STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
FLORIDA HEALTH SCIENCES CENTER ) INC., d/b/a TAMPA GENERAL HOSPITAL, )
)
Petitioner, )
)
vs. ) Case No. 00-0481
)
AGENCY FOR HEALTH CARE ) ADMINISTRATION and GALENCARE, INC., ) d/b/a BRANDON REGIONAL HOSPITAL, )
)
Respondents. )
) LAKELAND REGIONAL MEDICAL CENTER, ) INC., )
)
Petitioner, )
)
vs. ) Case No. 00-0482
)
AGENCY FOR HEALTH CARE ) ADMINISTRATION and GALENCARE, INC., ) d/b/a BRANDON REGIONAL HOSPITAL, )
)
Respondents. )
) ST. JOSEPH'S HOSPITAL, INC., )
)
Petitioner, )
)
vs. ) Case No. 00-0484
)
AGENCY FOR HEALTH CARE ) ADMINISTRATION and GALENCARE, INC., ) d/b/a BRANDON REGIONAL HOSPITAL, )
)
Respondents. )
)
UNIVERSITY COMMUNITY HOSPITAL, ) INC., d/b/a UNIVERSITY COMMUNITY ) HOSPITAL, )
)
Petitioner, )
)
vs. ) Case No. 00-0485
)
AGENCY FOR HEALTH CARE ) ADMINISTRATION and GALENCARE, INC., ) d/b/a BRANDON REGIONAL HOSPITAL, )
)
Respondents. )
)
RECOMMENDED ORDER
This case was heard by David M. Maloney, Administrative Law Judge of the Division of Administrative Hearings, from May 8, 2000, through June 10, 2000, in Tallahassee, Florida.
APPEARANCES
For Florida Health Sciences Center, d/b/a Tampa General Hospital, and St. Joseph's Hospital:
Robert A. Weiss, Esquire
Parker, Hudson, Rainer & Dobbs, LLP The Perkins House, Suite 200
118 North Gadsden Street Tallahassee, Florida 32301
For Lakeland Regional Medical Center: Jon Rue, Esquire
Sarah Evans, Esquire
Parker, Hudson, Rainer & Dobbs, LLP 1500 Marquis Two Tower
285 Peachtree Center Avenue, Northeast Atlanta, Georgia 30303
University Community Hospital:
James C. Hauser, Esquire Susan Harp, Esquire
Metz, Hauser & Husband, P.A. Post Office Box 10909 Tallahassee, Florida 32302-2902
Galencare, Inc., d/b/a Brandon Regional Hospital: Stephen A. Ecenia, Esquire
R. David Prescott, Esquire Thomas W. Konrad, Esquire
Rutledge, Ecenia, Purnell & Hoffman, P.A.
215 South Monroe Street, Suite 420 Post Office Box 551
Tallahassee, Florida 32302-0551 Agency for Health Care Administration:
Richard A. Patterson, Esquire
Agency for Health Care Administration 2727 Mahan Drive
Building Three, Suite 3431 Tallahassee, Florida 32308-5403
STATEMENT OF THE ISSUE
Whether the Certificate of Need application (CON 9239) of Galencare, Inc., d/b/a Brandon Regional Hospital ("Brandon") to establish an open heart surgery program at its hospital facility in Hillsborough County should be granted?
PRELIMINARY STATEMENT
On January 28, 2000, the Division of Administrative Hearings received a notice from the Agency for Health Care Administration ("AHCA" or the "Agency"). The notice advised DOAH of AHCA's receipt of a request for formal administrative proceeding from Florida Health Sciences Center, Inc., d/b/a
Tampa General Hospital ("Tampa General"). Attached to the notice was Tampa General's petition containing the request. The petition contests the preliminary decision of AHCA to grant Brandon's Certificate of Need application to establish an open heart surgery program at its hospital facility in Hillsborough County. The Agency's notice further requested that DOAH assign the matter to an administrative law judge to conduct all proceedings required by law.
In accord with the request and referral of the case, the matter was assigned Case No. 00-0481. The undersigned was designated the Administrative Law Judge to conduct the proceeding and an initial order was mailed to the parties on February 1, 2000.
The Agency also submitted a notice of related petitions.
It stated that four other petitions forwarded to DOAH were related to the case initiated by Tampa General. Filed by Lakeland Regional Medical Center, Inc. ("Lakeland Regional"); Manatee Memorial Hospital, L. P., St. Joseph's Hospital, Inc. ("St. Joseph's"); and University Community Hospital, Inc., d/b/a University Community Hospital ("UCH"), the petitions contested AHCA's preliminary decision on CON 9239 in favor of Brandon, just as Tampa General's. The four were assigned, respectively, DOAH Case Nos. 00-0482, 00-0483, 00-0484, and 00-0485, and were
consolidated by order of the Administrative Law Judge with the Tampa General case.
On February 14, 2000, following the filing of responses to the Initial Order, the case was set for hearing to commence May 10, 2000, and to run through June 9, 2000. Shortly thereafter, Manatee Memorial Hospital, L. P., filed a Notice of Voluntary Dismissal. Pursuant to the Notice an Order was entered closing the DOAH file in Case No. 00-0483.
The four remaining cases proceeded to final hearing as scheduled. At hearing, Brandon called and presented the testimony of fifteen witnesses: Michael Fencel, expert in hospital administration; Craig Randall Martin, M.D., expert in cardiology; R. Vijayanager, M. D. ("Dr. Vijay"), expert in cardiovascular surgery; Bruce Drennan, expert in business and economic development; Jane Ferguson; expert in critical care nursing, nursing administration, and open-heart surgery program administration; Star Amick, expert in nursing and nursing administration; Leela Beers, expert in cardiac catheterization program administration; John Butterick; David J. Anderson, expert in corporate and healthcare finance; Duane A. Ash, expert in healthcare finance; Gene Nelson, expert in health planning; Armand E. Balsano, expert in healthcare planning and healthcare finance; Sarah Loughran, expert in quantitative analysis of healthcare data; Scott L. Hopes, expert in healthcare planning,
epidemiology and biostatistics; and, Adithy Kumar Gandhi, expert in cardiology. Brandon offered 80 exhibits, marked as "Brandon Nos. 1-80." With the exception of rejected Brandon Nos. 21, 22 and 23, the exhibits were admitted into evidence.
St. Joseph's Hospital, by itself, called and presented the testimony of three witnesses: Isaac Mallah, expert in healthcare administration; John Dormois, M.D., expert in diagnostic and therapeutic cardiology; and Rod Randall, expert in diagnostic and therapeutic cardiology. St. Joseph's offered four exhibits jointly with Tampa General. They were marked as "Tampa General Nos. 1 through 4." All were received into evidence.
The Agency for Health Care Administration called one witness, Jeffrey Gregg, expert in health planning. The Agency offered one exhibit, "AHCA No. 1." It was received into evidence.
In concert, Lakeland Regional, St. Joseph's, and Tampa General, called and presented the testimony of two witnesses: Mark Richardson, expert in healthcare planning and
Richard Knapp, expert in healthcare accounting and healthcare finance.
Lakeland Regional, alone, called and presented the testimony of three witnesses: Jack Thomas Stephens, expert in hospital administration; Janet W. Fansler, expert in nursing,
nursing administration and cardiac services administration; and Margaret Elizabeth Voyles, expert in nursing and open-heart administration. Lakeland Regional offered 17 exhibits, marked as "Lakeland Nos. 1 through 17." Lakeland No. 12 was rejected. The others were received into evidence, with the exception of some comparisons in Lakeland No. 9 that were rejected so that Lakeland No. 9 was admitted in part and excluded in part.
Tampa General, on its own, called and presented the testimony of three witnesses: Maurine Ogden, expert in administration in cardiovascular programs with the exception of what takes place in operating rooms; Amy Joanne Paratore, expert in the administration of emergency trauma and air ambulance programs; Sandra MacLeod, M.D., expert in health care outcomes measurement. Tampa General offered four exhibits (jointly with St. Joseph's). The four were marked for identification as "Tampa General Nos. 1 through 4." All were received into evidence.
University Community Hospital called and presented the testimony of eight witnesses: Michael C. Carroll, expert in healthcare planning, healthcare finance, and hospital operations; Marc Bloom, M.D., expert in cardiac surgery and cardiovascular disease; Tomas Diaz; Brigitte Shaw; Richard A. Baehr, expert in healthcare planning, policy and healthcare finance; Mitchell B. O'Hara, M.D., expert in cardiology and
internal medicine; Karen Rivera and James Ellis Pope, M.D., expert in cardiology. Fifty-two exhibits of UCH's were marked as UCH Exhibits 1-52. UCH Exhibits 1-9, 12, 18, 20, 21, 25, 26,
and 28-52 were received in evidence. UCH Exhibits 10, 11, 13-17 and 27 were not offered. UCH Exhibit 19 was rejected and proffered. UCH Exhibits 22, 23 and 24 were rejected.
Four exhibits were offered by all the parties jointly.
Marked as "Joint Exhibits 1 through 4," the four were all received in evidence. Official recognition was taken of two exhibits, marked as "OR Exhibits 1 and 2."
Brandon and the Agency filed a joint proposed recommended order together with a memorandum of law on October 19, 2000.
The remainder of the parties filed a joint proposed recommended order and memorandum of law on the same date. The filings were timely.
FINDINGS OF FACT
District 6
District 6 is one of eleven health service planning districts in Florida set up by the "Health Facility and Services Development Act," Sections 408.031-408.045, Florida Statutes. See Section 408.031, Florida Statutes.
The district is comprised of five counties: Hillsborough, Manatee, Polk, Hardee, and Highlands. Section 408.032(5), Florida Statutes.
Of the five counties, three have providers of adult open heart surgery services: Hillsborough with three providers, Manatee with two, and Polk with one. There are in District 6 at present, therefore, a total of six existing providers.
Existing Providers
Hillsborough County
The three providers of open heart surgery services ("OHS") in Hillsborough County are Florida Health Sciences Center, Inc., d/b/a Tampa General Hospital ("Tampa General"), St. Joseph's Hospital, Inc. ("St. Joseph's"), and University Community Hospital, Inc., d/b/a University Community Hospital ("UCH"). For the most part, Interstate 75 runs in a northerly and southerly direction dividing Hillsborough County roughly in half. If the interstate is considered to be a line dividing the eastern half of the county from the western, all three existing providers are in the western half of the county within the incorporated area of the county's major population center, the City of Tampa.
Tampa General
Opened approximately a century ago, Tampa General has been at its present location in the City of Tampa on Davis Island at the north end of Tampa Bay since 1927.
The mission of Tampa General is three-fold. First, it provides a range of care (from simple to complex) for the west
central region of the state. Second, it supports both the teaching and research activities of the University of South Florida College of Medicine. Finally and perhaps most importantly, it serves as the "health care safety net" for the people of Hillsborough County. Evidence of its status as the safety net for those its serves is its Case Mix Index for Medicare patients: 2.01. At such a level, "the case mix at Tampa General is one of the highest in the nation in Medicare population." (Tr. 2452).
In keeping with its mission of being the county's health care safety net, Tampa General is a full-service acute care hospital. It also provides services unique to the county and the Tampa Bay area: a Level I trauma center, a regional burn center and adult solid organ transplant programs.
Tampa General is licensed for 877 beds. Of these, 723 are for acute care, 31 are designated skilled nursing beds, 59 are comprehensive rehabilitation beds, 22 are psychiatry beds, and 42 are neonatal intensive care beds (18 Level II and 24 Level III). Of the 723 acute care beds, 160 are set aside for cardiac care, although they may be occupied from time-to-time by non-cardiac care patients.
Tampa General is a statutory teaching hospital. It has an affiliation with the University of South Florida College of
Medicine. It offers 13 residency programs, serving approximately 200 medical residents.
Tampa General offers diagnostic and interventional cardiac catheterization services in four laboratories dedicated to such services. It has four operating rooms dedicated to open heart surgery. The range of open heart surgery services provided by Tampa General includes heart transplants.
Care of the open heart patient immediately after surgery is in a dedicated cardiovascular intensive care unit of
18 beds. Following stay in the intensive care unit, the patient is cared for in either a 10-bed intermediate care unit or a 30- bed telemetry unit.
Tampa General's full-service open heart surgery program provides high quality of care.
St. Joseph's
Founded by the Franciscan Sisters of Allegheny, New York, St. Joseph's is an acute care hospital located on Martin Luther King Boulevard in an "inner city kind of area" (Tr. 1586) of the City of Tampa near the geographic center of Hillsborough County.
On the hospital campus sit three separate buildings: the main hospital, consisting of 559 beds; across the street, St. Joseph's Women's Hospital, a 197-bed facility dedicated to the care of women; and, opened in 1998, Tampa Children's
Hospital, a 120-bed free-standing facility that offers pediatric services and Level II and Level III neonatal intensive care services.
In addition to the women's and pediatric facilities, and consistent with the full-service nature of the hospital, St. Joseph's provides behavioral health and oncology services, and most pertinent to this proceeding, open heart surgery and related cardiovascular services.
Designated as a Level 2 trauma center, St. Joseph's has a large and active emergency department. There were 90,211 visits to the Emergency Room in 1999, alone. Of the patients admitted annually, fifty-five percent are admitted through the Emergency Room.
The formal mission of St. Joseph's organization is to take care of and improve the health of the community it serves. Another aspect of the mission passed down from its religious founders is to take care of the "marginalized, . . . the people that in many senses cannot take care of themselves, [those to whom] society has . . . closed [its] eyes . . .". (Tr. 1584).
In keeping with its mission, it is St. Joseph's policy to provide care to anyone who seeks its hospital services without regard to ability to pay. In 1999, the hospital provided $33 million in charity care, as that term is defined by AHCA. In total, St. Joseph's provided $121 million in unfunded
care during the same year. Not surprisingly, St. Joseph's is also a disproportionate Medicaid provider.
The only hospital in the district that provides both adult and pediatric open heart surgery services, St. Joseph's has three dedicated OHS surgical suites, a 14-bed unit dedicated to cardiovascular intensive care for its adult OHS patients, a 12-bed coronary care unit and 86 progressive care beds, all with telemetry capability.
St. Joseph's provides high quality of care in its OHS. UCH
University Community Hospital, Inc., is a private, not-for-profit corporation. It operates two hospital facilities: the main hospital ("UCH") a 431-bed hospital on
Fletcher Avenue in north Tampa, and a second 120-bed hospital in Carrollwood.
