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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: Ms. Kathy Swanson

Senior Vice President

Orlando Health, Inc. and

President, Arnold Palmer Medical Center

(321) 843-7000

2. 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

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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

1 Per their website at http://www.orlandohealth.com/arnoldpalmerhospital/HowardPhillipsCenter/HowardPhillipsCenter.aspx?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.

http://www.orlandohealth.com/arnoldpalmerhospital/HowardPhillipsCenter/HowardPhillipsCenter.aspx?pid=2656

http://www.orlandohealth.com/arnoldpalmerhospital/HowardPhillipsCenter/HowardPhillipsCenter.aspx?pid=2656


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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.

http://www.floridahealthfinder.gov/FacilityLocator/FacilityProfilePage.aspx

http://www.floridahealthfinder.gov/FacilityLocator/FacilityProfilePage.aspx


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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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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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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 OTSA* District Total Procedures

UF Health Shands Hospital 1 3 13

Baptist Medical Center Downtown 1 4 10

All Children’s Hospital 2 5 47

Florida Hospital 3 7 12

Jackson Memorial Hospital 4 11 22

Miami Children’s Hospital 4 11 15

Total 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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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 Hospitals

Arnold Palmer Medical Center*

UF Health

Shands Hospital

Baptist Medical Center

Downtown

All

Children’s Hospital

Florida

Hospital-Orlando

Jackson Memorial Hospital

Miami

Children’s Hospital

Arnold Palmer Medical Center 113 141 106 5.1 233 244

UF Health Shands Hospital 113 73 151 114 334 344

Baptist Med Center Downtown 141 73 221 137 343 353

All Children’s Hospital 106 151 221 147 264 262

Florida Hospital-Orlando 5.1 114 137 147 236 262

Jackson Memorial Hospital 233 334 343 264 236 9.4

Miami Children’s Hospital 244 344 353 262 262 9.4

Source: hppts://maps.google.com.

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 Hospital-

Orlando, 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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Transplant Service Area 3 Existing Provider and CON application #10208

Pediatric Inpatient Bone Marrow Transplant Programs

Source: MicroSoft MapPoint ® 2013.


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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) 2009 2010 2011 2012 2013 Total

UF Health Shands Hospital (TSA 1) 23 8 14 8 13 66

Baptist Med Center Downtown (TSA 1) 10 15 9 5 10 49

All Children’s Hospital (TSA 2) 53 41 30 35 47 206

Florida Hospital-Orlando (TSA 3) 1 1 1 16 12 31

Jackson Memorial Hospital (TSA 4) 1 3 22 10 22 58

Miami Children’s Hospital (TSA 4) 11 16 20 13 15 75

State Total 99 84 96 87 119 485 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 Hospital-

Orlando, 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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• 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

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

http://www.orlandohealth.com/orlandohealth/formedicalprofessionals/ped_res_faculty.aspx?pid=7034


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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 Brevard Lake Orange Osceola Seminole St. Lucie Volusia Total

All Children’s Hospital 6 1 4 4 0 0 3 18

Baptist MC Downtown 0 3 0 0 0 0 0 3

Florida Hospital 1 1 5 0 0 0 1 8

Jackson Memorial Hospital 0 0 0 0 0 2 0 2

Miami Children’s Hospital 0 0 0 0 0 0 0 0

Shands Hospital at UF 0 4 7 0 1 0 5 17

Total 7 9 16 4 1 2 9 48

% by County 14.6% 18.8% 33.3% 8.3% 2.1% 4.2% 18.8% 100.0% Source: CON application #10208, Volume 1, page 14.

