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LIFEMARK HOSPITALS OF FLORIDA, INC., D/B/A PALMETTO GENERAL HOSPITAL vs AGENCY FOR HEALTH CARE ADMINISTRATION, 01-000357CON (2001)

Court: Division of Administrative Hearings, Florida Number: 01-000357CON Visitors: 21
Petitioner: LIFEMARK HOSPITALS OF FLORIDA, INC., D/B/A PALMETTO GENERAL HOSPITAL
Respondent: AGENCY FOR HEALTH CARE ADMINISTRATION
Judges: ELEANOR M. HUNTER
Agency: Agency for Health Care Administration
Locations: Tallahassee, Florida
Filed: Jan. 26, 2001
Status: Closed
Recommended Order on Monday, April 14, 2003.

Latest Update: Oct. 10, 2003
Summary: Whether the adult open heart surgery rule in effect at the time the applications were filed until January 24, 2002, or the rule as amended on that date applies to this case. Whether either or both, Lifemark Hospital of Florida, Inc., d/b/a Palmetto General Hospital ("Palmetto General") and Miami Beach Healthcare Group, Ltd., d/b/a Aventura Hospital and Medical Center ("Aventura Hospital") demonstrated the existence of not normal circumstances for the issuance of certificates of need ("CONs") to
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01-0357.PDF

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS


LIFEMARK HOSPITALS OF FLORIDA, ) INC., d/b/a PALMETTO GENERAL ) HOSPITAL, )

)

Petitioner, )

)

vs. ) Case No. 01-0357

)

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Respondent, )

)

and )

) MIAMI BEACH HEALTHCARE GROUP, ) LTD., d/b/a AVENTURA HOSPITAL ) AND MEDICAL CENTER and MOUNT ) SINAI MEDICAL CENTER OF )

FLORIDA, INC., )

)

Intervenors. )

) MOUNT SINAI MEDICAL CENTER OF ) FLORIDA, INC., )

)

Petitioner, )

)

vs. ) Case No. 01-0358

)

AGENCY FOR HEALTH CARE ) ADMINISTRATION and LIFEMARK ) HOSPITALS OF FLORIDA, INC., ) d/b/a PALMETTO GENERAL HOSPITAL, )

)

Respondents. )

)

MIAMI BEACH HEALTHCARE GROUP, ) LTD, d/b/a AVENTURA HOSPITAL AND ) MEDICAL CENTER, )

)

Petitioner, )

)

vs. ) Case No. 01-0359

)

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Respondent, )

)

and )

) LIFEMARK HOSPITALS OF FLORIDA, ) INC., d/b/a PALMETTO GENERAL ) HOSPITAL, )

)

Intervenor. )

)


RECOMMENDED ORDER


Pursuant to notice, the Division of Administrative Hearings, by its designated Administrative Law Judge, Eleanor M. Hunter, held a final hearing in the above-styled case on August 13-16, August 19-23, August 26-30, and September 11-12, 2002, in Tallahassee, Florida.

APPEARANCES


For Petitioner Lifemark Hospitals of Florida, Inc., d/b/a Palmetto General Hospital:


C. Gary Williams, Esquire Michael J. Glazer, Esquire Ausley & McMullen

227 South Calhoun Street Post Office Box 391 Tallahassee, Florida 32302

For Petitioner Mount Sinai Medical Center of Florida, Inc.:


Geoffrey D. Smith, Esquire Sandra L. Schoonover, Esquire Blank, Meenan & Smith, P.A.

204 South Monroe Street Post Office Box 11068

Tallahassee, Florida 32302-3068


For Petitioner Miami Beach Healthcare Group, Ltd, d/b/a Aventura Hospital and Medical Center:


Stephen A. Ecenia, Esquire

R. David Prescott, Esquire

Rutledge, Ecenia, Purnell & Hoffman, P.A.

215 South Monroe Street, Suite 420 Post Office Box 551

Tallahassee, Florida 32302-0551

For Respondent Agency for Health Care Administration: Michael O. Mathis, Esquire

Agency for Health Care Administration

2727 Mahan Drive

Building Three, Suite 3431 Tallahassee, Florida 32308-5403


STATEMENT OF THE ISSUES


  1. Whether the adult open heart surgery rule in effect at the time the applications were filed until January 24, 2002, or the rule as amended on that date applies to this case.

  2. Whether either or both, Lifemark Hospital of Florida, Inc., d/b/a Palmetto General Hospital ("Palmetto General") and Miami Beach Healthcare Group, Ltd., d/b/a Aventura Hospital and Medical Center ("Aventura Hospital") demonstrated the existence of not normal circumstances for the issuance of certificates of

need ("CONs") to establish adult open heart surgery programs in Dade County.

PRELIMINARY STATEMENT


In September 2000, Aventura Hospital and Palmetto General each filed an application for a CON to establish an additional adult open heart surgery program in Agency for Health Care Administration ("AHCA") District 11, for Dade and Monroe Counties, Florida. In December 2000, AHCA issued a State Agency Action Report ("SAAR") preliminarily denying both applications. That decision was published in the Florida Administrative Weekly, Volume 26, Number 52, on December 29, 2000.

Aventura Hospital and Palmetto General timely filed petitions for formal administrative proceedings to contest AHCA's decision. Palmetto General's petition was assigned Division of Administrative Hearings ("DOAH") Case No. 01-0357CON; and Aventura Hospital's petition was assigned DOAH Case No. 01- 0359CON. Mount Sinai Medical Center of Florida, Inc., d/b/a Mount Sinai Medical Center ("Mount Sinai"), an existing provider of open heart surgery in the same district, timely filed a petition to intervene in DOAH Case No. 01-0357CON, which was granted, and a separate petition in support of the denial of the Palmetto General application, which was assigned DOAH Case No.

01-0358CON. AHCA requested and DOAH assigned an administrative

law judge to conduct the hearing which was held from August 13 through September 12, 2002, in Tallahassee, Florida.

At the hearing, Aventura presented the testimony of


Kevin Coy, M.D., expert in cardiology, interventional cardiology, and internal medicine; David Carbone, expert in hospital administration; David L. Galbut, M.D., expert in cardiovascular and thoracic surgery; James E. Provo, M.D., expert in emergency medicine; Cynthia Boily, R.N., expert in nursing, nursing administration, and nursing education; Marilyn Zitzke, expert in health care consulting to initiate open heart surgery programs; Matt Harrell, expert in health care architecture; W. Eugene Nelson, expert in health care planning with an emphasis on open heart surgery program planning; Robert Beiseigel, expert in health care finance; and David Pfeil, expert in Medicare disproportionate share reimbursement. Aventura Hospital's Exhibits 1-12, 14-25, 27, 28, 33-36, 38-58, and 60-71 were

received in evidence.


Palmetto General presented the testimony of Ralph Aleman, expert in health care facility administration; Eugene Letourneau, expert in emergency nursing and emergency nursing management; Benjamin Rodriguez, R.N., expert in nursing and nursing administration; Jose Pinero, M.D., expert in clinical cardiology and internal medicine; Yescinia Perez, expert in hospital social work; Charles W. Cole, Jr., expert in health care facilities

architecture and construction cost estimates; Manuel Mayor, M.D., expert in cardiology and interventional cardiology;

Patricia Greenberg, expert in health care planning and health care finance; Alex Contreras-Soto; and Robert J. Greene, expert in health care planning. Palmetto General's Exhibits 1-29,

    1. , 45, and 47 were received in evidence.


      Mount Sinai presented the testimony of Donald Williams, M.D., expert in cardiothoracic surgery; James Jollis, M.D., expert in cardiology, internal medicine and clinical research; Edward Hengtgen, expert in architecture including health care architecture; Steve Sklavonous; Mark Richardson, expert in health care planning; Rick Knapp, expert in health care finance and financial feasibility analysis, and Robert J. Greene. Mount Sinai's Exhibits 1-7 and 9-43 were received in evidence.

      AHCA presented the testimony of Jeffrey Gregg, expert in health care planning and CON review. AHCA Exhibits 1 and 2 were received in evidence.

      On October 8, 2002, counsel for Aventura Hospital filed a Motion for Official Recognition of Final Order in DOAH Case Nos. 01-2891CON and 01-2892CON, which was styled Columbia Hospital Corporation of South Broward, d/b/a Westside Regional Medical Center vs. AHCA. Palmetto's Response in Opposition, filed on October 15, 2002, asserted that Aventura Hospital's Motion was, in effect, a motion to reopen the record and to receive

      additional evidence. The Motion for Official Recognition is granted. See generally Health Quest Realty XII v. Department of

      Health and Rehabilitative Services, 477 So. 2d 576, 577 n. 3 (Fla. 1st DCA 1985); Section 90.202(5), Florida Statutes.

      The last volume of the transcript of the final hearing was filed October 18, 2002. After a Joint Unopposed Motion for Extension of Time to File Proposed Recommended Orders (PROs) was granted on December 6, 2002, the PROs were filed on January 17, 2003.

      FINDINGS OF FACT


      1. The Agency for Health Care Administration ("AHCA") administers the certificate of need ("CON") program for health care facilities and services in Florida. Section 408.034, Florida Statutes.

