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.
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.
The Issue Whether the applications for certificates of need to establish Medicare-certified home health agencies filed by Aaction Home Health Care, Inc. (Aaction) and Nursing Unlimited 2000, Inc. (Nursing Unlimited), on balance, satisfy the applicable review criteria so as to entitle either or both to award of a certificate of need.
Findings Of Fact The Applicants Nursing Unlimited 2000, Inc., was formed for the purpose of obtaining a certificate of need for a Medicare certified home health agency, and to serve as the entity into which would be merged certain existing licensed non-Medicare certified home health agencies in Dade County. Aida Salazar-Rebull is a co- founder, director, officer, and shareholder of Nursing Unlimited, and she currently owns, operates, and serves as the administrator of LTC Professional Consultants, Inc. (LTC), a licensed non- Medicare certified home health agency in Dade County. Ms. Salazar will serve as Nursing Unlimited’s administrator, and after CON approval will merge LTC into Nursing Unlimited and continue its current operations. Elia Murias is also a co- founder, director, and shareholder of Nursing Unlimited, and she currently owns and operates Nursing Love & Care, a licensed non- Medicare certified home health agency in Dade County. Upon CON approval, Ms. Murias, a registered nurse, will serve as Nursing Unlimited’s director of nursing, and will merge the operations of Nursing Love & Care into Nursing Unlimited. For the past 12 years LTC has provided home health care services directly to Medicaid and private pay patients, and to Medicare patients through contracts with Medicare certified agencies. LTC is accredited by the Joint Commission on Accreditation of Health Care Organizations (JCAHO), which accreditation will be transferred to Nursing Unlimited. Since its inception, the number of patients served by LTC has increased every year. LTC enjoys an excellent reputation among local health care providers and patients. LTC’s continual growth over the past ten years, coupled with the letters of support in the application, demonstrate a record of providing high quality care to underserved communities and population subgroups. LTC currently provides home health services in northwest, west central, central, and east central Dade County, and as Nursing Unlimited will serve the same geographic area. LTC places particular emphasis on its service to underserved population subgroups such as Hispanics, Haitians, Blacks, low-income clients, and HIV-positive patients. Nursing Unlimited will continue to serve those population subgroups. Although approximately 53 percent of the Dade County population is Latin, only two of the over 30 existing Medicare certified home health agencies are Latin owned and operated. LTC and Nursing Love & Care are Latin owned and operated, as would be Nursing Unlimited. The entire staff of LTC is bilingual, and some staff are multi-lingual, as would be the staff of Nursing Unlimited. Approval of Nursing Unlimited's application would enhance the availability and accessibility of services to the Latin community. Aaction Home Health Care, Inc. (Aaction), is an existing home health care agency providing services in Dade County since approximately 1988. Like Nursing Unlimited, Aaction's target population is the Hispanic community of Miami and Hialeah. The geographical area which Aaction now serves and will continue to serve at an enhanced level, if approved, is a low- income, high crime and low education area. Aaction's success in those difficult areas is based on its ability to recruit and retain indigenous staff who know the problems. Over 30 letters of recommendation and support, mostly from Hispanic physicians, are attached to Aactions's application and attest to the agency's past and anticipated future service in the community. Aaction has applied for JCAHO accreditation. Need Analysis The review of CON applications must be in context with the criteria set forth in Section 408.035(1), Florida Statutes. Pursuant to the parties’ prehearing stipulation, both applicants satisfy all of the applicable review criteria, except this: The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing home health care services in District 11. Section 408.035(1)(b), Florida Statutes. Aaction and Nursing Unlimited both contend there is a need in District 11 for at least two new or additional Medicare certified home health agencies. Each asserts that both CON applications can and should be approved; their respective applications are not mutually exclusive, and accordingly, they need not be comparatively reviewed with one another. The focus of the sole remaining criterion at issue, Subsection 408.035(1)(b), is on existing home health care providers. As acknowledged by AHCA in its State Agency Action Report (SAAR), in pure numbers the instant CON application proposals would increase availability and access in District 11. There is no AHCA rule formula or methodology to determine a numeric need, nor is there a fixed need pool applicable to this proceeding. In the absence of an Agency numeric need rule, the applicants each proposed reasonable need methodologies within their applications. AHCA did not propose any need methodology at hearing. AHCA's former home health agency numeric need methodology rule was invalidated because it was anti-competitive, understated potential actual need, and failed to consider health care economics, efficiency and cost containment. Principal Nursing v. AHCA, DOAH No. 93-5711RX (Final Order January 26, 1994); AHCA v. Principal Nursing Services, Inc., 650 So. 2d 1113 (Fla. 1st DCA 1995) (Affirmed the Final Order as to the need methodology, but reversed as to other portions of the rule unrelated to the issues here). Nursing Unlimited, through Michael Schwartz, applied the invalidated need methodology to demonstrate that even under that excessively conservative approach, at least 2 additional home health agencies are needed in District 11. When the applications were filed the most current home health visit utilization data was for calendar year 1994. The number of visits in 1994 was divided by the age 65+ population to determine a use rate, i.e., the number of home health visits per 100,000 population. The 1994 use rate was applied to the projected age 65+ population growth for the three horizon years of 1995-1997, a projection of 102,039 more patient visits in 1997 than there were in 1994, based on population growth alone. Next, Mr. Schwartz determined a cost-efficient agency size (CEAS) by determining from a review of District 11 existing home health agencies the point at which the average cost per home health visit was less than the statewide average cost per visit. In this case, the result was a CEAS of 34,973, which was divided into the number of projected new visits in the horizon year 1997 resulting from population growth alone, which calculation shows a numeric need for three new home health agencies in District 11. At the time the CON application was filed there was one approved, but not yet licensed home health agency, which was subtracted by the applicant from the net need figure, thus resulting in a net need for two new agencies. The recent historical data shows that home health care visits have been on the increase, both in terms of visits per 100,000 population and in terms of visits per patient. The amount of time spent by patients in the hospital is decreasing, which translates into increased need by patients for visits from home health agencies. The need for home health will continue to increase because it is a cost-effective alternative to nursing home placement and hospital care. Home health care services are less costly than care received in hospitals, in nursing homes, or on an outpatient basis. Thus, allowing greater access to home health services should reduce the overall cost of health care to payors, including Medicare. To address this trend Michael Schwartz offered a realistic, yet still conservative, numeric need projection which assumes an increased use rate beyond that which is based on population increase alone. Mr. Schwartz considered the cumulative increase in visits that occurred over the three-year period 1991-1994 and projected this forward to the horizon year of 1997. Although federal Health Care Finance Agency (HCFA) data suggests that visits will grow nationally at seven percent per year. Mr. Schwartz assumed only a seven percent increase over three years, which resulted in a growth of approximately 180,124 visits by 1997, and which divided by the CEAS yields a need for 5.2 new agencies. In hindsight, the conservative nature of this projection is apparent from a review of utilization data which has become available since the filing of the CON application. For example, rather than a growth in visits of 180,000 over the period 1995-1997, there was an actual increase of over 410,000 visits in 1995 and 1996 alone. Utilization data for 1997 is not yet available. Aaction presented three separate need methodologies in its application prepared by Mark Richardson. The first two methodologies applied a static use rate based on visits in 1994 to the projected population to determine total visits at the planning horizon. Recognizing that cost efficiencies maximize at an approximate range between 30,000 and 90,000 visits per year, Aaction divided the total projected visits by a conservative CEAS of 50,000. These methodologies yielded a need in District 11 for two additional home health agencies at the planning horizon. Using a CEAS of 30,000 visits would yield a need for three agencies instead of two. AHCA has recently determined that static use rates are inappropriate. (Allstar Care, Inc., etc. vs. AHCA, DOAH No. 96-4064, Final Order November 4, 1997). Nonetheless, application of over-conservative methodologies in this case can help counter the agency's unsubstantiated assertion that many visits are fraudulent or unnecessary. In its third methodology, Aaction assumed more realistically that home health use rates would continue to increase as suggested by historic data. In order not to overstate the potential growth rate, Aaction used a rate equal to one-half of the 1993-94 actual growth rate. Utilizing a 50,000 visit CEAS, this methodology yields a need of 7 to 9 new home health agencies in District 11 at the planning horizon. Using a 30,000 visit CEAS yields a net need for over 15 new home health agencies. Recalculating the need formulas by application of the now available 1995 and 1996 data, using a growth rate at 50 percent of the actual rate, and a CEAS of 50,000 visits, results in a need for 7 to 8 new agencies. If the static use rate were applied, the need would be 5 to 6 new agencies. Application of Aaction’s initial need methodologies with a static use rate based on 1996 utilization data yields a need for over 5 new agencies when a 50,000 visit CEAS is used. If a 30,000 visit CEAS is utilized, these methodologies yield a net need for 9 new home health agencies. Applying Aaction’s third methodology (i.e., utilization projected to increase at 50 percent of the actual increase between 1995 and 1996) yields a net need for over 7 or over 12 new agencies, depending on whether a 50,000 visit or 30,000 visit CEAS is applied. There are other indications of need for additional home health agencies in District 11. For example, a review of 1996 utilization data reveals that District 11 has only 1.7 home health agencies per 100,000 population, which is the lowest ratio of any district in the state. The average of all districts is 2.4 home health agencies per 100,000 population. Both applicants proposed fair and reasonable need methodologies which demonstrate a need in District 11 for at least 2 additional home health agencies, and potentially more. There is, therefore, a need for at least 2 more Medicare- certified home health agencies in District 11. Approval of both applications will increase the availability and accessibility of home health services in the proposed service areas within Dade County. Home health services are typically delivered in close proximity to the location of the agency and providers. Nursing Unlimited’s agency location is in the center of a large Latin and Haitian population, with the nearest Medicare certified home health agency approximately 15 miles away. Aaction's commitment is to a population that is difficult to serve. Local population accessibility to the proposed home health services would be increased by approval of both applications. Medicare-certified agencies apply their own admission criteria and decide whether to accept patients, leaving some patients in need and without access to services in the applicants' service area. An informal survey directed by Michael Schwartz suggests there are existing agencies which refuse to treat AIDS patients, that do not provide services at night and on weekends, and that refuse to treat people in poverty areas. The targeted Medicare-eligible population would enjoy enhanced accessibility and availability of home health services by both applicants, if approved. The addition to the district of a Medicare-certified home health agency (Nursing Unlimited) which utilizes a JCAHO- approved centralized case management system would also tend to enhance the availability, accessibility, and adequacy of services provided in the district. When non-Medicare-certified agencies receive a request to care for Medicare patients, the request must be forwarded to a Medicare-certified entity, which in turn will contact the patient. The non-Medicare agency may then be authorized under subcontract to contact and serve the patient and to bill the Medicare-certified agency for its services. In turn, the Medicare-certified agency will add on its overhead and forward a higher bill to Medicare. This process also results in delays in patient treatment. Approval of these applications would likely result in better patient care, without delays, and at lower costs. AHCA has determined that eliminating such subcontract arrangements will eliminate an unnecessary level of administrative costs. AHCA also discourages subcontract arrangements which remove direct control of patient care from the Medicare certified entity. See Allstar Care, supra. District 11 home health visits increased by 410,000 visits in 1995 and 1996. A projection of 600,000 new visits during 1995 through 1997 is reasonable. Nursing Unlimited and Aaction each project approximately 25,000 visits during their second year of operation. Approval of these applicants would not adversely impact the utilization of existing home health providers in the district. Both applicants here will specifically enhance access by the needy Hispanic population. AHCA offered no competent evidence to contradict the conclusions of the applicants' experts, nor did it effectively challenge the accuracy, validity, or reliability of the methodologies they employed. AHCA's expert and sole witness, James McLemore, is an application review specialist who candidly admitted he has no experience in the development of need methodologies but relies instead on the expertise of health care planners such as Mr. Schwartz or Mr. Richardson. Mr. McLemore's anecdotal testimony regarding fraudulent or phantom visits, and AHCA's concern that both state and federal agencies are investigating fraud in the home health care business, raise compelling licensing issues but are insufficient to defeat otherwise convincing evidence in favor of these certificates of need.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the Agency for Health Care Administration enter its final order granting CON No. 8428 to Nursing Unlimited 2000, Inc. and CON No. 8432 to Aaction Home Health Care, Inc. DONE AND ORDERED this 22nd day of December, 1997, in Tallahassee, Leon County, Florida. MARY CLARK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of December, 1997. COPIES FURNISHED: Michael Manthei Broad and Cassel 1130 Broward Financial Center 500 East Broward Boulevard Fort Lauderdale, Florida 33394 Moses E. Williams Office of the General Counsel Agency for Health Care Administration Fort Knox Building 3, Suite 3400 2727 Mahan Drive Tallahassee, Florida 32308-5403 R. David Prescott Ruthledge Ecenia Underwood Purnell and Hoffman, P.A. Post Office Box 551 Tallahassee, Florida 32302-0551 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