Per the applicant, residents of Service Area 3 rely primarily on out-of-

area 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

Hospital Number Percent

All Children’s Hospital 18 37.5%

Shands Hospital at the University of Florida 17 35.4%

Florida Hospital 8 16.7%

Baptist Medical Center Downtown 3 6.3%

Jackson Memorial Hospital 2 4.2%

Total 48 100.0% 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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Pediatric BMT Outmigration Rates by Service Area Florida Residents

Calendar Year (CY) 2009-2012

% Outmigration by Service Area Year 2009 2010 2011 2012

SA 1 9% 13% 8% 8%

SA 2 0% 0% 20% 10%

SA 3 100% 91% 70% 56%

SA4 21% 8% 4% 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 Annual Average

All Children’s Hospital 41

Miami Children’s Hospital 15

Shands Hospital at UF 13

Jackson Memorial Hospital 12

Baptist Medical Center Downtown 10

Florida Hospital 6

Total 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


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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 Volume by Reporting Source

Hospital CON Office Discharge Data Difference % Difference

Jackson Memorial Hospital 20 7 13 65%

Florida Hospital 14 7 7 50%

Baptist Medical Center Downtown 5 4 1 20%

All Children’s Hospital 37 32 5 14%

Miami Children’s Hospital 10 10 0 0%

Shands Hospital at UF 8 10 -2 -25%

Total 94 70 24 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

Discharges by County of Residence

Hospital Brevard Orange Seminole Volusia SA 3 Total


Florida Hospital 1 2 1 4

Shands Hospital at UF 1 1

Total 2 2 1 4 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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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-of-

area 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

BMT Discharges 67

0-14 Population 3,287,056

Discharge Rate 2.04

2011

BMT Discharges 68


Discharge Rate 2.06

2012

BMT Discharges 70


Discharge Rate 2.11

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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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.


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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.


17

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 immuno-

suppressed 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


18

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 post-transplant 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 age-

appropriate 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.


19

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).


20

(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.


21

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,


22

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


23

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 decision-

making 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).

3 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.


24

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.


25

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.

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


26

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


27

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.

12. 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 59C-1.044(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


28

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).


29

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.


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.


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.


30

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:


31

Florida Pediatric Bone Marrow Transplantation Program Utilization July 1, 2012 – June 30, 2013

Hospital OTSA* District Total Procedures

UF Health Shands Hospital 1 3 13

Baptist Medical Center Downtown 1 4 10


Florida Hospital 3 7 12

Jackson Memorial Hospital 4 11 22

Miami Children’s Hospital 4 11 15

Total 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 (ICD9-

41.00 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 Total Procedures Percentage

All Children’s Hospital 7 58.33%

Florida Hospital 2 16.67%

Shands Hospital at UF 2 16.67%

Baptist Medical Center Downtown 1 8.33%

Total Procedures 12 100.0% 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.


32

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)


33

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

Health Central

Total = 7

South

Seminole Hospital

Total = 7

Arnold Palmer Medical Center

Total = 5

South Lake

Hospital

Total = 5

Orlando Regional Medical Center

Total = 4

Dr. P. Phillips Hospital

Total = 3

Quality of Care/Treatment 2 2 1 2 2 1

Resident/Patient/Client Rights 1 1 1 1 1 0

Nursing Services 1 0 1 1 0 1

Resident/Patient/Client Assessment 1 0 0 1 1 1

Admission, Transfer & Discharge Rights 0 1 1 0 0 0

Physician Services 1 1 0 0 0 0

Admission/Personnel 0 0 1 0 0 0

Emergency Access 0 1 0 0 0 0

Infection Control 1 0 0 0 0 0

Resident/Patient/Client Abuse 0 1 0 0 0 0 Source: Agency for Health Care Administration Complaint Review Records.

The applicant demonstrates the ability to provide quality care.


34

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


35

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).


d/b/a Arnold Palmer Medical Center Pediatric Bone Marrow Transplantation Program

Staffing Patterns Year One

Ending 12/31/16

Year Two Ending

12/31/17

Year Three Ending

12/31/15

NURSING

Registered Nurses (RNs) 7.3 7.3 7.3

Other: Med Assistant/Nurse Practitioner 1.0 1.0 1.0

ANCILLARY

Other 0.5 0.5 0.5

SOCIAL SERVICES

Licensed Clinical Social Worker (LCSW) 0.5 0.5 0.5

TOTAL 9.3 9.3 9.3 Source: CON application #10208, Schedule 6A.

Conclusion:

Funding for this project and all capital projects should be available as

needed.


