeding involving a challenge to a numerical need (under the fixed need pool) for an additional hospice program, it was expressly found: "40. An admission consists of several components: (a) a physician's diagnosis and prognosis of a terminal illness; (b) a patient's expressed request for hospice care; (c) the informed consent of the patient; (d) the provision of information regarding advance directive to the patient; and (e) performance of an initial professional assessment of the patient. At that point, the patient is considered admitted. A patient does not have to sign an election of Medicare benefits form for hospice care prior to being admitted." 2002 Fla. Div. Admin. Hear. LEXIS at *26- 27(emphasis added). See also § 400.6095(2)-(4), Fla. Stat. This finding of fact was adopted by AHCA in its Final Order. A patient cannot be admitted for Medicare reimbursement without a physician's order. In order to be eligible to elect hospice care under Medicare, an individual must be entitled to Part A of Medicare and be certified by their attending physician, if the individual has an attending physician, and the hospice medical director as being terminally ill, i.e., that the individual has a medical prognosis that his or her life expectancy is six months or less if the illness runs its normal course, and consent. 42 C.F.R. §§ 418.3, 418.20(a)- (b), and 418.22(a),(b),(c)(i)-(ii). AHCA has defined the term "admitted" by and through its Final Order in Big Bend Hospice and there is no persuasive evidence in this case to depart from that definition, although the definition of the term was discussed during the hearing. The Agency's definition of "admitted" establishes the outer time limit when the 48-hour period ends for the purpose of the 48-hour rule. Persons The 48-hour rule requires the applicant to indicate the number of persons who are referred but not admitted to hospice within 48 hours of the referral (excluding cases where a later admission is requested). The term "persons" is not defined by AHCA statute or rule. However, the term is generically defined by statute. "The word 'person' includes individuals, children, firms, associations, joint adventures, partnerships, estates, trusts, business trusts, syndicates, fiduciaries, corporations, and all other groups or combinations." § 1.01(3), Fla. Stat. "The singular includes the plural and vice versa." § 1.01(1), Fla. Stat. The term "persons" used in the 48-hour rule is not vague, ambiguous, or capricious. In context, it refers to individuals who are eligible for hospice services within the meaning of the 48-hour rule as discussed herein and who request hospice services. The Agency has not established by rule or otherwise a specific number of persons that can trigger a special circumstance under the 48-hour rule or the specific duration for counting such persons. The numeric need formula does not encompass every health planning consideration. The need formula is based on general assumptions such as population, projected deaths, projected death rates applying statewide averages, and admissions. The special circumstances set forth in Rule 59C- 1.0355(4)(d) compliment other portions of the rule and the statutory review criteria and allows an applicant to identify factors that may be unique to a particular service area, such as a particular provider not providing timely access to persons needing hospice services or a service area that is rural or urban that affects access. One size may not appropriately fit all. Rather, the term is capable of being applied on a case-by-case basis when (hospice) CON applications are reviewed by the Agency prior to the issuance of the SAAR and thereafter, if necessary, in a de novo proceeding, through and including the issuance of a final order. The Agency's exercise of discretion is not unbridled. Excluding cases where a later admission date has been requested10 The 48-hour rule provides in part: "3. That there are persons referred to hospice programs who are not being admitted within 48 hours (excluding cases where a later admission date has been requested). The applicant shall indicate the number of such persons." There is some testimony that the parenthetical may be interpreted broadly by the Agency, although Mr. Gregg suggested that the parenthetical was literally limited to when a specific request is made for a later admission date. There are numerous circumstances beyond the control of a hospice that delay an admission other than when a later admission date is requested under the rule. These circumstances do not necessarily indicate an access problem.11 Petitioners provided examples of situations (other than when a later admission date is requested) that may arise when a person would not be admitted with 48 hours after being referred such as when a patient or family is unresponsive to a contact made by the hospice provider; a patient was out of a hospice program's service area when the initial request for hospice services was made and no immediate plans to transfer to the service area; the patient/family/caregiver chose to stay with another benefit, e.g. skilled nursing facility, versus electing their hospice Medicare benefit; a patient residing in a non-contract hospital, e.g., VA Hospital, when the initial request is made and patient admitted to hospice service when the patient is transferred out of that facility into a contract facility, hospice inpatient setting or home; patient meeting the admission criteria at a later date; a delay in obtaining a physician order for assessment; or when a patient is incompetent at the time the initial request to consent for care or other delays in obtaining consent. There are also factors where a referral does not end in an admission. Persons falling in this category would not be counted under the 48-hour rule. The Agency and Palm Coast suggest that the Agency may consider these non-enumerated factors, whereas LifePath and Suncoast suggest the Agency's discretion is limited. Compare Agency/Palm Coast PFO at paragraphs 90-95, and 141 with LifePath/Suncoast PFO at paragraphs 61-67. The persuasive evidence indicates that the Agency should consider these factors. Nevertheless, the plain language of the parenthetical excludes from consideration legitimate circumstances that would reasonably explain a delay in admission other than the affirmative request for a later admission date and, as a result, is unreasonably restrictive. 