Conclusions Having reviewed the Notice of Intent to Impose Fine dated March 3, 2009, attached hereto and incorporated herein (Ex. 1), and all other matters of record, the Agency for Health Care Administration ("the Agency") has entered into a Settlement Agreement (Ex. 2) with the Respondent and being otherwise well-advised in the premises, finds and concludes as follows: ORDERED: The attached Settlement Agreement is approved and adopted as part of this Final Order, and the parties are directed to comply with the terms of the Settlement Agreement. Each party shall bear its own costs and attorney's fees. The Respondent shall remit to the Agency, within ninety (90) days of this Final Order, the sum of Two Thousand Dollars ($2,000.00). A check should be made payable to the "Agency for Health Care 1 Filed November 9, 2009 11:58 AM Division of Administrative Hearings. Administration." The check, along with a reference to this case number, should be sent directly to: Agency for Health Care Administration Office of Finance and Accounting Revenue Management Unit 2727 Mahan Drive, MS # 14 Tallahassee, Florida 32308 Unpaid amounts will be subject to statutory interest and may be collected by all methods legally available. The above-styled case is hereby closed. DONE and ORDERED this s3 day o tJ-?t?<: ,2009, in Tallahassee, Leon County, Florida. Care Administrat1 A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW OF PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: Ann Lisenby Parmer Lisenby Home Care, Inc. 412 North Cove Blvd. Panama City, Florida 32401 (U. S. Mail) Shaddrick A. Haston Assistant General Counsel Agency for Health Care Administration 2727 Mahan Drive, Bldg #3, MS #3 Tallahassee, Florida 32308 (Interoffice Mail) Jan Mills Agency for Health Care Administration 2727 Mahan Drive, Bldg #3, MS #3 Tallahassee, Florida 32308 (Interoffice Mail) Finance & Accounting Agency for Health Care Administration 2727 Mahan Drive, Bldg #2 Mail Stop Code #14 Tallahassee, Florida 32308 (Interoffice Mail) CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of this Final Order was served on the above-named person(s) and entities by U.S. Mail, or the method designated, on this _6ay of /}6 , 2009. Richard Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Building #3 Tallahassee, Florida 32308-5403 (850) 922-5873 Ce1t1f1ecl Article Number SENDERS RECORD CHARLIE CRIST GOVERNOR March 3, 2009 ANN LISENBY PARMER LISENBY HOME CARE, INC. 412 N COVE BLVD PANAMA CITY, FL 32401 JFlORl AAGENCY F,OR HIcAl.lCH CARE AOMAINISlllATION Better Health Care for all Floridians oqJ521 CASE #: 2009002407 NOTICE OF INTENT TO IMPOSE FINE Pursuant to Section 400.474 (6) (f), Florida Statutes (F.S.), a fine of $5,000 is hereby imposed for failure to submit the home health agency quarterly report within 15 days after the quarter ending September 30. As required in section 400.474(6) (f), F.S., the agency shall impose a fine of$ 5,000. TO PAY NOW, PAYMENT SHOULD BE MADE WITHIN 21 DAYS AND MAil.ED WITH A COPY OF THIS NOTICE OF INTENT TO: Agency for Health Care Administration Finance and Accounting, Revenue Section OMCManager 2727 Mahan Drive, MS #14 Tallahassee, FL 32308 Include License Number: 20651096 and Case Number: 2009002407 in check memo field. EXPLANATION OF RIGHTS Pursuant to Section 120.569, F.S., you have the right to request an administrative hearing. In order to obtain a formal proceeding before the Division of Administrative Hearings under Section 120.57(1), F.S., your request for an administrative hearing must conform to the requirements in Section 28-106.201, Florida Administrative Code (F.A.C), and must state the material facts you dispute. SEE ATTACHED ELECTION OF RIGHTS FORM. Agency for Health Care Administration By: Anne Menard, Manager Home Care Unit cc: Agency Clerk, Mail Stop 3 Legal Intake Unit, Mail Stop 3 2727 Mahan Drive,MS#34 Tallahassee. Florida 32308 Visit AHCA online at http://ahca.myfl · • I EXHIBIT I No Theme Page 1 ofl HOME HEALTH AGENCY QUARTERLY REPORT For the Quarter July 1 to September 30, 2008 Send an e-mail with this information to home.ti_ alth@ahca.myflorida.com by 5 p.m. on Wednesday, October 15, 2008 to avoid a $5,000 fme. NAME OF HOME HEALTH AGENCY Lisenby home Care, Inc LICENSE# 20651096 STREET ADDRESS & CITY: 412 N. Cove Blvd, Panama City, Fl 32401 On September 30, 2008, there were _3_ insulin-dependent diabetic patients receiving insulin injection services from my home health agency. On September 30, 2008 there were _36_ patients receiving home health services from my home health agency AND licensed hospice services. On September 30, 2008, there were a total of_77_ patients receiving home health services from my home health agency. The following professional nurses (RNs or LPNs), whose primary job responsibility is to provide home health services to patients, received remuneration from my home health agency in excess of $25,000 between July 1, 2008 and September 30, 2008. NONE Name Florida License Number Insert additional names and license numbers if necessary. http://webmail.att.net/wm/en-US/toolbar/advnotheme.html 10/2/2008 psPS - Track & Confirm Page 1 of 1 • !:fQ!DtltltlJllSlgn.J.n Track & Confirm Search Results Label/Receipt Number: 7160 3901984813801355 Status: Delivered Your item was delivered at 9:48 AM on March 19, 2009 in PANAMA CITY, FL 32401. Track &Confirm Enter Label/Receipt Number. N..-o---t-i--f-i-·c-··d·-·o·-·n- - -Q. rn·t·i01J$------- ---- Track & Confirm by email Get current event information or updates for your item sent to you or others by email. (Bo>) Return Receipt (Electronic) Verify who signed for your item by email. ( tJo>) Copyright© 1999-2007 USPS. All Rights Reserved. No FEAR Act EEO Data FOIA '\:,_· J-i t;.-,pe ; :;•,· • l.\!!.'-'l·/•. ;- t' ip!;,,; http://trkcnfrm1.smi.usps.com/PTSinternetWeb/InterLabellnquiry.do 03/24/2009 STATE OF FLORIDA
Conclusions Having reviewed the Notice of Intent to Deny the renewal license application for a home health agency, attached hereto and incorporated herein (Ex. 1), and other matters of records, the Agency for Health Care Administration ("Agency") finds and concludes as follows: By Order dated August 26, 2008, the Administrative Law Judge closed its files in the above-styled case. Petitioner filed a status report withdrawing the application for renewal oflicense on August 20, 2009, attached hereto and incorporated herein (Ex. 2). The denial of the renewal application for Petitioner home health agency is upheld and the application for license renewal has been withdrawn. Upon consideration of the foregoing, it is ORDERED that the Agency's file is hereby closed. DONE and ORDERED at Tallahassee, Leon County, Florida this ffj day of ,2009. A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW PROCEEDING SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN THIRTY (30) DAYS OF THE RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: Monica L. Rodriguez Attorney for Petitioner Dresnick & Rodriguez, P.A. One Datran Center 91 South Dadeland Blvd, Suite 1610 Miami, Florida 33156 (U.S. Mail) Nelson E. Rodney Assistant General Counsel Agency for Health Care Administration 8350 NW 52nd Terrace, Suite #103 Miami, Florida 33166 (Interoffice Mail) Home Care Unit Agency for Health Care Administration' 2727 Mahan Drive, MS #34 Tallahassee, Florida 32308 (Interoffice Mail) Stuart M. Lerner Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (U.S. Mail) Jan Mills Agency for Health Care Administration 2727 Mahan Drive, Bldg #3, MS #3 Tallahassee, Florida 32308 2 (Interoffice Mail) CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true copy of the foregoing was sent to the above-named addressees by U.S. Mail, or the method designated, on thisLday of s5xpf 009. Richard Shoop. Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Building 3 Tallahassee, Florida 32308-5403 (850) 922-5873 3 CHARLIE CRIST GOVERNOR June 23, 2008 Kelly Marie Damas, Admin istrator- 1 / / ·.:;, '. TEHC LLC '- -...· , .. ' ' 3317NW10thTerrSte404 i' r:;_'.'./fl Fort Lauderdale, Fl 33309 J:.:·:>r 1.< \ ii{;;_ License Number: 204390961 Case#: 2008007748 NefltE't)iKIN1'ENT:·q,oDENY It is the decision of this Agency that the application for renewal licensure as a home health agency, for TEHC, LLC., located at 3317 NW 10th Terrace, Suite 404, Fort Lauderdale, Fl 33309, is DENIED. The basis for this action is pursuant to authority of Section 120.60 Florida Statutes (F.S.) and Section 408.815 (1), (c) and (d), F.S. which states as follows: (1) In addition to the grounds provided in authorizing statutes, grounds that may be used by the agency for denying and revoking a license ... include any of the following actions by a controlling interest: A violation of this part, authorizing statutes, or applicable rules. A demonstrated pattern of deficient performance. The home health agency did not demonstrate compliance with Chapter 400, Part III, F.S. and the state home health agency rules, Chapter 59A-8, Florida Administrative Code (F.A.C.) at the home health agency licensure survey conducted Mr..y 5 through May 8, 2008. The plan of correction due June 7, 2008 as submitted to the Agency's Field Office was not acceptable. Non compliance was found in the following areas: The home health agency failed to ensure the Director of Nursing established and conducted an on-going quality assurance _program that evaluated the effectiveness of all the provided service for consistency with professional standards and anticipated outcomes. (H 224) The pertinent statutes and rules that apply include the following: 59A-8.0095(2) (c), F.A.C. "Director of Nursing: (c) The director of nursing shall establish and conduct an ongoing quality assurance program which assures: 2727 Mahan Drive,MS#34 Tallahassee, Florida 32308 EXHIBIT j Visit AHCA Online at http://ahca.myflo rida.com 'Tehc LLC Page 2 · ·-:June 23;·2008· Case assignment and management is appropriate, adequate, and consistent with the plan of care, medical regimen and patient needs; Nursing and other services provided to the patient are coordinated, appropriate, adequate, and consistent with plans of care; All services and outcomes are completely and legibly documented, dated and signed in the clinical service record; Confidentiality of patient data is maintained; and Findings of the quality assurance program are used to improve services." The home health agency failed to ensure that the Registered Nurse (RN)provide case management for 5 of 17 nursing and therapy patients. This was evidenced by: failure to provide an assessment prior to documenting a start of care comprehensive assessment for one patient; failure to provide supervision for the Licensed Practical Nurse (LPN) in the performance of duties for two patients and failure to assure progress reports were made to the physician for patients receiving nursing services when the patient's condition changed for two patients. The pertinent statutes and rules that apply include the following: 59A-8.0095 (3) (a), F.A.C. "Registered Nurse. A registered nurse shall be currently licensed in the state, pursuant to Chapter 464, F.S., and: Be the case manager in all cases involving nursing or both nursing and therapy care. Be responsible for the clinical record for each patient receiving nursing care; and Assure that progress reports are made to the physician for patients receiving nursing services when the patient's condition changes or there are deviations from the plan of care." The home health agency failed to ensure that the RN retained full responsibility for the care given and making supervisory visits to the patient's home for 3 of 17 sampled patients as evidenced by failure to provide supervision for the LPN in the performance of duties for two patients; failure to provide supervision for the Home Health Aide (Aide) and failed to prepare a written Aide assignment/instructions for services to be provided to the patient for 3 patients. (H 231) The pertinent statutes and rules that apply include the following: 59A-8.0095 (3) (b), F.A.C., "Registered Nurse. A registered nurse may assign selected portions of patient care to licensed practical nurses and home health aides but always retains the full responsibility for the care given and for making supervisory visits to the patient's home." The home health agency failed to provide supervision for the LPN in the perfonnance of duties for 2 of 17 patients. (H 235) Tebc LLC Page 3 --+---- ----:June-23--;-2008·--------- ·-- --------- --- The pertinent statutes and rules that apply include the following: 59A-8.0095 (4) (a), F.A.C., "Licensed Practical Nurse. A licensed practical nurse shall be currently licensed in the state, pursuant to Chapter 464, F.S., and provide nursing care assigned by and under the direction of a registered nurse who provides on-site supervision as needed, based upon the severity of patients medical condition and the nurse's training and experience. Supervisory visits will be documented in patient files. Provision shall be made in agency policies and procedures for annual evaluation of the LPN's performance of duties by the registered nurse." The home health agency failed to ensure the LPN reported any changes in the patient's condition to the RN and document the changes in the patient's clinical record for 1 of 17 sampled patients. (H 236) The pertinent statutes and rules that apply include the following: 59A-8.0095 (4) (b), F.A.C., "Licensed Practical Nurse A licensed practical nurse shall: Prepare and record clinical notes for the clinical record; Report any changes in the patient's condition to the registered nurse with the reports documented in the clinical record; Provide care to the patient including the administration of treatments and medications; -------and --- , ---------------- , -------------, ------------------ -------------·· Other duties assigned by the registered nurse, pursuant to Chapter 464, F.S." The home health agency failed to ensure that the care provided followed the plan of treatment for 11 of 17 sampled patients. The home health agency also failed to ensure a verbal order obtained by a home health agency nurse was put into writing and signed by the attending physician for 1 of 17 sampled patients. (H 302) The pertinent statutes and rules that apply include the following: Section 400.487 (2) F.S., "When required by the provisions of chapter 464; part I, part III, or part V of chapter 468; or chapter 486, the attending physician, physician assistant, or advanced registered nurse practitioner, acting within his or her respective scope of practice, shall establish treatment orders for a patient who is to receive skilled care. The treatment orders must be signed by the physician, physician assistant, or advanced registered nurse practitioner before a claim for payment for the skilled services is submitted by the home health agency. If the claim is submitted to a managed care organization, the treatment orders must be signed within the time allowed under the provider agreement. The treatment orders shall be reviewed, as frequently as the patient's illness requires, by the physician, physician assistant, or advanced registered nurse practitioner in consultation with the home health agency." 