Findings Of Fact The Petitioner, Medical Center Hospital, is a 208 bed not-for-profit hospital located in Charlotte County, Florida. Its primary service area is Charlotte County. It has secondary service areas including DeSoto County and the peripheral areas of Lee and Sarasota Counties, which adjoin Charlotte County. It has filed an application for a Certificate of Need authorizing it to establish a cardiac catheterization (cardiac cath) lab at its facility in Punta Gorda, Florida. After review by HRS staff personnel, the Department initially elected to deny the Certificate of Need application. HRS District 8 includes Collier, DeSoto, Lee, Sarasota, Hendry and Charlotte Counties. Charlotte County is in the approximate geographic center of that district and is the third most populous county in the district. There are 622 acute care beds in Charlotte County divided among three acute care hospitals. There are no cath labs in Charlotte County and in all of District 8, there are only three: (1) Memorial of Sarasota in Sarasota County, (2) Lee Memorial in Lee County and (3) Ft. Myers Community Hospital in Lee County. Charlotte County has a significant population of elderly citizens. This elderly portion of the population is that portion composed of persons of the age of 60 years or older. The population growth of the county and the surrounding areas has been very rapid and continues to be. Charlotte County has historically grown at a rate faster than that of the State of Florida. The county has the largest percentage of elderly persons of any county population in the United States, with approximately 34 percent of its citizens being in the elderly category. Statistically, this elderly age group has the highest degree of damage to coronary arteries and major vessels of the heart. The population of persons over 45 years of age is the broader age group of candidates for cardiac catheterization, comprising approximately 55 percent of the total population of the county. Approximately 40 percent of Petitioner's hospital patient volume, based upon its total admissions, consists of cardiac patients. This percentage is actually higher when computed in terms of patient days of care. Significantly, Medicare eligible patients, the more elderly patients, constitute the predominant number of Petitioner's hospital admissions. The 1981 and 1982 Medicare patient days were 67.16 percent of the Petitioner's total patient days. Patients in the primary and secondary service areas of the Petitioner's hospital, as well as the other two acute care hospitals in Charlotte County, who require cardiac cath services must now be referred out of that county. This referral process, with attendant delays in providing sometimes critical emergency care to patients, disruption of their living routines and those of their families attending them, causes a significant adverse impact on patients in terms of costs, personal health risks, stress and overall adverse effects on the quality of patient care. The economic costs of this referral process are significantly higher than if a cardiac cath facility were located in Charlotte County, especially in terms of the duplicated services and duplicated expenses involved in care for such cardiac patients since many of the aspects of care provided by the Petitioner as the initial admitting facility are duplicated when the patient arrives at the referral facility. A referral for cardiac cath to another physician and hospital involves transfer of the patient, if the patient is already an inpatient at the Petitioner's facility or one of the other two Charlotte County hospitals. The cost of an ambulance or helicopter transfer is significant and must be borne by the patient or the patient's reimbursement provider. The patient must be admitted to the referral facility as an inpatient. This leads to an additional facility charge, not to mention additionalmental and physical stress, on the patient. In turn, another physician at the referral facility must admit the patient to that second facility. He, in turn, will charge a fee. Further, additional laboratory tests and procedures are performed at the referral facility as part of the standard patient "work-up." These include all manner of blood examinations and tests and analyses, chest x-rays, EKG's and the like. Fees are charged for all of these tests and procedures which, in the case of an inpatient requiring cardiac cath, would have already been performed at Use referring facility. Added to this duplication of costs is the stress occasioned the cardiac patient by simply having to go to another hospital at a distance from his home, to a new doctor, to have that new doctor with whom he is unfamiliar, perform a procedure that the patient is apprehensive about. Additional real-life, practical problems involving equipment breakdown can result in additional inpatient time and expense at can result in additional impatient time and expense at the referral facility, since, in the present scenario, that is the only facility in the area with a cardiac cath lab and appropriate equipment. The transporting of a high risk patient, who should not be subjected to the transfer process due to the stress an risk it poses, but must be because the cath procedure cannot be legally performed by the referring facility (Petitioner), presents a clinically significant and often unacceptable risk of death for such patients. Without the cardiac cath lab capability at Petitioner's facility, optimal care to cardiac patients cannot be provided by the physicians and facilities attempting to treat such patients in the Charlotte County area. The minimum service volume requirement (as delineated in the cardiac cath rule at paragraph (i)(4)) requires that a minimum of 300 cardiac cath procedures be performed annually in a cardiac cath lab within three years following the initiation of those services. The number of cardiac cath procedures generated from the Charlotte County area is and has been significantly high for a long period of time. Dr. Rosenfield established that from his practice alone in Charlotte County, 175 to 160 cases have been referred for cardiac cath services since January, 1983. Based on the practices of other cardiologists and physicians in the area, Dr. Rosenfield was able to establish that 400 to 500 cardiac cath procedures a year could be performed in Petitioner's lab, if authorized. In addition to the actual patients referred out of the area, for instance to Lee County, for cardiac cath services, are those patients who refuse referrals. In these instances, patients, although recommended to undergo a cath procedure, refuse to because they are afraid or otherwise unwilling to go to an unfamiliar hospital outside of their county or to an unknown physician. Dr. Rosenfield had approximately 50 to 100 cases in his practice, in 1984, he would have referred to a cardiac cath facility in Lee County or other areas, but his patients refused to accept that arrangement. In short, it was established that the Petitioner can meet the minimum service volume requirement embodied in the so-called "cardiac cath rule." The frequency of cardiac caths being performed in District 8 facilities is increasing in an unbroken trend. Catheterizations are typically performed earlier in a patient's illness and hospital stay than in former times in order to earlier and better diagnose the patient's condition. This results in a higher quality of care for the cardiac patient and lessening of the overall cost of that patient's care both by reducing the number of hospital days and avoidance of unnecessary, sometimes duplicative diagnostic tests. There is a clear national and District 8 trend in cardiac medical practice which consists of performing more therapeutic cardiac caths as a useful tool of preventive cardiac medicine. Actual recent historical utilization and demand for cardiac cath service in District 8 has not been consistent with the prediction embodied in the calculations provided for in Rule 10-5.11(15)(1), Florida Administrative Code. That rule seeks to predict future cardiac cath procedures required in a future year (here 1986) by multiplying the 1981 actual cardiac cath use rate by the 1986 projected population in the District. The resultant figure is then divided by 600 to yield the number of cardiac caths needed as determined by the rule methodology. In the instant situation however, that abstract mathematical calculation projects that 1,833 procedures would be performed in 1986, yielding "need" for three cardiac cath labs. However, in District 8, in 1983, the actual cardiac cath procedures performed, without consideration of the six months of cardiac cath procedures performed by the Lee Memorial Lab in 1983 (annualized), were actually 2,089 procedures, significantly in excess of the need calculation the rule demonstrates for the year 1986, three years later. Utilizing the Department's rule-based mathematical calculation of need, it would be 1990 before enough procedures are projected to warrant a fourth cardiac cath lab in the District. In 1990, 2,128 procedures would be projected by the rule. Actual 1983 procedures, again only including six months of operation of the Lee Memorial Lab without annualizing that six month's experience, fall only 39 procedures short of what the formula shows to be the 1990 "need." If Lee Memorial's 1983 procedures were annualized, the resultant number of District 8 procedures in 1983 is 2,255, more than the Respondent's projected 1990 "need." Thus, the situation established for District 8 in Charlotte County is clearly a "not normal" factual situation, in that the Department's rule methodology shows for 1986, the "horizon" year at issue, and indeed even for 1990, that less procedures will be "needed" than the Petitioner established have already been performed in a single year, i.e. 1983. Thus, due in part to the high percentage of elderly patients who have more frequent need of cardiac cath procedures in the Charlotte County and District 8 population, the need calculation provided for in the above rule clearly does not mesh with nor address what the actual need is already. It is also significant to note that the actual numbers of cardiac cath procedures performed in District 8 cath labs in 1981, as compared to the numbers of unverified procedures reported to HRS, clearly result in a showing of a need for a fourth cath lab consistent with the need determination formula. Six- hundred thirty-three cardiac cath procedures were performed in 1981 at the Ft. Myers Community Hospital and Memorial Hospital of Sarasota. These procedures were "right heart" cath procedures which were included within complete Catheterizations or other Catheterizations procedures, which were counted as one procedure for reporting to HRS, but which in actuality involve separate procedures and billing. The addition of 633 procedures to the 1,482 procedures reported to and employed by HRS in its calculations herein results in a total of 2,115 actual 1981 procedures. Thus, the revised 1981 use rate results in a total of 2,511 projected procedures, for a 1986 horizon year need of 4.2 cath labs. The 1984 real utilization rate reveals in turn, as projected through the year end of 1984, an immediate need in District 8. This is predicated on the Department's acknowledged policy of granting one cath lab for each 600 procedures. If the 2,274 procedures actually experienced in 1984 in District 8 is divided by 600 there results a need of 3.79, or four, cath labs for 1984 based upon the 1984 actual utilization rates. It is also noteworthy that if 1983 actual use rates are utilized, the resulting computation reveals the need for four cath labs for the year 1986. The additional basis upon which the Respondent, HRS opposes the grant of the application is the feared inability of the Petitioner to meet the requirement of Rule 10-5.11(15)(i)5.a. which requires that cardiac cath labs in a facility not performing open heart surgery must submit with their CON applications a written referral agreement with a facility providing open heart surgery within 30 minutes travel time by emergency vehicle under average travel conditions. The Petitioner's application however, (Exhibit 5 in evidence) shows that indeed written referral agreements for open heart surgery between the Petitioner and Memorial Hospital of Sarasota and Ft. Myers Community Hospital have been executed. Ft. Myers Community Hospital is accessible from the Petitioner's location in 20 to 25 minutes travel time by an emergency vehicle, with normal driving time of 30 to 35 minutes. In the context of financial feasibility and control or economy in health care costs to the public, it is established that the Petitioner presently has space available in its existing facility and substantially all of the equipment necessary to perform cardiac catheterization procedures. The cost of its proposed lab will be a maximum of $87,000. That cost includes purchase of new equipment and modifications to the existing examination table.1 It is significant that the cost of this project is substantially less than that which existing health care providers may spend without undergoing certificate of need review, as long as they do not seek to offer a new service. The cost of the project is minimal in relation to the benefits to be derived by patients of the health care service area by institution of the additional cardiac cath service represented by this application. In a similar vein, no issue has been raised concerning the financial feasibility of the Petitioners installation and operation of the proposed cardiac cath lab service.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses, as well as the pleadings and arguments of the parties, it is, therefore RECOMMENDED: That a Certificate of Need authorizing the installation and operation of a cardiac catheterization laboratory for its facility at Punta Gorda, Charlotte County, Florida be issued to Adventist Health Systems/Sunbelt, d/b/a Medical Center Hospital. DONE and ENTERED this 9th day of May, 1985 in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of May, 1985. COPIES FURNISHED: William B. Wiley, Esquire 666 Lewis State Bank Building Tallahassee, Florida 32301 Gary L. Wilkins, Esquire 590 Harbor Blvd., Northwest Suite 204 Port Charlotte, Florida 33952 John M. Carson, Esquire Department of Health and Rehabilitative Services 1317 Winewood Blvd. Building 2, Room 407 Tallahassee, Florida 32301 E. G. Boone, Esquire and Robert T. Klingbeil, Esquire Post Office Box 1596 Venice, Florida 34284 David H. Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