48 hours Licensed hospice programs are required to provide hospice services to terminally ill patients, 24 hours a day and seven days a week. It is important that terminally ill persons who request hospice services (or if requested on their behalf), receive access to hospice services in a timely fashion. There is evidence that approximately 30 percent of patients that are admitted to hospice die within seven days or less after admission, i.e., an average length of stay of seven days or less. While the opinions of experts conflict, the 48-hour period is a quantifiable standard assuming that there is a precise and reasonable definition of referred and admission. Ultimate Findings of Fact Having considered the entire record in this proceeding, it is determined that the term "referred" is not impermissibly vague or arbitrary or capricious. A person is "referred" to a hospice program when a terminally ill person and/or their legal guardian or other person acting in a representative capacity, e.g., licensed physician or discharge planner, on their behalf, requests hospice services from a licensed hospice program in Florida. This definition presumes that prior to or contemporaneous with the request for hospice services a determination has been made by a physician licensed pursuant to Chapter 458 or Chapter 459, Florida Statutes, that the person is terminally ill, i.e., "that the patient has a medical prognosis that his or her life expectancy is 1 year or less if the illness runs its course." §§ 400.601(10) and 400.6095(2), Fla. Stat. This determination may be made by, e.g., the hospice's medical director, who presumably would be licensed pursuant to one of these statutes. The Agency and Palm Coast implicitly suggest that a referral (pursuant to the 48-hour rule) does not include a determination by a physician that the person is terminally ill. When it comes to "referral" in the generic, non- emergency physician/patient setting, the patient is examined by a physician; the physician determines that the patient needs a further evaluation by a specialist; and the physician refers the patient to the specialist.12 This is usually followed with a written order. The patient, or his or her authorized representative on the patient's behalf, must consent to and request any further examination for the ensuing service to be provided. The point is that the physician makes the referral. In order to apply the plain and commonly understood meaning of the term "referred" in the context of the 48-hour rule, the physician's determination is a critical component of the referral process, coupled with the patient's request and ultimate consent for services. Access to hospice services and the time it takes to deliver the service is of the essence for the prospective hospice patient. Having a written and dated physician certification of terminal illness would likely make recordkeeping easier and more predictable to assist in determining when the 48-hour period starts, in conjunction with the request for services. However, the potential delay in obtaining a written certification from a physician who has determined the patient is terminally ill should not be required to begin the 48-hour period and the referral in light of the purpose of the 48-hour rule. Thus, while a determination of terminal illness is necessary to start the running of the 48 hours under the 48-hour rule, reduction of that determination to writing is not. This definition, coupled with the 48 hour admission requirement and consideration of other factors affecting an admission, provides a sufficient standard for determining whether a person is receiving hospice services in a timely fashion.13 Whether access has been denied to a sufficient number of "persons" under the rule for the purpose of determining whether a special circumstance may justify approval of a hospice CON application in the absence of numeric need can be determined on a case-by-case basis by the Agency in the SAAR or later, if subject to challenge in a Section 150.57(1), Florida Statutes, proceeding in light of the facts presented. See generally Humhosco, Inc. v. Department of Health and Rehabilitative Services, 476 So. 2d 258, 261 (Fla. 1st DCA 1985). The use of the word "persons" in the rule is not vague or arbitrary or capricious. The time period of "48 hours" is not vague or arbitrary or capricious. Given the plight of terminally ill persons needing hospice services, it is not unreasonable for the Agency to have chosen this time period, in conjunction with "referred" and "admitted" as the beginning and stopping points for determining whether access is being afforded on a timely basis. The parenthetical language "(excluding cases where a later admission date has been requested)" is arbitrary and