        Aventura Hospital


      2. Miami Beach Healthcare Group, Ltd., d/b/a Aventura Hospital and Medical Center ("Aventura Hospital") is the applicant for CON No. 9395 to establish an adult open heart surgery program in Dade County, in AHCA District 11. Aventura Hospital is a 407-bed community hospital located in the recently incorporated City of Aventura in northeast Dade County. It is approximately one mile west of the Atlantic Ocean on U.S. Highway 1, three-tenths of a mile south of the Broward/Dade County line. It is halfway between Fort Lauderdale and downtown Miami.

      3. Aventura Hospital is owned by the Hospital Corporation of America ("HCA"), which operates hospitals in 30 states and 3 countries, including 40 hospitals in Florida.

      4. The 407 beds at Aventura Hospital include 327 acute care beds, 32 adult psychiatric beds, 24 adult substance abuse beds, and 24 obstetrics beds. Services, in addition to those provided in the specialty beds, include general medical/surgical services, oncology, a breast diagnostic center, children's after-hours walk in clinic, comprehensive cancer center, dialysis, intensive care, orthopedics, inpatient and outpatient surgery, and physical, speech and occupational therapies. It is a Baker Act facility.

      5. The Aventura Hospital staff has from 700 to 750 medical doctors, and 1,200 to 1,300 employees. The emergency room ("ER") has approximately 34,000 annual visits. According to one ER physician on the staff, the average age of patients presenting at the Aventura Hospital ER is 84 years old. That results in a higher than average hospital admission rate from the ER, 35 to 40 percent, as compared to 15 percent nationally.

      6. The staff includes 52 clinical cardiologists, 27 invasive cardiologists and five cardiovascular thoracic surgeons. They currently perform, at Aventura Hospital, inpatient and outpatient cardiac catheterizations ("caths"), pacemaker implants, echocardiograms, cardiac stress and cardiac nuclear testing, diagnostic and transesophageal echocardiograms,

        diagnostic and interventional vascular surgeries. For the 12 months ending June 30, 2001, 422 open heart patients left the Aventura Hospital's primary service area for their surgeries, and 1,132 received cardiac cath procedures. At Aventura Hospital, from April 1999 through March 2000, 178 diagnostic cardiac caths were performed. In terms of total cardiology services, Aventura Hospital is the largest non-open heart provider in the District, ranking second to Mount Sinai Medical Center ("Mount Sinai"). In calendar year 2001, there were 3,489 cardiovascular disease discharges from Aventura Hospital.

      7. The boundaries of the primary service area, from which Aventura Hospital draws most of its patients, are Hollywood Boulevard to the north, U.S. Highway 441 to the west, the Bal Harbour/Miami Shores communities near 125 Street to the south and the Atlantic Ocean to the east. Parkway Regional Medical Center ("Parkway Regional") in Dade County, and Memorial Regional Medical Center ("Memorial Regional") in Hollywood, in Broward County, are the closest hospitals to Aventura Hospital. The primary service area has a population of approximately 250,000 residents and includes growing retirement communities such as Sunny Isles Beach, Hallandale Beach, Southeast Hollywood, North Miami Beach, part of Miami Shores, and Bal Harbour. Parkway Regional and Aventura reported a combined total of 1,721 ischemic heart diseases (IHD) discharges in calendar year 2000. IHD is

        the diagnostic category for patients experiencing a narrowing of the arteries who are most likely ultimately to require open heart surgery.

      8. An international patient services department at Aventura Hospital assists patients, particularly from Canada, and Central and South America. Aventura Hospital is a member of the Miami Medical Alliance, also known as Salud Miami, which has promoted Miami as a destination for health care. Miami Heart Institute (Miami Heart), Mount Sinai, Baptist Hospital (Baptist), South Miami Hospital (South Miami), Miami Children's Hospital and Jackson Memorial Hospital (Jackson Memorial) are among the members of the Alliance.

      9. At the time the CON application was filed, Aventura Hospital was scheduled for expansion with the addition of a

        three-story tower and other capital projects costing an estimated


        $50 million. Subsequently, in December 2001, Aventura Hospital received approval from HCA for the expenditure of an additional

        $80 million to build the tower up to nine stories immediately, with the structure capable of ultimately being increased to 12 stories. It is expected to be able to withstand a direct hit from a Class V hurricane. In the past, Aventura Hospital has been entirely evacuated twice due to hurricane warnings.

      10. When construction is complete, the ER will be approximately three times larger, relocated to the first floor of

        the new tower, and projected to receive 50,000 visits annually. Ten new operating rooms on the second floor will include two that are properly-sized for cardiovascular surgeries. Because of higher ceilings in the new tower, the second floor of the new building will connect to the third floor of the existing building, on which the cardiac cath lab and related diagnostic equipment is located. If the open heart program is approved, a ten-bed cardiovascular intensive care unit ("CVICU") will be added to the second floor of the new building, and a second cardiac cath lab will be constructed. A dedicated elevator will connect the surgery suites to a 42-bed intensive care unit ("ICU") on the third floor. The remaining floors will consist of single patient rooms equipped or capable of being equipped for telemetry monitoring. The projected building cost for the portion of the construction related to the open heart surgery program is $3 million.

      11. Mount Sinai which purchased Miami Heart from HCA, has agreed to close one of its two open heart surgery programs within one year following the issuance of an adult open heart surgery CON to Aventura Hospital. Otherwise, Mount Sinai is committed to operate both programs for five years from June 30, 2000.

        Jeffrey Gregg, the head of the CON program at AHCA testified that he believes that it is "unprecedented" for an applicant to submit a letter from an existing provider committing to close a program.

        (Tr. 3061). Aventura Hospital has also offered to commit to providing 2.5 percent of the patient days generated by the adult open heart surgery program to Medicaid and charity patients.

        Palmetto General


      12. Lifemark Hospitals of Florida, Inc., d/b/a Palmetto General Hospital ("Palmetto General") is an applicant for CON No. 9394 to establish an adult open heart surgery program, also in Dade County, AHCA District 11. Palmetto General is a 360-bed acute care hospital located in the City of Hialeah in northwest Dade County at the intersection of 122nd Street, Northwest, and the Palmetto Expressway.

      13. Palmetto General is an affiliate of the Tenet Health Care Corporation ("Tenet"), which operates 16 hospitals in Florida, five in Dade County. They are, in addition to Palmetto General, Hialeah Hospital, North Shore Medical Center, Parkway Regional in northern communities, and Coral Gables Hospital in the south. Tenet owns Florida Medical Center, which has an adult open heart surgery program in Broward County. Tenet also operates the open heart program at the Cleveland Clinic in Broward County.

      14. The 360 beds at Palmetto General are divided into 253 acute care beds (excluding obstetrics and pediatrics), 48 adult psychiatric beds, and 10 neonatal intensive care beds. Services available on the Palmetto General campus include outpatient

        imaging and surgery, psychiatry, oncology, rehabilitative therapies, and intensive care.

      15. Palmetto General has a staff of 600 physicians, 350 of whom are on the active staff, and 1,500 employees.

      16. Palmetto General has approximately 40 cardiologists on staff, 19 of whom are invasive cardiologists. The services available include ultrasound, exercise testing, arrhythmia studies, including halter monitoring and electrophysiology, surgical insertions of pacemakers and defibrillators, and diagnostic cardiac caths. For the 12 months ending June 30, 2001, 1,658 cardiac caths and 668 open heart procedures were performed on patients from the Palmetto General primary service area. At Palmetto General, there were 528 diagnostic cardiac caths performed from April 1999 through March 2000, making it the largest cardiac cath provider in Dade County, which does not also have an open heart program. In calendar year 2001, there were 3,089 cardiovascular disease discharges from Palmetto General.

      17. The primary service area for Palmetto General includes the communities of Hialeah, Hialeah Springs, Miami Lakes, and portions of Opa Locka. Approximately 450,000, or 22 percent of the 2.2 million people living in District 11, live in the Hialeah area, over 50,000 are over 65 years old. The 65 and older population in the Palmetto General primary service area is projected to increase by 10 percent by 2005. Seventy to 80

        percent of the residents of Palmetto General's primary service area are Hispanic, many first-generation. Most of the staff and employees of Palmetto General are Hispanic or speak Spanish. In addition to Palmetto General, the primary service area includes two other hospitals, Hialeah Hospital and Palm Springs General Hospital ("Palm Springs General"). Of the three, only Palmetto General has a cardiac cath lab.

      18. About 400 suspected heart attack patients are treated in the ER at Palmetto General each year. The ER has approximately 60,000 annual visits. It is the third busiest ER in the county. Although the use rate for open heart surgery has been flat or declining throughout the district, it has increased in the Palmetto General service area. While District 11 had an absolute increase of 51 open heart cases from 1999 to 2000, there was a 91-case increase in the Palmetto General service area. Together Palmetto General, Hialeah Hospital, and Palm Springs reported 2,206 IHD discharges, 982 of those from Palmetto General.

      19. Subsequent to filing the open heart CON application, Palmetto General developed a $23 million master facility plan of capital expenditures to upgrade the facility in response to operational deficiencies and capacity constraints. Tenet approved the expenditure of $6 million in the first year. When entirely implemented, the plan will result in doubling the size

        of the ER, expanding maternity labor and delivery areas, building a new 18-bed intensive care unit with space to add ten more beds later, and refurnishing existing operating rooms and adding three more. Palmetto General also, in 2002, experienced significant discord among the medical staff which apparently has been resolved with a change in the hospital's senior management.

