STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED (954)

Transcription

1 STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED A. PROJECT IDENTIFICATION 1. Applicant/CON Action Number Tenet St. Mary s, Inc./CON # South Ocean Boulevard, Suite 3-B Highland Beach, Florida Authorized Representative: Robert J. Greene (954) Service District Pediatric Open Heart Surgery Program Service Planning Area IV (Districts 7 and 9 serving the following counties: Brevard; Orange; Osceola; Seminole; Indian River; Martin; Okeechobee, Palm Beach and St. Lucie) B. PUBLIC HEARING A public hearing was requested and held at 1:00 p.m. on Monday, June 29, 2009, at the Treasure Coast Health Council, Inc. Conference Room, Suite 101, 600 Sandtree Drive, Palm Beach Gardens, Florida 33403, with regard to Certificate of Need applications and Ms. Barbara Jacobowitz, Executive Director, Treasure Coast Health Council, Inc., acted as the hearing officer and conducted the proceedings. Ms. Jacobowitz submitted a record of the public hearing through two cassette tapes, an 86-page steno graphed report issued by Kathy Szabo, Registered Professional Reporter of Prose Court Reporting Agency, Inc., a public hearing sign-in sheet (for both CON #10054 and CON #10055) and a copy of the public hearing agenda. Twenty-one names were included on the CON #10055 public hearing sign-in sheet. Two signers of the public hearing for CON #10055 requested an opportunity to provide oral testimony and seven signers of the public hearing for concurrent and companion CON #10054 requested an opportunity to provide oral testimony.

2 The public hearing was granted pursuant to a request submitted by representatives of the Service Employees International Union (SEIU) Healthcare-United for Quality Care 1. May Va Lor, SEIU Healthcare Florida read into the record the written statement of Betsy Marville, ICU Nurse, St. Mary s Medical Center and Executive Vice President for SEIU Healthcare Florida representing 1,100 nurses and ancillary employees at St. Mary s. Nurse Marville indicated that there is concern about the applicant being able to fund the projects considering that Tenet Healthcare is rolling back employees retirement, paid time off, and extended illness benefits. She noted that scaling back of accrued sick leave days and sick-day-banking is especially worrying to nurses who have characteristically higher illness and injury rates. Concern was also expressed that the recruitment of nurses to meet project needs may be difficult considering unfavorable changes to the extended illness bank. Nurse Marville indicated that she joins with the hospital in wanting to provide innovative and life-saving treatment and care but stressed the need for financial review to confirm that the hospital has the revenue to adequately finance the project. SEIU Healthcare Florida included in testimony that it does not oppose the application. Scott Manis, Chief Operating Officer, St. Mary s Medical Center indicated that data on current cardiovascular cases, the volume of normal and high risk births at St. Mary s and the hospital s NICU Level III program justify the project, with St. Mary s being the largest provider of pediatric and neonatal services in District 9. He also indicated St. Mary s is one of 23 adult and one of 13 pediatric trauma centers, the fifth busiest in Florida, the largest hospital in Palm Beach County and the largest pediatric facility and largest NICU between Fort Lauderdale and Orlando. Mr. Manis stated that St. Mary s delivered 27,300 babies between January 2002 and May 2009, has a separate 12-bed children s emergency department and identified many other pediatric services (some of them being the Mollie Wilmot Center and the Florida Department of Health s Children s Medical Services clinical and administrative offices being on campus). According to Mr. Manis, St. Mary s had 3,200 pediatric admissions in 2008, representing a 20 percent volume growth over the past two years. He also stated that St. Mary s has 202 pediatricians on staff, representing 22 pediatric subspecialties and 78 physicians from St. Mary s geographic area have written letters of support for the program. St. Mary s also has the support of seven area hospitals including two with Level III NICU programs. Affiliation and planned coordination with medical student rotations and residency programs was also discussed. Mr. Manis stated that charity care at the hospital increased from $27 million in 2002 to 1 2

3 almost $46 million in 2008 and that St. Mary s is the safety-net hospital for the region, has been a disproportionate share hospital for at least 15 years and ranks eighth in the state in terms of adjusted Medicaid and charity patient days as a percentage of total patient days. The third speaker was Bob Greene who stated that both the pediatric cardiac catheterization and pediatric open heart surgery programs use the same need formula; that is a normative rate of 30,000 resident live births for one program and that the need methodology is not a use rate. Mr. Green indicated that applying the one program per 30,000 births to the 239,000 births statewide in 2007, there ought to be six programs with an average of about 100 cases but the state has eight programs that on average are doing about 161 cases with Pediatric Service Area V programs alone averaging about 181 cases each annually. Mr. Greene indicated the state s current methodology and formula for need determination might be used as a guideline but is not accurate. Further, Arnold Palmer Hospital in Orlando (District 7 and the only authorized provider in Pediatric Service Area IV) is not being utilized in any meaningful degree by the residents of District 9. Mr. Greene stated that during the last seven years, Arnold Palmer provided no pediatric cardiac catheterizations and only one to three pediatric open heart surgeries per year to District 9 residents. Mr. Greene further commented that the DRGs used in the formula have been changed but the Agency has not kept up with those changes and so the state need methodology formula is not accurate and underestimates need. However, the Agency s need formula is based on the number of live births in the planning area and not the number of procedures. Mr. Greene indicated the applicant developed an alternative need methodology to more accurately account for need and that this alternate need methodology revealed special and not normal circumstances to warrant project approval (these are discussed in-depth in section E.1.d). The fourth speaker was Gary Williams, an attorney with the law firm of Ausley and McMullen. Mr. Williams submitted three letters of support and three support petitions that are described in detail under the letters of support section below. The fifth speaker was Dr. David Kantor, Medical Director of St. Mary s Neonatal Intensive Care Nursery. Dr. Kantor stated that he represents 13 neonatologists and six nurse practitioners (other ancillary staff was also mentioned). Dr. Kantor indicated the hospital has been a leader in innovation and trend-setting in such areas as artificial surfactants and nitric oxide (for severe lung and respiratory illnesses among newborns) and other innovations. Dr. Kantor also stated the project would be a natural progression for the hospital since it is already a major provider 3