capricious because it precludes consideration of other factors that reasonably demand consideration given the rule's purpose. There is persuasive evidence that persons may not access hospice services (be admitted within 48 hours after being referred) within the 48-hour period based on circumstances that are outside the control of the hospice provider and arguably outside the parenthetical language. To the extent the parenthetical language is construed to limit consideration to one circumstance, the failure to consider other circumstances could unreasonably skew upward or overstate the number of persons that may fit outside the 48-hour period and indicates a lack of timely access when the contrary may be true, having considered the circumstances. The 48-hour rule can remain intact notwithstanding severance of the parenthetical language. The remaining portions of the rule provide an applicant with a viable avenue to demonstrate a lack of timely access based on a special circumstance. Finally, even if the 48-hour rule was not in existence, under applicable statutory and rule criteria, see, e.g., Subsections 408.035(2), Florida Statutes, an applicant may provide evidence that persons are being denied timely access to hospice services in a service area. However, such evidence would not necessarily be classified as a special circumstance unless the evidence fit within Florida Administrative Code Rule 59C-1.0355(4)(d)1. and 2.
The Issue Whether a need exists for an additional hospice in Agency for Health Care Administration service area 1. Whether the certificate of need application of Bay Medical Center to establish the hospice, on balance, meets the criteria for approval.
Findings Of Fact The Agency For Health Care Administration (“AHCA”) is the state agency which administers the certificate of need (“CON”) program for health care facilities and services in the state. AHCA published a need for one additional hospice program in service area 1, in Volume 22, Number 5 of the Florida Administrative Weekly (February 2, 1996). Bay Medical Center (“BMC”), which currently operates a hospice in service area 2A, is the applicant for CON 8377 to establish the additional hospice program in service area 1. Hospice of Northwest Florida, Inc. (“HNWF”) is an existing provider of hospice services in both service areas 1 and 2A. Service area 1 encompasses Escambia, Santa Rosa, Okaloosa, and Walton Counties. Adjacent service area 2A includes Bay, Holmes, Washington, Jackson, Calhoun and Gulf Counties. Hospice care is provided to terminally ill persons, defined as those with a life expectancy of six months or less if their disease runs its normal course. It is palliative and comfort-oriented, rather than curative. Clinical, pschosocial, and spiritual services are provided by an interdisciplinary team, which includes a physician, nurses, social workers, home health aides, chaplains, and bereavement counselors. In addition to paid staff, hospices also use volunteers. Social workers, chaplains, and bereavement counselors work with patients' families for up to a year following death. Services are provided in patients' homes, nursing homes, or acute care hospitals. Hospice care is less expensive than aggressive acute care for the terminally ill. It is estimated that every dollar of hospice care saves a dollar and a half in Florida. Hospice services began in the United States in the 1970’s and were approved for government reimbursement in the 1980’s. Routine home hospice care is reimbursed at a per diem rate, for which the hospice provides care, and pharmaceutical drugs and supplies. Hospices also receive financial support from fund raising activities, and typically provide substantial community services which are otherwise unfunded and not reimbursed. These include community outreach programs in churches and schools, and services to families in which a death was accidental. In 1985, the national hospice penetration rate or P Factor (the percentage of total deaths in which patients received hospice care) was approximately 8 percent. By 1995, the P Factor had increased to 17 percent, with the greatest rate of growth in the most recent five years. In Florida, approximately 29.6 percent of all deaths occur after a person has been admitted to a hospice program. In service area 1, the P Factor is 21 percent. Bay Medical Center BMC is a legislatively - created independent special governmental district, authorized initially to provide health care services to Bay County, but now also to surrounding areas. It operates a 353-bed public, not-for-profit full service hospital in Panama City, Florida, but does not receive tax support. Over 190 physicians staff BMC’s hospital with every specialty, except rheumatology, endocrinology, and neonatology. BMC’s tertiary services include an open heart surgery program. BMC also provides ambulatory or outpatient services. Since 1992, BMC has operated a hospice program in service area 2A, with offices in Panama City (on the campus of the BMC hospital) and in Marianna. The Marianna office opened in February 1997, as a result of the Florida Legislature's 1995 amendment to the enabling legislation allowing BMC to offer services beyond Bay County. The 1995 legislation also expressly authorizes BMC to provide hospice services and to create other organizations to further its mission. The Board of Directors of BMC created the Bay Medical Center Hospice (BMCH). BMCH is governed by a board of directors which is separate and distinct from the board of BMC, although BMC is the entity licensed to operate the hospice program in service