      20. Palmetto General maintains that its master facility plan is independent of its plans for an open heart surgery program, although the master plan supports and facilitates that proposal. Mount Sinai and Aventura Hospital contend that Palmetto General has impermissibly amended the architectural plans for the open heart surgery program. The plans, as submitted in the CON, showed the addition of two open heart operating rooms on the ground floor, with an area of shelled-in space, and mechanical/electrical space, and part of the roof, above that on the first floor, and an elevator and corridor on the second floor within the same area designated as being within the scope of work. A separate area of work, on the schematic drawing of the second floor, showed a four-bed CVICU.

      21. On the master facility plan, the two open heart surgery operating rooms are in the same location but reconfigured. The space above is still shown as shelled-in and it may have columns. On the second floor, the four-bed CVICU for open heart patients is no longer a separate unit but is included in an existing ten-

        bed CVICU. The CVICU is adjacent to the existing cardiac cath lab and to an area shown for cath lab expansion, previously a part of the roof on the CON drawing. As a result of the use of the existing space for the CVICU, the total area devoted to the open heart program is reduced in size. Although the two open heart operating rooms are reconfigured and the four-bed open heart CVICU will not be an entirely separate unit, the concept for the open heart surgery program is essentially unchanged.

        Construction detailed drawings of the master plan were expected to be completed in January 2003.

      22. If the open heart surgery program CON is approved, Palmetto General will commit to providing 7.5 percent of open heart and angioplasty services to Medicaid and charity care patients.

        Existing District 11 Providers


      23. Baptist, Cedars Medical Center ("Cedars"), Jackson Memorial, Mount Sinai, Miami Heart, Mercy Hospital ("Mercy"), South Miami, and Kendall Medical Center ("Kendall") are the eight hospitals in Dade County which have open heart surgery programs. Mount Sinai and Miami Heart are, as previously noted, both owned by Mount Sinai. They are located within two miles of each other on Miami Beach, near the Julia Tuttle Causeway. Jackson Memorial which, like Mount Sinai, is a University of Miami Medical School teaching hospital is located in downtown Miami, across the street

        from Cedars and near Mercy. Kendall is further south and west. South Miami and Baptist are in South Central Dade County.

      24. In the summer and fall of 2000, when AHCA published the fixed need pool, and Aventura Hospital and Palmetto General filed their applications, four of the eight open heart programs in Dade County were operating at volumes below 350 cases a year. In 1999, those programs and volumes were Cedars, with 340 surgeries, Jackson Memorial with 332, South Miami at 211, and Kendall with

187. In 2001, Cedars increased to 361 open heart cases and Jackson Memorial reported 513. The programs at Kendall and South Miami have continued to operate below 350 cases a year. The volume at Kendall was 184 in 2000, and 295 in 2001. South Miami reported 175 and 148 in calendar years 2000 and 2001, respectively. Like Aventura Hospital, Cedars, and Kendall are owned by HCA. South Miami and Baptist Hospital, which are 3.5 miles apart, are both affiliated with the Baptist health care system.

  1. Because volumes were below 350 at existing programs, AHCA published a numeric need for zero additional programs in District 11 for the January 2003 planning horizon. The rule on numeric need, as revised on January 24, 2002, reduced the minimum volume for existing providers to 300 open heart surgeries for the 12-month period specified in the rule, although it implicitly increased the expected size of each existing program to 500 cases

    by increasing the divisor in the numeric need formula. Under either rule, the applicants must demonstrate the existence of not normal circumstances for the approval of any additional open heart surgery programs in the district. Under the old rule, with

    350 as the divisor in the formula, the numeric calculation, before being reduced to zero because of low volume programs, resulted in a need for 2.1 additional programs. That number is a negative one under the new rule.

  2. Aventura Hospital projected that its open heart surgery volumes would be 240, 312, and 347 during the first three years of operations, anticipating these to be the years ending in September of 2004, 2005, and 2006, respectively. Palmetto General projected volumes of 148, 210, and 250 open heart surgeries and 225, 230, and 310 angioplasties, in the first three years.

  3. From 1996 to 2001, the total annual volume of open heart surgeries in District 11 declined by 346, from 3,821 in 1996, to 3,421 in 2000, then increased slightly to 3,475 in 2001. Therefore, if Aventura Hospital and Palmetto General achieve projected volumes, it will result largely from redirecting cases from existing providers including one that would close if Aventura's CON is approved. The declining open heart volumes also reflects a technological improvements and a shift to less invasive angioplasty procedures. The number of angioplasties

    performed in District 11 increased from 6,384 in 2000, to 7,682


    in 2001.


    Mount Sinai and Miami Heart


  4. Mount Sinai is one of six statutory teaching hospitals in Florida, with 19 accredited training programs, including residencies and fellowships. The cardiovascular and thoracic surgery residency program is shared with Jackson Memorial. In addition to the University of Miami, Mount Sinai is affiliated with the medical schools at Nova Southeastern University, Barry University, and the University of South Florida. Mount Sinai has the largest open heart volume in District 11, with over 40 percent of the total volume. It also has the broadest geographical draw for patients, with only 60 percent of the cases originating from the District. In the year from April 1999 to March 2000, Mount Sinai reported performing 1,034 adult open heart surgeries and 4,318 adult inpatient cardiac caths. In calendar years 2000 and 2001, the volume of open heart surgeries at Mount Sinai remained virtually constant at 980 and 976, respectively. Angioplasties increased during that same period of time from 1,037 to 1,067.

  5. At Miami Heart, from April 1999 through March 2000, 483 open heart surgeries and 4,179 cardiac caths were performed. The combined total of therapeutic cardiac caths or angioplasties performed at Mount Sinai and Miami Heart is approximately 2,500 a

    year. There is evidence that Mount Sinai has begun to phase-out open heart cases at Miami Heart where the volume dropped to 390 surgeries in 2000, and to 296 in 2001.

  6. In a travel time study commissioned by Mount Sinai, the drive time from Palmetto General ER to Mount Sinai ER was 28 minutes to travel the 15.5 miles. From various zip codes within the Palmetto General service area to the Mount Sinai ER, travel times ranged from 14 minutes to 36 minutes. Driving times from Aventura to Mount Sinai ranged from 18 to 37 minutes. Due to its close proximity, to Mount Sinai, it reasonably should take approximately the same driving time to reach Miami Heart.

  7. In an Aventura Hospital survey of transfers of high- risk cardiac patients, the average times were estimated to range from 59 minutes from Aventura Hospital to Mount Sinai and 1 hour and 26 minutes from Aventura Hospital to Miami Heart Institute. Those times must include more than actual drive time, otherwise the differences between Mount Sinai and Miami Heart would not be so significant. One would also anticipate that, while under common ownership, transfers from Aventura Hospital to Miami Heart would have been less cumbersome. The accompanying narrative in the CON suggests that time frames may have been counted from the time the decision to transfer is made to the time the patient arrives at the receiving facility. The testimony regarding the data compilation process was vague and inadequate and, therefore,

    the conclusions are unreliable. The Mount Sinai study showed travel times of 27 minutes to Miami Heart and 28 minutes to Mount Sinai from Palmetto General. That difference of one minute is confirmed in data underlying Aventura Hospital time travel study.

  8. Based on projected volumes, prior transfers, referral patterns and market shares, an open heart program at Palmetto General will reduce the volumes at Mount Sinai and Miami Heart by

    92 to 107 open heart surgeries a year, for a financial loss of


    $1.6 million. An open heart program at Aventura is expected to reduce the combined volume at Mount Sinai and Miami Heart by 196 cases. A combined reduction of approximately 300 cases and the closure of one of the programs would leave the remaining Mount Sinai program at approximately 900 open heart cases, with a loss of $4.7 million. Mount Sinai was projected to experience a net loss from operations of $32 million in 2002. There was testimony that overall financial management and the potential for profitable operations have improved.

  9. Despite the fact that an Aventura program will have almost double the adverse impact of one at Palmetto General, Mount Sinai, in the asset purchase agreement resulting in its acquisition of Miami Heart from HCA, agreed not to contest the application filed by Aventura Hospital.

    Jackson Memorial


  10. Jackson Memorial is the hospital designated to provide indigent care in Dade County, through a public health trust funded by a portion of sales taxes. In the 12 months ending March 2000, 334 open heart surgeries and 3,644 cardiac caths were performed at Jackson Memorial. In 2000 and 2001, the open heart volume increased to 438 and 513 surgeries, respectively.

  11. The Mount Sinai travel time study, showed that the distance from Palmetto General to Jackson Memorial was 10.7 miles and that the average drive took 22 minutes.

  12. Jackson Memorial will lose an estimated 46 cases to Palmetto General, in the third year of an open heart program in 2004, and 12 cases to an Aventura Hospital program, or a combined total of approximately 60 cases a year.

    Mercy


  13. Mercy had a volume of 412 open heart surgeries and 2,704 cardiac caths, from April 1999 through March 2000. In calendar year 2000 and 2001, the open heart volumes at Mercy were

    492 and 478, respectively.