36

TABLE 1

CON application #10208: Orlando Health, Inc. d/b/a Arnold Palmer Medical Center

9/30/2012

9/30/2011

Current Assets $704,660,000

$606,109,000

Cash and Current Investment $63,406,000

$47,159,000

Due from Memorial Healthcare System $0

$0

Total Assets

$2,640,111,00

0

$2,158,829,00

0

Current Liabilities $285,612,000

$243,325,000

Total Liabilities

$1,507,268,00

0

$1,120,026,00

0

Net Assets

$1,132,843,00

0

$1,038,803,00

0

Total Revenues

$1,743,702,00

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

Cash Flow from Operations $132,974,000

$116,325,000

Working Capital $419,048,000

$362,784,000

FINANCIAL RATIOS

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%

d. 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


37

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.


38

TABLE 2


CON application# 10208 Dec-17 YEAR 2

VALUES ADJUSTED

2012 DATA Peer Group 8 YEAR 2 ACTIVITY

FOR INFLATION

ACTIVITY PER DAY

Highest Median Lowest

ROUTINE SERVICES 918,773,841 1,489

2,345 1,245 744

INPATIENT AMBULATORY 0 0

443 226 3

INPATIENT ANCILLARY SERVICES 3,678,261,223 5,960

9,445 4,320 3,298

OUTPATIENT SERVICES 2,811,991,850 4,556

4,434 3,316 2,075

TOTAL PATIENT SERVICES REV. 7,409,026,914 12,005

14,890 10,152 6,722

OTHER OPERATING REVENUE 94,487,338 153

482 108 28

TOTAL REVENUE 7,503,514,252 12,158

15,107 10,260 6,823

DEDUCTIONS FROM REVENUE 5,890,913,148 9,545

* * *

NET REVENUES 1,612,601,104 2,613

3,239 2,363 1,971

EXPENSES

ROUTINE 301,733,539 489

568 397 278

ANCILLARY 496,725,216 805

1,604 839 544

AMBULATORY 0 0

0 0 0

TOTAL PATIENT CARE COST 798,458,755 1,294

0 0 0

ADMIN. AND OVERHEAD 499,905,047 810

0 0 0

PROPERTY 173,450,683 281

0 0 0

TOTAL OVERHEAD EXPENSE 673,355,730 1,091

1,383 1,007 366

OTHER OPERATING EXPENSE 0 0

0 0 0

TOTAL EXPENSES 1,471,814,485 2,385

2,909 2,305 2,009

OPERATING INCOME 140,786,619 228

430 181 -554

8.7%

PATIENT DAYS 378,109

ADJUSTED PATIENT DAYS 617,169

TOTAL BED DAYS AVAILABLE 616,850

VALUES NOT ADJUSTED

ADJ. FACTOR 0.6127

FOR INFLATION

TOTAL NUMBER OF BEDS 1,690

Highest Median Lowest

PERCENT OCCUPANCY 61.30%

82.1% 65.7% 50.0%

PAYER TYPE PATIENT DAYS % TOTAL

SELF PAY 20,694 5.5%

MEDICAID 86,917 23.0%

35.6% 15.6% 1.1%

MEDICAID HMO 24,821 6.6%

MEDICARE 78,219 20.7%

51.8% 33.5% 16.9%

MEDICARE HMO 41,358 10.9%

INSURANCE 0 0.0%

HMO/PPO 118,299 31.3%

31.0% 15.4% 5.5%

OTHER 7,801 2.1%


39

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.


40

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.


41

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

Annual Total Allocation

Year-to-Date Total Allocation

As of August 22, 2013

LIP $4,718,173 $4,718,173

DSH $4,417,440 $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

Medicaid & Medicaid HMO

Percentage

Charity Percentage of

Charges

Combined Medicaid &

Charity Care

Orlando Regional Medical Center 28.13% 4.44% 32.57%

District 7 Average 17.50% 4.89% 22.39% Source: Florida Hospital Uniform Reporting System data.


42

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 2011 2012

Medicaid Days 119,165 136,211

Total Days 450,225 434,595

Medicaid Percentage 26.5% 31.3%

Charity Care Amount $350,270,562 $461,965,675

Hospital Net Revenue $1,487,173,069 $1,539,051.996

Charity Care Percentage* 23.6% 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.


43

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 2016-

2018). 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.


44

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 59C-

1.044, 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.


45

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.


46

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

state agency action report - the agency for health care...

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