'Tehc LLC Page 4 _June 2},-200&------- ----- Chapter 59A-8.0215(2), F.A.C., "Home health agency staff must follow the physician, physician assistant, or advanced registered nurse practitioner's treatment orders that are contained in the plan of care. If the orders cannot be followed and must be altered in some way, the patient's physician, physician assistant, or advanced registered nurse practitioner must be notified and must approve of the change. Any verbal changes are put in writing and signed and dated with the date of receipt by the nurse or therapist who talked with the physician, physician assistant, or advanced registered nurse practitioner's office." The home health agency failed to ensure 9 of 17 patients were advised of the payment for home health agency services before care was started and were clear about the payor source and any charges required from the patient. (H 304) The pertinent statutes and rules that apply include the following: Section 400.487 (1), F.S., "Services provided by a home health agency must be covered by an agreement between the home health agency and the patient or the patient's legal representative specifying the home health services to be provided, the rates or charges for services paid with private funds, and the sources of payment, which may include Medicare, Medicaid, private insurance, personal funds, or a combination thereof. A home health agency providing skilled care must make an assessment of the patient's needs within 48 hours after the start of services." Chapter 59A-8.020 (2), F.A.C., "At the start of services a home health agency must establish a written agreement between the agency and the patient or client or the patient's or client's legal representative, including the information described in Section 400.487(1), F.S. This written agreement must be signed and dated by a representative of the home health agency and the patient or client or the patient's or client's legal representative. A copy of the agreement must be given to the patient or client and the original must be placed in the patient's or client's file." Chapter 59A-8.020 (3), F.A.C., "The written agreement, as specified in subsection (2) above, shall serve as the home health agency's service provision plan, pursuant to Section 400.491(2), F.S., for clients who receive homemaker and companion services or home health aide services which do not require a physician, physician assistant, or advanced registered nurse practitioner's treatment order. The written agreement for these clients shall be maintained for one year after termination of services." The home health agency failed to demonstrate effective communication between interdisciplinary team members to coordinate services as outlined in the plan of care for 3 of 17 'patients and failed to ensure that 8 of 17 sampled patients received the skilled nursing services in accordance with the physician's VvTitten plan of care. (H 306) The pertinent statutes and rules that apply include the following: 'Tehc LLC Page 5 --·-- June 23, 20-08 ··· - ----- Section 400.487 (6), F.S., "Tl1e skilled care services provided by a home health agency, directly or under contract, must be supervised and coordinated in accordance with the plan of care." The home health agency failed to ensure the registered nurse completed the initial evaluation visit for 1 of 17 patients. The Director of Nursing who signed the initial evaluation visit never made a home visit to the patient. (H 307) The pertinent statutes and rules that apply include the following: 59A-8.008 (1), F.A.C.., "In cases of patients requiring only nursing, or in cases requiring nursing and physical, respiratory, occupational or speech therapy services, or nursing and dietetic and nutrition services, the agency shall provide case management by a licensed registered nurse directly employed by the agency.'' The home health agency failed to provide written notice for tenninating home health services to 1 of 3 sampled patients. There was no written notification regarding the date of termination; reason for termination or a referral to another agency with a plan for continued services prior to the termination. (H 316) The pertinent statutes and rules that apply include the following: Chapter 59A-8.020 (4), F.A.C., "When the agency terminates services for a patient or client needing continuing home health care, as determined by the patient's physician, physician assistant, or advanced registered nurse practitioner, for patients receiving care under a physician, physician assistant, or advanced registered nurse practitioner's treatment order, or as determined by the client or caregiver, for clients receiving care without a physician, physician assistant, or advanced registered nurse practitioner's treatment order, a plan must be developed and a referral made by home health agency staff to another home health agency or service provider prior to termination. The patient or client must be notified in writing of the date of termination, the reason for termination, pursuant to Section 400.491, F.S., and the plan for continued services by the agency or service provider to which the patient or client has been referred, pursuant to Section 400.497(6), F.S. This requirement does not apply to patients paying through personal funds or private insurance who default on their contract through non-payment. The home health agency should provide social work assistance to patients to help them determine their eligibility for assistance from government funded programs if their private funds have been depleted or will be depleted." The home health agency failed to develop a plan of care for 6 of 17 sampled patients that included all of the required items needed to appropriately serve patients including goals to support the physician's treatment orders, level of staff to provide the services to reach the goals, and the frequency of visits to conduct the services by appropriate home health agency staff. (H 320) Tehc LLC Page 6 -June 23, 2008 The pertinent statutes and rules that apply include the following: Section 400.487 (2). f.S., "When required by the provisions of chapter 464; part I, part III, or part V of chapter 468; or chapter 486, the attending physician, physician assistant, or advanced regis1ered nurse practitioner, acting within his or her respective scope of practice, shalJ establish treatment orders for a patient who is to receive skilled care " Chapter 59A-8.0215 (1), F.A.C., "A plan of care shall be established in consultation with the physician, physician assistant, or advanced registered nurse practitioner, pursuant to Section 400.487, F.S., and the home health agency staff who are involved in providing the care and services required to carry out the physician, physician assistant, or advanced registered nurse practitioner's treatment orders. The plan must be jncluded in the clinical record and available for review by all staff involved in providing care to the patient. The plan of care shall contain a list of individualized specific goals for each skilled discipline that provides patient care, with implementation plans addressing the level of staff who will provide care, the frequency of home visits to provide direct care and case management." The home health agency failed to demonstrate evidence that patients were informed in advance about any changes to the plan of care prior to implementation of the changes for 1 of 17 patients. (H 321) The pertinent statutes and rules that apply include the following: Chapter 59A-8.0215 (3), F.A.C., "The patient, caregiver or guardian must be informed by the home health agency personnel that: He has the right to be informed of the plan of care; He has the right to participate in the development of the plan of care; and He may have a copy of the plan if requested." The home health agency failed to maintain a clinical record in accordance with accepted professional standards for 12 of 17 patients. (H 350) The pertinent statutes and rules that apply include the following: Section 400.491 (1), F.S,, "The home health agency must maintain for each patient who receives skilled care a clinical record that includes pertinent past and current medical, nursing, social and other therapeutic information, the treatment orders, and other such information as is necessary for the safe and adequate care of the patient. When home health services are terminated, the record must show the date and reason for termination " 'Tehc LLC Page 7 June 23,-2008 The home health agency failed to include all of the required items in the discharged patient clinicai records for 3 of 3 patients. There were no tem1ination summaries as required. (H 356) The pertinent statutes and rules that apply include the following: Chapter 59A-8.022(5), F.A.C., "Clinical records must contain the following: Source ofreferral; Physician, physician assistant, or advanced registered nurse practitioner's verbal orders initiated by the physician, physician assistant, or advanced registered nurse practitioner prior to start of care and signed by the physician, physician assistant, or advanced registered nurse practitioner as required in Section 400.487(2), F.S. Assessment of the patient's needs; Statement of patient or caregiver problems; Statement of patient's and caregiver's ability to provide interim services; Identification sheet for the patient with name, address, telephone number, date of birth, sex, agency case number, caregiver, next of kin or guardian; Plan of care or service provision plan and all subsequent updates and changes; Clinical and service notes, signed and dated by the staff member providing the service which shall include: Initial assessments and progress notes with changes in the person's condition; Services rendered; Observations; Instructions to the patient and caregiver or guardian, including administration of and adverse reactions to medications; (i) Home visits to patients for supervision of staff providing services; G) Reports of case conferences; (k) Reports to physicians, physician assistants, or advanced registered nurse practitioners; (1) Termination summary including the date of first and last visit, the reason for termination of service, an evaluation of established goals at time of tennination, the condition of the patient on discharge and the disposition of the patient." The home health agency failed to submit their comprehensive emergency management plan to the local county health department for review and approval. (H 376) The pertinent statutes and rules that apply include the following: Section 400.497(8) (c), F.S. "Preparation of a comprehensive emergency management plan pursuant to s. 400.492. (c) The plan is subject to review and approval by the county health department. During its review, the county health department shall contact state and local health and medical stakeholders when necessary. The county health department shall complete its review to . Tehc LLC Page 8 - --June 23.1008 ensure that the plan is in accordance with the criteria in the Agency for Health Care Administration rules within 90 days after receipt of the plan and shall approve the plan or advise the home health agency of necessary revisions. If the home health agency fails to submit a plan or fails to submit the requested information or revisions to the county health department within 30 days after vvTitten notification from the county health department, the county health department shall notify the Agency for Health Care Administration. The agency shall notify the home health agency that its failure constitutes a deficiency, subject to a fine of $5,000 per occurrence. If the plan is not submitted, information is not provided, or revisions are not made as requested, the agency may impose the fine." Chapter 59A-8.027 (2), F.A.C., "The plan, once completed, will be forwarded electronically for approval to the contact designated by the Department of Health." Section 400.492, F.S., "Each home health agency shall prepare and maintain a comprehensive emergency management plan that is consistent with the standards adopted by national or state accreditation organizations and consistent with the local special needs plan. The plan shall be updated annually ... " Chapter 59A-8.027(3) and (4), F.S., "The agency shall review its emergency management plan on an annual basis and make any substantive changes. (4) Changes in the telephone numbers of those staff who are coordinating the agency's emergency response must be reported to the agency's county office of Emergency Management and to the local County Health Department. For agencies with multiple counties on their license, the changes must be reported to each County Health Department ap.d each county Emergency Management office. The telephone numbers must include numbers where the coordinating staff can be contacted outside of the agency's regular office hours. All home health agencies must report these changes, whether their plan has been previously reviewed or not, as defined in subsection (2) above." · The home health agency failed to renew the application for a Certificate of Exemption that authorizes the performance of waived laboratory tests. (H 390) The pertinent statutes and rules that apply include the following: Section 483.091,F.S. "Clinical laboratory license.--A person may not conduct, maintain, or operate a clinical laboratory in this state, except a laboratory that is exempt under s. 483.031, unless the clinical laboratory has obtained a license from the agency A license is valid only for the person or persons to whom it is issued and may not be sold, assigned, or transferred, voluntarily or involuntarily, and is not valid for any premises other than those for which the license is issued. 483.031 Application of part; exemptions.--This part applies to all clinical laboratories within this state, except: (1) A clinical laboratory operated by the United States Government. (2) A clinical laboratory . Tehc LLC Page 9 · - · June 23;-2008 that performs only waived tests and has received a certificate of exemption from the agency under s. 483.106. (3) A clinical laboratory operated and maintained exclusively for research and teaching purposes that do not involve patient or public health service. 483. l 06 Application for a certificate of exemption.--An application for a cenificate of exemption must be made under oath by the owner or director of a clinical laboratory that performs only waived tests as defined ins. 483.041. A certificate of exemption authorizes a clinical laboratory to perform waived tests. Laboratories maintained on separate premises and operated under the same management may apply for a single certificate of exemption or multiple certificates of exemption ... EXPLANATION OF RIGHTS Pursuant to Section 120.569, F.S., you have the right to request an administrative hearing. In order to obtain a formal proceeding before the Division of Administrative Hearings under Section 120.57(1), F.S., your request for an administrative hearing must conform to the requirements in Section 28-106.201, Florida Administrative Code (F.A.C), and must state the material facts you dispute. SEE ATTACHED ELECTION AND EXPLANATION OF RIGHTS FORMS. Anne Menard, Manager Home Care Unit cc: Agency Clerk, Mail Stop 3 Legal Intake Unit, Mail Stop 3 Arlene Mayo-David, AHCA Delray Beach Field Office Manager Track & Confirm Search Resuhs Label/Receipt Number: 7160 3901 9845 4743 6663 Status: Delivered Your item was delivered at 11:36 AM on June 26, 2008 in FORT LAUDERDALE, FL 33309. Track.& Confirm FAQs Enter Label/Receipt Number. Options Track & Confirm by email Get current event information or updates for your item sent to you or others by email. ( /,h,>) fgnns Oov'I Services .Jobs Priv11.c;y Policy Tenns_ofUse • Nation;il_&.Premier Accounts Copyright© 1999-2007 USPS. All Rights Reserved. No FEAR Act EEO Data FOIA http://trkcnfrm l .smi.usps.com/PTSintemetWeb/Inter Labellnquiry .do 7/21/2008 STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION Agency ,i' ., :, In RE: Licensure Renewal Application of Care Admi :i: : TEHC,LLC AHCA No. 2008007748 License No. 204390961 I REQUEST FOR FORMAL HEARING The law firm of Dresnick & Rodriguez, P.A., notices its appearance as counsel for TEHC, LLC, in conjunction with the above-referenced matter. All pleadings, documents, and other communications should be provided to TEHC's counsel at the address below. TEHC disputes the allegations of fact contained in the Notice oflntent to Deny and requests that this pleading be considered a demand for a formal hearing, pursuant to Sections 120.569 and 120.57(1), Florida Statutes, and pursuant to Rule 28-106.2015,. Florida Administrative Code, before an Administrative Law Judge appointed by the Division of Administrative Hearings. In support of this Petition, TEHC states the following: The Petitioner is TEHC, TLC, 3317 NW 10th Terrace. Suite 404. Fort Lauderdale, FL 33309. TEHC's telephone number is 954-351-1895, and the facsimile number is 954-351-1820. TEHC's counsel should be contacted at the address and fax number below. TEHC disputes allegations of fact including, but not limited to, those in paragraphs 1, 6, 7, 8, 9, 11, 12, 15 and 16 of the Notice oflntent to Deny, and requests an Administrative Hearing regarding these allegations. In addition, TEHC disputes that they DRESNICK & RODRIGUEZ, P.A., ONEDATRAN CENTER, SUITE 1610, 9100 SOUTH DADELAND BOULEVARD, MIAMI, F'L 33156-7817 • (305) 670-9800 AHCA No. 2008007748 License No. 204390961 have demonstrated a pattern of deficient performance, and that the plan of correction submitted in June, 2008 was not acceptable. TEHC received the Notice oflntent to Deny on June 26, 2008. The Agency's file number in this case is 2008007748. Respectfully submitted, DRESNICK & RODRIGUEZ, P.A. Attorneys for TEHC, LLC One Datran Center 9100 South Dadeland Blvd, Suite 1610 Miami, FL 33156 Off: (305) 670-9800 Fax: (305) 670-9933 '£' Monica L. Rodriguez) Florida Bar No. 986283 2 DRESNICK & RODRIGUEZ, P.A., ONE DATRAN CENTER, SUITE 1610, 9100 SOUTH DADELAND BOULEVARD, MIAMI, FL 33156-7817 • (305) 670-9800 AHCA No. 2008007748 License No. 204390961 CERTIFICATE OF SERVICE I HEREBY CERTIFY that the original of the foregoing has been furnished by telefax and U.S. Mail on July 16, 2008 to: Nelson Rodney, Assistant General Counsel, Agency for Health Care Administration, 8350 N.W. 52nd Terrace, Suite 103, Miami, FL 33166, with a copy via telefax and U.S. Mail to Richard Shoop, Agency Clerk, 2727 Mahan Drive, Mail Stop # 3, Tallahassee, Florida 32308. '-<:;.., )...f?. .c..,...:_ Monica L. Rodriguez O ') 3 DRESNICK & RODRIGUEZ. P.A., ONEDATRAN CENTER, SUITE 1610, 9100 SOUTH DADELAND BOULEVARD, MIAMI, FL 33156-7817 • (305) 670-9800 08/20/2009 15 51 FAX 305 870 9933 ?RESN ICK & RODRIGUEZ, PA 002/003 STATE OF FLORJDA
The Issue The ultimate issue to be resolved in this proceeding is whether a license should be issued to the Intervenor to operate a home health agency in Palm Beach County, Florida. Intervenor contends that it is not required to obtain a Certificate of Need to operate in Palm Beach County because it is excluded from Certificate of Need requirements by a "grandfathering" provision. Petitioner contends that the Intervenor is not exempt from the requirement of obtaining a Certificate of Need and that a license should not have been issued allowing Petitioner to operate in Palm Beach County. Intervenor contends that Petitioner has no standing to attack Intervenor's license and that the Petition for Hearing was not filed in a timely manner.
