STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
THE NEMOURS FOUNDATION, d/b/a NEMOURS CHILDREN'S HOSPITAL,
Petitioner,
vs.
AGENCY FOR HEALTH CARE ADMINISTRATION,
Respondent.
/
Case Nos. 17-1913CON
17-1914CON
RECOMMENDED ORDER
Pursuant to notice, the Division of Administrative Hearings (DOAH), by its designated Administrative Law Judge, W. David Watkins, held a final hearing in the above-styled case on February 5 through 8, 26 through 28, and March 2, 2018, in
Tallahassee, Florida.
APPEARANCES
For The Nemours Foundation, d/b/a Nemours Children’s Hospital:
Stephen A. Ecenia, Esquire David Mark Maloney, Esquire Craig D. Miller, Esquire Rutledge Ecenia, P.A.
119 South Monroe Street, Suite 202 Post Office Box 551
Tallahassee, Florida 32301
For Agency for Health Care Administration:
Kevin Michael Marker, Esquire Richard Joseph Saliba, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 7
Tallahassee, Florida 32308 STATEMENT OF THE ISSUES
Whether there is need for a new Pediatric Heart Transplant and/or Pediatric Heart and Lung Transplant program in Organ Transplant Service Area (OTSA) 3; and, if so, whether Certificate of Need (CON) Application No. 10471 (heart) and/or 10472 (heart and lung), filed by The Nemours Foundation, d/b/a Nemours Children’s Hospital (Nemours or NCH), to establish a Pediatric Heart Transplant and/or Pediatric Heart and Lung Transplant program, satisfy the applicable statutory and rule review criteria for award of a CON.
PRELIMINARY STATEMENT
This proceeding involves CON Application No. 10471 filed by Nemours for the establishment of a new pediatric heart transplantation (PHT) program, and CON Application No. 10472 filed by Nemours for the establishment of a new pediatric heart/lung transplantation (PHLT) program, to be located in AHCA District 7, Subdistrict 7-2, OTSA 3. Nemours also submitted
CON Application No. 10473 for the establishment of a pediatric lung transplantation (PLT) program. The three applications were filed in October 2016, Other Beds & Programs Batching Cycle.
On February 17, 2017, the Agency for Health Care Administration (AHCA) issued State Agency Action Reports (SAARs) denying the PHT application and the PHLT application and granting the PLT application.
Nemours filed petitions challenging the two denials, and AHCA referred them to DOAH where the undersigned was assigned to conduct a formal hearing. On February 2, 2018, the parties filed a Joint Pre-Hearing Stipulation. The hearing commenced on February 5, 2018, and concluded on March 2, 2018.
At the hearing, Nemours presented the testimony of the following witnesses: Dana Bledsoe; Stephen Lawless, M.D., who was accepted as an expert in quality, safety, and risk management; Peter Wearden, M.D., who was accepted as an expert in pediatric cardiac surgery, pediatric heart, heart/lung and lung transplant, and ventricular assist devices; Norm Jeune; Leondra Chambers; Nicolas Maroulis; Victor Morell, M.D., who was accepted as an expert in pediatric cardiac surgery and transplant; Kathy Platt, who was accepted as an expert in health planning; Anthony Chang, M.D., who was accepted as an expert in pediatric cardiology; and Dawn Tucker, Ph.D., who was accepted as an expert in cardiac surgery, program administration, and cardiac nursing.
Nemours also offered the following exhibits which were received into evidence: Exhibits 1, 2, 7 through 27, 29 through
35, 47 through 49, 54, 61, 62, and 162; and deposition testimony was received from Dr. Jay Cummings, Dr. Michael Erhard, Marlin Hutchins, Robert Kroslowitz, Marni Stahlman, and Stephan Moore.
AHCA presented the testimony of the following witnesses: Bill Pietra, who was accepted as an expert in pediatric cardiology; Shelley Collins, M.D., who was accepted as an expert in pediatrics and hospital medical direction; Heather Cinca; Robin Denbesten; Jean Osbrach, who was accepted as an expert in social work; Stephan Moore, who was accepted as an expert in transplant program administration; Michael Weiss, M.D., who was accepted as an expert in neonatology and pediatric emergency transport; and Marisol Fitch, who was accepted as an expert in certificate of need and healthcare planning. AHCA also offered the following exhibits, which were received into evidence: Exhibits 3, 4, 8 through 11, 20 through 28, 34 through 39, and
41 through 50; and deposition testimony was received from Dr. Frederick Fricker and Timothy Bantle.
Final Hearing Transcript Volumes one through nine were filed with DOAH on March 28, 2018. Both parties timely filed their Proposed Recommended Orders (PROs) on April 16, 2018, and each has been carefully considered in the preparation of this Recommended Order.
All citations are to the 2018 Florida Statutes or Florida Administrative Code rules unless otherwise noted.
FINDINGS OF FACT
Based upon the demeanor and credibility of the witnesses and other evidence presented at the final hearing and on the entire record of this proceeding, the following Findings of Fact are made:
The Parties
The Applicant, Nemours
Nemours Children’s Hospital is a licensed Class II specialty children’s hospital located in Orange County, Health Planning District 7, Subdistrict 7-2, OTSA 3, which is owned and operated by The Nemours Foundation. Nemours is licensed for
100 beds, including 73 acute care, nine comprehensive medical rehabilitation, two Level II neonatal intensive care unit (NICU), and 16 Level III NICU beds, and is a licensed provider of pediatric inpatient cardiac catheterization and pediatric open-heart surgery.
As the primary beneficiary of the Alfred I. duPont Testamentary Trust established in the will of Alfred duPont, the Foundation was incorporated in Florida in 1936. The Foundation set out to provide children and families medical care and services, its mission being “[t]o provide leadership, institutions, and services to restore and improve the health of children through care and programs not readily available, with one high standard of quality and distinction regardless of the
recipient’s financial status.” Foundation assets reached
$5.5 billion, by the end of 2015. The Foundation has funded
$1.5 billion of care to Florida’s pediatric population through subspecialty pediatric services, research, education, and advocacy.
Nemours has established a pediatric care presence throughout the State of Florida. Nemours operates over
40 outpatient clinics throughout Florida that offer primary care, specialty care, urgent care, and cardiac care services to pediatric patients in central Florida, Jacksonville, and the panhandle region. Nemours also provides hospital care to pediatric inpatients at Nemours Children’s Hospital in Orlando, as well as through affiliations with Wolfson’s Children’s Hospital in Jacksonville, West Florida Hospital in Pensacola, and numerous hospital partners in central Florida.
The resources Nemours offers in the greater Orlando area are especially significant with 17 Primary Care Clinics, five Urgent Care Clinics, 10 Specialty Care Clinics, nine Nemours Hospital partners, and, of course, NCH itself. These clinics are located throughout OTSA 3 where Nemours determined access to pediatric care was lacking, including Orlando, Melbourne, Daytona Beach, Titusville, Kissimmee, Lake Mary, and Sanford, as well as neighboring Lakeland. The clinics are fully staffed with hundreds of Nemours-employed physicians who live in
the clinic communities. Through these satellite locations, as well as the Nemours CareConnect telemedicine platform, Nemours is able to bring access to its world-class subspecialists located at NCH to children throughout the State of Florida who otherwise would not have access to such care.
Nemours was established to provide state of the art medical care to children through its integrated model. Nemours’ development has been and continues to be driven by its mission and objective to be a top-tier, world-class pediatric healthcare system. NCH is the first completely new “green field” children’s hospital in the United States in over 40 years, allowing Nemours to integrate cutting-edge technology and a patient-centered approach throughout. Nemours has created a unique integrated model of care that addresses the needs of the child across the whole continuum, connecting policy and prevention, to the highest levels of specialized care for the most complex pediatric patients. From its inception, Nemours envisioned the development of a comprehensive cardiothoracic transplant program as proposed by the CON applications at issue in this proceeding.
NCH is located in the Lake Nona area, just east of downtown Orlando in a development known as Medical City. Medical City is comprised of a new VA Hospital, the University of Central Florida (UCF) College of Medicine and School of
Biomedical Sciences, the University of Florida (UF) Research and Academic Center, the Sanford Burnham Medical Research Institute, and a CON-approved hospital, which is a joint venture between UCF and AHCA, which will serve as UCF’s teaching hospital.
Medical City is intended to bring together life scientists and research that uses extraordinarily advanced technology. Co- location in an integrated environment allows providers and innovators of healthcare, “the brightest minds,” so to speak, to interact and to share ideas to advance healthcare and wellness efforts.
Agency for Health Care Administration
AHCA is the state health-planning agency that is charged with administration of the CON program as set forth in sections 408.031-408.0455, Florida Statutes.
Context of the Nemours Applications
Pursuant to Florida Administrative Code Rule 59C-1.044, AHCA requires applicants to obtain separate CONs for the establishment of each adult or pediatric organ transplantation program, including: heart, kidney, liver, bone marrow, lung, lung and heart, pancreas and islet cells, and intestine transplantations.
“Transplantation” is “the surgical grafting or implanting in its entirety or in part one or more tissues or
organs taken from another person.” Fla. Admin. Code R. 59A-3.065.
Heart transplantation, lung transplantation, and heart/lung transplantation are all defined by rule 59C-1.002(41) as “tertiary health services,” meaning “a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost effectiveness of such service.”
AHCA rules define a “pediatric patient” as “a patient under the age of 15 years.” Fla. Admin. Code R. 59C-1.044(2)(c).
