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JOHNSON AND JOHNSON HOME HEALTH CARE, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 83-002198 (1983)
Division of Administrative Hearings, Florida Number: 83-002198 Latest Update: Jul. 02, 1984

Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: Petitioner J & J seeks a Certificate of Need to establish a new home health agency in the Tampa Bay area to serve the residents of Hillsborough, Pinellas, Pasco, and Manatee Counties for an estimated project cost of $85,000. All necessary funding for the project is to be supplied by petitioner's parent, Johnson and Johnson. It is the expressed intent of J & J to provide only specialized patient services in the home to those patients who are acutely ill and in need of intensive or intermediate level clinical services in lieu of hospitalization. J & J intends to serve early hospital discharge patients who require more than single follow-up or maintenance care after discharge. It does not seek to provide maintenance-level care to patients, and would refer such patients to another home health agency. J & J does not intend to become a part of hospital rotation lists utilized to refer the less acutely ill homebound patient to a home health agency. J & J proposes to hire full-time clinical specialty certified registered nurses to provide services to ten general categories of patients. The specific diagnoses or treatment modalities which J & J expects to provide include cerebrovascular accident (CVA or stroke) with and without paralysis, oncology and chemotherapy, hyperalimentation, enteral therapy, respiratory therapy, intravenous antibiotics, other nutritional services and neuro-ortho. These proposed services are intended to be a replacement for more expensive in- hospital health care. J & J intends to accept only those patients within the above classifications who are sick enough to require home health care in lieu of hospitalization, and not those who can be treated strictly on an outpatient basis. The key factor for acceptance of a patient by J & J is not the diagnosis of the patient, but is the patient's acuity level. J & J has an ongoing research program to develop additional clinical specialty home health services based upon physician input, technical developments end patient needs. One of its reasons for establishing a home health agency in the Tampa Bay area is because J & J's national corporate headquarters are to be located in Tampa and this proximity would facilitate its research and development efforts. J & J has staffed its existing home health agencies in Texas and California, and proposes to staff its Tampa agency, with full-time nurses with acute care experience. Orientation continuing education programs for nurses are planned. The nurses are to be either certified as clinical specialists or develop their clinical expertise through J & J's own internal privileging program. The proposed new agency, as do the existing Texas and California agencies, will have its own pharmacist, therapists, dieticians, social workers and certified home health aides. It will also operate its own pharmacy and will provide and deliver durable medical equipment and supplies. Nurses will be on duty and/or on call 24 hours a day, seven days a week. As noted above,' J & J seeks to serve those patients who require special expertise in their care. Planning for discharge will begin during the patient's hospitalization and there will be a patient screening process before a patient is accepted. An assessment of the patient's home and family life will be made to determine that conditions are suitable for treatment and recovery at home. A registered nurse is to be assigned as the "primary nurse" to coordinate the patient's plan of care with the clinical specialist, therapists and physician. The patient's physician is to be given a weekly report of the patient's progress. An elaborate charting and recordkeeping system is anticipated and is provided at J & J's existing home health agencies. A prospective, con current and retrospective quality assurance program is to be instituted which involves a quarterly internal review and a utilization review by physicians. Based upon statistics which illustrate that 26,800 patients for every one million population group are discharged annually in the ten classifications which J & J seeks to serve, J & J predicts it can treat 1,430 patients per year in the four- county area. These figures are based on nationwide statistics and are not site-specific to the four-county area. J & J presently owns and operates three existing agencies in Texas and California. Certificates of need for home health agencies are not required in those states. The Dallas/Ft. Worth center opened on April 4, 1983, and had, as of the time of the hearing in this matter, a daily patient census of 70. The Houston center opened on April 11, 1983, and had a daily patient census of 60. The daily patient census at the Los Angeles center, which opened on July 6, 1983, was 60. These existing agencies also accept only specialty care patients who can receive services in lieu of hospitalization. The Texas centers have rejected as many as 47 percent of their referrals because the patients either did not meet the medical criteria for the J & J system, because of their home situation or, in some instances, because of financial reasons. In California, the charge for a visit by a registered nurse is $75.00, while the charge for a therapist visit is $65.00. The charges in both Texas centers are, and the proposed Florida center will be, $65.00 for a registered nurse's visit and $55.00 for a therapist's visit. All these charges are higher than the current cap or limit for Medicare reimbursement. The Petitioner's projected cost for an R.N. visit is $52.40. This cost is higher than the current Medicare cost cap for skilled nursing services. After the Florida four-county agency becomes fully operational, J & J projects that only 23 percent of the patients it serves will be Medicare patients. It is anticipated that the remaining patients will be primarily private pay, privately insured or self-insured patients who will be attracted to the J & J program because of its cost-savings potential. The existing operations in Texas and California serve 60 to 70 percent Medicare patients. These percentages are expected to decline due to J & J's efforts to educate and convince private reimbursers to use J & J's services in lieu of hospitalization. A large public relations firm has been retained by J & J to communicate with insurers end the medical community regarding the benefits of clinical, specialized home health care, especially as a replacement for hospital care. The patient mix of most of the existing licensed home health agencies in the four-county area is in excess of 95 percent Medicare. A license and certificate of need are only required under Florida law for home health agencies which serve Medicare patients. At least some of the existing agencies have accordingly severed their operations into those which serve and those which do not serve the Medicare patient. J & J does not believe it would be feasible to open its four-county agency as an unlicensed and uncertificated agency to serve only private pay patients because it believes that licensure will be helpful in convincing private insurers to use its agency. Also, a patient may begin his treatment as a non-Medicare patient, but bay later qualify for such benefits, and J & J desires to provide a continuity of treatment. Although J & J's proposed charges and costs are higher then the Medicare reimbursement system currently allows, J & J will attempt to obtain a waiver of the Medicare cap by demonstrating the highly specialized nature of the services it provides and by illustrating that J & J's home health care is in lieu of more expensive hospital care. Although J & J does not plan to serve all patients regardless of their ability to pay, it has and will continue to provide care to indigent and medically indigent patients. Approximately 20 such patients have been served in the existing agencies in Texas and California. There are approximately thirteen licensed home health agencies in Hillsborough, Pinellas, Pasco end Manatee Counties. Eleven of these agencies are members of FAHHA, a voluntary association whose membership is comprised of home health agencies licensed by the State of Florida. Though some of the existing agencies have expanded their operations by the opening of new submits in other areas, there have been no Certificates of Need issued to any new home health agency in the four-county area since 1978. The intervenor Gulf Coast provides home health services in Pinellas, Pasco and Hillsborough Counties, as well as Hernando County, through six different offices. In addition to providing maintenance and homemaker services to its patients, Gulf Coast provides most, if not all, the same specialty services proposed by J & J. Their patients include CVA patients with and without paralysis, oncology patients of which two are receiving I.V. chemotherapy at home and several hyperalimentation patients. Gulf Coast provides enteral and respiratory therapy, as well as I.V. antibiotic services. Its staff, which includes approximately 90 professionals, 140 ancillary staff and 50 contract personnel, includes socialists in the areas of pulmonary nursing, enterostomal therapy, oncology and psychiatric nursing. Gulf Coast has recently started an I.V. certification program for its nurses. Approximately one-third of the nurses have bad a year or more of prior experience in critical care units. A registered nurse is on-call 24 hours a day. Quality control assurances include monthly utilization review, both in-house and by a physician. Gulf Coast makes arrangements with local vendors and suppliers for all durable medical equipment and pharmaceutical supplies needed by its patients. It has experienced an annual growth in its average daily census of between 15 and 20 percent, and its administrators feel that it has the capacity to expand its services, even with its present staff, in the event of greater demand for the more specialty-type services proposed by J & J. Gulf Coast's current Medicare cost cap for registered nursing services is approximately $48 to $50 per visit. Its actual costs for such services, for which it is reimbursed, are approximately $37 or $38 per visit. The Intervenor Manasota is one of six licensed home health agencies in Manatee County. All its patients are Medicare patients, and some 70 percent of its referrals are hospital referrals from the two existing hospitals in Manatee County-- Manatee Memorial Hospital and Blake Hospital. In addition to maintenance level and homemaker services, Manasota has provided more specialized services to patients including nasogastric, gastrostomy, stomal, enterostomal and I.V. antibiotic therapy. It has the staff and capacity to provide chemotherapy and hyperalimentation, but has not bed any physician request for those services for their patients. Manasota has experienced a significant decline in the number of new patients it has admitted end in its average daily census. This appears to be related to the reduction in the number of discharges from Manatee Memorial Hospital and the fact that Blake Hospital owns its own home health agency. The decrease in patient census et Manasota has resulted in an increase in its cost per visit from $32.50 to $41.00 per visit. The Medicare cost cap for Manasota is approximately $44.30. Manasota has the capacity to expand to serve an increased number of Medicare patients. Blake Home Health is affiliated with Blake Hospital in Manatee County, and receives 75 percent of its referrals therefrom. It is the policy of Blake Hospital to refer all discharged hospital patients who require home health care to Blake Home Health unless the attending physician has specifically designated a different agency. Blake is available to serve its patients 24 hours a day end has access to the hospital pharmacy. It presently renders services in the areas of enteral, stomal end parenteral therapy and handles cerebrovescular cases. While nurses are available to Blake Home Health to perform I.V. antibiotic therapy and chemotherapy, Blake has never been requested to perform such services. Independent Home Health is an existing licensed home health agency located in Clearwater, and was recently purchased by Morton Plant Hospital. Independent presently provides and has performed all the specialized, home health services proposed by J & J. It operates 24 hours a day, with a nurse on call after 5:00 p.m. Its quality assurance program involves a monthly nursing audit and quarterly utilization review by a physician. Its charge for nursing services is $40 per visit. Independent has the ability to expand to provide further services. Global Home Health Services, Inc. has five offices in the four-county area, with a total average daily census of approximately 400. Global performs almost all of the specialized services proposed by J & J and has never had a request for services in those categories that it was unable to fulfill. The number of patients receiving home chemotherapy and hyperalimentation is very few, due to lack of demand for such services. It is open seven days a week, 24 hours a day. Global charges $47.00 per nursing visit, and makes all arrangements for the ordering and delivery of supplies, durable medical equipment and pharmaceuticals. Global has the ability, even with its present staff to serve 20 or 305 more patients and to expand the range of services it presently provides. The Visiting Nurses Association of Hillsborough County (VNA) is a public non-profit home health agency that serves any patient regardless of age, race or ability to pay. It provides all the services which J & J proposes to offer, although only about 3 percent of its total patients receive these specialized services. The VNA has its own continuing education programs and also conducts training programs for other home health agencies, specifically in the areas of I.V. chemotherapy and I.V. antibiotics. VNA offers 24-hour services, and has the ability and capacity to expand to meet any increased need or demand for home health services. Its cost per nursing visit is about $29, and it charges $35 per visit. Its average patient census 1as increased from 212 in 1980 to 720 in 1983. The existing agencies rely heavily on referrals from hospital rotation lists. None of the existing agencies about which evidence was adduced at the hearing have their own pharmacy or durable medical equipment or supply services. Many agencies, if not most, use some independent contractor, therapists on an as-needed basis. While each of the existing agencies experienced a growth in their average daily census in the Veers between 1980 and 1983, some agencies experienced a slight decrease in the number of patients and visits during the six months immediately prior to the hearing. Increased home health utilization in the future is suggested due to the new Medicare reimbursement system for hospitals. This system is based upon diagnostic-related groups (DRG's) and the amount of reimbursement is based upon the average length of stay for a given diagnosis, regardless of the patient's actual length of stay. The former system reimbursed hospitals for their actual costs of treating a patient. The DRG system will provide hospitals with the financial incentive to discharge patients at the earliest possible point. It can be expected that demand for home health care services for more acutely ill early discharge patients will increase. Officials responsible for discharging patients from Tampa General Hospital and St. Joseph's Hospital in Tampa were of the opinion that the existing home health agencies in Hillsborough County were doing a fine job in providing follow-up care of both chronically ill patients end those patients who are acutely ill with a good prognosis. While these persons were in favor of the adequate provision of more advanced and intensive home health care, they believe that their current needs are being met by the existing agencies.

Florida Laws (1) 400.462
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ALLSTAR CARE, INC. vs AGENCY FOR HEALTH CARE ADMINISTRATION, 96-004064CON (1996)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Aug. 28, 1996 Number: 96-004064CON Latest Update: Nov. 10, 1997

The Issue Whether any or all of the applications for certificates of need to establish medicare-certified home health agencies in Broward County (AHCA District 10) by Petitioners Allstar Care, Inc.; Medicorp Home Health Care Services; and Medshares of Florida, Inc., should be approved by the Agency for Health Care Administration.

