The Issue Whether there is need for a new Pediatric Heart Transplant and/or Pediatric Heart and Lung Transplant program in Organ Transplant Service Area (OTSA) 3; and, if so, whether Certificate of Need (CON) Application No. 10471 (heart) and/or 10472 (heart and lung), filed by The Nemours Foundation, d/b/a Nemours Children’s Hospital (Nemours or NCH), to establish a Pediatric Heart Transplant and/or Pediatric Heart and Lung Transplant program, satisfy the applicable statutory and rule review criteria for award of a CON.
Findings Of Fact Based upon the demeanor and credibility of the witnesses and other evidence presented at the final hearing and on the entire record of this proceeding, the following Findings of Fact are made: The Parties The Applicant, Nemours Nemours Children’s Hospital is a licensed Class II specialty children’s hospital located in Orange County, Health Planning District 7, Subdistrict 7-2, OTSA 3, which is owned and operated by The Nemours Foundation. Nemours is licensed for 100 beds, including 73 acute care, nine comprehensive medical rehabilitation, two Level II neonatal intensive care unit (NICU), and 16 Level III NICU beds, and is a licensed provider of pediatric inpatient cardiac catheterization and pediatric open-heart surgery. As the primary beneficiary of the Alfred I. duPont Testamentary Trust established in the will of Alfred duPont, the Foundation was incorporated in Florida in 1936. The Foundation set out to provide children and families medical care and services, its mission being “[t]o provide leadership, institutions, and services to restore and improve the health of children through care and programs not readily available, with one high standard of quality and distinction regardless of the recipient’s financial status.” Foundation assets reached $5.5 billion, by the end of 2015. The Foundation has funded $1.5 billion of care to Florida’s pediatric population through subspecialty pediatric services, research, education, and advocacy. Nemours has established a pediatric care presence throughout the State of Florida. Nemours operates over 40 outpatient clinics throughout Florida that offer primary care, specialty care, urgent care, and cardiac care services to pediatric patients in central Florida, Jacksonville, and the panhandle region. Nemours also provides hospital care to pediatric inpatients at Nemours Children’s Hospital in Orlando, as well as through affiliations with Wolfson’s Children’s Hospital in Jacksonville, West Florida Hospital in Pensacola, and numerous hospital partners in central Florida. The resources Nemours offers in the greater Orlando area are especially significant with 17 Primary Care Clinics, five Urgent Care Clinics, 10 Specialty Care Clinics, nine Nemours Hospital partners, and, of course, NCH itself. These clinics are located throughout OTSA 3 where Nemours determined access to pediatric care was lacking, including Orlando, Melbourne, Daytona Beach, Titusville, Kissimmee, Lake Mary, and Sanford, as well as neighboring Lakeland. The clinics are fully staffed with hundreds of Nemours-employed physicians who live in the clinic communities. Through these satellite locations, as well as the Nemours CareConnect telemedicine platform, Nemours is able to bring access to its world-class subspecialists located at NCH to children throughout the State of Florida who otherwise would not have access to such care. Nemours was established to provide state of the art medical care to children through its integrated model. Nemours’ development has been and continues to be driven by its mission and objective to be a top-tier, world-class pediatric healthcare system. NCH is the first completely new “green field” children’s hospital in the United States in over 40 years, allowing Nemours to integrate cutting-edge technology and a patient-centered approach throughout. Nemours has created a unique integrated model of care that addresses the needs of the child across the whole continuum, connecting policy and prevention, to the highest levels of specialized care for the most complex pediatric patients. From its inception, Nemours envisioned the development of a comprehensive cardiothoracic transplant program as proposed by the CON applications at issue in this proceeding. NCH is located in the Lake Nona area, just east of downtown Orlando in a development known as Medical City. Medical City is comprised of a new VA Hospital, the University of Central Florida (UCF) College of Medicine and School of Biomedical Sciences, the University of Florida (UF) Research and Academic Center, the Sanford Burnham Medical Research Institute, and a CON-approved hospital, which is a joint venture between UCF and AHCA, which will serve as UCF’s teaching hospital. Medical City is intended to bring together life scientists and research that uses extraordinarily advanced technology. Co- location in an integrated environment allows providers and innovators of healthcare, “the brightest minds,” so to speak, to interact and to share ideas to advance healthcare and wellness efforts. Agency for Health Care Administration AHCA is the state health-planning agency that is charged with administration of the CON program as set forth in sections 408.031-408.0455, Florida Statutes. Context of the Nemours Applications Pursuant to Florida Administrative Code Rule 59C-1.044, AHCA requires applicants to obtain separate CONs for the establishment of each adult or pediatric organ transplantation program, including: heart, kidney, liver, bone marrow, lung, lung and heart, pancreas and islet cells, and intestine transplantations. “Transplantation” is “the surgical grafting or implanting in its entirety or in part one or more tissues or organs taken from another person.” Fla. Admin. Code R. 59A-3.065. Heart transplantation, lung transplantation, and heart/lung transplantation are all defined by rule 59C-1.002(41) as “tertiary health services,” meaning “a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost effectiveness of such service.” AHCA rules define a “pediatric patient” as “a patient under the age of 15 years.” Fla. Admin. Code R. 59C-1.044(2)(c). AHCA rules divide Florida into four OTSAs, corresponding generally with the northern, western central, eastern central, and southern regions of the state. Fla. Admin. Code R. 59C-1.044(2)(f). The programs at issue in this proceeding will be located in OTSA 3, which is comprised of Brevard, Indian River, Lake, Martin, Okeechobee, Orange, Osceola, Seminole, and Volusia Counties. Currently, there are no providers of PHT in OTSA 3, and there are no approved PHLT programs statewide. The incidence of PHT in Florida, as compared to other types of solid organ transplants, is relatively small. The chart below sets forth the number of pediatric (ages 0-14) heart transplant discharges by year for the four existing Florida PHT programs during Calendar Years (CY) 2013 through 2016, and the 12-month period ending June 2017: HOSPITAL HEART TRANSPLANT CY 2013 CY 2014 CY 2015 CY 2016 12 MONTHS ENDING JUNE 2017 All Children’s Hospital 7 14 9 8 7 UF Health Shands Hospital 6 8 15 15 9 Memorial Regional Hospital 5 5 5 7 4 Jackson Health System 2 2 1 4 1 Total 20 29 30 34 21 The above historic data demonstrates that the incidence of PHT statewide is relatively rare, and does fluctuate from program to program and from year to year. As can be seen, the most recent available 12-month data reflects that only 21 PHTs were performed during that time, for an average program volume of only 5.25 cases. Florida has more existing and approved PHT programs than every other state in the country except California, which has more than double the pediatric population of Florida. And like Florida, two of the California programs are extremely low- volume programs. Additionally, evidence regarding the number of PHLT patients demonstrated just how rare this procedure is. From 2013 to 2016, there was an annual average of only four PHLTs nationally, with only one actual transplant on a Floridian. Nemours’ health planner stated that although Nemours projected in its application that it would perform one heart/lung procedure each year, it is a “very low-volume service,” and Nemours in actuality expects that there will be years with zero volume of PHLT. The CON Applications Nemours filed its applications for heart transplantation, heart/lung transplantation, and lung transplantation in the second Other Beds and Programs Batching Cycle of 2016. Nemours is proposing the development of a comprehensive cardiothoracic transplant program, which will be the only such program in Florida. This will be achieved by combining three types of transplant services (heart, lung, and heart/lung) in one comprehensive cardiothoracic transplant program. Each application was conditioned on the development of all three transplantation programs. Nemours is located in OTSA 3, where there is currently no PHT provider, PLT provider, or PHLT provider. There are, however, three providers of pediatric open-heart surgery and pediatric cardiac catheterization, and a large, growing pediatric population. Unlike any other facility in Florida, the Nemours Cardiac Center (Cardiac Center) is uniquely organized to treat all forms of congenital heart disease. The Cardiac Center employs a “programmatic approach” to offer the most beneficial environment and the finest care available for pediatric patients. The Cardiac Center, physically located at NCH, throughout Florida, is organized as a single Department of Cardiovascular Services to house Cardiac Surgery, Cardiac Anesthesia, Cardiac Intensive Care Unit (ICU), and Cardiology. Cardiac Center physicians throughout Florida are organized as a single entity with the goal of providing the highest quality, patient-centered care to all patients without the usual barriers created by the departmental “silos.” The entire Cardiac Center clinical team, including nurses and physicians, is dedicated solely to the special challenges of congenital heart abnormalities and makes the care of children with heart disease the life’s work of team members. The fully integrated organizational structure permits the team to take shared responsibility for all aspects of the delivery of quality care to these pediatric patients from admission to discharge. The Cardiac Center holds weekly patient consensus conferences, where all providers, including physicians, nurses, and the patients’ caregivers, participate in case reviews of all inpatients and those patients scheduled for surgery or catheterization. The Cardiac Center is “state of the art” with a designated cardiovascular operating room, a designated cardiovascular lab that includes an electrophysiology lab, and a dedicated comprehensive care unit. In addition, The Foundation has furthered the commitment to the Cardiac Center by funding an additional $35 million expansion to the sixth floor of NCH, adding an additional 31 inpatient beds, an additional operating room, and a comprehensive cardiovascular intensive care unit. Dr. Peter D. Wearden joined Nemours in 2015 as the chief of cardiac surgery, chair of the Department of Cardiovascular Services, and director of the Cardiac Center at Nemours. Dr. Wearden will serve as director of the Comprehensive Cardiothoracic Transplant Program at Nemours and will be instrumental in the development and implementation of the program. Dr. Wearden was recruited from the Children's Hospital of Pittsburgh (CHP), where he served as the surgical director of Heart, Lung, and Heart/Lung Transplantation. He was also the director of the Mechanical Cardiopulmonary Support and Artificial Heart Program. CHP rose to a US News and World Report top 10 program during Dr. Wearden’s tenure. CHP is at the forefront of organ transplantation and is where the first pediatric heart/lung transplantation was performed. Dr. Wearden is a trained cardiothoracic surgeon who completed fellowships in both cardiothoracic surgery (University of Pittsburgh) and Pediatric and Congenital Heart Surgery (Hospital for Sick Children, Toronto, Canada). He is certified by the American Board of Thoracic Surgery and holds additional qualifications in Congenital Heart Surgery from that organization. In his tenure as a board-certified pediatric transplant specialist, he has participated in over 200 pediatric cardiothoracic transplantations, of which he was the lead surgeon in over 70. In addition, he has procured over $20 million in National Institutes of Health research funding since 2004 specific to the development of artificial hearts and lungs for children and their implementation as a live-saving bridge to transplantation. Dr. Wearden was a member of the clinical team that presented to the Food and Drug Administration (FDA) panel for approval of the Berlin Heart, the only FDA-approved pediatric heart ventricular assist device (VAD)1/ currently available, and he proctored the first pediatric artificial heart implantation in Japan in 2012. A VAD is referred to as “bridge to transplant” in pediatric patients because the device enables a patient on a waiting list for a donated heart to survive but is a device on which a child could not live out his or her life. Both utilization of VADs and heart transplantation procedures are in the “portfolio of surgical interventions” that can save the life of a child with heart failure. Dr. Wearden is an international leader in the research and development of VADs. Victor Morell, an eminent cardiac surgeon and chief of Pediatric Cardiac Surgery at CHP, testified that Dr. Wearden’s presence in Orlando alone and the work that he will be able to do with VADs and a PHT program will likely save lives. Many of the physicians that comprise the Nemours Cardiac Center transplant team not only have significant transplant experience, but also have experience performing transplants together. These physicians came with Dr. Wearden from CHP, were trained by Dr. Wearden, or otherwise worked with Dr. Wearden at some point in their careers. The physicians recruited to the Nemours transplantation team were trained at or hail from among the most prestigious programs in the country. For example, Dr. Kimberly Baker, a cardiac intensivist, was trained by Dr. Wearden in the CHP ICU. Dr. Constantinos Chrysostomou, Nemours’ director of cardiac intensive care, worked with Dr. Wearden at CHP, and has experience starting the pediatric ICU in Los Angeles at Cedar Sinai Hospital. Dr. Steven Lichtenstein, chief of cardiac anesthesia, held the same position at CHP for 12 years before he was recruited to Nemours. Dr. Karen Bender, a cardiac anesthesiologist, was recruited by Dr. Wearden from the Children’s Hospital of Philadelphia – one of the leading programs in the country. Dr. Michael Bingler, a cardiac interventionalist, was at Mercy Children’s Hospital in Kansas City for eight years. Dr. Adam Lowry of the Nemours cardiac intensive care center previously trained at both Texas Children’s Hospital (the number one program in the country) and Stanford. The 11 physicians that comprise the Cardiac Center’s Cardiothoracic Physician Team have collectively participated in 1,146 cardiothoracic transplantations. These physicians came to Nemours to care for the most acute, critically ill patients, including those requiring PHT. In addition to the physician team, the expertise and skill of the non-physician staff in the catheterization lab, the operating room, and the cardiac ICU are crucial to a successful program. Dr. Dawn Tucker is the administrative director of NCH’s Cardiac Center and heads the nursing staff for NCH’s Cardiac Center, which includes 23 registered nurses with transplant experience. Dr. Tucker holds a doctorate of Nursing Practice and was formerly the director of the Heart Center at Mercy Children’s Hospital in Kansas City, where she oversaw the initiation of a PHT program. The average years of experience for total nursing care in cardiac units across the nation is two years. The average years of experience in the Nemours Cardiac Center is eight years. Medical literature shows the greater the years of nursing staff experience, the lower the mortality and morbidity rates. The nursing staff at Nemours, moreover, has extensive experience in dealing not only with pediatric cardiac patients, but with pediatric heart transplants as well. The Cardiac Center’s cardiothoracic nursing staff has over 220 years of collective cardiothoracic transplant experience. Nemours operates a “simulation center” that allows the Cardiac Center to simulate any type of cardiac procedure on a model patient before performing that procedure on an actual patient. The model patient’s “heart” is produced using a three- dimensional printer that creates a replica of the heart based on MRI’s or other medical digital imaging equipment. These replica hearts are printed on-site, using the only FDA-approved software for such use, and are ready for use in the simulation center within a day after medical imaging. Nemours Cardiac Center currently performs what the Society of Thoracic Surgeons has coined “STAT 5” cardiac procedures. STAT 5 cardiac procedures are the most complex; STAT 1 procedures are the least complex. A PHT is a STAT 4 procedure. Since Dr. Wearden’s arrival at the Nemours Cardiac Center, there have been no patient mortalities. The uncontroverted evidence established that Nemours has assembled a high-quality, experienced, and unquestionably capable team of physicians and advanced practitioners for its cardiothoracic transplantation programs and is capable of performing the services proposed in its applications at a high level. UF Health Shands While not a party to this proceeding,2/ UF Health Shands’ (Shands) presence at the final hearing was pervasive. AHCA called numerous witnesses affiliated with Shands in its case-in-chief. The scope of the testimony presented by Shands- affiliated witnesses was circumscribed by Order dated December 13, 2017 (ruling on NCH’s motion in limine) that: At hearing, the Agency may present evidence that the needs of patients within OTSA 3 are being adequately served by providers located outside of OTSA 3, but may not present evidence regarding adverse impact on providers located outside of OTSA 3. Baycare of Se. Pasco, Inc. v. Ag. for Health Care Admin., Case No. 07-3482CON (Fla. DOAH Oct. 28, 2008; Fla. AHCA Jan. 7, 2009). UF Health Shands Hospital is located in Gainesville, Florida. UF Health Shands Children’s Hospital is an embedded hospital within a larger hospital complex. Shands Children’s Hospital has 200 beds and is held out to the public as a children’s hospital. The children’s hospital has 72 Level II and III NICU beds. Unlike Nemours, Shands offers obstetrical services such that babies are delivered at Shands. It also has a dedicated pediatric intensive care unit (PICU) as well as a dedicated pediatric cardiac intensive care unit. The Shands Children’s Hospital has its own separate emergency room and occupies four floors of the building in which it is located. It is separated from the adult services. Shands Children’s Hospital is nationally recognized by U.S. News & World Report as one of the nation’s best children’s hospitals. The children’s hospital has its own leadership, including Dr. Shelley Collins, an associate professor of pediatrics and the associate chief medical officer. As a comprehensive teaching and research institution, Shands Children’s Hospital has virtually every pediatric subspecialty that exists and is also a pediatric trauma center. The children’s hospital typically has 45 to 50 physician residents and 25 to 30 fellows along with medical students. Over $139 million has been awarded to Shands for research activities. As a teaching hospital, Shands is accustomed to caring for the needs of patients and families that come from other parts of the state or beyond. Jean Osbrach, a social work manager at Shands, testified for AHCA. Ms. Osbrach oversees the transplant social workers that provide services to the families with patients at Shands Children’s Hospital. Ms. Osbrach described how the transplant social workers interact with the families facing transplant from the outset of their connection with Shands. They help the families adjust to the child’s illness and deal with the crisis; they provide concrete services; and these social workers help the families by serving as navigators through the system. These social workers are part of the multidisciplinary team of care, and they stay involved with these families for years. Shands is adept at helping families with the issues associated with getting care away from their home cities. Shands has apartments specifically available in close proximity to the children’s hospital and relationships with organizations that can help families that need some financial support for items such as lodging, transportation, and gas. Ms. Osbrach’s ability to empathize with these families is further enhanced because her own daughter was seriously ill when she was younger. Ms. Osbrach testified that, while she was living in Gainesville, she searched out the best options for her child and decided that it was actually in Orlando. Despite the travel distance, she did not hesitate to make those trips in order to get the care her child needed at that time. The Shands Children’s Hospital is affiliated with the Children’s Hospital Association, the Children’s Miracle Network, the March of Dimes, and the Ronald McDonald House Charities. Shands operates ShandsCair, a comprehensive emergency transport system. ShandsCair operates nine ground ambulances of different sizes, five helicopters, and one fixed-wing jet aircraft. ShandsCair does over 7,000 transports a year, including a range of NICU and other pediatric transports. ShandsCair is one of the few services in the country that owns an EC-155 helicopter, which is the largest helicopter used as an air ambulance. This makes it easier to transport patients that require a lot of equipment, including those on extracorporeal membrane oxygenation (ECMO). Patients on ECMO can be safely transported by ground and by air by ShandsCair. Shandscair serves as a first responder and also provides facility-to- facility transport. It has been a leader in innovation. The congenital heart program at Shands includes two pediatric heart surgeons, as well as pediatric cardiologists Dr. Jay Fricker and Dr. Bill Pietra, both of whom testified for AHCA. Dr. Fricker did much of his early work and training at the Children’s Hospital of Pittsburgh, and came to the University of Florida in 1995. He is a professor and chief of the Division of Cardiology in the Department of Pediatrics at Shands. He is also the Gerold L. Schiebler Eminent Scholar Chair in Pediatric Cardiology at UF. He has been involved in the care of pediatric heart transplant patients his entire career. Dr. Bill Pietra received his medical training in Cincinnati and did his early work at several children’s hospitals in Colorado. He came to the University of Florida and Shands in July 2014 and is now the medical director, UF Health Congenital Heart Center. Shands performed its first pediatric heart transplant in 1986. Shands treats the full range of patients with heart disease and performs heart transplants on patients, from infants through adults, with complex congenital heart disease. Shands provides transplants to pediatric patients with both congenital heart defects and acquired heart disease (cardiomyopathy). Shands will accept the most difficult cases, including those that other institutions will not take. Data presented by AHCA dating back to the beginning of 2014 demonstrate that Shands has successfully transplanted numerous patients that were less than six months old at the time of transplantation. This data also demonstrates that Shands serves all of central and north Florida, as well as patients that choose to come to Shands from other states. PHT patients now survive much longer than in the past, and in many cases, well into adulthood. Because Shands cares for both adult and pediatric patients, it has the ability to continue to care for PHT patients as they transition from childhood to adulthood. Managed care companies are now a significant driver of where patients go for transplantation services. Many managed- care companies identify “centers of excellence” as their preferred providers for services such as PHT. Shands is recognized by the three major managed-care companies that identify transplant programs as a center of excellence for PHT services. AHCA’s Preliminary Decision Following AHCA’s review of Nemours’s applications, as well as consideration of comments made at the public hearing held on January 10, 2017, and written statements in support of and in opposition to the proposals, AHCA determined to preliminarily deny the PHT and PHLT applications, and to approve the PLT application. AHCA’s decision was memorialized in three separate SAARs, all dated February 17, 2017. Marisol Fitch, supervisor of AHCA’s CON and commercial-managed care unit, testified for AHCA. Ms. Fitch testified that AHCA does not publish a numeric need for transplant programs, as it does for other categories of services and facilities. Rather, the onus is on the applicant to demonstrate need for the program based on whatever methodology they choose to present to AHCA. In addition to the applicant’s need methodology, AHCA also looks at availability and accessibility of service in the area to determine whether there is an access problem. Finally, an applicant may attempt to demonstrate that “not normal” circumstances exist in its proposed service area sufficient to justify approval. Statutory Review Criteria Section 408.035(1) establishes the statutory review criteria applicable to CON Applications 10471 and 10472. The parties have stipulated that each CON application satisfies the criteria found in section 408.035(1), (d), (f), and (h), Florida Statutes. The only criteria at issue essentially relate to need and access. However, the Agency maintains that section 408.035(1)(c) is in dispute to the extent that center transplant volume as a result of Nemours’ approval would lead to or correlate with negative patient outcomes. AHCA believes that there is no need for the PHT or PHLT programs that Nemours seeks to develop because the needs of the children in the Nemours service area are being met by other providers in the state, principally Shands and Johns Hopkins All Children’s Hospital. Section 408.035(1)(a) and (b): The need for the health care facilities and health services being proposed; and the availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the district of the applicant. Florida Administrative Code Rule 59C-1.044(6)(b).3/ The criteria for the evaluation of CON applications, including applications for organ transplantation programs, are set forth at section 408.035 and rule 59C-1.044. However, neither the applicable statutes nor rules have a numeric need methodology that predicts future need for PHT or PHLT programs. Thus, it is up to the applicant to demonstrate need in accordance with rule 59C-1.044. There are four OTSAs in Florida, numbered OTSA 1 through OTSA 4. NCH is located in OSTA 3, which includes the following counties: Seminole, Orange, Osceola, Brevard, Indian River, Okeechobee, St. Lucie, Martin, Lake, and Volusia. (See § 408.032(5), Fla. Stat; Fla. Admin. Code R. 59C- 01.044(2)(f)3.) OTSA 3 also generally corresponds with the pediatric cardiac catheterization and open-heart surgery service areas defined by AHCA rule. (See Fla. Admin. Code R. 59C- 1.032(2)(g) and 59C-1.033(2)(h)). Currently, there is no provider of PHT in OTSA 3, but there are three providers of pediatric cardiac catheterization and pediatric open-heart surgery: Orlando Health Arnold Palmer Hospital for Children; Florida Hospital for Children; and Nemours. There are no licensed providers of PHLT anywhere in the State of Florida. There are four existing providers and one approved provider of PHT services in Florida: UF Shands in OTSA 1; Johns Hopkins All Children’s Hospital in OTSA 2; Jackson Memorial Hospital in OSTA 4; and Memorial Regional Hospital, d/b/a Joe DiMaggio’s Hospital in OTSA 4; and a third approved program in OTSA 4, Nicklaus Children’s Hospital, which received final approval from AHCA in August 2017. As noted above, there is no fixed-need pool published for PHT, PHLT, or PLT programs. Alternatively, AHCA follows rule 59C-1.008(2)(e)2., which requires consideration of population demographics and dynamics; availability, utilization and quality of like services in the district, subdistrict, or both; medical treatment trends; and market conditions. To quantify the need for a new PHT program in District 7, OTSA 3, Nemours created and presented a methodology that started with the statewide use rate in its projected first year. Then for the second year, Nemours aggressively increased the use rate to the highest rate in any of the other transplant service areas in the state. Then, in an even more aggressive (and unreasonable) assumption, Nemours projected that it would essentially capture all of the cases in OTSA 3 by the second year of the program. In its application, the assumptions resulted in a projection that Nemours would do four transplants in the first year of operation and eight in the second. These projections fall short of the rule requirement that the applicant project a minimum of 12 transplants per year by the second year of operation. Fla. Admin. Code R. 59C-1.044(6)(b)2. At hearing, Nemours updated (increased) those first and second year projections to 7 and 13 cases, respectively. However, these updated projections included one child, aged 15 to 17, in year one, and two in year two. There are several reasons these projections lack credibility. First, as noted, Nemours assumed a near- 100 percent market share based on the highest use rate in the state by just year two. Second, when Nemours prepared its update, it used the most recent calendar year data. However, this was not the most current data. Calendar Year 2016 reflected 34 cases statewide, but that number had dropped to 21 for the most recent 12-month period available at the time of the hearing. Use of this most recent 12-month data would have significantly decreased the Nemours PHT volume projections. In addition, the projection of 13 cases by year two would place Nemours at a higher PHT case volume than three of the four established programs in the state, and would be at a level that is nearly equivalent to the much more established Shands program. This is not credible, especially considering that Nemours also admitted at hearing that only two OTSA 3 residents received pediatric heart transplants in 2016. The existence of unmet need cannot be based solely on the absence of an existing service in the proposed service area. Fla. Admin. Code R. 59C-1.008(2)(e)3. While Nemours’ own health planner agreed that the absence of a PHT program in OTSA 3 is not itself a basis for finding need, Nemours nevertheless argues that this rule is inapplicable in this proceeding because the title to this subsection of the rule is “Comparative Review” and a portion of this subsection addresses competing applications in the same cycle. As detailed further in the Conclusions of Law section herein, this interpretation is unconvincing and rejected. AHCA interprets this rule provision to apply to those batched applications submitted without the submission of a competing application in the same batching cycle, as with Nemours in this proceeding. Nemours initiated its cardiac catheterization and cardiac surgery