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UPJOHN HEALTHCARE SERVICES, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 83-003247 (1983)
Division of Administrative Hearings, Florida Number: 83-003247 Latest Update: Feb. 06, 1985

The Issue Whether HRS should grant Upjohn's application for certificate of need to establish a home health agency in Escambia County? Whether, in light of the recommended disposition of Upjohn's application, HRS should grant Baptist's application for a certificate of need to establish a home health agency to serve Escambia and Santa Rosa Counties? Whether an applicant for certificate of need and HRS can by stipulation divest the Division of Administrative Hearings of jurisdiction over the application and defeat the right of an existing provider to proceedings pursuant to Section 120.57(1), Florida Statutes (1984 Supp.)?

Findings Of Fact Since June 4, 1978, Upjohn has operated a home health service from its Pensacola office, one of 22 such offices in Florida, 16 of which are licensed as home health agencies. For more than three years, Upjohn has performed various services under contract to HRS from its Pensacola office. In Escambia, Santa Rosa, Okaloosa, Walton and Bay Counties, Upjohn now provides home nursing care, homemaking services, live-in companions and nurses' aides. Medicaid and medicare would pay for some, but not all, of the services Upjohn already provides in Escambia County, if Upjohn's Pensacola office were licensed as a home health agency. The certificate of need Upjohn seeks here is a prerequisite to such licensure. Upjohn provides services which are not offered by either of the home health agencies now licensed to serve Escambia County. Some people receiving these services must turn elsewhere for related services in order to obtain reimbursement from medicaid or medicare for the related services. This can create coordination problems such as the one mentioned at hearing: If employees from both agencies arrived at the same time, one might have to wait while the other "performed services", e.g., administered an injection. Like Upjohn, Baptist is already in the home health care business and provides services not offered by either of the licensed home health agencies serving Escambia County (one of which also serves Santa Rosa County.) Since October 2, 1983, Baptist has operated in Escambia and Santa Rosa Counties, albeit without the benefits of licensure as a home health agency. In 1984, to the time of final hearing, Baptist had seen 163 patients, ten to twelve of whom it had referred to NWFHHA because they were eligible for medicare benefits, but only if they received services from a licensed provider. Like Upjohn, Baptist provides various technical nursing services, such as hyperalimentation and intraveneous administration of antibiotics. Baptist also provides oxygen therapy and chemotherapy, once a physician has administered an initial dose. In addition, Baptist deals in durable medical equipment including bedside commodes, walkers, and the like. Baptist intends to offer physical, occupational and speech therapy if it receives a certificate of need, although it does not now offer these services. Durable medical equipment expenses and physical therapy fees are reimbursable by medicare Part B without regard to the provider's licensure. All of the services which the applicants provide and for which they are now reimbursed by medicare are available in Escambia and Santa Rosa Counties from providers who are licensed and eligible for reimbursement. COMPETITORS LICENSED Already licensed to provide services in Escambia and Santa Rosa Counties as a home health agency is Northwest Florida Home Health Agency, a nonprofit corporation that opened for business in 1975. The number of visits NWFHHA makes monthly has risen from 629 in 1980 to 1709 in 1984. Of the 902 patients NWFHHA served in the fiscal year ending March 31, 1984, only twelve were not eligible for medicare benefits. NWFHHA has headquarters in Gulf Breeze and is the only licensed home health agency serving Santa Rosa County. Nothing prevents NWFHHA staff from providing nursing services gratis on their own time, but there was no evidence that this occurs. NWFHHA offers only services that medicare reimburses, viz., skilled nursing, physical, occupational and speech therapy, and medical social worker and home health aide visits. NWFHHA's office hours are from eight o'clock in the morning until four o'clock in the afternoon Monday through Friday. After hours, nights and weekends a telephone answering service, "the doctors and nurses registry," answers calls placed to NWFHHA's office telephone, and relays messages to a nurse. A nurse is always on call, and registry personnel either telephone the FWFHHA nurse on call or contact her with a beeper pager system. The only other licensed home health agency serving Escambia County is the oldest, the Visiting Nurses' Association (VNA) which has been "absorbed" into the Escambia County Health Department. In the fiscal year ending June 30, 1983, the VNA served 465 medicare patients and 303 others, including patients unable to pay, those who could and did, and those whose insurance companies paid for services. The VNA does not sell or rent durable medical equipment but enjoys good relationships with suppliers and has never been unable to obtain equipment needed by its clients. The VNA provides skilled nursing services, including enteral therapy, post-colostomy and other stomal care, nutritional counseling, home health aides and, through another branch of HRS, social services. The VNA has never turned away a medicare or a medicaid patient in need of its services. VNA's office hours are from eight o'clock in the morning till half past four o'clock in the afternoon Monday through Friday. Between same hours on Saturdays, Sundays and holidays, VNA has "a weekend nurse" who can be reached through the doctors and nurses registry. (T.369) VNA's services are generally unavailable before eight o'clock mornings and after four-thirty evenings, and VNA cannot be reached by telephone during those hours, unless, like Judy Gygi, the director of the social work department at West Florida Hospital, a person has the VNA "call-back number." NEED In comparison to hospitals, home health agencies can open shop relatively quickly, once the decision to do so is made. A "planning horizon" of one year for home health agencies is more appropriate than the five-year horizon used for hospitals. This is particularly true here where both applicants are already engaged in offering the services for which certificates of need are sought. The need for home health services may be seen as a function of the age and size of a population. In 1985, Escambia County is projected to have a population of 254,100 persons of whom 23.04 percent would be younger than 15 and 10.1 percent would be 65 or older. The 1985 population of Santa Rosa County is projected at 62,600 of whom 24.63 percent would be under 15 and 7.9 percent would be 65 or over. For District 1 as a whole, comprising Escambia, Santa Rosa, Okaloosa and Walton Counties, the 1985 population is projected at 464,300, including 23.39 percent under 15 and 9.35 percent 65 or over. An expert retained by Upjohn predicted a need in 1985 for up to 27 home health agencies in District I, and for at least two and up to 18 home health agencies in Escambia County alone. Upjohn's expert invoked four methodologies. Common to each was the assumption that the average patient can be expected to receive 31.5 home visits, a number HRS generated to reflect statewide experience. Changes in medicare reimbursement for hospital care seem to have decreased the average length of stay in Escambia County hospitals by nearly a full day over the last two years or so. This is thought to have created additional home health clients who need significantly fewer visits than historical averages might suggest. VNA's recent experience has been on the order of 14 visits per patient as compared to NWFHHA'S recent average of approximately 36 visits per patient. At least two of the four methodologies generated predictions for 1985 of home health care visits in Escambia and Santa Rosa Counties, without regard to whether their cost was reimbursable by medicare. Nationally about 18 percent of Upjohn's services are reimbursed by medicare. A rough rule of thumb is that the "medicare need" is one fifth of the total need. Using a method he denominated "U.S. DHHS", Upjohn's expert predicted that there would be 5,836 home health referrals in Escambia County in 1985 as compared to 8,692 for the whole of District I, in 1985, so that the number for Escambia County would exceed two-thirds of the district total. Even assuming the "U.S. DHHS" methodology is a good one, something is amiss with the calculations, because the 1985 population of Escambia County is projected to amount to only 54.73 percent of the district total; and Escambia County is not projected to have as much as two thirds of any age cohort in District I in 1985. According to Upjohn's Exhibit No. 3, the "U.S. DHHS" method projects only medicare referrals, but this is an apparent error. According to the same exhibit, the "U.S. DHHS" predicts more than four times the number of medicare referrals for 1985 in Escambia and Santa Rosa counties than the only other medicare method, "DHRS Option 2," predicts. On the 20 percent medicare assumption, the "U.S. DHHS" calculations predict a level of home health care referrals in Escambia County ten times higher than the "District I Draft HSP" method predicts. The two "total referral" methods predicted 2,881 and 3,637 home health referrals for Escambia County and 696 and 878 for Santa Rosa County for 1985. Neither of these methodologies has been validated because, as Upjohn's Dr. Dacus explained, "there is just no reliable, verifiable data base, which reflects the total volume of home health care services." (T. 136). The final method, "DHRS Option 2", predicts 1,359 home health medicare referrals for Escambia County in 1985 and 267 such referrals for Santa Rosa County in 1985, a two-county total of 1626. Annualizing from Intervenors' Exhibits 2 and 5, the VNA can expect to make 5102 visits [2976 (12 divided by 7] in 1984 for which medicare Part A will reimburse; and NWFHHA can expect to make 20,388 visits (April, May and June home health aide, nurse, and paramedic visits quadrupled), for almost all of which it will seek reimbursement from medicare, if past experience is an indication. Dividing 5102 by 14 and 20388 by 36 yields a total of 931 medicare referrals for Escambia and Santa Rosa Counties for 1984, which suggests that the 1626 prediction for 1985 is a substantial overprediction. Area specific utilization rates suggest, on the generous assumption of a five percent increase in 1985 over 1984, and on the twenty percent medicare assumption, 4888 home health referrals for Escambia and Santa Rosa Counties in 1985. Assuming medicare visits increase in Escambia and Santa Rosa Counties by ten percent in 1985 over 1984 levels, 28,0389 visits can be expected. Upjohn's own policy is to form a subunit only "once you get up to around 15 or 20 thousand visits." (T.119) The national average is on the order of 7,000 visits per year per agency. NO NEED SHOWN TO BE UNMET But no net need was shown on this record because of the incomplete evidence as to what existing home health services already provide. The evidence did not show the total number of home health care visits now being made in Escambia and Santa Rosa Counties or either of them. Nor was it clear from the evidence whether the applicants and the licensed agencies are the only providers of home health services in the area. There has never been a waiting list for home health services in Escambia County and neither of the two Escambia county medicare providers had added staff in the twelve months preceding the final hearing. Specifically, there was no showing that medicare reimbursed services would be in any way lacking in 1985. The evidence affirmatively established that they would be readily available, unless the existing providers cease offering these services. The most interesting effort to show that there might be a problem was proof that a judgment for $105,000 against NWFHHA had not been paid. This amount exceeded the amount of NWFHHA's assets and no doubt presents serious legal problems for this nonprofit corporation. But this evidence 1/ falls short of establishing by a preponderance that NWFHHA will cease to provide home health services in 1985. Upjohn's expert witness testified that the only capital costs for home health agencies was "so low...just the cost of the office, having the office there. (T.114) Even if NWFHHA is stripped of its assets in order to satisfy the outstanding judgment or to obtain discharge in bankruptcy, its viability as an ongoing enterprise would persist. Office rent would be its chief working capital requirement and revenues would readily cover that. Both the VNA and NWFHHA can provide significantly more home health services without adding additional staff. To the extent Upjohn and Baptist serve non-medicare patients that VNA would otherwise have served, VNA's ability to deliver home health services to medicare-eligible patients is enhanced. Nothing in the evidence established that any medicare-eligible patient in Escambia or Santa Rosa Counties has encountered difficulty in obtaining home health services in the past or will in the foreseeable future. FINANCES Home health agencies differ from hospitals and other similar health care providers in that their fixed costs only amount to one or two percent of total costs. In order to serve more patients, they need only add staff. Patients' homes are the principal workplace, and capital expenditures entailed in expanding are minimal. The record is replete with theories about economies and diseconomies of scale, but these offer little practical guidance. "If you try [to] plot a curve of home health care average charge per visit [versus the number of visits] you cannot get a defined line. You get a very steady [flat] line with a lot of random variances across it." (T.115) The mix of services offered is more significant than the volume of services, although there is some correlation between volume and mix. (T.117, 118) "[G]oing further and further away...[to see] patients...increase(s) travel costs...[s]o you get an expanding component of travel expense" (T.119) if the geographical area being served expands. The medicare program reimburses costs of home health services up to a cap, which is $50.26 per visit for the current fiscal year. The rate of reimbursement for services to medicaid patients is much lower ($16 per visit). The average cost per NWFHHA medicare visit during the 1983-1984 fiscal year was $23.26, and the average cost per VNA medicare visit was $29.62 during the 1982- 1983 fiscal year. Because of differences in the mix of services, the applicants' average cost figures are not strictly comparable, but there was no proof that the cost of providing medicare services would go down if these applications are granted. 2/ Neither applicant showed projected costs at less than what the existing providers are experiencing. NWFHHA's costs are the lowest in Florida and there is nothing in the evidence to suggest that Baptist or Upjohn will be able to provide medicare services for as little as the existing providers. As a result, the medicare program and so the tax payers would be paying more for the same services, as far as the evidence shows, if either application is granted.

