STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED

STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED A. PROJECT IDENTIFICATION 1. Applicant/CON Action Number Orlando Health, Inc. d/...
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STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED

A.

PROJECT IDENTIFICATION

1.

Applicant/CON Action Number Orlando Health, Inc. d/b/a Arnold Palmer Medical Center/CON #10208 1414 Kuhl Avenue MP-8 Orlando, Florida 32806 Authorized Representative:

2.

Ms. Kathy Swanson Senior Vice President Orlando Health, Inc. and President, Arnold Palmer Medical Center (321) 843-7000

Service District/Subdistrict Organ Transplant Service Area 3: District 7 (Orange, Osceola, Brevard, and Seminole Counties); District 9, (Indian River, Martin, Okeechobee, and St. Lucie Counties, excluding Palm Beach County); Lake County only in District 3 and Volusia County only in District 4.

B.

PUBLIC HEARING A public hearing was not held or requested. However, letters of support were submitted by the applicant and the Agency received an e-mail letter of opposition on the proposal to establish a pediatric bone marrow transplantation program, as discussed below. Letters of Support Twenty unduplicated letters of support were included in Volume 1, Tab 3 of the application. Of the 20 support letters, all were signed with a date range from November 12, 2013 to December 13, 2013. The 20 support letters were each individually composed, with a county-of-origin as follows: Orange (14 letters); no address provided (three letters) and Alachua, Osceola and Polk (one letter each). Twelve of the 20 support letters were highlighted in Volume 1, Item C of the application. The 20

CON Action Number: 10208 support letters are briefly described below as follows: elected or other government official (three letters); hospital executive (one letter); physicians (five letters); community leaders (four letters) and former/current patient family members (seven letters). Bill Sublette, Chairman, Orange County School Board, states that in his current position and being a former legislator, he has served as the chair of the Howard Phillips Center for Children and Families’ (HPC)1 Community Leadership Council. Mr. Sublette indicates that HPC is a hallmark in the Central Florida area and that among its many other programs, HPC partners with the Orange County Public School System to provide health care services on school campuses for low-income teens. He further states he firmly believes that the applicant has the capacity and dedication to complete the proposed project. William D’Aliuto, Regional Managing Director, Central Region, Florida Department of Children and Families (DCF), states that DCF collaborates closely with HPC, having DCF staff co-located at HPC, working in tandem with the Child Protection Team and other programs. Mr. D’Aliuto also states that his expectation is any new development by HPC/Orlando Health, Inc. will be of similar quality to the programs that HPC provides “which have a well-deserved reputation for service excellence in the Central Florida community”. Dick Batchelor, Dick Batchelor Management Group, Inc., states that as a former legislator and a supporter and staunch advocate of HPC, he knows first-hand the important work that is done at HPC. He also states that the applicant has the commitment and capacity to complete the proposed project with standards of integrity. Timothy Goldfarb, Chief Executive Officer, UF Health Shands Hospital, states Shands has a long and supportive relationship with Orlando Health, Inc., a shared commitment to graduate medical education. He notes that UF Health Shands and Arnold Palmer Medical Center are designated teaching hospitals. Mr. Goldfarb also states that UF Health Shands commits to provide laboratory services to Arnold Palmer Medical Center, through Shands medical laboratory at Rocky Point, should the

Per their website at http://www.orlandohealth.com/arnoldpalmerhospital/HowardPhillipsCenter/HowardPhillipsCenter.as px?pid=2656, The Howard Phillips Center for Children and Families provides dignity and healing for children, families and individuals who face overwhelming challenges like child abuse, sexual trauma, developmental disabilities, and lack of access to medical care. HPC is a component within Arnold Palmer Hospital for Children, within Arnold Palmer Medical Center. 1

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CON Action Number: 10208 proposed project be approved. Per the Agency’s Health Finder website at http://www.floridahealthfinder.gov/FacilityLocator/FacilityProfilePage.as px, the UF Health Medical Lab Rocky Point is located at 4800 SW 35th Street, Gainesville, Florida 32608. Don Eslin, MD, Chair, Department of Pediatrics and Attending Physician, Children’s Center for Cancer and Blood Diseases, Arnold Palmer Hospital for Children, states he has been a practicing pediatric oncologist since 2000 and has been in the Orlando area since 2004. Dr. Eslin indicates that long stays and follow-up care in the treatment of pediatric bone marrow transplantation patients in other counties outside of central Florida present problems that would not occur if the proposed project were approved. Vincent Giusti, MD, states he has been a practicing pediatric oncologist in the Orlando area since 1971. Dr. Giusti also states that since Florida Hospital does not have a pediatric transplantation physician on its staff and because of his concerns, as a physician, about Florida Hospital’s program, he must refer his patients outside the local area. Per Dr. Giusti, the unique nature of pediatric bone marrow transplantation calls for a close link between the child’s physician and the transplant physician and team, which is not available when the child is admitted to a hospital distant from the patient’s home. Susan Kelly, MD, states she has been a board-certified pediatric oncologist, practicing in Orlando since October 2012 and was a pediatric bone marrow transplant specialist for over eight years. Dr. Kelly points out that pediatric bone marrow transplantation for her area patients is requiring transfer to All Children’s Hospital or other locations throughout the country, which requires the patient to be away from home for three to four months. Dr. Kelly indicates “this fractionates their care and can result in errors as details of care are often not transferred with the patient despite everyone’s best intensions”. She also indicates changes in health care teams are very stressful and can affect outcomes, indicating travel and being away from their support system has a negative effect on children’s wellbeing. Dr. Kelly further indicates that due to Florida Hospital not having an operational program, sending children away has become the norm rather than the exception. Robert Sutpnin, MD, and Amy Smith, MD, pediatric oncologists with Orlando Health, Inc. provide comments similar to Dr. Kelly’s.

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CON Action Number: 10208 Linda Sutherland, Executive Director, Healthy Start Coalition of Orange County, indicates that in her current position and being a former Orange County School Board member, among other child advocacy roles, she is well aware of the value of the HPC and its programs. Ms. Sutherland states she is certain the applicant will offer services that meet a high standard of excellence, should the proposed project be approved. Robert H. (Bob) Brown, President/CEO, Heart of Florida United Way, states a high regard for HPC and that in light of HPC’s commendable services to the community, he further supports future endeavors by Orlando Health, Inc., including the proposed project. Ann Manley, Ed. D., Director of Grants, Dr. Phillips Charities, states being a member of the HPC Community Leadership Council and indicates confidence in the applicant’s ability and capacity to implement the proposed project. Bobby Bridges, Chair, HPC Community Leadership Council, states his belief that the proposed project would unquestionably be delivered with integrity and deep commitment to optimal treatment standards. Seven support letters from family members of current or former area pediatric bone marrow transplantation patients, cite the financial, emotional, travel distance and continuity of care challenges that develop when having to seek and obtain pediatric bone marrow transplantation services outside the local area (which is described as the existing situation). C.

PROJECT SUMMARY Orlando Health, Inc. d/b/a Arnold Palmer Medical Center (APMC) seeks approval to establish a pediatric inpatient autologous and allogeneic bone marrow transplantation (BMT) program at APMC in Transplant Service Area 3. Orlando Health, Inc. operates Orlando Regional Medical Center, Dr. P. Phillips Hospital, Arnold Palmer Medical Center, South Seminole Hospital, South Lake Hospital (50 percent controlling interest) and Health Central, all Class 1 acute care hospitals. APMC’s 443 licensed bed compliment includes 331 acute care beds, 60 Level II and 52 Level III neonatal intensive care unit (NICU) beds, pediatric cardiac catheterization and pediatric open heart surgery programs. The facility’s bed count will not change as a result of the project.

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CON Action Number: 10208

Project costs total $956,589. The project involves 1,000 gross square feet (GSF) of renovation space (no new construction), with a construction cost of $734,100. Total project costs include building, equipment and project development costs. The applicant proposes to condition the project to a commitment to subsidize the stay at The Ronald McDonald House for any pediatric bone marrow transplant patient and/or their immediate family, in any case where the family cannot afford to pay for the stay. Orlando Health, Inc. will measure this condition by furnishing AHCA with annual statements reflecting the numbers and dollar amounts of free stays that it has paid for. D.

REVIEW PROCEDURE The evaluation process is structured by the certificate of need review criteria found in Section 408.035, 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. 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 with consultation from the financial analyst, Felton Bradley, Bureau of Central Services, who reviewed the financial data and Said Baniahmad of the Office of Plans and Construction, who reviewed the application for conformance with the architectural criteria.

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CON Action Number: 10208

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 408.035, and 408.037; 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. There is no fixed need pool publication for pediatric bone marrow transplant programs. Therefore, it is the applicant's responsibility to demonstrate the need for the project, including a projection of the expected number of pediatric bone marrow transplants that will be performed in the first years of operation. There is presently one operational and no CON approved pediatric bone marrow transplant programs in Service Area 3. As previously noted Service Area 3 includes District 7 and District 9 (excluding Palm Beach County), Lake County only in District 3 and Volusia County only in District 4. The operational program is at Florida Hospital. Data reported to the Agency for the most recent reporting period of July 1, 2012 through June 30, 2013 show the following pediatric bone marrow transplant utilization data: Florida Pediatric Bone Marrow Transplantation Program Utilization July 1, 2012 – June 30, 2013 Hospital UF Health Shands Hospital Baptist Medical Center Downtown All Children’s Hospital Florida Hospital Jackson Memorial Hospital Miami Children’s Hospital

OTSA* 1 1 2 3 4 4

District 3 4 5 7 11 11 Total

Total Procedures 13 10 47 12 22 15 119

Source: Agency for Health Care Administration Utilization Data for Pediatric Organ Transplantation Programs published September 27, 2013. Note: *OTSA is Organ Transplant Service Area as defined in Rule 59C-1.044(2)(f) Florida Administrative Code and is synonymous with “TSA” or “Service Area” for this review.

