The Issue Whether there is need for a new Pediatric Heart Transplant program in Organ Transplant Service Area (OTSA), 4 and, if so, whether Certificate of Need (CON) Application No. 10421, filed by Variety Children’s Hospital, d/b/a Nicklaus Children’s Hospital (NCH,) to establish a Pediatric Heart Transplant program, satisfies the applicable statutory and rule review criteria for award of a CON to establish a Pediatric Heart Transplant program at NCH.
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, NCH NCH, formerly Miami Children's Hospital, was established in 1950 by Variety Club International. NCH is South Florida’s only licensed specialty hospital exclusively for children, with more than 650 attending physicians and 130 pediatric subspecialists. NCH has 289 licensed beds, of which 218 are acute care, 20 are child psychiatric, 21 are Level II neonatal intensive care unit (NICU), and 30 are Level 3 NICU. NCH is part of the Miami Children’s Health System, a not- for-profit corporation. NCH does not deliver any babies. Thus, many children that have been treated at NCH have been referred to NCH based upon its excellent reputation in the community. NCH is continually recruiting additional physicians in order to expand the pediatric subspecialty coverage it is able to offer. Dr. Leonard Feld, the President of Pediatric Specialists of America (NCH’s employed physician group), came to NCH a little over a year ago, after a distinguished clinical and administrative career involving pediatric kidney transplant. He was drawn to NCH because of the depth and breadth of the existing medical staff and the administration’s commitment to advance the field of pediatric medicine through innovation and subspecialization. Dr. Feld is responsible for ensuring NCH’s quality of care from a medical perspective. He is confident NCH will implement a world-class PHT program if its CON is approved. NCH has several nationally-recognized subspecialty programs, including eight programs listed by U.S. News and World Report as Top 50 Programs, and two Top 10 Programs. NCH’s pediatric cardiac surgery program is currently ranked 40th by U.S. News and World Report, but this number is artificially suppressed because NCH does not provide heart transplants. NCH is the highest ranked cardiac program on the U.S. News and World Report ranking that does not have a PHT program. NCH is a leader in clinical research, with its staff being published in over 800 medical journals in the last half dozen years, over 200 ongoing clinical trials, and 49 active cardiac studies. NCH’s Accreditation Council for Graduate Medical Education (ACGME) accredited pediatric residency and fellowship program is the largest in the southeastern United States, and has a 95-percent, first-time Board pass rate, which is a testament to its quality. NCH is focused on providing pediatric patients in Miami-Dade County with the right care, in the right setting, at the right time. To this end, NCH has expanded its urgent and ambulatory care centers throughout Miami-Dade County to ensure that patients have convenient access to pediatric outpatient and subspecialty care. NCH is a world-renowned, international heart center. NCH’s cardiac team has cared for children from 39 countries and has performed 4,643 open-heart operations since 1995, more than any other program in Florida. NCH has invested hundreds of millions of dollars in creating a telehealth program to allow access to pediatric subspecialists in areas where subspecialists are in short supply. NCH’s transport team, which consists of six ambulances and two helicopters owned by NCH and additional contracted transports, such as fixed wing aircraft, transports approximately 3,000 children per year. Recently, the transport team received the field’s most prestigious honor when it was named the Association of Air Medical Services’ Neonatal Transport Team of the Year. NCH has established relationships with Lee Memorial Health System, in Lee County, and Jupiter Medical Center, in Palm Beach County. These relationships will create access portals for transplant if NCH’s CON application is approved. NCH’s excellent reputation and excellent outcomes have made it the largest pediatric cardiac surgery program in the state, performing 25 percent of all pediatric cardiac surgeries in Florida. In OTSA 4 and Miami-Dade County, NCH is the overwhelming provider of choice, performing 62.2 percent of the pediatric cardiac surgeries in OTSA 4 and 72.7 percent of those in Miami-Dade County. It is noteworthy that the pediatric cardiac surgery program at NCH has a higher surgical volume than any of the four existing Florida PHT centers. NCH is on the forefront of technology and innovation. NCH physicians have pioneered surgical techniques and developed pediatric surgery tools and equipment used throughout the industry. NCH also has found innovative ways to use existing technology to improve care. For example, NCH uses social media to improve communication between families and caregivers, uses 3D printed hearts and virtual reality to better plan surgeries, posts real-time outcomes on the Internet for transparency, and photographs and digitally records every cardiac surgery to eliminate guesswork in the event of future surgeries on the same patient. NCH’s cardiac programs operate on the most challenging cases, including, in some instances, when other providers have determined the patient was inoperable and terminal. In 2016, NCH opened a six-story, state-of-the-art advanced pediatric intensive care tower. Technical advances located in the new tower include an intraoperative MRI, which allows the physicians to take an MRI without moving the patient from the operating room table, and one of the most advanced cardiac catheterization laboratories in the country, which allows NCH to perform pediatric heart catheterizations that cannot be performed in other hospitals. NCH has a robust pediatric cardiology physician team, including 14 pediatric cardiologists, five pediatric cardiac intensivists, and three pediatric cardiac surgeons. Either during training or prior to coming to NCH most, if not all, of these physicians have had experience working in hospitals with pediatric transplant programs, and all of them are currently exposed to patients at NCH that are candidates for heart transplant. NCH’s Chief of Pediatric Medicine, Dr. Redmond Burke, is a Harvard-trained pediatric cardiac surgeon who has been instrumental in many advances in pediatric cardiac surgery. He performed the first endoscopic cardiac surgery and the first casual ring division. He invented the venous pole circuit, a less invasive, less traumatic form of cardiopulmonary bypass, and he also invented the first portable extracorporeal membrane oxygenation (ECMO) machine to transport critically ill patients to NCH for care. Dr. Burke has been a pioneer in pediatric cardiac surgery technology. Dr. Hannan, another one of NCH’s pediatric cardiac surgeons, also trained at Harvard Medical School. He has performed approximately 2,000 open-heart operations at NCH. He was part of the team that created the Society of Thoracic Surgeons (STS) database reporting program, revolutionizing outcome monitoring in pediatric cardiac surgery. Recently, NCH recruited a third pediatric cardiac surgeon, Dr. Kristine Guleserian, who is one of the highest volume pediatric heart transplant surgeons in the country. Dr. Guleserian trained at Harvard Medical School. Dr. Guleserian is a world-renowned pediatric heart transplant and cardiac surgeon. In 2006, she performed the world’s youngest surviving combined heart/liver transplant on a three-year-old girl. She has performed 133 pediatric cardiac transplants, including transplant on one of the smallest pediatric patients to ever receive an artificial heart. Dr. Guleserian serves on numerous boards and committees dedicated to improving and advancing the field of pediatric cardiac surgery and heart transplant. Beyond its pediatric cardiac surgeons, NCH has developed the infrastructure of a world-class pediatric cardiac program, including several physicians who are nationally recognized industry leaders in their subspecialties. For example, Dr. Cecilio Lopez is one of the foremost experts in the country in echocardiography. He is currently on the Board of Directors for the American Society of Echocardiography, International Society for the Nomenclature of Pediatric and Congenital Heart Disease, and the Intersocietal Accreditation Commission, and is also the immediate past President of the Society of Pediatric Echo. Dr. John Rhodes is the former director of the cardiac catheterization lab at the world- renowned PHT program at Duke Children’s Hospital and Health Center. He is currently involved in cutting-edge clinical trials that involve the closing of large atrial septal defects and transcatheter valve replacement. Dr. Rhodes’ involvement in all major pediatric cardiac trials allows him to provide his patients with treatment options that other hospitals cannot. Finally, Dr. Anthony Rossi was one the first and is one of the most experienced pediatric cardiac intensivists in the country, and was instrumental in developing the concept of using a dedicated pediatric cardiac intensive care unit (CICU). In addition to the physicians already on staff, NCH has plans to recruit two additional pediatric cardiac intensivists and a pediatric cardiac heart failure specialist. The Intervenor, Jackson Jackson is the public safety net hospital system for Miami-Dade County and has been in existence since 1918. Its mission is centered on a mandate to treat all Miami-Dade County residents regardless of their ability to pay. Its main campus, Jackson Memorial Hospital, includes the Holtz Children’s Hospital (Holtz) and the Women’s Hospital. Pediatric cardiac services provided by Jackson, via Holtz, include PHT and pediatric heart failure, as well as cardiac surgery and cardiology services. Holtz provides services for patients 21 years of age and under through its affiliation with the University of Miami, which provides physician services to JMH. Holtz cares for patients with all types of diseases, including, but not limited to, chronic illness; congenital heart disease; cardiology; cardiovascular, liver, kidney and intestinal disease; burn; trauma; neurology; and solid organ and bone marrow transplantation. Holtz has 373 beds, including 60 Level II NICU beds and 66 Level III NICU beds. The NICU at Holtz cares for the most complex infants, high-risk patients, and births. In addition, Holtz has a 30-bed pediatric intensive care unit (PICU) consisting of individual, separate patient rooms, fully equipped and capable of treating critically ill children. The PICU cares for pediatric pre- and post-operative transplant, cardiac, burn, trauma, and surgical patients, among others. Patients in the PICU have highly acute conditions, frequently requiring ventilator support, ECMO support for cardiac patients, and access to subspecialty care. PICU nursing for the most critical patients is provided on a one-to-one ratio. Adjacent to the PICU on the same floor are two pediatric operating rooms, the pediatric cardiac catheterization laboratory, and the transplant unit. Patients are assigned to the transplant unit based on the type of organ transplanted and the patient’s acuity. Holtz has dedicated pediatric and neonatal pharmacies. Pharmacy, nursing, rehabilitation, and dietary services are provided by specialists in pediatrics and neonatology. Holtz offers a wide variety of child life services, including diversionary techniques to alleviate pain and promote child development and therapies to provide a sense of normalcy in the lives of pediatric patients cared for at Holtz. In addition, Holtz provides pediatric palliative care through its Pedi Pals program which provides care for pediatric patients who are critically ill and have frequent hospitalizations or care needs at home. Services include pain management, bereavement services, and pastoral care as needed or indicated by families. Holtz also provides a Prescribed Pediatric Extended Care program (PPEC) that offers day care type services for children with complex medical conditions, including cardiac patients. This allows the patients’ parents and caregivers the ability to work while their children are cared for in a medically supervised setting. JMH’s transplant program has been in operation for over 45 years. Holtz and JMH provide a wide range of solid organ transplantation in conjunction with the Miami Transplant Institute (MTI) and the University of Miami (UM). MTI is a joint program between JMH and UM, employing nearly 300 people and 40 physicians dedicated to transplantation. It is the third largest transplant program, and the second largest pediatric transplant program, in the United States. In the past year, MTI performed over 420 adult and over 70 pediatric solid organ transplants, all at JMH. Pediatric transplant programs at JMH include heart, kidney, pancreas, kidney/pancreas, liver, lung, intestinal, and multi-visceral. JMH also performs bone marrow transplants. Due to the scope of both pediatric and adult solid organ transplant services offered at JMH, pediatric patients are easily transitioned into adult services for uninterrupted treatment at JMH. PHT recipients will require lifelong care and follow up, frequently retransplantation, and adult services as they age. The cardiothoracic surgery program at JMH has existed for over 50 years. It is multidisciplinary, caring for both children and adults with heart, lung, and mediastinal disease and includes a robust transplant and assistive device program. The program has a team of cardiothoracic surgeons, four of whom have PHT experience. Dr. Eliot Rosenkranz is JMH’s primary pediatric heart transplant surgeon. He has been at JMH since 2000. The PHT team also includes Dr. Matthias Loebe and Dr. Nicolas Brozzi, who both have extensive experience in transplanting solid organ pediatric patients, teenagers, and young adults, and who provide support to Dr. Rosenkranz, whenever needed. JMH has a heart failure program that includes a multidisciplinary team of physicians, nurses, therapists, and other providers who review the best modalities to treat and medically manage patients with heart failure. In addition to cardiology services, the heart failure program includes the cardiac transplant service. JMH’s pediatric heart failure program, led by Dr. Paolo Rusconi, was only the eighth program in the U.S. to be accredited by the Health Care Colloquium, and the only program in Florida to receive such designation for programs demonstrating quality in heart failure patient management. Other cardiac-related services provided at JMH include interventional cardiology, under the direction of Dr. Satinder Sandhu; echocardiography and non-invasive imaging; electrophysiology, diagnostic pediatric and cardiothoracic radiology; and general cardiology. 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 PHT Application 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” is defined by rule 59C- 1.002(41) as a “tertiary health service,” 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). However, the United Network for Organ Sharing (UNOS), which regulates, monitors, and reports organ transplant and procurement data, defines pediatric patients as the age group 0–17. The STS, which reports risk-adjusted cardiac surgery data, also defines pediatric patients as the ages 0–17. As a practical matter, none of the clinicians that testified for either party limited their definition of pediatric patients to ages 0–15. Heart transplantation is considered a last resort for patients with end-stage heart disease who may have no other medical or surgical therapies available. Typically, persons listed for heart transplantation have a life expectancy of less than one year. These patients often have significant limitations of their activity and lifestyle prior to transplantation. At hearing, the cardiologists who testified agreed that whenever possible, PHT should be delayed as long as medically possible, since transplanted hearts typically have a limited, yet greatly variable period of viability, ranging from under a year to possibly decades. However, in any event, retransplantation is frequently necessary. The two most common causes of end-stage heart disease requiring a transplant in children are cardiomyopathy, which is a progressive deterioration of the function of the heart muscle, and congenital heart defects that are not amenable to further surgical correction. The conditions that require heart transplantation in children are different across age cohorts (and from adults). Infants or neonates requiring transplantation typically have congenital heart defects that require surgical intervention relatively soon after birth. These conditions are typically dealt with anywhere from infancy to seven or eight years of age. With the older pediatric age group (eight years of age to adolescence), the indications for transplant are different. Many children are perfectly healthy until then, and then contract a serious illness, such as viral cardiomyopathy. In this condition, the heart enlarges and children develop restrictive cardiomyopathy, leading to sudden heart failure or progressive decline of their function, ultimately requiring a transplant. ECMO, also known as extracorporeal life support (ECLS), is an extracorporeal technique of providing both cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of gas exchange to sustain life. Generally it is only used in the later treatment of a person with heart or lung failure as it is solely a life- sustaining intervention. Congress, through the National Organ Transplant Act, established the Organ Procurement Transplant Network (OPTN) to manage a national list of organ donors and available organs, along with the collection of data regarding organ transplant. OPTN administers these duties through a contract with UNOS. Patients exhibiting symptoms of possible heart failure are referred to the heart failure team for initial evaluation. The evaluation includes assessment of the patient’s medical history and anatomy, imaging, and review of alternative treatments to transplantation by various medical specialists. Because the goal recognized by most physicians is to delay or avoid PHT, in many cases, patients are not listed for PHT or may be removed from the waitlist when continued medical management or other palliative surgical intervention is proper. If PHT is required, patients and their parents will meet with the PHT surgeon to discuss the procedure. All information from the assessment is reviewed by the multidisciplinary transplant review committee, which includes pertinent medical and surgical specialists, social workers, financial counselors, and other members necessary for decision- making. Upon approval by the transplant committee, and consent from the patient’s family, patients are listed with UNOS according to severity of disease, how soon the patient will require a new organ, and the expectation of their survival without a new organ. Donor information, including donor location/region, blood type, age, donor size, and other factors that are used to identify potential organ matches, is provided by the donor hospital to the organ procurement agency. When a potential match is identified, the recipient hospital with the highest priority patient is provided the donor information or provided an “offer.” At that time, the recipient hospital reviews the donor information to confirm whether the organ is appropriate for the matched recipient. In some infrequent circumstances, a donor is not appropriate due to both the condition of the donor and the condition of the recipient. If the donor is appropriate, the process for the transplant procedure begins. 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 program at issue in this proceeding will be located in OTSA 4, which is comprised of Broward, Collier, Miami-Dade, Monroe, and Palm Beach Counties. For purposes of CON review, Florida is divided into 11 health planning districts. § 408.032(5), Fla. Stat. The CON at issue in this proceeding will be in District 11. Currently, there are two providers of PHT in OTSA 4: DiMaggio and Jackson. As discussed below, historically Jackson’s PHT volumes have been extremely low. Jackson is located in District 11. DiMaggio is located in District 10. In addition to these two programs, there are only two other PHT providers in Florida: UF Health Shands Hospital (Shands), located in Gainesville, OTSA 1, District 3; and Johns Hopkins All Children’s Hospital (All Children’s) located in St. Petersburg, OTSA 2, District 5. 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 0-17) heart transplant discharges by year for the four Florida PHT programs during Calendar Years (CY) 2013 through 2015: HOSPITAL HEART TRANSPLANT CY 2013 CY 2014 CY 2015 All Children’s Hospital 7 14 9 UF Health Shands Hospital 6 8 9 Memorial Regional Hospital 5 5 5 Jackson Health System 2 2 1 Total 20 29 30 History and Utilization of Existing Providers of PHT in OTSA 4 The Jackson Program At JMH, the surgical component of a PHT is a small piece of a very complex process. The critical components of the PHT process, managed by the cardiology and heart failure team at JMH, include timely referral for transplant, heart failure and transplant evaluation, pre- and post-operative transplant care (inpatient and outpatient), heart transplantation, and lifelong immunosuppression management. JMH is approved by OPTN and UNOS to provide PHT. JMH’s adult and PHT programs are certified by the Centers for Medicare and Medicaid Services (CMS) under a single certification. Certification with CMS requires OPTN membership and regulation compliance. Jackson has a long history of running extremely low- volume pediatric and adult transplant programs, and has had a series of regulatory violations stemming from its failure to support and grow its adult and pediatric transplant programs, the consequence of which includes being under a federal Medicare/Medicaid System Improvement Agreement. For several years, Jackson was unable to meet the Children’s Medical Services’ volume thresholds for a pediatric cardiac program, resulting in the program being placed on probation. The evidence demonstrated that currently and historically, Jackson has not performed 90 “on-pump” (heart/lung bypass) pediatric heart surgeries on an annual basis. Jackson’s transplant volume for young children, infants, and neonates is nearly nonexistent. Jackson has not done a transplant on a patient under 30 days of age since 1998. Since 2007, Jackson has done no transplants on patients aged one to five. In the past six years, Jackson has only done five transplants on patients under 10 years of age. Unlike NCH, Jackson is concentrated on providing cardiac surgery primarily to adults. In CY 2015, JMH had 37 pediatric (age 0-17) cardiac surgery cases, representing only 3.9 percent of its total cases. By contrast, during the same period NCH had 201 pediatric cardiac surgery cases, representing 21.2 percent of its total cases. The difference in focus between JMH and NCH is even more pronounced when it comes to cardiac surgeries on neonates. In 2016, NCH did 200 on-pump pediatric cardiac surgeries, of which 52 were performed on neonates, meaning neonates accounted for 26 percent of NCH’s on-pump cases. During the same period, Jackson only performed 42 on-pump cases, of which only seven were neonates, meaning neonates only accounted for 16 percent of Jackson’s on-pump cases. Jackson is also performing about two times the national average in terms of the percentage of its cases that are performed on adult patients. Performing pediatric cardiac surgery on neonates is typically more complex than performing congenital heart defect surgery on adult patients. Jackson only has one pediatric cardiac surgeon. Jackson advised Children’s Medical Services it intended to recruit a second pediatric surgeon in 2012, but this did not occur. Jackson’s low cardiac surgery and transplant volumes make it difficult, if not impossible, for it to recruit a highly skilled pediatric cardiac and transplant surgeon. Dr. Rosenkranz testified that there is no need to recruit a second pediatric heart surgeon. Jackson and NCH treat very different universes of patients. Jackson has not performed a PHT on a Miami-Dade County resident in the last three years; whereas, NCH performs 73 percent of the pediatric cardiac heart surgeries for Miami- Dade County residents and expects a significant percentage of its transplant cases to come from this patient population. Jackson concentrates predominantly on pediatric cardiomyopathy cases. NCH is more focused on pediatric congenital heart defects and anticipates these patients will represent a significant portion of its transplant patients. Jackson’s patients tend to be older patients, whereas a significant percentage of NCH’s patients are neonates and infants. In pediatric cardiac surgery, 25 percent of NCH patients are neonates (under 30 days), and 30 percent are infants (31 days to one year). Jackson has not done a transplant on a neonate since 1988. In fact, Jackson has only performed three transplants on infants and no transplants on any patients between one and five years old since 2008. Jackson tends to be risk averse, whereas NCH treats the most complex patients. For example, Jackson has not had a single transplant patient on ECMO, whereas, based upon NCH’s 20 years of historical data, it expects to have a pool of approximately 10 patients a year on ECMO that may benefit from transplant. In August 2011, AHCA sent JMH a letter advising JMH that it had abandoned both its pediatric heart and pediatric lung transplant programs due to not performing a single pediatric heart or lung transplant for over twelve consecutive months in 2010. The letter, addressed to JMH’s President and CEO, stated: Re: Abandonment of Pediatric Heart Transplant Program Dear Mr. Migoya: In the course of our regular data collection and analysis responsibilities, Agency staff has confirmed that your pediatric heart transplant program has been idle, i.e. no transplants have been performed, for a period in excess of 12 consecutive months, from January 2010 through December 2010. Accordingly, pursuant to Certificate of Need rule sections 59C-1.002(41)(a),59C-1.004(1}, 59C-1.0085(5), and 59C-1.020 Florida Administrative Code, and section 408.036(1), Florida Statutes, the re-establishment of a pediatric heart transplant program in the future will require a new certificate of need. The program will be removed from the Agency's inventory of authorized transplant programs. Within 14 days of receipt of this letter, please advise this Agency if the above findings are inaccurate. Should you have any questions regarding this request, please contact Steve Love of my office at (850)412- 4345. Sincerely, /S/ Jeffrey N. Gregg, Chief Bureau of Health Facility Regulation (NCH Ex. 46). Following receipt of the above letter, JMH drafted a response in which JMH did not take issue with the accuracy of the data cited in AHCA’s letter. Rather, JMH’s letter recited the reasons for its low PHT volume, including “low regional volumes, financial challenges in the system resulting in bad publicity, and intense competition from a new start-up program . . . .” It is unclear whether the draft response was ever sent to AHCA, however, no witness at hearing disputed the accuracy of the data contained in AHCA’s letter. AHCA’s representative, Marisol Fitch, testified that the letter did not revoke or rescind JMH’s CON, which is evidenced by the fact that AHCA did not notify JMH of its right to dispute a revocation or rescission pursuant to chapter 120, Florida Statutes. Ms. Fitch further advised that there was no final order revoking JMH’s CON, nor had it ever been voluntarily surrendered by JMH. Either of these actions would have been required to delete services from the program inventory. According to AHCA, JMH has an active PHT program, is currently listed in AHCA’s inventory of PHT programs, and at no time has AHCA taken further steps to terminate JMH’s PHT license. At hearing, and again in its PRO, JMH objected to the legal status of its PHT program being placed at issue in this proceeding. JMH is correct that this proceeding is not concerned with the validity of JMH’s PHT license, however, consideration of the past volumes of PHT being provided at JMH and AHCA’s documentation of periods of time when no PHTs were provided, is relevant to the statutory review criteria to be applied to the NCH application. The DiMaggio Program DiMaggio is also licensed to perform PHT services within OTSA 4. DiMaggio is part of the Memorial Healthcare System (Memorial) in Broward County, Florida. DiMaggio offers pediatric and adult congenital heart surgery and PHT. DiMaggio also offers a heart failure program that includes both medical management and surgical services. Adult heart transplant is also offered by Memorial on the same campus. DiMaggio received its CON for PHT services in 2009 and received UNOS approval in 2010, performing its first transplant in December 2010. DiMaggio has provided PHT related services and heart failure management since that time. DiMaggio’s PHT surgeon is Dr. Frank Scholl and its pediatric heart failure program is led by Dr. Maryanne Chrisant. During CY 2013 through CY 2015, Memorial performed five PHTs each year. The Proposed NCH Program As noted, NCH proposes to establish a PHT program on its hospital campus in Miami, OTSA 4, District 11. Due to its robust pediatric cardiac program, NCH already has most of the infrastructure in place to support the transplant program. NCH has a staff of pediatric cardiac physicians with expertise in caring for patients with end-stage diseases requiring transplants, clinical staff and nurses with experience caring for chronically ill children and families, nutritionists, respiratory therapists, social workers, psychologists, and psychiatrists. The NCH staff and physicians are available on a 24-hour basis at NCH’s dedicated cardiac intensive care unit. NCH also has educational and training opportunities available for staff, patients, and families. NCH has a very well trained and experienced nursing staff, many with advanced certifications and specialized pediatric training. NCH has an excellent nurse training program in place to grow the skills of its nursing staff. NCH has been an American Nurses Credentialing Center (ANCC) Magnet Program institution for three consecutive years, a statistic only seven percent of hospitals across the country have been able to achieve. NCH uses cardiac-dedicated nurses to care for its cardiac patients, and only uses dedicated cardiac advanced registered nurse practitioners to care for post-surgical cardiac patients in its dedicated CICU. NCH’s dedicated CICU has recently been relocated to the new advanced pediatric intensive care tower. There are distinct advantages to having a dedicated CICU when it comes to caring for complex cardiac patients, including transplant patients. It allows NCH to have extremely seasoned physician cardiac intensivists, cardiac nurse practitioners, cardiac nurses, and other support staff such as dieticians and social workers, who treat a high volume of pediatric cardiac surgery patients and understand their unique issues and complications. The constant exposure to complex cardiac patients allows NCH’s team to recognize complications sooner and react quicker, resulting in better care and shorter lengths of stay. In contrast to NCH’s dedicated pediatric CICU, Jackson does not have a dedicated CICU. Heart transplant patients are placed in the same ICU as all other pediatric critical care patients. The cardiac surgeons at NCH use innovative technology to improve their patients’ outcomes and reduce patients’ length of stay in the hospital. One way NCH has earned its reputation for excellence is by operating on the toughest cases. NCH is the place where patients turn when other hospitals refuse to operate because the case is too complex. NCH is willing to take “hits” to its mortality/morbidity statistics to give the sickest patients a chance to live. Despite having the highest volume of pediatric cardiac surgeries in Florida, NCH cannot perform PHT on its patients. These patients and their families must choose to continue alternative treatment at NCH, or be transferred away from their team who has been caring for them through the events that led up to the transplant, which often includes multiple prior heart surgeries. It is difficult on patients and families to lose continuity of care at this stage in their disease process. While Jackson raised some criticisms of NCH not having an adult cardiac program for continuity of care after patients reach adulthood, the evidence shows the largest and best pediatric heart programs in the United States are often located in pediatric-only programs, with no immediately available adult programs. Dr. Rhodes and Dr. Guleserian testified that even at places like Duke and Texas Children’s that have adult programs, the two programs are completely separate. Moreover, NCH has a relationship with the Cleveland Clinic to transition patients when they need an adult program. Dr. Rhodes also refuted JMH’s claim that there needed to be a back-up adult interventional cardiologist on-site to run a quality interventional program. This is contrary to the Society of Cardiac Angiography and Intervention’s recommendation. Further, Dr. Rhodes performs catheterizations on adults and has this training should it be necessary. There are also other adult interventional cardiologists on staff at NCH. Jackson also argued NCH’s program would be inferior because NCH does not offer other solid organ transplant services. However, as Dr. Guleserian explained, kidney and liver transplants are very different than heart transplants. Even in hospitals where both heart and other solid organ transplants are offered, the heart program is separated because it is unique. Heart transplant patients are much more similar to cardiac surgery patients than other solid organ transplant patients. Dr. Guleserian does not endorse comingling heart transplant patients with other solid organ transplant patients. After evaluating NCH’s existing cardiac infrastructure, Cassandra Smith-Fields, accepted as an expert in transplant program development and operation, concluded that NCH had everything necessary to establish a PHT program, with the exception of recruiting a heart failure specialist. Ms. Smith- Field’s expert opinion, which is credited, and is based on 32 years of professional experience working in transplant programs, is that NCH will be able to implement a high-quality PHT program. AHCA’s Preliminary Decision Following AHCA’s review of NCH’s application, as well as Jackson’s written Letter of Opposition, AHCA determined to preliminarily deny the application. The Agency’s decision was memorialized in a SAAR, dated February 19, 2016. The SAAR is mostly a restatement of the information presented in the NCH application. There is only one paragraph in the entire document that purports to explain why the Agency chose to preliminarily deny the application: The Agency indicates that OTSA 4 has relatively low but stable pediatric heart transplant volume for the four-year period ending June 30, 2015 and no outmigration for the 12-month period ending June 30, 2015, therefore it is reasonable to conclude that a third provider in OTSA 4 would likely reduce already relatively low volumes at the existing pediatric heart transplantation provides in OTSA 4. Marisol Fitch, supervisor of AHCA’s CON and commercial-managed care unit, testified for the Agency. 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 that they present to the Agency for our analysis.” In addition to the applicant’s need methodology, “we (AHCA) look at availability and accessibility of service in the area to determine whether there is an access problem.” With respect to whether NCH had demonstrated need for its PHT program, Ms. Fitch testified: The Agency did not feel that the applicant demonstrated need for the project in organ transplant area four. We did not find that there was an underserved population or that there were financial issues at stake or a quality issue, and so we did not feel that the applicant demonstrated that need for the project was produced within the four corners of the application. Statutory Review Criteria Section 408.035(1)(a): The need for the health care facilities and health services being proposed. The statutory criteria for the evaluation of CON applications, including applications for organ transplantation programs, are set forth at section 408.035, Florida Statutes, and rule 59C-1.044. However, neither the applicable statutes nor rules have a numeric need methodology that predicts future need for PHT programs. Thus, it is up to the applicant to demonstrate need in accordance with rule 59C-1.044. To quantify the need for a new PHT program in District 11, NCH used the two need methodologies described in detail below. Methodology 1: Ratio of Transplants to Cardiac Surgeries NCH’s first need methodology evaluates the ratio of PHT volume at the four existing Florida transplant centers to the volume of pediatric cardiac surgeries. It then applies this ratio to NCH’s cardiac surgery volume to determine the internal demand for this service at NCH. There is a positive correlation between the number of pediatric cardiac surgeries and the number of PHTs. The more pediatric cardiac surgeries a hospital performs, the more need there will be for PHTs. Conversely, low-volume pediatric cardiac surgery providers, such as Jackson, are also low-volume PHT providers. Using data from STS and UNOS, NCH determined that during CY 2014: All Children’s Hospital performed 146 cardiac surgeries and 14 transplants for a percentage of 9.6%; UF Health Shands Hospital performed 84 cardiac surgeries and 8 transplants for a percentage of 9.5%; Memorial Regional Hospital performed 61 cardiac surgeries and 5 transplants for a percentage of 6.0%; and Jackson performed 55 cardiac surgeries and 2 transplants for a percentage of 3.6%. The above data strongly suggests there is a correlation between the number of pediatric cardiac surgeries performed and the number of transplants performed. This correlation is supported by AHCA’s rule 59C-1.044(6)(b)4., which sets forth minimum volume thresholds for pediatric cardiac surgeries (125) and cardiac catheterizations (200), and with data reflecting that nationally, PHT programs are located in hospitals with the largest pediatric cardiac surgery programs. To forecast pediatric cardiac surgical volume in OTSA 4, NCH used AHCA’s CY 2014 discharge rates for OTSA 4 residents and applied those to the forecasted pediatric population for each of the planning years. This resulted in a forecast of 259 pediatric cardiac surgeries for the 12-month period ending June 30, 2018, increasing to 261 cases during the 12 months ending June 30, 2020. Using CY 2014 AHCA data, NCH then determined that it had a 62.2 percent market share of all pediatric cardiac surgeries performed in OTSA 4 on OTSA 4 patients. Applying this market share to the forecasted surgeries, NCH determined that it would perform 161 pediatric cardiac surgeries on OTSA 4 residents during the 12 months ending on June 30, 2018; 162 during the 12 months ending on June 30, 2019; and 163 during the 12 months ending on June 30, 2020, i.e., more than any other provider is currently performing. NCH assumed a 25 percent in-migration percentage, and provided a conservative ramping-up ratio of three percent PHT to cardiac surgery for the 12-month period ending June 30, 2018; six percent for the 12-month period ending June 30, 2019; and seven percent for the 12-month period ending June 30, 2020. The assumption used is significantly lower than All Children’s or Shands’ ratios, despite the fact that NCH is forecasted to have significantly more pediatric cardiac surgeries than either of those two hospitals. Applying these conservative assumptions, NCH could reasonably expect to perform six PHTs for the 12-month period ending June 30, 2018; 14 for the 12-month period ending June 30, 2019; and 15 for the 12-month period ending June 30, 2020. Jackson criticized NCH’s surgical ratio analysis, pointing out that AHCA defines pediatric as 0-14, not 0-17. However, as discussed above, STS and UNOS define pediatric as 0-17. Thus, the use of this age group is appropriate when considering the likely patients to be served. Moreover, the difference in the results using 0-14 data, versus 0-17 data, is de minimus. As a result of Jackson’s criticisms, NCH’s health care planner re-ran her analysis using 0-14 AHCA data. This resulted in almost the same outcome, with six PHTs projected for the 12-month period ending June 30, 2018; 13 for the 12-month period ending June 30, 2019; and 15 for the 12-month period ending June 30, 2020. Jackson’s argument that there is no positive correlation between the number of pediatric cardiac surgeries performed and the number of PHTs likely to accrue from that surgical volume is rejected. While there is a not a specific ratio, or “magic” number which can be reliably applied to each institution, there is a range within which the ratio of cardiac surgery to PHTs will fall. According to Dr. Gulesarian, whose testimony is credited, for any particular institution, that ratio will likely vary from year to year depending upon a number of variables, most importantly, the complexity of the cardiac surgeries being performed. Specifically, the more complex and higher risk the surgeries, the more likely a heart transplant will be necessary. Methodology 2: Ratio of Transplant Volume to Common Indicators NCH’s second need methodology evaluates the most common indications for PHTs and compares that to the cases by hospital and resident origin to determine the need for a PHT program at NCH. To do this, NCH’s health care planner worked with NCH’s physicians to compile a list of the 24 most common indicators for PHT, and to determine their corresponding International Classification of Disease, 9th Revision (ICD-9) codes. Using AHCA data, NCH then determined that in 2014, there were 499 pediatric cases in Florida with the target ICD-9 codes. NCH had the most cases with 121, constituting 24.2 percent of all cases in Florida. The second greatest, All Children’s, only had 66, constituting 13.2 percent. In OTSA 4, for the years 2012–2014, NCH had a total of 296 patients with these common indicators, accounting for 55.6 percent of the volume for all OTSA 4 hospitals. Notably, the two existing PHT providers in OTSA 4, Jackson and DiMaggio, only had volumes of 51 and 125, respectively, during this same time period. Combined, these two hospitals still had a significantly lower volume of the targeted ICD-9 codes than did NCH. Using AHCA data, NCH then determined that, from 2012 through 2014, an average of 11.2 percent of patients at the four existing transplant hospitals that had a primary diagnosis of one of the identified ICD-9 codes received a transplant. Using just 2014 data, this average was 15.2 percent. This increase was due to DiMaggio, which opened in 2010, increasing from 3.4 percent in 2012 to over 11 percent in 2014. Using NCH’s market share in OTSA 4 and the population forecasts, NCH was able to determine its forecasted volume of patients with these common indicators. NCH then applied a very conservative ramping up ratio of ICD-9 volume to PHTs of five percent in 2018, eight percent in 2019, and 10 percent in 2020 to forecast the number of PHTs NCH could expect. When the above ratios are applied to the expected ICD-9 volumes, the result is six PHTs for the 12-month period ending June 30, 2018; 11 for the 12-month period ending June 30, 2019; and 13 for the 12-month period ending June 30, 2020. At hearing, Jackson criticized NCH’s common indicators methodology, pointing out variability where All Children’s volume of common indicators only went from 64 to 66 between 2013 to 2014, yet the number of transplants doubled from seven to 14. However, as Ms. Greenberg explained, NCH looked at multiyear trends, not a single point in time. A single point in time may have large fluctuations due to things like what occurred at All Children’s: the head pediatric cardiology surgeon left, which shifted patients from All Children’s to Shands. A change in surgery personnel was one of the factors identified by Dr. Gulesarian as potentially affecting PHT volumes. Criticism was also raised regarding NCH’s use of ICD-9, instead of the newer ICD-10, codes because the conversion resulted in the inclusion of certain indicators, e.g., Eisenmenger Syndrome, Coronary Artery Disease, and Ehlers-Danlos Syndrome, as being among the list of most common indicators for heart transplant. NCH’s planner demonstrated that any differences due to the inclusion of these ICD-10 codes was de minimus or nonexistent. Thus, even had the newer codes been used, they would not have materially affected the volume projections for the proposed PHT program. Jackson is correct that both need methodologies put forth by NCH are “institution specific,” and are better characterized as an internal demand analysis than as a need methodology. Neither method identifies either an unserved population or an access issue. Rather, they project a volume of patients NCH anticipates would be available to receive a PHT at NCH if approved. Section 408.035(1)(b): The availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the service district of the applicant. Section 408.035(1)(e): The extent to which the proposed services will enhance access to health care for residents of the service district. Disparity in Use Rates OTSA 4 represents 32 percent of Florida’s pediatric population. The five-county OTSA is home to more than 1.3 million residents age 17 and under. Yet, despite having approximately one-third of the pediatric population, OTSA 4 only provides one-tenth of the state’s PHTs. The chart below presents the PHT use rates in Florida by OTSA for CY 2013 through CY 2015: 1 10.1 11.2 13.3 11.6 2 10.7 5.8 8.6 8.4 3 9.6 15.4 9.3 11.4 4 3.9 3.1 3.1 3.3 Statewide 8.2 8.1 8.0 8.1 Average Use Rates per 1,000,000, Age 0 to 17 OSTA CY2013 CY2014 CY2015 3-Yr Avg (NCH Ex. 75). As can be seen from the above, the three-year average use rate in OTSA 4 (CY 2013 through CY 2015) is 3.3 percent, compared to OTSA 1 at 11.6 percent, OTSA 2 at 8.4 percent, and OTSA 3 at 11.4 percent for the same time period. There was no evidence that there was anything unique about the pediatric patients in Miami-Dade County to justify this disparity in PHT use rates. To the contrary, Dr. Rosenkranz conceded that he did not know of anything that would justify any disparity in the use rate in OTSA 4, and he would expect it to match the rest of Florida: Q. . . . So for those counties in OTA 4, from a clinical perspective, are you aware of anything unique about those counties that would make the prevalence of pediatric heart disease or heart malfunctions that result in transplant any different than any other parts of Florida? A. Nothing that I'm aware of. Q. You would expect it to be similar to other parts of Florida, correct? A. Yes, I would. (NCH Ex. 176; pp. 25). Dr. Rhodes similarly testified there was no clinical reason for the relatively low use rate in South Florida, other than the fact that the largest