Findings Of Fact Petitioner's name and address are North Broward Hospital District d/b/a North Broward Medical Center, 201 E Sample Road, Pompano Beach, Florida 33604. The North Broward Hospital District is a Special Taxing District created by the Florida Legislature. It currently owns and operates three public, nonprofit hospitals in Broward County including Broward General Medical Center ("BGMC") and North Broward Medical Center Respondent, Department of Heath and Rehabilitative Services ("HRS"), is responsible for the administration of Section 381.493 through 381.499, Fla. Stat. ("the CON statute"), and Fla. Administrative Code Ch. 10-5 ("the CON rules"). Under the foregoing, authorities, HRS reviews applications for CONs to construct, purchase or otherwise implement certain new health care facilities and new institutional health care services, as defined by the CON statute. One of these new institutional health care services subject to HRS' review under the CON statute and CON rules is open-heart surgery service, as defined in Fla. Admin. Code Rule 10-5.11(16)(a). By formal application under the CON statute and CON rules which was deemed complete by HRS effective October 16, 1985, NBMC applied for a certificate of need ("CON") to institute an open-heart surgery service at 201 E. Sample Road, Pompano Beach, Florida 33604. Exhibit "A" is a true, correct, and authentic copy of NBMC's application for certificate of need for open-heart surgery. NBMC's application was denied by HRS by letter dated February 28, 1986, received by NBMC open March 10, 1986. Exhibit "B" is a true, correct, and authentic copy of said letter. Publication of the denial appears at Vol. 12; No. 11, Florida Administrative Weekly (March 14, 1986). HRS' basis for denying the application is contained in the "State Agency Action Report". Exhibit "C" is a true, correct, and authentic copy of HRS' State Agency Action Report pertaining to NBMC's application. NBMC has petitioned HRS for formal Section 120.57(1), Fla. Stat., administrative proceedings challenging the denial of its application for open- heart surgery. Exhibit "D" is a true, correct, and authentic copy of that petition. In its application, NBMC stated that one of its sister hospitals, BGMC, currently provided open-heart surgical services. NBMC proposed in its application to utilize the same open-heart surgical team at NBMC as was then practicing at BGMC. Applicants for CONs for open-heart surgery services must satisfy certain regulatory standards prescribed in CON Rule 10-5.11(16). These standards include: (k)1. There shall be no additional open- heart surgery programs established unless: The service volume of each existing and approved open-heart surgery program within the service area is operating at and is and expected to continue to operate at a minimum of 350 adult open-heart surgery cases per year or 130 pediatric heart cases per year; and The conditions specified in (e)4., above will be met by the proposed program. (E.S.) Rule 10-5.11(16)(e)4. provides in pertinent part as follows: There shall be a minimum of 200 adult open- heart procedures performed annually, within three years after initiation of service, an any institution in which open-heart surgery is performed for adults. (E.S.) Exhibit "E" is a true, correct, and authentic copy of CON Rule 10-5.11(16). 10. In 43 Fed. Reg. 13040, 13048 (March 28, 1978) (42 C.F.R. 121.207), the Secretary of the United States Department of Health and Human Services ("HHS") set forth the federal CON standards for open-heart surgery, as part of the National Guidelines for Health Planning. The National Guidelines for Health Planning are referenced in HRS's State Agency Action Report. Exhibit "F" is a true, correct, and authentic copy of that portion of the Nation Guidelines for Health Planning which pertain to the implementation of open-heart surgery services. The National Guidelines for Health Planning also provide that approval of new open-heart surgery services should be contingent upon existing units operating and continuing to operate at a level of at least 350 procedures per year. The National Guidelines for Health Planning further provide as follows: In some areas, open-heart surgical teams, including surgeons and specialized technologists, are utilizing more than one institution. For these institutions, the guidelines may be applied to the combined number of open-heart procedures performed by the surgical team where an adjustment is justifiable in line with Section 121.6(B) and promotes more cost effective use of available facilities and support personnel. In such cases, in order to maintain quality care a minimum of 75 open-heart procedures in any institution is advisable, which is consistent with recommendations of the American College of Surgeons. (E.S.) HRS' CON Rule 10-5.11(16); which contains the "350" standard, does not contain any comparable exception for institutions sharing open-heart surgical teams. NBMC's application for CON projects 200 open-heart surgeries by the end of the third year of operations and, when combined with BGMC's open-heart procedures satisfies the exception contained in the National Guidelines for Health Planning, as described above. There are no disputed issues of material fact that will require an evidentiary hearing in this matter. The parties therefore agree that the matter shall be submitted pursuant to legal memoranda and oral argument. The parties' legal memoranda will be due on June 17, 1986, and oral argument will be held on the scheduled hearing date of June 19, 1986. The parties agree to allow responses to the legal memoranda, which responses shall be submitted no later than June 26; 1986.
Findings Of Fact Parkway Regional Medical Center, Inc. (formerly Parkway General Hospital, Inc.) is a Florida corporation, wholly-owned by American Medical international, Inc., of Beverly Hills, California. Parkway is located at 160 Northwest 170th Street, North Miami Beach, Florida. Biscayne Medical Center is wholly-owned by Humana, Inc. of Louisville, Kentucky. Biscayne is located at 2801 Northeast 209th Street, Miami, Florida. Both Parkway and Biscayne are located in DHRS District XI, and both propose to establish adult cardiac catheterization capabilities in DHRS District XI. The Local Health Council for District XI has not formally adopted its district plan. Both the Parkway and Biscayne applications are consistent with the State Health Plan. (Stipulated). In March, 1983, DHRS sent a letter to hospitals throughout Florida requesting information concerning the number of cardiac catheterization procedures performed in their laboratories during the calendar year 1981 and the number of cardiac catheterization laboratories now in use. Based upon information received in response to this letter, DHRS prepared an inventory which contains the following for District XI: FACILITY NUMBER OF ADULT CATHS. NUMBER OF ADULT LABS. American Hospital of Miami 531 1 Baptist Hospital of Miami 416 1 Cedars of Lebanon Hospital 367 1 Jackson Memorial Hospital 905 1 Mercy Hospital 494 1 Miami Heart Institute 1,268 1 Mount Sinai Medical Center 872 2 South Miami Hospital 485 1 St. Francis Hospital 535 1 University of Miami Hospital & Clinics 71 0 5,942 10 Although the DHRS survey letter requested information regarding number of catheterization "procedures," some of the hospitals responded on the number of patients catheterized rather than the number of procedures. This resulted in an understatement of procedures, since some patients receive multiple procedures. Rule 10-5.11(15)(d), F.A.C., defines "procedure" as follows: Procedure means an angiographic study, a physiologic study or a therapeutic activity within a cardiac catheterization laboratory which utilizes the equipment customarily used in cardiac catheterization. DHRS plans for cardiac catheterization on a two-year planning horizon. Therefore, the need for Parkway's and Biscayne's proposals should be determined based on projected procedures and population in the year 1986, since the decision is to be made in 1984. The DHRS 1986 population projection for District XI (persons 15 years and older) is 1,529,144. The DHRS inventory reflects 5,942 adult catheterization procedures performed in District XI hospitals in 1981. Rule 10-5.11(15)(1), F.A.C., contains a formula for determining need for additional cardiac catheterization laboratories. One step in the need determination methodology is calculation of the 1981 use rate. Utilizing the 5,942 procedures contained in the DHRS inventory, the 1981 use rate for District XI is 424.73 procedures per 100,000 population. Applying the need determination methodology in Rule 10-5.11(15)(1), F.A.C., to the 1981 use rate and projected population for District XI, the number of adult cardiac catheterization procedures projected for District XI from 1981 through 1986 is as follows: YEAR POPULATION 15 AND OVER 1981 USE RATE NUMBER PROJ. PROCEDURES 1981 1,399,299 424.73 5,942* 1982 1,427,404 424.73 6,061 1983 1,455,477 424.73 6,180 1984 1,483,615 424.73 6,302 1985 1,511,721 424.73 6,422 1986 1,529,144 424.73 6,494 * Actual number of procedures reported in DHRS inventory. Current information from each of the District XI hospitals with adult cardiac catheterization laboratories shows that application of the need methodology formula in Rule 10-5.11(15)(1) understates the number of adult cardiac catheterizations actually performed in District XI in 1982 and 1983, as follows: ACTUAL PROCEDURES ACTUAL YTD PROJECTED 1982 1983 1983 Mercy 441 317 543 Cedars 401 333 571 Miami Heart 833 486 833 St. Francis 917 495 990 JMH 986 580 994 American 576 321 550 Baptist 618 517 886 S. Miami 512 417 715 Mt. Sinai 983 647 1,109 6,267 4,113 7,191 Actual Use Rate 1982 - 439.17 Projected Use Rate 1983 - 494.23 For District XI, from 1980 through 1982, the use rate increased by 9 percent in 1980, 7 percent in 1981 and 3 percent in 1982. If the number of adult cardiac catheterization procedures actually performed in 1983 is projected for a full year, the District XI use rate would have increased by 12-1/2 percent in 1983. Rule 10-5.11(15)(o) provides that additional cardiac catheterization laboratories will not be approved where they would reduce the average volume of procedures performed by existing and approved laboratories in the service area below 600 adult procedures. Assuming an average of 600 procedures per lab, utilizing the projected number of procedures for 1986 and the use rates calculated for 1981, the number of adult cardiac catheterization laboratories required in District XI for 1986 would be 0.8. In accord with DHRS' policy, the 0.8 laboratory should be "rounded up" to 1.0. Therefore, under DHRS' interpretation of Rule 10-5.11(15), correct application of the need formula demonstrates a need for 1 additional adult cardiac catheterization laboratory in District XI. Initially, DHRS took the position that the 0.8 (0.7 for 1984) should be rounded down. However, this view was corrected by later testimony which established that the DHRS procedure is to "round up" such fractions. Parkway's emergency room is the third most active in Dade County and is the major emergency room between downtown Miami and the Broward County line. Parkway's proposed cardiac catheterization laboratory will be located on the same floor as and adjacent to the coronary care unit and the emergency room. Parkway's proposed cardiac catheterization laboratory will be dedicated solely to cardiac catheterization with the capability of mobilizing 24 hours a day, 7 days a week. Parkway's proposed cardiac catheterization laboratory will contain appropriate staffing and equipment. Based upon the number of patients referred by Parkway cardiologists to other institutions in the Miami area having cardiac catheterization facilities, Parkway projects utilization of its proposed cardiac catheterization laboratory in the first year of operation to be 250 to 