UCH is accredited by the JCAHO "with commendation," the highest rating available. It provides patient care regardless of ability to pay.
UCH's cardiac surgery program is called the "Pepin Heart & Vascular Institute," after Art Pepin, "a 14-year heart transplant recipient [and] . . . the oldest heart transplant recipient in the nation alive today." (Tr. 2841). A Temple Terrace resident, Mr. Pepin also helped to fund the start of the institute.
Its service area for tertiary services, including OHS, includes all of Hillsborough County, and extends into south Pasco County and Polk County.
The Pepin Institute has excellent facilities and equipment. It has three dedicated OHS operating suites, three fully-equipped "state-of-the-art" cardiac catheterization laboratories equipped with special PTCA or angioplasty devices, and several cardiology care units specifically for OHS/PTCA services.
Immediately following surgery, OHS patients go to a dedicated 8-bed cardiovascular intensive care unit. From there patients proceed to a dedicated 20-bed progressive care unit ("PCU"), comprised of all private rooms. There is also a 24-bed PCU dedicated to PTCA patients. There is another 22-bed interventional unit that serves as an overflow unit for patients receiving PTCA or cardiac catheterization. UCH has a 22-bed medical cardiology unit for chest pain observation, congestive heart failure, and other cardiac disorders. Staffing these units requires about 110 experienced, full-time employees.
UCH has a special "chest pain" Emergency Room with specially-trained cardiac nurses and defined protocols for the treatment of chest pain and heart attacks. UCH offers a free van service for its UCH patients and their families that operates around the clock.
As in the case of the other two existing providers of OHS services in Hillsborough Counties, UCH provides a full range of cardiovascular services at high quality.
Manatee County
The two existing providers of adult open heart surgery services in Manatee County are Manatee Memorial Hospital, Inc., and Blake Medical Center, Inc. Neither are parties in this proceeding. Although Manatee Memorial filed a petition for formal administrative hearing seeking to overturn the preliminary decision of the Agency, the petition was withdrawn before the case reached hearing.
Polk County
The existing provider of adult open heart surgery services in Polk County is Lakeland Regional Medical Center, Inc. ("Lakeland").
Licensed for 851 beds, Lakeland is a large, not-for- profit, tertiary regional hospital. In 1999, Lakeland admitted approximately 30,000 patients. In fiscal 1999, there were about 105,000 visits to Lakeland's Emergency Room.
Lakeland provides a wide range of acute care services, including OHS and diagnostic and therapeutic cardiac catheterization. It draws its OHS patients from the Lakeland urban area, the rest of Polk County, eastern Hillsborough County
(particularly from Plant City), and some of the surrounding counties.
Lakeland has a high quality OHS program that provides high quality of care to its patients. It has two dedicated OHS surgical suites and a third surgical suite equipped and ready for OHS procedures on an as-needed basis. Its volume for the last few years has been relatively flat.
Lakeland offers interventional radiology services, a trauma center, a high-risk obstetrics service, oncology, neonatal intensive care, pediatric intensive care, radiation therapy, alcohol and chemical dependency, and behavioral sciences services.
Lakeland treats all patients without regard to their ability to pay, and provides a substantial amount of charity care, amounting in fiscal year 1999 to $20 million.
The Applicant
Brandon Regional Hospital ("Brandon") is a 255-bed hospital located in Brandon, Florida, an unincorporated area of Hillsborough County east of Interstate 75.
Included among Brandon's 255 beds are 218 acute care beds, 15 hospital-based skilled nursing unit beds, 14 tertiary Level II neonatal intensive care unit ("NICU") beds, and 8 tertiary Level III NICU beds.
Brandon offers a wide array of medical specialties and services to its patients including cardiology; internal medicine; critical care medicine; family practice; nephrology; pulmonary medicine; oncology/hematology; infectious disease; neurology; psychiatry; endocrinology; gastroenterology; physical medicine; rehabilitation; radiation oncology; pathology; respiratory therapy; and anesthesiology.
Brandon operates a mature cardiology program which includes inpatient diagnostic cardiac catheterization, outpatient diagnostic cardiac catheterization, electrocardiography, stress testing, and echocardiography. The Brandon medical staff includes 22 Board-certified cardiologists who practice both interventional and invasive cardiology. Board certification is a prerequisite to maintaining cardiology staff privileges at Brandon. Brandon's inpatient diagnostic cardiac catheterization program was initiated in 1989 and has performed in excess of 800 inpatient diagnostic cardiac catheterization procedures per year since 1996.
Brandon's daily census has increased from 159 to 187 for the period 1997 to 1999 commensurate with the burgeoning population growth in Brandon's primary service area. Brandon's Emergency Room is the third busiest in Hillsborough County and has more visits than Tampa General's Emergency Room. From 1997- 1999, Brandon's Emergency Room visits increased from 43,000 to
53,000 per year and at the time of hearing were expected to increase an additional 5-6 percent during the year 2000.
Brandon has also recently expanded many services to accommodate the growing health care needs of the Brandon community. For example, Brandon doubled the square footage of its Emergency Room and added 17 treatment rooms. It has also implemented an outpatient diagnostic and rehabilitation center, increased the number of labor, delivery and recovery suites, and created a high-risk ante-partum observation unit. Brandon was recently approved for 5 additional tertiary Level II NICU beds and 3 additional tertiary Level III NICU beds which increased Brandon's Level II/III NICU bed complement to 22 beds.
Brandon is a Level 5 hospital within HCA's internal ranking system, which is the company's highest facility level in terms of service, revenue, and patient service area population. Brandon has been ranked as one of the Nation's top 100 hospitals by HCIA/Mercer, Inc., based on Brandon's clinical and financial performance.
The Proposal
On September 15, 1999, Brandon submitted to AHCA CON Application 9239, its third application for an open heart surgery program in the past few years. (CON 9085 and 9169, the two earlier applications, were both denied.) The second of the three, CON 9169, sought approval on the basis of the same two
"not normal" circumstances alleged by Brandon to justify approval in this proceeding.
CON 9239 addresses the Agency's January 2002 planning horizon. Brandon proposes to construct two dedicated cardiovascular operating rooms ("CV-OR"), a six-bed dedicated cardiovascular intensive care unit ("CVICU"), a pump room and sterile prep room all located in close proximity on Brandon's first floor. The costs, methods of construction, and design of Brandon's proposed CV-OR, CVICU, pump room, and sterile prep room are reasonable.
As a condition of CON approval, Brandon will contribute $100,000 per year for five years to the Hillsborough County Health Care Program for use in providing health care to the homeless, indigent, and other needy residents of Hillsborough County.
The administration at Brandon is committed to establishing an adult open heart surgery program. The proposal is supported by the medical and nursing staff. It is also supported by the Brandon community.
The Brandon Community in East Hillsborough County
Brandon, Florida, is a large unincorporated community in Hillsborough County, east of Interstate 75. The Brandon area is one of the fastest growing in the state. In the last ten years alone, the area's population has increased from
approximately 90,000 to 160,000. An incorporated Brandon municipality (depending on the boundaries of the incorporation) has the potential to be the eighth largest city in Florida.
The Brandon community's population is projected to further increase by at least 50,000 over the next five to ten years. Brandon Regional Hospital's primary service area not only encompasses the Brandon community, but further extends throughout Hillsborough County to a populous of nearly 285,000 persons. The population of Brandon's primary service area is projected to increase to 309,000 by the year 2004, of which approximately 32,000 are anticipated to be over the age of 65, making Brandon's population "young" relative to much of the rest of the State.
The community of Brandon has attracted several new large housing developments which are likely to accelerate its projected growth. According to the Hillsborough County City- County Planning Commission, six of the eleven largest subdivisions of single-family homes permitted in 1998 are located nearby. For example, the infrastructure is in place for an 8,000-acre housing development east of Brandon which consists of 7,500 homes and is projected to bring in 30,000 people over the next 5-10 years. Two other large housing developments will bring an additional 5,000-10,000 persons to the Brandon area.
The community of Brandon is also an attractive area for relocating businesses. Recent additions to the Brandon area include, among others, CitiGroup Corporation, Atlantic Lucent Technologies, Household Finance, Ford Motor Credit, and Progressive Insurance. CitiGroup Corporation alone supplemented the area's population with approximately 5,000 persons. The community of Brandon has experienced growth in the development of health care facilities with 5 new assisted living facilities and one additional assisted living facility under construction. The average age of the residents of these facilities is much higher than of the Brandon area as a whole.
Existing Providers' Distance from Brandon's PSA
Brandon's primary service area ("PSA") is comprised of
12 zip code areas "in and around Brandon, essentially eastern Hillsborough County." (Tr. 1071).
Using the center of each zip code in Brandon's primary service area as the location for each resident of the zip code area, the residents of Brandon's PSA are an average of 15 miles from Tampa General, 16.4 miles from St. Joseph's, 17.3 miles from UCH and 24.6 miles from Lakeland Regional Medical Center. In contrast, they are only 7.7 miles from Brandon Regional Hospital.
Using the same methodology, the residents of Brandon's PSA are an average of more than 40 miles from Blake Medical Center (44.9 miles) and Manatee Memorial (41 miles).
Numeric Need
Publication
Rule 59C-1.033, Florida Administrative Code (the "Open Heart Surgery Program Rule" or the "Rule") specifies a methodology for determining numeric need for new open heart surgery programs in health planning districts. The methodology is set forth in section (7) of the Rule. Part of the methodology is a formula. See subsection (b) of Section (7) of the Rule.
Using the formula, the Agency calculated numeric need in the District for the January 2002 Planning Horizon. The calculation yielded a result of 3.27 additional programs needed to serve the District by January 1, 2002.
But calculation of numeric need under the formula is not all that is entailed in the complete methodology for determining numeric need. Numeric need is also determined by taking other factors into consideration. The Agency is to determine net need based on the formula "[p]rovided that the provisions of paragraphs (7)(a) and (7) (c) do not apply." Rule 59C-1.033(b), Florida Administrative Code.
Paragraph (7)(a) states, "[a] new adult open heart surgery program shall not normally be approved in the district" if the following condition (among others) exists:
2. One or more of the operational adult open heart surgery programs in the district that were operational for at least 12 months as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than 350 adult open heart surgery operations during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; . . .
Rule 59C-1.033(7)(a), Florida Administrative Code.
Both Blake Medical Center and Manatee Memorial Hospital in Manatee County were operational and performed less that 350 adult open heart surgery operations in the qualifying time periods described by subparagraph (7)(a)2., of the Rule. (Blake reported 221 open heart admissions for the 12-month period ending March 31, 1999; Manatee Memorial for the same period reported 319). Because of the sub-350 volume of the two providers, the Rule's methodology yielded a numeric need of "0" new open heart surgery programs in District 6 for the
January 2002 Planning Horizon. In other words, the numeric need of 3.27 determined by calculation pursuant to the formula prior to consideration of the programs described in (7)(a)2.1, was "zeroed out" by operation of the Rule. Accordingly, a numeric need of zero for the district in the applicable planning horizon
was published on behalf of the Agency in the January 29, 1999, issue of the Florida Administrative Weekly.
No Impact on Manatee County Providers
In 1998, only one resident of Brandon's PSA received an open heart surgery procedure in Manatee County. For the same period only two residents from Brandon's PSA received an angioplasty procedure in Manatee County. These three residents received the services at Manatee Memorial. Of the two Manatee County programs, Manatee Memorial consistently has a higher volume of open heart surgery cases and according to the latest data available at the time of hearing has "hit the mark" (Tr. 1546) of 350 procedures annually. Very few residents from other District 6 counties receive cardiac services in Manatee County.
Similarly, very few Manatee county residents migrate from Manatee County to another District 6 hospital to receive cardiac services. In 1998, only 19 of a total 1,209 combined open heart and angioplasty procedures performed at either Blake or Manatee Memorial originated in the other District 6 counties and only two were from the Brandon area.
Among the 6,739 Manatee County residents discharged from a Florida hospital in calendar year 1998 following any cardiovascular procedure (MDC-5), only 58(0.9 percent) utilized one of the other providers in District 6, and none were discharged from Brandon. Among the 643 open heart surgeries
performed on Manatee County residents in 1998, only 17 cases were seen at one of the District 6 open heart programs outside of Manatee County. There is, therefore, practically no patient exchange between Manatee County and the remainder of the District.
In sum, there is virtually no cardiac patient overlap between Manatee County and Brandon's primary service area. The development of an open heart surgery program at Brandon will have no appreciable or meaningful impact on the Manatee County providers.
CON 9169
In CON 9169, Brandon applied for an open heart surgery program on the basis of special circumstances due to no impact on low volume providers in Manatee County. The application was denied by AHCA.
The State Agency Action Report ("SAAR") on CON 9169, dated June 17, 1999, in a section of the SAAR denominated "Special Circumstances," found the application to demonstrate "that a program at Brandon would not impact the two Manatee hospitals . . .". (UCH Ex. No. 6, p. 5). The "Special Circumstances" section of the SAAR on CON 9169, however, does not conclude that the lack of impact constitutes special circumstances.
In follow-up to the finding of the application's demonstration of no impact to the Manatee County, the SAAR turned to impact on the non-Manatee County providers in District
The SAAR on CON 9169 states, "it is apparent that a new program in Brandon would impact existing providers [those in Hillsborough and Polk Counties] in the absence of significant open heart surgery growth." Id. In reference to Brandon's argument in support of special circumstances based on the lack of impact to the Manatee County providers, the CON 9169 SAAR
states:
[T]he applicant notes the open heart need formula should be applied to District 6 excluding Manatee County, which would result in the need for several programs. This argument ignores the provision of the rule that specifies that the need cannot exceed one.
(UCH No. 6, p. 7).
The Special Circumstances Section of the SAAR on CON 9169 does not deal directly with whether lack of impact to the Manatee County providers is a special circumstance justifying one additional program. Instead, the Agency disposes of Brandon's argument in the "Summary" section of the SAAR. There AHCA found Brandon's special circumstances argument to fail because "no impact on low volume providers" is not among those special circumstances traditionally or previously recognized in case law and by the Agency:
To demonstrate need under special circumstances, the applicant should demonstrate one or more of the following reasons: access problems to open heart surgery; capacity limits of existing providers; denial of access based on payment source or lack thereof; patients are seeking care outside the district for service; improvement of care to underserved population groups; and/or cost savings to the consumer. The applicant did not provide any documentation in support of these reasons.
