STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
TARPON SPRINGS HOSPITAL ) FOUNDATION, INC., d/b/a HELEN ) ELLIS MEMORIAL HOSPITAL, )
)
Petitioner, )
)
vs. )
)
AGENCY FOR HEALTH CARE )
ADMINISTRATION, )
)
Respondent, )
)
and )
) HCA HEALTH SERVICES OF FLORIDA, ) INC., d/b/a REGIONAL MEDICAL ) CENTER BAYONET POINT and THE ) MORTON F. PLANT HOSPITAL ) ASSOCIATION, INC., d/b/a MORTON ) PLANT HOSPITAL, )
)
Intervenors. )
Case No. 05-1465CON
)
RECOMMENDED ORDER
Pursuant to notice, the case was heard by Charles A. Stampelos, a duly-designated Administrative Law Judge at the Division of Administrative Hearings on May 9-10, 12, 15-19, and 22-26, 2006, in Tallahassee, Florida.
APPEARANCES
For Petitioner Tarpon Springs Hospital Foundation, Inc., d/b/a Helen Ellis Memorial Hospital:
Geoffrey D. Smith, Esquire Susan C. Smith, Esquire Smith and Associates
2873 Remington Green Circle Tallahassee, Florida 32308
For Respondent Agency for Health Care Administration:
Michael O. Mathis, Esquire
Agency for Health Care Administration 2727 Mahan Drive, Building 3
Tallahassee, Florida 32308
For Intervenor HCA Health Services of Florida, Inc., d/b/a Regional Medical Center Bayonet Point:
Stephen A. Ecenia, Esquire
R. David Prescott, Esquire
Rutledge, Ecenia, Purnell & Hoffman, P.A.
215 South Monroe Street, Suite 420 Tallahassee, Florida 32301
For Intervenor Morton F. Plant Hospital Association, Inc., d/b/a Morton Plant Hospital:
Robert A. Weiss, Esquire Karen A. Putnal, Esquire Parker, Hudson, Rainer
& Dobbs, LLP
The Perkins House, Suite 200
118 North Gadsden Street Tallahassee, Florida 32301
STATEMENT OF THE ISSUE
The issue in this case is whether the Certificate of Need (CON) Application No. 9822 filed by Tarpon Springs Hospital Foundation, Inc., d/b/a Helen Ellis Memorial Hospital in December 2004, to establish an adult open heart surgery (OHS)
program in Agency for Health Care Administration (the Agency or AHCA) Service District 5, should be approved.
PRELIMINARY STATEMENT
In the October 2004, batching cycle, the Agency published a zero fixed need for adult OHS programs in District 5 for the January 2007 planning horizon. District 5 consists of Pinellas and Pasco Counties.
CON applications seeking approval to establish an OHS program in District 5 in the absence of a fixed need were filed by Mease Hospital-Countryside (Mease), Palms of Pasadena Hospital (Palms), St. Anthony's Hospital (St. Anthony's), and Helen Ellis.
After review and analysis, the Agency denied all of the applications. Notice of the Agency's decision was published in Volume 31, Number 10, Florida Administrative Weekly, dated March 11, 2005, pages 1047-1048.1
Thereafter, Helen Ellis filed a petition requesting an administrative hearing to contest the Agency's preliminary determination. Mease, St. Anthony's, and Palms abandoned their CON applications.
The Morton F. Plant Hospital Association, Inc., d/b/a Morton Plant Hospital (Morton Plant), HCA Health Services of Florida, Inc., d/b/a Regional Medical Center Bayonet Point (Bayonet Point), and Largo Medical Center (Largo) filed
petitions to intervene in the cases involving Helen Ellis. Largo voluntarily dismissed its petition to intervene.
On May 8, 2006, the parties filed a Joint Prehearing Stipulation limiting the disputed issues of material fact.
The final hearing was held in Tallahassee, Florida, on May 9-10, 12, 15-19, and 22-26, 2006.
During the final hearing, Helen Ellis called the following witnesses: Norm Stein, Chief Executive Officer of University Community Hospital, accepted as an expert in hospital administration; Brigitte W. Shaw, Chief Executive Officer of the Pepin Heart Hospital and Research Institute; Donald D. Evans, Chief Executive Officer of Helen Ellis; Peter P. Wozniak, Chief Operating and Chief Nursing Officer at Helen Ellis; Najam Javeed, M.D., accepted as an expert in cardiology and interventional cardiology; Dr. Nikiforos Stamatiadis, accepted as an expert in civil engineering with an emphasis in traffic and transportation engineering and a specialized focus in the problems of elderly drivers; Raul Jiminez, M.D., a cardiac electrophysiologist, accepted as an expert in internal medicine, cardiology, and cardiac electrophysiology; Jose R. Roca, M.D., accepted as an expert in internal medicine, cardiovascular diseases, and interventional cardiology; Dr. Monica G. Noether, accepted as an expert in health care economics; Scott H. Bronleewe, M.D., accepted as an expert in surgery and
cardiothoracic surgery; Richard Diaz, Jr., accepted as an expert in civil engineering and transportation and traffic analysis; Linda Pearson, accepted as an expert in urban planning; Daniel
J. Sullivan, accepted as an expert in health care finance; and Gene Nelson, accepted as an expert in health care planning, with particular expertise in health care planning for open heart surgery.
Helen Ellis (HE) Exhibits numbered 1-11, 11A-11f, 18-40, 41A-41D, 42A-42C, 43-56, 56A-56I, 57-64, 65A-65F, 66, 66A-66H,
67-68, 69A-69H, and 70-98, including several deposition transcripts, were admitted into evidence.
The Agency did not present any witnesses or offer any exhibits during the final hearing.
Morton Plant called the following witnesses: Harrel Ziecheck, Chief Operating Officer, Morton Plant Hospital, accepted as an expert in health care administration; Michael D. Williamson, M.D., accepted as an expert in cardiology and interventional cardiology; Patrick A. Cambier, M.D., accepted as an expert in internal medicine, cardiovascular disease, and interventional cardiology; Robert C. Pergolizzi, accepted as an expert in land use planning and transportation planning; and Mark M. Richardson, accepted as an expert in health care planning.
Morton Plant (MP) Exhibits numbered 1-12, 13-1-13-10, 14- 15, and 16-17, including several depositions and prior hearing testimony, were admitted into evidence. Morton Plant Exhibits numbered 15A and 15B were officially recognized.
Bayonet Point called the following witnesses: Steven A. Rector, Chief Executive Officer, Regional Medical Center Bayonet Point, accepted as an expert in hospital administration; Joanne Cattell, R.N., Chief Nursing Officer, Regional Medical Center Bayonet Point, accepted as an expert in nursing administration; Suzanne Baker, RN Director of Patient Care Services for the cardiac surgical step-down unit, Regional Medical Center Bayonet Point; Darryl Weiner, accepted as an expert in health care finance, including financial feasibility determination; and Richard A. Baehr, accepted as an expert in health care planning and health care finance.
Bayonet Point (BP) Exhibits numbered 1, 2A-2N, 3, 4-1-4-7,
5, 6-1-6-1, 7-1-7-1, 8-18, 19 (pages 1-55), and 20-26, including several depositions, were admitted into evidence.
On June 8, 2006, Helen Ellis filed a motion requesting that the final hearing be closed and the motion was granted, without objection, on June 12, 2006. Helen Ellis attached to the motion a copy of the exhibits to Morton Plant Exhibit number 14, which will be included in the record of this proceeding.
On June 21, 2006, Volumes 1-18 of the final hearing Transcript (T) were filed with the Division of Administrative Hearings. Volume 19 of the final hearing Transcript was filed on September 21, 2006.
On August 10, 2006, Bayonet Point filed copies of each patient medical record underlying Bayonet Point Exhibit number
26. Pursuant to the parties' agreement, the documents are confidential.
On September 13, 2006, Helen Ellis filed a motion to re- open the record, which was opposed by Morton Plant and Bayonet Point. The motion was denied on September 22, 2006.
On October 9, 2006, Helen Ellis, Morton Plant, and Bayonet Point, filed separate proposed recommended orders and Helen Ellis and Morton Plant filed separate memoranda of law. (Morton Plant's oral motion to exclude data and projections beyond 2011 is denied.) The Agency did not file a proposed recommended order or join in any proposed recommended order. All of the post-hearing submissions have been considered in the preparation of this Recommended Order.
FINDINGS OF FACT
The Parties
AHCA. The Agency for Health Care Administration is the state agency authorized to evaluate and render final
determinations on CON applications pursuant to Section 408.034(1), Florida Statutes.2
Helen Ellis. Tarpon Springs Hospital Foundation, Inc., d/b/a Helen Ellis Memorial Hospital, is a not-for-profit corporation that is the license holder for Helen Ellis Memorial Hospital (Helen Ellis), a 168-bed general acute care hospital located in Tarpon Springs, Pinellas County, Florida.
Helen Ellis is owned by the City of Tarpon Springs and has a 75-year history of providing hospital services to the residents of the Tarpon Springs and surrounding communities. The hospital currently serves the northern Pinellas County and southwestern Pasco County areas, including the communities of Tarpon Springs, Holiday, Palm Harbor, and portions of New Port Richey.
In September 2000, University Community Health, d/b/a University Community Hospital (UCH), acquired a 40-year lease from the City of Tarpon Springs to operate Helen Ellis.3 Pursuant to the agreement, UCH assumed management responsibility for Helen Ellis. UCH paid off approximately $25 million of Helen Ellis' debt and continues to financially support the hospital, notwithstanding financial losses at Helen Ellis over the past several years.4
UCH currently offers significant residency training opportunities, and is expanding its residency programs to
include two additional residencies: one in interventional cardiology and one in electrophysiology (EP). Pepin Heart is involved in developing research protocols with teaching institutions such as Duke University and Cleveland Clinic, and Moffitt Cancer Center UCH's main campus serves as a tertiary referral facility in northern Hillsborough County.
The close working relationship with Pepin Heart is a benefit to Helen Ellis' cardiology program.
Helen Ellis plans to use the same perfusionists, anesthesiologists, and other medical support staff that are used at the Pepin Heart program.
The operating room, critical care and cardiac catheterization nurses are expected to receive training at Pepin Heart.
Helen Ellis expects to use the technological linkages to Pepin Heart, such as a "PACS" system. The PACS linkage will allow experts at Pepin Heart to review information and consult on patients being treated at Helen Ellis.
Helen Ellis has a cardiology program with over 20 cardiologists on staff, including interventional cardiologists, who currently perform their interventional procedures at Morton Plant and Bayonet Point. Some of these cardiologists testified in support of the development of an OHS program at Helen Ellis, and have indicated they will refer their patients to Helen Ellis
for OHS and percutaneous coronary intervention (PCI) services if the hospital's application is approved.
Helen Ellis is accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and has a reputation for providing high quality of care.
Helen Ellis has received awards for providing excellent health care services in general and performs high quality cardiac services.
Helen Ellis' emergency department services are also high quality.5 The hospital's Quality Assurance and Performance Improvement Plans were included in the CON application and have been updated annually.
Helen Ellis provides a full range of diagnostic cardiac catheterization procedures, including halter monitoring, stress tests, EKG, diagnostic catheterization, and other procedures used for diagnoses of cardiac disease.
Helen Ellis operates a cardiac rehabilitation program for patients who have OHS or PCI and are in need of follow-up care. Cardiac rehabilitation is an important component of a high quality cardiology service line.
In 2005, the Agency approved Helen Ellis' request to offer emergency PCI services under the exemption process established by the Legislature in 2004 for hospitals that can demonstrate they meet the statutory criteria. The program was
implemented in December of 2005.6 Helen Ellis is one of two or three hospitals in the state providing this service under an exemption.
In its first four months of operating the emergency PCI program at Helen Ellis, the hospital performed 34 emergency PCI procedures. (Of these, two patients were transferred by life flight to UCH on a non-emergent basis for OHS. A third patient was transferred to Morton Plant (for additional intervention) on a non-emergent basis two days after the procedure was performed at Helen Ellis. T 177; HE 91 at 42-43.) This volume is significant, given that the state has established 36 procedures as the necessary annual volume to continue to perform these procedures. § 408.036(3)(n)1.b., Fla. Stat. Generally, this volume of emergency PCI procedures is an indicator of the potential demand for cardiac services in the Helen Ellis proposed service area (PSA).
Patients diagnosed with an Acute Myocardial Infarction (AMI) should be treated within 90 minutes after the patient enters the emergency room.
Helen Ellis has maintained an 81-minute door-to-door balloon time (from the time the patient hits the door to the time the balloon is inflated in the first artery) for the 34 PCI procedures, which is below the 90-minute ACC standard. This
practice is indicative of high quality of care, because "time is muscle" for heart attack patients.