Findings Of Fact The Parties Allstar Allstar Care, Inc., with its offices in Miami, is a Florida corporation that operates a licensed Medicare-certified home health care agency in Dade County. It serves, principally, patients aged 65 and over who are Medicare- and Medicaid-eligible by providing them at home: skilled nursing; physical therapy; occupational therapy; speech therapy; and the services of home health aides, when provided physician's order to do so. It also serves at-home indigents with like services when provided appropriate physician's orders. In 1996, Allstar provided a total of 122,000 visits. Fifty percent of them were by home health aides providing assistance with the patients' daily living needs, such as bathing, oral care, dressing, and assistance with meals. Forty- five percent of the visits were by skilled nurses. In addition, licensed social workers employed by Allstar provided social and emotional support for the patient and the patient's family. From 1994 to date, Allstar has provided Medicare- certified home health services in Dade County. It is reasonable to expect that Allstar will provide the same range of services that are described in its application for Broward County that Allstar currently provides in Dade. Medicorp A sister home health agency to Medcorp Home Health Services, Medicorp Home Health Services is a home health agency that serves patients in Wilton Manors and Oakland Park in Broward County, Florida. Although not Medicare-certified, it is Medicaid-certified. Medicorp was founded primarily to bring services to unserved and underserved areas, particularly "the projects," (Tr. 13,) in Broward County, that is areas of low-income housing the building of which was financed by the federal government's Department of Housing and Urban Development. Commencing operations in 1991 with an initial investment of $8,000 and as its only employee, current owner and administrator Beverly Cardozo, LPN and certified respiratory therapist, Medicorp has experienced rapid growth. Last year it grossed $1.8 million. Medshares Medshares of Florida, Inc., is a member of the family of Medshares companies commonly referred to as "Medshares." Medshares provides various home health services, such as Medicare-certified home health services; private nursing services; management services for home health agencies; infusion services; and consulting services. Medshares began in Tennessee in 1985 and since that time has expanded to operation in nine states with 52 locations. In 1996, Medshares provided approximately one million visits through its Medicare-certified home health agencies and approximately 1.7 million visits through its non-Medicare-certified and managed home health agencies. Medshares' long-range plan includes development of Medicare-certified agencies through the southeast. Development of such an agency is a logical step for Medshares, since Medshares currently operates in several other southeastern states. Medshares experiences a low-employee turnover rate of approximately 50 percent, which is less than half of the national average for home health operations. Medshares attribute this low turnover rate to its participatory management style as well as its employee benefits packages. For example, Medshares offers educational packages to any of its employees who wish to further his or her education. For its nurses, Medshares funds the cost of nursing certification by the American Nurses Association. AHCA The Agency for Health Care Administration is the "single state agency [designated by statute] to issue, revoke or deny certificates of need . . . in accordance with the district plans, the statewide health plan, and present and future federal and state statutes." Section 408.034(1), Florida Statutes. Petitioners: Non-competitors The Petitioners each claimed in the hearing that there is sufficient need in the District to support the granting of all three applications. They do not, therefore, view each other as competitors in this proceeding. Filing of the Applications and Preliminary Action by AHCA All three petitioners, Allstar, Medicorp, and Medshares, submitted timely applications for certificates of need to establish Medicare-certified home health agencies in Broward County, AHCA District 10: CON 8448 (Allstar), CON 8418 (Medicorp), and CON 8419 (Medshares). The applications were deemed complete by AHCA. Following preliminary review, however, the agency denied the applications. The State Agency Action Report ("SAAR") sets forth AHCA's findings of fact and determinations upon which the decisions were based. Allstar, Medicorp, and Medshares each filed a timely petition for hearing. The District AHCA District 10 is composed of Broward County, alone and in its entirety. The service area for review of CON applications for Medicare-certified home health agencies is the district. In this case, therefore, the service area is Broward County. In Broward County, there are roughly 190 home health agencies. Of these, however, only 35 are licensed Medicare- certified home health agencies (34 providers hold the 35 licenses). Three are approved Medicare-certified home health agencies, and another three are exempt Medicare-certified home health agencies. Need for Additional Medicare-certified home health agencies in District 10 No AHCA Methodology AHCA did not publish a fixed need pool for Medicare certified home health agencies for the July 1997 planning horizon in Florida because, at the time the Letters of Intent were filed (and when the Formal Hearing was conducted, as well), AHCA did not have any methodology pursuant to rule for projecting need for additional Medicare-certified home health agencies. Reasonable Methodologies of the Petitioners In the absence of AHCA methodology, expert health planners for each of the three petitioners developed reasonable methodologies which, when applied to data relevant in time by demographics to the case, show a need for at least a number in excess of three. Changes in the Health Care Marketplace The methodologies developed by the petitioners recognize ongoing changes in the health care marketplace that began with the implementation of the Medicare prospective payment system. The changes have progressively encouraged the use of less intensive, less costly settings for the provision of health care services. The least intensive and least costly health care service is home health care service. The tremendous demand for non-Medicare and Medicare-certified home health services beyond what would be expected due to simple population growth is the result. Use rates, therefore, are escalating beyond escalation due to population growth alone. AHCA recognizes that there has been a significant trend toward increased use of home health services. Not surprisingly, therefore, AHCA did not criticize the use of compound rates of increase to compute use rates in the need methodologies developed by any of the three petitioners. Allstar's Methodology and Determination of Numeric Need Allstar's health planner determined a need for at least six additional Medicare-certified home health agencies in Broward County for the appropriate planning horizon. The methodology used by Allstar in its application was conceptually identical to that approved in the Recommended and Final Orders in Shands Teaching Hospital and Clinics, Inc. v. AHCA, DOAH Case No. 96-4075 (Recommended Order issued 3/20/97, Final Order 5/12/97). The source of the data used by Allstar to develop its need methodology was the Medicare cost reports that existing providers file with the Federal Health Care Financing Administration, ("HCFA"). Data from 1995 was not available in the spring of 1996 when Allstar's application was filed, so Allstar used a 1994 data base period. The 1994 base period used by Allstar is the last for which data on visits was available from AHCA before the deadline for filing applications in this case. Allstar selected 1997 as the planning horizon because it usually takes one year from the date the application is submitted to get a home health care service in place. The planning horizon selected by Allstar is reasonable. Allstar relied on population estimates published by AHCA in January 1996, the most currently available populations statistics when the application was filed. Allstar received February 1996 population data from AHCA after the application was filed, but before the omissions response was due. When Allstar's methodology is replicated using the February 1996 population data, it does not substantially alter the projected numeric need. Allstar calculated a 1994 District 10 use rate by dividing the total patient visits in 1994 by the 1994 District 10 population 65 years of age and older. Use of the 65-and-older cohort is reasonable since Medicare eligibility begins at age 65 and, historically, 98 percent of all Medicare-certified home health care visits are delivered to that age group. The calculation yields a historic use rate of 6.83 visits per capita. Most use rates developed by health care planners for acute care services are constant. They assume conditions that are found in the base period will remain unchanged. Constant use rates are inappropriate in the instance of Medicare-certified home health care agencies. District 10 historical data from Medicare cost reports for the period 1989 through 1994 show use rates, ranging from 2.82 per capita in 1989 to 6.83 per capita in 1994. This dramatic increase is consistent with the increase in use rates in other AHCA districts. The combination of managed care and Medicare's prospective pay system is producing care for patients in less costly non-institutional settings like the home of the patient. Hence, home health care use rates have increased. The historical use rate trend line developed by Allstar, when extrapolated to 1997, yields 10.47 visits per capita in 1997. Consistent with conservative planning, and in an attempt to avoid either overstating or understating the horizon year use rate, Allstar averaged the trended and constant use rates for 1997, yielding a use rate of 8.65. Since a use rate of 8.65 represents the result of averaging two numbers, the 1997 projected rate is both a median and a mean. It is also both conservative and reasonable. When AHCA's population projection for 1997 is multiplied by the 8.65 use rate, the result is a projection of 2,365,443 Medicare-certified visits in July 1997. The mean agency size in 1994, measured by number of visits, was 54,101. The median number of visits in 1994 was 54,803. Dividing the average agency size of 54,101 visits into the number of projected visits in 1997 yields a gross need for 44 Medicare-certified home health care agencies in 1997. Allstar then subtracted the number 35 (representing the licensed Medicare-certified home health agencies) and another 3 (representing the approved agencies) from 44, yielding the need for 6 new Medicare-certified home health agencies. AHCA criticized Allstar's methodology on two bases. First, Allstar used population estimates published in January 1996, instead of more recent population estimates for February 1996, estimates available to Allstar at the time it filed its omissions response. Second, Allstar calculated its average or mean number of visits by using the total number of licensed Medicare-certified home health agencies in District 10, as opposed to only those licensed agencies which actually reported visits. As to the first criticism, Allstar's health planner explained on rebuttal that the January 1996 population estimates were all that were available when it prepared the application. It is true that the February 1996 population estimates became available prior to the filing of the omissions response and although "there was no . . . formal notification," (Tr. 650), Allstar became aware of their availability before it filed the response. Allstar's health planning expert examined the February 1996 data and concluded that "while different, [the data] . . . weren't significantly different." (Tr. 651). In light of the lack of any significant difference, Allstar's expert summed up the company's analysis of the problem and its approach at that moment in time this way: We had already invested a lot of energy in running the need [with the January 1996 data] and simply made the decision not to go back and redo all of that work based on the February document. (Tr. 650-651.) Since there was no "significant difference," between the January and February data, it does not seem appropriate to require the effort needed to project need based on a calculation employing the more up-to-date data, an effort that would not alter the result of Allstar's projected numeric need. In point of fact, after filing the omissions response, Allstar's expert did the analysis with the more current data and determined that the February population estimates, "had no affect on the conclusion of how many net agencies were needed." (Tr. 652.) As for the second criticism, Allstar's health planner appreciated that there was a choice to be made in its methodology between visits as to total number of licensed Medicare-certified home health agencies in District 10 and the subset of that group consisting of only like agencies which reported visits. Allstar rejected the use of only those who reported visits. By doing so, it assumed that non-reporters did not provide any visits. To do otherwise, that is, to exclude non- reporters, results in the assumption, when using an average number of visits as a component in the methodology, that the non- reporting agencies, on average, had just as many visits as the reporting agencies. Such an assumption is much more likely to be incorrect than the assumption that Allstar made. The law requires Medicare-certified home health agencies to report. In all likelihood, therefore, the non-reporting agencies did not report precisely because, being new agencies, they had no visits to report. Allstar's approach is thus the more valid approach. In short, AHCA's criticism of Allstar's methodology in this regard does nothing to alter the conclusion that Allstar's methodology is reasonable. Medshares' Methodology and Determination Although Medshares used a somewhat different methodology to determine projected need, its methodology was also reasonable. Medshares’ methodology, too, yielded projected need in 1997 for Medicare-certified home health agencies in AHCA District 10 in a number greater than three, the number of applicants involved in this proceeding. Medicorp's Methodology Medicorp's application did not contain a need methodology. At hearing, over AHCA's objection, Medicorp's expert in health planning testified as to the reasonableness of its methodology which also yielded a numeric need in excess of three. The objection of AHCA was treated as a Motion to Strike, and the testimony was allowed. As explained in the Conclusions of Law, the objection is now moot since AHCA did not provide a methodology of its own when it presented its case in chief, and since reasonable methodologies yielding numeric need in excess of the number of petitioners were proven by both Allstar and Medshares. Aside from numeric need, in the case of Medicorp, there is a special need. Special Need for Medicorp Medicorp presented evidence in its application showing the need for an agency, like Medicorp, located among and willing to focus on serving the needs of the District's underserved and, in some cases, unserved, minority and low-income residents. Medicorp's primary service area includes zip code 33311, a federally-designated area of restricted health care. As one might expect from this designation, residents of this zip code have the lowest income per capita, the highest rate of unemployment, and highest rate of Medicaid eligibility in Broward County. A large proportion of the residents of zip code 33311 live in HUD housing. And, the zip code has the highest concentration of HIV/AIDS sufferers in the county. Medicorp's Administrator, Beverly Cardozo, testified that her existing, non-certified agency, Medicorp Home Health Services, currently is providing substantially free care to up to 400 Medicare-eligible patients living in government-subsidized housing within Medicorp's primary service area. Ms. Cardozo and Medicorp have been providing this care since approximately 1994, when Medicorp instituted its "Slice of Life" program consisting of the establishment of health fairs at these housing projects. Since 1994, Ms. Cardozo has been attempting to make arrangements with a Medicare-certified agency to provide the necessary care to Medicare-eligible residents in the projects to provide care, in some cases, desperately necessary. Only one agency agreed to go into the projects. Eventually, it ceased conducting business, leaving Medicorp to provide free health care. In addition to providing this care, Ms. Cardozo has recruited other local providers and business people to donate time and goods for the care of these Medicare-eligible patients. She also has arranged for the provision of care by a wound specialist. Ms. Cardozo's testimony, together with Medicorp's Exhibits 3 and 4, show that a significant portion of the District 10 Medicare-eligible population is underserved. In particular, many of the low-income residents of Wilton Manor and Oakland Park, areas targeted for care by Medicorp's application, are not receiving much-needed care. This care would be made available on a continuous basis by Medicorp's trained and dedicated staff. Notwithstanding numeric need, therefore, there is a special need in District 10 for the Medicorp proposal. Local Health Plan "The District 10, August 1994 CON Allocation Factors Report [used by AHCA in the SAAR for these three applicants] provides [six] . . . preferences in the review of applications pertaining to Medicare certified home health agencies." AHCA No. 5, p. 5. The First Preference AHCA maintains that "Medicorp-[sic] and Medshares do not meet preference one of the [local plan] due to their lack of demonstration that there are identifiable subgroups who are Medicare-eligible and are currently being denied access to Medicare-certified home health agency services." AHCA PRO, p. 5. There is, however, no requirement expressed in the preference that denial of access be shown in order to meet the preference. With regard to Allstar, AHCA makes the same argument related to access denial in relationship to the Hispanic population identified by Allstar as an identifiable subgroup of the District's population to which it will provide service. Again, the preference does not expressly require a showing of denial of access. Allstar demonstrated that Broward County is 8.26 percent Hispanic; that Allstar has bilingual, indeed, multilingual capabilities in Dade County available for use in Broward should the CON be granted; and that it will locate its offices close to south central Broward near the largest Hispanic population. Allstar meets the express requirements of the preference. As explained above, Medicorp proposes to provide care concentrated in the most severely depressed area of District 10, geographically centered in zip codes 33311 and 33312. The proposed agency will provide care to the subgroup of predominantly black residents of the inner city HUD housing projects. It is true that this area may have "the highest concentration and number of Medicaid eligibles as well as the highest percentage of HIV and AIDS cases in the District . . .," and that "this population [is] . . . predominantly 'Medicaid eligibles,' and finally, that these patients could be served through a non-Medicare certified home health agency," AHCA No. 5, p. 6, (e.s.). But these factors do nothing to defeat Medicorp's satisfaction of the preference. Medicorp has demonstrated that it will provide service to an identifiable subgroup of District 10 Medicare-eligible patients based on "ethnicity" and "geographic location." It clearly meets the preference. Medshares meets the priority as well. Based upon geographic analyses contained in its application, Medshares identified lower-income Hispanics and African-Americans, including lower-income females, and persons afflicted with HIV/AIDS as groups in District 10 that it would serve. Medshares’ patient material will be provided in both English and Spanish. It plans to provide a full range of home health care services to these groups with special emphasis on low-income females who typically receive little or no prenatal care, and low-income families in need of pediatric services. And, it will locate in Fort Lauderdale, the urban area in Broward County with the highest number of AIDS cases. Medshares meets the preference. Preference Two All three of the applicants have committed to serve Medicaid and indigents, promoted by Preference Two, as follows: Allstar: 1 percent Medicaid, 0.5 percent indigent; Medicorp 10 percent Medicaid, 2 percent indigent; and Medshares 1.4 percent Medicaid, 2 percent indigent. Preference Three All three of the applicants state they will provide for the provision of maintenance services, as called for by Preference Three of the Local Plan, to Medicaid and indigent patients. Preference Four AHCA agrees that Medicorp and Medshares meet preference four which gives priority to those applications that show reasonable expectations for reaching a patient load of at least 21,000 visits by the end of the first year of operation. As to Allstar, it reasonably projected only 13,265 visits in its first operational year. Allstar's projection, however, includes a rate of 2,000 visits per month by the end of the first year, a monthly rate that leads to 21,000 per year when annualized. None of the Medicare-certified home health agencies opening in Broward County since 1992 have met the 21,000 "priority" threshold. In light of this reality and the reasonableness, in Allstar's view, of interpreting the preference as requiring only a demonstration of capacity to reach 21,000 visits rather than a projection that it actually reach 21,000, Allstar argues that it meets Preference Four of the Local Plan. There may be some room in the wording of the preference to interpret it as allowing a demonstration of capacity by the end of the first year to have achieved 21,000 visits rather than actually reaching the 21,000 visits, but there was no evidence that AHCA has ever made such an interpretation. For its part, AHCA flatly asserts, "Allstar does not meet this preference." AHCA PRO, p. 6. In the absence of an authoritative interpretation in Allstar's favor, Allstar must be considered as not meeting the preference. Preference Five There is no question that all three applicants meet Preference Five. The application of each demonstrates the development of patient transfer and referral services with other health provider agencies as a means of ensuring continuity of care. Preference Six The applications of Medicorp and Medshares demonstrate that they will participate in the data collection activities of the local health council. Allstar has agreed to report data to the regional health planning council but not to the local health council. Medicorp and Medshares meet preference six; Allstar does not. State Health Plan Preference Just as the District 10 Health Plan, the Florida State Health Plan establishes certain preferences for applicants for Medicare-certified home health services certificates of need. The State Health Plan, too, contains six preferences. Preference One Among the three applicants, only Medicorp demonstrated a willingness to commit a specific percentage of total annual visits to AIDS/HIV patients. The State Health Plan in its first allocation factor, however, does not contain a "percentage" requirement in order for preference to be given. All that is required is that the applicant "propos[e] to serve AIDS patients." AHCA Exhibit 10. Consistent with this requirement, all three applicants propose to serve AIDS patients; Medshares proposes to condition its application on such service and Medicorp, additionally, has in place policies and procedures for quality assurance and safety precautions in caring for the HIV/AIDS patient. All three applicants, therefore, meet the preference. Preference Two Although there does not appear to be a universally accepted definition of what "high technology services" means in the home health arena, and although AHCA does not define them, all three applicants have reasonably identified them in their application and have proved sufficient intent to provide them. For example, Medshares proposes to provide a full range of nursing and therapy services, including cardiac care; continuous IV therapy; diabetes care; oncology services; pediatrics; rehabilitation; pain therapy; total parenteral nutrition; speech therapy; physical therapy; occupational therapy; enterostomal therapy; respiratory therapy; audiology therapy; and infusion therapy. Several of these services are unquestionably "high tech." AHCA answers that none of the three showed that the full range of services, including those that are "high tech," were not sufficiently available and accessible in the same service area. Neither, of course, did AHCA. In the context of a litigated case, the wording of the preference is awkward for achievement of the result AHCA seeks: Preference shall be given to an applicant proposing to provide a full range of ser- vices, including high technology services, unless these services are sufficiently avail- able and accessible in the same service area. AHCA No. 5, p., 10. All three applicants receive preference under this part of the State Health Plan. Preference Three There is no definition of "disproportionate share" of Medicaid and indigent patients in AHCA. Nor was there any evidence of such a definition provided in this proceeding by AHCA by way of testimony or in any other way. The term, as used in acute services, contemplates and necessitates the use of Medicaid utilization data of the type that AHCA has never collected for Medicare-certified home health agencies. Nonetheless, both Medicorp and Medshares are entitled to the benefit of this preference. Medicorp's principals have demonstrated a commitment to serving what would constitute a disproportionate share of Medicaid and indigent patients by any common understanding of the term "disproportionate share." Medicorp, as a new entity, is entitled to the benefit that flows from the history of service of its principals and predecessors. Medshares, too, has a history of providing home health services to Medicaid eligible persons and indigents, and Medshares plans to serve all patients in need regardless of ability to pay. Allstar is excused from complying with this preference given the absence of a meaningful definition. Preference Four The preference is not applicable in this case, since it can only apply to multi-county districts. It is worth noting, however, that home health care has been cited as an area of critical need in Broward County by the Broward Regional Health Planning Council. It is also worth re-iterating that several zip code areas within Medicorp's primary service area have been designated by the Federal government as currently and historically medically underserved. Medicorp can fill the needs of the underserved in the Broward County HUD housing projects as a Medicare-certified home health agency should its application be granted. Preference Five Medshares has made an unqualified commitment to provide consumer survey data measuring patient satisfaction to AHCA. Without doubt, it fully meets the preference. Allstar currently collects patient satisfaction data, as well as family and physician satisfaction data. Allstar further stated in its application that, "though there is currently no systematic effort by the department to collect such data, [Allstar] will make this data available to the department, or its designated representative, upon development and implementation of an appropriate data collection and reporting system." AHCA No. 5, p. 13. Likewise, Medicorp indicated willingness to participate in an HRS consumer satisfaction data collection effort "upon the State's development and implementation of an appropriate system." Id., at 12, (e.s.) Medicorp, moreover, is willing to make survey results available to the AHCA, HCFA, the District 10 local planning council, and the Office of Comprehensive Health Planning. Allstar and Medicorp, at least, are entitled to partial credit under this preference. Preference Six Each of the three applicants is entitled to this preference; each proposes a quality-assurance program and JCAHO accreditation. Increase in Availability and Access; Improvement in Quality of Care, Efficiency, Appropriateness, and Adequacy of the Service Assuming existing providers are available, efficient, appropriate, accessible, giving quality care, and are adequately utilized, adding three new Medicare-certified home health agencies is still justified when cost-effective agency size is taken into consideration. The cost-effective size of an agency can be determined using Medicare cost reports. In Florida, the cost-effective size of an Medicare-certified home health agency ranges from 30,000 visits to 95,000 visits annually. Allstar's regression analysis of a cost-effective Medicare-certified home health agency size, measured in terms of visits, took into consideration the type of visits performed, AHCA's geographic price index, and the affects of population density on costs. Adding new Medicare-certified home health agencies is appropriate when the mix of services is taken into account, and when as in this case, adding three such agencies into the marketplace will not reduce the cost-effective size of existing agencies below 30,000 annual visits. Medicorp, moreover, has proven the restricted access to services experienced by Medicare patients residing in inner city HUD housing projects in North Broward County and has established that all payer groups in these areas, including Medicare and Medicaid, are underserved. It was established by Medicorp that the predominantly minority residents of Fort Lauderdale's public housing and surrounding areas of Wilton Manors and Oakland Park are woefully underserved. The already-established role of Medicorp as the accepted and known provider in these areas demonstrates how access to these home health services will improve by Medicorp entering areas that other providers will not serve. Financial Feasibility Short Term It was stipulated that Medshares’ application is financially feasible in the short term, that is, able to obtain the capital for start-up (including any construction costs, if necessary) as well as sufficient working capital to sustain a business until it becomes self-sufficient. While Medicorp's financial feasibility remained an issue going into hearing, it appears from AHCA's proposed recommended order that it continues to challenge only Allstar's short-term financial feasibility. See AHCA PRO, p. 8. In any event, Medicorp proved that adequate funding is available from outside sources to fund the start-up costs and early operations. Its project is therefore financially feasible in the short term. The total project costs for Allstar's proposed project is $102,903, based on reasonable historical data typical of the start-up equipment and expenses for similar Medicare-certified home health agencies in the same geographic area. Allstar's projected start-up costs of $24,956 are reasonable. To fund the proposed project, Allstar has established and maintains an escrow account with Republic Bank in the amount of $150,000 (almost $50,000 more that the projected total project cost). Allstar has adequately demonstrated its ability to fund the project; the project is financially feasible in the short term. b. Long term AHCA maintains that none of the applicants demonstrated long-term financial feasibility for one reason alone: lack of need for the proposals. Contrary to this assertion, there will remain need in Broward County for Medicare-certified home health agencies even if these three applicants receive the applied-for CONs. The projects of all three applicants are financially feasible in the long term. Allstar's and Medicorp's Reliance Solely on Independent Contractors AHCA contends the HCFA interpretation of the federal condition of participation found in 42 CFR s.484.14(a) requires full-time salaried employees to staff at least one qualifying service. Even if the interpretation is correct, it is no impediment to either the Allstar or the Medicorp application. Medical social work is a qualifying service under the federal regulation. Allstar presently staffs its medical social worker in its Dade County office exclusively with a full-time salaried employee for whom an Internal Revenue Service W-2 form must be maintained. Allstar intends to staff its Broward County office in the same manner. (Even if the social medical worker position were staffed with a part-time employee, Allstar would comply with the federal regulation so long as the part-time employee were salaried and received a W-2 form.) Up until hearing, AHCA legitimately maintained that Medicorp violates the federal regulation because of Assumption 11 to the pro forma in its application which stated that, "[i]t is assumed that all caregiving nurses are independent contractors." At hearing, however, Medicorp witnesses testified that nursing staff and CNA staff will be employed. Ms. Cardozo testified that she currently employs these staff and, if awarded a CON, would continue to do so. Similarly, the application repeatedly refers to Medicorp's staff consisting of the same employees working for Medicorp's sister agency, Medcorp. Any inconsistency between the testimony elicited by Medicorp at hearing and the assumption in its pro forma is of no moment in this case. With regard to financial feasibility, the assumption, even if incorrect in part, is not necessarily fatal to the application. (AHCA's finding of financial infeasibility, in the case of Medicorp was not based on the incorrectness of Assumption 11. Moreover, while one would usually expect full- time employees to cost more than less-than full-time independent contractors as to total cost, the direct hourly rate cost of independent contractors is usually higher than the direct hourly rate cost of employees.) Probable Impact on the Cost of Services Only Medshares demonstrated that it would foster competition which would promote quality assurance and cost effectiveness. In the case of Medicorp, eliminating the subcontract arrangements through which it, Medicorp, now provides services to Medicare patients will eliminate an unnecessary level of administrative costs. Other benefits flow from eliminating the need for Medicorp to subcontract with an authorized entity. For example, AHCA discourages such arrangements because removal of direct control of patient care from the authorized entity raises not just quality assurance issues but also the potential for fraud. In any event, granting all three applications should not reduce the cost effectiveness of any providers of Medicare- certified home health care services in Broward County in the future. Past and Proposed Provision of Services to Medicaid and Indigent Patients As detailed above, Allstar is committed to provide home health care services to Medicaid eligible and indigent patients. This commitment, in the absence of any data to the contrary, is an adequate one. That Allstar will make good on this commitment is supported by indicia aside from the express commitment contained in the application. Allstar has a relationship with Jackson Memorial to increase the number of indigent patients Allstar serves. Its brochures and business cards state that it accepts Medicaid patients. This acceptance is confirmed by Allstar at its public presentations and in conversations with referring physicians. Finally, the majority of Allstar's staff is bilingual, and it has nurses who speak as many as five languages. It has the capacity and intent to make a multilingual staff available in Broward County. Medicorp clearly has a history of providing health services to Medicaid patients and the medically indigent. This commitment has been demonstrated through operation of Medicorp's sister agency by Medicorp's principals. If anything, as discussed above, Medicorp's principals have shown a singular dedication to the medically indigent population through operation of health fairs and other charities. Consistent with this dedication, Medicorp has conditioned its application on provision of at least 10 percent of its total visits to Medicaid patients and at least 2 percent of its visits to the medically indigent. Medshares, too, has a history of providing services to Medicaid patients and the medically indigent. In 1995, it provided over $650,000 in uncompensated care. It participates in Medicaid waiver programs in two states which have them. Its application describes its indigent care plan. The pro forma projections of revenue and expense in the application describe the levels of indigent and Medicaid eligible persons that Medshares expects to serve. Medshares offers a CON condition that 1.4 percent of total patients will be Medicaid patients and 2 percent of total patients will be indigent patients.

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 granting CON Nos. 8418, 8419, and 8448 to Medicorp Home Health Care Services, Medshares of Florida, Inc., and Allstar Care, Inc., respectively. DONE AND ENTERED this 3rd day of September, 1997, in Tallahassee, Leon County, Florida. DAVID M. MALONEY 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 3rd day of September, 1997. COPIES FURNISHED: Robert J. Newell, Jr., Esquire Newell & Stahl, P.A. 817 North Gadsden Street Tallahassee, Florida 32303 Michael Manthei, Esquire Broad & Cassell Broward Financial Centre, Suite 1130 500 East Broward Boulevard Fort Lauderdale, Florida 33394 Alfred J. Clark, Esquire Suite 201 117 South Gadsden Street Tallahassee, Florida 32301 Richard Patterson, Esquire Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403 Jerome W. Hoffman, General Counsel Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403

USC (1) 42 CFR 484.14(a) Florida Laws (3) 120.57408.034408.039
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ALLSTAR CARE, INC. vs AGENCY FOR HEALTH CARE ADMINISTRATION, 92-002289CON (1992)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Apr. 10, 1992 Number: 92-002289CON Latest Update: Oct. 22, 1993

Findings Of Fact Background Respondent published a fixed need pool for Medicare- certified home health agencies for the certificate-of-need (CON) review cycle commencing in March, 1992, and determined that Service District XI did not need any additional home health agencies. On February 17, 1992, Petitioner timely notified Respondent that the fixed need pool calculation was in error. On March 6, 1992, Petitioner timely filed a petition challenging the fixed need pool determination, thereby commencing DOAH Case No. 92-2289. On February 24, 1992, Petitioner filed a letter of intent to submit a CON application for the development of a Medicare-certified home health agency in District XI. On March 24, 1992, Petitioner timely submitted an application for CON 6951 to establish a home health agency in Service District XI. On July 17, 1992, Respondent notified Petitioner of the intent to deny the application. Petitioner timely filed a petition challenging the intent to deny, thereby commencing DOAH Case No. 92-4795. Petitioner is adversely and substantially affected by Respondent's decisions concerning the fixed need pool and intent to deny Petitioner's CON application. Need for Proposed Health Care Facilities and Services in Relation to Applicable District Plan and State Health Plan Fixed Need Bed Pool Respondent calculated the fixed need bed pool based on Rule 59C-1.031, which is set forth in the Conclusions of Law. The purpose of the rule is to determine the required number of home health agencies by finding the cost efficient agency size (CEAS) "in number of visits at which economy of scale is achieved." Once the optimal number of visits is thereby determined, Respondent can calculate how many home health agencies are required in a specific service district. Pursuant to the rule, Respondent divided 181 nonexcluded home health agencies into four equal groups of equal numbers of agencies. These groups were divided by median numbers of visits and arrayed, as required by the rule, into groups from the lowest to the highest number of visits. Respondent then calculated for each group the median number of visits and mean cost per agency. The results of these calculations are as follows: Group Median # of Visits Average Cost Per Visit 1 5,000 $42.14 2 15,000 $45.88 3 31,000 $46.93 4 64,000 $45.95 Pursuant to Rule 59C-1.031, Respondent determined the percentage reductions, comparing "each grouping to the previous grouping." Respondent next checked for a cost reduction of at least 5 percentage points between two groups, as required by the rule. Between groups 1 and 2, there was no reduction of cost, but rather an increase of 8.88 percent. Between groups 2 and 3, there was no reduction, but an increase of 2.29 percent. Between groups 3 and 4, there was a reduction, but only of 2.09 percent. Under the rule, the only role of the first group, and its average cost per visit, is to serve as a standard against which the second group can be measured. Thus, Respondent did not calculate the percentage reduction between the average cost of the first group, which has the lowest average cost, and the average cost of any other group. Petitioner contends that the rule requires or permits a rolling comparison of group 4 with group 1. If so, the reduction between groups 4 and 1 would be 8.29 percent. There are no mean visit cost reductions of at least 5 percent between groups 1 and 2, 2 and 3, or 3 and 4. Under the rule, Respondent is required to choose the median number of visits of the grouping for which the average cost per visit was at least 5 percent less than the average cost per visit of the "previous grouping." If two or all three of the comparisons yield at least 5 percent reductions, then, rather than take the grouping corresponding to the greatest reduction or the lowest average cost per visit, the rule identifies the last of the qualifying reductions as the CEAS. As noted above, the CEAS is used to calculate the fixed need pool. In the absence of any 5 percent reduction between groups 1 and 2, 2 and 3, or 3 and 4, Respondent identified two alternatives. First, it could find that there was no fixed need pool. As Respondent's Health Services and Facilities Consultant Supervisor testified, Respondent could have declined to publish a fixed need pool because it could not apply the rule. "And at that point, the certificate of need reviewer would have to rely on other criteria other than fixed need-pool in determining whether there was a need." Tr., p. 87. In the second alternative identified by Respondent, it could select group 4 as the CEAS because the comparison between it and group 3 resulted in the only positive reduction in average costs per visit, unless group 1 was compared with some other group. An unfortunate concomitant of this alternative is that group 4 represents the second highest cost per visit. Despite this fact, Respondent chose the second alternative and proceeded to calculate the fixed need pool for home health agencies accordingly. The effect of Respondent's selection of group 4 was to calculate the fixed need bed pool based upon a relatively high number of visits per facility. The CEAS in this case was 64,000 visits. Thus, roughly 1/13th of the agencies would be needed under Respondent's fixed need pool than would have been needed if the CEAS had been set at 5000 visits, which corresponds to the least expensive group--group 1. The practical effect of Respondent's selection of group 4 was that the fixed need pool for Service District XI was zero. If group 1 had been selected, the fixed need pool would have been 14. The interpretation given the rule by Respondent lacks reason, as does the interpretation for which Petitioner contends. The correct interpretation requires the adoption of the first alternative in which Respondent acknowledges the inapplicability of the rule and leaves parties free to litigate the issue of need without regard to any published fixed need pool. Both rejected interpretations ignore the plain language of the rule. Respondent's argument falters by setting up group 1 as a "previous group" to group 4. The rule leaves no doubt that the groups are to be arrayed in ascending order of size. Given the rule's obvious reliance upon the principle of economies of scale, there is no reasonable basis for inferring the authority for a final comparison of group 4 to group 1. On the other hand, Petitioner's interpretation disregards the requirement that a substantial reduction of 5 percent triggers the identification of the CEAS group. Petitioner's argument that this interpretation most closely follows the intent of the rule is erroneous. In fact, two contradictory intentions emerge from close study of the rule. The more evident is that the rule intends to restrict market access without substantial regard to the principle of cost containment. In the absence of a rule challenge, the rule must be applied without regard to this feature. But Respondent's unchallenged disregard of the critical principle of cost- containment does not militate strongly in favor of allowing Respondent to extend the reach of this dubious aspect of the rule by engrafting upon it layers of nonrule policy to cover contingencies, which, incidentally, Respondent should have easily foreseen. The rule reflects a bias toward restricting market entry by home health agencies without regard to cost efficiency. As noted above, the rule precludes the possibility that the group with the lowest number of visits (and thus generating the largest fixed need pool) could ever be selected as the CEAS. Also as noted above, the rule's preference for later reductions of at least 5 percent, without regard to comparing average costs or even percentage reductions, again encourages the selection as the CEAS of the group with the larger number of visits (thus generating the smallest fixed need pool). Third, as Respondent contends, in no way can Rule 59C-1.031 be interpreted to require Respondent to select the CEAS based on the group with the lowest average cost per visit. As Respondent's Health Services and Facilities Consultant Supervisor testified, "the only reason why we regulate home health agencies under the certificate of need program and why we restrict market entry is based on the argument that larger size agencies are more cost-effective." The Supervisor added: "If that assumption were no longer true generally, then there would be actually no reason for us to control market entry for home health agencies." Tr., p. 81. In fact, Respondent has detected a decreasing correspondence between the size of a home health agency in number of visits and its average cost per visit, as agencies' costs migrate toward applicable cost ceilings. This was easily predictable and means that many more cases can be anticipated in which no CEAS will emerge from the rule's formula because no later group represents a 5 percent reduction in cost from a previous group. Implicitly acknowledging this practical problem with the rule, as well as hopefully the counterproductive effect of the rule upon the attainment of cost-containment, Respondent has also proposed the deregulation of home health agencies in terms of the issuance of CON's. The other source of the intent of the rule is derived from the definition of the CEAS, which is the objective of the rule's calculations. The CEAS is the "cost efficient agency size . . . at which economy of scale is achieved." "Economy of scale" is defined in the following statement: The behavior pattern of costs recognizes that gains in operating efficiencies act to reduce costs per unit to a certain point (economies of scale) and that[,] as the level of production continues to increase[,] operating inefficiencies take effect (diminishing returns). Respondent's interpretation of the rule, which stresses the intention to restrict market access without substantial regard for the principle of cost containment, fails to account adequately for the fact that diminishing returns or diseconomies of scale may actually have already begun before the second group is considered. The intent of the rule is to find the cost efficient agency size at which economies of scale are achieved. If, as here, the economies of scale are only encountered within the first group (i.e., the group with the agencies with the smallest number of visits), then it is impossible to justify Respondent's interpretive nonrule policy that exacerbates the tendency of the rule to restrict market access without substantial regard to the principle of cost containment. Thus, Respondent's claim that its interpretation of the rule is most consistent with the intent of the rule is flawed. In fact, the rule contains contradictory intentions, and Respondent, at best, has adopted the interpretation most consistent with the more dubious intent inferable from the rule. Petitioner's interpretation is most consistent with the better intent inferable from the rule--i.e., the CEAS is the "cost efficient agency size . . . at which economy of scale is achieved." However, Petitioner's interpretation fails to take into account the intent of the rule favoring larger providers. Petitioner's deemphasis of this aspect of the rule commendably pursues the critical principle of cost containment. But Petitioner's contrivance of the rolling comparison in which group 4 is compared to group 1 suffers from a disregard of the language of the rule regarding the arraying of the groups in ascending order and the comparison of each of the three largest groups with its previous group. There is no other reasonable conclusion than that the rule could not produce a fixed need pool, Respondent's determination of a fixed need pool of zero is incorrect, and the parties should have been allowed to litigate the question of need without regard to Respondent's incorrect determination of a fixed need pool of zero and without a showing of not-normal circumstances. Need in General The absence of the fixed need pool does not mean that the inputs to the formula are without value. To the contrary, the above-described calculations under the rule clearly justify determining need on the basis of the finding that the most cost efficient agency size is the agency in which the median number of visits is 5000. To achieve this most cost-efficient agency size, the number of home health agencies in District XI could be expanded by 14. Thus, Petitioner has proved the need for another home health agency. The applicable district and state health plans fail to identify any groups with a quantifiable lack of services or special need for home health care services. Plan language regarding preferences implies a comparative evaluation process, which is, at most, not readily applicable to the present situation involving a single applicant. In any event, it appears that Petitioner would serve a variety of subgroups of District XI that are specified in the district plan as medically underserved, even though the plan does not indicate that any of these groups currently has unmet needs in terms of home health agency services. It also appears that Petitioner would serve a greater percentage of Medicaid-eligible and medically indigent patients that is typical for existing home health agencies in District XI. Based on the findings of the preceding paragraph, Petitioner was entitled to full compliance with the corresponding preferences of the district plan, rather than the noncompliance and partial compliance that it was given for these preferences in the State Agency Action Report (SAAR). Respondent should have given Petitioner full compliance on the remaining preferences under the district plan, although several of them appear to have little to do with need. Petitioner has a working arrangement with the prime referral source, physicians. Also, by virtue of its acquisition of an existing home health agency, Petitioner will also have working arrangements with various health care providers in the area. The deficiency with the district plan cited in the SAAR concerning working arrangement with AIDS referral networks is of little importance as the AIDS referral networks, which have their own home health agencies, will be competitors of Petitioner. The SAAR likewise incorrectly gives Petitioner partial or no compliance with preferences in the State plan with respect to AIDS patients, which Petitioner clearly proposes to serve; counties underserved by existing home health agencies, which includes Dade County based on the above-described calculations concerning the most cost efficient agency size; and the proposal of a comprehensive quality assurance program and the seeking of accreditation by the Joint Commission on Accreditation of Healthcare Organizations, both of which Petitioner proposes to do. Based on the foregoing, Petitioner has clearly demonstrated a need for the proposed project without regard to not-normal circumstances and despite the absence of a valid fixed need pool for home health agencies in the subject batching cycle. Availability, Quality of Care, Efficiency, Appropriateness, Accessibility, Extent of Utilization, and Adequacy of Like and Existing Health Care Services According to the SAAR, there are sufficient home health agencies in District XI. However, Petitioner has proved that the proposed project will increase the availability or access of home health agency services based on the above-described calculations concerning the most cost efficient agency size. Ability of Applicant to Provide Quality of Care The parties have stipulated that this criterion is either not applicable to Petitioner's application or that the application has adequately addressed the criterion. Availability and Adequacy of Other Health Care Facilities and Services According to the SAAR, there are sufficient home health agencies in District XI. However, Petitioner has proved that existing home health agencies are not adequate or sufficiently available based on the above-described calculations concerning the most cost efficient agency size. Probable Economies and Improvements in Service that May Be Derived from Operation of Joint, Cooperative, or Shared Health Care Resources The parties have stipulated that this criterion is either not applicable to Petitioner's application or that the application has adequately addressed the criterion. Need for Special Equipment and Services Not Reasonably and Economically Accessible in Adjoining Areas The parties have stipulated that this criterion is either not applicable to Petitioner's application or that the application has adequately addressed the criterion. Need for Research and Educational Facilities The parties have stipulated that this criterion is either not applicable to Petitioner's application or that the application has adequately addressed the criterion. Availability of Resources for Project Accomplishment and Operation, Effects of Project on Clinical Needs of Health Professional Training Programs, Extent to which Services Will Be Accessible to Schools for Health Professions, Availability of Alternative Uses of Such Resources for the Provision of Other Health Services, and Extent to which the Proposed Services Will Be Accessible to All Residents of the Service District The parties have stipulated that these criteria are either not applicable to Petitioner's application or that the application has adequately addressed the criteria. The sole exception concerns the extent to which the proposed services will be accessible to all residents of the service district. Petitioner has proved that the proposed services would be accessible to all residents of the service district. Immediate and Long-Term Financial Feasibility of Project The parties have stipulated that these criteria are either not applicable to Petitioner's application or that the application has adequately addressed the criteria. The sole exception concerns the extent to which the long-term financial feasibility of the project is a function of Petitioner's utilization assumptions. The SAAR predicates its assignment of only partial compliance with this criterion upon Petitioner's failure to demonstrate access problems and justify the projected patient volume. However, to the extent that these criticisms reflect an incorrect need determination, Petitioner has proved that the proposed project satisfies the criterion of long-term financial feasibility based on the above-described calculations concerning the most cost efficient agency size. Special Needs and Circumstances of Health Maintenance Organizations The parties have stipulated that this criterion is either not applicable to Petitioner's application or that the application has adequately addressed the criterion. Needs and Circumstances of Entities Providing a Substantial Portion of Their Services or Resources to Individuals Not Residing in the Service District in which the Entities Are Located or in Adjacent Service Districts The parties have stipulated that this criterion is either not applicable to Petitioner's application or that the application has adequately addressed the criterion. Probable Impact of Proposed Project on Costs of Providing Health Services Proposed by Applicant Based on Effects of Competition on Supply of Health Services Being Proposed and Improvement or Innovations in the Financing and Delivery of Health Services which Foster Competition and Service to Promote Quality Assurance and Cost-Effectiveness The parties have stipulated that this criterion is either not applicable to Petitioner's application or that the application has adequately addressed the criterion. Costs and Methods of Proposed Construction The parties have stipulated that this criterion is either not applicable to Petitioner's application or that the application has adequately addressed the criterion. Applicant's Past and Proposed Provision of Health Care Services to Medicaid Patients and the Medically Indigent The parties have stipulated that this criterion is either not applicable to Petitioner's application or that the application has adequately addressed the criterion.