area 2A. The BMCH board members live and work in each of the six counties of service area 2A. BMC, which holds the existing license, is the applicant in this proceeding. The board of BMC met on the day that the letter of intent was due, February 19, 1996. A few days prior to the meeting the Chairman of the Board executed the letter of intent, and sent it to a health planning consultant in Tallahassee. After the Board met and passed the resolution authorizing the filing of the letter of intent, the consultant filed the letter of intent with AHCA in Tallahassee. In service area 2A, BMCH has an average daily census of 58-64 patients. BMC projected and HNWF stipulated that BMC can reasonably attain 250 admissions for a total of 12,471 patient days in year one, and 300 admissions for 18,706 patient days in year two of operation in service area 1. BMCH currently advertises its hospice services on television and radio stations, and in newspapers with coverage extending into service area 1. Fund-raising events, including the holiday tree lighting program, are used to market hospice services. Hospice services are also explained in newsletters which reach 27,000 households and all physicians in the area. BMC purchased over 100 sixty-second radio spots, which aired on three stations over a two month period in 1996. The hospice radio spots reached an estimated 87,000 people an average of five times each. BMC estimates a total project cost of $129,591, if CON 8377 is approved, to extend hospice services into service area 1. BMC proposes to condition CON 8377 on the provision of a minimum of 12.8 percent Medicaid and 3.65 percent charity care by the end of the second year of operation, and the care of 7 AIDS patients (with a minimum of 350 total visits) each year. Hospice of Northwest Florida HNWF is an existing provider of hospice services in AHCA service areas 1 and 2A. It is the only licensed hospice in service area 1 and competes with only BMC in 2A. HNWF, organized by hospitals in Pensacola, was issued a CON in December 1982 and a license in 1983, to operate a hospice in Escambia, Santa Rosa, Okaloosa, Walton, Holmes, Washington and Jackson Counties. The home office of HNWF is located in Pensacola. HNWF admitted its first patients and families in January 1984. In 1987, HNWF opened a branch office in Fort Walton Beach, later apparently consolidated with a Niceville office, to serve Okaloosa and Walton Counties. An additional branch office was opened in Marianna in 1991. An adjunct medical director for the Marianna and Niceville offices was hired in 1996. In December 1995, HNWF received a CON waiver and its license was amended to allow it to operate in the remainder of service area 2A, in Bay, Gulf, and Calhoun Counties. HNWF then opened a branch office in Panama City, in August 1996. HNWF also operates, and is expanding from six to eight beds, a residential facility in Pensacola, to house hospice patients without homes or without at-home caregivers. Prior to opening the Panama City office, HNWF historically served Holmes, Washington, and Jackson Counties, while BMCH served patients in Bay, Gulf, Washington, and Calhoun Counties. From 1993 to the present time, HNWF has increased its contracts or agreements from the Pensacola hospital to all of the hospitals in the service areas, including two military hospitals, from none to virtually all assisted living facilities, and from five to all except two or three nursing homes. HNWF operates an extensive outreach and educational effort, including a monthly half-hour television show, which is estimated to reach over 200,000 people in Escambia and Santa Rosa Counties. Other efforts include radio talk show appearances, speaking engagements reaching over 5,000 people in 1996, and extensive direct physician contact. HNWF also relies on it chaplaincy and bereavement programs to extend information about hospice care, particularly to culturally diverse groups of people. Despite these efforts, the number of hospice patients in service area 1 has remained relatively constant. HNWF served 969 patients in calendar year (CY) 1995, and 963 in CY1996. HNWF contends that its lack of growth is due, in part, to declining referrals from nursing homes despite increased referrals from other sources. HNWF attributes the nursing home decline to government investigations of suspected excessive nursing home reimbursements. There is no waiting list for HNWF's services, and its goal is to admit patients within 24 hours of referral. HNWF criticized BMCH’s outreach efforts as inadequate and misdirected, attracting only “easy” patients, those easily diagnosed as qualified for hospice care by well-informed referral sources. On this basis, HNWF expects BMC to take hospice patients from HNWF and not from any growth in hospice patients. HNWF also expects competition from BMC to adversely affect its ability to provide enhanced and unfunded services, including bereavement services in schools, on military bases, and in work- places, and its ability to operate satellite offices and the residential facility. Revenues from patient care are supplemented by donations and grants. In 1992, HNWF established a foundation to coordinate fund raising efforts. The approval of the BMC application, according to HNWF, will also affect the types of hospice services available in the area. In general, more sophisticated hospice services can be provided by larger hospices, including palliative chemotherapy and radiation. BMC’s expert testified that HNWF will continue to be a large hospice with or without the approval of a CON for BMC, and