Florida Laws (3) 120.57400.462400.471
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ABC HOME HEALTH SERVICES, INC. vs DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 90-000946 (1990)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Feb. 12, 1990 Number: 90-000946 Latest Update: Oct. 26, 1990

Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The letter of intent and authorizing board resolution to establish a new Medicare certified home health agency filed by ABC for District Four for the September, 1989 batching cycle was timely filed with HRS and the Health Planning Council for Northeast Florida, Inc., and met all statutory and rule requirements for filing. The CON application to establish a new Medicare certified home health agency filed by ABC for District Four for the September, 1989 batching cycle was timely filed with HRS and the Health Planning Council for Northeast Florida, Inc. The CON application to establish a new Medicare certified home health agency for District Four for the September, 1989 batching cycle was deemed complete and accepted for review by HRS, effective November 13, 1989. There is a numeric need for one additional Medicare certified home health agency in District Four as determined by HRS and published pursuant to Rule 10-5.011(1)(d), Florida Administrative Code. Local Health Plan The 1989-90 CON Allocation Factors Report for HRS District Four (Health Plan) is the applicable health plan with regards to this proceeding. In its application ABC addressed the recommendations found in the Health Plan. The Health Plan recognizes that under the new methodology for determining numeric need, a licensed home health agency within an HRS district could serve any and all counties within the district. However, the Health Plan contains recommendations for allocating home health agencies. The Health Plan makes the following recommendations: Geographic Preference Home health agencies should be allocated to counties on the following basis: Preference should go to applicants who will establish their program in a county which does not have any CON approved agencies or subunits based in the county. Consideration should be given to counties with a low number of Medicare visits per 1,000 persons 65 years and older. Competing Applications In the case of competing applications for the same or similar geographic area, preference should be given to those applicants which demonstrate: They will meet identified needs in the most cost-effective manner. They are addressing a current or potential geographic access problem in the district. They will serve the widest spectrum of the population, including the medically indigent. They have written agreements with a broad spectrum of local hospitals, nursing homes, mental health resources and/or other service providers in order to help ensure continuity of care. They demonstrate in their CON application how they will comply with any conditions placed on the CONs. They will serve AIDS patients. ABC proposes to locate its agency office in Duval County because it contains medical centers, hospitals with discharge planners and physician staff for referrals, and because of enhanced recruiting and retaining of appropriate staff. However, it proposes to serve all patients referred to it in all counties located throughout District Four, including Baker County. Baker County has no CON approved home health agency based within the county. However, it is presently being served by home health agencies based in Duval County. Because of its small population, with a relatively low percentage of the population being 65 years old or older, its distance from hospitals and the recruiting and staffing problems it would engender, it is doubtful that Baker County could support a main office for a home health care agency. In fact, the 1988 Local Health Plan indicated that Baker County should probably not have a home health agency physically located within the county. Baker County has the lowest number of citizens 65 years of age or older and the lowest usage rate for home health agencies. There is no data or documentation to show why the usage of home health services in Baker County is low. However, HRS makes the assumption from the usage rate only that Baker County is underserved. Duval County is not considered as being underserved in terms of Medicare units. By locating in Duval County, ABC does not specifically comply with preference 1A or 1B. However, ABC has proposed to serve all patients within District Four referred to it regardless of where the patient is located, and regardless of the patient's payor class. (Medicare, Medicaid, private pay or indigent) While 1A and 1B of the Health Plan's recommendation is concerned with geographic preferences, 2A through 2F of the Health Plan's recommendations are preferences that relate mainly to situations involving competing applications in the same batch. ABC meets a majority of those preferences, including: 1A. ABC will be among the lowest in cost of the existing providers in District Four. 1B. ABC goes to the patient and has stated it will serve all of the patients within District Four referred to it. 1C. ABC proposed to serve all patients referred to it, including the medically indigent and medicaid. Because of the situation with Medicaid patients, ABC did not project any Medicaid patients. However, ABC proposed to serve all patients on which it has referrals including Medicaid patients. 1D. ABC did not have written referrals with hospital, nursing homes and other resources for patient referrals. However, ABC stated that this was its standard operating procedure and if granted a CON they would establish written referrals. 1E. ABC does not specifically address how they would comply with any condition placed on the CON. 1F. Again, ABC proposed to serve all patients within District Four referred to it, including AIDS and HIV patients. Since ABC has no control over which patients are referred to it, then its payor mix is just a projection. Whether an AIDS or HIV patient is on Medicare, Medicaid, private pay or medically indigent ABC has proposed to served them. In fact, it has a corporate policy to train and educate its employees in this area of service. ABC has shown that it intends to serve AIDS and HIV patients on which it has referrals. State Health Plan The 1989 Florida State Health Plan is the applicable health plan in this proceeding. The State Health Plan is a comprehensive three-volume document which describes Florida's health system and the services available to Florida residents. Specifically, the State Health Plan addresses certain preferences which HRS uses in reviewing home health CON applicants. They are as follows: Preference shall be given to an applicant proposing to serve AIDS patients. Preference 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. Preference 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 HRS service district and proposing to serve such patients within its market area. Preference shall be given to an applicant proposing to serve counties which are underserved by existing home health agencies. Preference shall be given to an applicant who makes a commitment to provide the department with consumer survey data measuring patient satisfaction. Preference shall be given to an applicant proposing a comprehensive quality assurance program and proposing to be accredited by the Joint Commission on Accreditation of Healthcare Organizations. As to 16A, ABC has proposed to serve all patients in District Four that are referred to it by referring agencies, including AIDS and HIV patients regardless of their of payor class. ABC has a stated commitment to serving AIDS and HIV patients. The evidence establishes that of all AIDS cases reported in District Four, Duval County has approximately 69 percent. District-wide 52 percent of all reported AIDS cases have ended in death whereas in Duval County the percentage is 56. Very few AIDS patients are medicare eligible. A higher percentage of AIDS patients in Duval County are served as indigents or under Medicaid, notwithstanding HRS' Medicaid Project AIDS Care. As to 16B, ABC proposes to provide the full range of services, including high technology services. ABC included in it application excerpts from its high tech policy manual. There was no data available from local health council on what high tech services are available from existing providers. As to 16C, while ABC's payor mix does not indicate that they would be serving a disproportionate share of Medicaid and indigent patients there is no data indicating what access problem, if any, exists for Medicaid and indigent case patients needing home health care services. ABC proposes service to all patients within District Four that are referred to it be referring agencies. As to 16D, while there is no data available that any county within District Four is in fact underserved, ABC has stated that it will serve all counties in District Four and there is no evidence to show that ABC will not serve all counties in District Four. As to 16E, ABC has indicated it will comply with this requirement and there is no evidence to show that ABC will not furnish the data in terms of consumer survey response. As to 16F, ABC has a quality assurance program in place and HRS agreed that ABC could provide quality of care to its patients. Statutory Criteria Section 381.705(1)(a), Florida Statutes - Availability and Access to Services District Four has 20 Medicare certified home health agencies, with five located in Duval County and, one approved but not yet established Medicare certified home health agency. However, as stated in the State Agency Action Report (SAAR) there is a market for another home health agency in District Four as determined by the fixed need pool. ABC's stated commitment to serve all counties in District Four and to serve all patients in those counties referred to it by referring agencies regardless of whether the patient's payor class should enhance the convenience and accessibility to patients. Section 381.705(1)(b), Florida Statutes - Quality of Care, Efficiency and Adequacy of Existing Area Providers There is no specific data available from HRS concerning the quality of care, efficiency and adequacy of services being provided by existing care providers in District Four. ABC did not conduct a survey to assess the existence of quality care problems in District Four. However, the existence of quality care problems in District Four would be difficult to gauge since the in- home provision of services makes them largely beyond public or professional scrutiny. In fact, generally, with few exceptions, application for home health agencies do not address this criterion. The parties stipulated that the provisions of Section 381.705(1)(c) through (g), Florida Statutes were deemed to have been met or otherwise not applicable. Section 381.705(1)(h), Florida Statutes - Availability of Resources and Funds and Accessibility of Service to all Residents of Service District The evidence establishes that ABC has sufficient resources and funds to accomplish what it proposes. HRS has no data suggesting significant access problems for Medicaid patients to home health care nor was there sufficient evidence that AIDS or HIV patients suffer an access problem for home health care. However, due to improvements in terms of Medicaid reimbursement any access problem that may exist should be reduced. ABC has a stated commitment to serving all patients in District Four regardless of the patient's payor class. This commitment should improve the accessibility of home health care to underserved patients if, in fact, there is an access problem for the Medicaid, AIDS, HIV or indigent patients. Section 389.705(1)(i), Florida Statutes - Financial Feasibility ABC projects it will do 12,000 home visits in year one and 14,000 home visits in year two. These projections are based on ABC's experiences in other districts, particularly District Three. These projections also represent approximately 25 and 29 percent of the new visit pool market for each year, respectively. However, ABC clients would not necessarily all come from the new visit pool. ABC's projected home care visits are reasonable based on its experience in other Florida districts and its experience in other states, notwithstanding its lack of an established referral network in District Four and being a new entrant into the District Four market. ABC's financials displayed in its application are reasonable and consistent with its Florida experience. ABC's payor mix and visit each correlate to its actual Florida experience. ABC's pro forma expenses for year one and year two are reasonable. ABC projects a first year profit of $3,914 and a second year profit of $5,010 and after the second year, ABC should continue to show a profit. ABC's proposed project will benefit ABC by allowing it to meet its long term goals. ABC's existing Florida agencies are operating in financially sound manner and there is no reason to believe that ABC's proposed agency will not operate in the same manner. ABC's liquidity ratio is 0.7 to one which means that ABC has excess current liabilities over current assets and is one factor used for determining the general health of a company. ABC has an accumulated deficit of $651,836. From all of the above, ABC's proposed agency is feasible in both the short term and the long term. It was stipulated that Section 381.705(1)(j) and (k), Florida Statutes were deemed to have been met or otherwise inapplicable. Section 381.705(1)(l), Florida Statute - Impact on Competition Since ABC has a stated commitment to serve all patients in all counties in District Four referred to it regardless of the payor class and is offering a full range of services, including high tech, its proposal should only serve to enhance competition within District Four, notwithstanding that the proposal is primarily a Medicare home health care provider which would not provide any financial competition. The parties stipulated that Section 381.705(1)(m), Florida Statutes was deemed to have been met or otherwise inapplicable. Section 381.705(1)(n), Florida Statutes - Medicaid and Indigent Care Very few medicaid and indigent patients are served by the existing agencies in District Four. Most of these patients are served by the Visiting Nurses Association (VNA) which is subsidized by United Way, local governments and other sources. There is no data or documentation that Medicaid patients do not in fact have a significant access problem. Medicare is the predominant payor source in Florida and is ABC's primary payor source even though ABC has a stated commitment to serve all patients regardless of payor class. A high percentage of Florida's Medicaid budget for home health services is used for co-insurance for medicare. Therefore, Medicaid patients that are "dually eligible" are receiving home health care under Medicare. Florida's Medicaid program does not reimburse for physical therapy, speech therapy or occupational therapy for adults. In a Medicare certificate home health agency there is only a certain pool of profit available to serve Medicaid and indigent patients. Therefore, if the percentages of Medicaid service goes up then indigent or charity cases must suffer or the agency cannot operate in the "black". While HRS usually places a condition on the CON concerning Medicaid services, a majority of the recently issued CONs for home health care had no such condition placed on them. The parties stipulated that Section 381.705(2) and (3), Florida Statutes were deemed to have been met or otherwise inapplicable. State Agency Action Report (SAAR) HRS up to and including, the home health care agency batching cycle immediately preceding the instant September 1989 batch, used not applicable (N/A) on those criteria that were not typically addressed by applicants or were not considered to be applicable to an applicant. HRS now enters a "no" in those situations but a "no" in this situation has no adverse or negative impact on HRS' decision. Typically, approved applicants do not meet all the statutory criteria. Some of the criteria may be only partially met and some may not be met at all.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That a final order be entered granting ABC's application for a certificate of need (CON No. 6015). DONE and ENTERED this 26th day of October, 1990, in Tallahassee, Florida. WILLIAM R. CAVE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 26th day of October, 1990. APPENDIX TO THE RECOMMENDED ORDER 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, ABC 1. 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: 6(2,3); 7(8); 8(7,8,11); 9(8,10); 11(7,14); 15(4); 16(16,17,18,19); 17(16,18); 18(16,21); 19(16,22); 20- 21(23,24); 23(25); 25(4,25); 28-29(25-27); 31-38(29); 40-42(29); 45(32); 48- 52(33,34,35,36); 54-58(32,37,38,41); 61-64(43); 68-70(45,46,47); 72- 77(47,48,49); 79-81(47,49,50); 83(51); 85-87(53); 89(53); 90(54). 2. Proposed findings of fact 1-5, 10, 12-14, 22, 24, 26, 27, 30, 39, 43, 44, 46, 47, 53, 59, 60, 65-67, 71, 78, 82, 84, 88, 91 and 92 are unnecessary. Specific Rulings of Proposed Findings of Fact Submitted by Respondent, HRS 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: 3-9(5,6,7,9,12,13,14); 12- 26(14,18,19); 28-29(15,16); 44-46(32) 48-51(39,40). Findings of fact 1 and 2 are covered in the preliminary statement. Proposed findings of fact 10, 11 as to the last 2 sentences, 27, 30, 31, 32 other than last sentence, 33, 35, 36 other than last sentence, 37, 38, 39, 41, 42, 47 and 52 are not supported by substantial competent evidence in the record. The last two sentences of finding of fact 34 are adopted in finding of fact 25, otherwise not supported by substantial competent evidence in the record. Proposed finding of fact 43 is unnecessary. The first two sentences of proposed finding of fact 53 are adopted in finding of fact 36, otherwise not supported by substantial competent evidence in the record. Copies furnished to: R. Terry Rigsby, Esq. F. Philip Bank, P.A. 204-B South Monroe Street Tallahassee, FL 32301 Edward Labrador, Esq. Assistant General Counsel 2727 Mahan Drive, Suite 103 Tallahassee, FL 32308 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, FL 32399-0700 Linda Harris, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, FL 32399-0700

Florida Laws (1) 120.57
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HOSPICE OF PALM BEACH COMPANY, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 85-004270 (1985)
Division of Administrative Hearings, Florida Number: 85-004270 Latest Update: Apr. 28, 1986

The Issue Whether Petitioner Hospice of Palm Beach County, Inc. (Hospice) is entitled to a certificate of need (CON) from the Department of Health and Rehabilitative Services, Respondent, (HRS) in CON Action No. 3702 for a home health agency in Palm Beach County and the District IX service area?