pediatric cardiac surgery provider in the state (NCH), which is doing 25 percent of the pediatric cardiac surgeries in the state, does not have a PHT program. Dr. Feld echoed these opinions and testified that if NCH’s CON application is approved, with the addition of Dr. Guleserian, NCH will be able to rectify the disparate use rate. Ms. Greenberg testified that the PHT use rate data shows a disparity that would indicate that residents of OTSA 4 have an access issue to PHT because many children are going without the service. On cross-examination, however, she conceded that patients who leave OTSA 4 in order to receive a PHT could also at least partially explain the disparity. But in either case, she concluded, whether it was lack of service or due to out migration, the low use rate indicated an access issue in OTSA 4. The most convincing explanation for the disparate use rate came from Cassandra Smith-Fields who testified that the use rate disparity has resulted from the PHT programs being placed in the wrong hospitals. This opinion was echoed by Dr. Rhodes, who cited data showing that transplant programs across the nation were usually located at high-volume pediatric surgery providers. NCH presented compelling data based upon its sheer volume of pediatric cardiac surgeries that approving NCH’s PHT application will have a substantial impact in resolving the current disparity in PHT use rates. As noted previously, NCH performs 25 percent of all pediatric cardiac surgeries in Florida, 62.2 percent of those performed in OTSA 4, and 72.7 percent of those done in Miami-Dade County. Inability to Transfer NCH Patients on ECMO Several NCH cardiologists testified there are a significant number of their patients that are simply too sick to be transferred from NCH to another facility to receive a PHT. Many of these patients do not even get listed for a heart transplant since they likely would not survive the necessary transfer. Dr. Burke provided 20 years of data showing 275 post- surgical pediatric heart patients that had been placed on ECMO after surgery. One hundred and forty-seven of those children died. While he could not opine as to exactly which of those patients’ lives could have been saved if NCH had been able to offer them a PHT, he testified that each of those children were a potential candidate for a PHT in order to have a chance to save their lives. Dr. Rossi explained the difficulties of moving patients on ECMO. Patients must be chemically paralyzed while on ECMO, because the slightest movement of the patient can cause the cannula to shift, potentially resulting in death. The risk of moving ECMO patients is so serious that when a patient is going to be taken off ECMO, the operation is performed at the patient’s bedside because it is too risky to even move the patient down the hall to the operating room. Dr. Rossi explained that the only time one would ever transport a patient on ECMO is when not moving the patient would result in certain death. Despite NCH’s award-winning transport team, its experience with patients transported on ECMO is that two-thirds of the patients die during the transport. Multiple NCH physicians discussed the inherent dangers of just moving a patient on ECMO down the hall for procedures. While some patients are too sick to transport, they may yet be appropriate candidates for PHT. Approximately five percent of Dr. Guleserian’s transplant patients have been patients transplanted while on ECMO. Ms. Smith-Fields testified that in her program, when there is a high-risk pediatric surgery taking place, the patient will often be pre-cleared as a PHT patient so that if the surgery is not a success, the patient can be supported on ECMO and immediately listed for transplant without any processing delays. While NCH did pioneer a portable ECMO machine to transfer patients on ECMO, it has only been used to bring patients to NCH. Those patients were certain to die if they were not transported on ECMO, and one-third of them lived because of those transports. However, when that risk is contrasted with the risk of transporting NCH patients on ECMO to be listed for PHT, the risk of transport is greater than the risk of waiting to see if the patient recovers on ECMO. Approximately half of NCH’s cardiac surgery patients who go on ECMO after a failed surgery survive. It would not be advisable to take the risk of transport on ECMO because the odds of the patient dying are increased. Credible testimony established that there are significant risks to a patient being transported while on ECMO. Thus, even assuming that transporting a patient on ECMO from NCH to a transplant facility was an option, forcing a patient to accept the high, and potentially fatal, risks of this transport presents a major access issue. Organ Out-migration from OTSA 4 The evidence did not establish that there is currently significant out-migration of PHT patients from OTSA 4 or Miami-Dade to other Florida or out-of-state PHT programs. Considering the risks inherent in transport discussed above, this is not surprising. However, there is a demonstrated out- migration of donor hearts from Florida. During CY 2010 through August 2015, there were 205 pediatric hearts recovered throughout Florida. In 2014, specifically, there were 38 hearts recovered and 29 pediatric heart transplants performed the same year. Because there were more hearts recovered than transplanted in the state, Florida is a net exporter of donor pediatric hearts. At hearing, Jackson asserted that its low volume of PHTs was caused by the lack of viable pediatric hearts to be transplanted in OTSA 4. However, this argument was inconsistent with the SRTR data showing approximately 25 percent of the adult and pediatric donor hearts harvested in Florida in 2015 (41 hearts) were being sent out of state, many to children’s hospitals. The data also reflects that OTSA 4 is a net exporter of donor hearts. To the extent there is any merit to Jackson’s claim about the lack of viable pediatric hearts, however, the evidence also showed that adding PHT programs to an area increases the number of hearts procured in that region. This is known as the “push/pull phenomenon.” As explained by Ms. Smith-Field, the push/pull phenomenon results when the presence of transplant centers within a given donor service area “pushes” the designated organ procurement organizations to a better job of procuring organs. Quality of Jackson’s PHT Program Based upon persuasive evidence presented at hearing, there is a strong positive correlation between the number of pediatric cardiac surgeries a hospital performs and its PHT volumes. Not surprisingly, nationally PHT programs are almost universally located in the hospitals with the highest volume of pediatric cardiac surgery. For procedures such as cardiac surgery, the number of procedures performed directly correlates to the quality of the outcomes. Generally speaking, surgeons and facilities with higher volumes experience higher quality. This volume-outcome relationship is expressly recognized by AHCA in several of its CON rules which require minimum projected volumes, including organ transplantation. Jackson has struggled with low pediatric cardiac surgery volumes since at least 2012, when it was unable to meet the Children’s Medical Services pediatric cardiac volume requirements and was placed on probationary status. The compelling evidence showed that in both its pediatric cardiac surgery program and its PHT program, Jackson has been a chronically low-volume provider. Indeed, it was undisputed that Jackson has the lowest PHT volume in the state. Jackson’s PHT waitlist activity indicates continued low volume. Ms. Smith-Fields compared Jackson’s waitlist additions to her program’s experiences and concluded Jackson’s waitlist additions are not indicative of an active program: And so the other thing I guess that really stood out for me when I looked at this was how many patients were put on the waitlist? So this says that they added two patients to the waitlist in 2014. That's telling me that's not a very active program. In my own program in 2015, where we did 15 transplants, we put 24 candidates on the list that year. Lucille Packard did 20 transplants last year, they put 32. So I just run the ratios, if I put two patients on the list, I am only expecting to do one or two transplants, that's going to keep you being a very small program. Several NCH physicians discussed the correlation between volume and quality, and expressed concerns that Jackson’s PHT program was just too low volume for them to feel comfortable recommending patients go there. Ms. Smith-Fields examined Jackson’s PHT scorecards and had several concerns about the quality of Jackson’s PHT program, including: Jackson taking too long to waitlist patients; having patients on the waiting list too long; and putting patients on inactive status for unusually long periods of time. She agreed that risk aversion is a common phenomenon in small transplant programs. Jackson unconvincingly attempted to explain its perennially low PHT volumes by suggesting that Dr. Rusconi was better at medically managing patients to avoid transplant. In response, Dr. Guleserian testified that all PHT programs do everything they can to medically manage their patients in an effort to avoid transplantation. According to Dr. Guleserian, to believe that Jackson has found some magic formula to avoid transplantation, but is somehow hiding this secretly away from the rest of the transplant world, is not plausible. She explained that she sits on various national committees and boards dedicated to PHT, and if such an approach had been developed with those kinds of results, she would be aware of it. Moreover, there is no evidence of record to suggest that all four Florida PHT programs do not have heart failure programs at least as robust and successful as Jackson’s program. Jackson’s contention that its low PHT volume is the product of a particularly successful heart failure program is not credible. While it is undisputed that PHT should be considered the intervention of last resort, the evidence also established that for some children, there is no alternative to PHT. This is reflected by the fact that in CY 2015 a total of 30 PHTs were performed in the four Florida PHT programs. Whatever the reason(s) for its consistently low PHT volumes, the fact remains that during CY 2010 through CY 2015, Jackson performed a total of only seven PHTs, by far the lowest volume of any of the PHT providers in the state. During this same period of time, the other three Florida PHT programs performed a combined total of 121 PHTs. Given the well- documented relationship between volume and outcome of surgical procedures, Jackson’s low PHT volume alone raises legitimate quality of care concerns. Adverse Impact on Jackson and DiMaggio The evidence demonstrated NCH only rarely refers PHT candidates to Jackson and DiMaggio. Jackson only presented evidence of one potential transfer patient it claimed was referred by NCH in the last several years. However, no specific referring cardiologist was identified, no NCH witnesses corroborated the referral, and no records were produced to corroborate the referral was from NCH. NCH presented evidence of two of its patients that sought transplant at Jackson. One of these patients died without being listed for transplant (despite at least one of the cardiologists at Jackson fighting to get the patient either listed or transferred to Shands), and the other patient ultimately received their transplant at Shands. The consistent testimony from NCH physicians was that they are hesitant to refer PHT patients to Jackson because of its low volume and other perceived quality issues. This is particularly concerning since NCH’s patients represent 60 percent of the pediatric cardiac surgeries performed in OTSA 4, and many of these patients have congenital heart defects that will eventually result in them requiring a PHT. Jackson argued that NCH referring its patients to Shands and All Children’s, rather than Jackson, was the reason why Jackson had been unable to grow its transplant program. Some Jackson witnesses intimated NCH was intentionally sabotaging Jackson’s program by not referring its patients because of prior fallings-out between the hospitals and their physicians. While the evidence showed there had been several failed attempts for NCH and Jackson to work collaboratively with pediatric cardiac patients, it did not show that this was the reason why NCH physicians rarely refer patients to Jackson. Rather, the lack of referrals was based upon quality concerns. Indeed, credible testimony established that NCH physicians are advising their patients about the correlation between volume and quality as documented in the medical literature, resulting in those PHT candidates, who have the financial means and clinical ability to travel, choosing to pursue their PHTs at higher- volume programs. Given, NCH’s dominant market position and quality concerns, these referral patterns do not appear likely to change. The greater weight of the evidence established that approval of the NCH PHT program would have minimal, if any, impact on the volume of PHTs being performed at Jackson. For the same reasons identified with respect to Jackson, approval of the NCH program will likely have minimal, if any, impact on the volume of PHTs performed at DiMaggio. 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. NCH has a demonstrated record of providing quality cardiac services to its patients. NCH’s cardiology and heart surgery program is ranked 40th in the United States by U.S. News and World Report. In addition, NCH has more pediatric programs ranked among “America’s Best” by U.S. News and World Report than any other hospital in Florida. NCH’s dedicated CICU, staffed with a dedicated cardiac team, will be able to provide high quality care for PHT patients. NCH’s cardiac nursing staff has an average of 12 years’ experience caring for heart patients. NCH’s cardiac physicians are all highly qualified, with decades of experience. Jackson alleged quality deficiencies related to NCH’s staffing, clinical review committee, protocols and procedures, laboratory and pathology services, and staff and patient family educational programs. However, none of these alleged deficiencies persuasively shed doubt on NCH’s ability to provide excellent quality of care to its PHT patients. Section 408.035(1)(d): The availability of resources, including health personnel, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation. Short Term Financial Feasibility The parties stipulated to NCH’s ability to initially fund the project. Availability of Health and Management Personnel NCH’s existing management personnel will oversee the proposed project. Given the relatively small size of the project, the existing management staff is more than capable of overseeing and managing this additional program. Based upon its PHT volume projections, which are credible, NCH is expecting its average daily census (ADC) of cardiac patients to increase by only one to two patients a day as a result of the PHT program. NCH currently has a dedicated cardiac clinical staff of 16 to 20 registered nurses, nurse practitioners, and technicians who are more than capable of handling the projected increase in ADC. In addition, NCH currently has eight registered nurses and four advanced nurse practitioners that have dedicated heart transplant experience. Upon approval of the program, NCH will ensure that all staff is properly trained and educated prior to the implementation of the PHT program. This includes the training to prepare both a nutritionist and a transplant coordinator. With the successful recruitment of Dr. Guleserian, who has performed 133 pediatric heart transplants, NCH’s surgeons and other physicians are more than capable of staffing the PHT program. NCH will not have any difficulty recruiting a high- quality heart failure specialist given NCH’s reputation, cardiac surgery volumes and market shares, and reputable physician team already in place. Section 408.035(1)(f): The immediate and long-term financial feasibility of the proposal. As noted, the parties stipulated that NCH has the financial ability to fund the proposed program. As to long-term financial feasibility, NCH has $586 million in net assets with a net operating income of $100 million per year. NCH is well-positioned to absorb any potential losses that the PHT program might incur, and is dedicated to maintaining the program, regardless of profit or loss, due to its commitment to meeting the needs of the community. NCH has a history of funding financially unprofitable programs when there is a critical need for them in the community. An example is NCH’s LifeFlight program, which generates no profit for NCH and, in fact, operates at a $3 million per year loss. Jackson raised issues regarding errors in NCH’s financial schedules attached to the CON application. Ms. Greenberg incorrectly included a full-time physician’s salary in the financial schedule, at the wrong amount. Physicians are not employed directly by NCH and should not have been included. Ms. Greenberg’s third-year financial projection, while correctly listing staffing costs as a line item, failed to include that cost in the final total. However, correcting for these minor errors shows that this program will still be profitable. It is also worth noting that when AHCA is evaluating transplant programs, it looks at the financial health of the entire applicant, not just the program under CON review in a vacuum. As Ms. Fitch explained: THE COURT: Okay. I have heard testimony today, and you may have heard it as well, from Mr. Balsano regarding an addition error that apparently existed on the NCH pro formas. You have testified that the Agency found the project to be financially feasible in the long-term. At the time the Agency made that determination, had that addition error been revealed to the Agency? THE WITNESS: Not that I know of. But I will say, in terms of the Agency, typically we don’t see that transplant programs are necessarily profitable on their own. We do look at the entire system to determine whether a facility can maintain a program. We have seen a number of programs come in that, on their own, are not financially feasible but in an entire health system, it is a feasible feat for an application. So I heard Mr. Balsano’s testimony, and while I think that’s a significant addition error, I don’t know that that would have necessarily changed the review. I don’t want to speak for the financial analysis unit, but I have seen programs that on their own are not financially feasible but the Agency determines that the health system can support it, based on their total system. Given the overall financial strength of NCH, and its commitment to continue to fund the PHT program regardless of its profitability, the long-term financial feasibility of the program is not in question. Section 408.035(1)(g): The extent to which the proposal will foster competition that promotes quality and cost- effectiveness. As detailed above, there is an unexplained use rate disparity between Miami-Dade County, OTSA 4, and the rest of the state with regard to PHT. This disparity is a strong indicator that there is an access issue for residents of District 11. The evidence established that Jackson has not performed a PHT on any Miami-Dade County resident in the past three years. The access issue is particularly pronounced for complex cases, both because Jackson appears to be reluctant to list and transplant complex cases, and because a significant population of critically ill children cannot be safely transferred from NCH to Jackson. Approval of NCH’s application will provide residents of District 11 and OTSA 4 access to a high-volume, high-quality cardiac program for PHT, something they do not have access to now. There is no question that approval of the NCH program will foster competition. As Dr. Burke testified, in his experience approval of a new PHT provider serves as a stimulus to existing providers. There is also little question that once established, the NCH program will be high-volume, particularly relative to the volumes of PHT being done at Jackson and DiMaggio. Section 408.035(1)(g): The costs and methods of the proposed construction, including the costs and methods of energy provision and the availability of alternative, less costly, or more effective methods of construction. NCH did not propose construction for this project. This criterion is not in dispute. Section 408.035(1)(g): The applicant’s past and proposed provision of health care services to Medicaid patients and the medically indigent. NCH has a long history of providing health services to Medicaid patients and the medically indigent. In CY 2013 and CY 2014 NCH provided $2,327,848 and $1,193,660 in charity care, respectively, representing 2.1 and 2.5 percent of its net patient revenue. NCH provided $106,941,948 in conventional Medicaid and $134,616,815 to patients under Medicaid Managed Care in CY 2014. NCH's projects that annually, over 60 percent of the PHT patient days will be Medicaid. This payor mix is based on NCH’s complex cardiac patient payor mix, and is reasonable. NCH has and will continue to provide health care services to Medicaid patients and the medically indigent. Inasmuch as the majority of pediatric patients qualify for Medicaid, and NCH has a history of providing care to Medicaid patients and the medically indigent, both Jackson and AHCA concede the proposal’s compliance with this criterion is not in dispute.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered approving CON Application No. 10421 filed by Variety Children’s Hospital, d/b/a Nicklaus Children’s Hospital, subject to the conditions contained in the applications. DONE AND ENTERED this 15th day of May, 2017, 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 15th day of May, 2017. COPIES FURNISHED: Richard Joseph Saliba, Esquire Kevin Michael Marker, Esquire Agency for Health Care Administration Mail Stop 3 2727 Mahan Drive Tallahassee, Florida 32308 (eServed) Geoffrey D. Smith, Esquire Susan Crystal Smith, Esquire Stephen B. Burch, Esquire Smith & Associates Suite 202 1499 South Harbor City Boulevard Melbourne, Florida 32901 (eServed) Thomas Francis Panza, Esquire Panza, Maurer, & Maynard, P.A. Suite 905 2400 East Commercial Boulevard Fort Lauderdale, Florida 33308 (eServed) Elizabeth L. Pedersen, Esquire Panza, Maurer & Maynard, P.A. Suite 905 2400 East Commercial Boulevard Fort Lauderdale, Florida 33308 (eServed) Paul C. Buckley, Esquire Panza, Maurer & Maynard, P.A. Suite 905 2400 East Commercial Boulevard Fort Lauderdale, Florida 33308 (eServed) Angelina Gonzalez, Esquire Panza, Maurer, & Maynard, P.A. Suite 905 2400 East Commercial Boulevard Fort Lauderdale, Florida 33308 (eServed) Christopher Charles Kokoruda, Esquire Eugene Shy, Jr., Esquire Laure E. Wade, Esquire Miami-Dade County West Wing, Suite 109 1611 Northwest 12th Avenue Miami, Florida 33136 (eServed) Abigail Price-Williams, Esquire Miami-Dade County West Wing, Suite 109 1611 Northwest 12th Avenue Miami, Florida 33136 Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 (eServed) Justin Senior, Secretary Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 1 Tallahassee, Florida 32308 (eServed) Stuart Williams, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 (eServed) Shena L. Grantham, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 (eServed) Thomas M. Hoeler, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 (eServed)
Findings Of Fact Donald Davis is the promoter behind the formation of Community Hospital of Collier, Inc. He is a health care management consultant and a principal of the firm Health Research and Planning Associates, Inc. In his profession he concentrates on the promotion and development of health care facilities. He has engaged previously in the business of forming corporations for the purpose of submitting applications and obtaining Certificates of Need. He also provides consulting services to health service corporations. Neither Davis nor the other principals of the applicant corporation, including his wife, have any experience or expertise in constructing or operating hospitals, and Davis admitted that the sole purpose for forming the entity known as Community Hospital of Collier, Inc. was for the purpose of submitting an application and prosecuting it in order to obtain a Certificate of Need for an acute care hospital for District VIII. Mr. Davis' own company, Health Research and Planning Management Associates, Inc. was paid $15,000 by Community Hospital of Collier, Inc. to develop the Certificate of Need application at issue. Community has "a couple of thousand dollars" in its own bank account. The officers and directors of Health, Research and Planning Management Associates, Inc. are the same as those of Community Hospital of Collier, Inc. On June 15, 1983, after having previously filed a letter of intent, Mr. Davis filed an application for a Certificate of Need for a 152-bed acute care hospital on behalf of Community Hospital of Collier, Inc. Mr. Davis is an officer and director of that corporation. The articles of incorporation for Community Hospital of Collier, Inc. which gave it its de jure status were not signed until July 29, 1983 and were not filed with the Secretary of State until August 19, 1983. Be that as it may, Mr. Davis maintains that the Board of Directors of Community ratified the filing of the application. That authorization found at page 44 of the application, however, refers to the Board of Directors of Community Health Care of Okaloosa/Walton. The resolution was dated June 7, 1983 and Mr. Davis testified that the use of the name Community Health Care of Okaloosa/Walton in the caption of that Board of Director's resolution was a "typographical error." In any event, the applicant corporation had no legal existence at the time the application was filed on June 15, 1983, however, by its later acts in filing and prosecuting the application it implicitly, at least, ratified the action of its promoter, Mr. Davis, in filing the application since the officers and directors consisted of Mr. Davis, his wife and a third individual. Be that as it may, Community negotiated a stock purchase agreement with National Medical Enterprises (NME) on August 15, 1984. Pursuant to this agreement, NME is obligated to purchase all capital stock of Community if a Certificate of Need for 100 beds or more is awarded. In return for the sale of the stock of the applicant corporation to NME, Mr. Davis and the other two board members of Community will receive a total of $600,000 in addition to the $15,000 Mr. Davis has already received for his efforts in preparing and prosecuting the Certificate of Need application. The only asset of Collier is the inchoate Certificate of Need. Upon consummation of the stock purchase agreement, Mr. Davis will resign from the Board of Directors and presumably NME will appoint its own board. Community has given full authority to NME to prosecute the application as it sees fit, including making certain changes NME deemed appropriate to the application, including seeking 150 beds instead of 152 and changing the method and means of financing the project (mostly equity instead of debt). Additional changes in NME's approach to prosecution of the application include the proposed method of recruitment of personnel and management of the hospital. Community has no agreements with any other group, entities or individuals to provide financial, personnel and other resources necessary to construct, manage and operate an acute care hospital and did not demonstrate that it has any such resources in its own right. Mr. Frank Tidikis, Vice-President for Operations for the eastern region for National Medical Enterprises, testified concerning the financial and management resources and staffing arrangement NME proposes for the new hospital should it be authorized. He enumerated many medical specialties that NME intends to place on the staff of the hospital, but neither Community nor NME have done any studies revealing what types of medical specialties are presently available in the Collier County area, how many physicians in those specialties are available and what ratio exists or is appropriate for various types of physicians to the community population. The proposed staffing pattern, sources and method of recruitment was predicated solely on NME's past experience in obtaining hospital staff in other areas of the nation, and not upon any study or other investigation showing the availability of appropriate types of trained staff people in reasonable commuting distances of the proposed hospital, which would be located in northern Collier County. If NME consummates the purchase agreement, the hospital would be locally managed by a board of directors consisting of 51 per cent of the hospital's own medical staff and 49 per cent lay members chosen from the community at large. FINANCING Mr. Michael Gallo was Community/NME's expert in the area of health care finance, being NME's Vice-President for Finance. It was thus established that the total cost of the project, if approved, would be approximately $23,600,000. This amount would be financed by NME which proposes to make a 35 per cent equity contribution in the amount of approximately $8,500,000 and which will finance the balance of the project cost at a rate of approximately 13 per cent interest for 20 years. NME projects that an average daily patient census of 45 would be necessary to "break even." A daily census of 45 would yield 6,425 patient days per year, with the facility projected to break even in its first year of operation. NME projects that by the third year of operation, a return on investment of 10 to 12 per cent would be achieved. NME's projections are based on an assumed average length of stay per patient of 5.6 days. NME allocated two and sone-half per cent of its projected gross revenues for indigent patient care, and four per cent of projected gross revenues allocated to bad debt, that is, uncollectible hospital bills, not necessarily related to indigent patients. The $600,000 which NME must pay Community Hospital of Collier and Mr. Davis in order to acquire the assets of that corporation (i.e. the CON) will be treated as a project cost and will be depreciated as though it were a part of the buildings. Community/NME projects its total revenue per adjusted patient admission to amount to $4,843, with projected total revenue per adjusted patient day at $865. It predicts these figures will increase by about five per cent for successive years as a factor of inflation. The proposed hospital site consists of approximately 12 acres, available at a price of $30,000 to $50,000 per acre. The application itself originally proposed a location in the central or southern portion of Collier County. However, after NME entered into the agreement with the applicant corporation for the stock purchase and became involved in the prosecution of the application, the location was changed. Thus, it was discovered at the outset of the hearing that indeed, the proposed location of Community of Collier's hospital would be in the northern portion of Collier County in close proximity to Lee County. 1/ The proposed $360,000 to $600,000 land cost would of course, be added to the total cost of Community's proposed project. It has not been demonstrated what use would be made of the entire 12 acres, nor that the entire 12 acres is required for the hospital, its grounds, parking and ancillary facilities. STAFFING One of the reputed benefits of Community's proposed project is that it would afford a competitive hospital in the Collier County health services market to counter what Community contends is a virtual monopoly held by Naples Community Hospital, as well as to promote the attraction of more qualified medical staff to that "market". In this context, Community contends that its facility, by being built and operating as an alternative acute care hospital, would attract more physicians to the Collier County area and thus, arguably, render health services more readily available. Community thus decries the supposed "closed staff" plan of Naples, contending that Community offers an "open" staffing plan, which would serve to attract more physicians to the geographical area involved and enhance Community's ability to appropriately staff its hospital. Naples Community Hospital, on the other hand, experiences numerous physicians vacationing in the area requesting staff privileges. Many of these physicians apparently do not have any intention of permanently locating in the Naples/Collier County area, however, and therefore in order to determine which physicians are seriously interested in locating there, Naples has a screening procedure which includes an interview with the Chief of Staff, the Assistant Director for Staff Development, and the chief of the service for which a physician is applying for privileges. This preliminary screening procedure is not tantamount to a closed staffing situation, which only exists where a fixed number of physicians are permitted on a hospital staff, with others waiting until an opening occurs. In the open staff situation, as exists at Naples, no matter how rigorous the screening process, there is not a finite number of staff physicians available. Any physician who qualifies under the hospital bylaws and assures the screening committee of his intention to locate in the area served by the hospital is admitted to the staff. Thus, the staffing pattern for physicians at Naples Community Hospital augurs just as well for the attraction of physicians to the Collier County vicinity as does the staffing method proposed by Community. In that vein Naples has granted privileges to 13 new physicians in the preceding calendar year and had 8 applications pending at the time of hearing. Only one applicant was denied privileges during that year. Additional factors which must be considered in the context of staffing such a hospital concern the ability of the applicant to provide quality of care and appropriate, available resources including health care and management personnel to operate the facility. Aside from demonstrating that NME, through the stock purchase agreement, may obligate itself to provide ample funds and other resources to fund, staff and operate the project, and that it has successfully staffed and operated hospitals in numerous locales, Community did not demonstrate what likely sources would be drawn upon for nurses and other staff members to staff its hospital in order to avoid recruiting most of them from nearby facilities, including Naples Community, which could precipitate a diminution in the quality of health care at these other facilities. In short, other than showing that NME's management has the financial resources and experience to accomplish the staffing and operation of the hospital, there was no demonstration by Community which would establish the availability of sufficient health care personnel to operate and manage its hospital at adequate levels of care. COMPETITION Community contends that its facility should be built in order to foster competition in the provision of health care services in Collier County. It took the position, through its expert witness, Dr. Charles Phelps, that the Naples hospital holds a monopolistic position in Collier County inasmuch as it is the only hospital in the county. It should be pointed out somewhat parenthetically, however, that this "County market area" theme ignores the fact that this application is for an acute care hospital in District VIII, which is not subdivided by rule into County sub-districts for health care planning purposes. Further, Community originally proposed locating its hospital in the central or southerly portion of Collier County, but as of the time of the hearing, proposed to locate its hospital in the northerly portion of Collier County with a service area it itself proposed which will include the southerly portion of Lee County. This area is also within the service areas of Naples Community Hospital, Lee Memorial Hospital, Fort Myers Community Hospital and the soon to be constructed Gulf Coast Osteopathic Acute Care Hospital. Thus, in its attempt to establish Naples Community Hospital as occupying a monopolistic position in the "Collier County health care market", Community did not establish that Collier County either legally or practically is a separate health care market demarcated by the county boundary with Lee and Hendry Counties, such that Naples' status as the sole acute care hospital within the legal boundaries of Collier County is monopolistic. Indeed, it competes for patients with the Lee County hospitals named above in the northern Collier-southern Lee County market area involved. Community attempted to demonstrate a monopolistic situation in favor of Naples Community Hospital by comparing its relative increase in costs per day and costs per patient stay with Fort Myers Community Hospital and Lee Memorial Hospital. Naples Community Hospital did indeed exhibit the largest rate of cost increase in both those categories. Community's expert, Dr. Phelps, opined that lack of competition in the Naples area caused the disparity in rate of increase in costs between Lee County hospitals and the Collier County hospital. Naples called Ed Morton, who was accepted as an expert witness in hospital financial analysis, reimbursement, hospital auditing and accounting, financial feasibility and corporate finance. It was thus established that Naples does not occupy a monopoly position and provides health care at lower costs than would be the case should the Community Hospital facility be constructed. Mr. Morton demonstrated that analyzing total costs per adjusted patient day does not reliably indicate the efficiency of a hospital, since such daily costs fluctuate with the average length of stay. A better indicator for determining hospital efficiency is to analyze total revenue per adjusted admission. A comparison of Lee Memorial, Naples Community Hospital, Fort Myers Community Hospital and NME's six Florida hospitals was employed based on data provided to the hospital cost containment board for the years 1980 through 1983, in order to show which hospital operated more efficiently and tended less toward monopolistic market positions. In making this comparison, Mr. Morton employed the "total revenue per adjusted admission" and "total revenue per adjusted patient day" methods of comparing the hospitals. He used this approach because it reduces to a common denominator the various values and statistics utilized in the hospital cost containment board formulas. It was thus established that Naples has the lowest total revenue per adjusted admission and lowest total revenue per adjusted patient day of all the hospitals depicted in the comparison study (Naples Exhibit 23). Naples total revenue per adjusted admission is $400 to $1,900 less than each of the other hospitals. One reason Naples experiences less total revenue is because its charges are lower, since it employs some 1,600 volunteer workers. If these workers were paid at a minimum wage they would reflect a cost of approximately $600,000 per year. Further, the hospital over the years has obtained large donations of money and labor through funding drives, all of which have enabled it to keep charges down for its patients and to continue to operate certain services at a deficit. For instance, Naples has a discreet pediatric unit, which means a physically separate, self-contained pediatric care unit, with specialized staff, who perform no other services than those they are designated to perform in pediatrics. That unit operates at a deficit repeatedly since 40 per cent of the Naples pediatric patients originate from the Immokalee area, which is characterized by an extremely high percentage of indigent persons. Naples' witness Morton performed a patient origin study which shows that approximately 84 per cent of Naples' patients originate in Collier County, 12 per cent originate in Lee County, particularly southern Lee County, and two per cent originate from unrelated areas. The Naples Community Hospital is located in Naples, approximately in the mid-section of Collier County and a significantly greater distance from the northern Collier/Lee County line than will be the Community facility, if built. Community expects to draw approximately one-half, or six per cent, of the 12 per cent of Naples' patient load which is derived from Lee County. NCH however, at the present time, competes with Fort Myers Community Hospital and Lee Memorial Hospital, in particular, for patients from both southern Lee County and northern Collier County, Community's proposed service area. Thus, NCH does not maintain a monopoly serving Collier County or Community's proposed service area to the exclusion of these other hospitals. The placement of Community's facility at a point much closer to the Lee County border than is Naples' present facility would result in the injection of a fourth or fifth strong competitor into the Collier County-southern Lee County patient origin and health service market area, rather than merely the addition of a second competitor for Naples Community Hospital. ADVERSE COMPETITIVE EFFECTS Both Lee Memorial Hospital and Fort Myers Community Hospital already draw a substantial number of patients from southern Lee County, as well as northern Collier County. Gulf Coast Osteopathic Hospital, after protracted litigation, has secured approval of a Certificate of Need to build an osteopathic acute care hospital in the southerly portion of Lee County. That Final Order authorizes 60 beds. It is fair to assume, inasmuch as these hospitals are already drawing from southerly Lee County, that the capture of the patient market in southern Lee County will be made much more pervasive with the addition of the Gulf Coast Osteopathic acute care facility. That being the case, insofar as the 1989 horizon year is concerned, far less than 12 per cent of the Lee County origin patient days now available to hospitals located in Collier County will actually be available. Community will thus draw even less than its own projected six per cent of its patient days from Lee County. In any event, it is logical to conclude that substantially all the patient days resultantly available to a Collier County situated facility will be derived from Collier County upon the advent of the Gulf Coast Hospital. Thus, any patients drawn to Community, if its facility were built, would be at the direct expense of NCH. That being the case, it is reasonable to conclude that the analyses performed by Mr. Morton, Naples' expert, which reveal that Community Hospital will potentially siphon off as many as 80 patient days per day from Naples Community Hospital, is accurate. If this occurs, it would mean that approximately 29,200 annual patient days would be garnered by Community. Mr. Morton's analysis established that a resultant raising of rates by Naples would have to occur in the amount of $240 per patient day. Failure of Naples to so raise its rates to patients, would cause an annual revenue deficiency of 6.5 million dollars. This increase of $240 per patient day would result in a $1,536 increase in the average charge per adjusted admission, based upon the average length of stay at Naples which is 6.2 days. Even if Community obtained only half its patients from the Naples Community Hospital, (a likely understatement of its patient market impact), the resulting loss to Naples per patient day would be $220 with a concomitant necessary increase, in average patient charges per admission in the amount of $768, in order for NCH to remain financially viable. If Naples were unable to raise its charges to compensate for this loss of patients to the Community facility, then it would have to curtail services currently rendered on a deficit basis, such as its discrete pediatric unit, which experiences a 40 per cent indigent patient utilization. Community's own projections show that it expects to garner 27,790 patient days, which for the above reason, are likely to all be gained at the expense of NCH. This will result in the loss to NCH of at least 76 patient days per day with a resultant revenue shortfall nearly as high as that postulated by Morton as a result of his patient origin study and adverse impact analysis. Thus, in terms of lost patient days and lost revenue, both the figures advanced by Naples and those advanced by Community reveal that a substantial adverse impact will be occasioned to Naples by the installation of Community's hospital, especially in view of its location at approximately the midpoint between the Lee County boundary and NCH's facility in Naples. Naples derives approximately 54 per cent of its gross patient revenues from Medicare reimbursement. Four per cent of its revenues are represented by Medicaid patient reimbursement. Eight to nine per cent of its billings are not collected because of non-reimbursable, indigent patient care and bad debts. Community will obtain from 76 to 80 patient days per day case load now enjoyed by Naples Community Hospital. Community projects that its billable case load will be characterized by four per cent Medicaid reimbursable billings, and six and one- half per cent of its annual case load will be represented by indigent and bad debt uncollectible billings. Forty-six per cent of NCH's indigent and bad debt cases come from the Immokalee area lying east of State Road 887 and north of State Road 846, and the Community Hospital would be built approximately midway between that area and the location of NCH. Therefore, based upon Community's own projection of total billings for 27,790 patient days, or at most, 29,200 days per year, (according to NCH's figures which depict the loss to NCH of 80 patient days instead of 76) it becomes obvious that Community's bad debt, indigent case billings would actually be in the neighborhood of 17 per cent of its total, billable case load, rather than the six and one-half per cent it projects in its application and evidence. This would render the bad debt, indigent patient-based uncollectibles of Community to be on the order of four million dollars per year. Such a high magnitude of bad debt, uncollectible billing experience can reasonably be expected since Community's Hospital would be constructed between the source of most of the indigent bad debt case load and NCH's location. This location is also in the center of the most affluent, rapidly developing residential area of Collier County. Given the fact that Community-NME's proposed location is likely to attract a high indigent, bad debt case load from the economically depressed Immokalee area, approaching the magnitude of 17 per cent of total case load, if a policy of freely accepting indigent, uncollectible cases were followed by Community-NME, but considering also the fact that Community proposes to locate its hospital in the service area it has delineated to include the most concentrated source of more affluent, privately paying patients available to these competing hospitals, it cannot be concluded that Community-NME plans to incur such a high financial risk by free acceptance of indigent, charity cases. Rather it seeks to largely serve the collectible, private-paying patient source of northwestern Collier County, hence its recently altered proposed location. This determination