that the additional program will create additional demand for the service. The parties stipulated that subsections 408.035(1)(m) and (3), Florida Statutes, and Rule 59C-1.0355(7) and (8), Florida Administrative Code, are not applicable to this proceeding. At hearing, the parties also stipulated that BMC's list of capital projects meets the requirements of subsection 408.037(2)(a). Rule 59C-1.0355(4)(a) - Numeric Need; Subsections 408.035(1)(b) - like and existing services; (d) - available alternatives Rule 59C-1.0355, the hospice rule, includes the formula for calculating the numeric need for hospice programs. Numeric need exists if the projected total number of hospice patients in service area one for the planning horizon (1400 for July 1997) minus the actual number of hospice patients in the base year (969 in calendar year 1995) is equal to or greater than 350 (in this case, 431). The statewide P Factor, 29.6 percent, is used in the formula to calculate the ratio of projected hospice patients to projected total deaths. The statewide rate represents the normative minimum applied to each service area by operation of the formula in the rule. In service area 1, the P Factor in the base year was 21 percent. The statewide P Factor is an average of rates for various disease categories and ages. Those rates range from a high of hospice care for 70.9 percent of deaths due to cancer in people 65 and over, to a low of 14.1 percent for people under 65 with all other diseases. BMC cites HNWF's relatively low hospice penetration rate as proof of the need for an additional hospice program to create and accommodate additional potential demand. HNWF asserts, however, that certain local circumstances cause the deviation from the statewide P Factor. HNWF also contends that more people received hospice services than the number used in the formula for the base year. The result, according to HNWF is an excess projected demand for hospice services by the July 1997 planning horizon. The extenuating local circumstances cited by HNWF, are the sizable active duty military population, the strong Medicaid AIDs program, the aggressiveness of home health agencies, the prevalence of cancer centers, and the established practice parameters of medical doctors in the service area. The number of active duty military in service area 1 is 23,162. The number of those who die from terminal illnesses is statistically insignificant, because it is military policy to retire personnel who are diagnosed with terminal illnesses, which enhances death benefits to survivors. BMC's expert confirmed that policy and the improbability of serving military patients, although HNWF has served military base families after active duty casualties. Military families represent some of those served by HNWF in the base year, who are not included in the numeric need formula as hospice admissions. In the numeric need formula, according to BMC's expert, military personnel are included in projected deaths to younger age cohorts from causes other than cancer. Of the 431 projected additional hospice admissions, BMC’s expert calculated that, at most, 3 projected hospice deaths of those result from including the active duty military population. By contrast, HNWF's expert testified that the military population of 23,162 multiplied by the statewide death rate of .008 results in an estimated 186 deaths, or approximately 62 hospice patients. The background information in support of the fixed need pool, prepared by AHCA, shows that AHCA calculates projected hospice patients by age and disease. The actual base year service area non-cancer deaths under 65 (1010) divided by the actual service area total deaths (4562), times total projected deaths (4816) gives the total projected deaths non-cancer under 65 (1066). Of the 1066 deaths, 150 are expected to be hospice patients. It is not reasonable to assume that 186 deaths will occur among active duty military, or that 62 of the 150 non- cancer hospice patients under 65 will be in that group. It is more reasonable to assume, as BMC's expert did and as the state numeric need methodology does, that the age cohort of that group has and will continue to have a significantly lower death rate and lower hospice admissions than the 65 and over population. HNWF's expert health planner was unable to distinguish service area 1 from the rest of the state in terms of the strength of the Medicaid AIDs waiver program, the presence of prisons, the existence of home health agencies, the presence of cancer centers, or physicians' practice patterns. Similarly, BMC's expert found no statistical relationship between home health agency visits and hospice utilization. BMC's expert also noted that some hospices provide services to prisoners. HNWF's expert agreed that there is no prohibition to providing hospice services to prisoners. In some areas of the state, such as Gainesville and Tampa, cancer centers co-exist with high levels of hospice utilization. There was no evidence to distinguish physicians' practice patterns in service area 1 from the areas of the state. The argument that HNWF served more than the reported 969 in the base year, through it AIDs support groups, in schools, and for families in which deaths were accidental also does not distinguish HNWF. The evidence shows that hospices typically provide services to persons other than patients and their families, and benefit in terms of marketing and fund-raising. The incidence of AIDS in service area 1 is below that of the state. That could affect the gap between 21 percent and 29 percent, by approximately 3 or 