Although Helen Ellis can provide a range of cardiac services, including cardiac catheterization and emergency PCI procedures, it currently lacks the authority to provide OHS and PCI on a non-emergency basis. Also, Helen Ellis' ability to perform some emergency PCI procedures under the emergency PCI exemption is limited. For example, because of current regulatory prohibitions, Helen Ellis cannot perform an emergency PCI on a patient who does not have an acute ST segment elevation AMI. There are also some non-regulatory limitations on Helen Ellis' ability to perform the full range of EP procedures without OHS backup.
Patients of referring physicians often bypass Helen Ellis (in favor of Morton Plant and Bayonet Point) for cardiology services because no OHS services are offered at Helen Ellis. (Mr. Baehr stated that the by-pass figure could be as high as 40 to 60 percent. T 2325.)
Helen Ellis has two cardiac catheterization laboratories, which are adequate to meet the demand should Helen Ellis's CON application be approved. Helen Ellis has the capacity to schedule cases within its normal hours of operation and can expand its lab capacity by extending normal hours of operation, which are currently 7:30 a.m. to 3:30 p.m.
The original lab is used and will continue to be used for diagnostic cardiac catheterizations, peripheral vascular and renal procedures, and other radiology interventions. The second new laboratory is predominantly used for electrophysiology (EP) procedures,7 diagnostic catheterizations, and emergency PCI procedures. If necessary, Helen Ellis can add a third catheterization lab without CON review.
For the calendar year 2005, Helen Ellis reported to the Agency performing between 971 and 1,064 (from October 2005 data source, T 2297) inpatient and outpatient diagnostic cardiac catheterization cases, making it the third or fourth largest volume provider of such services in the state among the 57 hospitals that do not at present provide OHS. HE 60; BP 19 at
The 971 diagnostic cardiac catheterization procedures exceeded the volume of approximately six hospitals that either already provide or are approved to provide OHS. HE 60.
Since the time when UCH assumed the management of Helen Ellis in September 2000, Helen Ellis' average annual utilization of its acute care beds has remained under 60 percent. For calendar year 2005, Helen Ellis' average utilization of its existing 150-acute care beds (at the time Helen Ellis had 15 skilled nursing beds) was approximately 50 percent. Nevertheless, Helen Ellis projects an increase in utilization of its acute care beds to nearly 70 percent by the
first quarter of operation of its proposed OHS program in 2008, the beginning of the "halo effect."
Morton Plant. Morton F. Plant Hospital Association, Inc., is licensed to operate Morton Plant Hospital (Morton Plant), a tertiary acute care hospital. Morton Plant is located in Clearwater, Pinellas County, Florida. Morton Plant is licensed to operate 687 beds, as well as a 120-bed skilled nursing facility on its campus. Morton Plant offers a full range of cardiac care services including OHS and PCI.
Morton Plant is located approximately 13 to 18 miles south of Helen Ellis. See, e.g., MP 12.
Morton Plant is accredited by the JCAHO and has a reputation for providing high quality of care. The parties stipulated that Morton Plant offers high quality of care in its OHS and PCI programs.
Morton Plant Hospital is part of a four-hospital system referred to as Morton Plant Mease Health Care. Morton Plant Mease Health Care is affiliated with BayCare Health System, a network of nine not-for-profit hospitals in Pinellas, Hillsborough, and Pasco Counties.
The BayCare System includes Morton Plant, Mease- Dunedin, Mease Countryside, and St. Anthony's in Pinellas County; St. Joseph's Hospital in Hillsborough; and North Bay Hospital in Pasco County.
Morton Plant is currently completing a major expansion of its cardiovascular services program initiated in 2000, including the construction of a new dedicated heart hospital on its campus that is designed to streamline all aspects of pre- and post-surgical care for cardiology patients. (The cost for this project is $55 million.) The expansion in the number of cardiac catheterization labs, surgical suites, and recovery beds in Morton Plant's cardiovascular program is increasing the capacity of the program.
Morton Plant has developed several centers of excellence, and is a regional referral center for OHS and other cardiothoracic services. Morton Plant started its cardiovascular program in 1975 and was the first hospital in the Tampa Bay area to perform angioplasty in 1981.
The active medical staff of Morton Plant currently comprises approximately 850 physicians all of whom are board- certified, pursuant to Morton Plant's medical staff admission requirements. Some of the cardiologists on the medical staff at Helen Ellis have privileges to perform interventional cardiology procedures at Morton Plant.
Morton Plant has a structured continual improvement process which has resulted in continuous improvements in Morton Plant's quality and efficiency of care.
Morton Plant currently operates three state-of-the-art cardiac catheterization labs that are used exclusively for cardiac catheterization procedures. Morton Plant also operates an EP lab that is used exclusively for these procedures. When construction is completed, Morton Plant will have four cardiac catheterization labs, two EP labs, and one shelled-in space for catheterization lab expansion.
Morton Plant's cardiac catheterization labs routinely operate from 7:30 or 8:00 a.m. to 5:00 p.m., depending on the season. During peak season, one or two labs may remain open later if necessary. One lab is open on Saturdays if necessary. The labs are available 24 hours a day, seven days a week for emergent cases.
Morton Plant also operates one EP lab exclusively for these studies.
Urgent cases are given priority in these labs regardless of whether the patient is referred from an affiliated hospital or non-affiliated hospital. These patients are brought directly to the hospital, and usually directly to the catheterization lab upon their arrival, and go into the next available "open-heart lab." Morton Plant refers to this process as a "direct admit" protocol, which streamlines the treatment of emergency patients.
Morton has provided enhancements to the emergency service system in District 5.
As part of its cardiovascular services program, Morton Plant provides transportation for OHS patients and their families to and from Morton Plant. In addition, Morton Plant, with Morton Plant North Bay Hospital (North Bay) (a 120-bed facility in New Port Richey, Pasco County), purchased and operates an advanced life support ambulance that is equipped for the transport of patients "in an emergency state," e.g., requiring interventional cardiology services, to any hospital in the community, including Morton Plant, Bayonet Point, etc. The ambulance is based in southwest Pasco County and is available to serve patients in the community. T 1117-1118, 1153-1155.
Patients transferred to Morton Plant or Bayonet Point have received high quality care in a timely fashion with no adverse outcomes arising from the transfer.
As stipulated, Morton Plant performed between 775 and 812 OHS cases in 2004 making it the sixth largest OHS provider among 64 operational hospitals in Florida. As reported by the Agency, Morton Plant had 751 OHS discharges between July 2004 and June 2005 and continued to rank sixth among OHS providers. HE 57. According to Morton Plant's internal data, Morton Plant performed 682 OHS cases in calendar year 2005 and retained its approximate position in volume among providers (using Agency
data). Internal documents indicate that Morton Plant PCI volume has also declined from 2946 in 2003 to 2677 in 2005. MP 7, 13. (Dr. Williamson opined that the decline is "probably related to drug eluting stents." T 2444.)
Bayonet Point. HCA Health Services of Florida, Inc. (HCA), operates Regional Medical Center Bayonet Point (Bayonet Point), located in Hudson, Pasco County, Florida. Bayonet Point is a regional OHS referral center and provides high quality of care. Bayonet Point is a 290-bed licensed tertiary acute care hospital located approximately 18 miles north of Helen Ellis.
HCA also owns Oak Hill Hospital located approximately
16 miles from Bayonet Point in adjacent Hernando County to the north. Oak Hill initiated a new OHS program in February, 2006. The precise quantity of procedures performed at Oak Hill is unknown.
In addition to Bayonet Point and Oak Hill, HCA also offers OHS and PCI services in the Tampa Bay area at Brandon Regional Medical Center east of Tampa; Northside Hospital in St. Petersburg; and at Largo Medical Center in central Pinellas County. Northside Hospital is approximately 13 miles southeast of Morton Plant. Largo Medical Center is approximately three miles south of Morton Plant. The Bayfront/All Children's (Bayfront) program is located approximately seven miles southeast of Northside Hospital.
The parties stipulated that Bayonet Point offers high quality of care in its OHS and PCI programs. Additionally, the parties stipulated that Largo Medical Center offers high quality of care in its program at the volumes it has operated historically, i.e., below 300 OHS cases per year.
As stipulated, in 2004, Bayonet Point performed between 741 and 771 OHS cases, making it the seventh largest provider in the state of Florida. As reported by the Agency, Bayonet Point had 684 OHS discharges between July 2004 and June 2005, remaining the seventh largest provider. HE 57. (Bayonet Point data suggested performing 803 OHS cases in 2004 and for calendar year (CY) 2005, 601 OHS cases.) OHS case volume has decreased from approximately 1,361 OHS cases in CY 1999 to the numbers reported above. Bayonet Point's PCI procedures volumes were relatively flat from 2002 through 2004, but declined in 2005.8 PCI volumes as of March 2006 were slightly higher than in 2005.
Bayonet Point offers all major health care services, except obstetrics, psychiatric, and pediatric services. The hospital serves the residents of Northern Pinellas County, Hernando County, and Pasco County.
Bayonet Point has received awards for providing excellent health care services, including cardiology and open heart. Bayonet Point participates in community services.
Bayonet Point recently completed a $40 million expansion and renovation project for its cardiac surgery program
-- The Heart Institute. The project included the expansion and renovation of four cardiovascular operating rooms (CVOR) and accompanying areas surrounding the CVOR's, the 20-bed CSU, the pre-operative and post-operative areas, the step-down unit, and the cardiac catheterization recovery area.
As noted, Bayonet Point has four CVOR's dedicated for OHS patients and a 24-bed cardiac procedural recovery unit (CPRU) with all private rooms for patient recovery after EP studies, cardiac catheterizations, and cardiac interventional catheterization procedures are performed.
Bayonet Point's four cardiac catheterization labs are located adjacent to the CPRU. Patients are monitored, educated, and prepared for the procedures in the lab prep/recovery area.
Bayonet Point is in the process of replacing one of its cardiac catheterization labs and an EP lab at a cost in excess of $3 million in order to implement new technologies.
The 20-bed CSU has all private rooms for immediate post-surgery OHS patients. Post-surgery OHS patients move from the ICU into the cardiac surgical step-down unit (CSSU). In addition to the 20-bed CSU, Bayonet Point also has a 20-bed CCU for critical care patients who could be either interventional or medical-critical care patients. These patients may need a
longer recovery period than provided in the CPRU. All of these rooms are private.
Bayonet Point is an accredited chest pain center, able to provide services in its emergency department (with 18-beds) to cardiac patients who present with chest pain and ST Elevation Myocardial Infarctions (STEMI). The emergency department participates in improvement programs to monitor and improve the quality of care provided to cardiac patients. Bayonet Point has reduced the turn-around times for cardiac enzyme results, and getting patients to the cardiac catheterization labs and has increased compliance with standard of care protocols in the treatment of cardiac patients.
Bayonet Point offers a full range of cardiac services, except for heart transplantation, pediatric cardiology, and phase 2 and 3 cardiac rehabilitation services.
All medical staff members are required to be board- certified or board-eligible.
Bayonet Point utilizes electronic medical record documentation and has also implemented a bar code scanning system for medication administration to improve patient safety. Medication orders are electronically scanned to the pharmacy. Bayonet Point physicians can access medical records remotely from their offices. This year, Bayonet Point will implement a
"PACS" program, a technology that allows for digital access to radiology exams.
Bayonet Point treats patients without the ability to pay as well as Medicaid patients.
Current Trends in Treating Acute Myocardial Infarction (AMI)
There are three alternatives for patients presenting with severe coronary heart blockage, or acute myocardial infarction (heart attack): medical therapy in the form of thrombolytic drugs; interventional cardiac catheterization, commonly referred to as angioplasty or PCI; and OHS.
Patients with cardiovascular problems have also benefited from the use of statin drugs that lower cholesterol levels.
From approximately the early 1980s through the mid- 1990s, thrombolytic therapy was the preferred treatment for AMI.
It is generally accepted that PCI has emerged as the preferred treatment for an AMI.
A major development in PCI technology occurred with the advent of stent technology in 1994. A stent is a metallic device placed in an artery through a cardiac catheter and designed to help keep the artery open.
The bare metal stents introduced in 1994, however, had a tendency to result in clotting problems, resulting in
recurrence of the arterial blockage (restenosis) in approximately 20 to 30 percent of the cases, which often resulted, for example, in the removal and replacement of the stent or reintervention of the vessel. Real world experience indicates that half of that number required the reintervention of the vessel, i.e., "target vessel revascularization."
During the spring of 2003, drug-eluting stents (with a special chemical coating) became available. The chemical coating on these stents has reduced the restenosis or recurrence rate for drug-eluting stents. With approximately three years of real world experience, the recurrence rate is now in the range of seven to eight percent with the use of drug-eluting stents and five to six percent revascularization. There are no long- term studies regarding the efficacy of drug-eluting stents.
The emergence of PCI as the preferred treatment for AMI and coronary artery blockage has contributed to the decline in OHS volume, both nationally, statewide, and in District 5. Whether this particular trend will continue is subject to debate.9 For example, it was explained that while CABG alone might be down volume-wise, valve/CABG are up, valves alone are up, and there are a variety of arrhythmia procedures, which are done now that were not done five years ago.