Findings Of Fact Hospice provides special interdisciplinary services, including medical, psychological, spiritual, counseling and volunteer services, for persons in the terminal stages of illness. Hospice is licensed by HRS as a hospice under Chapter 400, Part V, Florida Statutes. Hospice has been qualified by the United States Health Care Financing Administration for participation in the Medicare hospice program. See Part 418, 42 Code of Federal Regulations. Hospice was the first hospice program in Florida to be accredited by the Joint Commission on the Accreditation of Hospitals (JCAH) as a hospice. JCAH accreditation includes approval of the home care component of Hospice's service. HRS has approved issuance of a certificate of need (CON No. 3693) for the establishment by Hospice of its own 24-bed freestanding inpatient facility. Hospice's inpatient facility will be the first free- standing hospice facility in Florida. Hospice's present service area is within Palm Beach County. Hospice's service area reaches from the southern border of Boynton Beach in Palm Beach County north to the Martin County line. Hospice's service area also extends west within the County to include service to Belle Glade, a multi-ethnic rural community. Approximately 25 percent of Hospice's patients are medically indigent, with little or no ability to pay for care. Over 28 percent of Hospice's patients in fiscal 1985 were members of ethnic minorities. Hospice was one of five applicants in its "batching" cycle seeking a certificate of need to establish a home health agency within local health District IX. The others were Palm Beach Gardens Home Health Agency (CON #3699), MEA (CON #3700), Coastal Health Corporation (CON #3701) and Medical Personnel Pool of Treasure Coast, Inc. (CON #3706). (A sixth applicant, Medical Personnel Pool of Palm Beach, Inc., CON #3698, was granted a certificate in an earlier cycle and not considered by HRS in this batch.) By letter dated June 14, 1985, HRS indicated that it had determined to deny Hospice a certificate of need to establish a home health agency in Palm Beach County. Hospice's substantial interests are affected by HRS' determination of denial. Section 400.601(3), Florida Statutes (1985), requires Hospice to provide care to terminally ill patients regardless of ability to pay, and to make such care available 24 hours a day, 7 days a week. Unless Hospice receives a certificate of need to establish a home health agency, it is ineligible for licensing by HRS under Chapter 400, Part III, as a home health agency and corresponding certification as a Medicare home health service provider. See § 400.462(2), Fla. Stat. (1985). Without a certificate of need for home health care, Hospice's financial ability to serve its hospice patients is not as great as it might be if it held such a CON. Without certification as a home health agency, Hospice cannot presently collect any reimbursement for home health care of medically indigent Medicaid patients. Hospice often experiences difficulty in collecting even private insurance payments for home health care of patients with such insurance. Hospice will suffer injury in fact as a result of HRS' determination and its interests are among those regulated by this action. Hospice filed a timely petition for a Section 120.57 administrative proceeding concerning HRS' decision on CON Action 3702. Prior to the decision in Department of Health and Rehabilitative Services v. Johnson and Johnson Home Health Care, 447 So.2d 361 (Fla. 1st DCA 1984), HRS followed a rule generally precluding the issuance of a certificate of need for a new home health agency until the average daily census of each existing home health agency within the same service area had reached 300 patients. This rule was known as the "Rule of 300." In Johnson and Johnson, supra, the First District Court of Appeal struck the "Rule of 300" as arbitrary and inconsistent with Section 381.494(6)(c), Florida Statutes, which lists numerous criteria for evaluation of CON applications. In particular, the Court noted, the "Rule of 300" did not allow new agencies "where existing agencies are able but unwilling to provide services of a particular type or for a particular class of patients." 447 So.2d at 362. After the "Rule of 300" was struck, a statewide task force was created to develop new criteria to evaluate CON applications for new home health agencies. The statewide association of hospices, Florida Hospices, Inc., attempted to participate in the development of new criteria, but did not participate in this process. On April 5, 1985, HRS proposed new rule criteria for home health agency evaluations, which were the subject of a proposed rule challenge in September 1985 before the Division of Administrative Hearings. This proposed rule was struck down as invalid on March 12, 1986. These new criteria were proposed for use in addition to other relevant statutory and applicable rule criteria." In acting on the five CON applications in Hospice's "batch," HRS applied its invalidated proposed rule criteria and determined that within District IX as a whole (which includes Indian River, Martin, Okeechobee, St. Lucie and Palm Beach Counties), no new home health agencies were needed. However, in its analysis of the five applications in this batching cycle, HRS also stated that the District IX Local Health Council had indicated that Palm Beach County should be considered a separate subdistrict for home health agency evaluation. Although it found no need for new home health agencies in District IX as a whole in its analysis of this batching cycle, HRS, using its own newly proposed rules, found an existing need for two new home health agencies in Palm Beach County. HRS stated in its June 14, 1985, letter that Hospice's application was denied for the following reason: Use of the methodology developed by the special statewide work group to determine the need for home health agencies in District IX shows no numeric need for additional agencies in this district. HRS has determined for purposes of this proceeding that the following need exists in District IX for home health agencies, indicating a net need of five new agencies in District IX and a net need in Palm Beach County for five new agencies: Application Submittal Date: 12/84 Planning Horizon: 7/86 District 9 1986 (July) population: 65+ = 257,346 District 9 1986 (July) population: <65 = 809,845 1. 257,346 x .0578 = 14,875 Projected use for 65+ population 2. 809,845 x .00058 = 470 Projected use for <65 population 3. (14,875 + 470) x 33.3 = 510,989 Projected visits 7/86 4. 9,000 + (510,989 x 270) - 24,330 5. 410,989 9,000 ? 21,000 = 24 Agencies needed in District 9 for 7/86 24 Agencies - 19 licensed and approved = 5 Agencies needed in District 9 Subdistrict Allocation: Need: Indian River Projected 2 Existing 1 Net 1 Martin 2 2 0 Okeechobee 0 1 (1) Palm Beach 18 13 5 St. Lucie 2 2 0 This need is related solely to the planning horizon of July 1, 1986 established by HRS for Hospice's CON batch and other home health applications filed before the end of 1984. This need is not related to the later planning horizons applicable to District IX home health agency CON applications filed after 1984. Therefore, applicants in batches following Hospice's, which was the last batch submitted in 1984, are not substantially affected by this determination of need. For the purposes of this hearing, there are only two (2) denials by HRS of certificates of need for home health agencies in District IX and proposing service in Palm Beach County in CON batches prior to Hospice's (Joseph Morse Geriatric Center, CON Action No. 3621; A Professional Nurse, CON Action No. 3492) that have been challenged in administrative proceedings and are still pending without Final Order in those proceedings. Thus, Hospice's CON application as a home health agency is, in the worst case, third in line for licensure as a home health agency in District IX, without regard to the special circumstances of Hospice's case and assuming these denials by HRS are reversed in final agency action. Since there is a need for more than 3 new home health agencies in District IX and Palm Beach County based on the planning horizon applicable to Hospice's batch and no other valid request is pending in Hospice's batch, there is a numeric need for granting a CON to Hospice as a home health agency. There is a special need for access within Hospice's actual service area in Palm Beach County to home health services for the terminally ill, which services are provided by a hospice as opposed to existing or other proposed traditional home health agencies. There is additional need for access by the medically indigent to home health services within Hospice's service area in Palm Beach County, and within Palm Beach County in general. The 1985 District IX Hospice Services Plan provides that hospices generally should be licensed as a special type of home health agency. Of all pending applicants in this and the immediately prior batching cycles since 1984 seeking a certificate of need to provide home health services in Palm Beach County, Hospice is committed to providing the greatest percentage of its services for Medicaid and other medically indigent patients, in accordance with the State Health Plan. Hospice, due to its existing and proposed provision of home health services to the medically indigent, its service in Belle Glade, and its service to AIDS patients, as well as its services to the elderly, serves the need for care of low-income persons, medically underserved groups and the elderly. Hospice can provide higher quality of home health care to the terminally ill in its service area than any other existing home health provider or current applicant for a certificate of need to provide home health services in Palm Beach County. Hospice offers a new type of home health service within its service area for terminally ill patients and their families, including a special pediatric program for children with irreversible diseases. This type of service is an alternative to inpatient care, nursing home and traditional home health services. The applicant home health agencies affiliated with hospitals in District IX in Hospice's batching cycle have not shown that they can achieve greater economies or improvements of service than Hospice. Hospice provides the following research and health educational facilities: a) rotational internships for fourth- year medical students at the University of Miami Medical School; training for R. N. candidates at Florida Atlantic University; research support service to the Tropical Disease Center and Palm Beach County Public Health Department through Hospice's care for AIDS patients in the Belle Glade area; d) training for graduate students in psychology at Florida Atlantic University; e) training for seminary students at St. Vincent's Seminary in Boynton Beach; f) training for candidates for master's degrees in social work from Florida State University; and g) designation as second research and training site by the International Hospice Institute, an international research and professional education accrediting institution. No other home health agency in Palm Beach County provides or has proposed to provide the research or educational facilities referenced in the preceding paragraph. Hospice proposes to control its home health agency rather than to allow the home health agency to control its hospice functions. Hospice will have a positive effect on the clinical needs of health professional training in hospice care and related services in District IX and will make such training available to health professional schools. Hospice's proposal, which is based on a conservative growth projection of its historical patient service care needs, demonstrates the immediate and long-term financial feasibility of Hospice's non-profit project goals. Hospice's provision of home health services under a certificate of need will have a positive effect on the costs of and charges for home health services for the terminally ill and their families. Due to its inpatient hospital capability, Hospice is a regional resource and teaching center for the care of the terminally ill. Hospice has a positive impact on competition among providers of care to the terminally ill. Hospice has a positive impact on promotion of quality assurance due to its accreditation by the Joint Commission on Accreditation of Hospitals. No other home health agency in District IX is accredited by that national joint commission for provision of home health services. According to HRS' own determination, the District IX health plan calls for evaluation of home health services needs within the subdistrict of Palm Beach County. Under HRS' determination, that county subdistrict needs five additional home health agencies without regard to the special needs of the terminally ill. In addition, the 1985 District IX plan for hospice health services provides that hospices should be licensed as special home health agencies. Nothing in the 1985 District IX Health Plan suggests that "surplus" home health agencies in other District IX counties can provide access to service needed by the terminally ill and their families within Palm Beach County. According to HRS' determination, the provision of the State Health Plan addressing home health services deals with access of Medicaid and medically indigent patients to home health services. Hospice's proposal meets this goal of the State Health Plan because Hospice will provide 25% of its care to the medically indigent, even if Medicare reimbursement is available as a result of CON approval and home health agency licensure. On a percentage basis, Hospice proposes to provide 3 times more home health care services to the medically indigent than any other District IX applicant in its batching cycle and even a greater incidence than any District IX home health agency applicant in the immediately preceding batching cycle. Hospice's proposal also satisfies other goals and priorities of the State Health Plan not considered by HRS, including but not limited to the continued fostering of the hospice care alternative, potential increased provider participation in the Medicaid home health services program, and creation of funding mechanisms for hospice care of the medically indigent. Hospice is the only hospice program located within Palm Beach County providing and proposing to provide home health care to terminally ill patients and their families in its service area. Hospice can provide a higher quality of home care for the terminally ill than any other existing home health care provider in Palm Beach County due to its accreditation by JCAH and qualification for the Medicare hospice program including home health services. Hospice's home health care, due to provision of additional hospice services, and continuity of home health personnel serving each patient and patient family, is also more appropriate for the terminally ill than other traditional home health services. Hospice's on-call home health personnel must, by Hospice policy, reside no farther than 30 minutes from patients to be served on a round-the-clock basis. The 1985 District IX Health Plan endorses the 30-minute travel maximum for provision of hospice care at home. Even prior to Hospice's provision of service in Belle Glade, nearly one-third of Hospice's patients were members of ethnic minorities. The Belle Glade area served by Hospice is populated by ethnic minorities in need of home health care service. Hospice's development of a special program to serve AIDS patients in Belle Glade and throughout Palm Beach County will make needed home health care available to this underserved group. Other home health agencies recognize the special type of home health care provided by Hospice through their referrals to it. The existence of the Gold Coast Home Health Agency serving Broward County was the basis for HRS' determination that of all five applicants, only Hospice did not meet the criterion in Section 381.494(6)(c)6, Florida Statutes, evaluating the need for special services in adjoining areas. Both traditional and hospice-based home health agencies exist in adjoining District IX areas. Hospice has at present a paid staff of 33 and approximately 270 volunteers. As shown in its financial statements submitted with its application, Hospice has a broad base of community support sufficient to achieve its goals with the aid of the Medicare reimbursement mechanism. Since home health care is a vital component of hospice care, the operation of a home health agency by a hospice is both logically and philosophically a natural outgrowth of the developing hospice movement in the United States. Hospice has excellent prospects for the immediate and long-term financial feasibility of its project, especially if the regular Medicare reimbursement mechanism is made available. Hospice served more than 565 patients in fiscal 1985 and currently serves approximately 110-20 patients per month. Its estimated patient census used to calculate its 1985 and 1986 operating income and expenses in its CON application, therefore, is based on historical data and is conservative. Since Hospice has received approval for the first free- standing inpatient facility for the terminally ill in Florida, it will serve as a regional resource and training center for care of complex cases. Hospice, unlike any other applicant, will offer services complementary to home health care not available in adjacent service districts. Hospice's market entry as a licensed home health agency should stimulate other hospices to seek to meet the rigorous JCAH standards. Hospice provides many services not offered by traditional home health agencies at per visit charges that are competitive with those presently charged by those agencies. Hospice's market presence encourages competition among all home health agencies serving Palm Beach County, particularly for care of patients who are terminally ill or in the near-final stages of a catastrophic illness.