Recommendation Based on the foregoing, it is hereby RECOMMENDED that the Agency for Health Care Administration issue a final order approving the application for CON 6951. ENTERED on September 8, 1993, in Tallahassee, Florida. ROBERT E. MEALE Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 8th day of September, 1993.

Florida Laws (2) 120.57408.035 Florida Administrative Code (1) 59C-1.030
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HOME HEALTH CARE OF BAY COUNTY FLORIDA, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 87-002151 (1987)
Division of Administrative Hearings, Florida Number: 87-002151 Latest Update: Dec. 17, 1987

Findings Of Fact This proceeding involves certificate of need (CON) application No. 4912 by Home Health Care of Bay to establish a Medicare-certified home health agency to serve Bay County Florida. Home Health Care of Bay's CON application was timely filed on December 15, 1986. Home Health Care of Bay's application was deemed complete on March 2, 1987. On April 30, 1987, DHRS preliminarily denied Home Health Care of Bay's CON application based on a determination that: There was no need demonstrated by Home Health Care of Bay for an additional home health agency in Bay County. Home Health Care of Bay is owned by Mark Ehrman, M.D. Dr. Ehrman is a board-certified internist, hematologist, and oncologist. Dr. Ehrman has been in private practice in Fort Walton Beach, Florida, since November, 1984. Prior to 1984, Dr. Ehrman was involved in the organization and delivery of medical services, the teaching of medicine, and the practice of medicine in Canada. Home Health Care of Bay will serve all patients regardless of race, income, sex, ethnic background, religion, or physical handicap. Home Health Care of Bay will provide 3 percent Medicaid and 3 percent indigent home health visits. Dr. Ehrman, both in his office and in his durable medical equipment (DME) company, goes to great lengths to ensure that indigent persons receive medical services. Dr. Ehrman, in his office practice, provides medical services to all persons regardless of their ability to pay. He is a participating physician in Medicare, Medicaid, and other insurance programs. Dr. Ehrman's participation in these programs and his determination not to screen patients financially has increase access to medically underserved patients. Dr. Ehrman's private practice includes approximately 5 percent Medicaid patients. In the past, home health agencies have tended to focus on acute medical problems. The traditional model for home health care has been to shorten an acute hospital stay for a discrete problem. Even chronically ill patients still came to the hospital when they had an acute episode. There has been little focus on avoiding hospitalization. There is now a shift in home health care which attempts to avoid hospitalization in appropriate cases. Dr. Ehrman, in treating patients at home, has become involved with sophisticated triage procedures, home pain management, and other procedures which maximize a patient's time outside the hospital. Such procedures allow patients to remain safely and comfortably in their homes. Procedures which can be safely done in the home include the starting of I/V morphine drips or I/V antibiotics. These procedures have traditionally not been done in the home. Nationally, and in Bay County, several factors are causing a shift to home health use. First, pressure is being applied in the form of reimbursement mechanisms to reduce the expense of institutional care. Patients are discharged from the hospital sooner and there is more pressure to use home health services. Second, an increased incidence of chronic illnesses, such as AIDS, will increase the use of home health services. The incidence of AIDS and AIDS related diseases will continue to increase and has obvious implications for increased home health usage. Home health care will make "hospital-like" care more available and less expensive for AIDS patients. Third, health consumers want to maintain the quality of their lives and remain at home as long as possible. HOME HEALTH CARE OF BAY'S PROPOSAL Home Health Care of Bay will provide medical personnel services in the disciplines of registered nursing, certified home health aides, occupational therapy, speech therapy, physical therapy, and medical/social work. These services will be provided to Medicare, private insurance, and indigent patients. Home Health Care of Bay will provide traditional home health services and many "high-tech" services which currently are not available at all or are not routinely done in Bay County. Such services include the transfusion of blood and blood products, professional pain management, the drawing of arterial blood gases, the care of Groshong and Hickman catheters, and the care of subcutaneous pumps and subcutaneous venous access devices. Home Health Care of Bay's proposed services will be utilized by many different types of patients, including renal patients, chronic pulmonary patients, chronic heart disease patients, and cancer patients. Home Health Care of Bay will provide health care services to AIDS patients. Petitioner's Exhibit 5 contains a complete list of services which Home Health Care of Bay will provide. Home Health Care of Bay's services will be available 24 hours a day, 7 days a week. This is an important commitment because home health care patients need services regardless of the time of day or day of the week. Even more important than the discrete list of services that Home Health Care of Bay will provide is the integration of all these services into one agency. In that way, patients are not shuttled from place to place; their care can be organized and integrated for maximum benefit. This integration will be accomplished by formulation of a plan of therapy which will include evaluation by a social worker and a physician in order to deal with the patient's total needs. Home Health Care of Bay's commitment to a total integration of patient services is evidenced by its plan to provide 4 percent of its visits in the medical/social work category. Such services are important in providing comprehensive care. The provision of medical/social work services will help patients and their families identify both medical and non- medical needs. Once such needs are identified, the patients and families can be channeled to the appropriate services, agencies and resources. Home Health Care of Bay will provide the physician with direct and timely communication about the patient. This will include daily delivery of complete medical records. Such a service is crucial in order to provide home care to patients with complicated problems. Home Health Care of Bay has a budget line item for marketing of $21,000 in the first year and $18,000 in the second year of operation. This money will be used to change the perception and pattern of home health use. Patients and doctors will be made aware of the availability of new home health services and the integration of those services with existing services. Home Health Care of Bay's marketing effort will overcome the reluctance of some physicians to utilize home health services. The demographics of the subdistrict of Bay County were analyzed and compared to the demographics of District II. The analysis shows that from 1986 to 1989, 3,076 persons 65 and over will be added to the population of Bay County. This represents a growth rate of 21.5 percent in Bay County compared to a district growth rate of 12.4 percent. Of the elderly growth in District II of 7,355, approximately 40 percent of such growth is occurring in Bay County. Forty percent (40 percent) is a high percentage in a 14 county district and indicates that the elderly population in Bay County is growing at a very rapid rate. Elderly persons are the most frequent users of home health services. Thus, rapid population growth is occurring in the segment of the population most in need of home health services. STATUTORY CRITERIA 1/ Consistency With State Health Plan Home Health Care of Bay`s proposal was reviewed for conformity with the State Health Plan and is consistent with that plan. The 1985-1987 Florida State Health Plan states: Home health agencies provide nursing, health aid, therapy and other kinds of services to patients in their homes. This allows individuals to remain at home rather than use more expensive institutional care to recover from acute illness or to manage chronic conditions. The State Health Plan further states: Home health services can be a cost effective form of long term care for the elderly and the infirm. The provision of home health services proposed by Home Health Care of Bay will provide residents of Bay County with a lower cost alternative to institutionalized long term care as referenced in the above State Health Plan excerpts. The State Health Plan also addresses the unwillingness of many providers to serve the medically needy: Medicare is the largest payor for home health care to the elderly, though some private insurers and Medicaid both cover home health services. Policy makers are increasingly concerned about providers' willingness to serve Medicaid recipients and medically indigent Floridians. Home Health Care of Bay has committed to provide at least 3 percent Medicaid and 3 percent indigent visits. Such a commitment will greatly increase access of medically underserved groups. Approval of a provider who accepts a significant portion of Medicaid patients will encourage current providers to accept such patients in order to retain their Medicare and private referrals. Physicians and discharge planners are much more willing to refer to an agency that will care for all their patients. The State Health Plan contains the following objective: OBJECTIVE 1.5.: To assure that the number of home health agencies in each service area promote the greatest extent of competition consistent with reasonable economies of scale by 1987. The methodology utilized by Home Health Care of Bay to project need maximizes competition consistent with economies of scale by allowing additional providers to enter the market while maintaining existing agencies at a size at which they can operate efficiently. Consistency With Local Health Plan Home Health Care of Bay's proposal was reviewed in relation to the 1986 District Two Health Plan and is consistent with that plan. The local health plan contains a section on long-term care services, including home health services. This section contains a numerical methodology to determine need. That methodology indicates a need for an additional agency in Bay County. The local health plan also contains priorities for home health services. Priority C states that: Priority will be given to home health services applications who have a history of providing, or will commit to provide, services to Medicare, Medicaid and medically indigent patients. Dr. Ehrman, the owner of Home Health Care of Bay, has a record in his practice of providing services to all payor groups. He has committed to continue to do so in his home health agency. Priority D of the Local Health Plan states: Priority will be given to home health services applicants who have a history of providing, or will commit to provide, a public marketing program for their services which includes pamphlets, public service announcement and various other community awareness activities. Home Health Care of Bay has budgeted for and committed to an extensive marketing program. A marketing priority is unusual in a local health plan and indicates an awareness of the need to educate the public about home health services. Determination Of Need DHRS currently has no rule governing the need for home health agencies. A historical summary of the regulation of home health agencies in Florida is described in a memorandum prepared by Ms. Marta V. Hardy. Ms. Hardy was the Deputy Assistant Secretary for Regulation and Health Facilities, DHRS, from September 1984 through June 1987. Ms. Hardy was responsible for all CON decisions and was the ultimate decision-maker in regard to the preliminary denial of Home Health Care of Bay's CON. In the fall of 1984, DHRS attempted to promulgate a rule to replace the invalidated Rule of 300. This proposed rule was based on a use rate methodology, but was invalidated in a rule challenged proceeding in 1985. After the invalidation of the proposed rule, DHRS implemented an interim policy which it used to review home health agencies. This interim policy is reflected in the "Bob Sharpe memo," dated May 15, 1986. The interim policy was applied to home health agency application beginning with the first batching cycle in 1986. The interim policy utilized a variation of the previously invalidated rule and attempted to correct the problems which caused the proposed rule to be found invalid. The interim policy is a use rate/population methodology which projects the number of Medicare enrollees using home health services in the future. This number is multiplied by the average number of visits per Medicare home health user. The total number of visits is divided by an agency size of 9,000 visits to yield the gross number of agencies needed. The total number of licensed and approved agencies is subtracted from the gross need number to yield the net number of agencies needs. The interim policy phased in the needed agencies over a three year period. DHRS defended the interim policy in circuit court when the Florida Association of Home Health Agencies (FAHHA) sought to stop DHRS from using the policy. DHRS defended the interim policy in December, 1986, before the First District Court of Appeal. Use of the interim policy resulted in the approval of 23 home health agencies. DHRS abandoned its interim policy sometime in the fall of 1986. No notice was given to the public or to interested parties that a change in DHRS policy had occurred. DHRS published no document rescinding the Sharpe memo. Only after applications were filed in the second batching cycle of 1986, were applicants informed that DHRS had changed its interim policy. Applicants in the December, 1986, batching cycle, including Home Health Care of Bay, were asked for an unlimited extension of time within which DHRS could render a decision. Applicants who refused to agree to an extension were evaluated on the basis of the "statutory need criteria." Applicants who did not agree to an extension were denied. In only one instance was a CON granted after abandonment of the interim policy. This occurred in Franklin County, where no home health agency existed at the time of that approval. DHRS' new "policy" was not developed by DHRS health planners. The "policy" put the burden of proof on the applicant to demonstrate an unmet need. Such a demonstration would be difficult to make. The Office of Community Medical Facilities, the office within DHRS responsible for preliminary CON review, reviewed Home Health Care of Bay's application using the "policy" based on "the thirteen statutory criteria." Such a review required Home Health Care of Bay to prove need by demonstrating an unmet need. However, as evidenced by the Office of Community Medical Facilities' review of Home Health Care of Bay's application, a policy requiring an applicant to meet a negative burden of proof is unreasonable. It imposes a standard which is virtually impossible for an applicant to meet. Ms. Joyce Farr was the DHRS employee responsible for the review of Home Health Care of Bay's application and for the development of the related State Agency Action Report (SAAR). The SAAR was the only work product Ms. Farr prepared in regard to Home Health Care of Bay's application. Ms. Farr has never been qualified as an expert witness in the home health area. Ms. Farr has no formal education in health planning and is unfamiliar with Medicare reimbursement. Ms. Farr does not consider herself to be an expert in financial feasibility projections, staffing, or quality of care. Ms. Farr is not in a policy-making position at DHRS. Ms. Farr was given no instructions by her superiors as to how to review Home Health Care of Bay's application. DHRS presented the testimony of Ms. Farr to attempt to explain how Home Health Care of Bay's application was reviewed. Ms. Farr was tendered and accepted, not as an expert health planner, but as an expert in "CON review." Ms. Farr articulated the standard she used to determine need: [I]f an applicant or residents of a county or community resources of a county or just about any organization basically says that there is an unmet need, meaning that there is no home health services available or there is an accessibility problem where certain groups are not being served -- certain services are not being offered -- I become aware of it by their simply documenting, "I cannot get home health services," like CAPS [Capitol Area Community Aging Agency] that said, "They aren't serving these people. We need somebody in here to serve these people." That would show that there was an unmet need. Unless an applicant, or community resource, could demonstrate an accessibility problem, no need existed according to Ms. Farr. Ms. Farr did not review the Medicare cost reports of current providers to determine the services they provided prior to recommending denial of Home Health Care of Bay's application. Ms. Farr reviewed utilization data of current providers for only one year. Ms. Farr did no analysis of the types of visits provided by existing providers. Ms. Farr looked only at the total number of visits. The only information Ms. Farr utilized in regard to the type of visits being provided was information given to her by existing providers. In determining that no need existed for medical/social work services, Ms. Farr relied on the list of social service agencies included in the local health plan, but did no analysis as to what services such agencies offered. Ms. Farr determined that no Medicaid access problem existed in Bay County based on information current providers gave her. She did not verify these representations with the Medicaid office. Ms. Farr did no charge comparison in her review. At the time of her review, Ms. Farr did not know when a new competitor last entered the market in Bay County. Ms. Farr did not address Objective 1.5 of the State Health Plan in her review. She was unaware of Objective 1.5 until it was pointed out to her in deposition. Ms. Farr utilized no planning horizon in determining need, though she admitted that one of the purposes of CON review is to plan for future health needs. Ms. Farr's review of Home Health Care of Bay's application was deficient for several reasons. First, Ms. Farr's review did not look at a projection of future need. It did not analyze demographics or utilize a planning horizon. It contains no elements of a needs analysis. A mere review of what currently exists misses the point of health planning. Second, in making a determination of no need, Ms. Farr relied solely on comments of existing providers who told her that there was no need for a competing agency. Dr. Deborah Kolb, vice-president of Jennings, Ryan, Federa & Co., participated in the preparation of Home Health Care of Bay's CON application. In preparing the needs assessment portion of the application, Dr. Kolb reviewed the State Health Plan, the Local Health Plan, utilization data, home health CON decisions, and services offered by current providers. The need methodology which appears in Home Health Care of Bay's application is contained in Dr. Kolb's expert report. The methodology appearing in her report and the application was the interim policy in use by DHRS at the time the application was filed. This was the methodology in the Bob Sharpe memo. Home Health Care of Bay will provide home health services to the residents of Bay County. Bay County is in DHRS Service District II. According to the 1986 District II Health Plan, District II is composed of 14 separate subdistricts. Each subdistrict is composed of one county. Bay County is a reasonable service area for Home Health Care of Bay. Dr. Kolb utilized a two-year planning horizon to project the need for home health agencies. This is a reasonable planning horizon. Table 3 of Dr. Kolb's report analyzes need on a district-wide basis. Two time frames, July, 1988, and January, 1989, are shown because Home Health Care of Bay's application was filed in December, 1986. Two years from that date would be December 1988. The official population projections from the Governor's Office focus on July and January of each year. Use of the two project dates straddles the December, 1988, planning horizon. The population numbers of District II for 65 and over are 62,546 for January, 1988, and 63,558 for January, 1989. The 1984 Medicare use rate, which is an estimate of the number of Medicare home health visits per elderly person in Florida for 1984, is multiplied by the projected elderly population to arrive at a projected number of visits. The number of projected visits in Table 3 of 118,565 in July, 1988, and 120,483 in January, 1989, is a result of multiplying the use rate by the projected population. To determine the number of agencies needed, the projected number of visits is divided by optimal agency size. This calculation yields a gross agency need of 13 agencies in the district in July, 1988, and January, 1989. The number of licensed and approved agencies, 12, is subtracted from gross need, 13, to yield net need of one (1) agency in July, 1988, and January, 1989. Dr. Kolb utilized 9,000 for the optimal agency size figure. This is consistent with the interim policy and with data which suggests that is where economies of scale occur. An optimal agency size of 9,000 appears in the Local Health Plan methodology. Table 4 of Dr. Kolb's report presents the same analysis as Table 3, described above, on a subdistrict basis to determine where the one agency found to be needed in District II should be located. Use of the same methodology results in a gross agency need of three. The two existing agencies are subtracted from the gross need of three to yield a net need for one agency in July, 1988, and January, 1989, in Bay County. The methodology described above is a reasonable one for determining need. The methodology utilizes a common health planning approach. It is the same methodology used by DHRS as an interim policy. It is the same type of methodology used by DHRS in planning for other types of health services. Beyond the numerical analysis discussed above, other factors indicate the need for an additional home health agency in Bay County. Bay County has a very low home health use rate and a very high nursing home use rate. The Bay County home health use rate is 1.5 visits per person 65 years and older. The Bay County use rate is significantly lower than the state use rate of 1.89. This disparity indicates a gap between real need and historical utilization. At the same time, Bay County has a nursing home use rate of 41 beds per thousand elderly compared to a state rate of 23 beds per thousand. Additionally, the occupied nursing home beds per thousand elderly is much greater in Bay County than in the state. In the state there are 21.3 occupied beds per thousand elderly. The utilization of Bay County's nursing home beds is approximately 75 percent greater than utilization in the state as a whole. These statistics suggest an inappropriate allocation of resources between home health care services and more expensive institutional nursing home services. Nursing home utilization would decrease with more sophisticated home health care. Many people are inappropriately institutionalized in nursing homes and could be cared for at home. From a medical perspective, Dr. Ehrman was of the opinion that an additional home health agency was needed. Availability, Quality Of Care, Efficiency, Appropriateness, Accessibility, Extent Of Utilization, And Adequacy Of Like And Existing Services There are currently two Medicare-certified home health care agencies serving Bay County. One way to evaluate agency performance is to analyze the mix of services and the number and types of visits being provided. Current providers have concentrated heavily on providing nursing and aide visits. Of approximately 18,000 visits provided each year, approximately 16,000 visits comprised the nursing and aide categories. Neither provider did any specifically medical/social work visits in 1985 or 1986. Additionally, the total number of visits delivered to the residents of Bay County has remained constant in 1985 and 1986. Bay County's constant use rate illustrates the need for more education in regard to home health services. While current providers do certain high tech procedures if directed to by a doctor, current providers are not committed to consistently doing high tech procedures. High tech services are not the most profitable. Their margins are often low and it is more economically beneficial for current providers to provide aide services. Transfusions, initiation of I/V antibiotics, continuous infusion of morphine, pain nursing, and catheter care are all services which existing agencies have rarely done or do with great difficulty. Without doing such procedures as a regular basis, competency is difficult to maintain. Bay Home Health Care Agency d/b/a Home Health of Panama City (Home Health of Panama City) is a free-standing home health agency and has been in business for 11 1/2 years. Home Health of Panama City does no Medicaid visits. Bay Medical Center Home Health receives referrals from Home Health of Panama City because Home Health of Panama City does not take Medicaid or indigent patients. Home Health of Panama City does no medical/social work visits. Home Health of Panama City has no money budgeted for marketing. Bay Medical Center Home Health is a hospital based home health agency. It functions as a department of Bay Medical Center, an acute care hospital located in Panama City, Florida. In the past two years, Bay Medical Center Home Health has provided no medical/social work visits though some of those services were provided by nurses during nursing visits or by other departments of Bay Medical Center. Bay Medical Center Home Health does not currently provide care of certain high tech devices such as the Denver pleuroperitoneal pump or the subclavian pump. Its staff would have to be trained to provide such care. Bay Medical Center Home Health has never given blood transfusions or cared for a Denver shunt. Bay Medical Center Home Health has a very low number of average visits per patient (6.8) when compared to the state average of 30 visits per patient. Bay Medical Center Home Health does a low percentage of Medicaid visits. In 1986, Bay Medical Center Home Health was reimbursed for 120 Medicaid visits out of a total of 3,280 Medicaid-reimbursed visits provided in District II. A comparison of reimbursed Medicaid visits provided by Bay Medical Center Home Health to District II as a whole demonstrates a Medicaid access problem. In 1986, Bay County had 25 percent of the district's population and 16 1/2 percent of the district's Medicaid eligible. Yet only 3.7 percent of the district's Medicaid-reimbursed home health visits were provided in Bay County. If services were Medicaid accessible, the number of Medicaid visits would be closer to the Medicaid percent of the population. Bay Medical Center Home Health Care's Medicaid visits represented only 1 percent of their total visits for 1986. When Home Health of Panama City's zero (0) Medicaid visits is considered, out of all home health visits provided in Bay County only 0.7 percent were Medicaid visits. Approximately 25 percent of Dr. Ehrman's patients from the Panama City area are Medicaid or indigent. This evidences a need for more Medicaid services. Bay Medical Center Home Health has no line item for marketing and advertising. Ability of the Applicant To Provide Quality of Care Dr. Ehrman is a highly trained and experienced physician. While in Canada, Dr. Ehrman established a hematology and oncology health care delivery system in Montreal. This system is still in existence and working well. Dr. Ehrman has been instrumental in improving the delivery of health care in his practice area. He has established tumor boards at local hospitals and provided many new procedures and devices in the home. Dr. Ehrman has raised the level of awareness on the part of other practitioners in his area as to a team approach to the delivery of services. This has increased the type of home services now available. Dr. Ehrman has responded to the needs of his patients for a multi- disciplinary approach to oncology by associating a clinical psychologist. This person deals with the psychological needs of the cancer patients seen by Dr. Ehrman. Dr. Ehrman has been instrumental in beginning many new and innovative practices in his office. For instance, he administers chemotherapy to Medicare patients in his office. He accomplished this by arranging with local pharmacists to mix and supply chemotherapy drugs. Dr. Ehrman will work with these same pharmacists in Home Health Care of Bay. Dr. Ehrman is involved in a durable medical equipment company. Many new devices and treatments were first used in the area by Dr. Ehrman's company. Dr. Ehrman has been a leader in the community in keeping up with new home health care developments. Home Health Care of Bay will have adequate staff on a full-time basis and add staff as utilization increases. Dr. Ehrman currently contracts with two nurses who are well trained and have over 1,000 hours of in-service training. Home Health Care of Bay is committed to keeping up with state-of-the- art home health care services and will add new services as they are developed. Availability and Adequacy of Alternatives There are no realistic alternatives to the establishment of a new home health agency. The alternative of nursing home care is not satisfactory. Most persons would prefer home care to nursing home care when at all possible. The alternative to home care which is currently being used is to shuttle the patient from the emergency room to the hospital to the doctor's office. Eventually the patient drops out of the system or settles for a lower level of services. Availability of Resources, Including Health Manpower, Management Personnel and Funds for Capital and Operating Expenditures . . . Extent to Which the Proposed Services Will Be Accessible to All Residents The staffing requirements for Home Health Care of Bay are shown on Table 11 of the application. That staffing plan is reasonable. Home Health Care of Bay will have a full-time administrator at a salary of $27,000. A capable administrator can be recruited at that salary. Home Health Care of Bay will employ a full-time nurse supervisor at a salary of $21,000. A nurse supervisor can be hired at that salary. Home Health Care of Bay will employ a full-time clerical person at an annual salary of $16,000. A clerical person can be hired at that salary. The above salaries and Home Health Care of Bay's ability to recruit such persons is reasonable based on Dr. Ehrman's experience employing similar personnel in his office. Home Health Care of Bay will hire contract staff to provide skilled nursing services, physical therapy services, speech therapy services, occupational therapy services, medical/social work services, and home health aide services. Such persons can be contracted with to provide the type of services Home Health Care of Bay proposes based on discussions with such persons. Dr. Ehrman currently contracts with two nurses in Ft. Walton Beach to provide nursing services similar to those proposed by Home Health Care of Bay. Such services are provided mainly to non-Medicare patients and the arrangement has worked very well. Funds for Capital and Operating Expenditures Project costs are depicted on Table 25 of the application. The costs are reasonable. Home Health Care of Bay can be started for $22,600. Immediate and Long-Term Financial Feasibility of the Proposal At hearing, DHRS admitted the short-term financial feasibility of Home Health Care of Bay's proposal. The statement of projected income and expense in Figure 7 of the application and on page 14 of Dr. Kolb's report was prepared under Dr. Kolb's supervision. The majority of assumptions on which the pro forma is based have been stipulated to by DHRS as reasonable assumptions on which to base a financial projection. The only assumptions not admitted by DHRS relate to utilization and payor mix. DHRS, however, introduced no evidence that refuted the reasonableness of these assumptions. The utilization projection used to calculate gross revenue in the pro forma was 3,800 visits in 1988 and 8,500 visits in 1989. The utilization projections are reasonable based on the agency's demographic base and Dr. Ehrman's commitment to education and marketing. The projection of costs and charges depicted on page 45 of the application is reasonable based on Dr. Ehrman's current office experience. The number of visits is multiplied by the charge per visit type to calculate gross revenue. This calculation yields a gross revenue of approximately $200,000 in year 1 and $462,000 in year 2. The payor mix for Home Health Care of Bay is found on Table 7 of the application. Home Health Care of Bay predicts 3 percent Medicaid visits, 80 percent Medicare visits, 14 percent private pay and insurance visits, and 3 percent indigent visits. The pay mix projections are reasonable based on the mix of patients Dr. Ehrman currently sees. Ms. Farr admitted that the projections were reasonable. The difference between Medicare and Medicaid reimbursement and full charges results in the contractual allowances figure. Bad debt and charity deductions were calculated based on 3 percent indigent and 3 percent Medicaid visits. Deductions from gross revenue, which are funds not received because of contractual allowances, bad debts, or charity, are subtracted to yield net revenue. Deductions from revenue are approximately $38,000 in year 1 and $135,000 in year 2. Net revenue is approximately $162,000 in year 1 and $327,000 in year 2. The second portion of the pro forma lists expenses. This list contains all the expenses expected for a new home health agency. All the expenses listed are reasonable. The pro forma shows a loss of $28,505 in the first year and a profit of $13,207 in the second year. Home Health Care of Bay has the equity to sustain a loss in the first year. In the second year of operation, based on the above assumptions, expenses are $314,000 and net revenue is $327,000 for a net income of $13,000. These projections indicate that the project is financially feasible in the long term. Table 26 on page 41 of the application presents the project timetable anticipated when the application was filed. Any delay in this timetable due to this litigation will not materially change the projections or commitments contained in the application. Impact of the Proposal on Costs of Providing Health Services, Including Effects of Competition and Improvements in Financing and Delivery of Health Services Which Foster Competition and Services To Promote Quality Assurance and Cost Effectiveness The introduction of a new home health agency into the Bay County market will stimulate competition. Such competition will stimulate growth in competitors and increase the overall level of services. Approval of a new competitor where there has been no new competition for nine to ten years will put pressure on providers to provide a wider range of services as well as higher quality services. Ms. Young, administrator of Bay Medical Center Home Health, admitted that if Home Health Care of Bay's CON is approved, her agency might begin educating physicians in regard to available services, rather than waiting for physicians to request a service. As the current providers testified, as agency visits go up or down, the number of staff required can be adjusted without incurring unreasonable costs. Current providers have control over their costs and staffing. Home Health Care of Bay's charges are competitive. In some areas, such as skilled nursing and home health aide, Home Health Care of Bay's charges are lower than current providers' charges. Price competition allows competition for private pay patients. Impact The addition of Home Health Care of Bay to the home health market will not significantly affect current providers. Studies have indicated that new entrants into the home health market do not significantly affect existing providers. The elderly population of Bay County is growing rapidly. When the 1984 home health use rate is applied to elderly population growth between 1986 and 1989, approximately 5,800 new visits are attributable to population growth alone. Home Health Care of Bay projects it will deliver 3,800 visits in its first year of operation and 8,500 visits in its second year. Thus, a large percentage of those visits are attributable to population growth alone. Home Health Care of Bay's marketing and education programs will raise the local use rate and generate more visits. Dr. Kolb analyzed the financial impact of Home Health Care of Bay's project on current providers. Her analysis considers a worst case scenario and assumes that current providers' visit levels will be affected by the introduction of a new provider. The analysis then calculates the financial impact on current provider. In order to do this, Table 11 calculates the average cost per visit from existing agencies' 1985 Medicare cost reports. Home Health Care of Panama City's average cost per visit is $37.18. Bay Medical Center Home Health's average cost per visit is $41.76. The Medicare program pays agencies the lower of Medicare cost caps or actual costs. The current providers in Bay County are well below the Medicare cost caps and so will be paid their actual costs. Table 11 calculates the difference between actual agency costs and Medicare cost caps. Home Health of Panama City was 18 percent below its cost caps. Bay Medical Center Home Health was 24 percent below its cost caps. Thus, Home Health Care of Bay could provide the number of visits it projects and even if all those visits came from existing providers, the current providers could still operate at a level of cost that would be Medicare reimbursable. The approval of Home Health Care of Bay's application will not have a significant adverse impact on existing providers.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health and Rehabilitative Services enter a Final Order granting CON No. 4912 to Home Health Care of Bay County, Florida, Inc., to establish a Medicare-certified home health agency in Bay County, Florida. DONE AND ENTERED this 17th day of December, 1987, in Tallahassee, Florida. DIANE K. KIESLING Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of December, 1987. APPENDIX TO THE RECOMMENDED ORDER IN CASE NO. 87-2151 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on the proposed findings of fact submitted by the parties in this case. Specific Rulings on Proposed Findings of Fact Submitted by Petitioner, Home Health Care of Bay County, Florida, Inc. Each of the following proposed findings of fact are adopted in substance as modified in the Recommended Order. The number in parentheses is the Finding of Fact which so adopts the proposed finding of fact: 1-3(1-3); 5(4); 7-10(5-8); 12-16(48- 52); 18(53); 19 & 20 (54); 21(55); 24-27(56-59); 28- 31(59-62); 37-52(9-24); 54-57(25-28); 58-77(28-47); 78-89(63-74); 91-102 (75- 86); 104-114(87-97); 116-129(97-110); 130(110); 131(111); 133-135(112); 136- 139(113); 140 & 141(114); 142-153(115-126); 154-163(126-135); 165-175(136-146); 179-182(147-150); 183(150); 184 & 185(151); 186(152); 187 & 188(153); 189- 191(154); 192 & 193(155); 194 & 195(156); 196(157); 197(158); 200-203(159-162); 207(163); 209(164); 210(165); 212-218(166-172); and 219-225(172-178). 2. Proposed findings of fact 17, 32-36, 53, 90, 103, 115, 132, 164, 176- 178, 198, 199, 204-206 and 211 are subordinate to the facts actually found in this Recommended Order. Proposed findings of fact 22, 23 and 208 are rejected as being unsupported by the competent, substantial evidence. Proposed findings of fact 4 and 11 are rejected as being unnecessary and/or irrelevant. Specific Rulings on Proposed Findings of Fact Submitted by Respondent, Department of Health and Rehabilitative Services Each of the following proposed findings of fact are adopted in substance as modified in the Recommended Order. The number in parentheses is the Finding of Fact which so adopts the proposed finding of fact: 1(1 & 2); 2(3); 6(Footnote 1); 7(148) and 13(4). Proposed findings of fact 3-5, 8-12, 14-40, 43-45 and 47-53 are subordinate to the facts actually found in this Recommended Order. Proposed finding of fact 42 is rejected as being unsupported by the competent, substantial evidence. Proposed findings of fact 4 and 46 are rejected as being unnecessary and/or irrelevant. COPIES FURNISHED: Byron B. Mathews, Jr., Esquire Vicki Gordon Kaufman, Esquire McDermott, Will and Emory 101 N. Monroe Street Tallahassee, Florida 32301 Theodore E. Mack, Esquire Assistant General Counsel Department of Health and Rehabilitative Services Regulation & Health Facilities Ft. Knox Executive Center 2727 Mahan Drive Tallahassee, Florida 32308 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 =================================================================