4 of many pediatric services (along with many non-pediatric services). Dr. Kantor also commented on inherent travel/transportation challenges the project would largely resolve. The sixth speaker was Dr. Renato Dubois, a local pediatric cardiologist with 20 years of experience in Florida, 16 of those years being in West Palm Beach. Dr. Dubois stated he is part of an independent physician group of six pediatric cardiologists serving Palm Beach, Martin, St. Lucie, Indian River counties and also our western communities. He stated that his group works closely with St. Mary s but does not have a direct association. Dr. Dubois indicated his group transfers about 130 patients per year for catheterization and open heart surgery. The seventh speaker was Arthur Dunn, a Palm Beach Gardens resident who said that he had 41 years experience in health care administration, which included 25 years as a CEO and interim CEO at various hospitals (no specific hospital name was mentioned). Mr. Dunn indicated that he has served in the American Hospital Association as chairman of their Institute of Clinical Hospital Nursing Education and that throughout his years of experience he has seen a continuous nursing shortage and expects such shortage to continue but that facilities survive in spite of such shortages. Sean Frazier, an attorney with Greenberg and Traurig representing Miami Children s Hospital (a Service Area V pediatric cardiac catheterization and pediatric open heart services provider) spoke in opposition to the projects. Mr. Frazier stated that Miami Children s Hospital operates a program with Orlando Regional Medical Center at the Arnold Palmer Congenital Heart Institute. He indicated that CON planning requires regional review, stressing that operation of a large and successful pediatric program is not an automatic precursor to offering the most tertiary or even quaternary highest level services that can possibly be offered to those children in need. Mr. Frazier indicated that Arnold Palmer Hospital is, statewide, the lowest, the smallest provider of pediatric open heart surgery and that reduction of only one to three cases from the lowest provider will negatively impact the provider and this should be considered in the review process. Mr. Frazier stated that reduced volumes at existing facilities would impact quality and lead to worse outcomes. Mr. Frazier stated that fewer patients at Memorial Regional and Jackson Memorial would likely occur if the project was approved, which would lead to adverse impacts on quality at those facilities. The financial ability of the applicant s parent (Tenet) to fund the projects was also questioned. The recruitment and retention of qualified staff was another point of concern. Mr. Frazier stressed that you may not consider an alternative need methodology when an existing 4

5 need methodology is in place, but you may examine not normal circumstances which he then discussed. He stated that District 9 should have 100 percent out-migration and it is natural that Palm Beach County and Martin County residents head south as the area from Miami- Dade to Broward up to Palm Beach County is essentially the I-95 corridor and for all practical purposes runs in one long string of south Florida. Mr. Frazier also indicated that live births are declining in both Pediatric Service Area IV and District 9. Mr. Frazier concluded that with the number of live births in the local community declining and with no other evidence from the existing rule that a new program should be provided, the project should be denied. Mr. Greene spoke again and refuted that Arnold Palmer has the lowest number of cases, stating that the lowest number of cases would be attributed to Shands and the Baptist-Jacksonville program. 2 He also stated that peer review journals (some of which are provided in the application attachments) indicate that lower volumes can achieve good outcomes, that volume alone is not a good indicator of quality and that high volume centers can have poor outcomes. Mr. Greene believed that volumes would not be seriously reduced at existing facilities and provided applicable statistics to reflect those volumes. The ninth speaker was Joey Bulfin, St. Mary s Chief Nursing Officer and also on the Board of Directors, State of Florida Center for Nursing. Ms. Bulfin stated St. Mary s nursing shortage vacancy average is 6.19 percent, with the statewide average being 9.5 percent. She also reported a turnover rate at St. Mary s of 7.5 percent, compared to a statewide turnover rate of 20 percent. She stated there were no nursing vacancies in the NICU, PICU or pediatric ER; the average nursing experience among pediatric unit staff is 12 years and in the NICU, about 17 years. Recruitment was stated to be ongoing through a nurse residency program with retention mechanisms in place. Ms. Bulfin concluded that there is a waiting list of nurses interested in employment in the children s hospital at St. Mary s and that recruitment and retention is not a problem. Ms. Bulfin did not provide the number of nurses on the employment waiting list. 2 Agency for Health Care Administration utilization data for CY 2008 confirms that Shands Hospital at UF (94) and Baptist Medical Center/Shands Jacksonville (104) reported fewer pediatric open heart surgery procedures than Arnold Palmer (115). 5