Florida Laws (3) 120.57400.462400.601
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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
# 5
NURSE WORLD, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 85-002628 (1985)
Division of Administrative Hearings, Florida Number: 85-002628 Latest Update: May 20, 1987

Findings Of Fact The parties have stipulated that the only statutory criteria at issue are those related to need and long term financial feasibility as it relates to need, specifically Subsections 381 494(6)(c~ 1,2,9, and 12, Florida Statutes and Rule 10-5.011(1 (b)l. and 3. Florida Administrative Code. Nurse World, Inc. is an existing non-Medicare home health care agency and is a provider of temporary nursing services in District VII. The five biggest home health agencies in District VII are Nurse World, Visiting Nurse Association (VNA), Upjohn, PRN (no full name ever given), and Norrell. Nurse World is the largest of these as far as active staff, but is the only one of these that is not Medicare-certified. HRS is the agency responsible for certification and licensure of home health agencies. A home health agency in Florida must obtain a CON from HRS before it can be licensed and become eligible to receive Medicare reimbursement. Medicare is a federally funded health program for the elderly and certain disabled persons. Medicare reimbursement is limited to reimbursement for skilled nursing, physical therapy, speech therapy, occupational therapy, home health aid services, and medical social services. The Medicare program reimburses home health agencies on a cost reimbursement basis with a cap for each discipline. Home health agency costs in excess of Medicare caps must be absorbed by the agency. Consequently, traditional concepts of price competition have no applicability to home health agencies providing Medicare reimbursable services. Individuals become Medicare eligible for home health agencies' services in two ways. First, age makes an individual eligible when a person is over 65 and has paid a sufficient number of quarters to social security. Another way is for an individual under 65 to be declared disabled. The 1985 State Health Plan is the most current plan. The only portion of the 1985 State Health Plan which is applicable to home health agency applications is that access to home health services should be improved, specifically access for Medicaid and indigent patients. Nurse World's application satisfies this requirement. Only certain portions of the District VII local health plan are applicable to Nurse World's application. The methodology employed in the local plan was derived from a rule which was declared invalid. See infra on the inapplicability of these portions of the plans. The portions of the local plan which are applicable are the priorities that a home health agency provide a full range of service, improve access for underserved groups, and have interrelationships with the existing health care facilities and community. Since Nurse World, Inc.'s inception in August of 1981, it has grown from a staff of approximately 50-75 nurses to a current staff of close to 700 active field employees including registered nurses (R.N.s), licensed practical nurses (LPNs), nurse aides, and ancillary personnel. Nurse World's growth is due in part to quality patient care and effective and efficient employee management. A background check is done on personnel prior to hiring. Some of Nurse World's employees are screened by competency examinations. Ninety percent of its staff is made up of LPNs, Emergency Medical Technicians (EMTs) or Physician Aides (PAs). All receive additional training by Nurse World. Other home health agencies in District VII often call Nurse World to obtain nurses to fill out their shifts whereas Nurse World has never had that problem. In line with HRS' position that applicants must demonstrate that existing agencies cannot meet existing need, Nurse World submitted considerable reputation-type testimony. Upon proper predicate and under certain circumstances, evidence of character reputation and evidence of modus operandi, are admissible. "Character is distinct from reputation; reputation is evidence of character," Ehrhardt, Florida Evidence, Subsection 405.1 (2d Ed. 1984). See same text, Subsection 404.11 on modus operandi. Indeed, CON applicants traditionally try much of a contested case upon evidence of their own professional reputations, and the reputation of their competitors, privy to the case or not. This entire line of inquiry was prompted by HRS' negative burden of proof concept and upon authority of Balsam v. Department of Health and Rehabilitative Services, 486 So. 2d (Fla. 1st DCA 1986). In these contexts, reputation evidence, a hearsay exception, was admitted in evidence. Nurse World's reputation as reported from all sources in the community (District VII) is excellent, particularly for quality of care, reliability, and speed of response. This type of reputation evidence was also supplemented by opinion evidence from various witnesses' personal on-going experience. Nurse World also presented testimony that Upjohn does not have a good reputation, that VNA has an unfavorable attitude towards indigent patients, and that UpJohn and VNA nurses will contact a doctor less appropriately than Norrell or Nurse World when there is a change in the patient's condition. There was a modicum of evidence that a better nurse knows when to call a doctor and when not to. Nurse World is a continuing education unit (CEU) provider, offering seminars covering state of the art nursing skills twice monthly. This service naturally increases the proficiency and quality of Nurse World's own employees who attend, but additionally, its continuing medical education seminars serve the community as a whole, since every two years LPNs and R.N.s, must each complete 24 hours of additional training so as to be eligible to renew their professional licenses. Nurse World is the only home health agency in Central Florida that has a CEU provider number. Unlike most hospital CEUs in the area, its continuing medical education services are free of charge and it maintains a suggestion box for topics to be addressed. Its use of video tape instruction both in-house and for seminars is an advanced technique. Nurse World has the exclusive contract to provide nursing services to Hospice of Central Florida. Hospice of Central Florida is a Medicare-certified home health agency, which has no nursing staff of its own. It has only support staff. Nurse World provides all its nurses. After switching to VNA, Hospice switched back to Nurse World. Nurse World has guaranteed in its application that if the CON is issued, it will provide 3 percent of its patient visits to indigents and 3 percent of its patient visits to Medicaid-eligible patients. It is satisfied for any CON grant to be conditioned on such a requirement. Nurse World's proposal to devote 6 percent of its patient visits to the traditionally medically underserved is relatively high for a home health agency. Nurse World presently provides $8,000 in indigent care through its Hospice contract and provides one free patient visit for every five patient visits at Brookwood AMI Hospital. It also has an indigent volunteer services program which provides basic nursing skills training to families so that they can care for their loved ones at home. Nurse World is a "full service" agency. It is considered "high-tech", providing in the home C-pap, IV therapy, respirator, feeding through a chest tube catheter, hyperalimentation, passive motion and other services previously available only in hospitals. This element of its services is particularly significant because of Nurse World's availability to handle difficult cases such as AIDS victims, infants, and multiply-afflicted elderly patients on a 24 hour a day, 7 days a week basis. Nurse World proposes to offer and does offer a full range of services. No other home health agency in District VII provides the full range of services to the degree and over the 24 hour a day period as Nurse World does. These types of difficult cases appear to be underserved in District VII. Nurse World is the only home health agency in the District that effectively staffs its office seven days a week, 24 hours a day. Nurse World has done so ever since it took its first critical care patient and entered into high tech nursing. This relates directly to quality of care and being responsive to patients' needs with no endangering delay as discussed below in relation to high tech protocols. Among health care providers generally and among home health care agencies particularly, Nurse World has a unique approach to insure immediate access and responsiveness to its patients: it mans its telephones with live dispatchers with immediate access to professionals on call. No other Central Florida home health agency does this. At all times there is at least a registered nurse available by phone when a patient reaches Nurse World. There is always a second professional backup behind the professional on the phone, often the Director Ms. Denner, herself. Nurse World has adopted this approach because it feels there is not enough time for turnaround response with other systems when a critical care high tech patient or confused elderly patient gets in trouble or has an emergency. Answering services hold calls; beepers require the professional on call to find a phone and return a call to the answering service, receive the emergency message, and then, finally, call the patient. Nurse World's method allows for the professional who receives the call at any hour of the day or night, even on a weekend, to respond to most situations immediately over the phone, and if necessary to contact the 911 emergency number and the patient's own regular nurse within minutes. Nurse World was the first nursing service in the Central Florida area to render home health services to an AIDS patient, includes AIDS nursing in its continuing medical education efforts, and now gets referrals for Medicare on that basis. No other home health agency is dealing with AIDS patients to the extent that Nurse World is. Nurse World also has an agreement with Centaur, the AIDS support group for Central Florida, through which Nurse World will provide nurses at cost or at its "break even indigent rate". Nurse World has provided health care services to AIDS patients for a very minimal charge since this area of home health care-has been identified and has accelerated numerically. There are approximately 80-100 identifiable AIDS cases in the area. Nurse World has provided the bulk of care for these approximately 80- 100 diagnosed AIDS cases. Other agencies are reluctant to provide this care. Bona fide AIDS patients are eligible for Medicare. The Medicare bureaucracy is processing AIDS case applicants quickly, in 3 to 6 months, basically because there is that necessity. Dr. Robbins, a physician practicing in the Brevard, Seminole, and Orange County area in infectious diseases and internal medicine specializes in the treatment of AIDS. He sees a need for Nurse World to become Medicare certified to render services to the Medicare eligible AIDS patients, because in his experience, Nurse orld renders the best services qualitatively to these types of patients. Any number of AIDS patients (either on or off Medicare) above the number actually served by Nurse World or treated by Dr. Robbins has not been statistically demonstrated, but all testimony on the subject supports the 80-100 existing case figure and the concept that the AIDS numbers are escalating in both Medicare-certified and uncertified categories. One problem situation arising with increasing AIDS patients qualifying for Medicare is basically the same problem for all patients so qualifying. Once qualified, patients naturally must utilize one of the Medicare-certified home health agencies. The continuity of care of a patient is interrupted when Nurse World can no longer render nursing services to a former patient due to that patient becoming Medicare eligible. A break in the continuity of care unfavorably affects the quality of care rendered any patient. The patient and staff often develop a rapport and a break in care can emotionally depress the patient, leading to medical (physical) setbacks. Quality of care is likewise negatively impacted by switches in car givers because the more often a nurse sees a given patient over a period of time, the more that nurse is able to monitor the quality and progress of that patient. There is modest evidence that Nurse World is proficient in scheduling the right nurse for the right patient. Nurse World is the only home health agency that actually video tapes some cases and then trains specific nurses before ever sending them into the patient's home. There is presently a tendency to get people out of hospitals sooner than before due to the new diagnostic related grouping (DRG) regulations. Physicians then routinely refer these patients for home health care visits. As a result, in the last few years, there has been a quantifiable increase in the number of home health care visits requested in District VII. As a result of the increased demand and the inability of the Medicare-certified home health agencies to answer that demand (need), patients referred for Medicare home health services frequently will be seen only once or twice a week rather than three weekly visits as requested by their physicians. This is a significant deficiency in appropriate care for high tech critical care cases, including but not limited to the multiply- afflicted elderly. Also, nursing homes in the area are now experiencing sicker patients due to individuals getting out of the hospitals earlier through DRGs. The scope of nursing home care has increased. The patients released from hospitals cannot go directly home if their case is too complicated. Thus, many patients first go into nursing homes before going to their own homes. Nurse World provides temporary staff relief for the Americana Health Care Center, a skilled nursing home facility in-Winter Park, Florida. According to the testimony of Jill Miller, R.N., Director of Nurses for Americana, Nurse World's staff meets the high standards set at Americana whereas the other home health care agencies she has sometimes used have not. Nurse World personnel, however, are unable to follow the Medicare eligible patients home after release from Americana because Nurse World has no Medicare certificate. This breaks the continuity of care for Americana Medicare patients and can result in all the unfavorable physical and emotional setbacks set out above. Although the break in this continuity of Nurse World care is pronounced and more easily demonstrated using the Americana facility, and although it may be inferred that continuity of care is extremely important especially for the predominantly elderly population that uses Medicare regardless of which nursing home they exit, the continuity of exclusive care by Nurse World personnel specifically, falls short of representing a "special need" as that phrase has come to be understood in CON practice. This is also true for newly qualifying AIDS patients and hospital releases. Nurse World has provided high-tech in-service training at Americana free of charge. Nurse World is the only home health agency that staffs hospitals, nursing homes, and private duty visits. This sharpens the nurses' skills, especially their critical skills. Generally the existing Medicare-certified home health agencies still do not take home high-tech patients. It is advantageous to professional health care providers, the individual patients, and the community at large to encourage home care for high-tech patients. Caring for high- tech patients at home rather than in the hospital results in a cost savings to the community and for the individual patients as it is obviously much cheaper to care for patients at home. Also, the patients tend to get better quicker in their home environment. Examples of Nurse World's expertise in this area are that Nurse World was the first agency in the southeast United States to take home a baby on C-pap, a very sophisticated involved respirator. Nurse World is still the only agency located in District VII to have provided the C-pap at home. There is still no C-pap patient within District VII. Nurse World took home the first critical care, high tech patient in the Central Florida area four years ago. It is also the only agency that provides continuous passive motion care at home. Continuous passive motion care is a "state of the art" physical therapy device that provides continuous physical therapy. Nurse World has averaged three to four of these patients a week over the last year. Caring for high-tech critical care patients at home even when a "mini-intensive care unit" is necessary, costs the community much less than hospital care which can total $716 per day for a non-critical patient. Nurse World employs the largest number of critical care nurses in the area of any provider. Nurse World was the first agency that did blood gases on a patient at home, the first to take home a patient on a ventillator, the first to do home hyperalimentation, and the first to do a home I.V. patient. Two other agencies in the Orlando area now render high-tech services but not to the extent that Nurse World does. They began these services on a limited basis about a year after Nurse World began. Nurse World's "firsts" in these areas are significant because being in the vanguard of opening up these areas of practice has caused it to establish its own written in-home high tech policy and procedure (protocols) which the industry may voluntarily adopt since there is no HRS rule covering the subject matter. Most important about the protocols as developed and maintained by Nurse World are fail-safe techniques for dealing with malfunction of high tech machinery, power failure, isolation techniques for AIDS patients (sometimes considered "high tech"), and direct and immediate telephone contact with professional staff in any emergency. HRS does not presently have any methodology pursuant to rule or policy for projecting need for a home health agency. The methodology that HRS employed in reviewing the Nurse World application was contained in the District VII local health plan. That plan had adopted an HRS proposed rule which was subsequently declared invalid in Home Health Services v. Department of Health and Rehabilitative Services, 8 FALR 1510 (March 12, 1986). Sharon Gordon-Girvin, an expert in health planning, testified on behalf of Nurse World. She presented two methodologies for projecting the need for a home health agency in District VII. After the proposed rule was declared invalid, HRS developed a policy for determining the need for additional home health agencies, reflected in Petitioner's Exhibit 78, which was employed between March and August of 1986. That policy was actually used in reviewing home health agency applications, and in making decisions. HRS issued certificates of need for home health agencies based on that policy. Applying that HRS policy, which Gordon-Girvin considers "reasonable," there is a need for 35.3 home health agencies in District VII in 1986. 1986 is the planning horizon year applicable to the Nurse World application. There are 16 existing Medicare home health agencies in District VII. Direct, competent and substantial evidence supports the 16 figure which includes newly certified Profile Medical Services. HRS documentation confirms this. Uncorroborated hearsay evidence of an additional home health agency in District VII was struck. Therefore, the net need is for 19.3 home health agencies in District VII in 1986. HRS, when using this methodology, had a policy of giving out only one/third of the net need in each of three consecutive years. Gordon-Girvin would not term this latter policy nreasonable" and no one offered any acceptable justification for it. No reasonableness of this "award only 1/3 of need" policy was demonstrated and it has since been abandoned, but even by such a system, the net need in 1986 would be for 6.4 additional home health agencies in District VII in 1986. The gross need and the net need continue to increase through 1989. The methodology reflected in Exhibit 7B basically has two constants, the home health use rate and the optimal size visits. They act as constants. The increase in the number of agencies needed is attributable to the growth of the population. Ms. Gordon-Girvin also employed a methodology employed by District III as a point of comparison to see how the number of agencies needed in District VII could be affected by using a very conservative methodology. District III's methodology was selected as a conservative comparison to the former state health policy. Also, no other local health council has a need methodology. Employing the methodology reflected in Petitioner's Exhibit 7A, there is a need for 17 home health agencies in District VII or a net need for 1 additional home health agency. (Gross need minus 16 existing certified agencies). This is a very conservative methodology because it changes very slowly over time. In fact, the net need remains at 1 through 1989. Ms. Gordon-Girvin opined that this methodology employed in Petitioner's Exhibit 7A, is also a reasonable methodology but is very conservative and relies on hospital discharge rates in contrast to the discredited and abandoned HRS policy which is a use-based methodology. There are no other methodologies being employed by planners in Florida and no other methodologies were put forth by either party. Presently, HRS has no rule or policy designating a numeric methodology to determine the need for new medicare home health agencies in any given district. HRS review of CON applications for home health agencies is based solely on statutory criteria, the merits of the proposal, and the district need for the agency as demonstrated by the individual applicant. 80th need methodologies employed by Ms. Gordon Girvin contemplate the need for home heath agencies at the District level. That is, agencies operating in all four of District VII's counties. In reality, the existing home health agencies operate in only one or two mounties. For example, Profile Medical Services, the only successful applicant in the current batch, was recently issued a certificate of need under the HRS policy since discredited and abandoned, but its CON is limited so that it can operate only in 8revard county, so that actually only one-fourth the district need is being met. At the time the Nurse World application was reviewed, there were 11 licensed and approved CON home health agencies in District VII. Six of these agencies only operate in one county and five operate in only two counties. HRS is not aware of any Medicare-certified home health agency that operates in all four counties in District VII under a single certificate of need. Because HRS' policy has been invalidated as a rule and since it has been subsequently abandoned by HRS, it would be invalid to employ it in these proceedings. Even if the District III methodology determined a net need of one is reasonable, it would be unreasonable and unjustified to apply it as modified by HRS' uncodified award only 1/3 of need per year" policy, apparently also abandoned prior to hearing. Therefore, by the only reasonable need methodology presented (that of District III) there is room for one home health agency, not limited by county and not limited by the "award only 1/3 of need per year" policy. The 1/3 limitation should not apply in any case because it has no current application by HRS and because its effect varies the horizon year. Since HRS had no need methodology or policy in place at date of hearing, it took the-position that an applicant must demonstrate need by finding people who are not getting the service. Ms. Gordon-Girvin, Petitioner's expert who had been employed at HRS in health planning for 11 years, opined that there is no adequate quantifiable technique available as a health planning methodology that will allow a health planner to make use of a negative demonstration of need. She suggested use of responses to a newspaper advertisement and then demolished that method of proof as "impractical". Another difficulty with this type of negative demonstration approach is that existing agencies can deal with increased need demands by simply continuing to add staff. Gordon-Girvin knew of no applicant that had acquired a CON by proving lack of access. Additionally, a similar agency position (the Rule of 300) has been struck down by the courts. This negative burden of proof concept has been given short shrift by the courts and is rejected here as well. See Department of Health and Rehabilitative Services v. Johnson and Johnson Home Health Care, Inc., 447 So. 2d 361 (Fla. 1st DCA 1984). Richard Gramming, an expert in health planning, testified on behalf of Nurse World. He presented Petitioner's Exhibit 6 which demonstrated that there is a capacity for other agencies in District VII and that if one of those agencies were to be Nurse World, the impact would not be very significant on the available number of visits. The multiplication of the Medicare home health use rate by the 65+ population for District VII produces the potential number of Medicare home health visits for District VII which for 1986 is 317,304. The total number of home health agency visits, Medicare and non-Medicare, for 1984 in District VII was 309,920. Of these visits, 266,531 were Medicare visits. When the actual number of Medicare visits is subtracted from the potential number of Medicare visits, there are 50,773 Medicare visits available for current and existing providers. When Nurse World's projected number of visits from year two (5,625) are subtracted there are still 45,148 Medicare visits available for current providers. Nurse World's approval should have no serious impact on the short or long term financial positions of the existing Medicare providers with the possible exception of Hospice, which may have to hire its nurses elsewhere. An interest such as Hospice's is not one which Chapter 381 is designed to protect. Mr. Gramming's projections are very conservative and the untapped market is probably larger, since the Medicare eligible due to disability were not factored into his formulas and the use rate in the formula was kept constant, whereas it has been increasing over time. A review of Nurse World's past growth rate and conservatively projected growth rate reveals that Nurse World is financially secure for a long-term position. In light of the potential market as demonstrated by the foregoing findings of fact, a long-term financial feasibility of Nurse World will be assured. Home health agencies are labor intensive rather than capital intensive, with few fixed costs. The entry of Nurse World into the market will tend to keep costs as they are or perhaps lower costs through increased competition. Medicare costs caps are more effective in preventing cost inflation. Nurse World has met its minimal burden of proof to establish there will be no significant adverse impact on cost if the Nurse World application is approved; HRS has not gone forward to demonstrate there will be any adverse impact on costs if the application is approved. Nurse World has demonstrated that access to health care by the underserved population will be improved and that the opportunity for specialization within the existing market place will be enhanced by their entry into the market. Nurse World's actual growth rate from 1984 to 1985 and from 1985 to 1986 has been 20 percent per year in gross revenues. Twenty percent growth is logically anticipated for the current year despite a more conservative 12 percent calculation.