Findings Of Fact This proceeding is an offshoot of a long and bitter feud between former business partners. Two couples, the Collisters and the Schacks, together established a home health agency that provided services in Broward County, Florida. The agency was set up to provide skilled nursing and other therapeutic services to homebound patients in their place of residence. The agency was incorporated as "A Associated Home Health Agency, Inc." on February 26, 1974. It thereafter provided services to homebound patients in Broward County. To facilitate payments for the agency's Medicare or Medicaid patients, the agency obtained a provider identification number from the Federal Department of Health, Education and Welfare. The federal department issued the agency Provider Identification No. 10-7093. Sometime in late 1974 or early in 1975, the agency opened an office in Palm Beach County and began serving patients there. The Broward County office operated as the parent office of the Palm Beach County office. The Department of Health, Education and Welfare issued provider No. 10-7305 to the Palm Beach office operating as a suboffice of the Broward County office. The provider number was issued to the Palm Beach County office on June 18, 1975. The relationship between the Schacks and the Collisters deteriorated shortly after the expansion into Palm Beach County. The Schacks were operating the Broward County office, and the Collisters were operating the Palm Beach County office. The two offices began to operate independently of each other from the point of view of day-to-day operations beginning in December, 1975, when an accountant was hired for the Palm Beach County office. From then on, agency patients in Broward County were served by the Schacks, operating out of the Broward County office. Agency clients in Palm Beach County were served by the Collisters, operating out of the Palm Beach County office. For more than a year after December, 1974, the parties continued to operate legally as A Associated Home Health Agency, Inc., with a parent office in Broward County and a suboffice in Palm Beach County. While this was their legal umbrella, the parties operated independently of each other subsequent to December, 1974. The parties were unable to work out a settlement of their difficulties. There is some question as to whether they both ever signed any document that outlined how an ultimate separation should occur. Whether they both signed it or not, the parties acted as if a memorandum dated February 18, 1976, set the terms of their separation. Under this memorandum, the Schacks agreed not to compete in Palm Beach County, and the Collisters agreed not to compete in Broward County. Basically, each office would retain its balance sheets for November 30, 1975. The Broward office would be allowed to keep the logo, and the Palm Beach County office would keep the existing corporation. The Broward County office would form a new corporation. The Schacks filed Articles of Incorporation for a new corporation on June 30, 1976. The Certificate of Incorporation was issued July 1, 1976. The Schacks incorporated as "Associated Home Health Agency, Inc." Thereafter, the Collisters continued to operate in Palm Beach County as "A Associated Home Health Agency, Inc." (Petitioner). The Schacks continued to operate in Broward County, Florida, as "Associated Home Health Agency, Inc." (Intervenor). The parties had not entered into any agreement as to who would retain the provider identification numbers that had been issued by the Federal Department of Health, Education and Welfare. The Palm Beach County office could not continue to operate under Provider No. 10-7305 because it was a provider number for a suboffice. After July 1, 1976, the Palm Beach County office could not have been considered a suboffice of the Broward County office. The parties apparently quarreled about this with the federal agency. The federal agency recognized that the original provider number (10-7093) could have been assigned to the original corporation, then housed in Palm Beach County. In order to minimize confusion, however, it assigned the original provider number to Intervenor and issued a new provider number (10-7154) to Petitioner. It appears that the federal agency's reason for assigning the original provider number to the Intervenor was simply to avoid confusion. It does not appear that the federal agency had any intention of granting any special rights to either party by choosing to assign the original provider number to Intervenor. The Schacks and the Collisters operated thereafter for some years without bothering each other. The Intervenor annually applied for licensure to operate in Broward County in 1978 and 1979. In 1980, however, despite its covenant not to compete in Palm Beach County, the Intervenor applied for a license to operate in Broward, Dade and Palm Beach Counties. The application was denied. The Intervenor did the same thing with respect to the year June 1, 1981, to May 31, 1982. This application was also denied. Intervenor did the same thing for the June 1, 1982, to June 30, 1983, year. Intervenor's application for licensure in Dade and Palm Beach Counties was denied by letter dated May 5, 1982. Intervenor requested an administrative hearing to challenge that denial. Intervenor provided some additional documentation to the Department and ultimately submitted a new application to be licensed to operate in Palm Beach County. The Department issued a license allowing Intervenor to operate In Broward and Palm Beach Counties on July 8, 1982. The executive director of the Petitioner became aware sometime in July, 1982, that Intervenor was operating in Palm Beach County. He wrote to the Department, which replied that on July 8, 1982, Palm Beach County was added to the service area of Intervenor. The Department's reply was dated July 19, 1982. It did not advise Petitioner that it had any right to a hearing respecting the licensure of Intervenor in Palm Beach County. Through counsel, Petitioner requested a clarification and stated that misrepresentations had been made in Intervenor's application. Further correspondence with the Department did not generate any explanation until, by letter dated October 26, 1982, the Department advised Petitioner that it had a right to request an administrative hearing with regard to the licensure of Intervenor in Palm Beach County. This letter was the first notification to Petitioner that it had a right to hearing with respect to Intervenor's licensure in Palm Beach County. The letter advised Petitioner that it could request a hearing within thirty days of receipt of the letter. Petitioner requested a formal hearing within that period and also filed a Petition for Writ of Mandamus in Circuit Court in Leon County, Florida. Upon the filing of the request for hearing, the Department forwarded the matter to the office of the Division of Administrative Hearings, and this proceeding ensued. The Intervenor has been operating in Palm Beach County since the Department issued a license on Jul 8, 1982. Petitioner has suffered a loss of business and a loss of revenue as a result of Intervenor's operations in Palm Beach County. There is no evidence from which it could be concluded that Intervenor has suffered from its reliance upon licensure by the Department so that the Department should now be estopped from denying licensure in Palm Beach County. While money has been spent to set up Intervenor's business in Palm Beach County, it was not Intervenor's money. There is no evidence that Intervenor or any government agency made any expenditures for Intervenor to operate in Palm Beach County prior to the time that Petitioner requested a hearing. Furthermore, it was Intervenor itself which euchred the Department into issuing a license without notifying Petitioner and others. In its application for licensure to operate in Palm Beach County, Intervenor stretched the facts and stated that it had done business in Palm Beach County prior to April 30, 1976. This was not true.
The Issue The issue for determination is whether Petitioner must reimburse Respondent for payments totaling $29,701.19 that Petitioner admittedly received from the Medicaid Program between May 1, 1996, and March 31, 1998, in compensation for the provision of home health services. Respondent contends that Petitioner is not entitled to retain the payments in question, primarily on the allegations that the compensated services were not medically necessary, were improperly documented, or both.