Florida Laws (1) 120.57
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MEDSHARES OF FLORIDA, INC. vs AGENCY FOR HEALTH CARE ADMINISTRATION, 96-004040CON (1996)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Aug. 28, 1996 Number: 96-004040CON Latest Update: May 01, 1998

The Issue Whether applications for Certificates of Need filed by Medshares of Florida, Inc., and National Healthcare, L.P., for Medicare Certified Home Health Agencies in Health Planning District 8 for the July 1997 Planning Horizon, should be granted or denied by the Agency for Health Care Administration.

Findings Of Fact The District District 8 is composed of Sarasota, DeSoto, Charlotte, Lee, Glades, Hendry, and Collier Counties. Rule 59C-1.031(2)(e), Florida Administrative Code, Section 408.032(5), Florida Statutes. If granted, the requested certificates of need will enable Medshares and NHC to provide Medicare-certified home health services throughout the entire district. The parties disagreed as to the number of District 8 home health companies with Medicare-certified home health agency CONs. For purposes of the 1997 planning horizon, the district has thirty-five home health care companies (reporting and non- reporting) with certificates of need for Medicare-certified home health agencies. The Parties Medshares of Florida, Inc., (Medshares) was formed "pretty much immediately prior to the application [in this case]." AHCA No. 10, p.15. Although it recently received a CON to establish a Medicare-certified home health agency in District 9, there has not been enough time for Medshares to build a record in Florida. But Medshares is a member of a family of companies (the "Medshares Family") founded in Tennessee in 1985. The Medshares family has now expanded into 12 states. Through 2000 employees, it provides various home health services, including Medicare-certified home health services, private nursing services, management services for home health agencies, infusion services, and consulting services. In 1996, the Medshares Family provided approximately one million visits through its Medicare-certified home health agencies and approximately 1.7 million visits through its non- Medicare-certified and managed home health agencies. Recent growth in Medshares Family business is attributable to increased admissions, not to increased home health visits. It is Medshares Family policy for each of its home health agencies which have operated for three years to seek accreditation from the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO). This policy, of course, is applicable to a Medshares District 8 agency should the Medshares application in this case be granted. In the nursing home business for over 26 years, National HealthCare, L.P., (NHC) is a national nursing home company and a southeastern regional home health care company. It has thirty- three home care offices in three states and did in excess of 750,000 home health visits in 1996. It owns or manages one hundred and five nursing homes throughout the United States. It owns eight nursing homes in Florida of which five have a superior rating. NHC manages thirty-two other centers in Florida. NHC currently has three nursing home facilities which it owns or manages in District 8. The facilities, in Collier, Sarasota, and Charlotte Counties, have a total of 420 beds. Because of this ownership of existing facilities in the district, NHC has developed significant community linkages, training programs, and community involvement in the district. Obtaining a certificate of need for a Medicare-certified home health agency in District 8 will enhance NHC's continuum of care in District 8. NHC has a well-developed corporate and regional management structure dedicated to providing high quality care to its patients. The management structure places a significant amount of decision making at the home health agency level. The corporate and regional structure's purpose is to support the local delivery of health care services. The Agency for Health Care Administration is designated by statute as the "single state agency to issue, revoke, or deny certificates of need . . . in accordance with the district plans, the statewide health plan and . . . federal and state statutes." Section 408.034(1), Florida Statutes. Need Projections Paragraph (a) of Section 408.035 AHCA's rule setting a home health agency need methodology was invalidated several years ago. See Principal Nursing v. Agency for Health Care Administration, 16 FALR 10465, reversed in part, 650 So. 2d 1113 (Fla. 1st DCA 1995). AHCA did not publish a fixed need pool for Medicare-certified home health agencies for the July 1997 planning horizon applicable to these applicants. AHCA did not propose any methodology in its initial, free-form review or testimony of the applications. Instead, AHCA left it to the applicants to develop and present need methodologies in support of their applications. Medshares' Need Methodologies and AHCA Criticism The Medshares application presented various need methodologies and estimates of need for additional Medicare- certified home health visits in District 8. The primary Medshares methodology is a clinical need model based upon data obtained from the National Center for Health Statistics. The model develops home health use rates by sex for four age groups, 0-64, 65-74, 75-84, and 85+, and by geographic region. Patient volume and visits projections are made by developing individual use rates for each diagnostic category collected in the data survey. Each use rate is the result of dividing the total number of visit characteristics for the specific age and sex combination by the matching age and sex population estimates. To project need for 1997, the developed use rates are applied to the projected 1997 District 8 population by diagnostic category. For the 1997 planning horizon for District 8, Medshares' clinical need model estimates total visits of 3,488,290, which is an increase of approximately 1.6 million visits over 1994 (the latest year for which data was available at the time of the application). The Agency criticized Medshares' clinical need model because it included population aged 64 and under. The criticism fails on two counts. First, Medicare-certified home health agencies are expected to provide home health services to persons under age 65. Second, inclusion of the population and use rates for those under age 65 does not have any significant impact on Medshares needs projections since only 3 per cent of the originally projected visits are attributable to population under 65. AHCA's major criticism of Medshares clinical need model is that it considers the model's total visits projection of 3.4 million in 1997 to be an unreasonable increase over the actual visits in 1996 shown in AHCA publications. (These publications were not available at the time of the filing of the applications and so were not used by Medshares.) AHCA's published actual visits for 1996 of 2.4 million, however, are, without doubt, not accurate. The figure assumes that 9 agencies which did not report in 1996 conducted the same number of visits in 1996 as they reported in 1995, that is, 900,000. Whether this assumption is to high or too low, there is little question that it is not correct. If, for example, an agency not reporting in 1996 did not do so because it did not conduct any visits (not an unreasonable assumption since the agencies are obligated by law to report) then the 1995 reported visits are much too high for that agency as a figure for 1996 visits. On the other hand, if the non-reporting agency simply failed to report in 1996, the number of 1995 visits is likely lower than the actual number of visits in 1996. Home health care visits have been on the increase in District 8, a trend mirroring the state-wide trend. Utilization of home health care agencies is increasing because of growth in elderly population and an increase in the number of visits per patient. Furthermore, the amount of time spent by patients in hospitals has been decreasing. The decrease translates into an increased need by the patients for home health care visits. The need for home health care will continue to increase because it is a cost-effective alternative to nursing home placement and hospital care. In sum, AHCA's criticism of the Medshares clinical need methodology is based on inaccurate assumptions. Perhaps AHCA is correct that Medshares' projected visits for 1997 is unreasonably high. But the projection squares with the direction that home health visits are going, both because of increase in population and increase in use rate as well as decrease in hospital's lengths of stay. In addition to the clinical need model, Medshares projected need by two other methodologies. Through the first of these two, the clinical need model was tested by comparing its results to projections based upon the average Medicare-certified home health use rate growth from 1991 to 1995. This methodology yielded an estimate of 3.6 million for the 65 and over population of District, thus supporting the need projected by the clinical need model. In the second of the two additional methodologies, Medshares estimated the number of home health visits based upon the number of hospital discharges of patients within a certain Major Diagnostic Category (MDC). This methodology yielded an estimated need for 2,704,910 visits in 1997. All three of Medshares' methodologies provided an estimate of need for at least two additional Medicare-certified home health agencies in District 8 in 1997. NHC's Need Methodologies One of NHC's methodologies computes the increase in the home health use rate from 1993 to 1994 and applies a reduced increase in use rates to the projected population for each year to the horizon year of 1997. The methodology yields projected visits of 2,403,630 visits in 1997, for an increase from 1994 of 550,950 visits. In contrast to AHCA's determination that the Medshares' methodologies were unreasonable, AHCA agreed that NHC's methodology was reasonable. AHCA found fault with the NHC opinion of need, however, because of the data NHC used in its calculation of need. The AHCA document relied on by NHC for its base year (1993) visits of 1,656,112 was later revised by AHCA to reflect 1,702,106 visits in 1993. As a result, AHCA contends, the initial use rate increase used by NHC (7.6 per cent from 1993 to 1994) is higher than the actual use rate increase (4.8 per cent), which means that NHC's projections are overstated. Other criticisms were leveled by AHCA at NHC methodologies used in the application. The Agency's criticisms do not hold sway. Overlooking for the moment that any error was caused by faulty data provided NHC by the Agency, given the undisputed increase in the use rate, the NHC forecast for 1997 visits compared to actual 1996 visits shows the 1997 forecast to be conservative. After taking all of the Agency's criticisms into account, there was competent substantial evidence to establish a need for five more home health agencies in the district. The inadequacy of the criticisms was underscored when NHC's health planning expert used a "median agency size" in his calculations, an approach now favored by AHCA as it attempts to develop a new rule methodology for ascertaining Medicare-certified home health agency numeric need. Employing such a method still yielded a need for at least two more Medicare-certified home health agencies in the district. State Health Plan Preferences The Florida State Health Plan establishes six preferences for applicants of certificates of need for Medicare- certified home health agencies. The State Health Plan provided for preference to an applicant proposing to serve AIDS patients, (Preference 1). Both Medshares and NHC meet Preference 1. Medshares will provide services to AIDS and HIV-positive patients. The Medshares family has a history of providing services needed by these patients and Medshares proposes to condition its certificate on provision of services to AIDS patients. NHC is actively involved and has seen patients for Bay Aids Services Information Coalition, Tallahassee AIDS Support Services and Big Bend - Comprehensive AIDS Residential Education Services. NHC provided extensive documentation in its application to demonstrate current provision of significant levels of AIDS care. It has the organizational capability to continue to do so. Preference is given by the State Health Plan to an applicant proposing to provide a full range of services, including high technology services, unless they are sufficiently available and accessible in the same service area, (Preference 2). NHC surveyed existing home health agencies in the district to reveal that 29 agencies do not provide dietary guidance, 28 do not provide homemaker services, 26 do not provide medical supplies, 21 do not provide respiratory services, six do not provide speech therapy and five do not provide social services. NHC will provide all of these. NHC meets Preference 2. Medshares provides a full range of skilled nursing, homemaker, and therapy services including cardiac care, continuous IV therapy, diabetes care, oncology services, pediatrics, rehabilitation services, pain therapy, total parenteral nutrition, speech, physical and occupational therapies, respiratory therapies, audiology therapy, and infusion therapy. Medshares meets Preference 2. The State Health Plan provides a preference to applicants with a history of serving a disproportionate share of Medicaid and indigent patients in comparison with other providers within the same AHCA service district and proposing to serve such patients within its market area (Preference 3). There is no definition of "disproportionate share" and no data available to determine the level of Medicaid and indigent care provided by home health providers in District 8. Nonetheless, it is fair to find that NHC meets this preference and Medshares, based on the experience of the Medshares family, meets the spirit of this preference. In addition, both have committed to continue to provide Medicaid and indigent care; in the case of NHC, 2 per cent of patient visits to Medicaid patients and 1.5 per cent of its visits to the indigent, in the case of Medshares, its application is conditioned on 1 per cent of its patients being Medicaid and another 1 per cent being indigent. The State Health Plan provides a preference to an applicant proposing to serve counties under served by existing home health agencies (Preference 4). No demonstration was made that any of the counties in District 8 were underserved by existing home health agencies. The fifth State Health Plan preference is for applicants which commit to provide the department with consumer survey data measuring consumer satisfaction. Both Medshares and NHC meet this preference. The final preference in the State Health Plan is for an applicant proposing a comprehensive quality assurance program and proposing to be accredited by the Joint Commission on Accreditation of Hospital Organizations. Both Medshares and NHC meet this preference with NHC conditioning its application on implementation of a quality assurance program and successfully obtaining JCAHO accreditation. The District 8 Health Plan The District 8 Health Plan contains two allocation preferences for applicants for Medicare-certified home health agencies. The first is for the applicant able to demonstrate community contacts and relationships with hospitals, nursing homes, hospices, psychiatric, substance abuse, mental health, and other outpatient facilities within the proposed service area. The second is for the applicant showing a commitment to, or a historical record of, service to the medically indigent or other healthcare underserved population groups. NHC has developed significant community linkages through its existing nursing home beds in the health planning district with the types of health care providers listed in the preference. Further, NHC has agreed to condition its CON on the satisfaction of this preference. Medshares does not have operations in the district currently. But its application contained evidence of contact with local District 8 health care providers. As discussed earlier, both NHC and Medshares meet the second preference of the local health care plan. Availability and Access Paragraph 408.035(1)(b) Access issues become much less important for applicants who have demonstrated a numeric need for their proposals. Nonetheless, the addition of both NHC and Medshares Medicare- certified home health agencies will enhance both availability and access to these health services. Competition and Cost Effectiveness Paragraph 408.035(1)(l) Competition among home health providers in District 8 is more restricted than the number of providers would indicate because the District 8 market is dominated by a few large providers. Four companies provide 75 per cent of home health visits. Seventeen of the agencies are hospital-based and 10 of these are owned by one hospital. Competition will be enhanced by approval of the Medshares and NHC proposals. Both Medshares and NHC have the ability to compete effectively with the large providers in District 8. Cost effectiveness should be enhanced as well. District 8 has the highest average cost per home health visit in Florida. The 1994 average was $71.48. Generally, hospital-based home health agencies have higher costs. Hence, it is not surprising that District 8, with its many hospital-based agencies, has the highest average cost per home health visit. The cost per visit projected by Medshares in its second year is $65.21. Approval of the Medshares and NHC applications should help to lower the district-wide average cost per visit. Past and Proposed Provision of Services to Medicaid Patients and the Medically Indigent Paragraph 408.035(1)(n) As discussed above, both Medshares and NHC meet this statutory criterion. Multi-level Health Care System Paragraph 408.035(1)(o) Home health services play a key role in the continuum of care in a multi-level health care system by providing a less restrictive and less costly setting for discharges of patients from hospitals and nursing homes to their homes or assisted living facilities. Medshares participates in programs which promote a continuum of care, including a pre-heart transplant and post-heart transplant program, a "Healthy Homecomings" program for high risk pregnancies and a program which enables physically challenged persons to remain employed. NHC proposes to provide home health care in a continuum of care in conjunction with NHC's own nursing home and assisted living facilities located throughout District 8. An award to NHC would expand the continuum of care already provided by NHC.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the Agency for Health Care Administration enter its final order granting the applications of Medshares of Florida, Inc., and National HealthCare L.P. for CON Nos. 8412 and 8413, respectively. DONE AND ORDERED this 3rd day of February, 1998, in Tallahassee, Leon County, Florida. DAVID M. MALONEY 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 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of February, 1998. COPIES FURNISHED: Mark Thomas, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308-5403 Alfred W. Clark, Esquire Post Office Box 623 Tallahassee, Florida 32301-0623 Gerald B. Sternstein, Esquire Frank P. Rainer, Esquire Sternstein, Rainer & Clarke, P.A. 314 North Calhoun Street Tallahassee, Florida 32301 Jerome W. Hoffman, General Counsel Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403

Florida Laws (5) 120.57408.032408.034408.035408.039
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CARE FIRST, INC. vs AGENCY FOR HEALTH CARE ADMINISTRATION, 96-004053CON (1996)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Aug. 28, 1996 Number: 96-004053CON Latest Update: Jul. 02, 2004

The Issue Whether the applications for certificate of need numbers 8380, 8381, 8382 and 8383, filed by Petitioners RHA/Florida Operations, Inc., Care First, Inc., Home Health Integrated Health Services of Florida, Inc., ("IHS of Florida,") and Putnam Home Health Services, Inc., meet, on balance, the statutory and rule criteria required for approval?