program in June/July 2016. In its PHT application, Nemours projected that it would meet or exceed the rule minimum required volumes of 200 cardiac catheterizations and 125 open-heart surgery cases by the end of 2017. Actual volumes achieved by Nemours in CY 2017 were 97 open-heart cases and 196 cardiac catheterizations. The incidence of PHLT is extremely low. During the four calendar years, 2013 through 2016, there were only 16 PHLT transplants performed nationwide. Only one Florida resident received a PHLT during that four-year period, and that was performed in Massachusetts. Also during that four-year period, only three Florida residents were registered for PHLT. There is no evidence in this record as to why two of the three registered Florida residents did not obtain a PHLT. Based on the national use rate for PHLTs from CY 2013 through CY 2016, Nemours projects that it will perform an average of one PHLT per year. Nemours acknowledges that due to the extremely low incidence of PHLTs, there may be some years that no PHLTs are performed at Nemours. Geographic Access There is no evidence of record that families living in central Florida are currently being forced to travel unreasonable distances to obtain PHT services. Indeed, there are five existing or approved programs within the state, with at least two located very reasonably proximate to OTSA 3. According to the analysis of travel distances for PHT patients living in OTSA 3 contained in the Nemours application (Exhibit 15), only some residents located in Brevard and Indian River Counties are not within 120 miles of an existing PHT program. There was agreement that patients that need a PHT are approaching the end-stage of cardiac function, and in the absence of a PHT will very likely die. Accordingly, it is reasonable to infer that the parents of a child living in central Florida and needing a PHT will travel to St. Petersburg or Gainesville for transplant services rather than let their child die because the travel distance is too far. To the contrary, the evidence in this record from witnesses on both sides, as well as common sense, is that families will go as far as necessary to save their child. The notion that there is some pent-up demand for PHT services among central Florida residents (especially when there is no evidence of a single OTSA 3 patient being turned down or unable to access a PHT) is without support in this record. The parents of four pediatric patients testified at the final hearing. Two testified for Nemours. The other two testified for AHCA and were parents of children that received PHTs at Shands. One of the Nemours witnesses was the parent of a child that has not received a transplant. The other received transplant services at Johns Hopkins All Children’s Hospital in St. Petersburg. The parents of the two Shands patients were representative of the two broad categories of PHT patients. One was a patient with a congenital heart defect that lives in Cocoa Beach (Brevard County). The patient likely had the heart defect since birth, but it was not diagnosed until she was six years old. That patient was asymptomatic at the time of diagnosis but deteriorated over a period of years. While she was first seen at Shands, the family had the time and researched other prominent institutions, including Texas Children’s Hospital, Boston Children’s Hospital, Children’s Hospital of Pittsburgh, and the Mayo Clinic in Rochester, Minnesota. They did this because, like all of the parents that testified, they “would have gone to the ends of the earth” to save their child. This family researched the volumes and experience of the programs they considered and looked for what they felt was the best program for their child, and ultimately chose Shands. It was clear that they felt Shands was the right choice. Their daughter received her heart transplant at Shands, is doing well, and is now considering what college to attend. Additionally, this family did not find the two hours and 35 minute travel time from their home in Brevard County to Shands to be an impediment, and actually consider Shands as being relatively close to their home. This testimony supports the obvious truism that obtaining the best possible outcome for a sick child is the paramount goal of any parent. The other parent witness called by AHCA has a daughter that, on Christmas Eve in 2008, went from perfectly healthy to near death and being placed on life support within a 24-hour period. As opposed to a congenital heart defect, this patient had cardiomyopathy. This family lives in Windermere, a suburb of Orlando. She acquired a virus that attacked her heart. She was initially treated at Arnold Palmer Children’s Hospital where she had to be placed on ECMO. From there, she was safely airlifted to Shands while still on ECMO where, upon arrival, the receiving team of physicians informed the family that she was one of the most critically ill children they had ever seen. After an 11-hour open-heart surgery, a Berlin Heart was successfully implanted and kept her alive for four months until an appropriate donor heart became available. This patient also had an excellent outcome and is now a student at the University of Florida. The following exchange summarizes how the child’s mother felt about the inconvenience of having to travel from the Orlando area to Gainesville: Q If a family in Orlando told you, or in your city of residence told you that their child was critically ill and they were worried about having to travel and potentially spend time in Gainesville to get care, what would you tell them? A Well, I would tell them to just take it a day at a time and – when your child is critically ill, convenience never really comes into your mind. What comes into your mind is how do I help my child live. And so you will go anywhere. And it’s just an hour and a half, it just doesn’t matter. When you are talking about saving your child, it means nothing. It literally means nothing. It is clear from the testimony of these two parents that nothing about having a gravely ill child is “convenient.” It creates great stress, but it was also clear that having an experienced provider was more important than just geographic proximity. The mothers of the two Shands patients persuasively spoke of their concerns about further diluting the volumes of the existing programs that could result from approval of a sixth pediatric heart transplant program in Florida, particularly when there are two other programs that are not that far from the Orlando area.4/ While transplantation is not an elective service, it is not done on an emergent basis. As noted, the number of families affected is, quite fortunately, very small. While having a child with these issues is never “convenient,” the travel issues that might exist do not outweigh the weight of the evidence that fails to demonstrate a need for approval of either application. The Orlando area, being centrally located in Florida, is reasonably accessible to all of the existing providers. Most appear to go to Shands, which is simply not a substantial distance away. The credible evidence is that families facing these issues are able to deal with the travel inconvenience. In addition, Nemours presented evidence regarding the various locations at which they provide services, ranging from Pensacola to Port St. Lucie. Clearly, Nemours sees itself as providing some cardiac services to patients in these locations, but it would also suggest that patients seen at these locations may be referred to NCH for transplant services, which would mean that some patients would be bypassing closer facilities. As observed by AHCA, for Nemours to posit that it is appropriate for patients to travel from Pensacola or Jacksonville to Orlando while asserting that it is not acceptable for patients in Orlando to go to Gainesville or St. Petersburg is an illogical inconsistency. Financial Access Nemours asserts that approval of its proposed programs will enhance financial access to care. Nemours currently serves patients without regard to ability to pay and will extend these same policies to transplant recipients. Approximately half of Nemours’ projected PHTs are to be provided to Medicaid recipients, the other half to commercially insured patients.5/ However, there was no competent evidence of record that access to PHT or PHLT services was being denied by any of the existing transplant providers because of a patient’s inability to pay. Transplant Rates at Shands In its need methodology, Nemours utilized the use rate from OTSA 1 where Shands is located because it is the highest use rate in the state. Despite this, Nemours then asserted that Shands is not performing as many PHTs as it could or should. The Nemours CON applications are not predicated on any argument that their proposed programs are needed because of poor quality care at any of the existing pediatric transplant programs in Florida. Indeed, Dr. Wearden stated his belief that Shands provides good quality care in its transplant programs, and he respects the Shands lead surgeon, Dr. Mark Bleiweis. As evidence of his respect for the Shands PHT program, Dr. Wearden has referred several transplant patients to Dr. Bleiweis at Shands. Despite that position, Nemours argued that the Shands program is unduly conservative and cautious in its organ selection and may have some “capacity” issues due to a few cited instances of apparent surgeon unavailability. These assertions, made by Nemours witnesses with no first-hand knowledge of the operations of the Shands program, are not persuasive. With regard to whether the Shands program is unduly “cautious,” “conservative,” or “picky,” Nemours relied on a document produced by Shands in discovery. Nemours also relied on data reported by Shands to the Scientific Registry of Transplant Recipients (SRTR). The data included a list of all of the organs offered to Shands since the beginning of 2015, the sequencing of the offer of that organ to Shands, whether the organ was transplanted at Shands or elsewhere, the primary and secondary reasons the organ was refused (if refused) and other information. The SRTR exhibit demonstrates that a high number of the organs that are offered are not acceptable for transplant on patients waitlisted at Shands. It also shows that organs that are accepted may have to be examined by many different centers before being deemed potentially acceptable. This demonstrates the extensive level of complexity, nuance, and clinical judgment involved in the decision to accept an organ for transplant in a pediatric patient. Indeed, Dr. Wearden agreed that the decision by a program to accept or turn down an organ involves both clinical expertise and judgment, and that there are many reasons an organ might be turned down, which helps explain why the transplanted percentage of total organs offered nationally is on average, so small. Dr. Wearden chose a few examples of organs that were not taken by Shands to express an opinion that Shands may be unduly conservative in its organ selection. However, this assertion was credibly refuted by Dr. Pietra, a transplant cardiologist and the medical director of the UF Health Congenital Heart Center. Dr. Pietra discussed the complexity of these cases and how simply looking at the SRTR data does not provide enough information to reach Dr. Wearden’s conclusion. An organ that might be acceptable for one patient would not be acceptable for another for a host of reasons. Many more organs are rejected by transplant centers than are accepted. Dr. Pietra credibly opined that being conservative and cautious are important traits for a transplant surgeon, particularly for one that wants the accepted organ to work well for the patient long-term. That does not mean that Shands is rejecting organs when it should have taken them, nor does the SRTR data support the proposition that the Nemours program should be approved because its program may have accepted an organ for a particular patient that Shands might have rejected. Nemours also argues that Shands performs PHTs at a rate lower than the region and the country, and that this should mitigate for the approval of another program. This assertion is predicated on waitlist information reported in the SRTR data. Patients that are placed on the waitlist have different status designations, depending on the severity of their condition. That status may change, up or down, over time. Due to the shortage of organs, until a patient reaches status 1A, he or she is unlikely to be offered an organ. The evidence reflected that Shands puts patients on the PHT organ waitlist at a time earlier than the moment they require the transplant surgery under what is called the “pediatric prerogative.” This helps those patients maintain their status on the list but does not result in organs being provided to less severely ill patients to the detriment of those in greater need. Further, the record evidence supports the finding that Shands waitlists patients because the clinical determination has been made that the child will ultimately require a transplant. This was corroborated by the parent of a Shands PHT patient who testified that when her daughter was placed on the waitlist, Dr. Fricker concluded at that time that her daughter would ultimately need a PHT, even though she was placed on a lower status initially, and it was a few years before the transplant occurred. Transplant surgeon Dr. Victor Morell, of the Children’s Hospital of Pittsburgh, testified that he waitlists his PHT patients not only when they need the procedure performed immediately, but rather when, in his clinical judgment, he determines the patient will ultimately need a PHT. This testimony supports the finding that there is nothing clinically unusual or inappropriate about how the Shands program waitlists patients. Shands realizes that its philosophy, which is contemplated within and permitted under the United Network for Organ Sharing (UNOS) rules, makes its statistics, both in terms of percent of patients transplanted and waitlist mortality, look worse. While Shands’ waitlist mortality may be higher than expected as reflected in the SRTR data, it is still significantly lower than in the UNOS region or the United States. Shands advocates for its patients by their waitlist practices because it believes it helps secure the best outcomes for its patients. It does not indicate need for a new PHT program. Nemours also suggests that there may be a “capacity” problem at Shands because the organ rejection information provided by Shands shows that, during the 3-year period of CY 2015 through CY 2017, there were seven entries showing as either a primary or secondary reason for organ rejection that the surgeon was unavailable. However, this included both adult and pediatric hearts, and further investigation revealed that in only four instances were there potential PHT recipients at Shands. Of those four hearts that were rejected, two were not accepted by any PHT provider, and the two that were accepted were placed with adult transplant patients, not PHT patients. Shands has two PHT transplant surgeons. In very few instances at Shands, an organ was offered but not accepted because the surgeon was not available for one of several reasons. In one instance, there was another transplant scheduled. A surgeon could be ill, could be gone, or may have just completed another long surgery and be too fatigued to safely perform another. Like Shands, Nemours also has two experienced PHT surgeons. Although Dr. Wearden believes that Nemours would endeavor to not reject an organ for this reason, this ambition ignores reality. He cannot guarantee that the same could not or would not happen at Nemours for the same reasons it occasionally occurs at Shands. As explained by Dr. Pietra, when there are only small to medium volume programs, there is not likely to be a sufficient number of surgeons such that this scenario can be avoided entirely. Not Normal Circumstances In both its heart and heart/lung applications, Nemours articulated the following “not normal circumstances” in seeking approval: Florida does not have any approved pediatric heart/lung transplant programs. Florida's only two approved pediatric lung transplant programs have not performed any lung transplant programs in the last two reporting years according to AHCA reporting data. Significantly, there are no pediatric heart transplant or lung transplant programs in AHCA's Organ Transplant Service Area OTSA 3 in which NCH is located-an area of the State with one the fastest growing and youngest populations. Florida has no other pediatric comprehensive, multi-organ thoracic transplant program. Florida has no other pediatric comprehensive, multi-organ thoracic transplant program that is part of a pediatric specific integrated delivery system such as Nemours offers. NCH offers a unique, dedicated model of cardiothoracic care developed at its Alfred I. duPont Hospital for Children (AIDHC) in Wilmington, Delaware and implemented upon the opening of the program at NCH. The key and differentiating element of this Model of Care is a unified team of cardiac clinical and administrative professionals who serve children with cardiac problems in dedicated facilities (the "Cardiac Team"). The Cardiac Team only cares for children with cardiac diagnoses. As such, the Cardiac Team of anesthesiologists, surgeons, cardiologists, nurses, and other support personnel do not "float" to other hospital floors or departments as in a typical hospital setting. This dedicated model of cardiac care allows the Cardiac Team to develop highly specialized knowledge and relationships to provide the best treatment protocols for patients with cardiac conditions. NCH has developed state-of-the art facilities and innovative clinical pathways for the care of the most complex pediatric thoracic patients. NCH has and will bring new opportunities for research in pediatric cardiology, cardiac surgery, and pulmonary medicine, particularly clinical translational and basic research into the linkages between childhood obesity and cardiac conditions. Nemours operates a regional network of clinics in Florida, with primary locations in Pensacola, Jacksonville, and Orlando, that will operate in partnership with NCH for the appropriate regional referral of patients in Florida for pediatric thoracic care. NCH can reduce the out-migration of pediatric, thoracic transplant patients from OTSA 3 to other parts of the State as well as the out-migration of these patients to other out-of-state transplant programs. Similarly, NCH will reduce the outmigration of organs donated in Florida to other states ensuring that Florida recipient patients are first priority for organs donated in Florida. NCH has in place the infrastructure, facilities, and resources to seamlessly add thoracic transplant services to its existing comprehensive cardiac surgery program. Additional needed staff are already being recruited to this program. As a result, the project has minimal incremental cost that will need to be incurred. Total project costs are, therefore, estimated to be $715,425.00. In addition, according to Nemours, an additional “not normal” circumstance has emerged since the filing of the applications: the approval of Nemours’ PLT application in the absence of a PHT program at the facility, which it contends is “a very unusual situation.” Noteworthy about these purported reasons for approval are that: (1) none of them are specifically directed at a unique circumstance relating to a need for another PHT program; and (2) most of them are either a recitation of the fact that there is no existing program in the service area or are about Nemours’ capability to provide these services. They are not directed at whether there is a need for its proposed programs. In fact, the main thrust of Nemours’ case was directed at proof regarding its capabilities. But the flaw in this theme is best demonstrated in the testimony of Dawn Tucker, the last witness called by Nemours. Ms. Tucker is the cardiac program administrative director for Nemours. When asked why she supported the proposed program, she talked about the experience of the team, a desire to care for sick patients, an organization (Nemours) that financially supports the program, and the network of centers that Nemours has in Florida. These factors address why Nemours “wants” these CONs. None of them addresses the threshold issue of whether there is a “need” for these programs in OTSA 3. More specifically, the first, third, and fourth bullet points are all based on the absence of a program in OTSA 3. By rule, that is not a basis for establishing need. Fla. Admin. Code R. 59C-1.009(2)(e)3. AHCA appropriately rejected the absence of a program in OTSA 3 as the sole basis upon which need for the proposed projects could be established. The second bullet point relates to the pediatric lung transplant application that is not at issue in this matter. The fifth and sixth bullet points relate to the Nemours integrated model of care. But again, this does not address whether there is a need for the proposed programs. The fact that Nemours has an employed-physician model is not unique or “not normal.” AHCA considered the information regarding the model of care and correctly noted that the model of care does not itself enhance access or improve outcomes. It should be noted that Shands’ doctors are employed by the University of Florida. In addition, the reliance on this model does not guarantee a robust program. This bullet point references the much older and more established Alfred I. duPont Hospital for Children in Wilmington, Delaware, that is touted as the model for Nemours. Nemours presented evidence relating to its more established hospital in Delaware that also provides PHT services. However, the PHT program at duPont is a low-volume program, performing only one PHT in 2016. None of the managed- care companies that recognize Shands as a center of excellence also recognizes the duPont Hospital as such. One of the companies--Lifetrac--acknowledges duPont as a “supplemental” program, whereas Shands is one of its “select” programs. This demonstrates that simply having the financial resources of the duPont Foundation or the model of care used by that organization does not guarantee high volumes or success. The “not normal circumstance” bullet points regarding Nemours’ facilities, research, and other infrastructure similarly do not demonstrate need. Otherwise, a hospital could obtain a CON for a new program by spending the money in advance and then demanding approval based upon those expenditures. AHCA recognized that Nemours had recruited some very qualified clinicians, but correctly noted that that does not create or evidence need for the proposed programs. The remaining bullet point asserts that approval of the PHT and PHLT programs could reduce outmigration of both patients and organs. By definition, because neither of these transplant programs exists in OTSA 3, all patients leave OTSA 3 for these services. Again, that alone does not establish need, nor is it automatically a “not normal” circumstance. As discussed herein, Nemours has not demonstrated a sufficient need or an access problem that justifies approval of either application. With regard to the outmigration of organs from Florida, Nemours has argued that Florida is a net exporter of organs and that this is a “not normal” circumstance justifying approval of its application. However, organs harvested in one state are commonly used in another. There is nothing unusual or negative about that fact. Indeed, Dr. Wearden agreed that in his experience, this is a common occurrence. There is a national allocation system through UNOS and this sharing, as explained by Dr. Pietra, facilitates the best match for organs and patients. UNOS divides the country into regions for the purpose of allocation of donor organs, with Florida being one of six states in Region 3. The evidence of record did not establish that approval of the Nemours applications would result in the reduction of organs leaving Florida, or even that such would be a desirable result. Nemours also argued at hearing that approving their applications would increase the number of donor organs that are procured and transplanted in Florida. Nemours suggested that its programs would increase public awareness and implied that it would accept organs for future patients that surgeons at other programs turn down. However, these arguments are purely conjectural and are rejected. No record evidence exists which demonstrates that a Nemours program would increase the supply of organs in Florida. Indeed, Nemours presented no such relevant data or statistical evidence in its applications to demonstrate that this will occur. Finally, Nemours argues that its PHT and PHLT applications should be approved because it does not make sense for AHCA to have approved the PLT program but denied the other two applications. Nemours goes on to note that while there are hospitals in the country that do PHTs but not PLTs, there are no hospitals that do lungs but not hearts. Regardless of whether that is true, Florida law separates these three services into separate CON applications, which are reviewed independently. The wisdom of the rule is not at issue in this proceeding. Regardless of any overlap in the skill sets required to perform these procedures, approval of the pediatric lung transplant application does not determine need for pediatric heart or pediatric heart/lung programs. Nemours failed to establish that “not normal” circumstances currently exist that would warrant approval of either the PHT or PHLT programs. Nor did Nemours credibly demonstrate any other indicators of need for its proposed programs. Section 408.035(1)(c): The ability of the applicant to provide quality of care and the applicant’s record of providing quality of care. The parties stipulated that Nemours is a quality provider. However, AHCA maintains that this criterion is in dispute to the extent that center transplant volume as a result of Nemours’ approval would lead to or correlate with negative patient outcomes. Nemours failed to demonstrate that it would achieve the volumes it projected unless it takes significant volumes from other Florida providers.6/ Approval of Nemours will not create transplant patients that do not exist or are not currently able to reasonably access services. While Nemours has assembled a team of professionals with varying levels of transplant experience, it has not been demonstrated that it will achieve volume sufficient to reasonably assure quality care.7/ Section 408.035(1)(e): The extent to which the proposed services will enhance access to health care for residents of the service district. Approval of the Nemours PHT and PHLT programs would unquestionably improve geographic access to those services for the very few residents of OTSA 3 that need them. However, given the extreme rarity of pediatric heart and heart/lung transplants, approval of the Nemours programs would not result in enhanced access for a significant number of patients. Moreover, there was no credible non-hearsay evidence presented at hearing that any resident of OTSA 3 that needed PHT or PHLT services was unable to access those services at one of the existing PHT programs in Florida or, for PHLT, at a facility elsewhere. Based upon persuasive evidence at hearing, there is also clearly a positive relationship between volume and outcomes. As with any complex endeavor, practice makes perfect. In this instance, maintaining a minimum PHT case volume provides experience to the clinicians involved and helps maintain proficiency. According to the credible testimony of Dr. Pietra, programs should perform no fewer than 10 PHTs per year. “If you can stay above 10, then your program is going to be exercised at a minimum amount to keep everybody sort of at a peak performance.” The clear intent of the minimum volume requirement of 12 heart transplants per year contained in rule 59C- 1.044(6)(b)2. is to ensure a sufficient case volume to maintain the proficiency of the transplant surgeons and other clinicians involved in the surgical and post-surgical care of PHT patients. In addition, pediatric transplant programs are measured statistically based on outcomes, such as mortality and morbidity. Because of this, the loss of even one patient in a small program can be devastating to that hospital’s mortality statistics. As such, small programs may become less willing to take more complicated patients. In a perverse sort of way, adding more programs that dilute volumes may decrease, rather than increase, access because of the fear a small program might have for taking more complex patients. Adequate case volume is also important for teaching facilities, such as Shands, to benefit residents of all the OTSAs by being able to train the next generation of transplant physicians. The mothers of the two Shands patients that testified made note of the complexity of their daughters’ conditions and how their cases were used for training purposes. There was no persuasive evidence of record that approval of the Nemours applications would meaningfully and significantly enhance geographic access to transplant services in OTSA 3. The modest improvement in geographic access for the few patients that are to be served by the two programs is not significant enough to justify approval in the absence of demonstrated need. There is no evidence that approval of the Nemours applications will enhance financial access nor that patients are not currently able to access PHT or PHLT services because of payor status. Section 408.035(1)(g): The extent to which the proposal will foster competition that promotes quality and cost- effectiveness. It is clear that establishing and maintaining a transplant program is expensive. Given the limited pool of patients, the added expense of yet a sixth Florida program is not a cost-effective use of resources. This criterion also relates to the Nemours position that AHCA should approve the PHT and PHLT applications simply because the PLT application was approved, and it would not be cost-effective for Nemours unless the PHT and PHLT applications were also approved. However, each of these applications must rise or fall on its own merit. As of the hearing, Nemours had not yet implemented its PLT program. Given the absence of need for either the PHT or PHLT programs, the cost-effective solution might be for Nemours to reconsider implementation of the PLT program. 408.035(1)(i): The applicant’s past and proposed provision of health care services to Medicaid patients and the medically indigent. AHCA agreed at hearing that Nemours satisfies section 408.035(1)(i). Nonetheless, Nemours provides a very high level of Medicaid services, and projects a high-level volume related to Medicaid patients and charity care patients. As noted, approximately half of the PHTs projected by Nemours will be performed on Medicaid patients. Conformance with this criterion would mitigate toward approval had there been persuasive evidence that Medicaid and medically indigent patients are currently being denied access to PHT and PHLT services. However, no such evidence was presented.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying CON Application Nos. 10471 and 10472 filed by The Nemours Foundation, d/b/a Nemours Children’s Hospital. DONE AND ENTERED this 31st day of July, 2018, in Tallahassee, Leon County, Florida. S W. DAVID WATKINS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of July, 2018.