6 Mr. Williams spoke again and emphasized that neither Miami Children s Hospital nor any hospital in Miami-Dade County has legal standing to object or contest the approval of the application, though they can make comments at public hearings. He also stated that it s important to note that open heart surgery cases have been increasing as demonstrated by volumes reported by the Broward and Miami-Dade hospitals. Geographic maldistribution of the existing programs was again highlighted. Finally, he thanked the hearing requestor for not opposing the CON applications (#10054 and #10055) but expressed frustration that the public hearing venue was being used to address labor and union issues. Ms. Jacobowitz read from the attendee list to verify that all parties that wished to provide testimony had done so and if anyone wished to provide any additional testimony. With all statements complete, there was no further discussion and the public hearing was adjourned. Letters of Support Letters of support submitted to the Agency through the aforementioned public hearing were as follows: the Honorable Robert Wexler, House of Representatives (19 th District-Florida), Congress of the United States and the Honorable Kelly Skidmore, House of Representatives (District 90), Florida Legislature. Representative Wexler stated that St. Mary s is the largest safety-net provider in the area and provides a significant level of care to low income, uninsured and vulnerable populations. He also stated patients who transfer out of their local communities are more likely to experience lapses in care because of the combination of hardships families endure in traveling long distances, having multiple practitioners and undergoing duplicative testing. Representative Skidmore stated there is a critical mass of patients in the five-county area served by St. Mary s (Palm Beach, Martin, Okeechobee, St. Lucie and Indian River Counties) to support the program. She also stated project approval would generate fewer lapses in continuity of care caused by transfer and travel difficulties. Three separate signed petitions were submitted to the Agency through the aforementioned public hearing. The three petitions stated support for CON #10055 and concurrent and companion CON # One of the three petitions included 93 signatures by the applicant s NICU staff. One of the petitions included 55 signatures by the applicant s pediatric department staff and one of the petitions included 31 signatures by the applicant s pediatric ER staff. 6

7 Tenet St. Mary s, Inc. included approximately 99 unduplicated letters of support in the application. The support letters include the following: a member of the Congress of the United States, House of Representatives (one letter); a member of the Florida Senate (one letter); members of the Florida House of Representatives (seven letters); Board of County Commissioners of Palm Beach County (one letter); City Commission of the City of West Palm Beach (one letter); Board of Governors-St. Mary s Medical Center (one letter); Medical Executive Committee-St. Mary s Medical Center (one letter); Director, Palm Beach County Health Department (one letter); senior executives of acute care hospitals (seven letters); Pediatrix Medical Group of Florida, Inc. (one letter); a practice group affiliated with a federally qualified health center [FQHC] (one letter); a practice group in Palm Beach and Martin Counties (one letter); other physicians (57 letters signed by 76 physicians) and other letters of support (22 letters). These letters are summarized below. The Honorable Ron Klein, Member of the U.S. House of Representatives, offered his support and indicated that the St. Mary s Medical Center project would raise the standard of care for babies and children it serves to the same level of care that residents of Dade and Broward Counties receive and that St. Mary s is currently a large pediatric facility with the largest NICU between Fort Lauderdale and Orlando. The Honorable Dave Aronberg, Florida Senate (27 th District) indicated similar comments. The following Florida House of Representatives members offered their support: the Honorable Ellyn Setnor Bogdanoff (District 91); the Honorable Mary Brandenburg (District 89); the Honorable Carl Domino (District 83); the Honorable Adam Hasner, Majority Leader (District 87); the Honorable Mark Pafford, Deputy Minority Whip (District 88); the Honorable William Snyder (District 82) and the Honorable Priscilla Taylor (District 84). Representative Bogdanoff commented that St. Mary s is Palm Beach s safety-net hospital that provides a significant level of care to vulnerable populations. Representative Brandenburg stated that St. Mary s is centrally located within the region and that the project would be a natural step. Representative Domino stated that St. Mary s is the largest and most experienced provider of pediatric hospital services between Fort Lauderdale and Orlando. Majority Leader Hasner stated that St. Mary s already had the infrastructure in place to enhance the project and that traveling long distances to obtain specialized health care for children is a challenge. Deputy Minority Whip Pafford indicated that St. Mary s has a proven track record and is dedicated to being the most respected provider of pediatric services in the Palm Beach County area. Representative Snyder stated the service proposed is vital to the Treasure Coast and is currently not provided in Palm Beach, Martin, Okeechobee and St. Lucie Counties and surrounding areas. Representative Taylor commented on what she called St. Mary s administrative and medical 7