The District 5 population as a whole has a higher percentage of elderly than the state of Florida. Pinellas
County is the most densely populated county in the state. In 2005, the percentage of population in Helen Ellis' proposed service area (PSA) (65 and over) was estimated to be 25.8, higher than the District 5 average. By 2011, a general aging of the population will begin as "baby-boomers" turn 65 years of age.
Today's older OHS patients tend to have more co- morbidities than in the past. These increased co-morbidities, such as stroke history, chronic pulmonary disease, diabetes, etc., increase the risk of OHS and make recovery from OHS more difficult. The greater risk has created an even greater demand for highly skilled OHS surgical teams.
It is reasonable to expect the patients that Helen Ellis would receive for OHS services would have these co- morbidity characteristics.10
Both surgeon and hospital volume are predictors of mortality with respect to OHS services. However, volume should not be used independently as a measure of outcomes or the quality of care of an OHS program.
The ability to consistently obtain the best outcomes for patients depends, in part, upon the level of experience and expertise of the surgeons, anesthesiologists, perfusionists, respiratory therapists, and surgical and critical care nurses. Geographic access issues are also a consideration. Generally,
hospitals with higher OHS volumes provide an environment conducive for gaining the necessary experience with both routine and non-routine cases.
Some studies reflect that high-volume OHS programs achieve good outcomes and lower mortality for patients, compared to lower-volume OHS programs. One study indicated that "hospital procedure volumes only is modestly associated with coronary bypass outcomes and, therefore, may not be an adequate metric for coronary artery bypass surgery."
On the other hand, studies also indicate that some low- volume programs can achieve good outcomes, although there is greater variability with respect to outcomes among low-volume programs than occurs in high-volume programs. The better results with respect to OHS mortality appear to have been obtained by high-volume surgeons (and OHS team members) at high- volume hospitals, and overall, at least with respect to CABG, high hospital procedure volume has been associated with lower rates of hospital mortality, especially in elderly patients, 65 and older. The effect of volume is even more apparent in elderly patients.
Review of clinical data suggests that while there are some statistically significant correlations between volume and outcomes, particularly in elderly patients, volume is not alone a good predictor of quality. There are low-volume programs that
achieve excellent outcomes, whereas there are high-volume centers with poor outcomes.
The level of the quality of care delivered in an OHS program depends on a host of factors independent of volume. In particular, the Society of Thoracic Surgeons (STS) has identified 21 criteria that were considered to be important in establishing a high quality program. Volume is listed, but no specific volume was identified. (The STS collects data from OHS programs nationwide which allows OHS facilities to benchmark their programs.)
UCH participates in the STS data base and Helen Ellis has agreed to participate in national STS reporting.
Taken as a whole, the credible evidence does not support the assertion that an OHS program operating at volumes of approximately 150-200 cases annually in the start-up years would necessarily result in a low quality program.
Whether an OHS program such as that offered by Helen Ellis in this proceeding is likely to be a lower volume program after 2011 was the subject much debate in this proceeding. However, by 2011, and continuing for the next 18 years, the "baby boomers" will become the seniors of tomorrow which is likely to result in an increase in the number of people needing cardiovascular care. Given the demographics of the PSA, including the aging of the PSA population, it is more likely
than not that the number of OHS/PCI and related procedures will increase rather than decrease over time.
Section 408.035(1), Florida Statutes - Need for the service being proposed/fixed need pool.
Zero Fixed Need Pool
Florida Administrative Code Rule 59C-1.033(7) includes a numeric need formula for determining the need for new OHS programs. There is no specific need formula for PCI services, although approval for OHS is required before a hospital can implement PCI services except as stated herein.
Under the numeric need formula, the Agency published a fixed need pool of zero for District 5 (Pinellas and Pasco Counties) in the CON batching cycle at issue in this case because Largo Medical Center performed less than 300 OHS cases in the prior year and East Pasco Medical Center (EPMC) (now known as Florida Hospital Zephyrhills), located in eastern portion Pasco County, Florida, was approved but was not yet operational at the time the fixed need pool was published.
(EPMC initiated its OHS program in January, 2006, and by mid-May had performed approximately 50 OHS cases.)
The fixed need pool calculation was not challenged.
In light of the zero fixed need pool, Helen Ellis is required to prove that "not normal" circumstances exist within
District 5 in order to obtain approval of its proposed OHS program.
In many OHS cases, "not normal" circumstances have been proven by the existence of serious impediments or barriers to access to existing services, including geographic, financial, or programmatic access barriers. However, there is no pre-set list of factors which may be considered "not normal."
The parties stipulated that approval of an OHS program in Helen Ellis will have no impact on the lower-volume program at Largo Medical Center. It was further stipulated that Largo Medical Center is able to provide high quality of care at its current and historic OHS case volumes, which have been less than 300.
It was also stipulated that a new OHS program at Helen Ellis would have no impact on the approved program at EPMC. (EPMC supports the approval of the Helen Ellis application.)
Helen Ellis' Proposed Service Area (PSA)
There are six existing providers of OHS services in District 5: Bayonet Point, Morton Plant, Largo, Bayfront/All Children's, Northside, and EPMC. Of the six District 5 OHS providers, only Morton Plant and Bayonet Point significantly compete with Helen Ellis.
In its application, Helen Ellis defined its PSA as all zip codes where Helen Ellis derives two percent or more of its
total MDC-5 or all cardiovascular discharges, excluding OHS, angioplasty, and stent procedures, for year ending June 2004. HE 1 at 25; T 894, 1215-1216. The market share varies across these areas from 2.4 percent in zip code 34653 to 59.8 percent in zip code 34689, with an overall market share of 17.3 percent through June 2004. Id.
Based on this market share data, Helen Ellis' PSA consists of nine zip codes: 34683 and 34684 (Palm Harbor), adjacent and south of Helen Ellis' home zip code 34689; 34688, adjacent and west of 34689; and 34689 (Tarpon Springs), Helen Ellis home zip code; 34690 and 34691 (Holiday), adjacent and north of Helen Ellis; and 34652, 34653, and 34655 (New Port Richey), farther north and northeast of Helen Ellis. Helen Ellis' PSA is reasonable.
Helen Ellis is located in zip code 34689 (Tarpon Springs), and no OHS hospital provider is physically located in this PSA, although Morton Plant and Bayonet serve the residents of this PSA.
Helen Ellis calculated its OHS and PCI projections for the PSA by multiplying the population in the forecast years by the use rate.
The estimated adult population (ages 15 and older) in the PSA is projected to grow from approximately 184,215 in 2005 to approximately 199,056 in 2009; 200,705 to 202,354 in 2010;
and 205,652 in 2011. HE 65A and 65C; BP 19 at 43-44. (Ms.
Pearson's population projections have been considered, but are not persuasive.)
For the PSA, the adult population (ages 15 and over) is projected to increase approximately 16,490 to 18,139 from 2005 to 2010 and approximately 21,437 by 2011. HE 69C; BP 19 at 43- 44; BP 20. Of the projected population growth of 16,490 between 2005 and 2010, zip codes 34652, 34653, and 34655 account for approximately 53 percent of the total projected adult population growth, with an approximate 30 percent growth in zip code 34655. These zip codes accounted for approximately 40 percent of the adult population within the PSA in 2005 and over approximately
41 percent by 2010. BP 19 at 43-44; BP 20. Also, the most notable increases are projected for zip codes 34688 and 34655 at
20.4 and 19.9 percent, respectively, with the 2010 population projected at 10,188 and 29,915, respectively. BP 20.11
While the numbers differ somewhat due in part to using differing calendar/fiscal years years, the number of OHS cases for residents within the PSA decreased from approximately 448 for the year ending March 31, 2003, to approximately 433 for the year ending March 31, 2004, then to approximately 403 for the year ending March 31, 2005, and 411 for year ending June 2005. MP 13-2; BP 19 at 46; HE 69C.
OHS case volumes and use rates in District 5, statewide, and within the PSA have declined between 1999 and 2005, whereas the use rates for therapeutic catheterizations has increased overall during this time frame with a slight decline during the first six months period ending June 30, 2005.12
Based upon data for July 2003 through June 2004, approximately eighty-one percent (155/191)13 of the inpatient diagnostic cardiac catheterization discharges from Helen Ellis were performed on residents (within the PSA) from four zip codes: 34683 (14) (adjacent and south of zip code 34689); 34689 (88); 34691 (36) (adjacent and north of zip code 34689); and 34690 (17)(east and adjacent to zip code 34691). Zip code 34684
(11) is east and adjacent to zip code 34683. Thus, 166 out of
191 (approximately 87 percent) inpatient cardiac catheterization discharges were performed at Helen Ellis on residents from five zip codes, including zip code 34689 and four other zip codes adjacent to zip code 34689, the site of Helen Ellis. Approximately 65 percent of the inpatient cardiac catheterizations originated from zip codes 34689 and 34691.
HE 1 at 26. See also BP 19 and 29 for total inpatient catheterizations at Helen Ellis for year ending June 30, 2005.
For the same time period (ending June 2004), approximately 60 per cent (581/968) of the adult cardiology discharges from Helen Ellis originated from zip codes 34689
(386/968) and 34691 (195/968). (Helen Ellis garnered 59.8 and
34.5 percent share of the total discharges in each zip code.) Approximately 12.7 percent of these discharges originated from zip codes 34652, 34653, 34655, and 34688. HE 1 at 25; see also MP 13 at 6 and 9 for similar data for April 2004 through March 2005.
The experts differ, in part, on Helen Ellis' projected market share for the nine zip code PSA and outside these zip codes (out-of-area) and the OHS use rate. There is no exact science applied to develop a market share or, for that matter, the applicable use rate.
In its CON application, Helen Ellis provided projections for calendar years 2008-2010, the projected first, second, and third years of operation. For calendar year 2008, Helen Ellis used a market share of 21.65 percent, and an "out-of area" rate of 17.2 percent. Helen Ellis then applied the 21.65 percent market share (103/478 OHS cases[14]) and a 17.2 "out-of- area" share (22 OHS cases) and projected that it would perform
125 OHS cases during the first year of operation; 200 OHS cases (33.95 percent market share); and 229 OHS cases (38.15 percent market share) for the second and third years of operation, respectively. HE 1 at 46; T 1220-1221.
In its CON application, Helen Ellis stated that cardiologists at Helen Ellis estimated "that approximately 25
percent of the cases are never seen at Helen Ellis due to anticipation of angioplasty, stenting or open heart intervention, as well as EMS routing procedures in place." HE 1 at 35. See also T 1186, 1220.
At the final hearing, Helen Ellis offered Exhibit 65A, which is a revised OHS utilization forecast for years 2009- 2011, i.e., revised projected initial years of operation. Helen Ellis projected performing between 144 (25 percent market share (MS)) and 202 (35 percent MS) OHS cases the first year of operation (2009); 207 (35 percent MS) to 266 (45 percent MS) for the second year of operation (2010); and 242 (40 percent MS) to
303 (50 percent MS) for the third year of operation (2011).
Helen Ellis used a constant 20 percent out-of-area draw number throughout the first three years of operation. HE 65A; T 919- 926.15
As support for his assumptions, Mr. Nelson provided the actual first year of operation market shares for four recent start-up programs. While every area will have different factors that affect market shares for a new OHS provider, these recent experiences provide some support for Mr. Nelson's lower end projections.
Mr. Nelson opined that the most reasonable projection would be somewhere between his low and high end projections.
Mr. Richardson and Mr. Baehr criticized Mr. Nelson's approach (in the CON application, as supplemented in Helen Ellis Exhibits 65 and 69) in several ways: 1) the OHS use rate is lower today than when the CON application was filed in
December 2004; 2) Helen Ellis's projected year one market share was very aggressive; and 3) Helen Ellis' projections of OHS cases from out of the PSA, as set forth in Helen Ellis Exhibit 65A (20 percent) are not realistic. See, e.g., T 1559-1662, 2163-2243; MP 13.
Both Mr. Richardson and Mr. Baehr felt that
Mr. Nelson's application of Mr. Nelson's assumed market share to each of the nine zip codes in Helen Ellis' PSA was unrealistic, in part, because approximately 60 percent of Helen Ellis' adult cardiology discharges originated from two zip codes. HE 1 at
25.
Mr. Richardson and Mr. Baehr opined that Helen Ellis'
projected market share of 40 to 50 percent within the PSA by the third year of operation is unrealistic based, in part, on Helen Ellis' established market share for its mature cardiology programs, which is 16.5 percent for the year ending March 2005 (17.3 percent for the year ending June 2004). HE 1 at 25; MP 13 at 9. Mr. Richardson also noted that Helen Ellis derived over
50 percent of its cardiology patients from zip codes 34689 and 34691. MP 13 at 6; T 1641-1643.