Findings Of Fact Care First The Proposal Care First, the holder of a non-Medicare-certified home health agency license, was established in March of 1996. Owned by Mr. Freddie L. Franklin, Care First is the successor to another non-Medicare-certified home health agency also owned by Mr. Franklin: D. G. Anthony Home Health Agency ("D. G. Anthony"). Established in May of 1995, D. G. Anthony provided over 10,000 visits in its first 10 months of operation mostly in Leon and Wakulla Counties, pursuant to a contract with Calhoun-Liberty Hospital Association, Inc. Very few of the 10,000 patients were referred to D. G. Anthony by Calhoun-Liberty; they became D. G. Anthony's patients through community-based networks, including physicians, created through the efforts of Mr. Franklin and D. G. Anthony itself. D. G. Anthony was dissolved in 1996. Both its patient census and its staff of 45 were absorbed by Care First. D. G. Anthony's contract with Calhoun-Liberty was substantially assumed by Care First so that it provided service to Medicare patients as Calhoun-Liberty's subcontractor. From the point of view of the federal government, the Medicare patients served by Care First were Calhoun-Liberty's patients, even those who had not been referred to Care First by Calhoun Liberty and who had been referred from other community sources. Care First, therefore, was simply a sub- contractor providing the services on Calhoun-Liberty's behalf. The contract was terminated effective December 1, 1996. Calhoun-Liberty was free to terminate Care First with 30 days notice, a peril that motivated Mr. Franklin to seek the CON applied for in this proceeding. With the termination of the contract, Care First ceased serving Medicare patients, "because Mr. Franklin did not want to enter into another subcontractor arrangement because of all the issues and problems," (Tr. 934,) associated with such an arrangement. Mr. Franklin is involved with nursing homes as the administrator at Miracle Hill Nursing Home in Tallahassee. He is an owner of Wakulla Manor Nursing Home in Wakulla County, and he owns a 24 bed CLF, Greenlin Villa, also in Wakulla County. Miracle Hill has the highest Medicaid utilization of any nursing home in District 2. Both Miracle Hill and Wakulla Manor are superior rated facilities. On the strength of Mr. Franklin's extensive experience with community-based organizations and health care services, as well as Care First's succession to D. G. Anthony and other historical information and data. Care First decided to proceed with its application. In the application, Care First proposes to establish a home health agency that, at first, will serve primarily Franklin, Gadsden, Jefferson, Leon, Liberty and Wakulla Counties. It plans to expand into Madison and Taylor Counties in its second year of operation. Five of these eight counties have high levels of poverty; six of the eight are very rural, with the population spread widely throughout the county. Ninety-six percent of Care First's patients are over age Minority owned, approximately 65% of the patients are members of minorities. Many of the patients live in rural areas and are Medicaid recipients or are uninsured low income persons who do not qualify for Medicaid but cannot afford home health care. Since it will be serving the same patient base as a Medicare-certified agency, Care First has committed to the provision of 7% of its visits to Medicaid patients and 1% of its visits to patients requiring charity/uncompensated care. Care First projects 18,080 visits in its first year and 29,070 in its second year. Care First will promote efficiency through the use of a case management approach. Each patient will be assigned a case manager who will act as the patient advocate to provide care required and to identify and assist the patient with access to other "quality of life" enhancing services. Care First proposes an appropriate mix of services, including skilled nursing, physical therapy, speech and language therapy, occupational therapy, home health aide services and social services. Care First estimates its total project cost at $25,808. Of this amount, $2,000 is indicated as "start-up cost", with nothing allocated to salaries. Care First indicates no "capital projects" other than its proposal for the home health agency in District 2. Care First's proposal would be funded from a $60,000 bank line of credit. Projected Utilization Potential patients will be able to gain access to Care First through several avenues, including physician referral, hospital referral, nursing home discharge, assisted living referrals from community agencies and organizations such as Big Bend Hospice and through private referral. In addition, there are several natural linkages to the community for Care First. Wakulla Manor and Miracle nursing facilities offer Care First's services to discharged residents in need. Very often, residents and families choose Mr. Franklin's agency because they are familiar with him, staff or the quality of care provided. Residents of Greenlin Villa, owned by Mr. Franklin, frequently chose Care First when in need of home health agency services. Mr. Franklin's civic, church, and community involvement is impressive. He is president of the Florida Health Care Association, chairman of the board of the Tallahassee Urban League, superintendent of the Wakulla County Union Church Group, and serves on the advisory board for the Allied Health Department for Florida A&M University. In the past, he has served on the Board of Trustees of Tallahassee Community College. He was accepted as an expert in long-term care administration in this proceeding based in part on his service on the Governor's Long Term Care Commission. Miracle Hill has held a "Superior" licensure rating for the last ten consecutive years. It is the highest rating awarded by the AHCA licensure office and is intended to blazon the high quality of care provided by the facility. Although reported through Calhoun-Liberty, very few of D. Anthony's and Care First's past referrals have been generated through that affiliation. Rather, they have come through community contacts and getting the referrals from "talking with physicians," (Tr. 922), in Tallahassee and the surrounding areas, many of whom Mr. Franklin has gotten to know through his post as Administrator of Miracle Hill Nursing Home. By far, it is through physician referrals that Care First receives most of its patients. Care First's physician referral list includes 47 doctors who referred patients to D. G. Anthony since May, 1995. These doctors practice in urban areas and some have rural clinic offices which they staff on certain days of the week. Physicians are willing to refer patients to Care First because of the quality of care which has been provided by Care First, as well as the reputation of its owners. The Care First application included letters of support from eight physicians who have referred patients to Care First in the past and state that they will continue to support Care First with referrals in the future. Among the letters included are those from Dr. Earl Britt, a practitioner of internal medicine and cardiology in Tallahassee, and Dr. Joseph Webster, who practices internal medicine and gastroenterolgy in Tallahassee. Many of the patients of these two physicians are elderly. Dr. Britt's patients often have chronic hypertension or heart disease, are diabetic or suffer strokes. These two physicians provided over half the total number of patient referrals to D.B. Anthony and Care First. Dr. Britt and Dr. Webster established through testimony that Freddie Franklin and Care First have an excellent reputation for provision of quality of care and enjoy significant support among physicians within the service area. Moreover, Dr. Britt, although based in Tallahassee, stressed the importance of Care First's proven ability to provide home health services in the rural setting both from the standpoint of understanding the needs of the rural patient and from being able to travel over rural terrain in order to deliver services. (Tr. 1151, 1152, 1154). Approximately 11,500 visits were performed by D. G. Anthony staff from the period of May 1995, through April 1996, before they became the staff of Care First. Since the agency has established a presence in the district and has physician and other referral mechanisms in place, it is reasonable to project that Care First will continue to grow and will experience between 18,000 and 20,000 visits in its first year and 28,000 to 31,000 visits in year two as a Medicare-certified home health agency. These projections stem from the historical and very recent monthly growth of D. G. Anthony, as well as demand it is experiencing from Franklin and Jefferson Counties, two counties it does not serve regularly at present but plans to serve regularly in the future. The reasonableness of Care First's projections is bolstered by the conservative number of visits per patient the projections assume, 35, when typically Medicare-certified agencies average at least 35 visits and as many as 60 visits per patient. Care First's utilization projections are reasonable. It enjoys an excellent reputation for quality of care and ability to deliver services. Together with its predecessor, D. G. Anthony, it has a proven track record and has benefited from a referral network that remains in place. These factors, together with the conservative assumptions upon which its projected utilization is based demonstrate that its projected utilization is reasonable. Financial Feasibility of Care First The total project cost for the Care First agency is projected to be $25,808. The majority of the costs are reasonable for this type of health care project. The majority of the project development costs, the application fee and much of the cost of the consultant and legal fees, have already been paid by Care First. Care First's Schedule 2 was prepared in conformance with the requirements of the agency and accurately lists all anticipated capital projects of Care First. The necessary funding for the Care First project will come from Care First's existing $60,000 line of credit with Premier Bank, in Tallahassee. This method of funding the project is reasonable, appropriate, and adequate. Care First has demonstrated the short term financial feasibility of its project. Care First's schedule 6 presents the anticipated staffing requirements for its home health agency. The staffing projections are based upon the historical experience of D. G. Anthony and Care First, taking into consideration the projected start-up and utilization of the agency. The projected salaries are based upon current wages being paid to Care First employees, adjusted for future inflation. Care First's schedule 6 assumptions and projections are reasonable, and adequate for the provision of high quality care. The staffing proposed by Care First is sufficient to provide an RN or an LPN and an aide in each of the eight counties Care First proposes to serve in District 2. Care First's schedule 7 includes the payor mix assumptions and projected revenue for the first two years of operation. Medicare reimburses for home health agency services based upon the allowable cost for providing services, with certain caps. The Care First revenues by payor type were based upon the historical experience of D. G. Anthony and Care First, as well as the preparation of an actual Medicare cost report. The Care First payor mix assumptions and revenue assumptions are reasonable. Care First's projection of operating expenses in Schedule 8A is also based on the historical experience of D. G. Anthony and Care First, as modified for the mix of services to be offered and the projected staffing requirements. The use of historical data to project future expenses adds credibility to the projections. Care First's projected expenses for the project are reasonable. The Care First application presents a reasonable projection of the revenues and expenses likely to be experienced by the project. Care First has reasonably projected a profit of $8,315 for the first two year of operation. Care First's proposal is financially feasible in the long term. As the result of its community contacts, Care First has been offered the use of donated office space in Franklin, Jefferson, Wakulla, and Gadsden counties. The use of donated office space will decrease the cost of establishing a physical presence and providing services in those counties since Care First will not have a lease cost for a business office and a place to keep supplies. Quality of Care Through the experience of D. G. Anthony, Care First has identified the particular needs of the community it served. This experience has been carried over into Care First's provision of services. In the 9 months of Care First's existence at the time of hearing, it provided quality of care. Its predecessor, D. G. Anthony, also provided quality of care. While Care First's experience is relatively limited, there is no reason to expect, based on the experience of both Care First and its predecessor D. G. Anthony, that quality of care will not continue should its application be granted. IHS of Florida The Application IHS of Florida is a wholly-owned subsidiary of Integrated Health Services, Inc. ("IHS") formed for the specific purpose of filing CON applications. IHS operates other home health agencies under other subsidiary names. Pernille Ostberg is a senior vice president of the Eastern Home Care Division of Symphony Home Care Services, Integrated Health Services. In that capacity she oversees nearly 195 operations in six states, including Florida. Her operations include home health agencies, durable and medical equipment distributions, and infusion therapy offered by pharmacists. Under Ms. Ostberg's guidance, IHS has grown to its current roster of 195 agencies in only three years, from a beginning of only five agencies. IHS first acquired Central Park Lodges, primarily a nursing home company which also owned five home health agencies. Once these agencies became Medicare certified, IHS made a corporate decision to acquire additional Medicare certified home health agencies. Beginning approximately three years ago, IHS undertook a series of acquisitions which included Central Health Services, Care Team, ProCare/ProMed, and Partners Home Health. More recently, IHS has acquired the Signature Home Health and Century Home Health Companies. And, immediately prior to the final hearing in this matter, IHS acquired First American Home Health Care, making IHS the fourth largest provider of home health services in America. Of all the home health agencies overseen by IHS, 95% are Medicare certified, and 62-63 are located in Florida. IHS now has a presence in all districts except District 1 and 2. IHS personnel also have extensive experience in starting up new home health agencies. IHS personnel have opened over 40 locations across the United States. IHS employees have extensive experience bringing new home health agencies through successful surveys by the Joint Commission on the Accreditation of Hospital Organizations ("JCAHO") recommendations. Of 18 branches personally taken through initial survey by IHS's Pernille Ostberg, none were recommended to change their operations and none were cited for a deficiency. IHS has recently opened, licensed, and certified new home health agencies in AHCA Service District 5, 6, and 10. They have also received licensure in District 7, 8, and 11. Based on the extensive expensive of IHS personnel, a start up home health agency typically experiences 8,000 - 15,000 visits per first year. Opening a new program requires two months for licensure. It will require a registered nurse for three months to make certain all manuals are in place and that quality personnel are recruited. After achieving licensure, one must wait for a certification survey, which may take as long as six months. The three IHS home health agencies that became certified recently have experienced 200 visits in the first month, a good sign of growth. IHS' umbrella organization for home health organizations is Symphony. Most of their home health companies retained their original names. Other IHS home health companies include ProCare, Central Health Services, Partners Home Health, Nurse Registry, and First American. IHS of Florida has applied for applications in other districts. This applicant filed applications in District 7, 8 and 10 and each were approved. IHS of Florida's CON application number 8382 was prepared by Patti Greenberg with the significant input of IHS and IHS of Florida's operational experts. Ms. Greenberg has prepared 75-100 CON applications, 20-25 of which sought approval for Medicare Certified Home Health Agencies. Each of these prior applications had been approved or otherwise reached settlement before litigation. The Proposed Project Once the needs analysis was complete, IHS examined geographic issues within the 14 county district. IHS examined where the populations required home health agencies and what niche of the market IHS could expect to achieve. Projected visits were determined by examining month by month, how this agency would grow. This projected utilization was subdivided among sub-visit types. Existing IHS home health agencies visit mix (skilled nursing as opposed to home health aide or therapy visits) was used to estimate skill type of the projected total volume. The projected utilization was also subdivided by payor class. This payor class projection was derived specifically for District 2, its poverty levels and its managed care penetration. In the aggregate, IHS projects 7,650 visits in year one and 17,100 visits in year two. This projection is reasonable and achievable. Witnesses for the Agency agreed that IHS of Florida's projected number of visits was "definitely attainable". Past and Proposed Service to Medicaid Patients and for Medically Indigent The payor class analysis allowed IHS to conclude it should condition its approval of its application under the performance of 5% Medicaid and 1% charity care. The balance of the population served by an IHS Medicare Certified Home Health agency would be covered by Medicare. The condition is important as it is a requirement which, if not achieved, will subject IHS of Florida to fines and penalties by the agency. Improved Accessibility The applicant will improve the efficacy, appropriateness, accessibility, effectiveness and efficiency of home health services in District 2 if approved. IHS of Florida will provide good quality of care, should its application be granted. Quality of Care Through competitive forces, the applicant's approval will also improve the quality of care offered by home health agencies in District 2. The approval of IHS of Florida's application will also comply with the need evidenced by the extent of utilization of like and existing services in District 2. Economies from Joint Operations Certain economies derived from the operation of joint projects are achieved by IHS of Florida's proposal. IHS has a home office and corporate umbrella which oversees all of its operations for home health services. This master office offers economies of sale by sharing resources across a wide array of home health agencies in Florida and other states. Thus, the incremental expense for corporate overhead is reduced as compared to a free-standing home health agency. Additionally, this national oversight provides better economies to provide the most recent policies and procedures, billing systems, and other systems of business operation. Financial Feasibility IHS of Florida has the resources to accomplish the proposed project. As demonstrated on schedule 1, and schedule 3 of IHS exhibit 1, the budget for the project is only $144,000. This budget includes all appropriate equipment for both the initial and satellite offices. Budgeted amounts include all required lease expenses, equipment costs and even start-up costs such as salaries for the recruitment of training and staff prior to opening. In total, $52,000 of pre-opening expenses are projected, which is reasonable. IHS of Florida filed applications for other home health agency start-ups in three different districts. The applicant had more than $180,000 in cash on hand and an additional $226,000 assured from a commitment letter from IHS which was also contained in the application. A letter of commitment from Mark Levine, a director and executive vice president of IHS, indicated IHS will provide $250,000 in capital for this specific project. Additionally, IHS will provide up to $1 million in working capital loan to assure no cash flow problems ever arise. A similar letter of commitment appears in each of the CON applications which IHS of Florida has filed. IHS has committed to fund each of the CON applications applied for by IHS of Florida. Each of these letters of commitment for the various CON applications sought by this applicant are on file with the AHCA. In total, the applicant projects $600,000 in capital commitments assured. IHS' balance sheet, reveals access to $60 million in cash and cash equivalent. The record clearly demonstrates an ability of IHS to fund all capital contributions required by the applicant. The current assets of IHS approximate $240 million. In addition to having cash in the bank, IHS is a growing concern and is, in fact, a Fortune 500 company that is publicly traded on the New York Stock Exchange. IHS generates revenues which exceed its annual expenses. In the last year, IHS derived $30 million more than it experienced in expenses. The application is financially feasible in the short- term. IHS' application is also feasible in the long-term. IHS of Florida's utilization projections are reasonable. Budgeted staffing and salaries are reasonable. The cost limit calculation and reimbursement calculation by payor source, which is provided in great detail in Schedule 5 of IHS of Florida's application, is reasonable. Projected expenses associated with this project were reasonably calculated based on the actual experience of other IHS Home Health operations. The reasonableness of these costs are also demonstrated when compared with the cost per visit by existing agencies in District 2. In fact, IHS of Florida predicted it would be a lower cost provider than the expected cost of existing agencies at the time IHS of Florida's operations would begin. IHS of Florida's proposal will have a healthy, competitive effect on the cost of providing services by other providers. Putnam The Proposal Putnam proposes to establish a Medicare-certified home health agency with its primary office located in Bay County. Bay County was selected as the primary office based upon the locations of existing and approved agencies in District 2, the aggregate utilization of each, and the number of individuals aged 65 and over distributed among the existing District 2 counties and agencies. Mr. Alan Anderson is Putnam's sole stockholder, Director, and President. Under the ownership and administration of Alan Anderson, Putnam has provided Medicare-certified home health services in AHCA District 3 continuously since 1986. Mr. Anderson is also the sole owner, director, and president of Anderson Home Health, Inc., a Medicare-certified home health agency serving AHCA District 4 since 1992. Anderson Home Health's CON was obtained by Putnam through the same process undertaken by the prospective applicants in this proceeding. Putnam's District 3 agency has successfully served District 3 residents since 1986 at first through its Palatka office, then growing to its current size of four offices. In District 4, Anderson Home Health, Inc. has also experienced successful operations having grown from its principal office in Duval County to a total of four offices. Putnam's District 3 home health agency began with the original office located in Palatka, followed by offices opened in Gainesville, Ocala and Crystal River. Anderson Home Health, Inc.'s District 4 operation began with the original office located in Jacksonville; the second office was opened in Daytona Beach, followed by the opening of the third office in Orange Park; and the fourth office was opened in Macclenny. Putnam's District 3 agency is JCAHO accredited "with commendation." As part of CON application No. 8383, Putnam has agreed to certain conditions upon award. First, the proposed project will locate its primary office in Bay County. Putnam also conditions its approval with the provision that 0.25% of its admissions will be persons infected with the HIV virus. Four percent of its patients will be Medicaid or indigent patients. Finally, Putnam has conditioned its approval upon the provision of various special programs such as high tech home health services, a volunteer program, and the establishment of a rural health care clinic. History or Commitment to Provide Services to Medicaid and Indigent Patients For Medicare reimbursement purposes, Putnam proposes to maintain a Medicare-only agency and private sister agency which provides services to non-Medicare patients. The private sister agency will provide service to the Medicaid and indigent patients. The costs of providing services to these non-paying or partial paying patients will be absorbed by the agency as a contribution to the community. The establishment of a private sister agency to handle the non-Medicare patients is common in the home health industry. As a condition in the application, Putnam will accept up to 3.0% Medicaid patients. Although it stated in its application that it would accept between .5%-1.0% indigent patients, its conditioning of the application on 4.0% Medicaid and indigent patients would necessitate that it accept at least 1.0% indigent (if not more, should the Medicaid patients fall below 3%) in order to meet the 4.0% Medicaid and indigent care condition. The percentages proposed by Putnam are consistent with the statewide average (approximately 95% Medicare) and the District average (approximately 92.1% Medicare). Bay County's average of Medicare patients is approximately 96.4% Medicare. To meet the 4.0% Medicaid and indigent condition, Putnam's average of Medicare patients might have to be less than the Bay County average but not by much. Certainly, meeting the condition is achievable. The agency's position is that Putnam's Medicaid/indigent commitment is not a ground for denial of the application. Quality of Care Putnam has continuously owned and operated a licensed Medicare-certified home health agency in District 3 since 1986 and has been JCAHO accredited with commendation status since 1994. In an effort to continuously provide quality care, Putnam has developed a comprehensive set of policies and procedures to guide its staff, its physicians, volunteers, patients, as well as patients families. No evidence was presented to suggest that Putnam does not have a history or ability to provide quality care. Availability of Resources, Including Health Manpower, Management Personnel and Funds for Capital and Operating Expenditures Putnam has provided Medicare-certified home health service to the residents of District 3 for ten years. Putnam will be able to share its existing personnel and operations expertise with the proposed District 2 agency. Administrative, Managerial, and Operational Personnel Putnam intends to utilize existing administrative personnel in the start up and overall operation of the proposed agency. These management personnel include the Chief Executive Officer, Chief Operating Officer, Chief Financial Officer, Data Processing Director, Director of Volunteers, Personnel Director. These experienced personnel will be available to provide valuable management support to the proposed agency. The proposed agency will be operated by an administrator who will report directly to Putnam's CEO, Alan Anderson. The agency's administrator will be actively involved in budget preparation, physician relations, community education, and preparation for regulatory agency surveys. The proposed agency will rely upon the demonstrated experience of key personnel in its initiation. Ms. Nora Rowsey, experienced in the start-up phases of home health agencies, will personally supervise and implement the start up phase of the proposed District 2 agency. Putnam intends to hire individuals to work within the proposed agency who already have experience in the provision of the necessary services. Current employees of Putnam's as well as contract personnel of the District 3 agency have indicated a willingness to provide services in Bay County once the application is approve. Funding and Capital Resources Putnam projects the total costs of initiating the proposed agency to be approximately $70,000. Putnam has simultaneously applied for two other Medicare-certified home health agencies, in Districts 6 and 7. Each of these projects area also projected to cost approximately $70,000. Putnam, therefore, has projected costs associated with all three projects of approximately $210,000. Additionally, there is a $10,000 contingency cost related to the District 3 offices bringing the total expenditure for all capital projects of $220,000. Putnam's application includes two letters from First Union National Bank of Florida which substantiate that there are funds on hand to finance all of Putnam's capital expenditures, including the District 2 proposed agency. As of April 18, 1996, Putnam's bank account had a twelve month average balance of $245,949.02. As of April 18, 1996 the accounts of both Putnam and Anderson Home Care Inc., had a combined twelve month average balance of $676,656.93. The evidence established that these funds exist and are available for all proposed capital projects. In the two years prior to hearing, Putnam showed sound management, significant growth, and a strong financial position. It continues to do so. In an interoffice memorandum dated May 28, 1996, from Roger L. Bell to Richard Kelly, Health Services and Facilities Consultant, Putnams' financial position was described as follows: The current ratio of .62 indicates the current assets are not adequate to cover short term liabilities. The long term debt to equity and equity to assets ratios are very weak. This, along with the negative equity make a weak financial position. The profit margin at .1% is also very weak, and raises some concern with the applicant's ability to cover operating expenses . Putnam Ex. No. 4. This criticism was answered by Putnam. The agency may not have considered certain factors applicable to a predominantly Medicare-reimbursed home health agency. Putnam's current liabilities are payable in a longer term than the receivables are collectible. Furthermore, with provision of 98% Medicare services, which is solely cost reimbursed, there remains only two percent of the operation left to make a profit. A .1% profit from the small amount of insurance and private pay patients indicated financial health. Putnam, moreover, is a viable operation because of its historical success, its knowledge of the industry, its expansion to six locations, its growth in staff, and its growth in patient visits. Putnam has the resources available to provide the necessary administrative, managerial, and operational manpower needed by the proposed home health agency. AHCA's financial criticisms are unfounded; Putnam has on hand the capital necessary for the accomplishment of the proposed project. Putnam has the experience and know-how to make the proposed project work in District 2's rural areas. Financial Feasibility Putnam has the resources to implement this project if approved. Putnam has the same capability that existed when three offices were opened during the period from April 1992 through February 1993, and the same resources when four offices were opened in 1995. In every instance, the new offices were started up with cash on hand from operation. Mr. Anderson, Putnam's President and sole shareholder and director, testified that he spends much time in the financial area of the operations. As of November 29, 1996, after deducting all accounts payable, Putnam has a cash balance of approximately $390,000. Anderson Home Health, Inc. had a balance of approximately $425,000. Mr. Anderson testified that the First Union letters in the application at pages 231 and 232 were correct and that Putnam is in even better shape now than when the letters were written. Putnam is financially feasible in the short term. AHCA contends Putnam's project is not financially feasible in the long term because the projected visits stay the same in the second year and because it does not project a profit in year two of operation. This fails to take into account Putnam's performance over the past ten years which, as the agency conceded at hearing, is an important consideration . Mr. Anderson purchased Putnam in 1986. At that time the agency had a single office in Palatka doing 4,000 visits. Following Mr. Anderson's purchase of the agency it had grown to over 55,000 visits and close to a hundred employees. After the success experienced by Mr. Anderson in Palatka, Putnam filed a CON application for District 4, with a proposed principle site in Jacksonville. The District 4 CON was approved by the agency--without any concerns for financial feasibility nor with any concerns for Putnam's cash flows. Without having any experience or referral sources in Jacksonville, Putnam began doing approximately 7,000 visits. The number of visits jumped to 45,000 in the second fiscal year, 123,000 in the third fiscal year, and as of September 30, 1996 the Jacksonville office performed 158,000 visits. Aside from the extraordinary growth experienced in the Palatka and Jacksonville offices, already discussed, Putnam has opened rural offices also doing very well. The Macclenny office in rural Baker County had over 15,000 visits in the first twelve months and is currently averaging over 1800 visits. The Crystal River office in rural Citrus County made over 12,000 visits in its first year and is currently doing approximately 1400 visits a month. Every new office opened by Putnam or Anderson Home Health since 1991 has been break even or better. Putnam has a proven track record for the successful and profitable operation of new Medicare-certified home health agencies. Putnam's project is financially feasible in the long term. Utilization Projections The application sets forth reasonable utilization projections. Based on Putnam's utilization in the past, there is no reason to believe the projections set forth in the application are or unreasonable or will not be achieved. Impact on Costs Putnam is a high tech provider of home health services and will provide some services not currently available or available only in a limited number of agencies. The impact of approval of Putnam's application on costs in the District will be minimal due to the reimbursement issues associated with Medicare which is cost based. RHA A Not-for-Profit Corporation in District II RHA is not-for-profit corporation whose purpose is to provide a continuum of care to the community. All profits are returned to its nursing homes or agencies as a way of continuing to build the programs. RHA owns two nursing homes in AHCA District II; Riverchase Care Center in Gadsden County and Brynwood Center in Jefferson County. If approved, RHA is proposing to locate its Medicare certified home health agency in existing space within the Riverchase and Brynwood nursing facilities. Both of these facilities are managed and operated by HealthPrime, Inc., a company which operates approximately 40 facilities in 13 states. While RHA is technically the owner and therefore applicant for this CON, HealthPrime would operate the proposed Medicare certified home health agency within the nursing homes. RHA's home health agency would have two offices. The office located in the Riverchase facility would serve Gadsden, Liberty, Franklin, Gulf, Wakulla, Jackson, Calhoun, Washington, Holmes and Bay Counties. The office located in the Brynwood facility would serve Leon, Jefferson, Madison and Taylor Counties. Financial Feasibility The only questions raised by AHCA concerning RHA's financial feasibility went to the ability of RHA to fund this project in conjunction with other CON projects listed on Schedule 2 of its CON application. The largest project on Schedule 2 of RHA's application was a CON application for a 20 bed addition to Riverchase Care Center. At hearing it was determined that since the filing of the instant home health CON application, the 20 bed application had been withdrawn, was no longer viable, and was not being pursued by RHA. Once AHCA's financial expert learned that the 20 bed addition to the Riverchase Care Center had been administratively withdrawn and that its costs should therefore no longer appear on Schedule 2, questions about the financial feasibility of the project were resolved. RHA's project was shown to be financially feasible in the short term based upon the financing commitment of HealthPrime. RHA proved that its assumptions and projections made in its financial analysis are reasonable. These assumptions were based on actual experience in the operation of similar skilled nursing facility based home health agencies, as well as prior experience of other home health agencies in their first two years of operation. RHA's proposed project shows a net income in years one and two and is financially feasible in both the short and long term. Availability and Access of Services To the extent that the number of people needing home health care will increase in the future, there is need for new providers of home health services to provide such availability and access. RHA's willingness to condition its application on service to AIDS, indigent and Medicaid patients can only improve the availability and access to services in the district. In addition, RHA's approval to provide nursing home based home health services is unique to the provision of home health services in District II. Efficiency RHA's proposal, which would place its home health agency within its nursing homes, is unique among the applicants in this proceeding. Such an arrangement provides not only an efficient continuum of care to the patients, it also provides efficiencies and cost savings in the sharing of resources. RHA's proposed project is cost effective because it utilizes existing space and equipment in its nursing homes. Skilled nursing home based Medicare certified home health agencies are specifically recognized by the Federal Medicare program in their cost reports. Home health reports are filed as a part of the nursing home cost report and there is an allocation of the nursing home's cost to the home health agency. This benefits both the provider and the Medicare program through cost savings. RHA's cost per visit to the Medicare program of $48 will be substantially less than the District II average of $66 per visit projected for the time RHA will be operational under the applied- for CON. RHA's proposed project will have no impact on its costs of providing other health care services. Appropriateness and Adequacy RHA proposes to provide the entire range of home health services throughout the district. Given the project need in the planning horizon, RHA's proposal is more than adequate to meet the demand for such services. Quality of Care An applicant's ability to provide quality care is another important factor in statutory and rule criteria. RHA and HealthPrime have shown, through operation of their nursing homes in Florida, all of which have superior ratings, that they have the ability to provide quality health care. In addition, HealthPrime, which will actually operate the home health agency, has experience operating four other nursing home based home health agencies. HealthPrime will utilize its quality assurance programs already in place in its other home health agencies and will seek JCAHO accreditation of this proposed agency. By combining a home health agency with its existing nursing homes, RHA will improve the case management of its patients by providing vertical integration of its services in a continuum of care. Such continuum of care provides a stability in personnel and providers that are working with the patient. Economies and Improvements from Joint or Shared Services As previously discussed, RHA's unique proposal to operate a nursing home based home health agency not only offers a continuum of care for the patient, it also provides fiscal economies to the agency as well as the Medicare program. Resource Availability Based on RHA's experience of hiring personnel for its existing nursing homes in the district, there will be no problem in hiring sufficient personnel for RHA's agency. Fostering Competition The addition of other Medicare certified home health agencies in a district consisting of 10 counties and only 23 providers will promote increased competition and more options for patients. Findings Applicable to All Four Applicants No Fixed Need Pool The agency has no rule methodology to determine the need for Medicare-certified home health agencies. The agency's most recent home health need methodology was invalidated in Principal Nursing vs. Agency for Health Care Administration, DOAH Case No. 93-5711RX, reversed in part, 650 So.2d 1113 (Fla. 1st DCA 1995). There is, therefore, no numeric need determination, or "fixed need pool", established by the agency applicable in this proceeding. District 2 AHCA District 2 is composed of 14 counties. The applicants propose to concentrate their service in various, different parts of the district. Local and State Health Plan Preferences District 2 Health Plan Services to Medicaid and Medically Indigent The first preference under the District 2 Health Plan provides a preference to applicants with a history of providing services to Medicaid or medically indigent patients or commitment to provide such services in the future. Mr. Franklin of Care First has such a history. He is an owner of Wakulla Manor, which had a Medicaid occupancy rate of 88.09% for the period of July-December, and the administrator of Miracle Hill Nursing Home which had a Medicaid occupancy rate of 95.74% for the same period. In the face of such a record, Care First’s commitment of 7% Medicaid and 1% uncompensated/charity patients might seem to pale. But it is a significant commitment, given the nature of the home health agency business, and one upon which Care First agrees its application should be conditioned. IHS conditioned its application on 5% Medicaid and 1% charity care. Putnam conditioned its application on an “Indigent and Medicaid participation equal[ling] 4.0%.” Putnam Ex. No. 1, pg. 51. Putnam, moreover, proposes a Medicare-only agency. Establishment of a private sister agency, a practice common in the home health care industry, will allow Putnam to provide service to the Medicaid and indigent patients separate from its Medicare-only agency. RHA has provided a high percentage of Medicaid/charity days at its Riverchase facility (92.10%) and at its Brynwood facility (90.24%). In addition, RHA is willing to condition its CON on the provision of a minimum of 1% of annual visits to indigent care and 5% to Medicaid. Service to Unserved Counties. Preference 2 states that “[p]reference should be given to any home health services CON applicant seeking to provide home health care services in any county within the District which is not presently served by a home health agency.” There are no counties within District 2 that are not presently served by a home health agency. Service Through a County Public Health Unit Preference 3 states that “[p]reference should be given to a home health services CON applicant seeking to develop home health care services to be provided through a county public health unit in the district in order to more adequately serve the elderly and medically indigent patients who are isolated or unable to travel to permanent health care sites." Of the four applicants, only IHS of Florida’s application is conditioned on working with public health units. IHS has experience working with public health units, working with them currently in Martin County, Manatee County and Broward County. Nonetheless, IHS of Florida will not be providing its services “through” a public health unit. Public Marketing Program Preference 4 states, “[p]reference should be given to a home health services applicant who has a history of providing, or will commit to provide, a public marketing program for services which included pamphlets, public service announcements, and various other community awareness activities. These commitments should be included on the granted CON as a condition of that CON.” Care First currently markets its services to the community and commits to a public marketing program in the future as a condition of its CON. IHS of Florida committed to performing at least one community awareness activity per calendar quarter as a condition of its application. It also indicated, moreover, that it would work to develop public service announcements and marketing programs with the help of public health units or any other appropriate vehicle. The latter indication, however, was not made a condition of the application. Putnam provides educational services to the community, its employees, patients and patients’ families, including the provision of pamphlets, and presenting audio and video tapes as appropriate to the patient and their families. Putnam, however, did not condition its application on a commitment to a public marketing program or commit to such a program in any other way in its application. RHA stated it would accept a condition on its CON to provide a public marketing program for services, including pamphlets, public service announcements and other community awareness activities. It did not reflect such a condition on the “Conditions” page of the application, but, given its statement that it would accept such a condition, there is nothing to prevent the agency from imposing such a condition should it grant RHA’s application. Access Requirements Preference 5 is, “[p]reference should be given to a home health services CON applicant who agrees, as a condition of the CON, to meet the following access requirements for each county in which services are provided: 1) 24 hour local telephone call (or toll-free) contact. 2) 24 hour call/response capability. 3) Maximum on one (1) hour response time following call. Care First currently meets the requirements of Preference 5 in the counties in which it now provides services, and has committed to continue to meet these requirements as a Medicare certified home health agency in all counties in which it will provide services. Care First has made as conditions of its CON, provision for 24-hour accessibility by answering service and installation of a toll-free access line and maintenance of a log of calls during the hours the agency is closed, including documenting of response time to each call. IHS of Florida conditioned grant of its CON on a 30 minute response time, and 24-hour phone availability on a toll-free hot line. Putnam presently provides the services in this preference in its District 3 Medicare certified home health agency and agrees to meet this preference within 90 days of initiating services. It did not, however, make a commitment to meet this preference on the “conditions,” page of its application. There is nothing to prevent the agency from making Putnam’s CON, if granted, conditional upon compliance with this preference. RHA has agreed to have its CON conditioned to meet the access requirements of Preference 5. 2. State Health Plan Service to Patients with AIDS The first preference under the State Health Plan is that “[p]reference shall be given to an applicant proposing to serve AIDS patients.” All four applicants are committed to serving AIDS patients. Full Range of Services. Preference 2 of the State Health Plan is “[p]reference shall be given to an applicant proposing to provide a full range of services, including high technology services, unless these services are sufficiently available and accessible in the same service area." There are currently 11 hospital-based Medicare certified home health agencies in District 2. Several of them provide the high tech services which are sometimes needed by discharged hospital patients. Very few referrals for high tech care have been received by D. G. Anthony or Care First since May, 1995, and there is no indication such services are not available in District 2. Care First has identified, however, an unmet need for the pediatric and pre-hospice home health agency services and has conditioned its application on the provision of those services to the community. IHS of Florida proposes, among other high tech services, infusion therapies, pain management therapies and chemotherapy. There is no evidence, however, that these therapies are not available in District 2. The same is true of Putnam as to the high tech therapies it proposes to provide. There is no evidence that they are not available in District 2. Although RHA indicated in its application that it intended to provide the entire range of services that a home health agency can provide, again, there is not evidence that they are not available in District 2. Disproportionate Share Provider History Preference 3 is “[p]reference shall be given to an applicant with a history of serving a disproportionate share of Medicaid and indigent patients in comparison with other providers within the same AHCA service district and proposing to serve such patients within its market area." Care First, having been formed in March, 1996, did not have a history of providing Medicaid and indigent patients. Care First has committed to 7% of its visits to Medicaid patients, well above the average of existing District 2 agencies of 2-3% Medicaid. Care First has committed to 1% of its visits to charity/uncompensated care. IHS of Florida has committed to 5% Medicaid and 1% charity care. Like Care First, IHS of Florida, as a newly formed corporation, does not have a history of serving a disproportionate share of Medicaid/indigent care patients. Putnam’s commitment is 3% to Medicaid and 1% to charity care. This commitment will be met through its sister home health agency and not the Medicare-certified home health agency for which the CON is sought. RHA has committed to set aside 5% total annual visits to Medicaid patients and 1% of annual visits to indigent care. It has a history of providing a disproportionate share of services to Medicaid patients at its two skilled nursing facilities in District 2, Riverchase Care Center in Quincy and Brynwood Center in Monticello. Underserved Counties Preference 4 is [p]reference shall be given to an applicant proposing to serve counties which are underserved by existing home health agencies. The rural areas of District 2 are traditionally underserved. Putnam will serve Bay County, an underserved county; the three other applicants will serve rural areas of more than one county in District 2. Consumer Survey Data Preference 5 is "[p]reference shall be given to an applicant who makes a commitment to provide the department with consumer survey data measuring patient satisfaction." Care First has committed to providing such data to the agency. IHS of Florida will maintain a data base of results of patient satisfaction surveys and make them available to the agency, just as it already does. Putnam will make available to the agency the results of surveys similar to surveys measuring patient satisfaction Putnam has already developed. Putnam has conditioned its application on providing these surveys to the agencies as well as surveys measuring physician satisfaction. RHA has cited on its “Conditions” page, “. . . (it) will provide the Agency for Health Care Administration with consumer survey data.” Quality Assurance Program and Accreditation The State Health Plan’s Sixth Preference is “[p]reference shall be given to an applicant proposing a comprehensive quality-assurance program and proposing to be accredited by either the National League for Nursing or the Joint Commission on Accreditation of Healthcare Organizations." Care First included in its application a copy of its Quality Assurance Program which has been in use since May, 1995. The program meets the state and federal licensure and certification requirement and the stringent requirements of JCAHO. Moreover, Care First has conditioned its application upon JCAHO accreditation. IHS of Florida submitted documentation regarding its Quality Assurance Program through initiatives such as Total Quality Management and Continuous Quality Improvement. It will seek accreditation from JCAHO within one year of receiving its CON. Putnam, an existing home health agency in District 3 since 1986, has over the years developed and refined a comprehensive quality assurance program which is above the industry standard. The District 3 agency, using its quality assurance program, has attained its JCAHO accreditation “with commendation,” a distinction received by less than 4% of all applicants. Putnam will seek accreditation from JCAHO for its District 2 operation within one year of receiving its CON. RHA is willing to condition its CON on the provision of a comprehensive quality assurance program and accreditation by the JCAHO. Need 1. Numeric Need Since there is no published fixed need pool applicable to this proceeding, the parties, other than the agency, developed their own methodologies for determining numeric need. Each of the methodologies employed by the parties was reasonable. After taking note of the statistics for actual patient visit growth in District 2 from 1991 to 1994, Michael Schwartz began with a conservative number of 60,000 new patient visits per year, a number half of the growth for the lowest growth year of that time period. Multiplying that number times the three horizon years of 1994-97 equals 180,000 new patient visits from 1994 which yields a need for 5.2 agencies. The reasonableness of numeric need in excess of four is supported by other factors. After the filing of the four applications at issue in this proceeding, there are two fewer Medicare-certified home health agencies with certificates of need in District 2. At the same time, home health care visits have been on the increase not only in the district as discussed, above, but in the state as well. Statewide, home health care visits grew from 18 million to 22 million between 1991 and 1994. The utilization of home health care agencies is increasing because of population growth and an increase in the number of visits per patient. The amount of time spent by patients in the hospital is decreasing. The decrease translates into increased need by patients for visits from home health agencies. The need for home health is going to continue to increase because it is a cost-effective alternative to nursing home placement and hospital care. From 1991 to 1994, the number of home health visits more than doubled: from 369,396 to 869,893. This trend continued in 1995. The recent significant growth in the utilization of home health agencies in District 2 is expected to continue. The growth is attributable not only to a population increase in the district but to increase in the use rate for home health agency services as well. The growth in use rates can be explained, in part, by the increase in the senior population (65 and older) and the pressure exerted by managed care for earlier hospital discharges and home health agency services as a viable alternative in some cases to inpatient treatment. The senior population in District 2 is reasonably expected to grow approximately 8% in the five years after 1996, with 15% growth expected reasonably in the 75 to 84 year old population and even higher growth, 25%, in the population over 84 years old. 2. Other Indications of Need Local physicians have experienced difficulty arranging for the existing home health agencies to provide services to patients located in remote areas of District 2. Specialized groups, such as AIDS patients, would, in all likelihood, benefit from additional home health agencies in District 2. Furthermore, a study conducted by IHS of Florida showed that the district has an unusually high rate of diabetes and in four counties has a diabetes death rate 100% greater than the statewide average. Well Springs home health agency is one of the two Medicare-certified home health agencies to cease providing Medicare-certified home health services after the four applicants in this proceeding filed the applications at issue here. Well Springs was licensed in all 14 counties of District 2 and had physical locations in Franklin, Gadsden, Bay, Leon, Liberty, Taylor and Madison Counties. It had a significant share of the District 2 Medicare certified home health agency market with 13.1% of the 1994 visits, the second highest in the District. With Well Springs discontinuing Medicare-certified home health agency services, a void was left for such services in District 2, particularly in those counties in which Well Springs had a physical presence.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the Agency for Health Care Administration enter its final order granting CON Nos. 8380, 8381, 8382 and 8384 to RHA/Florida Operations, Inc., Care First, Inc., Home Health Integrated Health Services of Florida, Inc., and Putnam Home Health Services, Inc., respectively. DONE AND ENTERED this 9th day of June, 1997, in Tallahassee, Florida. DAVID M. MALONEY 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 9th day of June, 1997. COPIES FURNISHED: Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308-5408 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308-5403 Richard Ellis, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308-5408 W. David Watkins, Esquire Watkins, Tomasello & Caleen, P.A. 1315 East Lafayette Street, Suite B Tallahassee, Florida 32301 Mark Emanuel, Esquire Panza, Maurer, Maynard & Neel NationsBank Building, Third Floor 3600 North Federal Highway Fort Lauderdale, Florida 33308 Paul Amundsen, Esquire Amundsen & Moore 502 East Park Avenue Tallahassee, Florida 32301 Theodore E. Mack, Esquire Cobb Cole & Bell 131 North Gadsden Street Tallahassee, Florida 32301