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CON Action Number: 10208 For the 12-month period ending June 30, 2013, 12 procedures were performed at Florida Hospital (the operational pediatric inpatient BMT provider in Service Area 3). The reviewer notes that while the applicant and physician support letters state that Florida Hospital’s pediatric BMT program is not operational, Agency records shown in the table above are inconsistent with this conclusion, at least through the reporting period ending June 30, 2013, which is relevant to this review. See page 14 of this report for discussion of local health council and Agency hospital inpatient discharge data reporting system discrepancies, regarding pediatric BMT procedure totals. Below is a chart to indicate distances between existing pediatric bone marrow transplantation providers, including the applicant. The figures shown are in driving miles. Pediatric Bone Marrow Transplantation Facilities Mileage Chart Including Applicant Arnold Palmer Medical Center*

Hospitals Arnold Palmer Medical Center UF Health Shands Hospital Baptist Med Center Downtown All Children’s Hospital Florida Hospital-Orlando Jackson Memorial Hospital Miami Children’s Hospital Source: hppts://maps.google.com.

113 141 106 5.1 233 244

UF Health Shands Hospital 113 73 151 114 334 344

Baptist Medical Center Downtown 141 73 221 137 343 353

All Children’s Hospital 106 151 221 147 264 262

Florida HospitalOrlando 5.1 114 137 147 236 262

Jackson Memorial Hospital 233 334 343 264 236

Miami Children’s Hospital 244 344 353 262 262 9.4

9.4

The above chart shows that there is driving distance of 5.1 miles (0 hours and 10 minutes driving time) between the applicant and Florida HospitalOrlando, the sole TSA 3 pediatric BMT provider. Again, the applicant and support letters indicate Florida Hospital’s pediatric BMT program is not operational and applicable patients are not referred there. The applicant and support letters further indicate that the nearest pediatric BMT providers to which applicable Orlando area residents are referred are All Children’s Hospital in TSA 2 (106 driving miles/one hour and 40 minutes driving time) and UF Health Shands Hospital in TSA 1 (113 driving miles/one hour and 41 minutes driving time). All other operational pediatric BMT programs are outside TSA 3, at a minimum of 141 driving miles one-way and greater than two hours driving time. The map below shows the applicant’s location and the service area’s existing licensed pediatric BMT program.

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CON Action Number: 10208 Transplant Service Area 3 Existing Provider and CON application #10208 Pediatric Inpatient Bone Marrow Transplant Programs

Source: MicroSoft MapPoint ® 2013.

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CON Action Number: 10208 Below is a five-year chart to account for pediatric inpatient bone marrow transplants. Pediatric Bone Marrow Transplantation Procedures June 30, 2009 through June 30, 2013 Facility/Transplant Service Area (TSA) UF Health Shands Hospital (TSA 1) Baptist Med Center Downtown (TSA 1) All Children’s Hospital (TSA 2) Florida Hospital-Orlando (TSA 3) Jackson Memorial Hospital (TSA 4) Miami Children’s Hospital (TSA 4) State Total

2009 23 10 53 1 1 11 99

2010 8 15 41 1 3 16 84

2011 14 9 30 1 22 20 96

2012 8 5 35 16 10 13 87

2013 13 10 47 12 22 15 119

Total 66 49 206 31 58 75 485

Source: Agency for Health Care Administration Organ Transplantation Program Utilization data published October 2009 – September 2013.

Historic data also show for the five years ending June 30, 2013, All Children’s Hospital maintained the highest volume of pediatric bone marrow transplantations, followed by Miami Children’s Hospital, UF Health Shands Hospital, Jackson Memorial Hospital, Baptist Medical Center Downtown and Florida Hospital-Orlando. During the five-year period, pediatric inpatient bone marrow transplantations tended to trend upward or downward depending on the facility, with Florida HospitalOrlando, Jackson Memorial Hospital and Memorial Children’s Hospital tending to trend upward, UF Health Shands Hospital and All Children’s Hospital tending to trend downward and Baptist Medical Center Downtown tending to trend relatively evenly. None of the providers trended upward or downward consistently for each of the five years. The applicant states the following reasons justify the project: •

The current and projected volume of pediatric BMT program discharges is sufficient to support a high quality pediatric BMT program at APMC.



There is no operational pediatric BMT program located in Organ Transplant Service Area 3. The applicant notes the low volume at Florida Hospital and that during the most recent 24 months, zero procedures were reported for the 4th quarter of 2012 and 2011 and 1st quarter of 2013 and 2012. As a result, a larger percentage than normal of children must receive this needed service by traveling outside the service area, experiencing average travel times above those recognized as reasonable by health care planners.

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CON Action Number: 10208



The proposed program is needed to assure that residents of Organ Transplant Service Area 3 have timely access to pediatric BMT surgery and other related and expanding therapeutic services associated with a pediatric BMT program, and to ensure high quality continuity of care.

Orlando Health, Inc. also states the following “not normal” circumstances exist and warrant project approval: •

The Florida Hospital program has had difficulty maintaining a number of other pediatric specialist groups that are essential for the care of children undergoing BMT;



The pediatric BMT program at Florida Hospital is, in fact, not operational and has had difficulty sustaining a program in the past;



The pediatric BMT program at Florida Hospital lacks a physician trained in pediatric BMTs; and



As a result of these and other factors, physicians who refer pediatric patients to BMT programs do not refer patients to the Florida Hospital program.

The pediatric BMT program, if approved, is to complete its first year of operation December 31, 2016 and is forecasted to perform 19 pediatric BMTs in its first year and 20 in both years two and three. Orlando Health, Inc. states APMC’s ability to achieve these volumes is assured as many required medical, nursing and other staff, including qualified pediatric BMT physicians are already on staff at the hospital. Rule 59C-1.044(9)(a), Florida Administrative Code, states that pediatric allogeneic and autologous bone marrow transplantation programs shall be limited to teaching and research hospitals with training programs relevant to pediatric bone marrow transplantation. Arnold Palmer Medical Center is a statutory teaching hospital. Arnold Palmer Medical Center has a Pediatric Residency Program in Hematology/Oncology.2

Source: Orlando Health, Inc. website at http://www.orlandohealth.com/orlandohealth/formedicalprofessionals/ped_res_faculty.aspx?pid=7034. 2

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CON Action Number: 10208 Orlando Health, Inc. states that “the only pediatric bone marrow transplant physicians in Service Area 3 are located in Orlando”, as are all of the pediatric hematology and oncology specialists in the region. The applicant also states a total of 13 such physicians in Orlando that refer children in the region for bone marrow transplantation. The applicant offers the stated number of pediatric bone marrow transplantation referrals, by patient county, to operational pediatric BMT providers, for the period 2009-2012 (see the table below). Number of Patients, by County, Referred/Treated at a Florida Pediatric Bone Marrow Transplantation Provider 2009-2012 Hospital All Children’s Hospital Baptist MC Downtown Florida Hospital Jackson Memorial Hospital Miami Children’s Hospital Shands Hospital at UF Total % by County

Brevard 6 0 1 0 0 0 7 14.6%

Lake 1 3 1 0 0 4 9 18.8%

Orange 4 0 5 0 0 7 16 33.3%

Osceola 4 0 0 0 0 0 4 8.3%

Seminole 0 0 0 0 0 1 1 2.1%

St. Lucie 0 0 0 2 0 0 2 4.2%

Volusia 3 0 1 0 0 5 9 18.8%

Source: CON application #10208, Volume 1, page 14.

Per the applicant, residents of Service Area 3 rely primarily on out-ofarea pediatric BMT programs, rather than the program at Florida Hospital. Again, per Orlando Health, Inc., from 2009-2012, 83.3 percent of Service Area 3 residents, age 0-14, were discharged from a hospital other than Florida Hospital after undergoing a pediatric BMT procedure. The applicant also indicates that for the same period, “nearly 73 percent of Service Area 3 pediatric BMT patients were treated at either All Children’s Hospital or Shands UF” (see the table below). Pediatric BMT Discharge by Hospital Service Area 3 Residents 2009-2012 BMT Discharges Number Percent 18 37.5% 17 35.4% 8 16.7% 3 6.3% 2 4.2% 48 100.0%

Hospital All Children’s Hospital Shands Hospital at the University of Florida Florida Hospital Baptist Medical Center Downtown Jackson Memorial Hospital Total Source: CON application, Volume 1, page 15, Table 1.

Per Orlando Health, Inc., “no other service area has experienced this level of patient outmigration to receive pediatric BMT services”. The applicant offers a stated outmigration rate by service area, 2009-2012 (see the table below).

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Total 18 3 8 2 0 17 48 100.0%

CON Action Number: 10208 Pediatric BMT Outmigration Rates by Service Area Florida Residents Calendar Year (CY) 2009-2012 % Outmigration by Service Area Year SA 1 SA 2 SA 3 SA4

2009 9% 0% 100% 21%

2010 13% 0% 91% 8%

2011 8% 20% 70% 4%

2012 8% 10% 56% 6%

Source: CON application #10208, Volume 1, page 15, Table 2.

Orlando Health, Inc.’s above table indicates outmigration rates over the four-year period ranged from 56 percent to 100 percent in Service Area 3 and that the highest outmigration rate recorded for any other service area during a single year was 21 percent (TSA 4 in CY 2009). Per Orlando Health, Inc., “these unusually high and persistent outmigration rates associated with Service Area 3 pediatric BMT patients indicate not normal circumstances”. Orlando Health, Inc. indicates that using Agency data, over the five-year period ending June 30, 2013, the average pediatric BMT program utilization ranged between a high of 41 admissions (at All Children’s Hospital) to a low of six admissions (at Florida Hospital). The reviewer confirms the accuracy of the stated averages (see the table below). Pediatric BMT Utilization by Hospital June 30, 2009 through June 30, 2013 Hospital All Children’s Hospital Miami Children’s Hospital Shands Hospital at UF Jackson Memorial Hospital Baptist Medical Center Downtown Florida Hospital Total

Annual Average 41 15 13 12 10 6 97

Source: CON application, Volume 1, page 16, Table 3.