8 team s impressive credentials and noteworthy track record within the field of pediatric care, also indicating that St. Mary s is at the vanguard of pediatric care and services globally. The Board of County Commissioners of Palm Beach County issued a June 2, 2009 resolution (R ) and the City Commission of the City of West Palm Beach issued a June 1, 2009 resolution (Resolution No ) in support of the project. The Board of Governors-St. Mary s Medical Center and the Medical Executive Committee-St. Mary s Medical Center both issued timely resolutions to support the project, similar to those issued by the Palm Beach County Commission and West Palm Beach City Commission. Jean Malecki, MD, MPH, FACPM, Director, Palm Beach County Health Department, expressed concern about significant health outcomes, such as increases in repeat teen births, infant deaths and pre-term birth rates that affect the quality of life in the community. She also cited the increase of underinsured and underserved clients in Palm Beach County and the four surrounding counties served by St. Mary s as substantiating the critical need for expansion of pediatric continuity of care that the projects would provide. Dr. Malecki also commented on hardships in maintaining accessible and continuous pediatric cardiovascular care due to a lack of transportation to distant locations in Broward and Miami- Dade Counties. She indicated that when patient transfer occurs, important medical history details may be lost to the distant practitioner and that there can be feelings of confusion on the part of the family due to mis-communicated or misunderstood information. Senior executives of seven acute care hospitals, all within Palm Beach County (with the exception of Martin Memorial Health Systems, Inc., Martin County) wrote letters of support. These senior executives are as follows: Robert Krieger, Chief Executive Officer, Delray Medical Center; Brian Gibbins, Jr., Hospital Administrator, Glades General Hospital; Mark Nosacka, Chief Executive Officer, Good Samaritan Medical Center; Martin Robitaille, President and Chief Executive Officer; Martin Memorial Health Systems, Inc.; David Pettit, Chief Executive Officer, Palm Beach Gardens Medical Center; Kevin DiLallo, Chief Executive Officer, Wellington Regional Medical Center and Mitch Feldman, Chief Executive Officer, West Boca Medical Center. Mr. Pettit provided the most in-depth support letter of these seven hospital senior executives and made some comments similar to Dr. Malecki, (Director, Palm Beach County Health Department). A generalized theme among these is that St. Mary s is a high quality provider with extensive pediatric services, that the project would complement those services and that currently patients and 8

9 hospitals must undergo the challenges of transfer to Broward or Miami- Dade County. Alan S. Livingstone, MD, Lucille & DeWitt Daughtry Professor and Chairman, DeWitt Daughtry Family Department of Surgery, University of Miami Health System - Miller School of Medicine, stated that UM s Medical School is in full agreement to assist St. Mary s in implementing the pediatric open heart surgery program. Dr. Livingstone indicated that UM will provide the expertise of two highly skilled pediatric heart surgeons (Drs. Ricci and Rosenkranz both faculty members at UM) whose historical outcomes rival the best in the country. Drs. Ricci and Rosenkranz are stated to be prepared to maintain a full time presence in the St. Mary s service area and well known to the pediatric cardiologists in Palm Beach County as they presently treat many Palm Beach County patients. UM also offered to: recruit as necessary an additional cardiovascular surgeon; train physicians currently on staff at St. Mary s to assist the operating surgeon; assist in recruiting a board-certified or board-eligible anesthesiologist trained in pediatric open heart surgery; train the nursing staff and operating room technicians, and facilitate the recruitment of a perfusionist, physician, specially trained nurse, technician, or physician assistant under the supervision of the operating surgeon to operate the heart lung machine. The physicians mentioned above, Marco Ricci, MD Associate Professor of Surgery and Director, Pediatric Cardiac Surgery and Eliot Rosenkranz, MD, Associate Professor of Surgery, Miller School of Medicine, University of Miami also submitted letters indicating they look forward to working with St. Mary s. Frederick C. Morin III, MD, Dean of the University of Vermont College of Medicine, stated that his university has signed an affiliation agreement with St. Mary s to develop a program for placement of UVM medical students at St Mary s as part of their clinical educational experience. Dr. Morin further stated that the creation of a pediatric open heart surgery and cardiac catheterization program would enhance the medical education experience. Eleven physicians with Pediatrix Medical Group of Florida, Inc., a 13 physician, seven ARNP and three hospital associate group practice in West Palm Beach, signed a petition which stated that St. Mary s provides care to the sickest newborns in the district, that the project would complement an already solid foundation of pediatric specialists and support programs and it would relieve the challenges of traveling long distances for needed care. Similarly, a six physician and one ARNP group practice in Okeechobee County (Lakeshore Pediatrics & Dental), affiliates of the Florida Community Health Centers, Inc. (a federally qualified health center and member of the Florida Association of 9