Recommendation Upon consideration of the foregoing findings of fact and conclusions of law, it is, RECOMMENDED that a Final Order be entered granting Petitioner Nurse World a CON to establish and operate a home health agency in District VII (Orange, Osceola, Brevard, and Seminole counties), conditioned upon its providing 3 percent indigent and 3 percent Medicaid qualified services. DONE and RECOMMENDED this 20th day of May, 1987, at Tallahassee, Florida. ELLA JANE P. DAVIS, 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 May, 1987. COPIES FURNISHED: Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Eric J. Haugdahl, Esquire 1363 East Lafayette Street Suite C Tallahassee, Florida 32302 John Rodriguez, Esquire Department of Health and 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 APPENDIX The following constitute rulings pursuant to Section 120.59(2), Florida Statutes, upon the parties proposed findings of fact (FOF): Petitioners proposed findings of fact: 1-4 To the extent not covered under "Background and Procedure," these are subordinate and unnecessary. Covered in FOF 2. Covered in FOF 8. Covered in FOF 9. Covered in FOF 3 & 10. Covered in FOF 3. Covered in FOF 10. Covered in FOF 10. Covered in FOF 12. 13-15 Covered in FOF 13. 16 Covered in FOF 16. 17-20 Covered in FOF 7. Covered in FOF 14. Covered in FOF 16-17. Rejected as a conclusion of law; see FOF 13 and conclusions of law. Accepted but subordinate to the facts as found. 25-26 Accepted but subordinate to the facts as found, cumulative FOF 7. 27-28 Rejected as unnecessary, as mere "puffing" and as subordinate to the facts as found. See FOF 10 and 18 on proposal 28. 29. Rejected as unnecessary and subordinate to the facts as found. See FOF 25.l 30-34 To the extent supported by the admissible direct competent substantial record evidence, these are covered in FOF 16; otherwise rejected. 35. Covered in FOF 6.l 36-37 To the extent supported by the record, covered in FOF 16, otherwise rejected. 38 Covered in FOF 10 and 15. 39-40 To the extent supported by the record and to the extent necessary to a determination of this cause, covered in FOF 17- 21, otherwise rejected. 41-42 Covered in FOF 19. 43-44 Covered in FOF 20-21. Covered in FOF 22. To the extent not covered in FOF 8 and 11 rejected as cumulative. Unnecessary, as mere "puffing", and as subordinate to the facts as found in FOF 14 and 25. Covered in FOF 23. Covered in FOF 24. Covered in FOF 14-16, and 25. Covered in FOF 25. Covered in FOF 25 but cumulative. Accepted as true, but rejected as subordinate and unnecessary. Except as covered as to capability of Nurse World in FOF 14 and 25, it is also largely immaterial to these proceedings in that Mrs. WiIdermuth's child is not eligible for Medicare, cannot become eligible for Medicare and resides outside District VII in Volusia County. 54-56 Covered in FOF 25. 57 Covered in FOF 3 and 8. 58-50 Covered in FOF 25. 61-62 Subordinate to the facts as found. See FOF 39 and 42. Cumulative, see FOF 23. Covered in FOF 15. 65-73 and 75-78 Except as covered in FOF 11 and 16 these proposals are rejected as subordinate, unnecessary or cumulative to the facts as found. 74 Covered in FOF 11 and 18. Covered in FOF 27-34. Rejected as a conclusion of law. 81-89 Covered in FOF 26-35 and conclusions of law. 90 Accepted for the reasons set out in the transcript reference, but as a FOF it is subordinate and unnecessary. 91-95 Covered in FOF 26-35. 96 Rejected as irrelevant since no such out of state methodology was offered. See FOF 28. 97-105 Covered in FOF 30-35. Rejected as a conclusion of law. Covered in FOF 36. Covered in FOF 37. 109-110 Accepted but unnecessary. 111-119 Covered in FOF 36-42. 120 Accepted but rejected as unnecessary. Respondent's proposed findings of fact: 1 Covered in background and procedure. 2 Covered in FOF 2, 8, 14 and 15. 3 Covered in FOF 13. 4 Covered in FOF 11. 5 Covered in FOF 10. 6 Covered in FOF 14 and 25. 7 Covered in FOF 8 and 23 (among others). 8 Covered in FOF 4. 9 Covered in FOF 5. 10 Covered in FOF 6. 11-12 Covered in FOF 26-35.

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HEALTH CARE AND RETIREMENT CORPORATION OF AMERICA, INC., D/B/A HEARTLAND OF VOLUSIA COUNTY vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 85-003235 (1985)
Division of Administrative Hearings, Florida Number: 85-003235 Latest Update: Oct. 14, 1986

The Issue In their Prehearing Stipulation the original parties described the background and general nature of the controversy as follows: In January, 1985, HCR filed an application for certificate of need to develop a new 120 bed nursing home in Collier County, Florida. By notice dated June 28, 1985, HRS stated its intention to deny HCR's application. HCR timely filed a request for formal administrative proceeding, and the proceeding was forwarded to the Division of Administrative Hearings. By application supplement dated May 15, 1986, HCR has reduced this application to a 90-bed new nursing home. The nursing home will provide skilled nursing care to Alzheimer's patients and to patients discharged from hospitals in need of additional intensive nursing care, in addition to the typical nursing home patient. HRS has denied HCR's application because, pursuant to Rule 10-5.11(21), Florida Administrative Code there is insufficient need for the additional nursing home beds proposed by HCR. In the Prehearing Statement the Petitioner described its position as follows: HCR contends that there is an identifiable need for a nursing home in Collier County, Florida, to serve the needs of patients who suffer from Alzheimer's disease and similar disorders and patients who are discharged from hospitals with a continuing need for a high level of intensive care, often provided through sophisticated technical or mechanical means. Existing nursing homes in Collier County do not offer adequate facilities for such patients and refuse admission to such patients. These patients have experienced an inability to obtain such care in Collier County. HCR's proposed nursing home will provide needed care which is otherwise unavailable and inaccessible in Collier County. The application meets all criteria relevant to approval of a certificate of need. HCR further contends that the nursing home formula shows a need for additional nursing home beds in Collier County. Previously, in circumstances where a need for additional nursing home services has been identified, HRS has approved certificates of need even though the nursing home formula showed a need for zero additional beds or a small number of additional beds. In the Prehearing Statement the Respondent described its position as follows: HRS contends, pursuant to the formula contained in Rule 10-5.11(21), Florida Administrative Code, that there is insufficient need in the January, 1988 planning horizon demonstrated for additional nursing home beds in Collier County to warrant approval of a-new nursing home. Therefore, HRS contends that the HCR application should be denied. Further in its original application, HCR did not identify services proposed specially for Alzheimer's disease patients or "sub-acute" patients. HCR did not and has not complied with provision of Chapter 10-5.11(21)(b 10., Florida Administrative Code, regarding mitigated circumstances. The Respondent also identified the following as an issue of fact to be litigated. "HRS contends that it should be determined whether HCR's supplement dated May 15, 1986, is a significant change in scope for which the application was originally submitted." Because of its late intervention into this case, the Intervenor's position is not described in the Prehearing Statement. In general, the Intervenor urges denial of the application on the same grounds as those advanced by the Respondent. The Intervenor did not attempt to become a party to this case until the morning of the second day of the formal hearing. Respondent had no objection to the Petition To Intervene. The original Petitioner objected on the grounds that the effort at intervention was untimely and that the Intervenor was without standing. The objection to intervention was overruled and the Intervenor was granted party status subject to taking the case as it found it. Accordingly, intervention having been granted at the conclusion of the evidentiary presentation of the other parties, the Intervenor was not permitted to call any witnesses or offer any exhibits. Intervenor's participation before the Division of Administrative Hearings was limited to an opportunity to file proposed findings of fact and conclusions of law. Following the hearing a transcript of proceedings was filed on July 8, 1986. Thereafter, all parties filed Proposed Recommended Orders containing proposed findings of fact. Careful consideration has been given to all of the Proposed Recommended Orders in the formulation of this Recommended Order. A specific ruling on all proposed findings of fact proposed by all parties is contained in the Appendix which is attached to and incorporated into this Recommended Order. The Petitioner also filed an unopposed post-hearing motion requesting that its name be corrected in the style of this case. The motion is granted.