  14. The average driving time from Palmetto General to Mercy ranged from 24 minutes to 38 minutes, averaging 27 minutes in Mount Sinai's expert's study.

  15. If Palmetto General is approved, a reduction of 44 open heart cases is expected at Mercy. An Aventura Hospital program is expected to result in a five-case reduction at Mercy.

    Cedars


  16. The volume at Cedars was 316 open heart cases from April 1999 through March 2000. In calendar years 2000 and 2001, the volume increased to 334 and 361 open heart surgeries, and to 1,323 and 1,468 angioplasties, respectively.

  17. The average driving time to Cedars, from Palmetto General, was 23 minutes, in the Mount Sinai travel time study, with a range of drive times from 17 minutes (starting at

    4:19 a.m.) to 30 minutes (starting at 7:06 a.m.).


  18. If Palmetto General is approved to become an open heart provider, Cedars' volume is expected to be reduced by 20 surgeries. If Aventura Hospital becomes an open heart provider, Cedars' volume will be reduced by an estimated 14 cases.

    Kendall


  19. Kendall had a volume of 180 open heart cases for the year ending March 2000. Kendall has consistently been a low volume open heart provider, increasing from 136 surgeries in 1989, to 295 in 2001.

  20. Kendall is located in southwestern Dade County, well beyond the primary service areas of Palmetto General and Aventura Hospital. The common feature shared with Palmetto General is

    that Kendall is also considered an Hispanic or Spanish-speaking hospital, although every hospital in Dade County is staffed to serve Spanish-speaking patients. Mount Sinai's study found the average drive time from Palmetto General to Kendall to be 23 minutes, covering 14.6 miles.

  21. Estimates of case reductions at Kendall are six if Palmetto General is approved and one if Aventura Hospital is approved.

    South Miami and Baptist


  22. South Miami reported a volume of 199 open heart cases for the year ending March 2000. The volume of open heart surgeries has been low, over the years, from 132 in 1989, to 148 in 2001, never exceeding 215 cases in any one year. South Miami has become a referral center for complex, multi-vessel angioplasties. Angioplasties increased, at South Miami, from 723 in 2000, to 837 in 2001.

  23. Like Kendall, South Miami and Baptist have no overlap with the primary service areas of Aventura Hospital and Palmetto General.

  24. If Palmetto General offers open heart services, then South Miami would lose approximately nine cases in the third year of operations. If Aventura Hospital's CON is approved, then South Miami would lose an estimated two cases that year.

  25. The volumes at Baptist, from April 1999 through March 2000, were 472 open heart surgeries and 4,730 cardiac

    caths. The Baptist volume of open heart cases declined to 428 in 2000, and 408 in 2001.

  26. Baptist's volume is expected to decline by 14 cases lost to Palmetto General, and two to Aventura Hospital.

    Existing District 10 Providers


  27. Mount Sinai, in its proposed recommended order, suggested that Memorial Regional, the Cleveland Clinic, and Florida Medical Center all in Broward County, are available open heart providers for northern Dade County residents.

  28. Tenet operates the open heart program at the Cleveland Clinic, which is 17 miles north of Palmetto General. The average travel time to the Cleveland Clinic, in the Mount Sinai study, was 26 minutes, but that is unreliable because it includes one run where the driver obviously had to speed, at 4:42 a.m., to average over 60 miles per hour.

  29. The staff at Cleveland Clinic is not predominantly Spanish-speaking. The medical staff is also closed so that only Cleveland Clinic doctors practice at that hospital. Patients have interruptions in their continuity of care when referred to an entirely different medical staff. In addition, the Cleveland Clinic is a referral hospital drawing patients from outside the area. It does not function as a community hospital. The

    Cleveland Clinic is not, therefore, an alternative provider for Dade County residents.

  30. At Memorial Regional, six miles north of Aventura Hospital, there were 766 open heart surgeries performed in one 12-month period in 1999 and 2000 and 641 in calendar year 2000.

    Twenty-six percent of the Aventura Hospital primary service area open heart surgeries were performed at Memorial Regional in 2001, as compared to 5 percent from the Palmetto General Area. Over 30 percent of the angioplasties performed on Aventura Hospital service area residents were performed at Memorial Regional in 2001, and less than 4 percent for Palmetto General service area residents. If Aventura Hospital is approved, the loss in volume from Memorial Regional would be approximately 103 cases a year.

  31. Aventura Hospital noted that Memorial Regional has experienced capacity problems. In Columbia Hospital Corporation of South Broward vs. AHCA, the administrative law judge found that the proposal to establish a new hospital in Miramar was intended to " . . . allow Memorial Regional and Memorial West the opportunity to decompress and operate at reasonable and efficient occupancies into the foreseeable future without the operational problems caused by the current over-utilization."

  32. There is evidence that the relief resulting from the construction of the Miramar Hospital, will not alter the

    difficulties that Aventura Hospital-based doctors experience in gaining access to the cardiac cath lab at Memorial Regional.

  33. Florida Medical Center has approximately 450 open heart surgery cases a year. It is a Tenet facility in Western Broward County. The financial data from Florida Medical Center was used in Palmetto General's projections of income and expenses, but there was no evidence that Florida Medical Center's open heart program is a viable alternative to programs at either Aventura Hospital or Palmetto General.

    Review Criteria


    Subsection 408.035(1) - need in relation to applicable district health plan; 59C-1.030(2)(a)-(e) - need that the population has, particularly low income, ethnic minorities, elderly, etc.; relocation of a service; needs of medically underserved, Medicare, Medicaid and indigent persons; and Subsection 408.035(11) - past and proposed Medicaid and indigent care.


  34. The District 11 health plan includes preferences for applicants seeking to provide tertiary services who have provided the highest Medicaid and charity care, and who have demonstrated the highest ongoing commitment to Medicaid and indigent patients.

  35. Aventura Hospital provided approximately 1 percent charity, 6 to 7 percent Medicaid and 17 percent Medicare in 2001. It qualified as a disproportionate share Medicare hospital. Aventura Hospital's proposed CON commitment is to provide a minimum of 2.5 percent of open heart surgery and angioplasty patient days to Medicaid and charity patients.

  36. Palmetto General is and, for at least the last ten years, has been a disproportionate share Medicaid and Medicare provider. Over 20 percent of the total care at Palmetto General has been given to Medicaid patients in recent fiscal years. The care to indigent patients was approximately $8 million in one year. In this regard, Palmetto serves as a "safety net" hospital for poor people, like Jackson Memorial and Mount Sinai. Palmetto General will meet the needs of ethnic minorities, and more Medicaid, low income and indigent patients.

  37. Aventura Hospital is serving an older population and, in effect, would be relocating an open heart program from Miami Heart. In a service like open heart surgery, Medicare is the dominant payor.

    Subsection 408.035(2) - availability, quality of care, accessibility, extent of utilization of existing facilities in the district; Rule 59C-1.033(4)(a) - two-hour travel time; and Subsection 408.035(7) - enhanced access for residents of the district.


  38. The applicants contend that the existing programs in the district are geographically maldistributed to the detriment of the residents of northeast and northwest Dade County. They also contend that those access issues outweigh the fact that district residents can reach open heart providers within the two- hour travel time standard in the open heart rule.

  39. In its proposed recommended order, Mount Sinai noted that if Dade County is divided in half using " . . . State Road

    836 (also known as the Palmetto Expressway), which runs east-west in the center of the County, near Miami International

    Airport . . . ," there are four existing open heart providers in the north and four in the south. This statement must be inaccurate because Palmetto General's location was described as being on the Palmetto Expressway with no existing open heart providers in the same service area.

  40. The existing programs in District 11 are inappropriately dispersed geographically to serve the population, as it is distributed throughout Dade County. The Hialeah area, with 22 percent of the population, is larger than 14 counties in Florida which have at least one open heart surgery program. The population in the Aventura Hospital primary service area, 250,000 residents, is roughly half that of Hialeah, but is equal to or larger than five counties in Florida which have open heart surgery programs.

  41. If the applicants' patients are not transferred to other hospitals, then the volume of open heart procedures at those hospitals will decline. The medical literature and experts in the field demonstrate a relationship between volume and quality. In Florida, the old rule and new rule set the minimums for existing providers at 350 and 300, respectively.

  42. If Aventura Hospital's open heart CON is approved, almost 200 surgeries will be lost from Miami Heart and Mount

    Sinai, approximately half of that from the program that will be closed, and just over 100 from Memorial Regional. The effect on the low volume providers will be negligible, one lost case to Kendall and two from South Miami.

  43. Based on its projections, Aventura Hospital expects to reach 347 open heart surgeries in its third year of operation. Even assuming that most of the cases would be redirected from other providers, the projection is aggressively based on the assumption that Aventura Hospital will have a market share of 87 percent of its primary service area.

  44. If Palmetto General's open heart CON is approved, the greatest impact will also be on Mount Sinai and Miami Heart, a loss of approximately 100 surgeries a year, and on Jackson Memorial, a loss of 46 surgeries a year. Palmetto General projected that it would reach a volume of 250 open heart surgeries by the end of the third year of operations. South Miami would lose nine and Kendall would lose six open heart cases.