Florida Laws (3) 120.57408.039949.02
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VARI-CARE, INC., D/B/A HOSPITALITY HOME HEALTH vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 84-001085 (1984)
Division of Administrative Hearings, Florida Number: 84-001085 Latest Update: Jan. 11, 1985

The Issue The issues presented in this case concern the entitlement of Vari-Care, Inc., d/b/a Hospitality Home Health, Inc.(Vari-Care) and A All Care Home Health Agency (A All Care) to be granted a certificate of need to provide home health services in HRS Service District IX. In this regard there are two basic issues. The first issue concerns the question of whether there is a need for the provision of additional home health services through the recognition of the contending applicants for certificate. The second issue concerns the matter of the comparative or competitive review of the credentials of the two applicants who vie for this recognition. These matters are considered in keeping with Section 381.494, Florida Statutes, and the related provisions of Section 10- 5.11, Florida Administrative Code. The recognition would be as envisioned in the definition of home health care agency as set forth in Section 400.462(2) Florida Statutes. EXHIBITS In furtherance of its presentation Petitioner, Vari-Care, presented twelve exhibits which were received. A All Care, as Petitioner, presented eight exhibits which were received. HRS offered one exhibit and it was received. Intervenor, Palm Beach Regional Visiting Nurse Association, Inc. (Visiting Nurse) offered five exhibits and they were received. Intervenor A Associated Home Health Agency, Inc. (A Associated), offered two exhibits and they were received.