Findings Of Fact The evidence presented at final hearing established the facts that follow. The Agency is responsible for administering the Florida Medicaid Program. As one of its duties, the Agency must recover "overpayments . . . as appropriate," the term "overpayment" being statutorily defined to mean "any amount that is not authorized to be paid by the Medicaid program whether paid as a result of inaccurate or improper cost reporting, improper claiming, unacceptable practices, fraud, abuse, or mistake." See Section 409.913(1)(d), Florida Statutes. This case arises out of the Agency's attempt to recover alleged overpayments from Monef, a Florida-licensed home health agency. As an enrolled Medicaid provider, Monef is authorized, under a Medicaid Provider Agreement with the Agency, to provide home health services to Medicaid recipients. Under the Medicaid Provider Agreement, Monef assented to comply with “all local, state and federal laws, rules, regulations, licensure laws, Medicaid bulletins, manuals, handbooks and Statements of Policy as they may be amended from time to time.” The home health services at issue consisted of skilled nursing care rendered either by a registered nurse (“RN”) or a licensed practical nurse (“LPN”), as the needs of the recipient required, together with personal care provided by a home health aide. The "audit period" that is the subject of the Agency's recoupment effort is May 1, 1996 to March 31, 1998. During this audit period, the Medicaid Program reimbursed Monef for all of the skilled nursing and home health aide services that are the subject of this dispute. Largely (though not entirely) on the allegation that the home health services in question were not medically necessary, the Agency contends that Monef collected overpayments totaling $29,701.19 in compensation for services rendered to nine separate patients. The following table summarizes the Agency's allegations. PATIENT NAME GROUND(S) FOR DENIAL ALLEGED OVERPAYMENT Louisiana S. No medical necessity $8,498.17 Robert M. No medical necessity $3,615.54 Mario P. No medical necessity $2,403.33 Angel S. No medical necessity $2,089.12 Ana G. No medical necessity $2,015.94 Joann N. No medical necessity $1,705.12 C. Watson No medical necessity $1,268.76 Yvette F. Service refused $122.16 Rosa P. Multiple $7,983.05 Medical Necessity The proof was in conflict concerning the medical necessity of the challenged home health services that Monef provided to the foregoing patients. There were three categories of expert opinion evidence on this issue, described below. The attending physicians' opinions. To be Medicaid compensable, home health services must be provided pursuant to a written treatment plan that is prepared individually for each recipient and approved by his or her attending physician. The treatment plan——called a "plan of care" or "plan of treatment"—— must be reviewed and updated periodically (about every two months) and also as the patient's condition changes. A required component of all plans of care is the attending physician's certification that the services specified in the plan are medically necessary.1 The fact that a treating doctor, by prescribing, recommending, or approving a medical service, has attested to its medical necessity is not sufficient, in itself, to support a finding that the resulting care was medically necessary. See Rule 59G-1.010(166)(c), Florida Administrative Code. Nevertheless, the attending physician's opinion regarding medical necessity is relevant evidence, even if it is not inherently dispositive. In this case, all of the services that the Agency contends were not medically necessary had been determined to be medically necessary by the respective patients' treating physicians. The peer-review organizations' opinions. During the audit period, the Medicaid Program would not reimburse a home health agency for any home visits in excess of 60 visits per recipient per fiscal year unless the provider had obtained authorization to provide such care, in advance, from the Agency or its designee. Such "prior authorization" was required to be based on medical necessity. At times during the audit period the Agency was under contract with a company called Keystone Peer Review Organization ("KePRO"), which acted as the Agency's designee in regard to pre-approving services above the 60-visit limit. At other times this function was performed by Florida Medical Quality Assurance, Inc. ("FMQAI"). In a couple of instances, the Agency itself gave Monef prior authorization to perform services that it now contends were not medically necessary. By statute, a peer-review organization's written findings are admissible in an administrative proceeding as evidence of medical necessity or lack thereof. See Section 409.913(5), Florida Statutes. Monef had obtained prior authorization based on medical necessity for most of the services that the Agency has challenged as medically unnecessary. The opinions of the Agency's designees, KePRO and FMQAI, are relevant evidence of medical necessity. Dr. Sullenburger's opinion. Dr. John Sullenburger is the Agency's Medicaid physician. He would have testified at the final hearing as an expert witness for the Agency, but the parties stipulated that Dr. Sullenburger's ultimate opinion, based on the medical records, was that each of the claims that the Agency alleges was not medically necessary was, in fact, unnecessary. By entering into this stipulation, Monef effectively waived its right to cross-examine Dr. Sullenburger and thereby expose the particular facts upon which his opinion was based. For its part, the Agency relinquished the opportunity to have the doctor explain the reasons why he had concluded that the patients' attending physicians——and also, in many instances, the Agency's designated peer-review organizations——had erred in making their respective determinations that the subject services were medically necessary. As a result of the parties' stipulation concerning Dr. Sullenburger's testimony, the factfinder was left with a naked expert opinion that merely instructed him to decide the ultimate factual issue of medical necessity in the Agency's favor. In making findings regarding medical necessity, the factfinder settled on the following rules of thumb. Greatest weight was accorded the opinions of KePRO and FMQAI. These were deemed to have the highest probative value because the peer- review organizations' determinations of medical necessity were made before the services in question were provided, and neither of the Agency's designees had any discernable motive to stretch the truth one way or the other. Certainly, the peer-review organizations more closely resemble a disinterested, neutral decision-maker than either the patient’s treating physician or the Agency's expert witness (whose opinions were formed after the services had been rendered and the claims paid); indeed, if anything, KePRO and FMQAI might be expected to tilt in the Agency's direction (although there was no evidence of such bias in this case).2 The hearsay opinions of the treating physicians, on the one hand, and Dr. Sullenburger, on the other, were considered to be about equally persuasive——and none was particularly compelling.3 It should be stated that the attending physicians' certifications of medical necessity, each of which lacked analysis that might have connected the facts concerning a patient's medical condition with the need for services, were as conclusory as Dr. Sullenburger's ultimate opinion. Consequently, in those instances where a peer-review organization gave Monef a mandatory prior authorization to render services that the attending physician had certified as being medically necessary, it has been found that, more likely than not, the services in question were medically necessary. In contrast, a closer question arose in those instances where there was no evidence of prior authorization when such was required. The expert opinions——the attending physician's on one side, Dr. Sullenburger's on the other—— essentially canceled each other out. While ordinarily in an evidential tie the party without the burden of proof (here, Monef) would get the nod, in this case the Agency had the slightest edge, on the strength of Rule 59G-1.010(166)(c), Florida Administrative Code. Under this Rule, an attending physician's approval of a service is not, "in itself," sufficient to support a finding of medical necessity.4 Because of the Rule, Monef needed to introduce some additional, persuasive evidence (e.g. the attending doctor's testimony regarding the need for the service) to overcome Dr. Sullenburger's opinion.5 Louisiana S. At the time that the services in question were provided, from May 7, 1997, until December 20, 1997, this patient, an obese woman in her late 60s, was being treated for diabetes, hypertension, and coronary artery disease. She was not able to self-administer the insulin shots that were needed to prevent complications from diabetes. For the period from May 5, 1997, through June 30, 1997, KePRO gave prior authorization to 53 skilled nursing visits and 23 home health aide visits.6 Monef was reimbursed for 42 skilled nursing visits and 23 home health aide visits conducted in this period. From July 1, 1997, until September 1, 1997, Monef provided a total of 66 combined skilled nursing and home health aide visits to Louisiana S. The Medicaid Program paid for 60 of them. Because these were the first 60 visits of the fiscal year, which began on July 1, 1997, prior authorization was neither needed nor obtained. During the period between September 1, 1997, and November 1, 1997, Monef made 96 skilled nursing visits, out of 124 that KePRO had pre-approved, and 20 of 27 authorized home health aide visits. KePRO gave prior authorization for 124 skilled nursing and 27 home health aide visits for the period from November 1, 1997 to January 1, 1998, of which 54 and 18, respectively, were made. Based on the levels of service that KePRO had approved before July 1, 1997, and then after September 1, 1997, it is reasonable to infer, and so found, that the first 60 combined visits to this patient in fiscal year 1997-98 would have been pre-approved had Monef been required to obtain prior authorization. The home health care services that Monef provided to Louisiana S. between May 9, 1997, and December 30, 1997, for which the Medicaid Program paid $8,498.17, were medically necessary. Robert M. Robert M., a man in his mid-40s who received home health care from Monef from November 26, 1997, through March 27, 1998, suffered from arteriosclerosis, hypertension, acute bronchitis, and schizophrenia. His residence was an assisted living facility ("ALF").7 FMQAI gave prior authorization for 61 skilled nursing and 61 home health aide visits to occur between November 26, 1997, and January 26, 1998. Monef provided 55 nursing and 59 home health aide visits during this period. Monef requested prior approval for 25 skilled nursing and 63 home health aide visits for the period from January 26, 1998, and March 26, 1998. Although prior authorization was needed for these services, which exceeded the limit for fiscal year 1997-98, there is no evidence in the record that FMQAI granted Monef's request for approval. FMQAI authorized 23 skilled nursing visits and 30 home health aide visits for the period from March 26, 1998, to May 28, 1998. However, Monef provided just one skilled nursing visit during this time, on March 27, 1998. The home health care services that Monef provided to Robert M. between November 26, 1997, and January 26, 1998, and on March 27, 1998, were medically necessary. Lack of medical necessity was established, however, for the services provided between January 26, 1998, and March 26, 1998. The Medicaid Program paid the following claims, totaling $1,442.49, for this period: One RN visit, $34.04; 21 LPN visits, $549.99; and 51 home health aide visits (35 at $17.46 apiece and 16 at $15.46 each), $858.46. Mario P. From November 25, 1997, through March 28, 1998, Mario P., a septuagenarian who was being treated for acute gastritis, an enlarged prostate, and mental illness, received home health visits at the ALF where he lived, the services provided by Monef. FMQAI approved 43 skilled nursing and 61 home health aide visits for the period from November 26, 1997, through January 26, 1998; 11 skilled nursing and 62 home health aide visits for January 26, 1998, until March 26, 1998; and 25 skilled nursing visits for March 1, 1998, through May 1, 1998 (overlapping the immediately preceding period by about three- and-a-half weeks). The actual number of skilled nursing and home health aide visits for which the Medicaid Program reimbursed Monef was within the pre-approved service levels for each period. The home health care services that Monef provided to Mario P. between November 26, 1997, and March 28, 1998, for which the Medicaid Program paid $2,403.33, were medically necessary. Angel S. Angel S. was a man in his middle 50s who had been diagnosed with gastroduodenitis (an inflammation of the stomach and duodenum) and mental illness. Monef obtained prior authorization from KePRO to provide Angel S. with 34 skilled nursing and 62 home health aide visits between November 25, 1997, and January 25, 1998. During this time, the Medicaid Program reimbursed Monef for 32 skilled nursing and 44 home health aide visits. FMQAI pre-approved 26 skilled nursing and 27 home health aid visits for January 25, 1998, through March 25, 1998. Monef was reimbursed for 20 and 21 such visits, respectively. The home health care services that Monef provided to Angel S. between November 25, 1997, and March 25, 1998, for which the Medicaid Program paid $2,089.12, were medically necessary. Ana G. When she was a client of Monef, Ana G., a woman in her 60s, was suffering from acute gastritis and major depression. She lived in an ALF. FMQAI pre-approved 50 skilled nursing visits and 40 home health aide visits for the period from November 25, 1997, through January 25, 1998. In that time, Monef rendered 28 skilled nursing visits and 42 home health aide visits for which it received compensation from the Medicaid Program. For the period from January 25, 1998, through March 25, 1998, FMQAI gave prior authorization for 9 skilled nursing and no home health aide visits. During this time, Monef provided 15 skilled nursing visits and 15 home health aide visits for which Medicaid paid. The services that Monef rendered to patient A. Garcia between November 25, 1997, and March 23, 1998, were medically necessary except for 17 home health aide visits (at $17.46 apiece) and 6 skilled nursing visits (at $24.19 each), making a total of $441.96 in overpayments. Joann N. In her late 30s at the time of the services in question, Joann N.'s principal diagnosis was major depression. She also suffered from hypertension and a type of diabetes. Because Joann N.'s primary diagnosis was a mental illness, the home health services provided to her may not have been Medicaid-compensable due to an exclusion that bars coverage for mental health and psychiatric services.8 The Agency, however, did not disallow Monef's claims on this basis, relying instead exclusively on the allegation that the services were not medically necessary. None of the skilled nursing and home health aide visits that Monef provide Joann N. between February 16, 1997, and September 1, 1997, was pre-approved. There is evidence that Monef sought KePRO's prior authorization of 26 skilled nursing and ten or 12 home health aide visits for the period from April 16, 1997, to June 16, 1997, but no proof was adduced showing that approval was granted. Based on the number of combined visits that Monef provided both before and after July 1, 1997 (the start of fiscal year 1997-98), it does not appear that prior authorization was required. There are no grounds in the record, however, from which to infer that prior authorization(s) would have been given if needed. Accordingly, lack of medical necessity was established for all of the home health services that Monef provided Joann N, for which the Medicaid Program paid a total of $1,705.12. C. Watson C. Watson was a teenager with cerebral palsy and quadriplegia who received care in her home between May 12, 1997, and March 31, 1998. The Agency alleges that all of the skilled nursing services that Monef provide C. Watson were medically unnecessary but acknowledges that the home health aide visits were appropriate and covered. The Agency itself pre-approved the home health care visits that Monef had requested for the period from May 12, 1997, through June 30, 1997, namely, 24 skilled nursing and 40 home health aide visits. The Medicaid Program reimbursed Monef for 12 skilled nursing and 38 home health aide visits made during this period. The Agency gave prior authorization for home health care to be provided between July 1, 1997, and September 1, 1997. FMQAI also pre-approved the following services for the same period: five skilled nursing visits and 43 home health aide visits. Monef was reimbursed for 17 skilled nursing visits made during this time. For the periods of September 1, 1997 to November 1, 1997; November 1, 1997 until January 1, 1998; and January 1, 1998 through March 1, 1998, KePRO pre-approved levels of skilled nursing services (nine, four, and nine visits, respectively) that were not exceeded by Medicaid-paid claims for these services rendered by Monef during the subject timeframes. FMQAI gave prior authorization for four skilled nursing visits to occur between March 1, 1998 and May 1, 1998, but Monef did not submit any claims for such services rendered during this period. Lack of medical necessity was established for 12 skilled nursing visits made during the period from July 1, 1997 through September 1, 1997. The Medicaid Program paid a