Findings Of Fact Based on the stipulations of the parties, on the exhibits received in evidence, and on the testimony of the witnesses at the hearing, I make the following findings of fact. Findings based on admitted facts The parties agree that HCR properly filed a letter of intent and application for certificate of need for a new nursing home to be located in Collier County. The application was reviewed by HRS in the ordinary course of its activities, and HRS initially denied the application. HRS continues to oppose issuance of a CON because (a) there is an insufficient need, pursuant to Rule 10-5.11(21), Florida Administrative Code, for additional nursing home beds to warrant approval of a new nursing home [Section 381.494(6)(c)1., Florida Statutes]; (b) the long term financial feasibility and economic impact of the proposal is questionable because of low occupancy being experienced by existing nursing homes "Section 381.494(6)(c)9., Florida Statutes]. HRS proposes no other basis for denial of the application. The parties agree that HCR meets all criteria for a certificate of need, with the exception of those two criteria listed in the immediately foregoing paragraph relating to need and financial feasibility/economic impact (relevant to low occupancy), which HRS contends have not been met. The parties agree that HCR would provide good quality care to patients, that the project would be financially feasible if the occupancy projections asserted by HCR were obtained, that the costs and methods of proposed construction are appropriate and reasonable, and that the proposed facility would be adequately available to underserved population groups. The rest of the findings In January 1985, HCR filed an application for a certificate of need to develop a new 120-bed nursing home facility in Collier County, Florida. The original application described a traditional approach to nursing home care. By notice dated June 28, 1985, HRS stated its intention to deny HCR's application. HCR timely filed a request for formal administrative proceedings and this proceeding ensued. By application supplement dated May 15, 1986, HCR made certain changes to its original application. These changes included reducing the size of the proposed nursing home from 120 to go beds and changing the-concept of the nursing home from a traditional nursing home to one specifically designed to address the treatment of Alzheimer's disease patients and sub-acute care patients. The supplement specifically provided that 30 of the 90 proposed beds would be "set aside to offer a therapeutic environment for patients with Alzheimer's or similar disorders." The project description in the original application contained no such provision. HCR's proposed facility would consist of 90 nursing home beds, 30 assisted living beds, and an adult day care facility located adjacent to the nursing home portion of the facility. Those portions of the facility relating to assisted living and adult day care do not require certificate of need review. The estimated cost of the portion of the project which requires certificate of need review is $3.5 million. HCR estimates that approximately 33 1/3 per cent of the patients in the facility will be Medicaid reimbursed. It is proposed that 30 of the 90 nursing home beds be designed and staffed specifically to provide care and treatment necessary to meet the special needs of certain patients who suffer from Alzheimer's disease and dementia and exhibit need for care different from that found in the typical nursing home. It is proposed that another 30-bed wing be staffed and equipped to provide sub-acute, high-tech services such as ventilator, I.V. therapy, pulmonary aids, tube feeding, hyperalimentation and other forms of care more intensive than those commonly found in a nursing home and necessary for the care of patients discharged from hospitals and patients in the last stages of Alzheimer's disease. The remaining 30-bed wing would be devoted to traditional nursing home care. HRS has adopted a rule which establishes a methodology for estimating the numeric need for additional nursing home beds within the Department's districts or subdistricts. This methodology is set out in Rule 10-5.11(21), Florida Administrative Code. This rule determines historic bed rates and projects those bed rates to a three-year planning horizon. Allocation to a subdistrict such as Collier County is adjusted by existing occupancy in the subdistrict and the subdistrict's percentage of beds in relationship to the total number of beds in the district. Additional beds normally are not authorized if there is no need for beds as calculated under the rule. HRS calculated need utilizing current population estimates for January 1986 and projected need for the population estimated for January 1988, arriving at a need of approximately 16 additional nursing home beds for the January 1988 planning horizon. HCR projected need to the January 1989 planning horizon and projected a numeric need of approximately 38 additional nursing home beds. There are no applicants for additional nursing home beds in the January 1989 planning horizon (batching cycle). Alzheimer's disease is a primary degenerative disease of the central nervous system which results in a breakdown of the nerve cells in the brain. The disease is progressive, in that it begins subtly, often with forgetfulness or simple personality changes, and ultimately results in death following a phase in which the patient is bedridden and totally dependent upon others for survival. The cause of the disease is not known. The disease is much more common in the older age groups and is very common in the southwest Florida area. (However, nothing in the evidence in this case suggests that Alzheimer's disease is more common in southwest Florida than in other parts of the state.) There is no known cure for Alzheimer's disease. Alzheimer's disease patients are characterized by such symptoms as memory loss, communication problems, difficulty understanding, confusion, disorientation, inability to recognize care givers, waking at night, wandering, inability to socialize appropriately, and incontinence. The progress of the disease can be divided into stages. During the initial stage, the patients will display forgetfulness and subtle personality changes. As the disease progresses, the patients encounter increasing difficulty performing more than simple tasks, tend to be more emotional, become more confused, encounter difficulty with concentration and retaining thoughts, and often display poor judgment and a denial of the significance of their actions. In the next stage, the patients begin to require assistance to survive. Forgetfulness and disorientation increase and wandering patients are often unable to find their way. The patients become incontinent, experience sleep disturbances, become restless at night, and wander during the day, leading to considerable family distraction and difficulties for the care givers. The patients encounter difficulty recognizing family members and often become paranoid and fearful of those family members within the house. violence and aggressive outbursts may occur. Finally, the patients progress to a stage in which they are totally inattentive to their features physical needs, requiring total care. These Patients are totally incontinent, experience frequent falls, develop seizures, and eventually become bedridden, going into a fetal position and becoming totally unable to provide any care for themselves. Traditionally, most nursing homes offer no special programs for patients who suffer from Alzheimer's disease and mix these patients with other patients in the nursing home. There is no nursing home in Collier County which provides program specifically designed for the treatment of Alzheimer's disease patients. The nearest nursing home where such care can be found is in Venice, some 92 miles from Naples. The total facility proposed by HCR is designed to provide a continum of care for Alzheimer's disease patients and their family care givers. The adult day care portion of the facility would enable family members to place Alzheimer's disease patients in day care for a portion of the day in order for the family care givers to maintain employment, perform normal household chores, and find relief from the extremely demanding task of constantly supervising and caring for an Alzheimer's disease victim. The adult day care portion of the facility would be designed and staffed to provide a therapeutic program for the Alzheimer's disease patient and the patient's family. The assisted living portion of the facility would allow an Alzheimer's disease patient in the early stages of the disease to live in an environment, with his or her spouse if desired, where immediate care and routine supervision at a level lower than that required by a nursing home patient would be provided. Thirty nursing home patient and who do not display those characteristics which are disruptive to non-Alzheimer's patients, such as wandering, combativeness, and incontinence. For those Alzheimer's patients who should not be mixed with other nursing home patients because of their disruptive routines and who require unique programs and facility design features to meet their specific needs, a 30-bed wing would be set aside. Finally, for Alzheimer's patients in the final stages of the disease who require total care and are bedridden, and for patients discharged from local hospitals who require high-tech services, a 30-bed wing designed, staffed and equipped to provide such services would be set aside. The facility would provide a high level of staffing to meet the demanding, personal care needs of Alzheimer's patients and would provide 24-hour nursing supervision in that portion of the facility dedicated to intensive services for the bedridden and high-tech patient. The design and equipment of the proposed facility are particularly addressed to the needs of Alzheimer's disease patients. Physically, the facility would allow patients freedom of movement both inside the facility and in an outside courtyard with porches, but the facility would be sufficiently secure to prevent the patient from wandering away from the facility. There would be amenities such as therapeutic kitchens which would allow patients still able to cook to do so. Fixtures in the facility would be designed so that the Alzheimer's disease patients could easily identify the functions of fixtures such as wastebaskets, toilets, and sinks. Features such as low frequency sound systems, lever door knobs, square instead of round tables, barrier-free doorways, special floor coverings, appropriate labeling, automatic bathroom lighting, and provisions for seating small groups of patients together would all provide the special care required by the Alzheimer's patient. The concept of a separate unit for Alzheimer's disease patients is a new one, growing out of increased medical awareness of the disease. The proposed unit would be a prototype for the Petitioner. There are four nursing homes in Collier County and 413 licensed nursing home beds. There are no approved but unlicensed nursing home beds in Collier County. At the time that HRS initially reviewed the HCR application, Collier County nursing homes were reporting an average occupancy of approximately 70 percent. At the time of the hearing, average occupancy of existing nursing home beds in Collier County was 83.5 per cent. Existing nursing home beds in Collier County are underutilized and there are a number of nursing home beds available to the public. Also there are available alternatives to nursing homes in Collier County. HCR has projected reaching 95 per cent occupancy within one year of opening. This projection seems overly optimistic and unwarranted by prior history, as only one existing facility has an occupancy rate that high. HCR's occupancy projections are based on assumptions that the future growth will be similar to that experienced between 7/1/85 and 12/1/85. But more recent data shows that growth has been decreasing and that there was no growth for the most recent period prior to the hearing. If projected occupancy is not met, projected revenues will not be realized, and projections of financial feasibility will not materialize. The record in this case does not contain evidence of patients' need for nursing home care documented by the attending physicians' plans of care or orders, assessments performed by the staff of the Department of Health and Rehabilitative Services, or equivalent assessments performed by attending physicians indicating need for nursing home care. The local health plan (Policy 1, priority 4) requires an occupancy level of at least 90 per cent before new nursing homes can be approved. The local health plan (Policy 1, priority 6) also provides, "No new community nursing home facility should be constructed having less than 60 beds. However, less than 60 beds may be approved as part of an established acute care hospital facility."

Recommendation For all of the foregoing reasons, it is recommended that the Department of Health and Rehabilitative Services issue a Final Order in this case denying the Petitioner's application for a certificate of need to construct either its original proposal or its supplemented proposal. DONE AND ENTERED this 14th day of October, 1986, at Tallahassee, Florida. MICHAEL M. PARRISH, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of October, 1986.

Florida Laws (2) 105.08120.57
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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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AGENCY FOR HEALTH CARE ADMINISTRATION vs FAITH HOME HEALTH, INC., 11-004457 (2011)
Division of Administrative Hearings, Florida Filed:Tampa, Florida Sep. 01, 2011 Number: 11-004457 Latest Update: Jun. 06, 2012

The Issue Whether Respondent committed the violations alleged in the Amended Administrative Complaint, and, if so, what penalty should be imposed.