Orlando Health, Inc. further indicates that “even in the two most recent 12-month periods, where Florida Hospital’s reported utilization appears more robust, there have been quarterly periods where the program’s utilization has been zero”. The applicant states this occurred in the periods October through December 2012 and January through March, 2013. The reviewer confirms that per Agency records, this is correct. Orlando Health, Inc. contends that Florida Hospital’s actual pediatric BMT program utilization is less than the levels displayed in the Agency’s publication due to differences in reporting between the CON office and the Agency’s hospital inpatient discharge data reporting system. Orlando Health, Inc., contends that most of the difference may be due to counting 12

CON Action Number: 10208 of some patients age 15 or older among the pediatric population and references Agency rule. The reviewer confirms that Rule 59C-1.044(2)(c), Florida Administrative Code, defines that a pediatric patient is under the age of 15. Orlando Health, Inc. continues by stating that “the difference is not limited to Florida Hospital”. The applicant compares stated statewide pediatric BMT utilization as reported to the CON office and the Agency’s hospital inpatient discharge data reporting system (see the table below). Pediatric (Ages 0-14) BMT Cases by Hospital Calendar Year 2012 Hospital Jackson Memorial Hospital Florida Hospital Baptist Medical Center Downtown All Children’s Hospital Miami Children’s Hospital Shands Hospital at UF Total

Volume by Reporting Source CON Office Discharge Data 20 7 14 7 5 4 37 32 10 10 8 10 94 70

Difference 13 7 1 5 0 -2 24

% Difference 65% 50% 20% 14% 0% -25% 26%

Source: CON application #10208, Volume 1, page 17, Table 4.

Orlando Health, Inc. points out that per the above table, Florida Hospital had the second highest percent difference (50 percent) in reporting between the two data sources and that “only Jackson Memorial was higher”. Orlando Health, Inc. contends that “this finding is significant because it shows that the proportion of pediatric BMT patients leaving Service Area 3 for treatment is greater than would be inferred from the data reported to the CON office” (see the table below). Pediatric BMT Discharges by Hospital Service Area 3 Residents Calendar Year 2012 Hospital All Children’s Hospital Florida Hospital Shands Hospital at UF Total

Discharges by County of Residence Brevard Orange Seminole Volusia 1 3 1 2 1 1 2 2 1 4

SA 3 Total 4 4 1 9

Source: CON application #10208, Volume 1, page 18, Table 5.

Orlando Health, Inc. concludes that “nearly 56 percent of children who need a bone marrow transplant left Service Area 3 for this service during 2012” and asserts that “for various reasons, children and their families are reluctant or unable to utilize Florida Hospital’s pediatric BMT program”. The applicant maintains and provides redacted Arnold Palmer Medical Center patient records (Volume 2, Tab 6 of the application) that

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CON Action Number: 10208 eight patients ages 0-14 who were BMT patients in 2012 were referred by APMC physicians to programs outside the service area for this service (none were referred to Florida Hospital). The applicant states that typically, the travel time standard for regionalized services like BMT is two hours or less and references Agency rule. The reviewer confirms that Rule 59C-1.044, Florida Administrative Code, does not contain a travel time standard. A mileage chart to account for the driving miles between and among existing pediatric BMT providers and the applicant was provided earlier. Orlando Health, Inc. contends that “unfortunately, transporting a child who is ill with cancer, and on a regimen that includes chemotherapy, is the reality”. These patients are stated to be “typically nauseous and have other complications which result in the trips typically taking more than two hours”. Orlando Health, Inc. further contends that reliance on out-ofarea pediatric BMT programs “imposes tremendous hardships” on these patients and their families who reside in Service Area 3 and compromises their care. Orlando Health, Inc. states that the number of patients who may be eligible for and benefit from bone marrow transplantation has expanded in recent years and that per Agency inpatient discharge data, this expansion of BMT as a treatment modality has resulted in an increasing use rate trend in Florida (see the table below). Growth in the Florida BMT Pediatric Use Rate 2010-2012 2010 67 3,287,056 2.04 2011 68 3,297,377 2.06 2012 70 3,316,540 2.11

BMT Discharges 0-14 Population Discharge Rate BMT Discharges 0-14 Population Discharge Rate BMT Discharges 0-14 Population Discharge Rate Source: CON application #10208, Volume 1, page 30, Table 6.

According to Orlando Health, Inc., the above three-year trend can be projected to 2018, indicating a statewide use rate of 2.34 per 100,000 children, ages 0-14.

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CON Action Number: 10208 Utilization Forecast Orlando Health, Inc. previously stated the proposed program will include TSA 3 counties and additionally, Polk County, which the applicant states “makes sense” because Florida Hospital’s 2012 patient origin data includes discharges of Polk County residents. The applicant further states that redacted patient records also show evidence of patients from Polk County being treated by pediatric hematology and oncology staff at Arnold Palmer Medical Center. The applicant previously forecasted to perform 19 pediatric BMTs in its first year of operation and in years two and three, 20 pediatric BMTs each of those years. Orlando Health, Inc. maintains these totals (one more procedure for each year than shown in the table below) by stating “it is appropriate to add volume representing pediatric BMT patients who have traveled outside Florida to access services”. Orlando Health, Inc. states that during 2011-2013, it referred five children to out of state providers. Hence, the applicant adds one pediatric BMT procedure than what is shown in the table below and thereby satisfies Rule 59C-1.044(9)(a)1.a., Florida Administrative Code. Forecast Pediatric BMT Use Rates and Discharges Arnold Palmer Medical Center Service Area 2016-2018 Indicator 2012 2013 2014 2015 2016 2017 2018 Florida Use Rate 2.11 2.14 2.18 2.22 2.26 2.30 2.34 Growth Factor* 1.02 1.02 1.02 1.02 1.02 1.02 Proposed Service Area Use Rate** 2.01 2.04 2.07 2.11 2.15 2.18 2.22 0-14 Population of APMC Service Area 797,673 n/a n/a n/a 840,964 851,744 862,078 Projected BMT Disharges 16 n/a n/a n/a 18 19 19 Source: CON application #10208, Volume 1, page 31, Table 7. * These are approximate values due to rounding up. Actual year-to-year growth rates are slightly less. **These are approximate values due to rounding.

Impact on Florida Hospital The applicant indicates that between 2012 and 2018, the pool of pediatric BMT patients that Arnold Palmer Medical Center expects to treat is forecast to grow by 25 percent (from 16 to 20 procedures). Agency records indicate Florida Hospital performed 24 pediatric BMT procedures for the 24-month period ending June 30, 2013. This is an average of 14 procedures in the 24-month period. Orlando Health, Inc. previously indicated that eight pediatric BMT candidates at APMC were referred to out-of-area programs (not to Florida Hospital). Per Orlando Health, Inc., if the 22 cases that were potentially available to Florida Hospital in 2012 increased by the same proportion over the time period, Florida Hospital could expect to treat 27-28 pediatric BMT patients in 2018. 15

CON Action Number: 10208

Orlando Health, Inc. contends that should Florida Hospital “elect to revive its dormant pediatric BMT program”, it could anticipate serving seven to eight patients and that this is the equivalent to the number reported through Agency inpatient discharge data system totals, and the same or more than the numbers reported to the CON office. In conclusion, Orlando Health, Inc. asserts that the high levels of outmigration (as described above) “are unacceptable” and that “for all intent and purpose, there is no pediatric BMT program in Service Area 3”. 2.

Applications for the establishment of new pediatric allogeneic and pediatric autologous bone marrow transplantation program shall not normally be approved in a service planning area unless the following additional criteria are met: (a)

Requirements for Pediatric Allogeneic and Autologous Bone Marrow Transplantation Programs: Pediatric allogeneic and autologous bone marrow transplantation programs shall be limited to teaching and research hospitals with training programs relevant to pediatric bone marrow transplantation. (Rule 59C-1.044(9)(a) Florida Administrative Code). Arnold Palmer Medical Center is a statutory teaching hospital. The applicant discusses the following broad categories: Orlando Health Research Activities; Pediatric Cancer Research and Medical Education. (1)

Applicants shall be able to project that at least 10 pediatric transplants will be performed each year. If both allogeneic and autologous pediatric transplants are performed, at least 10 of each shall be projected. New units shall be able to project the minimum volume for the third year of operation. The applicant estimates 19, 20 and 20 pediatric inpatient bone marrow transplants for the first three years of operation, respectively (ending December 31, 2016-2018).

(2)

Applicants shall be able to project that at least 10 pediatric transplants will be performed each year. If both allogeneic and autologous pediatric transplants are performed, at least 10 of each shall be projected. New units shall be able to project the minimum volume for the third year of operation. 16

CON Action Number: 10208

As of the end of year three, the applicant indicates that of the 20 pediatric BMTs, 10 are forecast to be allogeneic and 10 autologous. (3)

A program director who is a board-certified hematologist or oncologist with experience in the treatment and management of pediatric acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The program director must have formal training in bone marrow transplantation. Orlando Health, Inc. states that Susan Kelly, MD, will serve as Program Director. Dr. Kelly is board-certified in Pediatrics and Pediatric Oncology and has completed fellowships in both pediatric oncology and pediatric stem cell transplant at Duke University. She spent three years of research in stem cell transplant and served four years as director of the pediatric bone marrow transplant program at Shands UF. Dr. Kelly’s curriculum vita is included in Volume 2, Tab 5 of the application.

(4)

Clinical nurses with experience in the care of critically ill immuno-suppressed patients. Nursing staff shall be dedicated full time to the program. The applicant indicates that nurses in the APMC Center for Pediatric Cancer and Blood Disorders, the pediatric hematology/oncology unit and in pediatric critical care, have extensive experience in care of critically ill immunosuppressed patients. Orlando Health, Inc. indicates that 7.3 FTE registered nurses will be dedicated to this program.