Mr. Richardson suggested that Helen Ellis will achieve a market share of 20.6 percent and 17.4 percent out-of- area share or a total of 114 OHS cases by year 2010, based on a total of 456 (473 for Helen Ellis) projected OHS cases within the PSA. (Mr. Richardson used a 2010 population number of 200,705 versus 202,354 number used by Mr. Nelson.) MP 13 at 8; HE 65A.
Mr. Baehr suggested that Helen Ellis will have 20, 24, and 27.5 percent market shares in year 1 through 3 (2008- 2010) and a constant out-of-area percentage of 17.2, which yields Helen Ellis 94, 112, and 127 OHS cases for years 2008, 2009, and 2010.16 These numbers are based on Mr. Baehr's projection of 390, 386, and 382 available OHS cases for the PSA for years 2008, 2009, and 2010, respectively, which are substantially lower than Mr. Nelson's numbers, in particular for 2010 - 473 for Mr. Nelson versus 382 for Mr. Baehr, and
Mr. Richardson's number for 2010. BP 19 at 50 and 52; MP 13 at 8; HE 65A. (Using Helen Ellis' CON application market share projections for years 2008 through 2010 and OHS case projections for these years of 390, 386, and 382, and holding the out-of- area percentage at 17.2, Mr. Baehr projected Helen Ellis would garner 102, 158, and 176 OHS cases for these years of operation. (Like Mr. Richardson, Mr. Baehr used a population number of 200,705 for 2010. Mr. Nelson used a number of 200,175 in the
application. As revised, Mr. Nelson used 202,354.) MP 13 at 8; BP 19 at 50-52; HE 1 at 34; HE 65A.
According to Mr. Baehr, Mr. Nelson used an overall increasing use rate, which he believes is inconsistent with actual experience. Mr. Baehr used a declining use rate with a slower rate of decline, which results in decreased utilization. T 963-964, 991-992, 999-1000, 2210-2211. (Regarding Helen Ellis Exhibit 65A, Mr. Baehr stated that Mr. Nelson used constant use rates within particular age subgroups which had the impact of having overall increasing use rates because of the changing population, i.e., the use rate is growing. T 2237. Using age- specific use rates is more accurate than using a composite use rate. T 1024-1031, 2355-2356, 2390.)
Mr. Nelson explained that AHCA uses a constant use rate which is updated every batching cycle, "[s]o it is not truly a fixed or a static use rate." He further explained that he used an age-specific use rate, characterized as "a constant use rate" rather than a composite use rate. T 1000, 2379-2390.
The health care planning experts agree on some points and disagree on others. The material disputed issues of fact center on what is a reasonable forecast for Helen Ellis' market share (including any bump-up and out-of-area volume) for adult OHS cases for the revised years of operation (2009, 2010, and
2011) and what is the pool of potential OHS cases from within and outside the PSA.
Based on the weight of the evidence and having considered the conflicting opinions among the experts, it is concluded that Helen Ellis can achieve a projected market share of 25 percent and an out-of-area draw of 20 percent for the first year of operation (2009), and approximately 35 percent market share and a 20 percent out-of-area draw for year two (2010), which includes a reasonable "ramp up." These assumptions yield approximately 144 OHS cases projected to be performed at Helen Ellis for 2009 (year one) and approximately
207 OHS cases for 2010 (year two). HE 65A. Compare with HE 1 at Notes to Schedule 7A for OHS utilization projections for years one and two, 125 and 200, respectively. (In the prior case and considering similar concerns regarding variability, it was determined that Helen Ellis would perform between approximately 115 and 139 OHS cases for 2009 and approximately
182 OHS cases for 2010. Tarpon Springs, Recommended Order at 24-25.)
Given current trends, these projections may be optimistic and likely variable depending, in part, on physician referral patterns and market share adjustments. Several cardiologists strongly support Helen Ellis' application and
physician and other clinical testimony regarding projected OHS referrals to Helen Ellis is persuasive.17
Section 408.035(2) and (5), Florida Statutes: Availability, Quality of Care, Accessibility, and Extent of Utilization of Existing Health Care Facilities and Health Services in District 5 and the Extent the Proposed Services will Enhance Access to Health Care for Residents of District 5
There are six existing providers of OHS services in District 5, but only two (Morton Plant and Bayonet Point) have significant service area overlap.18
Adult OHS programs are located within a two-hour travel time under average travel conditions for at least 90 percent of the District 5 population as required by Florida Administrative Code Rule 59C-1.033(4)(a); however, compliance with this standard does not preclude approval of a new OHS program.
This is a "not normal" circumstance case. Helen Ellis contends that the travel situation for the elderly (and their elderly caregivers) within the PSA is cumbersome and that they have difficulty driving to OHS providers in District 5, namely Morton Point and Bayonet Point. Thus, the elderly in need of OHS services are deprived of reasonable access to an existing OHS provider and, as a result, a "not normal" circumstance exists justifying approval of an OHS program at Helen Ellis.
In the prior case, no travel time study was conducted by any party and that while there was congestion on the roadways north and south of Helen Ellis (US 19 and Alternate US 19), especially during peak driving times and the peak season, the residents of the PSA had reasonable access to the OHS programs at Morton Plant and Bayonet Point and reasonably accessed the OHS program at UCH/Pepin in Hillsborough County.
The evidence in this case is different, in part, because experts for Helen Ellis and Morton Plant performed analyses of the travel situation. Helen Ellis also offered the testimony of Dr. Stamatiadis, an expert civil engineering with an emphasis in traffic and transportation engineering and a specialized focus in the problems of elderly drivers.
Almost all of the roadway segments between Helen Ellis and Morton Plant and Bayonet Point are rated Level of Service (LOS) "F," yet there are no significant improvements planned that would likely lead to any significant enhancements of this traffic congestion on these routes in the foreseeable future. See, e.g., MP 12E. See also T 1537-1538.
There are four improvements currently funded at various overpasses/intersections along a short stretch of and to the east and north of Morton Plant on US 19, which may improve the LOS somewhat in these areas. According to Mr. Pergolizzi,
these are the only improvements currently funded along US 19. MP 12E; T 1612-1614.
The accident rate on US 19 between Helen Ellis and Bayonet Point is significantly higher than would be expected. There are 12 out of the 20 worst accident intersections in Pasco County located on this stretch of the highway. This stretch of highway accounts for 21 percent of the Pasco County accidents and 35 percent of the county's traffic fatalities. Part of the problem is that there are 24 traffic lights that hinder traffic flow between the county line and Bayonet Point.
Further, Dr. Stamatiadis was concerned that fatalities on this stretch of highway were increasing, which is inconsistent with the national trend that traffic fatalities are decreasing. He was not aware of the number of elderly drivers/patients involved in these accidents on US 19.
Similar issues were raised regarding the potential routes used between Helen Ellis and Morton Plant. One route is Alternate US 19, a two-lane road running about 13 miles down the coast. The other route is US 19 to Gulf to Bay, a multilane route with numerous intersections and lanes and heavy traffic. This route is approximately 18 miles, but typically faster than the 13-mile Alternate US 19 route.
Based upon his 20 years of experience in studying the vulnerabilities of elderly drivers and what causes them to have
accidents, Dr. Stamatiadis opined that both of these routes to Morton Plant have all the indicia of problems associated with elderly drivers. He explained that the ability of an elderly driver to absorb and process information is less and that driving on US 19 would likely be confusing and dangerous for many elderly drivers. The roadway with multiple lanes of traffic, numerous signalized intersections, and confusing limited overpasses on US 19 contribute to the problem.
As to Alternate US 19, Dr. Stamatiadis advised that the numerous small roads that merge onto this road and the constant start and stop traffic would be difficult for the elderly.
Furthermore, based on research conducted by Dr.
Stamatiadis and his colleagues, elderly drivers are two times more likely than teenage drivers to have an accident and 50 percent more likely to suffer a fatality if involved in an accident. It is fair to say that elderly drivers are a vulnerable subset of drivers.
While his experience with the roadway system presented here is limited, Dr. Stamatiadis opined that the driving conditions presented in northern Pinellas County and southwestern Pasco County are not conducive conditions for elderly drivers within the PSA who drive to Morton Plant or Bayonet Point for OHS and related services.
As noted, the driving conditions are difficult for the elderly. But this factor alone does not resolve whether existing OHS programs are reasonably accessible.
Bayonet Point is approximately 18 miles to the north of Helen Ellis. The service area for Bayonet Point and the PSA for Helen Ellis for zip codes 34652, 34653, 34655, 34690, 34691, and 34689 (the location of Helen Ellis) overlap for OHS services; the service areas for OHS do not overlap for zip codes 34683, 34684, and 34688 (within Helen Ellis' PSA). The service areas for Bayonet Point and Helen Ellis for inpatient diagnostic cardiac catheterization discharges overlap regarding zip codes 34668, 34654, 34652, 34653, and 34655, although only the latter three zip codes are within Helen Ellis' PSA. BP 19 at 31, 35.
Morton Plant is approximately 13 to 18 miles south of Helen Ellis. See MP 12 indicating Morton Plant is 18 miles (by automobile travel) south of the centroid in zip code 34689. Seven (34653, 34655, 34691, 34688, 34689, 34683, and 34684) of the nine zip codes identified within Helen Ellis' PSA overlap with Morton Plant's service area for OHS; five (34653, 34655, 34689, 34683, 34684) out of nine zip codes overlap for inpatient diagnostic cardiac catheterization discharges. BP 19 at 33, 37. Travel Time Studies/Data
Experts for Helen Ellis and Morton Plant evaluated travel (by automobile) north and south of Helen Ellis (to
Bayonet Point and Morton Plant). The Diaz and Pergolizzi studies did not consider drive times by emergency transport vehicles between the centroids and the hospitals or between the hospitals.
For Helen Ellis, given time constraints, Mr. Diaz performed, what he characterized, as "a snapshot of data collection for the period of time" examined. His evaluation was "not a formal study," which would have been "far more complex in terms of length of time." T 798.
Mr. Diaz' evaluation was performed over three days of driving time, with one trip to each of the destinations from nine centroid19 locations within each of the nine PSA zip codes. This represented one trip for data collection and observation. T 798. (Dr. Stamatiadis agreed that a single run would not be adequate to support a conclusion as to average travel times.
T 303.) Travel was undertaken Tuesday through Thursday, at peak times 7:00 a.m. through 9:00 a.m. and 4:00 p.m. through
6:00 p.m. No runs were made from hospital to hospital by Mr. Diaz or Mr. Pergolizzi.
Mr. Diaz has personal and professional experience with this area.
Mr. Diaz ultimately recorded (from data sheets) the travel time in miles and minutes from the centroid locations to Helen Ellis, Morton Plant, and Bayonet Point. Several
inconsistencies were noted during the hearing. There were errors derived when several numbers were transferred from the data sheets to the actual "Travel/Drive Time Study." T 824- 8837; HE 48, 56A-I.20
Mr. Pergolizzi, for Morton Plant, completed travel time studies between the three hospitals and the centroids located within the nine zip codes. No runs were made from hospital to hospital. The studies were done Monday through Friday and conducted between 6:30 a.m. and 8:00 p.m.21 Fourteen one-way trips were made, seven that originated at the hospital and ended at the centroid and seven that originated at the centroid and ended at the hospital. Drivers used a "floating car technique," which means that drivers were instructed to drive with the prevailing conditions of traffic, not to weave in and out. The studies reflect some considerable ranges and variations in times and mileage, from which averages were calculated. MP 12.22
The Pergolizzi study resulted in travel data including average distances, a durational range (in minutes), and average duration, and average speed. MP 12.
Mr. Pergolizzi was critical of Mr. Diaz' use of a single run because generally there is too much variability. The variations observed by Mr. Pergolizzi confirmed this criticism.
T 1540; MP 12, Tables A-C. However, the variation between the studies was not significant.
The residents of the PSA, measured from centroid locations, reside approximately 10.5 miles (zip code 34652) to
23.9 miles (zip code 34682) from Bayonet Point; approximately
10.7 (zip code 34683) to 28.9 miles (zip code 34653) from Morton Plant; and 1.8 (zip code 34689) to 12.4 miles (zip code 34655) from Helen Ellis. MP 12.
The average drive time durations from centroid locations within the nine zip codes in Helen Ellis' PSA to Bayonet Point ranged from 18 minutes (zip code 34653) to 42 minutes (zip code 34683). The shorter times reflect trips from zip codes within the PSA that are relatively closer to Bayonet Point, i.e., 34652, 34653, and 34655, and the longer times reflect trips from zip codes within the PSA furthest from Bayonet Point and closer to Helen Ellis in comparison to Bayonet Point.
The Pergolizzi study also reflected average drive time durations to Morton Plant from the various centroids ranging from 27 minutes (zip code 34683) to 62 minutes (zip code 34653) (41 minutes from zip code 34689), with the shorter times reflecting trips from zip codes within the PSA that are closer to Morton Plant and the longer times reflecting trips from zip codes within the PSA furthest from Morton Plant. MP 12.