  45. Neither an Aventura nor a Palmetto area program will keep the existing low volume providers below 300 or 350 open heart surgeries. With or without them, South Miami and Kendall are expected to continue to operate below the objective set by the open heart rule.

  46. The absence of a material adverse impact on low volume providers is the result of the absence of any overlap in the service areas of the applicants and South Miami and Kendall.

  47. In District 11, only Cedars is likely to end up having open heart surgery volumes in a range between 300 and 350 cases as a result of the approval of both programs.

  48. Difficulties and delays in patient transfers for open heart or angioplasty services were raised as possible not normal circumstances in Dade County.

  49. Aventura Hospital witnesses presented anecdotal evidence of patients who could have benefited from the availability of angioplasty and open heart case without transfers. The evidence was inadequate to demonstrate that access to existing facilities is not available within a reasonable time.

  50. Palmetto General provided a review of medical charts to show patients whose outcomes would have been improved if it had an open heart program. Physicians who testified about those patients differed in their conclusions concerning the urgency of transfers, the need for primary angioplasty or thrombolytics, and the causes of delays. No medical records indicated patient outcomes after they were transferred.

  51. Aventura Hospital and Palmetto General also contend that the residents of their primary service area are at a

    disadvantage by not having timely access to primary angioplasty for patients who are having heart attacks. Treatment in their ERs is limited to administering thrombolytic or clot-busting drugs in an effort to save heart muscle.

  52. Increasingly, research has shown the benefits of primary angioplasty over thrombolytics as the most effective treatment to restore blood flow to heart muscle. The benefits include lower mortality rates and few complications, and are enhanced if the "door-to-balloon" time is less than 90 minutes.

  53. In Dade County, transfer times typically range from two to five hours, including the time to contact a receiving facility, to find a receiving physician, to receive insurance authorization, to summon an ambulance, and to prepare the patient medically for transfer, as well as the actual travel time.

  54. Research also shows that the quality of an open heart surgery program continues to be linked to its volume. In Florida, AHCA has not revised its rules either to provide for angioplasty services without open heart surgery back-up, or to reduce the tertiary designation of open heart surgery programs. Therefore, the need for more timely access to angioplasty is rejected as a not normal access issue.

  55. Palmetto General, due to operational difficulties is unlikely to meet the 90-minute reperfusion goal. In fact, most hospitals with open heart programs do not.

  56. Palmetto General does not plan to construct a second cardiac cath lab for use at the time it establishes an open heart program. Mount Sinai witnesses questioned the ability of a hospital with one cath lab to provide emergency primary angioplasty services.

  57. An additional cath lab is not required in the open heart rule and, while difficulties in scheduling are likely to occur, successful open heart programs have been operated with one cath lab initially, including Tenet-operated Delray Medical Center.

  58. Palmetto General can, when needed, construct a second cardiac cath lab in approximately six months without CON review.

  59. AHCA has not revised the open heart surgery rule to respond to the development of primary angioplasty as a preferred treatment. By its adoption of a new rule maintaining the link between angioplasty and open heart surgery, and maintaining the tertiary nature of open heart surgery, AHCA has placed the State of Florida on the side of the debate which is more concerned about the link between volumes and quality in open heart programs.

  60. Palmetto General also attempted to demonstrate the existence of access constraints at Jackson Memorial. The evidence showed discrepancies in lengths of stay, with indigent patients generally hospitalized longer. But those discrepancies

    were subject to other interpretations, including the possibility that indigent patients are more sick because lengths of stay were longer before and after indigent patients are transferred to and from Jackson Memorial.

  61. The maldistribution of open heart programs in Dade County as compared to the areas of significant population growth is a not normal circumstance affecting the availability, access, extent of utilization, and quality of care of existing facilities in the district. The commitment to the closure of an existing program is also a not normal circumstance in favor of the Aventura Hospital proposal.

    Subsection 408.035(3) - applicant's quality of care; Rule 59C- 1.030(2)(f) - accessibility of facility as a whole; Subsection 408.035(10) - costs and methods of construction.


  62. The parties stipulated that both Aventura Hospital and Palmetto General have a record of providing quality care with regard to the scope and intensity of services provided historically, and that both are accredited by the Joint Commission on Accreditation of Health Care Organizations.

  63. The parties also stipulated that both applicants can establish quality perfusion services and recruit qualified perfusionists at the costs identified in their applications.

  64. Palmetto General failed to identify any surgeons who would staff their proposed open heart program. Two cardiac surgeons in a group which submitted a letter of interest included

    in the Palmetto General CON application were killed in a car accident a month before the final hearing.

  65. While the absence of named surgeons affects the certainty of referrals, there is no requirement, in AHCA rules, that surgeons be named in CON applications. One board-certified and a second at least board-eligible surgeon must be on the hospital staff if it starts an open heart program. Tenet has the resources and the senior management at Palmetto General has the experience to recruit qualified medical and nursing staff.

  66. The plan for a four-bed CVICU at Palmetto General was criticized as allocating too few beds for open heart surgery patients. Using the normile statistical methodology, one expert witness testified that a six-bed CVICU is required to accommodate the expected patient census in the third year of an open heart program.

  67. Using an average daily census of 1.43 patients and a target occupancy rate of 70 percent in the four-bed CVICU, however, only two beds are needed in the first year. Subsequently, as needed, acute care beds may be converted to ICU beds without CON review.

    Subsection 408.035(4) - needs that are not reasonably and economically accessible in adjoining areas.


  68. Mount Sinai contends that the residents of the Aventura

    and Hialeah areas reasonably and economically receive open heart services in Broward County.

  69. The statistical data and evidence of capacity constraints, even after the Miramar hospital is constructed, and the closure of one of the programs that residents of the Aventura Hospital primary service area have relied on and its relocation to their area, is more appropriate than increasing their reliance on Memorial Regional.

  70. The evidence does not demonstrate that the residents of the Palmetto General service area have reasonable access to Cleveland Clinic, Memorial Regional or any other Broward County hospital with an open heart surgery program.

    Subsection 408.035(5) - needs of research and educational facilities.


  71. Aventura Hospital is not a statutory teaching hospital.


    It does have podiatry, nursing, and occupational and physical therapy students training at the hospital.

  72. Residents and interns from the primary care program at Nova Southeastern University, from the Barry University School of Podiatry, and area nursing and technical schools receive some of their training at Palmetto General. Although one rating service places Palmetto General in the category of a teaching hospital, it is not a statutory teaching hospital.

  73. A program at Aventura Hospital will have a greater adverse effect on Mount Sinai, while one at Palmetto General will have a greater adverse effect on Jackson Memorial. Both Mount Sinai and Jackson Memorial are statutory teaching hospitals.

    Subsection 408.035(6) - management personnel and funds for project accomplishment; Subsection 408.035(8) - immediate and long term financial feasibility.


  74. Both Aventura Hospital and Palmetto General have adequate funds and experienced management to establish open heart surgery programs.

  75. In the pre-hearing stipulation, the parties agreed that the applicants have sufficient available funds for capital and operating expenses to initiate open heart surgery programs and to operate the programs, in the short term, until financially self- sufficient.

  76. Aventura Hospital reasonably projected net profits of approximately $543,000 from an open heart program in the first year of operation, and $1 million in the second year. Aventura Hospital reasonably relied on the experiences of other HCA open heart providers in the area, particularly Miami Heart and JFK Medical Center in Palm Beach County.

  77. Mount Sinai questioned the reasonableness of Palmetto General's projection that it will generate higher profits than Aventura Hospital with lower case volumes. It also questioned Palmetto General's ability to attain the volumes projected.

  78. Palmetto General projected a net profit of just over


    $700,000 in the first year, $1.18 million in the second year, and


    $1.5 million in the third year, with 148 open heart cases in the first year, 210 in the second year, and 250 in the third year.

    By comparison, Aventura Hospital's first three-year projections for open hearts were 240, 312, and 347. Aventura's projected volume was potentially overstated in view of the experience at HCA facility Columbia Westside in Broward County which has achieved approximately half the open hearts projected. But the differences in projections reasonably reflect Aventura's draw from a smaller but older population and Palmetto General's draw from a larger, poorer but younger population.

  79. Palmetto General's projected volumes are reasonable considerating the number of actual open heart surgeries, 668, originating from its primary service area in the 12-months ending in June 2001.

  80. Palmetto General reasonably and conservatively based its reimbursement rates on those received at Florida Medical Center in Broward County, which actually has a lower reimbursement rate than Dade County.

  81. Mount Sinai also demonstrated that charges at three South Florida Tenet facilities, Delray Medical Center, North Ridge Medical Center, and Florida Medical Center were significantly higher than those at Mount Sinai. But those

    facilities operate successfully in competitive markets in Districts 9 and 10, which supports the testimony that, for open heart surgery, charges are not very relevant. Most compensation is derived from fixed-rate reimbursement from Medicare.

    Subsection 408.035(9) - extent to which proposal fosters competition that promotes quality and cost effectiveness.


  82. In the District, HCA, the parent of Aventura Hospital, after the sale of Miami Heart, continues to operate Cedars, which has exceeded 350 cases for the first time in 2001, and Kendall, which at 295 cases in 2001, has been a chronically low volume open heart provider. That would raise doubts about the projected volumes at Aventura Hospital, but for the demographics of its location and the closure and, in effect, proposed relocation of the Miami Heart program to a more geographically appropriate area of the District. The relocation, therefore, makes the proposal a "wash" resulting in no net increase in programs or competition in the District.