AHCA rules divide Florida into four OTSAs, corresponding generally with the northern, western central, eastern central, and southern regions of the state. Fla. Admin. Code R. 59C-1.044(2)(f). The programs at issue in this proceeding will be located in OTSA 3, which is comprised of Brevard, Indian River, Lake, Martin, Okeechobee, Orange, Osceola, Seminole, and Volusia Counties.
Currently, there are no providers of PHT in OTSA 3, and there are no approved PHLT programs statewide.
The incidence of PHT in Florida, as compared to other types of solid organ transplants, is relatively small. The chart below sets forth the number of pediatric (ages 0-14) heart transplant discharges by year for the four existing Florida PHT
programs during Calendar Years (CY) 2013 through 2016, and the 12-month period ending June 2017:
HOSPITAL | HEART TRANSPLANT | ||||
CY 2013 | CY 2014 | CY 2015 | CY 2016 | 12 MONTHS ENDING JUNE 2017 | |
All Children’s Hospital | 7 | 14 | 9 | 8 | 7 |
UF Health Shands Hospital | 6 | 8 | 15 | 15 | 9 |
Memorial Regional Hospital | 5 | 5 | 5 | 7 | 4 |
Jackson Health System | 2 | 2 | 1 | 4 | 1 |
Total | 20 | 29 | 30 | 34 | 21 |
The above historic data demonstrates that the incidence of PHT statewide is relatively rare, and does fluctuate from program to program and from year to year. As can be seen, the most recent available 12-month data reflects that only 21 PHTs were performed during that time, for an average program volume of only 5.25 cases.
Florida has more existing and approved PHT programs than every other state in the country except California, which has more than double the pediatric population of Florida. And like Florida, two of the California programs are extremely low- volume programs.
Additionally, evidence regarding the number of PHLT patients demonstrated just how rare this procedure is. From 2013 to 2016, there was an annual average of only four PHLTs nationally, with only one actual transplant on a Floridian.
Nemours’ health planner stated that although Nemours projected in its application that it would perform one heart/lung procedure each year, it is a “very low-volume service,” and Nemours in actuality expects that there will be years with zero volume of PHLT.
The CON Applications
Nemours filed its applications for heart transplantation, heart/lung transplantation, and lung transplantation in the second Other Beds and Programs Batching Cycle of 2016. Nemours is proposing the development of a comprehensive cardiothoracic transplant program, which will be the only such program in Florida. This will be achieved by combining three types of transplant services (heart, lung, and heart/lung) in one comprehensive cardiothoracic transplant program. Each application was conditioned on the development of all three transplantation programs.
Nemours is located in OTSA 3, where there is currently no PHT provider, PLT provider, or PHLT provider. There are, however, three providers of pediatric open-heart surgery and pediatric cardiac catheterization, and a large, growing pediatric population.
Unlike any other facility in Florida, the Nemours Cardiac Center (Cardiac Center) is uniquely organized to treat all forms of congenital heart disease. The Cardiac Center
employs a “programmatic approach” to offer the most beneficial environment and the finest care available for pediatric patients. The Cardiac Center, physically located at NCH, throughout Florida, is organized as a single Department of Cardiovascular Services to house Cardiac Surgery, Cardiac Anesthesia, Cardiac Intensive Care Unit (ICU), and Cardiology. Cardiac Center physicians throughout Florida are organized as a single entity with the goal of providing the highest quality, patient-centered care to all patients without the usual barriers created by the departmental “silos.”
The entire Cardiac Center clinical team, including nurses and physicians, is dedicated solely to the special challenges of congenital heart abnormalities and makes the care of children with heart disease the life’s work of team members. The fully integrated organizational structure permits the team to take shared responsibility for all aspects of the delivery of quality care to these pediatric patients from admission to discharge. The Cardiac Center holds weekly patient consensus conferences, where all providers, including physicians, nurses, and the patients’ caregivers, participate in case reviews of all inpatients and those patients scheduled for surgery or catheterization.
The Cardiac Center is “state of the art” with a designated cardiovascular operating room, a designated
cardiovascular lab that includes an electrophysiology lab, and a dedicated comprehensive care unit. In addition, The Foundation has furthered the commitment to the Cardiac Center by funding an additional $35 million expansion to the sixth floor of NCH, adding an additional 31 inpatient beds, an additional operating room, and a comprehensive cardiovascular intensive care unit.
Dr. Peter D. Wearden joined Nemours in 2015 as the chief of cardiac surgery, chair of the Department of Cardiovascular Services, and director of the Cardiac Center at Nemours. Dr. Wearden will serve as director of the Comprehensive Cardiothoracic Transplant Program at Nemours and will be instrumental in the development and implementation of the program.
Dr. Wearden was recruited from the Children's Hospital of Pittsburgh (CHP), where he served as the surgical director of Heart, Lung, and Heart/Lung Transplantation. He was also the director of the Mechanical Cardiopulmonary Support and Artificial Heart Program. CHP rose to a US News and World Report top 10 program during Dr. Wearden’s tenure. CHP is at
the forefront of organ transplantation and is where the first pediatric heart/lung transplantation was performed.
Dr. Wearden is a trained cardiothoracic surgeon who completed fellowships in both cardiothoracic surgery (University
of Pittsburgh) and Pediatric and Congenital Heart Surgery (Hospital for Sick Children, Toronto, Canada). He is certified by the American Board of Thoracic Surgery and holds additional qualifications in Congenital Heart Surgery from that organization.
In his tenure as a board-certified pediatric transplant specialist, he has participated in over 200 pediatric cardiothoracic transplantations, of which he was the lead surgeon in over 70. In addition, he has procured over
$20 million in National Institutes of Health research funding since 2004 specific to the development of artificial hearts and lungs for children and their implementation as a live-saving bridge to transplantation.
Dr. Wearden was a member of the clinical team that presented to the Food and Drug Administration (FDA) panel for approval of the Berlin Heart, the only FDA-approved pediatric heart ventricular assist device (VAD)1/ currently available, and he proctored the first pediatric artificial heart implantation in Japan in 2012.
A VAD is referred to as “bridge to transplant” in pediatric patients because the device enables a patient on a waiting list for a donated heart to survive but is a device on which a child could not live out his or her life. Both utilization of VADs and heart transplantation procedures are in
the “portfolio of surgical interventions” that can save the life of a child with heart failure. Dr. Wearden is an international leader in the research and development of VADs. Victor Morell, an eminent cardiac surgeon and chief of Pediatric Cardiac Surgery at CHP, testified that Dr. Wearden’s presence in Orlando alone and the work that he will be able to do with VADs and a PHT program will likely save lives.
Many of the physicians that comprise the Nemours Cardiac Center transplant team not only have significant transplant experience, but also have experience performing transplants together. These physicians came with Dr. Wearden from CHP, were trained by Dr. Wearden, or otherwise worked with Dr. Wearden at some point in their careers. The physicians recruited to the Nemours transplantation team were trained at or hail from among the most prestigious programs in the country.
For example, Dr. Kimberly Baker, a cardiac intensivist, was trained by Dr. Wearden in the CHP ICU. Dr. Constantinos Chrysostomou, Nemours’ director of cardiac intensive care, worked with Dr. Wearden at CHP, and has
experience starting the pediatric ICU in Los Angeles at Cedar Sinai Hospital. Dr. Steven Lichtenstein, chief of cardiac anesthesia, held the same position at CHP for 12 years before he was recruited to Nemours. Dr. Karen Bender, a cardiac anesthesiologist, was recruited by Dr. Wearden from the
Children’s Hospital of Philadelphia – one of the leading programs in the country. Dr. Michael Bingler, a cardiac interventionalist, was at Mercy Children’s Hospital in Kansas City for eight years. Dr. Adam Lowry of the Nemours cardiac intensive care center previously trained at both Texas Children’s Hospital (the number one program in the country) and Stanford. The 11 physicians that comprise the Cardiac Center’s Cardiothoracic Physician Team have collectively participated in 1,146 cardiothoracic transplantations. These physicians came to Nemours to care for the most acute, critically ill patients, including those requiring PHT.
In addition to the physician team, the expertise and skill of the non-physician staff in the catheterization lab, the operating room, and the cardiac ICU are crucial to a successful program. Dr. Dawn Tucker is the administrative director of NCH’s Cardiac Center and heads the nursing staff for NCH’s Cardiac Center, which includes 23 registered nurses with transplant experience. Dr. Tucker holds a doctorate of Nursing Practice and was formerly the director of the Heart Center at Mercy Children’s Hospital in Kansas City, where she oversaw the initiation of a PHT program.
The average years of experience for total nursing care in cardiac units across the nation is two years. The average years of experience in the Nemours Cardiac Center is
eight years. Medical literature shows the greater the years of nursing staff experience, the lower the mortality and morbidity rates. The nursing staff at Nemours, moreover, has extensive experience in dealing not only with pediatric cardiac patients, but with pediatric heart transplants as well. The Cardiac Center’s cardiothoracic nursing staff has over 220 years of collective cardiothoracic transplant experience.
Nemours operates a “simulation center” that allows the Cardiac Center to simulate any type of cardiac procedure on a model patient before performing that procedure on an actual patient. The model patient’s “heart” is produced using a three- dimensional printer that creates a replica of the heart based on MRI’s or other medical digital imaging equipment. These replica hearts are printed on-site, using the only FDA-approved software for such use, and are ready for use in the simulation center within a day after medical imaging.