300, increasing to 400 in the second year. Parkway does not intend to perform coronary angioplasty in its proposed cardiac catheterization laboratory but does intend to perform streptokinase procedures on an emergency basis on patients exhibiting acute chest pain and EKG abnormalities. Parkway has a written agreement with Cedars Medical Center pursuant under which Cedars will accept open-heart surgery patients from Parkway. Travel time from Parkway to Cedars under normal conditions is fifteen minutes. Biscayne's proposed adult catheterization equipment will be installed, and the procedures will be performed, in its "Special Procedures" Room, rather than a separate cardiac catheterization laboratory. If approved, Biscayne's cardiac catheterization laboratory would be available 24 hours a day and seven days a week on an "on call" basis. However, the anticipated regular hours for the laboratory will be 7:00 a.m. to 3:00 p.m., five days a week. Biscayne will staff its laboratory with a cardiopulmonary nurse, an x- ray technician, and a registered nurse. Biscayne proposes to perform only "diagnostic" cardiac catheterization procedures for the diagnosis of coronary artery disease. Biscayne takes the position that therapeutic procedures such as streptokinase and angioplasty are not medically safe without an in-house open heart surgery program. Biscayne has a written transfer agreement with Jackson Memorial Hospital in Miami whereby all Biscayne patients requiring open heart surgery will be transferred to, and accepted by, Jackson for such treatment. The driving time between Jackson and Biscayne is twenty minutes. Biscayne projects 300 cardiac catheterization procedures in its first year of operation and 400 procedures in the second year of operation. These projections are based on the number of patients Biscayne cardiologists currently transfer to other hospitals for cardiac catheterization and an assumed capture rate of 60 percent of all potential procedures generated in Biscayne's service area. Biscayne's "special procedures" room is a multipurpose facility which will be shared with the radiology department. The latter operates three radiographic/fluoroscopic rooms (R&F) and one "special procedures" room. All four rooms are equipped for doing routine radiographic studies and special procedures. "Special procedures" as used by Biscayne refers to investigational studies for the diagnosis of medical conditions through the use of special imaging equipment, such as x-ray and fluoroscopy. About 1400 special procedures were performed at Biscayne in 1982. These procedures were performed in various areas of the hospital, including the R&F rooms, the special procedures room, surgical suites and the critical care unit. Special procedures normally take about one hour to complete. However, the procedure known as angiography is only performed in Biscayne's special procedures room. An angiogram involves an investigation of blood vessels by means of x-rays of injected substances or dyes. Last year, about 400 of the 1400 special procedures performed at Biscayne were angiograms. Angiographic studies of all blood vessels except the coronary arteries are currently performed in the special procedures room. Angiographic studies of the coronary arteries require cardiac catheterization equipment. Over a year ago, DHRS issued Biscayne a certificate of need to renovate and replace equipment in two R&F rooms and the special procedures room. Also, digital angiographic equipment was added to for the special procedures room. Per this certificate of need, Biscayne has purchased the new equipment and renovated these rooms. Construction was scheduled to be complete in October, 1983, but has been delayed. Biscayne will not have to purchase all new equipment (as will Parkway) to add cardiac catheterization capabilities to its special procedures room. Instead, special General Electric equipment will be added to the existing angiographic equipment which will enhance its capabilities to include cardiac catheterization. As a result, Biscayne can provide cardiac catheterization at a projected additional cost of $298,566 compared to Parkway's projected cost of $822,701. However, Biscayne's projection does not recognize that some of the special procedure facility costs should be allocated to cardiac catheterization. Biscayne's pro forma income statement for the cardiac catheterization project allocates 43 percent usage of the special procedures room to this function. As noted by Parkway, a 43 percent special procedures room equipment cost allocation would raise Biscayne's cardiac catheterization capability costs to $683,314. Biscayne does not intend that the inclusion of cardiac catheterization capability will lower the number of special procedures that will be done in a normal eight-hour day. The capacity of the special procedures room as stated by Biscayne's Director of Radiology and supervisor of Biscayne's proposed special procedures room/catheterization laboratory, is 6 per day, 5 days week, for an annual total of 1,560. Biscayne's CON application for the special procedures room projects 1,484 special procedures in the first year and 1,524 in the second year, allowing for 76 additional procedures in the first year and 36 in the second year. Biscayne projects 300 cardiac catheterizations in the first year and 400 in the second year, thereby exceeding the capacity of the combined special procedures room/cardia catheterization laboratory by 224 procedures in the first year and 364 in the second year. Biscayne's proposed sharing of special procedure facilities is a cost savings measure, and in this respect is superior to Parkway's proposal. Although Biscayne could mobilize its cardiac catheterization laboratory on an emergency 24 hour, 7 day basis as required by DHRS Rule (discussed below), it would likely encounter scheduling and use conflicts under true emergency conditions, or even full utilization as noted above. Parkway argues that Biscayne's shared facility plan violates American Heart Association guidelines recommending cardiac catheterization labs be dedicated solely to this use. However, the evidence did not indicate that departure from this guideline would have any adverse impact on the quality of care provided. Parkway is located in Northeast Dade County directly on the Golden Glades Interchange, where Interstate 95, the Florida Turnpike and the Palmetto Expressway intersect. The majority of Parkway's service area is in Dade county, and 86.17 percent of Parkway's patients come from Dade County. Biscayne is located in Northeast Dade County near the Broward County line. The majority of Biscayne's primary service area is within Broward county, and more than 60 percent of Biscayne's patients originate from Broward County. Broward County is within DHRS District X. Comparative statistical information demonstrates that Parkway is more fully utilized, delivers more acute care and has greater patient activity than Biscayne: BASIC STATISTICAL INFORMATION PARKWAY BISCAYNE Licensed Capacity 412 458 Beds in Service 412 330 Discharges 12,917 9,202 Average Length of Stay 9.1 days 8.1 days Patient Days 110,385 79,634 Occupancy 73.4 percent 47.6 percent Bed Mix Med-Surg. 394/72.9 percent occ. 284/65.2 percent occ. Intensive Care 18/89.9 percent occ. 26/77.5 percent occ. E.R. Utilization Visits 27,520 13,110 The Hospital Cost Containment Board (HCCB) was formed in 1979 to monitor hospital costs/charges and to encourage cost containment for Florida hospitals through public awareness and the dissemination of information to the public. The HCCB is a division of the Florida Department of Insurance. Each year, the HCCB collects the prospective budget of each hospital sixty days prior to the first day of the fiscal year for each hospital. The HCCB reviews the data and budget submitted by a hospital, and then determines to accept the budget, reject the budget, or call a public hearing to make the hospital justify its budget. All HCCB action is based on the figures and budgets submitted by the hospitals themselves. The HCCB reviews the financial data submitted to it by various criteria which it labels "screens." The "total net revenue" screen is one of the screens utilized to compare a hospital's average patient charge to others in its peer group. "Total net revenue" refers to the amount of money a hospital actually receives for services provided to patients after all deductions are subtracted. In addition, the HCCB "adjusts" its various financial screens to eliminate the effect of outpatient care and revenues from inpatient activity. Thus, the screens are labeled, for example, as "adjusted revenues" or "adjusted costs." Comparisons between Biscayne and Parkway by using HCCB calculations of data and projections submitted by the two hospitals indicate the following (1983 budgets): Cost to the hospital per adjusted admission Cost to the hospital per adjusted day Total net revenue per adjusted admission Total net revenue per adjusted day PARKWAY BISCAYNE PARKWAY OVER BISCAYNE DOLLARS PERCENT $3954 $3438 $516 15.0 percent $ 458 $ 393 $ 65 16.5 percent $4263 $3595 $668 18.6 percent $ 494 $ 411 $ 83 20.2 percent Comparisons using the same screens for 1984 budgets are as follows: PARKWAY BISCAYNE PARKWAY OVER BISCAYNE DOLLARS PERCENT $4033 $3563 $470 13.2 percent $ 498 $ 422 $ 76 18.0 percent $4346 $3726 $620 16.6 percent $ 537 $ 442 $ 95 21.5 percent Cost to the hospital per adjusted admission Cost to the hospital per adjusted day Total net revenue per adjusted admission Total net revenue per adjusted day As indicated, Parkway's costs to provide hospital services and patient charges for these services have been, and are projected to be, substantially higher than those for Biscayne. PARKWAY BISCAYNE Rate of Increase from 1980 Base Year to 1983 Budget: Per Adjusted Admission 65.1 percent 48.4 percent Per Adjusted Day 65.8 percent 42.8 percent Rate of Increase from 1980 Base Year to 1981 Budget: Per Adjusted Admission 42.4 percent 33.8 percent Per Adjusted Day 50.7 percent 36.0 percent In addition to being more expensive than Biscayne, Parkway exceeds the 80th percentile of its hospital "peer group" in most financial screens. The HCCB places each hospital in a certain peer group based on a number of factors including beds in service, physician mix, Medicare utilization, hospital services index, and median family income. The objective of peer groups is to batch hospitals with similar characteristics for comparison purposes. Biscayne and Parkway are in the same peer group for budget year 1984. Each hospital is then compared to the 80th percentile in its peer group to determine whether that hospital "breaks the screen" or exceeds the standards set by law. "Breaking the screen" means that hospital is in the upper 20th percentile in its peer group. For budget year 1983, Parkway broke the screen for cost per adjusted day and adjusted admission, total net revenue per adjusted day and adjusted admission, and rate of change increases (1980-1983) per adjusted admission and adjusted day. It should be noted that Parkway's screen breaking during this period is at least partly attributable to its 25 million dollar renovation- expansion project. For budget year 1984, however, Parkway again broke the screens for cost per adjusted day, total net revenue per adjusted admission and adjusted day, and rate of change increases per adjusted admission and adjusted day for budget years 1981-1984. Biscayne did not break any of the screens during these same time periods. As noted by the HCCB, Parkway's current profit margin is 13.5 percent compared to the 9.3 percent average for proprietary hospitals in Florida.
Recommendation Based on the foregoing, it is RECOMMENDED that the Department of Health and Rehabilitative Services enter a Final Order granting the application of Biscayne Medical Center to establish cardiac catheterization capabilities in District XI, and denying the application of Parkway Regional Medical Center, Inc. DONE and ENTERED this 8th day of March, 1984, in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 8th day of March, 1984. COPIES FURNISHED: James C. Hauser, Esquire John H. French, Jr., Esquire Post Office Box 1876 Tallahassee, Florida 32302 Keith E. Rounsaville, Esquire Harold W. Mullis, Jr., Esquire Post Office Box 1102 Tampa, Florida 33601 Claire D. Dryfuss, Esquire Assistant General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard, Suite 406 Tallahassee, Florida 32301 Jean Laramore, Esquire G. Steven Pfeiffer, Esquire 325 North Calhoun Street Tallahassee, Florida 32301 David H. Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
The Issue The issue for determination is whether Petitioner should be awarded a certificate of need authorizing the establishment of cardiac catheterization laboratory services at its facility in Port Charlotte, Florida. As a result of stipulations of the parties presented at hearing, matters for consideration were limited to whether Petitioner meets the criteria of availability of funds for capital expenditures for the project in accordance with Section 381.705(1)(h), Florida Statutes; and whether Petitioner has shown the existence of need for additional services by any existing medically underserved groups in the service area.