4 percent. Late referrals to hospice services can adversely affect utilization rates. The federal government program, Restore Trust, initiated a HCFA Inspector General's investigation into charges of waste, fraud, and abuse in nursing homes and home health agencies. The decline in referrals to hospice programs coincided with the investigation, while hospice referrals and admissions in non-nursing home settings increased. There is no evidence, however, that service area 1 nursing homes were subject to more intense scrutiny than any others in the state. In fact, the Executive Director of HNWF testified that the effects of Restore Trust were national. The active duty military population difference of 3 fewer projected hospice deaths, and the 3 or 4 percent gap in the P Factor due to the lower incidence of AIDs are insufficient to explain the gap between P Factors of 21 and 29 percent. BMC's expert's estimate that ninety percent of the gap results from the lower than average P Factor is, at most, reduced to eighty-six percent. From 1994 to 1996, as the hospice utilization statewide reached 27.7 percent, the rate increased from 22 to 27 percent in service area 2A. By contrast, the rate increased from 17 to 22 percent in service area 1. For the six months ending December 31, 1996, the rate in service area 1 declined to 18 percent, while that in service area 2A increased to 24 percent. One of the highest rates in service area 2A is in relatively rural Washington County, in which BMC and HNWF have the greatest overlap in services. HNWF has approximately 60 percent and BMC has 40 percent of the hospice market in Washington County. In western Washington County, hospice rates range from 27 to 100 percent, with the remainder of the county in the 18 to 27 percent range. In service area 2A, there has been a steady increase in hospice admissions for HNWF and BMC, except for a decline at BMC immediately after HNWF opened an office in Panama City. Subsection 408.035(1)(a) - need in relation to district and state health plans; Rule 59C- 1.0355(5) and (4)(e) District health plan allocation factor one favors applicants having hospice services available seven days a week, district-wide for 24 hours a day as needed, regardless of a client’s ability to pay. BMCH currently complies with the requirement in service area 2A and can do so in service area 1. By carefully selecting patients, hiring staff in appropriate locations to serve the patients, and expanding slowly geographically, as HNWF has done, BMC can meet the requirements. Initially, BMC will focus on adjacent Okaloosa and Walton Counties. District allocation factor two, for proposals to add beds or use existing inpatient facilities rather than construct new facilities, is met by BMC. By proposing to contract with existing hospitals and nursing homes, BMC also meets the preference in Rule 59C-1.0355(4)(e)2. State health plan preference one, for applicants who seek Medicare certification, is consistent with BMC’s current and proposed operations. State health plan preference two favors members of the National Hospice Organization ("NHO") and applicants accredited by the Joint Commission on Accreditation of Health Care Organizations ("JCAHO"). BMCH is a member of the NHO. BMC is JCAHO-accredited, after receiving a rating of ninety-six of a possible one hundred in the scoring system in December 1996. Recently, BMCH was separately surveyed by the JCAHO, and received favorable exit comments. BMCH is also annually surveyed by AHCA, which identified no deficiencies in its January 1996 report. BMCH and HNWF each had one complaint regarding practices and procedures in 1996. A BMCH nurse disposed of controlled drugs when no longer needed in the patient's home, without the required signature of the patient's family representative on the disposal record. HNWF received a complaint and disciplined the responsible admitting nurse who failed to convene the appropriate staff to timely prepare an Interdisciplinary Care Plan. Neither incident indicates that the hospices are not providing a high quality of care. It is reasonable to expect BMC hospice to meet the requirements of the preference and to provide appropriate hospice care. See, also, subsection 408.035(1)(b) and (c), on the quality of care of the existing hospice and the applicant’s ability to provide quality of care. In proposing to establish a physical presence in rural, underserved Walton County, BMC meets state preference three and the preference in Rule 59C-1.0355(4)(e)4. State health plan preference four for applicants proposing to meet unmet needs of specific groups, such as children, is consistent with BMC's current and proposed operations. The same preference is also a requirement of Rule 59C-1.0355(4)(e)1. State health plan preference five favors applicants proposing residential services to patients without at-home assistance. BMC proposes to provide caregivers or to use existing inpatient facilities to provide residential services. The proposal is, therefore, also consistent with Rule 59C- 1.0355(4)(e)3 as it relates to those who are without primary caregivers at home or who are homeless. The sixth and final state health plan preference, for hospices proposing to use additional beds in existing facilities rather than new construction, is not applicable to the BMC proposal. On balance, the BMC application meets the preferences in the rule, and in state and district health plans. Subsection 408.035(1)(b) and (1)(d) - availability and quality of like and existing services; other alternatives Alternatives to hospice care include home