Nemours Cardiac Center currently performs what the Society of Thoracic Surgeons has coined “STAT 5” cardiac procedures. STAT 5 cardiac procedures are the most complex; STAT 1 procedures are the least complex. A PHT is a STAT 4 procedure. Since Dr. Wearden’s arrival at the Nemours Cardiac Center, there have been no patient mortalities.
The uncontroverted evidence established that Nemours has assembled a high-quality, experienced, and unquestionably capable team of physicians and advanced practitioners for its cardiothoracic transplantation programs and is capable of performing the services proposed in its applications at a high level.
UF Health Shands
While not a party to this proceeding,2/ UF Health Shands’ (Shands) presence at the final hearing was pervasive. AHCA called numerous witnesses affiliated with Shands in its case-in-chief.
The scope of the testimony presented by Shands- affiliated witnesses was circumscribed by Order dated December 13, 2017 (ruling on NCH’s motion in limine) that:
At hearing, the Agency may present evidence that the needs of patients within OTSA 3 are being adequately served by providers located outside of OTSA 3, but may not present evidence regarding adverse impact on providers located outside of OTSA 3.
Baycare of Se. Pasco, Inc. v. Ag. for Health Care Admin., Case No. 07-3482CON (Fla. DOAH Oct. 28, 2008; Fla. AHCA Jan. 7, 2009).
UF Health Shands Hospital is located in Gainesville, Florida. UF Health Shands Children’s Hospital is an embedded hospital within a larger hospital complex. Shands Children’s Hospital has 200 beds and is held out to the public as a children’s hospital. The children’s hospital has 72 Level II
and III NICU beds. Unlike Nemours, Shands offers obstetrical services such that babies are delivered at Shands. It also has a dedicated pediatric intensive care unit (PICU) as well as a dedicated pediatric cardiac intensive care unit.
The Shands Children’s Hospital has its own separate emergency room and occupies four floors of the building in which it is located. It is separated from the adult services. Shands Children’s Hospital is nationally recognized by U.S. News &
World Report as one of the nation’s best children’s hospitals. The children’s hospital has its own leadership, including
Dr. Shelley Collins, an associate professor of pediatrics and the associate chief medical officer.
As a comprehensive teaching and research institution, Shands Children’s Hospital has virtually every pediatric subspecialty that exists and is also a pediatric trauma center. The children’s hospital typically has 45 to 50 physician residents and 25 to 30 fellows along with medical students. Over $139 million has been awarded to Shands for research activities.
As a teaching hospital, Shands is accustomed to caring for the needs of patients and families that come from other parts of the state or beyond. Jean Osbrach, a social work manager at Shands, testified for AHCA. Ms. Osbrach oversees the transplant social workers that provide services to the families
with patients at Shands Children’s Hospital. Ms. Osbrach described how the transplant social workers interact with the families facing transplant from the outset of their connection with Shands. They help the families adjust to the child’s illness and deal with the crisis; they provide concrete services; and these social workers help the families by serving as navigators through the system. These social workers are part of the multidisciplinary team of care, and they stay involved with these families for years. Shands is adept at helping families with the issues associated with getting care away from their home cities. Shands has apartments specifically available in close proximity to the children’s hospital and relationships with organizations that can help families that need some financial support for items such as lodging, transportation, and gas.
Ms. Osbrach’s ability to empathize with these families is further enhanced because her own daughter was seriously ill when she was younger. Ms. Osbrach testified that, while she was living in Gainesville, she searched out the best options for her child and decided that it was actually in Orlando. Despite the travel distance, she did not hesitate to make those trips in order to get the care her child needed at that time.
The Shands Children’s Hospital is affiliated with the Children’s Hospital Association, the Children’s Miracle Network, the March of Dimes, and the Ronald McDonald House Charities.
Shands operates ShandsCair, a comprehensive emergency transport system. ShandsCair operates nine ground ambulances of different sizes, five helicopters, and one fixed-wing jet aircraft. ShandsCair does over 7,000 transports a year, including a range of NICU and other pediatric transports. ShandsCair is one of the few services in the country that owns an EC-155 helicopter, which is the largest helicopter used as an air ambulance. This makes it easier to transport patients that require a lot of equipment, including those on extracorporeal membrane oxygenation (ECMO). Patients on ECMO can be safely transported by ground and by air by ShandsCair. Shandscair serves as a first responder and also provides facility-to- facility transport. It has been a leader in innovation.
The congenital heart program at Shands includes two pediatric heart surgeons, as well as pediatric cardiologists Dr. Jay Fricker and Dr. Bill Pietra, both of whom testified for AHCA.
Dr. Fricker did much of his early work and training at the Children’s Hospital of Pittsburgh, and came to the University of Florida in 1995. He is a professor and chief of
the Division of Cardiology in the Department of Pediatrics at Shands. He is also the Gerold L. Schiebler Eminent Scholar Chair in Pediatric Cardiology at UF. He has been involved in the care of pediatric heart transplant patients his entire career.
Dr. Bill Pietra received his medical training in Cincinnati and did his early work at several children’s hospitals in Colorado. He came to the University of Florida and Shands in July 2014 and is now the medical director, UF Health Congenital Heart Center.
Shands performed its first pediatric heart transplant in 1986. Shands treats the full range of patients with heart disease and performs heart transplants on patients, from infants through adults, with complex congenital heart disease. Shands provides transplants to pediatric patients with both congenital heart defects and acquired heart disease (cardiomyopathy). Shands will accept the most difficult cases, including those that other institutions will not take. Data presented by AHCA dating back to the beginning of 2014 demonstrate that Shands has successfully transplanted numerous patients that were less than six months old at the time of transplantation. This data also demonstrates that Shands serves all of central and north Florida, as well as patients that choose to come to Shands from other states.
PHT patients now survive much longer than in the past, and in many cases, well into adulthood. Because Shands cares for both adult and pediatric patients, it has the ability to continue to care for PHT patients as they transition from childhood to adulthood.
Managed care companies are now a significant driver of where patients go for transplantation services. Many managed- care companies identify “centers of excellence” as their preferred providers for services such as PHT. Shands is recognized by the three major managed-care companies that identify transplant programs as a center of excellence for PHT services.
AHCA’s Preliminary Decision
Following AHCA’s review of Nemours’s applications, as well as consideration of comments made at the public hearing held on January 10, 2017, and written statements in support of and in opposition to the proposals, AHCA determined to preliminarily deny the PHT and PHLT applications, and to approve the PLT application. AHCA’s decision was memorialized in three separate SAARs, all dated February 17, 2017.
Marisol Fitch, supervisor of AHCA’s CON and commercial-managed care unit, testified for AHCA. Ms. Fitch testified that AHCA does not publish a numeric need for transplant programs, as it does for other categories of services
and facilities. Rather, the onus is on the applicant to demonstrate need for the program based on whatever methodology they choose to present to AHCA. In addition to the applicant’s need methodology, AHCA also looks at availability and accessibility of service in the area to determine whether there is an access problem. Finally, an applicant may attempt to demonstrate that “not normal” circumstances exist in its proposed service area sufficient to justify approval.
Statutory Review Criteria
Section 408.035(1) establishes the statutory review criteria applicable to CON Applications 10471 and 10472.
The parties have stipulated that each CON application satisfies the criteria found in section 408.035(1), (d), (f), and (h), Florida Statutes. The only criteria at issue essentially relate to need and access. However, the Agency maintains that section 408.035(1)(c) is in dispute to the extent that center transplant volume as a result of Nemours’ approval would lead to or correlate with negative patient outcomes.
AHCA believes that there is no need for the PHT or PHLT programs that Nemours seeks to develop because the needs of the children in the Nemours service area are being met by other providers in the state, principally Shands and Johns Hopkins All Children’s Hospital.
Section 408.035(1)(a) and (b): The need for the health care facilities and health services being proposed; and the availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the district of the applicant. Florida Administrative Code Rule 59C-1.044(6)(b).3/
The criteria for the evaluation of CON applications, including applications for organ transplantation programs, are set forth at section 408.035 and rule 59C-1.044. However, neither the applicable statutes nor rules have a numeric need methodology that predicts future need for PHT or PHLT programs. Thus, it is up to the applicant to demonstrate need in accordance with rule 59C-1.044.
There are four OTSAs in Florida, numbered OTSA 1 through OTSA 4. NCH is located in OSTA 3, which includes the following counties: Seminole, Orange, Osceola, Brevard, Indian River, Okeechobee, St. Lucie, Martin, Lake, and Volusia.
(See § 408.032(5), Fla. Stat; Fla. Admin. Code R. 59C- 01.044(2)(f)3.) OTSA 3 also generally corresponds with the pediatric cardiac catheterization and open-heart surgery service areas defined by AHCA rule. (See Fla. Admin. Code R. 59C-
1.032(2)(g) and 59C-1.033(2)(h)).
Currently, there is no provider of PHT in OTSA 3, but there are three providers of pediatric cardiac catheterization and pediatric open-heart surgery: Orlando Health Arnold Palmer Hospital for Children; Florida Hospital for Children; and
Nemours. There are no licensed providers of PHLT anywhere in the State of Florida.
There are four existing providers and one approved provider of PHT services in Florida: UF Shands in OTSA 1; Johns Hopkins All Children’s Hospital in OTSA 2; Jackson Memorial Hospital in OSTA 4; and Memorial Regional Hospital, d/b/a Joe DiMaggio’s Hospital in OTSA 4; and a third approved program in OTSA 4, Nicklaus Children’s Hospital, which received final approval from AHCA in August 2017.