Findings Of Fact The parties have stipulated that Petitioner does not meet the criteria of Section 381.705(1)(a), Florida Statutes, because there is no numeric need for the program established by any agency rule formula and that no emergency or other not normal circumstances exist, including problems of geographic, financial or programmatic access, justifying the program in the absence of such enumerated need. Petitioner's agreement to this stipulation was conditioned upon an assumption that previous Certificates of Need, formerly granted by final orders of Respondent to other entities in previous batching cycles and now the subject of legal appeals by Petitioner in the appellate court, will eventually be confirmed by that court to have been properly issued. The parties have stipulated that Petitioner, as the result of nonexistence of numeric or nonnumeric need, has not met criteria regarding its ability to provide quality care, a requirement of subparagraph (c) of Section 381.705(1), Florida Statutes; has not met criteria regarding availability and adequacy of other health care facilities in the applicant's service district, a review component set forth in Section 381.705(1)(d), Florida Statutes; has not met criteria regarding immediate and long term financial feasibility of Petitioner's proposal, a requirement of Section 381.705(1)(i), Florida Statutes; has not met criteria regarding the impact of the proposed project on the costs of providing such health services, a requirement of Section 381.705(1)(l), Florida Statutes; and has not met criteria, as required by Section 381.705(2)(a)-(d), Florida Statutes, regarding alternative services, efficiency of existing services, alternatives to new construction or the likelihood of patients obtaining the proposed service in the absence of Petitioner's proposal. The parties have stipulated that review requirements of subparagraphs (e), (f), (g), (j), and (k) of Section 381.705(1), Florida Statutes, are found not to be applicable to this proceeding. Those subparagraphs relate, respectively, to economics of shared services, need for special services, need for research and educational facilities, special needs of health maintenance organizations and needs of entities serving residents outside the service area. The parties have stipulated that the criteria ofSection 381.705(1)(b), Florida Statutes, has not been met because they were not addressed or challenged by Petitioner. However, Petitioner does contest the accessibility by medically underserved groups of existing and approved providers in the service district. With the exception of the availability of funds for capital and operating expenditures related to the project in Petitioner's application and the extent to which the proposed services will be accessible to all residents of the service district, further stipulation between the parties also establishes that the review criteria contained in Section 381.705(1)(h), Florida Statutes, does not apply to this proceeding. Portions of Rule 10-5.011(b), Florida Administrative Code, relating to accessibility of services to residents of the service district are also excepted from consideration in this proceeding by the parties' stipulation. By stipulation of the parties, it is established that the review requirement of Section 381.705(1)(l), Florida Statutes, relating to the probable impact of the proposed project on the cost of providing services proposed by Petitioner, is met. The parties' stipulation further establishes that requirements of Section 381.705(1)(m) and Section 381.705(1)(n), Florida Statutes, have been met. These statutory subparagraphs relate, respectively, to methods and costs of proposed construction, and Petitioner's past and proposed provision of health care services to medicaid and medically indigent patients. Petitioner is a separate, albeit subsidiary,corporation from its parent, Bon Secours Health Systems, Inc., (Bon Secours) a "not for profit" corporation based in Marriottsville, Maryland. Approximately 80 percent of the total project cost of $1,450,000 cost is expected to come from the parent organization and not Petitioner's corporation. The project has been approved by Petitioner's corporation and management approval has been granted by Bon Secours, subject only to final board approval and reevaluation by the parent corporation on an annual basis until the actual capital expenditure is incurred. Petitioner's parent corporation uses either a line of credit or goes to the tax exempt bond market to meet capital expenditure needs. The bond market is utilized when capital needs exceed $15 million for the year. Whether the funding source for Petitioner's project would come from a line of credit or bond financing would not be known until the actual year in which the expenditure is incurred. Bon Secours includes Petitioner in its obligated group which consists of a system-wide master trust indenture established in 1985. The group consists of eight hospitals and three long term care facilities. Weaker entities in the group have the benefit of the credit strength of the group's entire system. In this regard, Bon Secours enjoys a Standard & Poors and Moodys' bond rating of A+ and A-1, respectively. The corporation is a good credit risk with a strong financial position and good earnings record. Over the next five years, Bon Secours has the ability to raise in excess of $100,000,000 in the bond market for funding purposes, inclusive of the project which is the subject of theseproceedings. Although final approval of Petitioner's project by Bon Secours' board of directors is expected shortly, that approval had not occurred at the time of final hearing. As a result, the proof fails to establish that Bon Secours is committed to provide financing for Petitioner's project. Petitioner presented expert testimony regarding accessibility by medically underserved groups to Petitioner's and other cardiac catheterization programs. Petitioner's expert placed the size of the medically indigent population, a subcategory of the medically underserved group, at six to seven percent of the total population of the service area. Due to the lack of specificity of the methodology used in arriving at the cited percentage figure, no credibility can be ascribed to that population percentage. However, both Respondent and Petitioner concede the existence of this group in the district service area sought to be served by Petitioner's project. Petitioner has not established whether the medically indigent population is denied access to cardiac catheterization programs within the district service area. While Petitioner's hospital is a medicaid provider with a proactive policy of aiding the medically indigent, the availability of cardiac catheterization services exist for this group at Intervenor's medical center facilities, located only five miles from Petitioner's hospital. Intervenor is also a medicaid provider. The proof fails to establish that medicaid patients or medically indigentpatients are presently denied or turned away from Intervenor's facility. Further, the duplication of such services at Petitioner's hospital could effectively reduce the number of cardiac catheterization procedures required for the medical staff of Intervenor's laboratory to maintain proficiency. In point of fact, there is unused cardiac catheterization capacity at Intervenor's facility. As established by Intervenor's exhibit number one, there were 562 cardiac catheterization procedures performed at Intervenor's facility in 1988. The State Health Plan recites a minimum goal of 600 such procedures a year as a proficiency measurement; the Local Health Plan maintains that a minimum of 300 procedures should be performed to insure proficiency.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered denying Petitioner's application for approval of a cardiac catheterization Certificate of Need. DONE AND ENTERED this 29th day of June, 1989, in Tallahassee, Leon County, Florida. DON W.DAVIS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Fl 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 29th day of June, 1989. APPENDIX The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-3. Adopted in substance, except that part (l) of proposed finding 3 was met by Petitioner. 4.-5. Addressed in part. To the extent that the last sentence of proposed finding 5 suggests the establishment of final approval by the parent corporation, it is rejected. 6. Accepted with the exception of approval by the parent corporation. The record supports a finding of approval by management of that corporation, but not the board of directors. 7.-8. Adopted in substance. Adopted in part, remainder rejected due to witness's inability to support her calculations as to percentages of the population within the service district classified as medically indigent. Addressed in part, remainder unnecessary to conclusion. Addressed in part, remainder rejected on basis of relevancy. Addressed. Rejected on basis of relevancy. Addressed in part, remainder rejected as argumentative and speculative. Respondent's Proposed Findings. 1.-2. Rejected. Treated in preliminary discussion. 3.-21. Adopted in substance. 22.-23. Adopted by reference. 24.-25. Addressed in substance. 26.-30. Adopted by reference. 31.-33. Adopted by reference. Intervenor's Proposed Findings. 1.-3. Adopted in substance. 4. Rejected as unnecessary. 5.-9. Adopted in substance. 10. Adopted by reference. 11.-12. Adopted in substance. COPIES FURNISHED: Joseph R. Buchanan, Esq. Suite 900, Sun Bank Building 777 Brickell Avenue Miami, FL 33131 Edgar Lee Elzie, Jr., Esq. 215 South Monroe Street, Suite 804 Tallahassee, FL 32301 E. G. Boone, Esq. 1001 Avenida del Circo Venice, FL 34284 Gregory L. Coler Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Sam Power Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 John Miller, Esq. General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with two violations of Section 458.331(1)(t), Florida Statutes, and one violation of Section 458.331(1)(m), Florida Statutes.
Findings Of Fact Background facts At all times material to this case, the Respondent, Rene A. Munecas, M.D., has been licensed to practice medicine in the State of Florida. Dr. Munecas is board-certified in Obstetrics. As of the date of the events from which the charges in this case arise, Dr. Munecas had practiced obstetrics for approximately 45 years. Dr. Munecas has practiced obstetrics in the State of Florida since 1970. Dr. Munecas was born in Cuba, and he attended medical school in that country. He graduated from the Havana University, School of Medicine, in 1950. He then did a two-year internship in obstetrics at the University Hospital, Havana, Cuba, followed by a two-year residency in obstetrics at the same hospital. Dr. Munecas practiced obstetrics in Cuba until 1961, at which time he moved to the United States. In this country he did a one-year rotating internship at the Highland Park General Hospital, Highland Park, Michigan, followed by a two-residency in obstetrics/gynecology (OB/GYN) at Jackson Memorial Hospital in Miami, Florida. He completed his OB/GYN residency training at Orange Memorial Hospital in Orlando, Florida. Upon completion of his residency training in this country, he practiced in Michigan until 1970, when he moved to Florida. During the many years Dr. Munecas has practiced in Florida, there has been only one prior instance of disciplinary action concerning his practice of medicine. 1/ The prior disciplinary proceeding did not arise from any misconduct by Dr. Munecas, but from concerns as to whether he was "unable to practice medicine with reasonable skill and safety to patients by reason of illness . . . or as a result of any mental or physical condition." 2/ By the time of the final hearing in the prior disciplinary proceeding, all of the medical experts were of the view that Dr. Munecas was able to practice with reasonable skill and safety so long as he continued to be monitored by his treating psychiatrist. The final order in that case (dated August 27, 1984) concluded as follows: ORDERED AND ADJUDGED that Respondent be placed on probation for a period of two (2) years during which time Respondent shall appear semi-annually before the Board and shall continue to be monitored by his treating psychiatrist, Dr. DeJesus who shall submit quarterly reports concerning Respondent to the Board during the two year probation period. No appearances by the treating psychiatrist, Dr. DeJesus, before the Board are required. Facts regarding patient A. B. There is very little evidence in the record of this proceeding concerning the quality or sufficiency of the written medical records kept by Dr. Munecas regarding his treatment of Patient A. B. 3/ There is no clear and convincing evidence that Dr. Munecas failed to keep written medical records justifying the course of treatment of patient A. B. Patient A. B., born July 4, 1965, was seen by Dr. Munecas on August 11, 1994, in the outpatient obstetrical clinic of Baptist Hospital of Miami. She was pregnant with twins. The hospital record indicates periodic visits to the clinic from August 11 through November 17, 1994. Her weight at the initial visit of August 11 was 210 pounds. She was 5 feet, 2 inches, tall. An outpatient ultrasound performed on November 3, 1994, indicated that both twins were in breech position. The results of that ultrasound were reported on November 4, 1994, and were known to Dr. Munecas prior to November 18, 1994, when another outpatient ultrasound was performed on patient A. B. At approximately 6:30 a.m. on November 19, 1994, patient A. B.'s membranes ruptured, and she was taken to the hospital. Dr. Munecas ordered an x-ray of the patient's abdomen for the purpose of ascertaining fetal position. An x-ray of A. B.'s abdomen was taken at about 8:15 a.m. For reasons not clear in the evidence in this case, a second x-ray of A. B.'s abdomen was taken about 10 minutes later. The two x-ray films did not provide any useful information about the position of either of the twins. A few minutes later, Dr. Munecas performed a pelvic examination of patient A. B., for the purpose of trying to determine the positions of the twins. On the basis of that examination Dr. Munecas was of the opinion that twin "A" was in a vertex position, and twin "B" was in a breech position. Later in the day, this opinion was shown to be incorrect. 4/ Dr. Munecas decided it was appropriate to deliver the twins vaginally, and began to take steps to implement that plan of treatment. Among other things, Dr. Munecas attempted to induce labor by administration of Pitocin, which induces labor by increasing uterine contractions. At approximately 5:00 p.m. on November 19, 1994, Dr. Munecas ordered a portable ultrasound examination of patient A. B.'s abdomen. 