10 Community Health Centers, Inc.) stated they look to St. Mary s as their nearest tertiary care hospital and that the project would allow for pediatric cardiac care much closer to home. Seventy-two other physicians wrote letters of support. Some relatively common themes in these letters were: transfer of pediatric patients in need of catheterization/open heart procedures creates challenges (emotional and financial) where continuity of care is broken or compromised leading to a poorer quality of life and poorer health care outcomes; delays in care due to the transfer arrangement process can generate poorer health care outcomes, greater morbidity and mortality; follow-up care requires continued travel back to the providing hospital in many cases; complications may lead to additional co-morbidities and a critical mass of patients exists in the area to warrant project approval. Some of these physicians include: Harry Bayron, MD, Medical Director, Pediatrix Medical Group of Florida, Inc.; Debra Anne Jones, MD, FACOG, President, Prenatal and Gynecological Specialists of the Palm Beaches, Inc.; John Burigo, MD, FACOG, past president and current board member, Florida Obstetrical and Gynecological Society; Janice Jones, MD, Chief of Staff, St. Mary s Medical Center. Some 22 other letters of related but non-physician support were included in the application. These letters included the following: Dona Akin, Operations Chief, Hendry County Public Safety; Brian Blizzard, Deputy Chief, St. Lucie County Fire District; Brent Braunworth, Batallion Chief, West Palm Beach Fire Rescue; Darrel Donatto, Division Chief of EMS, Town of Palm Beach Fire Rescue; David Dyal, BS and paramedic, Assistant Fire Chief, City of Stuart Fire Rescue; Michael Landress, EMT- P, BA, EMS Coordinator, City of Boynton Beach Fire Rescue; Cory Richter, Batallion Chief, Indian River County Fire Rescue; Brian Burrell, RN and EMT-P, Regional Clinical Manager, Omniflight Helicopters, Inc.; Dwight Chenette, MBA, MPH, Chief Executive Officer, Health Care District of Palm Beach County; Paul Gionfriddo, President and Roberta Jurney, Executive Director, Quantum Foundation; Sister M. Avril Chin Fatt, OSF, Congregational Minister, Franciscan Sisters of Allegany; Dennis Gallon, Ph.D., President, Palm Beach Community College and Dennis Grady, Executive Director, Chamber of Commerce of the Palm Beaches. Letters of Opposition Betsy Marville, ICU Nurse, St. Mary s Medical Center and Executive Vice President for SEIU Healthcare Florida submitted a letter at the public hearing which expressed concern about project funding but stated that the union is not opposed to the project (see Public Hearing above). 10

11 The Agency received three letters of opposition to this project and CON # All three were signed and dated June 19, 2009 and were from District 10, Pediatric Service Area V. Richard Perryman, MD, Chief of Cardiac Surgical Services at Memorial Regional Hospital-Joe DiMaggio Children s Hospital stated involvement in pediatric cardiac surgery in south Florida since 1987 and that he could not recall any time when pediatric patient care had been compromised in any way by transfer, which he stated is usually not more than one hour. He also stated that most children with congenital heart disease can be seen on a nonemergency basis. Dr. Perryman stated he is on the staff at St. Mary s and that interventions are transferred expeditiously to Joe DiMaggio Children s Hospital. He indicated that these patients have received exemplary care without any compromise to their clinical outcome and that he sees no reason to dilute the experience of the existing pediatric cardiac surgery programs and interventional cardiology programs by the creation of another as yet inexperienced, untested and yet to be formed program. Dr. Perryman stated that congenital cardiac surgery programs rely on volumes of patients to insure optimum performance and that project approval would dilute volumes. He stated the project would be unnecessary and problematic. Frank Scholl, MD, FACS, FACC, Chief of Pediatric Cardiac Surgery, Memorial Regional Hospital-Joe DiMaggio Children s Hospital expressed concern about reduced volumes if the project was approved. He stated that he is also on the staff at St. Mary s. According to Dr. Scholl, the quality of pediatric cardiac surgery program is among the best in the country, per the Society of Thoracic Surgeons Congenital Cardiac Surgery Database and that applicable District 9 patients benefit from that. Dr. Scholl stated that patients in District 9 as well as District 10 would be affected in a negative way and suffer by project approval, particularly due to anticipated reduced patient volume. He indicated there is no access issue for District 9 patients and that the transport can be accomplished in 40 minutes by air and 90 minutes by ground, depending on patient acuity. Jon Bandes, Administrative Director of Planning and Grant Programs, Memorial Health Care System on behalf of South Broward Hospital District d/b/a Memorial Regional Hospital/Joe DiMaggio Children s Hospital indicated that the hospital s emergency helicopter transport service transfers more than 200 children each year to and from health care facilities as far away as central Florida and the Florida Keys. He also stated that approximately 22 percent all pediatric cardiac catheterizations and 20 percent of all open heart surgery cases performed at his facility in fiscal year 2009 originated from District 9. He notes 16 points of opposition to the project, some are as follows: the 11

12 Agency shows no published need for the project; approval would disrupt existing providers, duplicate services and impact volumes necessary to assure quality; and approval would likely jeopardize his hospital s Department of Health Children s Medical Services designation since volumes would likely drop and labor costs would likely rise. C. PROJECT SUMMARY Tenet St. Mary s, Inc. (CON #10055) is proposing to establish a pediatric open heart surgery program at St. Mary s Medical Center, located in District 9, Palm Beach County, Pediatric Service Planning Area IV, which includes both Districts 7 and 9. The applicant has filed concurrently with this application CON #10054 for the establishment of a pediatric cardiac catheterization program. St. Mary s Medical Center is a 463-bed for-profit general hospital licensed for 328 acute care beds, 40 adult psychiatric beds, 50 comprehensive medical rehabilitation beds, 25 Level II NICU beds and 20 Level III NICU beds. St. Mary s Medical Center is a Regional Perinatal Intensive Care Center (RPICC) and a Medicaid Disproportionate Share Hospital (DSH). The applicant conditions, in Schedule C, that the program will be located at St. Mary s Medical Center, th Street, West Palm Beach, Florida and that 30 percent of the combined pediatric open heart surgery and cardiac catheterization programs total annual cases will be provided to Medicaid, Medicaid HMO, Health Care District and charity care patients. The total project cost is estimated at $4,287,349. No construction is proposed but there is 4,540 gross square feet of renovation at a cost of $1,731,075. The total costs include the following: building costs; equipment costs; project development costs; financing costs and start-up costs. D. REVIEW PROCEDURE The evaluation process is structured by the certificate of need review criteria found in Section , Florida Statutes. These criteria form the basis for the goals of the review process. The goals represent desirable outcomes to be attained by successful applicants who demonstrate an overall compliance with the criteria. Analysis of an applicant's capability to undertake the proposed project successfully is conducted by assessing the responses provided in the application, and independent information gathered by the reviewer. 12