As noted above, there is no fixed-need pool published for PHT, PHLT, or PLT programs. Alternatively, AHCA follows rule 59C-1.008(2)(e)2., which requires consideration of population demographics and dynamics; availability, utilization and quality of like services in the district, subdistrict, or both; medical treatment trends; and market conditions.
To quantify the need for a new PHT program in District 7, OTSA 3, Nemours created and presented a methodology that started with the statewide use rate in its projected first year. Then for the second year, Nemours aggressively increased the use rate to the highest rate in any of the other transplant service areas in the state. Then, in an even more aggressive (and unreasonable) assumption, Nemours projected that it would essentially capture all of the cases in OTSA 3 by the second year of the program.
In its application, the assumptions resulted in a projection that Nemours would do four transplants in the first year of operation and eight in the second. These projections fall short of the rule requirement that the applicant project a minimum of 12 transplants per year by the second year of operation. Fla. Admin. Code R. 59C-1.044(6)(b)2. At hearing, Nemours updated (increased) those first and second year projections to 7 and 13 cases, respectively. However, these updated projections included one child, aged 15 to 17, in
year one, and two in year two.
There are several reasons these projections lack credibility. First, as noted, Nemours assumed a near-
100 percent market share based on the highest use rate in the state by just year two. Second, when Nemours prepared its update, it used the most recent calendar year data. However, this was not the most current data. Calendar Year 2016 reflected 34 cases statewide, but that number had dropped to
21 for the most recent 12-month period available at the time of the hearing. Use of this most recent 12-month data would have significantly decreased the Nemours PHT volume projections.
In addition, the projection of 13 cases by year two would place Nemours at a higher PHT case volume than three of the four established programs in the state, and would be at a level that is nearly equivalent to the much more established
Shands program. This is not credible, especially considering that Nemours also admitted at hearing that only two OTSA 3 residents received pediatric heart transplants in 2016.
The existence of unmet need cannot be based solely on the absence of an existing service in the proposed service area. Fla. Admin. Code R. 59C-1.008(2)(e)3. While Nemours’ own health planner agreed that the absence of a PHT program in OTSA 3 is not itself a basis for finding need, Nemours nevertheless argues that this rule is inapplicable in this proceeding because the title to this subsection of the rule is “Comparative Review” and a portion of this subsection addresses competing applications in the same cycle. As detailed further in the Conclusions of Law section herein, this interpretation is unconvincing and rejected. AHCA interprets this rule provision to apply to those batched applications submitted without the submission of a competing application in the same batching cycle, as with Nemours in this proceeding.
Nemours initiated its cardiac catheterization and cardiac surgery program in June/July 2016. In its PHT application, Nemours projected that it would meet or exceed the rule minimum required volumes of 200 cardiac catheterizations and 125 open-heart surgery cases by the end of 2017. Actual volumes achieved by Nemours in CY 2017 were 97 open-heart cases and 196 cardiac catheterizations.
The incidence of PHLT is extremely low. During the four calendar years, 2013 through 2016, there were only 16 PHLT transplants performed nationwide. Only one Florida resident received a PHLT during that four-year period, and that was performed in Massachusetts. Also during that four-year period, only three Florida residents were registered for PHLT. There is no evidence in this record as to why two of the three registered Florida residents did not obtain a PHLT.
Based on the national use rate for PHLTs from CY 2013 through CY 2016, Nemours projects that it will perform an average of one PHLT per year. Nemours acknowledges that due to the extremely low incidence of PHLTs, there may be some years that no PHLTs are performed at Nemours.
Geographic Access
There is no evidence of record that families living in central Florida are currently being forced to travel unreasonable distances to obtain PHT services. Indeed, there are five existing or approved programs within the state, with at least two located very reasonably proximate to OTSA 3.
According to the analysis of travel distances for PHT patients living in OTSA 3 contained in the Nemours application
(Exhibit 15), only some residents located in Brevard and Indian River Counties are not within 120 miles of an existing PHT program.
There was agreement that patients that need a PHT are approaching the end-stage of cardiac function, and in the absence of a PHT will very likely die. Accordingly, it is reasonable to infer that the parents of a child living in central Florida and needing a PHT will travel to St. Petersburg or Gainesville for transplant services rather than let their child die because the travel distance is too far. To the contrary, the evidence in this record from witnesses on both sides, as well as common sense, is that families will go as far as necessary to save their child. The notion that there is some pent-up demand for PHT services among central Florida residents (especially when there is no evidence of a single OTSA 3 patient being turned down or unable to access a PHT) is without support in this record.
The parents of four pediatric patients testified at the final hearing. Two testified for Nemours. The other two testified for AHCA and were parents of children that received PHTs at Shands. One of the Nemours witnesses was the parent of a child that has not received a transplant. The other received transplant services at Johns Hopkins All Children’s Hospital in St. Petersburg.
The parents of the two Shands patients were representative of the two broad categories of PHT patients. One was a patient with a congenital heart defect that lives in Cocoa
Beach (Brevard County). The patient likely had the heart defect since birth, but it was not diagnosed until she was six years old. That patient was asymptomatic at the time of diagnosis but deteriorated over a period of years. While she was first seen at Shands, the family had the time and researched other prominent institutions, including Texas Children’s Hospital, Boston Children’s Hospital, Children’s Hospital of Pittsburgh, and the Mayo Clinic in Rochester, Minnesota. They did this because, like all of the parents that testified, they “would have gone to the ends of the earth” to save their child. This family researched the volumes and experience of the programs they considered and looked for what they felt was the best program for their child, and ultimately chose Shands. It was clear that they felt Shands was the right choice. Their daughter received her heart transplant at Shands, is doing well, and is now considering what college to attend. Additionally, this family did not find the two hours and 35 minute travel time from their home in Brevard County to Shands to be an impediment, and actually consider Shands as being relatively close to their home. This testimony supports the obvious truism that obtaining the best possible outcome for a sick child is the paramount goal of any parent.
The other parent witness called by AHCA has a daughter that, on Christmas Eve in 2008, went from perfectly healthy to
near death and being placed on life support within a 24-hour period. As opposed to a congenital heart defect, this patient had cardiomyopathy. This family lives in Windermere, a suburb of Orlando. She acquired a virus that attacked her heart. She was initially treated at Arnold Palmer Children’s Hospital where she had to be placed on ECMO. From there, she was safely airlifted to Shands while still on ECMO where, upon arrival, the receiving team of physicians informed the family that she was one of the most critically ill children they had ever seen.
After an 11-hour open-heart surgery, a Berlin Heart was successfully implanted and kept her alive for four months until an appropriate donor heart became available. This patient also had an excellent outcome and is now a student at the University of Florida. The following exchange summarizes how the child’s mother felt about the inconvenience of having to travel from the Orlando area to Gainesville:
Q If a family in Orlando told you, or in your city of residence told you that their child was critically ill and they were worried about having to travel and potentially spend time in Gainesville to get care, what would you tell them?
A Well, I would tell them to just take it a day at a time and – when your child is critically ill, convenience never really comes into your mind. What comes into your mind is how do I help my child live. And so you will go anywhere.
And it’s just an hour and a half, it just doesn’t matter. When you are talking about saving your child, it means nothing. It literally means nothing.
It is clear from the testimony of these two parents that nothing about having a gravely ill child is “convenient.” It creates great stress, but it was also clear that having an experienced provider was more important than just geographic proximity. The mothers of the two Shands patients persuasively spoke of their concerns about further diluting the volumes of the existing programs that could result from approval of a sixth pediatric heart transplant program in Florida, particularly when there are two other programs that are not that far from the Orlando area.4/
While transplantation is not an elective service, it is not done on an emergent basis. As noted, the number of families affected is, quite fortunately, very small. While having a child with these issues is never “convenient,” the travel issues that might exist do not outweigh the weight of the evidence that fails to demonstrate a need for approval of either application. The Orlando area, being centrally located in Florida, is reasonably accessible to all of the existing providers. Most appear to go to Shands, which is simply not a substantial distance away. The credible evidence is that
families facing these issues are able to deal with the travel inconvenience.
In addition, Nemours presented evidence regarding the various locations at which they provide services, ranging from Pensacola to Port St. Lucie. Clearly, Nemours sees itself as providing some cardiac services to patients in these locations, but it would also suggest that patients seen at these locations may be referred to NCH for transplant services, which would mean that some patients would be bypassing closer facilities. As observed by AHCA, for Nemours to posit that it is appropriate for patients to travel from Pensacola or Jacksonville to Orlando while asserting that it is not acceptable for patients in Orlando to go to Gainesville or St. Petersburg is an illogical inconsistency.
Financial Access
Nemours asserts that approval of its proposed programs will enhance financial access to care. Nemours currently serves patients without regard to ability to pay and will extend these same policies to transplant recipients. Approximately half of Nemours’ projected PHTs are to be provided to Medicaid recipients, the other half to commercially insured patients.5/ However, there was no competent evidence of record that access to PHT or PHLT services was being denied by any of the existing transplant providers because of a patient’s inability to pay.
Transplant Rates at Shands
In its need methodology, Nemours utilized the use rate from OTSA 1 where Shands is located because it is the highest use rate in the state. Despite this, Nemours then asserted that Shands is not performing as many PHTs as it could or should.
The Nemours CON applications are not predicated on any argument that their proposed programs are needed because of poor quality care at any of the existing pediatric transplant programs in Florida. Indeed, Dr. Wearden stated his belief that Shands provides good quality care in its transplant programs, and he respects the Shands lead surgeon, Dr. Mark Bleiweis. As evidence of his respect for the Shands PHT program, Dr. Wearden has referred several transplant patients to Dr. Bleiweis at Shands.