(5)

An interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoietic and lymphopoietic malignancies, and non-neoplastic disorders. The team shall direct permanent follow-up care of the bone marrow transplantation patients, including the maintenance of immunosuppressive therapy and treatment of complications. Orlando Health, Inc. states that Arnold Palmer Medical Center has a group of five pediatric hematology/oncology physicians now on staff and practicing at the hospital: Amy

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CON Action Number: 10208 Smith, MD (transplant physician); Vincent Giusti, MD; Don Eslin, MD; Robert Sutphin, MD and Federico Laham, MD, MS, FAAP. The applicant also states that these five physicians practicing at APMC’s Pediatric Cancer and Blood Disorders Center have expertise in all areas specified in this criterion. (6)

Age appropriate inpatient transplantation units for posttransplant hospitalization. Post-transplantation care must be provided in a laminar air flow room; or in a private room with positive pressure, reverse isolation procedures, and terminal high efficiency particulate aerosol filtration on air blowers. The designated transplant unit shall have a minimum of two beds. This unit can be part of a facility that also manages patients with leukemia or similar disorders. APMC indicates that the proposed program patient beds for post-transplantation care will be developed in an existing special care area of the second floor of the Arnold Palmer Hospital for Children. Per the applicant, only children are treated in the hospital, so the entire hospital is ageappropriate for these patients. It is also stated that all the interior finishes will be monolithic in nature, to sustain a high level of cleanliness. Two existing patient rooms will be renovated to establish the transplant unit.

(7)

A radiation therapy division on-site which is capable of sub-lethal x-irradiation, bone marrow ablation, and total lymphoid irradiation. The division shall be under the direction of a board-certified radiation oncologist. The application indicates that Orlando Health, Inc. has a radiation therapy department on-site with appropriate capability to provide the services specified in this criterion. Volume 3, Tab 13 of the application includes the curriculum vitae of Naren Ramakrishna, MD, PhD, Director, Neurological and Pediatric Radiation Oncology at Orlando Health Cancer Center Orlando. The same tab includes a 2013-2014 Scope of Services Department of Radiation Oncology. Other topics the applicant discusses in this criterion are: service provided (equipment list, treatment and procedures and special procedures); types of patient service (including adult and pediatric patients) and the type, number and skill mix of staff. 18

CON Action Number: 10208

Orlando Health, Inc. states it has seven board-certified radiation oncology physicians, its radiation oncology department operates Monday through Friday, from 8:00 a.m. to 4:30 p.m. and that patients undergoing radiation treatment can be treated from 7:00 a.m. to 8:00 p.m. based on patient load. The applicant also indicates that nursing staff hours are flexible to accommodate treatment hours. (8)

An ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital. The program must include outcome monitoring and long-term patient follow-up. The applicant discusses the Arnold Palmer Hospital’s participation in the Children’s Oncology Group (see Item E.2.a.1 of this report). The applicant states that complementing the Children’s Medical Group is APMC’s membership in two consortiums – the Pediatric Oncology Experimental Therapeutic Investigators Consortium (POETIC) and the Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC). Per the applicant, POETIC is led by Memorial Sloan Kettering Cancer Center and The Children’s Hospital Denver and that the applicant is “the only POETIC center south of The Johns Hopkins Hospital and east of MD Anderson Cancer Center Texas”. Orlando Health, Inc. states that the NMTRC is focused on creating novel treatments for neuroblastoma (for which there are currently few if any options) and the most common type of central nervous system malignancy – medullablastoma.

(9)

An established research-oriented oncology program. The applicant previously addressed this criteria in detail in its description of the hospital’s Children’s Center for Cancer and Blood Disorders and its research-oriented oncology program activities (CON application 10208, Volume 1, pages 79-80).

19

CON Action Number: 10208

(b)

Additional Requirements for Pediatric Allogeneic Transplantation Programs: (1)

A laboratory equipped to handle studies including the use of monoclonal antibodies, if this procedure is employed by the hospital, or T-cell depletion, separation of lymphocyte and hematological cell subpopulations and their removal for prevention of graft versus host disease. This requirement may be met through contractual arrangements. Orlando Health, Inc. states that it expects to meet this requirement through contractual agreement, citing a letter signed by Timothy Goldfarb, CEO, UF Health Shands, confirming UF’s commitment to provide such laboratory services through its Shands medical laboratory. Per the applicant, the UF Health commitment letter is located in Volume 2, Tab 4 of the application. However, the stated commitment letter was in Volume 1, Tab 3.

(2)

An on-site laboratory equipped for the evaluation and cryopreservation of bone marrow. Orlando Health, Inc. states that it has made provision to provide on-site the capability for evaluation and cryopreservation of bone marrow. Per the applicant, an additional 280 square feet of space is accounted for to accommodate this requirement and is included in Schedule 1 and Schedule 9 of the application (see Item E.3.f. of this report).

(3)

An age appropriate patient convalescent facility to provide a temporary residence setting for transplant patients during the prolonged convalescence. Orlando Health, Inc. states two temporary residence settings for families facing a prolonged stay in Orlando to accompany a child undergoing bone marrow transplantation, including the post-transplantation period when they may be discharged from the hospital setting but still require frequent monitoring and outpatient clinic care.

20

CON Action Number: 10208 The applicant discusses the 16-room Hubbard House, which it describes as a “home-away-from-home” and the 37-room Ronald McDonald House. (4)

An age appropriate outpatient unit for close supervision of discharged patients. The applicant states that the Arnold Palmer Hospital Center for Pediatric Cancer and Blood Disorders comprises three principal components:   

Pediatric and adolescent 20-bed inpatient unit at Arnold Palmer Hospital Pediatric Outpatient Clinic at Arnold Palmer Hospital for outpatient visits; and Radiation oncology.

The applicant discusses the Pediatric Hematology/Oncology Outpatient Clinic, being under the direction of a nursing operations manager. The services provided are discussed, as well as the type, number and skill mix of staff. 2.

Agency Rule Criteria Chapter 59C-1.044, Florida Administrative Code, contains criteria and standards by which the department is to review the establishment of organ transplantation programs under the certificate of need program. Appropriate areas addressed by the rule and the applicant's responses to these criteria are as follows: a.

Coordination of Services. Chapter 59C-1.044(3), Florida Administrative Code. Applicants for transplantation programs, regardless of the type of transplantation program, shall have: 1.

Staff and other resources necessary to care for the patient's chronic illness prior to transplantation, during transplantation, and in the post-operative period. Services and facilities for inpatient and outpatient care shall be available on a 24-hour basis. Orlando Health, Inc. and Arnold Palmer Medical Center are stated to have the staff and resources to care for a pediatric bone marrow transplant patient’s chronic illness prior to,

21

CON Action Number: 10208 during the procedure and upon the post-operative period. The applicant reports having staff and other resources for inpatient and outpatient care 24 hours a day. Orlando Health, Inc. indicates that it is an active member of the Children’s Oncology Group (COG) since its formation in 2000, with COG being “the only pediatric NCI funded cooperative research network and is the largest pediatric cancer research group in the world”. Additionally, Arnold Palmer Medical Center currently provides care to patients with acute and chronic conditions in its Center for Children’s Cancer and Blood Disorders and within that, the Pediatric Brain Tumor Program. Each of these, including a Pediatric BMT Process Overview and Additional Chronic Illness and Acute Care Capability, are discussed in further detail by the applicant (Volume 1, pages 35-46). The reviewer notes that per the applicant’s Schedule 6A, discussed later in this report, incremental FTEs specific to support the program include: 7.3 FTEs for registered nurses (RNs); 1.0 FTEs for medical assist and nurse practitioner; 0.5 FTS for “Ancillary:Other” and 0.5 FTEs for a licensed clinical social worker (LCSW). This is a total incremental increase of 9.3 FTEs for each of the first three years of operations (ending December 31, 2018). 2.

If cadaveric transplantation will be part of the transplantation program, a written agreement with an organ acquisition center for organ procurement is required. A system by which 24-hour call can be maintained for assessment, management and retrieval of all referred donors, cadaver donors or organs shared by other transplant or organ procurement agencies is mandatory. This is not applicable to bone marrow transplantation programs.

3.

An age-appropriate (adult or pediatric) intensive care unit which includes facilities for prolonged reverse isolation when required. The applicant states that an appropriate pediatric intensive care unit (PICU) is available at Arnold Palmer Medical

22

CON Action Number: 10208 Center, with 17 private inpatient beds, including two negative airflow isolation rooms and four dedicated trauma rooms. Arnold Palmer Medical Center’s 2013-2014 Scope of Services-Pediatric Intensive Care Unit, Pediatric Hematology/Oncology Inpatient and Pediatric Hematology/ Oncology Outpatient Clinic and related material are included in the application’s Volume 2, Tab 7. 4.

A clinical review committee for evaluation and decisionmaking regarding the suitability of a transplant candidate. The applicant indicates its intent to establish a clinical review committee for the evaluation and decision-making for the suitability of pediatric bone marrow transplant candidates. The Arnold Palmer Medical Center bone marrow transplant clinical review committee is stated to consist of the following members:        

Transplant Program Director (Susan Kelly, MD3) Transplant Attending Physician Transplant Coordinator Transplant Pharmacist Transplant Clinic & Inpatient Nursing Clinical Social Worker Child Life Specialist; and Spiritual Counselor (as needed).

Per the applicant, the committee with meet weekly to discuss potential new candidates, patients approaching treatment initiation and patients currently in treatment, including inpatients and outpatients. The applicant provides Arnold Palmer Medical Center’s written Blood and Marrow Transplant Program and related materials (in the application’s Volume 2, Tab 8).

Per Orlando Health, Inc., Susan Kelly, MD, is board-certified in Pediatrics and Pediatric Oncology, is active nationally in the Pediatric Blood and Bone Marrow Transplant Consortium (PBMTC) and is Vice Chair, Oncology Strategy Group. 3

23

CON Action Number: 10208 5.