The Issue BAMI and VENICE filed competing applications for a certificate of need to construct a 100-bed acute care hospital in Englewood, Florida. The sole issue is which application should be granted, and which should be denied.
Findings Of Fact DHRS is the state agency empowered to review, issue, deny, and revoke certificates of need for health care projects. 381.494(8), Fla. Stat. (1981). In January, 1982, VENICE and BAMI separately applied to DHRS for a certificate of need to construct a 100-bed acute care hospital in Englewood, Florida. When the applications were filed, Florida law required the appropriate health systems agency to initially review applications for certificates of need. On March 10, 1982, the Project Review Committee of the South Central Florida Health Systems Council, Inc.--the appropriate health systems agency--considered the competing applications, then voted to approve the proposal submitted by VENICE, and deny the proposals submitted by BAMI and a third applicant (not involved in this proceeding). On March 27, 1982, the Board of Directors of the South Central Florida Health Systems Council, Inc. disagreed with the Project Review Committee's recommendation and voted to recommend (to DHRS) approval of the BAMI proposal and disapproval of the VENICE proposal. DHRS then independently reviewed the two competing applications. On April 30, 1982, it issued a (free-form) certificate of need to BAMI to construct a 75,000 square foot, 100-bed acute care hospital in Englewood. Conversely, it denied VENICE's application, asserting: (1) that the interest and depreciation expense per projected patient day for the first two years of operation of the BAMI proposal was less than that projected for the VENICE proposal; (2) that the estimated labor and materials cost per square foot for the BAMI proposal was lower than the amount estimated for the VENICE proposal; (3) and that the provision for 30 semiprivate rooms in the BAMI proposal offered patients an alternative unavailable in the all-private room hospital proposed by VENICE. VENICE thereafter requested a formal hearing to contest DHRS's action, which request resulted in this proceeding. Bami BAMI seeks a certificate of need to construct a new 100-bed acute care hospital in Englewood, Florida, to be known as Englewood Community Hospital. BAMI proposes to relocate and merge its existing Englewood Emergency Clinic and Primary Care Center into the proposed Englewood Community Hospital. The service area for the BAMI proposal includes the following communities in Sarasota, Charlotte, and Lee counties: Englewood, North Port, Warm Mineral Springs, El Jobean, Grove City, Rotunda West, Placida, Cape Haze, and Boca Grande. The proposed hospital contains 92 medical/surgical beds and 8 intensive care unit (ICU) beds. The 92 medical/surgical beds contain a mix of 32 private be and 60 semiprivate beds. The hospital will provide ambulatory surgical services, diagnostic and special procedures, radiology services, nuclear medicine, ultrasonography, cardio-pulmonary, emergency room, and clinical laboratory services. The following services would be shared with its affiliate, Fawcett memorial Hospital in Port St. Charlotte, Florida: business office, medical records, data processing, materials management, personnel, education, public relations, administration, dietary, bio-medical engineering, laboratory, sterile processing, vascular laboratory, and occupational therapy. The proposed hospital will be a wholly-owned subsidiary of BAMI, and will have its own board of directors, board of trustees, and medical staff. BAMI is an experienced health care provider. Its principals have been in the health care business since 1964, and have built and operated 25 health care facilities in the mid-western United States. BAMI owns and operates several health care facilities in Florida: the 400-bed Fort Myers Community Hospital in Fort Myers, Florida; the 254-bed Fawcett Memorial Hospital in Port Charlotte, Florida; the 120-bed Kissimmee Memorial Hospital in Kissimmee, Florida; the Englewood Emergency Clinic and Primary Care Center in Englewood, Florida; the Ambulatory Surgical Center in Tampa, Florida; and the Emergency Clinic and Primary Care Center in Bonita Springs, Florida. BAMI also owns two smaller hospitals, one in Georgia and the other in Alabama. It is experienced in building and opening new hospitals, having built both the Fort Myers Community Hospital and the Kissimmee Memorial Hospital. It also expanded Fawcett Memorial Hospital from 96 beds to 254 beds. BAMI has financial assets of approximately $63,842,400 and a net worth exceeding $13.5 million. Venice VENICE seeks a certificate of need to construct a 100-bed satellite acute care hospital in Englewood, to be known as the Englewood-North Port Hospital. The service area for this proposed hospital consists of Englewood, North Port, Rotunda West, Placida, Warm Mineral Springs, Boca Grande, and Cape Haze. VENICE's proposed hospital contains 96 medical/surgical beds and four ICU beds. No semiprivate rooms will be available. All of the 96 medical/surgical beds will be placed in private rooms. The proposed satellite hospital will share the following services with VENICE's existing 300-bed "mother" hospital in Venice, Florida: specialized laboratory services, physical therapy, nuclear medicine, pulmonary functions, and specialized radiology services. For specialized and more sophisticated services, patients will be transported from the Englewood hospital to the larger hospital in Venice. The following support services will also be shared with the "mother" hospital: purchasing, bulk storage, laundry, dietary management, data processing, financial management, personnel recruitment, and educational services. In order to share these services, the existing Venice Hospital will be required to operate a transportation system. For many years, VENICE has owned and operated Venice Hospital, a fully licensed and accredited 300-bed general acute care hospital at 540 The Rialto, Venice, Florida. Venice neither owns nor operates any other hospital, although it has applied for a certificate of need to construct a 50-bed psychiatric hospital. The present management of Venice Hospital is inexperienced in the construction and opening of new hospitals. II. COSTS AND METHODS OF CONSTRUCTION Construction costs for the competing BAMI and VENICE proposals are broken down into categories and depicted in the following table: COMPARATIVE CONSTRUCTION COSTS CATEGORY BAMI VENICE Total Project Cost $13,355,000 $18,170,000 Total Project Per Bed Cost 135,500 181,700 Total Direct Construction Equipment Cost for and Fixed 11,670,190 13,874,516 Gross Square Feet 75,327 75,000 Construction Costs 155 173 Per Square Foot Number of Stories One Two Expansion Potential 100 additional 200 additional EQUIPMENT Movable 3,500,000 2,272,444 Bami Construction of the BAMI hospital can begin by September 1, 1983, and be completed by December 31, 1984. The new hospital can be opened by January 1, 1985. The BAMI hospital will be a one-story building, a design which is efficient for a hospital of this size. It will consist of a steel structure with curtain walls. The building is functional and economical, and can be expanded horizontally to 200 beds with minimum disruption to existing services and staff. The design of this hospital is similar to the 120-bed Kissimmee Memorial Hospital built by BAMI in 1979. BAMI's cost estimates are based on the actual costs of constructing the Kissimmee Memorial Hospital. BAMI proposes to construct the hospital by using an affiliate, F & E Community Developers of Florida, Inc. The use of an in-house contractor will allow BAMI to build the hospital in a short time period, at less cost and with higher quality. BAMI's proposal contains both active and passive energy conservation elements. The passive elements include overhangs, shaded glass, and movable windows. Active elements include the selection of quality equipment and a computerized control system for the electric reheat heating/ventilation/air conditioning ("HVAC") system. The architectural and construction plans for BAMI's proposed hospital are virtually complete. Schematic drawings were submitted and approved by DHRS in August, 1981. Preliminary plans have also been approved by DHRS. DHRS approval entailed a review of architectural, electrical, and mechanical preliminary drawings. Venice If the VENICE proposal is approved, construction could begin between April and July, 1984. The hospital could open for occupancy on January 1, 1986, a year later than BAMI's proposal. VENICE's architectural and construction plans are at an early stage, consisting only of a program summary and block design. Architectural, electrical, and mechanical preliminary drawings have not yet been submitted to DHRS and approved. The construction cost estimates submitted by VENICE are less reliable than those submitted by BAMI, since they were derived from less developed plans and were based on assumptions presented by persons who did not testify at hearing. VENICE's proposed hospital consists of a reinforced concrete structure with a modular precast concrete exterior. Although it will consist of two stories, the building will be stressed for the subsequent addition of two stories. When and if it is expanded to four stories, it would be a 300-bed hospital. The planned vertical expansion increases the initial cost of the building by approximately ten percent. Because of the extensive sharing of medical and support services between the proposed satellite hospital and the "mother" hospital in Venice, the ancillary medical and support facilities of the satellite have been down-sized. The VENICE proposal will also require horizontal expansion in the future. Areas such as radiology, laboratory, and emergency rooms will require immediate expansion as beds are added to the facility. It has not been shown at what point, in the planned expansion, VENICE's proposed hospital would become a free-standing hospital--when it would no longer be required to rely on its "mother" hospital in Venice. VENICE proposes an energy efficient facility. The multiple-story design minimizes site use and roof coverage. The relatively narrow wings provide for optimum use of daylight. VENICE contends that its HVAC system is more cost effective than the system proposed by BAMI. This contention is not substantiated by convincing evidence. The VENICE witness who testified on this question was an architect, not a mechanical engineer. He was unfamiliar with the computerized energy control system proposed by BAMI and used assumptions made by others who did not testify at the hearing. Bami III. HOSPITAL EQUIPMENT BAMI's proposed movable hospital equipment will cost approximately $3,500,000. Included are three radiology rooms: one general radiographic room, one standard R and F room, and one R and F room with angiographic capability. Also included are 8 ICU beds, four operating "rooms--two major and two minor-- nuclear medicine, and ultrasound capability. Venice The equipment cost for the VENICE proposal is $2,272,444. Included are 3 operating rooms, one with cystographic capability; four ICU beds and two radiology rooms--one R and F, and one general radiographic. More sophisticated diagnostic procedures, such as nuclear medicine and specialized radiology, will be provided at the "mother" hospital in Venice, not at the proposed Englewood satellite. To utilize these procedures, patients will be transported from Englewood to Venice. VENICE acknowledges that its proposed hospital will utilize less sophisticated diagnostic equipment than BAMI's. VENICE's equipment cost would have to be increased approximately $700,000 if it were to provide eight ICU beds and specialized radiology and nuclear-medicine to match BAMI's proposal. The equipment cost differential indicates the different levels of care proposed by the two hospitals. The VENICE proposal requires the development of a transportation "shuttle" system between the "mother" hospital in Venice and the satellite in Englewood. The system would consist of two trucks in addition to vans or ambulances. The plans for this essential transportation system are, however, not fully developed. The need for van or ambulance transportation between the two facilities has not been fully considered. Further, the transportation plan estimates a 25-minute one-way driving time between Englewood and Venice year- round. During the busy winter months, it is likely that the driving time will increase. Although VENICE proposes to lease the necessary trucks, neither the leasing costs nor associated costs have been fully taken into account. IV. FUNDS FOR OPERATING AND CAPITAL EXPENDITURES Bami BAMI will finance the $13,555,000 required to open its proposed hospital with bond proceeds, an equipment lease, and an equity contribution. It will obtain $7,905,000 from taxable bonds with a maturity of 25 years, and an interest rate of 12.5 percent. There will be a 2-year holiday on principal payments. BAMI will finance the $3,500,000 equipment cost pursuant to a lease agreement with Financial and Insurance Services, Inc., with an eight-year term and an interest rate of 15 percent. BAMI will make an equity contribution of $2,150,000. This will be in the nature of a contribution of capital from a parent corporation to a subsidiary corporation. As of September 30, 1982, BAMI had a net worth exceeding $13,500,000. BAMI will provide up to $1,000,000 in operating capital to cover initial start-up costs of the proposed hospital. In addition, BAMI has obtained a $5,000,000 line of credit which will be available to cover any potential cash shortages occurring during the start-up phase of the hospital. Venice VENICE will obtain the $18,170,000 required for its proposal from tax- free bond financing and an equity contribution. The bonds, which will have a maturity of 30 years and an interest rate of 10.52 percent, will be an obligation of the Venice Hospital. A debt service reserve fund of $1,900,750 will be required in order for the bonds to obtain an "A" rating. In unrelated applications, VENICE has proposed a major renovation of its existing hospital and the construction of a new free-standing 50-bed psychiatric hospital. These projects, if undertaken, will require additional equity contributions of $1,221,000 and additional bond financing in the amount of $10,370,000. To obtain the bond financing, VENICE will be required to maintain a one-to-one historical debt coverage ratio. VENICE has not convincingly established that it will be able to carry out all three projects and still maintain the required one-to-one debt coverage ratio. VENICE proposes to locate its proposed hospital on 15 acres of land costing $135,000. But the land sales contract provides only for the sale of 250 acres at a cost of $2,250,000. (The present owners wish to sell the entire 250- acre parcel and not lesser amounts.) The source of the $2,250,000 needed to acquire the property has not been identified. The bond proceeds could not be used. To purchase the 250 acres and fund the equity for its three proposed health care projects, VENICE will require $4,311,000. The source of these funds has not been identified. VENICE contends that one possible source would be Board Designated Funds. However, VENICE's audited financial statements for the period ending September 30, 1982, suggest otherwise. PROPOSED SITES Bami BAMI, through a subsidiary, has contracted to purchase approximately 12 acres as a site for its proposed Englewood hospital. The 12-acre site is part of a 60-acre parcel of land that is zoned OPI, a zoning classification which will permit the construction of a hospital. The 12-acre site is located on Morningside Drive, an access road to Pine Street. Although Morningside Drive is a dirt road, it will be paved. Under the contract, the current owner will pay all paving costs in excess of $65,000. The initial $65,000 in paving costs will be borne by BAMI and has been included in BAMI's estimated construction costs. Pine Street, a major north- south transportation artery in the Englewood area, is currently being resurfaced in both Sarasota and Charlotte counties. A second access to Pine Street has been acquired by the current owner. A watermain is available at the BAMI site. The current owner of the property will construct a sewage treatment plant and provide sewer service to the proposed hospital at prevailing rates. The sewage treatment plant will be located on a 7.5-acre portion of the 48 contiguous acres retained by the current owner. The BAMI site is located in an A-11 flood zone with an elevation of ten feet. Fill dirt will be used to raise it to an acceptable elevation of twelve feet. A current owner of the BAMI site envisions the entire 60 acres as an Englewood medical center. If necessary he will allow BAMI to purchase an additional 12 acres contiguous to the site. BAMI has not yet, however, obtained a legally enforceable right to purchase additional property adjoining its 12- acre site. Although the 12-ace site will permit the planned 100-bed future expansion, the site would be crowded with little space remaining for future improvements. Venice The VENICE site is an undesignated 15-acre portion of a 250-acre parcel of land located off State Road 777, also known as South River Road. It is uncertain whether the hospital will have one or two access roads to State Road 777. A watermain is available at the VENICE site. Sewage treatment will be provided by a nearby privately owned sewage treatment plant until the hospital, eventually, constructs its own. The zoning classification of the VENICE site will not permit construction of a hospital. Before the hospital could be built, Sarasota County would be required to rezone the property to OPI. Use of the property for a hospital is also inconsistent with Sarasota County's comprehensive land use plan, adopted October 31, 1981. Such a rezoning process would take a minimum of three or four months, and perhaps longer. Approximately 100 individual steps are involved. Hearings would be held by the Sarasota Planning Commission and the Sarasota County Commission. VENICE has not yet filed an application to rezone either the 15 acres or the entire 250-acre parcel. Neither has it shown that it is likely to succeed in having the property rezoned to a classification permitting hospital use. Bami VI. EFFICIENT AND ALTERNATIVE USES OF HEALTH CARE RESOURCES As part of its application, BAMI proposes to merge its existing Englewood Emergency Clinic and Primary Care Center into its proposed Englewood hospital. If the BAMI application is denied and VENICE's granted, BAMI will continue to operate the Emergency Clinic and Primary Care Center. As a result, the Emergency Clinic and VENICE's Englewood hospital would be providing duplicative emergency services. The costs resulting from this duplication would be approximately $894,800 in 1985; $975,300 in 1986; and $1,063,100 in 1987. For cost effectiveness, BAMI's proposed hospital will share some ancillary and support services with Fawcett Memorial Hospital in nearby Port Charlotte. Fawcett Memorial will also provide tertiary level services, such as renal dialysis and CAT scans to patients of the proposed Englewood hospital. BAMI operates a multi-hospital system, with subsidiaries which provide ancillary and specialized support services. These services include physical therapy, inhalation therapy, cardiopulmonary function, speech therapy, data processing, and collection services. Corporate level expertise in accounting, property management, pharmacy management, personnel, and marketing, is also available. The multi-hospital system allows BAMI to obtain favorable purchasing contracts and capital for future expansion. Venice Venice Hospital, the only hospital in south Sarasota County, has a high rate of occupancy. Although presently a 300-bed facility, it has an ultimate capacity of 400 beds. It recently applied for a certificate of need to add 24 ICU/PCU beds and additional beds, beyond that, are needed. It has a shelled-in fourth floor that will accommodate an additional 45-bed nursing unit. Completing the fourth floor at Venice Hospital would be a more cost-effective alternative way to add beds than constructing a new hospital in Englewood. As already mentioned, the "mother" hospital in Venice will share numerous ancillary and support services with the proposed satellite hospital in Englewood. VENICE proposes to share, among other things, its present laboratory with the proposed Englewood satellite. As a result, the laboratory in the satellite hospital has been reduced to a minimal size. It has not been convincingly established that the Venice Hospital laboratory, even if expanded as proposed, can process the additional laboratory work-load arising from an Englewood satellite. The laboratory at the existing Venice Hospital presently operates 24-hours per day, seven days a week. Even if its application to expand its laboratory is granted, the total area of the laboratory would be less than the accepted space guidelines required for a 324-bed hospital. VII. AVAILABILITY, APPROPRIATENESS, AND ACCESSIBILITY OF PROPOSED HEALTH CARE SERVICES Scope of Services Although both proposed hospitals would share services with affiliated hospitals, BAMI proposes more of an autonomous, full-service and free-standing hospital than that proposed by VENICE. BAMI will equip its hospital with a more complete and sophisticated range of diagnostic services and, unlike VENICE, has not down-sized its ancillary and support services. For the VENICE proposal to become a free-standing facility comparable to BAMI's, the space devoted to ancillary medical services and support services would have to be expanded by 30 percent and 50 percent, respectively. The costs of such an expansion have not been determined. Economic Access Both parties will enter Medicaid contracts covering their proposed hospitals. BAMI projects that .1 percent of its patients will be Medicaid; VENICE projects .2 percent. BAMI hospitals treat all emergency patients, regardless of ability to pay. Third party payment is accepted. On elective admissions, self-pay patients are requested to make reasonable deposits and sign promissory notes. In specific instances, patients can be admitted without making financial arrangements in advance. Patients are not referred to other hospitals because of inability to pay. If an indigent is defined as "one who cannot pay," Fawcett Memorial Hospital provided between $600,000 and $700,000 in indigent care during 1982. This figure represents approximately 3.9 percent of gross revenue. Similarly, Venice Hospital treats emergency patients regardless of their ability to pay. Promissory notes are obtained from self-pay patients if necessary. The credit policies of Venice Hospital are similar to BAMI's. Venice Hospital had a bad debt or charity to gross receipts ratio of between 2.5 percent and 3.0 percent in 1982. Venice Hospital also has a Hill-Burton requirement to provide indigent care in the amount of approximately $125,000 per year. This requirement stems from a federal grant awarded in 1970. Access to Osteopathic Physicians BAMI's proposed hospital will have an open medical staff, including licensed medical doctors and osteopathic physicians. BAMI has a practice of allowing osteopathic physicians on its medical staff. For several years, osteopathic physicians have been included on the staff of all BAMI hospitals. Fort Myers Community Hospital, a BAMI hospital, is one of two hospitals in the Fort Myers area with osteopathic physicians on its staff. Kissimmee Memorial Hospital, also owned by BAMI, has the only two osteopathic physicians in Kissimmee on its staff. Fawcett Memorial Hospital has the only osteopathic physician in Port Charlotte on its staff. In contrast, VENICE has not added osteopathic physicians to its staff with similar enthusiasm. It granted staff privileges to its first osteopathic physician six to nine months prior to hearing. Two months before the hearing, staff privileges were granted to a second. Venice Hospital has, however, changed its bylaws to comply with the law prohibiting discrimination against osteopathic physicians. Geographic Access The geographic locations of the sites for the two proposed hospitals, as described above, provide equal access to the service area. The BAMI site is closest to the existing population concentrations of the Englewood area, while the VENICE site is closer to Interstate 75. Both sites will require the paving of an access road to major traffic arteries. No significant advantage in access is afforded to either. VIII. COMPETITION The existing Venice Hospital currently serves the hospital needs of approximately 64 percent of the people in the greater Englewood area. These patients comprise approximately 26.8 percent of Venice Hospital's total patient days. BAMI's existing Fawcett Memorial Hospital in Port Charlotte currently serves between ten and twelve percent of the hospital needs of the people in the greater Englewood area. These patients account for approximately 11.3 percent of Fawcett Memorial's total patient load. In addition, BAMI's Englewood Emergency Clinic and Primary Care Center has treated over 20,000 patients since it opened in February, 1980. The existing Venice Hospital holds a dominant market share in the greater Englewood area. It is only twelve miles north of Englewood and is the only hospital in south Sarasota County. The closest competitor in Sarasota County is Sarasota Memorial Hospital, approximately 20 miles north of the Venice Hospital. Venice Hospital has been in operation for approximately 30 years. In contrast, Fawcett Memorial Hospital is approximately 21 miles east of Englewood. In the mid-1970s, it was converted from a nursing home to a 96-bed hospital, and in 1976, it was expanded to 254 beds. Approval of BAMI's proposal will enhance competition among hospitals serving the greater Englewood area. The competition will not, however, adversely affect Venice Hospital's long-term viability. The construction of either hospital in the Englewood area will change existing hospital utilization and physician referral patterns. New referral patterns will form and an increasingly autonomous group of physicians will develop. Local physicians will utilize the Englewood hospital, whether it is owned by BAMI or VENICE. Bami IX. PROJECTED COSTS OF PROVIDING HEALTH CARE SERVICES BAMI forecasts an occupancy rate of 60 percent at its proposed Englewood hospital in 1985; 75 percent in 1986; and 80 percent in 1987, with an average length of stay of 8.5 days. These figures are credible in view of the population growth in the Englewood area, the undisputed need for a new hospital, and the elderly population. To project total cost and gross revenue per patient day, various calculations are made. BAMI's employee salary expenses are based on its experience at nearby Fawcett Memorial Hospital, adjusted by an inflation factor. Non-salary expenses are derived from its experience at Kissimmee Memorial Hospital, a hospital of similar size with a utilization rate similar to that projected for the Englewood hospital. Depreciation of plant and equipment is calculated using the straight-line method. Revenue projections are derived using the American Hospital Association's Monitrend median inpatient revenue, inflated at 9 percent per year. An indigent/bad debt deduction of four percent of total patient revenue is used. These assumptions provide a credible basis from which total cost and gross revenue per patient day can be calculated. Using these assumptions, total costs per patient day is forecast to be $482.00 in 1975; $479.60 in 1986, and $510.32 in 1987. Gross revenue per patient day is forecast to be $552.00 in 1985; $601.68 in 1986; and $655.83 in 1987. These forecasts are credible and accepted as reasonably reliable. Venice VENICE's primary contention is that its proposed hospital, although costing more to build, will--in the long run--result in lower costs to patients and increased savings to the community. This contention was not substantiated by convincing evidence. In forecasting its costs and revenues, VENICE projected an occupancy rate of 65 percent in 1986; 80 percent in 1987; and 80 percent in 1988. The 1986 projection is unreasonably high; it envisions a 70.4 percent utilization rate during the opening month. VENICE's projected salary expenses are derived from its current experience at Venice Hospital, adjusted for inflation. Although this figure is reliable, the projected non-salary expense per patient day is not. The nonsalary expense is not based on Venice Hospital's most