Despite that position, Nemours argued that the Shands program is unduly conservative and cautious in its organ selection and may have some “capacity” issues due to a few cited instances of apparent surgeon unavailability. These assertions, made by Nemours witnesses with no first-hand knowledge of the operations of the Shands program, are not persuasive.
With regard to whether the Shands program is unduly “cautious,” “conservative,” or “picky,” Nemours relied on a document produced by Shands in discovery. Nemours also relied on data reported by Shands to the Scientific Registry of
Transplant Recipients (SRTR). The data included a list of all of the organs offered to Shands since the beginning of 2015, the sequencing of the offer of that organ to Shands, whether the organ was transplanted at Shands or elsewhere, the primary and secondary reasons the organ was refused (if refused) and other information.
The SRTR exhibit demonstrates that a high number of the organs that are offered are not acceptable for transplant on patients waitlisted at Shands. It also shows that organs that are accepted may have to be examined by many different centers before being deemed potentially acceptable. This demonstrates the extensive level of complexity, nuance, and clinical judgment involved in the decision to accept an organ for transplant in a pediatric patient. Indeed, Dr. Wearden agreed that the decision by a program to accept or turn down an organ involves both clinical expertise and judgment, and that there are many reasons an organ might be turned down, which helps explain why the transplanted percentage of total organs offered nationally is on average, so small.
Dr. Wearden chose a few examples of organs that were not taken by Shands to express an opinion that Shands may be unduly conservative in its organ selection. However, this assertion was credibly refuted by Dr. Pietra, a transplant cardiologist and the medical director of the UF Health
Congenital Heart Center. Dr. Pietra discussed the complexity of these cases and how simply looking at the SRTR data does not provide enough information to reach Dr. Wearden’s conclusion.
An organ that might be acceptable for one patient would not be acceptable for another for a host of reasons. Many more organs are rejected by transplant centers than are accepted.
Dr. Pietra credibly opined that being conservative and cautious are important traits for a transplant surgeon, particularly for one that wants the accepted organ to work well for the patient long-term. That does not mean that Shands is rejecting organs when it should have taken them, nor does the SRTR data support the proposition that the Nemours program should be approved because its program may have accepted an organ for a particular patient that Shands might have rejected.
Nemours also argues that Shands performs PHTs at a rate lower than the region and the country, and that this should mitigate for the approval of another program. This assertion is predicated on waitlist information reported in the SRTR data.
Patients that are placed on the waitlist have different status designations, depending on the severity of their condition. That status may change, up or down, over time.
Due to the shortage of organs, until a patient reaches
status 1A, he or she is unlikely to be offered an organ. The evidence reflected that Shands puts patients on the PHT organ
waitlist at a time earlier than the moment they require the transplant surgery under what is called the “pediatric prerogative.” This helps those patients maintain their status on the list but does not result in organs being provided to less severely ill patients to the detriment of those in greater need. Further, the record evidence supports the finding that Shands waitlists patients because the clinical determination has been made that the child will ultimately require a transplant. This was corroborated by the parent of a Shands PHT patient who testified that when her daughter was placed on the waitlist, Dr. Fricker concluded at that time that her daughter would ultimately need a PHT, even though she was placed on a lower status initially, and it was a few years before the transplant occurred.
Transplant surgeon Dr. Victor Morell, of the Children’s Hospital of Pittsburgh, testified that he waitlists his PHT patients not only when they need the procedure performed immediately, but rather when, in his clinical judgment, he determines the patient will ultimately need a PHT. This testimony supports the finding that there is nothing clinically unusual or inappropriate about how the Shands program waitlists patients.
Shands realizes that its philosophy, which is contemplated within and permitted under the United Network for
Organ Sharing (UNOS) rules, makes its statistics, both in terms of percent of patients transplanted and waitlist mortality, look worse. While Shands’ waitlist mortality may be higher than expected as reflected in the SRTR data, it is still significantly lower than in the UNOS region or the United States. Shands advocates for its patients by their waitlist practices because it believes it helps secure the best outcomes for its patients. It does not indicate need for a new PHT program.
Nemours also suggests that there may be a “capacity” problem at Shands because the organ rejection information provided by Shands shows that, during the 3-year period of
CY 2015 through CY 2017, there were seven entries showing as either a primary or secondary reason for organ rejection that the surgeon was unavailable. However, this included both adult and pediatric hearts, and further investigation revealed that in only four instances were there potential PHT recipients at Shands. Of those four hearts that were rejected, two were not accepted by any PHT provider, and the two that were accepted were placed with adult transplant patients, not PHT patients.
Shands has two PHT transplant surgeons. In very few instances at Shands, an organ was offered but not accepted because the surgeon was not available for one of several reasons. In one instance, there was another transplant
scheduled. A surgeon could be ill, could be gone, or may have just completed another long surgery and be too fatigued to safely perform another.
Like Shands, Nemours also has two experienced PHT surgeons. Although Dr. Wearden believes that Nemours would endeavor to not reject an organ for this reason, this ambition ignores reality. He cannot guarantee that the same could not or would not happen at Nemours for the same reasons it occasionally occurs at Shands. As explained by Dr. Pietra, when there are only small to medium volume programs, there is not likely to be a sufficient number of surgeons such that this scenario can be avoided entirely.
Not Normal Circumstances
In both its heart and heart/lung applications, Nemours articulated the following “not normal circumstances” in seeking approval:
Florida does not have any approved pediatric heart/lung transplant programs.
Florida's only two approved pediatric lung transplant programs have not performed any lung transplant programs in the last two reporting years according to AHCA reporting data.
Significantly, there are no pediatric heart transplant or lung transplant programs in AHCA's Organ Transplant Service Area
OTSA 3 in which NCH is located-an area of the State with one the fastest growing and youngest populations.
Florida has no other pediatric comprehensive, multi-organ thoracic transplant program.
Florida has no other pediatric comprehensive, multi-organ thoracic transplant program that is part of a pediatric specific integrated delivery system such as Nemours offers.
NCH offers a unique, dedicated model of cardiothoracic care developed at its Alfred I. duPont Hospital for Children (AIDHC) in Wilmington, Delaware and
implemented upon the opening of the program at NCH. The key and differentiating element of this Model of Care is a unified team of cardiac clinical and administrative professionals who serve children with cardiac problems in dedicated facilities (the "Cardiac Team"). The Cardiac Team only cares for children with cardiac diagnoses.
As such, the Cardiac Team of anesthesiologists, surgeons, cardiologists, nurses, and other support personnel do not "float" to other hospital floors or departments as in a typical hospital setting. This dedicated model of cardiac care allows the Cardiac Team to develop highly specialized knowledge and relationships to provide the best treatment protocols for patients with cardiac conditions.
NCH has developed state-of-the art facilities and innovative clinical pathways for the care of the most complex pediatric thoracic patients.
NCH has and will bring new opportunities for research in pediatric cardiology, cardiac surgery, and pulmonary medicine, particularly clinical translational and basic research into the linkages between childhood obesity and cardiac conditions.
Nemours operates a regional network of clinics in Florida, with primary locations in Pensacola, Jacksonville, and Orlando, that will operate in partnership with NCH for the appropriate regional referral of patients in Florida for pediatric thoracic care.
NCH can reduce the out-migration of pediatric, thoracic transplant patients from OTSA 3 to other parts of the State as well as the out-migration of these patients to other out-of-state transplant programs. Similarly, NCH will reduce the outmigration of organs donated in Florida to other states ensuring that Florida recipient patients are first priority for organs donated in Florida.
NCH has in place the infrastructure, facilities, and resources to seamlessly add thoracic transplant services to its existing comprehensive cardiac surgery program. Additional needed staff are already being recruited to this program. As a result, the project has minimal incremental cost that will need to be incurred. Total project costs are, therefore, estimated to be
$715,425.00.
In addition, according to Nemours, an additional “not normal” circumstance has emerged since the filing of the applications: the approval of Nemours’ PLT application in the absence of a PHT program at the facility, which it contends is “a very unusual situation.”
Noteworthy about these purported reasons for approval are that: (1) none of them are specifically directed at a unique circumstance relating to a need for another PHT program; and (2) most of them are either a recitation of the fact that
there is no existing program in the service area or are about Nemours’ capability to provide these services. They are not directed at whether there is a need for its proposed programs.
In fact, the main thrust of Nemours’ case was directed at proof regarding its capabilities. But the flaw in this theme is best demonstrated in the testimony of Dawn Tucker, the last witness called by Nemours. Ms. Tucker is the cardiac program administrative director for Nemours. When asked why she supported the proposed program, she talked about the experience of the team, a desire to care for sick patients, an organization (Nemours) that financially supports the program, and the network of centers that Nemours has in Florida. These factors address why Nemours “wants” these CONs. None of them addresses the threshold issue of whether there is a “need” for these programs in OTSA 3.
More specifically, the first, third, and fourth bullet points are all based on the absence of a program in OTSA 3. By rule, that is not a basis for establishing need. Fla. Admin. Code R. 59C-1.009(2)(e)3. AHCA appropriately rejected the absence of a program in OTSA 3 as the sole basis upon which need for the proposed projects could be established.
The second bullet point relates to the pediatric lung transplant application that is not at issue in this matter.