is borne out by the experience of NME's other Florida hospitals, which are characterized by a very low percentage acceptance of indigent, bad debt, patient service. Thus, it is quite likely that NCH would be relegated to continued service of this large number of indigent, nonpaying patients while Community/NME would serve a patient base composed of largely private-paying and Medicare reimbursed patients drawn primarily from NCH, a significant financial detriment to that entity, which at present experiences a rather precarious operating ratio, characterized by, at best, a three per cent profit margin. Such an eventuality would force upon NCH the choice of raising its rates substantially or curtailing services, or both, with the probable alternative of seeking taxpayer subsidization of such an increased charity case load. NCH effectively competes with the pertinent hospitals in Lee County for the same patient base, due to its lower charges, as shown by the fact that Naples has the lowest revenue per adjusted admission and per adjusted patient day of the hospitals in Collier and Lee Counties. Thus, any increase in charges at Naples necessitated by the adverse effect of the installation of Community's hospital would put it at a distinct additional disadvantage in competing with the Lee County hospitals. A similar financial resultant adverse impact would be imposed on Lee Memorial, Fort Myers Community and Gulf Coast in terms of declining utilization and revenues. It is further noteworthy that Community's own projection of annual patient days reveals that it will experience an occupancy rate of approximately 50 per cent. It has not been established how 27 to 29 thousand patient days with a concomitant occupancy rate of only SO to 51 per cent can support a 150-bed free standing, acute care hospital with a full complement of ancillary services, which fact renders the financial feasibility of Community's proposed hospital substantially in doubt. In terms of the relationship of adverse impacts on existing hospitals to the legislative goals of hospital cost and rate containment, it should be pointed out that the current utilization rate of all hospitals in this area District VIII are declining, partly as a result of the impact of the "diagnostic related groups" (DRG) method of reimbursement. The utilization at NCH for the first six months of 1984 has dropped to 62.3 per cent. The utilization rate of the Lee County hospitals has been reduced to approximately 65.4 per cent. The addition of another acute care hospital to this area, which is established to likely experience a utilization of only 50 to 51 per cent itself, would only cause the current low utilization rates to plummet more drastically. This situation would substantially impair the financial viability of all existing hospitals in the relevant area of District VIII, and Community, as well. Thus, if the proposed Community Hospital were added to this area, it would only aggravate the problem the CON approval process is designed to prevent, that of avoiding escalating health care rates and costs, concomitant decline in adequate levels of service and unnecessary duplication of services. GEOGRAPHIC ACCESSIBILITY In support of its assertion that by 1989 a portion of its service area will not be accessible within 30 minutes driving time of an existing hospital, Community adduced the testimony of Mr. Michael Dudek, accepted as an expert traffic engineer. Mr. Dudek plotted the time and distance of travel from NCH, Cape Coral Hospital, Lee Memorial Hospitals Fort Myers Community Hospital, Eastpoint Hospital, the future Gulf Coast Hospital and proposed Lee Memorial 100-bed satellite facility. He employed the "floating car method" in determining travel times from each hospital to points 30 minutes from the hospital. He projected future travel times along the same routes with a view toward growth in traffic volume based upon population growth. Mr. Dudek opined that in 1989 there will be, under average traffic conditions, a portion of northern Collier and southern Lee Counties which will not be within 30 minutes average travel time of any existing hospital. In his own opinion, in peak travel seasons, coextensive with seasonal, winter population peaks in this geographic area, the situation will be aggravated such that the territory where residents are more than 30 minutes driving time from existing hospitals will expand. Mr. Dudek conceded that vehicles on roads adjacent to main artery roads would reach various main arteries at different times, depending on the density of the population in the residential neighborhoods between those main traffic arteries. He did not map his proposed 30-minute driving time contour lines to indicate these variables. Further, he acknowledged that even during the 1989 projected peak traffic season, the geographical triangle in which Community-NME will locate its proposed hospital, was not outside the driving time projected for Naples Community Hospital. He apparently based his conclusions on the premise that road and traffic improvements would not occur so as to significantly compensate for the population and traffic growth posed by various real estate developments of regional impact which have been filed and proposed for north Collier and south Lee Counties. Naples, presented the testimony of Mr. Jack Barr, also accepted as an expert traffic engineer. Mr. Barr used the "average car method" in conducting a travel-time study to determine the points on arterial roads 30-minutes distance from all existing hospitals in Lee and Collier Counties as well as from the proposed Lee Memorial Satellite Hospital. (Naples Exhibit 76). The distances between those points are interpolated and plotted on the basis of estimated average speeds on the non- arterial segments of the roadways that would be traversed by people making their way to the arterial roads. Mr. Barr also surveyed proposed road improvements in the Collier and Lee County areas (Naples Exhibit 7C). He predicated this survey on the most recent Department of Transportation traffic maps. He performed his original field study during a four-week period in December and January, 1982. The travel times for Collier County were then revised and updated on October 24, 1984 with a field survey and for Lee County on August 14 through 23, 1984. Mr. Barr was unable to determine any significant statistical difference between the contours he plotted in his 1982-83 survey and those plotted in the 1984 updated survey. Mr. Barr employed information obtained from the Southwest Florida Regional Planning Council, the Lee County Planning Department and the Collier County Traffic Planner, as well as information from his own files on proposed residential building projects with which he has been associated professionally or become aware of in the area. It was thus established that that portion of north Collier County and southern Lee County, where most of the proposed residential development will occur, and which is in Community's proposed service area, is currently partially or totally within 30-minutes driving time of three existing and one approved hospital. All the proposed major residential developments in the north Collier/south Lee County area are within 30 minutes travel time of at least one existing hospital and most lie within the 3 minute contour lines for the proposed Lee Memorial Satellite Hospital. The travel time contours will remain substantially unchanged for the next ten years based upon major road improvements planned in the next ten years. Information as to road improvements was obtained from the approved Collier County Comprehensive Plan, from average daily traffic counts on U.S. 41 conducted by the Department of Transportation and Collier County, from the Lee County Transportation and Improvement Program which shows the status of road improvements for 1985 through 1989, and from the Department of Transportation Road Improvement Program extending through the fiscal year 1989 for Lee and Collier Counties. All the roads included in the DOT projection for the next five years are committed and will be built. Although there will not be a decrease in traffic along U.S. 41, rather the increase in traffic that would normally occur on U.S. 41 will be largely offset by traffic shifting over to parallel routes which are to be developed through the road improvement programs established by Mr. Barr. There has been a steady decrease in use of the formerly highly congested U.S. 41 artery because of the development of parallel highways such as Airport Road. Mr. Barr established that the road improvements upon which his opinion is partly based are being implemented, and since most are funded by gasoline tax monies earmarked for that purpose, it is reasonable to assume that the DOT sponsored improvements will continue to be made. Further, although Community sought to show that a portion of the population of its service area is beyond a 30- minute travel time from existing acute care hospitals, it did not demonstrate that that population now or in 1989 amounts to more than 10 per cent of the Collier County population. In his capacity as a traffic-engineer, Mr. Barr has worked in Lee and Collier Counties for approximately seven years, representing public and private clients. He has monitored the implementation of the Collier Comprehensive Plan as it relates to roadways and real estate development and established that road improvements are indeed being implemented. His testimony and opinion, predicated on more accurate surveying techniques, supported by local planning and Department of Transportation documentation, is better corroborated and more competent than that of Mr. Dudek and is accepted. Thus, it has not been shown that the 30 minute travel time points and distances attributable to existing hospitals will recede sufficiently to create the new service area contemplated by Community. EXISTING SERVICE - AVAILABILITY, QUALITY, ADEQUACY OF CARE, ACCESSIBILITY To ALL, INCLUDING INDIGENTS NCH affords adequate availability and access to acute care services for patients in Collier and southern Lee Counties, including indigent patients. Community's proposed facility would not have a level 2 or 3 nursery, and would not have a discreet pediatric unit, both of which Naples has. Thus, access to pediatric, as well as obstetric services, would not be enhanced by the advent of Community's hospital, for indigent or other patients originating in Community's proposed service area. Additionally, inasmuch as NCH's pediatric unit operates at a deficits the addition of such services, even of their limited scope, by Community may, for financial reasons, result in the curtailment of such services, especially for indigent, in view of the considerations expressed above. The physician-director of the Collier County Health Department, Dr. Polkowski was called and accepted as an expert witness on behalf of Naples in the area of public health, for the purpose of discussing the distribution of medically indigent persons and availability of services in Collier County. Her work requires her to routinely review U.S. Bureau of Census data on age and health characteristics of the population of Collier County and to travel throughout the county to acquire knowledge of the health characteristics of the population. It was thus established that the highest concentration of poverty level patients occurs in Census Tracts 112, 113, 114 and 104, with a particularly high concentration in Census Tract 112 which comprises the Immokalee area in northeastern Collier County. A particular health problem in that area is teenage pregnancy, with 90 births to females under 19 years of age in 1983 out of a county-wide statistic for such births of 172. Eleven per cent of the babies born to women under 19 years of age in Collier County are low birth weight babies, which typically necessitate higher levels of neonatal, specialized care because of the increased chances of serious health problems occasioned by low birth weight. There are three recognized levels of care for newborn babies in Florida. Naples Community Hospital has a Level 1 and 2 nursery. Level 1 represents babies who have no exceptional conditions. Level 2 is for those babies with respiratory and other serious problems requiring enhanced levels of care and is characterized by such special equipment as isolettes, intensive care bassinets with respirators, cardiac monitors, apnea monitors, resuscitation and cardiac resuscitation equipment. The staffing level of the Level 2 nursery is at a ratio of one neonatal specialized nurse to three babies rather than the one nurse per six babies of the Level 1 nursery. The Level 2 and 3 babies have serious and frequently chronic health conditions for the short, and sometimes the long-term, often characterized by quite high patient costs. The Immokalee area has the highest poor as well as non white concentration in the bounty. There are approximately 14,000 permanent residents, but during the wintertime the population swells to over 20,000 when predominantly Mexican American migrant farm workers arrive in the area. The poor population has a higher mortality rate for infants and manifests more serious medical problems on a greater per capita basis than does the more affluent population lying to the west and southwest. The Immokalee area population has a high rate of tuberculosis, venereal disease, parasites and hepatitis. The current level of services provided to the indigent population by Naples Community Hospital however, is of a high quality. Richard Akin is the Director of the Collier Health Services, a private, nonprofit primary health care organization which offers primary medical and dental care services to the rural, poor population of northeast Collier County. Most of these patients are migrant farm workers who have absolutely no means of paying their own medical bills. Collier Health Services provides primary medical care at three locations in the county with the largest center being at Immokalee. The Immokalee facility has seven staff positions which include such specialties as pediatrics, family practice, internal medicine and obstetrics. The Immokalee facility records approximately 60-thousand patient visits per year. Seventy-five per cent of these are represented by Mexican- American farm workers who are employed in the area seasonally. Another 10 to 12 per cent per year are Haitian immigrants employed in agriculture. Between 60 and 80 per cent of all patient visits are not paid for by the patient. The Immokalee primary care facility refers 4,000 to 4,500 patients to a hospital annually, with about 12 to 15 such referrals per day. These are for normal, non-emergency care situations. Additionally, between 400 and 450 patients are referred to a hospital for emergency care per year. All the primary care center's emergency and non emergency patients are referred to NCH. Mr. Akin has attempted to refer patients from the Immokalee facility to other area hospitals such as in Lee County, but without success. NCH is located in fairly close proximity to the Immokalee Primary Care Center, and, even though most patients have no means of paying for medical care, NCH treats and admits them without questioning them in advance concerning their ability to pay, insurance, Medicaid and the like. Mr. Akin has previously attempted to refer his indigent patients to the Fort Myers area hospitals with little success in having them admitted. LeHigh Acres Hospital is considerably closer, being 24 miles away, but Mr. Akins has had little success in having the indigent patients he serves admitted there. Instead, he refers to Naples since the patients are treated with the same dignity and decency as paying patients at that hospital. In excess of 50 per cent of the patients he refers from the primary health center to Naples never pay anything for the services received. Approximately 30 per cent of the non-emergency patients referred to Naples annually are pediatric referrals. About 30 per cent of the emergency referrals are also pediatric patients. Four hundred to four-hundred fifty non- emergency patients annually are obstetric patients who come to full term and are delivered. It is unlikely that any of the pediatric patients would be referred to a hospital, such as the proposed Community facility, which does not have a discreet pediatric unit with a specialized staff and equipment, since the primary care center in Immokalee has the capability of treating any overnight, routine pediatric problem itself, and any pediatric patient that cannot be handled on a one-day admission at the facility, can be sent to the discreet, specialized pediatric unit at Naples Community Hospitals which Community of Collier will not offer. The standard procedure at Naples Community Hospital for admitting patients who do not have a private physician or a private physician referral, is nondiscriminatory. That is, in the triage process, when a patient arrives at the emergency room, for instance, only the patient's name, address, age, date of birth and questions eliciting his medical status are asked upon his arrival. Depending on the nature of the injury involved, the on-call medical specialist for that type of injury is then summoned to the emergency room. If it appears necessary to admit the patient to the hospital, the on-call specialist authorizes the admission. When the admission determination is made, there is no information available on the admitting documents and no questions are asked to indicate whether the patient is a paying patient, a nonpaying migrant worker, an insured patient, or a Medicare patient. Naples presently has a labor and delivery area with a birthing room and a three-stage cohort type of nursery. Infants move through three different stages in the nursery depending on age, so as to reduce infections. Seventeen of the 24 beds on the floor are designated as OB beds. Whenever more than 17 patients must use that floor, they are able to expand to gynecological medical surgical beds on the same floor which thus gives a total capacity for OB patients of 24 beds. The OB services as proposed by Community are essentially duplicative of the services in existence at Naples Community Hospital, although with a less intensive level of care for 08 and pediatric patients. Essentially all the other services proposed by Community duplicate these services already available to area residents at NCH and the other pertinent hospitals. Thus, it is apparent that if Community's facility is located where proposed, it will actually serve an area that is more elongated north to south rather than east to west, and will in reality serve the more affluent, private- paying patient origin areas lying in west-central and northwest Collier County. The reason for this is that most of the indigent patient population will bypass Community of Collier's Hospital and go to Naples for the above delineated reasons, and Community would then tend to draw patients from the more populated, wealthier areas on a north-south line from the Naples area up to and across the Lee County line rather than on an east-west axis. The fact that Community/NME would serve primarily privately-paying patients is exemplified by the fact that NME's other Florida hospitals typically have no (or very minimal) Medicaid patient days, such that that parent company's policy is not one of encouraging service to Medicaid or indigent patients. It is thus apparent that with the advent of Community/NME's hospital that there would be created two different patient bases or patient markets, with Naples continuing to serve the vast majority of the indigent, Medicaid, or bad- debt patient base. Community/NME would garner its patient base largely from private-paying, more affluent patients with substantially less bad debt ratio. This would siphon off much of Naples's private paying base, such that, with its already slim or sometimes nonexistent profit margin, its financial viability would become more and more in doubt. This would raise the alternative mentioned above of either raising its rates substantially, causing health care costs for the consuming public to rise significantly, seeking relief from the taxpayers of Collier County, or curtailment of available services to indigents and all other patients, especially GE and pediatrics; possibly even all three cost coverage alternatives. Such an eventuality would ultimately result in a reduction in the quality of health care afforded the patient public. NAPLES AVAILABLE AND PROPOSED SERVICES Mr. Mike Jernigan was tendered by NCH and accepted as an expert in health care planning and hospital financial management. Mr. Jernigan is employed as Director of Planning at Naples and prepared the instant Certificate of Need application seeking 30 beds. Naples has recently added 43 psychiatric beds under previously issued Certificates of Need. The instant application contemplates relocation of the 43 psychiatric beds to the fourth floor of a support building, there creating a discrete psychiatric care unit. Naples amended its request at hearing so as to seek 20 instead of 30 medical/surgical beds to be added to the space to be vacated by the 43 psychiatric beds. No significant construction will be required in the vacated space, rather semiprivate rooms will be converted to private rooms. The 1.7 million dollar project cost is chiefly attributable to the construction of the facility which will house the licensed 43 psychiatric beds. Thus, the reduction in the number of acute care beds sought from 30 to 20 will not significantly alter the 1.7 million dollar project cost. Naturally, the minor project costs attributable to installation of 10 acute care beds in the vacated, former psychiatric bed space will be lessened by an amount attributable to 10 beds. In any event, NCH has been demonstrated to have adequate financial resources to undertake the project outlined in its application and has those funds committed. Naples can add these 20 proposed beds and successfully operate them as a minor addition to its now feasibly operating acute care hospital. Naples has recently opened a free standing, primary care center called North Collier Health Center, in the vicinity of the proposed site of Community/NME's hospital. That facility includes a radiology room, laboratory and emergency medical service station, in addition to offering normal, primary care services. It is staffed 24 hours a day, seven days a week with a physician, but does not have inpatient beds. A similar primary care center has been constructed on Marco Island. Both of these centers have been added to Naples complement of facilities and services in implementation of a long-range health care expansion plan designed to make Naples' services more accessible and available to the public throughout its Collier County, southern Lee County service area. Given Naples low and sometimes non existent margin of revenue over expenses, the construction of these two facilities was rendered largely financially feasible through the donation of the land for both of them through community fund raising efforts, and the construction of the Marco Island facility was accomplished with entirely donated funds. The EMS substation at the North Collier Primary Care Center is operated and financed by the county, and the sleeping quarters at that sub station and at the Naples main campus facility for EMS personnel are provided free of charge at some financial loss to the hospital. Such an arrangement constitutes good health care planning, even though it results in some financial detriment to Naples, since it makes the emergency medical technicians immediately available to assist emergency patients who are transported to the primary care centers by their own means, and shortens the reaction time for emergency personnel since they are not located at separate locations from the hospital or primary care centers. These arrangements further Naples' long range goal in making its emergency primary care and primary care services more available and accessible to the public in its service area, which goal receives strong public support as evidenced by the large public donations which largely made the installation and operation of these facilities possible. Since Naples is a not-for-profit hospital, any excess of revenue over expenses it experiences is used to acquire new and needed equipment or expand facilities, including facilities and services such as these. The installation of Community/NME's hospital at its proposed locations especially, would duplicate the services offered at North Collier Primary Care Center and to a great extent those offered at the main campus of NCH in Naples. It was established through the testimony of Miles Price, an architect specializing in hospital design, that the construction costs, architectural costs and related inflation factors depicted in Naples' application are reasonable and accurate with regard to the relocation and construction for the psychiatric beds, which are to be moved, and the installation of the 20 acute care beds proposed. Acquisition of equipment necessary for the operation of the 20 proposed beds will be financially assisted by its present shared purchasing arrangements, whereby it is able to obtain resultant discounts in acquisition of the necessary equipment needed for installation and operation of the new beds. BED NEED AND BED ALLOCATION Thomas Porter was tendered and accepted as an expert in health care planning in Florida. Subpart (23) of Rule 10-5.11, F.A.C. is the acute care bed need determination methodology. It is the policy of HRS in accordance with the legal mandate referenced herein to facilitate the use of subpart (23) of the rule by regularly compiling and disseminating district bed need information, including that depicted in Community's Exhibit 16, which includes a memorandum from Phil Rond, the Administrator of the Office of Comprehensive Health Planning of HRS. If the formula at subpart (23) of the above rule is employed using historical utilization data from the years 1981 through 1982, a net bed need of 375 for all of District VIII results and that is the current bed need status of the district advocated by Community. However, as established by the memorandum from Mr. Rond incorporated in Exhibit 16, the most recent utilization data includes that for the year 1983, which is the most recent hospital reporting period envisioned by the formula and above rule. When the 1983 utilization data is added to the 1981-1982 information, a drop in total bed need for District VIII occurs from a figure of 4,147 beds to 3,654 beds. When licensed and approved beds are subtracted from that figure, a minus bed need results and District VIII has an excess of 118 beds. The rule formula at subpart (23)(g) dictates that the three most recent annual hospital licensure reporting periods must be used for the utilization data necessary to operate the need determination formula. 2/ The use of the most recent utilization data, including 1983, for District VIII causes the overall projected occupancy level contemplated in the methodology (at 10.5.11(23)(g)(2)) to fall below 75 per cent, when the bed need calculation is carried out to its conclusion. Given the projected occupancy falling below 75 per cent, the end result is that gross bed need in District VIII is 3,654 beds, rather than 4,147 beds as postulated by Community. Community contends that the 1983 utilization data should not be used since it was not available for Districts I and II and should not be used for any district until it is available and disseminated for all districts 3/ The reason the department promulgated Mr. Rond's special memorandum with regard to the bed need projections for District VIII, was to alert users of that information that in that particular district the drop in the most recent utilization data triggered the rule mechanism of subpart (23)(g)(2) because it revealed that the overall projected occupancy levels would fall below 75 per cent, all of which showed on a district-wide basis an over-bedding of 118 acute care beds. Mr. Larry Bebe is Acting Executive Director and Planner for the District VIII Health Council. He was accepted as an expert witness in health care planning and public health administration. Mr. Bebe considers the local health council plan to be a valuable planning tool for purposes of allocating beds in District VIII on a less than district-wide basis. The plan was adopted in March, 1984, but has not yet been adopted as a rule by HRS. According to the District VIII Health Council Plan, that district is sub-districted by counties, except for Glades and Hendry Counties which are combined in a two-county sub- district. This form of sub-districting has been done for approximately seven years. District VIII is sub-districted on a county basis rather than on other geographical boundaries, because population data, useful in planning allocation of beds, is only available in the form of county-based population projections by age-specific cohorts from the Bureau of Economic and Business Research at the University of Florida (BEBR). Further, in considering the location of existing hospitals, the greatest proportion of people in the seven county area of District VIII can be located within a reasonable time and access to health care services by allocating the beds on a county sub-district basis. The population data promulgated by the BEBR is employed by HRS, is generally accepted as authoritative in Certificate of Need proceedings, and is herein. It is not available by age-specific cohort in the census tract geographical subdivisions attempted to be used by Community in 4 in delineating its purported service area. 4/ Performance of population based health care planning must be done consistently and future need must be projected based upon preparing utilization rates predicated on the same population geographical area each time. A common geographical basis for allocation of beds, such as counties, is most appropriate since that is the basis on which the most accurate population data is available. The bed allocation methodology used by the local health council to allocate beds by county sub-districts is contained in Naples Exhibit No. 35. Bed allocation on a county sub-district basis is determined by taking the overall bed number available from the state methodology rule formula and breaking it down into county sub-districts according to the District VIII health plan methodology. This methodology takes into account existing hospital utilization and location, changes in population, and projected patient days. All items of information to operate the allocation formula are obtained on a county basis. Under the District VIII health plan methodology, when existing beds are subtracted from needed beds, a projected need for 20 medical/surgical beds in Collier County results with an excess of 41 existing beds in Lee County for the horizon year of 1989. Mr. Porter corroborated Mr. Bebe's testimony and established that, although not adopted by HRS rule, the sub-districting of District VIII by county for health planning purposes conforms with HRS policy in terms of population and geographical criteria and constitutes a reasonable and rational health planning tool. The methodology used by the local health councils to allocate beds to the counties incorporates standard, accepted health planning practices and HRS' policy is not to interfere with that allocation of beds on a sub-district basis, so long as the subdistricting allocation does not exceed the bed need number for the district as a whole. Mr. Porter demonstrated that it is possible under the state Subpart (23) methodology to find no need or excessive beds at a district level, however, by applying the local health council methodology a positive mathematical need might be shown in one or more county sub-districts. Thus, it has been shown that the local health council allocation method which reveals a 20-bed need for Collier County is the result of a rational, standard, accepted health planning practice with regard to determining projected bed need on a less than district- wide basis. However, although that methodology shows a formula-based "need" in Collier County, the above findings reflecting the severely declining utilization experience in Collier County at NCH, together with its already scant operating ratio, when considered with the future effect on its utilization rate caused by the advent of Gulf Coast Hospital, show that no true need for any beds exists. Bed need projections are not the only pivotal considerations in determining entitlement to a CON. Brown and Kendall Lakes Hospital, Inc., Humana, Inc. d/b/a Kendall Community Hospital v. HRS, 4 FALR 2452A, (Final Order entered October 6, 1982).
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED: That the application for a Certificate of Need submitted by Community Hospital of Collier, Inc. for 150-beds for northern Collier County be DENIED, and that the application for a Certificate of Need submitted by Naples Community Hospital, Inc. for the addition, as amended, for 20 beds be DENIED, and that, in view of the application involved in Case No. 84-0909 having been withdrawn, that that case be CLOSED. DONE and ENTERED this 16th day of August, 1985 in Tallahassee, Florida. P. MICHAEL RUFF 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 16th day of August, 1985.
Findings Of Fact Respondent St. Augustine Artificial Kidney Center, Inc. (AKC) filed an application for a certificate of need with Respondent Department of Health and Rehabilitative Services (HRS) on June 2, 1980, to construct and operate an eight-station outpatient free standing hemodialysis center at St. Augustine, Florida, for an estimated capital expenditure of $144,650. Petitioner University Hospital Academic Fund, Inc. (Academic Fund) also filed an application with Respondent on June 16, 1980, to construct a similar facility at St. Augustine, with a proposed project cost of $138,131.64. The Academic Fund application stated that it was in the process of incorporating a separate entity to operate the proposed facility. By letter of July 28, 1980, the Academic Fund informed HRS that it planned to form a new corporation named St. Johns Renal Services, Inc. to operate the facility and that any certificate of need which might be granted should be issued in the name of that corporation. However, no such corporation has yet been formed. (Testimony of Goldberg, Exhibits 1-2) The two applications were comparatively reviewed by the Health Systems Agency of Northeast Florida, Area 3, Inc. (HSA) during July 1980. The review consisted of evaluation at various agency levels and culminated in a determination by the HSA Board of Directors on July 24, 1980, that the application of the Academic Fund should be recommended to HRS for approval. The HSA reports on the two applications were transmitted to HRS by a letter of Fred J. Huerkamp, Executive Director of the HSA, dated August 7, 1980. Although the HSA Board of Directors did not specifically vote to deny the application of AKC, the HSA report on the AKC application stated that inasmuch as the Board of Directors had adopted the recommendations of its Health Needs and Priorities Committee recommendations to approve the Academic Fund application, it had also adopted the implicit denial of the AKC application by the committee. The HSA report itself recommended denial of the AKC application. The HSA found that there was a need for an eight-station dialysis facility in St. Augustine under its Health Systems Plan because only three such dialysis facilities are located in the applicants' proposed service areas, two of which are in Jacksonville and one in Daytona Beach, thus necessitating considerable present travel to prospective patients residing in St. Johns County and contiguous portions of adjacent counties. One of the Jacksonville facilities is an inpatient unit at University Hospital. The HSA also found that the two applicants were virtually equal with respect to probable quality of service, financial resources, and costs of operation. The HSA decided that the Academic Fund application should be approved because funds received for operation of the facility could, in part, be utilized to enhance the overall patient care capabilities of University Hospital, particularly with medical staff teaching expenses. The Academic Fund is a nonprofit corporation which provides a billing service for professional fees of the physicians who are salaried employees of University Hospital and who participate in a University of Florida teaching program there. The organization is comprised of these physicians and operates in a manner similar to a medical group practice plan. A percentage of fund assets are donated to University Hospital to support its teaching program. The hospital is a tax-supported indigent care facility. (Testimony of Dewberry, Goldberg, Huerkamp, Exhibits 1- 3) The two competing applications also were reviewed by the Florida End Stage Renal Disease Network 19, Inc., (Network 19) , a federally funded organization under the Department of Health and Human Services which performs a planning function to determine the need for new or expanded services with respect to dialysis and kidney transplants in Florida. It makes recommendations to the federal Health Care Finance Administration in such matters for determination of eligibility of a provider for participation in the Medicare and Medicaid reimbursement programs. By agreement with HRS, Network 19 also provides review and recommendations as to certificate of need applications submitted by proposed dialysis facilities. HRS considers such recommendations during its certificate of need review process as "other pertinent data" under Rule 10-5.10(5), F.A.C. On July 29, 1980, Network 19 transmitted its recommendation to HRS which stated that although it had found both applications to be essentially equal under the Network's review criteria and standards, AKC was chosen over the Academic Fund in light of the fact that it had submitted the first application and because of its expected greater cost efficiency of operation. The organization projected a need for eight dialysis stations in St. Augustine by mid-1982. The basis for the finding that AKC would be more cost efficient was that the AKC application projected a profit during the first year of operation whereas the Academic Fund application indicated a deficit for the initial year. (Testimony of Moutsatsos, Hudson, Exhibit 4) HRS reviewed the two applications, together with the recommendations of Network 19 and the HSA, and determined that the AKC application should be approved. By a letter of October 3, 1980, the Administrator of HRS' Office of Community Medical Facilities transmitted a certificate of need to AKC, subject to any request for a hearing filed pursuant to Chapter 10-5, F.A.C. By letter of the same date, the Administrator advised the Academic Fund that its application had not been favorably considered because the proposed project did not demonstrate "favorable feasibility" when compared with the financial aspects of the AKC proposal, and that it presented a less favorable alternative method of providing services in St. Augustine. The Administrator also informed the HSA by letter of the same date that the HSA recommendation had been rejected for reasons contained in an attached "State Agency Report." Both the Academic Fund and HSA thereafter filed appeals of the HRS decision. (Exhibits 1-3) The HRS medical facilities consultant, Nancy E. Hudson, who reviewed the applications and made the initial staff recommendation, favored the AKC proposal as being more financially feasible in that it planned to charge the Medicare "screen" or maximum of $138 per treatment, as opposed to the Academic Fund's plan to charge $133, plus a $5 laboratory fee. She was of the opinion that the Fund's proposed charges would be less cost effective because experience showed that laboratory fees would normally exceed $5, and thus require either an additional charge to patients or obtaining an exception to the Medicare "screen." She further found that AKC had considerable experience in the field of free standing dialysis facilities since its principals operated several other facilities in Florida, whereas the Academic Fund had not involved itself in such an enterprise apart from its members' participation in the dialysis unit at University Hospital. Although Hudson recognized that the Academic Fund's proposal stated overall lesser project costs, she testified that she could not adequately assess the resources of the applicant, particularly due to the fact that it had indicated its intention to form a new corporation to operate the facility. She also felt that competition in the area would be adversely affected if the Academic Fund, which was affiliated with University Hospital, was granted approval to set up the facility at St. Augustine. The Administrator of HRS' Office of Community Medical Facilities accepted the staff recommendations and approved the AKC application. He, too, was of the opinion that the AKC experience factor was important and placed reliance on the recommendations of Network 19, even though he did not view the fact that AKC had filed its application first to constitute a valid reason for preference. (Testimony of Hudson, Forehand, Exhibits 1-3) AKC plans to spend $144,650 to establish its proposed facility and begin operations, whereas the Academic Fund intends to allocate $138,131.64 for its project. AKC estimates a first-year net income of $16,476, while the Academic Fund estimates a first year net loss of some $42,000. Financial statements submitted by both applicants show that they will have sufficient financial resources to meet the projected initial costs of establishment and operation of the planned facility. AKC shows a proposed cost of $35 for supplies per treatment and the Academic Fund estimates a $50 per treatment cost of supplies. The difference in expected costs is explained by the fact that AKC intends to obtain bulk negotiated discount prices from various manufacturers as its principals have done in past operations, compared to the Academic Fund's plan to seek out the "best list" prices it can obtain. AKC plans to purchase necessary equipment in the amount of an estimated $115,350, but the Academic Fund plans to expend only $96,105. The discrepancy between these figures is, in part, based upon the fact that AKC plans to install individual television sets at each dialysis station which it considers essential for the comfort of patients. Additionally, the Academic Fund plans to purchase generally less expensive equipment for its facility than does AKC. AKC believes that for essentially the same treatment costs, it will offer a better center for patients, and that efficiency in controlling costs will maintain a high quality of care. The Academic Fund is somewhat pessimistic concerning the number of patients who will use its services during the first year, thus providing a basis for the anticipated first-year loss in revenues. Approximately fifteen patients in the proposed service area reasonably can be expected to transfer to a facility in St. Augustine. However, the Academic Fund expects to gradually acquire about three to twelve patients during its first year of operation, whereas AKC estimates that it will have some twelve patients at the outset, primarily due to the accessibility of the new facility. (Testimony of Levy, Dewberry, Anderson, Cunio, Exhibits 1-4) The applicants have made satisfactory arrangements for ancillary services, including acute backup, kidney transplant, and home training services with qualified medical facilities. Both plan to use University Hospital at Jacksonville as a backup hospital and Shands Teaching Hospital at Gainesville for any necessary transplant services. The Academic Fund intends to use University Hospital for home training services and AKC will utilize Dialysis Clinics, Inc. of Jacksonville. Both applicants plan to have a nephrologist available at the facility and other personnel staffing proposed is sufficient for proper operation. AKC plans to utilize a smaller staff than the Academic Fund, thus reducing expenses. (Testimony of Levy, Dewberry, Anderson, Cunio, Exhibits 1-3) Both of the applicants reasonably can be expected to offer a satisfactory quality of care in the operation of a dialysis facility. Academic Fund will draw upon its staff of experienced physicians who operate the 24- station unit at University Hospital. Their association with the Hospital assures ready access to that "backup" facility in the event of acute need. Both applicants plan to use the two local St. Augustine hospitals for routine hospitalization requirements. AKC's principals, Doctors Cunio and Anderson, have had extensive experience in the ownership of free standing dialysis facilities. Dr. Cunio is the Director of the Mercy Hospital Dialysis Unit in Miami and has had a close affiliation with the South Florida Artificial Kidney Center and Dade Dialysis Center in Miami. Dr. Anderson is the Medical Director of the South Florida AKC and its satellite unit in Fort Myers. He has been affiliated in the management and direction of the Dade Dialysis Center, Hialeah Dialysis Center and Indian River Artificial Kidney Center in Stuart. He is also the operator and owner of Suncoast Artificial Kidney Center in Naples. The South Florida Artificial Kidney Center was commended by the Mayor of Metropolitan Dade County, Florida, in 1977, in a proclamation that November 7th of that year would be "South Florida Artificial Kidney Center Day," in recognition of its ten years of success in the treatment of patients. Although the University Hospital dialysis unit received an unfavorable report as the result of a state Medicare survey in 1980, the deficiencies were primarily housekeeping in nature and did not directly reflect unfavorably upon the quality of medical services provided to patients. (Testimony of Dewberry, Cunio, Anderson, Exhibits 1-2, 5-0)
Recommendation Case No. 80-2137: That the petition of the Health Systems Agency of Northeast Florida, Area 3, Inc. be DISMISSED. Case No. 80-2138: That the application of St. Augustine Artificial Kidney Center, Inc. for a certificate of need to establish an eight-station free standing dialysis center in St. Augustine, Florida be APPROVED, and that the competing application of the University Hospital Academic Fund, Inc. for a similar facility be DENIED. DONE and ENTERED this 14th day of July, 1981, in Tallahassee, Florida. THOMAS C. OLDHAM 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 14th day of July, 1981. COPIES FURNISHED: Honorable Alvin J. Taylor, Secretary Department of HRS 1317 Winewood Boulevard Tallahassee, Florida 32301 Eric J. Haugdahl, Esquire Assistant General Counsel Department of HRS 1317 Winewood Boulevard Tallahassee, Florida 32301 Eleanor Hunter, Esquire 702 Lewis State Bank Bldg. Post Office Box 471 Tallahassee, Florida 32301 E. G. Boone and Richard Whitton, Esquires 1001 Avenida del Circo Post Office Box 1596 Venice, Florida 33595 Health Systems Agency of Northeast Florida, Area 3, Inc. 1045 Riverside Avenue, Suite 260 Jacksonville, Florida 32204
The Issue The issue presented is whether the application of Respondent Adventist Health System/Sunbelt, Inc. d/b/a East Pasco Medical Center for a certificate of need to add 24 acute care beds to its existing facility should be approved.