  83. By contrast, the approval of a program operated by Tenet which has five Dade County hospitals, none with an open heart program, does introduce a new provider into the market in a location with special needs due to the larger critical mass of people, their ethnicity, relative poverty and fewer, more distant alternate open heart providers.

    Subsection 408.035(12) - nursing home beds.


  84. The criterion related to nursing home beds, by stipulation of the parties, is inapplicable to this case.

    Summary of Findings


  85. On balance, Palmetto General is preferable as the hospital with the larger critical mass of population, the status as a disproportionate share provider of Medicaid and Medicare, the improved geographical access for a large ethnic group with relatively high IHD and heavy demands for services, including cardiac care services in its ER and in the ERs of other hospitals within its primary service area. In addition, the detriment to existing providers, predominantly Mount Sinai and Jackson Memorial will not reduce the volumes below 350 open heart cases.

  86. On balance, the Aventura Hospital proposal, while less compelling, because it is not a Medicaid disproportionate share hospital, is not a new entrant to the market, and has a population which is half that in the Palmetto General primary service is also entirely approvable. The hospital has facilities superior to those at Palmetto General. It is better prepared to implement an open heart program, with plans to open a second cardiac cath lab immediately and with the cardiothoracic surgeons identified for the program. Within its service area population, Aventura Hospital has a large population of elderly people, who present to its hospital with symptoms of heart attacks.

  87. The troubling adverse impact on Memorial Regional is offset by the evidence of crowding and scheduling difficulties specifically in the Memorial Regional cardiac cath lab. The troubling adverse impact on the combined Miami Heart and Mount Sinai programs is offset by the Asset Purchase Agreement which contemplated the relocation of at least a portion of the Miami Heart cases to Aventura Hospital. Even with the additional loss of 100 open heart cases to Palmetto General, Mount Sinai will remain the largest Dade County provider, retaining from 900 to 1,000 annual open heart cases.

  88. The approval of both applications will improve access to open heart surgery and angioplasty care in District 11.

    CONCLUSIONS OF LAW


  89. The Division of Administrative Hearings has jurisdiction over the parties to and the subject matter of these proceedings. Sections 120.569, 120.57(1), and 120.60(5), Florida Statutes.

  90. The parties to this proceeding have standing.


    Subsection 408.039(5)(c), Florida Statutes.


  91. The applicants, Aventura Hospital and Palmetto General, have the burden of demonstrating that their applications should be granted. An applicant for a certificate of need has the burden of demonstrating that its application should be granted. Boca Raton Artificial Kidney Center v. Department of

    Health and Rehabilitative Services, 475 So. 2d 260 (Fla. 1st DCA 1985). The award of a Certificate of Need must be based on a balanced consideration of all statutory and rule criteria.

    Department of Health and Rehabilitative Services v. Johnson and Johnson Home Healthcare, Inc., 447 So. 2d 261 (Fla. 1st DCA 1984); Balsam v. Department of Health and Rehabilitative

    Services, 486 So. 2d 1341 (Fla. 1st DCA 1988). The weight to be given each criterion is not fixed but depends on the facts and circumstances of each case. Collier Medical Center, Inc. v.

    Department of Health and Rehabilitative Services, 462 So. 2d 83 (Fla. 1st DCA 1985).

  92. Florida follows the general proposition that a change in a licensure statute or rule during the pendency of an application is operative as to that application. Lavernia v.

    Department of Professional Regulation, 616 So. 2d 53 (Fla. 1st DCA 1993), rev. denied, 624 So. 2d 267 (Fla. 1993); Agency for Health Care Administration v. Mount Sinai Medical Center, 690 So. 2d 689 (Fla. 1st DCA 1997). The last case can be distinguished because a rule was invalidated not amended. In addition, the general proposition is inconsistent with rules and decisions intended to assure the fairness of the CON review process. Rule 59C-1.030(3)(b), Florida Administrative Code, provides that:

    The agency shall deem the application complete or withdrawn within 7 calendar days of the receipt of the requested information.

    Subsequent to an application being deemed complete by the agency, no further application information or amendment will be accepted by the agency.


    The imposition of new criteria without allowing an amendment places an applicant in the untenable position of not being allowed to offer proof that its proposal meets the criteria. In addition, after June 1999, Subsection 120.54(1)(f), Florida Statutes, as amended, prohibits agencies from adopting retroactive rules unless expressly authorized by statute. For these reasons, the open heart surgery rule in existence at the time the applications were filed is applied to this proceeding.

  93. Open heart surgery is listed as one of several tertiary services by rule. Transfers are inherent to the classification system. A "tertiary health service" is defined in Section 408.032(17), Florida Statutes, as follows:

    1. health service, which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost-effectiveness of such service.


  94. Because the fixed numeric need is zero, each applicant must demonstrate not normal circumstances for approval. See Rule 59C-1.033(7)(a), Florida Administrative Code.

  95. In this case, it is not a "not normal" circumstance that patient transfers may result in delays and difficulties, as such is the nature of the tertiary classification.

  96. It is not a "not normal" circumstance that some emergency heart attack patients will present to hospitals which are not licensed to perform primary angioplasty. That too is inherent in the regulatory scheme that requires open heart surgery back-up for angioplasties.

  97. It is, however, a not normal circumstance for the geographical maldistribution of open heart providers to be so skewed to one end of a county of over two million people that, the existing providers primary service areas, in one instance exclude almost a half a million people and in the other instance exclude a quarter of a million people.

  98. Because of the absence of overlapping service areas, the applicants will not drive any applicant other than Cedars to volumes between 300 and 350 cases, and will have no effect on the programs which have operated as low volume providers for over ten years. Halifax Hospital Medical Center, Etc. vs. AHCA, DOAH Case No. 95-0742 (R.O. 9/30/96, F.O. 1/15/97), aff'd, 698 So. 2d 841 (Fla. 1st DCA 1997); and Florida Health Sciences Center, Inc., d/b/a Tampa General Hospital vs. AHCA, DOAH Case No. 00-0481 (R.O. 3/30/01, 10/17/91 F.O.).

  99. It is also a not normal circumstance that the approval of two applicants in the same district at the same time is not shown, by any credible evidence, to impede the development of either program. HCA Health Services of Florida, Inc., d/b/a Oak Hill Hospital vs. AHCA, DOAH Case No. 00-3216 (R.O. 10/4/01, F.O. 5/21/02).

  100. Palmetto General also qualifies for its disproportionate share Medicaid and Medicare status, service to ethnic minorities and indigents, its commitment to provide Medicaid open heart and angioplasty services, its quality of care, the educational and training programs it provides, and the immediate and long term financial feasibility of the proposed program. The proposal, therefore, complies with the requirements of Subsections 408.035(1)-(11), Florida Statutes, and Rules 59C-

    1.030 and 59C-1.033, Florida Administrative Code.


  101. Mount Sinai objected to the physical changes in Palmetto General's schematic plans, and evidence related to the poverty and ethnicity of the primary service area, as impermissible amendments to the application.

  102. As noted in the Findings of Fact, the changes in the floor plan are not substantial and do not alter operational plans. Manor Care, Inc. v. DHRS, 558 So. 2d 26 (Fla. 1st DCA 1989).

  103. The issue related to ethnicity and poverty are not impermissible amendments, as a matter of fact and law, having been raised in the CON application, as follows:

    Given the large population of Hispanic patients in the PGH PSA and the well published prevalence of diabetes among Hispanics . . . .


    Palmetto General Omissions Response, Volume 1, Page 2,


    and


    One of the most likely acknowledged problems in healthcare today is the lack of accessibility to healthcare services by Medicaid and indigent patients.


    Palmetto General Omissions Response, Volume 1, page 98.


  104. Aventura Hospital also meets the criteria related to the needs of a large and growing elderly population, as reflected by its disproportionate Medicare status, as a superior facility which is well-equipped and well-staffed, with excellent plans for an open heart program, which will be relocated to a more appropriate facility to meet the needs of the residents. As such, the Aventura proposal meets the requirements of Subsections 408.035(1) and (11) - partially, and Subsections 408.035(2) - (4), (6)-(8), and (10), Florida Statutes, and Rule 59C-1.030 - partially, and Rule 59C-1.033, Florida Administrative Code.

RECOMMENDATION


Based on the foregoing Findings of Fact and Conclusions of Law, it is

RECOMMENDED that a final order be entered issuing CON Application No. 9394 to Lifemark Hospitals of Florida, Inc., d/b/a Palmetto General Hospital, and CON Application No. 9395 to Miami Beach Healthcare Group, Ltd., d/b/a Aventura Hospital and Medical Center.

DONE AND ENTERED this 14th day of April, 2003, in Tallahassee, Leon County, Florida.


ELEANOR M. HUNTER

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675 SUNCOM 278-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us


Filed with the Clerk of the Division of Administrative Hearings this 14th day of April, 2003.