The fifth and sixth bullet points relate to the Nemours integrated model of care. But again, this does not address whether there is a need for the proposed programs. The fact that Nemours has an employed-physician model is not unique or “not normal.” AHCA considered the information regarding the model of care and correctly noted that the model of care does not itself enhance access or improve outcomes. It should be noted that Shands’ doctors are employed by the University of Florida. In addition, the reliance on this model does not guarantee a robust program. This bullet point references the much older and more established Alfred I. duPont Hospital for Children in Wilmington, Delaware, that is touted as the model for Nemours. Nemours presented evidence relating to its more established hospital in Delaware that also provides PHT services. However, the PHT program at duPont is a low-volume program, performing only one PHT in 2016. None of the managed- care companies that recognize Shands as a center of excellence also recognizes the duPont Hospital as such. One of the companies--Lifetrac--acknowledges duPont as a “supplemental” program, whereas Shands is one of its “select” programs. This demonstrates that simply having the financial resources of the duPont Foundation or the model of care used by that organization does not guarantee high volumes or success.
The “not normal circumstance” bullet points regarding Nemours’ facilities, research, and other infrastructure similarly do not demonstrate need. Otherwise, a hospital could obtain a CON for a new program by spending the money in advance and then demanding approval based upon those expenditures. AHCA recognized that Nemours had recruited some very qualified clinicians, but correctly noted that that does not create or evidence need for the proposed programs.
The remaining bullet point asserts that approval of the PHT and PHLT programs could reduce outmigration of both patients and organs. By definition, because neither of these transplant programs exists in OTSA 3, all patients leave OTSA 3 for these services. Again, that alone does not establish need, nor is it automatically a “not normal” circumstance. As discussed herein, Nemours has not demonstrated a sufficient need or an access problem that justifies approval of either application.
With regard to the outmigration of organs from Florida, Nemours has argued that Florida is a net exporter of organs and that this is a “not normal” circumstance justifying approval of its application. However, organs harvested in one state are commonly used in another. There is nothing unusual or negative about that fact. Indeed, Dr. Wearden agreed that in his experience, this is a common occurrence. There is a
national allocation system through UNOS and this sharing, as explained by Dr. Pietra, facilitates the best match for organs and patients. UNOS divides the country into regions for the purpose of allocation of donor organs, with Florida being one of six states in Region 3. The evidence of record did not establish that approval of the Nemours applications would result in the reduction of organs leaving Florida, or even that such would be a desirable result.
Nemours also argued at hearing that approving their applications would increase the number of donor organs that are procured and transplanted in Florida. Nemours suggested that its programs would increase public awareness and implied that it would accept organs for future patients that surgeons at other programs turn down. However, these arguments are purely conjectural and are rejected. No record evidence exists which demonstrates that a Nemours program would increase the supply of organs in Florida. Indeed, Nemours presented no such relevant data or statistical evidence in its applications to demonstrate that this will occur.
Finally, Nemours argues that its PHT and PHLT applications should be approved because it does not make sense for AHCA to have approved the PLT program but denied the other two applications. Nemours goes on to note that while there are hospitals in the country that do PHTs but not PLTs, there are no
hospitals that do lungs but not hearts. Regardless of whether that is true, Florida law separates these three services into separate CON applications, which are reviewed independently.
The wisdom of the rule is not at issue in this proceeding. Regardless of any overlap in the skill sets required to perform these procedures, approval of the pediatric lung transplant application does not determine need for pediatric heart or pediatric heart/lung programs.
Nemours failed to establish that “not normal” circumstances currently exist that would warrant approval of either the PHT or PHLT programs. Nor did Nemours credibly demonstrate any other indicators of need for its proposed programs.
Section 408.035(1)(c): The ability of the applicant to provide quality of care and the applicant’s record of providing quality of care.
The parties stipulated that Nemours is a quality provider. However, AHCA maintains that this criterion is in dispute to the extent that center transplant volume as a result of Nemours’ approval would lead to or correlate with negative patient outcomes.
Nemours failed to demonstrate that it would achieve the volumes it projected unless it takes significant volumes from other Florida providers.6/ Approval of Nemours will not create transplant patients that do not exist or are not
currently able to reasonably access services. While Nemours has assembled a team of professionals with varying levels of transplant experience, it has not been demonstrated that it will achieve volume sufficient to reasonably assure quality care.7/
Section 408.035(1)(e): The extent to which the proposed services will enhance access to health care for residents of the service district.
Approval of the Nemours PHT and PHLT programs would unquestionably improve geographic access to those services for the very few residents of OTSA 3 that need them. However, given the extreme rarity of pediatric heart and heart/lung transplants, approval of the Nemours programs would not result in enhanced access for a significant number of patients. Moreover, there was no credible non-hearsay evidence presented at hearing that any resident of OTSA 3 that needed PHT or PHLT services was unable to access those services at one of the existing PHT programs in Florida or, for PHLT, at a facility elsewhere.
Based upon persuasive evidence at hearing, there is also clearly a positive relationship between volume and outcomes. As with any complex endeavor, practice makes perfect. In this instance, maintaining a minimum PHT case volume provides experience to the clinicians involved and helps maintain proficiency. According to the credible testimony of Dr. Pietra, programs should perform no fewer than 10 PHTs per year. “If you
can stay above 10, then your program is going to be exercised at a minimum amount to keep everybody sort of at a peak performance.”
The clear intent of the minimum volume requirement of
12 heart transplants per year contained in rule 59C- 1.044(6)(b)2. is to ensure a sufficient case volume to maintain the proficiency of the transplant surgeons and other clinicians involved in the surgical and post-surgical care of PHT patients.
In addition, pediatric transplant programs are measured statistically based on outcomes, such as mortality and morbidity. Because of this, the loss of even one patient in a small program can be devastating to that hospital’s mortality statistics. As such, small programs may become less willing to take more complicated patients. In a perverse sort of way, adding more programs that dilute volumes may decrease, rather than increase, access because of the fear a small program might have for taking more complex patients.
Adequate case volume is also important for teaching facilities, such as Shands, to benefit residents of all the OTSAs by being able to train the next generation of transplant physicians. The mothers of the two Shands patients that testified made note of the complexity of their daughters’ conditions and how their cases were used for training purposes.
There was no persuasive evidence of record that approval of the Nemours applications would meaningfully and significantly enhance geographic access to transplant services in OTSA 3. The modest improvement in geographic access for the few patients that are to be served by the two programs is not significant enough to justify approval in the absence of demonstrated need. There is no evidence that approval of the Nemours applications will enhance financial access nor that patients are not currently able to access PHT or PHLT services because of payor status.
Section 408.035(1)(g): The extent to which the proposal will foster competition that promotes quality and cost- effectiveness.
It is clear that establishing and maintaining a transplant program is expensive. Given the limited pool of patients, the added expense of yet a sixth Florida program is not a cost-effective use of resources.
This criterion also relates to the Nemours position that AHCA should approve the PHT and PHLT applications simply because the PLT application was approved, and it would not be cost-effective for Nemours unless the PHT and PHLT applications were also approved. However, each of these applications must rise or fall on its own merit. As of the hearing, Nemours had not yet implemented its PLT program. Given the absence of need for either the PHT or PHLT programs, the cost-effective solution
might be for Nemours to reconsider implementation of the PLT program.
408.035(1)(i): The applicant’s past and proposed provision of health care services to Medicaid patients and the medically indigent.
AHCA agreed at hearing that Nemours satisfies section 408.035(1)(i). Nonetheless, Nemours provides a very high level of Medicaid services, and projects a high-level volume related to Medicaid patients and charity care patients. As noted, approximately half of the PHTs projected by Nemours will be performed on Medicaid patients. Conformance with this criterion would mitigate toward approval had there been persuasive evidence that Medicaid and medically indigent patients are currently being denied access to PHT and PHLT services.
However, no such evidence was presented.
CONCLUSIONS OF LAW
Jurisdiction and Standing
The Division of Administrative Hearings has jurisdiction over the subject matter of and the parties to this proceeding. §§ 120.569, 120.57(1), and 408.039(5), Fla. Stat.
Whether Nemours’ proposed PHT and PHLT CON applications should be approved or denied must be based upon a balanced consideration of applicable statutory and rule criteria. Dep’t of HRS v. Johnson and Johnson Home Healthcare,
Inc., 447 So. 2d 361 (Fla. 1st DCA 1984); Balsam v. Dep’t of
HRS, 486 So. 2d 1341 (Fla. 1st DCA 1986). “[T]he appropriate
weight to be given to each individual criterion is not fixed, but rather must vary on a case-by-case basis, depending upon the facts of each case.” Collier Med. Ctr., Inc. v. Dep’t of HRS, 462 So. 2d 83, 84 (Fla. 1st DCA 1985).
Nemours bears the burden, in this matter, to prove by a preponderance of the evidence that its CON applications should be approved. See Boca Raton Artificial Kidney Ctr., Inc. v.
Dep’t of HRS, 475 So. 2d 260, 263 (Fla. 1st DCA 1985);
§ 120.57(1)(j), Fla. Stat.
An administrative hearing involving disputed issues of material fact is a de novo proceeding in which the administrative law judge independently evaluates the evidence presented. Fla. Dep’t of Transp. v. J.W.C. Co., 396 So. 2d 778,
787 (Fla. 1st DCA 1981).
Furthermore, “while hearsay evidence is admissible in administrative hearings to supplement or explain other evidence, it is insufficient in itself to support a finding.” Kaye v. Dep’t of HRS, 654 So. 2d 298, 299 (Fla. 1st DCA 1995); Harris v.
Game & Fresh Water Fish Comm’n, 495 So. 2d 806, 808 (Fla. 1st DCA 1986); § 120.57(1)(c), Fla. Stat.