(UCH No. 6, p. 29). Following reference to the Agency's publication of zero need in District 6, moreover, the SAAR reiterated that
[t]he implementation of another program in Hillsborough County is expected to significantly [a]ffect existing programs, in particular Tampa General Hospital, an important indigent care provider.
(Id.)
Typical "not normal circumstances" that support approval of a new program were described at hearing by one health planner as consisting of a significant "gap" in the current health care delivery system of that service.
Typical Not Normal Circumstances
Just as in CON 9169, none of the typical "not normal" circumstances" recognized in case law and with which the Agency has previous experience are present in this case.
The six existing OHS programs in District 6 have unused capacity, are available, and are adequate to meet the
projected OHS demand in District 6, in Hillsborough County ("County"), and in Brandon's proposed primary service area ("PSA"). All three County OHS providers are less than 17 miles from Brandon. There are, therefore, no major service geographic gaps in the availability of OHS services.
Existing providers in District 6 have unused capacity to meet OHS projected demand in January 2002. OHS volume for District 6 will increase by only 179 surgeries. This is modest growth, and can easily be absorbed by the existing providers. In fact, existing OHS providers have previously handled more volume than what is projected for 2002. In 1995, 3,313 OHS procedures were generated at the six OHS programs. Yet, only
3,245 procedures are projected for 2002. The demand in 1995 was greater than what is projected for 2002.
Neither population growth nor demographic characteristics of Brandon's PSA demonstrate that existing programs cannot meet demand. The greatest users of OHS services are the elderly. In 1999, the percentage in District 6 was similar to the Florida average; 18.25 percent for District 6,
18.38 percent for the state. The elderly percentage in Hillsborough County was less: 13.21 percent. The elderly component in Brandon's PSA was less still: 10.44 percent. In 2004, about 18.5 percent of Florida and District 6 residents are projected to be elderly. In contrast, only 10.5 percent of PSA
residents are expected to be elderly. Brandon's PSA is "one of the younger defined population segments that you could find in the State of Florida" (Tr. 2892) and likely to remain so.
Brandon's PSA will experience limited growth in OHS volume. Between 1999 - 2002, OHS volume will grow by only 36. The annual growth thereafter is only 13 surgeries. This is "very modest" growth and is among the "lowest numbers" of incremental growth in the State. Existing OHS providers can easily absorb this minimal growth.
Brandon's PSA,
is not an underserved area . . . there is excellent access to existing providers
and . . . the market in this service area is already quite competitive. There is not a single competitor that dominates. In fact, the four existing providers [in Hillsborough and Polk Counties] compete quite vigorously.
(Tr. 2897).
Existing OHS programs in District 6 provide very good quality of care. The surgeons at the programs are excellent. Dr. Gandhi, testifying in support of Brandon's application, testified that he was very comfortable in referring his patients for OHS services to St. Joseph and Tampa General, having, in fact, been comfortable with his father having had OHS at Tampa General. Likewise, Dr. Vijay and his group, also supporters of the Brandon application, split time between Bayonet Point and Tampa General. Dr. Vijay is very proud to be associated with
the OHS program at Tampa General. Lakeland also operates a high quality OHS program.
In its application, Brandon did not challenge the quality of care at the existing OHS programs in District 6. Nor did Brandon at hearing advance as reasons for supporting its application, capacity constraints, inability of existing providers to absorb incremental growth in OHS volume or failure of existing providers to meet the needs of the residents of Brandon's primary service area.
The Agency, in its preliminary decision on the application, agreed that typical "not normal" circumstances in this case are not present. Included among these circumstances are those related to lack of "geographic access."
The Agency's OHS Rule includes a geographic access standard of two hours. It is undisputed that all District 6 residents have access to OHS services at multiple OHS providers in the District and outside the District within two hours.
The travel time from Brandon to UCH or Tampa General, moreover, is usually less than 30 minutes anytime during the day, including peak travel time. Travel time from Brandon to St. Joseph's is about 30 minutes.
There are times, however, when travel time exceeds
30 minutes. There have been incidents when traffic congestion has prevented emergency transport of Brandon patients suffering
myocardial infarcts from reaching nearby open heart surgery providers within the 30 minutes by ground ambulance.
Delays in travel are not a problem in most OHS cases.
In the great majority, procedures are elective and scheduled in advance. OHS procedures are routinely scheduled days, if not weeks, after determining that the procedure is necessary. This high percentage of elective procedures is attributed to better management of patients, better technology, and improved stabilizing medications. The advent of drugs such as thrombolytic therapy, calcium channel blockers, beta blockers, and anti-platelet medications have vastly improved stabilization of patients who present at Emergency Rooms with myocardial infarctions.
In its application, Brandon did not raise outmigration as a not-normal circumstance to support its proposal and with good reason. Hillsborough County residents generally do not leave District 6 for OHS. In fact, over 96 percent of County residents receive OHS services at a District 6 provider.
Lack of out-migration shows two significant facts:
(a) existing OHS programs are perceived to be reasonably accessible; and (2) County residents are satisfied with the quality of OHS services they receive in the County. This
96 percent retention rate is even more impressive considering
there are many OHS programs and options available to County residents within a two-hour travel time.
In contrast, there are two low-volume OHS providers in Manatee County, one of them being Blake. Unlike Hillsborough County residents, only 78 percent of Manatee County residents remain in District 6 for OHS services. Such outmigration shows that these residents prefer to bypass closer programs, and travel further distances, to receive OHS services at high-volume facility in District 8, which they regard as offering a higher quality of service.
In its Application, Brandon does not raise economic access as a "not normal" circumstance. In fact, Brandon concedes that the demand for OHS services by Medicaid and indigent patients is very limited because Brandon's PSA is an affluent area.
Brandon does not "condition" its application on serving a specific number or percentage of Medicaid or indigent patients.
There are no financial barriers to accessing OHS services in District 6. All OHS providers in Hillsborough County and LRMC provide services to Medicaid and indigent patients, as needed. Approving Brandon is not needed to improve service or care to Medicaid or indigent patient populations.
Tampa General is the "safety net" provider for health care services to all County residents. Tampa General is an OHS provider geographically accessible to Brandon's PSA. Tampa General actively services the PSA now for OHS.
Brandon did not demonstrate cost savings to the patient population of its PSA if it were approved. Approving Brandon is not needed to improve cost savings to the patient population.
Brandon based its OHS and PTCA charges on the average charge for PSA residents who are serviced at the existing OHS providers. While that approach is acceptable, Brandon does not propose a charge structure which is uniquely advantageous for patients. Restated, patients would not financially benefit if Brandon were approved.
Tertiary Service
Open Heart Surgery is defined as a tertiary service by rule. A "tertiary health service" is defined in Section 408.032(17), Florida Statutes, as follows:
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.
As a tertiary service, OHS is necessarily a referral service. Most hospitals, lacking OHS capability, transfer their patients to providers of the service.
One might expect providers of open heart surgery in Florida in light of OHS' status as a tertiary service to be limited to regional centers of excellence. The reality of the six hospitals that provide open heart surgery services in District 6 defies this health-planning expectation. While each of the six provides OHS services of high quality, they are not "regional" centers since all are in the same health planning district. Rather than each being a regional center, the six together comprise more localized providers that are dispersed throughout a region, quite the opposite of a center for an entire region.
Brandon's Allegations of Special Circumstances.
Brandon presents two special circumstances for approval of its application. The first is that consideration of the low-volume Manatee County providers should not operate to "zero out" the numeric need calculated by the formula. The second relates to transfers and occasional problems with transfers for Brandon patients in need of emergency open heart services.
"Time is Muscle"
Lack of blood flow to the heart during a myocardial infarction ("MI") results in loss of myocardium (heart muscle). The longer the blood flow is disrupted or diminished, the more myocardium is lost. The more myocardium lost, the more likely the patient will die or, should the patient survive, suffer severe reduction in quality of life.
The key to good patient outcome when a patient is experiencing an acute MI is prompt evaluation and rapid treatment upon presentation at the hospital. Restoration of blood flow to the heart (revascularization) is the goal of the treating physician once it is recognized that a patient is suffering an MI. If revascularization is not commenced within
2 hours of the onset of an acute MI, an MI patient's potential for recovery is greatly diminished.
The need for prompt revascularization for a patient suffering an MI is summed up in the phrase "time is muscle," a phrase accepted as a maxim by cardiologists and cardiothoracic surgeons.
Recent advances in modern medicine and technology have improved the ability to stabilize and treat patients with acute MIs and other cardiac traumas. The three primary treatment modalities available to a patient suffering from an MI are: 1) thrombolytics; 2) angioplasty and stent placement; and, 3) open
heart surgery. Because of the advancement of the effectiveness of thrombolytics, thrombolytic therapy has become the standard of care for treating MIs.
Thrombolytic therapy is the administration of medication to dissolve blood clots. Administered intravenously, thrombolytic medication begins working within minutes to dissolve the clot causing the acute MI and therefore halt the damage done by an MI to myocardium.
The protocols to administer thrombolysis are similar among hospitals. If a patient presents with chest pain and the
E.R. physician identifies evidence of an active heart attack, thrombolysis is normally administered. If the E.R. physician is uncertain, a cardiologist is quickly contacted to evaluate the patient.
Achieving good outcomes in cases of myocardial infarctions requires prompt consultation with the patient, competent clinical assessment, and quick administration of appropriate treatment. The ability to timely evaluate patient conditions for MI, and timely administer thrombolytic therapy, is measured and evaluated nationally by the National Registry of Myocardial Infarction. The National Registry makes the measurement according to a standard known as "door-to-needle" time. This standard measures the time between the patient's
presentation at the E.R. and the time the patient is initially administered thrombolytic medication by injection intravenously.
Patients often begin to respond to thrombolysis within 10-15 minutes. Consistent with the maxim, "time is muscle," the shorter the door-to-needle time, the better the chance of the patient's successful recovery.
The effectiveness of thrombolysis continues to increase. For example, the advent of a drug called Reapro blocks platelet activity, and has increased the efficacy rate of thrombolysis to at least 85 percent.
As one would expect, then, thrombolytic therapy is the primary method of revascularization available to patients at Brandon. Due to the lack of open heart surgery backup, moreover, Brandon is precluded by Agency rule from offering angioplasty in all but the most extreme cases: those in which it is determined that a patient will not survive a transfer. While Brandon has protocols, authority, and equipment to perform angioplasty when a patient is not expected to survive a transfer, physicians are reluctant to perform angioplasty without open heart backup because of complications that can develop that require open heart surgery. Angioplasty, therefore, is not usually a treatment modality available to the MI patient at Brandon.
Although the care of choice for MI treatment, thrombolytics are not always effective. To the knowledge of the cardiologists who testified in this proceeding, there is not published data on the percentage of patients for whom thrombolytics are not effective. But from the cardiologists who offered their opinions on the percentage in the proceeding, it can be safely found that the percentage is at least 10 percent.
Thrombolytics are not ordered for these patients because they are inappropriate in the patients' individual cases. Among the contraindications for thrombolytics are bleeding disorders, recent surgery, high blood pressure, and gastrointestinal bleeding. Of the patients ineligible for thrombolytics, a subset, approximately half, are also ineligible for angioplasty. The other half are eligible for angioplasty. Under the most conservative projections, then at least 1 in 20 patients suffering an MI would benefit from timely angioplasty intervention for which open heart surgery back-up is required in all but the rarest of cases.
In 1997, 351 people presented to Brandon's Emergency Room suffering from an acute MI. In 1998, the number of MIs increased to 427. In 1999, 428 patients presented to Brandon's Emergency Room suffering from an acute MI.
At least 120 (10 percent) of the total 1206 MI patients presenting to Brandon's Emergency Room from 1997 to
1999 would have been ineligible for thrombolytics as a means of revascularization. Of these, half would have been ineligible for angioplasty while the other half would have been eligible. Sixty, therefore, is the minimum number of patients from 1997 to 1999 who would have benefited from angioplasty at Brandon using the most conservative estimate.
Transfers of Emergency Patients
Those patients who presented at Brandon's Emergency Room with acute MI and who could not be stabilized with thrombolytic therapy had to be transferred to one of the nearby providers of open heart surgery. In 1998, Brandon transferred an additional 190 patients who did not receive a diagnostic catheterization procedure at Brandon for either angioplasty or open heart surgery. For the first 9 months of 1999, 114 such transfers were made. Thus, in 1998 alone, Brandon transferred a total of 516 cardiac patients to existing providers for the provision of angioplasty or open heart surgery, more than any other provider in the District. In 1999, Brandon made 497 such transfers. Not all of these were emergency transfers, of course. But in the three years between 1997 and 1999 at least
60 patients were in need of emergency transfers who would benefit from angioplasty with open heart backup.
Of those Brandon patients determined to be in need of urgent angioplasty or open heart surgery, all must be
transferred to existing providers either by ambulance or by helicopter. Ambulance transfer is accomplished through ambulances maintained by the Hillsborough County Fire Department. Due to the cardiac patient's acuity level, ambulance transfer of such patients necessitates the use of ambulances equipped with Advanced Life Support Systems (ALS) in order to monitor the patient's heart functions and to treat the patient should the patient's condition deteriorate.
Hillsborough County operates 18 ambulances. All have ALS capability.
Patients with less serious medical problems are sometimes transported by private ambulances equipped with Basic Life Support Systems (BLS) that lack the equipment to appropriately care for the cardiac patient. But, private ambulances are not an option to transport critically ill cardiac patients because they are only equipped with BLS capability. Private ambulances, moreover, do not make interfacility transports of cardiac patients between Hillsborough County hospitals.
There are many demands on the ambulance transfer system in Hillsborough County. Hillsborough County's 18 ALS ambulances cover in excess of 960 square miles. Of these 18 ambulances, only three routinely operate within the Brandon area.
Hillsborough County ambulances respond to 911 calls before requests for interfacility transfers of cardiac patients and are extremely busy responding to automobile accidents, especially when it rains. As a result, Hillsborough County ambulances are not always available on a timely basis when needed to perform an interfacility transfer of a cardiac patient.