13 Applications are analyzed to identify strengths and weaknesses in each proposal. If more than one application is submitted for the same type of project in the same district (subdistrict), applications are comparatively reviewed to determine which applicant best meet the review criteria. Section 59C-1.010(2) (b), Florida Administrative Code, allows no application amendment information subsequent to the application being deemed complete. The burden of proof to entitlement of a certificate rests with the applicant. As such, the applicant is responsible for the representations in the application. This is attested to as part of the application in the Certification of the Applicant. As part of the fact-finding, the consultant, Steve Love analyzed the application in its entirety with consultation from the financial analyst Felton Bradley, who evaluated the financial data, and Architect Scott Waltz, who reviewed the architectural and schematic drawings. E. CONFORMITY OF PROJECT WITH REVIEW CRITERIA The following indicate the level of conformity of the proposed project with the criteria and application content requirements found in Florida Statutes, sections , and ; applicable rules of the State of Florida, Chapter 59C-1 and 59C-2, Florida Administrative Code. 1. Fixed Need Pool a. Does the project proposed respond to need as published by a fixed need pool? Or does the project proposed seek beds or services in excess of the fixed need pool? Rule 59C-1.008(2), Florida Administrative Code. In Volume 35, Number 13, dated April 3, 2009 of the Florida Administrative Weekly, a fixed need pool of zero was published for additional pediatric open heart surgery programs in Service Planning Area IV for the July 2011 planning horizon. As of April 3, 2009, Service Planning Area IV had one operational pediatric open heart surgery program, located at Arnold Palmer Medical Center in Orlando (District 7). The applicant is applying for a pediatric open heart surgery program in the absence of published need and proposes special and not normal circumstances. 13

14 b. In addition to the published zero fixed need pool, Ch. 59C-1.033, Florida Administrative Code, outlines the criteria currently in effect for evaluating applications for pediatric open heart surgery programs and standards which open heart surgery programs must follow: Pediatric open heart surgery programs shall be established on a regional basis. A new pediatric open heart surgery program shall not normally be approved unless the number of live births in the service planning area, minus the number of existing and approved programs multiplied by 30,000, is at or exceeds 30,000. Service Planning Area IV consists of Districts 7 and 9. The following table shows the number of live births by county in Districts 7 and 9. Total Resident Live Births by County CY 2007 Rates per 1,000 County # Live Births Population Brevard 5, Indian River 1, Martin 1, Okeechobee Orange 16, Osceola 4, Palm Beach 15, St. Lucie Seminole 4, Total 54, Source: Florida Department of Health, Office of Vital Statistics Annual Report As shown above, the number of live births in Service Planning Area IV in 2007, according to the Florida Department of Health s Office of Vital Statistics Annual Report 2007, was 54,260. Applying the formula to this number (54,260 30,000) results in a total of 24,260. This number (24,260) is 5,740 live births short of the 30,000 required by rule. The applicant submits additional information regarding need. St. Mary s provides Agency for Health Care Administration population estimates which project District 9 s pediatric population to rise to 337,832 (a 2.5 percent increase from 329,451 in July 2009) by July 2011 compared to the statewide increase of 2.1. The applicant also notes that the Agency s current population estimates revised Agency population estimates for January 2006 and states that the revised for Pediatric Service Area IV is an increase of 24,230 pediatric residents, or an 8.1 percent increase over the projections the Agency had for its 2002 application. St. Mary s contends that this is a substantial change in material circumstances compared to its earlier application and is indicative of the rapid growth of the District 9 pediatric population. 14

15 c. Special and Not Normal Circumstances The applicant contends that need for an additional pediatric open heart surgery provider is based on various conclusions as shown on the applicant s assessments and described below. The applicant references what it calls normative expectations in its need argument stating that the DRGs in the rule should accurately account for all pediatric open heart surgery cases. The applicant comments that when the DRGs presently used are run against the Agency detailed inpatient database for CY 2007, it results in 746 pediatric open heart surgery cases which is only 56 percent of the 1,302 cases statewide as reported by the facilities to the local health councils and then published in Agency's "Fixed Need Pool" (FNP) publication of April 4, For the three South Florida hospitals with pediatric open heart surgery programs (Memorial Regional Hospital, Jackson Memorial Hospital and Miami Children s Hospital), the "new" Agency DRG's listed above produce only 58 percent of the cases reported in the April 4, 2008 FNP publication (299 cases vs. 514). Miami Children s, Jackson Memorial and Memorial Regional s facilities are located approximately 82, 74 and 57 miles south of St. Mary s. The applicant concludes that the DRGs in the rule are obsolete and contends that the DRGs currently used do not accurately account for all pediatric open heart surgery cases because they underestimate pediatric open heart surgery cases at 56 percent statewide and 58 percent in Pediatric Service Area V, where the majority of District 9 patients receive their care. The applicant contends that the rule's need determination formula should work and estimate need accurately for pediatric service areas and the state, but it doesn t. According to the applicant, 30,000 births should generate 100 cases for the population age 0-14 years of age. However, over the last three years, there have been cases per 30,000 resident live births in Florida and the 2007 rate for District 9 would be 111 cases, based on 84 open heart surgery cases and 22,680 resident live births in District 9. St. Mary s states that the open heart surgery program is expected to generate 64 cases in year one and 66 cases in year two, which is low volume. The applicant provides a discussion of its intent to seek Children s Medical Services (CMS) approval for the program and adds DRG 237 and 238 (Major Cardiovascular Procedures/Closed Heart procedures) which shows an average during CY of 108 procedures provided to District 9 age 0-14 cohort age residents. St. Mary s notes that CMS also includes these DRGs and the patient age 0-15