Shands did not seek to intervene in this proceeding, and, therefore, its standing is not at issue. However, AHCA was certainly within its rights to present the testimony of
witnesses from Shands as part of its case in chief. See Baycare
of Sw. Pasco, Inc. v. Ag. for Health Care Admin., Case No. 07- 3482 (Fla. DOAH Oct. 28, 2008; Fla. AHCA Jan. 7, 2009) (A party
opposing approval of an application may “present evidence that residents of a district did not ‘need’ a new facility in the district because the needs of the residents were met by a near- by facility outside the district.”).
Statutory and Rule Criteria
The parties stipulated to the following in their Joint Prehearing Stipulation:
Section 408.035(1), Florida Statutes, establishes the statutory review criteria applicable to CON Applications 10471 and 10472.
CON Applications 10471 and 10472 satisfy the criteria found in Section 408.035(1), (d), (f), and (h), Florida Statutes. The Agency agrees that it found in the SAARs published for CON applications 10471 and 10472 that Nemours demonstrated it is a quality provider. However, the Agency maintains that section 408.035(1)(c) is in dispute to the extent that center transplant volume as a result of Nemours’ approval would lead to or correlate with negative patient outcomes.
The Health Facility and Services Development Act codified at sections 408.031 through 408.045 is intended “to provide for community health needs in a responsible and cost effective manner without unnecessary duplication of health
services.” Home Health Prof’l Servs., Inc. v. Dep’t of HRS, 463
So. 2d 345, 347 (Fla. 1st DCA 1985).
Pediatric heart and pediatric heart/lung transplantation are regulated as tertiary health services pursuant to rule 59C-1.002(41). A tertiary health service is defined 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. § 408.032(17), Fla. Stat.
Fundamental to CON review is community need for the project being proposed. The ultimate question in any CON case is whether there is a need for the proposed project. See, e.g., Gulf Court Nursing Ctr. v. Dep’t of HRS, 483 So. 2d 700, 706
(Fla. 1st DCA 1985) (stating that CON applications are to be reviewed “in context with . . . the need for the health care facilities . . . .”). Indeed, the first criterion listed in section 408.035 is “[t]he need for the health care facilities and health services being proposed.” § 408.035(1)(a), Fla.
Stat. To ignore, or minimize, the issue of need, is to ignore the very essence of the CON process and the laws governing it. Additionally, the motivations of a health facility, however noble, do not trump the statutory requirement that need be demonstrated. Mem’l Healthcare Grp. Inc., d/b/a Mem’l Hosp.
Jacksonville v. Ag. for Health Care Admin. and Shands
Jacksonville Med. Ctr., Case No. 12-0429 (Fla. DOAH Dec. 7, 2012; Fla AHCA Apr. 10, 2013).
Nemours failed to demonstrate need for its proposed programs. It also failed to demonstrate a lack of access to these services for residents of OTSA 3. While Nemours may have demonstrated that it is a quality provider, that it has capital resources to fund the proposed programs, and that it has recruited some staff with transplant experience, those are insufficient reasons to justify approval of its applications on balance under the pertinent statutory and rule provisions.
As noted, there are no existing or approved PHT or PHLT programs in OTSA 3. Relevant to this circumstance is rule 59C-1.008(2)(e)3., which provides:
The existence of unmet need will not be based solely on the absence of a health service, health care facility, or beds in the district, subdistrict, region or proposed service area.
This rule is applicable to the review of Nemours’ transplant applications. This is clear from the plain, unambiguous language of rule 59C-1.008(2)(e)3. AHCA’s interpretation that this rule applies to applications not reviewed with competing applications is a reasonable one and, as discussed below, this interpretation is subject to deference.
When the rest of this subsection of the rule is read in context, it is clear that it is applicable to the Nemours applications.
Nemours’ argument that this provision does not apply simply because subsection (2)(e) is titled “Comparative Review,” is not convincing. First, by way of example, subsection (2) of this rule is entitled “Fixed Need Pools,” and yet rule 59C- 1.008(2)(e) explicitly provides prescriptions for AHCA to follow if no “need” methodology exists--clearly evidencing that subsection (2) applies to applications not involving fixed need pools notwithstanding the title of the subsection.
Similarly, subsection (2)(e)3. applies here, notwithstanding the fact that Nemours’ applications were not reviewed with any competing applications. No competing PHT or PHLT applications were submitted with Nemours’ in the second Other Beds and Services Second Batching Cycle of 2016, but the Nemours applications were still submitted in a batching cycle subject to competitive and comparative review. Competitive applications could have been submitted. It makes no logical, legal, policy, or health planning sense to say that this rule provision would apply to these Nemours’ applications if a neighboring facility had applied simultaneously, but would not apply to consideration of need for these same applications if no such competing application is submitted. Similarly, Nemours’ interpretation would mean that if it and a facility such as
Orlando Health, Inc., were to apply simultaneously in a subsequent batch, the rule applies, but does not apply here to the same Nemours project and application. This is rejected.
Again, Nemours’ applications in this proceeding were still submitted pursuant to a batching cycle, and were potentially subject to comparative review, which is the focus of rule 59C-
1.008 and its subsections.
Accordingly, the fact that there are no existing PHT or PHLT programs in OTSA 3 is not itself a demonstration of the need for either program. Nemours must affirmatively demonstrate through additional evidence that there is an unmet need in the service area, and it has failed to do so.
Threshold Volume Criteria in Rule 59C-1.044(6)(b).
Rule 59C-1.044(6) regulates “Heart Transplant Programs.” However, the parties disagree over which portions of rule 59C-1.044(6)(b) apply to PHT programs. The disputed subsection provides in full:
(b) Need Determination. An application for a Certificate of Need to establish a heart transplantation program shall not normally be approved in a service area unless:
Each existing heart transplantation provider in the applicable service area performed a minimum of 24 heart transplants in the most recent calendar year preceding the application deadline for new programs, and no other heart transplantation program has been approved for the same service planning area;
The application contains documentation that a minimum of 12 heart transplants per year will be performed within 2 years of Certificate of Need approval. Such documentation shall include, at a minimum, the number of hearts procured by Florida hospitals during the most recent calendar year, and an estimate of the number of patients in the service planning area who would meet commonly-accepted criteria identifying potential heart transplant recipients;
The application includes documentation that the annual duplicated cardiac catheterization patient caseload was at or exceeded 500 for the calendar year preceding the Certificate of Need application deadline; and that the duplicated patient caseload for open heart surgery was at or exceeded 150 for the calendar year preceding the Certificate of Need application deadline; and,
An application for a pediatric heart transplantation program shall include documentation that the annual duplicated cardiac catheterization patient caseload was at or exceeded 200 for the calendar year preceding the Certificate of Need application deadline; and that the duplicated cardiac open heart surgery caseload was at or exceeded 125 for the calendar year preceding the Certificate of Need application deadline.
Nemours argues that only paragraph 4. applies to PHT proposals, while AHCA argues that paragraphs 2. and 4. apply.8/ Under AHCA’s interpretation, applicants would not normally be approved unless they documented they would provide at least
12 transplants by the end of year two, and the minimum volume
requirements for cardiac catheterizations and open-heart surgery set forth in paragraph 4. are met.
Nemours cites to the conclusions of law set forth in Variety Children’s Hospital, d/b/a Nicklaus Children’s Hospital v. State of Florida, Agency for Health Care Administration,
Case No. 16-1695CON (Fla. DOAH May 15, 2017; Fla. AHCA Aug. 1,
2017) in support of its argument that only paragraph 4. of the rule applies. In that case, the ALJ noted that Nicklaus’ transplant program expert “testified that the requirement for an annual minimum of 24 PHTs to be performed by all existing providers would not be an appropriate pediatric standard, since it would result in all but one or two of the very largest programs in the country not meeting the standard in any given year.” Id., RO at 77. The ALJ noted further that “the 24 PHT
threshold requirement does not appear to have been a strict prerequisite to approval of new PHT programs, since at the time of DiMaggio’s approval, Jackson was performing few, if any, PHTs.” Id.
The arguments and observations led the ALJ to conclude “[f]rom a common sense perspective,” (Id., RO at 78) that the 24 transplant requirement should not apply to PHT programs in Florida, and that when it came to OTSA 4, the requirement would be a deathblow to applications for new programs due to Jackson’s low PHT volumes. Id.
The conclusions of the Nicklaus Recommended Order
with regard to the 24 transplant requirement in paragraph 1., were not accepted by AHCA. See Variety Children’s Hospital,
d/b/a Nicklaus Children’s Hospital, above, where AHCA wrote:
The Agency’s interpretation that the requirements of subsections 1-3 of rule 59C-1.044(6)(b) apply to its determination whether there is need for a new PHT program in TSA 4 is a reasonable interpretation of the rule and should be given deference by the ALJ. Indeed, the plain language of the rule itself states the Agency must look at the requirements of subsection 1-3 of rule 59C-1.044(6)(b) when determining the need for a new heart transplant program. Thus, the Agency finds that it has substantive jurisdiction over the conclusions of law in paragraph 214 and 215 of the Recommended Order since they involve an interpretation of an Agency rule, and that it can
substitute conclusions of law that are as or more reasonable than those of the ALJ. Therefore, the Agency grants Exception 1, rejects the conclusions of law in
Paragraph 214 in toto, and modifies the conclusions of law in Paragraph 215 as follows:
215. However, even if this provision applied Since the provision of rule 59C-1.044(6)(b)1 apply, NCH has must demonstrated sufficient, not normal circumstances to justify its approval based upon all of the findings herein, regardless of whether because the 24 transplants threshold has not been achieved by Jackson and DiMaggio.