total of $319.13 for these visits (One RN visit at $31.04 and 11 LPN visits at $26.19), and this sum constitutes an overpayment subject to recoupment. The rest of the skilled nursing visits that Monef furnished to C. Watson were medically necessary. Yvette F. Yvette F. was a patient in her 30s suffering from complications relating to HIV infection. On Christmas Day, 1997, Yvette F. refused most of the skilled nursing services that had been scheduled, to spend time with her family. The Agency has sought to recoup the $122.16 that the Medicaid Program paid for an RN's visit to Yvette F.'s home on December 25, 1997. This sum reflects four hours of service. The medical records in evidence establish that the patient's refusal of treatment occurred after the RN had arrived at her residence, and that, despite the patient's refusal of service, the RN did perform an assessment on Yvette F. that day. The Agency failed to establish that, under these circumstances, Monef is entitled to no reimbursement. Yet, common sense instructs that the covered claim should not encompass four hours of services when clearly that much time was not spent on this particular visit. Unfortunately, nothing in the record, including the parties' legal arguments, provides guidance for resolving this particular problem. In the absence both of controlling authority and evidence of the actual time spent, the factfinder has determined that the claim should be equitably apportioned to do rough justice, with Monef being compensated for one hour of service and the balance returned to the Medicaid Program. On this basis, then, lack of medical necessity has been shown for three hours of skilled nursing services, making an overpayment of $91.62. Rosa P. Rosa P. was a woman in her late 30s with multiple health problems, including uncontrolled diabetes, recurring infections, renal failure, respiratory insufficiency, and mental illness. Monef rendered home health care to Rosa P. from November 22, 1996, until February 1, 1998, for which the Medicaid Program paid $24,543.27 on 1,012 separate claims. The Agency seeks to recoup a little more than one- third of the amount previously paid to Monef for this patient's home health care, alleging a number of grounds to disallow a number of claims. The following table summarizes the Agency's contentions regarding the challenged claims. ("Doc." is an abbreviation for "documentation." "PC" is an acronym for plan of care. The alphanumeric claim identifiers in the left-hand column were assigned by the Administrative Law Judge for ease of reference.) CLAIM ID DATE(S) SERVICE(S) GROUND(S) FOR DENIAL ALLEGED OVERPAYMENT RP-1 11-22-96 Nursing No doc. $29.04 RP-2 12-9-96, 12- 10-96, 12- 14-96 Aide No doc./POT not followed (x3) $52.38 RP-3 12-25-96 to 1-5-97 Aide No PC rendered (x11) $192.06 RP-4 1-6-97, 1-7- 97, 1-9-97, 1-10-97, 1- 11-97, 1-12- 97 Aide POT not followed (x6) $104.76 RP-5 1-22-97 to 3-22-97 All POT not signed by MD or RN $4,009.37 RP-6 3-24-97 to 5-2-97 Aide No PC rendered (x40) $698.40 RP-7 5-2-97 Nursing No doc. $29.04 RP-8 5-3-97 to 7- 4-97 Aide No PC rendered (x62) $1,032.52 RP-9 7-21-97 to 7-26-97 Aide POT not followed (x6) $87.309 RP-10 8-4-97 to 8- 10-97 Aide PC not rendered (x7) $122.22 RP-11 10-29-97 Nursing Documented only 1 of 2 billed visits $31.04 RP-12 11-3-97 Aide No doc. $17.46 RP-13 11-4-97 Aide No doc. $17.46 RP-14 11-14-97 Aide No doc. $17.46 RP-15 11-15-97 Aide No doc. $17.46 RP-16 11-16-97 Aide No doc. $17.46 RP-17 11-22-97 to 11-26-97 Aide No doc. (x10) (2 billed visits per day) $52.3810 RP-18 12-1-97 Aide No doc. $17.46 RP-19 12-2-97 Aide No doc. $17.4611 RP-20 12-3-97 Aide No doc. $17.46 RP-21 12-28-97 to 2-28-98 Nursing POT not signed by MD or RN $1,724.37 The total of these alleged overpayments, without adjustment for the several minor arithmetic or typographical errors in the Agency’s papers, see endnotes 9 - 11, is $7,983.05. Each claim or claim set will be addressed in turn below. RP-1. The medical records contain a "Time Record Nursing Progress Note" dated November 22, 1997, that documents a skilled nursing visit to the patient on that day. Therefore, the Agency failed to prove its allegation of overpayment regarding RP-1. RP-2. Included in the patient's records is a "Weekly Activity Report and Time Slip" for the week beginning Monday, December 9, 1996, that was filled out by the home health aide who cared for Rosa P. during that seven-day period. To keep track of tasks performed, the form instructed the aide to check boxes in a table that cross-referenced particular duties (e.g. oral hygiene, change linens, turn & position), which are described in the left-hand column, with the days of the week, which are listed, Monday through Sunday, in the top row. For the days in question (December 9, 10, and 14, 1996), the aide checked boxes showing that, among other things, she had given the patient a shower and assisted her in a wheelchair, both of which are Medicaid-covered services. See Paragraphs 133, 137, infra. Handwritten notes inscribed on the Agency's work papers next to each of the three dates at issue state: "only p/c [personal care] [is a] shower —— not following POT [plan of treatment]." The first of these points is incorrect: assistance with a wheelchair, like showering a patient, is a covered home health aide service. The plan of care that covered the subject dates disproves the second assertion. The written treatment plan explains that the home health aide will "provide personal care, asst [assist] [with] ADL's [activities of daily living] including bath, skin/foot care." The aide was following this course of action on December 9, 10, and 14, 1996. The Agency did not prove an overpayment in connection with RP-2. RP-3. The Agency seeks to recoup payments of $17.46 apiece for 11 home health aide visits made between December 25, 1996 and January 5, 1997, on the ground that the aide did not perform any covered personal services. Although a dozen such visits were made during this particular period, the Agency's work papers reveal that the claim for services rendered on December 29, 1996, was approved. The aide's time sheets for the relevant period substantiate the Agency's allegation, with one exception. The aide's entry on December 26, 1996, is identical to that of December 29, 1996, the latter which the Agency correctly deemed sufficient to make Medicaid financially responsible. On both days, the aide helped the patient with a tub bath and shampoo, which are covered personal services. For the other ten days, review of the aide's time sheets reveals that many services were rendered in the category of "light housekeeping" and "meal preparation." These fall within the exclusion for "housekeeping, homemaker, and chore services, including shopping" and hence are not covered services. Handbook, at p. 2-6; see also Rule 59G-4.130(8)(a)2., Florida Administrative Code (1996).12 (Curiously, the Agency did not specifically rely upon this exclusion.) In its Proposed Recommended Order, Monef points out that the aide made a written notation each day concerning the patient's voiding of bowel and bladder. Because the non- exclusive list of covered home health aide services included "toileting and elimination," see Rule 59G-4.130(5)(b)3.b., Florida Administrative Code (1996), it is possible that the aide was providing a compensable service during the period in question. The trouble is, it cannot be determined from the evidence whether the aide actually assisted the patient——or whether the aide merely wrote down on the time sheet what had been observed regarding the patient's use of the bathroom facilities. Although the question is close, it is determined that simply observing and commenting daily about the patient's elimination of bodily wastes is not enough, without more, to constitute a Medicaid-compensable home health aide service.13 Being unable on the present record to find that the aide did more than watch and write, it is determined that covered services in the area of "toileting and elimination" were not persuasively shown to have occurred. Consequently, lack of medical necessity has been established as to 10 home health aide visits. The total overpayment on RP-3 is $174.60. RP-4. For the week from Monday, January 6 through Sunday, January 12, 1997, the Agency alleges that six home health aide visits are not covered because the aide failed to follow the plan of treatment. Notations on the Agency's work papers suggest another basis: "only shower - incomplete," meaning, presumably, that the only covered personal care provided was assistance in the shower. See discussion regarding RP-2, supra. The aide's time sheet for the relevant period contradicts the Agency's contention. First, bathing assistance was not the only covered personal care rendered on the days in question. The aide also helped the patient with her wheelchair, which is a service covered under the rubric of "transfer and ambulation." Rule 59G-4.130(5)(b)3.e., Florida Administrative Code (1996). Second, the aide's entry for January 8, 1997——for which claim the Agency is not seeking to recover——is substantially the same as those for the challenged days. The only material difference is that on January 8 the aide checked the box indicating that she had shampooed the patient's hair. Nothing in the Rule or the Handbook, however, provides that a shower with shampoo is covered but a shower without shampoo is excluded from coverage, and the Agency failed to prove a factual basis, or advance a logical one, for drawing such distinction. Consequently, the Agency did not establish an overpayment with regard to RP-4. RP-5. The medical records in evidence contain a "Home Health Certification and Plan of Care" for Rosa P. that was signed and dated, on January 22, 1997, by the RN and by the patient's attending physician, Dr. John Prior. This plan of care covers the period from January 22, 1997 through March 22, 1997. The Agency did not present any evidence that either the doctor's or the nurse's signature appearing on this form are inauthentic or that either or both failed to sign on January 22, 1997, as recorded. Therefore, the Agency's allegation that the plan of treatment for the period in question is invalid was not proved. RP-6. This claim set encompasses five full weeks plus five days of home health aide service, or 40 visits in all. The Agency alleges that no covered personal care was provided during these visits. The time sheets demonstrate that the aide provided a covered service, namely assistance in the shower, on all days between March 24, 1997 and April 6, 1997, and also on the five days from April 28 through May 2, 1997. The Agency therefore failed to prove its allegation as to these 19 visits. The Agency made its case, however, in connection with the remaining 21 visits from April 7 to April 27, 1997, inclusive. The time sheets for these dates do not adequately document the provision of a covered service.14 Accordingly, lack of medical necessity was established for 21 home health aide visits at $17.46 each, making a total overpayment on RP-6 of $366.66. RP-7. The Agency has sought to recover payment of $29.04 for an RN visit to the patient on May 2, 1997, alleging lack of documentation. The medical records show that on this particular date, an LPN treated the patient from 8:00 a.m. to 8:45 a.m. Later that same day, at 5:00 p.m., an RN arrived to provide care, which she did, afterwards leaving the patient’s residence at 5:45 p.m. These two visits are documented in separate "Time Record Nursing Progress Note" forms. The Agency did not establish that the nursing notes are inauthentic or incredible.15 Thus, the allegation regarding RP-7 was not proved. RP-8. The Agency contends that 62 home health aide visits between May 3, 1997, and July 4, 1997, were not compensable because no covered personal care was provided. The aide's time sheets establish that a covered personal care (assistance in the shower) was given on May 3 through May 17, inclusive (15 visits at $17.46 apiece), and also on June 20 through 22, 1997 (three visits at $17.46 each). Shower assistance was also provided on May 26 through June 1, 1997 (seven visits at $15.46 each). Skin care, a covered service, was provided on June 7, 1997 (one visit, $15.46). And ambulation assistance, a covered personal care service, was rendered on seven visits from June 9, 1997, through June 15, 1997, at $15.46 per visit. For the remaining 29 visits, however, the aide's time sheets fail adequately to document the provision of a covered service. Ten of these visits were billed at $15.46, the others at $17.46 apiece. Thus, with respect to RP-8, the Agency established an overpayment of $486.34. RP-9. This claim set involves six home health aide visits on the dates of July 21 through July 26, 1997, inclusive, during which, the Agency alleges, the plan of treatment was not obeyed. (The Agency did not seek to recoup the payment made for aide services rendered on Sunday, July 27, 1997, even though that date’s visit is included within the same time sheet as the Monday through Saturday visits, and the services rendered on July 27 were identical to those performed earlier in the week.) According to the pertinent time sheet, covered personal care services (bathing and assistance with ambulation) were provided in connection with the challenged claims. Further, the plan of treatment in effect at that time stated that the aide would "assist with personal care, ambulation, prepare meals, grocery shop, wash clothes, [and] straighten bedside unit." The time sheet establishes that the aide complied with these instructions. Accordingly, the Agency failed to prove its allegation regarding RP-9. RP-10. The Agency alleges that none of the home health aide visits from August 4 through August 10, 1997, entailed covered personal care services. The aide's time sheet for that week, however, documents that bathing care, specifically showering, was provided. Because showering the patient is clearly a covered item, the Agency failed to carry its burden of proof in respect of RP-10. The patient's medical records contain two "Time Record Nursing Progress Note" forms dated October 29, 1997, which document separate RN visits on that date, one lasting from 4:30 p.m. to 5:15 p.m., the other from 6:00 p.m. until 7:40 p.m. The Agency therefore did not establish, by a preponderance of evidence, its allegation that Monef had provided documentary support for only of one of two nursing visits on October 29, 1997. RP-12, -13, -14, -15, and -16. The Agency alleges that these five home health aide visits, occurring over a two- week period from November 3, 1997 to November 16, 1997, are not adequately documented. The visits of Monday, November 3, and Tuesday, November 4, 1997, which the Agency challenges, are reported on the same time sheet as those of November 5 through 9, 1997, which the Agency accepts. The duties performed on each of these days, both challenged and unchallenged, were identical, except that on November 4 and 8 the aide shampooed the patient. Numerous covered personal care services were rendered each day during the week, including bathing, oral hygiene, skin care, and assistance with ambulation. The duty descriptions on the aide's time sheet for the week beginning Monday, November 10, 1997——a week that included three challenged visits (November 14 through 16)——are substantially similar to one another (though the Agency accepted claims for November 10 through 13) and nearly identical to those given for the preceding week. Once again, covered personal care services rendered consistently throughout the week of November 10 to 16, 1997, included bathing, oral hygiene, skin care, and ambulation assistance. The evidence, therefore, does not support the Agency's allegation that the services in question were not adequately documented. RP-17. The Agency alleges that home health aide visits made from November 22 through November 26, 1997, were not documented. The medical records demonstrate that one such visit per day was provided, for a total of five. The records show further, however, that Monef was reimbursed for two visits for each of the days in question, receiving double the amount to which it was entitled based on the documented number of visits. The Agency, therefore, has proved an overpayment of $87.30 (five visits at $17.46 apiece). RP-18, -19, and -20. The Agency contends that there is insufficient documentation for home health visits on December 1 through 3, 1997. But the aide's time sheet for the week beginning Monday, December 1, 1997, adequately establishes that such visits actually occurred——and that covered personal care services (bathing, oral hygiene, skin care, and ambulation assistance) were provided during each of them. However, as with RP-17, the records show that Monef was reimbursed for two visits for each of the days in question, receiving double the amount to which it was entitled based on the documented number of visits. The Agency, therefore, has proved an overpayment of $50.38 (two visits at $17.45 apiece and one billed at $15.46) with regard to RP-18, RP-19, and RP-20. RP-21. The Agency seeks to recover payments for all nursing services rendered from December 28, 1997 through February 28, 1998, on the ground that the plan of treatment for the subject period was not signed and dated by the attending physician, as required. In fact, the pertinent treatment plan was signed by a Dr. Roxana Lopez, and by the RN. Neither signature, however, was dated. Thus, the Agency is correct in its assertion that the plan of treatment is deficient. But, the record also contains a letter from KePRO dated December 29, 1997, which grants prior authorization for 124 skilled nursing and 61 home health aide visits for the period from December 28, 1997 through February 28, 1998. According