The Pergolizzi average time durations from the centroids within the PSA to Helen Ellis ranged from 6 minutes (zip code 34689 - the home zip code) to 28 minutes (zip code 34655). The average mileage distances ranged from 1.8 miles (34689) to 12.4 miles (34655) to Helen Ellis.
There are differences between the drive times (in minutes) set forth in the Diaz and Pergolizzi studies. However, they are not significant, except as noted. T 809-810, 1596- 1597, 1615. Notwithstanding several criticisms, the Pergolizzi study is the more persuasive.
Using the Pergolizzi data, the drive time to Helen Ellis or Bayonet Point is approximately a one minute difference in favor of Helen Ellis from the centroid in zip code 34652; closer to Bayonet Point by eight minutes from the centroid in zip code 34653; and six minutes closer to Bayonet Point from the centroid in zip code 34655.
Zip codes 34652, 34653, and 34655 account for approximately 11 percent of the adult cardiovascular discharges (ACDs) for the year ending June 2004 and approximately 12 percent of the inpatient cardiac catheterization discharges (ICCDs) for the same time period. However, for 2005, approximately 40 percent of the adult population within the PSA resided in these three zip codes.
Helen Ellis is closer than Morton Plant from the centroids located in zip code 34683 by 16 minutes and in zip code 34684 by 22 minutes.
Helen Ellis is closer than Bayonet Point from the centroids located in zip code 34688 by 25 minutes; zip code 34689 by 2823 minutes; zip code 34690 by 13 minutes; and zip code 34691 by 12 minutes.
For year ending June 30, 2004, within the PSA, zip codes 34688, 34689, 34690, and 34691 accounted for approximately
75 percent of the ICCD's and approximately 70 percent of the ACD's at Helen Ellis. For 2005, approximately 12 percent of the adult population within the PSA resides in the zip code 34689; approximately 12 percent projected for 2010.
In travel minutes, Bayonet Point and Helen Ellis are located approximately the same distance (one minute favoring Helen Ellis) from one zip code (34652); Bayonet Point is closer than Helen Ellis from two zip codes (34653 and 34655); Helen Ellis is closer than Bayonet Point in four zip codes (34688, 34689, 34690, and 34691); and closer than Morton Plant from the two remaining zip codes (34683 and 34684).
Stated somewhat differently, travel to Helen Ellis is improved (over travel to Bayonet Point) by 25 to 28 minutes in two zip codes (34688 and 34689); over Bayonet Point by 12 to 13 minutes in two zip codes (34691 and 34690); over Bayonet Point
by one minute in one zip code (34652); and over Morton Plant by
16 to 22 minutes in two zip codes (34683 and 34684). Travel time to Bayonet Point is six to eight minutes less than to Helen Ellis in two zip codes (34655 and 34653). See T 1541. Thus, in six of nine zip codes (zip code 32352 is one of the three because the difference is de minimus) in the PSA, there would be enhancements in travel times for residents needing OHS/PCI services if the Helen Ellis OHS program is approved.
Treatment of Patients at Helen Ellis Prior to Transfer to OHS Providers
OHS is defined as a tertiary health service by Agency rule.24 It is expected that patients will be transferred from community-type hospitals to regional OHS referral centers for open heart surgery and PCIs, unless a hospital, such as Helen Ellis, offers emergency PCIs and can perform them on appropriate patients.
Dr. Bronleewe, an expert in surgery and cardiovascular surgery, is part of the five-member Bloom group currently performing OHS at UCH (Pepin Heart) and EPMC. He also currently practices thoracic and vascular surgery at Helen Ellis. If Helen Ellis' application is approved, he intends to reside in Tarpon Springs and perform OHS at Helen Ellis on a full-time basis, remaining part of the Bloom group.
Dr. Bronleewe discussed various categories of patients who receive OHS. Less than three percent of OHS patients are considered emergency cases. T 651-659. An emergency case means that the patient is likely to die or have irreparable harm done to him or her do not go immediately to the operating room. "The true emergencies are the patients that are hemodynamically compromised, got blood pressure problems, EKG problems, ongoing chest pain, they're dying. So you have to rush those patients to surgery. In fact, that category of patient care is with a tenfold mortality rate compared to the stable elective patient that we might operate on." According to Dr. Bronleewe, these emergency cases "are very, very rare." T 651-652. "[E]mergencies are not as common as they used to be because stents are better and they can intervene on an acute heart attack early on." T 626.
Ninety-five to 97 percent of OHS cases are elective, if elective is defined as not having to rush the patient to the operating room as an unstable patient. T 651-654.
Dr. Bronleewe described two categories of elective cases. The first category involves those cases in which the underlying condition has been known for months or even years and the point has been reached when surgery is needed. Approximately 15 to 20 percent of these OHS patients are truly elective and can return home and later undergo OHS. The second
elective category involves a patient who has had a recent physical, and/or stress test, and a diagnostic cardiac catheterization reveals a vessel disease. The patient is stable. However, this sub-set of patients is generally kept in the hospital as a precaution and OHS is scheduled typically the next day or two days later, or even later depending on the severity of the condition. This category of patients is referred to as "urgent," which translates to OHS performed sometime during the hospitalization. Approximately 70 to 75 percent of OHS patients fit within this category. A patient within this category may have a "left main" blockage.
Approximately 15 to 20 percent of the elective, non-urgent class of OHS patients are released from the hospital and later undergo OHS. T 651-659.
Dr. Bronleewe stated there was "a lot of flexibility in the majority of cases as far as scheduling although we do most of the cases within 24 to 48 hours of the cath "
T 648.
Dr. Bronleewe further explained that 80 to 90 percent of the patients receiving OHS receive a cardiac catheterization "the day before" the OHS. Surgery may be postponed, however, because the patient requests a specific surgeon or because the patient has a health issue which must be addressed before surgery. T 625.
Further, Dr. Bronleewe stated that true emergencies arising from an angioplasty procedure are rare, for example, occurring at UCH about once every two to two and one-half years. T 645-656; see also HE 85 at 19-21.
Notwithstanding the above, Helen Ellis contended that there are inordinate delays in transferring patients needing cardiac services from Helen Ellis to area OHS providers. The evidence does not support this claim. In making this finding, consideration was given to the evidence offered by Helen Ellis, including but not limited to Helen Ellis Exhibits 96 and 97 (Lori Farrell, R.N., depositions and exhibits).
Ms. Farrell works as a part time relief charge nurse in intensive/critical care units at Helen Ellis and has worked at Helen Ellis since 1991. Ms. Farrell was responsible for accumulating the total number of patients (either OHS candidates or patients needing a PCI with OHS back-up) admitted at Helen Ellis who had been transferred out of Helen Ellis.
Farrell deposition Exhibit 3 is a summary data compilation which identifies, for 164 different patient records, the elapsed time to transfer a patient requiring interventional cardiac services from Helen Ellis to an area OHS provider from the time the transfer order was written until the time the patient transferred out of Helen Ellis. Ms. Farrell contended that the exhibit showed that there is a portion of the Helen
Ellis patient population which would benefit from OHS at Helen Ellis because of purported delays in transferring such patients.
Of the 164 patients, 144 were transferred and 20 of the 164 expired, between the months of July 2005 and March 2006. Ms. Farrell did not know whether a transfer order had been written for any of the 20 patients who expired or how many, if any, of the 164 patients presented with an AMI. Of the 144 patients transferred, Ms. Farrell stated that 69 appeared to have been transferred for OHS and 75 for a PCI. The list of 144 transferred patients is not, according to Ms. Farrell, a complete list of patients transferred for OHS during this time frame.
In a nine-month period between July 2005 and March 2006, 12 patients were transferred from Helen Ellis on
intra-aortic balloon pumps, with eight of these occurring after Helen Ellis started performing emergency PCIs. There is no persuasive evidence that these patients suffered any adverse outcomes as a result of the transfer, although potential risks were present.
Between October 2005 and March 2006, Helen Ellis documented the number of patients who received a diagnostic cardiac catheterization at its labs and who were transferred. According to Ms. Sotrop, she compiled a document derived from Helen Ellis' MAC lab system, which reflected that a physician
documented his belief that patients needed one or more of these procedures, not that they actually received the procedure at the receiving hospital. On an annualized basis these numbers were:
64 CABGs, 188 PCIs, and 40 abnormal valve cases or a total of 292 such cases. HE 91 at 27-37, Exhibit 5; T 1074, 1262-1263, 2135-2136. (In its application, Helen Ellis projected 550, 788, and 829 total OHS/PCI cases for 2008, 2009, and 2010, respectively. HE 1 at 36, 47. As revised, Helen Ellis projected 542 and 778 OHS/PCI cases for 2009 and 2010, respectively. HE 65A and C.)
According to the AHCA database, Helen Ellis transferred 103 out of a total of 259 adult cases with the primary diagnosis of "ischemic heart disease" to another facility during the year ending June 30, 2005. It is unknown whether or how many of these patients received interventional cardiology services at the receiving facility. The number of transfers increased to 133 out of a total of 1,158 patients admitted to Helen Ellis with broader MDC-5 diagnosis of "diseased of the heart" for the same time period.
Ms. Farrell believed that it takes an excessively long time to transfer cardiac patients out of Helen Ellis to area OHS providers. A review of patient medical records does not support this belief.
Dr. Bronleewe stated that there have been a half a dozen or more patients sent to UCH from Helen Ellis for emergency or urgent surgery based on findings of the cardiac catheterizations at Helen Ellis. He agreed that the system has worked well with respect to both transfer times and patient outcomes. (The drive time between Helen Ellis and UCH is approximately 45 to 60 minutes.) T 633, 641-642.
Several Helen Ellis cardiologists expressed concern regarding the difficulty transferring patients from Helen Ellis in need of urgent PCI or OHS services. Delay is attributable to a lack of bed availability and the lack of cardiac catheterization availability at existing providers, as well as the lack of critical care ambulances available to transport these patients.
These cardiologists also testified that due to the travel distances between Helen Ellis and Morton Plant or Bayonet Point, they cannot round on their patients and that transferred patients lose continuity of care.
Having primary care physicians involved with patient care is beneficial to the patients and OHS surgeons.
Helen Ellis' cardiologists testified that patients transferred from Helen Ellis to other OHS programs have received good quality of care and have not suffered any significant
adverse effects from the transfers. However, they expressed concerns regarding the transfer process.
Helen Ellis cardiologists also expressed concern that even in non-emergency cases, not allowing Helen Ellis to perform PCI services is detrimental to their patients because patients have to undergo duplicate procedures if the diagnostic cardiac catheterization reveals that the patient needs a PCI, and that not having an OHS program at Helen Ellis poses a potential risk to some patients.
Dr. Javeed and Dr. Roca gave examples of elderly patients that they believed were too acutely ill to be safely transferred. Some had significant blockages in the left anterior descending (LAD). According to them, other patients were too sick to be transferred, which enhanced the transfer risk.
Dr. Javeed is the chief of medicine and medical director of the cardiac catheterization lab at Helen Ellis. He performs approximately 500 diagnostic cardiac catheterizations and approximately 200 interventional procedures a year. He performs out-patient diagnostic procedures primarily at Bayonet Point, but also performs inpatient cardiac catheterizations (not typically out-patient) at Helen Ellis to a lesser extent, i.e.,
30 to 40 diagnostic cardiac catheterizations. He also performs
procedures at Morton Plant. He is on-call every Thursday to perform emergency PCI's at Helen Ellis.
He does not recall "a bad outcome on a patient when he was waiting [at Helen Ellis] because it's a small percentage of [his] practice, but "it doesn't mean that it can't happen." T 350-351. He described several typical (day-to-day) patients who he believed could have benefited Helen Ellis having an OHS program. See, e.g., HE 19-22; T 363-383. But none of the patients suffered an adverse outcome as a result of, for example, being transferred.
Dr. Roca is an expert in internal medicine, cardiovascular diseases, and interventional cardiology. He performs interventions at Morton Plant, Bayonet Point, and Largo Medical Center, and now at Helen Ellis on an emergency basis.
Dr. Roca discussed the status of several sick and elderly patients seen at Helen Ellis who ultimately were transferred for procedures. See, e.g., HE 24-25; T 475-504, 509-525. He was concerned with the necessity to transfer
patients to an OHS provider. The prospect of transfer increased patient and family anxiety and the potential for adverse outcomes, notwithstanding that the identified patients did not suffer adverse cardiac outcomes as a result of being transferred to, for example, Morton Plant.
Dr. Abbott, an invasive cardiologist, also described the condition of a several recent patients and ultimate transfers from Helen Ellis. HE 84 at 9-54. See also Endnote 25.
Patients are routinely transferred to Bayonet Point and Morton Plant for OHS and PCI services and have consistently received high quality of care in a timely fashion. There are no unreasonable delays in receiving or accepting a patient and beginning necessary treatment of the patient upon arrival at these facilities. Emergency patients needing OHS or PCI services are treated immediately and appropriately. Non- emergency patients needing OHS and PCI services are scheduled in a timely fashion.