Written protocols for patient care for each type of organ transplantation program including, at a minimum, patient selection criteria for patient management and evaluation during the pre-hospital, in-hospital, and immediate post-discharge phases of the program. Orlando Health, Inc. states that development of the Arnold Palmer Medical Center’s Blood and Marrow Transplant Program Policy and Procedures Manual is in process under the guidance of Susan Kelly, MD, Program Director. The applicant also notes that a “Table of Contents” establishing the comprehensive set of policies and guidelines to be completed, authorized and implemented has been created and is included in the application’s Volume 2, Tab 8.

6.

Detailed therapeutic and evaluative procedures for the acute and long-term management of each transplant program patient, including the management of commonly encountered complications. The applicant indicates that its detailed therapeutic and evaluation procedures for the acute and long-term management of patients, including the management of commonly encountered complications, is under development as part of its written protocols on patient care (Arnold Palmer Medical Center’s Blood and Marrow Transplant Program Policy and Procedures Manual). Orlando Health, Inc. includes a detailed description of its proposed program which addresses this in its response to Item 2. a.1. on pages 35-46 of CON application #10208.

7.

Equipment for cooling, flushing, and transporting organs. If cadaveric transplants are performed, equipment for organ preservation through mechanical perfusion is necessary. This requirement may be met through an agreement with an organ procurement agency. This is not applicable to bone marrow transplantation programs.

24

CON Action Number: 10208 8.

An on-site tissue-typing laboratory or a contractual arrangement with an outside laboratory within the State of Florida, which meets the requirements of the American Society of Histocompatibility. Orlando Health, Inc. states having secured a commitment with UF Health for the provision of tissue typing and indicates that Shands medical laboratory at Rocky Point will provide these required laboratory services. The UF Health commitment letter is located in Volume 1, Tab 3 of the application. The reviewer notes in previous support letters (Item B of this report) that UF Health Shands commits to provide laboratory services to Arnold Palmer Medical Center, through Shands medical laboratory at Rocky Point.

9.

Pathology services with the capability of studying and promptly reporting the patient's response to the organ transplantation surgery, and analyzing appropriate biopsy material. The applicant indicates that board-certified pathologists and the full resources of the Orlando Health and the Arnold Palmer Medical Center pathology and laboratory services are available to provide pathology and laboratory support for the proposed project. The applicant also indicates that organ transplantation surgery it not required for bone marrow transplant procedures, the lab has appropriate capability for analyzing biopsy material, as necessary. Per the applicant, a complete scope of service description of Orlando Health Clinical Laboratories, sample policies and procedures related to laboratory services and a laboratory manager job description are provided in Volume 2, Tab 11 of the application. However, Tab 10 of Volume 2 contained this information.

10.

Blood banking facilities. Per the applicant, Orlando Gonzalez, MD4 is the medical director of the Arnold Palmer Medical Center blood bank which is available 24 hours a day, seven days a week.

Per Orlando Health, Inc., Orlando Gonzalez, MD, is board-certified in anatomic and clinical pathology as well as pediatric pathology. 4

25

CON Action Number: 10208 Services are stated to serve a patient population of neonates, pediatrics and women, with the facility having the only Level I pediatric trauma center in the area. Per the applicant, sample policies and procedures related to blood collection, blood administration and obtaining and dispensing blood products provided in Volume 2, Tab 11 of the application. However, upon review, the stated materials, including the curriculum vitae for Dr. Gonzelez, were found in Tab 10. 11.

A program for the education and training of staff regarding the special care of transplantation patients. The applicant states that Orlando Health, Inc. and Arnold Palmer Medical Center “have in place a large, vigorous and effective internal staff training and development department, which will incorporate the requirements of the proposed project into its existing training and education activities”. The applicant also states that prior to implementing the proposed project, all inpatient and outpatient nursing staff will have the appropriate education in order to care for children receiving bone marrow transplant. Per Orlando Health, Inc., the Association of Pediatric Hematology Oncology Nurses (APHON) in association with the Pediatric Blood and Marrow Transplant Consortium (PBMTC) offer a course in pediatric cell transplantation. It is further stated every BMT nurse will be part of the APHON Mentoring Program. Orlando Health, Inc. states that the curricula for BMT staff training will include some or all of the following depending on needs assessment, training and experience of BMT staff members:    

APHON/PBMTC Foundations of Pediatric Hematopoietic Progenitor Cell Transplantation: A Core Curriculum Pediatric Blood and Marrow Transplant Consortium Educational Program Nurses will be sent to bone marrow transplant conferences Nursing staff will be sent to an existing BMT facility for education and “hands on” experience

26

CON Action Number: 10208     12.

APHON Pediatric Oncology Nursing: Scope and Standards of Practice Essentials of Pediatric Oncology Nursing: A Core Curriculum Nursing Care of Children and Adolescents with Cancer (APHON 2011); and APHON mentoring program.

Education programs for patients, their families and the patient's primary care physician regarding after-care for transplantation patients. The applicant indicates that educational materials are under development for patients and their families regarding pre-, during and post-transplantation care. Orlando Health, Inc. provides the table of contents of a 121-page Blood and Marrow Transplant: A Patient and Family Handbook (Volume 2, Tab 9). Per Orlando Health, Inc., transplant candidates and their families will be offered this handbook and the transplant coordinator will review the key points with them.

b.

Staffing Requirements. Applicants for transplantation programs, regardless of the type of transplantation program, shall meet the following staffing requirements. Chapter 59C1.044(4), Florida Administrative Code. 1.

A staff of physicians with expertise in caring for patients with end-stage disease requiring transplantation. The staff shall have medical specialties or sub-specialties appropriate for the type of transplantation program to be established. The program shall employ a transplant physician, and a transplant surgeon, if applicable, as defined by the United Network for Organ Sharing (UNOS) June 1994. A physician with one-year experience in the management of infectious diseases in the transplant patient shall be a member of the transplant team. Orlando Health, Inc. states that Arnold Palmer Medical Center has a group of six pediatric hematology/oncology physicians now on staff and practicing at the hospital: Susan Kelly, MD (Program Director); Vincent Giusti, MD; Don Eslin, MD; Robert Sutphin, MD; Federico Laham, MD, MS, FAAP and Alejandro Jordan-Villegas, MD, MS. Drs. Smith, Giusti, Eslin and Sutphin are members of the

27

CON Action Number: 10208 Pediatric Hematology/Oncology Specialty Section, MD Anderson Cancer Center Orlando. These physicians’ curricula vitae are included in Volume 2, Tab 5 of the application. 2.

A program director who shall have a minimum one year formal training and one year of experience at a transplantation program for the same type of organ transplantation program proposed. The applicant previously stated that Susan Kelly, MD, will be the pediatric bone marrow transplant program director. Per the applicant and Dr. Kelly’s curriculum vitae, she meets or exceeds the formal training and experience requirements to serve as the program director.

3.

A staff with experience in the special needs of children if pediatric transplantations are performed. The applicant cites the many pediatric specialties and functions provided by Arnold Palmer Medical Center and indicates that its staff will meet this criterion. Per Orlando Health, Inc., Arnold Palmer Medical Center is “the largest facility dedicated to children and women in the United States”.

4.

A staff of nurses, and nurse practitioners with experience in the care of chronically ill patients and their families. Orlando Health, Inc. reports that Arnold Palmer Medical Center has “a wide and deep capacity to care for related chronic conditions which may impact pediatric bone marrow transplantation patients during the course of their care, both pre- and post-transplant. The applicant previously noted the hospital’s Center for Children’s Cancer and Blood Disorders, the Pediatric Brain Tumor Program, and the hematology/ oncology inpatient and outpatient units. Nursing staff curricula vitae with experience in the care of chronically ill patients and their families is included (Volume 2, Tab 9).

28

CON Action Number: 10208 5.

Contractual agreements with consultants who have expertise in blood banking and are capable of meeting the unique needs of transplant patients on a long-term basis. The applicant states it has all resources in-house to meet the needs of transplant patients on a long-term basis. Per the applicant, Orlando Gonzalez, MD (as previously stated) is the medical director of the Arnold Palmer Medical Center blood bank which is available 24 hours a day, seven days a week. Sample policies and procedures related to blood collection, blood administration and obtaining and dispensing blood products are provided in Volume 2, Tab 10 of the application.

6.

Nutritionists with expertise in the nutritional needs of transplant patients. Orlando Health, Inc. and Arnold Palmer Medical Center have nutritionists with appropriate knowledge, skill and expertise to address the nutritional needs of patients to be served in the proposed bone marrow transplantation program. Volume 2, Tab 11 of the application includes the curriculum vitae of Stephanie Holmes, MS, RD/LD, Clinical Nutrition Manager, APMC. There is also a 2013-2014 Scope of Service Food and Nutrition Department. The applicant discusses pediatric nutrition services, services provided by the clinical nutrition services section of the hospital, nutrition staff orientation and competencies in food and nutrition services.

7.

Respiratory therapists with expertise in the needs of transplant patients. The applicant states that Orlando Health, Inc. and Arnold Palmer Medical Center have all the necessary personnel and resources in place to provide appropriate respiratory care services to bone marrow recipients in the proposed program. Volume 2, Tab 11 of the application includes the curriculum vitae of Phillip McCabe, RRT, Manager, Respiratory Care, Supervisor, Pediatric/Women’s Respiratory Care and Acting Manager, Pediatric Pulmonary Function & Sleep Physiology Laboratory, Arnold Palmer Hospital for Children & Women. 29

CON Action Number: 10208 There is also a 2013-2014 Scope of Service Respiratory Care Services. 8.