Findings Of Fact The Seventh Day Adventist Church owns Respondent Advent-ist Health System/Sunbelt, Inc. That corporation, which occupies a strong financial position, operates not-for-profit hospitals in several states, including Florida. One of the Florida hospitals is East Pasco Medical Center (East Pasco), located in Zephyrhills. Zephyrhills is in eastern Pasco County, which, for health planning purposes, is known as Subdistrict 2 of District 5. East Pasco is an 85-bed acute care hospital which provides most of the common services found in a community hospital. In addition to providing general acute care and obstetrics (OB), it has an intensive care unit (ICU) and offers neurosurgery and kidney dialysis services. East Pasco also has completed but not yet opened an 11-bed skilled nursing unit (SNU) and a 10-bed observation unit. The 11 beds in the SNU and the 10 beds in the observation unit are in addition to the 85 acute care beds for which East Pasco is licensed. For licensure purposes, acute care beds are not divided into types of service. East Pasco's current configuration for its 85 acute care beds is as follows: 68 medical-surgical beds, 8 ICU beds, and 9 OB beds. East Pasco has an active emergency room which experiences up to 30,000 visits per year. East Pasco obtains approximately 55 percent of its in-patient admissions through its emergency room. East Pasco is accredited by the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO). Petitioner Humana of Florida, Inc. d/b/a Humana Hospital Pasco (Humana) is an existing 120-bed acute care hospital in Dade City. It is situated approximately 10 minutes away from East Pasco. Humana provides the same services that East Pasco provides, including medical-surgical, ICU/CCU, OB, kidney dialysis, and neurosurgery. Like East Pasco, Humana is accredited by the JCAHO. However, Humana's accreditation is "with commendation", the highest rating given by the JCAHO. Like East Pasco, Humana has a large medical staff, primarily consisting of physicians who have their offices located in Zephyrhills or Dade City. The medical staff rosters of Humana and East Pasco are virtually identical. Dade City is also located in east Pasco County, and the primary service areas of Humana and East Pasco are virtually identical. Like East Pasco, Humana serves the Medicaid and indigent patient populations. In its fiscal year 1991, Humana provided 6 percent of its patient days to Medicaid patients. In fiscal year 1992, that increased to 8.8 percent, the same as East Pasco. Humana's Medicaid patient days increased substantially with the introduction of OB services at Humana since Medicaid patients receive primarily OB services. East Pasco has been designated as a disproportionate share provider under the State's program to give economic incentives to hospitals serving a certain percentage of Medicaid patients. East Pasco also serves the indigent patient population pursuant to a contract between it and Pasco County. In September, 1991, East Pasco filed its application for a certificate of need (CON) requesting approval for 24 additional medical-surgical beds (acute care beds) for the July, 1996, planning horizon. In January, 1992, the Agency notified East Pasco of its intent to approve the application and issue to East Pasco CON No. 6783. Humana filed this challenge to the Agency's intent to grant the application, and this proceeding ensued. All parties subsequently stipulated that Humana has standing to initiate and maintain this proceeding and that Humana was not obligated to present evidence of its standing. East Pasco has proposed a new unit to house the 24 additional medical- surgical beds to be located on the third floor of a new three-story tower. That third floor would consist of 13,000 gross square feet (GSF), would cost $4,087,810, and would consist of only private rooms with three nurse stations. East Pasco proposes no new services, only additional beds. Construction of the three-story tower has not yet commenced but is awaiting the outcome of this proceeding. The first floor of the new tower will be a wellness center, a project which did not require CON review. The second floor will house a new ICU. East Pasco presented conflicting evidence as to the size of that new ICU. The Agency approved East Pasco's second floor ICU as a 12-bed ICU with a cost below the threshold cost which would have required CON review. In spite of the exemption from review obtained by East Pasco, it is specifically found that East Pasco intends to place a 16-bed ICU on the second floor of the yet-to-be-constructed tower. Thus, East Pasco would achieve its 16-bed ICU by relocating its existing 8-bed ICU and converting other beds to ICU beds. Thus, if the 24 new beds sought are approved they will produce 16 additional medical-surgical beds and 8 additional ICU beds. Resolution of the number of beds proposed for the second floor of the new tower is required in this proceeding for two reasons. First, the cost of this project is impacted. If 8 of the new beds are to be used as ICU beds rather than as medical-surgical beds, they will be more expensive to construct and equip. Second, corporate approval of corporate projects is a prerequisite in Florida's CON process. East Pasco's Board of Directors met on August 14, 1991, to authorize the filing of this application. This application proposes 24 medical-surgical beds, the corporate resolution filed with the Agency authorized 24 acute care beds, but the minutes of the Board's meeting reflect that the Board itself approved 24 beds for ICU and PCU services. Although ICU, PCU, and medical-surgical beds are all acute care beds, they are constructed, equipped, and staffed differently. For the reasons described below, there is no need in District 5 or in the east Pasco County Subdistrict for East Pasco's proposed 24 additional medical-surgical beds. Rule 59C-1.038, Florida Administrative Code, includes the numeric need methodology for projecting acute care bed need. Under that Rule, applications for acute care beds will "not normally" be approved unless there is numeric need. For the September, 1991, application batching cycle, the Agency published a fixed need of zero acute care beds needed in District 5, Subdistrict 2, which is composed of only East Pasco and Humana hospitals. This fixed and published need of zero was not challenged. Per paragraph (7)(d) of the Rule, additional acute care beds will "not normally" be approved unless the subdistrict occupancy is at or exceeds 75 percent. All parties agree that calendar year 1990 is the proper period to ascertain whether this standard is met. In 1990, the acute care bed occupancy rate in the Subdistrict was 55.33 percent. The parties agree that the Rule's occupancy standard is not met. Therefore, no additional beds should normally be approved. There is ample unused capacity in District 5 and in the Subdistrict to meet acute care demand. Humana's occupancy is well below 50 percent. In years and 2 for the proposed unit, East Pasco projects 1,042 and 1,760 patient days, respectively. Humana has sufficient unused capacity to accommodate that projected demand. Utilization trends support the lack of need shown by the need methodology and the occupancy standard. Acute care utilization in the Subdistrict has decreased since 1986. In 1986, the two Subdistrict hospitals generated 42,830 patient days, a 57.2 percent occupancy. In 1991, notwithstanding population growth in the Subdistrict, the two Subdistrict hospitals generated 41,756 patient days, a 55.8 percent occupancy. Clearly, then, there is no increased demand for acute care services, but only a reshuffling of market share between the two hospitals. Contrary to East Pasco's suggestion, first quarter utilization does not show need and has, in fact, been decreasing. For example, the first quarter (January-March) of 1986 generated 13,572 patient days in the Subdistrict, a 73.6 percent occupancy; in the first quarter of 1992, there were 12,482 patient days, a 66.9 percent occupancy, the lowest first quarter utilization in the last 6 years in the Subdistrict. Additionally, the average length of stay (ALOS) in the Subdistrict continues to decline. In the first quarter of 1991, the ALOS was 5.4 days; in the first quarter of 1992, the ALOS was 5.1 days. Accordingly, although East Pasco shows an increased number of admissions over the last several years, the continued decline in the ALOS has resulted in a decreasing number of patient days. The population growth in the Subdistrict is not so substantial as to demonstrate need. Humana relied upon population projections produced by a national firm specializing in demographic analyses. Such a population data source is generally more reliable than a county's own projections, relied upon by East Pasco. The Subdistrict is growing but not at an extraordinary pace. In comparison, the West Pasco Subdistrict is growing faster. There are no geographic access problems to receiving acute care services which would support a finding of need. There are many hospitals available and accessible to residents of the Subdistrict within 30 minutes travel time or less. The entire Subdistrict is within a 30-minute travel time of Humana and of East Pasco. Most of the Subdistrict is also within 30 minutes travel time to other acute care hospitals, including University Community Hospital in Tampa, Lakeland Regional Medical Center in Lakeland, and South Florida Baptist Hospital in Plant City. The Zephyrhills area in particular is within 30 minutes travel time to those other facilities. Humana is an available alternative to the proposed project. Humana is geographically accessible to the entire Subdistrict, provides all the services that East Pasco provides, and provides good quality of care. Humana's medical staff roster includes the same physicians that practice at East Pasco. Humana already serves the same geographic service area that East Pasco serves. Indeed, several East Pasco witnesses testified that patients are transferred to Humana when East Pasco is full, thereby acknowledging Humana as an alternative for Subdistrict residents. Hospitals situated outside the Subdistrict are also available and appropriate alternatives to the proposed project. These hospitals have unused capacity to accommodate the projected demand from the Subdistrict. Notably, residents of the Subdistrict have historically greatly utilized hospitals located outside the Subdistrict. In 1990, 63.7 percent of the Subdistrict's residents went to a hospital other than Humana or East Pasco. Thus, physicians and residents regard hospitals situated outside the Subdistrict as appropriate and viable alternatives. Since East Pasco does not propose to offer any new service, and since there is accessible unused capacity at Humana and these other facilities, there are better alternatives to adding new beds at East Pasco. In addition, although approving more beds at East Pasco would improve availability of services at East Pasco, such is not a planning consideration or a review criterion. East Pasco and Humana provide similar levels of Medicaid care. In calendar year 1991, Medicaid comprised 8.8 percent of all patient days at East Pasco, less than in 1990. From September, 1991, to August, 1992, 8.8 percent of all patient days at Humana were Medicaid days. The two hospitals also provide similar amounts of indigent care. Therefore, Humana is economically accessible to all residents of the Subdistrict. Facilities located outside the Subdistrict also are economically accessible. Physician preferences are not significant in formulating conclusions of need on a District or Subdistrict basis. Physicians may well have their own reasons for doing things which may be contrary to sound health care planning principles. Further, physicians' personal preferences are not relevant to ascertaining how existing resources can be best and most efficiently used. The acute care bed Rule provides that additional beds "may" be approved at a specific facility if its occupancy exceeds 75 percent even though no beds can be authorized pursuant to the mathematical calculations established by the Rule. While East Pasco achieved an occupancy rate of 78.78 percent in calendar year 1990, that statistic merely "opens the door" for an evaluation of whether there are compelling circumstances to justify the approval of beds at a specific facility despite the absence of need demonstrated by the acute bed methodology. There are no factors or circumstances which would justify the approval of 24 additional medical-surgical beds at East Pasco pursuant to the specific facility provision. First, there are accessible and available alternatives for meeting projected demand. The majority of east Pasco County residents outmigrate even when beds are available at East Pasco. There is an excess capacity in the Subdistrict and in the District. Second, East Pasco's application discusses seasonal overcrowding due, in large part, to using in-patient beds for "observation" patients. Observation patients are those with a hospital stay of less than 24 hours. East Pasco has recently completed a new 10-bed observation unit. In 1991, East Pasco averaged observation patients per day; therefore, this new 10-bed unit will ease the strain on East Pasco's in-patient beds. Third, East Pasco's application relies on the "overflow" of patients in the winter season to justify its proposed bed addition. The actual amount of "overflow" is reflected in East Pasco's transfer log, which shows that there were not that many patients transferred in 1991. In fact, there were several months in which there were zero transfers. Fourth, the proposed beds are only intended to handle "seasonal" population demands. The proposed unit would not be open year-round. East Pasco was below 75 percent occupancy from May to October, 1991. East Pasco acknowledges that the proposed beds are only for part of the year and are intended to accommodate the demands of the seasonal population, who are not necessarily residents of the Subdistrict. East Pasco's application in reality requests approval for adding 24 beds at a cost of over $4,000,000 to accommodate, by East Pasco's own projections, an average daily census of three patients the first year and five patients the second year in a unit that would be closed at least six months out of each year. That is an excessive expenditure to provide access to relatively few people, where access to nearby facilities exists. Although East Pasco has shown that on certain days it has exceeded its OB capacity, and although East Pasco maintains that its most common capacity problem is the lack of available ICU beds, East Pasco's application itself does not suggest that it intends to increase the number of OB or ICU beds. Further, although on certain days East Pasco has experienced over 100 percent occupancy and has placed patients in the hallways, that situation can be obviated by referring patients to other hospitals, and the situation will be alleviated when East Pasco soon opens its additional 10-bed observation unit and 11-bed SNU. East Pasco has, therefore, shown that it has an occupancy rate sufficient to entitle it to review despite the lack of need under the acute care bed Rule, but it has shown no other reasons why its application should be approved. The Florida State Health Plan includes various preferences for reviewing CON applications. On balance, the East Pasco application is not consistent with that Plan. The first group of preferences relates to the addition of hospital beds. The first item in that group provides that no additional beds should generally be approved unless the subdistrict occupancy is at or exceeds 75 percent or unless the applicant-facility is at 80 percent. Since calendar year 1990 data was used to calculate the need formula and Subdistrict occupancy standard, it is appropriate to use that same data to determine East Pasco's occupancy for evaluating this preference, rather than using two different time periods as the Agency did. In 1990, the Subdistrict was below 75 percent, and East Pasco's occupancy was below 80 percent. Therefore, this preference is not met. The second item under this group provides that "in the event that acute care bed need is shown", preference shall be given to an applicant who provides a disproportionate share of Medicaid and indigent services in the Subdistrict. This preference is not met since no "acute care bed need is shown". The next group of preferences is entitled "transfer and conversion of acute care beds". Because East Pasco does not propose to transfer or convert acute care beds, East Pasco does not satisfy any of the preferences included under this grouping. The next group of preferences is entitled "indigent care". The first item provides that preference shall be given to an applicant who provides a disproportionate share of Medicaid and charity care in relation to other hospitals in the District or Subdistrict. This preference is not met. Although East Pasco has historically provided more Medicaid and indigent care than Humana, there is no showing that East Pasco will provide disproportionately more Medicaid and indigent care for medical-surgical services specifically. Most of East Pasco's Medicaid participation is for OB and newborn services, not medical- surgical services. Both Humana and East Pasco provide less than 1 percent of their gross revenues for indigent care. Given that most of the Subdistrict population is elderly, indigent care is not a major issue. Also, it was stipulated that East Pasco does not know how much indigent care it provides for medical-surgical services only. The second item under this group relates to whether CON approval would negatively affect the financial viability of a disproportionate share hospital. This preference is not relevant to East Pasco's application. The third group of preferences is entitled "emergency services". The first item relates to the applicant's record of accepting indigent patients for emergency care. East Pasco presented no information on this in its application except for its proof that it has a contractual obligation to do so. The second item relates to whether the facility/applicant is a trauma center. East Pasco is not a designated trauma center. The third item relates to whether the applicant demonstrates a full range of emergency services. East Pasco did not address this in its application. The fourth item addresses whether the facility has ever been fined by HRS for violations of emergency services statutes. East Pasco did not address this item in its application. Therefore, East Pasco does not meet the preferences in this group. The fourth group of preferences is entitled "teaching, research, and referral hospitals". The application does not address these particular preferences, and East Pasco does not hold itself out as a teaching, research or referral hospital. Therefore, East Pasco does not satisfy the items under this grouping. The fifth group of preferences is entitled "specialized services". East Pasco does not propose to provide any specialized services and, therefore, items under this grouping are not satisfied. The District 5 Local Health Plan includes recommendations for reviewing CON applications. On balance, the East Pasco application does not satisfy that plan. The first preference relates to whether the applicant provides a disproportionate share of Medicaid and charity care. For the reasons indicated above regarding the State Health Plan, this preference is not met. Further, East Pasco's application does not suggest that the 24 medical-surgical beds sought will enhance its Medicaid or indigent participation. The second recommendation provides that "if a numeric bed need exists as shown by the state bed methodology", preference is given to an applicant who has generated certain occupancy levels. Because no numeric bed need was shown per the Rule methodology, this recommendation is not met. The third recommendation relates to the transfer of existing acute care beds. Because East Pasco does not propose a transfer of beds, its application is not consistent with this recommendation. The fourth recommendation gives preference to applicants who document the cost-effectiveness and efficiency of their project. East Pasco does not satisfy this preference. East Pasco failed to show any cost efficiencies for its project. East Pasco proposes to spend over $4 million to serve, on the average, 3 to 5 patients per day in years 1 and 2. That is cost-inefficient. East Pasco did not prove that the charges or costs of providing medical-surgical services would be any less than what it currently charges. East Pasco's application includes two pro formas: a hospital-wide pro forma and an incremental pro forma for the proposed 24-bed unit. The person who prepared those pro formas did not testify, and the person who did testify did not participate in preparing the pro formas. Further, the witness only testified to the reasonableness of the incremental pro forma; he did not testify, directly or indirectly, regarding the hospital-wide pro forma. An incremental pro forma alone does not demonstrate long-term financial feasibility, even if the incremental pro forma were reasonable. An incremental pro forma alone does not reflect the project as a whole. At East Pasco, there are several projects and activities on-going or planned that must be evaluated. In addition to the existing 85 beds, East Pasco has underway: (1) opening a 10-bed observation unit; (2) opening an 11-bed SNU; (3) a planned wellness center on the first floor of the proposed 3-story tower; and (4) the planned relocation and enlargement of its ICU to the second floor of the proposed tower. Those projects add expenses, put strains on cash, and require debt. Without considering all the activity at the hospital, one cannot reasonably ascertain whether the proposed $4.1 Million third-floor project is financially feasible. For example, a small project could show an incremental profit but the hospital as a whole could lose money. East Pasco simply assumes that its 24-bed unit will be financially feasible in 1994 and 1995, years 1 and 2 of the project. The health care field is too dynamic and volatile for such assumptions. For example, East Pasco had an operating loss in 1990 but did well in 1991. By not analyzing the hospital-wide pro forma and proving its reasonableness, East Pasco did not show the required financial feasibility. It only demonstrated the results of one component of an entire operation. East Pasco has left unanswered the question of whether the facility as a whole will be able to finance this project in conjunction with all its other requirements. Further, the application lacked sufficient and clear presentation of the assumptions underlying the hospital-wide pro forma. Restated, the hospital-wide pro forma is not self-explanatory. The incremental pro forma, showing the proposed revenues and expenses for the 24-bed medical-surgical unit for years 1994 and 1995, is not reasonable. The projected revenues are overstated, and the projected expenses are understated. The assumptions underlying the financial projections are unreasonable. Further, the profit projections are unrealistic; in year two, East Pasco projects a profit of about $615,000 on an average daily census of less than 5 patients per day. On its face, that is unrealistic. In 1991, East Pasco generated 24,517 patient days, which was virtually the same as its 1990 utilization. In 1993, East Pasco projects 26,220 days. In year 1 of this project (1994), East Pasco projects 27,262 days hospital-wide, including the 1,042 incremental days associated with this project. Thus, in just a 3-year period, East Pasco projects almost 3,000 additional patient days, and even more for year 2 (1995). It is not reasonable to assume such an increase in utilization since utilization during the first quarter of 1992 declined from first quarter 1991. Therefore, patient day projections are overstated, thereby causing overstated projected gross revenue. East Pasco's projected daily charge is based on the hospital-wide average charge. It is not based on historical charges for medical-surgical services specifically. It is unreasonable to use charges for hospital services as a whole when the proposed project is for medical-surgical services only. Because the underlying assumption is invalid, projected revenues lack credibility. In calculating deductions from gross revenues, East Pasco assumed the hospital-wide payor mix and did not specifically ascertain the payor mix (and, therefore, the deductions) for medical-surgical services specifically. Again, this is an unreasonable assumption. Deductions from gross revenue should have been analyzed for medical-surgical services specifically. Due to the invalid assumption, the deductions from revenue figures lack credibility. East Pasco projects 5.8 FTEs for year 1 and 6.0 FTEs for year 2. East Pasco proposes to operate the 24-bed unit as an independent unit. These staffing levels are insufficient. East Pasco's proposed utilization equates to a 4.8 average daily census, which requires two nurses at all times. By East Pasco's admission, to staff a unit with two persons at all times throughout the year requires 9.2 paid nursing FTEs in addition to ward clerks and other support personnel. If the volume fluctuated and the census exceeded 7 or 8, more than two nurses would be needed. Thus, the 5.8 and the 6.0 FTE numbers are too low. The proposed staffing does not allow one RN to be on the floor at all times. To maintain one RN on the floor at all times throughout the year requires 4.2 FTEs; East Pasco budgeted for one. East Pasco does not have excess RNs available from its existing staff to cover the proposed addition. The supplies expense shown on the incremental pro forma was based on a hospital-wide average. The proposed project is for a specific service, and one cannot reasonably use a hospital-wide average instead. Accordingly, the calculation of expense for supplies is not reasonable. The pro forma includes an expense item entitled "other". East Pasco offered no explanation for that expense. Also, the pro forma did not include a line-item for the HCCCB indigent care tax, which is 1.5 percent of net revenue. East Pasco's proposed 24-bed medical-surgical unit will cover 13,000 GSF and will cost more than $4.1 million. All rooms will be private. The unit will have three nurse stations. According to East Pasco, the unit is to be a basic medical-surgical floor and is not intended to be a progressive care unit (PCU). This proposed design is not reasonable and is excessively large by at least 30 percent. This design is inefficient and, in reality, is not the design of a basic medical-surgical unit, but is instead the design of a PCU. There are three main reasons why the design is excessive. First, it is not necessary or reasonable to have all private rooms. A regular medical- surgical unit should have about an equal split of semi-private rooms. Notably, East Pasco's new 11-bed SNU has 5 private and 3 semi-private rooms for patients who will require hospitalization for up to 90 days. Second, these private rooms are almost twice the minimum size required by state licensure regulations. Third, three nurse stations are unnecessary; only one nurse station is needed for a basic 24-bed medial-surgical unit. East Pasco currently has 68 medical- surgical beds on 2 units, and each such unit has only 1 nurse station. The existing 68 medical-surgical beds at East Pasco average about 360 GSF per bed. The proposed 24 beds will average 542 GSF per bed. All private rooms and 3 nurse stations are, clearly, the design for a PCU. A PCU is a step- down unit from an ICU, which has high staff-to-patient ratios thereby requiring more nurse stations. East Pasco's projected construction cost for the 24-bed medical- surgical unit is $142.91 per GSF. This is unreasonably understated. It is uncontroverted that an SNU is less costly to construct than a medical-surgical unit. According to its projections, East Pasco's 11-bed SNU cost $171 per GSF in 1992. Clearly, that SNU cost is substantially greater than East Pasco's projected construction cost at issue. This inconsistency was never explained by competent evidence. In evaluating East Pasco's estimates, the Agency's architect relied upon 1991 Means construction cost data. He averaged the Means' medium figure ($123 per GSF) with the high figure ($172 per GSF) to derive a 1991 estimate of $147.50 per GSF. To that, one must add a 10 percent contingency factor, inflation, and an architectural fee. That totals $187.69 per GSF. The $187.69 projected figure is consistent with the 1992 SNU cost figure of $171. Thus, for construction costs alone, East Pasco underestimated by $44.77 per square foot, which is about $582,000. East Pasco proposed to construct a three-story tower; the third floor will house the proposed 24 medical-surgical beds. The second floor will house a 16-bed ICU, comprised of relocating the existing 8 ICU beds and converting 8 other acute care beds. East Pasco's application project costs only cover the third floor; East Pasco maintains the second floor is exempt from CON review and thus its cost is not relevant. As described below, East Pasco unreasonably failed to include costs of the second floor in its application. A hospital project costing $1,000,000 or more (other than an out- patient project) requires CON review. In its letter for exemption East Pasco states that the second floor would contain 12 ICU beds and cost $975,000 (calculated by multiplying 6,500 GSF by $150/foot). That letter is erroneous for several reasons: (1) the $150/foot is in 1992 dollars and does not include inflation; (2) the $150/foot does not include a 10 percent construction contingency fee, which is necessary and reasonable; (3) the $150/foot does not include an 8.4 percent architectural/engineering fee, which is necessary and reasonable; and (4) the $150/foot does not include any debt or financing fee. Including these necessary amounts alone shows that the second floor, in truth, exceeds the $1,000,000 threshold. Also, the cost for equipping an ICU bed is $45,000 per bed; for 16 beds, that is $720,000 for equipment. Surely the size and cost of a 16-bed ICU is different from and greater than a 12-bed ICU. East Pasco stated in its exemption request letter that the second floor would have 12 beds even though East Pasco intends 16 beds. East Pasco and the Agency correctly argue that the exemption given to East Pasco by the Agency for its second-floor ICU project is not part of the instant application and cannot be considered in this proceeding. However, the accuracy and reasonableness of the costs projected by East Pasco attendant to the 24 additional beds it seeks are an integral part of this proceeding, as is the scope of the project being reviewed and challenged. The second and third floor projects are, in truth, one project. It is East Pasco's intention to add 16 medical-surgical beds and 8 ICU beds to its facility. To establish the 16-bed ICU unit, East Pasco needs additional acute care beds; East Pasco does not have 8 available beds among its existing bed complement to convert to ICU purposes. The OB beds often run at 100 percent occupancy and, during the peak season, the medical-surgical beds run high occupancy. Thus, East Pasco cannot fully implement the second floor without approval of the proposed 24 new beds. There will be no community benefits in terms of charges if this application is approved. "Net revenues" must be the basis for comparing charges between facilities. Net revenues refers to what third party payors (such as Medicare, Medicaid, HMO/PPOs and most insurors) actually pay for hospital services as opposed to what hospitals charge. Few patients ever pay gross charges, particularly in the elderly East Pasco Subdistrict. In 1991, Humana's average net revenue per day was lower than East Pasco's. Humana's actual net revenue per admission in its fiscal year 1992 was $4,180. East Pasco's projected 1992 net revenue per admission is $5,301. Thus, for 1992, third party payors paid, on behalf of their patients, less per admission at Humana than at East Pasco. In its application, East Pasco projects an 8 percent per year increase in charges. An annual increase of 8 percent is not promoting charge-efficiency. East Pasco's application did not demonstrate cost-efficiencies resulting from approval, but rather, cost-inefficiencies. First, Humana would lose patient volume should East Pasco be approved. Humana currently receives transfers and direct admissions when East Pasco is full. Loss of patient volume would increase operating costs per patient day at Humana. Second, there is no need for additional beds in the Subdistrict. There is already excess capacity in the Subdistrict. Exacerbating excess capacity promotes cost-inefficiency. East Pasco admits the unit will not even be open six months out of the year because there is no need for it then. Third, East Pasco projects very low census in years 1 and 2, about 3 patients per day in year 1 and less than 5 patients per day in year 2. Spending over $4,000,000 to accommodate such low utilization is inefficient and unreasonable. Approval of East Pasco's application would not promote positive competition. There is competition now in the Subdistrict between Humana and East Pasco. East Pasco already captures a larger market share of the Subdistrict than Humana. Approving this application would only tip the scales more in favor of East Pasco and would adversely impact Humana's already poor financial condition. The quality of care delivered at Humana is very good. The JCAHO rates all acute care hospitals, and its rating is widely recognized in the hospital industry. The JCAHO evaluates many factors and components of a hospital. Humana is accredited "with commendation", the highest rating given. Only 5-6 percent of all acute care hospital in the country receive that highest ranking. Humana maintains a good utilization management program. Humana implements an excellent quality improvement plan, including soliciting and reviewing patient satisfaction comments. Mortality statistics cannot, by themselves, meaningfully measure the quality of care delivered at a hospital. Although the Health Care Finance Administration (HCFA) produces such a report for Medicare patients, the report itself represents that it is not intended to measure quality of care, and the American Hospital Association does not view HCFA mortality statistics as a measure of quality of care. There are many factors which influence mortality statistics at a hospital and, even more importantly, mortality is only one clinical outcome resulting from a hospital admission. When East Pasco is full, there is no medical problem or complication resulting from transferring patients to Humana or from directly admitting patients at Humana. There is no diminution of care or loss of continuity of care in transferring to or directly admitting to Humana. Emergency medical services are available in the Subdistrict, and, therefore, transfer is not a problem. Also, driving to Humana or to a hospital outside the Subdistrict is neither a problem nor an unusual circumstance. The large seasonal population drive to Florida in the winter, and, therefore, it is a mobile patient population. Most of its residents seeking hospital services receive them outside the Subdistrict. Subdistrict residents currently leave the Subdistrict to receive a variety of hospital services, including: in-patient cardiac cath, open heart surgery, Level II NICU, psychiatric services, substance abuse services, and comprehensive rehabilitation services. Thus, there is no merit to the suggestion that transferring patients from East Pasco to Humana or elsewhere is problematic. There would not be community benefits regarding Medicaid/indigent care by approving this application. As indicated, for all hospital services, Humana and East Pasco provide similar amounts of Medicaid and indigent care, although indigent care at both facilities is relatively insignificant. Therefore, access to Medicaid and indigent care does not provide a basis for approving East Pasco's application. Also, East Pasco's payor mix in its application was based on hospital-wide averages. East Pasco has not shown the amount of Medicaid or indigent care which would be specifically provided to, or which is needed for, medical-surgical patients. Finally, East Pasco's Policy and Procedure Manual includes several provisions requiring deposits upon in-patient admission absent verification of third party payor coverage. Such provisions are inconsistent with the proposition that East Pasco accepts all patients regardless of ability to pay. In Florida, an application for a CON must include a certified copy of an authorizing resolution of the applicant's Board of Directors. East Pasco included its corporate resolution in its CON application, that resolution being adopted at an August 14, 1991, meeting. That resolution clearly states, among other things, authorization to file an application for up to 24 additional acute care beds. The minutes of that meeting clearly reflect the Board's approval for 24 beds for ICU and PCU. The application itself requests approval of 24 medical-surgical beds. PCU, ICU, and medical-surgical beds are all types of acute care beds. Accordingly, East Pasco did file a proper corporate resolution consistent with the minutes and consistent with the application. The minutes and the application, however, are inconsistent. Although the corporation resolution is technically correct and fulfills the requirements for a CON application, the inconsistency among the corporate resolution, the minutes, and the application raised questions about the actual intent of East Pasco. The intent became more questionable during the final hearing when East Pasco's witnesses contradicted each other as to the number of beds to be placed in the to-be-constructed ICU on the second floor of the to-be-constructed 3-story tower. It is clear that the Agency only approved the construction of a 12-bed ICU on the second floor. It is also clear that East Pasco in fact intends to construct a 16-bed ICU on that second floor. It is also clear that East Pasco intends to construct a "medical-surgical" unit on the third floor in accordance with a design for a PCU. While the corporate resolution technically complies with the requirements for a CON application, the questionable nature of its accuracy, when considered in conjunction with the conflicting evidence of the scope of this project, raises concern as to East Pasco's projections regarding revenue, expenses, staffing, and the actual services to be made available in the Subdistrict. The lack of clarity as to East Pasco's proposal is a compelling reason to deny East Pasco's application. East Pasco's occupancy rate is quite high. It is higher even during the "peak season," i.e., November through April. The projections contained in East Pasco's application are based upon the historic high occupancy rate experienced at East Pasco. Those projections, however, do not take into account, nor did the Agency consider in reviewing East Pasco's application, the fact that East Pasco now has more than the 85 beds which formed the basis for its historic occupancy rate and its projections related to this project. Construction has been completed on the 10-bed observation unit and the 11-bed SNU. East Pasco already has an expanded capacity in place which should alleviate some of its occupancy problems. For example, East Pasco has experienced an increased number of out-patient observation days. With its new observation unit, the beds previously used for observation days are now available for in-patients which, in turn, will likely alleviate East Pasco's most common capacity problem-the lack of available ICU beds. Similarly, the SNU beds will also be available for in-patients.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is, RECOMMENDED that a Final Order be entered denying East Pasco's application for Certificate of Need No. 6783. DONE and ENTERED this 9th day of February, 1993, at Tallahassee, Florida. LINDA M. RIGOT 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 9th day of February, 1993. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 92-1497 Petitioner's proposed findings of fact numbered 1-32, 34-82, and 84-96 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed finding of fact numbered 83 has been rejected as being unnecessary for determination of the issues herein. Petitioner's proposed findings of fact numbered 33 and 97 have been rejected as not constituting findings of fact but rather as constituting recitation of the testimony, argument of counsel, or conclusions of law. The Agency's proposed findings of fact numbered 2-6, 8, 13, 14, 27, 28, 31-33, 37, 40, 41, 43, 44, 47, 49, 51, and 90 have been adopted either verbatim or in substance in this Recommended Order. The Agency's proposed findings of fact numbered 20, 21, 34, 45, 52, 54, 56-58, 68, 71, 73, 82, and 89 have been rejected as being unnecessary for determination of the issues herein. The Agency's proposed finding of fact numbered 1 has been rejected as not constituting a finding of fact but rather as constituting recitation of the testimony, argument of counsel, or a conclusion of law. The Agency's proposed findings of fact numbered 7, 9, 19, 26, 48, 59, 61, 62, and 64 have been rejected as being irrelevant to the issues under consideration herein. The Agency's proposed finding of fact numbered 46 has been rejected as being subordinate to the issues involved in this proceeding. The Agency's proposed findings of fact numbered 10-12, 15-18, 22-25, 29, 30, 35, 36, 38, 39, 42, 50, 53, 55, 60, 63, 65-67, 69, 70, 72, 74-81, 83-88, and 91-93 have been rejected as not being supported by the weight of the credible, competent evidence in this cause. East Pasco's proposed findings of fact numbered 1-3, 5-7, 10, 13, 16- 18, 20, 22-24, 37, 38, 40, 45, 46, 48, 62, 63, 66-69, 73, 78, 79, 81, 82, 85, 89, 118, 119, 131, 135, 140, 174, 178-180, and 192 have been adopted either verbatim or in substance in this Recommended Order. East Pasco's proposed findings of fact numbered 15, 25, 26, 55, 56, 70, 83, 90, 92, 94, 95, 100, 121, 127-129, 145, 146, 163, 164, 171-173, 176, 177, 184-189, 191, and 194 have been rejected as being unnecessary for determination of the issues herein. East Pasco's proposed findings of fact numbered 19, 87, and 88 have been rejected as not constituting findings of fact but rather as constituting recitation of the testimony, argument of counsel, or conclusions of law. East Pasco's proposed findings of fact numbered 4, 8, 9, 11, 12, 14, 21, 30, 31, 33-36, 39, 41, 51, 61, 86, 96-98, 102, 103, 105, and 154 have been rejected as being irrelevant to the issues under consideration herein. East Pasco's proposed finding of fact numbered 84 has been rejected as being subordinate to the issues involved in this proceeding. East Pasco's proposed findings of fact numbered 27-29, 32, 42-44, 47, 49, 50, 52-54, 57-60, 64, 65, 71, 72, 74-77, 80, 91, 93, 99, 101, 104, 106-117, 120, 122-126, 130, 132-134, 136-139, 141-144, 147-153, 155-162, 165-170, 175, 181-183, 190, and 193 have been rejected as not being supported by the weight of the credible, competent evidence in this cause. COPIES FURNISHED: Edward G. Labrador, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 103 Tallahassee, Florida 32308 James C. Hauser, Esquire Messer, Vickers, Caparello, Madsen, Lewis, Goldman & Metz Post Office Box 1876 Tallahassee, Florida 32302-1876 Darrell White, Esquire William Wiley, Esquire McFarlain, Wiley, Cassedy & Jones 215 South Monroe Street Suite 600 Tallahassee, Florida 32301 Sam Power, Agency Clerk Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue Whether the application of Delray Community Hospital for a certificate of need to add 24 acute care beds meets, on balance, the applicable criteria for approval.
Findings Of Fact The Agency For Health Care Administration ("AHCA") administers the state certificate of need ("CON") program for health care services and facilities. In August 1994, AHCA published a numeric need of zero for additional acute care beds in District 9, Subdistrict 5, for southern Palm Beach County. In September 1994, NME Hospitals, Inc. d/b/a Delay Community Hospital, Inc. ("Delray") applied for a certificate of need ("CON") to add 24 acute care beds in District 9, Subdistrict 5, for a total construction cost of $4,608,260. AHCA published its intent to approve the application and to issue CON No. 7872 to Delray, on January 20, 1995, in Volume 21, No. 3 of the Florida Administrative Weekly. By timely filing a petition, Bethesda Memorial Hospital, Inc. ("Bethesda"), which is located in the same acute care subdistrict, challenged AHCA's preliminary decision. Bethesda also filed a petition challenging Rule 59C-1.038, Florida Administrative Code, the acute care bed need rule, which resulted in a determination that the need methodology in the rule is invalid. Bethesda Memorial Hospital, Inc. v. AHCA and NME Hospital, Inc., DOAH Case No. 95-2649RX (F.O. 8/16/95). Delray and Bethesda are in a subdistrict which includes five other hospitals, Wellington Regional Medical Center ("Wellingon"), West Boca Medical Center ("West Boca"), Palm Beach Regional Medical Center ("Palm Beach Regional"), J. F. Kennedy Medical Center ("JFK"), and Boca Raton Community Hospital ("BRCH"). The hospitals range in size from 104 to approximately 400 beds. Wellington, West Boca, and Palm Beach Regional have fewer, and Bethesda, JFK and BRCH have more than Delray's 211 beds. Bethesda, located in Boynton Beach, is accredited by the Joint Commission for the Accreditation of Hospital Organizations ("JCAHO") for the maximum time available, 3 years. Bethesda has 330 beds, and offers obstetrics, pediatrics, and emergency room services. An average of 10 patients a month are transferred, after their condition is stabilized, from the emergency room at Bethesda to other hospitals, and most are participants in the Humana health maintenance organization ("HMO"), which requires their transfer to an Humana- affiliated hospital. Approximately one patient a month is transferred for open heart surgery or angioplasty after stabilization with thrombolitic therapy at Bethesda. Bethesda has a 12-bed critical care unit, a 12-bed surgical intensive care unit, and a telemetry or progressive care unit. From October to April, Bethesda also opens a 10-bed medical intensive care unit. Even during this "season," when south Florida experiences an influx of temporary winter residents, Bethesda's critical care beds are very rarely full. Only one time during the 1994-1995 season was a patient held overnight in the emergency room waiting for a bed at Bethesda. Only diagnostic cardiac caths are performed at Bethesda due to the absence of back-up open heart surgery. Delray is located on a medical campus with Fair Oaks Hospital, a 102 bed psychiatric facility, and Hillhaven Convalescent Center, which has 108 beds. Delray is physically connected to Pinecrest Rehabilitation Hospital, which has 90 beds. The campus also includes a medical mall, with outpatient services, a home health agency, and medical office buildings. Delray has a medical staff of 430 physicians. Delray is a for-profit hospital owned and operated by NME Hospitals, Inc., a wholly owned subsidiary of National Medical Enterprises, which after merging with American Medical International, does business as Tenet Health Care Corporation ("Tenet"). Tenet owns, operates, or manages 103 facilities, including Fair Oaks and Pinecrest Rehabilitation Hospital. Delray owns Hillhaven Convalescent Center, but it is managed by the Hillhaven nursing home management company. NME Hospitals, Inc., also owns West Boca Medical Center, which is approximately 10 to 12 miles from Delray. South Florida Tenet Health System is an alliance of the Tenet facilities, which has successfully negotiated managed care contracts offering the continuum of care of various levels of providers within one company. AHCA published a numeric need of zero for additional acute care beds in the southern Palm Beach County subdistrict, for July 1999, the applicable planning horizon. Delray's application asserts that special circumstances exist for the approval of its application despite the absence of numeric need. AHCA accepted and reviewed Delray's application pursuant to the following section of the acute care bed need rule: (e) Approval Under Special Circumstances. Regardless of the subdistrict's average annual occupancy rate, need for additional acute care beds at an existing hospital is demonstrated if a net need for beds is shown based on the formula described in paragraphs (5)(b), (7)(a), (b), (c), and (8)(a), (b), (c), and provided that the hospital's average occupancy rate for all licensed acute care beds is at or exceeds 75 percent. The deter- mination of the average occupancy rate shall be made based on the average 12 months occupancy rate made available by the local health council two months prior to the begining of the respective acute care hospital batching cycle. The need methodology referred to in the special circumstances rule indicated a net need for 1442 additional beds in District 9. All parties to the proceeding agree that the net need number is unrealistic, irrational, and/or wrong. That methodology was invalidated in the previously consolidated rule challenge case. Delray also met the requirement of exceeding 75 percent occupancy, with 75.63 percent from January through December 1993. In 1994, Delray's occupancy rate increased to 83 percent. In 1993, occupancy rates were 55.6 percent in District 9 and 52.5 percent in subdistrict 5. At individual hospitals, other than Delray, occupancy rates ranged from lows of 25.5 percent at Wellington and 35 percent at Palm Beach Regional to highs of 58 percent at BRCH and JFK. A study of four year trends shows declining acute care occupancy at every subdistrict hospital except Delray. Delray points to occupancy levels in intensive care units as another special circumstance for adding new beds. Currently, Delray has 8 beds in a trauma intensive care unit ("TICU"), 8 in a surgical intensive care unit ("SICU"), 7 in a critical or coronary care unit ("CCU"), 7 in a medical intensive care unit ("MICU"), and 67 beds in a telemetry or progressive care unit ("PCU"). For the fiscal year ending May 31, 1994, occupancy rates were 80 percent in the PCU, 91 percent in CCU, and 128 percent in SICU. If the CON is approved, Delray plans to allocate the 24 additional beds to increase the PCU by 10, CCU by 7, and the SICU by 7 beds. Expert testimony established 75 percent to 80 percent as a range of reasonable occupancy levels for intensive care units. A PCU, telemetry, or step down unit serves as a transition for patients leaving ICUs who require continued heart rate monitoring. PCU staffing ratios are typically 1 nurse to every 4 patients. CCU is used for patients who have had heart attacks or other serious cardiac problems and continue to need closer personal monitoring. SICU is used primarily for post-surgery open heart patients. The TICU is used for patients with neurological injuries and those in need of neurosurgery. When the ICUs are full, overflow patients are placed in holding areas of the ICU, the emergency room ("ER"), telemetry unit, or in a medical holding unit behind the emergency room. During the season, from November to April, from 20 to 55 patients are in holding areas, most of whom would otherwise be in an ICU or PCU bed. Critical care nurses are moved to the holding areas to care for critical patients. Additional staffing requirements are met, in part, by using contract nurses from an agency owned by Tenet, called Ready Staff. Other temporary or traveling nurses go through a three day orientation and are paired with regular staff mentors. Traveling nurses have three to six month contracts to work at various hospitals throughout the county, as needed. Intensive care nurses are cross-trained to work in any of the ICUs, but the same nurses usually are assigned to open heart and trauma patients. Since May 1991, Delray has been the state-designated level II trauma center for southern Palm Beach County, as is St. Mary's Hospital for the northern areas of the County. Trauma patients are transported by ambulance or helicopter, and treated in two designated trauma rooms in the emergency department. The state designation requires Delray to have one of its eight trauma surgeons, trauma nurses, anesthesiologists, and certain other ancillary services available in the hospital at all times. Delray also must have a bed available in its TICU. CON Review Criteria By supplemental prehearing stipulation, the parties agreed that Delray's CON application includes the information and documents required in Section 408.037, Florida Statutes. The parties also stipulated that the project is financially feasible in the short term, and that proposed construction costs and methods, and equipment costs are reasonable. Based on prehearing stipulations, the statutory review criteria in dispute are as follows: 408.035(1)(a) - need in relation to district and state health plans; 408.035(1)(b) and (1)(d) - availability, accessibility, efficiency, and adequacy of other hospitals; 408.035(1)(b) and (1)(c) - quality of care at other hospitals and the applicant's ability to provide and record of providing quality of care; 408.035(1)(h) - availability of critical care nurses; and 408.035(1)(i) - long term financial feasibility. State and District Health Plans The 1993 Florida State Health Plan has a preference for approving additional acute care beds in subdistricts with at least 75 percent occupancy, and at facilities equal to or in excess of 85 percent occupancy. Subdistrict 5 and Delray do not meet the preference. See, Finding of Facts 9 and 10. The state health plan also includes a preference for hospitals which are disproportionate share Medicaid providers. Delray does not meet the preference, and notes that 70 percent of its patients are over 65 years old and entitled to Medicare reimbursement. In fact, there are no disproportionate share providers in the subdistrict. Delray meets the state plan preference for proposing a project which will not adversely affect the financial viability of an existing, disproportionate share provider. The state health plan also has four preferences related to emergency services, for accepting indigent patients in ER, for a trauma center, for a full range of ER services, and for not having been fined for ER services violations. Delray meets all four preferences related to emergency services. The 1990 District 9 Health Plan, with a 1993 CON Allocation Factors Report, favors applicants who serve Medicaid/Indigent, handicapped, and underserved population groups. In 1992 and 1993, approximately 2.5 percent of the patients at Delray were in the Medicaid program. Delray also provided 3 percent indigent and charity care for 1993. The hospital's 1992 financial reports do not indicate that it provided any indigent or charity care. In 1993- 1994, Delray had the lowest percentage of Medicaid and charity patients at a state designated level II trauma center. AHCA proposes to condition approval of CON 7872 on Delray's providing 2.4 percent of total annual patient days to Medicaid and 1 percent of total annual patient days to charity care, as projected by Delray in Table 7 of the application. Under the district health plan, priority is given for applicants who document cost containment. One example of cost containment, according to the plan, is sharing services with other area hospitals to enhance efficient resource utilization and avoid duplication. Delray describes its patient- focused care model as an example of cost containment. In response to rising labor cost, the underutilization of certain required categories of employees, and the large number of staff interacting with each patient, Delray created the model which emphasizes cross-training of staff to work in teams led by a registered nurse. Delray has not proposed sharing services with other hospitals, and has not documented cost containment as that is described in the district health plan. Availability, Accessibility, Efficiency and Adequacy of Other Hospitals Additional acute care beds at Delray will not meet any demonstrated numeric, geographic, or financial need. Acute care beds are available in adequate numbers in the subdistrict. Roughly half, or 800, of the subdistrict's 1700 beds were empty most days in 1993 and 1994. Bethesda's expert in health care planning and financial feasibility testified that some available, more appropriate alternatives to the approval of additional beds at Delray are the transfer of patients to other subdistrict hospitals, including Tenet's West Boca, the transfer of unused bed capacity from one area of the hospital to another, or the transfer of unused bed capacity from West Boca to Delray. Bethesda also contends that Delray could find alternatives to placing outpatient surgery and outpatient cardiac cath patients in inpatient beds from four to twenty-three hours for observation and care. In support of Delray, AHCA's expert testified that institution-specific demand, in Delray's case, has reached the level of community need, because other subdistrict hospitals are not adequate or available to treat the type of patients treated at Delray. All of Delray's patients come from areas of the county which overlap the service areas of other hospitals, which shows the absence of any geographic access barriers. A diagnostic related group, or DRG, analysis shows that most of the categories of diagnosed illnesses or injuries treated at Delray are also treated at other subdistrict hospitals. The DRGs exclusively treated at Delray are related to trauma. Others treated in the subdistrict only at Delray and JFK are related to angioplasty and open heart surgery. Of