Although located in adjacent Hillsborough County, UCH's Pepin Heart Institute serves as a regional referral center for OHS services for Pasco and Pinellas counties. Patients can be transferred from Helen Ellis to UCH for cardiac services by ground transportation within approximately 45 to 60 minutes.
Helen Ellis did not offer persuasive evidence that patients experienced adverse outcomes as a result of being transferred to another facility for OHS or PCI services. Nor did Helen Ellis demonstrate any inordinate delays in transferring patients to other facilities for PCI and/or OHS services.25
It is determined that patients awaiting transfer from Helen Ellis to an area OHS provider have not experienced adverse outcomes as a result of being transferred. Nevertheless, Drs. Roca and Javeed, for example, testified that there have been a number of very sick patients (typical patients) received at Helen Ellis who had the potential for an adverse outcome awaiting transfer. Also, the emergency PCI exemption has not resolved all of the transfer issues faced by the acutely ill patients at Helen Ellis. The fact is that there are very sick patients that might have avoided potentially risky transfers if Helen Ellis had the ability to perform OHS.
Having considered the totality of the circumstances, including that OHS services are tertiary in nature and the relative small percentage of emergency patients requiring OHS services, approval of an OHS program at Helen Ellis would improve access for a number of prospective patients residing within the PSA in need of OHS and PCI services and also reduce the potential for adverse outcomes.
Section 408.035(3), Florida Statutes: History and Ability of Helen Ellis to Provide Quality of Care
The parties stipulated that Helen Ellis has a record of providing high quality of care. See Findings of Fact 5-25.
Helen Ellis has received awards indicating it provides high quality of care in general and performs high
quality cardiac services. Its emergency department services are also high quality. The hospital's Quality Assurance and Performance Improvement Plans were included in the CON application and have been updated annually.
Helen Ellis' emergency PCI program meets all guidelines of the American College of Cardiology and staffing and equipment criteria to achieve good quality of care for these patients.
UCH/Pepin Heart Institute provides high quality of care. Like Morton Plan and Bayonet Point, it is a regional referral hospital for patients needing OHS, PCI, and other cardiac-related services.
UCH has committed to oversee implementation of Helen Ellis' OHS program. Its relationship with Helen Ellis is a positive one from a quality of care standpoint.
Helen Ellis will share in and utilize the same experienced open heart surgeons that are currently providing OHS services at the UCH/Pepin Heart Institute. This five-member surgical group, under the medical direction of Dr. Marc Bloom, comprises experienced cardiovascular surgeons also on the medical staff at Helen Ellis, where they maintain offices, and provide vascular and thoracic surgery at the hospital. This surgical group intends to have an exclusive contract with Helen Ellis to provide OHS services at Helen Ellis and currently has
an exclusive contract with UCH to provide all OHS surgical services at UCH and, at the newly operational OHS program EPMC, approximately 20 minutes' travel time from UCH.
This surgical group performs approximately 500 OHSs a year at UCH, spread among the members of the group. Members of the group also perform vascular and thoracic surgeries, as well as valve surgery and pacemaker implants.
Dr. Bloom and his surgical group will provide OHS coverage full time, 24 hours per day, 7 days a week, at Helen Ellis.
Dr. Bronleewe is a member of the Bloom group and intends to move to Tarpon Springs and be the full-time, on-site surgeon for the OHS program at Helen Ellis. Dr. Bronleewe would have backup from his group to cover for his days off and vacation days. Also, Dr. Bronleewe's group typically uses an OHS surgeon as a first assist in 80 to 90 percent of OHS cases performed by the group.
Notwithstanding some criticisms regarding being spread too thin, this surgery group appears to have ample capacity to cover this program along with its other obligations. However, if volume becomes an issue, they have the ability and are willing to recruit an additional surgeon.
Unlike the surgical staffing proposed in the last proceeding, this proposal is much more likely to result in a
high quality of care operation and removes the potential problems associated with the prior proposal.
Delivery of high quality OHS services requires experience and skill on the part of the entire OHS team, including the surgeon, perfusionists, cardiac anesthesiologists, recovery nurses, and ancillary hospital services. Ongoing repetition is important. Helen Ellis plans to use the same perfusionists, anesthesiologists, and other medical support staff that are used at the UCH/Pepin program as well as the same policies, practices, and protocols. The operating room, critical care and cardiac catheterization nurses are expected to receive training at the UCH/Pepin program, depending on their levels of experience. Helen Ellis expects to use technological linkages, such as a "PACS" system, with Pepin Heart.
The parties stipulated that Helen Ellis' proposed staffing projections, staffing ratios, and staffing salaries are reasonable and appropriate.
Despite a perceived shortage of nurses, it appears that Helen Ellis will be able to attract enough nurses to adequately staff its OHS program in light of its relationship with the UCH/Pepin program. The same can be said for the other personnel necessary to adequately staff an OHS program.
Section 408.035(4), Florida Statutes: Availability of Resources, Including Health Personnel, Management Personnel, and Funds for Capital and Operating Expenditures for Project Accomplishment and Operation
Helen Ellis' proposed staffing projections, staffing ratios, and staffing salaries are reasonably appropriate. The weight of the evidence indicates that Helen Ellis will be likely to attract personnel to adequately staff the OHS program.
Helen Ellis has management personnel available to operate the OHS program.
While existing providers offered some evidence challenging UCH's ability to fund this project, the weight of the evidence supports UCH's ability to fund this project
UCH has committed the funds necessary to accomplish the proposed project at an estimated total cost of $9,386,142 and all other capital projects listed on Schedule 2 of the CON application.
Section 408.035(6), Florida Statutes: Immediate and Long- Term Financial Feasibility
Helen Ellis can obtain sufficient funds to fund the start-up costs shown in Helen Ellis' CON application. The parties stipulated that Helen Ellis' proposed costs and methods of construction are appropriate and reasonable.
Helen Ellis' project is financially feasible in the short term.
Long-term financial feasibility refers to the ability to break even or have positive income within two years according to the pro forma financial schedules (Schedules 7A and 8A) contained in the CON application.
Helen Ellis' pro formas indicate that the proposed OHS program will have a positive net income in year 2 of operation. (The project, if approved, will not be operational in the year projected in the CON application.)
Mr. Sullivan conceded that the pro formas contain an understatement in bad debt and charity allowances, but even correcting for this understatement, the project will likely have a positive new income of $4.1 million for year 2 of operation.
The pro formas included the expense related to the use of drug eluting stents rather than bare metal stents. The costs included in the pro formas are sufficient to cover more than one drug eluting stent for each procedure.
The pro formas were also criticized because Helen Ellis did not use a sister hospital with an OHS program as a proxy for non-labor cost and expense experience, instead relying on the actual historical costs experienced at Helen Ellis without an OHS program. To the extent there might be higher costs for other general departments such as the pharmacy, etc., this appears to have been accounted for by the longer lengths of stay for OHS patients.
Notwithstanding the financial condition (losses over the past several years, i.e., $9 million loss in 2001 decreasing to a loss of $4 million in 2004) of Helen Ellis, the long-term financial feasibility of this project is largely determined by whether Helen Ellis can achieve the projected number of OHS and PCI cases for year 2.
Generally OHS programs and associated PCI programs tend to be financially feasible. Typically, while the number varies from hospital to hospital, OHS and PCI programs will break even at 125 to 200 OHS cases per year.
Overall, notwithstanding the historical negative financial condition of Helen Ellis, and despite other criticisms of Helen Ellis' long-term financial feasibility, if Helen Ellis attains the projected numbers of OHS/PCI cases, the project is expected to be financially feasible in the long term. Even at lesser OHS case volumes, given the potential variability in potential volume in light of physician testimony, the project is likely to be financially feasible in the long-term.
Finally, approval of an OHS program would have a substantial positive financial effect on Helen Ellis.
Section 408.035(7), Florida Statutes: Extent to which the Proposal will Foster Competition that Promotes Quality and Cost-Effectiveness
Section 408.035(7), Florida Statutes, specifically requires a demonstration that a CON applicant "will foster
competition that promotes quality and cost-effectiveness." An applicant must demonstrate improved competition and also that competition promotes "quality and cost-effectiveness." See Central Florida Regional Hospital, Inc. vs. Agency for Health Care Administration, DOAH Case No. 05-0296CON (DOAH Aug. 23, 2006; AHCA Jan. 1, 2007).
The OHS case market shares in the Helen Ellis PSA are balanced between Morton Plant and Bayonet Point which is not surprising because of their location in relation to the PSA and other OHS providers. For year ending June 30, 2005, Morton Plant's OHS market share within the PSA was 44.7 percent and Bayonet Point's market share was 46.2 percent. Compare HE 31 with BP 19 at 41.26
The market shares significantly favor Bayonet Point over Morton Plant in zip codes 34652 (91.7 (44 OHS discharges) to 4.2 (2 OHS discharges) percent; 34653 (78.3 (54) to 17.4 (12) percent); and 34690 (68.2 (15) to 31.8 (7) percent.
Conversely, the market shares significantly favor Morton Plant over Bayonet Point in zip codes 34683 (73.5 (25) to 14.7 (5) percent); 34684 (93.2 (55) to 1.7 (1) percent); and 34688 (90.0 (9) to 0.0 (0) percent).
The market shares are somewhat balanced between Morton Plant and Bayonet Point in zip codes 34655 (34.5 (20) to
51.7 (30) percent) and 34689 (52.5 (32) to 31.1 (19) percent)
and balanced in zip code 34691 (43.5 (20) to 43.5 (20) percent).
There were 229 OHS discharges out of 370 or approximately 62 percent of the OHS discharges performed at Morton Plant and Bayonet Point where the market shares significantly favored one of the providers; 101 OHS discharges or approximately 27 percent where the market shares were somewhat balanced; and 40 OHS discharges or approximately 11 percent evenly split.
Morton Plant and Bayonet Point have overlapping service areas and compete for cardiac patients and staff. However, generally the greater percentages of market shares are in the northern PSA zip codes for Bayonet Point and the southern PSA zip codes for Morton Plant, with an even draw in zip code 34691. There are virtually no other OHS providers in District 5 competing with these providers. BP 19 at 35 and 41; HE 31.
Dr. Monica Noether testified that the competition between Morton Plant and Bayonet Point "is not all that great" and "that they are not really competing head to head for the majority of their patients." T 538, 541, 604-605. See also HE 31; T 541 ("If there were more head-to-head competition, you would see the zip codes would be divided 50/50 or 40/60 or something like that . . . ."). Dr. Noether's opinion is supported to some degree by the above analysis of the market
shares for these providers. Dr. Noether also opined that an OHS program at Helen Ellis would enhance competition, both for OHS and PCI services and for hospital services generally. In her view, a Helen Ellis OHS program would also make UCH a stronger managed care competitor.
Dr. Noether also applied the Herfindahl-Hirschman Index (HHI) to support her opinions. This measure "considers all of the competitors in an existing market and their relative size distribution and creates an index where higher numbers suggest more concentrated numbers and lower numbers suggests [sic] a more competitive," less concentrated market. For example, one firm will have 100 percent of the market, "then one hundred squared is 10,000," and "10,000 is the maximum value that HHI can take." Generally, the lower the HHI, the less concern there is about market concentration. The HHI is a single measure that describes the entire market where, for example, firms operate.
The HHI is used by the Department of Justice (DOJ) and the Federal Trade Commission (FTC) as one analytical tool in their guidelines for the review of proposed horizontal mergers for compliance with anti-trust laws. The HHI is used by these entities to measure market concentration as the result of the elimination or reduction of competitors, rather than to measure
the effect of the addition of competitors to a market. The DOJ and FTC use the HHI as a starting point.
The traditional use of the HHI is to test thresholds for markets that are not particularly concentrated. The three standard thresholds used by the DOJ and FTC are under 1,000; or between 1,000 and 1,800; and 1,800 and over. Under the HHI calculation, adding a third provider to an area with two providers will result in a lower HHI. Under an HHI calculation, the Pinellas/Pasco market is concentrated and would remain concentrated if another competitor (Helen Ellis) is added to the market. Compared to the FTC and DOJ guideline thresholds, the HHI calculated number would be high both before and after addition of another OHS provider.
According to Dr. Noether, without an OHS program at Helen Ellis, the HHI for Bayonet Point and Morton Plant's service area was 5,073, but if Helen Ellis's OHS program is approved, even at relatively low initial volumes, the HHI goes down by 20 percent to 4,000. She stated that 5,073 "is a fairly concentrated measure which is not surprising" given two large providers. She explained that this level of reduction in HHI demonstrates a substantial competitive impact and a beneficial effect on competition.
Dr. Noether agreed that regulatory "need" is not an economic concept. T 592-594.