to this letter, Monef's request for pre-approval was made on December 22, 1997. One of the items that must be submitted to the peer- review organization with a request for prior authorization is the written plan of treatment. Thus, it is reasonable to infer, and so found, that KePRO had in its possession the deficient plan of treatment and, in granting prior authorization, overlooked the fact that the doctor had not dated her signature. Monef did not urge that KePRO's pre-approval of the services in question effected a waiver of the Agency's right to disallow the ensuing claims based on what is, in these circumstances, clearly a technicality,16 or that the Agency should be estopped from raising this particular objection, although little imagination is required to perceive the potential merit in either argument. It is not necessary to reach waiver or estoppel issues, however, for KePRO's approval letter establishes persuasively that the doctor and the nurse signed the plan of treatment before December 29, 1997——and hence at or before the start of care and services thereunder. Plainly, in other words, the attending physician timely approved the plan of treatment, even though she failed to date her signature. Under the particular facts of this case, therefore, where the treatment plan is in substantial compliance with the requirements, and neither the Medicaid Program nor the patient suffered any conceivable prejudice as a result of a demonstrably harmless (on these facts) and unintentional deficiency, it is determined that the Agency has failed to prove a sufficient basis to recoup payments totaling $1,724.37 for pre-approved, medically necessary services that were actually provided to an eligible patient. The following table summarizes the foregoing findings relating to claims for services to Rosa P. CLAIM ID DATE(S) SERVICE(S) GROUND(S) FOR DENIAL ACTUAL OVERPAYMENT RP-1 11-22-96 Nursing No doc. $0 RP-2 12-9-96, 12- 10-96, 12- 14-96 Aide No doc./POT not followed (x3) $0 RP-3 12-25-96 to 1-5-97 Aide No PC rendered (x11) $174.60 RP-4 1-6-97, 1-7- 97, 1-9-97, 1-10-97, 1- 11-97, 1-12- 97 Aide POT not followed (x6) $0 RP-5 1-22-97 to 3-22-97 All POT not signed by MD or RN $0 RP-6 3-24-97 to 5-2-97 Aide No PC rendered (x40) $366.66 RP-7 5-2-97 Nursing No doc. $0 RP-8 5-3-97 to 7- 4-97 Aide No PC rendered (x62) $486.34 RP-9 7-21-97 to 7-26-97 Aide POT not followed (x6) $0 RP-10 8-4-97 to 8- 10-97 Aide PC not rendered (x7) $0 RP-11 10-29-97 Nursing Documented only 1 of 2 billed visits $0 RP-12 11-3-97 Aide No doc. $0 RP-13 11-4-97 Aide No doc. $0 RP-14 11-14-97 Aide No doc. $0 RP-15 11-15-97 Aide No doc. $0 RP-16 11-16-97 Aide No doc. $0 RP-17 11-22-97 to 11-26-97 Aide No doc. (x10) (2 billed visits per day) $87.30 RP-18 12-1-97 Aide No doc. $17.46 RP-19 12-2-97 Aide No doc. $15.46 RP-20 12-3-97 Aide No doc. $17.46 RP-21 12-28-97 to 2-28-98 Nursing POT not signed by MD or RN $0 The Agency, in sum, proved overpayments totaling $1,165.28 in relation to Rosa P. The Bottom Line The Agency established that Monef received overpayments in connection with six patients. The following table summarizes these overpayments. PATIENT NAME GROUND(S) FOR DENIAL OVERPAYMENT Robert M. No medical necessity $1,442.49 Ana G. No medical necessity $441.96 Joann N. No medical necessity $1,705.12 C. Watson No medical necessity $319.13 Yvette F. Service refused $91.62 Rosa P. Multiple $1,165.28 Accordingly, the Agency is entitled to recover from Monef the principal sum of $5,165.60.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order requiring Monef to repay the Agency the principal amount of $5,165.60. DONE AND ENTERED this 14th day of November, 2001, in Tallahassee, Leon County, Florida. JOHN G. VAN LANINGHAM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of November, 2001.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: Petitioner filed an application with HRS for a Certificate of Need to establish and operate a new home health agency in Hillsborough, Manatee, Pasco and Pinellas Counties. HRS has given notice of its intent to deny the application on the grounds that the proposed project is not consistent with Rule 10-5.11(14)(a) and (b), Florida Administrative Code. That preliminary determination is the subject of a pending formal administrative proceeding filed pursuant to Section 120.57(1), Florida Statutes. The Florida Association of Home Health Agencies (FAHHA) is an organization formed in 1975 to represent the interests of home health care agencies in Florida. Its members consist of seventy (70) licensed home health care agencies in Florida. As of 1981, there were approximately 144 home health agencies licensed in Florida. The membership of the FAHHA fear that if the challenged rule were invalidated, there would be a proliferation of other new home health agencies into the markets served by association members. This, it is felt, would redistribute existing patient censuses and result in increased costs per patient. Gulf Coast Home Health Services, Inc. is a private, for-profit organization operating a home health care agency in Hillsborough County. It provides medical and other therapeutic services to patients in their homes as ordered by the patient's physician. Such services are provided under a variety of programs, including Medicare, Medicaid, private pay and third-party private insurance carriers. Its Administrator believes that the challenged rule helps to keep costs from escalating and that the rule's invalidation would have a negative economic impact upon his agency. Effective July 1, 1977, the Florida Statutes were amended to require a certificate of need as one of the prerequisites for licensure of a new home health agency. Emergency rules were promulgated by HRS to include proposed new home health agencies in the certificate of need program and to establish standards against which applications for certificate of need for new home health agencies could be judged. Emergency Rule 10-ER77-12 amended Rule 10-5.11(14), Florida Administrative Code, by setting forth a formula methodology for determining, on a county by county basis, the number of home health agencies necessary to meet the needs of the population. The Emergency Rule further stated that mitigating and extenuating circumstances could be considered in approving a certificate of need for a new home health agency even though the formula methodology of need determination did not clearly indicate need. Three examples of mitigating and extenuating circumstances were provided in the Emergency Rule, but they were not stated to be all-inclusive. In the summer of 1977, HRS began the process of developing a permanent rule containing criteria upon which certificate of need determinations for home health agencies would be based. There ensued exchanges of correspondence, discussions, meetings and a workshop among representatives of the Department of HRS, local health systems agencies, individual home health agencies and representatives of FAHHA to discuss what type of regulation would be most appropriate. One of the prime concerns at the workshop was the proliferation of home health agencies and the stabilization of the industry. As indicated by a majority vote or a show of hands of the attendees at the workshop, it was the consensus that the formula methodology for determining need, as set forth in the Emergency Rule, should be deleted and substituted with a "rule of 300." As finally adopted by HRS in 1977, Rule 10-5.11(14) provided that a certificate of need for a proposed new home health agency or subunit could not be issued until the daily census of the existing home health agencies or subunits providing services within the same service area reached an average of 300 patients, in the aggregate, for the immediate preceding calendar quarter unless need could be demonstrated by application of the three mitigating and extenuating circumstances listed in subparagraph (b) of the Rule. The three circumstances listed included documented population variances, documentation that the population of the proposed service area is being denied access to home health care services in that existing agencies are unable to provide services to all persons in need of home health care, and documentation that approval of the proposed agency would foster cost containment for all providers in the area. As to the numerical figure of 300, the rule, as originally adopted in 1977, meant that if the total average number of patients being serviced in a particular health service area by all existing home health agencies exceeded 300 patients on a daily basis, then a need was indicated for a new home health agency. For example, if there were three agencies in a given area with patient censuses of 401, 400 and 100, the average would exceed 300 and a need would be indicated. The "rule of 300" was suggested and proposed for adoption by representatives from the FAHHA. The number 300 was selected by the Association for the average "based upon the experience of various home health providers in the state. It's the consensus of the association's members that an agency operates with optimum administrative efficiency up to a patient level of approximately 300. As the census begins to climb to any significant degree beyond the 300 level, administrative efficiency declines. In conclusion, the association urges the adoption of the 300-average-patient-census rule. It is fair to the HSA's because it allows them to control unwarranted growth with a minimum of administrative difficulty. It is fair to the agencies because it assures them of the potential for an adequate patient census while maintaining their flexibility to have a larger or smaller census. 1/ The representatives from the FAHHA and private existing home health agencies felt that the rationale for the "rule of 300" was to afford the industry a chance to recover from rising costs resulting from the proliferation of new home health agencies. It was believed that traditional formula-based methodologies for need determinations would not work because of the ease of expansion of services and service areas and because the data base necessary for the formula methodology was not available. According to an FAHHA witness, the 1977 "rule of 300 came about due to a lack of successful alternatives." (TR. 329). The HRS representative in charge of drafting the 1977 rule admitted that, at that point in time, "no one could make a decision about whether or not the rule of 300 would be good, bad or indifferent. . ." (TR. 35). No empirical data, statistical analysis or studies were considered by HRS to illustrate that the "rule of 300" as adopted in 1977 was justified. Rule 10-5.11(14) was amended in 1979 to its present form, and this is the rule which is being challenged in this proceeding. No reason or rationale for the amendment was provided by witnesses for HRS or the intervenors or by any documentary evidence adduced at the hearing. Notice of intent to amend many portions of Chapter 10-5, Florida Administrative Code, was published in the Florida Administrative Weekly. The notice provided as follows: "PURPOSE AND EFFECT:" To amend Rule 10-5 for administration of the 'Health Facilities and Health Services Planning Act' in compliance with legislative intent and mandate, to eliminate references to the Section 1122 program which has been terminated in Florida, and to adopt health planning guidelines developed by HEW. "SUMMARY OF RULE:" These amendments will provide administrative rules under which the Certificate of Need program will be administered in compliance with state and federal requirements." No specific reference to Rule 10-5.11(14) or home health agencies was provided in the notice filed in the Florida Administrative Weekly. No specific reference to home health agencies or the "rule of 300" was provided in the HRS detailed statement of facts and circumstances justifying the proposed rules, the HRS statement of purpose or effect, the HRS summary of the rule or the HRS economic impact statement, as filed with the Joint Administrative Procedures Committee or the Secretary of State. Copies of the proposed amendment were sent to a representative of FAHHA and to existing home health care agencies. The 1979 amendment to Rule 10-5.11(14), Florida Administrative Code, made substantial changes to the manner in which new home health agencies' applications for a certificate of need were to be evaluated. The "rule of 300" was no longer to be applied as an average figure for all existing home health agencies or subunits, in the aggregate. Instead, the amendment required that a certificate of need shall not be issued until the daily census of each existing agency within the service area has reached an average of 300 patients for the immediate preceding calendar quarter, unless need could be demonstrated by application of the mitigating and extenuating circumstances listed in the amended rule. While the former 1977 rule listed three mitigating and extenuating circumstances which "may be considered" even though application of the 300 figure did not indicate need, the 1979 amendment provided only two circumstances which "must be met" before the Department could issue a certificate of need in the event that application of the "rule of 300" did not indicate need. In its entirety, the 1979 amendment to Rule 10-5.11(14) provides as follows: "(14)(a) A Certificate of Need for a proposed new home health agency or subunit shall not be issued until the daily census of each of the existing home health agencies or subunits providing services within the health service area of the proposed new home health agency or subunit has reached an average of 300 patients for the immediate preceding calendar quarter unless the need for the proposed new home health agency or subunit can be demonstrated by application of the mitigating and extenuating circumstances in Rule 10-5.11(14) (b) herein. (b) Mitigating and extenuating circumstances which must be met for the department to issue a Certificate of Need for a proposed new home health agency or subunit even though the previously described need determination procedure does not clearly indicate needs are: Documentation that the population of the proposed service area is being denied access to home health care services in that existing home health agencies or subunits within the proposed service area are unable to provide service to all persons in need of home health care, or Documentation that approval of such proposed new home health agency or subunit would foster cost containment for all providers in the health service area." Home health agencies in existence in 1977 were not required to meet the "rule of 300," but rather were grandfathered. No applicant for a certificate of need for a home health agency from the effective date of the 1977 "rule of 300" to the present has been able to satisfy the numerical component of the rule and no applicant has ever satisfied the mitigating or extenuating circumstance relating to the fostering of cost containment "for all providers in the health service area." Indeed, there was great confusion as to the meaning of "all providers" on the part of those responsible for enforcing and administering the certificate of need program within HRS. Between 1977 and 1979, four applicants were able to satisfy the other mitigating or extenuating circumstance regarding accessibility by demonstrating that the existing home health agencies were unwilling to service indigent or Medicaid patients, whom the applicants promised to serve. A survey of 100 home health agencies in Florida revealed that only six of the 100 had an average active census greater than 300 during the second quarter of 1980. A home health agency provides health and medical services and supplies to individuals in the individual's own home. Such services include part-time or intermittent nursing care, medical social services, nutritional guidance, physical, occupational or speech therapy and homemaker services. While an agency may not provide skilled nursing or medical services to a patient without a physician's order, the spectrum of services provided by any particular agency is a matter of choice. Inasmuch as patients are visited and treated in their own place of residence, the home health care business in not capital intensive. In terms of equipment and facilities, the initial capitalization of a home health care agency is not very high and the costs are variable and adjustable as compared with other health care facilities. Since there are low fixed costs involved in operating a home health agency, economies of scale are generally not expected. An agency may expand its services and its service area with relatively little expense. Rule 10-5.11(14), as amended, does not provide for a consideration of the level of care or the quality of care being offered by the existing facilities or by the applicant for a new facility. It does not measure the efficiency of existing agencies with respect to the size or level of services offered. Given the facts that the "rule of 300" does not purport to measure or quantify the number of patients needing home health care or the quality, size or scope of services offered by existing agencies, the rule does not even provide an effective measure of utilization of existing agencies. It does not require consideration of the financial feasibility of the applicant's proposal. The rule does not consider principles of cost containment for the public, as opposed to other providers in the area. While the rule does not prohibit a consideration of these factors if the 300 figure is met, it does, on its face, preclude the approval of a new home health agency when the 300 figure is not met, absent the two "mitigating or extenuating circumstances" relating to access and cost containment for other providers.