Social workers, psychologists, psychiatrists, and other individuals skilled in performing comprehensive psychological assessments, counseling patients, and families of patients, providing assistance with financial arrangements, and making arrangements for use of community resources. The applicant indicates that Orlando Health, Inc. and Arnold Palmer Medical Center “employ a number of patient services directed toward assessing patient needs, counseling patients and families and assisting patients and families in assisting patients and families in accessing needed financial and community resources”. Clinical social workers are stated to be key members of this team. Volume 2, Tab 11 of the application includes 2013-2014 Scope of Services Child Life, Music and the Arts, Scope of Services Department of Patient and Family Counseling and Scope of Services Spiritual Care. Also included is hospital staff, including the curriculum vitae of Lisa Cox Gibbon, Ph.D., Pediatric Neuropsychologist, Division of Neuropsychology and Mary Norris, MPH, MSW, LCSW, BCD, Manager, Patient and Family Counseling.

3.

Statutory Review Criteria

a.

Is need for the project evidenced by the availability, quality of care, accessibility and extent of utilization of existing health care facilities and health services in the applicant's service area? ss. 408.035(1)(a) and (b), Florida Statutes. As stated previously, there is presently one operational and no CON approved pediatric bone marrow transplant programs in Service Area 3. As noted at the beginning of this review, Service Area 3 includes District 7 and District 9 (excluding Palm Beach County), Lake County only in District 3 and Volusia County only in District 4. The operational program is at Florida Hospital. Also as previously stated, data reported to the Agency for the most recent reporting period, July 1, 2012 through June 30, 2013 show the following pediatric bone marrow transplant utilization data:

30

CON Action Number: 10208 Florida Pediatric Bone Marrow Transplantation Program Utilization July 1, 2012 – June 30, 2013 Hospital UF Health Shands Hospital Baptist Medical Center Downtown All Children’s Hospital Florida Hospital Jackson Memorial Hospital Miami Children’s Hospital

OTSA* 1 1 2 3 4 4

District 3 4 5 7 11 11 Total

Total Procedures 13 10 47 12 22 15 119

Source: Agency for Health Care Administration Utilization Data for Pediatric Organ Transplantation Programs published September 27, 2013. Note: *OTSA is Organ Transplant Service Area as defined in Rule 59C-1.044(2)(f) Florida Administrative Code and is synonymous with ‘TSA’ for this review.

For the 12-month period ending June 30, 2013, 12 procedures were performed at Florida Hospital (the sole licensed provider of authorized pediatric bone marrow transplants in Service Area 3). Agency records indicate that for the 12-month period ending June 30, 2013, of the 12 Service Area 3 residents (0-14 years of age) that were discharged with a blood and bone marrow transplant procedure (ICD941.00 to 41.09), two patients (16.67 percent) received the procedure at the Service Area 3 provider (Florida Hospital) and the remaining 10 patients (83.33 percent) received the procedure at a non-Service Area 3 provider. All Children’s Hospital (Service Area 2) served seven of the 12 patients (58.33 percent). Below is a table to account for these totals and percentages. Transplant Service Area 3 Pediatric Residents (0-14 Years of Age) With a Blood or Bone Marrow Transplant Discharge (ICD9-41.00 to 41.09) 12 Months Ending June 30, 2013 Hospital All Children’s Hospital Florida Hospital Shands Hospital at UF Baptist Medical Center Downtown Total Procedures

Total Procedures 7 2 2 1 12

Percentage 58.33% 16.67% 16.67% 8.33% 100.0%

Source: Florida Center for Health Information and Policy Analysis database run date of 12/23/13.

The applicant previously stated it plans to include Polk County residents as part of its service area. Florida Center for Health Information and Policy Analysis hospital discharge data for the 12 months ending June 30, 2013, indicates that eight Polk County pediatric bone marrow transplantation patients were discharged from All Children’s Hospital. The applicant previously stated that the Service Area 3 pediatric bone marrow transplantation population is discharged primarily from All Children’s Hospital and UF Health Shands Hospital. The data above indicates that this is correct in that nine of 12 or 75.0 percent of SA 3 cases were discharged from these facilities during the 12-month period ending June 30, 2013. 31

CON Action Number: 10208

The applicant also notes that there are reporting differences between pediatric bone marrow transplantation procedure totals reported to the CON Office and those reported to the Florida Center for Health Information and Policy Analysis. The reviewer confirms that for the 12-month period ending June 30, 2013, Florida Hospital reported 12 pediatric BMTs to the local health council and for the same period the Agency’s Florida Center for Health Information and Policy Analysis hospital inpatient discharge data indicates Florida Hospital reported two procedures. The applicant previously projected the pediatric BMT program, if approved, is to complete 19 procedures (year one) and 20 procedures (year two and year three, each). Orlando Health, Inc. reiterates that the proposed project is needed to assure residents of TSA 3 timely access to pediatric bone marrow transplantation and other related and expanding therapeutic services associated with BMT program and to ensure high quality continuity of care. The applicant also states the project would rectify the unusually high rate of outmigration of TSA 3 residents for the planned service. The project is stated to improve access. b.

Does the applicant have a history of providing quality of care? Has the applicant demonstrated the ability to provide quality care? ss. 408.035(1)(c), Florida Statutes. Orlando Health, Inc. states that it has a long and distinguished history of providing quality care to all the populations served by its facilities. The applicant maintains it will bring all its quality resources to bear, coupled with the clinical criteria and standards, discussed previously in the application. The applicant includes a copy of its license and Joint Commission accreditation (in Volume 2, Tab 4). The applicant references what are stated to be numerous “Arnold Palmer Hospital Milestones” from 1989 through 2013 (Volume 1, pages 101-103). Some of these are shown below:  

Recognized by U.S. News and World Report as one of the Best Children’s Hospitals in the country (2008, 2010-2013) Ernest Amory Codman Award, recognized by the Joint Commission in the prevention of HIV transmission from mother to child (2006 and 2007)

32

CON Action Number: 10208  

The Hewell Kid’s Kidney Center, the first dialysis center in Central Florida exclusively for kids (2011); and American Association of Critical Care Nurses recognizes the pediatric intensive care unit with silver-level Beacon Award for Excellence.

Orlando Health, Inc. discusses Arnold Palmer Hospital’s quality improvement structure and collaborative quality committee and includes a copy of these policies in the application’s Volume 3, Tab 14. The applicant also mentions the proposed program’s clinical standards and guidelines, patient selection and care protocols and key personnel for the development, implementation and operations, as discussed earlier in the application. The applicant indicates plans to apply for and obtain certification by the Foundation for the Accreditation of Cellular Therapy (FACT), for the proposed program at the earliest possible time. Per the applicant “FACT Standards are the only set of requirements that emphasize the clinical use of cellular therapy products collected and processed with vigorous controls”. Agency complaint data indicates that Orlando Health, Inc.’s hospitals had 31 substantiated complaints for the three-year period ending January 20, 2014. Arnold Palmer Medical Center had five of the 31. A single complaint can encompass multiple complain categories. Orlando Health, Inc.’s substantiated complaint history is itemized below. Orlando Health, Inc. Substantiated Complaints January 20, 2011 through January 20, 2014

Complaint Category Quality of Care/Treatment Resident/Patient/Client Rights Nursing Services Resident/Patient/Client Assessment Admission, Transfer & Discharge Rights Physician Services Admission/Personnel Emergency Access Infection Control Resident/Patient/Client Abuse

Health Central

South Seminole Hospital

Arnold Palmer Medical Center

South Lake Hospital

Orlando Regional Medical Center

Dr. P. Phillips Hospital

Total = 7 2 1 1 1 0 1 0 0 1 0

Total = 7 2 1 0 0 1 1 0 1 0 1

Total = 5 1 1 1 0 1 0 1 0 0 0

Total = 5 2 1 1 1 0 0 0 0 0 0

Total = 4 2 1 0 1 0 0 0 0 0 0

Total = 3 1 0 1 1 0 0 0 0 0 0

Source: Agency for Health Care Administration Complaint Review Records.

The applicant demonstrates the ability to provide quality care.

33

CON Action Number: 10208 c.

What resources, including health manpower, management personnel, and funds for capital and operating expenditures, are available for project accomplishment and operation? ss.408.035(1)(d) Florida Statutes The financial impact of the project will include the project cost of $956,589 and year two incremental operating costs of $2,636,587. The audited financial statements of Orlando Health, Inc. and Controlled Affiliates for the periods ending September 30, 2012 and 2011 were analyzed for the purpose of evaluating the applicant’s ability to provide the operational funding, development, and start-up costs necessary to implement the project as proposed. Short-Term Position: The applicant’s current ratio of 2.5 is above average and indicates current assets are approximately two and a half time’s current liabilities, a strong position. The ratio of cash flows to current liabilities of 0.5 is below average, a weak position. The working capital (current assets less current liabilities) of $419 million is a measure of excess liquidity that could be used to fund capital projects. Overall, the applicant has an adequate short-term position (see Table 1 below). Long-Term Position: The ratio of long-term debt to net assets of 1.1 is well above average and indicates the applicant may have difficulty acquiring future debt financing if necessary, a weak position. The ratio of cash flow to assets of 5.0 percent is well below average and illustrates a relatively low cash flow and is considered a weak position. In fiscal year end 2012 the applicant had approximately $82.2 million in operating revenue in excess of expenses which resulted in a margin of 4.7 percent. Overall, the applicant has a weak long-term position (see Table 1 below). Capital Requirements: Schedule 2 indicates the applicant has capital projects totaling $200,956,589 which includes the CON subject to this review. Available Capital: The applicant states that the funding for this project will come from cash from existing operations. The audited financial statements of the applicant for the most recent year show cash and cash equivalents of $63.4 million and $419 million in working capital with a current ratio of 2.5. The audit also indicated an operating cash flow of approximately $133 million with operating income of $82.2 million and a margin of 4.7

34

CON Action Number: 10208 percent. As mentioned above, funding for this project will be funded by operating cash flows of the hospital. It appears that the funding for the project and the entire capital budget would be available as needed. Staffing: Currently, the applicant does not provide any inpatient transplant services and approval would result in a new product line – pediatric bone marrow transplantation. However, Arnold Palmer Medical Center has staff with expertise and experience regarding pediatric bone marrow transplantation and related skill and know-how, as described previously. The table below shows the applicant’s projected staffing for years one through three, ending December 31, 2018. Notes to Schedule 6A indicate the staffing schedule is based on incremental inpatient volume and the acuity levels anticipated to arise from the proposed project. The FTE total is 9.3 for each of the first three years, with each staff FTE total remaining constant throughout the three-year period (see the table below). Orlando Health, Inc. d/b/a Arnold Palmer Medical Center Pediatric Bone Marrow Transplantation Program Staffing Patterns

NURSING Registered Nurses (RNs) Other: Med Assistant/Nurse Practitioner ANCILLARY Other SOCIAL SERVICES Licensed Clinical Social Worker (LCSW) TOTAL

Year One Ending 12/31/16

Year Two Ending 12/31/17

Year Three Ending 12/31/15

7.3 1.0

7.3 1.0

7.3 1.0

0.5

0.5

0.5

0.5 9.3

0.5 9.3

0.5 9.3

Source: CON application #10208, Schedule 6A.