Dr. Noether also opined that her expected competition would also promote cost-effectiveness, suggesting that patient transfers for OHS and PCI have financial implications, such as physician inefficiencies, duplicate procedures, complications arising from transfers, and probable longer hospital stays. Dr. Noether did not perform an analysis to support her opinions regarding cost-effectiveness and did not quantify the extent, if any, of any cost savings. T 584. Rather, she rendered her opinions based on physician and other clinical testimony.27
Dr. Noether also opined it is likely that an OHS program at Helen Ellis would have a beneficial effect on Helen Ellis and UCH system's ability to effectively negotiate managed care contracts. Dr. Noether did not analyze managed care rates in this market. T 579. Rather, she relied on other evidence, such as the testimony of Mr. Sullivan. T 567-569. For example, Mr. Sullivan determined (based on his independent analysis of information gathered by another in an unrelated CON application submittal) that the current managed care case mix adjusted net revenues for HCA and BayCare are higher than UCH. T 1350-1361, 1443-1444.28
There is evidence that UCH's ability to compete in the greater Tampa Bay market for better managed care reimbursement would be enhanced by having full service
hospitals, including Helen Ellis, in Hillsborough and Pinellas Counties.
Residents within District 5 and, in particular the PSA, have reasonable access to existing OHS providers within District 5. Morton Plant and Bayonet Point offer high quality OHS and PCI programs and continue to upgrade their respective programs at will. It was not proven that these Morton Plant and Bayonet Point are delivering OHS services in a manner that does not promote quality and cost effectiveness.
Nevertheless, the persuasive evidence indicates that the residents of District 5 and, in particular the PSA, would benefit from having another OHS provider in the area. While it is difficult to quantify the degree of enhanced competition, the persuasive evidence indicates that approval of Helen Ellis CON application "will foster competition that promotes quality and cost-effectiveness," for the patients needing OHS and PCI services. The approval of this project is likely to increase competition and access and afford patients (and physicians) another alternative.
Section 408.035(8), Florida Statutes: Costs and Methods of Proposed Construction
The parties stipulated that the proposed costs and methods of construction for the project are appropriate and reasonable.
Section 408.035(9), Florida Statutes: Applicant's Past and Proposed Provision of Health Care Services to Medicaid Patients and the Medically Indigent
Helen Ellis is a not-for-profit hospital that provides community services to all levels of patients regardless of ability to pay. Helen Ellis did not offer to allocate, as a condition for the approval of a CON, any specific percentage of Medicaid or indigent care. Nevertheless, Helen Ellis agreed to accept any reasonable condition imposed by AHCA.
Adverse Impact
Morton Plant and Bayonet Point will suffer material adverse financial impacts if the Helen Ellis OHS project is approved, but the loss of OHS and PCI procedures is not expected to adversely impact the quality of care offered at each program and both programs are likely to continue to be in strong financial positions despite approval.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties to and subject matter of this proceeding pursuant to Sections 120.569, 120.57(1), and 408.039(5), Florida Statutes.
Morton Plant and Bayonet Point have standing to participate as parties in this proceeding pursuant to Section 408.039(5), Florida Statutes.
As the applicant, Helen Ellis has the burden of proving, by the preponderance of the evidence, entitlement to a CON. Boca Raton Artificial Kidney Center, Inc. v. Department of Health & Rehabilitative Services, 475 So. 2d 260 (Fla. 1st DCA 1985); § 120.57(1)(j), Fla. Stat.
The award of a CON must be based on a balanced consideration of all applicable and statutory rule criteria. Balsam v. Department of Health & Rehabilitative Services, 486 So. 2d 1341 (Fla. 1st DCA 1986). "[T]he appropriate weight to be given to each individual criterion is not fixed, but rather must vary on a case-by-case basis, depending upon the facts of each case." Collier Medical Center, Inc. v. Department of Health & Rehabilitative Services, 462 So. 2d 83, 84 (Fla. 1st DCA 1985).
The CON review criteria set forth in Section 408.035(1)-(9), Florida Statutes, and Florida Administrative Code Rule 59C-1.033, are applicable to Helen Ellis's proposed OHS program. The parties stipulated that Helen Ellis met AHCA's rules regarding minimum content and timely submission requirements.
Pursuant its rule methodology, the Agency determined that there is no fixed need pool for an additional OHS program in District 5 for the applicable planning horizon.29 Accordingly, Helen Ellis was required to demonstrate "not
normal" circumstances in order to obtain approval of its CON application. See generally Humana, Inc. v. Department of Health
& Rehabilitative Services, 469 So. 2d 889 (Fla. 1st DCA 1985).
There is no specific statutory or rule definition of what constitutes "not normal" circumstances. However, it has been said that "[t]he applicant must demonstrate and there must be some finding of fact that, without the requested lab [here OHS services], the existing facilities are (or will be) unavailable or inaccessible, or the quality of care is (or will be) suffering from over utilization, or other evidence of that nature." Humana, Inc. v. Department of Health & Rehabilitative Services, 492 So. 2d 388, 392 (Fla. 4th DCA 1986)(citations omitted). By their nature, "not normal" circumstances cannot be classified as typical. To the contrary, "not normal" circumstances must be a departure from the normal state of affairs. See Florida Health Sciences Center, Inc. vs. Agency for Health Care Administration (Brandon), DOAH Case Nos. 00- 0481, 00-0482, 00-0484, and 00-0485 (DOAH March 30,2001; AHCA Aug. 6, 2001, at 3-4), per curiam aff'd, 827 So. 2d 984 (Fla. 1st DCA 2002).
The Agency has previously approved new OHS programs in the absence of a fixed need pool. For example, these cases include the Agency's approval of an OHS programs at Boca Raton Community Hospital and Martin Memorial, Boca Raton Community
Hospital, Inc. vs. Agency for Health Care Administration (Boca Raton), DOAH Case Nos. 01-2713, 01-2715, 01-2894, 01-2896-01-
2898, and 01-2913, (DOAH Sept. 23, 2004; AHCA Jan. 7, 2005); at
Brandon Regional Hospital, Florida Health Sciences Center, Inc., supra; at Oak Hill Hospital and Citrus Memorial, HCA Health Services of Florida, Inc. vs. Agency for Health Care
Administration (Oak Hill), DOAH Case Nos. 00-3216CON-00-3218CON, 00-3220CON, and 00-3221CON (DOAH Oct. 4, 2001; AHCA Jan. 24,
2002); and at Aventura Hospital and Palmetto General, Lifemark Hospitals of Florida, Inc. vs. Agency for Health Care
Administration (Lifemark), DOAH Case Nos. 01-0357CON - 01- 0359CON, (DOAH April 14, 2003; AHCA Sept. 30, 2003).
This is a difficult case. There is no controlling precedent. Not all of the factors present in other approved, "not normal" OHS cases are present here. If the focus of this proceeding were limited to comparing, for example, the number of acute care licensed beds, the extent of out-migration (out of the AHCA service district) for OHS patients, whether the applicants are disproportionate share providers (Medicare and/ or Medicaid), or whether the hospitals seeking an OHS program provide other tertiary care services, the result may be different here. Compare Lifemark, Boca Raton, Oak Hill, and Brandon. Nevertheless, "not normal" circumstances were proven here.
There are six providers of OHS services in District
Four operational OHS programs, including Morton Plant, are located in the southern portion of Pinellas County, with Bayonet Point located in western Pasco County and EPMC located in the eastern portion of Pasco County.
Helen Ellis did not prove that significant number of the residents from the nine zip codes in its PSA do not have reasonable access to existing OHS programs in District 5, including but not limited to Morton Plant and Bayonet Point.
Existing OHS programs in District 5 are available, accessible and appropriately utilized. Relevant here, Morton Plant, Bayonet Point, and Largo, provide high quality of care in their existing OHS and PCI programs.
Nevertheless, the availability and accessibility of OHS services by residents of District 5, in particular the PSA, will be enhanced if Helen Ellis' OHS project is approved. Importantly, for a number of residents who are classified as emergency, and not infrequently certain elderly and very sick urgent patients, having an OHS program at Helen Ellis is likely to reduce the overall potential for risks associated with, in part, waiting for required medical treatment pending transfer. Compare Florida Health Sciences Center, Inc., 2001 WL 361427, at
*16-27 for detailed findings regarding the condition of patients awaiting transfer.
Helen Ellis has a record of providing high quality of care and has the ability to provide high quality of care in an OHS program if an adequate number of OHS cases are performed for the projected years of operation. As updated, Helen Ellis projects that it will perform approximately 144 OHS cases for 2009 and approximately 207 OHS cases for 2010. These numbers are likely optimistic, yet achievable. (There is no persuasive evidence that Helen Ellis will perform more than 300 OHS procedures by 2011.)
The persuasive evidence indicates that the Helen Ellis projected number of OHS cases would make Helen Ellis a lower volume provider of OHS services. The recent trends indicate that the number of OHS cases performed in Florida and nationally may continue to decline although the precise amount is uncertain, notwithstanding the potential "baby boomer" effect set to begin in 2011.
The persuasive evidence indicates that there is a relationship between volume and mortality rates, i.e., the higher the volume, the lower the mortality rates. However, there are other factors that should be considered including but not limited to the proficiency of the OHS team. Helen Ellis proposes to partner with UCH and use the cardiovascular surgeons associated with the Bloom group, with Dr. Bronleewe residing in Tarpon Springs. Unlike the arrangement proposed in the prior
proceeding, the current proposal is clinically acceptable and is likely to foster a high quality of care OHS program at Helen Ellis.
Helen Ellis demonstrated that it has the available resources, including health personnel, management personnel, and funds for capital and operating expenditures to accomplish the OHS project and operation.
The parties proposed operation of the OHS program at Helen Ellis is likely to be financially feasible in the short- term or immediate. The long-term financially feasibility of the OHS program is dependent on Helen Ellis obtaining the projected number of OHS cases. This is a closer call, given the range of potential OHS cases that may be projected to be performed at Helen Ellis during the second year of operation in 2010, but appears achievable.
Approval of an OHS program at Helen Ellis is likely to foster competition among the existing providers of OHS services in District 5 and is also likely to promote quality and cost-effectiveness, notwithstanding that, as the main competitors of Helen Ellis, Morton Plant and Bayonet Point provide high quality OHS and PCI services and perform such in a cost-effective manner.
The parties stipulated that the cost and methods of the proposed construction are reasonable.
Helen Ellis has a history of providing health care services to Medicaid patients and the medically indigent. Helen Ellis declined to accept any conditions regarding this issue.
It was not proven that Helen Ellis will enhance provision of OHS services to Medicaid patients and the medically indigent. On the other hand, it appears that Medicaid patients and the medically indigent in District 5 have reasonable access to area providers.
While there was overlapping evidence offered in the prior case and this case on most issues, Helen Ellis presented a better overall case here. Prior concerns with certain surgical/clinical aspects of the proposal have been remedied. The physician/clinical evidence, which overlapped in both cases, is more persuasive here. While it was not persuasively proven that specific cardiac outcomes have been compromised by having patients transferred from Helen Ellis to area OHS providers, physician testimony and other clinical evidence regarding the potential risks (from real life experiences) to their elderly, sick patients awaiting transfer is persuasive. Transfers, although the norm, are not without risk for those patients who are candidates for OHS or PCI.
Further, while Morton Plant and Bayonet Point compete for OHS patients and staff within the PSA, the level of competition would be enhanced if Helen Ellis's project is
approved, all to the benefit of the residents of the PSA needing OHS services. The quality of care offered at Helen Ellis, already high by stipulation, would necessarily be enhanced. The extent and increase of the elderly population within the PSA and the lack of any adverse impact on low volume, District 5 providers (e.g., Largo and EPMC) cannot be overlooked, see
Florida Health Sciences Center, Inc., AHCA Final Order at 10.
Overall, and consistent with Agency precedent, Helen Ellis proved that there are "not normal" circumstances existing in District 5 to justify approval of its CON application. On balance, Helen Ellis' CON application No. 9822 should be granted.
Based on the foregoing Findings of Fact and Conclusions of Law, it is
RECOMMENDED that the Agency for Health Care Administration enter a final order granting Helen Ellis' CON application No.
9822.
DONE AND ENTERED this 16th day of January, 2007, in Tallahassee, Leon County, Florida.
S
CHARLES A. STAMPELOS
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 16th day of January, 2007.
ENDNOTES
1/ Helen Ellis filed a prior CON application No. 9629 to establish an open heart surgery program. The application was denied. See Tarpon Springs Hospital Foundation, Inc. d/b/a Helen Ellis Memorial Hospital vs. Agency for Health Care Administration (Tarpon Springs), DOAH Case No. 03-1425CON (DOAH March 21, 2006; AHCA Sept. 6, 2006).
2/ All citations are to the 2005 version of the Florida Statutes unless otherwise indicated.
3/ UCH operates four hospitals in the greater Tampa Bay area including University Community Hospital on Fletcher Avenue in Tampa, Carrollwood Community Hospital in the northern Hillsborough community of Carrollwood, Sun Coast Hospital in Largo in central Pinellas County and Helen Ellis in Tarpon Springs in northern Pinellas County. UCH's main campus on Fletcher Avenue in Tampa is a 431-bed tertiary hospital that has medical school teaching affiliations with the University of South Florida. UCH's main campus is known for its centers of excellence. UCH's main campus also includes the Pepin Heart Hospital & Research Institute (Pepin Heart). Pepin Heart is a mature OHS interventional cardiology program that offers a full range of open heart and interventional cardiology services. A
new free-standing 274-bed Pepin Heart was recently completed at a cost of approximately $50 million on the UCH main campus.