At times, due to inordinate delay caused by traffic congestion, inter-facility ambulance transport, even if the ambulance is appropriately equipped, is not an option for cardiac patients urgently in need of angioplasty or open heart surgery. It has happened, for example, that an ambulance has appeared at the hospital 8 hours after a request for transport. Some cardiac surgeons will not utilize ground transport as a means of transporting urgent open heart and angioplasty cases.
Expeditious helicopter transport in Hillsborough County is available as an alternative to ground transport. But, it too, from time-to-time, is problematic for patients in urgent need of angioplasty or open heart surgery.
Tampa General operates two helicopters through AeroMed, only one of which is located in Hillsborough County. AeroMed's two helicopters are not exclusively devoted to cardiac patients. They are also utilized for the transfer of emergency medical and trauma patients, further taxing the availability of
AeroMed helicopters to transfer patients in need of immediate open heart surgery or angioplasty.
BayCare operates the only other helicopter transport service serving Hillsborough County. BayCare maintains several helicopters, only one of which is located in Hillsborough County at St. Joseph's. BayCare helicopters are not equipped with intra-aortic balloon pump capability, thereby limiting their use in transporting the more complicated cardiac patients.
Helicopter transport is not only a traumatic experience for the patient, but time consuming. Once a request has been made by Brandon to transport a patient in need of urgent intervention, it routinely takes two and a half hours, with instances of up to four hours, to effectuate a helicopter transfer. At the patient's beside, AeroMed personnel must remove the patient's existing monitors, IVS, and drips, and refit the patient with AeroMed's equipment in preparation for flight. In more complicated cases requiring the use of an intra-aortic balloon pump, the patient's balloon pump placed at Brandon must be removed and substituted with the balloon pump utilized by AeroMed.
Further delays may be experienced at the receiving facility. The national average of the time from presentation to commencement of the procedure is reported to be two hours. In most instances at UCH, it is probably 90 minutes although
"[t]here are of course instances where it would be much faster
. . .". (Tr. 3212). On the other hand, there are additional delays from time-to-time. "[P]erhaps the longest circumstance would be when all the labs are full . . . or . . . even worse
. . . if all the staff has just left for the day and they are almost home, to then turn them around and bring them all back." (Id.)
Specific Cases Involving Transfers
Delays in the transfer process were detailed at hearing by Brandon cardiologists with regard to specific Brandon patients.
In cases in which "time is muscle," delay is critical except for one subset of such cases: that in which, no matter what procedure is available and no matter how timely that procedure can be provided, the patient cannot be saved.
Craig Randall Martin, M.D., Board-certified in Internal Medicine and Cardiovascular Disease, and an expert in cardiology, wrote to AHCA in support of the application by detailing two "examples of patients who were in an extreme situation that required emergent, immediate intervention . . . [intervention that could not be provided] at Brandon Hospital." (Tr. 408).
One of these concerned a man in his early sixties who was a patient at Brandon the night and morning of October 13 and
14, 1998. It represents one of the rare cases in which an emergency angioplasty was performed at Brandon even though the hospital does not have open heart backup.
The patient had presented to the Emergency Room at approximately 11:00 p.m., on October 13 with complaints of chest pain. Although the patient had a history of prior infarctions, PTCA procedures, and onset diabetes, was obese, a smoker and had suffered a stroke, initial evaluation, including EKG and blood tests, did not reveal an MI. The patient was observed and treated for what was probably angina. With the subsiding of the chest pain, he was appropriately admitted at 2:30 a.m. to a non- intensive cardiac telemetry bed in the hospital. At 3:00 a.m., he was observed to be stable.
A few hours or so later, the patient developed severe chest pain. The telemetry unit indicated a very slow heart rate. Transferred to the intensive care unit, his blood pressure was observed to be very low.
Aware of the seriousness of the patient's condition, hospital personnel called Dr. Martin. Dr. Martin arrived on the scene and determined the patient to be in cardiogenic shock, an extreme situation. In such a state, a patient has a survival rate of 15 to 20 percent, unless revascularization occurs promptly. If revascularization is timely, the survival rate doubles to 40 percent. Coincident with the cardiogenic shock,
the patient was suffering a complete heart block with a number of blood clots in the right coronary artery. The patient's condition, to say the least, was grave. Dr. Martin described the action taken at Brandon:
. . . I immediately called in the cardiac catheterization team and moved the patient to the catheterization laboratory.
* * *
Somewhere around 7:30 in the morning, I put a temporary pacemaker in, performed a diagnostic catheterization that showed that one of his arteries was completely clotted. He, even with the pacemaker giving him an adequate heart rate, and even with the use of intravenous medication for his blood pressure, . . . was still in cardiogenic shock.
* * *
And I placed an intra-aortic balloon pump
. . ., a special pump that fits in the aorta and pumps in synchrony with the heart and supports the blood pressure and circulation of the muscle. That still did not alleviate the situation . . . an excellent indication to do a salvage angioplasty on this patient.
I performed the angioplasty. It was not completely successful. The patient had a respiratory arrest. He required intubation, required to be put on a ventilator for support. And it became apparent to me that I did not have the means to save this patient at [Brandon].
I put a call to the . . . cardiac surgeon of choice . . . . [Because the surgeon was on vacation], [h]is associate [who happened to be in the operating room at UCH] called me back immediately . . . and said ["]Yes, I'll
take your patient. Send him to me immediately, I will postpone my current case in order to take care of your patient.["]
At that point, we called for helicopter transport, and there were great delays in obtaining [the] transport. The patient was finally transferred to University Community Hospital, had surgery, was unsuccessful and died later that afternoon.
(Tr. 409-412).
By great delays in the transport, Dr. Martin referred to inability to obtain prompt helicopter transport. University Community Hospital, the receiving hospital, was not able to find a helicopter. Dr. Martin, therefore, requested Tampa General (a third hospital uninvolved from the point of being either the transferring or the receiving hospital) to send one of its two helicopters to transfer the patient from Brandon to UCH.
Dr. Martin described Tampa General's response:
They balked. And I did not know they balked until an hour later. And I promptly called them back, got that person on the telephone, we had a heated discussion. And after that person checked with their supervisor, the helicopter was finally sent.
There was at least an hour-and-a-half delay in obtaining a helicopter transport on this patient that particular morning that was unnecessary. And that is critical when you have a patient in this condition.
(Tr. 413, emphasis supplied.)
In the case of this patient, however, the delay in the transport from Brandon to the UCH cardiovascular surgery
table, in all likelihood, was not critical to outcome. During
the emergency angioplasty procedure at Brandon, some of the clot causing the infarction was dislodged. It moved so as to create a "no-flow state down the right coronary artery. In other words, . . ., it cut off[] the microcirculation . . . [so that] there is no place for the blood . . . to get out of the artery. And that's a devastating, deadly problem." (Tr. 2721). This "embolization, an unfortunate happenstance [at times] with angioplasty", id., probably sealed the patient's fate, that is,
death. It is very likely that the patient with or without surgery, timely or not, would not have survived cardiogenic shock, complete heart block, and the circumstance of no circulation in the right coronary artery that occurred during the angioplasty procedure.
Adithy Kumar Gandhi, M.D., is Board-certified in Internal Medicine and Cardiology. Employed by the Brandon Cardiology Group, a three-member group in Brandon, Dr. Gandhi was accepted as an expert in the field of cardiology in this proceeding. Dr. Gandhi testified about two patients in whose cases delays occurred in transferring them to St. Joseph’s. He also testified about a third case in which it took two hours to transfer the patient by helicopter to Tampa General.
The first case involves an elderly woman. She had multiple-risk factors for coronary disease including a family
history of cardiac disease and a personal history of “chest pain.” (Tr. 2299). The patient presented at Brandon’s Emergency Room on March 17, 1999 at around 2:30 p.m. Seen by the E.R. physician about 30 minutes later, she was placed in a monitored telemetry bed. She was determined to be stable.
During the next two days, despite family and personal history pointing to a potentially serious situation, the patient refused to submit to cardiac catheterization at Brandon as recommended by Dr. Gandhi. She maintained her refusal despite results from a stress test that showed abnormal left ventricular systolic function. Finally, on March 20, after a meeting with family members and Dr. Gandhi, the patient consented to the cath procedure. The procedure was scheduled for March 22.
During the procedure, it was discovered that a major artery of the heart was 80 percent blocked. This condition is known as the “widow-maker,” because the prognosis for the patient is so poor.
Dr. Gandhi determined that “the patient needed open heart surgery and . . . to be transferred immediately to a tertiary hospital.” (Tr. 2305-6). He described that action he took to obtain an immediate transfer as follows:
I talked to the surgeon up at St. Joseph’s and I informed him I have had difficulties transferring patients to St. Joseph’s the same day. [I asked him to] do me a favor and transfer the patient out of Brandon
Hospital as soon as possible by helicopter. The surgeon promised me that he would take care of that.
(Tr. 2261).
The assurance, however, failed. The patient was not transferred that day. That night, while still at Brandon, complications developed for the patient. The complications demanded that an intra-aortic balloon pump be inserted in order to increase the blood flow to the heart. After Dr. Gandhi’s partner inserted the pump, he, too, contacted the surgeon at St. Joseph’s to arrange an immediate transfer for open heart surgery. But the patient was not transferred until early the next morning. Dr. Gandhi’s frustration at the delay for this critically ill patient in need of immediate open heart surgery is evident from the following testimony:
So the patient had approximately 18 hours of delay of getting to the hospital with bypass capabilities even though the surgeon knew that she had a widow-maker, he had promised me that he would make those transfer arrangements, even though St. Joseph’s Hospital knew that the patient needed to be transferred, even though I was promised that the patient would be at a tertiary hospital for bypass capabilities.
(Tr. 2262).
Rod Randall, M.D., is a cardiologist whose practice is primarily at St. Joseph’s. He had active privileges at Brandon until 1998 when he “switched to courtesy privileges,”
(Tr. 1735) at Brandon. He reviewed the medical records of the first patient about whom Dr. Gandhi testified.
A review of the patient’s medical records disclosed no adverse outcome due to the patient’s transfer. To the contrary, the patient was reasonably stable at the time of transfer. Nonetheless, it would have been in the patient’s best interest to have been transferred prior to the catheterization procedure at Brandon. As Dr. Randall explained,
[W]e typically cath people that we feel are going to have a probability of coronary artery disease. That is, you don’t tend to cath someone that [for whom] you don’t expect to find disease . . . . If you are going to cath this patient, [who] is in a higher risk category being an elderly female with . . . diminished injection fraction
. . . why put the patient through two procedures. I would have to do a diagnostic catheterization at one center and do some type of intervention at another center. So, I would opt to transfer that patient to a tertiary care center and do the diagnostic catheterization there.
(Tr. 1764, 1765). Furthermore, regardless of what procedure had been performed, the significant left main blockage that existed prior to the patient’s presentation at Brandon E.R. meant that the likely outcome would be death.
The second of the patients Dr. Gandhi transferred to St. Joseph’s was a 74-year-old woman. Dr. Gandhi performed “a heart catheterization at 5:00 on Friday.” (Tr. 2267). The cath revealed a 90 percent blockage of the major artery of the heart,
another widow-maker. Again, Dr. Gandhi recommended bypass surgery and contacted a surgeon at St. Joseph’s. The transfer, however, was not immediate. “Finally, at approximately 11:00 the patient went to St. Joseph’s Hospital. That night she was operated on . . . ”. (Tr. 2267). If Brandon had had open heart surgery capability, “[t]hat would have increased her chances of survival.” No competent evidence was admitted that showed the outcome, however, and as Dr. Randall pointed out, the medical records of the patient do not reveal the outcome.
The patient who was transferred to Tampa General (the third of Dr. Ghandhi's patients) had presented at Brandon’s ER on February 15, 2000. Fifty-six years old and a heavy smoker with a family history of heart disease, she complained of severe chest pain. She received thrombolysis and was stabilized. She had presented with a myocardial infarction but it was complicated by congestive heart failure. After waiting three days for the myocardial infarction to subside, Dr. Gandhi performed cardiac catheterization. The patient “was surviving on only one blood vessel in the heart, the other two vessels were 100 percent blocked. She arrested on the table.” (Tr. 2271). After Dr. Gandhi revived her, he made arrangements for her transfer by helicopter.
The transfer was done by helicopter for two reasons: traffic problems and because she had an intra-aortic balloon
pump and there are a limited number of ambulances with intra- aortic balloon pump maintenance capability. If Brandon had had the ability to conduct open heart surgery, the patient would have had a better likelihood of successful outcome: “the surgeon would have taken the patient straight to the operating room. That patient would not have had a second arrest as she did at Tampa General.” (Tr. 2273).
Marc Bloom, M.D., is a cardiothoracic surgeon. He performs open-heart surgery at UCH, where he is the chief of cardiac surgery. He reviewed the records of this 54-year-old woman. The records reflect that, in fact, upon presentation at Brandon’s E.R., the patient’s heart failure was very serious:
She had an echocardiogram done that . . . showed a 20 percent ejection fraction . . . I mean when you talk severe, this would be classified as a severe cardiac compromise with this 20 percent ejection fraction.
(Tr. 2712). Once stabilized, the patient should have been transferred for cardiac catheterization to a hospital with open- heart surgery instead of having cardiac cath at Brandon. It is true that delay in the transfer once arrangements were made was a problem. The greater problem for the patient, however, was in her management at Brandon. It was very likely that open heart surgery would be required in her case. She should have been transferred prior to the catheterization as soon as became known
the degree to which her heart was compromised, that is, once the results of the echocardiogram were known.
Adam J. Cohen, M.D., is a cardiologist with Diagnostic Consultative Cardiology, a group located in Brandon that provides cardiology services in Hillsborough County.
Dr. Cohen provided evidence of five patients who presented at Brandon and whose treatments were delayed because of the need for a transfer.
The first of these patients was a 76-year old male who presented to Brandon’s ER on April 6, 1999. Dr. Cohen considered him to be suffering “a complicated myocardial infarction.” (Brandon Ex. 45, p. 43) Cardiac catheterization conducted by Dr. Cohen showed “severe multi-vessel coronary disease, cardiogenic shock, severely impaired [left ventricular] function for which an intra-aortic balloon pump was placed
. . .”. (Id.) During the placement of the pump, the patient stopped breathing and lost pulse. He was intubated and stabilized.