recent 1982 expenses, and is not adjusted by the requisite inflation factor. The depreciation schedule and assumptions used by VENICE in forecasting its revenues and costs are also questionable. Discrepancies went unexplained. The testimony of Deborah Kolb, Ph.D., an expert in health care financial and need analysis, is considered more credible. She concluded that VENICE understated 1986 depreciation expense for its proposed hospital by approximately $300,000, an error which would have increased its projected patient costs per day by $13.70. VENICE also projects room charges at its proposed hospital which are significantly lower than those projected for its "mother" hospital in Venice. This difference in room charges was not adequately explained or justified. Although VENICE's controller attributed the difference to cost savings resulting from the satellite hospital concept, these savings were not meaningfully itemized or identified in VENICE's revenue and cost projections. VENICE also failed to identify, and reflect in its projections, increased costs resulting from use of its satellite concept. For example, in 1986, 532 Englewood patient are projected as requiring sophisticated nuclear medicine tests at the "mother" hospital in Venice; 141 Englewood patient are projected as requiring special radiology tests at Venice Hospital. When asked who would absorb the costs of transporting patients between the satellite hospital in Englewood and the "mother" hospital in Venice, VENICE's controller responded that Venice Hospital would. However, those costs have not been quantified. Moreover Venice Hospital does not currently pay for ambulance transportation of its patients and does not have vans which transport patients on 24-mile round trips. This amounts to a significant and additional cost of operation, which has not been fully considered in the financial forecasts. Moreover, VENICE utilized cost per patient day based on Venice Hospital's 1981 costs rather than the higher 1982 costs. (Revenue per patient day increased 23.8 percent, in 1982.) In addition, projected revenues at VENICE's proposed Englewood satellite were not adjusted downward to take into account the less-sophisticated medical services which would be provided. As a result, VENICE's projected revenues per patient day are questionable and lack credibility. Venice Hospital received funds from three philanthropic organizations: Venice Hospital Blood Bank, Venice Hospital Auxiliary Volunteers, and Venice Health Facilities Foundation. Without the infusion of these funds, charges to Venice Hospital's patients would be higher. Venice Hospital's own fund raising literature states that patient charges, alone, do not cover the full costs of providing medical services. These community-raised funds, then, pay part of the costs of providing medical care. But in calculating cost savings to the community from its proposed Englewood hospital, VENICE has not identified or taken into account these additional funds raised from the community. VENICE's comparison of its projected patient charges with those of BAMI's is, accorded little weight. The two proposed hospitals are significantly different, one providing more extensive and sophisticated medical care than the other. This difference was not adequately taken into account in the financial comparison. Additional costs to Venice Hospital resulting from the Englewood satellite hospital were not fully considered. Comparisons based on historical charges by Venice Hospital and Fawcett Memorial Hospital are also misleading since these hospitals are different in size and occupancy rate--and the proposed Englewood hospital will duplicate neither. Moreover, Venice Hospital historical room rates used for the comparison were selectively chosen. VENICE also relies on projected HVAC life cycle savings, which, as already mentioned, were not convincingly established. Finally, the costs of acquiring VENICE's site-- necessitating a 250-acre purchase--were not fully reflected in the comparison. X QUALITY OF CARE The parties stipulated that both proposals will provide high quality medical care. The only question is whether bed-configuration will affect the quality of care provided. BAMI proposes a mix of 32 private and 60 semiprivate medical/surgical beds, with an additional 8 ICU beds. In contrast, VENICE proposes 96 private medical/surgical beds and 4 ICU beds. BAMI's mix of private and semiprivate rooms will allow consumers a choice and is preferable to VENICE's all private-room proposal. Private and semiprivate rooms confer various benefits. BAMI's proposed 32 private rooms will be adequate to serve those patients requiring private rooms while, at the same time, affording patients a choice between private and semiprivate. The VENICE proposal will not allow such a choice. It has not been shown, however, that bed configuration will affect the quality of medical care rendered patients. XI. COMPARISON: BAMI'S PROPOSED HOSPITAL IS PREFERABLE TO VENICE'S Both proposed hospitals would provide necessary and quality medical care to people in the Englewood area. On balance, however, BAMI's proposal is preferable. BAMI's free-standing hospital will provide more complete and sophisticated medical care, with less need to transport patients between "mother" and satellite hospitals. VENICE's satellite hospital will require extensive transporting of patients, food, linens, equipment, lab samples, and medications between the "mother" hospital in Venice and the satellite hospital in Englewood. BAMI, a multi-hospital system, is more experienced in constructing and operating new hospitals. The BAMI proposal will cost approximately $2,000,000 less to build, yet be of comparable quality and equipped with more sophisticated diagnostic equipment. While VENICE's construction plans are preliminary, BAMI's are detailed and virtually complete. VENICE's site requires rezoning, BAMI's does not. If BAMI's application is approved, its hospital could be opened by January 1, 1985,a year earlier than VENICE's. BAMI is financially able to begin construction immediately while VENICE--because of other projects simultaneously undertaken--may not be. Apart from zoning, both hospital sites are equally acceptable, although BAMI's 12-acre site is minimally sufficient for the anticipated future expansion to 200 beds. BAMI's financial ability to purchase is assured, while VENICE's is not. BAMI's proposal would avoid a duplication of emergency medical services in Englewood, while VENICE's would cause it. For patients preferring osteopathic physicians, BAMI's hospital would, most likely, be preferable. For patients preferring semiprivate rooms, BAMI's proposal would be preferable. Competition between hospitals serving the Englewood area would be enhanced with the BAMI proposal and decreased with VENICE's. Although VENICE argued that the costs to its patients would, over the long run, be less than BAMI's, this proposition was not convincingly proved.
The Issue Whether Certificate of Need application (Number 9078) for an adult kidney transplantation program, filed by St. Luke's Hospital Association, meets the statutory and rule criteria for approval.
Findings Of Fact The Agency for Health Care Administration (AHCA) is the state agency authorized to administer the Certificate of Need (CON) program for health care facilities and services in Florida. Pursuant to Rule 59C-1.044, Florida Administrative Code, AHCA requires applicants to obtain separate CONs for the establishment of each adult or pediatric organ transplantation program, including heart, kidney, liver, bone marrow, lung, lung and heart, pancreas and islet cells, and intestines transplantations. For purposes of determining the need for organ transplantation services, the State of Florida is divided, by rule, into four service planning areas, corresponding generally with the northern, western central, eastern central and southern regions of the state. St. Luke's and Existing Providers St. Luke's Hospital Association operates St. Luke's Hospital (St. Luke's), a 289-bed, non-for-profit hospital with 17 beds for skilled nursing care and 272 acute care beds. St. Luke's is located on Belfort Road in Jacksonville, Duval County, Florida, AHCA, District 4, organ transplantation service planning area one. Available services at St. Luke's include obstetrics, open heart surgery, neurosurgery, adult bone marrow, and adult liver transplantation. The transplant services have been added during the last six or seven years. The severity of the illnesses and diseases treated at St. Luke's is represented by its relatively high Medicare case weight of 1.7 in 1997, after the addition of relatively low intensity obstetrics services. In 1998, St. Luke's applied for CONs to establish adult pancreas and islet cell, and adult kidney transplant programs. St. Luke's received the CON to establish the pancreas and islet cell transplant program. The application for a CON to establish an adult kidney transplant program is at issue in this proceeding. The parties stipulated that the letter of intent and application, for CON Number 9078, to establish the adult kidney transplant program, were timely filed. Methodist Medical Center, Inc., d/b/a Methodist Medical Center (Methodist) is a 244-bed acute care hospital, serving primarily adults, with special units for diabetes, hospice, and occupational medicine programs. The services do not include either obstetrics or pediatrics. In 1989, Methodist received a CON allowing its establishment of kidney transplant services. Methodist is located approximately one and a half miles north of downtown Jacksonville. Methodist's representatives contend that an additional kidney transplant program in Jacksonville, at St. Luke's, is not needed and will be detrimental to Methodist. St. Luke's, it was argued, will draw from a limited supply of organs and increase Methodist's financial losses. Those losses at Methodist were expected to range between $5 million and $8 million in 1999. Methodist's accountant described the hospital's financial health as poor to critical. The kidney transplant program provides a positive financial contribution at Methodist, largely due to Medicare reimbursements. At the time of the final hearing, Methodist was managed by Shands-Jacksonville, an affiliate of Shands Teaching Hospital and Clinics (Shands) at the University of Florida in Gainesville, and of University Medical Center in Jacksonville (University Hospital). Shands is also located in organ transplant service area one, but Gainesville is in AHCA District 3, not in 4 like Jacksonville. University Hospital is located across the street from Methodist and serves essentially the same inner-city, lower socio-economic population. St. Luke's was first established in the late 1800's. Previously located directly across the street from Methodist, St. Luke's was relocated near the intersection of J. Turner Butler Boulevard at Interstate 95, south of downtown Jacksonville in 1984. In 1987, St. Luke's became affiliated with the Mayo Clinic in Jacksonville (Mayo-Jacksonville). The two facilities share an administrator. St. Luke's receives approximately three- fourths of its admissions from Mayo-Jacksonville physicians. The Mayo-Jacksonville clinic is located approximately 12 miles from St. Luke's at J. Turner Butler Boulevard and Highway A-1-A. The multi-specialty and multi-subspecialty clinic, is staffed by 230 full-time salaried physicians. The governing board of Mayo-Jacksonville reports to the executive committee of its sole corporate member, the Mayo Foundation for Medical Education and Research (Foundation) in Rochester, Minnesota. The Foundation is the parent organization for the original Mayo Clinic in Rochester (Mayo-Rochester) and its affiliated hospitals, St. Mary's Hospital (with 1100 beds) and Methodist Hospital (with 700 to 800 beds), both in Rochester, Minnesota. In addition to the one in Jacksonville, the Foundation has also established a clinic in Scottsdale, Arizona (Mayo-Scottsdale). The Mayo-Scottsdale clinic is affiliated with a local inpatient hospital. Other related organizations include the Mayo Medical School and the Mayo Graduate School of Medicine. Issues Related to Need St. Luke's contends that its transplant surgeons would increase the total number of kidney transplants in Florida, by using less than ideal donor organs and by expanding waiting lists to enhance the possibility of donor/recipient matches. St. Luke's expects to overcome some of the usual limitations on available cadaveric organs because living donors can also be used to provide kidneys. Finally, St. Luke's maintains that a need exists for dual transplant programs, particularity the combination of kidney and pancreas programs. St. Luke's proposes to provide adult kidney transplants as an alternative to life-long dialysis or death for patients suffering from end-stage renal disease. Nationally, the number of dialysis patients increased from 123,822 in 1987 to 287,000 in 1996. The number of patients waiting for kidney transplants increased from 13,000 in 1987 to 41,000 in 1999. The mortality for patients on waiting lists also increased from over 1700 in 1996 to over 2000 in 1997. Due to the large and growing demand for organs, the federal government contracts with the United Network for Organ Sharing (UNOS) to coordinate the allocation of cadaveric organs. UNOS has designated five organ procurement organizations (OPOs) in Florida, one at the University of Florida in Gainesville (the UF OPO), and the others at centers in Orlando, Tampa, Fort Myers, and Miami. When cadaveric organs become available and are retrieved by surgeons from the nearest OPO, UNOS governs the priority in offering the organs. Organs are offered first to the United States military transplant centers, second to potential recipients who are six antigen or "perfect matches," then as paybacks to OPOs who have provided "perfect matches," and finally to various categories of other high-grade matches. After the organ is offered but not taken in the mandatory UNOS sharing hierarchy, the organ becomes available to local programs within the procuring OPO. St. Luke's will participate in the UNOS program for kidneys as it currently does for other organs, and expects to follow the medical protocols established at Mayo-Rochester, where kidney transplants have been performed for 30 years. St. Luke's has included $100,000 in start-up costs for Mayo-Rochester staff to train the St. Luke's staff. In establishing its successful liver transplant program, St. Luke's allocated $75,000 for comparable start-up costs. Rule 59C-1.044(8)(d), Florida Administrative Code, provides for the determination of the need for new programs, in part, based on the number of transplants performed at existing providers, which must exceed 30. An applicant must also provide a reasonable projection of volume, in excess of 15 a year by the second year of the proposed new program. Currently, two adult kidney transplant programs are approved or operational in each of the four service planning areas of Florida: at Shands in Gainesville and Methodist in Jacksonville in the north, which is service planning area one and coincides with the UF OPO; at Southwest Florida Regional in Fort Myers and Tampa General in western central Florida, which is service planning area two; at Florida Hospital in Orlando and Bert Fish Memorial in Volusia County in eastern central Florida, in service planning area three; and at the Cleveland Clinic Florida in Broward County and Jackson Memorial in Miami in the south, in service planning area four. At the time of this hearing, Bert Fish Memorial and the Cleveland Clinic were approved but not operational. The six operational Florida programs increased in volume from 442 transplants in 1994 to 641 in 1997, or an average increase of 13.2% a year. However, recent growth has been less dramatic. Using one year longer to establish a trend, from 1994 to 1998 data, the average annual increase was 9% a year. Kidney transplant volumes ranged, in 1997, from a low of 45 at Southwest Florida to highs of 150 at Jackson Memorial and 162 at Tampa General. From 1994 to 1997, the volume of kidney transplants within service planning area one increased from 35 to 52 at Methodist, and from 106 to 127 at Shands. As the parties stipulated, that volume exceeds the required minimum of 30 transplants at each provider in the service planning area. As also required by rule and stipulated by the parties, there are no new approved but not yet operational providers within service planning area one. Methodist notes that St. Luke's would be the first Florida program approved in a city which already has an existing kidney transplant service. The United States Renal Disease System (USRDS) is a national organization which collects and reports statistics on patients with end-stage renal disease (ESRD). USRDS is divided into regional networks, including Network Seven which is the ESRD Network of Florida, Inc. The Board of Directors of Network Seven adopted the following motion: The Network Seven Board of Directors reviewed the report of the Network's task force regarding the need for additional renal transplant resources for Service Area 1. After a lengthy discussion, the Board unanimously agreed that the Standardized Transplantation Ratio for Florida's Service Area 1 would not justify the establishment of a new stand-alone renal transplant program in this area. However, it agreed that the availability of a multi-organ transplant service (ie: pancreas and kidney) would be beneficial to those ESRD patients in residing [sic] Service Area 1. Two dual organ kidney and pancreas transplant programs are currently located in Florida, at Shands in Gainesville and at Jackson Memorial in Miami. Methodist notes that both are associated with medical schools at teaching hospitals, and are geographically well-suited to serve north and south Florida. Methodist's transplant surgeon who is the medical director of its program, and served on the Network 7 task force, agreed that a kidney/pancreas program is desirable. Apparently, most pancreas transplants are also done with kidneys but not vice versa. Relatively, few kidney/pancreas transplants are performed, although the number has doubled nationally since 1991. In 1997, there were 3 kidney/pancreas transplants at Shands, 3 at Mayo- Rochester and 33 at Jackson Memorial. The low volume of the dual transplant procedures reflected both medical skepticism and the absence of insurance reimbursement for the procedure when it was considered experimental. Having performed six dual transplants for no charge in 1998, Shands has been able to convince a majority of its third-party payors in Florida to pay for the procedure. The federal government, through the Medicare program, also changed its policy and now reimburses for kidney/pancreas transplants. As a result, the number of dual transplants is reasonably expected to increase. No CON is issued, under the Florida system, to authorize the dual kidney/pancreas program only. As Methodist noted, St. Luke's did not offer to condition its CON by limiting itself to a dual transplant program. The standardized transplantation ratio (STR), on which the Network Seven Board relied, is the ratio of first kidney transplants to the expected number based on the estimated national rate adjusted for age. For the four Florida organ transplant service planning areas, the STRs reported by Network Seven are as follows: Region 1 (North) 1.00 Region 2 (West Central) 1.35 Region 3 (East Central) 1.19 Region 4 (South) .66 A STR of 1.0 indicates generally, that a region is performing transplants as expected based on the national average. Therefore, the suggestion that the performance is mediocre is rejected. Methodist supports its argument that no need exists for an additional kidney transplant program at St. Luke's, based on Network Seven's finding that the STR for the region is roughly what should be expected. St. Luke's, however, asserted that the STR could be raised to the level of region two with the approval of a new program. In fact, the approval of a program at the Cleveland Clinic in Broward County, in region four, was supported by Methodist's expert health planner, among others, in part, by the desire to raise the STR. That situation can be distinguished based on geography and the failure in region four to meet expectations, while a better performance than the national average is not to be expected necessarily from the approval of another program in the same city in region one. While the STR is helpful in an analysis of need, Rule 59C-1.044(8)(d), Florida Administrative Code, requires consideration of the projected transplant volume based on the number of end-stage renal disease patients. Basically, these are patients whose kidneys have ceased to function. From June to December 1998, Network Seven estimated that the number of patients with kidney failure in service planning area one increased from approximately 2800 to 3000. Using expected population growth only, not the historical growth rate, St. Luke's conservatively estimated in its CON that number of patients would reach approximately 2900 by the end of the year 2000. Because some patients are not medically appropriate transplant candidates or will, for other reasons, never receive the service, St. Luke's used a ratio of patients to project transplant cases. Using only 20% of patients between ages 14 and 65, St. Luke's reasonably projects a need for over 300 kidney transplant surgeries in service planning area one in the year 2000. Using population increase and the lower historical growth rate of 9.5%, St. Luke's established a need for up to 450 kidney transplants in 2000 in service planning area one. Either number is sufficient to document St. Luke's ability to perform at least 15 kidney transplants by the end of the second year of operation, as required by rule. Methodist's expert further reduced by 40% the number of potential transplant patients to get what the projected to be the actual number of surgeries. This number is intended to take into consideration the limited number of cadaveric organs. The result is, however, unrealistically lower numbers, in the range of the actual number of surgeries currently performed in area one and is, therefore, rejected. In fact, despite the limitations on cadaveric organs, the number of kidney transplants has continued to increase. St. Luke's experience with liver transplants is also evidence of its ability to exceed the minimum number of 15 kidney transplants in the second year of operation. Specifically, St. Luke's expects to perform 15 kidney transplants in the first year, and 30 in the second year. More than double the projected number of Florida residents received liver transplants, 25 or 26 as compared to 12 or 13 cases in the first seven months of that program at St. Luke's. Compared to projections of 15 liver transplants in year one, 30 in year two, St. Luke's transplant surgeons actually performed 113 after 18 months. Significantly, the volume at Shands has also increased based on the annualized volume for the first quarter of 1999. St. Luke's also demonstrated that it is successfully transplanting livers which were rejected by other Florida programs. Currently, the same team of transplant surgeons harvests all abdominal organs, livers, kidneys, and pancreases, but can use only the livers at St. Luke's. The surgeons who perform the liver transplants at St. Luke's will also perform kidney transplants. As a result of the team's aggressive use of organs and recent changes in federal government requirements for notice of potential donors and reimbursement policies, St. Luke's is reasonably expected to assist in expanding the available supply of cadaveric organs and in increasing the number of transplant surgeries. Subsection 408.035(1)(a) - need in relation to district plan The District 4 health plan, developed by the Health Planning Council of Northeast Florida, Inc., includes preferences applicable to the evaluation of St. Luke's application. Preference one applies to applicants who will meet identified needs with acceptable quality in an economical manner. St. Luke's expert conceded that its proposal will be more costly and require longer average lengths of stay when compared to that at Methodist but not as compared to other Florida programs. St. Luke's projected an average length of stay of 7.6 days at $50,123 per case, but the Florida average is 10.5 days at $81,048. No construction is required for implementation of the project which has a total cost of $238,450. Therefore, St. Luke's proposal generally meets the requirements of preference one. Preference two, for applicants who will alleviate a geographic access problem, is not met by St. Luke's. One argument advanced by St. Luke's and rejected is that the existing providers are not using organs at the appropriate rate. Considering 1997 data, Shands and Methodist appear not to accept and use kidneys at the expected rate, as calculated and assigned by UNOS. The reported expected acceptance rate for Methodist is 30.7% in contrast to an actual rate of 11.5%. Shand's assigned expected rate is reported to be 53.8% but its actual rate of acceptance is shown as 37.4%. Corrected UNOS data shows the opposite result, that acceptance rates are higher than expected. UNOS data is inconsistent and inconclusive. In general, the data is so unreliable as to have no significant probative value. St. Luke's meets preference three by caring for HIV positive patients. St. Luke's also demonstrated its access to adequate staff for a kidney transplant program, meeting the requirement of preference four. Methodist questioned St. Luke's failure to list a certified transplant nephrologist on its staff, but physician services are provided by salaried employees of Mayo-Jacksonville. Preference five favors applicants who demonstrate that a new service will not have a significant negative impact on similar facilities. Even though there may be sufficient numbers of kidney disease patients who qualify for and have access to transplants in service area one, the geographic overlap of the programs is an issue of concern related to impact. Methodist primarily serves transplant service area one patients. St. Luke's draws 50% of its patients from Duval and the five surrounding counties, 35% from other areas of Florida, and 15% from elsewhere, primarily Georgia and the southeastern United States, but that also includes 3% of international origin. It is reasonable to expect St. Luke's to maintain approximately the same patient origin mix in a kidney program. This mix will require St. Luke's to perform only 8 kidney transplants on patients from service area one in order to reach the minimum volume requirement of 15 in the second year, which is actually projected for the first year. Currently, 16 Mayo-Jacksonville patients who are on the waiting list for kidney transplants at Methodist would likely receive transplants at St. Luke's if it had a program. Taking into consideration growth and applying a traditional impact analysis, Methodist will lose two to four cases, and Shands will lose nine cases in the first year of a competing program at St. Luke's. With that level of impact, both programs remain substantially above the minimum required by AHCA rule. One expert equated the loss of ten cases from Methodist, to a financial loss of $100,000, after reimbursement deductions and reduced expenses. The overall magnitude of Methodist's financial losses is so great that the loss of the contribution from the kidney transplant program is insufficient to affect the hospital's profitability. Similarly, the loss of nine cases from Shands leaves volume significantly above the minimum required. Methodist and St. Luke's differ in their reliance on cadaveric and living donors, which also should help alleviate any impact of competition for cadaveric organs on the existing program at Methodist. While Methodist uses 50% living donors, St. Luke's projects a more traditional mix of 30% living. It is reasonable to expect that the growth in transplants, and the differences in patient and organ origins will allow Methodist to avoid any detrimental effect from the establishment of a program at St. Luke's. Methodist suggested that the approved program in Volusia County, and to a lesser extent, that in Broward County will also be unable to achieve minimum volumes if a program is established at St. Luke's. Methodist's support for the Volusia County program, however, lends credence to St. Luke's assertion that the geographic overlap is minimal. St. Luke's demonstrated that the number of projected transplants, taking into