Findings Of Fact At all times material hereto, Faith Home operated as a home health agency with its principal place of business located at 3202 North Howard Avenue, Tampa, Florida. Faith Home's license number is 299991078. Joni Miller is a registered nurse (RN) surveyor for AHCA. Ms. Miller holds an associate of arts degree in nursing and practiced as an RN for almost 30 years. She practiced as an RN in the areas of coronary care, research, home health, cardiology, and sports medicine. Ms. Miller has completed the requisite classes in surveyor training and is a certified home health surveyor. Ms. Miller was received without objection as an expert in nursing. Jeanette Peabody is an RN who worked for AHCA as an RN specialist. Ms. Peabody obtained an associate of arts degree in applied science with a major in nursing. In 1995, Ms. Peabody was licensed as an RN in Pennsylvania. Thereafter, she worked for various health-related entities, including (but not limited to) two home health agencies and the Pennsylvania Department of Health. She became licensed as an RN in Florida in 2004. Ms. Peabody became a certified surveyor after receiving the appropriate training. While working for AHCA, Ms. Peabody conducted surveys of health care facilities and agencies for compliance with the applicable rules and regulations. Ms. Peabody was received as an expert in nursing. Beverly Eubanks is the chief operating officer for Faith Home, a position she has held for 15 years. Ms. Eubanks is an RN, who received her associate's degree in nursing from Manatee Community College in 1990. Faith Home primarily serves the underprivileged, low-income families, and public housing residents. Celina Okpaleke is the sole owner of Faith Home and has been its owner since 1997. Ms. Okpaleke is a licensed physician assistant, having been licensed in 1996. Her duties at Faith Home are to oversee its day-to-day management. Prior to the February 2011 survey, Ms. Okpaleke had not been going to the Faith Home office every day.2/ The methodology for any survey includes the following: the team arrives at the location; the team is introduced to the survey entity's staff members; the team explains to the entity's staff members the nature of the survey, including a list of items required for the team to conduct the survey; and there is a request for work space. Upon receipt of the required items, the team reviews the material, conducts interviews, conducts visits with patients at their various locations, interviews staff, and reviews the accumulated information. In the event the surveyors have any questions, the surveyors will make requests to the appropriate entity staff, and additional materials may be provided to the surveyors. The survey findings are reviewed with the staff, and, at the end of the survey, the team conducts an exit conference with the appropriate staff. Any entity staff is welcomed to be present. In the event any documentation is missing, the entity is allowed to provide that material after the surveyors have left the facility. In those instances when an agency is out of compliance, AHCA will make a return visit to ensure the agency has corrected the deficiencies. There was credible testimony that this survey procedure was the same procedure used during the Faith Home survey and follow-up survey. It is recognized as a good nursing practice to document in a patient's record or chart the care, treatment or other services being provided to a patient. This includes all medical and medically-related support services. Faith Home has numerous policies that govern how it is to be run. A few of the pertinent policies are set forth below. "Patient Visits," last revised on December 1, 2010, provides: All patients will be seen according to physician's orders and in compliance with the plan of treatment. At each visit, a progress or visit note will be completed. On the visit note (progress not [sic]/visit note) the patient's progress toward meeting established goals shall be documented. In addition, the patient's response to treatment will be documented as well as any other pertinent assessment information. All patient visits will be performed according to a pre-established schedule. If there is [sic] any changes in visit schedule, time or staff, the patient will be consulted prior to the change. "Initial Assessment Process for Medicare [P]atients," last revised on December 1, 2010, reflects in pertinent part: Upon admission, each patient will receive initial assessment in order to determine patient's needs. To achieve this goal, the following important processes must be performed: * * * More in depth functional assessments performed by a qualified PT [physical therapist] or OT [occupational therapist] are available to those patients who need one. These assessments are documented on the appropriate PT/OT Evaluation form. * * * Initial assessments will be performed within 48 hours of referral or within 48 hours of a patient's return home from an impatient [sic] stay, or on the physician-ordered start of care [SOC] date. MSW will make assessments within one (1) week of referral based on the patient's priority level as determined by RN and/or MD, PT, ST, and OT will make evaluations within one (1) week of referral based on the patient's priority level as determined by the RN and/or MD. Administration/start of care assessment data must be completed within five (5) calendar days of the SOC date. The agency then has seven (7) calendar days from the SOC date to encode the data, check for errors and lock the data for transmission. The data will than [sic] be transmitted on a monthly basis; data minimum no later than the month[.] "Oasis Data Set," last revised on December 1, 2010, reflects in pertinent part: The agency has implemented the OASIS data set and is actively collecting data as of March 15, 1999. Current assessment data and notes utilized by the agency have been incorporated into the OASIS core data. OASIS requirements apply to all patients . . The only exclusions are as follows: Patients under the age of 18 Patients receiving maternity services Patients receiving ONLY no skilled services such as personal care, homemaker, chore, or companion services. OASIS data are collected at the following points: Start of Care * * * Resumption of Care following impatient [sic] stay * * * Follow-up/Recertification * * * 4. Follow-up/SCIC * * * 5. Discharges and Death * * * Do not administer OASIS data set as an interview. Questions are meant to be part of the professional opinion of the staff member performing the assessment, based upon the evaluation of the patient. Be sure to incorporate agency assessment material (Discharge Summary, etc.) with the OASIS data set. The OASIS data set does not constitute a complete assessment. "Policies & Procedures for Accectance [sic] of Patients/Cases" last revised on December 1, 2010, reflects in pertinent part: B) Qualifying Criteria for Accepting a Patient * * * 7) Client must have a telephone or use of phone in close distance for emergency situation. Running water and electricity are also important factors for providing adequate care in the home. * * * D) Criteria for Acceptance of Skilled Nursing Clients * * * A copy of MD orders may accompany Skilled Nursing Admission. If nurse [is] able to receive a faxed copy of orders, Faith Home Health will fax them. If not, a copy of the order will be sent to patient's residence with supplies. "Policies & Procedures for Admissions," last revised on December 1, 2010, reflects in pertinent part: Admission & Assessment Policies & Procedures * * * 7) All documentation will be kept in the patient's Faith Home Health folder. "Caregiver Job Descriptions," last revised on December 1, 2010, reflects in pertinent part: Registered Nurses * * * Activities may include: * * * 11. Recording pertinent information. * * * LICENSED PRACTICAL NURSE * * * Activities may include: * * * 7. Recording all pertinent observations and treatments[.] * * * Certified Nurse Aide * * * Activities may include: * * * 22. Keeping a record of observations and care given[.] Home Health Aide * * * Activities may include: * * * 10. Maintaining a proper record of activities. The February 2011 Survey In early February 2011, Ms. Peabody was the lead surveyor in the annual Florida licensure recertification survey conducted at Faith Home (FH survey). Ms. Miller was also a member of the FH survey team. This FH survey team conducted reviews, interviews, home visits, and conferences over the course of three days. During the February 2011 FH survey, Ms. Peabody requested and was provided Faith Home's records for patient 5. The home health certification and plan of care (HHC/POC) for patient 5 provided the SOC date as December 14, 2010. The HHC/POC ordered skilled nursing visits to occur one to two times a week for nine weeks. According to the HHC/POC, at each visit, the skilled nurse was to perform various treatments with respect to patient 5's multiple medical issues, including assessing vital signs, cleaning a toe wound and applying a dressing, instructing the patient on diet and nutrition, and reporting any changes to the "MD [medical doctor] & supervisor ASAP [as soon as possible]." Patient 5 did not receive skilled nursing visits during the weeks of December 19 or 26, 2010. During the following skilled nursing visits, patient 5 did not receive wound care treatment: December 13, 2010, and January 6, 13, 18, and 21, 2011. Additionally the HHC/POC called for a PT to evaluate and treat patient 5. There were orders that the PT was to administer therapeutic home care exercises in order to increase patient 5's functional abilities. Patient 5 did not have the physical therapy evaluation or treatment as directed. There was no PT evaluation or treatment documentation for patient 5, and there was no documentation that the MD or supervisor was notified that the treatments did not take place. Following the review of the documentation provided, Ms. Peabody afforded Faith Home the opportunity to provide any additional documentation they had with respect to the care and treatment provided to patient 5. No additional documentation was forthcoming to the surveyors. Ms. Eubanks contended that patient 5 was seen by a nurse during the week of December 18, 2010. She testified that there was no wound care treatment necessary for patient 5 because the wound had healed. Ms. Eubanks "believe[d]" the wound had resolved by December 9, 2010, and that no PT was ordered because patient 5 was still "refusing it." Ms. Eubanks also testified that no wound care treatment was required because it was not on the OASIS data collection sheet. Ms. Eubanks's testimony is not credible as the HHC/POC is clear as to the physician's order regarding patient 5's toe wound care and the PT evaluation and treatment. The OASIS data form may be the methodology "to track your [Faith Home] benchmarks and your progression to see how you rank" among other home health agencies, but it does not take the place of a HHC/POC executed by a physician. Further, although a patient always has the right to decline a health care service, that response does not preclude the physician from ordering the particular care to be provided. Based on the violations observed and documented during the February 2011 survey, Ms. Miller went back to Faith Home in June 2011 to follow up on the areas of concern. Ms. Miller reviewed five patients at the June 2011 revisit, one of whom was part of the February 2011 survey, patient 5.3/ Patient 5J's HHC/POC, signed on April 16, 2011, ordered skilled nursing visits to occur one to two times a week for nine weeks. According to the HHC/POC, at each visit, the skilled nurse was to perform various treatments with respect to patient 5J's multiple medical issues. The HHC/POC included an assessment of patient 5J's vital signs including the endocrine, cardiac, and neuro, with instructions regarding the disease process and management; fall prevention; diet and nutrition; and skin, nail, and foot care. It also included an order to report "any changes or concerns to [the] MD & supervisor ASAP." This April 16, 2011, HHC/POC also ordered a home health aide (HHA) to provide services two to three times a week for nine weeks for patient 5J. The HHA was to assist patient 5J with the activities of daily living (ADL). During the follow-up survey, Ms. Miller was unable to find documentation of any nurse's treatment for patient 5J during three of the nine-week certification period. The skilled nursing visit notes on April 21 and May 5, 2011, failed to reflect any assessment of patient 5J's vital signs, including the cardiovascular system. The lines drawn through certain boxes do not indicate review or assessment of patient 5J. Further, there was no evidence of any HHA visits during the seventh week through the ninth week of the certification period for patient 5J. This totaled six missed HHA visits for patient 5J. With respect to patient 7, the HHC/POC, with a SOC date of December 18, 2010, ordered a PT to evaluate and treat patient 7. The PT was to administer a therapeutic home care exercise program to patient 7 to increase strengthening.4/ The HHC/POC also ordered the skilled nurse to "report any changes and or concerns to the MD & RN ASAP." Patient 7 did not receive the physical therapy evaluation until December 29, 2010, 11 days after it was ordered. The PT's care plan for patient 7 involved physical therapy two times a week for three weeks. At the time of the FH survey, there was no documentation that the physician was notified of the delay or the reason for the delay in performing the PT evaluation on patient 7. Ms. Eubanks provided a "Communication/Status Report" (C/SR) pertaining to patient 7, dated January 3, 2011. Although this C/SR purports to put Faith Home services (including the PT) on hold until the patient returns from being with the "daughter and family for a couple of weeks," it is at odds with the credible evidence presented by AHCA. The physical therapy documentation reflects that patient 7 was provided PT services twice during the week of January 9, 2011, just one week after Faith Home was "notified" the patient would be gone "for a couple of weeks." Additional physical therapy documentation reflects that service was also provided twice during the week of January 17, 2011.5/ Ms. Eubanks's contention that this C/SR was faxed to patient 7's physician to notify him/her of the change in plans is not credible. There was no testimony or documentation of the physician's actual fax number or the actual number to which this C/SR was purportedly faxed, nor did the person who actually faxed the C/SR testify. Patient 11's HHC/POC, signed December 15, 2010, ordered skilled nursing care two to three times a week for nine weeks. At the end of the HHC/POC orders, there is an order to "Report any changes and or concerns to MD & supervisor ASAP." Although it is noted on the HHC/POC that the "Certification period [was] extended due to [a] procedure on [the] left second toe," there was no actual doctor's order to provide wound care to patient 11's left second toe. There is, however, a "60 Day Summary" notation which states: Wound to [the] right great toe healed without complication. Skilled nurse currently caring for left second toe. No S&S of infection noted. Blood pressure and blood sugar has remained stable through out [sic]. This summary statement is not an order for care to patient 11's left second toe. When a nurse observes a new wound in need of care, the nurse should immediately document the toe wound and contact the physician. The burden then falls to the physician to decide what, if any, order is appropriate for the wound care. This recording/reporting process was not followed, and there was no documentation of patient 11's wound to the left second toe. However, the skilled nursing visits record that wound care was provided to patient 11's left second toe. Ms. Eubanks testified that patient 11's podiatrist, Dr. Rappaport, wrote an order to discontinue wound care to the right great toe because it had healed. Other than the 60-day summary note found in the HHC/POC signed December 15, 2010, there was no order signed by Dr. Rappaport that discontinued care to the right great toe, and no order for care to patient 11's left second toe was introduced at hearing. Although Ms. Eubanks testified that patient 11 had the left second toe nail bed removed, she never testified that she was present when that nail bed was removed or that she was the attending skilled nurse who provided the post nail bed removal care. Her testimony is at odds with the credible evidence presented by AHCA. Patient 13's HHC/POC, with a SOC date of December 21, 2010, ordered skilled nursing care one to two times a week for six weeks with specific skilled nursing tasks to be performed. There was no documentation that a skilled nurse provided care during the weeks of December 26, 2010, or January 9, 2011. Patient 13's HHC/POC also ordered a physical therapy evaluation. As part of the HHC/POC, the PT was to administer therapeutic home care exercises to increase functional strength, range of motion (ROM), balance and endurance, and transfers and to report "any changes and or concerns to [the] MD & RN CM [case manager] ASAP." Patient 13's physical therapy evaluation was not conducted until January 5, 2011, roughly two weeks after it was ordered. The physical therapy care plan directed that patient 13 was to be seen two times a week for the first week and three times a week for the next four weeks. Although there are "missed visit reports" that document a PT's attempt