In the Nicklaus case, the fundamental discussion
centered on the minimum volume requirement for existing
providers set forth in paragraph 1. of the rule. As noted, that section is not applicable to the application sub judice, since there are no existing providers of PHT in OTSA 3. However, in its Final Order in Nicklaus, AHCA concluded that “[I]ndeed, the plain language of the rule itself states the Agency must look at the requirements of subsection 1-3 of rule 59C-1.044(6)(b) when determining the need for a new heart transplant program.” Thus, while paragraph 1. of the rule is inapplicable under the facts of this case, the minimum volume requirement of paragraph 2. applies, according to the AHCA Final Order.
Florida courts have determined that an agency is given broad discretion and is entitled to great deference when interpreting its governing statutes and promulgated rules. Bd. of Podiatric Med. v. Fla. Med. Ass’n, 779 So. 2d 658, 660
(Fla. 1st DCA 2001); Miles v. Fla. A & M Univ., 813 So. 2d 242,
245 (Fla. 1st DCA 2002); Verizon Fla., Inc. v. Jacobs, 810 So.
2d 906, 908 (Fla. 2002). Furthermore, “[i]f an agency’s interpretation of a rule is one of several permissible interpretations, the agency’s interpretation must be upheld despite the existence of other reasonable alternatives.” Suddath Van Lines, Inc. v. Dep’t of Envtl. Prot., 668 So. 2d
209, 213 (Fla. 1st DCA 1996); Pershing Indus., Inc. v. Dep’t of Banking and Fin., 591 So. 2d 991, 993 (Fla. 1st DCA 1991).9/
With regard to rule 59C-1.044(6)(b)2., the undersigned has found that Nemours has not reasonably projected that it will perform at least 12 PHTs by the end of the second year of operation. Accordingly, this rule requirement has not been met by Nemours, which mitigates for denial of the application. However, had need for the proposed PHT program been persuasively demonstrated, the failure to meet this rule requirement would not, in and of itself, have been a sufficient basis for denial of the application.
With regard to rule 59C-1.044(6)(b)4., it is undisputed that at the time of the filing of its CON application, Nemours had not reached the threshold of
200 duplicated pediatric cardiac catheterizations in the calendar year preceding the CON application deadline, nor had it reached the level of 125 duplicated cardiac open-heart surgery cases for the calendar year preceding the CON application deadline. Accordingly, this rule requirement has not been met by Nemours, which weighs against approval of the application. However, had the need for the proposed PHT program been persuasively demonstrated, the failure to meet this rule requirement would not, in and of itself, have been a sufficient basis for denial of the application.
While Nemours has demonstrated its full commitment and great desire to become a “Center of Excellence in Pediatric
Thoracic Transplant Services”, it has failed to persuasively establish that need exists in OTSA 3 for its proposed PHT and PHLT programs. Specifically, Nemours has failed to demonstrate that residents of OTSA 3 are currently unable to access these services. Additionally, Nemours has not demonstrated the existence of “not normal circumstances” to support approval of its applications in light of its failure to meet the requirements for approval set forth in the applicable statutory review criteria and administrative code rules, as discussed above. Accordingly, Nemours has failed to carry its burden to demonstrate on balance its entitlement to the requested CONs.
Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying CON Application Nos. 10471 and 10472 filed by The Nemours Foundation, d/b/a Nemours Children’s Hospital.
DONE AND ENTERED this 31st day of July, 2018, in Tallahassee, Leon County, Florida.
S
W. DAVID WATKINS Administrative Law Judge
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-3060
(850) 488-9675
Fax Filing (850) 921-6847 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 31st day of July, 2018.
ENDNOTES
1/ A VAD is a device that assists the heart ventricle. The Berlin Heart is a type of VAD that maintains blood flow in babies and small children with serious heart failure. The Berlin Heart sits outside of the patient and connects to the patient’s heart via two urethane valves (or cannula’s). The device has a reservoir that fills up with blood from the patient, then a compressor forces air on the other side of the membrane and ejects the blood back into the patient, doing the work of the heart for the patient.
2/ Only existing health care facilities located in the same service district as the applicant have standing to initiate or intervene in a challenge to a CON application. § 408.039(5)(c), Fla. Stat. Shands is located in Service District 3, while Nemours is located in Service District 7.
3/ Florida Administrative Code Rule 59C-1.044(6)(b) provides:
(b) Need Determination. An application for a Certificate of Need to establish a heart transplantation program shall not normally be approved in a service area unless:
Each existing heart transplantation provider in the applicable service area performed a minimum of 24 heart transplants in the most recent calendar year preceding the application deadline for new programs, and no other heart transplantation program has been approved for the same service planning area;
The application contains documentation that a minimum of 12 heart transplants per year will be performed within 2 years of Certificate of Need approval. Such documentation shall include, at a minimum, the number of hearts procured by Florida hospitals during the most recent calendar year, and an estimate of the number of patients in the service planning area who would meet commonly-accepted criteria identifying potential heart transplant recipients;
The application includes documentation that the annual duplicated cardiac catheterization patient caseload was at or exceeded 500 for the calendar year preceding the Certificate of Need application deadline; and that the duplicated patient caseload for open heart surgery was at or exceeded 150 for the calendar year preceding the Certificate of Need application deadline; and,
An application for a pediatric heart transplantation program shall include documentation that the annual duplicated cardiac catheterization patient caseload was at or exceeded 200 for the calendar year preceding the Certificate of Need application deadline; and that the duplicated cardiac open heart surgery caseload was at or exceeded 125 for the calendar year preceding the Certificate of Need application deadline.
4/ The parent of the patient called by Nemours, whose child had actually received a transplant spoke of the economic hardship
that the family had endured. While this parent spoke of the added distance of going to St. Petersburg as a cause of those hardships, the evidence was not persuasive that this additional travel specifically was enough to cause the difficulties she described. Indeed, she testified that she would have stayed at her daughter’s bedside wherever she was treated, which suggests that disruption to work and family was an inevitable part of this tragic situation. Nemours makes no claim that its programs would eliminate the disruption involved in the lives of families whose child is diagnosed with a condition requiring PHT. The other parent, whose child is not a transplant patient, indicated that he did not have a good experience with Shands, but that family eventually chose to go all the way to Pittsburgh for care, further indicating that travel is not a primary factor when seeking care for a very sick child. (“I would go to the ends of the earth to give my son quality care and treatment that he needed, yes.”).
5/ The Nemours’ applications note that the pediatric thoracic transplants will be reimbursed by Medicaid under the Florida Medicaid Inpatient Payment System utilizing all-payor diagnosis- related groups (APR-DRGs).
6/ Nemours’ volume projections assume that only eight of the
13 PHTs to be performed in the second year will be on residents of OTSA 3.
7/ While Nemours’ witness, Dr. Lawless, questioned the nature and extent of the relationship between PHT volume and quality, its cardiologist and heart surgeon, Dr. Wearden, did not deny its existence, conceding instead that there is some relationship. Additionally, another Nemours clinician witness opined that some minimum volume is desirable to ensure proficiency and quality outcomes.
8/ At page 17 of AHCA’s PRO, paragraph 1. and 4. are identified as the applicable provisions of rule 59C-1.044(6)(b). However, since there are no existing PHT providers in OTSA 3,
paragraph 1. is inapplicable.
9/ Notwithstanding AHCA’s Final Order determination in Nicklaus that all four paragraphs of rule 59C-1.044(6)(b) apply to PHT applications, it is difficult to square that conclusion with the fact that paragraph 3. requires volumes of 500 and 150 for open- heart surgeries and cardiac catheterizations, respectively, while paragraph 4. requires volumes of only 200 and 125 for the two procedures, respectively. An interpretation that the volume
requirements of paragraph 3. apply to PHT applications renders paragraph 4. unnecessary, and results in an internally inconsistent rule.
COPIES FURNISHED:
Richard Joseph Saliba, Esquire
Agency for Health Care Administration Fort Knox Building III, Mail Stop 7 2727 Mahan Drive
Tallahassee, Florida 32308 (eServed)
Kevin Michael Marker, Esquire
Agency for Health Care Administration Mail Stop 7
2727 Mahan Drive
Tallahassee, Florida 32308 (eServed)
Stephen A. Ecenia, Esquire Rutledge Ecenia, P.A.
119 South Monroe Street, Suite 202 Post Office Box 551
Tallahassee, Florida 32301 (eServed)
Craig D. Miller, Esquire Rutledge Ecenia, P.A. Suite 202
119 South Monroe Street Tallahassee, Florida 32301 (eServed)
Jennifer F. Hinson, Esquire Rutledge Ecenia, P.A.
119 South Monroe Street, Suite 202 Post Office Box 551
Tallahassee, Florida 32301 (eServed)
David Mark Maloney, Esquire Rutledge Ecenia P.A.
Suite 202
119 South Monroe Street Tallahassee, Florida 32301 (eServed)
Richard J. Shoop, Agency Clerk
Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3
Tallahassee, Florida 32308 (eServed)
Stefan Grow, General Counsel
Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3
Tallahassee, Florida 32308 (eServed)
Justin Senior, Secretary AHCA
2727 Mahan Drive, Mail Stop 1
Tallahassee, Florida 32308 (eServed)
Shena 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)
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
| Issue Date | Document | Summary |
|---|---|---|
| Oct. 31, 2018 | Agency Final Order | |
| Jul. 31, 2018 | Recommended Order | Nemours failed to establish need for its proposed pediatric heart and heart/lung transplant programs. |