A helicopter transfer was requested. There was only one helicopter equipped to conduct the transfer. Unfortunately, “the same day . . . there was a mass casualty event within the City of Tampa when the Gannet Power Plant blew up . . .”. (Brandon Ex. 45, p. 44). An appropriate helicopter could not be
secured. Dr. Cohen did not learn of the unavailability of helicopter transport for an hour after the request was made.
Eventually, the patient was transferred by ambulance to UCH. There, he received angioplasty and “stenting of the right coronary artery times two.” (Id., at p. 47.) After a slow
recovery, he was discharged on April 19.
In light of the patient’s complex cardiac condition, he received a good outcome. This patient is an example of another patient who should have been transferred sooner from Brandon since Brandon does not have open heart surgery capability.
The second of Dr. Cohen’s patients presented at Brandon’s E.R. at 10:30 p.m. on June 14, 1999. He was 64 years old with no risk factors for coronary disease other than high blood pressure. He was evaluated and diagnosed with “a large and acute myocardial infarction”
Two hours later, the therapy was considered a failure because there was no evidence that the area of the heart that was blocked had been reperfused. Dr. Cohen recommended transfer to UCH for a salvage angioplasty. The call for a helicopter was made at 12:58 a.m. (early the morning of June 15) and the helicopter arrived 40 minutes later.
At UCH, the patient received angioplasty procedure and stenting of two coronary arteries. He suffered
“[m]oderately impaired heart function, which is reflective of myocardial damage.” (Brandon Ex. 45, p. 58). If salvage angioplasty with open heart backup had been available at Brandon, the patient would have received it much more quickly and timely.
Whether the damage done to the patient’s heart during the episode could have been avoided by prompt angioplasty at Brandon is something Dr. Cohen did not know. As he put it, “I will never know, nor will anyone else know.” (Brandon Ex. 45,
p. 60). The patient later developed cardiogenic shock and repeated ventricular tachycardia, requiring numerous medical interventions. Because of the interventions and mechanical trauma, he required surgery for repair of his right femoral artery. The patient recently showed an injection fraction of
45 percent below the minimum for normal of 50 percent.
The third patient was a 51-year-old male who had undergone bypass surgery 19 years earlier. After persistent recurrent anginal symptoms with shortness of breath and diaphoresis, he presented at Brandon’s E.R. at 1:00 p.m. complaining of heavy chest pain. Thrombolytic therapy was commenced. Dr. Cohen described what followed:
[H]he had an episode of heart block, ventricular fibrillation, losing consciousness, for which he received ACLS efforts, being defibrillated, shocked, times three, numerous medications, to convert him
to sinus rhythm. He was placed on IV anti- arrhythmics consisting of amiodarone.
The repeat EKG showed a worsening of progression of his EKG changes one hour after the initiation of the TPA. Based on that information, his clinical scenario and his previous history, I advised him to be transferred to University Hospital for a salvage angioplasty.
(Brandon Ex. 45, p. 62). Transfer was requested at 1:55 p.m. The patient departed Brandon by helicopter at 2:20 p.m.
The patient received the angioplasty at UCH. Asked how the patient would have benefited from angioplasty at Brandon without having to have been transferred, Dr. Cohen answered:
In a more timely fashion, he would have received an angioplasty to the culprit lesion involved. There would have been much less occlusive time of that artery and thereby, by inference, there would have been greater salvage of myocardium that had been at risk.
(Brandon Ex. 45, p. 65). The patient, having had bypass surgery in his early thirties, had a reduced life expectancy and impaired heart function before his presentation at Brandon in June of 1999.
The time taken for the transfer of the patient to UCH was not inordinate. The transfer was accomplished with relative and expected dispatch. Nonetheless, the delay between realization at Brandon of the need for a salvage angioplasty and actual receipt of the procedure after a transfer to UCH
increased the potential for lost myocardium. The lack of open heart services at Brandon resulted in reduced life expectancy for a patient whose life expectancy already had been diminished by the early onset of heart disease.
The fourth patient of Dr. Cohen’s presented to Brandon’s E.R. at 8:30, the morning of August 29, 1999. A fifty-four-year-old male, he had been having chest pain for a month and had ignored it. An EKG showed a complete heart block with atrial fibrillation and change consistent with acute myocardial infarction. Thrombolytic therapy was administered. He continued to have symptoms including increased episodes of ventricular arrhythmias. He required dopamine for blood
pressure support due to his clinical instability and the lack of effectiveness of the thrombolytics.
The patient refused a transfer and catheterization at first. Ultimately, he was convinced to undergo an angioplasty. The patient was transferred by helicopter to UCH. The patient was having a “giant ventricular infarct . . . a very difficult situation to take care of . . . and the majority of [such] patients succumb to [the] disease . . .”. (Tr. 2703). The cardiologist was unable to open the blockage via angioplasty.
Dr. Bloom was called in but the patient refused surgical intervention. After interaction with his family the patient consented. Dr. Bloom conducted open heart surgery. The
patient had a difficult post-operative course with arrythmias because “[h]e had so much dead heart in his right ventricle
. . .”. (Id.) The patient received an excellent outcome in that he was seen in Dr. Bloom’s office with 40 percent injection fraction. Dr. Bloom “was just amazed to see him back in the office . . . and amazed that this man is alive.” (Tr. 2704).
Most of the delay in receiving treatment was due to the patient’s reluctance to undergo angioplasty and then open heart surgery.
The fifth patient of Dr. Cohen’s presented at Brandon’s E.R. on March 22, 2000. He was 44 years old with no prior cardiac history but with numerous risk factors. He had a sudden onset of chest discomfort. Lab values showed an elevation consistent with myocardial injury. He also had an abnormal EKG. Dr. Cohen performed a cardiac cath on March 23, 2000. The procedure showed a totally occluded left anterior descending artery, one of the three major arteries serving the heart. Had open heart capability been available at Brandon, he would have undergone angioplasty and stenting immediately. As it was, the patient had to be transferred to UCH. A transfer was requested at 10:25 that morning and the patient left Brandon’s cath lab at 11:53.
Daniel D. Lorch, M.D., is a specialist in pulmonary medicine who was accepted as an expert in internal medicine,
pulmonary medicine and critical care medicine, consistent with his practice in a “five-man pulmonary internal medicine critical care group.” (Brandon Ex. 42, p. 4). Dr. Lorch produced medical records for one patient that he testified about during his deposition. The patient had presented to Brandon’s E.R. with an MI. He was transferred to UCH by helicopter for care.
Dr. Lorch supports Brandon’s application. As he put it during his deposition:
[Brandon] is an extremely busy community hospital and we are in a very rapidly growing area. The hospital is quite busy and we have a large number of cardiac patients here and it is not infrequently that a situation comes up where there are acute cardiac events that need to be transferred out.
(Brandon Ex. 42, p. 20).
Transfers Following Diagnostic Cardiac Catheterization
Brandon transfers a high number cardiac patients for the provision of angioplasty or open heart surgery in addition to those transferred under emergency conditions. In 1996, Brandon performed 828 diagnostic cardiac catheterization procedures. Of this number, 170 patients were transferred to existing providers for open heart surgery and 170 patients for angioplasty.
In 1997, Brandon performed 863 diagnostic catheterizations of which 180 were transferred for open heart
surgery and 159 for angioplasty. During 1998, 165 patients were transferred for open heart surgery and 161 for angioplasty out of 816 diagnostic catheterization procedures. For the first nine months of 1999, Brandon performed 639 diagnostic catheterizations of which 102 were transferred to existing providers for open heart surgery and 112 for angioplasty.
A significant number of patients are transferred from Brandon for open heart surgery services. These transfers are consistent with the norm in Florida. After all, open heart surgery is a tertiary service. Patients are routinely transferred from most Florida hospitals to tertiary hospitals for OHS and PCTA. The large majority of Florida hospitals do not have OHS programs; yet, these hospitals receive patients who need OHS or PTCA.
Transfers, although the norm, are not without consequence for some patients who are candidates for OHS or PCTA.
If Brandon had open heart and angioplasty capability, many of the 1220 patients determined to be in need of angioplasty or open heart surgery following a diagnostic catheterization procedure at Brandon could have received these procedures at Brandon, thereby avoiding the inevitable delay and stress occasioned by transfer. Moreover, diagnostic catheterizations and angioplasties are often performed
sequentially. Therefore, Brandon patients determined to be in need of angioplasty following a diagnostic catheterization would have had access to immediate angioplasty during the same procedure thus reducing the likelihood of a less than optimal outcome as the result of an additional delay for transfer.
Adverse Impact on Existing Providers Competition
There is active competition and available patient choices now in Brandon's PSA. As described, there are many OHS programs currently accessible to and substantially serving Brandon's PSA. There is substantial competition now among OHS providers so as to provide choices to PSA residents.
There are no financial benefits or cost savings accruing to the patient population if Brandon is approved. Brandon does not propose lower charges than the existing OHS providers.
Balanced Budget Act
The Balanced Budget Act of 1997 has had a profound negative financial impact on hospitals throughout the country. The Act resulted in a significant reduction in the amount of Medicare payments made to hospitals for services rendered to Medicare recipients.
During the first five years of the Act's implementation, Florida hospitals will experience a $3.6 billion
reduction in Medicare revenues. Lakeland will receive $17 million less, St.Joseph's will receive $44 million less, and Tampa General will receive $53 million less.
The impact of the Act has placed most hospitals in vulnerable financial positions. It has seriously affected the bottom line of all hospitals. Large urban teaching hospitals, such as TGH, have felt the greatest negative impact, due to the Act's impact on disproportionate share reimbursement and graduate medical education payment.
The Act's impact upon Petitioners render them materially more vulnerable to the loss of OHS/PTCA revenues to Brandon than they would have been in the absence of the Act.
Adverse Impact on Tampa General
Tampa General is the "safety net provider" for Hillsborough County. Tampa General is a Medicaid disproportionate share provider. In fiscal year 1999, the hospital provided $58 million in charity care, as that term is defined by AHCA.
Tampa General plays a unique, essential role in Hillsborough County and throughout West Central Florida in terms of provision of health care. Its regional role is of particular importance with respect to Level I trauma services, provision of burn care, specialized Level III neonatal and perinatal intensive care services, and adult organ transplant services.
These services are not available elsewhere in western or central Florida.
In fiscal year 1999, Tampa General experienced a net loss of $12.6 million in providing the services referenced above. It is obligated under contract with the State of Florida to continue to provide those services.
Tampa General is a statutory teaching hospital. In fiscal year 1999, it provided unfunded graduate medical education in the amount of $19 million.
Since 1998, Tampa General has consistently experienced losses resulting from its operations, as follows:
FY 1998-$29 million, FY 1999-$27 million; FY 2000 (5 months)-$10 million.
The hospital’s financial condition is not the result of material mismanagement. Rather, its financial condition is a function of its substantial provision of charity and Medicaid services, the impact of the Act, reduced managed care revenues, and significant increases in expense.
Tampa General’s essential role in the community and its distressed financial condition have not gone unnoticed. The Greater Tampa Chamber of Commerce established in February of 2000 an Emergency Task Force to assess the hospital's role in the community, and the need for supplemental funding to enable it to maintain its financial viability.
Tampa General requires supplemental funding on a continuing basis in order to begin to restore it to a position of financial stability, while continuing to provide essential community services, indigent care, and graduate medical education. It will require ongoing supplemental funding of $20-
25 million annually to avoid triggering the default provision under its bond covenants.
As of the close of hearing, the 2000 session of the Florida Legislature had adjourned. The Legislature appropriated approximately $22.9 million for Tampa General. It is, of course, uncertain as to what funding, if any, the Legislature will appropriate to the hospital in future years, as the terms which constitute the appropriations must be revisited by the Legislature on an annual basis.
Tampa General has prepared internal financial projections for its fiscal years 2000-2002. It projects annual operating losses, as follows: FY 2000-$20.1 million; FY 2001-
$20.6 million; FY 2002-$31.9 million. While its projections anticipate certain "strategic initiatives" that will enhance its financial condition, including continued supplemental legislative funding, the success and/or availability of those initiatives are not "guaranteed" to be successful.
If the Brandon program is approved, Tampa General will lose 93 OHS cases and 107 angioplasty cases during
Brandon's second year of operation. That loss of cases will result in a $1.4 million annual reduction in TGH's net income, a material adverse impact given Tampa General’s financial condition.
OHS services provide a positive contribution to Tampa General's financial operations. Those services constitute a core piece of Tampa General's business. The anticipated loss of income resulting from Brandon's program pose a threat to the hospital’s ability to provide essential community services.
Adverse Impact on UCH
UCH operated at a financial break-even in its fiscal year 1999. In the first five months of its fiscal year 2000, the hospital has experienced a small loss. This financial distress is primarily attributed to less Medicare reimbursement due to the Act and less reimbursement from managed care.
UCH's reimbursement for OHS services provides a good example of the financial challenges facing hospitals. In 1999, UCH's net income per OHS case was reduced 33 percent from 1998. Also in 1999, UCH received OHS reimbursement of only 32 percent of its charges.
UCH would be substantially and adversely impacted by approval of Brandon's proposal. As described, UCH currently is a substantial provider of OHS and angioplasty services to residents of Brandon's PSA. There are many cardiologists on
staff at Brandon who also actively practice at UCH. UCH is very accessible from Brandon's PSA.
UCH reasonably projects to lose the following volumes in the first three years of operation of the proposed program:
a loss of 78-93 OHS procedures, a loss of 24-39 balloon angioplasties, and a loss of 97-115 stent angioplasties. Converting this volume loss to financial terms, UCH will suffer the following financial losses as a direct and immediate result of Brandon being approved: about $1.1 million in the first year, and about $1.2 million in the second year, and about $1.3 million in the third year.
As stated, UCH is currently operating at about a financial break-even point. The impact of the Balanced Budget Act, reduced managed care reimbursement, and UCH's commitment to serve all patients regardless of ability to pay has a profound negative financial impact on UCH. A recurring loss of more than
$1 million dollars per year due to Brandon's new program will cause substantial and adverse impact on UCH.
Adverse Impact on St. Joseph’s
If Brandon's application is approved, St. Joseph’s will lose 47 OHS cases and 105 PTCA cases during Brandon's second year. That loss of cases will result in a $732,000 annual reduction in SJH's net income. That loss represents a material impact to SJH.