16 21 cohort to reach its projected 100 minimum. CMS Cardiac Facilities Standards December 2005 indicate that for volume purposes they also include adults 21 years or older with congenital heart disease. The standards indicate that minimum volume is 100 for the initial certification and that there is a once every three years review where the facility must meet 150 minimum procedures. The applicant then addresses need based on resident live births as the only significant variable that determines need for pediatric open heart surgery cases. However, St. Mary s contends that historical utilization data suggests this is not true based on its contention that the rule designates 100 surgeries per 30,000 live births and that the fact that existing providers all exceed the 100 volume. The applicant contends that since District 9 has more births and ranks higher than Districts 3 and 5, which both have programs, a geographic imbalance exists. The applicant also cites Broward County having only 256 more live births (less than one percent) in CY 2007 than District 9, which consists of five counties as further evidence of the geographic imbalance. The applicant also indicates that Pediatric Service Area IV has the highest number of births per program from For example, in 2007 Pediatric Service Area IV had 54,260 births per program, ranking it number one in the state and 81.6 percent higher than the state average of 29,884 births per program. The applicant also contends that the rule s constant use rate when established was appropriate because there was no evidence that the use rate for pediatric open heart surgery operations increased. However, the applicant presents data which demonstrates that the state s resident pediatric open heart surgery use rate has increased from the 1990 level of 2.74 cases per 1,000 live births to 4.23 cases per 1,000 live births in 2007 or by 54 percent. St. Mary s states that each pediatric open heart surgery program should perform at least 100 cases to maintain proficiency and quality of care and provides data which shows that all programs are exceeding the 100 minimum case volume. While the applicant acknowledges that transfers are inherent in a regional planning scheme, St. Mary s contends that transfers are sometimes not done smoothly or effectively and provides a patient record review from August 20, 2007 through April 30, 2009, to support this contention. Thirtyeight of the 56 total patient transfers were for pediatric open heart surgery. Twelve of the these patients had documented problems with transfer due to difficulties and delays. All involved transfers to Pediatric Service Area V providers and the average time from the physician s order to transfer was three hours and 19 minutes. One-third of the transfers involved problems with transfer by helicopter. The applicant also discusses transfers in general stating that the majority of admission 16

17 sources are first by physician and second, by hospital transfer. Per the applicant, there has been an increasing trend of deaths after open heart surgery for District 9 resident patients who were newborn transfers and hospital transfers. The applicant reports that for the first half of 2008, 15.4 percent of the patients from District 9 who were admitted as hospital and newborn transfers for open heart surgery expired compared to 10 percent of the patients in Pediatric Service Area IV and nine percent for the state. The applicant concludes that all Pediatric Service Area V providers exceed the 100 case per program standard set years ago by 50 to 60 percent; that the sole Pediatric Service Area IV provider, Arnold Palmer Medical Center is not available, accessible, nor utilized to any significant degree by District 9 patients. St. Mary s contends that access and quality would be enhanced by approval of the pediatric open heart and cardiac catheterization projects. St. Mary s safety net hospital status; provision of tertiary services and quality of care standards with regard to its RPICC and other specialty care programs are cited. The applicant also states that the projects will minimize transfer times and reduce time to treatment, and contends that volume only should not be used as a measure of outcomes are reasons to approve the projects. The applicant contends that its partnership agreement with the University of Miami School of Medicine will ensure the development and implementation of a high quality pediatric program at St. Mary s. 2. Agency Rule Preferences Does the project respond to preferences stated in agency rules? See Chapter 59C of the Florida Administrative Code. Chapter 59C of the Florida Administrative Code does not contain preferences relative to pediatric open heart surgery programs. However, the rule does contain standards the Agency utilizes in assessing the applicant s ability to provide quality care. References to adult open heart surgery programs have been deleted as they are not pertinent to the review. a. Service Availability Ch. 59C (4) Florida Administrative Code (1) Each pediatric open heart surgery program must have the capability to provide a full range of open heart surgery operations, including at a minimum: 17