Conclusion: Funding for this project and all capital projects should be available as needed.

35

CON Action Number: 10208

TABLE 1 CON application #10208: Orlando Health, Inc. d/b/a Arnold Palmer Medical Center 9/30/2012

9/30/2011

$704,660,000

$606,109,000

$63,406,000

$47,159,000

$0 $2,640,111,00 0

$0 $2,158,829,00 0

$285,612,000 $1,507,268,00 0 $1,132,843,00 0 $1,743,702,00 0

$243,325,000 $1,120,026,00 0 $1,038,803,00 0 $1,587,419,00 0

Interest Expense

$39,508,000

$37,313,000

Excess of Revenues Over Expenses

$82,183,000

$64,447,000

$132,974,000

$116,325,000

$419,048,000 FINANCIAL RATIOS

$362,784,000

Current Assets Cash and Current Investment Due from Memorial Healthcare System Total Assets Current Liabilities Total Liabilities Net Assets Total Revenues

Cash Flow from Operations Working Capital

d.

9/30/2012

9/30/2011

Current Ratio (CA/CL)

2.5

2.5

Cash Flow to Current Liabilities (CFO/CL)

0.5

0.5

Long-Term Debt to Net Assets (TL-CL/NA)

1.1

0.8

Times Interest Earned (ER+Int/Int)

3.1

2.7

Net Assets to Total Assets (TE/TA)

42.9%

48.1%

Total Margin (ER/TR)

4.7%

4.1%

Return on Assets (ER/TA)

3.1%

3.0%

Operating Cash Flow to Assets (CFO/TA)

5.0%

5.4%

What is the immediate and long-term financial feasibility of the proposal? ss. 408.035(1)(f), Florida Statutes. A comparison of the applicant’s estimates to the control group values provides for an objective evaluation of financial feasibility, (the likelihood that the services can be provided under the parameters and conditions contained in Schedules 7 and 8), and efficiency, (the degree of economies achievable through the skill and management of the applicant). In general, projections that approximate the median are the most desirable, and balance the opposing forces of feasibility and efficiency. In other words, as estimates approach the highest in the group, it is more likely that the project is feasible, because fewer economies must be realized to achieve the desired outcome. Conversely, as estimates approach the lowest in the group, it is less likely that the project is feasible, because a much higher level of economies must be realized to achieve the desired outcome. These relationships hold true for a constant intensity of service through the relevant range of outcomes. As these relationships go 36

CON Action Number: 10208 beyond the relevant range of outcomes, revenues and expenses may, either go beyond what the market will tolerate, or may decrease to levels where activities are no longer sustainable. Comparative data were derived from hospitals in peer groups that reported data in 2012. The applicant will be compared to the hospitals in Peer Group 8 (Major Teaching Group). Peer Group 8 has a total of nine facilities including the applicant. Per diem rates are projected to increase by an average of 2.71 percent per year. Inflation adjustments were based on the new CMS Market Basket Price Index as published in the 3rd Quarter 2013 Health Care Cost Review. Projected net revenue per adjusted patient day (NRAPD) of $2,537 in year one and $2,613 in year two is between the control group median and highest values of $2,302 and $3,155 in year one and $2,363 and $3,239 in year two. NRAPD appears to be reasonable (see Table 2 below). The applicant’s NRAPD in 2012 was reported as $2,406. The difference in the NRAPD reported in 2012 and the year two projected NRAPD of $2,613 results in an average compound annual increase of approximately 1.7 percent. This level of increase is below the inflation percentage outlined in the CMS Market Basket, 3rd Quarter 2013, index. Revenues appear reasonable. Projected cost per adjusted patient day (CAPD) of $2,315 in year one and $2,385 in year two is between the control group median and highest values of $2,245 and $2,833 in year one, and $2,305 and $2,909 in year two. With CAPD between median and the highest in the Peer Group, costs are considered feasible (see Table 2 below). The applicant’s CAPD in year 2012 was reported as $2,225. The difference in the CAPD reported in 2012 and the year two projected CAPD of $2,385 results in an average compound annual increase of approximately 1.4 percent. This level of increase is below the inflation percentage outlined in the CMS Market Basket, 3rd Quarter, 2013, index. The year two operating profit for the hospital of $140.8 million computes to an operating margin per adjusted patient day of $228 (8.7 percent) which is between the peer group’s median and highest values of $181 and $430 respectively. The applicant reported an operating margin per adjusted patient day of $181 in 2012. Conclusion: This project appears to be financially feasible.

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CON Action Number: 10208

TABLE 2 Orlando Health, Inc. CON application# 10208 2012 DATA Peer Group 8 ROUTINE SERVICES INPATIENT AMBULATORY INPATIENT ANCILLARY SERVICES OUTPATIENT SERVICES TOTAL PATIENT SERVICES REV. OTHER OPERATING REVENUE TOTAL REVENUE DEDUCTIONS FROM REVENUE NET REVENUES EXPENSES ROUTINE ANCILLARY AMBULATORY TOTAL PATIENT CARE COST ADMIN. AND OVERHEAD PROPERTY TOTAL OVERHEAD EXPENSE OTHER OPERATING EXPENSE TOTAL EXPENSES OPERATING INCOME PATIENT DAYS ADJUSTED PATIENT DAYS TOTAL BED DAYS AVAILABLE ADJ. FACTOR TOTAL NUMBER OF BEDS PERCENT OCCUPANCY PAYER TYPE SELF PAY MEDICAID MEDICAID HMO MEDICARE MEDICARE HMO INSURANCE HMO/PPO OTHER

Dec-17 YEAR 2 ACTIVITY 918,773,841 0 3,678,261,223 2,811,991,850 7,409,026,914 94,487,338 7,503,514,252

YEAR 2 ACTIVITY PER DAY 1,489 0 5,960 4,556 12,005 153 12,158

5,890,913,148 1,612,601,104

9,545 2,613

* 3,239

* 2,363

* 1,971

301,733,539 496,725,216 0 798,458,755 499,905,047 173,450,683 673,355,730 0 1,471,814,485

489 805 0 1,294 810 281 1,091 0 2,385

568 1,604 0 0 0 0 1,383 0 2,909

397 839 0 0 0 0 1,007 0 2,305

278 544 0 0 0 0 366 0 2,009

140,786,619

228 8.7%

430

181

-554

378,109 617,169 616,850 0.6127 1,690 61.30% PATIENT DAYS 20,694 86,917 24,821 78,219 41,358 0 118,299 7,801

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VALUES ADJUSTED FOR INFLATION Highest Median Lowest 2,345 1,245 744 443 226 3 9,445 4,320 3,298 4,434 3,316 2,075 14,890 10,152 6,722 482 108 28 15,107 10,260 6,823

VALUES NOT ADJUSTED FOR INFLATION Highest Median Lowest 82.1% 65.7% 50.0% % TOTAL 5.5% 23.0% 6.6% 20.7% 10.9% 0.0% 31.3% 2.1%

35.6%

15.6%

1.1%

51.8%

33.5%

16.9%

31.0%

15.4%

5.5%

CON Action Number: 10208

e.

Will the proposed project foster competition to promote quality and cost-effectiveness? ss. 408.035(1)(g), Florida Statutes. Competition to promote quality and cost-effectiveness is driven primarily by the best combination of high quality and fair price. Competition forces health care facilities to increase quality and reduce charges/cost in order to remain viable in the market. Cost-effectiveness (as a result of competition) for transplant programs is limited on two fronts. First, from the payment perspective, the impact of competition on the price of services is limited to the payer type. Most consumers do not pay directly for hospital services rather they are covered by a third-party payer. The impact of price competition would be limited to third-party payers that negotiate price for services, namely managed care organizations. Therefore, price competition is limited to the share of patient days that are under managed care plans. From the facility’s perspective, incentive for cost-effectiveness is driven by the reimbursement rate. Currently, the fixed price payers’ (the majority payer) reimbursement does not cover the cost of providing the service. The difference is material and ensures that only large facilities with sufficient resources and economies of scale are able to absorb the losses generated by a transplant program over the long-term. Therefore, from the facility perspective, although cost-effectiveness may be impacted by this project, it is more likely to be driven by the facility’s need to reduce the gap between cost of service and the reimbursement rates rather than by competition. Florida Hospital (Orlando) is the sole licensed pediatric bone marrow plant program in Service Area 3. There are six licensed pediatric bone marrow transplant programs in the State of Florida. Transplant programs need to maintain a minimum level of procedures to remain proficient and ensure quality of outcomes. Therefore, these programs would need to attract a minimum number of patients. With the limits on price-based competition, these six programs would likely have to focus on promoting increased quality to differentiate themselves from one another in order to attract patients. Conclusion: Although price-based competition for the transplant program is limited, the potential for provider-based competition exists in this case due to a combination of the current regulatory environment and this project’s close proximity to an existing provider.