consideration the approved programs, is considerably lower than the expected numerical increase in surgeries. Projections of 30 at St. Luke's, six at the Cleveland Clinic, and 25 at Bert Fish during the year 2000 are achievable from the projected growth in kidney transplants. The data also indicates that the Florida waiting lists for transplant candidates could and should be expanded. Separate transplant provider lists are coordinated into the organ sharing list maintained by UNOS. Nationally, 150 people for every one million are on waiting lists for kidney transplants. That number, even adjusted to exclude older patients, is double the ratio for the Florida waiting list. Some expansion is reasonably expected as a result of the establishment of a new Florida program. The numbers needed and projected at each program, the differences in projected patient origins, the ability to expand the waiting list and the absence of an adverse impact from the establishment of the liver transplant program at St. Luke's provide some assurance that a kidney transplant program will not be detrimental to the existing providers. Preference six, for applicants who will maximize services to rural county residents, is met by St. Luke's service to surrounding rural areas. In addition to the general health plan preferences for CON applicants, the District 4 health plan includes specific preferences for transplant services. The parties stipulated that preferences one and five for applicants in major population areas (over 250,000) and for pediatric services are not at issue. Specific preference two applies to applicants with relationships with a broad spectrum of other health care providers, including agreements for patient transfers and organ procurement. In response, St. Luke's refers to its active participation in the UF OPO. As Methodist notes, however, a continuation of the existing relationship, with Mayo physicians performing kidney transplants at Methodist, is the most cost- effective and non-duplicative alternative. St. Luke's transplant surgeons will continue to provide coverage for the surgeons at Methodist. Transplant-specific preference three favors applicants who have a significant role in regional and national research efforts, including by government contracts or research grants. Methodist insists that a distinction be made between the well- known work of the Mayo Foundation and that of St. Luke's. The Mayo Foundation divides its services into three major segments - medical care, medical research, and medical education. Research is supported by over $100 million from government agencies and $80 million from the Foundation. Over a thousand residents and fellows are enrolled in Mayo educational programs. Over 75 transplant-specific research projects within the Mayo system are coordinated by a single institutional review board. Admittedly, a non-university facility, St. Luke's does participate in Mayo educational and research activities. Over 60 Mayo-Rochester physicians, residents, and fellows were rotating through Mayo-Jacksonville and practicing at St. Luke's at the time the CON application was filed. St. Luke's separate budget for basic science research also exceeded $10 million for over 200 active research protocols. The medical research building at Mayo-Jacksonville exceeds 80,000 square feet in size. For these reasons, St. Luke's demonstrated that its participation in educational and research activities satisfies the preference. Transplant preference four favors applicants with a specific commitment to provide charity care. In its application, St. Luke's commits to providing 6% of total kidney transplants to Medicaid or charity patients. One expert witness noted that St. Luke's commitment exceeds the statewide volume of 4% Medicaid/charity kidney transplant patients, which was the condition for approval of the Bert Fish CON. Most patients with end-stage renal disease are covered by Medicare. In calendar years 1996-1998, Shands provided over 30% Medicaid and from 4 to 8% charity care. Methodist provided from 9 to 11% Medicaid and approximately 2% charity care. By contrast, St. Luke's provided from .7% to 1.2% Medicaid and just over 2% charity case. St. Luke's meets the preferences by specifying a reasonable commitment for the kidney transplant program, although it has historically provided comparatively insignificant Medicaid and charity care. Since organ transplant service area one includes Districts 1, 2, and 3, as well as 4, St. Luke's and AHCA also considered the local health plans for those districts. Both noted that District 3 has a preference for organ transplant applicants which are teaching hospitals, as defined by Florida Statutes. St. Luke's does not meet that preference. It is not a statutory teaching hospital. On balance, St. Luke's does meet the intent of local health plans preferences and, therefore, the requirements of Subsection 408.035(1)(a), Florida Statutes. Subsection 408.035(1)(b) - increase/improve availability, access, quality of care, efficiency, utilization, and adequacy of like and existing facilities in the district In its application, St. Luke's illustrated the concern for renal patients as follows: End-stage renal disease is a large and growing problem in Florida and north Florida. with 14,168 ESRD patients in Florida and 2,822 ESRD patients in service planning area one during 1998, with 787 Florida residents added to the kidney waiting list during 1997, and with Florida resident deaths due to diabetes growing to 3,828 deaths by 1997, the magnitude of the ESRD problem is evident. St. Luke's Exhibit 1 at p. 96. St. Luke's plans to serve an increasing pool of patients within the District and the service planning area. With its aggressive use of organs, St. Luke's can also increase available cadaveric organs, thus increasing numerically, the accessibility, availability and utilization of kidney transplant services in the district. The efficiency of all providers is also reasonably expected to be enhanced due to the introduction of competition into the market. Currently, the relationship between Methodist and Shands is not competitive. Subsection 408.035(1)(c) - quality of care Modeled after that of the Mayo Clinic Rochester, St. Luke's kidney transplant program will be emulating a program with the nation's best survival rates despite its use of organs which have been rejected by others. St. Luke's is licensed by the AHCA, certified to participate in the Medicare and Medicaid programs, accredited by the Joint Commission on the Accreditation of Health Care Organizations (JCAHO), and certified by UNOS to perform transplants. The parties stipulated that St. Luke's has a history of providing a high quality of care. The evidence also supported a finding that St. Luke's will also provide the same high quality of care in kidney transplantation services, using the same physical spaces, by essentially the same staff. St. Luke's staff will require only specialized kidney transplant training and equipment. Subsection 408.035(1)(d) - available and adequate alternatives An alternative to a new kidney transplant provider is the expansion of the volume of cases performed at existing providers. There are no physical constraints to the alternative, only the need for additional staff and supplies. Methodist and Shands can absorb the projected increase in kidney transplant surgeries in the service planning area. Given that lack of constraint, the minimum volume established for existing providers by rule, gives the guidance to determine whether it is appropriate to expand volumes at existing providers or to introduce a new provider. Because there is no competition in the service area in which the existing providers are well above the minimum volume, and the projected volumes for the new programs are exceeded by the projected additional transplants, the establishment of an additional program is appropriate. Subsection 408.035(1)(e) - economies and improvements from joint operative or shared resources The advantages of developing a kidney transplant program at St. Luke's include: the ability to utilize the existing infrastructure which supports the liver and bone marrow transplant programs; and the ability to adopt Mayo Rochester's treatment protocols, standards, and training resources, and to participate in its research projects. The only clearly identified disadvantage is the risk of undermining the cooperation of Mayo-Jacksonville transplant surgeons with Methodist and the loss of some transplant surgeries from Methodist and Shands. On balance, the introduction of a kidney program in Florida, emulating the Mayo-Rochester program, offers a valuable sharing of Mayo resources. Subsection 408.035(1)(f) - need for equipment or services not accessible in adjoining areas St. Luke's proposal will not result in the introduction of any special equipment or services which are not reasonably or economically accessible in adjoining areas. Subsection 408.035(1)(g) - need for research and educational facilities; (1)(h) - needs of training programs and schools for health professionals Mayo-Jacksonville has active research, medical residency, and fellowship training programs in Jacksonville. Most of the inpatient care associated with the research and educational programs is provided at St. Luke's. A new program at St. Luke's offers new educational opportunities for Mayo- Jacksonville physicians. Subsection 408.035(1)(h) - availability of personnel for project accomplishment (see also Rule 59C-1.044) While the statutory criteria generally, considers whether CON proposals include plans to employ the necessary personnel, the organ transplant rule gives much greater detail. As required by rule, St. Luke's has the staff needed to care for the transplant patients. It offers 24-hour on-site dialysis, and is staffed by renal care and dialysis nurses, nutritionists, respiratory therapists, social workers, psychologists, dialysis laboratory workers and administrators. Physicians include board and UNOS certified transplant surgeons, anesthesiologists, pathologists, psychiatrists, nephrologists, endocrinologists, and immunologists and infectious disease specialists. In addition to the health care professionals needed for operation of a kidney transplant program, St. Luke's has significant experience with the data collection process necessary to evaluate adequately a transplant program. Among the requirements of the Rule are a 24-hour shared call system for organ procurement, and clinical review committees, which already exist. St. Luke's operates a 17-bed intensive care transplant unit capable of prolonged reverse isolation, if required. Equipment is available and in operation for cooling, flushing, and transporting organs, as are an on-site tissue typing laboratory and an in-house blood bank, as the parties stipulated. Subsection 408.035(1)(h) - availability of funds for project accomplishment and Subsection 408.035(1)(i) - immediate and long-term financial feasibility The total project cost is $238,450, which covers filing fees, staff training, and equipment. No renovation or construction costs are anticipated because St. Luke's has adequate capacity to implement the kidney program in existing spaces. Methodist's expert testified that the financial feasibility of the project cannot be determined due to errors on Schedule 2 of the CON application and the lack of reliable utilization projections. As previously determined, the utilization projections are supported by the projected number of area one patients with kidney failure who ultimately have transplant surgeries. Schedule 2 of the CON application lists the capital project commitments of the applicant. St. Luke's listed projects which total $35.9 million taken from a "1998 Capital Budget Request Summary." The total, in excess of $35 million, represents the budget request summary of just over 34 million, minus approximately $4 million that had already been spent, plus a little over $5 million for the two pending CONs and expansion of an intensive care unit (ICU). The ICU expansion cost of $500,000, was understated by $766,000. At the hearing, however, St. Luke's expert testified that he mistakenly listed St. Luke's "wish list," when he used $34 million, which exceeded "approved" projects by $17 to $18 million. That total would have been approximately $16,974,000. The available cash and investments for St. Luke's, approximately $80 million, is sufficient to cover the project costs and other capital projects at either $35 million or $16 million, or $21 million if, as asserted at hearing, the $16 million is understated by $5 million. The proposal is financially feasible in the short-term, even considering the decline in available cash and investments to $65 million at the time of the final hearing. In terms of long-term financial feasibility, the experts considered profits or losses from operations. St. Luke's experienced losses from operations of $4.5 million, $4 million, and $12.9 million in the years 1996, 1997, and 1998, respectively. When investment income is considered, however, St. Luke's had a positive income figure of $5.2 million in 1997 and losses reduced to $.7 million in 1998. St. Luke's explained the losses as temporary due to the initiation of costly new services, the enhancement of information systems, and an increase in charity care. The charges for kidney transplants at St. Luke's are expected to equal $57,200 a case, or $1.7 million in gross revenue for 30 cases at the end of the second year of operations. The expected charges are reasonable when compared to charges, in 1996, of $50,000 at Mayo-Rochester, $42,000 at Shands, $38,000 at Methodist, and a Florida average of $81,000. Kidney transplants continue to receive cost-based reimbursements from Medicare. From the $1.7 million in gross revenue, St. Luke's expert projected an incremental profit of approximately $100,000. In addition, the audited financial statements of the Foundation were submitted with St. Luke's CON, with a statement of the Foundation's willingness to fund the project. With over $1 billion in cash and investments and, for 1997, net income over $31 million, the Foundation is able to assure the short and long- term financial feasibility of the kidney transplant program at St. Luke's. Subsection 408.035(1)(j) - needs of a health maintenance organization (HMO) Although the Mayo organization includes a licensed Florida HMO, the proposal is not intended to serve its needs any more than those of any other potential patients. Mayo- Jacksonville and St. Luke's have contracts to provide services to a number of other HMOs. Subsection 408.035(1)(k) - substantial services to non-resident of the district or adjacent districts Currently, St. Luke's attracts 51% of its patients from Duval County, another 21% from the other counties in District 4, 16% from the rest of Florida, and the remaining 12% from outside of Florida. The patient origin for Mayo-Jacksonville is even more geographically dispersed than that of St. Luke's, with 22% of from outside of Florida. By comparison, nearly 99% of Methodist's patients come from North Florida. St. Luke's patient origin data indicates the reasonableness of its expectation that 15% of kidney transplant patients will come from outside Florida. St. Luke's, therefore, meets the criterion for substantial service to non-residents. Subsection 408.035(1)(l) - impact on costs, effects of competition on improvements or innovations in financing and delivering services with quality assurance and cost-effectiveness St. Luke's expects expanded transplant services to reduce its overall fixed cost per transplant. The introduction of a Mayo-affiliated medical program is reasonably expected to introduce beneficial competition to the market which currently has no competition. The fact that competition will come from a nationally-known, very successful program is expected to have a positive impact on existing programs. Subsection 408.035(1)(m) - costs and methods of construction Methodist contends that St. Luke's omission of architectural drawings or floor plans in the CON makes it impossible to consider the statutory criteria related to construction. While St. Luke's failed to include any architectural drawings, it did include descriptions of the existing spaces and in-house services which will support the program. Schedule 1 and 9 of the application show that no costs are associated with construction, expansion, remodeling or demolition. Architectural drawings were not submitted and not required by AHCA for CONs filed by the Cleveland Clinic (kidney transplant), Tampa General (lung transplant), and University Medical Center (heart transplant). In each instance, the facility proposed using existing spaces for the new programs. Based on AHCA's past practices in comparable circumstances, St. Luke's application is not flawed due to the absence of architectural plans. Subsection 408.035(1)(n) - history of and proposed services to Medicaid and medically indigent patients St. Luke's has historically provided limited Medicaid and charity care. See Findings of Fact 39 and 40. St. Luke's proposal to perform 3% Medicaid and 3% charity kidney transplants in the second year of operation is the equivalent of one Medicaid and one charity case. That commitment, however, exceeds the Florida average and the commitment AHCA required of Bert Fish program. The commitment made by St. Luke's is adequate for kidney transplant services. Subsection 408.035(1)(o) - past and proposed continuum of care in multi-level system St. Luke's affiliation with Mayo physicians' practices and the Mayo-Jacksonville clinic allow it to incorporate kidney transplant services into a multi-level system which includes home health and outpatient care. Subsection 408.035(2)(a) - capital expenditures proposals (a) less costly alternatives; (b) utilization of similar services; (c) alternatives to new construction; and (d) serious access problems Subsection 408.032(2), Florida Statutes, defines capital expenditures as follows: "Capital expenditure" means an expenditure including an expenditure for a construction project undertaken by a health care facility as its own contractor, which, under generally accepted accounting principles, is not properly chargeable as an expense of operation and maintenance, which is made to change the bed capacity of the facility, or substantially change the services or service area of the health care facility, health service provider, or hospice, and which includes the cost of the studies, surveys, designs, plans, working drawings, specifications, initial financing costs, and other activities essential to acquisition, improvement, expansion, or replacement of the plant and equipment. In this project, St. Luke's proposes to incur the cost for kidney transplant equipment to establish the new service. The least costly alternative is enhanced Mayo participation in the program at Methodist. Methodist is, however, sufficiently utilized, well in excess of the rule minimum. No new construction is required at St. Luke's to implement the kidney transplant service. Patients will not, however, experience serious problems with access to kidney transplant services if St. Luke's is not approved. There are no physical constraints on the expansion of services at Shands or Methodist. In the absence of physical constraints at existing providers, but in consideration of their volumes which are well in excess of that required, the introduction of competition of the Mayo quality at such low cost is, on balance, desirable for the health care system.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED That a final order be entered issuing CON 9078 to establish a new adult kidney transplant program at St. Luke's Hospital in Jacksonville. DONE AND ENTERED this 17th day of February, 2000, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 17th day of February, 2000. COPIES FURNISHED: Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Richard A. Patterson, Esquire Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308 F. Philip Blank, Esquire R. Terry Rigsby, Esquire Geoffrey D. Smith, Esquire Blank, Rigsby & Meenan, P.A. 204 South Monroe Street Tallahassee, Florida 32301 Michael J. Cherniga, Esquire Seann M. Frazier, Esquire Greenberg Traurig, P.A. Post Office Drawer 1838 Tallahassee, Florida 32302
Findings Of Fact EKTC was formed to apply for and operate a renal dialysis treatment center in Englewood, Florida, by Michael J. Kenny, M.D., the sole shareholder of this corporation. Dr. Kenny has entered into a preliminary agreement with Renal Care Centers, Inc. (RCC) to organize and manage the facility. The catchment area from which EKTC proposes to take patients includes the communities of Englewood, Grove City, Cape Haze, Boca Grande, El Jobean, Gulf Cove, North Port, Warm Mineral Springs, Placida, and Rotunda. Funds for start-up costs, including the purchase of the five dialysis machines required, will be provided by RCC as part of its management fee. These start-up costs are estimated at $60,000 which will be capitalized and amoritized over a five-year period. The equipment purchased will be owned by RCC. Florida End-Stage Renal Disease (ESRD) Network 19 maintains census records of renal disease patients in Florida by zip code location and treatment needed. DHRS relies on the data supplied by Network 19 to determine need for additional dialysis stations. In reviewing applications and making recommendations Network 19 gives more emphasis to access than to the effect additional kidney treatment centers will have on existing facilities. Englewood, 12 miles south of Venice, is in one of the fastest growing areas in Florida and has a high percentage of its population over 50 years of age. This is the age group having the greatest need for in-center dialysis treatment. There are presently dialysis treatment centers at Venice and at Port Charlotte, 21 road miles east of Englewood. There are five patients currently treated at CBC, Venice, who live in the Englewood area and nine patients currently treated at Port Charlotte AKC live in the proposed catchment area. Approval of this application will have an initial serious adverse impact on these facilities. CDC operates a ten-unit dialysis center in Venice and initially will be adversely affected by the grant of the certificate of need to EKTC. Renal dialysis patients usually require dialysis three times per week, with each dialysis taking from four to five hours. Full utilization would occur if two patients are dialyzed per machine per day. If the dialysis center is open six days per week and each patient requires three dialyses per week, then one machine at full utilization could dialyze four patients per week. However, experience has shown that such utilization is impractical and 80 percent of this figure, or 3.2 patients per station, has been accepted as "full" utilization so as to authorize additional dialysis centers when this percentage utilization is reached. This degree of utilization provides time at dialysis centers for transients and emergency cases which are not counted in determining the percentage utilization of the equipment. Numerous witnesses testified that the driving time between Englewood and CDC's facility at Venice varies from 20 to 90 minutes depending upon the traffic. No time distance study was presented to confirm these driving times. No credible evidence was submitted regarding the driving time between the homes of those patients living in Englewood who are currently treated in Venice and the Venice facility; nor was similar evidence presented regarding driving time to the Port Charlotte dialysis center from the homes of those Englewood residents currently receiving dialysis treatment at Port Charlotte. Between October 1983 and September 1984 CDC treated an average of just over 26 patients per month which, when divided by 40, gives a utilization rate of 65 percent. The maximum average number of patients in any one month during this period was 31, which gives a utilization rate of 77.5 percent. These utilization rates are below the 80 percent utilization recognized as the threshold to meet before additional dialysis centers are needed. Exhibit 4 shows that the Port Charlotte center, with eight stations, had an average of 31 patients per month during the first six months of 1983, for a utilization rate of 97 percent, but in the three following months the utilization rate dropped to 68 percent. A new hospital is under construction in Englewood and, when operational, could result in additional doctors, including nephrologists, coming to this area. More nephrologists coincide with additional renal disease patients and increase the potential for more renal dialysis stations. EKTC proposes to offer renal dialysis, training for home dialysis, and peritoneal dialysis. CDC provides no peritoneal dialysis and, although certified for home dialysis training, has provided no such training to date. EKTC is wholly owned by Michael J. Kenny, M.D., who is one of two nephrologists practicing in the Venice area, and, if this certificate of need is approved, Dr. Kenny has entered into a management agreement with RCC, a wholly- owned subsidiary of United Medical Corp. to set up and manage the facility. RCC has the experience, personnel, and resources to equip and operate the proposed facility and they are ready and willing to commence the operation once approval is granted. CDC questioned the validity of the CON granted to EKTC. Among the errors noted are: The State Agency Action Report (Exhibit 2) although signed and dated, does not indicate final state agency action taken. Dr. Kenny signed the application but failed to show himself as an officer of the corporation (EKTC) or authorized by the Board of Directors to apply for a certificate of need. No address in Englewood was shown for the proposed facility. The office address of EKTC's attorneys is the only address shown on the application. Dr. Joseph is not the proposed medical director as shown on the application. The projected cost of the project was changed from $37,167 on the initial application to $60,000 on the amended application without a new agency review and evaluation. EKTC has not paid the correct fee for the amended application. All of these objections are technical. By letter dated February 3, 1984 (Exhibit 3), DHRS forwarded CON No. 2934 to EKTC. Subsequent to filing the original application, Dr. Kenny completed the negotiations with RCC and the decision was made to buy the dialysis machines rather than rent them and this contributes most of the increase in initial costs. Not a major change. Likewise, Dr. Joseph backed out as medical director and Dr. Kenny assumed that role until he can obtain someone else to take over. Dr. Kenny is the sole stockholder in EKTC and to make an issue of the fact that he did not put a corporate title under his signature or present a Board of Directors' resolution authorizing him to sign the application elevates form over substance. At the time the application was submitted, no site had been selected for the proposed facility so the address shown was for mail purposes only. DHRS, following the recommendations of ESRD Network 19, historically has given favorable consideration to requests which improve access to care for area patients. This is true even when a need is not clearly shown. In recommending granting the five station renal dialysis center certificate of need to EKTC, ESRD Network 19 took the trend analysis of 116 ESRD patients per one million population, to arrive at a patient census for the catchment area of 18. From this it deducted patients dialysing at home, projected new home-trained patients, projected transplants and projected mortality; and added projected new patient acquisition, projected unsuccessful transplants, and projected home- trained patients returned to center, and ended up with 14 patients in the catchment area requiring in-center dialysis (Exhibit 5). To this it applied 3.2 patients per station, to arrive at a need for four to five stations. The addition of the proposed five dialysis stations in Englewood will greatly improve access for those patients in the catchment area and will have an immediate after it is adverse impact on CDC and Port Charlotte AKC. Experience has shown that approximately one-half of the patients in the Englewood catchment area will go to EKTC immediately opened and the others will follow during the next 12 to 18 months. The continued growth of Florida's population and, in particular, the faster growth of older people in this state, also historically has mitigated the long-term effect on existing renal dialysis centers losing patients to new centers.