the state level II trauma centers, Delray reported the highest percentage, 96.5 percent, of discharges of all patients were urgent or emergent cases. By comparison, the lowest were 65.6 percent at St. Joseph's Hospital in Tampa and 66 percent at West Florida Regional Medical Center, and the next highest was 94.2 percent at Bayfront Medical Center. Bethesda's expert suggested that the number was too high and could result from miscoding. Approximately 70 to 90 trauma patients are treated each month at Delray and approximately 50 percent of those are admitted to the hospital. One Bethesda witness, a doctor on the staff at both Bethesda and Delray, testified that he was called in once when Delray refused to go on "by-pass status," to send an incoming trauma patient to St. Mary's, knowing the patient was likely to need a CT scan. At the time, Delray's main scanner inside the hospital was inoperable or undergoing repairs. The patient who arrived by helicopter was taken by ambulance to another scanner on the campus, approximately 1000 yards away from the hospital. The same doctor also complained that ER patients who are upgraded to trauma status cannot be downgraded by trauma surgeons. There was no evidence how often the inside CT scan is unavailable and, consequently, no showing that altering this practice would result in an appreciable decline in the demand for trauma services at Delray. Similarly, there was no evidence of any impact on hospital admissions resulting from upgrading emergency patients to trauma patients. Trauma victims seldom require open heart surgery. Therefore, a different category of patients served only in the subdistrict at JFK and Delray is open heart surgery patients. Because of its location in an area with a large population over age 65 and due to the services it provides, one Delray witness described Delay, as a "cardiac" hospital. Delray has no pediatric or obstetric services. The percentage of residents over 65 in Delray's service area is about 35 percent, in contrast to a statewide level approaching 20 percent. Delray began an open heart surgery program in August, 1986. There are now approximately 50 cardiologists on staff, 19 performing cardiac catheterizations ("caths") and angioplasties, and three performing open heart surgeries. In fiscal year 1993, approximately 1900 cardiac caths, and 450 open heart surgeries were performed at Delray. In fiscal year 1994, that increased to approximately 2100 patients cathed and 540 open heart surgeries. Through April 1995, or 11 months into the fiscal year, there were approximately 2300 caths and 526 open heart surgeries. The cath labs are available twenty-four hours a day, seven days a week, within forty-five minutes notice. By comparison, the cath lab at Bethesda operates on weekdays until 3:30 p.m. Ten to twelve physicians use Delray's two cardiac cath labs and a third overflow lab, if needed. The cath labs at Delray and Bethesda are considered "open" because any qualified staff physician is eligible to receive privileges to use the lab. A backlog occurs in the Delray cath lab when critical care beds are not available for patients following caths. Delray has three open heart surgery operating rooms and three open heart surgeons, with the capacity to perform 1000 open heart surgeries a year. Within the subdistrict, approximately 11 miles from Delray, JFK also provides cardiac cath, angioplasty, and open heart surgery services. JFK has 369 beds and is equipped with two cardiac cath labs, each with the capacity to accommodate 2000 procedures a year. In fiscal year 1994, approximately 3200 caths were performed at JFK. The cath lab is "closed," meaning JFK has entered into an exclusive contract for services with one group of invasive cardiologists. JFK's medical staff has relatively little overlap, approximately 10 to 15 percent, with the medical staff at Delray. Across all patients and all diagnoses, there is also relatively little geographic overlap. JFK, by and large, serves the central area and Delray serves the southern area of Palm Beach County. The average census in thirty critical care beds at JFK was 16.5 patients in 1994, and 18.4 in the first six months of 1995. A high range of 70 percent to 80 percent occupancy in JFK's critical care beds is reached during the peak season. Although JFK's thirty critical care beds are not officially divided into different types of intensive care services, a de facto designation has developed. Depending on the patient mix, the same 16 beds are generally used for cardiac critical care. The average daily census for cardiac critical care was 13.4 in March 1994 and 23.4 in February 1995. Overall, there is no excess capacity in the district in critical care beds during the height of the season. The average occupancy of all critical care beds in southern Palm Beach County was 104 percent in February 1992, 98 percent in February 1993, and 93.5 percent in February 1994. Open heart surgery and angioplasty are more frequently than not scheduled up to a week ahead of time. Most cardiac patients can be admitted to any emergency room and stabilized with thrombolytic therapy before transfer to another hospital for an angioplasty or open heart surgery, without compromising their conditions. However, at Delray, cardiac patients are more likely to be emergent or urgent cases, remaining in the hospital for stabilization, scheduled for surgery within 24 hours, and remaining in SICU an average of forty-eight hours following surgery. The older patients are more difficult to transfer because they tend to have more consulting specialists on the staff of the hospital in the service area where they reside. Transferring open heart surgery patients from Delray to JFK is not beneficial as a health planning objective during the season, when JFK operates at reasonable levels of 70 percent to 80 percent occupancy in critical care beds and exceeds the capacity of its de facto cardiac critical care beds. Delray's emergency department can accommodate 23 patients at one time. Over the past three years, ER visits have increased by approximately 1,000 each year. Approximately 20 percent to 25 percent of patients treated in its emergency room, excluding trauma patients, are admitted to Delray. During the winter season, there are also more emergency room patients who do not have local physicians, most complaining of cardiac and respiratory problems. By federal law, certain priority categories of emergency patients must be taken to the nearest hospital. Federal law also prohibits patient transfers to a different hospital unless a patient's medical condition is stable, the patient consents, and the other hospital has an available bed and a staff doctor willing to take the patient. Patient condition and consent are major factors preventing transfers of elderly residents of the Delray service area to other hospitals. Delray also reasonably expects an increase in patients due to an increase in its market share, managed care contracts, and population in its service area. Managed care contracts, usually for 3 year terms, are not alone a reliable basis for making long term community health planning decisions. Combining trends in growth, population aging, declining lengths of stays in hospitals, market share and the greater consumption of inpatient services by people over 65, however, Delray reasonably expects an incremental increase of 1667 discharges by 1999. At 80 percent occupancy, the incremental patients attributable to population growth alone, according to Delray's expert, justifies an additional 34 beds. For a substantial part of 1994, ICU, CCU and medical/surgical beds at Delray exceeded reasonable occupancy standards. In the first four months of 1995, medical/surgical occupancy levels ranged from 96.7 percent to 119.4 percent. Given those levels and the projected growth, transfer of beds from medical/surgical units is not a reasonable option for increasing the supply of critical care beds. Delray is small when compared to all other high volume open heart surgery and level II trauma hospitals in Florida. Another option suggested by Bethesda's expert was the transfer of beds from West Boca to Delray. Because the beds have already been built, a transfer would not reduce capital or fixed costs at West Boca. The only effect that was apparent from the evidence in this case would be a statistical increase in subdistrict utilization. In addition, with 171 beds, West Boca is relatively small and in a growing area of Palm Beach County. Bethesda's contention that Delray could stop using inpatient beds for the four to twenty-three hour outpatients was not supported by the evidence. There was no showing that the physical plant or space exists for the construction of observation beds near an ambulatory surgery center. Given the testimony that all hospitals use inpatient beds for certain outpatients, and that Delray averages five to seven outpatients in inpatient medical/surgical beds at any time, there is no evidence of a practical alternative with any significant impact on the overcrowding at Delray. Bethesda also challenged the need for critical care for fractures, cellulitis, and fever of unknown origin, which were among the diagnoses listed for patients in the ER hold. However, Bethesda's expert also acknowledged that some patients in ER hold at Delray were waiting for medical/surgical beds not only ICU beds. Patients are placed in holding areas whenever assignment to an appropriate bed is not possible within thirty minutes of the issuance of orders to admit the patient. Delray proved that it is unique in the subdistrict in treating trauma patients and cardiac patients in a service area with minimal geographic and medical staff overlap with that of JFK. The transfer of such patients to other hospitals in the subdistrict is often not practical or possible. Delray also demonstrated that other subdistrict hospitals are not available alternative intensive care providers when their ICUs are also full or over optimal levels of occupancy, during the season. In addition, the demographic characteristics of Delay's service area support projected increases in inpatient days due to increased market share, population aging and growth. All of these factors indicate that Delray cannot, as Bethesda suggests, control its own growth, transfer, or redirect patients. Quality of Care and Availability of Critical Case Nurses Delray is JCAHO accredited. There is no evidence that quality of care affects hospital utilization in southern Palm Beach County. Open heart surgery mortality rates from 1990 to 1994 were 1.9 percent at JFK and 3 percent at Delray, but the data is not adjusted to take into consideration "case-mix," meaning the severity of illnesses, and is, therefore, meaningless as a comparison. A 1994 Medicare case mix index report shows Delray treating the sickest patients followed by JFK, then Bethesda. The sicker, older patients, exert more pressure on ICUs. Because ICU nursing ratios are one-nurse-to-one-patient or, more typically, one-to-two and PCU ratios are one-to-four, PCUs provide a step down from ICUs. PCU beds are used for patients who no longer need ICU care, but require more intense monitoring than that provided on the medical/surgical floors with nurse/patient ratios of one-to-twelve or one-to-twenty. In PCU or telemetry beds, radio signals transmit data to heart monitors. However, if PCU beds are not available, patients are left in the ICUs longer than necessary, aggravating the backlog cause by crowded ICUs. Critical care is a resource-intensive service, and Bethesda argues that Delray cannot increase the service because of the shortage of critical care nurses in Palm Beach County. However, the testimony presented by Bethesda is not consistent. Bethesda's expert in critical care nursing and critical care unit management testified that vacancies are difficult to fill, that there is a shortage of critical care nurses, but that Bethesda does not experience a shortage of critical care staff. There is no explanation why Bethesda has no shortage, but Delray would if its CON is approved. Delray's director of neuroscience and critical care testified that she maintains a file of available critical care nurses and can recruit the additional staff needed due to Delray's competitive salaries and benefits. Long Term Financial Feasibility There are no revenues or expenses during construction of the 24 beds, just construction costs. After the beds are in service, Delray projects net income of $1,951,164 in 1997 and $2,003,769 in 1998. In projecting revenues and expenses for the beds, Delray used its historical percentages of patients in each unit receiving a particular type of care and the historical cost of that care, and assumed that the same breakdown in the 24 new beds. Using the historical financial experience, Delray constructed a pro forma for the 24 beds, with an expected average daily census of 21.6 patients. If the 24 new beds are used only for existing holding area patients then, as Bethesda contends, Delray's pro forma should show a shift of revenues and expenses to the new beds, and the same amounts deducted from the remainder of the hospital. Delray already charges holding area patients based on the intensity of nursing care provided, even though the patients are not physically located in an ICU. The ER hold patients accounted for 2,210 patient days in 1994, which are reallocated to ICU beds in the pro forma. However, Delray also projected an incremental increase of 7,865 patient days which, contrary to Bethesda's claim, does not include or double- count the ER hold patient days. Of these, 54 percent of incremental patient days are projected to be in the ICUs or PCU. The additional patients will, therefore, spend 46 percent of total patient days in medical/surgical beds. Routine revenue estimates of $492 a day in year one were criticized as too low for the projected 54 percent ICU/46 percent medical/surgical mix. However, $492 a day is a reasonable estimate of incremental routine revenues for the hospital as a whole. In 1994, patients at Delray spent 44 percent of total days in medical/surgical beds as compared to the projection of 46 percent for new patients. There is no material variation from 44 percent to 46 percent, therefore $492 a day is a reasonable projected incremental routine revenue. Delray has demonstrated, in an incremental analysis, the financial feasibility of adding 24 critical care beds for existing and additional patients. Delray has also considered the financial impact of additional patients in all categories of beds. Although criticized by Bethesda for this approach, Delray explained that a critical care bed generates revenues from a medical/surgical bed when patient's condition is downgraded. The financial analysis is reasonable, particularly since Medicare pays a flat rate by DRG regardless of how a patient's total days are divided between ICUs and medical/surgical beds. Bethesda questioned whether the use of new beds for new patients will eliminate the use of holding areas. The movement of patients in and out of ICUs will be enhanced by having more ICU and PCU beds, even if the additional beds do not eliminate entirely the use of holding areas during the peak season. Projected average occupancies are expected to reach 98 percent in March 1997 and 1998. Delray also demonstrated that the share of its projected increased admissions which would have otherwise gone to Bethesda is approximately 150 patients, representing a net decline in revenue to Bethesda of approximately $257,000, in comparison to Bethesda's net income of $9 million in 1994. Bethesda also will no longer receive a county tax subsidy of $1 million in income and $3.5 million in restricted funds, after 1994.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered issuing Certificate of Need 7872, approving the addition of 24 acute care beds, to NME Hospital, Inc., d/b/a Delray Community Hospital, conditioned on the provision 2.4 percent of total annual patient days to Medicaid and 1 percent of total annual patient days to charity care. DONE AND ENTERED this 7th day of November, 1995, in Tallahassee, Leon County, 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 7th day of November, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-0730 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner, Bethesda Memorial, Proposed Findings of Fact. Accepted in Findings of Fact 14. Accepted in or subordinate to Findings of Fact 2, 7, and 10. Accepted in or subordinate to Findings of Fact 23 and 27. Accepted in or subordinate to Findings of Fact 21 and 23. Accepted in Findings of Fact 22. 21. 43. Accepted in or subordinate to Findings of Fact 21. Accepted in Findings of Fact 23. 8,9. Accepted in Findings of Fact 19 and 20. 10. Accepted except first sentence in Findings of Fact 15. 11-12. Accepted in Findings of Fact 16. Accepted in Findings of Fact 18. Rejected in Findings of Fact 15-18. 15-17. Accepted in or subordinate to Findings of Fact 21 and 22. Accepted in Findings of Fact 35. Rejected first sentence in Findings of Fact 30. Accepted in part and rejected in part in Findings of Fact 23-29. Accepted in or subordinate to Findings of Fact 14. Subordinate to Findings of Fact 14 and accepted in Findings of Fact 23-25. Accepted in or subordinate to Findings of Fact 4. 26. Rejected in Findings of Fact 27. 27-28. Accepted in Findings of Fact 30. Accepted in Findings of Fact 21. Rejected first sentence in Findings of Fact 38-43. 31-32. Rejected in or subordinate to Finding of Fact 43. 33. Accepted in Findings of Fact 40. 34-35. Accepted in or subordinate to Findings of Fact 39-41. 36. Accepted in Findings of Fact 37. 37(1). Accepted in Findings of Fact 40 and 41. 37(2). Accepted in Findings of Fact 11. 37(3). Accepted in Findings of Fact 39 and 43. 38-39. Accepted in part and rejected in part in Findings of Fact 40 and 40-48. Rejected in part in Findings of Fact 40 and 41. 49-51. Rejected in Findings of Fact 41. Subordinate to Findings of Fact 41. Rejected in Findings of Fact 38-42. 54(A). Rejected in Findings of Fact 33. 54(B). Accepted in or subordinate to Findings of Fact 33. 54(C). Rejected 54(D-E). Subordinate to Findings of Fact 34. 54(F). Accepted in Findings of Fact 19. 54(G). Subordinate to Findings of Fact 38. 54(H). Accepted in Findings of Fact 22. 54(I). Subordinate to Findings of Fact 34. 54(J). Subordinate to Findings of Fact 30. 54(K). Subordinate to Findings of Fact 28. 54(L). Rejected as speculative in Findings of Fact 35. 54(M). Subordinate to Findings of Fact 7 and 34. 54(N). Conclusions rejected. See Findings of Fact 16. 54(O-P). Conclusions rejected. See Findings of Fact 24. 54(Q). Accepted in Findings of Fact 21. 54(R). Conclusions rejected. See Findings of Fact 24. Accepted in Findings of Fact 12. Accepted in Findings of Fact 21 and 23. Accepted in preliminary statement. Accepted in Findings of Fact 12. Accepted in relevant part in Findings of Fact 29. Accepted in Findings of Fact 35. Accepted in or subordinate to Findings of Fact 26. 62-63. Accepted in part in Findings of Fact 27-29. Accepted in Findings of Fact 23, 27 and 28. Subordinate to Findings of Fact 26. Subordinate to Findings of Fact 30 Subordinate to Findings of Fact 26. Subordinate to Findings of Fact 30. Subordinate to Findings of Fact 26. Subordinate to Findings of Fact 27. Subordinate to Findings of Fact 27. Subordinate to Findings of Fact 26 and 27. Accepted in part in Findings of Fact 28. Accepted in Findings of Fact 23. Accepted in or subordinate to Findings of Fact 6. Accepted in Findings of Fact 26. Accepted in Findings of Fact 35-37. Accepted in Findings of Fact 27. 79-81. Accepted in or subordinate to Findings of Fact 27 and 28. 82-85. Accepted in or subordinate to Findings of Fact 28. Accepted in Findings of Fact 10. Accepted in or subordinate to Findings of Fact 27. Subordinate to Findings of Fact 28 and rejected in Findings of Fact 35. Rejected in general in Findings of Fact 27 and 28. Subordinate to Findings of Fact 27. Subordinate to Findings of Fact 28. Rejected in Findings of Fact 35. Accepted in Findings of Fact 30. 94-98. Accepted in part or subordinate to Findings of Fact 28 and 29. 99-100. Rejected in or subordinate to Finding of Fact 28 and 29. 101. Subordinate to Findings of Fact 35. 102-104. Subordinate to Findings of Fact 27, 28 and 35. 105. Accepted in Findings of Fact 28. 106-107. Subordinate to Findings of Fact 35. 108-111. Accepted in or subordinate to Findings of Fact 27. Subordinate to Findings of Fact 26. Subordinate to Findings of Fact 27. Accepted in Findings of Fact 35. Accepted in Findings of Fact 27. Subordinate to Findings of Fact 16. 117-122. Accepted in Findings of Fact 5 and 35. Rejected in Findings of Fact 37. Accepted in part and rejected in part in Findings of Fact 44. Respondent, AHCA, Proposed Findings of Fact. Accepted in or subordinate to preliminary statement. Accepted in or subordinate to Findings of Fact 1. Accepted in Findings of Fact 4. Accepted in Findings of Fact 13 and 25. 5-6. Accepted in or subordinate to Findings of Fact 1 and 8-10. Accepted in Findings of Fact 4 and 26. Accepted in or subordinate to Findings of Fact 24 and 31. Accepted in or subordinate to Findings of Fact 35. Subordinate to Findings of Fact 22. Accepted in Findings of Fact 21. Accepted in Findings of Fact 22. Accepted in part and rejected in part in Findings of Fact 8, 9 and 34. Respondent, NME, Proposed Findings of Fact. Accepted in Findings of Fact 2. Accepted in Findings of Fact 11. Accepted in Findings of Fact 4 and 6. Accepted in or subordinate to Findings of Fact 26. Accepted in Findings of Fact 6. 6-10. Accepted in or subordinate to Findings of Fact 24-26. Accepted in Findings of Fact 35. Subordinate to Findings of Fact 16. 13-14. Accepted in or subordinate to Findings of Fact 8-13 and 23-34. Accepted in Findings of Fact 9 and 10. Accepted in Findings of Fact 10. Accepted in Findings of Fact 5, 12 and 34. Accepted in Findings of Fact 9 and 10. Accepted in Findings of Fact 30. Subordinate to Findings of Fact 9. Accepted in or subordinate to Findings of Fact 13, 23 and 35. Accepted in or subordinate to Findings of Fact 11-12 and 28. Accepted in Findings of Fact 11. Accepted in or subordinate to Findings of Fact 11. Accepted in Findings of Fact 14 and 34. Accepted in or subordinate to Findings of Fact 25. Rejected. Accepted in Findings of Fact 35. Accepted in Findings of Fact 13 and 31. Accepted in Findings of Fact 24. Accepted in Findings of Fact 13. Accepted in Findings of Fact 36. Subordinate to Findings of Fact 12 and 13. Accepted in Findings of Fact 23 and 29. Accepted in Findings of Fact 29. 36-43. Accepted in or subordinate to Findings of Fact 11 and 12. 44-50. Accepted in or subordinate to Findings of Fact 22 and 23-29. Subordinate to Findings of Fact 6. Accepted in or subordinate to Findings of Fact 34. Accepted in or subordinate to Findings of Fact 28. Accepted except last sentence in Findings of Fact 24. 55-56. Accepted in or subordinate to Findings of Fact 22 and 33. Accepted in or subordinate to Findings of Fact 27 and 28. Accepted in Findings of Fact 22. Accepted in Findings of Fact 24. Accepted in Findings of Fact 26. Accepted in or subordinate to Findings of Fact 35. Accepted in Findings of Fact 23. 63-65. Accepted in or subordinate to Findings of Fact 30. 66-67. Accepted in or subordinate to Findings of Fact 31. 68-72. Accepted in or subordinate to Findings of Fact 7 and 30. 73-76. Accepted in or subordinate to Findings of Fact 8 and 9. Accepted in Findings of Fact 34. Accepted, except last phrase in Findings of Fact 15-20. Accepted in or subordinate to Findings of Fact 21-22. Accepted in or subordinate to Findings of Fact 22. Accepted in or subordinate to Findings of Fact 22-34. Subordinate to Findings of Fact 22. 83-86. Accepted in Findings of Fact 12 and 35-37. 87-89. Accepted in Findings of Fact 35-37. Accepted in Findings of Fact 30. Accepted in Findings of Fact 38 and 39. Accepted in Findings of Fact 38. Accepted in Findings of Fact 41. Subordinate to Findings of Fact 38. 95-99. Accepted in or subordinate to Findings of Fact 38-42. Accepted, except first sentence, in or subordinate to Findings of Fact 44. Subordinate to Findings of Fact 22. 102-104. Accepted in or subordinate to Findings of Fact 16 and 19. 105-106. Accepted in or subordinate to Findings of Fact 7. 107-108. Issue not reached. See Findings of Fact 14. 109-114. Accepted in or subordinate to Findings of Fact 44. COPIES FURNISHED: John Gilroy, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Kenneth Hoffman, Esquire W. David Watkins, Esquire OERTEL, HOFFMAN, FERNANDEZ & COLE 2700 Blair Stone Road Tallahassee, Florida 32301 Michael J. Glazer, Esquire C. Gary Williams, Esquire MACFARLANE, AUSLEY, FERGUSON & MCMULLEN Post Office Box 391 Tallahassee, Florida 32302 R. S. Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Tom Wallace Assistant Director Agency For Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Petitioner, Lakeland Regional Medical Center (LRMC), is a 897-bed private, not-for-profit, general acute care hospital located at 1324 Lakeland Hills Boulevard, Lakeland, Florida. It is considered a major regional referral hospital and provides a wide range of tertiary services, including open heart surgery. The facility is located in District 6 and is one of six facilities in the district having an existing open heart surgery program. Respondent, Department of Health and Rehabilitative Services (HRS), is the state agency charged with the responsibility of administering the Health Facility and Services Development Act, also known as the Certificate of Need (CON) law. On September 26, 1988 intervenor, Winter Haven Hospital, Inc. (WHH), filed with HRS an application for a CON seeking authority to establish an open heart surgery program at its facility in Winter Haven, Florida. After reviewing the application, on February 3, 1989, HRS published notice of its intent to issue the requested CON. If approved, this program would be in competition with similar programs operated by LRMC and intervenor, Hillsborough County Hospital Authority d/b/a Tampa General Hospital (TGH). Those two parties have initiated formal proceedings in Case Nos. 89-1286 and 89-1287 to contest the proposed grant of authority. Intervenor, Venice Hospital, Inc. (Venice), has a pending application for authority to establish an open heart surgery program in a separate administrative proceeding and has intervened in opposition to LRMC's rule challenge. It is noted that LRMC, WHH and TGH are located in District 6 while Venice is located in an adjoining, but separate, district. All parties have standing in this proceeding. In order for HRS to grant a certificate of need, it is necessary for an applicant to satisfy all relevant rule and statutory criteria. In this vein, the agency has promulgated Rule 10-5.011(1)(f), Florida Administrative Code (1987), which contains certain criteria pertaining to open heart surgery programs. That rule provides in relevant part as follows: (f)2. Departmental Goal. The Department will consider applications for open heart surgery programs in context with applicable statutory and rule criteria. The Department will not normally approve applications for new open heart surgery programs in any service area unless the conditions of Sub-paragraphs 8. and 11., below, are met. * * * 11.a. There shall be no additional open heart surgery programs established unless: (1) the service volume of each existing and approved open heart surgery program within the service area is operating at and is expected to continue to operate at a minimum of 350 adult open heart surgery cases per year or 130 pediatric heart cases per year, (Emphasis added) * * * The requirements of this rule, which are unambiguous, and other pertinent statutory and rule criteria, are to be applied by HRS to all applicants, including WHH, during the CON review process. Although the rule itself is not being challenged by LRMC, subparagraph 11.a. of the rule is at the heart of this controversy. Petitioner and TGH contend that the clear language of the rule requires that, absent the existence of not normal circumstances, HRS may not award a CON unless each existing and approved open heart surgery program in the service area is operating at and is expected to continue to operate at 350 procedures per year. Because there are now six approved and existing open heart surgery programs in the district, petitioner argues that the rule mandates that, before a new program can be authorized, each of the six programs must meet the required level of 350 procedures per year. They contend further that the particular policy applied by HRS to WHH's application is not apparent on the face of rule 10-5.011(1)(f)2. and thus it constitutes an unpromulgated rule. In preliminarily approving WHH's application, HRS admits that it used a so-called averaging policy which it agrees may be described in the following manner: HRS has formulated and is applying in reviews of Certificate of Need ("CON") applications for new open heart surgery services a policy of general applicability that is uniformly and consistently applied, which calls for the averaging of the utilization of existing and approved adult open heart surgery programs in the applicable service area, and which deems subparagraph 11.a.(I) of Rule 10-5.011(1)(f), Fla. Admin. Code, to be met if the average utilization of all such existing and approved programs in that service area is at least 350 cases (the "Averaging Policy"). Pursuant to its Averaging Policy, HRS will approve a CON application for a new adult open heart surgery program under Rule 10- 5.011(1)(f), Fla. Admin. Code, even if each existing and approved program in the proposed service area is not operating at a minimum of 350 adult cases per year, and even if no "not normal" circumstances are presented in the application or found to exist in the State agency Action Report. Stated another way, HRS deemed subparagraph 11.a. to have been met in WHH's case because, after dividing the total number of procedures performed district wide by the number of existing and approved programs, there were an average number of procedures in excess of 350 for each program in the district. It used this averaging process even though two programs were not operational at the time the review process took place, and only two (LRMC and TGH) of the six programs had actually performed more than 350 procedures during the specified time period being measured. 1/ Thus, the averaging policy used by HRS allows approval of a CON application for open heart surgery even if only some programs in a district, rather than each, have the required 350 case volume. The averaging technique has not been reduced to writing in a memorandum, manual or agency policy directive, and it has not been formally adopted as a rule. In this regard, HRS, but not WHH and Venice, has admitted that the policy is indeed a rule. The results of applying that "rule" are contained in the state agency action report issued by HRS and made a part of this record. HRS has consistently and uniformly applied this averaging technique in every open heart surgery case except one since the rule was adopted in substantially its present form on February 14, 1983. 2/ It has been applied without discretion by those HRS personnel who have the responsibility of administering the CON law and regulations. The proponents of the averaging policy argued first that the language in subparagraph 11.a. authorized its use. However, nothing in the language of the existing rule expressly refers to an averaging process. They also contended that when other provisions within the rule are read, the use of the policy becomes apparent. More particularly, they pointed to subsection (7) of the rule which requires that the provision of open heart surgery be consistent with the state health plan. That plan provides in part that one of its objectives is to maintain an average volume of 350 procedures at all programs in the state. However, the state health plan is not mentioned in subparagraph 11.a., subsection (7) does not track or mirror the averaging technique, and the same subsection does not alert the user of the rule to the fact that an averaging process will be applied.
The Issue Whether there is a need for a new Pediatric Heart Transplant (PHT) program in Organ Transplant Service Area (OTSA) 3, and, if so, whether Certificate of Need (CON) Application No. 10518, filed by Orlando Health, Inc., d/b/a Arnold Palmer Medical Center (APMC), to establish a PHT program, satisfies the applicable statutory and rule review criteria for award of a CON to establish a PHT program at the Arnold Palmer Hospital for Children (APH).
Findings Of Fact Based upon the credibility of the witnesses and evidence presented at the final hearing and on the entire record of this proceeding, the following Findings of Fact are made: The Parties Orlando Health, Inc., d/b/a Arnold Palmer Medical Center OH was originally formed by two community physicians 100 years ago as a 20-bed hospital in downtown Orlando. Today, OH is a large not-for-profit healthcare system with more than 3,300 beds serving Central Florida and beyond. Comprised of nine wholly-owned or affiliated hospitals and rehabilitation centers, OH serves as the region’s only Level One Trauma Center and Pediatric Trauma Center, and is a statutory teaching hospital system offering graduate medical education and clinical research in both specialty and community hospitals. OH has been actively involved in clinical research since the beginning of its graduate medical education and residency programs in the 1950s. OH’s primary service area includes approximately 2.2 million people, with a greater service area of Central Florida, which encompasses more than three million people today and is rapidly growing. OH experiences about 100,000 inpatient admissions and 1.5 million ambulatory visits each year. OH has 24,000 employees, including 2,000 physicians and 8,000 nurses. OH has long been recognized as the safety net provider for the Central Florida region. APMC is comprised of two hospitals, APH and Winnie Palmer Hospital for Women and Babies (WPH). APMC was founded on the premise that the close integration of specialty inpatient pediatrics and obstetrics services improves quality and outcomes. APMC is the single largest acute care facility in the nation dedicated to women and children. APH has achieved national ranking as a Top 50 Children’s Hospital by U.S. News and World Report, based on quality data metrics that focus on process, structure, and outcomes, for the past eight consecutive years for key programs, including pediatric cardiology. Since 2015, APH has been the only pediatric hospital in Florida to receive the Top Hospital award from Leapfrog, an achievement based on evaluation of numerous quality metrics, including outcomes data over time. APH has been a Magnet-designated facility since 2013. APH’s primary service area covers 25 counties. APH’s pediatric trauma center and dedicated pediatric emergency department receive approximately 55,000 visits per year. The Heart Center at APH (the Heart Center) is nationally ranked among the top pediatric cardiac programs in the country for its outcomes in complex congenital heart surgery. Dr. William DeCampli, APH’s chief of Pediatric Cardiac Surgery, and Dr. David Nykanen, APH’s chief of Cardiology, serve as the medical directors of the Heart Center. Dr. DeCampli and Dr. Nykanen will continue to serve as the medical directors of the Heart Center following implementation of APH’s proposed PHT program. The Heart Center is on the third floor of APH in the “corner pocket” of the hospital. It is intentionally designed so that the pediatric cardiovascular intensive care unit (CVICU), cardiovascular operating suite, and cardiac catheterization suite are in close proximity to each other, to promote the integration of care between the units and to ensure the safe transition of pediatric patients. APH’s 20-bed CVICU is more advanced than the intensive care units of most pediatric cardiac programs across the country. APH established a freestanding dedicated CVICU in January 2005, and was one of the first in the nation to do so. APH CVICU clinical staff are dedicated to the CVICU and specifically trained to care for the special needs of pediatric cardiac patients. Unlike many other pediatric cardiac programs in the country, APH’s CVICU has 24/7/365 attending physician in- house coverage which leads to better access for patients and better outcomes. APH’s commitment to this continuous on-site physician presence reflects a standard that all pediatric cardiac programs aspire to, but few have achieved. APH has three employed pediatric cardiac anesthesiologists providing 24/7/365 in-house coverage, rare among pediatric cardiac programs. The specialty of pediatric cardiac anesthesia is distinct from the specialty of general pediatric anesthesia. Pediatric cardiac anesthesiologists specialize in the complex defects and anatomy of the cardiovascular system in patients with congenital heart disease (CHD) for whom anesthesia and sedation poses heightened risk. Pediatric cardiac anesthesiologists provide anesthesia for cardiac procedures as well as for any non-cardiac procedures the CHD patient may require. APH is the highest ranked program in Florida in outcomes for the most complex category of congenital heart surgery. In 2007, the Heart Center’s surgical team published more than three times the number of investigational papers than the state’s leading academic pediatric cardiac surgery program. Nationally, APH has the highest neonate population with the lowest mortality rate. APH has a state-of-the-art echocardiography (echo) program with the entire infrastructure necessary for PHT. Echo is essential at every stage of diagnosing, treating, and evaluating the response to therapies and interventions in pediatric cardiac care, including PHT. Dr. Riddle, an echocardiologist at APH, has extensive experience in diagnosing and evaluating complex congenital heart anomalies, including patients requiring PHT. APH’s echo program is comprised of multiple components: the facility, the equipment, the physicians, the sonographers, the protocols, and the quality. APH’s echo lab is the “mission control center” for the program, with four large screens that enable clinicians to watch and discuss echos as they are being performed, and to review echos in meticulous detail, sometimes spending hours looking at complex echos. APH’s culture is the tremendous differentiator among pediatric cardiac programs. APH’s goal is to know every aspect of a patient’s care and anatomy, and APH clinicians, with the full support of administration, spend significant time doing that. All APH sonographers are certified and APH has weekly didactic sessions for sonographers, along with quality improvement and quality review sessions. All APH echo readers are dedicated echo physicians, with extensive training, who also are involved in constant didactic lectures and immersion in quality improvement measures. APH’s director of echo, Dr. Craig Fleishman, is nationally recognized and serves as the chair of the Scientific Sessions of the American Society of Echocardiography, the national governing and education body for echo. APH is the only pediatric heart program in Central Florida to achieve accreditation from the American Society of Echocardiography in transthoracic, transesophageal, and fetal echo. APH is highly skilled at diagnosing complex congenital heart anomalies, including those in fetuses when the patient’s heart may be no larger than a grape. APH’s echo surgical correlations, in which the echo gradients are compared to actual measurements during surgery, are “phenomenal.” Similar correlations occur in coordination with the APH cardiac catheterization lab. APH has used printed 3D heart modeling, but printed 3D modeling includes only data obtained from a computerized tomography (CT) scan or magnetic resonance imaging (MRI) , and does not show all of the finer complex structures of the heart and valves; thus, it has limited utility in evaluating treatment options for complex CHD. However, APH is implementing a virtual reality 3D modeling system that combines data from echo, CT, and MRI data, and even surgical images, to create a complete virtual 3D model of the heart that includes the fine details, including valve attachments. Unlike a printed 3D model, which once cut open, no longer represents the heart and cannot be put back together for further evaluation, virtual 3D modeling enables clinicians to evaluate multiple potential interventions and observe responses and to repeat as many times as may be necessary, using the same model. APMC has a large maternal fetal medicine program staffed by seven employed perinatologists specializing in high- risk pregnancies. The program is expected to have 10 employed perinatologists by the end of 2018. Agency for Health Care Administration AHCA is the state health-planning agency charged with administration of the CON program as set forth in sections 408.31-408.0455, Florida Statutes. Context of the Arnold Palmer Application Approximately one in 100 babies are born with CHD. The majority of these disorders can be treated, at least initially, with reconstructive surgery. The earlier a congenital heart defect can be repaired, the better the chances the patient has to not only survive but to grow normally in infancy and thrive. However, some children with CHD have a severity level such that current methods of reconstructive surgery are not adequate to produce what might be called a cure. Treatment of such cases is called “palliation.” As a result of medical and surgical advances in palliation, children are now surviving complex CHD in numbers that previously were not thought possible. However, in the most severe cases, the palliation is fairly short-term. Many children who receive palliative surgery ultimately will progress to end-stage heart failure despite having had multiple operations and extensive medical management, as their heart will eventually begin to have decreased function due to the underlying anomaly. Prior to the advances in palliative care, many children born with complex CHD simply did not survive long enough to receive a PHT. Today, the number of children who face heart failure later in life, rather than earlier, is increasing. Successful palliation has resulted in significantly more CHD patients requiring PHT at age 10, 15, or 20, rather than as infants or young children. Another category of children requiring PHT are those who do not have CHD, but who have an acquired problem known as cardiomyopathy. Children with cardiomyopathy may present in heart failure at any time and at any age, having gone from a state of completely normal function--exercising, growing, doing well in school--to within two or three days having end stage heart failure. About half of these children recover with medication and intensive care--which APH does extremely well on a regular basis. But those who do not recover will require a PHT. Patients with CHD tend to be more medically and surgically complex and higher risk than patients with cardiomyopathy with respect to PHT. On a percentage basis, and because of advancements in palliation, there are more CHD patients and fewer cardiomyopathies in the teenage cohort requiring PHT today than there were 10 years ago. 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 is defined by rule 59C-1.002(41) as a “tertiary health service,” 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). If approved, the proposed program at issue in this proceeding would 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 OSTA 3. However, that does not mean that OTSA 3 residents lack access to these transplant services. In fact, the unrefuted evidence demonstrated that pediatric residents of OTSA 3 have received transplants at Shands, by way of example. At hearing, APMC agreed that OTSA 3 residents are accessing these services at existing providers in Florida, with APH referring a few of these patients on average to Shands every year for these services. 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 (aged 0-14) heart transplant discharges by year for the four existing Florida PHT programs during the reporting period from June 30, 2013, to June 30, 2017: HOSPITAL HEART TRANSPLANT FY 12/13 FY 13/14 FY 14/15 FY 15/16 FY 16/17 UF Health Shands Hospital 13 4 17 12 9 John Hopkins All Children’s Hospital 6 13 10 9 7 Memorial Regional Hospital 5 3 4 11 4 Jackson Memorial Hospital 1 2 1 3 1 TOTAL 25 22 32 35 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 seen above, only 21 PHTs were performed statewide during the 12-month period July 1, 2016, to June 30, 2017, for an average program volume of only 5.25 cases for the four existing programs. There are four existing and one CON-approved PHT programs in Florida. This is more than every state in the country except California, which also has five programs but more than double the pediatric population of Florida. And three of the California programs have a volume of five per year or less. Texas, another geographically large state with over 1.4 million more children than Florida, has only two centers. The number of PHTs is also impacted by a national shortage in donor hearts. Unfortunately, there are not enough donor hearts to meet the demand for pediatric heart patients in the United States. While the total number of PHTs in the United States increased between 2012 and 2015, it has more recently declined from 2015 to 2017. Based on population, the number of PHTs in Florida is higher than the national average. Thus, while fortunately its incidence is rare, Florida residents in need of PHT are currently able to access this life-saving procedure. Arnold Palmer’s “Readiness” to Implement a PHT Program APH has over 14 years of experience performing complex congenital heart surgery and has met the majority of the demand for complex pediatric cardiac surgery in Central Florida for the past 25 years. In that time, APH has performed thousands of heart operations and achieved extraordinary outcomes, which are most dramatically apparent in the highest acuity levels. APH is the largest pediatric cardiac surgical program in Central Florida. Because WPH and APH are regional centers of excellence for neonatal and pediatric cardiac care, APH has a large proportion of complex, single-ventricle patients in its existing pediatric cardiac program. In turn, approximately 70 percent of the patients who ultimately require PHT have complex, single-ventricle physiologies. In addition, APH is a regional referral center for patients presenting with cardiomyopathies that may require PHT services. APH voluntarily participates in the Society for Thoracic Surgeons (STS) National Congenital Heart Surgery Database (the “STS database”). The STS is the official organ for the collegial development of the field of thoracic and cardiac surgery, both adult and pediatric. There are over 75,000 physician and institutional members of the STS. The STS maintains the largest worldwide data collection of multiple variables and data points pertaining to every cardiac surgery performed by its members. The data is rigorously analyzed to measure the actual and risk-adjusted expected performance and quality of each member facility, and to support quality improvement projects, as well as original research in the field. The STS is a national organization, and its publishing arm, the Annals of Thoracic Surgery, is one of the top-ranked journals in the world. Once a year, the STS updates a running, four-year cumulative tally of outcomes for each participating institution in the country and publishes a one-page report summarizing the facility’s performance.1/ The STS stratifies cardiac surgical cases by “STAT” level, which is a measure of acuity, complexity and risk.2/ STAT 1 is the simplest kind of congenital heart defect that generally requires a straightforward surgical repair, while STAT 5 reflects complex, high-acuity, and high- risk conditions and surgeries. The STS public report contains four columns. The first lists the STAT levels. The second column lists the facility’s number of deaths divided by the number of patients operated on at that facility within the given STAT category. The third column, “Expected” reflects the STS’ expectation of mortality within the reporting institution’s program based on the relative acuity of the cases performed at that institution and if the reporting hospital performs consistent with the national average for that STAT level. The data in the third column reflects the very high acuity level of APH’s CHD patient population, i.e., the risk factors for the patient not surviving their congenital heart defect and surgery. The fourth column, “Observed/Expected” (the “O/E ratio”), divides the program’s actual mortality by its expected mortality. The O/E ratio is widely accepted as the standard metric for evaluating performance in pediatric cardiac programs because in contrast to reporting raw mortality, the STS O/E ratio is risk-adjusted using multivariable regression models which enable the STS to risk adjust each institution’s mortality and compare it against the national norm; i.e., to produce a model containing every case that every program did within the four-year time period measured. An O/E ratio of less than one means the facility is doing better than the overall STS database. For STAT 2 cases, APH’s O/E ratio is 0.58, meaning that APH has achieved close to one-half the mortality that STS expects APH to have for APH’s STAT 2 cases. Even more impressive, however, is APH’s STAT 5 O/E ratio of 0.24. The analysis conducted by the STS shows that, statistically speaking, a patient in the highest risk STAT 5 category has a four-fold less risk of dying after an operation at APH than at an average pediatric cardiac surgery program in the country. APH has consistently achieved outstanding outcomes in its pediatric cardiac program, on a national basis, for more than a decade. AHCA has recognized APH as first in the state for overall pediatric heart surgery mortality. Mechanical cardiopulmonary support or cardiac extracorporeal membrane oxygenation (ECMO) (referred to as “CPS” within the APH pediatric cardiac program) is a very short-term method of sustaining life when a patient has rapid onset end- stage heart failure.3/ To place a patient on CPS, the cardiac surgeon makes an incision in the base of the neck to expose the main artery to the brain and the main vein draining from the brain. The vessels are controlled by the surgeon and opened, and cannulas are inserted into the vessels and advanced into the heart, or if the chest is open, may be placed directly into the heart, then sutured into place and connected to a heart-lung machine. Often the procedure is done while a baby is sustaining a cardiac arrest. CPS is not the preferred intervention for patients in heart failure who require PHT. Complications from CPS develop exponentially with each 24 hours on the circuit. Thus, CPS can be a contraindication for PHT. Complications from CPS include bleeding from fresh suture lines in the heart, arteries, pericardium, or chest wall; bleeding in the brain, or at IV line locations; and clotting caused by the CPS lines, which can be devastating if the clot travels to the brain, kidneys, bowel, or heart. There also is significant risk in moving a patient on CPS. Particularly in neonates, the movement of a cannula by even a few millimeters can obstruct circulation, or cause thrombus or ventilator issues. CPS thus is not a sustainable method for bridging a patient to PHT, when the majority of patients face long periods on a waitlist. The proper method for bridging to PHT is the use of ventricular assist device (VAD) therapy, relatively recently approved for use in pediatric patients. A VAD is a device that does not mechanically process or oxygenate the blood, and does not require transfusion, and, thus, provides far more stable and longer-term maintenance of life while a patient waits for PHT. In contrast to CPS, which cannot safely be used more than a few days to, at most, two weeks, a heart failure patient may safely remain on a VAD for months in the hospital while they await a donor heart. The ability to implement VAD therapy enhances quality of care for patients and increases a patient’s eligibility for PHT. Currently, the standard of care is that hospitals that do not provide PHT should not provide VAD therapy. Consequently, patients at APH with rapid onset heart failure do not have access to VAD therapy and must be placed on CPS. There is no question that OH has built a mature, high quality pediatric cardiac program at APH over the past 14 years. The organization has the demonstrated experience and success in complex reconstructive heart surgery and medical management of patients with heart disease. With the additional staffing described below, APH would be able to successfully implement a PHT program, assuming need for such a program is demonstrated. The Arnold Palmer Application APMC is proposing to establish a PHT program in Orlando, which is located in OTSA 3. The application was conditioned on APMC promoting and fostering outreach activities for pediatric cardiology services, which will include the provision of pediatric general cardiology outpatient services at satellite locations within OTSA 3. This condition is not intended to include any outreach activities beyond establishing outpatient clinics in OTSA 3. There is currently no PHT provider in OTSA 3. There are, however, three providers of pediatric open-heart surgery and pediatric cardiac catheterization within the OTSA. APMC proposes that Dr. William DeCampli and Dr. David Nykanen, who currently staff its pediatric cardiac program, would also staff the proposed transplant program. However, neither has worked in a transplant program in over 14 years. APMC acknowledges its need to recruit additional nurses to staff the program. It also concedes that it might recruit nurses without transplant experience, who may need to obtain necessary training at a different facility. Additionally, APMC has not yet recruited a physician specializing in pediatric heart failure, which the applicant agrees is necessary to implement the program. At hearing, much of APMC’s case focused on its readiness and desire to offer a full spectrum of services to cardiac patients at its hospital. This is reflected in the testimony of Sharon Mawa, a nurse operations manager in APMC’s CVICU: And I feel Arnold Palmer is ready. We—it’s all encompassed. When you have a heart program, you—you want to do it all . . . . And the only piece that we are unable to provide, that we’re—that we haven’t been ready for, and I feel like we’re ready for now, is heart transplant. And I think to do a heart program well, you should be able to do all of it for that patient. However, as detailed further below, such arguments do not demonstrate community need for the proposed service, but instead represent an institutional desire to expand the facility’s service lines. A public hearing was held in Orlando on January 8, 2018, pertaining to APMC’s PHT application. APMC participated in support of the application at this hearing. About one year earlier, on January 10, 2017, a public hearing was held in Orlando pertaining to a CON application to establish a PHT program submitted by Nemours Children’s Hospital (Nemours), which is also located in Orlando. OH/APMC participated at that hearing in opposition to the Nemours application. OH/APMC submitted written opposition to the Nemours PHT program at that time, urging the Agency to deny Nemours’ proposal. OH/APMC’s 2017 opposition to the Nemours PHT application included argument related to access and need for the service in OTSA 3. OH/APMC’s written opposition to the proposed Nemours program included letters of opposition authored by Dr. DeCampli and Dr. Nykanen. In urging the denial of the Nemours’ PHT application, Dr. Nykanen told AHCA: For the past 14 years at Arnold Palmer Hospital for Children we have referred our patients requiring advanced heart failure management, including cardiac transplantation, predominantly to Shands Children’s Hospital. We have been the largest referral source of these patients in the region over the past decade. Many of our patients have had the opportunity to be evaluated as outpatients, which is always preferable. The management of this patient population is medically intense but surgery is rarely an emergency. The geographic proximity of Gainesville to our region is not a significant barrier with respect to transport from one facility to the other. The availability of organs for transplantation mandates the time from assessment to surgery which is measured in weeks to months. The Shands team has been readily accessible to us day or night and I am aware of no financial or programmatic barriers to providing this specialized care to our patients. We have been pleased with the outcomes achieved. (emphasis added). In December 2017, several months after opposing Nemours’ PHT proposal, APMC submitted its own PHT application to AHCA. UF Health Shands UF Health-Shands Hospital (Shands), as an existing provider of PHT in OTSA 1, participated extensively in this proceeding notwithstanding its acknowledged lack of standing to formally intervene.4/ Shands is located in Gainesville, Florida and is the sole provider of PHT in OTSA 1. OTSA 1 extends from Pensacola to Jacksonville, south to Gainesville and west to Hernando County. 