COPIES FURNISHED:


Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive

Building Three, Suite 3431 Tallahassee, Florida 32308-5403

Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive

Building Three, Suite 3431 Tallahassee, Florida 32308-5403


Michael O. Mathis, Esquire

Agency for Health Care Administration 2727 Mahan Drive

Building Three, Suite 3431 Tallahassee, Florida 32308-5403


C. Gary Williams, Esquire Michael J. Glazer, Esquire Ausley & McMullen

227 South Calhoun Street Post Office Box 391 Tallahassee, Florida 32302


Geoffrey D. Smith, Esquire Sandra L. Schoonover, Esquire Blank, Meenan & Smith, P.A.

204 South Monroe Street Post Office Box 11068

Tallahassee, Florida 32302-3068


Stephen A. Ecenia, Esquire

R. David Prescott, Esquire

Rutledge, Ecenia, Purnell & Hoffman, P.A.

215 South Monroe Street, Suite 420 Post Office Box 551

Tallahassee, Florida 32302-0551


NOTICE OF RIGHT TO SUBMIT EXCEPTIONS


All parties have the right to submit written exceptions within 15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.


Docket for Case No: 01-000357CON
Issue Date Proceedings
Oct. 10, 2003 Final Order filed.
May 09, 2003 Letter to L. McCharen from T. Konrad enclosing filed exceptions to reommended order and agency should consider exceptions in rendering a final order filed.
May 08, 2003 Exceptions to Recommended Order filed by R. Prescott.
Apr. 14, 2003 Letter to G. Smith from Judge Hunter enclosing the in-camera inspection document which was filed on July 29, 2002 issued.
Apr. 14, 2003 Recommended Order cover letter identifying hearing record referred to the Agency sent out.
Apr. 14, 2003 Recommended Order issued (hearing held August 13-16, August 19-23, August 26-30, and September 11-12, 2002) CASE CLOSED.
Jan. 17, 2003 Aventura Hospital and Medical Center`s Proposed Recommended Order filed.
Jan. 17, 2003 Aventura Hospital and Medical Center`s Memorandum of Law in Support of Its Proposed Recommended Order filed.
Jan. 17, 2003 Proposed Recommended Order of Mount Sinai Medical Center filed.
Jan. 17, 2003 Notice of Filing Proposed Recommended Order filed by G. Smith.
Jan. 17, 2003 Letter to Judge Hunter from S. Fennelly stating correction to transcripts came proposed recommended was being prepared filed.
Jan. 17, 2003 Proposed Recommended Order by Palmetto General Hospital filed.
Jan. 17, 2003 Memorandum of Law in Support of Proposed Recommended Order Filed on Behalf of Lifemark Hospitals of Florida, Inc. d/b/a Palmetto General Hospital filed by M. Glazer.
Jan. 13, 2003 Agency for Health Care Administration`s Proposed Recommended Order filed.
Dec. 20, 2002 Transcripts (Volumes 22 - 28) filed.
Dec. 20, 2002 Notice of Filing Transcript sent out.
Dec. 06, 2002 Order issued. (unopposed motion is granted, the parties shall have up to and including January 17, 2003, to file their proposed recommended orders)
Dec. 05, 2002 Joint Unopposed Motion for Extension of Time to File Proposed Recommended Orders and for Extension of Pages With Request for Expedited Ruling filed by S. Fennelly.
Nov. 22, 2002 Subpoena Duces Tecum, Tenet Healthsystem Hospitals, Inc. filed.
Oct. 18, 2002 Transcript (Volumes 1-29) filed.
Oct. 18, 2002 Notice of Filing Transcript sent out.
Oct. 15, 2002 Palmetto`s Response in Opposition to Aventura`s Motion for Official Recognition of Final Order in DOAH Case No. 01-2891 Con, 01-2892 Con filed.
Oct. 08, 2002 Motion for Official Recognition of Final Order in DOAH Case No. 01-2891CON, 01-2892CON filed by S. Ecenia.
Sep. 25, 2002 Letter to Counsel from R. Gordon stating unable to locate Judges exhibits 2-38, issued.
Sep. 11, 2002 CASE STATUS: Hearing Held; see case file for applicable time frames.
Sep. 06, 2002 Palmetto General Hospital`s Rebuttal Witness List filed.
Sep. 06, 2002 Aventura Hospital and Medical Center`s Rebuttal Witness List filed.
Aug. 15, 2002 Notice of Filing Errata Sheet to Deposition (filed by Petitioner via facsimile).
Aug. 13, 2002 CASE STATUS: Hearing Partially Held; continued to date not certain.
Aug. 12, 2002 Motion for Judicial Notice filed by Intervenors.
Aug. 12, 2002 Joint Pre-hearing Stipulation filed.
Aug. 09, 2002 Motion for Judicial Notice filed by Intervenors.
Aug. 07, 2002 Amended Notice of Taking Deposition, S. Page (filed via facsimile).
Aug. 07, 2002 Amended Notice of Taking Deposition, C. Cole (filed via facsimile).
Aug. 06, 2002 Notice of Cancellation of Deposition, N. Delgado filed.
Aug. 06, 2002 Notice of Taking Deposition, I. Rodriguez filed.
Aug. 06, 2002 Cross-Notice of Taking Depositions, L. Thayer, C. Silk, D. Micin filed.
Aug. 06, 2002 Notice of Telephonic Deposition, S. McCracken filed.
Aug. 06, 2002 Cross Notice of Taking Depositions, M. Richardson, P. Greenberg, N. Delgado, A. Diskin, G. Delgado, Y. Perez, L. Castellanos, H. Chua, C. Cole filed.
Aug. 06, 2002 Notice of Taking Depositions, P. Greeberg, A. Brown, L. Thayer, C. Silk, D. Micin, L. Gold, S. McCracken, G. Ebra filed.
Aug. 05, 2002 Joint Motion for Protective Order filed.
Aug. 05, 2002 Letter to Judge Hunter from R. Prescott confirming approval of changing hearing date filed.
Aug. 05, 2002 Amended Notice of Taking Depositions, A. Brown, N. Delgado, A. Soto filed.
Aug. 05, 2002 Notice of Taking Depositions, A. Brown, A. Constreras-Soto filed.
Aug. 02, 2002 Amended Notice of Taking Depositions Duces Tecum G. Nelson, B. Beiseigle filed.
Aug. 02, 2002 Emergency Motion in Limine and Request for Expedited Hearing (filed by S. Schoonover via facsimile).
Aug. 02, 2002 Letter to Judge Hunter from G. Smith regarding employment agreement filed.
Aug. 01, 2002 Amended Notice of Taking Deposition Duces Tecum R. Stone filed.
Aug. 01, 2002 Motion to Quash Subpoena Duces Tecum and Renewed Motion for Protective Order filed by S. Fennelly
Aug. 01, 2002 Notice of Taking Deposition M. Soler, Y. Perez (filed via facsimile).
Jul. 31, 2002 Amended Notice of Taking Deposition Duces Tecum J. Gregg filed.
Jul. 30, 2002 Joint Motion for Protective Order Regarding Mount Sinai`s Notice of Depostion Duces Tecum filed.
Jul. 30, 2002 Cross Notice of Taking Depositions H. Roberts, M.D., C. Taylor, M. Harrell filed.
Jul. 30, 2002 Memorandum to Judge Hunter from G. Smith regarding Exhibit A to the Notice of Taking Deposition Duces Tecum filed on July 29, 2002 (filed via facsimile).
Jul. 29, 2002 Asset Purchase Agreement filed by Petitioner.
Jul. 29, 2002 Notice of Taking Deposition Duces Tecum, D. Steigman (filed via facsimile).
Jul. 26, 2002 Motion for Summary Recommended Order (filed by G. Smith via facsimile).
Jul. 26, 2002 Notice of Withdrawal of Motion (filed G. Smith via facsimile).
Jul. 26, 2002 Response in Oposition to Motion for Protective Order filed by Intervenor.
Jul. 26, 2002 Cross Notice of Depositions, H. Hurwit, R. Aleman filed.
Jul. 24, 2002 Notice of Telephonic Deposition Duces Tecum, C. Boily filed.
Jul. 24, 2002 Motion to Compel filed by Intervenor.
Jul. 24, 2002 Palmetto General Hospital`s Response to Aventura`s First Request for Production of Documents filed.
Jul. 23, 2002 Miami Beach Healthcare Group, LTD. d/b/a Aventura Hospital and Medical Center`s Responses to Palmetto General Hospital`s First Set of Interrogatories filed.
Jul. 23, 2002 Miami Beach Healthcare Group, LTD. d/b/a/ Aventura Hospital and Medical Center`s Response to Palmetto General Hospital`s Second Request for Production of Documents filed.
Jul. 23, 2002 Notice of Service of Aventura Hospital and Medical Center`s Answers to Palmetto General Hospital`s First Set of Interrogatories filed.
Jul. 22, 2002 Notice of Taking Deposition Duces Tecum filed by Lifemark.
Jul. 22, 2002 Amended Notice of Taking Depositions, R. Greene, P. Greenberg, Representative of Lifemark Hospitals (filed via facsimile).
Jul. 19, 2002 Notice of Taking Deposition Duces Tecum, Representatives of Tenet Healthsystem Hospitals, Inc. (filed via facsimile).