5/ The ultrasound examination was promptly performed, and by approximately 6:00 p.m. Dr. Munecas received the examination report. The report revealed that both twins were in a breech position. At some point after receiving the report of the ultrasound examination, Dr. Munecas changed his plan of treatment and decided that patient A. B. should be delivered by cesarean section. For reasons not clear from the record in this case, the cesarean section was not done until approximately 10:00 p.m. Twin "A" was delivered at 10:16 p.m., and twin "B" was delivered at 10:19 p.m. Both twins were healthy. Facts regarding current practice of obstetrics Ultrasound imaging is the procedure of choice for obtaining images to show fetal status. Ultrasound is superior to x-ray for such purposes for a number of reasons. Ultrasound produces fetal images that show more details than can be obtained by x-ray. The use of ultrasound also avoids certain potential fetal health risks that are associated with x-rays. Accordingly, except in the most unusual of circumstances, x-rays should not be used to obtain images of fetal status. Under the circumstances presented by patient A. B. on November 19, 1994, a reasonably prudent similar physician would have ordered an ultrasound. If for some reason an ultrasound was not available on the morning of November 19, 1994, a reasonably prudent similar physician would have relied on the results of the ultrasound that was performed on November 3, 1994. Pitocin is a drug that is commonly used by obstetricians to induce and enforce labor. The effect of Pitocin is to increase uterine contractions. Pitocin should only be used when it is desirable to induce labor. The obvious corollary is that Pitocin should never be administered to a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient A. B. because of risks to fetal safety inherent in a situation when twins are both in a breech position. Those risks can be avoided by cesarean section delivery. In circumstances like those presented by patient A. B., with both twins in a breech position, a reasonably prudent similar physician would find it unacceptable to attempt a vaginal delivery. The only acceptable course of treatment under such circumstances would be a cesarean section. 6/ Therefore, it was a departure from standards of care, skill, and treatment acceptable to a reasonably prudent similar physician for Dr. Munecas to attempt to induce labor by patient A. B. Facts regarding patient M. E. Patient M. E., born November 28, 1963, was seen by Dr. Munecas on May 2, 1995, in the outpatient obstetrical clinic of Baptist Hospital of Miami. The hospital record indicates periodic visits to the clinic from May 2 through June 21, 1995. The record also indicates that lab tests had been performed prior to May 2. Dr. Munecas' note for the visit of June 2 indicates his belief that the fetus may have had intrauterine growth retardation. The visits of June 14 and June 21 indicate increases in patient M. E.'s systolic and diastolic blood pressure, and increased protein in her urinalysis. Pre-eclampsia is a term used to describe a form of pregnancy-induced hypertension. Symptoms of pre-eclampsia include elevated blood pressure, presence of protein in the urine and/or the presence of swelling or edema of the hands and feet. A patient exhibiting symptoms of severe pre-eclampsia is at risk for three circumstances of extreme urgency. One is the possibility of a brain hemorrhage, which can be fatal. Second is the possibility of heart failure and pulmonary edema. Third is the possibility of liver hemorrhage, which can cause the liver to swell and burst. This third possibility manifests itself by right upper quadrant abdominal pain. In the early morning hours of June 22, 1995, patient M. E. awoke with severe right upper quadrant abdominal pain. When the pain continued, she called Dr. Munecas at home and described her pain to him. Dr. Munecas instructed her to go to the hospital. At approximately 4:50 a.m. on June 22, 1995, patient M. E. arrived at the hospital. Her blood pressure was taken in the supine position and read 196/111. Patient M. E. complained of continuous severe right upper quadrant abdominal pain. Dr. Munecas was called at home and advised of the patient's status. At that time, Dr. Munecas gave no orders, but indicated his desire for a perinatal consultation. At about 5:00 a.m., the hospital nursing staff called Dr. Lai. Dr. Lai gave no orders, but said that Dr. Munecas should call him at home. Hospital nursing staff called Dr. Munecas a second time at approximately 5:15 a.m. They requested his presence at the hospital to evaluate the patient. At about 6:00 a.m. on June 22, 1995, the hospital nursing staff again called Dr. Munecas and again requested his presence at the hospital. At this time the nursing staff also requested that Dr. Munecas prescribe medication to lower the patient's blood pressure. Dr. Munecas did not prescribe any medications for the patient. Instead, he ordered that an abdominal ultrasound be performed on the patient immediately to see if the patient had gallbladder problems. The ultrasound was promptly performed. It did not reveal any gallbladder problems. At approximately 6:05 a.m., a nurse manager called Dr. Munecas at home, and again requested his presence at the hospital. Dr. Munecas thereupon embarked for the hospital. He arrived at approximately 7:00 a.m. He promptly examined the patient and found her cervix to be dilated up to 2 centimeters. Dr. Munecas' impressions following the examination included "severe pre-eclampsia." Following the examination of patient M. E., Dr. Munecas performed an amniotomy on the patient. Amniotomy is a technique for the induction of labor. It is accomplished by manual rupture of the patient's membranes. An amniotomy should only be performed when it is desirable to induce labor. The obvious corollary is that an amniotomy should never be performed on a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient M. E. for two main reasons. First, following examination of patient M. E., it should have been obvious to any obstetrician that the patient was suffering from severe pre-eclampsia and that prompt action was necessary to minimize the risk of severe harm to the patient's health. Under the circumstances presented by patient M. E., on June 22, 1995, urgent delivery of the baby was the only acceptable course of patient treatment. Under the circumstances presented that day by patient M. E., there was no prospect for her to have an urgent vaginal delivery. A cesarean section was the only prospect for an urgent delivery of patient M. E. The second reason for which vaginal delivery was contraindicated for patient M. E., was the fact that the fetus appeared to have intrauterine growth retardation. Such a fetus is less able than a normal fetus to withstand the rigors of labor. Therefore, such a fetus is at greater risk for possible brain damage or death during vaginal delivery. Such risks are avoided by a cesarean section delivery. By inducing labor in patient M. E., Dr. Munecas exposed both patient M. E. and her fetus to unreasonable dangers which could be avoided by cesarean section delivery. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, would have gone to the hospital as quickly as possible following the first call from the hospital nursing staff describing the patient's status. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, in view of the obvious need for urgent relief of the severe pre- eclampsia, would have promptly made arrangements for a cesarean section delivery at the earliest possible time. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. Dr. Munecas appears to have voluntarily limited the scope of his medical practice since the incidents which gave rise to this proceeding. He limits his medical practice to gynecology and obstetrics in the office. He no longer performs major surgery or vaginal deliveries.
Recommendation On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect: Dismissing Count Two of the Administrative Complaint; Concluding that the Respondent is guilty of having violated Section 458.331(1)(t), Florida Statutes, as charged in Count One of the Administrative Complaint and as charged in two of the three paragraphs of Count Three of the Administrative Complaint; and Imposing a penalty consisting of a permanent restriction on the scope of the Respondent's medical practice to the following extent: the Respondent is restricted from all hospital-based obstetrical practice and is barred from performing or assisting in the labor or delivery of any hospital obstetrical patient. DONE AND ENTERED this 10th day of February, 2000, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH 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 10th day of February, 2000.
The Issue The issue for consideration in this hearing is whether the Intervenor, St. Joseph Hospital of Port Charlotte, should be issued Certificate of Need #6202 for the establishment of a cardiac catheterization laboratory at its facility in Port Charlotte, Florida.
Findings Of Fact At all times pertinent to the issues herein, the Department was the state agency responsible for the regulation and certification of health care facilities in this state and charged with the responsibility of issuing Certificates of Need, (CON), under the criteria set forth in Section 381.705 Florida Statutes and the Department's Rules. St. Joseph Hospital is a 212 bed general acute care hospital located in Port Charlotte, Florida, within the jurisdiction of the Department's District VIII. It is a not for profit, tax exempt corporation owned by Bon Secours Health Systems, a multi-hospital system. It offers varied medical and surgical services, including obstetrics and pediatrics, and operates a 24 hour emergency room. The facility is accredited by the Joint Commission on Accreditation and Health care Organization, and its laboratory is accredited by the American College of Pathology. Because St. Joseph opened a nursing home in Port Charlotte in 1975, Chapel Manor Nursing Home, Fawcett's predecessor, and at that time, the only nursing home in Port Charlotte, applied for and was issued a CON to convert from a nursing home to an acute care hospital and began operation as Fawcett Memorial Hospital that year. Fawcett is now a 254 bed general medical surgical acute care hospital providing a broad range of services with the exception of obstetrics and pediatrics, and is located directly across the street from St. Joseph. It offers diagnostic cardiac catheterization service only, implementing that service in August, 1989. Both Fawcett and St. Joseph have the same service area and utilize the same physicians on their medical staffs, which are practically identical. St. Joseph offers a full array of cardiology services with the exception of cardiac catheterization. As a result, any St. Joseph patient requiring cardiac catheterization must be discharged from St. Joseph and transferred to another hospital in the area which provides that service. Between January 1989 and February, 1990, approximately 97 St. Joseph patients required transfer because of the fact that St. Joseph had no pertinent program. Because of this fact, and recognizing that the Department had determined there was a numeric need for an additional cardiac catheterization lab within the district, specifically based on the under-served indigent and Medicaid patients, in February, 1990, St. Joseph submitted a letter of intent to file a CON application for the establishment of an adult inpatient cardiac catheterization laboratory at its facility in District VIII. This letter of intent was based on proper Board Resolution, and was filed not only with the District but also with the local Health Council, and the required notice was published in a local paper. Thereafter, in March, 1990, St. Joseph filed its CON application for the facility, along with the appropriate fee, with the Department, at the same time filing a copy with the local Health Council. The Department responded with an omissions letter, the requirements of which were met by St. Joseph in a timely manner, and the Department thereafter deemed the application complete. Notwithstanding Fawcett's allegations in the post hearing submission that St. Joseph's application was not complete, there was no evidence presented at hearing to so establish, and the Department deemed it both timely and ultimately complete. On on about July 17, 1990, the Department issued its State Agency Action Report and notified St. Joseph of its decision to approve the application. Approximately one month later, in a timely fashion, Fawcett filed its Petition challenging the Department's approval of St. Joseph's application. St. Joseph projects implementation of service by the unit in December, 1992. The unit will encompass approximately 3,800 square feet and will be part of and companion to a larger construction project designed to expand St. Joseph's surgical capacity. It will be located in a proposed two-story addition to the south side of the existing hospital. Total cost of the project, including construction of the building and equipment, is estimated to be approximately $2.6 million, one hundred percent of which will be financed by debt. It is estimated that interest costs over the term of the financing will be an additional $2.25 million. St. Joseph anticipates the charge for a cardiac catheterization will be $6,657.48 in 1993, and $7,123.50 in 1994. This is the same as the average charge for the procedure by existing providers in the district, adjusted for inflation in later years. The facility will be open routinely from 7:00 AM to 2:30 PM, Monday through Friday. An on-call team will, however, be available 24 hours a day although cardiac catheterization, usually an elective procedure, should not require much in the way of emergency services. Dr. Victor Howard, a Board certified internist and cardiologist, who is already on staff at St. Joseph, is projected to be the medical program director for the new facility without additional compensation. Cardiac catheterization is a relatively new diagnostic and therapeutic invasive procedure which involves the insertion of an extremely fine hollow tube through a blood vessel in the groin, up into the patient's heart. Because the patient faces danger from collateral problems such as bleeding, stroke, congestive heart failure and medication reactions, at least three staff members are required to assist the physician performing the catheterization. As with most procedures, the more it is done, the more proficient the individuals doing it become. By the same token, the