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 June 18, 2018 (ruling on APMC’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). Shands is located in Gainesville, Florida. Shands Children’s Hospital (SCH) is an embedded hospital within a larger academic health center. SCH has 202 beds and is held out to the public as a children’s hospital. SCH occupies multiple floors of the building in which it is located, and the children’s services are separated from the adult services. SCH has its own separate entrance and emergency department. SCH is nationally recognized by the U.S. News and World Report as one of the nation’s best children’s hospitals. SCH has its own leadership, including Dr. Shelley Collins, an associate professor of Pediatrics and the associate chief medical officer of SCH who was called as a witness by the Agency. As a comprehensive teaching and research institution, SCH has between 140 to 150 pediatric specialists who are credentialed. It has every pediatric subspecialty that exists and is also a pediatric trauma center. In the area of academics and training, SCH has over 180 faculty members and approximately 50 residents, and 25 to 30 fellows in addition to medical students. SCH has 72 Level II and III Neonatal Intensive Care Unit (NICU) beds. It also has a dedicated 24-bed pediatric intensive care unit, as well as a dedicated 23-bed pediatric cardiac intensive care unit, both of which are staffed 24/7 by pediatric intensive care physicians, pediatric intensive care nurses, and respiratory therapists. As a tertiary teaching hospital located in Gainesville, 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 the Agency. Ms. Osbrach oversees the transplant social workers that provide services to the families of patients at SCH. 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 help the families by serving as navigators through the system. These social workers are part of the multi-disciplinary team of care, and they stay involved with these families for years. Shands is adept at helping families with the issues associated with receiving care away from their home cities. Shands has relationships with organizations that can help families that need financial support for items such as lodging, transportation, and gas. Shands has 20 to 25 apartments in close proximity to the hospital that are specifically available for families of transplant patients. Shands also coordinates with the nearby Ronald McDonald House to secure lodging for the families of out-of-town patients. Ms. Osbrach’s ability to empathize with these families is further amplified because her own daughter was seriously ill when she was younger. As Ms. Osbrach testified, while she was living in Gainesville, she searched out the best option for her child and decided that that was actually in Orlando. She did not hesitate to make those trips in order to get the highest level of care and expertise her child needed at that time. SCH accepts all patients, including pediatric heart transplant patients, regardless of their financial status or ability to pay. At final hearing, both Ms. Osbrach and Dr. Pietra testified at length about the different funding sources and other resources and assistance that are available to families from lower social economic circumstances that have a child who may need a transplant. SCH is affiliated with the Children’s Hospital Association, the Children’s Miracle Network, the March of Dimes, and the Ronald McDonald House Charities. Both Shands and APMC witnesses agreed that the quality of care rendered by SCH is excellent. ShandsCair Shands operates ShandsCair, a comprehensive emergency transport system. ShandsCair operates nine ground ambulances of different sizes, five helicopters, and one fixed wing jet aircraft. It owns all of the helicopters and ambulances so it never has to wait on a third-party vendor. ShandsCair performs approximately 7,000 ground and air transports a year. ShandsCair selects the “best of the best” to serve on its flight teams. ShandsCair has been a leader in innovation, implementing a number of state-of-the-art therapies during transport, such as inhaled nitrous oxide and hypothermic for neonates that are at high risk for brain injury. ShandsCair is one of just three programs in the country that owns an EC-155 helicopter, which is the largest helicopter used as an air ambulance. This helicopter is quite large, fast, and has a range of approximately 530 miles one way. This makes it easier to transport patients that require a significant amount of equipment, including those on ECMO. The EC-155 has room for multiple patients and the ability to transport patients on ventricular assist devices, ventilators, and other larger medical equipment. The Orlando area is well within the operational range of both ShandsCair’s ground and air transport assets. Transporting Pediatric Patients on ECMO In its CON application, one of the reasons APMC contended that its application should be approved is that it is too dangerous to transport patients on ECMO. Timothy Bantle, a certified respiratory therapist and the manager of the ECMO program at Shands, was called as a witness by the Agency. The ECMO program at Shands was established in 1991, and Shands has supported over 500 patients on ECMO. When Mr. Bantle began working in the Shands ECMO program in 2008, all ECMO patients at Shands were supported by an ECMO machine that utilized a roller head pump. In addition to the machine’s bulky size and weight, there was an inherent risk of the occlusion pressure causing a rupture. In 2014, Shands began using a newer, much smaller CARDIOHELP ECMO machine. In addition to weighing at most 20 pounds, the CARDIOHELP ECMO machine utilizes a centrifugal pump, instead of a roller head pump, which eliminates the risk of circuit ruptures. The technology in the CARDIOHELP ECMO machines is outstanding, and it is much easier to manage patients on the newer machines than the older machines. Shands now has nine of the newer and far more compact CARDIOHELP ECMO machines. Shands uses the CARDIOHELP ECMO machine for both veno-arterial (VA) and veno-venous (VV) ECMO and for every patient population, including infants. In the current fiscal year, Shands has had 67 patients on the CARDIOHELP ECMO machine. Shands has safely transported both adult and pediatric patients on ECMO. When transporting a patient on ECMO, the transport team includes a physician, an ECMO primer, a nurse, and a respiratory therapist. In addition to being highly trained, the transport team discusses the specifics of each patient en route, including discussing the situation with the referring doctor so they arrive fully prepared. Mr. Bantle persuasively testified that a properly trained team, using the newer CARDIOHELP ECMO machine, can transport these patients safely. ShandsCair has safely transported numerous pediatric patients on VA- and VV-ECMO by both ground and air, including pediatric heart transplant candidates. The newer CARDIOHELP ECMO equipment makes transport of ECMO patients much easier. ShandsCair has flown simultaneous, same day ECMO transports to the Grand Cayman Islands and to Miami. Transporting ECMO patients on the CARDIOHELP ECMO machine has become so routine that Dr. Weiss does not go on those flights. ShandsCair has also safely transported small infants on VA-ECMO, including a three-kilogram infant who was recently transported from Nemours on VA-ECMO, and after arrival at Shands was transitioned to a VAD and is now awaiting a heart transplant. The testimony of Dr. Weiss and Mr. Bantle regarding Shands’ ability to safely transport pediatric patients on ECMO was substantiated by the testimony of Drs. Fricker, Pietra, and Collins. The overwhelming evidence established that ShandsCair can safely transfer pediatric patients, including infants, on ECMO by both ground and by air. Shands’ Pediatric Heart Program The congenital heart program at Shands includes two pediatric heart surgeons, and a number of pediatric cardiologists, including Dr. Jay Fricker and Dr. Bill Pietra, both of whom testified for the Agency. 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. 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 then went to Denver, specifically to do transplant training under Dr. Mach Boucek, who was one of the pioneers in pediatric infant transplant. He came to the University of Florida and Shands in August 2014, and he is now the medical director for the UF Health Congenital Heart Center. Shands performed its first PHT in 1986. Shands provides transplants to pediatric patients with both complex congenital conditions and cardiomyopathy patients. Shands takes the most difficult PHT cases, including those that other transplant centers will not take. PHT patients are referred to Shands from throughout the state, with many patients coming from central and north Florida. Every patient that is referred for transplant evaluation is seen and evaluated by Shands. While transplantation is not an elective service, it also is very rarely done on an emergent basis. Some conditions are diagnosed well in advance of the need for a transplant. It is not uncommon for a patient to be seen by a Shands physician for a number of years before needing a transplant. Pediatric transplant patients now survive much longer, and frequently well into adulthood. Unlike APH, Shands has the ability to continue to care for those patients as they transition from childhood to becoming adults. The Congenital Heart Center at Shands has a good relationship with APH. Physicians at APH have not only referred patients to Shands for transplant evaluation, they have also specifically recommended Shands to parents of children in need of a heart transplant. Shands operates a transplant clinic at Wolfson Children’s Hospital in Jacksonville. Approximately once a month a Shands transplant physician, a transplant coordinator, and nurses will go to Wolfson to evaluate patients with PHT issues. Wolfson personnel, such as ECHO techs and nurses, are also involved. Before APH filed its CON application, Dr. Pietra twice asked Dr. Nykanen about the possibility of Shands establishing a similar joint clinic at APH. Dr. Nykanen replied by stating he would need to confer with his colleagues, but never otherwise responded to these inquiries. Dr. Pietra testified that he would not be opposed to a joint venture clinic with APMC. Managed care companies are now a significant driver of where patients go for transplantation services. Managed care companies identify “centers of excellence” as their preferred providers for services such as pediatric heart transplantation. Shands is recognized by a majority of the major managed care companies that identify pediatric transplant programs as a center of excellence. In addition, the congenital heart surgery program at Shands has a three-star rating, which is the highest rating possible, and one that only 10 percent of such programs achieve. The quality of care provided by the PHT program at Shands is superb. The most recent Scientific Registry of Transplant Recipients data for Shands, for pediatric transplants performed between February 1, 2014, and December 31, 2016, is excellent. There is no credible evidence of record that any pediatric patient in OTSA 3 was denied access or unable to access an existing transplant program. To the contrary, the evidence established that UF Health Shands and ShandsCair are currently serving the needs of OTSA 3 residents who need a PHT. The APMC CON application was not predicated on any argument that a new program is needed because of poor quality care at any of the existing pediatric transplant programs in Florida. Rather, Dr. Nykanen, the co-director of The Heart Center at APH, testified that Shands provides outstanding medical care, and that he has been “happy with the care” received by the patients he has referred to Shands for PHT. At hearing, APMC witnesses suggested that the Shands program is unduly conservative in accepting donor hearts from beyond 500 miles, and may have some “capacity” issues in its pediatric cardiac intensive care unit (CICU). These statements, made by persons with no first-hand knowledge of the operations of the Shands program, are not persuasive. APMC called Cassandra Smith-Fields as an expert witness. Ms. Smith-Fields is the administrative director for the transplant program and dialysis services at Phoenix Children’s Hospital. Phoenix Children’s Hospital is the only PHT center in Arizona. Notably, two states bordering Arizona, Nevada and New Mexico, do not have PHT centers. Ms. Smith- Fields noted that the volume of transplants at Shands had recently declined from 18 to 11. However, in 2016, by volume, Phoenix Children’s Hospital was the second largest pediatric heart transplant center in the country with 24 transplants, but in 2017, its volume had dropped to 14. Ms. Smith-Fields agreed that “you have to always be careful drawing inferences from numbers that are low in any matter.” Ms. Smith-Fields testified that based upon her review of Scientific Registry of Transplant Recipients data for Shands, Shands did not appear to be aggressive in terms of accepting donor hearts beyond 500 miles. However, that criticism was based upon a one-year period when Shands’ PHT volume was lower than normal, and during which Shands was able to obtain donor hearts from within a 500-mile radius. Stephan Moore, director of the solid organ transplant and VAD programs at Shands, prepared an exhibit, which showed the location (by state and distance) of Shands donor hearts and lungs recovered from March 2, 2014, through March 18, 2018. This exhibit showed numerous trips by Shands beyond 500 miles to retrieve a donor organ, including trips to Texas, New Jersey, Illinois, and Ohio. During this four-year period, 27.6 percent of the organs recovered by Shands came from within Florida, and the remaining 72.3 percent were obtained from out of state. This data not only refutes Ms. Smith-Fields’ testimony on this issue, it also again illustrates why, due to the variability of PHT heart program volumes and availability of donor hearts, one should be extremely cautious in drawing conclusions based upon a single year of data. In addition, Dr. Pietra testified about the complexity of these cases and how an organ that might be acceptable for one patient would not be acceptable for another, for a host of reasons. Consequently, being conservative and cautious in choosing the right heart for each patient are good and important traits for a pediatric heart transplant program, particularly for one that wants the organ to work well for the patient long- term. Dr. Elise Riddle, a cardiologist practicing at APMC, testified that she was aware of instances when there had been a delay in obtaining a bed at Shands for a patient being referred for transplant services. However, Dr. Pietra testified that Shands has never refused a patient because a bed was not available, and that any delay would have been at most a matter of hours. In addition, Dr. Collins, who regularly reviews the throughput numbers of Shands CICU, testified that there was no need to expand the size of the unit. APMC did not question Dr. Collins about the unit’s occupancy rate, nor did it make any attempt to otherwise obtain that information. Dr. Riddle also testified that she had not been informed when a former patient had returned to the Orlando area following a successful PHT at Shands. However, Dr. Pietra testified at length about how Shands coordinates care with the patient’s primary care doctor and referring cardiologist post discharge, and works to develop a team to assist with follow care. Dr. Pietra testified: But we try to, again, develop a team and the team has to include like a local physician and usually a family practice or a pediatrician as the captain. If the patient’s got that, you feel a lot better about having a patient leave the local area and return to their hometown, as you say, so that they can be seen kind of in conjunction or collaboration with us in their hometown. If they have a referring cardiologist, that makes it that much easier sometimes to have a more sophisticated follow up done if needed. But again, the patient belongs to the transplant program in the long run, and so you are going to continue to offer them follow-up care basically for life. Since coming to Shands in August 2014, Dr. Pietra has updated many of the program’s protocols, including the protocols for immunosuppression, frequency of follow-up visits, and what is included in follow-up visits. Dr. Pietra has also initiated more written contracts between a prospective patient’s parents and the program, which make it very clear what the expectations are for the family. Two parents, one of whom lives in Clermont (one hour and 40 minute drive from Gainesville) and one of whom lives in Cocoa Beach (two hours and 35 minute drive from Gainesville) testified that their child had received a PHT at Shands in Gainesville, and that there were no issues with follow-up care for their children post-transplant. Volume/Outcome Relationship in Pediatric Heart Transplantation At the final hearing, experts for both sides agreed that there is a positive relationship between PHT volume and outcomes. In complex, highly specialized areas involving patients with rare diseases or conditions, volume provides experience not only for the surgeons but for the entire team. This is particularly true for pediatric heart transplantation, where higher volume keeps the entire team and ancillary staff functioning at a very high level. Both Dr. Pietra and Ms. Smith-Fields agreed that a minimum of 10 or more PHTs annually is a good standard for maintaining the proficiency of the entire transplant team. In Calendar Year 2017, there were only 32 PHTs in Florida. Both Dr. Pietra and Dr. Fricker testified about how the statewide volume made it very difficult to justify approving a sixth program in the State, and that the proliferation of programs would result in most of the programs not able to achieve the 10 or more transplants per year goal. Indeed, during the 12-month period of July 1, 2016, through June 30, 2017, none of Florida’s four existing PHT programs met the minimum volume standard of 10 PHTs. In addition, PHT programs are measured based on outcomes, and a single fatality in a small program can be devastating to that hospital’s quality metrics. As such, small programs are often less willing to take more complicated patients. Ironically, 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. Johns Hopkins All Children’s Hospital Johns Hopkins All Children’s Hospital (JHACH) is located in St. Petersburg, OTSA 2, AHCA District 5. According to reported AHCA data, JHACH performed seven PHTs during the 12 months ending June 2017. Several APMC witnesses made references to possible issues with the PHT program at JHACH based upon newspaper articles they had read. Such articles are hearsay, were not specifically identified or discussed by any witness, and accordingly, cannot form the basis of any finding of fact. Only one of APMC’s witnesses, Dr. Riddle, had any personal knowledge about JHACH, and she has not worked there or been involved in the care of any patients there since February 2016. The only APMC witness who actually looked at any data for JHACH, Ms. Smith-Fields, testified that JHACH had no deaths on its waiting list, that it was aggressive in retrieving donor hearts beyond 500 miles, and that had transplanted two patients during the first four months of this calendar year. When the Centers for Medicare and Medicaid Services (CMS) identifies a program as having deficient outcomes, it will send a peer review team to thoroughly assess the program. If necessary, CMS will enter a systems improvement agreement, which may include the appointment of a quality administrator to help the program improve its operations. There was no evidence presented that CMS had taken any such steps with JHACH. As discussed above, it was uncontroverted that there is a positive correlation between volumes and outcomes, and that a minimum of 10 transplants a year is an important volume threshold in order to maintain a high-quality program. With Florida already having five existing and approved programs, it is currently not possible for all five programs to achieve 10 transplants a year. Approving a new program in the State based upon rumors about the status of an existing program would in all likelihood only reduce the average volume even further below the 10 transplants per year standard, and lead to poorer outcomes. AHCA’s Preliminary Decision Following AHCA’s review of APMC’s application, as well as consideration of comments made at the public hearing held on January 8, 2018, and written statements in support of and in opposition to the proposals, AHCA determined to preliminarily deny CON application 10518. AHCA’s decision was memorialized in a SAAR dated February 16, 2018. 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. In addition to need methodologies presented by an applicant, AHCA also looks at availability and accessibility of services in the area to determine whether there is an access problem. Additionally, an applicant may attempt to demonstrate that “not normal” circumstances exist in the proposed service area sufficient to justify approval. Statutory Review Criteria Section 408.035(1), Florida Statutes, establishes the statutory review criteria applicable to CON Application No. 10518. The parties have stipulated that APMC’s CON application satisfies the criteria found in section 408.035(1)(f) and (h). The Agency believes that there is no need for the PHT program that APMC seeks to develop, because the needs of the children in the APMC service area are being met by other providers in the State, principally Shands and JHACH. 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)5/ 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 programs. Thus, it is up to the applicant to demonstrate need in accordance with section 408.035 and rule 59C-1.044. There are four OTSAs in Florida, numbered OTSA 1 through OTSA 4. APMC is located in OSTA 3, which includes the following counties: Seminole, Orange, Osceola, Brevard, Indian River, Okeechobee, St. Lucie, Martin, Lake, and Volusia Counties. (See § 408.032(5), Fla. Stat; Fla. Admin. Code R. 59C-1.044(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: APH, Florida Hospital for Children, and Nemours. There are four existing providers and one approved provider of PHT services in Florida: Shands in OTSA 1; JHACH in OTSA 2; Jackson Memorial Hospital in OTSA 4; and Memorial Regional Hospital, d/b/a Joe DiMaggio’s Hospital in OTSA 4; and an approved program in OTSA 4, Nicklaus Children’s Hospital, which received final approval from AHCA in August 2017. APMC’s Need Methodology 1: Ratio of Pediatric Cardiac Surgery Volume to PHT Case Volume To quantify need for a new PHT program in AHCA District 7, OTSA 3, APMC presented two “need methodologies.” According to the applicant, there is an observed correlation between a PHT center’s volume of congenital heart surgery and its PHT case volume. It should be noted that consistent with the rest of the application--which was focused on APH’s capabilities rather than community need for the service--both methodologies were designed to support the assertion that APMC could potentially attain a volume of 12 transplants by year two of operation. While APMC’s ability to generate 12 transplant cases is pertinent under rule 59C-1.044(6)(b), it is not indicative of unmet community need for this service. For example, if APMC retains or diverts patients who would otherwise have had access to these services through an existing provider, then they may be improving convenience whilst failing to satisfy any unmet community need. The first numeric methodology advanced by APMC in support of its proposal relied on an assumed correlation or a ratio between open-heart surgery cases and PHTs performed by the four existing PHT programs in Florida for calendar year 2016. The applicant then assumed that it would perform the mean rate experienced by the existing programs, in its second year of operation. When applied to APMC’s forecasted cardiac surgeries during the second year of operation (167), it arrived at a projected PHT volume of 11.7 by year two of operation. There are several issues with this methodology. The 11.7 projection is still below the threshold 12 transplants required under rule 59C-1.044(6)(b). The methodology also relied on figures for the 0-17 age cohort. APMC did not apply either methodology considering only 0-14 age data.6/ Additionally, APMC failed to demonstrate that there is any statistically predictive link between the two variables. The data presented in APMC’s application suggests that the correlation is weak, at best. For example, Bates page 0053 of the application reports Shands as having performed 140 pediatric cardiac surgeries and 15 pediatric heart transplants in 2016, while Memorial Regional Hospital performed more surgeries at 170, but less than half the transplants at seven for the same year. While APMC attempts to control for this variability by utilizing averages, such variability itself calls the causal relationship into question. Indeed, APMC’s own cardiac surgeon did not believe cardiac surgery volume and PHT volume to be directly related. An additional problem with APMC’s first methodology is that many of the numbers relied upon to reach its calculated forecast of 11.7 appear to be inflated. The 7 percent average, which APMC applies to its own facility, is not an accurate reflection of the true average rate among the four existing centers for 2016. While the 2016 transplant volume used represented the statewide total, APMC considered only the cardiac surgery volume reported by these four centers. Stated differently, APMC calculated a ratio considering the entire universe of one variable but not the other. The actual total number of cardiac surgeries performed statewide for 2016 for aged 0-14 was 1,216, not 491, as utilized as the denominator in calculating the ratio. As Ms. Fitch testified, when one uses the 1,216 surgeries in the formula, the ratio would be roughly 2.8 percent, not the 6.9 percent used by APMC. Then, applying APMC’s proffered number of 167 cardiac surgeries as representing its facility, the forecast would be about five PHTs, not 11.7. APMC only considered the open-heart surgeries performed at the four PHT hospitals, but certainly, the PHT patients, if they had open-heart surgery at all, may have had such surgeries at other facilities. As a pediatric OHS provider, APH is itself a good example of this, having provided 99 pediatric open-heart surgeries in 2016 that were not considered in the denominator of the formula. APMC’s Need Methodology 2: Ratio of PHT Volume to Common Indicators for PHT. APMC’s second need methodology is based on the identification of the International Classification of Disease (ICD) ICD-10 codes that are the most common indicators for PHT, taking into account acuity and based on APH’s actual experience. Starting with an analysis of ICD-9 codes and updating to ICD-10 codes as the most currently available model, APMC attempted to correlate the ICD-10 codes with the incidence of PHT in Florida hospitals using data from the AHCA inpatient database. This analysis produced an average ratio of the “most frequent indicators” to PHT cases, of 0.187. APMC then identified the volume of patients within OTSA 3 discharged under the top “most frequent” ICD-10 code indicators for PHT. Applying a conversion rate of 0.100 to this potential pool of PHT patients results in a forecast of 8.2 potential PHT cases in year 1 of APH’s PHT program. Holding constant the baseline potential patient volume in OTSA 3 and applying a conversion rate of 0.180 to years two and three resulted in a forecast of 14.8 PHT cases in OTSA 3 in years two and three. As with the previous methodology, this methodology is rejected, both as being an unreasonable basis for forecasting 12 PHTs by year 2, and as not being indicative of community need in OTSA 3 for this service. APMC presented no evidence that a link between the identified diagnosis codes and an eventual PHT exists or is predictive for any individual or group of individuals. Indeed, its health planner admitted that no statistical analysis was undertaken to test the validity of a causal relationship between these variables. Further, it is unconvincing that the average performance of the four existing long-established transplant programs over three recent calendar years is a reliable predictor of the prospective future performance of a new program by its second year of operation. This methodology, similar to the first, examined the age-range 0-17, even though rule 59C- 1.044 defines a pediatric patient as one aged 0-14. In considering the numbers of patients who presented at the four hospitals with one of the selected ICD-10 codes compared to the number of transplants, APMC acknowledged the variability in the ratios among the years and between the providers. This is evident from a review of the figures in the chart on Bates page 0055 of the APMC application. For example, according to the table, from 2014 to 2015, the number of inpatients with one of the ICD-10 codes decreased by one at Shands, but the number of PHTs performed over this same period doubled from 10 to 20. Such variability in the ratios suggests that there is no predictive link, and that it is instead other variables that affect PHT volume. Additionally, while this methodology considers diagnoses of patients actually treated in the four transplant hospitals to come up with a ratio, it then relies on average ICD volume of three Orlando hospitals instead of its own volume, without explanation. If APMC applied the ratio to its own ICD-10 volume of 138, as appears on Bates page 0056, without adding the other hospitals, its projected transplant volume would be 24.8 by year two, which is higher than any existing provider in the state. Or, if APMC applied only its own average ICD-10 volume over 2014-2016 of 46, it would result in a projected volume of 8.3 transplants at year two. While APMC’s approach is the one that gets it closest to a projected case volume of 12, it appears arbitrary and lacks credibility. Pediatric Population Growth in OTSA 3. In its application, and at hearing, APMC repeatedly referenced the growing pediatric population in central Florida as a factor supporting approval of its application. For example, APMC pointed out that OTSA 3 experienced the fastest growth rate for the 0-17 age cohort among all of the OTSAs for 2014, 2015, and 2016, and has a very robust projected annual growth rate of 2.7 percent through 2022. Moreover, each of the 10 counties in OTSA 3 is projected to experience rapid growth in the pediatric population, with the most dramatic growth rates in Orange, Osceola, and St. Lucie counties, at 10.3 percent, 12.4 percent, and 9.0 percent respectively. While the projected growth of the pediatric population in OTSA 3 is significant, such growth does not, in itself, demonstrate unmet demand or need for the project. Any increased demand for PHT due to population growth was not quantified by APMC in its application or at hearing, as APMC elected not to utilize a population and use rate analysis as a need methodology. No evidence of population demographics was presented to substantiate APMC’s transplant volume projections. On this issue, the following exchange from Dr. Nykanen’s deposition is informative: Q. When you referred to population information, is it your position that population demographics or population changes are in part a reason for the need for this project? A. As the population of Central Florida and as the population of this district increases the demand for cardiac services increases. So to the extent that you are serving more people, then I would agree, yes, that’s part of the – that’s part of the equation. Is it the tipping point? No. We don’t – we didn’t – nowhere in my discussions with Dr. DeCampli or administration was there the thought that, hey, the population is growing here so we need to provide this service. I think that the – it was more a question of, our program has grown to such a position that we need to provide this service in order to be able to be a quality program offering what we believe to be quality care for our patients. The fact that there are more people here is really not driving the need for it. That doesn’t drive the need, but it just – it does state that there may be more demand. That’s kind of the way that I feel about that. The above exchange, besides downplaying population growth as a significant argument for a PHT program, also reiterates the theme of APMC’s application and entire case, which is a focus on APMC and its institutional desire to expand the services it can provide to its patients. Another argument made by APMC in its application and at hearing is that approval of its program could reduce outmigration of PHT patients. By definition, because there is no existing PHT program in OTSA 3, all patients leave OTSA 3 for this service. However, that alone does not establish need for a new program. As discussed herein, APMC has not demonstrated a sufficient need or an access problem that justifies approval of its application. Outmigration of Donor Hearts There are four Organ Procurement Organizations (OPOs) in Florida, geographically distributed so that there is one OPO centrally located in each of the four OTSAs. The OPO in OTSA 3 has done well in procuring donor hearts notwithstanding the lack of a PHT program in its region. The establishment of a PHT program within an OPO region is known to positively correlate with an increase in the number of donor hearts that the OPO is able to procure. The number of hearts procured in Florida varies annually. In 2016, Florida OPOs procured 30 donor organs. Over 50 percent of the hearts procured in Florida leave the state. However, donor hearts also migrate into the state. With regard to the outmigration of organs from Florida, APMC has suggested that since Florida is a net exporter of organs, this is an additional reason for approval. However, organs harvested in one state are commonly used in another. There is nothing unusual or negative about that fact. There is a national allocation system through the United Network for Organ Sharing (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 APMC application would result in the reduction of organs leaving Florida, or even that such would be a desirable result. APMC also argues that approving its application would increase the number of donor organs that are both procured and transplanted within Florida. Specifically, the applicant suggested that its proposed program would increase public awareness of the need for donor hearts; and, by doing so, increase the supply of donor hearts. However, no record evidence was produced in an effort to demonstrate that the proposed program would increase the supply of organs in Florida. In fact, an APH pediatric cardiologist testified that it is unlikely that adding the proposed PHT program would impact the availability or supply of organs. Rule 59C-1.044(6)(b) Volume Standards Rule 59C-1.044(6)(b) includes additional criteria that must be demonstrated by an applicant. Subsection (6)(b)4. provides that an application for PHT include documentation that the annual duplicated cardiac catheterization patient caseload was at or exceeded 200, and that the duplicated cardiac open heart surgery caseload was at or exceeded 125 for the calendar year preceding the CON application deadline. Cardiac programs in Florida report their open-heart surgery volumes quarterly to a local health council, and the Agency publishes the calendar year totals. In the applicable baseline calendar year of 2016, APH’s duplicated OHS case volume for patients aged 0-14 was 139 OHS cases, satisfying the minimum OHS volume requirement.7/8/ APH also met the catheterization volume threshold by performing 227 cardiac catheterizations for patients aged 0-14 in the baseline 2016 calendar year. 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. 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, Gainesville, or OTSA 4 for transplant services rather than let their child die because the travel distance is too far. To the contrary, the evidence in this record, 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 instance of an OTSA 3 patient being turned down or unable to access a PHT) is without support in this record. The parents of two pediatric patients that received PHT at Shands testified on behalf of the Agency at the final hearing.9/ Their testimony substantiated AHCA’s position that residents of the greater Orlando area have reasonable access to PHT services. One of the testifying parents lives in Brevard County, which is directly east of Orlando. Her daughter likely had a 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. When she was first seen at Shands, her condition was not emergent and 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. Their goal was to find a program that did a good volume of transplants with above average survival rates. After doing this research, they chose Shands. Their daughter received her heart transplant at Shands, is doing well, and is now considering where to go to college. This family did not find the distance to be a problem. This parent also persuasively spoke of her concerns about further diluting the volumes of the existing programs that could result from approval of a sixth PHT program in Florida. This parent also observed that because of the shortage of donors, adding more transplant centers does not necessarily mean there will be more PHTs performed. The other lay witness is the parent of a very young boy who went from appearing to be perfectly healthy to almost dying, and being placed on life support within a 24-hour period. This family lives in Clermont, which is near Orlando. Shortly after her son’s two-month old check-up, the witness took her son to the local hospital thinking he had a urinary tract infection. The hospital sent him to APH for evaluation. As soon as he arrived there, he went into respiratory distress. An echocardiogram was done and showed he had a severely enlarged heart. APH recommended that he be transferred to Shands. Before being transferred, the mother spoke with her sister who coincidentally is a nurse in Chicago who works on the transplant floor. She also highly recommended Shands. Her son was safely transported to Shands by ShandsCair just over 24 hours after being first admitted to APH. When they arrived at Shands, both Dr. Bleiweiss and Dr. Fricker gave the parents their cell numbers and were always there to answer any questions. The infant was placed on a Berlin heart machine until an appropriate donor heart became available. This patient was able to undergo a transplant approximately three weeks after admission, and also had an excellent outcome. This mother testified that the distance to Shands was not a problem, that the social workers and nurses were always available to help, and that follow-up care at Shands has not been an issue. In fact, the patient is now able to have his labs done in Orlando. It is also notable that this patient’s transfer was uneventful and that the patient had no difficulties in being immediately admitted to Shands’ CICU. It is clear from the testimony of these parents that nothing about having a gravely ill child is “convenient.” But it was also clear that for both of these families, having an experienced provider care for their child was much more important to them than geographic proximity. The following exchange summarizes how the young boy’s mother felt about the inconvenience of having to travel from Clermont to Gainesville: Q If you want to hypothetically encounter a family who expressed to you a concern that their child needed a transplant, they resided in Orlando or the Orlando area, but they were concerned about having to travel to Gainesville to receive that service, what would you say to them? A That’s where they need to be and that everything will fall in place, but the most important thing is the care that your child needs. 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 the APMC 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 issues. The testimony of the two parents supports the Agency’s position that obtaining the best possible outcome for the child is the parents’ primary motivation in choosing a PHT program. Financial Access APMC asserts that approval of its proposed program will enhance financial access to care. APMC currently serves patients without regard to ability to pay and will extend these same policies to PHT recipients. APMC’s application indicates that Medicaid/Medicaid HMO will account for 26.8 percent of total patient days in years one and two of the proposal. Self- pay is expected to account for 9.0 percent of patient days in years one and two. However, there was no competent evidence of record that access to PHT services was being denied by any of the existing transplant providers because of a patient’s inability to pay. Not Normal Circumstances APMC alleged the existence of “not normal circumstances” in support of its application. They are categorized as “‘not normal’ circumstances relating to access to PHT for residents of OTSA 3,” and can be summarized as follows: APMC has the one of the largest NICUs under one roof in the country, resulting in a disproportionate volume of newborns at [APH] with complex forms of congenital heart disease; There are patients at APMC who are placed on ECMO or other heart-assist devices after surgery who are too sick to be transferred from APMC to another facility to receive transplant; Forcing patients to accept the high and potentially fatal risks of transport on ECMO presents a major access issue; Post-transplant follow-up care for patients is life-long and can be time- critical, and the ability to provide 24/7 rapid access to specialized transplant urgent care is medically optimal. The first argument related to the size of APMC’s NICU, does not speak to community need. Regardless of how many newborns APH sees, if the needs of these newborns are currently being met by existing programs, then it is difficult to see how this circumstance bears upon need or accessibility to this service. Additionally, to the extent that APMC suggests that the size of its NICU will correlate with a similarly large number of PHT patients, the proposition is unsupported by the record evidence. In fact, APMC admits that its pediatric cardiac surgery program is at the border of the lowest tercile of STS programs by volume. If APH’s NICU yields only a modest to medium cardiac surgery volume, there is no reason to conclude that this NICU will, by virtue of its size alone, yield a high PHT volume. Next, APMC argued that it has had patients who could have potentially benefitted from transplant but who did not receive such services due to their being too sick or otherwise unable to transfer. It is noteworthy that APMC did not identify these patients or provide data in any fashion to bolster this claim. The application referenced 33 NICU patients on ECMO in four years, but APMC conceded that most of these are babies on respiratory or “VV ECMO,” who eventually wean off. The application also references 11 CVICU patients placed on bypass at APMC in the last four years, but no testimony was presented as to the actual number of patients alleged to be unable to transfer. APMC did not maintain at hearing that any of its pediatric patients have died as a result of being unable to transfer to a transplant facility. In fact, any incidence of children being too sick or acute to transfer outside the OH system to a transplant facility appears to be a product of APH clinical decision-making about appropriateness for transplant referral, rather than that such patients were refused at a transplant center or could not have been transferred at an earlier time. At his deposition, Dr. Nykanen discussed the issue: I think that I do agree that patients— pediatric patients in Central Florida can get a heart transplant. And I have sent patients—my patients to Gainesville for a transplant because I felt at least in the patient’s [sic] that they’ve transplanted I can support that I’m doing the right thing for my patient. In answering that question, there are patients that I do not refer for transplant because I just feel that they are not a candidate for traveling for a transplant, medically a candidate for traveling without— for a transplant. So the term reasonable is—is it reasonably accessible. It is accessible, indeed, for the majority of the patients that I feel need a heart transplant. They can travel and get a transplant. However, for some patients it’s not an option for them. Either due to their medical complexity, risks that I consider with transport, and rarely family situation. APMC emphasized the risks of moving pediatric cardiac patients while on ECMO. However, as noted earlier, the credible testimony of witnesses presented by the Agency was that while there are always risks inherent with the treatment of critically ill children, with modern advancements in technology, these transports are done routinely and safely. It is also significant that while APMC cited various risks associated with ECMO transports and underscored the danger to the patient, no APMC witness could point to a single example of a patient that died due to complications with ECMO during a transport. The Agency in its preliminary decision noted that the application lacked any data illustrating mortality or negative outcomes related to pediatric ECMO transports, and no such evidence was forthcoming at hearing. APMC presented no evidence demonstrating that children of OTSA 3 who are transplanted at an existing provider are denied or otherwise unable to access follow-up care. The two mothers that testified for the Agency both stated that they have not had issues accessing follow-up care at Shands. APMC relies instead in its application on theoretical claims about emergent complications that could arise and the challenges of accessing a center. However, these arguments are unconvincing. Both parties agreed that transplant centers can and do work with a patient’s local providers so that patients can receive urgent medical care closer to home and then return to their transplant center as necessary. Dr. Pietra testified that Shands works with primary physicians and providers post- transplant. Shands has developed a thorough protocol for all of its patients, which includes frequent follow-ups. Additionally, Ms. Smith-Fields agreed that at her facility in Arizona (the only PHT provider in that state) the program coordinates with providers local to patients to ensure rapid acute care is accessible, if needed. APMC’s cardiologist, Dr. Riddle, testified that APH does provide acute care and other necessary care to children post-PHT, and that it competently does so. APMC maintained at hearing that post-transplant care is life-long, and that in the event of an emergent situation, immediate access is critical. However, the evidence indicates that existing transplant centers plan for these events. There are more frequent follow-up visits to a transplant center during the period immediately following the transplant. Both Dr. DeCampli and Dr. Riddle testified that organ rejection is more likely to occur during the first year after transplant. Additionally, diagnostic testing can often detect signs of rejection in advance, to allow a transplant center to respond before an acute episode occurs. Indeed, one of the functions of echocardiograms is to scan the heart and detect abnormalities or episodes of rejection. The record reflects that transplant centers, such as Shands, are capable of properly and safely monitoring these patients and dealing with issues of rejection. The evidence in this record does not support the proposition that geographic distance to existing centers is a barrier to patients receiving necessary follow-up care. Orlando Health’s Prior Position APMC’s claim that there is an accessibility issue or a need for PHT services in OTSA 3 is further undermined by its own contrary position on these issues just a few months prior to the submission of its application. In January 2017, OH and APH presented written opposition to Nemours Children’s Hospital’s attempt to establish a PHT program in Orlando. APH also presented oral argument from Drs. Nykanen and DeCampli in opposition to the proposed Nemours PHT program being approved by the Agency. The written statement of opposition, identified on its face to be on behalf of OH and APH for Children, unequivocally advanced the position that PHT services are not needed in OTSA 3, and that they are reasonably available to residents of the service area: Nothing supports the theory in the [Nemours] applications that the proposed services are unique or not otherwise available, or that there is a need for them among the population. * * * Specifically, CON application no. 10471 [Nemours’ PHT application] does not provide any facts that would lead the Agency to conclude that existing pediatric heart transplant services are not reasonably available to residents of the service area. For example, the data shown in CON application no. 10471, Exhibit 15, p. 75, does not reflect time travel distances; existing providers are within the typical two hour drive time standard accepted by health planning experts and the Agency for tertiary services. The personal letter authored by Dr. Nykanen and included as part of the APH opposition was unequivocal and specific in its conclusion that access to these services for residents of OTSA 3 is not a problem. Dr. Nykanen stood by his statement in this proceeding, testifying in his deposition: So we would—we would do anything for our child. I’d travel around the world, you know, halfway around the world if I thought that something would benefit my child. So geographic proximity in that sense probably doesn’t matter. And it doesn’t matter. If I’m an outpatient and I can get in my car and I can go to Gainesville. * * * And I don’t think that it—I honestly don’t think that a two-hour drive is that much of a barrier. It’s a pain and it’s inconvenient. * * * So I think what I intended with that statement and believe it to be true today is that if my child needed a transplant and I could travel to Gainesville and I could get there, I’ll do it, as a family. Is that an inconvenience, yes. Is it a huge barrier, probably not. Because if it, in the balance of things, meant that my child would survive or not, then I would do it. I’d go to London, England if I had to. APMC attempted to justify its prior position as mere concern about the inexperience of the Nemours cardiac program. However, this is contradicted by the record evidence in this case. Dr. Nykanen testified that, at the time of the Nemours public hearing, his expressed position was that there was not a need for PHT services in central Florida. The unambiguous statements by APMC opposing a local competitor’s attempt to establish the same health service that it now claims the children of central Florida need, further undermines the credibility of APMC’s current position, and underscores APMC’s focus on its own interests. The prior position taken by APMC with respect to need and accessibility in OTSA 3 was made with the intent that it be received and considered by the Agency in its decision on the Nemours application. AHCA witness, Marisol Fitch, found this clinical and health planning testimony to be persuasive, and APMC’s prior position that need and accessibility do not support approval of a new PHT program are in line with the record evidence. The glaring inconsistency in APMC’s past and current assertions calls into serious question the credibility of the general, theoretical, and unsubstantiated access problems that are alleged in APMC’s application. 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; Section 408.035(1)(d): The availability of resources, including health personnel, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation; and Rule 59C-1.044(3-4). Quality in the delivery of health care is APMC’s first and foremost strategic imperative. APMC defines “quality” as the simultaneous achievement of excellence in three areas: patient outcomes, patient experience, and patient access. APMC is very deliberate in its approach to metric- driven performance in quality and safety. APMC is the highest- rated system in all of Central Florida within the CMS rating system, which analyzes data for 66 quality improvement metrics. Similarly, APMC is the highest ranked Truven-rated health care system in Central Florida, and is ranked first among the over 30 hospitals analyzed and ranked by Vizient Southeast. The metrics analyzed by these rating organizations include, but are not limited to, mortality rates, readmission rates, cost containment, patient experience scores, emergency department wait times, and infection rates. Through deliberate focus and a compulsive commitment to quality, the APH Heart Center has performed at the highest levels with respect to quality of care and patient outcomes for well over a decade. For its part, the Agency does not dispute that the applicant is a quality provider. However, AHCA does maintain that approval of an unneeded sixth provider of PHT services in Florida could lead to or correlate with negative patient outcomes. Given the relatively low PHT volumes statewide, and agreement that volume is positively correlated with quality and outcome in transplantation, splitting state volume among six providers could negatively impact the quality of this service, as it concerns the residents of OTSA 3 and Florida more broadly. This service is defined by Florida law as a tertiary service of limited concentration. Indeed, APMC agrees that there should not be a PHT program in every hospital, particularly since organs are a limited resource. APMC failed to credibly demonstrate that it would achieve the PHT volumes it projected unless it diverts significant volumes from other Florida providers. Approval of a new program will not create transplant patients that do not exist or are not currently able to reasonably access services. The applicant has not demonstrated that it will achieve volume sufficient to reasonably assure quality care. Rule 59C-1.044(4) requires that applicants meet certain staffing requirements, including: “The program shall employ a transplant physician, and a transplant surgeon, if applicable, as defined by the United Network for Organ Sharing (UNOS) June 1994.” The applicant concedes that it still needs to hire a transplant surgeon and a cardiologist specializing in heart failure, to staff the proposed program. While APH has had difficulty recruiting and retaining a bone marrow transplant physician to implement the bone marrow program approved in 2014, given its outstanding reputation for quality it is likely that APMC would ultimately be successful in recruiting a PHT surgeon and an advanced heart failure cardiologist. 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 APMC’s proposed program would likely improve physical access to PHT services for the very few residents of OTSA 3 that need them. Generally speaking, adding an access point for a service will make that service more convenient and geographically proximate for some. However, given the rarity of PHTs, approval of the APMC program would not result in enhanced access for a significant number of patients. Moreover, there was no credible evidence presented at hearing that any resident of OTSA 3 that needed PHT services was unable to access those services at one of the existing PHT programs in Florida. Based upon persuasive record evidence, there is also clearly a positive relationship between PHT 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, maintaining a volume of no fewer than 10 PHTs per year is critical, “because your relative risk for the next patient that you do is at its lowest” if you stay above that volume. 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 the 12 months ending in June 2016, there were only 35 PHT’s performed in Florida. By the end of June 2017, that number had dropped to 21, with none of the four operational PHT programs meeting the 10-case minimum volume. And when the approved PHT program at Nicklaus Children’s Hospital becomes operational, the per-program volume of PHTs is likely to drop even further. Given the lack of demonstrated need for a sixth program, and low volume of PHT’s statewide, the undersigned is unable to recommend approval of the APMC program knowing that it would further dilute the pool of PHT patients, potentially adversely affecting the quality of care available at the existing programs. 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. There was no persuasive evidence of record that approval of APMC’s application 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 program is not significant enough to justify approval in the absence of demonstrated need. There is no evidence that approval of the APMC application will enhance financial access, or that patients are not currently able to access PHT 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 and entails a significant investment of resources. Given the limited pool of patients, the added expense of yet a sixth Florida program is not a cost- effective use of resources. Section 408.035(1)(i): The applicant’s past and proposed provision of health care services to Medicaid patients and the medically indigent. OH is the designated safety net provider for the Central Florida region. In 2016, OH provided approximately $437 million in unreimbursed charity care. OH’s commitment to provide health care services to its entire community without regard to ability to pay continues today. Fifty-five percent of the patients served by APH are Medicaid beneficiaries, and 5-7 percent are self-pay or uninsured. If approved, OH’s mission and role as a safety net provider would extend to its proposed PHT program.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying CON Application No. 10518 filed by Orlando Health, Inc., d/b/a Arnold Palmer Medical Center. DONE AND ENTERED this 26th day of December, 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 26th day of December, 2018.