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 =================================================================
Findings Of Fact MPP presently provides home health services to residents of Hillsborough and Polk Counties from its offices located in Tampa and Lakeland. Without these certificates of need herein requested MPP is not authorized to provide home health services to Medicare and Medicaid eligible persons. MPP is qualified to provide the proposed services. Walker is a non-profit 122-bed acute care community hospital located in Avon Park, Highlands County, Florida. Walker has provided health care services to residents of Highlands County since 1947. Although Walker does not currently provide home health services in Highlands County, it is fully qualified to provide the proposed services. Home health agencies (HHA) differ significantly from other health care providers chiefly in the fact that they are labor intensive and not capital intensive services. Most home health agencies contract with nurses, therapists, and other personnel to provide the services on an as-needed basis. Once an office is established with the necessary communications and accounting facilities, expansion of the agency is accomplished merely by signing up as many nurses, therapists, etc., as is needed to provide home health services as required. Theoretically, one home health agency could provide all of the services required in a district, subject only to the travel time needed for the in-home provider to reach the patient and the accessibility of the agency office to the hospital or doctor prescribed in the home health treatment. A proposed rule prevents this from occurring by the rule formula which limits the divisor in the formula (number of expected medical care visits per agency per year) to 21,000 expected visits per agency, which is then multiplied by a constant. Thus, if there were only one home health agency in a district and it was providing 65,000 home Medicare visits per year, use of the proposed rule methodology would show a need for additional HHAs. Although both Petitioners challenged DHRS' non-rule policy in determining the need for HHAs in District VI, all of the need calculations they submitted are predicated upon the need methodology as contained in proposed Rule 10-5.11(14), F.A.C., modified by the Petitioners using 1983 use rates and disregarding the "crossover" agencies. No need calculations based on any other methodology were presented. The methodology in the proposed rule provides [N]eed equals the [G]ross number of HHAs to be allocated in the district less the number of [L]icensed and approved HHAs in the district, or N = G - L. "G" is itself expressed by the formula MV x (A+B)/S where: MV = The 1982 statewide mean number of visits per Medicare home health care service user across age groups (31.5) A = The projected district population of persons 65 years or older times the Medicare home health services utilization rate standard for that population group [POPA x .0506]; B = The projected district population of persons less than 65 years of age who are estimated to be disabled times the Florida home health services utilization rate standard for disabled medical beneficiaries [POPB x .01755 x .0297]; S = The number of expected Medicare visits per agency per year. This number is obtained by adding to the base agency size of 9,000 visits per year an additional number of visits equal to the total number of Medicare visits in the projected year, divided by the base agency size, multiplied by a factor denoted as C. C is a standard which is set at 270 for applications timely filed in calendar years 1984 and 1985; 225 for applications timely filed in calendar years 1986 and 1987 and 180 for applications timely filed in calendar year 1988 or beyond. However, if the result of the calculation of S exceeds 21,000 visits projected, S shall be assigned a value of 21,000. The methodology employed in need calculation is based on a number of factors. MV (31.5) is a standard which is based on information obtained from the Health Care Finance Administration (HCFA) for Florida in 1982. If this standard is recomputed using 1983 HCFA data, MV is 33.3. The second, the Medicare home health care utilization rate standard (.0506), is also based on information reported by HCFA for Florida for 1982. The estimate for the proportion of the Florida population which is disabled (.01755) was also derived from the 1982 data for Florida, as was the factor which specifies the home health services utilization standard for disabled Medicare beneficiaries (.0297). The base agency size (9,000 visits annually), which is used in determining "S", the number of expected Medicare visits per agency per year, was developed by the HRS Office of Comprehensive Health Planning, based on a statistical analysis of data related to agency size, relative efficiency in terms of cost, and economies of scale. That analysis revealed that, in the range of about 9,000 visits, the first reasonable economies of scale begin to accrue in the operation of a home health agency. Therefore, this level of service provision was selected as the agency standard. The maximum level "S" can reach (21,000 visits annually) was found to be the point at which the major economies of scale appear to have been achieved. Thus, this level was selected as the maximum for the agency standard. The values as selected for "C" represent 3.0 percent, 2.5 percent, and 2.0 percent of the base agency size standard (9,000 visits annually). This factor is used to adjust "S" over time, its effect is that of increasing the number of home health agencies, which are projected as needed, gradually over a three-year period. It was selected as a standard based upon HRS' policy to encourage the development of health care markets in an orderly manner and to avoid the disruptive impact of a flood of new service providers immediately. The "C" factor changes over a time, which means that "S" will grow smaller and thus the gross number of agencies will increase. Thus, even MPP's expert witness agrees that the rule is not frozen. Rather, it is dynamic, though conservative, in effect. In fact, the result of the calculations of "G" (gross number of agencies) approximates the current, existing inventory of home health care agencies in Florida. The Local Health Plan for District VI makes no provision for establishing subdivisions within the district. Accordingly, an HHA located in any county in District VI can serve the entire district subject only to geographical limitations. There are 16 HHAs domiciled in District VI and six HHAs domiciled in adjacent districts but licensed to serve a contiguous county in District VI. These so-called crossover agencies presently serve or are licensed to serve Medicare patients in District VI. Counting these crossover agencies and the number of existing agencies, there are 22 licensed and approved HHAs in District VI. Using the proposed rule methodology and applying the estimated population for 1987 (two years from date of hearing) gives a calculated gross need of 19. Under the proposed rule methodology, there is presently a surplus of three HHAs in District VI. Under the proposed rule, these crossover agencies would have to apply for expedited review of an application to establish an office in the county in which they are licensed but not domiciled. Exactly what this review will consist of is subject to some dispute. However, until the proposed rule goes into effect, there is no occasion for these crossover agencies to seek a certificate to do that for which they are currently licensed. If the 1983 data from HCFA, which was the latest usage data available at the time of the hearing, is substituted for the 1982 data prescribed by the proposed methodology, and the overall district need is recomputed, an overall need of 21.63 is arrived at for District VI in 1987. This rounds off to 22 and is the same as the present number of licensed and approved HHAs in District VI. Both Petitioners contend that the six crossover agencies should not be counted in the total number of licensed and approved HHAs in District VI because there is no guarantee they now serve or will ever serve patients in District VI. If these agencies are excluded, there is a clear need under the proposed rule methodology for the three HHAs here being applied for. Under the proposed rule, each of these crossover agencies must apply within a time certain (60 days) following the effective date of the proposed rule for certificates of need to open an office in the county for which they are licensed. These crossover agencies may have grandfather rights to serve Medicare patients in those counties in which they are licensed and, if so, these rights cannot arbitrarily be abrogated. Petitioners especially contest counting the three Gulf Coast Home Health Services corporations as three crossover agencies because each of them is licensed to serve only Hillsborough County in District VI; because they have the same directors, corporate officers and owners; and because all of them would be unlikely to open additional offices in Hillsborough County. Nevertheless, each is a separate and distinct entity with its own corporate identity. As such, each has the same right to serve Medicare patients in Hillsborough County as does Total Professional Care, Inc., another crossover agency so licensed. The services provided by these crossover agencies, insofar as they provided services to Medicare patients in the counties in District VI in which they are licensed, are included in the usage data obtained from HCFA. This usage data, mean number of visits (MV), is a principal factor in the numerator of the methodology formula above discussed. Thus, the district usage includes those services provided by these crossover agencies. No evidence was presented regarding the actual number of visits provided to District VI patients by these crossover agencies. Accordingly, it is inconsistent to accept the proposed rule methodology and exclude the crossover agencies in the count of existing agencies to determine the gross number of HHAs needed. Respondent's contention that these crossover agencies are akin to health care providers who have been issued a CON but are not yet licensed and in operation is not fully concurred with. Those providers issued a CON are counted in the number of authorized and licensed beds before their facilities commence operations those facilities are usually capital intensive rather than labor intensive as are HHAs and a longer delay in commencing operations is required for those types of facilities than for an HHA due simply to the time needed to construct those facilities. In other respects, those approved but not yet licensed facilities are similar to these crossover agencies in that some of these crossover agencies may have grandfather rights to open an office in the county in District VI in which they are presently licensed. In this respect they are like the applicant who has been issued a CON to operate a nursing home but subsequently decides to forego construction because of unexpected costs or other reasons. Each would lose its right to operate the health care facility by reason of failure to timely comply with rule requirements. However, until such time as those rights are forfeited they should be counted in determining the number of beds or other health care facilities that are needed in, the district in the year those facilities are programmed to be in operation. Changes in Medicare reimbursement to health care providers, principally hospitals, by the advent of the DRG (Diagnostic Related Group) has led to an increase in demand for the services provided by home health agencies. This is especially true for surgery patients who can be released from a hospital sooner if dressing changes and nursing care can be provided at the patient's home. Under the DRG method of reimbursement, the hospital is paid a Flat fee for Medicare patients for a specific diagnosis and treatment. The sooner the patient can be released from the hospital, the less will be the cost to the hospital for providing treatment. If, for example, the cost for a hospital bed is $400 per day and the DRG for the patient's ailment is $2,000, if the patient is kept in the hospital for five days, the total payment received will exactly cover the cost of the room. If the patient is kept in the hospital more than five days the hospital will lose money, while if he is discharged before the five days the hospital will make a profit Walker's primary contention is that it should be allowed to operate an HHA so it can discharge surgical patients sooner and provide the needed care at the patient's home by persons supervised by the hospital doctors. This would allow Walker to make more profit and thereby have more funds available to take care of indigent patients. Walker presented several witnesses who averred that a hospital-associated HHA provides better care than does a free- standing HHA. All these witnesses are employees of Walker and this self-serving testimony is given little weight. Both the hospital-run HHA and the free-standing HHA will employ part-time workers to provide the home health care prescribed. There is no logical reason to assume the hospital-affiliated HHA will employ better qualified nurses, etc. to provide the home health services needed than will the free-standing HHA. Medicare reimburses hospital-based home health agencies at a higher level than free- standing HHAs. This is an add-on of approximately 13 percent over the reimbursement received by free-standing HHAs. This is based on the cost of providing services which is generally higher for hospital-based HHAs. Walker also raised the issue of availability of occupational therapy, respiratory therapy, and medical-social workers. One of the two agencies operating in Highlands County, Highlands County HHA, does not provide these services. The other, Upjohn, is newly authorized to provide home health services in Highlands County. In other counties in Florida in which Upjohn is authorized to provide home health services it provides a broad range of services to home health patients including occupational therapy, respiratory therapy, and medical, social workers. Respondent's expert witness opined that such services were now available in Highlands County. This opinion was based in part on hearsay evidence that the witness received from an Upjohn representative that such services are provided. No direct testimony was presented that Upjohn did, or did not, provide the services not presently provided by Highlands County HHA. Accordingly, there was no credible evidence to rebut the opinion of HRS witnesses that these services are available in Highlands County. MPP's offices are currently available on a 24-hour per day basis and this will continue if the application is granted. Walker is also available 24 hours per day and access to home health personnel will also be available. MPP has committed to allocate 2 percent of its gross annual visits from each office to Medicare patients. In addition, one totally uncompensated visit will be provided to an indigent for every 20 Medicare visits. MMP presented no evidence that it is currently providing uncompensated services. Walker, which is a church owned and backed non-profit hospital, projects that 7.5 percent of its home health agency visits will be to indigent persons. This mirrors the current hospital-provided services to Medicaid patients. Walker's primary contention, that because hospital- based HHAs provide better care or better supervised care doctors will be more willing to release patients sooner than they.: otherwise would if there is no hospital-based HHA available, is not supported by credible evidence. It is simply not credible that a nurse employed by a hospital-based HHA is more competent, trustworthy, or capable than is the same nurse when employed by free-standing HHA. The chance of losing hospital records when a patient is transferred to a free-standing HHA would appear no greater than when the patient is transferred to a hospital-based released from the hospital whether home health services is thereafter provided or not. In view of the confidentiality of patient records, it would be expected that these records be retained in the hospital files. Absent a rule or policy to provide a methodology to determine need for additional HHAs, new applicants for certificates have a nearly impossible task of proving need if there are existing HHAs which oppose the application. This is so because of the nature of HHAs that they can expand to cover all needs simply by engaging more part-time personnel to provide the home health services needed in the community, county, or even district.