health, acute, and nursing home care, all of which are available. The state policy, as reflected in numeric need methodology, encourages the use of hospice services until every service area achieves the state norm. Consistent with that policy, theoretically, HNWF could be even more aggressive in marketing and outreach than it has been. Historically, for BMC and HNWF, however, hospice services are more available, more accessible, better utilized, and higher in quality of care in areas in which they compete. Subsection 408.035(1)(c) - economics and improvements of joint, cooperative or shared resources Because BMC operates an existing hospice, it is reasonable to expect economics of scale and improvements based on its experience, if it establishes a second hospice. BMC expects to use existing human resources and billing departments. Subsection 408.035(1)(f) - need for special equipment or services not available in adjoining areas The statutory criterion is inapplicable to the case. Subsection 408.035(1)(g) and (h) - need for research, educational, health professional training BMC's is not a proposal which is intended to assist a research or educational program. In-service and volunteer training programs are proposed for the benefit of its staff and to assure the quality of its own services. Subsection 408.035(1)(h) - available manpower, management personnel; (1)(i) - immediate and long-term financial feasibility of the proposal BMC has over $21 million in cash, and revenues and gains in excess of $4 million for the year ending September 30, 1995. BMC has and continues to generate sufficient funds to provide over $24 million for planned capital projects over the next two years, including $129,591 in costs for the additional hospice program. BMC’s proposal is financially feasible in the short term. HNWF claims that the BMC proposal is not financially feasible in the long term, based on understated salaries, wages, and benefits, travel expenses, depreciation, and interest. Salaries, wages, and benefits are based on the staffing ratios at BMCH, which, according to HNWF, serves a more concentrated population in Panama City. Initially, BMC plans to serve Okaloosa and Walton Counties from a Destin office, with staff appropriately located throughout the areas to timely and efficiently serve patients. BMC plans to hire 6.6 full time equivalent (FTEs) administrative staff and 11.4 FTEs patient care staff. HNWF asserts that BMC will need an additional 1.7 FTEs for nurses, 2.6 for home health aides, and 1 FTE for a social worker. HNWF also questioned the ability of BMC to implement its proposed children's programs without a registered nurse with pediatric experience. HNWF asserted that .4 FTE for a chaplain was inadequate, as is reliance primarily on volunteer chaplains. The adequacy of the proposed staffing is supported by calculating the 50 day average length of stay times the annual volume of 250 patients, times 1.6 (the projected worked hours per patient day), which equals 10.85 FTEs for patient care. BMC's 11.4 FTEs for patient care in year one is a reasonable, conservative complement of staff. In addition, HNWF received 19 percent of its 1996 hours worked from volunteers, and has a history of hiring specialized staff and establishing specialized programs and departments when justified by the demand for those services. For its first seven or eight years, HNWF was well- served by a volunteer medical director. The bereavement coordinator was hired in 1990. The children's bereavement specialist was hired in 1993, when bereavement and social services became separate departments. Travel expenses, projected by BMC, were also criticized by HNWF. HNWF would increase miles for each visit from 13.9, as estimated in BMC’s CON application, to 18.3 miles per visit as experienced by HNWF. One assumption, which invalidates HNWF’s projection of travel distances, is that each separate visit will originate and end at the Destin office, not that BMC staff would make some visits going directly from their residences to the patient's home, or that they would arrange schedules to make several visits without returning to the office between each visit. In addition, BMCH will initially cover two counties rather than the entire service area. As a result of a mathematical error in the BMC CON application, the depreciation expense for year one of operations is $25,578, not $21,962. HNWF's expert's adjustments to interest expenses assumed that any additional expenses would require additional borrowing. BMC, however, has not materially underestimated expenses, considering the $3,616 difference in depreciation. The pro forma is conservatively based on revenues and expenses without reliance on charitable donations, although hospices typically depend on donations to break-even financially. In 1996, HNWF received a total of $339,780 in contributions. To estimate what BMC might expect in District 1, it is reasonable to exclude from HNWF's experience, approximately $80,000 in interest on reserve invested income (used by HNWF in 1996) and $90,000 in grants, since BMC has not applied for any grants. The balance, representing memorials and fund-raising of $240,000 reasonably indicates the level of contributions which a new BMC hospice might expect in service area 1. That level, for BMC, is proportionately half that projected by BMC, or $60,000 to $80,000 in year one, and $130,00 to $185,000 in year two of operations. With a projected loss in income of $28,091 in year one, a projected profit of $74,054 in year two, and considering historical hospice fund-raising, BMC's