18 (a) (b) (c) (d) (e) (f) Repair or replacement of heart valves; Repair of congenital heart defects; Cardiac revascularization; Repair or reconstruction of intrathoracic vessels; and Treatment of cardiac trauma. Applicants for pediatric open heart surgery programs shall document the manner in which they will meet the requirements of this paragraph. The proposed pediatric open heart surgery program will, at a minimum, provide repair and/or replacement of heart valves, repair of congenital heart defects, cardiac revascularization, repair and/or reconstruction of intrathoracic vessels and treatment of cardiac trauma, as required. Additionally, St. Mary s states its intent to provide back-up for angioplasty procedures, insert temporary and permanent pacemakers and Swan Ganz catheters, implement and apply circulatory assist devices, excise aneurysms and tumors and provide cardiopulmonary bypass. The University of Miami Miller School of Medicine intends to provide support to promote the project (CON #10055, Attachment 18). St. Mary's is designated as a state Level II Adult and a Pediatric Trauma Center. (2) Each pediatric open heart surgery program must document its ability to implement and apply circulatory assist devices such as intra-aortic balloon assist and prolonged cardiopulmonary partial bypass. The proposed pediatric open heart surgery program will implement centrifugal bypass pumps and intra-aortic balloon pumps. This is to be used in-house or during transfer to St. Mary s. The applicant also states that perfusionist members of the circulatory team will be available to supply circulatory assistance and cardiopulmonary partial bypass, as applicable, on a 24/7 basis. (3) A health facility with a pediatric open heart surgery program shall provide the following services: (a) (b) (c) (d) Cardiology, hematology, nephrology, pulmonary medicine, and treatment of infectious diseases; Pathology, including anatomical, clinical, blood bank, and coagulation laboratory services; Anesthesiology, including respiratory therapy; Radiology, including diagnostic nuclear medicine; 18

19 (e) (f) (g) (h) (i) Neurology; Inpatient cardiac catheterization; Non-invasive cardiographics, including electrocardiography, exercise stress testing, and echocardiography; Intensive care; and Emergency care available 24 hours per day for cardiac emergencies. St. Mary s currently provides the complete range of services listed in the nine criteria above. It is further stated these services are already provided to all patients (adults, neonates and children) with the exception of cardiac catheterization which is currently available to adult patients only. The applicant has on staff 202 pediatricians in 22 specialties and subspecialties. St. Mary s discusses laboratory and pathology services, anesthesiology, radiology and imaging services (including a new GE Innova 3131 Biplane Vascular System installed in the intervention suite), neurology, cardiology (with echocardiology and stress lab), neonatal intensive care services and children s emergency services. b. Service Accessibility Ch. 59C-1.033(4), Florida Administrative Code. (1) Hours of Operation. Pediatric open heart surgery programs shall be available for elective open heart operations eight hours per day, five days a week. Each pediatric open heart surgery program shall possess the capability of rapid mobilization of the surgical and medical support teams for emergency cases 24 hours per day, seven days a week. Applicants for pediatric open heart surgery programs shall document the manner in which they will meet this requirement. St. Mary s indicates the proposed open heart surgery and cardiac catheterization programs will be available for elective cases at a minimum of eight hours per day/five days per week and that the programs will have on-call policies to enable rapid mobilization of the surgical and medical support teams for emergency cases as needed. Emergency call coverage is stated to cover 24 hours per day/seven days per week and St. Mary's goal will be to mobilize the open heart surgery team within one hour of notification and most certainly within the required time as stated in this rule requirement. The applicant provides an extensive list of physicians that will be available to meet demand. 19

20 (2) Open Heart Surgery Team Mobilization. Pediatric open heart surgery shall be available for emergency open heart surgery operations within a maximum waiting period of two hours. The applicant states that the open heart surgery team will be able to mobilize within one hour of notification. St. Mary s states that it is currently able to mobilize surgical teams for pediatric and adult trauma within 30 minutes. The applicant reports that standard emergency call procedures will apply during on-call periods. (3) Underserved Population Groups. Pediatric open heart surgery shall be available to all persons in need. A patient's eligibility for open heart surgery shall be independent of his or her ability to pay. Applicants for pediatric open heart surgery programs shall document the manner in which they will meet this requirement. Pediatric open and closed heart surgery shall be available in each pediatric open heart surgery program service area. The applicant projects to provide in year two of the project 61.2 percent of total pediatric cardiac cath patient days to Medicaid patients. St. Mary s proposes to condition CON approval to the provision of 30 percent of the combined pediatric open heart surgery and cardiac catheterization programs total annual cases to Medicaid, Medicaid HMO, Health Care District and charity care patients. No specific charity care provision can be ascertained from the application. The applicant includes the parent s 17-page charity care policy (CON #10054, Attachment 15). St. Mary s Medical Center has a history of providing health care services to Medicaid patients and the medically indigent. According to Fiscal Year 2007 Hospital Actual Data, St. Mary s Medical Center provided 41.0 percent of patient days to Medicaid/Medicaid HMO patients, while the District 9 average was 13.2 percent. St. Mary s Medical Center provided 10.9 percent of patient days to charity care patients while the corresponding District 9 average was 3.2 percent. Treasure Coast Health Council, Inc.'s 2008 Annual Hospital Utilization Report, has St. Mary's ranked first among all hospitals in District 9 in the provision of inpatient admissions and patient days to Medicaid patients. St. Mary's provided 5,616 of District 9's 26,956 Medicaid admissions, or 20.8 percent. St. Mary's provided 35,252 of District 9 s 141,345 Medicaid patient days, or 24.9 percent. 20