Findings Of Fact "[HRS] has adopted a Rule 10-5.08, F.A.C., which makes provision for the review of CON applications in specific time sequences, known as "batching cycles." The purpose of this rule was to implement the statutory mandate of ss. 381.494(5), Florida Statutes, which required that: The Department by rule shall provide for the applications to be submitted on a timetable or cycle basis, provide for review on a timely basis; and provide for all completed applications pertaining to similar types of services, facilities, or equipment affecting the same service district to be considered in relation to each other no less often than four times a year. Rule 10-5.08, F.A.C., states that the letter of intent and application schedules were established "[i]n order that applications pertaining to similar types of services, facilities, or equipment affecting the same service district may be considered in relation to each other for purposes of competitive review. "Under Rule 10-5.08, F.A.C., June 15, 1984, was the beginning of a batching cycle for "hospital projects" that included certificate of need requests by hospitals for cardiac catheterization laboratories and open heart surgery programs. To enter a batching cycle, an applicant must first have filed a letter of intent ("LOI") with [HRS] and the Local Health Council at least thirty (30) days prior to filing an application. The LOI deadline for the June 15, 1984, batching cycle was thus May 16, 1984. There was, however, one exception to this requirement of filing an LOI thirty (30) days in advance. This exception, known as the "grace provision," was found at Rule 10 5.08(e), F.A.C. In cases where a letter of intent was filed within five working days of the letter of intent deadline, a grace period of 10 days from the deadline date for receipt of letters of intent shall be established to provide an opportunity for a competing applicant to file a letter of intent. "On or about May 14, 1984, St. Mary's Hospital in West Palm Beach submitted a letter of intent to file a CON application for a cardiac catheterization laboratory and an open heart surgery program. St. Marys' [sic] LOI was for entry in the June 15, 1984, batching cycle. This date of Nay 14, 1984, was within five (5) working days of the LOI deadline for the June 15, 1984, batching cycle. "Boca Raton Community Hospital [also] filed a letter of intent to apply for a CON for cardiac catheterization and open heart surgery. Boca Raton's LOI was filed in April of 1954, a time period greater than five (5) working days prior to the LOI deadline. "On May 29, 1984, Good Samaritan filed with [HRS] and the Local Health Council a letter of intent to establish cardiac catheterization and an open heart surgery program in order to compete for CON approval with the similar services proposed by St. Marys [sic]. Good Samaritan's May 29, 1984, LOI sought entry into the June 15, 1984, batching cycle. "May 29, 1984, was within ten (10) days from the deadline date for receipt of letters of intent for the June 15, 1984, batching cycle. "Good Samaritan does not view itself as directly competing with Boca Raton Community Hospital for patients or services due to the distance between these facilities. Good Samaritan does view itself to be in direct competition with St. Marys [sic]. All three hospitals are, however, in the same HRS Service District and [HRS] reviews CON applications for cardiac catheterization laboratories and open heart surgery on the basis of whether there is a need for such laboratories or programs in the service district. "On June 15, 1984, Good Samaritan submitted its [CON] application to [HRS], together with the required Four Thousand Dollar ($4,000.00) application fee. [HRS] refused to accept this application for review in its June 15, 1984, batching cycle and returned the application and the filing fee to Good Samaritan. [HRS] advised Good Samaritan that the next batching cycle it could enter for this application would be the October 15, 1984, batching cycle. "Good Samaritan timely filed a request for formal proceedings pursuant to ss. 120.57, Florida Statutes (1983), regarding [HRS's] refusal to accept its application in the June 15, 1984, batching cycle. The Division of Administrative Hearings has jurisdiction over the parties and over the subject matter of this proceeding. "Effective September 6, 1984, and subsequent to the Department's refusal to accept Good Samaritan's application for the June 15, 1984, batching cycle, [HRS] amended Rule 10-5.08(e). The new rule, as amended, reflects the requirements that the Department contends are applicable to Good Samaritan in this case prior to the amendment. "[HRS's] refusal to accept Good Samaritan's application in the June 15, 1984, batching cycle prevents Good Samaritan from having its proposed project reviewed comparatively and competitively with St. Marys' [sic] or Boca Raton's similar proposals, because [HRS] does not review CON applications comparatively and competitively unless they are filed in the same batching cycle. "[HRS] approved in part [sic] both St. Marys' [sic] and Boca Raton's CON applications. CON #3367 was issued to St. Marys [sic] for a cardiac catheterization laboratory and CON #3366 was issued to Boca Raton for a cardiac catheterization laboratory. These actions by [HRS], however, have not yet become final and are subject to formal administrative hearings requested by Good Samaritan. "[HRS] takes the position that the approvals of the cardiac catheterization laboratories at St. Marys [sic] and Boca Raton count against the need for an additional cardiac catheterization laboratory as proposed by Good Samaritan if Good Samaritan's application is considered in a later batching cycle."
Recommendation Based on the foregoing, it is RECOMMENDED: That HRS enter a final order requiring that Good Samaritan's CON application be reviewed in the June 15, 1984 batching cycle. DONE and ORDERED this 13th day of February, 1985, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of February, 1985.
The Issue The issue is whether Respondent Agency for Health Care Administration properly denied Petitioner Bert Fish Medical Center, Inc.'s application for a certificate of need to establish an adult kidney transplant program at its existing hospital located in Volusia County.
Findings Of Fact THE APPLICANT BFMC is a not-for-profit hospital located in New Smyrna Beach, Volusia County, Florida. The hospital is a 116-bed, Class 1, general acute-care hospital. BFMC proposes to establish an adult kidney transplant program on its third floor next to the inpatient unit. The applicant will designate seven acute-care beds for use in the program. The hospital currently offers no other special programs or tertiary services. BFMC is located in health planning District 4 which is comprised of seven counties. BFMC is located in organ Transplant Service Area 3 which is comprised of ten counties located within the following four health planning districts: District 4, Volusia County; District 3, Lake County; District 7, Orange, Seminole, Osceola, and Brevard Counties; District 9, Indian River, St. Lucie, Martin, and Okeechobee Counties. BFMC is a part of the Southeast Volusia Hospital District (SVHD) which encompasses southeastern Volusia County, including New Smyrna Beach, Edgewater, Oak Hill, and the unincorporated areas of south Volusia County. The legislature created the SVHD as a special taxing district to provide health care to all citizens without regard to their ability to pay. The SVHD commissioners are appointed by the Governor. They also serve as the directors of BFMC. East Volusia County is well developed, from Edgewater in the south, to the northern end of the county. Areas along the beaches, the Indian River, and the Halifax River are densely populated. Other areas of the county are less populated. BFMC is located two blocks east of highway U.S. 1. State Road 44, a four-lane highway, connects New Smyrna Beach to Interstate 95. The applicant is located approximately 50 miles from Florida Hospital in Orlando, Florida. Florida Hospital- Orlando currently is the only adult kidney transplant center in Transplant Service Area 3. BFMC offers the following inpatient and outpatient services: surgery (including a 14-bed intensive care unit for surgical and medical patients); medical and radiation oncology; cardiac catheterization; diabetic center; invasive radiology; MRI; CT scanning; and outpatient surgery. The hospital has an emergency room which is staffed on a 24-hour basis. BFMC operates a home health agency, a rehabilitation center, a diagnostic center, a primary care center and a clinic for the medically needy. The medical staff at BFMC consists of 128 physicians. Eighty-two percent of the doctors are board-certified in their respective medical fields. The remaining 18 percent of doctors are board-eligible in a medical specialty. The physicians at BFMC have medical specialties in the following areas: urology, nephrology, internal medicine, general surgery, vascular surgery, anesthesiology, cardiovascular surgery, transplant surgery, pain management, pathology, pulmonology, neurology, orthopedics, and orthopedic surgery. The 260 member nursing staff at BFMC includes 172 licensed nurses. Eighty-seven percent of the nurses are registered nurses. BFMC is a member of Halifax-Fish Community Health (Halifax-Fish), a partnership of the Halifax Hospital Medical Center (HHMC) and the SVHD. The goal of Halifax-Fish is to eliminate unnecessary duplication of services and to reduce health care costs. The HHMC owns and operates Halifax Medical Center, a general acute-care hospital located in Daytona Beach. Halifax Medical Center operates the third busiest emergency center in the state. Halifax Medical Center provides the following services which are not available at BFMC: (a) an adult bone-marrow transplant program; (b) adult and adolescent inpatient psychiatric services; and (c) a neonatal intensive care unit. The Halifax-Fish partnership provides the residents of eastern Volusia County with the following services: (a) two acute-care hospitals; (b) bone-marrow transplantation; (c) an HMO; (d) a PPO; (e) home health; (f) hospice; (g) long-term care; and (h) skilled nursing care. Halifax Medical Center filed a letter of intent to establish an adult kidney transplant program in the same batching cycle as BFMC. Subsequently, Halifax Medical Center withdrew its letter and offered its support to BFMC's application. The Organ Procurement and Transplant Network (OPTN) coordinates the listing of potential transplant recipients and the distribution of donated organs on a local, regional, and national level. The United Network for Organ Sharing (UNOS) is the entity that operates OPTN. UNOS has established standards for transplant surgeons, transplant physicians, and for certification of transplant centers. Most of the standards in AHCA's transplant rule, Rule 59C-1.044, Florida Administrative Code, are based on UNOS guidelines. UNOS has approved BFMC's membership application. Membership in UNOS signifies that BFMC has met applicable federal guidelines for the establishment of a kidney transplant program. It also means that UNOS will permit BFMC to participate in the national organ sharing program pending state authorization. There are six existing adult kidney transplant programs in Florida. These programs are located in the following districts and services areas: (a) Shands Hospital, District 3, Service Area 1; (b) Methodist Medical Center, District 4, Service Area 1; (c) Tampa General Hospital, District 6, Service Area 2; (d) Southwest Florida Regional Medical Center, District 8, Service Area 2; (e) Florida Hospital-Orlando, District 7, Service Area 3; and (f) Jackson Memorial Hospital, District 11, Service Area 4. PREHEARING STIPULATION The parties agree that BFMC timely filed its CON application, including the letter of intent, initial application, and response to omissions, with AHCA and the local health council. The initial CON application was filed on March 26, 1997. The response to omissions was filed on May 12, 1997. The parties agree that BFMC's CON application meets the publication requirements of Section 408.039(2)(d), Florida Statutes (1995), and Rule 59C-1.008(1)(i), Florida Administrative Code. The parties agree that BFMC's CON application meets the following requirements of Section 408.037, Florida Statutes: the application contains a certified copy of the resolution of its board of directors authorizing the filing of the CON application pursuant to Section 408.037(4), Florida Statutes; the application contains all of the minimum content items required by Section 408.037; and the application contains Schedules 1, 2, 3, 4, 6, 7, and 8 which are complete and reasonable and which properly document the required information. Other statutory and rule review criteria are addressed below. CERTIFICATE OF NEED REVIEW CRITERIA Need in Relation to State and District Health Plans: Section 408.035(1)(a), Florida Statutes. There is no published fixed need pool applicable here. Nevertheless, BFMC must show that its service area needs an additional adult kidney transplant program. The demonstration of need requires consideration of the following state and local health plan preferences. State Health Plan The state health plan has eight preferences which apply to all proposed transplant programs. The parties agree that BFMC's application complies with Preference 1. That preference requires the applicant to make a commitment to accept patients for organ transplants regardless of their ability to pay. Preference 2 favors applicants with a history of providing a disproportionate share of charity care and Medicaid patient days. BFMC is entitled to partial credit for this preference because it provides a high percentage of charity care. However, BFMC does not meet the Medicaid disproportionate share criteria. Preference 3 favors applicants with other existing organ transplantation programs. As the sole applicant, BFMC does not meet this criteria. However, BFMC's partner in the Halifax- Fish partnership, Halifax Medical Center, has a bone-marrow transplant program. Preference 4 favors teaching hospitals for the establishment of any organ transplantation program. BFMC does not meet this criteria because it is not a teaching hospital. However, Rule 59C-1.044, Florida Administrative Code, specifically excludes kidney transplant programs from the type of transplant programs which are restricted to teaching hospitals. Preference 5 favors applicants that are members of UNOS. The parties agree that BFMC meets this preference. The parties agree that BFMC meets the requirements of Preference 6. That preference favors an applicant that can demonstrate successful implementation of the Uniform Anatomical Gift Act. BFMC is not a teaching hospital. Therefore, it cannot receive credit for Preference 7. That preference favors teaching hospitals that document the establishment of a residence program related to the proposed organ transplantation program. Preference 8 favors facilities approved by the National Institute of Health (NIH) and Medicare for the establishment of additional transplant programs. BFMC does not meet the requirements of this preference because it is not an NIH approved facility or a Medicare designated center. Additionally, BFMC is seeking to establish an initial program, not an additional transplant program. As to state health plan preferences that apply to transplant programs, BFMC meets the requirements of at least three preferences and partially meets the requirements of at least two other preferences. Local Health Plan District 4 has eight local health plan preferences. Only six of these preferences are applicable here. The parties agree that Preference 5 and Preference 6 do not apply to BFMC's proposed project. Preference 1 favors applications for transplant centers to be located in a major metropolitan area. This preference defines "major metropolitan area" as a county with a population of 250,000 or more. BFMC meets this requirement because Volusia County's population exceeds 250,000. Preference 2 favors applicants who document that they have written relationships with a broad spectrum of other health care providers for patient transfer, tissue procurement, and/or joint venture with regard to the proposed service. BFMC meets the requirement of this preference. BFMC has agreements for transfer with nursing homes for the transfer of patients and emergency services. It has an agreement with a UNOS-designated organ procurement organization. The hospital has an agreement for laboratory services. BFMC and Halifax Medical Center provide an integrated health care system through the Halifax-Fish partnership. The partnership helps ensure continuity of care and non-duplication of costly services. BFMC does not meet the requirements of Preference 3. It is not recognized as a stand alone regional or national referral center. It does not have its own regional or national clientele. Preference 4 favors applicants that play a significant role in regional or national efforts such as comprehensive cancer centers designated by the National Cancer Institute. Pursuant to Preference 4, an applicant plays a "significant role" if it serves as the contracting agency for government medical research grants or if it has a formal affiliation with the lead agency and engages in active medical research with the lead agency. BFMC deserves partial credit for this preference based on its affiliation with Halifax Medical Center which participates actively in cancer research and operates a bone-marrow transplantation program. In cooperation with Halifax Medical Center, BFMC operates an Oncology Center which is dedicated to the outpatient treatment and management of a variety of cancers. The parties agree that BFMC meets the requirements of Preference 7. BFMC has submitted a plan to increase local organ donations. Preference 8 favors applicants who formally commit to a program of charity care, with the commitment spelled out in their CON application. BFMC's application meets this preference. SVHD's mission is to provide medical services to residents without regard to their ability to pay. BFMC's application is conditioned on the provision of 4 percent charity care, which equates to one person in each of the first two years of operation. Of the six applicable local health plan preferences from District 4, BFMC meets the requirements of four preferences in full and one preference in part. BFMC's application did not address the local health plan preferences for transplant programs in Districts 3, 7 and 9. AHCA sent an application packet to BFMC which indicated that District 4 was the applicable health planning district for BFMC's application. The application packet included a copy of the District 4 preferences. AHCA's omissions letter did not inform BFMC that it should address all local health plans for each district in Transplant Service Area 3. District 3 has one CON preference for transplantation programs. This preference favors programs at teaching hospitals. Shands Hospital, a teaching hospital in Gainesville, Florida, is located in District 3. BFMC does not meet this criteria. District 7 has two local preferences which address organ transplantation in general. The first favors applicants with residency programs. BFMC is not entitled to this preference. The second preference from District 7 favors applicants that agree to provide charity care. This preference requires the applicant to provide data detailing, by county and payor source, the admissions to the facility for the last year, and copies of any letters of support from referral facilities indicating their past good experiences in placing patients in need in the applicant's facility. BFMC is entitled to partial credit for this preference based on its commitment to provide charity care. District 9 does not have any local health plan preferences which apply to BFMC's application. Need in Relation to Rule Criteria: Rule 59C-1.044, Florida Administrative Code. The parties stipulated that BFMC's application met the threshold need determination set forth in Rule 59C-1.044(8), Florida Administrative Code. This rule requires each existing kidney transplant program in the transplant service area to have performed a minimum of 30 transplants in the most recent calendar year. Additionally, the applicant must document that it will perform a minimum of 15 transplants within two years of operation. The only hospital currently providing adult kidney transplant services in Transplant Service Area 3, Florida Hospital-Orlando, performed in excess of 100 transplants in the most recent calendar year. BFMC projects that it will perform 19 kidney transplants in its first year of operation, and 25 transplants in its second year of operation. BFMC based these projections on the number of persons on dialysis in Transplant Service Area 3. Nationally, about 50 percent of the persons on dialysis might be candidates for a kidney transplant. For persons below the age of 65, approximately 75 percent of the persons on dialysis could be candidates for a kidney transplant. In Transplant Service Area 3, there are about 2,161 persons on dialysis. Approximately 40 percent of those persons are not suitable for transplantation. Therefore, only 1,297 persons may be candidates for transplantation. Of the 1,297 persons that might be suitable for transplantation, only nine or ten percent will actually be willing to undergo a transplant. The number of persons willing to be listed as a candidate for a transplant is expected to increase by 12 percent annually. BFMC's projections have been adjusted for the relatively small number of pediatric cases in the transplant service area. The projections also consider the number of procedures performed by Florida Hospital-Orlando. The projections are reasonable based on the number of persons on dialysis in the transplant service area. On a statewide basis, there is a positive correlation between the number of available transplant centers, the number of people on the kidney transplant waiting list, and the number of transplants performed. Statistics from the Health Care Financing Administration (HCFA) indicate that, on a statewide basis, a greater number of transplant centers will result in a larger number of dialysis patients on the kidney transplant waiting list, and a larger number of transplants performed. Currently, Florida's percentage of transplant centers, compared to the total dialysis population, is significantly less than this same percentage for other states with similar numbers of persons on dialysis. Florida also lags behind other states with similar dialysis populations in the percentage of people on the transplant list and the number of transplants per the dialysis population. Volusia County is the appropriate location for an additional adult kidney transplant program within the ten-county area that comprises Transplant Service Area 3. Volusia County is second only to Orange County in the number of persons afflicted with one or more of the diseases which cause renal failure. Brevard County, which is located immediately adjacent to south Volusia County, is third. Together, Volusia County and Brevard County have more people on dialysis than Orange County. The Availability, Quality of Care, Efficiency, Appropriateness, Extent of Utilization, and Adequacy of Like and Existing Health Care Services in the Service District: Section 408.035(1)(b), Florida Statutes. There is no evidence that any patient on the UNOS waiting list has ever been turned away from a kidney transplant center in Florida. The kidney transplant program at Florida Hospital- Orlando has been in existence for 25 years. It performs four times the minimum number of transplants necessary before a new program may be considered in the service area. Despite its significant growth in the past few years, there is no evidence that Florida Hospital-Orlando is operating inefficiently. It has not reached its capacity for performing kidney transplants. Nevertheless, a new kidney transplant program at BFMC would improve access for patients who otherwise would not seek placement on the transplant waiting list. Patients that are appropriate candidates for placement on the kidney transplant waiting list often refuse that opportunity due to the distance from their home to the transplant center. They are not willing to travel very far from home for evaluation, for surgery, and for maintenance and follow-up after surgery. Kidney transplant patients require lifetime monitoring of immunosuppressants as well as continued treatment for the underlying disease. These patients are more willing to be placed on the waiting list and to consider a transplant, as an alternative to continued costly dialysis, if the transplant facility is close to their family and home. There is no evidence that BFMC's proposed program will adversely impact any other existing provider of kidney transplants. No provider of transplant services intervened in this proceeding to