Findings Of Fact Vari-Care and A All Care made application to the Department of Health and Rehabilitative Services (HRS) for the grant of certificates of need to establish home health care agencies in Palm Beach County, Florida, to serve residents in that locale. Following review of these applications, the department noticed the applicants of the intent to deny the applications. In the face of this rejection, the applicants made timely request for an administrative hearing to resolve the question of their entitlement to the grant of certificates of need. In view of the fact that the applications had been reviewed and considered by the department in the same "batch", the hearing had as its purpose the question of the need for additional home health care delivery through the efforts of these applicants and the matter of comparison of Petitioners' relative merits as would-be home health care providers. Several entities requested intervention, among them Florida Association of Home Health Agencies. That agency was denied intervention. Intervention was afforded to Palm Beach Regional Visiting Nurse Association Inc., and A Associated Home Health Agency, Inc., both of whom are holders of certificates to provide home health care services in Palm Beach County, Florida. In furtherance of its request, Vari-Care has established a separate corporation in the state of Florida to operate its intended home health agency. This corporation is known as Vari-Care, Inc., d/b/a Hospitality Home Health. At present Vari-Care offers health care through three nursing homes in the state of Florida, all of which are located in Palm Beach County. In addition, Vari-Care is a home health care provider in Alabama and Arizona. If recognized to provide home health care services through the certification process, Vari-Care proposes to offer services primarily for the benefit of those patients who are being discharged from its three nursing homes located in Palm Beach County. The nursing homes in question carry a superior rating. At the point of hearing, five to ten patients a week were discharged from the several nursing homes operated by Vari-Care. Those patients are presently receiving home health care services from other home health care providers and the administration of Vari- Care has not experienced difficulty in arranging for the delivery of that care for the benefit of the patients discharged from the Vari-Care facilities. Vari- Care contends that if it were allowed to follow-up the care of the patients discharged from the nursing homes it would promote a "continuum of care" tending to improve the quality of care and relieve patient anxiety. In this regard Vari-Care would hope to use some of the professional staff in the nursing homes to offer to deal with the needs of the patient who was homebound following discharge. The testimony tended to establish that this facet of continuity of care is tenuous at best. It is more likely that separate health care professionals would be involved with the patient in the nursing home and home setting. It would appear that the idea of "continuum of care" will only transpire to the extent of the affiliation between the nursing homes and the home health care arm of Vari-Care. Initially Vari-Care had indicated that it would have its base of operation in the nursing home facility. That position was amended and at the point of hearing the Vari-Care application contemplated the establishment of a separate operating facility for the benefit of the home health care business. Out of that facility Vari-Care would provide skilled nursing, physical therapy, occupational therapy, social services, meals on wheels and transportation services. Finally, Vari-Care in its operation does not preclude the possibility of attracting other patients who are not being discharged from its nursing homes, in marketing its home health care delivery. A All Care is a corporation in which Julie Monahann is the sole stockholder. At present Ms. Monahann is sole stockholder of A All Care Nursing, of Boynton Beach, Florida, which operates a private-duty nurse registry in the southern part of Palm Beach County. That registry has available approximately 200 nurses. Ms. Monahann contemplates the establishment of a certified home health care operation as an outgrowth of her present business. Not being the holder of a certificate of need, Ms. Monahann has been unable to serve patients who are the recipients of Medicare and wishes to have that opportunity. Provision of this care would be through some of the same nurses who are listed in the registry for Ms. Monahann's private duty nursing business. In pursuing the application of certificate of need, Monahann has been influenced by the erroneous perception that no other certified home health care provider was directing its efforts to serving homebound patients in south Palm Beach County. As stated, presently there are a number of licensed and certified home health care providers operating in Palm Beach County. Those agencies offer a comprehensive range of home health services. Visiting Nurse operates throughout Palm Beach County with its parent office in West Palm Beach and satellite offices in Jupiter, Boynton Beach and Belle Glade. In addition to serving Medicare and Medicaid patients, this home health care provider offers services to the indigent. It is the intention of the Visiting Nurse to move their Boynton Beach operation to Boca Raton. Should either of the applicants be recognized by the grant of a certificate of need, Visiting Nurse would be substantially affected. In the recent past, Visiting Nurse has experienced the introduction of additional home health care service by other home health care providers operating in Palm Beach County and it has tended to decrease the number of patient visits provided by Visiting Nurse and to negatively impact cost, by requiring an increase in cost of the provision of a home health care visit. The effect of a drop in the number of home visits and increase in cost impacts the quality control of Visiting Nurse in such matters as the ability to provide in-service education and provide the services of home care coordinators. Home care coordinators assist in the provision of continuity of care between the referring sources and the patient in the home. Finally, a diminution in home visits and increase in cost would adversely affect the treatment of indigent patients in the home, in that Visiting Nurse is a significant provider of indigent care to those patients in that category and pressures upon the financial standing of the provider would decrease the care available to indigent patients. A Associated, intervenor, serves Palm Beach County from two offices, one in Jupiter and the other in Lake Worth. This organization utilizes employee teams who live in a particular area of Palm Beach County where the patients are found. This would include the area of Boca Raton and Delray Beach which is found in south Palm Beach County, areas where both petitioners would place emphasis. With the advent of a new home health care agency in 1983, which is known as Coastal, A Associated experienced a decrease in patient referrals and an increase in the cost per visit, due to the need to fund the same amount of overhead in the face of a lesser number of visits. Given the previous experience with Coastal, the introduction of the two applicants into the marketplace in south Palm Beach County would substantially affect the rights and opportunities of A Associated and as a consequence patient rights. All told, there are nine licensed home health agencies serving Palm Beach County and approximately thirteen licensed home health agencies operating within District IX, which includes Palm Beach County and counties adjacent to Palm Beach County. Some agencies in Palm Beach County maintain multiple offices to facilitate the delivery of the health care. Those agencies include Visiting Nurse with its four offices, A Associated with its two offices, Community Home Health with two offices, A Visiting Redi Nurse with three offices, and Home Care of the Palm Beaches with two offices. Mederi Home Health Services has one office in Palm Beach County. A recent addition, Salhaven Home Health Care, licensed to operate as a home health agency will operate in the Jupiter area of Palm Beach County. Its services were to be provided within a month of the date of final hearing in this cause. Gold Coast Home Health Services provides home health service in south Palm Beach County from its Broward county office which is near the Broward County/Palm Beach County line and has operated in Palm Beach county since 1970. Coastal Home Health Services also referred to as Associated Home Health Services is presently operating in Palm Beach County, though it has its office in Broward County. Of these agencies, only Salhaven and Gold Coast decline to operate in the entire Palm Beach County area. Gold Coast operates from the southern boundary of the County to a central area. The aforementioned home health agencies are duly licensed and certified to provide home health care to Medicare recipients and as such, present alternatives to the services which the applicants would offer to Medicare patients within the Palm Beach county community. The home health care providers who service HRS District IX and in particular Palm Beach County, have the capacity to meet need for home health services in the questioned service area. In addition, those home health care agencies are capable of meeting foreseeable increases in the need for additional home health services either within their present resources or through expansion of resources. Neither adjustment would reduce their effectiveness or negatively impact cost considerations and quality of care. A number of patient referral agencies, i.e., nursing homes and hospitals, in the person of officials, provided testimony in the course of the hearing and did not indicate that placement of Medicare patients in need of home health care presented a problem in Palm Beach County. There is an ongoing liaison between the placement agencies such as hospitals and nursing homes and the several home health care providers serving Palm Peach County who offer assistance to homebound Medicare patients. In that context, there is a vigorous competition between the home health care providers to serve Medicare patients in need of home health care delivery. The vigor of the competition is evidenced by the experience of MederiInc., which has operated out of its Delray Beach office since September 1983, and has been disappointed in the number of patient referrals. This is attributable to the active competition between the home health care providers. As a consequence, Mederi has a high percentage of unused capacity without increasing administrative overhead, approaching the ability to accommodate fifty percent more patients. In fact, Mederi could provide twenty percent more home health care visits without increasing its direct patient care staff. The proposal for the applicants related to patient costs are not advantageous when compared to those costs related to the present home health care providers. The present Medicare home health providers in Palm Beach County are well within the "cost caps" established by the Medicare program. On the subject of patient cost for Medicare patients, there is a wide variety of cost per visit depending upon the given home health care provider; however, none of those costs are as high as those proposed by the applicants in this case. The Medicare reimbursement program is required to reimburse the home health care provider who holds a certificate of need and license on the basis of reasonable operating costs, provided those reasonable operating costs are less than the charges made by the agency for the services and provided the Medicare reimbursement cost implementations, "cost caps", are not exceeded. Vari-Care by its proposal would exceed the present "cost caps" and adversely affect the medicare program by the imposition of such costs. The applicants do not afford any unique services in the home health care setting. In fact, the applicants' provision of care does not rival the level of sophistication of some of the ongoing providers. Presently Community Home Health is receiving patient referrals from the three nursing homes of Vari-Care and is providing the Medicare home visits to those patients at a cost per visit much less than contemplated by Vari-Care. Actually, those costs per visit by Community are the lowest rates mentioned by any provider of home health care for Medicare patients in Palm Beach County. In the course of the hearing, one of the attempts to measure the question of the need for additional home health care delivery for Medicare patients was described in the terms of "unmet need". There being no established methodology by the department to measure the entitlement of the applicants to the grant of a certificate of need, the concept of "unmet need" provides a valuable insight in deciding the application question on this occasion. Using this measurement, no indication has been given which would tend to identify patients within Palm Beach County or in the overall HRS District IX, who are not receiving needed home health care services. Moreover, there is sufficient capacity within the present home health care providers to meet the need for home health care delivery for Medicare patients within the planning horizon contemplated by the applications under consideration. In a related vein, there does not appear to be a body of Medicare recipients whom the home health care providers have neglected, based upon a belief that the patients were inaccessible to the home health care professionals who deliver the services. The present home health care providers have located their central and satellite offices to cover Palm Beach County completely and in particular south Palm Beach County where the two applicants would establish their offices. The hours of operation of the present home health care providers are satisfactory and the applicants would not offer hours of operation which are significantly different. In addition, there is no indication that there is a lack of awareness on the part of the patients on the topic of availability of home health care services, quite the contrary, an intricate mechanism is in place which promotes the necessary referrals of those patients to home health care providers to assist the patient in the home setting. An example of this mechanism is seen in the broad-based referral arrangements between a number of hospitals and the home health providers in Palm Beach county or in some instances specific agreements between hospitals and a given provider. This is based upon the information presented at the hearing as to arrangements between Delray Community Hospital, St. Mary's, Humanna, Good Samaritan, Belle Glade Community, and Bethesda Hospitals, and the various providers. On the associated question of quality of care, as in the instance of availability of care there is no indication that the quality of care received by the patients in the home setting is lacking. If this problem existed, one would expect a hue and cry by the public or agencies charged with the function of monitoring quality of care. Such an upheaval has not been shown to exist in Palm Beach County related to the delivery of home health care to the Medicare patients. The only actual research in this regard was done by Delray Community Hospital and its informal survey did not indicate displeasure with the quality of home health care being received by its patients who were Medicare recipients. All home health care providers operating in Palm Beach County seem to have an awareness of the need to deliver quality care and have involved themselves in programs related to in-service training and quality assurance. Vari-Care in its nursing home experience in referring patients for home health care delivery has not experienced complaints from its patients related to the quality of home health care. The present home health care providers are mindful of the need for fiscal restraint given the breadth of competition and have instituted policies to promote efficiency, to include the utilization of contract professionals who are not full time employees of those providers. In carrying out the administration of its operations, the home health care providers in Palm Beach County are aware of the "cost caps" established by Medicare and do not exceed them. Neither has there been any indication that those providers have run afoul of other regulatory provisions of the Medicare program in efforts to deliver the Medicare services in the home. By contrast, the present applicants do not seem well apprised of the requirements of Medicare. At present, there are a number of demonstration projects by health maintenance organizations operating in Palm Beach County. Those projects include the delivery of home health care. It has been shown that patients within the health maintenance organization receive home health services, who ordinarily would be entitled to Medicare reimbursement. The effect of this arrangement is to decrease home visits by the home health care providers in Palm Beach County. On the other hand, some of the health care agencies have experienced problems where services were delivered to patients who were members of health maintenance organizations and the health maintenance organization refused to reimburse the home health agency for services rendered to members of the health maintenance organization. It is not certain what the future holds for delivery of home health care through health maintenance organizations, but at present the development tends to diminish the patient pool from which the home health care providers draw their clientele. While both applicants have sufficient financial ability to begin operation as a home health care provider, the short and long-term financial feasibility of the projects is not sound. Vari-Care has overestimated the amount of reimbursement that it hopes to receive from Medicaid by projecting a return of $55 per visit when it would only be entitled to $16, promoting a deficit of some $40,000. It also projects a charge for Medicare visits at $55 when the Medicare "cost cap" is $50 to $52, promoting a deficiency of at least $3 per visit and a total deficiency of some $24,000. A All Care has no established referral base such as the nursing homes referrals contemplated by Vari-Care, and its financial feasibility is questionable given that circumstance. Finally, both applicants face a competitive environment in which their survival and that of the on-going home health care providers, is jeopardized should the applicants be recognized by the issuance of certificates of need. Dr. Donald Davis, an expert in health care planning, testified in behalf of A All Care. He correctly identifies the fact that home health care services are labor intensive as opposed to an undertaking which requires extensive capital expenditure. Consequently, from his point of view, when competition is great in the home health care setting, patient cost will be lower and a more efficient system will evolve forming a basis for the recognition of additional home health agencies. Dr. Davis was also impressed with the fact that a lower number of home health care providers per capita were found in Palm Beach County as contrasted with Dade and Broward counties, in Florida, when the number of home health care providers are compared to the overall population in those counties, which by his observation might be an indication of the need for additional home health care providers. Here he did not contend that there is some optimum number of patients or visits which can be offered by a given home health care provider. Davis had misunderstood the number of home health agencies serving Palm Beach County in advancing his remarks. His belief was to the effect that only six Medicare home health agencies operated in Palm Beach County, instead of the nine that wore actually there. By comparison, Daniel Sullivan, who testified as a health planning expert, called as a witness by Visiting Nurse, felt that in the present environment, increased competition would result in increased costs to patients. He believes that the present providers can serve additional patients at a lower cost than the applicants could with the advent of the recognition of the two applicants. Sullivan stated that if the number of visits to patients were sufficiently reduced, as would occur when the applicants were recognized, the cost per visit would increase. Having considered the opinions of Davis and Sullivan, Sullivan is found to be the more compelling witness arid his opinions as set forth are accepted. In summary, if the applicants introduced their operations into the Palm Beach County and HRS District IX service area, health care costs would escalate and the quality of delivery of health care services through the present home health care providers would be adversely affected. Vari-Care presented the testimony of the health planning expert Mary Ellen Early. She presented a methodology for ascertaining the need for additional home health care service, there being no established methodology by rule. Early looked at the increase in population within Palm Beach County between 1970 and 1980, which is in the neighborhood of 65.3% compared to 43.5% in Florida. She noted that Palm Beach County had increased in population since 1983 on the order of 13.1% and was the fifth most populated county in the state. Of the five most populated counties, Palm Beach County has experienced the largest percentage of growth in the decade 1970 through 1980. She noted that Palm Beach County ranks third nationally in the percentage of elderly and that the percentage of elderly sixty five and older doubled between the years 1970 and 1980. She noted that 13,220 individuals fall into the age categories of seventy five years and older, a high risk population. Statistics by the local health planning agency, as discovered by Early, indicated a continuing increase in the sixty five and older population, projected to be 29.3% by 1990. With this background, in her needs formula Early used three variables. Her formula assumes that 6% of medical/surgical hospital discharges, 8% of individuals sixty five and older, and 50% of nursing home discharges would need home health care services showing a demand of 18,129 people that could require home health service. The calculations were made based upon 1982 statistics about the sixty five and older age group. Ms. Early was not mindful of, nor has any other party to this cause, indicated the exact number of individuals presently receiving home health services in Palm Beach County. Without that knowledge the projection is not useful because it can not be shown that additional services need to be provided. From the projection of the number of persons who would demand home health care and adding to that methodology the idea, in Early's mind, that the effect of discharges from hospitals and nursing homes as it pertains to diagnostic-related groupings, and the high occupancy rates in nursing homes in Palm Beach county, and the increase in Medicaid patient days and Medicare patient days in the period 1980 through 1983, together with the limited number of home health agencies within Palm Beach County compared to the other six most populace counties in Florida, a need exists for recognition of Vari-Care's application to serve homebound patients. In analyzing her remarks, the information provided in the course of the hearing does not tend to be firm enough to conclude that the referrals from hospitals and nursing homes, as a result of diagnostic related groupings, will significantly increase the number of home health care visits. Therefore, that element of the opinion of Early is discarded. Also, the needs methodology used by Early, overstates that need for Medicare home health care services in that it includes in its definition home health services not reimbursed by Medicare. It includes duplication of numbers of persons in need of home health care services by counting 65 year old and older persons discharged from the hospitals and then recounting those persons in a calculation related to the fact that 8% of individuals sixty five and older would need the home health care delivery. This was further brought to question in that contrary to the 8% estimate of sixty five population and over needing Medicare home health services, effective 1983, 5 1/2% of that age cohort population was in need of those services. Returning to the topic of the formula selected by Ms. Early, it can also be assumed that some of the patients being discharged from the nursing homes into the home health setting, will be sixty five years and older and the risk of double counting exists in that calculation. As with the circumstance of observations by Dr. Davis, there has been no showing of the ultimate number of services that may be provided by home health care provider. Therefore the ratio of the number of home health care providers to population in Palm Beach County, as one of the six most populated counties in contrasting this ratio with the counties with the high population groups, is meaningless. The evidence tends to reveal that the real question is whether all patients who wish to be afforded the home health care delivery, are being provided quality care at a reasonable cost, and this is occurring at present in Palm Beach County and throughout District IX. On balance, the needs formula and the other projections by Ms. Early as to the need for additional home health care services provided by Vari-Care are not accepted. Vari-Care places emphasis on the fact that it would offer services to Medicaid patients, who are primarily being served at present by Visiting Nurse. The inquiry in this cause has to do with services for the benefit of Medicare recipients. To the extent that the Medicaid recipients are involved in any way in this question, there is a suspicion that Vari-Care would not be willing to go forward with the provision of the amount of Medicaid service that it has proposed in its application given its misunderstanding of the reimbursement entitlement, the difference between the $16 allowed and the $55 which Vari-Care feels it is entitled to. Even if those costs were reduced and Medicaid services were provided at the level contemplated by Vari-Care, this would not be sufficient reason to afford a certificate of need to Vari-Care. The introduction of Vari-Care into the market place would also have an adverse impact on Visiting Nurse and as described would be brought to bear on the Medicaid patients who receive services from that organization. In view of the fact that no proof has been established tending to show the need for the recognition of either applicant for certificate of need, it is not necessary to comment on the relative qualifications of the applicants, beyond whet has already been established in these facts.

Florida Laws (3) 120.57400.462400.471
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HOME CARE ASSOCIATES OF NORTHWEST FLORIDA, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 87-002150 (1987)
Division of Administrative Hearings, Florida Number: 87-002150 Latest Update: Jul. 01, 1988

The Issue The ultimate issue is whether the application of Home Care Associates for a Certificate of Need to establish a Medicare-certified home health agency in Okaloosa and Walton Counties should be granted. The principal factual issue is whether there is a need for an additional agency and the principal legal issue is what criteria for need should be applied. The statutory criteria for determining need is Section 381.705, Florida Statutes. In this proceeding, the Petitioner showed its entitlement to a CON using the statutory criteria set out in Section 381.705, Florida Statutes. GENERAL STATEMENT Proposed Findings of Fact were filed by the Petitioner and the Intervenors. The Respondent adopted and incorporated the Intervenor's Proposed Findings of Fact adding to the Intervenor's findings its own proposed findings numbered 1 through 20. Proposed findings submitted by the parties are addressed in an Appendix hereto.

Findings Of Fact All home health care agencies in the State of Florida must be licensed and those home health care agencies which want to participate in the Medicare program must also obtain a Certificate of Need (CON). Medicare is a federally funded health program for the elderly and certain disabled persons. Medicare provides reimbursement only for the following part-time and intermittent home care: skilled nursing, physical therapy, speech therapy, home health aide, and medical social services. Medicare does not reimburse for custodial care or 24-hour-a-day care (adult congregate living facilities or nursing homes) or acute care services (hospitals). In order for a provider of Medicare home services to be reimbursed, the provider must have a CON and serve Medicare-eligible persons who: (a) are referred by order of a physician, (b) are home bound, (c) require skilled care, and (d) require skilled services only on a part-time basis. The patient must have rehabilitative potential and need skilled home care for Medicare to reimburse for home care. The overall goal of Medicare home health services is to have the patient functioning at his/her optimum level using rehabilitative services and having registered nurses and other skilled professionals to instruct the family and patient in rendering patient care. Medicaid provides reimbursement to providers only for skilled nursing services and home health aide services to patients who meet strict income and asset limitations. No reimbursement is provided for any other services. Medicaid has maximums or caps on reimbursement for services rendered under the program, and will pay for the services rendered up to the amount of the caps which are based upon allowable patient care costs. Medicaid reimburses only a fixed amount established by HRS for a specific service. Respondent, HRS, is the state agency responsible for administering the State Health Planning Act pursuant to Sections 381.701 through 381.715, Florida Statutes. The Petitioner, Home Care Associates of Northwest Florida, Inc. (Home Care), is a Florida corporation owned by Marck Ehrman, M.D., Warren A. Phillips, Dennis L. Sauls, Ronald O. White, and Steven P. Espy. Dr. Ehrman is a practicing hematologist/oncologist in Ft. Walton Beach, Florida. Home Care filed a Letter of Intent on October 8, 1986 and on December 15, 1986, it actually filed a CON application for a Medicare-certified home health agency to be established in Okaloosa and Walton Counties in the State of Florida. These counties are in Subdistrict IB of HRS District I which is composed of four counties. This application was identified by HRS as CON Action No. 4911. Okaloosa and Walton Counties are an appropriate service area for Home Care. Home Care's application was placed in the December 15, 1986 batching cycle by HRS, which preliminarily denied the application. There were no other applications for a Medicare- certified home health agency in Okaloosa and Walton Counties filed in said batching cycle with which Home Care's application could be comparatively reviewed. HRS published notice of its denial in 13 FAW 1806 (May 8, 1987). Home Care timely requested an administrative hearing by petition filed with HRS on May 11, 1987. Choctaw filed a timely Petition to Intervene on August 14, 1987, and Northwest filed its Petition to Intervene on August 28, 1987. Both petitions were filed more than one month before the scheduled final hearing, and Choctaw was granted standing to intervene by Order of the Hearing Officer dated August 20, 1987, and Northwest was granted standing to intervene by Order of the Hearing Officer dated September 4, 1987. Both Intervenors were determined to be existing providers of Medicare home health services in the geographic area for which Petitioner had applied for a CON. The basis for the denial of the Petitioner' application for Certificate of Need was based upon the Respondent's determination that: There was no need demonstrated by Home Care Associates of Northwest Florida for an additional home health agency to serve the residents of Okaloosa and Walton Counties. Marta V. Hardy was the Deputy Assistant Secretary for Regulation and Health Facilities, Department of Health and Rehabilitative Services, from September 1984 through June 1987. Ms. Hardy was responsible for home health agency policy and was the ultimate decision maker with regard to the preliminary denial of the instant Certificate of Need. (Petitioner's PFF paragraph 19) 1/ In the Fall of 1984, Respondent attempted to promulgate a proposed rule on home health care facilities to replace a rule on need which had been invalidated in an earlier rule challenge proceeding. This proposed rule was invalidated in 1985 because it was based on a use rate methodology which contained arbitrary criteria. On May 15, 1986, in response to invalidation of the proposed rule, Bob Sharp, administrator of Comprehensive Health Plans for the Department of Health and Rehabilitative Services, published an interim policy by memorandum which was used to review applications for CON's for home health agencies. This interim policy utilized a variation of the previously invalidated rule but attempted to correct criticisms which had resulted in the invalidation of the proposed rule. The Sharp memorandum was a public document and interested persons were aware of this memorandum and the policies expressed therein. The interim policy promulgated by Sharp was applied to home health agency applications beginning with the first batching cycle in 1986. The interim policy used a use rate/population methodology which projected the number of Medicare enrollees using home health services. The projected number of users was multiplied by the average number of visits per Medicaid home health user. Under the interim policy the total number of visits was divided by 9,000 to determine the gross number of agencies needed. Nine thousand visits was deemed by agency planners to constitute a large enough use base to sustain a home health agency based on the agency's assessment of the economies of scale of home health operations. The total number of licensed and approved agencies was subtracted from the gross number of agencies needed to yield the number of new agencies which could be approved. The interim policy provided that new agencies would be phased in over a three year period and resulted in the approval of 23 Certificates of Need between May 15, 1986 and December 1986. This interim policy was defended by the Respondent before the First District Court of Appeal in December 1986. During the Summer 1986, representatives of the Florida Association of Home Health Agencies (FAHHA) complained to the Governor's Office about the interim policy, contending that the interim policy put too many home health agencies in the field. As a result of FAHHA's complaints, meetings were held between members of the Governor's staff and representatives of the Department of Health and Rehabilitative Services to include Marta V. Hardy. As a result of these meetings, the Department abandoned its interim policy. Ms. Hardy was instructed that additional applications for home health agencies would have to be approved by her superiors. Medical or financial factors did not change during this period, which would warrant a change in policy. The Department changed its policy but did not publish any document rescinding Sharp's Memorandum. No notice was given to the public that the change in policy had occurred until after the second batching cycle of 1986, the one which contained the Petitioner's CON. Similarly, the Department did not notify the public that there was a need for additional services or agencies. Marta Hardy had instructed her staff not to issue any more home health agency CON's until a new methodology had been developed. The applicants were informed that the Department of Health and Rehabilitative Services had changed its interim policy and there was no numerical need methodology. Applicants were asked for an unlimited extension of time within which the Department could render a decision on their applications. In the absence of a rule on need, the Department required the applicants who refused to agree to an extension of time to demonstrate an unmet need based upon the broad statutory criteria found in Chapter 381, Florida Statutes. The Department of Health and Rehabilitative Services characterizes the procedure above as a free form action utilizing the statutory criteria found in Section 381.705, Florida Statutes. Using the free form procedure, one home health agency CON was granted in a county in which no existing service was being provided. The three existing Medicare-certified home health agencies in Subdistrict IB are: Northwest, Choctaw, and Okaloosa County Health Department (OCHD). OCHD is the home health agency of last resort for chronically ill patients in Okaloosa County. It renders services to those patients who would not be treated otherwise. It conducts few Medicare visits: 363 in 1985-86 and 225 Medicare visits in 1986-87. OCHD's costs to provide a home visit are high and the number of visits per patient is low. While rendering all classes of home health care, its services are limited, slow, and not competitive with the private agency in the County. It lacks the ability to perform high tech home care. Its program, which is directed by the Department of Health and Rehabilitative Services, is placing its current emphasis on maternal-child health. When OCHD is eliminated as a competitive element, Northwest is the only provider of Medicare-certified home health services in Okaloosa County and Choctaw is the only provider of medicare-certified home health care in Walton County. The market share of Northwest in Okaloosa County is 92 percent. It has provided home health services in Okaloosa County for nine years. Choctaw currently has a 100 percent market share in Walton County and has been the sole provider of home health services for over ten years. There are no alternative home health care providers in Walton County. Choctaw and Northwest provide all basic home health care services in their respective service areas. Neither Choctaw nor Northwest had provided technically innovative home health care services until the last few months when they added certain basic types of high tech care, such as infusion pumps. To the extent there has been an increase in the availability of such services, it appears to be a competitive response to the pending application of the Petitioner. The skills and services currently available in Walton and Okaloosa Counties in the area of home health are not state-of-the-art home health services which Home Care states it will provide. Home health agencies first must develop the capacity to provide sophisticated patient evaluation and high tech services if physicians are going to depend on and use these services when planning out-patient care. Petitioner is a durable medical equipment ("DME") company. This company has brought new technology to the Ft. Walton Beach area to include oxygen services, pulmonary rehabilitation, home dialysis, parenteral nutrition and hydration. A related company provides private duty nursing care to non- Medicare and non-Medicaid patients currently. Dr. Ehrman is also involved in Home Care Professionals. Home Care Professionals, a non-Medicare provider of home health care services and durable medical equipment, was developed to meet the needs of home care patients whose needs were not being met by current providers. Dr. Ehrman is already using computers to assist in the transmission of data from the patient's location to the doctor's location and to transmit and receive the results of lab tests. He plans and has allocated money to computerize Home Care. This will cut down on delays in transmitting and receiving information. Lab results and other patient information will be computerized. Dr. Ehrman plans to rigorously select his staff and provide to them in-service training in new procedures and high tech home health care. Home Care's nurses will be better trained than current providers' nurses. Home Care will assign a patient to one nurse. The Petitioner, Home Care, will provide a new, competitive alternative to the existing agencies which will provide incentive for all the agencies to improve their services and the quality of their care. Choctaw and Northwest staff their cases geographically east and west. Choctaw refers patients in the south end of Walton County to Northwest, and Northwest refers patients in the northern part of Okaloosa County to Choctaw. This practice, which is a technical violation of their DHRS licensing by county, is dictated by the geography of the service area and the natural and man-made obstacles, including Choctawhatchee Bay, I-10, and Eglin Air Force Base, which create geographical divisions which span both counties east and west while the counties run north and south. The largest and most rapidly growing population areas are in the southern portions of both counties. This is where the major acute care hospitals are located. The remaining population in these counties tends to be along the I-10/U.S 90 corridor where smaller hospitals are located. Patients which cannot be treated in these smaller hospitals have been referred historically to facilities and physicians in Pensacola, although this is changing as more patients are being sent to facilities and physicians in Ft. Walton Beach. Approval of this application is consistent with the boundaries of the subdistrict, will enhance competition encouraging the other providers to upgrade their services, and will tend to orient care along a north-south axis. The Petitioner would be he only provider licensed to serve both Walton and Okaloosa Counties which would be advantageous because it could legally staff on an east- west axis and avoid the problems created by the geographic division of Subdistrict IB. In determining the need for home health agencies in Subdistrict IB, a two year planning horizon was used. A two year planning horizon is reasonable. Two years from the Petitioner's filing date would be December 1988. Data for the periods ending July 1988 and January 1989 were used because the official population projections from the Governor's Office focus on July and January of each year. The two projected dates bracket December 1988, two years from the filing date. The population of elderly (65 and over) for Subdistrict IB is projected to be 16,868 for January 1988 and 17,350 for January 1989. The Medicare use rate the number of Medicare home health visits per elderly person in Florida for 1984 was multiplied by the projected elderly population to arrive at a projected number of visits. The number of visits projected to occur in July 1988 was 31,976, and 32,889 visits were projected for January 1989. An average of the two projections was used to estimate the number of projected visits in December 1988. Dr. Kolb, an expert in health planning, researched the optimal size of an agency. She determined that once an agency's visits reach the range of 6,000 to 9,000, economies of scale are achieved in which the fixed costs are spread sufficiently among all visits to make operations viable, and that once this scale of operations is reached, costs per visit become relatively static or are affected more by other factors. Her findings in this regard are consistent with the conclusions reached by HRS in adopting virtually the same criteria in the Sharp policy which it used to evaluate need in the first half of 1986. See Paragraph 15 above. The optimum size for an agency is riot wholly dependent upon ratio of costs per visit, but it is that size which keeps costs low, fosters healthy competition, sustains the quality and availability of service, encourages innovation, and meets the other statutory objectives. To determine the number of agencies needed, the projected number of visits was divided by 9,000, the optimal number of visits per agency, which showed a need for 3.6 agencies. Rounding up, this calculation shows a total need for four (4) agencies in the subdistrict in December 1988. There are three licensed and approved home health care agencies in Subdistrict IB. Subtracted from the four agencies needed in December 1988, one additional agency could be added. The addition of Home Care to the home health market will not significantly affect existing providers. Home Care projects it will deliver 3,800 visits in its first year of operation and 7,000 visits in its second year. A large percentage of those visits are attributable to population growth alone. If the state home health use rate of 1.9 is applied to the 4,588 population growth expected by 1990, an additional 8,717 home health visits will be generated. That growth alone will meet the volume of visits projected by Home Care. Home Care will do new procedures and will educate existing providers and physicians to the availability and desirability of using new services provided by Home Care. This will cause an increase in the local use rate. Approval of Home Care's application will increase the overall market for home health services. Dr. Ehrman is a highly trained and experienced physician. Dr. Ehrman has been instrumental in improving the nature and delivery of health care in his medical specialty and community. He has improved the way blood smears are done at the hospital lab and improved the administration of blood bank at the local hospital. He has organized and taught nurses about chemotherapy and developed a tumor board. He helped get radiological procedures improved. Dr. Ehrman has developed new and innovative practices in his office and has assisted patients in obtaining appropriate Medicare reimbursement for services and drugs. Northwest adduced evidence that it operates very close to its Medicare cost caps; however, Northwest pays out much of its revenue to related organizations in the form of management, consulting, and computer fees. For example, in the 1986 cost reporting period, Northwest paid $17,783 to related organizations. In 1985-86, Northwest provided 2,818 home health aide visits at a cost of $19.29 pea visit. In 1986-87, Northwest paid $76,849 to related organizations with shared members of their boards. Northwest provided 3,406 home health aide visits in 1986-87 at a cost of $28.95 per visit. These related organizations are for-profit entities. Open-ended management and administrative contracts with related organizations allow management to add expenses in order to reach the cost caps each year. If management and administrative fees were backed out of Northwest's "costs," it would be well below its cost caps. As Northwest's visits have increased, administrative, general, and other expenses also have increased (1985-86: $91,708; 1986-87: $198,635). However, the direct costs associated with providing the nursing care for those visits have decreased (1985-86: $89,281; 1986-87: $81,71). Thus, the increase in visits did not result in any overall cost- efficiencies or savings, but in an increase in money paid out as administrative expenses. There is no relationship between number of visits and cost per visit once an agency is beyond the volume needed to cover its minimal operating costs. An increase in number of visits does not necessarily result in lower costs per visit. An analysis of hospital utilization by Medicare reveals that the rate of use in District I is higher than both the Florida and national average. Analysis of the local nursing home use rate reveals it is 68 percent higher than the statewide nursing home use rate. This is in spite of the fact that Walton and Okaloosa Counties have more nursing home beds than other areas of the State and the beds in these counties are at 95 percent occupancy. Analysis of the home health use rate for Walton and Okaloosa Counties reveals that it is approximately 40 percent lower than the statewide use rate. Many nursing home placements and hospital admissions could be avoided if appropriate home health care were available and utilized. For example, a home health service could start antibiotics in the nursing home for patients who had received the medication before, rather than admit the patient to the hospital to start the treatment as is currently done. The proposed agency will not decrease the number of visits by existing agencies because of (1) the increase in population, (2) the shifts to home health care from acute care facilities and nursing homes, and (3) the increase in the types of home health care available. The application contains Home Care's projection of income and expenses for the first two years of operation. See Figure 7, Page 22 of the application. Evaluation of costs for a two year period shows that they are reasonable. The assumptions about payor mix, utilization projections, gross charges per visit type, salaries, inflation, depreciation, marketing, advertising, administrative expenses, bad debts/charity, travel expenses, depreciation, costs of medical supplies, and gross revenues made in the feasibility study were reasonable. The projections of revenue from visits and from medical supplies are reasonable and their sum constitutes gross revenue. Deductions for contractual allowances and bad debt/charity are reasonable and when deducted from gross revenue they determine net revenue. Dr. Kolb, an expert in health planning, supervised the preparation of the financial feasibility projections contained in the application. The methodology used by Dr. Kolb was reasonable, appropriate, and supported by the facts. Dr. Kolb conservatively estimated reimbursement to arrive at contractual allowances. Subsequent to her preparation of the pro forma and the filing of the application, the Legislature increased by 100 percent the amount Medicaid reimburses for home health services. Medicare has also subsequently increased its cost services. This increases the range of reimbursement available to the Petitioner and makes Dr. Kolb's predictions of financial success more viable. The amount of $22,600 is reasonable for the cost of this project. Equipment costs of $7,600 include office equipment and the lease- purchase of a computer terminal. The computer will be used for billing and for tracking patient problems. The depreciation expense is derived from an assumption of five years' depreciation on $7,600 worth of office equipment, When deductions from revenue are subtracted from gross revenue, net revenue is approximately $284,700 in the second year. Home Care has the capital to fund this project. Individual expenses on the expense column on the pro forma include salaries, contract services, administrative expenses, transportation, marketing and advertising, medical supplies, and depreciation. Administrative salaries and benefits are based on the assumption that in the first year there will be three administrative full time equivalents ("FTE"): an administrator, a nurse supervisor, and a clerical person. In the second year, this will increase to three and a half FTE's. The salaries for these positions in year two are $28,350 for the administrator, $22,050 for the nurse supervisor, and $28,800 for one and a half clerical personnel. In addition, an 18 percent fringe benefit figure is computed. Salary assumptions are based on area wage levels. Both the salary assumptions and the number of FTE's and salaries are reasonable. A breakdown of total per visit costs is depicted on HCA X-26. The expenses for contract visits represent the cost per visit in each of the listed categories. The contract rates in year one are: home health aide - $8.25; speech pathologist - $30.00; medical/social worker - $25.00; occupational therapist - $30.00; skilled nurse - $13.75; and physical therapist - $30.00. Medical supplies are assumed to be $1.00 per visit in the rest year and are inflated by 5 percent in the second year. This assumption is reasonable. Although not required, Petitioner has allocated funds for advertising and marketing which are not allowable expenses in computing reimbursable expenses; however, this will help in informing the public and medical professionals about the availability of home health services. The transportation expense is based on $.21 per mile which is reimbursed to employees. This is a reasonable assumption. Administrative expenses include rent ($12,000), telephone ($4,800), insurance ($5,000), postage ($2,000), office supplies ($3,000), legal and accounting fees ($4,000), dues ($500) , and licenses ($500). Most expense items are inflated 5 percent for the second year. The expense and inflation assumptions are reasonable. In order to test the reasonableness of the assumptions contained in the pro forma, Dr. Kolb compared the projected costs in the second year to Medicare cost limitations. Home Care's projections are 28 percent below the Medicare cost limits for 1987. Home Care could have $78,000 more in expense and still be below its Medicare cost limits. In both his private office practice and in his DME company, Dr. Ehrman tries to ensure that underserved groups receive medical services. Although there is a large medically indigent population in the area Dr. Ehrman serves, he does no financial screening in his office. Dr. Ehrman is a participating provider in Medicare. This means that he has agreed in advance to accept Medicare assignment for his services. Dr. Ehrman is also a Medicaid provider. Three to five percent of his patients are Medicaid. The assumption that Home Care will have the same financial policies which are reflected in Dr. Ehrman's practice is reasonable. The assumption that Home Care will provide three percent Medicaid and three percent indigent home health visits is reasonable. Home Care's project is financially feasible on both an immediate and long term basis.