Between 1997 and 2000, St. Joseph’s has experienced a pattern of significant deterioration in its financial performance. Its net revenue per adjusted admission had been reduced by 12 percent, while its costs have increased significantly.
St. Joseph's net income from operations has deteriorated as follows: FYE 6/30/97-$31 million; FYE 12/31/98-
$24 million; FYE 12/31/99-$13.8 million. A net operating income of $13.8 million is not much money relative to St Joseph's size, the age of its physical plant, and its need for capital to maintain and improve its facilities in order to remain competitive.
St. Joseph’s offers a number of health care services to the community for which it does not receive reimbursement. Unreimbursed services include providing hospital admissions and services to patients of a free clinic staffed by volunteer members of SJH's medical staff, free immunization programs to low-income children, and a parish nurse program, among others.
St. Joseph’s evaluates such programs annually to determine whether it has the financial resources to continue to offer them. During the past two years, the hospital has been forced to eliminate two of its free community programs, due to its deteriorating financial condition.
St. Joseph’s anticipates that it will have to eliminate additional unreimbursed community services if it experiences an annual reduction in net income of $730,000.
Adverse Impact to LRMC
The approval of Brandon will have an impact on Lakeland.
Lakeland will suffer a financial loss of about
$253,000 annually. This projection is based on calculated contribution margins of OHS and PTCA/stent procedures performed at the hospital.
A loss of $253,000 per year is a material loss at Lakeland, particularly in light of its slim operating margin and the very substantial losses it has experienced and will continue to experience as a result of the Balanced Budget Act of 1997.
In addition to the projected loss of OHS and other procedures based upon Brandon's application, Lakeland may experience additional lost cases from areas such as Bartow and Mulberry from which it draws patients to its open heart/cardiology program.
Lakeland will also suffer material adverse impacts to its OHS program due to the negative effect of Brandon's program on its ability to recruit and retain nurses and other highly skilled employees needed to staff its program. The approval of Brandon will also result in higher costs at existing providers
such as Lakeland as they seek to compete for a limited pool of experienced people by responding to sign-on bonuses and by reliance on extensive temporary nursing agencies and pools.
Nursing Staff/Recruitment
The staffing patterns and salaries for Brandon's projected 40.1 full-time equivalent employees to staff its open heart surgery program are reasonable and appropriate.
Filling the positions will not be without some difficulty. There is a shortage for skilled nursing and other personnel needed for OHS programs nationally, in Florida and in District 6. The shortage has been felt in Hillsborough County. For example, it has become increasingly difficult to fill vacancies that occur in critical nursing positions in the coronary intensive care unit and in telemetry units at Tampa General. Tampa General's expenses for nursing positions have "increased tremendously." (Tr. 2622). To keep its program going, the hospital has hired "travelers . . . short-term employment, registered nurses that come from different agencies,
. . . with [the hospital] a minimum of 12 weeks." (Tr. 2622). In fact, all hospitals in the Tampa Bay area utilize pool staff and contract staff to fill vacancies that appear from time-to- time. Use of contract staff has not diminished quality of care at the hospitals, although "they would not be assigned to the sickest patients." (Tr. 2176).
Another technique for dealing with the shortage is to have existing full-time staff work overtime at overtime pay rates. St. Joseph's and Lakeland have done so. As a result, they have substantially exceeded their budgeted salary expenses in recent months.
It will be difficult for Brandon to hire surgical RNs, other open heart surgery personnel and critical care nurses necessary to staff its OHS program. The difficulty, however, is not insurmountable.
To meet the difficulty, Brandon will move members of its present staff with cardiac and open heart experience into its open heart program. It will also train some existing personnel in conjunction with the staff and personnel at Bayonet Point.
In addition to drawing on the existing pool of nurses, Brandon can utilize HCA's internal nationwide staffing data base to transfer staff from other HCA facilities to staff Brandon's open heart program. Approximately 18 percent of the nurses hired at Brandon already come from other HCA facilities.
The nursing shortage has been in existence for about a decade. During this time, other open heart programs have come on line and have been able to staff the programs adequately. Lakeland, in District 6, has demonstrated its ability to recruit and train open heart surgery personnel.
Brandon, itself, has been successful, despite the on- going shortage, in appropriately staffing its recent additions of tertiary level NICU beds, an expanded Emergency Room, labor and delivery and recovery suites, and new high-risk, ante-partum observation unit.
Brandon has begun to offer sign-on bonuses to compete for experienced nurses. Several employees who staff the Lakeland, UCH and Tampa General programs live in Brandon. These bonuses are temptations for them to leave the programs for Brandon. Other highly skilled, experienced individuals who already work at existing programs may be lost to Brandon's program as well simply as the natural result of the addition of a new program. In the end, Brandon will be able to staff its program, but it will make it more difficult for all of the programs in Hillsborough County and for Lakeland to meet their staffing needs as well as producing a financial impact on existing providers.
Financial Feasibility Short-Term
Brandon needs $4.2 million to fund implementation of the program. Its parent corporation, HCA will provide financing of up to $4.5 million for implementation.
The $4.2 million in start-up costs projected by Brandon does not include the cost of a second cath lab or the
costs to upgrade the equipment in the existing cath lab. Itemization of the funds necessary for improvement of the existing cath lab and the addition of the second cath lab were not included in Brandon's pro formas. It is the Agency's position that addition of a cath lab (and by inference, upgrade to an existing lab) requires only a letter of exemption as projects separate from an open heart surgery program even when proposed in support of the program. (See UCH No. 7, p. 83).
The position is not inconsistent with cardiac catheterization programs as subject to requirements in law separate from those to which an open heart surgery program is subject.
Brandon, through HCA, has the ability to fund the start-up costs of the project. It is financially feasible in the short-term.
Long-Term
Open heart surgery programs (inclusive of angioplasty and stent procedures, as well as other open heart surgery procedures) generally are very profitable. They are among the most profitable of programs conducted by hospitals.
Brandon's projected charges for open heart, angioplasty, and stent procedures are based on the average charges to patients residing in Brandon's PSA inflated at 2 percent per year. The inflation rate is consistent with HCFA's August 1, 2000, Rule implementing a 2.3 percent Medicare
reimbursement increase. Brandon's projected payor mix is reasonably based on the existing open heart, angioplasty, and stent patients within its PSA. Brandon also estimated conservatively that it would collect only 45 to 50 percent of its charges from third-party payors.
To determine expenses, Brandon utilized Bayonet Point's accounting system. It provided a level of detail that could not be obtained otherwise. "For patients within Brandon's primary service area, . . . that information is not provided by existing providers in the area that's available for any public consumption." (Tr. 1002).
While perhaps the most detailed data available, Bayonet Point data was far from an ideal model for Brandon. Bayonet Point performs about 1,500 OHS cases per year. It achieves economies of scale that will not be achievable at Brandon in the foreseeable future. There is a relationship between volume and cost efficiency. The higher the volume, the greater the cost efficiency. Brandon's volume is projected to be much lower than Bayonet Point's.
To make up for the imperfection of use of Bayonet Point as an "expenses" proxy, Brandon's financial expert in opining that the project was feasible in the long-term, considered two factors with regard to expenses. First, it included its projected $1.8 million in salary expenses as a
separate line item over and above the salary expenses contained in the Bayonet Point data. (This amounted to a "double" counting of salary expenses.) Second, it recognized HCA's ability to obtain competitive pricing with respect to equipment and services for its affiliated hospitals, Brandon being one of them.
Brandon projected utilization of 249 and 279 cases in its second and third year of operations. These projections are reasonable. (See the testimony of Mr. Balsano on rebuttal and Brandon Ex. 74).
Comparison of Agency Action in CONs 9169 and 9239
Brandon's application in this case, CON 9239, was filed within a six-month period of the filing of an earlier application, CON 9169.
The Agency found the two applications to be similar.
Indeed, the facts and circumstances at issue in the two applications other than the updating of the financial and volume numbers are similar. So is the argument made in favor of the applications. Yet, the first application was denied by the Agency while the second received preliminary approval.
The difference in the Agency's action taken on the later application (the one with which this case is concerned), i.e., approval, versus the action taken on the earlier, denial, was explained by Scott Hopes, the Chief of the Bureau of
Certificate of Need at the time the later application was considered:
The [later] Brandon application . . ., which is what we're addressing here today, included more substantial information from providers, both cardiologists, internists, family practitioners and surgeons with specific case examples by patient age [and] other demographics, the diagnoses, outcomes, how delays impacted outcomes, what permanent impact those adverse outcomes left the patient in, where earlier . . . there weren't as many specifics.
(Tr. 1536, 1537). A comparison of the application in CON 9169 and the record in this case bears out Mr. Hopes' assessment that there is a significant difference between the two applications.
Comparison of the Agency Action with the District 9 Application
During the same batching cycle in which CON 9239 was considered, five open heart surgery applications were considered from health care providers in District 9. Unlike Brandon's application, these were all denied.
In the District 9 SAAR, the Agency found that transfers are an inherent part of OHS as a tertiary service.
The Agency concluded that, "[O]pen heart surgery is a tertiary service and patients are routinely transferred between hospitals for this procedure." (UCH Ex. 7, pp. 51-54).
In particular, the Agency recognized Boca Raton's claim that it had provided "extensive discussion of the quality
implications of attempting to deal with cardiac emergencies through transfer to other facilities." (UCH Ex. 7, p. 52). Unlike the specific information referred to by Mr. Hopes in his testimony quoted, above, however, the foundation for Boca Raton's argument is a 1999 study published in the periodical Circulation, entitled "Relationship Between Delay in Performing Direct Coronary Angioplasty and Early Clinical Outcomes." (UCH Ex. 7, p. 21). This publication was cited by the Agency in its SAAR on the application in this case. Nonetheless, a fundamental difference remains between this case and the District 9 applications, including Boca Raton's. The application in this case is distinguished by the specific information to which Mr. Hopes alluded in his testimony, quoted
above.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and the subject matter of these proceedings. Sections 120.569, 120.57, and 408.039(5), Florida Statutes.
The four existing providers of OHS services in District 6 have standing to challenge the Agency's preliminary action to approve Brandon's application. Each of the existing providers demonstrated that its substantial interests would be affected by approval of the application.
The Petitioners' renewed motion in limine made in
Petitioners' Joint Memorandum of Law submitted with their proposed order is granted. The testimony of Sarah Loughran is stricken from the record.
As the applicant, Brandon 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 250 (Fla. 1st DCA 1985). The award of a CON must be based on a balanced consideration of statutory and rule criteria. Department of Health and
Rehabilitative Services v. Johnson and Johnson Home Health Care, 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). In the case of an application that need not be premised on the existence of typical "not normal" circumstances, the weight to be given each criterion is not fixed but varies depending on the facts of the case. This case is such a case.
The record demonstrates that approval of Brandon's application will have no impact on the volume of open heart surgery cases performed at the two Manatee County existing providers whose volume at the time of the application was below
350 annually. This fact eliminates the "zeroing out" effect of the Manatee County providers' sub-350 performances. See Halifax Hospital Medical Center v. AHCA, DOAH Case No. 95-0742,
Recommended Order rendered September 30, 1996, in which it was undisputed that there would be no impact at all on the volume of OHS procedures performed at three sub-350 providers if the application at issue were approved. As written there,
Since the purpose of the "350-procedure" standard is to ensure that existing providers in the district have a sufficient volume of OHS procedures to ensure a high quality program, need for an additional program is established in this case because there is a clearly a net numeric need and the purpose of the "350-procedure" standard would not be thwarted.
(Id., Conclusion of Law 177). The same is true here. The purpose of the "350-procedure" standard in Rule 59C-1.033, Florida Administrative Code (the "Open Heart Rule") is not thwarted by an elimination of the zeroing-out effect in this case. In other words, the net numeric need in excess of three, the result of the calculation of the Open Heart Rules formula, should stand since the sub-performers in the district will not be affected by the granting of the application.
Brandon, in its attempt to justify its application, has referred to the elimination of the zeroing-out effect as a "not normal" circumstance (as does the Halifax order). The circumstance of a granting of the application having no effect on sub-350 performers, however, is not a typical "not normal" circumstance. To denominate it, as such, is a misnomer if doing so confuses it with a typical "not normal" circumstance.
Typical "not normal" circumstances have a compelling characteristic. They urge the granting of an application. The elimination of the zeroing-out effect does not urge the granting of the application. Its effect is merely to restore the net numeric need calculated pursuant to the open heart rule prior to consideration of the provisions in paragraph (7)(a), 2., of the Open Heart Rule.
This case, therefore, should proceed as a case in which numeric need of three has been established. This net numeric need is a starting point. It creates a presumption of need and a presumption that the application should be granted. Whether the applicant, consistent with its burden of proof, can sustain that presumption depends on a balanced consideration of the remaining statutory and rule criteria.
The record demonstrates criteria in favor of the applicant and in favor of the four existing providers in the district who oppose the application. The weightiest of these are two, one in favor of the opponents and one in favor of Brandon.
Granting the application will have an adverse impact on each of the four existing providers that are parties to the proceeding. The impact is particularly substantial in the case of Tampa General. The substantial, adverse, financial impact to Tampa General, the Hillsborough County health safety net, is
worthy of great consideration and weighs heavily in favor of denial of the application.
On the other hand, Brandon's case with regard to the multitude of patients at Brandon clinically determined to need angioplasty or open heart surgery dictates the conclusion that a substantial number of patients in the future will benefit if Brandon is able to provide open heart surgery services.
In many of the specific examples of cases offered by Brandon in which transfers were required for angioplasty or open heart surgery, the patient's outcome was either unknown or an existing provider's expert was able to opine that the outcome was not adverse. In the context of patients to whom the maxim "time is muscle" applies, however, regardless of the status of outcome or knowledge about outcome, any delay has serious potential to adversely affect outcome. A seriously ill patient at Brandon might "miraculously" survive an episode of multiple cardiac assault with an injection fraction of 40 percent after open heart surgery following a transfer from Brandon and the outcome be termed "positive." Who can say that the patient's injection fraction might have reached 50 percent, (within the range of normal) had open heart surgery services been available at the hospital at which the patient chose to present, that is, Brandon? As Dr. Cohen candidly testified with regard to whether the outcome of one of his patients would have been better had
angioplasty been available at Brandon, "I will never know. Nor will anyone else know." See paragraph 146, above.