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CON Action Number: 10208 f.

Are the proposed costs and methods of construction reasonable? Do they comply with statutory and rule requirements? ss. 408.035(1)(h), Florida Statues and Ch. 59A-3 or 59A-4, Florida Administrative Code. The applicant proposes to develop a two-bed inpatient pediatric autologous and allogeneic bone marrow transplantation program at Arnold Palmer Medical Center. The proposed new service will be developed in an existing special care area of the second floor of the existing hospital. The project would include renovations to the two existing semi-private patient rooms to meet the combination airborne infection isolation/protective environment (AII/PE) rooms as required by the Guidelines for Design and Construction of Health Care Facilities. A small amount of laboratory space (approximately 280 square feet) will also be upgraded to provide on-site evaluation and cryopreservation on bone marrow. Plans indicate both BMT unit patient rooms will be accessed through an anteroom and exceed minimum size requirements. It appears that toilet/shower rooms have been design to meet accessibility requirements. For environmental control of the patient room, windows will be sealed with fixed sash to prevent infiltration of outside air. The narrative indicates that the HVAC system will be modified and will include the addition of HEPA filters serving these rooms and perhaps the entire unit. Exhaust will be provided to the outside for combination AII/PE. The air flow pattern will be in accordance with the requirements of the Guidelines for Design and Construction of Health Care Facilities. Schematic plans indicate proposed BMT unit patient rooms will utilize the existing nursing unit’s supports rooms, including nurse station, clean holding, soiled utility, med room, nourishment, equipment storage and conference/multi-purpose room. The schematic plans provide a current list of applicable codes including the National Fire Protection Association (NFPA) Life Safety Code and the Florida Building code. The estimated construction costs and project completion forecast appear to be reasonable. The plans submitted with this application were schematic in detail with the expectation that they will necessarily be revised and refined during the Design Development (Preliminary) and Contract Document Stages. 40

CON Action Number: 10208

The architectural review of the application shall not be construed as an in-depth effort to determine complete compliance with all applicable codes and standards. The final responsibility for facility compliance ultimately rests with the owner. g.

Does the applicant have a history of and propose the provision of health services to Medicaid patients and the medically indigent? Does the applicant propose to provide health services to Medicaid patients and the medically indigent? ss. 408.035(1)(i), Florida Statutes. Orlando Health, Inc. states it extends and will continue to extend services to all patients in need of care regardless of ability to pay or source of payment. The table below illustrates Orlando Health, Inc.’s Orlando Regional Medical Center FY 2012-2013 low-income pool (LIP) and disproportionate share hospital (DSH) program participation, as of August 22, 2013. Orlando Health, Inc./Orlando Regional Medical Center LIP and DSH Program Participation FY 2012-2013 Program LIP DSH

Annual Total Allocation $4,718,173 $4,417,440

Year-to-Date Total Allocation As of August 22, 2013 $4,718,173 $4,417,440

Source: Agency Division of Medicaid, Office of Program Finance.

The applicant does not propose to condition project approval to its provision of Medicaid, Medicaid HMO or charity/medically indigent care patient days. Orlando Health, Inc. d/b/a Arnold Palmer Medical Center has a history of serving the Medicaid population and the medically indigent. Orlando Health, Inc.’s (which includes Arnold Palmer Medical Center) provision of Medicaid and charity care is presented below. Orlando Health, Inc. d/b/a Arnold Palmer Medical Center & District 7 Medicaid and Charity Care FY 2012 Applicant and District 10 Orlando Regional Medical Center District 7 Average

Medicaid & Medicaid HMO Percentage 28.13% 17.50%

Source: Florida Hospital Uniform Reporting System data.

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Charity Percentage of Charges 4.44% 4.89%

Combined Medicaid & Charity Care 32.57% 22.39%

CON Action Number: 10208 Schedule 7A for the proposal shows the following projections: Medicaid at 73.0 percent for year one and 75 percent for years two and three; Medicaid/Medicaid HMO at six percent for year one and five percent for years two and three and “Other Managed Care” at 21 percent for year one and 20 percent for years two and three. Notes to the schedule indicate that charity care is reflected as self-pay for which the applicant does not allocate any patient days for the first three years of the proposed project. The applicant provides stated Medicaid and charity care data for FY 2011 and 2012 (see the table below). Indicator Medicaid Days Total Days Medicaid Percentage Charity Care Amount Hospital Net Revenue Charity Care Percentage*

2011

2012

119,165 450,225 26.5% $350,270,562 $1,487,173,069 23.6%

136,211 434,595 31.3% $461,965,675 $1,539,051.996 30.0%

* As a percent of Total Net Patient Revenue Source: CON application #10208, Volume 1, page 120.

F.

SUMMARY Orlando Health, Inc. d/b/a Arnold Palmer Medical Center (CON application #10208) proposes to establish a pediatric inpatient autologous and allogeneic bone marrow transplantation program at Arnold Palmer Medical Center, in Orlando (Orange County), Florida, Organ Transplant Service Area 3. Project costs total $956,589. The project involves 1,000 gross square feet (GSF) of renovation space (no new construction), with a construction cost of $734,100. Total project costs include building, equipment and project development costs. The applicant proposes to condition the project to a commitment to subsidize the stay at The Ronald McDonald house for any pediatric bone marrow transplant patient and/or their immediate family, in any case where the family cannot afford to pay for the stay. Orlando Health, Inc. will measure this condition by furnishing AHCA with annual statements reflecting the numbers and dollar amounts of free stays that it has paid for.

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CON Action Number: 10208

Need There is no fixed need pool publication for pediatric bone marrow transplantation programs. It is the applicant's responsibility to demonstrate the need for the project. There is currently one operational (Florida Hospital Orlando) and no CON approved pediatric bone marrow transplantation program in Service Area 3. The applicant projects 19, 20 and 20 pediatric inpatient bone marrow transplants, respectively, for the first three years of operation (CY 20162018). The applicant contends that the following reasons support the need for the project:  

    

Current and projected volume estimates and a high quality program are sufficient to support the proposed project Service Area 3 needs to assure residents of the service area of better access of the proposed service and related service modalities associated with a comprehensive pediatric bone marrow transplantation program A long-standing and unusually high level of patient outmigration to receive the proposed service The uncertain status of the only pediatric bone marrow transplantation program in Service Area 3 (Florida Hospital) and that hospital’s difficulty in sustaining such a program in the past Florida Hospital’s lack of a pediatric bone marrow transplant physician Area physicians who refer pediatric bone marrow transplantation patients do not refer them to Florida Hospital; and An expansion of both the service modalities and the treatable conditions associated with a pediatric bone marrow transplantation program.

Twenty support letters (including five area physicians) support the project. Seven of the 20 support letters were from family members of current or former area pediatric bone marrow transplantation patients and indicated financial, emotional, travel distance and continuity of care challenges that developed in the existing situation, due to having to seek service outside the local area.

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CON Action Number: 10208 The project will likely improve access in Service Area 3. During the 12-month period ending June 30, 2013, most Service Area 3 pediatric bone marrow transplantation residents received these procedures at All Children’s Hospital (a Service Area 2 provider). Quality of Care The applicant demonstrated it met the rule requirements per Rule 59C1.044, Florida Administrative Code, with regard to the provision of quality of care for transplant programs and also demonstrated quality of care measures and appropriate policies and protocols in most cases in existence or in development to accommodate the proposed project. Agency complaint data indicates that the applicant’s family of hospitals, cumulatively, had 31 substantiated complaints for the three-year period ending January 20, 2014 and Arnold Palmer Medical Center had five of these. The applicant is a quality care provider and demonstrated the ability to provide quality care. Cost/Financial Analysis Funding for this project and all capital projects should be available as needed. This project appears to be financially feasible. Although price-based competition for the transplant program is limited, the potential for provider-based competition exists in this case due to a combination of the current regulatory environment and this project’s close proximity to an existing provider. Medicaid/Charity Care Commitment Schedule 7A indicates Medicaid/Medicaid HMO will comprise 79 percent of the project’s total year one (CY 2016) patient days and 80 percent of the project’s total year two patient days. The applicant is a safety net provider and participates in both the state’s low income pool program and disproportionate share hospital program. Orlando Health, Inc. does not propose to condition project approval to its provision of Medicaid, Medicaid HMO or charity/medically indigent care patient days. 44

CON Action Number: 10208

Architectural Analysis The project calls for renovation to develop a two-bed inpatient pediatric autologous and allogeneic bone marrow transplantation program and also renovation of a small amount of laboratory space, at Arnold Palmer Medical Center. Project plans meet requirements of the Guidelines of Design and Construction of Health Care Facilities, the National Fire Protection Association Life Safety Code and the Florida Building Code, along with pressure and isolation requirements, accessibility requirements and any other applicable building code and related code requirements. The estimated construction costs and project completion forecast appear to be reasonable. G.

RECOMMENDATION Approve CON #10208 to establish a pediatric inpatient autologous and allogeneic bone marrow transplantation program in Transplant Service Area 3. The total project cost is $956,589. The project involves 1,000 GSF of renovation space and a construction cost of $734,100. CONDITION: The applicant proposes to condition the project to a commitment to subsidize the stay at The Ronald McDonald House for any pediatric bone marrow transplant patient and/or their immediate family, in any case where the family cannot afford to pay for the stay. Orlando Health, Inc. will measure this condition by furnishing AHCA with annual statements reflecting the numbers and dollar amounts of free stays that it has paid for.

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CON Action Number: 10208 AUTHORIZATION FOR AGENCY ACTION

Authorized representatives of the Agency for Health Care Administration adopted the recommendation contained herein and released the State Agency Action Report.

DATE:

James B. McLemore Health Services and Facilities Consultant Supervisor Certificate of Need

Jeffery N. Gregg Director, Florida Center for Health Information and Policy Analysis

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