Jul. 19, 2002 Notice of Appearance and Substitution of Counsel (filed by Respondent).
Jul. 19, 2002 Notice of Taking Deposition Duces Tecum, J. Gregg filed.
Jul. 18, 2002 Miami Beach Healthcare Group, LTD.d/b/a Aventura Hospital and Medical Center`s Response to Palmetto General Hospital`s First Request for Production of Documents filed.
Jul. 16, 2002 Notice of Taking Depositions Duces Tecum, R. Knapp, M. Richardson, J. Jolis, G. Nelson filed.
Jul. 16, 2002 Letter to Parties from R. Del Cristo advising that he will not be able to attend the deposition (filed via facsimile).
Jul. 16, 2002 Amended Notice of Taking Deposition Duces Tecum, M. Zitsky filed.
Jul. 15, 2002 Notice of Taking Deposition Duces Tecum, C.Boiling, M. Zitsky filed.
Jul. 15, 2002 Amended Notice of Taking Deposition, Ali Bazzi filed.
Jul. 15, 2002 Notice of Taking Deposition Duces Tecum K. Moyer, S. Sonnenreich filed.
Jul. 15, 2002 Notice of Cancellation of Deposition A. Bazi, M.D. filed.
Jul. 15, 2002 Notice of Taking Deposition A. Bazzi, M.D. filed.
Jul. 12, 2002 Notice of Taking Deposition Duces Tecum K. Moyer filed.
Jul. 12, 2002 Notice of Cancellation of Depositions Dr. J. Sanchez, R. Fraga, A. Ing, R. Machado, Dr. P. Diaz, Dr. J. Marquez, Dr. J. Sanchez, Dr. M. Mayor, Dr. R. del Christo (filed via facsimile).
Jul. 12, 2002 Amended Notice of Taking Deposition G. Arcentales, B. Rodriquez, Palmetto Corp. Rep. (filed via facsimile).
Jul. 09, 2002 Motion for Protective Order (filed by Mount Sinai via facsimile).
Jul. 09, 2002 Motion to Compel filed by Intervenor.
Jul. 08, 2002 Notice of Taking Deposition of Corporate Representative filed.
Jul. 08, 2002 Amended Notice of Taking Depositions, E. Hannabergh, F. Osterman, J. Provo, E. Gorin, L. Katz, E. Naccarrato filed.
Jul. 03, 2002 Amended Notice of Taking Deposition Duces Tecum, D. Williams filed.
Jul. 02, 2002 Notice of Taking Deposition Duces Tecum, S. Sonnenreich, K. Moyer, D. Williams, A. Mendez, B. Katz, R. Stone, B. Krieger filed.
Jul. 01, 2002 Response to Second Renewed Motion to Compel filed by Intervenor.
Jun. 26, 2002 Notice of Taking Depositions, E. Hannabergh, F. Osterman, D. Galbut, E, Gorin, L. Katz, E. Naccarrato filed.
Jun. 25, 2002 Order Granting Continuance and Re-scheduling Hearing issued (hearing set for August 12 through 16, 19 through 23 and 26 through 30, 2002; 9:00 a.m.; Tallahassee, FL).
Jun. 21, 2002 Notice of Taking Deposition, M. Llaneras, R. Fraga, A. Ing, R. Machado, P. Diaz, J. Marquez, G. Arcentales, R. Aleman, R. Greene, J. Sanchez, M. Mayor, R. Del Christo, P. Greenberg filed.
Jun. 21, 2002 Joint Motion for One Week Continuance filed.
Jun. 21, 2002 Notice of Taking Deposition Duces Tecum, designated representatives of Lifemark Hospitals of Florida, Inc., d/b/a/ Palmetto General Hospital filed.
Jun. 21, 2002 Second Renewed Motion to Compel filed by G. Smith.
Jun. 21, 2002 Palmetto General Hospital`s Notice of Service of its First Interrogatories to Aventura Hospital and Medical Center filed.
Jun. 21, 2002 Palmetto General Hospital`s Second Request for Production of Documents to Aventura Hospital and Medical Center filed.
Jun. 04, 2002 Mount Sinai Medical Center`s Notice of Service of Answers to First Set of Interrogatories of Palmetto General Hospital filed.
Jun. 04, 2002 Mount Sinai Medical Center`s Response to Palmetto General Hospital`s First Request to Produce Documents filed.
Apr. 26, 2002 Palmetto General Hospital`s Response to Mt. Sinai`s Renewed Motion to Compel filed.
Apr. 25, 2002 Palmetto General Hospital`s Response to Mt. Sinai`s First Request for Production of Documents filed.
Apr. 25, 2002 Palmetto General Hospital`s Notice of service of Answers to Mt. Medical Center`s First Interrogatories filed.
Apr. 22, 2002 Renewed Motion to Compel (filed by Respondent via facsimile).
Apr. 19, 2002 Palmetto General Hospital`s for Request for Production of Documents to Mt. Sinai Medical Center of Florida, Inc. filed.
Apr. 19, 2002 Palmetto General Hospital`s Notice of Service of its First Interrogatories to Mt. Sinai Medical Center of Florida, Inc. filed.
Apr. 16, 2002 Order Granting Continuance and Re-scheduling Hearing issued (hearing set for July 29 through August 1, 5 through 9 and 12 through 16, 2002; 9:00 a.m.; Tallahassee, FL).
Apr. 15, 2002 Reply to Mounty Sinai`s Response and Opposition to the Joint Motion for Continuance filed by Aventura.
Apr. 12, 2002 Notice of Telephonic Hearing (filed by Intervenors via facsimile).
Apr. 10, 2002 Response in Opposition to the Joint Motion for Continuance (filed by Mount Sinai via facsimile).
Apr. 09, 2002 Joint Motion for Continuance filed.
Mar. 08, 2002 Mount Sinai Medical Center`s Second Request for Production of Documents to Palmetto General Hospital (filed via facsimile).
Sep. 27, 2001 Notice of Cancellation of Deposition, Lifemark Hospitals of Florida (filed via facsimile).
Sep. 27, 2001 Notice of Cancellation of Deposition, P. Greenberg (filed via facsimile).
Sep. 18, 2001 Order Granting Continuance and Re-scheduling Hearing issued (hearing set for July 9 through 12, 15 through 19 and 22 through 26, 2002; 9:00 a.m.; Tallahassee, FL).
Sep. 14, 2001 Supplement to Joint Motion for Continuance filed by Intervenors.
Sep. 13, 2001 Joint Motion for Continuance filed.
Sep. 12, 2001 Response to Motion to Compel filed by Intervenor.
Sep. 10, 2001 Notice of Taking Deposition (through designated representative(s) filed.
Sep. 10, 2001 Notice of Taking Depositions Duces Tecum P. Greenberg filed.
Aug. 31, 2001 Mount Sinai Medical Center`s First Request for Production of Documents to Palmetto General Hospital (filed via facsimile).
Aug. 31, 2001 Mount Sinai Medical Center`s First Set of Interrogatories to Palmetto General Hospital (filed via facsimile).
Aug. 31, 2001 Motion to Compel and Request for Expedited Hearing (filed by Mount Sinai via facsimile)
Aug. 30, 2001 Notice of Appearance and Substition of Counsel (filed by Agency for Health Care Administration via facsimile).
Jul. 09, 2001 Palmetto General Hospital`s First Request for Production of Documents to Aventura Hospital and Medical Center filed.
Jul. 03, 2001 Aventura Hospital and Medical Center`s First Request for Production of Documents to Palmetto General Hospital filed.
Apr. 26, 2001 Mount Sinai Medical Center`s First Request for Production of Documents to Palmetto General Hospital filed.
Apr. 26, 2001 Mount Sinai Medical Center`s Notice of Service of First Set of Interrogatories to Palmetto General Hospital filed.
Mar. 06, 2001 Order Granting Intervention issued (Miami Beach Healthcare Group, Ltd., d/b/a Aventura Hospital and Medical Center, Lifemark Hospitals of Florida, Inc., d/b/a Palmetto General Hospital, Mount Sinai Medical Center of Florida, Inc.).
Feb. 14, 2001 Order of Consolidation issued. (consolidated cases are: 01-000357, 01-000358, 01-000359)
Feb. 13, 2001 Notice of Hearing issued (hearing set for October 8 through 12, 15 through 19 and 22 through 26, 2001; 9:00 a.m.; Tallahassee, FL).
Feb. 13, 2001 Order of Pre-hearing Instructions issued.
Feb. 09, 2001 Response to Initial Orders filed by Petitioner.
Feb. 09, 2001 Motion to Consolidate (01-0357, 01-0358 and 01-0359) filed by Petitioner.
Feb. 02, 2001 Petition to Intervene (Miami Beach Healthcare Group, Ltd) filed.
Jan. 30, 2001 Initial Order issued.
Jan. 26, 2001 Petition for Formal Administrative Hearing filed.
Jan. 26, 2001 Notice (of Agency referral) filed.
Jan. 26, 2001 Notice of Related Petitions filed.

Orders for Case No: 01-000357CON
Issue Date Document Summary
Oct. 08, 2003 Agency Final Order
Apr. 14, 2003 Recommended Order Approval of OHS programs in Northeast and Northwest Dade County recommended; not normal circumstances to have all existing providers in central and southern county and on beach; and to have commitment to close one of the existing programs.
Source:  Florida - Division of Administrative Hearings

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