challenge BFMC's program. On the other hand, BFMC received support for its proposed program from numerous hospitals through out the transplant service area and in the adjacent transplant service area. An additional kidney transplant program will lead to a potential increase in the number of available donors. It will improve accessibility and availability of kidney transplant services, as well as the efficiency, appropriateness, and adequacy of the service in Transplant Service Area 3. The Ability of the Applicant to Provide Quality of Care and the Applicant's Record of Providing Quality of Care: Section 408.035(1)(c), Florida Statutes. The parties agree that BFMC's has a record of providing quality of care. BFMC's application demonstrates that it has the ability to provide quality of care for the proposed kidney transplant program. BFMC is accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The mechanisms for identifying and correcting potential problems are already in place at BFMC. BFMC's nursing staff has the necessary training and experience to deliver quality care to kidney transplant patients. BFMC is not a teaching or research hospital. Apart from its association with Halifax Medical Center, BFMC does not offer any tertiary services. However, the statutory and rule criteria do not require BFMC to be a teaching or research hospital in order to receive a CON for an adult kidney transplant program. BFMC is a "small" hospital. Nevertheless, it offers the essential services for a kidney transplant program. For example, BFMC performs cardiac catheterization which is required in a small percentage of kidney transplant cases. BFMC is already performing procedures which are more complex than kidney transplants. In addition to major cardiovascular procedures with cardiac cath, BFMC performs the following procedures: (a) stomach, esophageal and duodenal procedures greater than age 17 with cardiac cath; and (b) tracheostomy, except for mouth, larynx or pharynx disorder. Of all the transplant procedures, kidney carries the lowest DRG (diagnosis related group) weight. The DRG weight is an indication of the complexity and resource utilization of a procedure. The Availability and Adequacy of Other Health Care Facilities and Services in the District Which May Serve as Alternatives for the Services to be Provided by the Applicant: Section 408.035(1)(d), Florida Statutes. The parties agree that a patient in need of kidney transplant services has no acceptable alternative for long-term treatment. Dialysis is an interim outpatient alternative for patients who are candidates for a kidney transplant. Dialysis has higher long-term costs than transplantation. It is not the preferred treatment. A kidney transplant eliminates a patient's dependence on dialysis. It encourages personal and health care independence. A successful transplant greatly improves a patient's quality of life. BFMC's proposed program will lead to an increased awareness of the need for organ donors. The proposed project will result in the addition of persons on the transplant waiting list, the increased availability of organs for transplantation, and a growth in the number of transplants performed. An additional adult kidney transplant program in Transplant Service Area 3 will have a minor short-term impact, if any, on the kidney transplant program at Florida Hospital-Orlando. Probable Economies and Improvements in Service That May be Derived from Operation of Joint, Cooperative, or Shared Health Care Resources: Section 408.035 (1)(e), Florida Statutes. The parties stipulated that this provision does not apply to BFMC's proposed project. Need in the Service District for Special Equipment and Services Which are Not Reasonably and Economically Accessible in Adjoining Areas: Section 408.035 (1)(f), Florida Statutes. As discussed above, BFMC is located appropriately for the establishment of an additional adult kidney transplant program in Transplant Service Area 3. The proposed project is needed to improve access to the service. Need for Research and Educational Facilities, Health Care Practitioners, and Doctors of Osteopathy and Medicine at the Student, Internship, and Residency Training Levels: Section 408.035(1)(g), Florida Statutes. BFMC's proposed project will provide educational opportunities for the general public as well as medical professionals, residents, and students. If the project is approved, family practice residents from Halifax Medical Center will rotate through the program. Nursing students and allied technical support students, such as physical therapists, will receive training in the program. Availability of Resources Including Manpower, Management Personnel, and Funds for Project Accomplishment and Operation; Effects the Project Will Have on Needs of Health Professional Training Programs in the District: Section 408.035(1)(h), Florida Statutes. AHCA stipulated that BFMC has the necessary resources to establish and operate the proposed project. These resources include health manpower, management personnel, and funds for project accomplishment and operation. BFMC is willing to condition approval of its CON application on the performance of a study that would be defined by AHCA for the benefit of health care in the state. Immediate and Long-term Financial Feasibility of the Proposal: Section 408.035(1)(i), Florida Statutes. The parties have stipulated that BFMC's proposed project is financially feasible, immediately and in the long- term. Special Needs of Health Maintenance Organizations: Section 408.035(1)(j), Florida Statutes. The parties agree that this criteria does not apply to BFMC's CON application. Needs and Circumstances of Those Entities Which Provide a Substantial Portion of Their Services or Resources, or Both, to Individuals Not Residing in the District: Section 408.035(1)(k), Florida Statutes. BFMC has not provided evidence that it currently provides a substantial portion of its services or resources to individuals residing outside of its health planning district, District 4. However, BFMC proposes to serve the ten-county area comprising Transplant Service Area 3. This service area includes portions of health planning Districts 3, 4, 7, and 9. Probable Impact of the Proposed Project on the Cost of Providing Health Services Proposed by the Applicant: Section 408.035(1)(l), Florida Statutes. The parties stipulated that BFMC's application demonstrates compliance with this criteria. Costs and Methods of the Proposed Construction and the Availability of Alternative, Less Costly, or More Effective Methods of Construction: Section 408.035(1)(m), Florida Statutes. The parties stipulated that BFMS's application demonstrates compliance with this criteria. The Applicant's Past and Proposed Provision of Health Care Services to Medicaid Patients and the Medically Indigent: Section 408.035(1)(n), Florida Statutes. The parties stipulated that BFMS's application demonstrates compliance with this criteria. The Applicant's Past and Proposed Provision of Services Which Promote a Continuum of Care in a Multilevel Health Care System: Section 408.035(1)(o), Florida Statutes. Halifax-Fish is a multilevel health care system. As discussed above, it provides a continuum of care through the services of a HMO, PPO, home health agencies, tertiary care (NICU and bone-marrow transplant), adult and adolescent psychiatric beds, skilled nursing beds, hospice, and long-term care. Whether Less Costly, More Efficient, or More Appropriate Alternatives to the Proposed Inpatient Services are Available: Section 408.035(2)(a), Florida Statutes. Less costly, more efficient, or more appropriate alternatives to BFMC's proposed project are not available. Expanding the existing program at Florida Hospital-Orlando would not improve access for patients who are unwilling to travel to Orlando for evaluation, surgery, and follow-up services. BFMC has the necessary staff and facilities to establish a successful kidney transplant program. The applicant's utilization projection is reasonable. Whether the Existing Facilities Providing Similar Inpatient Services Are Being Used in an Appropriate and Efficient Manner: Section 408.035(2)(b), Florida Statutes. Florida Hospital-Orlando is being used in an appropriate and efficient manner. Florida Hospital-Orlando draws patients primarily from Orange County, certain other counties in the transplant service area, and out-of-state. It does not attract a large percentage of transplant patients from Volusia County. Florida Hospital-Orlando's patient origin for kidney transplants indicates that there is an existing geographic barrier to service for residents in the service area. That Patients Will Experience Serious Problems in Obtaining Inpatient Care of the Type Proposed, in the Absence of the Proposed New Service: Section 408.035(2)(d), Florida Statutes. As discussed above, many persons now on dialysis, who are potential candidates for transplant, do not seek a transplant because they do not have access to a program close to their home. BFMC's proposed project will make it possible for these people in Service Area 3 to obtain a transplant in or nearer to their community. The project will definitely improve access to the proposed service for handicapped and minority persons who find it especially difficult to travel. BFMC has a history of providing services to the chronically underserved. RULE CRITERIA Rule 59C-1.044(3)(c), Florida Administrative Code, requires an age-appropriate (adult or pediatric) intensive care unit which includes facilities for prolonged reverse isolation. The applicant's proposal meets this requirement. Additionally, AHCA stipulated that BFMC's application meets all architectural and construction requirements. BFMC has demonstrated compliance with Rule 59C- 1.044(4)(f), Florida Administrative Code. The proposed program includes nutritionists with expertise in the nutritional needs of transplant patients. Ms. Jayne Meade is a dietitian with experience in working with renal patients. Through the partnership with Halifax Medical Center, Ms. Kim Koeving will act as a consultant renal dietitian. Based on Ms. Meade's experience, supplemented by the expertise of Ms. Koeving, BFMC complies with this criteria. Furthermore, AHCA stipulated that BFMC's CON application met the specific criteria of Rule 59C-1.044(8)(a)3, Florida Administrative Code, which requires the applicant to demonstrate the availability of ancillary services, including post transplantation nutritional services. BFMC also demonstrated compliance with Rule 59C- 1.044(4)(g), Florida Administrative Code. That rule requires the proposed program to include respiratory therapists with expertise in the needs of transplant patients. BFMC has at least four respiratory therapists with expertise in the needs of transplant patients. Two of the therapists are on duty at all times. As to Rule 59C-1.044(8)(a)2., Florida Administrative Code, BFMC has demonstrated that outpatient services for the proposed program are available. These services include renal dialysis and ambulatory renal clinic services. BFMC meets this requirement through an agreement with Southeast Acute Care Services. As to Rule 59C-1.044(8)(b)3., Florida Administrative Code, BFMC's transplant team includes physicians who are board- certified or board-eligible in the areas of anesthesiology, nephrology, and psychiatry. There is no board certification for vascular surgery. Dr. Morris, the transplant surgeon, is board- certified in general surgery with a certificate in transplant surgery. Dr. Morris practices general, vascular, and thoracic surgery. Dr. Toub, the back-up transplant surgeon, is board- certified in surgery. Dr. Toub practices general, vascular and non-cardiac thoracic surgery. He also has experience in kidney transplantation. BFMC's program will have two transplant physicians. Dr. Chattopadhyay is board certified in internal medicine and nephrology. Dr. Latif is certified in internal medicine and board eligible in nephrology, awaiting the results of his boards. The proposed project will have a board certified urologist, Dr. Green, on the team. As to Rule 59C-1.044(8)(b)4., Florida Administrative Code, BFMC's application demonstrates that it includes a renal dietitian on its own staff as well as on the staff at Halifax Medical Center. Additionally, the team will include an experienced nephrology nurse, Valerie Holley, R.N. Ms. Holley has extensive experience with patients who have chronic renal failure. As to Rule 59C-1.044(8)(b)6., Florida Administrative Code, BFMC demonstrated that Dr. Gramer is an anesthesiologist with experience in both kidney and heart transplants. As to Rule 59C-1.044(8)(d)3., Florida Administrative Code, BFMC submitted data and information indicating a projected utilization of 19 transplants in the first year of operation, and 25 transplants in the second year of operation. These projections appear to be reasonable and achievable. They are based on a reasonable calculation of the percentage of persons currently on dialysis in the transplant service area who are potential candidates for transplantation. Despite the requirement of AHCA's rule, there is no evidence of a state or national standard which can serve as "commonly accepted criteria" for determining the number of dialysis patients who are potential kidney transplant recipients. BFMC's CON application demonstrates compliance with all other applicable rule criteria.
Recommendation Based on the forgoing Findings of Fact and Conclusions of Law, it is recommended that AHCA enter a Final Order granting BFMC's CON application No. 8724 for an adult kidney transplantation program. DONE AND ORDERED this 12th day of March, 1998, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 12th day of March, 1998. COPIES FURNISHED: Richard A. Patterson, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 R. Terry Rigsby, Esquire Blank, Rigsby and Meenan, P.A. 204 South Monroe Street Tallahassee, Florida 32301 R. Sam Power, Agency Clerk Agency for Health Care Administration Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Paul J. Martin, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308
The Issue Whether Petitioners (collectively referred to as "Humana") are entitled to exemptions from the Certificate of Need ("CON") Law, to establish certain services at their facilities, pursuant to Subsection 381.713(1)(b), Florida Statutes (1989), (a provision which was repealed by Chapter 91-282, Laws of Florida). Whether Intervenors have standing to contest the exemption requests of Humana.
Findings Of Fact Petitioners Humhosco, Inc. d/b/a Humana Hospital Brandon (Humana Brandon) in Hillsborough County applied for CON exemption to initiate open heart surgery services. Humhosco, Inc. d/b/a Humana Hospital Northside (Humana Northside) in St. Petersburg, Pinellas County, applied for a CON exemption to initiate open heart surgery and inpatient MRI services. Humana of Florida, Inc. d/b/a Humana Hospital St. Petersburg (Humana St. Petersburg), in Pinellas County applied for a CON exemption to establish a Level II neonatal intensive care unit (NICU). Humana of Florida, Inc. d/b/a Humana Hospital Pasco (Humana Pasco) in Dade City, Pasco County, applied for CON exemption to initiate inpatient cardiac catheterization. Humana of Florida, Inc. d/b/a Humana Hospital Bennett (Humana Bennett) in Plantation, Broward County applied for a CON exemption for a Level II NICU. Community Hospitals of Humana, Inc. d/b/a Humana Hospital Cypress (Humana Cypress) in Pompano Beach, Broward County applied for CON exemption to perform inpatient cardiac catheterization procedures, and for substance abuse and psychiatric beds. Community Hospital of The Palm Beaches, Inc. d/b/a Humana Hospital Palm Beaches (Humana Palm Beaches) in Palm Beach County applied for a CON exemption to perform inpatient cardiac catheterization procedures. Humana Hospital Pembroke Pines, Inc. d/b/a Humana Hospital Pembroke Pines (Humana Pembroke) in Broward County applied for CON exemptions for open heart surgery, inpatient cardiac catheterization, Level II NICU, psychiatric and comprehensive rehabilitation beds. Intervenors Adventist Health System/Sunbelt, Inc. (Adventist) filed a Notice of Voluntary Dismissal on June 3, 1991. Florida Hospital Association (FHA) is a trade association of approximately 225 hospitals in the State of Florida. The Association of Voluntary Hospitals of Florida, Inc. (AVHF) is a not-for-profit corporation representing approximately 90 private and public not- for-profit hospitals in the State of Florida. All Children's Hospital (ACH), a 144-bed children's specialty hospital with Level II and Level III NICU beds, is a Regional Perinatal Intensive Care Center (RPICC) located in St. Petersburg in HRS District 5 for Pinellas/Pasco Counties. Florida Medical Center, Ltd. (FMC) is a 459-bed acute care hospital in HRS District 10, Broward County, at which services include inpatient cardiac catheterization, open heart surgery, and short term psychiatric services. Lakeland Regional Medical Center (LRMC) is an 897-bed acute care hospital, located in Polk County in HRS District 6, with a range of cardiac services, including open heart surgery. Plantation General Hospital (Plantation), a general acute care hospital in HRS District 10, Broward County, offers cardiac catheterization and Level II NICU among its procedures and programs. South Broward Hospital District (SBHD), a legislatively-created special taxing district, operates a 737-bed Memorial Hospital in HRS District 10, Broward County, at which its services include open heart surgery, inpatient cardiac catheterization, Level II and III neonatal intensive care, short-term inpatient psychiatric treatment, and inpatient comprehensive rehabilitation. St. Anthony's Hospital is a 434-bed community hospital in St. Petersburg, Pinellas County, which is in HRS District 5, and offers inpatient cardiac catheterization. St. Joseph's Hospital is a 649-bed facility in Tampa, Hillsborough County, which is in HRS District 6, and provides inpatient cardiac catheterization and open heart surgery. St. Mary's Hospital, a 378-bed general, acute-care hospital in West Palm Beach, Florida, offers Level II and III NICU, and inpatient cardiac catheterization. Hillsborough County Hospital Authority, operates Tampa General Hospital (Tampa General) in HRS District 6, with 1,024 beds and a range of cardiac services, including open heart surgery. University Community Hospital (UCH) is located in HRS District 6, and is an existing provider of open heart surgery. Standing Adventist failed to present evidence of standing. FHA members include all of the petitioners and intervenors in this case. AVHF members include at least one member providing the same service in the same HRS District as the services which the eight Humana hospitals seek to establish by the exemption requests. ACH is an existing provider of Level II NICU in HRS District 5, the same service in the same area as proposed in the exemption request of Humana St. Petersburg. FMC provided 10% of its cardiac services in 1990 to HMP enrollees and is an existing provider of inpatient cardiac catheterization, open heart surgery, and short term psychiatric services in HRS District 10, which are, in part, the subjects of the Humana Cypress and Pembroke exemption requests. At LRMC, from October 1, 1989 through September 30, 1990, 163 open heart surgeries, 215 cardiac catheterizations, 22 angioplasties, and 1,434 other cardiology procedures were performed on patients discharged to zip codes included by Humana Brandon in its service area for its exemption request for open heart surgery. Plantation is an existing provider in HRS District 10 of inpatient cardiac catheterization, for which Humana Cypress requested exemption, and Level II NICU, for which Humana Bennett requested exemption, and both of which services are included in the Humana Pembroke exemption request. SBHD estimates the range of patients lost, as a result of approval of the exemption requests of Humana Pembroke and Humana Bennett, at between 25-344 cardiac catheterizations, 58-434 open heart surgeries, up to 232 substance abuse treatments, between 8-352 comprehensive rehabilitations, 25-1933 short-term inpatient psychiatric, and 58-1354 neonatal patients. St. Anthony's provides inpatient cardiac catheterization in St. Petersburg and Southern Pinellas County, the same service in an overlapping service area as proposed in the Humana Pasco exemption request. St. Joseph's service areas for inpatient cardiac catheterization and open heart surgery overlap those in the exemption requests of Humana Pasco for cardiac catheterization, and overlap those of Humana Brandon and Humana Northside for open heart surgery. St. Mary's is a Humana Care Plan provider for inpatient cardiac catheterization, in a service area overlapping that proposed for inpatient cardiac catheterization by Humana Palm Beaches, and for NICU at Humana Bennett, since St. Mary's is one of the designated statewide Regional Perinatal Intensive Care Centers. Tampa General is under contract to Humana HMO, PPO and insurance subscribers, and provided 116 open heart surgeries to patients included within the service area of the Humana Brandon exemption request, and projects its loss of gross revenue at $1.5 million from the approval of the Humana Brandon exemption request for open heart surgery. At UCH, which has a service area within the area proposed for open heart surgery at Humana Brandon, twenty open heart surgeries in fical year 1990, and forty open heart surgeries in the first six months of 1991 were performed on HMP enrollees, the latter generating approximately $2 million in gross revenues. Amendment of Applications for Exemption (Costs) The June 1990 Humana exemption requests failed to include the costs of the services proposed, as required by Florida Administrative Code 10- 5.005(2)(a). HRS reviewed the requests, failed to notify Humana of the omission of cost data, and failed to cite the absence of that data as a basis for its decisions. The cost of services is included implicitly within the statutory criterion for review of exemption requests, because cost may be a factor in distinguishing between services which are or are not available by exemption. Tertiary and Inpatient Institutional Health Services or Beds Subsection 381.702(20), Florida Statutes, defining "tertiary health services" was enacted subsequent to the HMO exemption in Subsection 381.713(1), Florida Statutes, without any concurrent, material amendment of the latter. NICU and comprehensive rehabilitation are included in Subsection 381.702(2), Florida Statutes, as examples of tertiary health services. Open heart surgery is included within the definition of tertiary health services in Florida Administrative Code Rule 10-5.002(66). Inpatient cardiac catheterization is an inpatient institutional health service. Short-term inpatient psychiatric and substance abuse services are included in "alcohol treatment, drug abuse treatment and mental health services" as defined in Subsection 381.702(9), Florida Statutes. Because they are within the definition of "health services" but not within the definition of "tertiary services", short-term inpatient pschiatric and substance abuse are also included within the definition of "institutional health services" which may be exempt from CON regulation if all other provisions of the HMO exemption provision are met. Certain inpatient institutional health services, such as substance abuse and psychiatric services are authorized by the issuance of licenses designating the number of approved beds which may be used in offering the service. Need methodology and physical plant requirements are factors which differ in the requirements for services offered in approved licensed beds. The HMO exemption provision encompasses inpatient services provided in licensed bed inventories, in the phrase "inpatient institutional health services." Nature and Control of Facilities Each of the eight Humana hospitals are health care facilities, as defined in Subsection 381.702(7), Florida Statutes. Each of the eight Humana hospitals are licensed acute care hospitals which primarily provide inpatient health services, as required by Subsection 381.713(1)(b)1., Florida Statutes (1989). Humana Pembroke Humana Pembroke Pines, Inc. was incorporated in December 1989. It acquired the assets of Pembroke Pines General Hospital, pursuant to an asset sale and purchase agreement, the performance of which was guaranteed by Humana, Inc. Humana Medical Plan, Inc. (HMP), an HMO, is a wholly-owned subsidiary of Group Health Insurance, Inc., which in turn is a wholly-owned subsidiary of Humana, Inc. Although HMP acquired 100% of the stock in Humana Pembroke Pines, Inc., documents filed with state and federal agencies, other than HRS and the Department of Insurance, continued to list Humana, Inc. as the insured or controlling entity. Humana first indicated to HRS that the acquisition of Pembroke Pines General Hospital would be made by Humana Hospital Pembroke Pines, Inc., with a possible change of ownership to another Humana subsidiary, and subsequently notified HRS that the acquiring subsidiary would be HMP. Based on Humana's notice that the acquisition would not result in a change in beds or services, HRS determined that the acquisition of Pembroke Pines was not reviewable under CON requirements. An internal memorandum dated February 1, 1990, indicates that Humana planned to take advantage of the HMO exemption request prior to the acquisition of Pembroke Pines General Hospital, but did not report its plans to HRS. On March 2, 1990, HRS issued a license to Humana Hospital Pembroke Pines, Inc. There is no evidence to support the assumption that HRS would not have approved the acquisition of Humana Pembroke, or that Humana's plans to utilize the HMO exemption would have invoked CON review of the acquisition and resulted in a denial of the acquisition. Humana Pembroke is controlled directly or indirectly by HMP, the Humana HMO, as required by Subsection 381.713(1)(b)2. Enrollment of 50,000 Individuals Within the Service Area Subsection 381.713(1)(b)2., Florida Statutes, required the enrollment of at least 50,000 enrollees within the HMO's service area. The term "service area" is not used in the statute on CON application review criteria. Rather that statute, in Section 381.705, Florida Statutes, uses the term "service district", which is defined in Subsection 20.19(7), Florida Statutes, as the organizational components of HRS. The term "service area" is also not used in Subsection 641.47(3), Florida Statutes; that statute defines the area in which an HMO does business as an approved "geographic area". The HMO service area, under the exemption provision, is the HMO's geographic area, because the requirement in subsection (2), that the HMO have 50,000 enrollees, otherwise would be indistinguishable from the requirement in subsection (3), that the facility's access area have 50,000 enrollees. HMP's appoved service area includes Broward, Dade, Flagler, Hillsborough, Orange, Osceola, Palm Beach, Pasco, Pinellas, Seminole and Volusia Counties, and approximates 400,000 enrollees. Facility Geographically Located So That Service Is Reasonably Accessible To The 50,000 Enrollees Accessibility standards for various services are established for CON applications by rules. There is no reason to distinguish between the standards used for the determination of accessibility to health services within the CON application process and the standards applicable to making that same determination within the CON exemption request process. Florida Administrative Code Rule 10-5.011(1)(o)6. establishes a standard of 45 minutes maximum ground travel time under average travel conditions for access to inpatient psychiatric services, which is the equivalent of a 15-mile radius for Humana Pembroke. Humana Pembroke's exemption request, filed in June 1990, as up-dated in July, identified 55,592 enrollees within a 15-mile radius of the hospital. This enrollment data was given by zip code in Attachment 3B for inpatient cardiac catheterization and in Attachment 3D for short term inpatient psychiatric services. 