operation of a hospice in service area 1 is reasonably expected to be financially feasible in the long term. Adverse Impact Subsection 408.035(1)(l) - probable impact on costs, effects of competition. Using BMC's experts' utilization projections for service area 1, HNWF projects that its net operating income will decline from a negative $408,070 to a negative $655,712 in year one, and from a negative $355,404 to a negative $612,696 in year two. Approximately $420,000 in total contributions to HNWF is expected each year, although that number has increased annually since 1993, from 183,750, to $224,415 in 1994, to $282,368 in 1995, and $339,780 in 1996. BMC suggests that the adverse impact analysis should consider HNWF's total operations in service areas 1 and 2A to determine financial feasibility. Health planning experts for both BMC and HNWF acknowledge that there are up to 431 more people available for hospice admissions than are currently receiving hospice services. They also agree that number will increase by approximately 100 a year as the population increases, and that the presence of a new hospice provider will increase hospice penetration rates. In addition, as HNWF's witnesses emphasized, nursing home hospice admissions were depressed temporarily due to a government investigation. BMC’s expert also noted that, as long as available admissions exist, increasing hospice utilization is largely a function of how the hospice delivers its services. For example, the historic requirement that patients have a caregiver at home has adversely affected HNWF’s penetration rate. As recently as November 1996, at least one referral source, Sacred Heart Hospital, in Pensacola was distributing an HNWF brochure which specifically required an eligible hospice patient to have “[a] capable caregiver in the home to meet the patient’s day-to-day basic needs." Essentially, the same requirement is included in a list of admissions criteria on page 49 of BMC's CON application. HNWF and BMC have both changed their policies and now admit patients without caregivers, which is reasonably expected to increase admissions of patients. With competition to identify and alleviate access barriers, HNWF and BMC are better able to increase hospice utilization rates by eliminating self-imposed constraints. Based on the rapid increase in hospice utilization in service area 2A after HNWF began to compete with BMC, it is reasonable to assume the same effect of competition in service area 1. By the year 2000, BMC's expert reasonably projects hospice penetration rates of 29 percent in service area 1, equaling the current statewide average. As the late entrant into a limited geographical area within the market, BMC is projected to capture approximately one-third of that market by the years 2000 to 2001, leaving two thirds for HNWF. At the same time BMC and HNWF are reasonably expected to divide in half the market in service area 2A. At those levels, HNWF will range, in total projected admissions for both service areas, from 1,186 to 1,400, from 1997 to 2001. The evidence that a BMC hospice in service area 1 will not adversely impact HNWF is more persuasive. The suggestion that health care providers or the public will be confused by the presence of BMCH in service area 1 is rejected. Subsection 408.035(1)(n) - The applicant’s past and proposed provision of health care services to Medicaid patients and the medically indigent. BMC is a disproportionate share Medicaid provider, having historically provided over 97 percent of all indigent care in Bay County. In 1995, the charity care write-off was over $8.5 million. The effect of approving BMC’s CON is increased hospice penetration in service area 1, caused by an expanding market for hospice services. As a disproportionate share provider of inpatient acute care services, BMC is uniquely capable of identifying and referring low income patients for hospice care. Subsection 408.035(1)(0) - The applicant’s past and proposed provision of services which promote a continuum of care in a multilevel health care system, which may include, but is not limited to, acute care, skilled nursing care, home health care, and assisted living facilities. BMCH is a part of a multilevel system with levels of care ranging from a 353-bed acute care tertiary hospital to a home health agency. Because of 1995 legislation, these services are available to persons beyond the boundaries of Bay County. Consistent with this statutory criterion, hospice services should also be extended.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency For Health Care Administration enter a Final Order issuing CON 8377 to Bay Medical Center to establish a hospice program in service area 1, conditioned on providing annually a minimum of 12.8 percent Medicaid care, 3.65 percent charity care, and service to a minimum of 7 AIDs patients with a minimum of 350 visits. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 19th day of May, 1997. ELEANOR M. HUNTER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 19th day of May, 1997. COPIES FURNISHED: Richard Ellis, Senior Attorney Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Darrell White, Esquire William B. Wiley, Esquire McFarlain, Wiley, Cassedy & Jones, P.A. Post Office Box 2174 Tallahassee, Florida 32315-2174 J. Robert Griffin, Esquire J. Robert Griffin & Associates, P.A. 2559 Shiloh Way Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency For Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Jerome W. Hoffman, General Counsel Agency For Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403