What is known is that Brandon's Emergency Room will receive annually a substantial number of patients suffering acute myocardial infarctions who are ineligible for thrombolytics. The number will be at least 40. At least 20 patients per year of the 40 so presenting will be eligible for angioplasty, a procedure that should be provided as soon as possible in order to save the patient' life or improve the patient's quality of life or life expectancy upon survival. The actual number, moreover, is likely to be quite higher than 20 since that number is the result of conservative estimate based on past activity without regard to likely increase in activity in the future.
Myocardial infarctions occur at all hours of the day and do not respect holidays. Nighttime transfers can present difficulties for timely transfers. The transfers of any MI patient to an existing open heart provider in Hillsborough County, the best choice based on distance and likely time consumed in the transfer process, will be subject to the vagaries of a transfer system beset by the difficulties of a modern, urban environment. Traffic congestion can delay the transfer. The ambulances with needed equipment may not be available. If helicopter transfer is opted for, the best
efforts to secure a speedy transfer may fail due to bureaucratic miscommunication or legitimate reluctance of a facility to allow its helicopter to be used for another facility, when its helicopter may be needed for another emergency transfer. The appropriately equipped helicopter may not be available because of a mass casualty event such as an explosion at a local power plant as occurred in one of the examples presented by Brandon or for some other equally unforeseen reason. The problems that beset transfers in Hillsborough County presented in the examples offered by Brandon are numerous, substantial, and, in all likelihood, not exhaustive.
There are also cases in which transfers are made without delay that call out for open heart surgery services to be provided at Brandon. It would almost always be better to be able to perform an immediate interventional angioplasty when the procedure is indicated during a diagnostic cardiac catheterization. The need for immediate action was obvious in the case of significant heart blockage, or the existence of a "widow-maker," observed during a cardiac catheterization described at hearing. This need exists even in cases in which it would have been better practice to have transferred the patient prior to the diagnostic cardiac catheterization. The need for open heart surgery services belongs to the patient who presents at Brandon no matter how the patient is managed.
The adverse financial impact to the existing providers and in particular to Tampa General should not be diminished. In the end, however, the balance must be struck in favor of the difference Brandon's open heart program will make in a substantial number of lives in years to come over the financial impact to existing providers.
Open heart surgery remains a tertiary service under Florida law: "a health service . . . which should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost-effectiveness of such service." Section 408.032(17), Florida Statutes. Assignment of the weight to be given the needs of Brandon patients to have access to angioplasty or open heart surgery services at Brandon, is enhanced by a number of factors consistent with the limitations of a service categorized as tertiary. Among these are the size of the Brandon community, its rapid growth and likely expansion of the population in need of open heart surgery services, the number of patients who opt to present at Brandon in need of such services, the maturity of Brandon's cardiology program, the time constraints that exist from time-to-time in transferring the patients in a timely fashion to existing providers, and the inability to provide angioplasty to patients in need whose need is discovered in the midst of a diagnostic cardiac catheterization. Given these factors, granting
Brandon's application will not do violence to the concept of the status of open heart surgery services as tertiary.
Brandon's CON application for open heart surgery, CON 9239 should be granted.
Based on the foregoing Findings of Fact and Conclusions of Law, it is
RECOMMENDED that a final order be entered granting the application of Galencare, Inc., d/b/a Brandon Regional Hospital for open heart surgery, CON 9239.
DONE AND ENTERED this 30th day of March, 2001, in Tallahassee, Leon County, Florida.
DAVID M. MALONEY
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 30th day of March, 2001.
COPIES FURNISHED:
Sam Power, Agency Clerk
Agency for Health Care Administration 2727 Mahan Drive
Building 3, Suite 3431
Tallahassee, Florida 32308-5403
Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive
Building 3, Suite 3431
Tallahassee, Florida 32308-5403
Richard A. Patterson, Esquire
Agency for Health Care Administration 2727 Mahan Drive
Building 3, Suite 3431
Tallahassee, Florida 32308-5403
Stephen A. Ecenia, Esquire
R. David Prescott, Esquire Thomas W. Konrad, Esquire
Rutledge, Ecenia, Purnell & Hoffman, P.A.
215 North Monroe Street, Suite 420 Post Office Box 551
Tallahassee, Florida 32302-0551
James C. Hauser, Esquire Metz, Hauser & Husband, P.A.
215 South Monroe Street, Suite 505 Post Office Box 10909 Tallahassee, Florida 32302
John H. Parker, Jr., Esquire Jonathan L. Rue, Esquire Sarah E. Evans, Esquire Parker, Hudson, Rainer & Dobbs 1500 Marquis Two Tower
285 Peachtree Center Avenue, Northeast Atlanta, Georgia 30303
Robert A. Weiss, Esquire Karen A. Putnal, Esquire
Parker, Hudson, Rainer & Dobbs, LLP The Perkins House, Suite 200
118 North Monroe Street Tallahassee, Florida 32301
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
| Issue Date | Proceedings |
|---|---|
| Aug. 28, 2001 | Notice of Appearance and Substitution of Counsel (filed by Respondent via facsimile). |
| Aug. 09, 2001 | Final Order filed. |
| May 21, 2001 | Petitioners` Joint Response to Written Exceptions filed by Brandon filed. |
| May 21, 2001 | Petitioners` Joint Response to Written Exceptions Filed by AHCA filed. |
| Mar. 30, 2001 | Recommended Order issued (hearing held May 8 through June 10, 2000) CASE CLOSED. |
| Mar. 30, 2001 | Recommended Order cover letter identifying hearing record referred to the Agency sent out. |
| Mar. 30, 2001 | Order issued (Petitioners` Joint Motion to Strike Portions of the Joint Proposed Recommended Order of Brandon & Agency is denied). |
| Dec. 08, 2000 | Galencare, Inc. d/b/a Barndon Regional Hospital`s Response to Petitioners` Joint Motion to Strike Portions of the Joint Proposed Recommended Order of Brandon and Agency filed. |
| Dec. 08, 2000 | Notice of Change of Address filed by J. Hauser. |
| Nov. 30, 2000 | Petitioner`s Joint Motion to Strike Portions of the Joint Proposed Recommended Order of Brandon & Agency filed. |
| Oct. 27, 2000 | Attachments to Kenneth Miller`s Deposition filed. |
| Oct. 19, 2000 | Galencare, Inc. d/b/a Brandon Regional Hospital`s and the State of Florida, Agency for Health Care Administration`s Joint Proposed Recommended Order filed. |
| Oct. 19, 2000 | Galencare, Inc. d/b/a Brandon Regional Hospital`s and the State of Florida, Agency for Health Care Administration`s Joint Memorandum of Law in Support of It Proposed Recommended Order filed. |
| Oct. 19, 2000 | Disk w/cover letter filed. |
| Oct. 19, 2000 | Petitioners` Joint Proposed Findings of Fact, Conclusions of Law, and Recommended Order filed. |
| Oct. 19, 2000 | Petitioners` Joint Memorandum of Law filed. |
| Oct. 18, 2000 | Ltr. to Judge D. Maloney from K. Putnal In re: represenation (filed via facsimile). |
| Oct. 17, 2000 | Ltr. to Judge D. Maloney from R. Weiss In re: proposed recommended orders filed. |
| Aug. 22, 2000 | Order Granting Motion to Extend Time for Filing Proposed Recommended Orders issued. |
| Aug. 21, 2000 | Unopposed Joint Request to Extend Due Date for Filing Proposed Recommended Order and Legal Memoranda to October 19 filed. |
| Aug. 10, 2000 | Ltr. to Judge D. Maloney from J. Hauser In re: exhibits filed. |
| Aug. 02, 2000 | Transcript (Volume 13 through 28) filed. |
| Jul. 10, 2000 | Transcript (Volume 9 through 12) (Division of Administrative Hearings) filed. |
| Jun. 23, 2000 | Order sent out. (Motion to Seal Pleadings granted) |
| Jun. 19, 2000 | Motion to Seal Pleadings (R. Patterson) filed. |
| Jun. 15, 2000 | Transcript Volumes 1 through 8 filed. |
| Jun. 07, 2000 | CASE STATUS: Hearing Held; see case file for applicable time frames. |
| Jun. 07, 2000 | Motion for Judicial Notice of Official State Actions w/exhibits filed. |
| Jun. 01, 2000 | Excerpt of Proceedings Testimony of Craig Randall Martin filed. |
| May 23, 2000 | Brandon Regional Hospital`s Motion in Limine with Respect to the Testimony of Judy Ploszek w/Exhibits filed. |
| May 19, 2000 | Brandon Regional Hospital`s Response to Motion to Exclude Evidence and Strike Testimony filed. |
| May 18, 2000 | (Respondent) Amended Notice of Taking Deposition Duces Tecum (Amended as to time only) filed. |
| May 18, 2000 | (Brandon Regional Hospital) Response to University Community Hospital`s Objection to Brandon Regional Hospital`s Notice of Supplement to its Exhibit List filed. |
| May 17, 2000 | Brandon Regional Hospital`s Response to Petitioners` Joint Emergency Motion in Limine to Preclude and Exclude Testimony and Evidence Relating to Patient Medical Conditions or Medical Records w/cover letter filed. |
| May 17, 2000 | (Respondent) Notice of Taking Deposition Duces Tecum filed. |
| May 16, 2000 | (Respondent) Notice of Filing Returns of Service filed. |
| May 16, 2000 | (Petitioner) Motion to Exclude Evidence and Strike Testimony (filed via facsimile). |
| May 16, 2000 | Brandon Regional Hospital`s Decision List filed. |
| May 09, 2000 | Lakeland Regional Medical Center, Inc.`s Joinder in and Adoption of Joint Motion in Limine (filed via facsimile). |
| May 09, 2000 | Tampa General Hospital`s Response to Brandon Regional Hospital`s Emergency Motion for Entry of an Order Excluding Testimony and Awarding Attorneys` Fees and Costs (filed via facsimile). |
| May 09, 2000 | Brandon Regional Hospital`s Response to Petitioners` Joint Motion to Exclude Certain Witnesses of Brandon filed. |
| May 09, 2000 | Petitioners` Joint Emergency Motion in Limine to Preclude and Exclude Testimony and Evidence Relating to Patient Medical Conditions or Medical Records filed. |
| May 09, 2000 | UCH`s Objection to Brandon`s Notice of Supplement to Its Exhibit List filed. |
| May 09, 2000 | Brandon Regional Hospital`s Response to Joint Motion in Limine filed. |
| May 09, 2000 | Brandon Regional Hospital`s Notice of Supplement to Its Exhibit List filed. |
| May 09, 2000 | Brandon Regional Hospital`s Notice of Attempt to Enter Prehearing Stipulation (filed via facsimile). |
| May 08, 2000 | (T. Konrad) (5) Affidavits of Service filed. |
| May 08, 2000 | (T. Konrad) (8) Affidavits of Non-Service filed. |
| May 08, 2000 | UCH`s Response to Brandon`s Supplement to Motion to Compel Production filed. |
| May 08, 2000 | (R. Weiss, J. Hauser, J. Rue) Prehearing Stipulation filed. |
| May 08, 2000 | Petitioners` Joint Motion to Exclude Certain Witnesses of Brandon filed. |
| May 08, 2000 | (T. Konrad) Notice of Filing filed. |
| May 08, 2000 | Brandon Regional Hospital`s Emergency Motion for Entry of an Order Excluding Testimony and Awarding Attorneys` Fees and Costs filed. |
| May 08, 2000 | (T. Konrad) Notice of Filing filed. |
| May 05, 2000 | UCH`s Cross Notice of Taking Depositions filed. |
| May 04, 2000 | (T. Konrad) Notice of Taking Telephonic Deposition Duces Tecum filed. |
| May 04, 2000 | (T. Konrad) (2) Amended Notice of Taking Deposition Duces Tecum filed. |
| May 03, 2000 | (T. Konrad) Amended Notice of Taking Deposition filed. |
| May 03, 2000 | Joint Motion in Limine filed. |
| May 02, 2000 | St. Joseph`s Hospital`s Response to Brandon`s Motion to Compel Document Production filed. |
| May 02, 2000 | Tampa General Hospital`s Response to Brandon`s Motion to Compel Document Production filed. |
| May 01, 2000 | Joint Motion for Extension of Time to File Prehearing Stipulation filed. |
| May 01, 2000 | St. Joseph`s Hospital`s Motion for Protective Order and Objections to Brandon`s Deposition Notices of SJH Witnesses filed. |
| Apr. 28, 2000 | Galencare, Inc. d/b/a Brandon Regional Hospital`s Supplement to Motion to Compel Document Production From University Community Hospital, Inc. d/b/a University Community Hospital filed. |
| Apr. 28, 2000 | (T. Konrad) Amended Notice of Taking Deposition filed. |
| Apr. 27, 2000 | Tampa General Hospital`s Motion for Protective Order and to Quash Brandon`s Subpoena of the Person Knowledgeable about all Documentation Related to Cases and Procedures Performed in Tampa General`s Open Heart Program filed. |