medical staff assistants to the physician in charge must have specialized skills and training, and the Department rules require that in order to properly provide for therapeutic catheterization patients, an open heart surgery facility must be available within thirty minutes of the facility where the catheterization is being carried out. St. Joseph intends to rely on Medical Center Hospital in Punta Gorda, approximately ten miles away, as the required backup open heart facility. Medical Center is within the maximum thirty minute drive time criteria. It provides not only an open heart surgery program but also both diagnostic and therapeutic cardiac catheterizations. Diagnostic catheterizations, as opposed to therapeutic catheterizations, can be done on an outpatient basis. Experience has indicated that staff assistant technicians, nurses and others, are frequently not reasonably available. As a result, there is continuing competition between hospitals providing the services requiring these individuals, and this competition is often severe. Nonetheless, Fawcett has, up to the present, been able to recruit and retain adequate numbers of experienced personnel without the necessity for paying a bonus over and above normal salary. By the same token, St. Joseph believes it, too, will be able to attract and retain sufficient numbers of qualified personnel to successfully operate its laboratory as approved. At the present time, St. Joseph has ten registered nurses on staff who have cardiac catheterization laboratory experience. The laboratory, if approved, will not open at St. Joseph until the second half of 1992. At that time, manpower requirements for the project call for 3.36 full time employees, (FTE's), and that number appears capable of being satisfied by the current staff, though a cardiovascular technician, (CVT), has not yet been hired for the lab. In addition, St. Joseph appears to have on hand adequate management and supervisory personnel. It projects salary and benefits expense of almost $140,000.00 in 1993 and almost $150,000.00 in 1994. Maintenance expense is expected to approximately $65,000.00 the second year of operation. The proposed project has been enthusiastically received by the medical community in the service area. Because, in that area, the treating physician determines where the patient will be treated, support for the project by the area cardiologists is important as a positive factor for consideration. Because it has both the financial and personnel resources to provide the service, access to the service will be improved for the medically indigent and the facility's current cardiology program will be enhanced. The Florida legislature has, by its passage of Section 381.705, Florida Statutes, laid the basic analytical framework to be used in determining whether the facility here in question is needed. Consistent with the terms of the enabling statute, the Department has promulgated Rule 10-5.011, F.A.C., to implement the provisions of the statute. The rule formula provides a showing of "need" if at least 300 procedures could be performed by the new program, based on the total number of catheterizations, diagnostic and therapeutic, projected for the District. Projections for Charlotte County alone indicate 180 additional catheterizations between 1989 and 1994. Consistent therewith, the Department has determined that within DHRS District VIII, the pertinent service district, there is a numeric need for one additional cardiac catheterization laboratory. Need, however, goes beyond the question of numeric need. It is also a factual issue that requires an analysis of health planning principles and standards used within the ultimate goal of providing the best quality medical care for the citizens of this state in a sound, economically justified manner. In that regard, it is appropriate to evaluate need with an eye that looks toward avoiding unnecessary and costly duplication of services that are unnecessary. Fawcett contends there is no need for an additional lab in District VIII, based on the underutilization of existing programs. The Department's rule, the use of which resulted in a determination of need for one additional unit, does not regulate capacity. District VIII consists of Sarasota, DeSoto, Glades, Hendry, Charlotte, Lee, and Collier Counties. Sarasota and Lee Counties each have three cardiac catheterization programs while Collier has one in its only hospital. Charlotte County has two, Fawcett and Medical Center. It has already been noted that Fawcett and St. Joseph are located across the street from one another. Medical Center, which is used for therapeutic catheterizations, is located not far from the other two, and all three are Medicaid providers. All three also serve generally the same service area and use, essentially, the same medical staff. Moreover, the three facilities' cardiology staffs are essentially identical. When evaluating the service availability, however, it must be noted that Charlotte County experienced the highest relative increase in population among all the District VIII counties during the decade of the 1980's, and projections are that it will continue to lead up through 1995. At the present time, Charlotte County has the highest percentage of residents over age 65, (34%), of any of the District VIII counties. Looking at the proposed service in light of the pertinent State Health Plan, that for 1989, four preferences should be considered when evaluating the need for the proposed service. One deals with giving preference to those who propose to establish both cardiac catheterization and open heart surgical services. Since there is no established need for an open heart surgery service in the District, St. Joseph could not and does not plan to provide for one. Consequently, this preference is not pertinent here. The second preference is for those applicants who propose to establish a cardiac catheterization program in a county without any existing program. Again, this is not pertinent to the current situation. The third preference is toward applicants with a history of providing a disproportionate share of Medicaid and charity care. Here, St. Joseph is not a disproportionate Medicaid share provider, a point made by Fawcett. By the same token, however, neither is Fawcett. Fawcett did not, over the years, keep an accurate record of the number of patients to whom it provided free medical services, or of the value of those services. It claims it did not realize the importance of those numbers, concerning itself more with the provision of the service rather than with the recording of it. It was not, for most of its existence, however, a Medicaid provider, applying for and gaining that certification as of September l, 1989. Yet, during those non-certified, unrecorded years, it claims to have provided care to patients regardless of their ability to pay. While this claim is accepted as true, it is impossible to quantify it. The fourth preference is given to applicants who agree to provide services to all patients regardless of ability to pay. St. Joseph has agreed to do so and has a history of providing care to the medically indigent. So does Fawcett, but Fawcett is not an applicant, so the preference issue does not, necessarily, apply. It is clear, however, that neither the existing providers nor the applicant are precluded or disqualified as a result of the application of these preferences. Turning to the local, (District) Health Plan, which is also to be considered in the evaluation of the projects, the 1989 update of the District VIII Plan, that pertinent here, also provides for applicants to be evaluated in light of several preferences. One calls for an applicant to provide certain services, all of which are provided currently by St. Joseph. The second preference calls for the laboratory to be open no less than 40 hours a week and to provide a maximum waiting time of one month for simple, elective cases. The evidence presented indicates that the currently operating facilities meet this criteria, but also that St. Joseph will likely do the same if approved. Another preference relates to the proposed program's impact on existing providers in the area. It is here that the parties disagree radically on whether or not such an impact exists. St. Joseph has taken the position that its program will have only minimal impact on the ability of Fawcett and other existing providers to continue to provide quality economic service. On the other hand, Fawcett projects a major negative impact on its services, and claims the Department apparently failed to consider, at the time it did its initial evaluation, whether or not St. Joseph's program would adversely impact on it's existing service. Fawcett contends that its presently improving financial posture will be definitely impacted adversely by St. Joseph's implementation of the new service, if approved, in that its anticipated positive financial improvement will be reduced, if not destroyed, by the opening of St. Joseph's proposed program. Evidence produced by Fawcett tends to indicate that by 1994, if current projections hold true, Charlotte County will experience an increase of only 180 diagnostic catheterizations per year. St. Joseph's projections indicate that in that timeframe it expects to perform 509 diagnostic catheterizations per year. Simple arithmetic, then, would reveal that if those figures are correct, 329 of the 509 projected diagnostic procedures would have to come from the number of procedures performed by both Fawcett and Medical Center. Since approximately 75% of the current cardiac catheterizations performed in Charlotte County are performed at Fawcett, by far the greatest impact would be on that institution. The figures projected indicate a loss by Fawcett, then, of 232 procedures in 1993 and 318 in 1994. Medical Center's projected losses would be somewhat less, but nonetheless, such a reduction, if realized, would result in a loss of revenue to each of the existing providers from current income levels. Fawcett experienced severe financial problems during the past several years prior to the incumbency of the present CEO. In 1987 and 1988, it had financial losses which were improved in 1989 to a result showing a marginal excess of revenue over expenses. For 1990, Fawcett expects to show a profit for the first time in several years. Its prior negative operating result, however, has had a negative impact on its debt to equity ratio which, itself, is significant in that it is used by lenders as an index or flag regarding the financial health of an institution which seeks to borrow money. Because of its poor financial condition in the past, Fawcett was unable recently to borrow money needed for 1990 capital projects, and it is the increasing profit margin, which Fawcett hopes will make it more competitive in the borrowing market, that is most threatened by the proposed initiation of St. Joseph's project. The improved financial picture which Fawcett experienced in the most recent financial years has been directly attributed to the revenue earned by its cardiac catheterization program. In 1989, Fawcett determined that each cardiac catheterization patient contributed $1,927.00 to the hospital's financial health, and Fawcett contends that each patient taken from it by the opening of St. Joseph's proposed program will result in a financial loss to it. Utilizing the 1989 contribution margin projected to 1993 and 1994 reflects that if St. Joseph's program is approved, and if the anticipated numerical patient load is lost, the net financial loss to Fawcett would be in excess of $446,000.00 in 1993 and in excess of $612,000.00 in 1994. If these figures are inflated to 1993 and 1994 dollars, the loss could well be greater. Fawcett contends that it is currently experiencing a healthy improvement in its financial position which it anticipates would be substantially and adversely affected by the loss of cardiac catheterization patients to St. Joseph if that facility's project were approved as proposed. No doubt there would be a negative impact, but the degree thereof is speculative. Both the statute and the rule mentioned previously set forth criteria for the evaluation of these projects. One is the existence of an alternative to the service provided. Whereas St. Joseph contends there is no alternative diagnostic procedure preferable to cardiac catheterization, Fawcett contends there are several alternatives to St. Joseph's proposed project. Nonetheless, prior to its application, St. Joseph considered some alternatives. One was the setting up of a mobile laboratory on an interim basis. Since this could be used only by outpatients, it was determined not to meet the need of those patients requiring an inpatient procedure or of the physicians who would perform in it, and the anticipated $1.3 million cost was considered excessive for a short term fix. It is so found. Another was the possibility of establishing the lab somewhere within the hospital's existing space, but a survey of the facility quickly revealed there is no available existing space. However, since a part of the service proposed by St. Joseph would include outpatient catheterization, this part of the need could be met by the laboratory established in Charlotte County by several cardiologists who practice on the staff of St. Joseph, and who recently established a facility in the county. By the same token, if a need for outpatient procedures is demonstrated, the existing inpatient program could, Fawcett contends, provide it. Finally, is the existence of under-utilized programs at Fawcett and the Medical Center which have existing excess capability which could be considered an adequate and available alternate to the St. Joseph program. Turning to the question of financial feasibility, another evaluation criteria, there is no doubt that St. Joseph has the ability to borrow the capital to make the project financially feasible in the immediate future. St. Joseph's financial condition is sound. As might be expected, there is substantial difference in opinion as to the reasonableness of the pro forma projections submitted by St. Joseph's as evaluated by the Department. In fact, the parties agree to very little. St. Joseph contends that the patient mix estimated in the application is reasonable and based on its experience and that of Lee Memorial Hospital, and that the staffing level is appropriate and reasonable, and there is little to contest. The major difference in positions is in the area of supply costs and the percentage of patients accounted for by Medicare. St. Joseph estimated a supply cost of $248.00 per admission in 1989 dollars, inflated by 7% per year up to 1993 and 1994, but Fawcett contends the