From July 2004 to June 2005, UCH performed 516 OHS cases. HE 57.
4/ During the six-year period for fiscal year (FY) 1999 through 2004, Helen Ellis incurred aggregate operating losses in excess of $37 million and $7.4 million in FY 2005. Helen Ellis incurred negative operating margins for FY 2003 through 2005.
The financial picture at Helen Ellis could be significantly improved if it offered OHS and related cardiology services. For example, 40 to 50 percent of Morton Plant's "bottom line" is generated through its cardiovascular program. T 1156-1157.
5/ Helen Ellis operates a busy ER, with approximately 21,000 patient visits in 2005, up from approximately 20,490 in 2004. The Helen Ellis ER has the physical capacity for approximately 26,000 visits. Helen Ellis has no plans to expand its ER.
6/ Therapeutic cardiac catheterization procedures, also called PCI, are designed to clear blockages in the arteries leading to the heart, while EP procedures address the rhythm or electrical impulses in the heart.
7/ In its first six months of operation (through March 2006), Helen Ellis performed over 90 EP procedures. Both Dr. Jimenez and Dr. Bloom testified to the high quality of care of the new EP program at Helen Ellis. Helen Ellis expects its EP volume to grow substantially over the next two years, and anticipates that if Helen Ellis is approved for OHS, the EP volume may exceed 800 cases per year. There are five physicians credentialed to perform EP procedures at Helen Ellis.
8/ In late 2004, Bayonet Point suspended nine cardiologists from its medical staff. One OHS surgeon left the facility around this time. Bayonet Point had approximately 20 interventional cardiologists on staff in 2004 and 12 in 2005. BP 24 at 22-23 (April 25, 2006, deposition). There was a sharp decline in Bayonet Point's PCI volume between the fourth quarter 2004 and the first quarter 2005, which appear to correspond with the time frame for the suspensions. It appears the suspensions had an affect on the decline of PCI's performed at Bayonet Point during this time frame.
9/ Northside has experienced increases in OHS cases (466 OHS cases between July 2004 and June 2005), whereas the Bayfront/All
Children's OHS program has declined (269 (combined) OHS cases for the same time period). Largo's OHS case volume has remained somewhat constant, with some increase between 2003 and 2004, i.e., approximately 231 to 271, but remaining below 300 OHS cases per year and 239 for July through June 2005. (Most of the numbers (cardiac catheterizations, OHSs, and PCIs) discussed in this record vary, but similar decreases or increases are recognized regardless of the data set used.) Part of the perceived decline in the volumes of OHS cases, aside from as noted herein, is due to a change in the Diagnostic Related Group (DRG) codes that were and are now included in the definition of OHS. Prior to 2002, defibrillator implant cases, as well as other procedures, were included with the DRG definition of OHS. In subsequent years, these cases were excluded from the definition. When the data is adjusted, the decline in OHS volume is less dramatic.
10/ Statistically, morbidity and mortality rates have dropped due to a multitude of reasons including, in part, improvement in techniques and better post-operative care.
11/ The projected adult population for the PSA zip codes for 2010 is: 34652 - 22,943 (increase of 1,433 or 6.6 percent);
34652 - 29,853 (increase of 2,364 or 8.6 percent); 34655 -
29,915 (increase of 4,969 or 19.9 percent); 34683 - 31,832
(increase of 1,955 or 6.5 percent); 34684 - 22,415 (increase of
52 or 0.2 percent); 34688 - 10,188 (increase of 1,726 or 20.4
percent); 34689 - 23,460 (increase of 1,903 or 8.8 percent);
34690 - 12,043 (increase of 831 or 7.4 percent); and 34691 - 18,056 (increase of 1,257 or 7.5 percent). The most notable increases within the PSA are in the 55 to 64 age group (12.9 percent increase); 65 to 74 age group (17.2 percent increase) and 75 and over age group (12.5 percent increase), with a projected increase of 9 percent for the entire PSA, which is higher than the projections for the remainder of District 5 and the District 5 total. BP 19 at 45; BP 20.
12/ Mr. Nelson agreed that the overall OHS use rate for Helen Ellis' PSA has declined, but opined that the "aging of the population," i.e., the increase in population ages 65 and older beginning in 2011, would offset the declining use rate to some degree. Mr. Baehr, however, noted that the OHS use rate has been declining in Helen Ellis' PSA for a number of years, notwithstanding the population 65 and older has been the fastest growing segment of the population during the same period of time.
13/ For the year ending June 30, 2005, Helen Ellis performed 157 inpatient cardiac catheterizations on patients within the PSA, of which 80 came from zip code 34689. BP 19 at 39.
14/ In the application, Helen Ellis projected that the number of OHS discharges within the PSA would be 478, 487, and 497 for 2008, 2009, and 2010, respectively. These numbers were revised downward in Helen Ellis Exhibit 65A: 462, 473, and 484 for years 2009, 2010, and 2011. Thus, for 2009 the number decreased from
487 to 462 and for 2010 the number decreased from 497 to 473. The application did not provide projections for 2011.
15/ From the time of the application to Helen Ellis Exhibit 65A an additional year was added (2011) and the PSA remained the same. Also, for the lowest projections, the population numbers increased slightly, the use rates were lower, and the number of projected OHS discharges (cases) decreased. The market share percentages increased for the first three years of operation: 25 percent for 2009 from 21.65 for 2008, 35 percent for 2010 from
33.95 percent in 2009, and 40 percent for 2011 from 38.15 percent for 2010. The out-of-area percentages increased from a constant 17.2 percent to a constant 20 percent.
16/ Mr. Baehr stated that Helen Ellis "could do better than that," but was concerned that that percentage would represent a
60 percent increase from his projected Helen Ellis' market share for diagnostic cardiac catheterization and MDC-5 of 17 percent. He also stated that Helen Ellis bump-up factor could be greater than 25 percent, but questions whether it can be achieved in the first year. T 2207-2208.
17/ For example, Dr. Javeed and Dr. Abbott testified that they each would likely refer between 50 and 75 OHS case per year to Helen Ellis in its first year of operation. While Dr. Roca did not quantify the number of OHS cases he would refer to Helen Ellis, it is reasonably inferred that he would refer OHS cases to Helen Ellis given his concerns regarding transfers. Dr.
Sharma, a cardiologist and board certified in several fields including interventional cardiology, testified that his group (of four interventional cardiologists) would, as an estimate, refer an additional 50 OHS cases. HE 90 at 9, 13, 18.
18/ The service areas of Largo, Bayfront, and Northside have very minor overlap with Helen Ellis' PSA.
19/ A centroid is the point within the zip code area that represents a center point of population density, not necessarily the geographic center point. T 1523. The centroids selected by Mr. Diaz and Mr. Pergolizzi were fairly similar. As noted herein, while the drive times and recorded miles varied somewhat, the differences were not significant such that the recorded drive times in minutes and recorded distances in miles by both experts were not comparable. When asked "generally speaking, how did your centroid locations compare to [those determined by Mr. Diaz] at issue," Mr. Pergolizzi stated in part: "They were very close. They are all within one half mile of one another. A couple of them were at the exact same location." T 1615.
20/ There are three errors on the Diaz study, HE 48: 31 minutes on the data sheet versus 17 as actually recorded on Helen Ellis Exhibit 48, T 824-825; 29 minutes on the data sheet versus 22 as actually recorded for zip code 34653 (for Helen Ellis) and 21 minutes on the data sheet versus 22 as actually recorded for the same zip code for Bayonet Point.
21/ Mr. Pergolizzi used Monday through Friday and not during peak periods rather than the traditional times for travel studies (Tuesday through Thursday and during peak hours) because he felt "that the need for healthcare could occur at just any time of the day." See T 1535-1536 for the percentages of runs performed Tuesday through Thursday and Monday and Friday.
22/ Dr. Stamatiadis voiced several concerns, e.g., a majority of the Pergolizzi runs were made during the off-peak periods increasing the potential for lowering the average times. T 255- 260.
23/ In the Pergolizzi study, for zip code 34689, the "duration range" was 27-40 minutes with an average duration of 34 minutes to Bayonet Point, whereas the "duration range" for the Helen Ellis trip was 4-9 minutes with an average duration of 6 minutes. MP 12.
24/ See Fla. Admin. Code R. 59C-1.002(41)(h). "'Tertiary health service' means a 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." § 408.032(17), Fla. Stat.
25/ Dr. Abbott's testimony regarding one of his patients who coded and died while remaining at Helen Ellis has not been overlooked. It appears that the patient was discharged from the Helen Ellis cardiac catheterization lab stable and upon returning to a telemetry bed coded and died. The records indicate that upon admission to Helen Ellis on March 22, 2004, which he recommended, the patient was pain free. Orders were written triggering the "rule out MI protocol." (The patient was known to have had an MI already.) At the time of admission, Dr. Abbott stated that the patient did not meet the criteria for thrombolytics or emergency PCI as defined by the American College of Cardiology, and it was his opinion that the patient did not need a cardiac catheterization on the date of admission to Helen Ellis. After being treated for a dye allergy on the 23rd, the patient received a cardiac catheterization on the 24th at approximately 11:50 a.m., which took 10 minutes. The record indicates that the patient denied having any pain at that time and was alert and oriented. Dr. Abbott's immediate inclination after the procedure was completed was that the patient could have benefited from bypass surgery, but he made no attempt to transfer the patient because the patient was stable. The patient coded and went into cardiac arrest and died at 12:58
p.m. on the 24th. At the time the patient coded, Dr. Abbott had spoken with an interventional cardiologist and had initiated transfer proceedings for the patient to go to Morton Plant. At the same time, he was "toying with the idea of leaving the sheath in," which potentially could have assisted an interventional cardiologist in performing a PCI. Whether that procedure could have been performed under the circumstances and whether it would have been successful is speculative. HE 84 at 870-887 (Oct. 4, 2005, hearing testimony).
26/ In the Helen Ellis PSA, during year end June 30, 2005, Morton Plant had a 54.2 percent market share for PCI cases, whereas Bayonet Point had a 42.6 percent market share. Morton Plant's market share exceeds 69.7 percent in four zip codes, whereas Bayonet Point's market share exceeds 56.5 percent in the five remaining zip codes. The market shares are somewhat balanced in zip codes 34690 (56.5 to 42.0 percent) and 34655 (53.6 to 43.1 percent), albeit favoring Bayonet Point. Within the PSA, 61 percent of Morton Plant's PCI cases came from zip codes 34683, 34684, and 34689 whereas 66 percent of Bayonet Point's PCI cases came from zip codes 34652, 34653, and 34655.
27/ Dr. Javeed testified that inefficiencies have resulted from a lack of an OHS program at Helen Ellis. T 347-349. Also, Dr.
Roca explained some of the quality implications of not having an OHS program at Helen Ellis, such as communication error due to a lack of patient records from prior hospitalizations; inability to have family present because of transportation issues; additional stress to the patient and family caused by transfers, longer lengths of stay, potential infections or complications, and patients undergoing duplicate procedures. Dr. Javeed voiced similar concerns. Greater physician choice was also cited as a potential quality enhancement if Helen Ellis' OHS program is approved.
28/ Mr. Richardson suggested that the approval of the Helen Ellis project would have no material impact in terms of improving Helen Ellis' market strength. T 1672-1673.
29/ Generally, "[t]he absence of numeric need under the need formula establishes, in effect, a rebuttable presumption of no need." Florida Health Sciences Center, Inc., infra.
COPIES FURNISHED:
Richard J. Shoop, Agency Clerk
Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3
Tallahassee, Florida 32308
William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive, Suite 3116
Tallahassee, Florida 32308
Dr. Andrew C. Agwunobi, Secretary Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3
Tallahassee, Florida 32308
Geoffrey D. Smith, Esquire Susan C. Smith, Esquire Smith and Associates
2873 Remington Green Circle Tallahassee, Florida 32308
Michael O. Mathis, Esquire
Agency for Health Care Administration 2727 Mahan Drive, Building 3
Tallahassee, Florida 32308
Stephen A. Ecenia, Esquire
R. David Prescott, Esquire
Rutledge, Ecenia, Purnell & Hoffman, P.A.
215 South Monroe Street, Suite 420 Tallahassee, Florida 32301
Robert A. Weiss, Esquire Karen A. Putnal, Esquire
Parker, Hudson, Rainer & Dobbs, LLP The Perkins House, Suite 200
118 North Gadsden 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 | Document | Summary |
|---|---|---|
| May 14, 2007 | Agency Final Order | |
| Jan. 16, 2007 | Recommended Order | The Applicant proved that "not normal" circumstances exist justifying approval of an open heart surgery program at Helen Ellis Memorial Hospital. |