1/ In its September 1990 CON application for inpatient cardiac catheterization, which has the slightly longer travel time of one hour, Humana Pembroke identified a service area with zip codes which would include only 21,375 of the 55,592 enrollees. When compared to enrollment data for the same zip codes in Humana's Exhibit 41, the most recent data available, enrollment in Humana Pembroke's zip codes for inpatient cardiac catheterization services and short term inpatient psychiatric services equals 27,083 HMP members, although one zip code, 33154, does not appear on Exhibit 41. Even accepting Humana's assertion that 321 enrollees reside in zip code 33154, total enrollment would equal 27,404. Humana has failed to demonstrate that Humana Pembroke is geographically located so as to be reasonably accessible to provide either inpatient cardiac catheterization or short term inpatient psychiatric services to 50,000 HMP enrollees. Limitation of Service to HMO Enrollees HRS preliminarily determined that Humana Pembroke's exemption request for inpatient cardiac catheterization services should be granted but that the service should only be available to HMP members. The text of subsection 381.713(1)(b), Florida Statutes, does not however restrict the provision of services to HMO enrollees, and the fact that a minimum number of enrollees must be in the service area to maximize the utilization of the service by enrollees does not compel such a conclusion. Subsection 381.713(1)(a), Florida Statutes, is a similar exemption provision which requires the enrollment of 50,000 individuals in an HMO's service area and a reasonably accessible facility, but also requires that 75% of reasonably expected patients be HMO enrollees. The Legislature was, therefore, obviously aware of the issue, yet in the applicable subsection failed to include any provision conditioning CON exemption approved upon provision of services only to HMO enrollees. Exemption Requests Based On Voting Trust Agreements Humana Pasco, Humana Palm Beaches, and Humana Cypress requested exemption approval to establish various inpatient institutional health services based on the control of those facilities by HMP by virtue of a voting trust agreement. The license-holder of Humana Pasco, Humana of Florida, Inc., is a wholly owned subsidiary of Humana, Inc. The license-holder of Humana Palm Beaches, Community Hospital of the Palm Beaches, Inc., is a wholly owned subsidiary of Humana, Inc. The license-holder of Humana Cypress, Community Hospitals of Humana, Inc., is a wholly owned subsidiary of Humana, Inc. On behalf of Humana Pasco, Humana Palm Beaches, and Humana Cypress, Humana, Inc., entered into Voting Trust Agreements (Agreements) designating HMP, the Humana HMO, as trustee, but did not report the change of control to state and federal agencies. The Agreements, dated May 29, 1990, have identical substantive provisions. The term of the Agreements is ten years, terminating May 28, 2000, with a provision that Humana, Inc. may not unilaterally terminate the Agreements, although Humana, Inc. subsequently offered to terminate one of the agreements. Each Agreement authorizes HMP to hold and vote the shares of stock of the respective Humana, Inc. subsidiary. Each Agreement obligates HMP to vote the shares in the best interest of Humana, Inc. and the applicable wholly-owned subsidiary. Each Agreement requires HMP to pay over all profits and dividends to Humana, Inc., with all convenient speed. Each Agreement provides that without the consent of Humana, Inc., HMP shall not increase or reclassify capital stock; sell, lease or exchange all or substantially all property or assets; or vote to consolidate, merge, or dissolve the Humana, Inc. subsidiaries. The Agreements provide that the trustee accepts the specified responsibilities, but recite no compensation. The Humana hospitals, including Humana Pasco, Humana Palm Beaches, and Humana Cypress, have chief operating officers who are known as executive directors, who report to HMP Vice-Presidents, but the executive directors receive incentive compensation for maximizing hospital utilization, as do all their superiors throughout the chain of command, up to and including the president of Humana Inc. Humana Pasco, Humana Palm Beaches, and Humana Cypress pay management fees to Humana, Inc., as does HMP, and are directly owned by corporate entities which have the same officers and directors as HMP. By virtue of the voting trust agreement, HMP votes the shares of stock in Humana Pasco, Humana Palm Beaches, and Humana Cypress, but no operational changes in the facilities have resulted from the establishment of the voting trust agreements. HMP, as voting trustee, has control of the assets of Humana Pasco, Humana Palm Beaches, and Humana Cypress. HMP is an HMO with in excess of 50,000 enrollees in its service area. See, Findings 60 and 61, above. The standard for determining if a proposed service is geographically accessible for 50,000 enrollees is the same as that established in the rules for CON applications for the same service. See, Findings 62 and 63, above. Humana Pasco. Humana Pasco's exemption request for inpatient cardiac catheterization asserted that 74,225 HMP enrollees reside within one hour's travel time of the facility. The applicable travel time standard for inpatient cardiac catheterization subject to CON review is one hour, under Florida Administrative Code Rule 10-5.032. Areas within a forty-mile radius of Humana Pasco are within one-hour average travel time of the facility. The zip codes for enrollees in the Humana Pasco exemption request are substantially different from those included within its service area in a 1987 CON application and from Hospital Cost Containment Board data on actual utilization of the facility. Humana failed to demonstrate that 50,000 HMP enrollees have geographic accessibility for inpatient cardiac catheterization services to Humana Pasco, based on the applicable travel time standard of one hour. 2/ Humana Palm Beaches. In the June 7, 1990 Humana Palm Beaches' exemption request for inpatient cardiac catheterization services, Humana asserted that there were 58,268 HMP enrollees within a 40-mile radius, or one-hour average travel time of the facility. In the July 31, 1990 submission of corrected information, Humana's attachment 3a asserts that 50,592 HMP enrollees reside in areas within 45 miles of Humana Palm Beaches. 3/ Humana's Exhibit 41, a computer printout of enrollees for May 1990, demonstrates that the enrollees in the zip codes listed on attachment 3a of the July submission equal 49,894 HMP members. Although not determinative of enrollment in the service area, HMP's reports to the Department of Insurance on enrollment in Palm Beach County and the Hospital Cost Containment Board data on zip codes with greater than 5% actual utilization of Humana Palm Beaches also show fewer than 50,000 enrollees. Humana attempted to assert that its enrollment figures are constantly increasing. Because the number of HMP members is so close to 50,000, that assertion becomes significant. A comparative review of the individual zip code enrollments asserted in Attachment 3A to the Humana Palm Beaches' July submission to those in Humana Exhibit 41 demonstrates that some zip codes lost members, presumably due to changing residential patterns. Therefore, it is impossible to make a general assumption that HMP's growth in membership is evenly distributed across zip codes within an area geographically accessible to a hospital. Humana has failed to establish that 50,000 enrollees have geographic access to Humana Palm Beaches for inpatient cardiac catheterization services using the one-hour travel time standard for CON review. Humana Cypress. Humana asserted that 50,962 HMP enrollees are geographically accessible to Humana Cypress for inpatient cardiac catheterization, or within the one-hour travel time or 15 miles, although its September 1990 CON application for the same service defines an area including approximately half that number. Humana asserted that 68,412 HMP enrollees are geographically accessible to Humana Cypress for inpatient substance abuse and short term inpatient psychiatric services, or within the 45-minute travel time or a 15-mile radius, although its September 1989 CON applications for the same services encompass an area with approximately 41,000 of the enrollees. When zip codes in the exemption requests are compared to Humana's exhibit 41, a computer printout of enrollees for May 1990, 4/ the enrollees in the zip codes submitted in the exemption request for inpatient cardiac catheterization total 50,581 and those submitted in the exemption requests for inpatient substance abuse and short term inpatient psychiatric services total 67,812. 5/ Humana has established that Humana Cypress is geographically accessible to provide inpatient cardiac catheterization to 50,000 HMP enrollees under the one-hour travel time requirement. Humana has established that Humana Cypress is geographically accessible to 50,000 HMP enrollees under the 45 minute travel time requirement for short term inpatient psychiatric and inpatient substance abuse services.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that a Final Order be entered Dismissing the Petition to Intervene filed by Adventist based on its Notice of Voluntary Dismissal; Denying the exemption requests of Humana Brandon for open heart surgery, Humana Northside for open heart surgery, Humana St. Petersburg for Level II NICU, and Humana Bennett for Level II NICU, Humana Pembroke for open heart surgery and Level II NICU, because those services are tertiary services, not institutional health services. Denying the exemption request for inpatient cardiac catheterization and short-term inpatient psychiatric services at Humana Pembroke for failure to establish geographic accessibility to 50,000 HMP enrollees. Denying the exemption requests of Humana Pasco and Humana Palm Beaches for failure to establish that 50,000 HMO enrollees have reasonable access to inpatient cardiac catheterization services at these facilities. Granting the exemption request of Humana Cypress for inpatient cardiac catheterization, short term inpatient psychiatric services, and inpatient substance abuse services, without limiting the provision of services to HMP enrollees. RECOMMENDED this 14th day of October, 1991, at Tallahassee, Florida. Eleanor M. Hunter Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of October, 1991.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: On September 14, 1977, respondent received petitioner's (BMA) application for approval of a capital expenditure proposal to establish a new twenty-station chronic renal dialysis facility in Clearwater, Florida. Petitioner is a subsidiary of National Medical Care, Inc., which is the largest provider of chronic dialysis services, operating some sixty facilities nationwide. BMA currently operates two facilities in the Florida Gulf Health Systems Agency (FGHSA) region -- a twenty-five station facility in Tampa and a twenty station facility in St. Petersburg. BMA also operates facilities in Sarasota, Gainesville and Orlando, Florida. The present application proposes to spend $470,000.00 for leasehold improvements and $140,000.00 for equipment for a total capital expenditure of $610,000.00. The proposed facility is designed to provide outpatient hemodialysis treatments to medically stable, ambulatory patients suffering from end state renal disease (ESRD). Such patients suffer negligible kidney functions and require either regular chronic dialysis treatment or transplantation. Those patients who undergo hemodialysis generally have three treatments per week, each treatment lasting from four to six hours. By letter dated December 12, 1977, the respondent's administrator notified petitioner that its capital expenditure proposal was not favorably considered for two reasons, both relating to the need for such services within the applicable service area. The first reason cited by the respondent was the finding by the FGHSA that only five additional stations would be needed in the year 1978. Due to the fact that the FGHSA failed to provide respondent with its recommendation within sixty days, respondent was required, pursuant to F.S. Section 381.494(5)(e), to deem that the proposal was recommended for approval by the FGHSA. The second reason for disapproval listed by the respondent was its own determination that a surplus of eleven stations would exist in the service area of 1978. This figure of eleven was amended at the hearing to four. Subsequent to the time that petitioner's application was considered at the local and state levels, respondent approved the application of Kidneycare of Florida, Inc. for the establishment of a ten station chronic renal dialysis facility in Clearwater, Florida. This action occurred on February 15, 1978, after an administrative hearing was held in which petitioner BMA was an intervenor. That case (Case No. 77-2203) is presently on appeal in the District Court of Appeal, Second District. Apparently, the BMA and the Kidneycare applications were submitted to and considered by the local and state reviewing authorities during the same period of time. The generally accepted formula for arriving at a projected need for additional dialysis stations is not in dispute. The starting point is the actual number of persons who are ESRD patients within the service area. To this number is added the number of patients expected to develop ESRD during the planning period. This sum is then reduced by the number of successful kidney transplants expected to occur and by the number of patients expected to die within the planning period. For planning purposes, veteran administration patients and dialysis machines are not to be included in the projections. In order to arrive at a valid project patient population figure for the planning period, it should be appropriate to add the number of transient patients or winter visitors to the area and subtract the number of patients trained for home dialysis. To arrive at the number of stations (machines) required to serve the project patient population at the end of the planning period, the projected patient pool is divided by the station utilization factor (a ratio of number of patients per station). The number of existing stations in the area is then subtracted from this figure, thus yielding the number of additional stations needed. Thus the ideal formula reads as follows: current patient pool + new patients successful transplants mortality factor home trainees + winter visitors V.A. patients = projected patient pool divided by station utilization factor number of existing non V.A. stations + additional stations needed This formula necessarily employs certain conjectural components and the dispute in this proceeding concerns the derivation and propriety of the statistics used to supply these conjectural components. It appears from the testimony and documentary evidence that the respondent relied exclusively on the data supplied by the FGHSA, with the exception of the station utilization factor. Therefore, it is presumed that the figures utilized by the FGHSA in its analysis were also utilized by respondent. In arriving at the projected patient pool, the petitioner and the HSA were in agreement with the number of new patients and the number of successful transplants. They were not in agreement with the projected morality figure or with the projected number of veterans administration patients. The HSA utilized the actual morality figure (21.8 percent) for the 1975-76 year. The petitioner utilized the figure of 15 percent. The actual morality rate for the 1976-77 year was 14.1 percent. Had the HSA had this more recent statistic available to it at the time, it would have utilized it. A more appropriate method would have been to average the two figures. This would have increased the number of deaths projected by the petitioner and decreased the number projected by the HSA. The evidence with respect to the patient cap at the V.A. hospital was based upon hearsay and thus is not sufficient to refute the HSA's projections in that area. Neither the HSA nor the petitioner took into account the number of transient patients or the number of existing patients who would undergo home dialysis training within the planning period. Each of these factors was deemed too speculative or conjectural for a meaningful computation of projected needs. Testimony was adduced to the effect that the intervenor Kidneycare had received a nine-year grant to establish home dialysis training in the subject service area, and that once this program was underway, it was expected that from 30 to 50 patients would be trained in home dialysis. The utilization factor per station or machine was also in dispute. In making their projections, both the petitioner and the HSA used a factor of 3.2. This result is obtained by assuming that each machine has a capacity for dialyzing two patients per day, and that each patient must be dialyzed three times per week. Assuming a capacity rate of 80 percent, the utilization factor is 3.2 patients per station. Using a capacity rate of 90 percent, the utilization factor is 3.6 patients per station. The respondent utilized the 3.6 factor in projecting future need. This 3.6 utilization standard has consistently been used by respondent in its review of other free-standing chronic renal dialysis facilities, and petitioner has failed to demonstrate that such a standard is unreasonable. The remaining area of the formula in dispute is the number of existing non-V.A. stations in the area to be served. The parties agreed that as of the end of 1977, there were 73 chronic renal dialysis stations in existence or authorized in the four county are covered by the FGHSA. The dispute arose over the actual utilization by Tampa General Hospital of its existing 14 stations. The assistant hospital administrator at Tampa General Hospital testified that it is the future intent of said hospital to reduce the number of stations available for stable chronic patients in order to make room for more unstable chronic and acute patients. This "future intent" is still in the recommendation stage and the testimony regarding this intent was not specific as to the actual number of stations to be withdrawn. The testimony established that a reasonable planning period for chronic renal dialysis equipment is one year. If one considers the one year period to commence at the time that the proposed facility can be operational, the testimony indicates that the one year period would run from the end of 1978 through the end of 1979. In applying the facts discussed above to the acceptable formula, it is found that the patient pool projected by the HSA must be increased by utilizing a lower mortality rate (18 percent in lieu of 21.8 percent) and that the petitioner's projected patient pool must be decreased by utilizing a higher number of deaths and a higher number of V.A. patients. The resulting figures must also be offset by applying a station utilization factor of 3.6 in lieu of 3.2 and by adding to the number of existing stations the ten stations for which the intervenor Kidneycare recently received approval from respondent. Applying these adjustments to the figures projected by the respondent, the projected patient pool for non-V.A. patients for the end of 1978 approximates 294, and the figure for the end of 1979 is somewhere close to 326. A utilization factor of 3.6 patients per station indicates an approximate need for 82 stations by the end of 1978 and 90 stations by the end of 1979.
Recommendation Based upon the findings of fact and conclusions of law recited above, it is recommended that respondent's denial based upon the ground of lack of demonstrated need for additional dialysis stations in the service area be reversed. It is further recommended that, a need having been shown for an additional seven stations in the planning period, petitioner be permitted to submit a revised or amended application within twenty days for approval of a seven station facility. Respondent should then act upon said revised application within fifteen days from receipt of the same. Respectfully submitted and entered this 9th day of May, 1978, in Tallahassee, Florida. DIANE D. TREMOR Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 904/488-9675 COPIES FURNISHED: Art Forehand, Administrator Office of Community Medical Facilities 1323 Winewood Boulevard Tallahassee, Florida 32301 Harold W. Mullis, Jr. Trenam, Simmons, Kemker, Scharf, Barkin, Frye and O'Neill Post Office Box 1102 Tampa, Florida 33601 Eric J. Haugdahl Assistant General Counsel 1323 Winewood Boulevard Building 1, Room 406 Tallahassee, Florida 32304 John H. French, Jr. 630 Lewis State Bank Building Tallahassee, Florida 32304
Conclusions THIS CAUSE comes before the State of Florida, Agency for Health Care Administration (“the Agency”) regarding Certificate of Need (“CON”) Application No. 10202, which sought the establishment of a 100-bed acute care hospital in Broward County, District 10, that had been filed by East Florida Healthcare, LLC (“East Florida”), in the second batching cycle of 2013. The Agency preliminarily denied the application. On December 30, 2013, East Florida filed a petition for formal hearing contesting the denial, which was forwarded to the Division of Administrative Hearings (“DOAH”). In January 2014, the above-named intervenors filed motions to intervene, which were granted. On April 15, Filed April 22, 2014 4:57 PM Division of Administrative Hearings 2014, East Florida filed a notice of voluntary dismissal and the DOAH issued an order closing the file and relinquishing jurisdiction back to the Agency. IT IS THEREFORE ORDERED AND ADJUDGED THAT: 1. The denial of CON Application 10202 is upheld. ) ORDERED this 5@Any of pur . 2014, in Tallahassee, Florida. , Secretary Agency For Héalth Care Administration