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 On September 28, 1977, Petitioner filed its application for a Certificate of Need and for Section 1122 Project Review with Respondent. The Applicati6n is for a 12-station chronic dialysis unit to serve the needs of End Stage Renal Disease (ESRD) patients in Jacksonville, Florida. Petitioner further submitted documentation that it has entered into an agreement with Shands Teaching Hospital in Gainesville, Florida, whereby the hospital agrees to serve as a dialysis back-up unit and as a transplantation center for Petitioner's patients. The proposed service area for Petitioner's facility includes Duval, Nassau, Baker, St. Johns, and Clay counties. The total project cost, including leasehold expenditures, is $708,422.00. Petitioner's application was reviewed by the Health Systems Agency of Northeast Florida, Inc. (the "HSA"). The HSA's governing body met on January 26, 1978, and adopted a motion which recommended denial of Petitioner's application. The rationale for this action was that sufficient dialysis stations would be available to meet the projected future patient load if the existing facilities at University Hospital were utilized on a 3-shift per day basis. The HSA also anticipated the availability of a limited number of new stations at the Veteran's Administration Hospital at some unknown point in the future. By letter dated February 23, 1978, Respondent denied Petitioner's application. The reasons given for denial were those set forth by the Health Systems Agency. On March 22, 1978, Petitioner filed a Petition For Formal Hearing pursuant to Sections 381.494(6)e and 120.57(1), Florida Statutes, and Section 10-5.10(8), Florida Administrative Code. The proper formula for projecting the number of patients who will need dialysis services at the end of a given 12-month period is as follows: Patients presently served (a) +New patients per year (x/l,000,000) +(b) =Total patients in 12 months (c) -Successful transplants -(d) -Mortality (y percent p/year) -(e) Net patients needing services: 12 months (f) The appropriate figures to be utilized in applying this formula to the case at hand are as follows: Patients Presently Served. - A telephone survey conducted by Respondent on April 18, 1978, determined that 90 chronic ESRD patients are presently being dialyzed at University Hospital, the sole chronic dialysis facility in the service area. New Patients Needing Services. - The Health Systems Agency projects population figures for the service area at 732,700 as of the end of 1978 and 748,800 by the end of 1979. These figures were obtained from the Florida Statistical Abstract, 1977. The yearly incidence of ESRD in the service area is conservatively projected to be 80 new patients per 1,000,000 population per year. By applying this incidence rate to the 1978 population projections but without taking into account subsequent population growth during the first three months of 1979, it can be determined that a minimum of 59 persons will enter the ESRD patient pool over the next 12 months. Successful Transplants. - The number of successful transplants is a function of the number of available kidneys minus an estimated percentage of rejections. The HSA projects that there will be six successful transplantations in the year ahead. Mortality. - The HSA projects a patient mortality rate of 15 percent per annum. This figure approximates the most recent statewide average and would result in a determination that 22 of the persons presently in the patient pool will die over the course of the next 12 months. The projections for each variable as cited above result in the following findings when manipulated in accordance with the accepted formula: 4/18/78 - 4/18/79 Patients presently served 90 +New patients per year (80/1,000,000) +59 Total patient pool: 4/18/78 149 -Successful transplants -6 143 -Mortality (15 percent per year) -22 Net patients needing services: 4/18/79 121 The determination of the number of dialysis stations needed to serve the 121 patients who will need services over the next 12 months is a function of dividing this number by the number of patients that each machine will dialyze in a given week (the so-called "utilization factor"). This utilization factor is determined by multiplying the number of patient shifts per day times the number of days per week that the stations are in operation. The sum is then divided by the number of times that the average patient must be dialyzed per week. The product of this division results in the maximum potential utilization of a station in a given week. However, a station should only be utilized at 90 percent of its maximum capacity in order to provide sufficient flexibility for changing patient needs, equipment failure, and other essential variables which reflect the life-sustaining nature of chronic renal dialysis. The parties agree that the proper utilization factor for planning purposes should be based on two shifts per day. Applying this variable to the formula described above results in a finding that 3.6 patients per station per week is the proper utilization factor. Respondent has been utilizing this 3.6 factor in prior applications and it is contained in Respondent's internal working document as being the standard for review. Dividing the projected patient pool at the end of the upcoming 12 months (121 patients) by 3.6 results in a finding that 34 stations will be necessary as of mid-April, 1979. University Hospital in Jacksonville, the sole ESRD chronic dialysis facility in the service area, presently operates 22 stations. By subtracting the number of existing stations (22) from the number of stations needed by this time next year (34), it can be determined that an additional 12 stations will be needed by mid-April, 1979. Petitioner meets all other relevant criteria for Certificate of Need and Section 1122 approval as set forth in the appropriate provisions of Statute and Rule. The stipulation Agreement entered into by the Parties and attached hereto as Exhibit "A" reflects a phasing in of new stations by Petitioner over the course of the next 12 months. This schedule will insure the availability of an adequate number of stations to meet the needs of a growing patient pool but will minimize the impact on the patient pool at University Hospital and thus is in the best interests of everyone involved.
The Issue Whether the Certificate of Need (“CON”) Application No. 10490 submitted by Baptist Hospital of Miami, Inc. (“Baptist Hospital” or “Baptist”), to establish a new adult autologous and allogeneic bone marrow transplant program in Florida’s Organ Transplant Service Area 4 (“TSA 4”) should be approved.
Findings Of Fact Bone Marrow Transplants Bone marrow transplantation is performed after a patient has received very high doses of chemotherapy in order to eradicate cancer. High doses of chemotherapy can cure cancerous cells or cause remission, but chemotherapy can also damage healthy cells. Damage may be done to progenitor cells that create the components for blood, including white blood cells. If progenitor cells are damaged by chemotherapy, the patient may succumb to infection and bleeding. To avoid this problem, physicians remove blood-producing progenitor cells from the patient's blood and bone marrow, and store them while the patient receives chemotherapy. The patient is then reinfused with progenitor blood cells, allowing the patient to make normal blood and recover. This infusion of progenitor cells is commonly referred to as bone marrow transplantation ("BMT"). BMT has become an essential method of fighting blood cancers. BMT is offered in hospital settings, and most transplants are performed on an inpatient basis. However, certain types of BMT services are more frequently being offered on an outpatient basis. BMTs are categorized as either autologous or allogeneic. In autologous BMTs, the patient's own blood and bone marrow cells are removed and then reinfused after chemotherapy. The process begins with apheresis to collect the patient's bone marrow and blood cells. The patient's blood is processed through a machine that separates progenitor cells and stores them. The process of apheresis may take up to five hours. The cells are frozen for later use. The process of freezing blood product is referred to as cryopreservation. The patient then receives chemotherapy and is then reinfused with the patient's own blood and bone marrow cells. Some cancer patients, such as acute leukemia patients, have malignant or compromised blood progenitor cells. In those cases, autologous transplantation is not an option. Instead, progenitor cells must be obtained from an alternative donor, such as a family member or a compatible nonrelative. Allogeneic transplants carry a higher risk of complications, primarily because the introduction of another person's progenitor cells may cause "graft vs. host" disease, which involves the patient’s rejection of the infused cells. Histocompatibility tests help determine whether donated progenitor cells will successfully match with the patient and reduce the chances of graft vs. host disease. BMT is a relatively rare procedure. In 2014, there were 17,303 BMT procedures in the United States involving patients over the age of 21. In 2016, there were 1,026 cases in Florida involving patients over the age of 15. The Regulatory Framework Section 408.032(17), Florida Statutes (2018),1/ defines a “tertiary health service” as 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. Examples of such service include, but are not limited to, pediatric cardiac catheterization, pediatric open-heart surgery, organ transplantation, neonatal intensive care units, comprehensive rehabilitation, and medical or surgical services which are experimental or developmental in nature to the extent that the provision of such services is not yet contemplated within the commonly accepted course of diagnosis or treatment for the condition addressed by a given service. As a tertiary health service, inpatient BMT may only be offered once a hospital has obtained a CON. See §§ 408.032(17), 408.036(1)(f), Fla. Stat.; Fla. Admin. Code R. 59C-1.044. The statutory review criteria for CONs are set forth in section 408.035. The criteria include factors such as: (a) the need for the health service proposed; (b) the applicant’s ability to provide quality care; (c) the extent to which the proposed service will enhance access to healthcare for residents in the applicable service district; and (d) the immediate and long-term financial feasibility of the proposal. AHCA has published Florida Administrative Code Rule 59C-1.044 governing CON review for transplantation services. Subsections (3), (4), (5) set forth criteria that applicants for several different types of transplant programs must satisfy. Subsections (9) and (10) set forth criteria that BMT applicants must "normally" meet before a new transplant program will be approved. AHCA may approve a CON for BMT services when an applicant demonstrates that not-normal circumstances are present. For many CON-regulated services, AHCA predicts the future need for additional beds or services by announcing a "fixed need pool," establishing a numerical need for new programs around the state. See, e.g., Fla. Admin. Code R. 59C-1.0355 (establishing fixed need pool methodology for hospices); 59C-1.036 (pertaining to nursing facility beds), 59C-1.039 (pertaining to comprehensive medical rehabilitation beds). The establishment of a fixed need pool creates a rebuttable presumption that a new service is or is not needed. Balsam v. Dep’t. of HRS, 486 So. 2d 1341 (Fla. 1st DCA 1986); Humhosco, Inc. v. Dep’t. of HRS, 476 So. 2d 258 (Fla. 1st DCA 1985). However, there is no fixed need pool for organ transplantation services such as BMT. With regard to need, a BMT CON applicant must reliably project that it will annually perform 10 autologous and 10 allogeneic transplants. See Fla. Admin. Code R. 59C-1.044(9)(b)1. (pertaining to adult allogeneic BMT programs and stating such applicants “shall be able to project that at least 10 adult allogeneic transplants will be performed each year. New units shall be able to project the minimum volume for the third year of operation.”); Fla. Admin. Code R. 59C-1.044(9)(c)1. (pertaining to adult autologous BMT programs and stating that such applicants “shall be able to project that at least 10 adult autologous transplants will be performed each year. New units shall be able to project the minimum volume for the third year of operation.”). Rule 59C-1.044(2)(f) provides that “[p]lanning for organ transplantation programs shall be done on a regionalized basis.” Accordingly, the rule establishes four transplant service areas (“TSA”), and each one corresponds to an area containing approximately 25 percent of Florida’s population. The TSA relevant to the instant case is TSA 4, which consists of Broward, Miami-Dade, Monroe, Collier, and Palm Beach Counties. The Parties Baptist Hospital Baptist Health South Florida (“BHSF”) is a not-for- profit, faith-based community healthcare organization that operates nine hospitals, approximately 50 outpatient centers, and a medical group serving South Florida, from the Keys to the Palm Beaches. Though each is separately incorporated, all of BHSF's hospitals report to BHSF leadership and represent an integrated hospital system. BHSF has traditionally offered cancer treatment throughout its hospitals. BHSF sought to create a comprehensive cancer institute to serve South Florida, the Caribbean, and Latin America. The cancer institute would offer complete cancer care, from screening and diagnosis, to treatment, and psychosocial support, all the way to palliative care. BHSF created the Miami Cancer Institute (“MCI”) to consolidate the cancer services it offered at many of its hospitals into a single location at Baptist Hospital. The goal was to offer integrated care, so that everything a cancer patient might need could be offered at one location. Though separately incorporated, MCI is an outpatient department of Baptist Hospital in Miami-Dade County, Florida.2/ All of MCI's services are billed through Baptist Hospital, and MCI’s management reports to Baptist Hospital’s administration.3/ MCI sees between 800 and 1,000 cancer patients a day. Because BMT is required to cure most hematological malignancies, including leukemia, myelodysplastic syndrome, pyelolymphatic disorders, myeloma, and lymphoma, BMT services are essential to MCI becoming a comprehensive cancer care center. Consultants and leaders at MCI also concluded that MCI must offer inpatient BMT in order for MCI to offer the full range of care needed by cancer patients. Therefore, Baptist applied to obtain the CON at issue in this proceeding. Baptist recently completed the process of becoming an affiliate of the Memorial Sloan Kettering (“MSK”) Cancer Center in New York. That alliance has now been formed and is operational. MSK is the United States’ leading center for cancer treatment and BMT. The alliance between Baptist and MSK is a strong, integrated linkage between the clinical and research efforts of both organizations. The alliance provides Baptist’s patients with the latest BMT protocols and techniques. MSK and its cancer research will now be able to add a genomic database of Hispanic cancer patients that may result in improved treatment for patients not of European descent. The University of Miami The University of Miami (“UM”) was established in 1925 and is one of Florida’s preeminent universities. The University of Miami Hospital and Clinics (“UMHC”), the Sylvester Comprehensive Cancer Center (“Sylvester”), and the Miller School of Medicine are all part of UM and are all located in Miami-Dade County, Florida. UM’s medical facilities (the Miller School of Medicine, the University of Miami Hospital, Sylvester, and Anne Bates Leach Eye Center) are located on a medical campus shared with Jackson Memorial Hospital in Miami. Sylvester is a 40-bed specialty care center hospital, and the care offered to the residents of South Florida has achieved significant statewide and national prominence. UM is recognized as a Prospective Payment System (“PPS”) exempt institute, which allows it special reimbursement treatment from Medicare for purposes of reimbursement for cancer care provided at Sylvester. There are only 11 such centers in the country. According to AHCA’s discharge database, 147 residents of TSA 4 received BMT treatment in calendar year 2016 at UM.4/ In 2016, UM performed the second highest number of BMTs in Florida.5/ AHCA AHCA is the state agency charged with administering Florida’s CON program. A CON is required before a hospital may offer inpatient BMT. A CON is not required to establish and operate an outpatient BMT program because outpatient services are exempt from CON review. The Non-Parties H. Lee Moffitt Cancer Center (“Moffitt”) is located in Hillsborough County, Florida. Moffitt is the largest BMT program in Florida, performing more than 400 BMT procedures annually. Moffitt is a recognized cancer hospital, and its physicians are recognized cancer researchers. Fifty to 60 residents of TSA 4 travel outside of South Florida each year in order to receive BMT, and the majority receive that treatment at Moffitt. Because the distance from Miami to Moffitt is 250 to 280 miles and a course of treatment can take two to three months, it is a substantial burden for patients in TSA 4 with limited resources to receive BMT treatment at Moffitt. Memorial Hospital West (“Memorial West”) is located in Broward County. Memorial West and UM are the only operational CON-approved adult service providers of BMT services in TSA 4. Memorial West has been a low volume provider of BMT. According to AHCA’s State Agency Action Report(“SAAR”), Memorial West performed nine inpatient BMT procedures in 2012, 15 in 2013, 20 in 2014, 15 in 2015, and four in 2016. Shortly before the final hearing in this matter, Memorial West affiliated with Moffitt in hopes of reinvigorating its largely inactive program. Moffitt has fully staffed and assumed all clinical operations in the Memorial West program. Under Moffitt leadership and clinical management, the Memorial West program performed eight allogeneic and 19 autologous BMTs between July 1, 2017, and January 26, 2018. Good Samaritan Hospital (“Good Samaritan”) is located in Palm Beach County. For many years, Good Samaritan reported to AHCA that it provided a moderately large volume of inpatient BMT. For instance, Good Samaritan reported doing 42 BMTs in 2016. However, it was recently discovered that Good Samaritan had been incorrectly reporting bone marrow biopsies as bone marrow transplants. All parties now acknowledge that Good Samaritan does not have a BMT program. The Prior Proceeding During the October 2015 Other Beds and Programs CON Batching Cycle, Baptist Hospital filed an application to establish a new adult inpatient autologous and allogeneic BMT program in TSA 4. On February 19, 2016, AHCA issued a SAAR preliminarily approving the application. On March 11, 2016, UM filed a petition challenging AHCA’s preliminary decision, and the petition was assigned DOAH Case No. 16-1698CON. After a nine-day hearing in September 2016, Administrative Law Judge (“ALJ”) James H. Peterson, III, issued a Recommended Order on March 30, 2017, recommending that AHCA deny Baptist’s CON application. AHCA rendered a Final Order on June 13, 2017, adopting ALJ Peterson’s recommendation.6/ The Current CON Application Baptist’s current application seeks to establish an adult inpatient autologous and allogeneic bone marrow transplant program located in TSA 4. On August 18, 2017, AHCA issued a SAAR preliminarily approving Baptist's CON application. Baptist has self-imposed three conditions on its application. The first condition is that the proposed BMT program will be located at Baptist Hospital. The second condition is that 12 acute-care beds will be delicensed so as to convert an 18-bed unit to a 6-bed inpatient BMT unit. The third condition is that Baptist will provide at least 10 percent of its inpatient BMT case volume on an annual basis to Medicaid (including managed Medicaid), charity, or self-pay payments. AHCA is requiring that Baptist establish an on-site cryopreservation lab as a condition of approval for its CON. Outpatient BMT has already begun at Baptist because a CON is not required for outpatient services. It is assumed that Baptist will achieve accreditation from the Foundation for the Accreditation of Cellular Therapy (“FACT”) for autologous BMT before the first inpatient procedures are performed. FACT accreditation is the key to receiving reimbursement from federal payors and private insurers. Baptist does not plan to perform any inpatient BMTs until it has completed a year of outpatient autologous procedures. AHCA received letters from several Florida state legislators and local government officials expressing support for Baptist’s application. The Statutory Review Criteria Section 408.035(1)(a) – The Need for BMT in TSA 4 Because the rule governing applicants for autologous and allogeneic BMT programs requires applicants to demonstrate the ability to perform 10 autologous and 10 allogeneic BMTs a year, a forecast of the future need for BMT by TSA 4 residents is necessary in order to evaluate whether Baptist can satisfy that requirement. AHCA’s discharge database includes inpatient treatments and excludes outpatient treatments because outpatients are not admitted. That database indicates that 215 TSA 4 residents received BMTs at a CON-approved hospital in Florida for the 12 months ending September 2016. Sixty-two TSA 4 residents received their treatment at a facility outside TSA 4 during the 12 months ending in December 2016. The number of outmigration cases has remained relatively constant over the last 10 years despite the fact that UM has entered the BMT market and steadily increased the number of BMTs it performs. Baptist’s current application projects the increase in TSA 4's adult inpatient BMT case volume for 2019 (year one of operation) and 2020 (year two of operation) using three different annual growth rates (five percent, seven percent, and nine percent). This analysis forecasts increases of 34 to 63 BMT cases in 2019 and 46 to 88 cases in 2020, depending on the growth rate applied. In other words, Baptist projects that inpatient BMT need in 2019 for TSA 4 will be between 249 and 278 cases, and Baptist projects that inpatient BMT need for TSA 4 in 2020 will be between 261 and 303 cases. UM predicts that the need for adult inpatient BMT in TSA 4 in 2020 will be 277 cases. Both parties’ need projections are reasonable. Even if the demand for BMT by TSA 4 residents only grows by five percent a year, the resulting number of BMT cases will be higher than Baptist's projected volumes of 22 cases in year one and 30 cases in year two. This indicates that there will be adequate growth to support Baptist's BMT program and the existing providers. With regard to the need for BMT in TSA 4, Baptist’s health planning expert testified that: the number of adult inpatient bone marrow transplant cases that will be performed on residents of TSA 4 will grow by more than the 22 and 30 cases that are forecasted for Baptist Hospital. In other words, the market is growing enough that Baptist can achieve its volume and existing providers can maintain at least their current level of service. There are circumstances indicating that a five percent annual growth rate for inpatient BMT is conservative and likely to underestimate the actual need among TSA 4 residents. For instance, national volume data for BMT from the Center for International Blood and Marrow Transplant Research (“the CIBMTR”) shows that there has been strong and continuous growth in autologous and allogeneic BMT over the last 10 years in the United States. In 2010, there were 16,668 BMTs in the United States. By 2014, that number had grown to 19,862, which represents a five percent average annual growth rate. More recent data from the CIBMTR indicates that there were 21,292 BMTs performed in the United States during 2015, which represents a seven percent growth rate from 2014 to 2015. The number of BMT procedures is reliably growing every year, and that is partially due to slight increases in population. This increase is also due to the fact that additional types of patients might benefit from BMT. There has also been an increase in the number of BMTs performed in Florida. Total adult inpatient BMT cases performed in all Florida hospitals have grown from 671 procedures for the 12 months ending September 2012, to 917 procedures for the 12 months ending September 2016. That amounts to an increase of 246 inpatient cases over a four-year period, or an average annual increase of 62 cases each year. In percentage terms, that is a 37 percent increase from 2012 to 2016 and an annual average percentage growth of nine percent per year. A review of the most recent yearly increase, from 2015 to 2016, demonstrates there were 68 new cases and a percentage growth of eight percent. As for circumstances specific to TSA 4, the total population in South Florida is increasing at a rate of approximately one percent per year. The segment of the population over the age of 15 is growing at a slightly higher rate than the total population. People over the age of 61 are receiving more BMTs than in the past. Because the elderly (65+) show the highest percentage population growth in TSA 4, the increased volume for this population will impact the overall volume growth forecasted for TSA 4. There is additional room for BMT use to increase in TSA 4 because that area’s utilization of BMT is low in comparison to other geographic areas. AHCA discharge data shows an overall adult BMT use rate for TSA 4 residents of 4.12 cases per 100,000 people, and the use rate for all of Florida is 5.07 cases per 100,000 people. The greater weight of the evidence demonstrates that the number of inpatient BMT cases in TSA 4 will increase to at least 249 cases in 2019 and to at least 261 cases in 2020. The greater weight of the evidence also demonstrates that the aforementioned forecasts are conservative and that the actual increases are likely to be higher. Section 408.035(1)(b) – The Existing Health Services in the Service District of the Applicant Section 408.035(1)(b) requires AHCA to evaluate “[t]he availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the service district of the applicant.” (emphasis added). Section 408.032(5) divides Florida into 11 health service planning districts. District 11 consists of Miami-Dade and Monroe Counties. UM is the only BMT provider in District 11. Memorial West is located in District 10, which encompasses Broward County. Therefore, section 408.032(5) excludes Memorial West from this analysis. Good Samaritan does not have a BMT program. While UM is the only authorized and operational provider of inpatient BMT services in Miami-Dade County, UM did not provide BMT to a single charity care patient between 2014 and 2016, despite committing to do so. UM's lack of service to charity BMT patients is consistent with its financial reports to the state. UM has the ability to provide charity care. In 2016, UMHC reported a net income of approximately $175 million. As the only existing local BMT provider in the community, UM's failure to provide any charity care presents an access limitation for charity patients. The lack of outpatient BMT presents another access issue. UM does not plan to perform any outpatient BMT procedures even though the medical trend is that more and more of the less complicated autologous BMT procedures are being performed on an outpatient basis. Some countries in Europe are even experimenting with autologous transplantation performed in the patient's home. For some patients that live in the Miami area, outpatient BMT presents a more convenient alternative than a long hospital stay. The inability to access a BMT provider willing to perform outpatient BMT is an access issue. Another access issue involves the utilization of UM’s BMT capacity. The number of BMT procedures performed at UM has steadily increased over time and jumped by more than 70 procedures in 2017 alone. UM's physicians predicted that the number of BMT procedures would grow by 65 in the current year, allowing UM to reach volumes it has never achieved before. Those volumes have allowed UM to conduct research and educational activities. As a result of increasing volumes, UM's BMT program has used a progressively higher number of beds within the hospital. UM's BMT program is on track to treat 240 patients and will have to utilize other beds in addition to the 12 beds originally set aside for BMT. Another access issue pertains to the types of cases that outmigrate from TSA 4. Baptist’s application contained data indicating that a disproportionate amount of the outmigration cases are complex in nature, and the SAAR states the following: the applicant notes that the highest level of outmigration was observed in allogeneic BMT patients which accounted for 41 percent of outmigration cases. [Baptist] states that these patients require the longest post-discharge treatment regimen and for this reason high levels of outmigration are evidence of a significant problem. Autologous cases with complications account for 23 percent of outmigration cases and autologous patients without complications account for four percent of outmigration cases. The applicant reiterates that the proposed project is expected to target these patients as a local alternative to care outside of OTSA 4. The fact that Good Samaritan does not have a BMT program may be the most significant access issue in this particular service district, and that amounts to a substantial change in circumstances since the prior proceeding. ALJ Peterson’s Recommended Order indicates that he evaluated the existing provision of BMT in District 11 based on the premise that Good Samaritan had an operational BMT program. The greater weight of the evidence demonstrates that access to BMT in District 11 is less than optimal, especially given that all parties now accept that Good Samaritan does not have a BMT program. Section 408.035(1)(c) – The Applicant’s Ability and History Regarding Quality of Care Baptist offers high quality healthcare. Evidence of past quality is demonstrated by Baptist's numerous accreditations and quality awards. U.S. News and World Report studied patient safety and mortality rates in U.S. hospitals and surveyed 30,000 physicians in 5,000 hospitals across the country. The publication ranked BHSF as the highest performing healthcare organization in South Florida, and eighth best in Florida. Since the CON application was filed, BHSF has risen to sixth best in the state. Baptist is one of only eight hospitals in the world, and the first hospital in Florida, to receive the Magnet Award, an award for nursing practice from the American Nursing Association. The American Nursing Association reviews quality metrics and nursing performance in all departments of the hospital to determine merit for the Magnet Award. Baptist has achieved high marks for patient satisfaction. Consumer Reports ranked Baptist highly for patient safety and quality. Consumer Reports rated Baptist Hospital the safest hospital in Miami-Dade County. Baptist assures that a high quality of care is maintained by implementing robust performance improvement plans. Baptist has a board-level quality committee that reviews outcome data on a bi-monthly basis. Baptist also has a medical executive committee where performance improvement peer review results are presented on a monthly basis. Baptist also has a number of collaborative teams over particular areas such as surgery, stroke, and tumors. These teams review outcomes in their particular areas and present them to the performance improvement steering council. Baptist's performance improvement plan will be applied to a BMT program. There will be a BMT group to monitor outcomes in the same way as other groups. Baptist has already developed extensive policies and procedures for its BMT program. These policies and procedures were developed by the recruited staff and will be reviewed for final approval by the BMT program’s new director, Dr. Gunther Koehne. Baptist expects Dr. Koehne to implement standards of care consistent with MSK's in order for Baptist's patients to participate in MSK's clinical trials. Baptist’s outpatient BMT unit is brand new and is equipped for patient needs. The outpatient and apheresis BMT units had already been constructed, equipped, and staffed by the time of the final hearing in this matter. Dr. Koehne testified that the facilities are both attractive and highly functional. Baptist has provided the space and equipment necessary to operate a BMT program. Baptist's CON application included plans for the renovation of a portion of the hospital where inpatient BMT patients will be served. The parties stipulated that the costs and methods of that construction were reasonable. Baptist has an age-appropriate intensive critical care unit which includes facilities for prolonged reverse isolation. Evidence was presented regarding the correlation of low volume BMT hospitals or doctors and their outcomes. The studies suggest that higher volumes and experience for physicians and their teams lead to better outcomes for patients. However, Dr. Hugo Fernandez, the Chair of the Department of Malignant Hematology and Cellular Therapies at Moffitt, testified that a volume of 10 allogeneic transplants and 10 autologous transplants is above the volume at which research shows lower volumes may affect quality. Dr. Fernandez testified that Memorial West began safely performing allogeneic transplants one year after receiving its CON. Dr. Claudio Anasetti, the Chair of the Blood and Marrow Transplantation Department at Moffitt, agreed that 20 transplants is a sufficient volume to ensure good outcomes. The aforementioned findings, and those yet to be discussed, demonstrate that Baptist will be able to offer high quality care to patients of an adult inpatient BMT program. Section 408.035(1)(d) – The Availability of Resources Section 408.035(1)(d) pertains to a review of the applicant’s resources for project accomplishment and operation. The statute expressly mentions “health personnel, management personnel, and funds for capital and operating expenditures.” Findings regarding Baptist’s current ability to provide the health and management personnel necessary for autologous and allogeneic BMT will be discussed below in relation to Baptist’s ability to satisfy the criteria of rule 59C-1.044 applicable to BMT centers. Baptist’s ability to fund the proposal will be discussed below in relation to the immediate and long-term financial feasibility of the proposal. Section 408.035(1)(e) – The Extent to Which the Proposed Services Will Enhance Access to Health Care for Residents of the Service District Baptist has a history of providing health care services to Medicaid and indigent/charity patients. Baptist Health System hospitals, including Baptist Hospital, provide 4.3 percent of its services to charity care patients, which is well above the average of 3.4 percent for hospitals in Miami- Dade County. Baptist Hospital also exceeds the county average. As noted in a previous section, the access to care in District 11 is less than optimal given: (1) UM’s lack of inpatient charity care; (2) the fact that UM performs no outpatient BMT; (3) the fact that Good Samaritan does not have a BMT program; and (4) the fact that a very high percentage of the outmigration cases are complex in nature, i.e., allogeneic and autologous with complications. The greater weight of the evidence indicates that a BMT program at Baptist is likely to alleviate issues pertaining to access to care in the service district. However, given that Baptist will likely be a relatively small program for the foreseeable future, those issues will not be resolved in their entirety in the short-term. Section 408.035(1)(f) – The Immediate and Long-Term Financial Feasibility of the Proposal Section 408.035(1)(f) refers to “financial feasibility” rather than “profitability.” The cost for Baptist's proposed BMT program is $7,624,433, and the greater weight of the evidence demonstrates that Baptist will be able to finance the completion of the BMT program along with its other planned capital projects. Baptist has a capital budget of $20,414,000 to finance routine items such as the replacement of outdated equipment and renovations of nursing units. This budget also covers additional clinical equipment that might be needed to begin a new service line. Baptist identified other capital commitments that it had planned or were underway at the time of application. Along with the BMT program, Baptist’s other significant capital projects include construction of a new medical tower at a cost of $125 million and relocation of a helipad at a cost of $5 million. In total, Baptist disclosed $195.8 million in capital projects in its application. Rather than using debt to finance the initiation of the BMT program, Baptist will use cash on hand. The application included a letter from BHSF's Chief Financial Officer committing to pay for the project’s start-up costs and to cover any operational losses that may be incurred as the BMT program ramps up: BHSF intends to make available the required funds to Baptist Hospital of Miami, Inc. for the purpose of establishment of the project described in CON Application No. 10490, through startup and project stabilization, including but not limited to the project costs identified on Schedule 1 of CON Application No. 10490. BHSF intends to fund this project from internal sources. BHSF’s ability to fund the project is documented in the attached BHSF audited financial statements. Baptist provided audited financial statements which demonstrate the wherewithal to afford this project. BHSF’s net income for 2016 was $162,640,710. BHSF had $263 million in cash flow in 2016 and possesses over $2.4 billion in cash and investments. While the audited financial statements state that the cash and other investments are “limited,” the explanatory notes to those statements state that “[a]ssets whose use is limited include assets set aside by the Board of Trustees for future capital improvements and education, over which the Board retains control and may at its discretion subsequently use for other purposes . . . .” This supports Baptist’s assertion that the unrestricted cash and investments can be used for any purpose. BHSF’s financial statements indicate that its current liabilities exceed its current assets by $100,470,725. While this is cause for concern, that is substantially ameliorated by the fact that BHSF’s total assets exceeded its total liabilities by $3,165,081,911 in 2016. Even if BHSF’s application understated (or even omitted) some expenses associated with initiating the BMT unit, those expenses are insignificant for an entity with the financial resources available to Baptist through BHSF. In short, the greater weight of the evidence demonstrates that Baptist can afford to initiate the proposed project and cover any operational losses during the first years of operation. With regard to long-term financial feasibility, Baptist expects to get little or no revenue from allogeneic transplants in year one because it plans to perform 10 cases in order to become FACT accredited. None of the managed payors such as Medicare HMO and Medicaid HMO will pay until there is FACT accreditation. Accordingly, the per case revenue is expected to be $88,000 in year one, but that amount is expected to increase to $175,000 in year two. After accounting for anticipated expenses, Baptist forecasts a $2.9 million loss in year one of the application and a $577,000 loss in year two of the application. During the final hearing, Baptist’s financial expert testified that the BMT program was projected to turn a small profit of $25,000 in year three of the application. Given how substantially the net loss from the BMT program narrowed from year one to year two by adding only eight patients, it is reasonable to infer that the program will come close to breaking even by adding an additional 10 patients at some point after year two of the application. Baptist’s projected expenses differ from its previous application because Baptist previously estimated both inpatient and outpatient revenues and expenses. The current application is for inpatient services only. Outpatient BMT services have already been established at Baptist, and the expenses for those facilities and staff are considered sunk costs when compared to the project at issue, inpatient BMT services. Those sunk costs include research facilities, staffing, nurses, and doctors, and they were appropriately excluded from the pro forma financial statements associated with this application. Existing hospital staff can absorb the additional demand for dietary and other services. Even if it were to be assumed that this project will never be a positive contributor to Baptist’s net income, that would not be a basis, by itself, for finding that the BMT program is not financially feasible over the long-term. UM’s healthcare planning expert testified that BMT programs are not profit centers, but healthcare institutions operate such programs in order to fulfill a “mission” and to help people. That testimony was convincing and is accepted. The evidence clearly and convincingly demonstrates that Baptist and BHSF are committed to having a BMT program. As noted above, Baptist considers a BMT program to be an integral component of its goal to have MCI be a full service cancer treatment center. Baptist and BHSF’s commitment to the project is further demonstrated by the fact that MCI has already begun treating patients via an outpatient BMT program. Baptist has incurred substantial expenses (such as construction and staffing) in preparing to have a BMT program at MCI. In short, the preponderance of the evidence demonstrates that this project is financially feasible in the long-term. Even if it is not ultimately profitable, Baptist is committed to funding the program's losses, and Baptist demonstrated the ability to cover operational losses indefinitely.7/ Section 408.035(1)(g) – The Extent to Which the Proposal Will Foster Competition that Promotes Quality and Cost-Effectiveness AHCA concluded in the SAAR that “[t]his project is not likely to have a material impact on competition to promote quality and cost-effectiveness.” Nevertheless, the SAAR presented the following regarding the implications of UM’s PPS-exempt status: In addition, the reviewer notes that the applicant will not be a PPS-exempt cancer hospital, as UMHC is designated, and therefore reimbursement to the two proposed Miami-Dade providers from Medicare will be different. The reviewer notes that according to the U.S. Government Accountability Office (GAO), in 2012, Medicare payments received by the 11 PPS- exempt cancer hospitals were, on average, 42 percent more per discharge than what Medicare would have paid a local PPS teaching hospital to treat cancer beneficiaries with the same level of complexity. The GAO also found that the PPS-exempt cancer hospital’s payment methodology lacks strong incentives for cost containment and has the potential to result in substantially higher total Medicare expenditures. The GAO concludes that until Medicare pays PPS-exempt cancer hospitals to encourage efficiency, Medicare remains at risk for overspending. According to FloridaHealthFinder.gov, based on data submitted to the Agency through the inpatient database, UMHC had 160 bone marrow transplants with charges ranging from (on average) $403,740 (25th percentile) to $662,662 (75th percentile) with an ALOS of 25.0 days for CY 2016 for all adults 18+. The statewide total charges, for the same time period, ranged (on average) from $188,363 to $458,097 with an ALOS of 22.8 days. While a BMT program at Baptist is unlikely to promote competition that will increase quality and cost-effectiveness, it appears that a BMT program at Baptist serving Medicare recipients would be less costly than the same service at UM, a PPS-exempt provider. However, given the relatively small size of the program at Baptist, it would probably be many years before any substantial savings could be achieved by shifting Medicare BMT patients from UM to Baptist. Section 408.035(1)(h) – The Costs and Methods of the Proposed Construction The parties stipulated that the costs and methods of construction were reasonable. Section 408.035(1)(i) – Baptist’s Past and Proposed Provision of Health Care Services to Medicaid Patients and the Medically Indigent As found above, Baptist Hospital has a significant record of providing more than the average level of service to Medicaid recipients and the indigent. Rule Review Criteria General Requirements for Organ Transplantation Programs Rule 59C-1.044 is entitled “Organ Transplantation” and sets forth additional criteria by which AHCA reviews applications for organ transplantation programs such as a BMT program. Subsection (1) of the rule provides that “[a]pplicants for each type of transplantation program shall meet the requirements specified in subsections (3), (4) and (5).” Rule 59C-1.044(3)(a) requires applicants to have staff and other resources necessary to care for the patient’s chronic illness before, during, and after transplantation. The rule also requires that “[s]ervices and facilities for inpatient and outpatient care shall be available on a 24-hour basis.” Findings regarding Baptist’s physician staff are set forth below during the discussion of requirements pertaining specifically to allogeneic BMT programs. Nevertheless, it is found here that Baptist can provide a comprehensive range of physician specialty support services on a 24-hour basis. These include (but are not limited to) services such as intensive care physicians, cardiologists, infectious disease specialists familiar with the care of severely immune-compromised patients, and interventional radiologists. Rule 59C-1.044(3)(c) requires a transplant services applicant to have “[a]n age-appropriate (adult or pediatric) intensive care unit which includes facilities for prolonged reverse isolation when required.” Baptist’s application satisfies this requirement. Baptist proposes utilizing its existing adult critical care resources when necessary for BMT patients. Baptist plans to transfer BMT patients from the six-bed adult BMT unit to the intensive care unit (“ICU”) when the ICU team determines the patient needs additional critical care support. Examples include patients who become hemodynamically unstable or those who need mechanical ventilation. Baptist’s application notes that it is developing a “Protective Environment” room to support BMT patients who may require critical care services. Rule 59C-1.044(3)(d) requires a transplant services applicant to have “[a] clinical review committee for evaluation and decision-making regarding the suitability of a transplant candidate.” Baptist satisfies this requirement in that Baptist has specifically identified eight physicians to serve on its clinical review committee and will place subsequently recruited BMT physicians on the committee. Baptist has also identified 17 other medical professionals (including many from the BMT Team Support staff) who will be placed on its clinical review committee. Rule 59C-1.044(3)(e) requires an applicant to have: [w]ritten protocols for patient care for each type of organ transplantation program including, at a minimum, patient selection criteria for patient management and evaluation during the pre-hospital, in- hospital, and immediate post-discharge phases of the program. Rule 59C-1.044(3)(f) requires an applicant to have “[d]etailed therapeutic and evaluative procedures for the acute and long term management of each transplant program patient, including the management of commonly encountered complications.” Baptist’s application states that: [t]he protocols, policies, treatment plans and guidelines for selection, evaluation, treatment and management of the BMT patients are currently being finalized under the direction of the BMT Medical Director, Lyle Feinstein, MD. Drafts of these [] protocols, policies, treatment plans and guidelines are presented in Appendix 5. The draft documents received in evidence and other information presented in Baptist’s application are sufficient to satisfy the required patient selection criteria established by rule. As for the evaluative procedures, the application states “[w]ritten protocols/policies defining therapeutic and evaluative procedures for the acute and long term management of each BMT patient are being finalized for the Fall 2017 initiation of the outpatient BMT program and for the development of this proposed inpatient BMT program.” The application includes examples of those final drafts. The draft documents received in evidence are sufficient to meet the required therapeutic and evaluative procedures established by rule. Rules 59C-1.044(3)(h), (i), and (j) require an applicant to have: (a) an onsite tissue-typing laboratory or a contractual arrangement with an outside laboratory within Florida meeting the requirements of the American Society of Histocompatibility; (b) pathology services; and (c) blood banking facilities. In the current application, Baptist states that it has contracted with the Laboratory Corporation of America (“LabCorp”) for tissue typing services. The application includes a certificate from the American Society of Histocompatibility and Immunogenetics indicating that LabCorp is accredited in the area of “Histocompatibility Testing for Other Clinical Purposes.” The application also demonstrates that LabCorp is licensed to operate within the State of Florida. The contract with LabCorp is sufficient to meet the criteria in rule 59C-1.044(3)(h). As for pathology services, Baptist explains in its application that its laboratory department has the technical resources and expertise necessary to fully support the proposed BMT program and provide the necessary information to best manage[] each BMT patient’s care. This in-house expertise and infrastructure, combined with the OneBlood and LabCorp external resources, will ensure that all BMT patients will have the required laboratory support to optimally meet their medical needs. The application specifies that Baptist’s laboratory department can provide the following services: chemistry, coagulation, cytology, flow cytometry, hematology, histology, microbiology, phlebotomy, serology, transfusion service, and urinalysis. The aforementioned services are available 24 hours a day, seven days a week. In addition, laboratory tests can be completed in approximately one hour on a STAT basis. The application states that the laboratory department has seven pathologists who are board certified in anatomic and clinical pathology and that those pathologists: are eminently qualified and [] can diagnose the spectrum of complications that may occur in the immunocompromised bone marrow transplant patient population. They are able to diagnose the different pathogens that may effect this population. Similarly, they are able to identify and diagnose the histologic features of graft vs. host disease. The record evidence is sufficient to meet the criteria for pathology services in rule 59C-1.044(3)(i). The application also states that: [t]he existing blood banking and transfusion facilities and services currently in existence at Baptist Hospital are appropriate for supporting the blood requirements associated with the proposed new BMT program. Combining these existing Hospital capacities with the support of OneBlood, acting as the area’s centralized blood collection, storage and distribution hub, all necessary blood banking services are available and supported. Further, with OneBlood providing the specialty BMT blood/marrow processing and storage services, the blood and blood banking needs of the BMT patients will be fully met. The application contains a June 6, 2017, letter from a OneBlood representative to Marisol Fitch of AHCA describing OneBlood’s capabilities and indicating OneBlood will be servicing Baptist’s BMT program. The record evidence is sufficient to meet the criteria for blood banking facilities and services in rule 59C-1.044(3)(j). Rule 59C-1.044(3)(k) calls for an applicant to have a “program for the education and training of staff regarding the special care of transplantation patients,” and Baptist’s current application demonstrates it has such a program. Rule 59C-1.044(3)(l) refers to “[e]ducation programs for patients, their families and the patient’s primary care physician regarding after-care for transplantation patients.” UM does not challenge Baptist’s ability to satisfy this criterion. Rules 59C-1.044(4)(a) and (b) set forth general requirements for the physician staff and the program director. These topics will be addressed in the discussion pertaining to the specific rule-based requirements for an adult allogeneic BMT program. Rule 59C-1.044(4)(d) sets forth general requirements for nurses and nurse practitioners. This topic will be addressed in the discussion pertaining to the specific rule-based requirements for an adult allogeneic BMT program. Rule 59C-1.044(4)(e) calls for an applicant to have “[c]ontractual agreements with consultants who have expertise in blood banking and are capable of meeting the unique needs of transplant patients on a long term basis.” Baptist’s current application demonstrates that OneBlood, as its provider of “specialty BMT blood/marrow processing and storage services,” meets the criteria established in that rule. Rules 59C-1.044(4)(f), (g), and (h) call for an applicant to have appropriately trained nutritionists, respiratory therapists, social workers, psychologists, and psychiatrists. Baptist has “clinical registered dieticians who are Certified Specialists in Oncology Nutrition, having the expertise of meeting the needs of patients with immunocompromised patients.” As for respiratory therapists, the application states that Baptist’s respiratory therapists “are experienced in providing respiratory support to BMT patients who develop pulmonary complications post-transplant such as pulmonary edema, bronchiolitis obliterans with organizing pneumonia and other complications seen post-transplant.” The application also states that Baptist’s respiratory therapists “will receive structured education about current standards of respiratory and pulmonary care for bone marrow patients by an expert in the field.” As for the requirements pertaining to social workers, psychologists, and psychiatrists, Baptist’s application states that it has a full complement of such professionals and four social workers assigned to the inpatient oncology unit. Baptist plans to have social workers “specifically trained and assigned to support bone marrow transplant patients and families.” Those “BMT social workers will be knowledgeable in the spectrum of community services and assets available to support bone marrow transplant patients and their families throughout the full continuum of bone marrow care, including pre- and post-transplant care.” Moreover, MCI is building a “Cancer Patient Support Center” that will be staffed by multidisciplinary teams of specialists and clinicians who will provide a wide array of support services such as Psycho-Oncology, Psychosocial Services, Integrative Medicine, Exercise Physiology, and Oncology Rehabilitation. Baptist’s application and the evidence of record is sufficient to meet the criteria established in rules 59C- 1.044(4)(f), (g), and (h). Rule 59C-1.044(5) pertains to data reporting requirements for facilities with organ transplant programs and is not at issue in this proceeding. As discussed above and in subsequent findings set forth below, Baptist’s application satisfies the requirements set forth in rules 59C-1.044(3) and (4). Requirements Specific to Bone Marrow Transplant Applicants Rule 59C-1.044 sets forth requirements specific to bone marrow transplant applicants. For instance, subsection (1) states that a bone marrow transplant applicant must be a teaching or research hospital. See Fla. Admin. Code R. 59C-1.044(1) (mandating in pertinent part that “[t]he following organ transplantation programs shall be restricted to teaching or research hospitals: liver, adult allogeneic bone marrow, pediatric allogeneic and autologous bone marrow ”). See also Fla. Admin. Code R. 59C-1.044(9)(b)(mandating that “[a]dult allogeneic bone marrow transplantation programs shall be limited to teaching and research hospitals.”); Fla. Admin. Code R. 59C-1.044(9)(c)(providing that “[a]dult autologous bone marrow transplantation programs can be established at teaching hospitals or research hospitals; or at community hospitals having a research program, or who are affiliated with a research program, as defined in this rule.”). Rule 59C-1.044(9)(b)9. pertains specifically to adult allogeneic BMT programs and requires an applicant to have “[a]n ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital. The program must include monitoring and long-term patient follow-up.” Rule 59C-1.044(9)(b)10. requires “[a]n established research-oriented oncology program.” The Research Criteria Rule 59C-1.044(2)(d) defines a “research hospital” as “[a] hospital which devotes clearly defined space, staff, equipment, and other resources for research purposes, and has documented teaching affiliations with an accredited school of medicine in Florida or another state.” Rule 59C-1.044(2)(d) defines a “research program” as “[a]n organized program that conducts clinical trial research, collects treatment data, assesses outcome data, and publishes statistical reports showing research activity and findings.” The evidence presented at final hearing demonstrated that Baptist Hospital has a robust research program and a good research team. Dr. Miguel Villalona-Calero was recognized as an expert in medical oncology and clinical and translational research. Dr. Villalona-Calero has been involved with cancer research his entire career. Dr. Villalona-Calero has served as principal investigator on numerous clinical trials, including National Cancer Institute ("NCI") clinical trials. In 1999, Dr. Villalona-Calero moved to Ohio State University where he became a full tenured professor and conducted many clinical trials with early therapeutics. By the time Dr. Villalona-Calero left Ohio State, the research he was conducting had become nationally and internationally known. Dr. Villalona-Calero has approximately 111 original publications resulting from his research. Dr. Villalona-Calero has been involved in approximately 21 grants from NCI related to translational research work. Dr. Villalona-Calero left Ohio State to join Baptist in September of 2015. Dr. Villalona-Calero was one of the first physicians Baptist recruited toward the goal of building the research component of Baptist's comprehensive cancer center. Dr. Villalona-Calero leads Baptist's research program with Dr. Jeffrey Boyd, Dr. Minesha Mehta, and Dr. Michael Zinner. Among the other clinical trials personnel on the fourth floor of MCI are coordinators, research nurses, and data managers. Dr. Villalona-Calero has recruited infusion nurses with the experience to respond to any emergencies that may occur during the clinical trials on the fourth floor. In addition to Dr. Villalona-Calero, Dr. Zinner, Dr. Boyd and Dr. Minesh Mehta, there are other investigators at Baptist who conduct research, including a radiation oncologist and a neuro-oncologist. Baptist's application contained the biographies of 13 additional investigators conducting research at Baptist. Dr. Koehne will also conduct research at Baptist, similar to the research he conducted at MSK. Dr. Koehne is well recognized in the bone marrow transplant field, specifically in the area of T-cell immunology and T-cell immunotherapy. The clinical trials office at Baptist is almost fully staffed. The only area for which Dr. Villalona-Calero is still recruiting is in the expanding area of early therapeutics. Staffing is complete for clinical research services, regulatory quality assurance, clinical trials administration, and finance. Dr. Villalona-Calero formed the clinical scientific review committee to review the scientific merit of all the cancer clinical trials to be performed at MCI. The clinical scientific review committee works in conjunction with the Institutional Review Board ("IRB"). The IRB rules on ethical issues such as informed consent. While the clinical scientific review committee is composed of MCI faculty, the IRB is an independent higher authority that must approve clinical trials before they may commence. Since the 2015 CON application, Baptist has constructed MCI, and it includes a research wing. Baptist now has its clinical trials personnel on the fourth floor of the research wing. The new research wing also houses the Center for Genomic Medicine and a Phase One Therapeutics Unit. Dr. Villalona-Calero designed the therapeutics unit that contains advanced cardiology equipment that permits printing of EKGs directly from the equipment. The unit also contains ten infusion areas, a centralized nursing station, and a centralized investigational pharmacy. Adjacent to the unit are the facilities to house the clinical trials personnel. Near the clinical trials personnel are a protocols support lab and a biorepository. The fourth floor of the research wing also contains treatment rooms. These rooms have monitoring capabilities not available in normal hospital rooms. Because a patient's condition can change quickly and unexpectedly during clinical trials, these rooms are also designed so that emergency procedures can be activated more quickly than in a normal hospital room. The fourth floor rooms are similar to ICU rooms. The clinical treatment rooms and their equipment are fully operational and open to patients. Dr. Villalona-Calero and Dr. Boyd also have laboratories at Florida International University (“FIU”). The labs at FIU allow for trials not suitable in a hospital, such as trials involving animals. BHSF funded the labs at FIU. Baptist has outcome monitoring and long-term patient follow-up as part of its research program. Additionally, Baptist's Center for Genomic Medicine is conducting cutting edge research at Baptist. Dr. Boyd was accepted as an expert in translational research and genomic medicine. Dr. Boyd is the Vice-President for Translational Research and Genomic Medicine, as well as the Deputy Director at MCI. Dr. Boyd is also employed by FIU as a tenured professor and chair of the Department of Human and Molecular Genetics, and associate dean for basic research and graduate programs. He has held both positions since July 2015. As founding director of the Center for Genomic Medicine at MCI, Dr. Boyd has created three operation units within MCI. First is the division of clinical genetics, a group of medical professionals whose function is to counsel and advise appropriate genetic testing – and in some cases treatment – for individuals at substantially increased risk for inherited cancer susceptibility. Second is a biobanking operation consisting of two discrete entities: the biospecimen repository facility ("BRF") and the protocol support lab ("PSL"). The BRF is charged with acquiring the consent of MCI patients for permission to bank excess tissue, blood and other fluids, annotate them, store them and ultimately distribute them for generic research purposes, as they may arise in the translational cancer research universe. The PSL obtains these biospecimens, processes them, and distributes them to laboratories that may be conducting a test associated with the clinical trial. Third is the molecular diagnostics laboratory ("MDL"), which is the clinical testing facility. The MDL performs targeted therapy, precision therapy, and precision medicine by obtaining DNA from patient tumors and manipulating that DNA with the goal of finding "druggable targets." The MDL contains a research and development division that carries out translational cancer research, primarily genetic and genomic type research using existing technology, and research to develop new types of testing that may become appropriate as the field evolves. The Center for Genomic Medicine at MCI conducts significant clinical research. This clinical research is specifically focused on cancer research. Baptist and FIU share a very close and expanding relationship related to medical school research and clinical care. FIU's medical school has 480 students (120 students per class). Most of these students' clinical experience during their four-year education period takes place at Baptist. Baptist has funded research laboratories for numerous faculty on the college of medicine staff. Baptist's research program has changed substantially since the 2015 CON application. For example, Baptist has ramped up its clinical trials program through its association with MSK, and the completion of the construction of the physical plant has allowed the opening of the Center for Genomic Medicine, where the above mentioned genomic research takes place. Baptist also conducts investigator-initiated trials that were not yet begun during the last CON application. The Teaching Criteria Rule 59C-1.044(2)(g) provides that a “teaching hospital” means “[a]ny hospital which meets the conditions specified in Section 408.07(45), F.S.” The statute defines teaching hospitals as hospitals that are officially affiliated with an accredited Florida medical school with at least seven accredited, graduate medical educational programs and the presence of at least 100 full time resident physicians. Baptist does not offer seven accredited graduate medical educational programs to at least 100 residents, and therefore does not meet the definition of a teaching hospital as set forth in section 408.07. However, Baptist engages in teaching activities. BHSF coordinates all of the clinical rotations for FIU medical students across the Baptist Health system. There are approximately 500 students participating in rotations at BHSF. Approximately 3,000 physicians are credentialed at BHSF. More than 500 of those physicians have faculty appointments at FIU. They serve as precepting physicians for the medical students who participate in clinical rotations. Baptist offers training to first and second year medical school students, including rotations in emergency medicine. After moving into their third and fourth years, students move into their core elective rotations which occur across the entire BHSF system. There are approximately two dozen elective rotations available to third and fourth year medical school students at Baptist, including general surgery and internal medicine. There are approximately 500 medical students rotating in a typical year at Baptist. Baptist provides accredited graduate medical education programs in family medicine, family sports medicine, and orthopedic sports medicine. Baptist also offers fellowships in radiology and minimally invasive surgery. Baptist offers a robust clinical training program in nursing and allied health. Baptist has between 3,500 and 4,000 nursing allied health students credentialed to rotate through all of BHSF. Despite the fact that Baptist does not meet the technical requirements to be a teaching hospital, it does satisfy the standards associated with a research hospital. Therefore, Baptist satisfies rules 59C-1.044(1) and (9). Volume Requirements When considered together, rules 59C-1.044(9)(b)1. and (c)1. require that an applicant for an adult autologous and allogeneic BMT program be able to project that at least 10 autologous and 10 allogeneic transplants will be performed each year.8/ As found in a previous section, a conservative estimate indicates that the number of BMT procedures should grow by at least five percent a year in TSA 4. Given the forecasted growth in BMT and the fact that Baptist refers approximately 70 patients a year to other facilities for BMT treatment, Baptist should have no difficulty satisfying the volume requirement. It is reasonable to expect that a substantial number of patients who begin their cancer treatment at Baptist will elect to stay with Baptist if their course of treatment leads to BMT. The greater weight of the evidence demonstrates that Baptist satisfies the volume requirements. Program Director Requirements 253. Rules 59C-1.044(9)(b)2. and (c)2. have virtually identical requirements for a program director. Rule 59C-1.044(9)(b)2. requires an applicant to have program director who is a board certified hematologist or oncologist with experience in the treatment and management of adult acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The program director must have formal training in bone marrow transplantation. Baptist has recruited Dr. Koehne to serve as the program director for its BMT program. After obtaining his medical degree and PhD in Germany, Dr. Koehne worked at MSK. MSK is one of the leading institutions for cancer and bone marrow transplant in the world. While at MSK, Dr. Koehne focused his research on post-transplant complications following allogeneic BMTs, including the reactivation of certain viruses. After undergoing clinical trials, a method developed by Dr. Koehne to treat such viral reactivations became the nationally recognized standard for treatment and has been licensed by biopharmaceutical companies. In addition to his appointment as a member at MSK, Dr. Koehne was a professor of medicine at Weill Cornell Medical College. Prior to coming to MCI, Dr. Koehne was the medical director of the BMT laboratory and associate attending physician at MSK. As medical director, Dr. Koehne oversaw the processing of bone marrow and gained familiarity with the equipment and processes for blood processing. Dr. Koehne has done extensive work in the field of BMT research. Before leaving MSK, Dr. Koehne served as principal investigator of three clinical research trials and co-investigator on three or four more trials. Dr. Koehne plans to continue these clinical trials at MCI, the results of some of which have already been published. Dr. Koehne has personally performed many BMTs throughout his career. MSK Cancer Center does 450 transplants a year. Approximately 250 of those cases are autologous and the rest are allogeneic. The greater weight of the evidence demonstrates that Baptist has satisfied the program director requirement. Nursing Requirements Rule 59C-1.044(4)(d) requires all transplant applicants to have a staff of nurses and nurse practitioners “with experience in the care of chronically ill patients and their families.” Rule 59C-1.044(9)(b)3., which specifically pertains to adult allogeneic BMT programs, requires an applicant to have “[c]linical nurses with experience in the care of critically ill immune-suppressed patients. Nursing staff shall be dedicated full time to the program.” UM does not contest the fact that Baptist has a nursing staff experienced in the care of chronically ill patients and their families. As for the requirements of rule 59C-1.044(9)(b)3., Baptist has approximately 130 critical care, clinical nurses experienced in the care of critically ill immunosuppressed patients within the critical care unit. Baptist has a history of effectively staffing specialty areas that require specialty education. Baptist's ICU is also appropriately staffed. This nursing expertise will be available to the BMT program. Baptist has developed a program for the education and training of staff regarding special care of BMT patients. Baptist included the 306-page plan in its CON application. This plan addresses the care requirements for providing bone marrow transplant care. The greater weight of the evidence demonstrates that Baptist satisfies the nursing requirements. Interdisciplinary Transplant Team Rule 59C-1.044(4)(a) pertains to all transplant applicants and requires them to have a “staff of physicians with expertise in caring for patients with end-stage disease requiring transplantation.” Furthermore, that staff “shall have medical specialties or sub-specialties appropriate for the type of transplantation program to be established.” Rule 59C-1.044(9)(b)4. applies specifically to adult allogeneic BMT programs and requires an applicant to have: [a]n interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoetic and lymphopoietic malignancies, and non-neoplastic disorders. The team shall direct permanent follow-up care of the bone marrow transplantation patients, including the maintenance of immunosuppressive therapy and treatment of complications. Baptist has substantially augmented its existing physician staff through the hiring of Dr. Koehne. Baptist will also rely on Dr. Feinstein to provide BMT services. Dr. Feinstein has experience starting a new BMT program and in achieving FACT accreditation. Dr. Feinstein has experience with both autologous and allogeneic transplantations. Dr. Feinstein has a strong background in BMT. MCI was also successful in recruiting Dr. Paba-Prada, who is experienced in autologous transplantation and treating patients with myeloma and lymphoma from Dana-Farber Cancer Center. Baptist’s application states the following regarding its physician staffing: Essential to the success of the proposed BMT program is the experienced team of 27 board certified hematologists and oncologists currently on staff at the Hospital, with three of these physicians currently trained and experienced to care for the adult BMT patients. With this large group of hematologists and oncologists currently on staff, providing patient care in the inpatient and outpatient settings, these physicians create a strong and experienced medical team to support the existing 9 multidisciplinary tumor site teams, including a team for Hematological Malignancies and BMT. To whatever extent that Baptist needs to recruit additional physicians in order to satisfy the rule-based requirements, it is noted that the program will not heavily taxed at the outset. There will probably never be more than two to three patients in the BMT unit at any one time during the first two years of operation. The greater weight of the evidence demonstrates that Baptist satisfies the physician staffing requirements. Laboratory Requirements Rule 59C-1.044(9)(b)7. calls for an applicant to have: [a] laboratory equipped to handle studies including the use of monoclonal antibodies, if this procedure is employed by the hospital, or T-cell depletion, separation of lymphocyte and hematological cell subpopulations and their removal for prevention of graft versus host disease. This requirement may be met through contractual arrangements. Rule 59C-1.044(9)(b)8. calls for an applicant to have “[a]n onsite laboratory equipped for the evaluation and cryopreservation of bone marrow. Baptist proposed to contract with OneBlood for laboratory services required to offer BMT. The application also indicated that Baptist would establish an onsite lab if required by AHCA. When AHCA approved Baptist's application, the approval was conditioned upon the establishment of an onsite laboratory for cryopreservation at Baptist. Since that requirement was announced, Baptist identified space, budgeted, and has now equipped a cryopreservation lab at the hospital. OneBlood offers services used in BMT at hospitals. OneBlood provides processing for allogeneic and autologous transplants. OneBlood provides blood processing services for other BMT programs in Florida. OneBlood provides services for both Miami Children's Hospital's BMT program and Memorial West's BMT program. Neither hospital has its own cryopreservation lab. OneBlood provides all processing required of – and has all the equipment needed for – an autologous BMT procedure including cryopreservation. OneBlood also provides all the processing required for an allogeneic BMT procedure. OneBlood has agreed to provide the processing required for Baptist's BMT program, as it does for Miami Children's Hospital and Memorial West. OneBlood offers cryopreservation and storage, thawing of stem cell collections, and CD 34 cell counts. OneBlood will offer T-Cell subset characterization (also referred to as "T-cell depletion") in 2018. To begin offering T-cell depletion, OneBlood only needs to acquire a cell separator. The cell separator is an automatic machine. OneBlood will have little difficulty gaining the additional accreditation to perform T-cell depletion because performing T-cell depletion only requires the acquisition of the cell separator. The OneBlood contract accommodates requests for services after hours and on weekends because OneBlood is available on call if products arrive during off hours. UM has used OneBlood for stem cell processing in the past. UM has successfully transferred blood product from OneBlood to UM for use in transplantation. UM has also successfully shipped blood products that were harvested at UM from UM to OneBlood. UM has successfully transferred blood product to OneBlood for use in a transplantation in Broward County. The greater weight of the evidence demonstrates that Baptist satisfies the laboratory requirements. Other Criteria Baptist satisfies the requirements in rules 59C- 1.044(9)(b)5. and 6. pertaining to inpatient transplantation units and a radiation therapy division. Rule 59C-1.044(9)(b)11. calls for an applicant to have a “patient convalescent facility to provide a temporary residence setting for transplant patients during the prolonged convalescence.” Baptist’s application notes that it “works cooperatively with a number of local hotels to ensure that patients and their families have accessible housing resources during extended hospital stays or extended recuperative stays." Baptist also has several apartments that can be used by patients, caregivers and/or family members. The application states that Baptist is in the process of constructing a new hotel facility that will be located on the northwest corner of the Baptist Hospital campus. This hotel will have 184 rooms and will house BMT patients and their families during post-transplant monitoring and evaluation. Rule 59C-1.044(9)(b)12. calls for an applicant to have an “outpatient unit for close supervision of discharged patients.” The application states that Baptist anticipated completing an outpatient unit on the third floor of MCI by the Fall of 2017. The greater weight of the evidence demonstrates that Baptist satisfies standards for convalescent housing and outpatient facilities. Not Normal Circumstances A prospective provider of a tertiary health service such as BMT can apply by satisfying all of the statutory and rule requirements or by demonstrating that not-normal circumstances exist. Ms. Fitch, the CON and commercial managed care unit manager for AHCA, explained the not-normal circumstances AHCA relied on to preliminarily approve Baptist’s CON: Q: What abnormal circumstances were presented within this application? A: Well, there were a couple of them. There was the utilization of the existing programs. Essentially the – there are three programs in OTSA 4. The first one, Good Sam, is essentially defunct. We had condition compliance reports; we noted it in the SAAR, that, through condition compliance reports, we found out that what Good Sam had been reporting were biopsies, because they reported zero inpatient or outpatient bone marrow transplants in calendar year 2016. So that program is essentially defunct. We also had Memorial West, which is significantly underutilized and not producing enough bone marrow transplants to be considered much of a viable program in the latter half of 2015 and certainly in 2016. We also have the overutilization of the one program at University of Miami Hospital and Clinics. They applied for a 12-bed unit. They advertised on their website for a 12-bed unit. They’re obviously doing more than what an average daily census of 12 beds would be. So that program seemed to be overutilized. So the utilization patterns that we were seeing [were] one not-normal circumstance for the population. Another not-normal circumstance is the charity care or lack of charity care within this OTSA 4, not seeing that charity care is being provided by the existing program, and so there [are] questions as to financial accessibility to the residents of OTSA 4. In addition to that, looking at the cost- effectiveness criteria under 408.035, looking at the data that is at Florida Health Line for charges amongst the – statewide for the exact same procedure, and then looking at the charges at University of Miami Hospital and Clinics, the charges at University of Miami Hospital and Clinics are significantly higher than the charges for the statewide average. And by “significantly higher,” it’s approximately $200,000 plus, both in the charges low category, which is the 25th quartile; and in the charges high category, which is the 75 quartile. So that cost- effectiveness issue is concerning. In addition to that, on the cost- effectiveness, University of Miami pointed out in their opposition statement that they are a PPS-exempt facility. And kind of exploring what that means, they’re one of only 11 PPS-exempt facilities in the nation, and how they get reimbursed by Medicare – of course Medicare is the bar in which all rates are set – and so how that affects cost-effectiveness within the OTSA 3 – 4, sorry. Q: Were previous programs approved by the agency applying this rule under not normally approved? A: Yes. The last two bone marrow transplant programs in OTSA 4 that were approved, both the University of Miami Hospital and Clinics and Memorial West, were approved under not-normal circumstances, because they did not meet all the rule criteria; specifically, both of those facilities were not statutory teaching hospitals. The fact that Good Samaritan does not have a BMT program, despite the previous reports to AHCA that it performed 42 BMTs in 2016, by itself, is significant enough to justify Baptist not strictly complying with the requirements of rules 59C-1.044(9)(b) and (c). The greater weight of the evidence demonstrates that not-normal circumstances are present in TSA 4. Adverse Impact If the CON at issue is granted, there is no persuasive evidence demonstrating that UM’s ability to conduct research or to maintain the proficiency of its physicians will be adversely impacted. However, it is very likely that patients who would have received their BMT treatment at UM will instead receive that treatment at Baptist. While the greater weight of the evidence demonstrates that UM should not experience any meaningful decline in volume, UM is very likely to be adversely impacted by the fact that its patient volumes (and the resulting increase in revenues) will not be growing as quickly if the CON at issue were not granted. As Baptist moves to recruit additional staff with experience with BMT and/or allogeneic procedures, it is possible that Baptist may hire UM employees. In sum, the greater weight of the evidence demonstrates that UM will be adversely impacted to a minor degree if the CON at issue is granted. Changed Circumstances To the extent the outcome of DOAH Case No. 16-1698CON is determined to have any relevance in this de novo proceeding, the evidence establishes that conditions have sufficiently changed such that conclusions regarding issuance of a CON to Baptist for an adult autologous and allogeneic BMT program in TSA 4 in DOAH Case No. 16-1698CON have no applicability to the new application at issue herein. Such changed circumstances include, but are not limited to, the following. Ms. Fitch testified that it was unknown during the prior proceeding that Good Samaritan was a defunct program. Multiple findings in ALJ Peterson’s Recommended Order corroborate Ms. Fitch’s testimony. The alliance between Baptist and MSK is another changed circumstance. Mr. Richardson described the significance of that alliance as follows: The Memorial Sloan Kettering alliance linkage is just not marketing and branding and saying you are a part of us. It actually appears to be a much stronger integrated linkage between Memorial Sloan Kettering and the Baptist Hospital Miami Cancer Institute operation. Basically the last go around, Baptist was in a six- to nine-month evaluation process, where they were providing policies, procedures, outcomes, just a huge amount of information to Sloan Kettering to basically see whether they would be accepted as part of the alliance. That all went through, and now as described here, it’s a real linkage; they basically, in terms of the – you have linkage between the clinical side and you have linkage between the research sides. So you have the ability for Baptist to tap into the expertise that is available at Sloan Kettering. So it’s not just a marketing name, Baptist Hospital linked with somebody else. It’s a true integrated operational linkage. Another changed circumstance is that MCI is now operational, and Baptist is performing outpatient autologous procedures. At the time of the 2015 CON application, MCI was aspirational and was being constructed. The current Baptist application is substantially better than the prior one. Baptist has gone to great lengths to improve its research capacity, and all of the available evidence indicates that Dr. Koehne is exceptionally well-qualified to be Baptist’s program director.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order approving the Certificate of Need Application No. 10490 submitted by Baptist Hospital of Miami, Inc. to establish a new adult autologous and allogeneic bone marrow transplant program in Florida’s Organ Transplant Service Area 4. DONE AND ENTERED this 15th day of August, 2018, in Tallahassee, Leon County, Florida. S G. W. CHISENHALL 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 15th day of August, 2018.