| Apr. 27, 2000 | Tampa General Hospital`s Motion for Protective Order and to Quash Brandon`s Subpoena of Doug Beal filed. |
| Apr. 27, 2000 | Tampa General Hospital`s Motion for Protective Order and to Quash Brandon`s Subpoena of the Person Responsible for Reporting Open Heart Program Case Volumes filed. |
| Apr. 27, 2000 | Tampa General Hospital`s Motion for Protective Order and to Quash Brandon`s Subpoena of Betty Viamontes filed. |
| Apr. 26, 2000 | LRMC`s Motion for Protective Order and Objections to Brandon`s Deposition Notices of LRMC`s Witnesses (filed via facsimile). |
| Apr. 25, 2000 | UCH`s Objections to Brandon`s Deposition Notices of UCH`s Witnesses filed. |
| Apr. 25, 2000 | UCH`s Response to Brandon`s Motion to Compel Document Production (filed via facsimile). |
| Apr. 25, 2000 | (T. Konrad) (2) Amended Notice of Taking Deposition filed. |
| Apr. 25, 2000 | Galencare, Inc. d/b/a Brandon Regional Hospital`s Motion to Compel Document Production From St. Joseph`s Hospital, Inc. d/b/a St. Joseph`s Hospital and Request for Expedited Hearing filed. |
| Apr. 25, 2000 | Galencare, Inc. d/b/a Brandon Regional Hospital`s Motion to Compel Document Production From Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital and Request for Expedited Hearing filed. |
| Apr. 25, 2000 | UCH`s Cross Notice of Taking Depositions (filed via facsimile). |
| Apr. 25, 2000 | Order sent out. (the motion for protective order is granted inasmuch as the documents shall be provided subject only to the conditions listed in subparagraphs 3A and 3C-H of the Emergency motion) |
| Apr. 25, 2000 | Joint Response of St. Joseph`s Hospital and Tampa General Hospital to Brandon`s Emergency Motion for Protective Order filed. |
| Apr. 25, 2000 | UCH`s Objections to Brandon`s Deposition Notices of UCH`s Witnesses (filed via facsimile). |
| Apr. 25, 2000 | UCH`s Response in Opposition to Brandon`s Emergency Motion for Protective Order (filed via facsimile). |
| Apr. 25, 2000 | (J. Hauser) Motion for Protective Order filed. |
| Apr. 24, 2000 | (R. Prescott) Subpoena filed. |
| Apr. 24, 2000 | (R. Prescott) (10) Subpoena Duces Tecum filed. |
| Apr. 24, 2000 | (15) (R. Prescott) Notice of Taking Deposition Duces Tecum filed. |
| Apr. 24, 2000 | Joint Response of St. Joseph`s Hospital and Tampa General Hospital to Brandon`s Emergency Motion for Protective Order filed. |
| Apr. 24, 2000 | (T. Konrad) Emergency Motion for Protective Order filed. |
| Apr. 21, 2000 | Order Cancelling Discovery Hearing sent out. |
| Apr. 21, 2000 | (R. Weiss) Notice of Taking Deposition Duces Tecum (filed via facsimile). |
| Apr. 21, 2000 | (R. Prescott) (3) Notice of Taking Deposition Duces Tecum filed. |
| Apr. 21, 2000 | (R. Prescott) (3) Notice of Taking Deposition Duces Tecum filed. |
| Apr. 20, 2000 | (R. Prescott) (15) Notice of Taking Deposition Duces Tecum filed. |
| Apr. 20, 2000 | (R. Prescott) (3) Notice of Taking Deposition Duces Tecum filed. |
| Apr. 20, 2000 | (T. Konrad) Notice of Filing filed. |
| Apr. 20, 2000 | (T. Konrad) (4) Subpoena Ad Testificandum filed. |
| Apr. 20, 2000 | (T. Konrad) (3) Subpoena filed. |
| Apr. 20, 2000 | (T. Konrad) (7) Affidavit of Service filed. |
| Apr. 20, 2000 | Joint Request to Cancel April 25 Hearing and to Abate Scheduling of Discovery Motion Hearing filed. |
| Apr. 19, 2000 | Brandon Regional Hospital`s Response to St. Joseph`s Hospital and Tampa General Hospital`s Motion to Compel Production of Documents filed. |
| Apr. 19, 2000 | Notice of Hearing on Discovery Issues Only sent out. (April 25, 2000; 10:00 a.m.; Tallahassee) |
| Apr. 19, 2000 | UCH`s Written Response and Objections to Brandon`s Second Request for Production of Documents filed. |
| Apr. 18, 2000 | St. Joseph`s Hospital`s Response to Brandon`s Second Request for Production of Documents filed. |
| Apr. 18, 2000 | Order and Notice of Hearing sent out. (April 25, 2000, 10:00 a.m. hearing on outstanding discovery) |
| Apr. 18, 2000 | Tampa General`s Response to Brandon`s Second Request for Production of Documents filed. |
| Apr. 17, 2000 | UCH`s Response to Motions for Protective Order Filed by Brandon and Duane Ashe Regarding April 18 Deposition of Duane Ashe filed. |
| Apr. 17, 2000 | Objections to Depositions of Woeltjen and Stein on April 21 (University Community Hospital) filed. |
| Apr. 14, 2000 | Galencare, Inc. d/b/a Brandon Regional Hospital`s Motion to Compel Document Production From University Community Hospital, Inc. d/b/a University Community Hospital filed. |
| Apr. 14, 2000 | Duane Ashe`s Motion for Protective Order and to Quash Subpoena Duces Tecum filed. |
| Apr. 14, 2000 | Brandon Regional Hospital`s Motion for Protective Order and to Quash Subpoena Duces Tecum Issued to Duane Ashe filed. |
| Apr. 14, 2000 | Tampa General Hospital`s Motion to Quash Brandon`s subpoena of Judy Ploszek (filed via facsimile). |
| Apr. 13, 2000 | Affidavit of Service for Ken Miller filed. |
| Apr. 13, 2000 | Tampa General Hospital`s Motion to Quash Brandon`s Subpoena of Judy Ploszek (filed via facsimile). |
| Apr. 13, 2000 | St. Joseph`s Hospital`s Motion to Quash Brandon`s Subpoena of George Wallace (filed via facsimile). |
| Apr. 13, 2000 | St. Joseph`s Hospital`s Motion to Quash Brandon`s Subpoena of George Wallace (filed via facsimile). |
| Apr. 13, 2000 | (T. Konrad) Notice of Filing filed. |
| Apr. 13, 2000 | (J. Hauser) Amended Notice of Taking Depositions Duces Tecum filed. |
| Apr. 12, 2000 | Notice of Taking Depositions Duces Tecum filed. |
| Apr. 12, 2000 | (J. Hauser) Notice of Taking Deposition Duces Tecum filed. |
| Apr. 12, 2000 | Notice of Taking Depositions Duces Tecum filed. |
| Apr. 11, 2000 | (T. Konrad) Notice of Filing filed. |
| Apr. 11, 2000 | Brandon Regional Hospital Witness List filed. |
| Apr. 11, 2000 | Brandon Regional Hospital`s Exhibit List filed. |
| Apr. 11, 2000 | St. Joseph`s Hospital`s and Tampa General Hospital`s Motion to Compel Production of Documents by Brandon Regional Hospital filed. |
| Apr. 11, 2000 | (J. Hauser) Notice of Taking Depositions Duces Tecum filed. |
| Apr. 11, 2000 | (T. Konrad) Notice of Filing filed. |
| Apr. 11, 2000 | UCH List of Witnesses & Exhibits (filed via facsimile). |
| Apr. 11, 2000 | St. Joseph`s Preliminary Witness and Exhibit Lists (filed via facsimile). |
| Apr. 11, 2000 | Tampa General`s Preliminary Witness and Exhibit Lists (filed via facsimile). |
| Apr. 11, 2000 | (J. Hauser) Notice of Taking Depositions Duces Tecum filed. |
| Apr. 10, 2000 | Lakeland Regional Medical Center`s Exhibit List (filed via facsimile). |
| Apr. 10, 2000 | Lakeland Regional Medical Center`s Witness List (filed via facsimile). |
| Apr. 10, 2000 | (T. Conrad) Notice of Correction filed. |
| Apr. 07, 2000 | (J. Menton) (3) Subpoena filed. |
| Apr. 07, 2000 | (J. Menton) (4) Subpoena Ad Testificandum filed. |
| Apr. 07, 2000 | Brandon Regional Hospital`s Response to University Community Hospital`s Motion to Compel filed. |
| Apr. 07, 2000 | (J. Hauser) (13) Notice of Taking Deposition Duces Tecum filed. |
| Apr. 07, 2000 | (J. Menton) (10) Notice of Taking Deposition filed. |
| Apr. 07, 2000 | Notice of Taking Deposition filed. |
| Apr. 06, 2000 | (J. Hauser) Notice of Taking Depositions Duces Tecum filed. |
| Apr. 05, 2000 | (K. Putnal) (11) Subpoena Duces Tecum filed. |
| Apr. 05, 2000 | (K. Putnal) (11) Return of Service filed. |
| Apr. 05, 2000 | (S. Ecenia) Notice of Taking Deposition Duces Tecum filed. |
| Apr. 05, 2000 | (K. Putnal) Notices of Filing filed. |
| Mar. 31, 2000 | UCH`s Motion to Compel Against Brandon Regarding UCH`s First Request for Production of Documents and UCH`s First Set of Interrogatories filed. |
| Mar. 30, 2000 | (K. Putnal) Withdrawal of Notice of Deposition and Subpoena (filed via facsimile). |
| Mar. 29, 2000 | Order sent out. (motion to supplement prehearing order is granted) |
| Mar. 24, 2000 | Notice of Taking Depositions Duces Tecum filed. |
| Mar. 24, 2000 | UCH`s Cross Notice of Taking Depositions filed. |
| Mar. 22, 2000 | Notice of Taking Depositions filed. |
| Mar. 21, 2000 | (J. Hauser) Notice of Taking Deposition Duces Tecum filed. |
| Mar. 21, 2000 | (R. Weiss) (4) Notice of Taking Deposition Duces Tecum (filed via facsimile). |
| Mar. 20, 2000 | (R. Weiss) (6) Notice of Taking Deposition Duces Tecum filed. |
| Mar. 16, 2000 | (J. Hauser) (2) Notice of Taking Depositions Duces Tecum filed. |
| Mar. 09, 2000 | (AHCA) Notice of Service of Answers to UCH`s First Set of Interrogatories to the Agency for Health Care Administration filed. |
| Mar. 09, 2000 | (AHCA) Response to UCH`s First Request for Production of Documents to the Agency for Health Care Administration filed. |
| Mar. 09, 2000 | Joint Reply to Brandon`s Response to Motion to Supplement Prehearing Order filed. |
| Mar. 08, 2000 | Order sent out. (objection to UCH`s request to produce no. 12, referenced in paragraph 2 of the objections to subpoenas is granted; |
| Mar. 08, 2000 | Order sent out. (the objection to UCH`s request to Produce No. 12 is overruled Brandon shall produce the document as subpoenaed) |
| Mar. 08, 2000 | Brandon Regional Hospital`s Response in Opposition to Motion to Supplement Prehearing Order filed. |
| Mar. 08, 2000 | Letter to Judge Maloney from Stephen Ecenia (attached document entitled Columbia/HCA Healthcare Corporation) filed. |
| Mar. 08, 2000 | Notice of Hearing (Galencare, Inc.) filed. |
| Mar. 08, 2000 | UCH`s Response in Opposition to Brandon`s Motion for Protective Order filed. |
| Mar. 08, 2000 | UCH`s Objection to Brandon`s Notice of Hearing on Motion for Protective Order (filed via facsimile). |
| Mar. 07, 2000 | Notice of Hearing (S. Ecenia) filed. |
| Mar. 07, 2000 | UCH`s Emergency Request to Resolve Brandon`s "Objection to Subpoenas" Regarding the Scheduled March 9 Depositions of Dan Miller, Sam Hankins, and Bob Marchesini filed. |
| Mar. 07, 2000 | UCH`s Notice of Emergency Motion Hearing filed. |
| Mar. 06, 2000 | (K. Putnal) Notice of Taking Depositions Duces Tecum (filed via facsimile). |
| Mar. 06, 2000 | (S. Ecenia) Motion for Protective Order filed. |
| Mar. 03, 2000 | (R. Prescott) Objection to Subpoenas filed. |
| Mar. 02, 2000 | Motion to Supplement Prehearing Order filed. |
| Mar. 02, 2000 | (AHCA) Response to UCH First Request for Admissions to the Agency for Health Care Administration filed. |
| Mar. 02, 2000 | (J. Hauser) Amended as to Location Only Notice of Taking Depositions Duces Tecum filed. |
| Mar. 01, 2000 | Notice of Taking Depositions Duces Tecum filed. |
| Mar. 01, 2000 | (2) Notice of Taking Deposition Duces Tecum filed. |
| Mar. 01, 2000 | Certificate of Service of UCH`s Responses to Brandon`s First Set of Interrogatories filed. |
| Feb. 24, 2000 | Lakeland Regional Medical Center, Inc.`s Notice of Serving First Interrogatories and First Request for Production of Documents to Galencare, Inc. d/b/a Brandon Regional Hospital filed. |
| Feb. 23, 2000 | Order Closing File of DOAH Case Number 00-483 Only sent out. |
| Feb. 22, 2000 | (J. Hauser) Notice of Taking Depositions Duces Tecum filed. |
| Feb. 21, 2000 | UCH`s Written Response and Legal Objections to Written Discovery Requests Served by Brandon filed. |
| Feb. 18, 2000 | (2) Subpoena Duces Tecum filed. |
| Feb. 18, 2000 | Notice of Filing filed. |
| Feb. 18, 2000 | (Manatee Memorial) Notice of Voluntary Dismissal filed. |
| Feb. 18, 2000 | (J. Hauser) Notice of Taking Deposition Duces Tecum filed. |
| Feb. 18, 2000 | Notice of Filing filed. |
| Feb. 16, 2000 | Subpoena Duces Tecum filed. |
| Feb. 16, 2000 | (J. Hauser) Notice of Taking Deposition Duces Tecum filed. |
| Feb. 16, 2000 | Notice of Filing filed. |
| Feb. 14, 2000 | Order of Consolidation and Notice of Hearing sent out. (Consolidated cases are: 00-000481, 00-000482, 00-000483, 00-000484, 00-000485; hearing will be held May 10 through June 9, 2000 (excluding May 29, 2000); 9:00am; Tallahassee) |
| Feb. 02, 2000 | (Stephen Ecenia) Notice of Appearance filed. |
| Feb. 01, 2000 | Initial Order issued. |
| Jan. 28, 2000 | Petition for Formal Administrative Proceeding filed. |
| Jan. 28, 2000 | Notice filed. |
| Jan. 28, 2000 | Notice of Related Petitions (00-0481, 00-0482, 00-0483, 00-0484, 00-0485) filed. |
| Jan. 26, 2000 | Letter to Parties from S. Ecenia (re: Notice of Appearance, Scheduling Hearing) filed. |
| Jan. 14, 2000 | Pre-hearing Order sent out. |
| Issue Date | Document | Summary |
|---|---|---|
| Aug. 06, 2001 | Agency Final Order | |
| Mar. 30, 2001 | Recommended Order | Brandon Regional`s open heart Certificate of Need should be granted. Transfer delays and their impact on a substantial number of patients weigh more heavily than the financial impact the program will have on existing providers. |