actual supply cost in 1989 dollars is $492.00 per admission. Assuming, arguendo, that Fawcett is correct, the projected supply costs would then be increased by in excess of $85,000.00 in 1993 and almost $126,000.00 in 1994, and this would result in a reduction of projected income for the service in both years. Fawcett's evidence and argument here are not persuasive, however. Fawcett also contends that St. Joseph's assumption that 58.9% of the cardiac catheterization patients would be Medicare, a figure which assumes that the Medicare patient utilization for catheterization would be the same as the facility as a whole, is not reasonable. Fawcett relies on the fact that St. Joseph is the sole obstetrics provider in Charlotte County and the majority of these obstetric patients are not Medicare patients. Considering that along with the fact that cardiac catheterization is a service which has a higher level of Medicaid utilization than St. Joseph presently provides, a more likely and reasonable predictor of the Medicare utilization of St. Joseph's program would be the Medicare utilization for the two existing catheterization programs. Fawcett's utilization in that regard is 64.6% and Medical Center's is 70.5%. Extrapolating from those figures, Fawcett contends a reasonable financial projection for St. Joseph's program would be 65% Medicare utilization. Since that type of service is reimbursed on the basis of DRG, the amount of income to the hospital is less, and the resultant contractual allowances, deductions from revenue, would be in excess of $61,000.00 in 1993 and more than $87,000.00 in 1994. Therefore, combining both the increase in projected supply costs and the decrease in projected income from Medicare, Fawcett contends that the projected number of catheterizations in 1994 and 1994, as modified using Fawcett's figures would result in a net reduction of approximately $210,000.00 in the former year and in excess of $126,000.00 in the latter. If those figures prove correct, St. Joseph's proposed program , it is suggested, would apparently not be feasible in the long term. On the other hand, St. Joseph contends its utilization figures for 1993 and 1994 are reasonable in that it projects a volume slightly greater than one-half of the number of procedures accomplished by Fawcett in its first year of operation. St. Joseph's expert evaluated the use projections for the first two complete years of operation and the costs assumptions and found both to be reasonable. Nonetheless, he also accomplished calculations of profitability utilizing Fawcett's suggested increased costs figures, and utilizing three different approaches, ultimately concluded that even looking at the worst case scenario, St. Joseph's proposal would be financially feasible both in the short and the long term. Independent analysis of the evidence leads to the conclusion that the projected staffing level and the salaries and benefits for that staff are reasonable. The anticipated reimbursements on the basis of the DRG's are reasonable. The projected utilization in the first and second years of operation are reasonable, and taken together, the evidence supports the conclusions drawn by St. Joseph's expert. It is so found. Another area for consideration is the impact St. Joseph's program would have on Fawcett's existing program. Fawcett's program has now been in operation for several years and even with approval of St. Joseph's, will continue to operate without competition until the second half of 1992, after which St. Joseph's program would be in a start-up configuration for at least a year. As such, it will be well into 1993 and possibly into 1994 before St. Joseph's program can be considered to have its full impact vis-a-vis the Fawcett program. Fawcett's expert, who concluded that St. Joseph's program would have a serious adverse effect on Fawcett's ability to contribute to its improving financial picture did not consider the fact that Fawcett does not currently perform outpatient cardiac catheterization procedures, and any of that nature done by St. Joseph should have no impact on Fawcett. The expert also did not consider in his analysis of impact any population growth beyond 1990 or growth in the demand for diagnostic catheterization procedures. Fawcett listed approximately $13.7 million in proposed capital expenses over the next five years which, it claims, will be adversely impacted by the effect of St. Joseph's proposed program on its cash picture. Many of the line items within this figure are much the same as normal routine replacement items, and only $3.5 million represent the cost of items specifically identified as needed to meet existing life safety code violations or for accreditation purposes. No doubt there will be some impact on Fawcett's operation by the opening of St. Joseph's program, yet Fawcett has not demonstrated clearly that the impact will result in a return to the pre-1990 negative cash position which was shown to now be reversing. Even accepting Fawcett's expert's assumptions, the likelihood is great that Fawcett's equity balance would increase by over $900,000.00 from 1992 to 1993 and by over $800,000.00 from 1993 to 1994. So long as Fawcett's cardiac catheterization program performs more than 182 procedures per year, its current break-even point, no negative impact to the hospital's overall financial picture is likely to occur. Assuming that Fawcett's procedures were no more than one-half its 1990 admissions, at current rates, its program would render a positive contribution of more than $650,000.00 to the hospital's financial picture. This figure could not be considered as other than a viable financial contribution. What is more, the implementation of the program at St. Joseph should not exert any upward pressure on the cost of other services rendered by St. Joseph, and should, by competition, moderate future price increases for this procedure at the two competing facilities. As regards Medicaid and indigent care, St. Joseph has been a Medicaid provider since 1965 and has a history of providing service to indigent patients and under-served groups. In fact, the value of care rendered without cost to patients by St. Joseph has climbed from $418,000.00 in 1988 to a projected $1.5 million in 1991. By the same token, its commitment to Medicaid has increased to almost 4% in 1990, in addition to approximately 2% of uncompensated care that same year. The obstetric unit has been shown to operate $500,000.00 a year in the red because of the volume of indigent care provided. Nonetheless, St. Joseph agrees to accept a condition to its CON requiring it to provide 1.5% Medicaid and 2% charity care. In comparison, Fawcett was not certified for Medicaid until late 1989 and its experience since that time has not been substantiated. This tends to underscore the Department's contention that Medicaid and charity patients are under-served within the Charlotte County area. Other criteria outlined within the statute have not been shown by evidence presented, as being significantly affected one way or the other by the implementation of St. Joseph's proposed program. Several of the statutory criteria are, in fact, not applicable to the proposed project in this case. Much the same can be said for the criteria outlined in Rule 10-5.011(1), F.A.C., which tend to overlap to a substantial degree with the statutory review criteria. Fawcett claims that the application filed with the Department by St. Joseph is "very incomplete" in that it omits significant information regarding project costs, capital expenses, source of funds, and a litany of other required information. It claims, therefore, that the Department could not have conducted any meaningful review of the application based upon the information provided. The Department's representative, Ms. Dudek, admits that most, if not all applications omit some information. That is the purpose of the omissions letter which is sent to an applicant after initial review. Not all information called for by the statute is deemed essential however. If an omission is considered immaterial, it will not cause the application to be denied, all other essential material being provided. There are primarily two criteria called for by the statute which are essential to Departmental approval. The first deals with the applicant's access to resources to develop and operate the project, and the second is that the applicant offer quality care. In this case, both were deemed to have been met as was stipulated to by Fawcett. In the instant case, the Department's representative concluded that St. Joseph's application was one of the most thorough and comprehensive, in terms of presentation and backup, to have been filed within the past few years.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered by the Department approving St. Joseph's application for an inpatient cardiac catheterization laboratory, (CON #6202) for District VIII. RECOMMENDED in Tallahassee, Florida this 4th day of April, 1991. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of April, 1991. APPENDIX TO RECOMMENDED ORDER CASE NO. 90-5815 The following constitutes my specific rulings pursuant to Sec 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. & 4. Accepted. 5. & 6. Accepted. 7. - 10. Accepted and incorporated herein. 11. & 12. Accepted. 13. & 14. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted. & 19. Accepted and incorporated herein. 20. & 21. Accepted and incorporated herein. 22. - 26. Accepted and incorporated herein. 27. - 34. Accepted. Rejected. - 39. Accepted. 40. - 42. Accepted and incorporated herein, except for the first sentence of Finding 41. Rejected. Accepted and incorporated herein. & 46. Accepted. Rejected. Rejected. - 51. Accepted and incorporated herein. Accepted. Accepted. Not proven. - 59. Accepted and incorporated herein. Accepted that the loss of revenue will have an impact but the loss has not been shown to be substantial. - 65. Accepted and incorporated herein. 66. & 67. Accepted. 68. - 76. Accepted incorporated herein in substance. Rejected that the loss of revenue would "cripple" the health trend. It would adversely affect it but not cripple it. - 83. Accepted and incorporated herein. 84. - 90. Accepted. Accepted. Accepted and incorporated herein. - 97. Accepted that there are alternatives, but rejected that they are acceptable or adequate. Rejected as too broad a statement. Rejected as to the conclusion of waste. & 101. Accepted. Ultimate conclusion rejected. Need for level of education and experience accepted. Accepted. Underlying fact accepted. Balance is editorialization. - 108. Accepted. Accepted. Not an appropriate Finding of Fact. Accepted. & 113. Accepted and incorporated herein. 114. - 116. Rejected. Accepted. & 119. Rejected. 120. & 121. Accepted and incorporated herein. Rejected. - 126. Accepted. 127. & 128. Accepted. 129. & 130. Rejected. 131. & 132. Accepted. 133. & 134. Rejected. Not a Finding of Fact but a comment of the state of the evidence. Accepted. & 138. Accepted. Accepted. Rejected. & 142. Accepted. Rejected. St. Joseph was a Hill-Burton hospital. Accepted. Accepted that St. Joseph receives funds from taxes and other sources, but the conclusions that aid to Medicaid an the indigent "is to be expected" is an unjustified conclusion. 146. Accepted. 147. Accepted but probative value questionable. 148. Accepted that it is less costly. 149. First two sentences accepted. Remainder not proven. 150. Rejected. 151. & 152. Accepted in the short term. 153. Accepted. 154. Not proven. 155. Rejected. 156. - 158. Rejected. 159. & 160. Accepted. FOR THE RESPONDENT AND INTERVENOR: 1. - 3. Accepted and incorporated herein. Accepted. - 8. Accepted and incorporated herein. Accepted. - 13. Accepted. 14. - 16. Accepted and incorporated herein. Accepted. & 19. Accepted and incorporated herein. 20. & 21. Accepted. 22. - 24. Accepted and incorporated herein. Accepted and incorporated herein. - 28. Accepted and incorporated herein. Accepted and Incorporated herein. - 35. Accepted and incorporated herein. 36. - 41. Accepted and incorporated herein. Accepted. - 45. Accepted and incorporated herein. 46. & 47. Accepted. 48. & 49. Accepted and incorporated herein. 50. & 51. Accepted. 52. - 54. Accepted and incorporated herein. 55. - 58. Accepted. 59. & 60. Accepted and incorporated herein. Accepted. Accepted. & 64. Not Findings of Fact but a comment on the state of the evidence. 65. & 66. Accepted and incorporated herein. Not a Finding of Fact but a statement of party position. Not a Finding of Fact but a comment on the evidence. & 70. Accepted and incorporated herein. 71. & 72. Accepted and incorporated herein. Accepted. Accepted. Not a Finding of Fact but a comment on the evidence. Accepted. - 80. Accepted and incorporated herein. Accepted but irrelevant to the issues here. Accepted but considered more a statement of party position and a comment on the evidence. & 84. Accepted and incorporated herein. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted and noted in the Conclusions of Law portion of the Recommended Order. - 100. More proper as Conclusions of Law than as Findings of Fact, but accepted where pertinent. COPIES FURNISHED: John D. C. Newton, II, Esquire Aurell, Radey, Hinkle & Thomas Suite 1000, Monroe-Park Tower P.O. Drawer 11307 Tallahassee, Florida 32302 Richard Patterson, Esquire DHRS 2727 Mahan Drive Tallahassee, Florida 32308 R. Terry Rigsby, Esquire Philip Blank, P.A. P.O. Box 11068 Tallahassee, Florida 32302 Linda K. Harris Acting General Counsel Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32399-0700 Sam Power Agency Clerk DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700
The Issue The main issue in these proceedings is whether the Respondent Doctors is entitled to a certificate of need to establish a cardiac catheterization laboratory in Sarasota County. The parties stipulate that the only statutory and rule criteria which remain to be reviewed by the Hearing Officer areas follows: 1. Sections 381.705(1)(a) , (b) , (c) , (d) , , and (h), Florida Statutes. Section 38l.705(1)(h)) will be reviewed insofar as it refers to the availability of health manpower, management personnel, funds for capital and operating expenditures, the alternative uses of the applicant's resources, and the extent to which the proposed services will be accessible to all residents of the district. Section 38l.705(1)(1) and (n), Florida Statutes. Section 381.705(2)(a) , (b) and () Florida Statutes. Rule 10-5.011(1)(e), Florida Administrative Code. 5. Rule 10-5.011 (8)b and (8)0, (9)b, (9)d, (9) e (1) and (9)e(ll) The other statutory criteria and the remaining subsections of the rule have either been stipulated to by the parties or are inapplicable.