Recommendation Having determined, based upon the facts adduced at hearing, that there is a need for another home health care agency and that the applicant meets the statutory criteria, it is RECOMMENDED that the Department of Health and Rehabilitative Services approve Certificate of Need Number 4911. DONE and ORDERED this 1st day of July, 1988, in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 1st day of July, 1988.

Florida Laws (2) 120.57400.461
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FAMILY CENTER HOME HEALTH CARE, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 81-003262 (1981)
Division of Administrative Hearings, Florida Number: 81-003262 Latest Update: Sep. 09, 1982

The Issue Whether or not the Petitioner is entitled to be issued a Certificate of Need to establish a home health agency to serve Putnam County, Florida.

Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, the documentary evidence received, post-hearing memoranda and the entire record compiled herein, the following relevant facts are found. Family Center Home Health Care, Inc. (Petitioner), filed an application seeking to establish a home health agency to serve Putnam County, Florida. Ms. Felice M. Knotts, R.N., M.S.N., is the person who completed the application for the issuance of a Certificate of Need on behalf of Petitioner. Ms. Knotts has been a registered nurse since approximately 1966, and is a Doctoral candidate for a degree in Health Services Administration. The application was referred to the North Central Florida Health Planning Council, Inc., pursuant to Sections 381.493-.499, Florida Statutes, for review and comments. The Health Systems Agency (HSA) staff, its project review committee and its Board of Directors each recommended denial to the Department of Health and Rehabilitative Services of a Certificate of Need with the Board recommending denial by a vote of 23 to 0. Need for the proposed project is to be measured against standards found in the Local Health System's plan and Chapter 10-5, Florida Administrative Code, pursuant to Section 381.494, Florida Statutes (1979). By letter dated October 27, 1981, Petitioner was advised by the Respondent that her proposal to establish a home health agency in Putnam County had been reviewed by the North Central Florida Health Planning Council, Inc., and was denied on the basis that the proposed project was inconsistent with the HSA's health system plan and Chapter 10-5.11 (14), Florida Administrative Code. In addition, the two (2) current home health agencies operating in Putnam County, even if combined, do not reach the average daily census maximum of three hundred (300) which is required for the establishment of another home health agency. As stated, currently there are two (2) home health agencies licensed to serve Putnam County, Upjohn Health Services and Central Florida Home Health Services. During 1980, Upjohn served six (6) patients and Central Florida Home Health Services served one hundred sixty-two (162) patients. Upjohn found demand insufficient in Putnam County to establish a sub-unit. At the time that Petitioner's application was reviewed by the Department of Health and Rehabilitative Services, Upjohn had a case load of five (5) patients while Central Florida had a case load of ninety-five (95). During the hearing herein, representatives of each agency indicated that it had sufficient capacity to meet future demands. Standard 1-1 in the Health System's plan requires that the need for new home health agencies be based on home health use rates, projected population and a minimum volume of 1,200 patients per year per agency. Based on current regional use rates of six (6) patients per 1,000 population and the projected population in 1985 of some 56,800 people in Putnam County, 341 Putnam County residents would need home health care during 1985. By use of this standard, the need could exist for less than one-third (1/3) of a single home health agency. Petitioner sought to introduce into evidence a chart which would purportedly show the need as required pursuant to Chapter 10-5, Florida Administrative Code. The chart was based on Ms. Knotts' contact with numerous physicians who practice in the subject area and purportedly recorded their responses in a document designated as Petitioner's Composite Exhibit No. 3. Based on the fact that none of the physicians who purportedly relayed information to Petitioner was present to testify during the course of this hearing, information contained in petitioner's survey is hearsay. As such, that information is not, standing alone, reliable or sufficient to support a basis for which a finding of fact can be made. Chapter 120.58(1)(a), Florida Statutes. Rule 10-5.11(14)(b), Florida Administrative Code, provides that a Certificate of Need for a proposed new home health agency shall not be issued until the daily census of each of the existing home health agencies or sub-units providing services within the health service area of the proposed new home health agency has reached an average of three hundred (300) patients for the immediate preceeding calendar quarter. That rule also allows for need to be shown for a proposed new home health agency by demonstrating mitigating and extenuating circumstances as follows: That the population of a proposed service area is being denied access to home health care services because existing agencies are unable to provide service for all persons in need of home health care or that approval of the new home health agency would foster cost contain ment for all providers in the health service area. Based on the above, it is concluded that the two (2) currently licensed home health agencies in Putnam County have not obtained the average daily census of three hundred (300) patients. Likewise, there was no substantial competent evidence that the population of Putnam County is being denied home health services or that creation of Petitioner's home health agency would foster cost containment for all providers in the health service area. In this regard, officials from the existing two (2) currently licensed home health agencies testified to the extensive under-utilization of existing services which would likely have the effect of increasing charges because of the duplication of under-utilized services which cannot be demonstrated to be cost-effective. Based thereon, I shall recommend that the Petitioner's application to create a home health care agency be denied.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That the Respondent, State of Florida, Department of Health and Rehabilitative Services, enter a final order denying Petitioner's application for the issuance of a Certificate of Need to establish a home health agency to serve Putnam County, Florida. RECOMMENDED this 20th day of August, 1982, in Tallahassee, Florida. JAMES E. BRADWELL, 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 20th day of August, 1982.

Florida Laws (1) 120.57
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HOME HEALTH CARE SERVICES, D/B/A SOUTHMED HEALTH CARE vs AGENCY FOR HEALTH CARE ADMINISTRATION, 96-004058CON (1996)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Aug. 28, 1996 Number: 96-004058CON Latest Update: Sep. 18, 1997

The Issue Whether there is need for any new Medicare certified home health agencies in AHCA District III, and if so, whether the applications filed with the Agency by the two petitioners in this case meet criteria for the award of a certificate of need?

Findings Of Fact The Parties Home Health Care Services d/b/a SouthMed Health Care, if operational, will be part of the HHCS Health Group. The group includes a number of interrelated medical corporations under the HHCS umbrella. Among them are these: the Cystic Fibrosis Pharmacy, Inc.; the HHCS Pharmacy; the Special Pulmonary Care Center; the HHCS Research Institute, Inc.; and the Center for Environmental and Industrial Medicine, Inc. HHCS also operates home health care agencies in Melbourne, Rockledge, Tampa, Port Charlotte, and Sarasota. Lake City Nursing Homes, Inc., is the owner and licensee of Lake City Extended Care Center, a 60-bed nursing facility in Columbia County, Florida. It is a provider currently of home health care for Medicaid recipients and private payors though its licensed home health agency located adjacent to the nursing home. By the CON application at issue in this proceeding, Lake City proposes to provide skilled nursing home based Medicare certified home health agency services as well. The Agency for Health Care Administration is the "single state agency [designated by statute] to issue . . . or deny certificates of need . . . in accordance with the district plans, the statewide health plan and present and future federal and state statutes." Section 408.034(1), Florida Statutes. Service Planning Area and Existing Providers AHCA District III consists of sixteen counties: Hamilton, Suwannee, Lafayette, Dixie, Columbia, Gilchrist, Levy, Union, Bradford, Putnam, Alachua, Marion, Citrus, Hernando, Sumter, and Lake. At the time of the submission of the applications at issue in this proceeding, there were twenty-nine existing Medicare certified home health agencies in District III. HHCS proposes to target a group of patients none of the other existing providers presently target. In another approach, Lake City proposes a nursing-home based, Medicare certified home health agency. Other than Lake City's existing non-Medicare certified agency, none of the existing providers are nursing-home based. In relation to the existing providers, therefore, Lake City and HHCS propose unique opportunities for home health care services in District III. HHCS' Application HHCS' application is targeted to a group of patients in District III not presently receiving services which rise to the level of their need. The group consists of post-transplant patients and patients with cystic fibrosis, chronic obstructive pulmonary disease ("COPD"), and diabetes. Targeting this group does not diminish HHCS' intent to provide home health care to others in District III in need. HHCS has agreed to condition the granting of the CON on providing 8 percent Medicaid and 2 percent charity care with no limit on the number of Medicaid patients it will serve. HHCS offers to provide services not commonly provided by other home health agencies. Among them are blood transfusions, home x-ray, on-line EKG communication with physician, organ transplantation support and care, Picasso system telecommunications with physician, and high-tech pharmacy service such as intravenous/infusion services, aerosolized pentamidine therapy, and complete HIV home care. In providing these sophisticated services, HHCS will use an integrated team approach to home health care involving various professionals in health care and health management. Lake City's Application If Lake City's application were granted, it would make Lake City the fourth home health agency in Lake County and the only home health agency in District III to be nursing-home based. By combining a Medicare certified home health agency with its existing nursing home, Lake City will improve the case management of its patients because such an arrangement offers vertical integration within a continuum of care. Vertical integration within a continuum of care promotes stability of personnel and providers who work with the patients. In turn, this organizational method provides potential for improving recovery from illness and higher quality of management of the patient and the patient's illness. Need Projections The Agency's methodology for determining need for home health agencies was declared invalid in 1993. At present, there is no Agency rule containing a home health agency need methodology. In the absence of a need methodology by rule, the applicants took different approaches to projecting need. HHCS projected need based upon previous studies of efficient agency size. HHCS identified four groups of Medicare patients (AIDS, COPD, cystic fibrosis, and diabetes) who, either because of age or disability, are chronic or long-term users of home health care services. HHCS looked at hospital discharges for those four categories to determine post-hospital placement. About an equal number of patients were referred to long-term facilities as were being referred to home health agencies. HHCS' application is geared to steering patients out of more expensive long-term care facilities and into care at home. Lake County has a use rate for home health higher than that of all of District III. Its use rate is also higher than the State's as a whole. Over a three-year period, home health visits in District III grew by 16 percent, whereas visits statewide grew by only 4 percent. Lake County uses home health services and continues to use them at a very high rate. Additional services are needed in order to sustain and meet the demand within the county and the District as a whole. Previous studies, moreover, have shown that all economies of scale are realized at around 30,000 visits per year. HHCS used 30,000 visits per year as an appropriate agency size to yield a need in the District for at least five new agencies. With the modification of a lower growth rate to make it more conservative, Lake City, on the other hand, utilized a need methodology put to use by a successful Medicare certified home health agency applicant for five Medicare certified home health agency CONs in the prior batching cycle. The Lake City methodolgy took the population of seniors (age 65 and over) in the district and projected that population forward through 1998 based on state population data. It then calculated the percentage of increase in population of seniors and the total number of visits provided in the district and projected the percent of increase in visits from 1991 through 1994 forward on through 1998. Lake City projected its increase in total visits utilizing an 11.5 percent growth rate in the number of visits which is conservative considering that the average growth rate per year from 1991 to 1994 was 31.7 percent. Lake City also identified a yearly increase of more than 20 percent in the rate of use of home health services due to the emphasis on managed care and less costly health care services. Inflating a conservative increase in the use rate of 20 percent forward, Lake City projected the number of visits that would be provided by existing agencies and subtracted that number from the total number of projected visits, leaving a total number of unserved visits. Dividing the number of unserved visits by the average agency size in District III, Lake City came up with a net need of 9.62 agencies in the horizon year of 1997. The methodologies of both HHCS and Lake City are fair and reasonable health planning methodologies. Lacking a need methodology, the Agency set forth eight criteria it suggested should be addressed in applications for Medicare certified home health agency CONs. These policies relate generally to access and require the showing of some type of access problem. Normally, however, need should not be determined on the basis of access problems alone. Both applicants demonstrated District III's need in the planning horizon year for more than two agencies, the number of applicants in this proceeding. There is, therefore, a need for at least two more Medicare certified home health agencies in District III. State and Local Health Plans The HHCS proposal is supported by the preferences in the District Health Plan. HHCS is an exemplary provider of care for persons with AIDS and it has committed to Medicaid and indigent care in excess of that suggested by the plan. HHCS will provide more than the full range of services suggested by the plan. For the same reasons it meets the preferences in the local plan, HHCS' application is supported by the preferences in the State Health Plan. In addition to those reasons, the application complies with the State Health Plan preferences for an applicant that proposes to serve counties presently underserved by home health care agencies; will provide consumer satisfaction data to the Agency; and has a comprehensive quality assurance program and is proposing to be accredited by the Joint Commission on Accreditation of Healthcare Organizations ("JCAHO"). Lake City's application is also supported by preferences in the District Health Plan. It has a history of providing a high percentage of Medicaid patient days at its nursing facility. This history backs up its commitment to provide a minimum of 1 percent annual visits to indigent care and 5 percent of annual visits to care of Medicaid patients, a commitment evidenced by its willingness to condition the grant of its CON on the percentages of annual visits it promises to indigent and Medicaid patients. Likewise, Lake City 's application is supported by preferences in the State Health Plan. It has agreed to condition its CON on providing care to AIDS patients. It will provide the entire range of services usually provided by a home health care agency. It is willing to condition its CON on cooperation with data collection efforts. Finally, it is willing to condition the grant of its CON on the provision of a comprehensive quality assurance program as well accreditation by the JCAHO. Availability, Access, Appropriateness and Adequacy of Like and Existing Health Care Services HHCS' application complies with the statutory requirements of Section 408.035(1)(b), Florida Statutes, in that it increases the availability and access to home health care in the District. HHCS will offer programs and services which presently are not readily available in District III. This will increase the availability of these services to the patients of the District and, in particular, to the patients of Lake County. Thus, geographic access is enhanced. HHCS' application also enhances access for those without means to gain access to home health care through its commitment to indigent care. It improves, too, the adequacy of services in the District through its targeting of a group presently underserved in the District. HHCS' proposal meets the requirements of the health care access criteria contained in Rule 59C-1.030(2)(a)(b) and (d), Florida Administrative Code. It provides services to all those who need care and participates in the Medicare and Medicaid programs. HHCS does not discriminate on the basis of race, ethnicity, or gender. Because Lake City is not targeting an underserved group in the manner of HHCS, its application addresses the issues of "availability and access" somewhat differently. To the extent there is a need for new providers of home health care, granting Lake City's CON will provide better availability and access to those in need of home health services. Likewise, Lake City's willingness to condition its application on service to AIDS, indigent and Medicaid patients will only improve availability and access to home health care services in the district Quality of Care HHCS conducts mock accreditation surveys to determine whether it is meeting the appropriate standards for quality of care. HHCS has an outside advisory board that does performance improvement and quality assurance review. There is also a utilization review committee and each office has full time quality assurance staff, quality management meetings, and quarterly reports to the Board of Directors. HHCS' team approach will enhance the quality of care as well as being cost effective. Its approach to treatment of HIV patients won for HHCS a contract with the Orange County Public Health Unit to provide complete HIV service to its patients. HHCS also measures patient satisfaction with services. Every patient is notified 48 hours after admission to the agency to make sure they were informed of precisely what to expect from the agency. Patients are contacted 30 days after admission and given an evaluation form. Survey forms are also sent out upon discharge and three months after discharge. The other home health agencies operated by HHCS are accredited with commendation by JCAHO and HHCS intends to seek JCAHO accreditation if granted a CON. The Lake City facility is managed by HealthPrime, a long term care management company which manages facilities for itself and others and which has been successful in improving distressed facilities. Since the commencement of its management of the Lake City facility, the facility has been recommended for a superior rating. HealthPrime has shown through its operation of the Lake City facility and other nursing homes in Florida, all of which have superior ratings, that it has the ability to provide quality of care. In addition, HealthPrime, which will actually operate the home health agency, has experience operating three other nursing home based, home health agencies. HealthPrime will use its quality assurance programs already in place in its other home health agencies and will seek JCAHO accreditation of the Lake City agency, if the CON is granted. To show its commitment to assuring quality of care, Lake City is willing to condition its CON on the understanding that it will not contract with other non-Medicare certified home health agencies to provide any of its services. Availability and Adequacy of Alternatives There is no adequate alternative to the HHCS proposal because of the applicant's targeting of the management of certain chronic illnesses. HHCS sees some of the targeted clients for management of cystic fibrosis already, but it is limited in its ability to serve these patients effectively without a physical presence in the District. For these patients to receive the full complement of home health care services HHCS is capable of rendering, there is no alternative save approval of its application. Economies and Improvements from Joint or Shared Services There are nine related companies within the HHCS Health Group. They include pharmacies which can deliver medications directly to the patient and can provide consultation with a doctor of pharmacy. This ensures compliance and dramatically increases therapeutic outcomes. Joint companies typically provide for economies and efficiencies and lead to the most cost-effective service. Lake City's proposal to operate a nursing home based, home health agency not only offers a continuum of care for the patient but also provides fiscal economies to the agency as well as the Medicare program. By providing skilled, nursing-facility based Medicare- certified, home health care, the Lake City facility can broaden its community base and provide cost-efficient services to the community. Under the arrangement proposed by Lake City, the home health agency, in practice, becomes a department of the nursing facility, providing a continuum of care and individual case management for the patient. Through case management, Lake City can help an individual through the various levels of care available. Case management helps the individual gain access to health care, making the process easier and less stressful. Case management poses potentials for containing cost and providing the best quality of care at the least cost. Financial Feasibility Short Term HHCS has projected the cost of its project at $92,392. The projection is based on historical information and actual vendors used by HHCS. Some of the expenditures, such as consultants and attorney's fees, have already been spent. HHCS intends to fund the $92,000 projected costs of the project through cash from operations and does not intend to seek any bank financing. If there is a need for financing, it is available as evidenced by the letter from the bank contained in the application. The letter is typical of letters banks issue when projects are merely proposed. The Agency has approved projects with similar letters of interest to support the capital requirements of a project. HHCS also has a line of credit for $600,000 and an equipment loan of $196,000, of which only $66,000 has been used. The line of credit was reduced by funds from operations from $125,000 on December 31, 1994, to $12,000 on April 25, 1995. Schedule 2 in the HHCS application lists other planned projects which require capital expenditures. These projects would be funded by a line of credit, assistance from the bank, and internal operations. HHCS' proposal is financially feasible in the short term. HHCS has the ability to secure funds necessary to capitalize the project and to secure any necessary working capital during the first year of operation. HHCS has demonstrated its ability to fund this project and all the projects on Schedule 2 in its pro forma sheet. Schedule 8A shows what would happen if all the projects listed on Schedule 2 actually occurred and what would be the financial impact on HHCS. Even if all the projects were completed, the cash available from operations is sufficient to fund the project. As for Lake City, AHCA raised questions about its weak financial status as a developmental stage corporation. But at hearing, AHCA acknowledged that Lake City would be financially feasible in the short term. While Lake City is a developmental stage company with limited cash investment, it is a heavy Medicaid provider. There are disincentives for such providers to keep large amounts of cash in equity. Lack of equity causes AHCA legitimate concerns. The concerns are dispelled by the personal guarantee by the owners of the company of the company's debt since the owners have sufficient assets to support their guarantees. In analyzing the financial strength of a nursing home that provides a high percentage of Medicaid-reimbursed care, it is necessary to determine whether the facility's fixed costs are covered by Medicaid payments and whether the facility has an adequate patient census. In the case of Lake City, both of these factors are positive. In addition, HealthPrime has made available a $200,000 loan to Lake City for this project. The loan commitment, by itself, is more than sufficient to cover the $77,014 start up cost of the Lake City proposed project. ii. Long Term HHCS' proposal demonstrated long term financial feasibility. The applicant's projections are conservative and the volume projections are easily achievable given the historical experience of HHCS and District III. The projected revenues contained on HHCS' Schedule 7 and the volume projections utilized in Schedule 5 are reasonable. AHCA found the volume projections to be achievable. The projected expenses for the proposed project are contained on HHCS' Schedule 8B. While AHCA criticized the format of this schedule, it concedes that it was not unauthorized. Direct patient care expense and other expenses can be determined to allow for a review as to reasonableness. Schedule 8B is based upon historical expense information; it contains all of the necessary expense items and is reasonable. AHCA similarly found that since HHCS' projections were reasonable for a new home health agency, the conclusion of financial feasibility in the long-term is reasonable. Lake City's assumptions in its financial projections were based on actual experience in the operation of similar skilled nursing facility based home health agencies, as well as experience of other home health agencies in their first two years of operation. The reasonableness of Lake City's financial and operational projections were undisputed at hearing and AHCA's financial expert acknowledged that the proposed project would be financially feasible in the long term Resource Availability Neither HHCS nor Lake City will have any problem in hiring sufficient personnel for their agencies. Efficiency HHCS' specialty team approach to home health results in fewer total visits and better outcomes at lower cost. HHCS operates a highly effective, cost efficient agency. As for the efficiency of Lake City's proposal, skilled nursing home-based Medicare certified home health agencies are specifically recognized by the Federal Medicare program in their cost reports. Home health costs are filed as a part of the nursing home cost report and there is an allocation of the nursing home's cost to the home health agency. A joint nursing home/home health agency operation benefits both the provider and the Medicare program through cost savings. In fact, HealthPrime has found the efficiencies of a skilled nursing home-based Medicare certified home health agency to be great enough to allow the home health agency to operate under the Medicare reimbursement cap. Projects Impact on Costs The approval of additional home health agencies in District III will foster competition among existing providers. HHCS is cost effective with a projected cost per visit of $67.55. Utilization of its related companies will not only promote a continuum of care but will also lead to cost effectiveness. Lake City's projected Medicare rate for 1997 will be substantially less than the District III average 1994 rates of existing home health agencies. This provides a cost savings to the state since it helps reduce Medicaid costs as well.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that the Agency for Health Care Administration grant CON applications 8387 and 8386 filed by Home Health Care Services d/b/a SouthMed Health Care and Lake City Nursing Homes, Inc., respectively. DONE AND ENTERED this 27th day of June, 1997, in Tallahassee, Leon County, Florida. DAVID M. MALONEY 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 27th day of June, 1997. COPIES FURNISHED: Cynthia S. Tunnicliff, Esquire Pennington Culpepper Moore Wilkinson Dunbar and Dunbar PA Post Office Box 10095 Tallahassee, Florida 32303-2095 Theodore E. Mack, Esquire Cobb Cole and Bell 131 North Gadsden Street Tallahassee, Florida 32301 Richard Patterson, Esquire Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403 Jerome W. Hoffman, General Counsel Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403

Florida Laws (4) 120.57408.034408.035408.039 Florida Administrative Code (1) 59C-1.030
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