to see the patient on six different January 2011 dates, there is no credible evidence that patient 13's physician was notified of those six missed visits as soon as possible. Ms. Eubanks points to a January 24, 2011, C/S Report (January note) for the reason the PT missed the visits with patient 13. This January note reflects that patient 13 had gone to Georgia to be with her daughter and would return the end of January 2011 or the first Tuesday in February. This January note prompts more questions than answers because it does not reflect exactly when patient 13 went to Georgia and only asks that the "nursing services" not the physical therapy services be held until patient 13's return. The missed visit reports indicate that a PT went to the residence and knocked on patient 13's door, but no one came to the door. Although the missed visit reports provide space for the patient's name (appropriately redacted), the date (of service), the discipline (in this case "PT" was checked), the reason (for the missed service; in this case phrases to the effect: drove by, no one answered door, etc.), and who completed the missed visit report (the PT's signature is illegible), none of these missed visit reports have a checkmark (or any indication) next to the "Y," which signifies that the physician was notified. Ms. Eubanks's posturing that these missed visit reports were left in an inbox at a public housing building facility so that the physician was notified is not credible. Ms. Eubanks also testified that patient 13 did not have a telephone, and "so there was no other way to contact [her] but actual face to face." This statement is in direct contradiction to Faith Home's policy that a client must have a telephone or that a phone be close by for communication purposes. Further, there was evidence that two skilled nursing visits took place: one on January 26, 2011, and the other on January 29, 2011, just two and five days, respectively, after the January note stating patient 13 would be gone until the end of January or the first of February. Patient 2's HHC/POC, signed September 13, 2010, ordered skilled nursing visits to occur up to seven days a week, and the nurse was to provide a complete assessment with each shift. According to the HHC/POC, the skilled nurse was to, among other things, monitor patient 2's GI status and provide G-tube care every shift, weigh the child weekly on Mondays when scales became available, and document it in the mom's notebook. Based on patient 2's condition, care had to be taken that the patient did not become dehydrated or lose a lot of weight. There was no documentation of patient 2's weight being recorded by the Faith Home skilled nurses during the scheduled Monday visits. Patient 2's records provided to the surveyors during the February 2011 FH survey failed to reflect documentation as to any G-tube care being provided on every shift. Ms. Eubanks testified that patient 2 was weighed weekly at his school. Based on the phrase in the HHC/POC "when a scale becomes available," Faith Home took the position it was not obligated to secure a scale to ensure it weighed the patient per the HHC/POC. Rather, Faith Home unilaterally decided that, because the Department of Children and Families (DCF) was having patient 2 weighed weekly at school, Faith Home was meeting its obligation. However, this position flies in the face of the physician's order for patient 2. Patient 2's record does not reflect where patient 2's weight was being recorded, either at home or school, nor does it reflect that the physician was being made aware of patient 2's weight on a regular basis. Faith Home did not document the lack of a scale, did not inform the physician that the weight was being monitored by DCF at patient 2's school and did not ensure that the physician was aware of patient 2's weekly weight status. Patient 3's HHC/POC, signed November 30, 2011, ordered an RN to be present 20 hours a day up to seven days per week. Additionally, the skilled nurse was to assess the patient and perform other specific care. One specific task was for patient 3's tracheotomy care to be performed twice a day and as needed.7/ Documentation for patient 3 failed to reflect the tracheotomy care twice a day or as needed between December 20, 2010, and January 22, 2011. Ms. Eubanks testified to patient 3's medical circumstances. Although Ms. Eubanks understood that AHCA's surveyors had patient 3's pediatric notes, she only pulled "random notes" for the "period because they had already copied everything that they wanted to take." Of Faith Home's documents that she discussed, Ms. Eubanks only presented two dates (out of the 34 days alleged in the AAC) that recorded some type of tracheotomy care for patient 3. Hence, her testimony lacks credibility in light of the overwhelming evidence AHCA provided. Patient 6's HHC/POC for the certification period of October 14, 2010, to December 12, 2010, ordered skilled nursing care three to four times a week for nine weeks and also provided for specific disciplines and treatments to be performed. There was evidence that a skilled nurse provided one visit to patient 6 on October 15, 2010; yet, there was no evidence that a skilled nurse provided the minimum number of visits to patient 6 during the remainder of the nine-week certification period. It was noted that two skilled nursing visits were made during the week of November 14, 2010. However, the HHC/POC ordered a minimum of three, up to four skilled nursing visits to be made. Patient 6's HHC/POC also ordered HHA services to be provided two to three times a week for nine weeks. The HHA was to assist patient 6 with ADLs. The HHA failed to provide patient 6 the minimum number of visits during weeks one, two, or three of the certification period. Ms. Eubanks testified that Faith Home could not provide services to patient 6 after October 14, 2010, as patient 6 was admitted to a local hospital. Further, Ms. Eubanks testified that the HHA documentation "has to be incorrect," although she also testified that the Faith Home documents were "true. There has been an error."8/ Ms. Eubanks's testimony is at odds with the credible evidence presented by AHCA. Patient 14's HHC/POC dated January 20, 2011, ordered skilled nursing services to be provided one to two times a week for four weeks then every other week (EOW) for nine weeks. The HHC/POC also ordered that a HHA was to assist patient 14 with ADLs, a PT was to evaluate and treat patient 14, a speech therapist was to evaluate and treat patient 14, and an occupational therapist was to evaluate and treat patient 14. On January 25, 2011, patient 14's medical doctor again ordered the physical therapy and directed the HHA to provide services three times a week for nine weeks. The evidence regarding patient 14 documented two skilled nursing visits missed during the first two weeks of the certification period (January 16, 2011, to March 16, 2011), and there was no evidence of any HHA service visits for the first two weeks of patient 14's certification period. Additionally, patient 14 did not receive three physical therapy visits. Ms. Eubanks testified that patient 14 was in an adult day care setting and that Faith Home missed no less than four skilled nursing visits. The "Missed Visit" reports (MVR) provided by Faith Home purport that patient 14 was in an adult day care setting; yet, that same MVR documentation fails to record that patient 14's physician was notified of the lack of services being provided. Further, the MVR dated (Wednesday) January 26, 2011, reflects that patient 14's daughter "made arrangements to have [patient 14] home next on Thursday by 3 p.m. Understands nurse do [sic] not go to day care." This MVP reflects that the date of the next Faith Home service visit will be February 4, 2011, a Friday, not a Thursday. Also, within the material provided by Faith Home, there is a C/SR dated January 20, 2011. That C/SR records that patient 14 is "requesting a hold on home health aide visit. Daughter will be able to provide service for the next few weeks." Yet, there is also a HHA note dated January 22 or 23, 2011,9/ detailing HHA services provided to patient 14 on that date. The inconsistencies in Faith Home's documentation presented during the hearing are damaging to its credibility as a whole. Patient 15's HHC/POC, dated December 15, 2010, ordered skilled nursing services to be provided two to three times a week for nine weeks. As part of the skilled nursing services, patient 15 was to have her vital signs assessed along with other specific assessments. The HHC/POC also contained an order to "Report any changes or concerns to [the] MD & supervisor ASAP." The evidence presented regarding the skilled nursing visits for November 3 and 5, 2010, failed to reflect patient 15's neurological assessments or any observations by the nurse and also failed to provide the "nursing diagnosis/problem." Other portions to these specific records contain words or phrases to provide information, a number with a percentage sign, a zero (Ø), or simple checkmarks indicating a system was observed or treated. These written words or markings provide clarity to patient 15's completed assessments or status. Patient 15's skilled nursing records for December 29 and 31, 2010, and January 2, 12, and 14, 2011, failed to document one or more of the patient's systems: cardiovascular, genitourinary, neurological, or musculoskeletal. Ms. Eubanks testified that certain portions of patient 15's skilled nursing notes were completed using a method called "charting by exception." According to this method, when the professional leaves an area of the chart blank, it indicates that nothing is wrong with the patient. A review of patient 15's skilled nursing notes simply does not support the use of this methodology. Specifically as an example, on the November 5, 2010, skilled nursing visit note, nothing is checked or notated in the neuro-sensory section; yet, at the "PAIN" section, there is a "Ø" marked through all five lines. If the "charting by exception" method was being used, this area should have been left blank as there was no pain. It is impossible to determine when charting by exception is in place when one area of a record has check marks or specific notations regarding an assessment or status and another section (or sections) is left blank even though the HHC/POC specifically ordered that assessment. There is no base line by which the next skilled nurse would know if there had been a change in patient 15's assessment or status such that her attending physician or the supervisor should be appropriately notified. Ms. Eubanks's testimony is not credible in light of the evidence presented by AHCA. The June 2011 Follow up Survey Both parties presented medical records for Patient 2J. Patient 2J's two HHC/POCs appear to be identical in scope; yet, one was signed on April 25, 2011, while the other was signed on April 27, 2011. Within the HHC/POCs, the doctor ordered skilled nursing services to be provided once in the first week, then one to two times a week for eight weeks. As part of the skilled nursing services, patient 2J was to have her vital signs assessed and other specific assessments completed. The HHC/POCs also ordered a PT to evaluate and treat patient 2J. Ms. Eubanks testified that the PT evaluation was ordered on April 8, 2011, when it "came upon [sic] assessment." However, the HHC/POCs ordering the PT evaluation were not signed until April 25 or April 27, 2011. Patient 2J's actual physical therapy evaluation occurred on April 21, 2011, either four or six days before it was ordered. Faith Home either delayed 13 days in having the physical therapy evaluation completed, or Faith Home obtained a physical therapy evaluation prior to having a physician's order to provide the service. In either instance, Faith Home did not follow its own policies for providing services. Although the PT created a care plan for patient 2J, there is no physician's order directing the physical therapy care plan be used. Further, the physical therapy services were actually performed by a physical therapist assistant (PTA) and provided to patient 2J during weeks four, five, six, and seven of the certification period. An extra PTA visit was noted in week seven. Again, Faith Home provided services that were not in compliance with their own policies. Patient 3J had an April 5, 2011, order for physical therapy to be provided three times a week for six weeks based on her gait instability, her osteoarthritis in her knees, and her degenerative spinal joint disease. There was no evidence of any physical therapy being provided to patient 3J during the applicable certification period. Ms. Eubanks testified that patient 3J's actual care started in February 2011, despite the HHC/POC documentation that it started on March 24, 2011. Ms. Eubanks blamed a nursing supervisor for the wrong start date (March 24, 2011) and confirmed that the difference in start dates would make a difference in the dates of Faith Home services. Even if one were to accept the February 2011, order for physical therapy services, that order is incomplete because it fails to enumerate how many times a week and how many weeks the physical therapy services were needed. It is an incomplete order. Ms. Eubanks's testimony is not credible in light of the evidence presented by AHCA. Patient 4J's HHC/POC contained a SOC date of April 8, 2011. Therein it ordered skilled nursing services to be provided two to three times a week for nine weeks. As part of the skilled nursing services, patient 4J was to have her vital signs assessed along with other specific assessments. Additionally, the HHC/POC contained an order for a PT to evaluate and treat. Ms. Miller was unable to locate any documentation of home health services provided to patient 4J after May 5, 2011 (four missed visits), and there was no evidence that any physical therapy services were provided to patient 4J. Ms. Eubanks testified that patient 4J was in the hospital when Faith Home services were not provided to patient 4J. Although Ms. Eubanks relied on a discharge instruction sheet to make the claim, there is no date on the discharge instruction sheet, and no one testified as to the exact date that patient 4J was admitted to or discharged from the hospital. Ms. Eubanks's testimony is not credible as it relied on an undated discharge instruction sheet. Further, although the physical therapy referral for patient 4J was faxed to the physical therapy agency, that agency never received the referral and never provided the service. Faith Home failed to have a system in place to ensure services ordered by the physician were obtained. Ms. Okpaleke, as the owner of Faith Home, engaged an expert to help Faith Home "correct all the cites . . . and implement a plan of correction . . . to make sure that we were in compliance." Ms. Okpaleke terminated the expert's employment after the summer. Ms. Okpaleke then started monitoring Faith Home's practices and ensured that Faith Home returned to compliance with AHCA's regulations. Ms. Miller's salary at the time of the FH survey was $20.15. Ms. Miller expended approximately 30 hours in conducting the recertification survey of Faith Home. Based on her rate of pay, AHCA expended $1,370.20 for Ms. Miller's services. Ms. Peabody's salary while employed by AHCA during the FH survey was $21.07 an hour. Ms. Peabody expended approximately 42 hours preparing for, conducting, and completing the FH survey. Based on her rate of pay, AHCA expended $1,048.23 for Ms. Peabody's services. Mr. Bronson Sievers is the health facility evaluator supervisor for AHCA. His salary is $19.87 an hour. Mr. Sievers expended approximately ten hours reviewing the statement of deficiencies to determine if the appropriate citations had been used and the appropriate penalty assessed. Based on his rate of pay, AHCA expended $198.70 for Mr. Sieivers services. Mr. Sievers responsibility included the supervision of several AHCA programs and included the home health agencies. Mr. Sievers determined that the repeated violation warranted a Class III violation, which resulted in a $1,000.00 fine because it may affect the clients' well-being and health. Mr. Sievers provided AHCA's interpretation of the fine imposed when a home health agency demonstrates a pattern of failing to provide the specified services to its clients or patients.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner, Agency for Health Care Administration, enter a final order finding that Faith Home: Violated section 400.484 by committing a Class III violation as identified during the February 2011 survey and found again during the June 2011 survey and imposing an $1,000.00 administrative fine; Violated section 400.474(5) as found in no less than 107 instances when Faith Home failed to provide services ordered by an appropriate authority and imposing a $45,000.00 administrative fine; and Pursuant to section 400.484(3), AHCA shall assess and receive $2,617.13 for the investigation costs associated with this case as evidenced by the time expended by the three agency witnesses. DONE AND ENTERED this 19th day of April, 2012, in Tallahassee, Leon County, Florida. S LYNNE A. QUIMBY-PENNOCK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 19th day of April, 2012.

Florida Laws (10) 120.569120.57400.462400.464400.474400.484400.487400.492400.497408.811 Florida Administrative Code (2) 59A-8.00359A-8.0215
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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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