Findings Of Fact Respondent Doctors is a 168 bed, acute care general hospital. The hospital has a 40 bed cardiac care unit in which all beds are monitored. Hospital Corporation of America (HCA) owns Doctors. HCA owns or operates four hundred hospitals, including nineteen in Florida. Three of the in-state hospitals have cardiac catheterization laboratories (CCLs) . Two of the existing labs, located in Bradenton and Tallahassee, are available to assist in training and preparation which may be needed in the creation of a cardiac catheterization lab at Doctors. In September 1987, Doctors applied for Certificate of Need No. 5283 to establish a cardiac catheterization laboratory. The certificate of need has been preliminarily approved by the Respondent HRS. The initial agency action has been challenged by the Petitioner, Memorial. Memorial is the primary existing health care facility which would compete with Doctors by providing cardiac catheterization services in the same city where the new lab is to be located. Consistency with State and Local Health Plans The local health plan does not directly address the need for CCLs in the area. As nothing in the plan is relevant, no inconsistencies are created with the plan in the balancing of criteria with regard to the certificate of need determination. The State Health Plan provides that an average of 600 cardiac catheterization procedures per laboratory are to be maintained in each district through 1990. To determine the use rate under Rule 10-5.011, Florida Administrative Code, HRS must look to the number of procedures provided in the district between June 1984 and July 1986. The data reveals that seven programs completed 5,841 procedures. The required averages were exceeded by over two hundred procedures per lab. The need criteria has been met by Doctors for purposes of the State Health Plan, and the local plan, as it existed at the time of the initial review of the application. Existing Facilities Memorial is an 849 bed, acute care hospital which is a regional referral hospital in the area. The hospital provides Level 3 cardiac services. These services include angioplasty and open heart surgery in addition to cardiac catheterization. Memorial's first catheterization lab opened in 1978. Memorial currently contains two CCLs that assist in fulfilling the health care needs of the district. Before the recent addition of three CCLs within the district, Memorial served as the center for cardiac services. Manatee County and Charlotte County now have their own CCLs, which reduces Memorial's pool of potential patients in need of those services. In spite of reductions in the patient pool in the past, Memorial's use of its two CCLs has continued to grow. The Sarasota County area has a unique characteristic in that many tourists who arrive in the winter months (October-April) make use of the two local hospitals, Doctors and Memorial. The use of Memorial's CCLs increases as the local cardiologists need to complete a number of diagnostic tests in order to evaluate these new patients quickly, in times of critical need. Because of the season, Memorial's CCLs are heavily utilized for emergency procedures in the winter months. Accordingly, patients who have elective procedures scheduled are often reprioritized because of the emergency needs for use of the CCLs for more seriously ill patients. This last-minute rescheduling results in prolonged hospitalizations for the nonemergency patients and increases the cost of their medical care. Although the quality of testing does not appear to suffer from the season, a significant pool of patients is denied the opportunity for convenient medical care. The treating physicians are denied lab use and test results at the anticipated times within these patients' courses of treatment. Because of Memorial's inability to make the labs readily accessible to the pool of patients scheduled for elective procedures in the winter, a need exists for a CCL for this pool of patients. Doctors primarily seeks to provide cardiac catheterization services for diagnostic purposes. However, the lab will be capable of providing immediate endocardiac catheterization pacemaking in cases of cardiac arrest. A rapid mobilization team will be available for emergency procedures when the need arises. Angioplasty and open heart surgery procedures are not planned in conjunction with the CCL services. The lab will be in operation from 7:30 a.m. to 4:00 p.m. Monday through Friday, excluding holidays. Quality of Care Doctors currently provides quality care. There are no complaints outstanding, and the hospital has sufficient capabilities and support services to provide for a CCL. Doctors is JCAH accredited and provides the necessary services required under the catheterization rule. The same cardiologists are on staff of both Memorial and Doctors. Most of these physicians admit patients to both hospitals. Approximately one-third of Doctors' admissions are patients with cardiac problems. Many of these patients require catheterization and are transferred to Memorial. If it is determined that a catheterization is needed before admission, physicians admit those patients to Memorial. Alternative Care The other CCL which currently exists in Sarasota is an outpatient lab. This facility is owned and operated by a group of invasive cardiologists who also perform catheterizations at Memorial. Because the outpatient lab restricts a patient's selection of a physician able to perform a cardiac catheterization to the lab owners, this lab is not a realistic alternative for most patients or the referring physicians. A hospital-based lab gives those involved greater personal choice, and it is better equipped to handle unanticipated emergencies. Reasonable and Economic Accessibility Memorial's CCL services are not always accessible at the times scheduled for elective procedures. Some patients have remained hospitalized for days until they can be rescheduled. The delays increase the costs attached to the procedures due to the length of the hospital stay and the additional services required. Patients admitted to Doctors who require the services of a CCL are moved to Memorial by ambulance and have to be admitted there. These transfers cost patients an additional $180-$340. The ambulance charges are not reimbursed by medicare so the majority of the patients pay these charges themselves. The proposed lab will be capable of providing a range of diagnostic tests without the need to admit patients to another hospital prior to, or during treatment at, Doctors. This will reduce costs two ways: The additional ambulance and hospital costs will be omitted, and the proposed charge for the service is less than the current charge set by Memorial. Availability of Resources Doctors currently has a staff of trained cardiac nurses. There are two nurses on staff who have taught cardiac catheterization techniques at an accredited nursing school prior to moving to Sarasota. Although the husband and wife team was originally recruited to the area by Memorial, the two nurses chose to leave that facility because of the stress from the high level of activity in those labs. Doctors plans to cross train staff and to allow for a trained special procedures staff with alternating roles and duties. The proposed CCL will be staffed with 2.5 FTEs. These consist of the 1 FTE cardiac nurse and 1.5 FTE special procedures technicians. The budgeted FTEs do not include an allocation of time for an administrative director or secretarial/clerical services. The assistant hospital administrator anticipates that provisions will be made for management personnel at a later stage of the lab's development. Although the number of FTEs scheduled is less than those anticipated for a CCL which provides more complex procedures, the number scheduled by Doctors is reasonable for the number of services and kind of services it seeks to provide for the type of cardiac patients in its care. The proposal for the lab, as described in the application and revised in the omissions response, is financially feasible. The proposed expenditure of funds will serve the needs of the hospital's current patient pool as well as the special needs of the community for cardiac catheterization services. While Doctors' proposal does not increase geographic access, it will increase access in the population center, where services are currently inaccessible for one pool of patients at certain times. A need for a project is evidenced by the utilization of like and existing services. The rule which contains the need methodology takes into account the utilization of existing facilities in determination of numeric need. Numeric needs exists in this district, pursuant to Rule 10-5.011. Written Referral Agreement Doctors submitted a written referral agreement with a facility with open heart surgery services within 30 minutes travel time by emergency vehicle under average travel conditions. The agreement meets the general requirements of HRS. The agency does not require a detailed agreement during the preliminary granting of a certificate of need because other local providers do not wish to assist applicants during the CON process. However, such applicants are able to obtain more detailed agreements after the certificate is approved. The agency has determined that the agreement is sufficient. Because a rational basis has been given for the determination, the agency's acceptance of the agreement is given great weight by the Hearing Officer. Competition and Service Doctors' project will affect competition between Doctors and Memorial. Doctors will provide services for patients who would have gone to Memorial for such services in the past because Doctors was unable to provide the service. This is because of the geographic location and the fact that the same cardiologists are on staff at both hospitals. It appears that Doctors will be providing services for patients who are not in critical need of the services. This will allow Memorial to concentrate on the more complex cases has traditionally dealt with in the past. The stress from "unhappy" elective patients will be reduced at Memorial's labs, but so will the economic incentive for the staff which is related to the number of procedures performed. The elective cardiac catheterizations are quicker and easier to perform and increase the earnings of the lab staff. Both hospitals compete directly for staff. There is a "revolving- door" situation in staffing as local heath care personnel negotiates and works in either hospital, most of the time. Because of cash bonuses offered by Doctors for joining its staff Memorial is concerned about the adverse impact upon its CCL staff. Testimony presented at hearing showed by substantial and competent evidence that Memorial is committed to equipping its two labs with the most responsive equipment available for its more complex needs. The preservation of its current lab staff has been planned for by an able administrator. Recruitment is done nationwide and plans are being made with the local community college to provide nurses training involving cardiac catheterizations. The evidence also demonstrated that Memorial plans to meet the competition by improving the health services delivery, quality assurance, and cost-effectiveness. It appears that there is room for all three labs in Sarasota, and that healthy competition will occur in the area. Past and Proposed Indigent care Doctors has given little care to the medically indigent in the past. In fact, the hospital has maintained a written policy suggesting that those who cannot pay for services should be transferred by physicians to another hospital. Rather than admit such patients, the Doctors has chosen to pay into an indigent care fund. The new assistant director maintains that the current hospital policy is to provide health care to Medicaid and indigent patients in the CCL. Doctors projects that 2.5 per cent of its catheterization volume will be Medicaid and .75 per cent will be indigent care. Alternatives to the Project The alternative which has been developed and studied by Doctors is its past use of Memorial's CCLs. This use has been found to be more costly for elective cardiac catheterizations than the current proposal. The status quo has not met the needs of the elective catheterization patients in the geographical area. Similar Inpatient Services Memorial is using its similar facilities in an efficient manner. It is not using the facilities in an appropriate manner as most elective catheterization patients do not want to be in a hospital any longer than necessary. These people are predominantly type A personalities who do not like being rescheduled and charged additional hospital costs. Problems in Outpatient Inpatient Care Elective catheterization patients have a problem obtaining local inpatient care when they want it and when their cardiologists have prepared for it in their treatment plans. This does not appear to be a serious health problem, but the evidence has demonstrated it is a serious problem. Proposed Volume of Catheterizations Based upon numeric need, utilization of Memorial, physician support, and the growth history of other providers within the district, the projected utilization of 246 procedures in 1990, 294 in 1991, and 351 in 1992 is reasonable. There is no evidence which has been extrapolated from reliable data which shows that the proposed lab, coupled with alternative treatments and currently available noninvasive technological advancements, will reduce the average number of procedures per lab within the district below 600 each year. Due to the population growth projections for Sarasota County, approval of Doctors' application will have minimal impact on lab utilization at Memorial or other facilities within the district. Doctors' projected number of procedures will not decrease procedures at Memorial below its 1987 level of 2,495 cardiac catheterization procedures performed on an annual basis.
Findings Of Fact Petitioner, Mease Health Care, Inc. (Mease), is a private, not-for- profit acute care community hospital in Dunedin, Florida. It is located in District V, a health planning district established by respondent, Department of Health and Rehabilitative Services (HRS). Intervenors, Morton F. Plant Hospital, Inc. (Plant) and Bayfront Medical Center, Inc. (Bayfront), are acute care hospitals also located within District V. Mease has pending in Case Nos. 89-1652 and 89-4888 a challenge to HRS's fixed need pool determination for new cardiac catherization services and an application for a certificate of need (CON) authorizing it to establish a new inpatient cardiac catherization program in Dunedin, Florida. In the instant case, Mease has challenged an HRS policy as being an illicit rule. Respondent is the state agency responsible for the administration of the Health Facility and Services Development Act. For the purpose of assisting it in administering the act, HRS has promulgated Rule 10-5.011(1)(e), Florida administrative Code (1989), which pertains to inpatient cardiac catherization services and defines the requirements for the establishment of such services. Paragraph 8.c. of the rule contains the formula used for calculating fixed need pools for new inpatient cardiac catherization programs. The formula is: NN PCCPV - ACCPV - APP, where NN is the annual net program volume need, PCCPV is the projected adult cardiac catherization program volume, ACCPV is the actual adult cardiac catherization volume, and APP is the projected program volume for approved programs. This formula was applied by HRS to the September 1988 batching cycle, which was the first batching cycle after the rule became effective. For that cycle, HRS calculated NN to be -53 for District V. NN was therefore less than 300. Paragraph 8.d. of the rule provides the following relevant instructions on how the formula should be applied to batching cycles subsequent to September 1988: If NN is less than 300 in the first batching cycle after the rule becomes effective, the ACCPV value which is subtracted from the PCCPV will be the same value as ACCPV in the first batching cycle until the projected net need in a future batching cycle reaches a program volume of 300 or more. . . For the March and September 1989 batching cycles, which were the two batching cycles immediately subsequent to the first batching cycle after the rule became effective, HRS did not keep the ACCPV value constant, "or the same . . . as in the first batching cycle", even though NN was "less than 300 in the first batching cycle." Put another way, in all batching cycles after September 1988 HRS has recalculated ACCPV even though in the first batching cycle NN was a negative number and therefore was less than 300. HRS's affidavit confirms that this is the manner in which ACCPV has been calculated in all cases since the adoption of the rule. Since the policy has been consistently used in the above manner in all cases, creates rights and requires compliance, and is not apparent from a literal reading of the rule, the policy necessarily constitutes a rule. There is no dispute that the policy has not been formally adopted as a rule.
