Recommendation Based upon the findings of fact and conclusions of law recited above, it is recommended that the decision of the respondent to deny petitioner's proposal to establish a new ten station dialysis facility in Dade County be AFFIRMED. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 21st day of August, 1978. DIANE D. TREMOR Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Bart Pelstring, Administrator Dialysis Associates, Inc. 2125 Biscayne Boulevard Miami, Florida 33137 Eric J. Haugdahl Assistant General Counsel Department of HRS 1323 Winewood Boulevard Suite 406 Tallahassee, Florida 32301 Mr. Art Forehand, Administrator Office of Community Medical Facilities 1323 Winewood Boulevard Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= STATE OF FLORIDA DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES DIALYSIS ASSOCIATES, INC., Petitioner, vs. CASE NO. 78-779 DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, OFFICE OF COMMUNITY MEDICAL FACILITIES, Respondent. /
The Issue The issue in this case is whether insurance benefits under the Florida State Employee's Group Health Self Insurance Plan should be provided for lung transplantation.
Findings Of Fact Mildred McNeill is a 45 year old woman, married to state employee John McNeill, and insured under the family coverage of the State of Florida Employees Group Health Insurance Plan. Mrs. McNeill has end stage emphysema. As of August 1989, Mrs. McNeill's life expectancy was less than 12 months. Such end stage emphysema is unusual in a person of Mrs. McNeill's age. Other than the emphysema, she has no other major health problems. The evidence establishes that Mrs. McNeill is an appropriate candidate for lung transplantation, without which she will die in the very near future. One witness called lung transplantations for emphysema victims technically simple and stated that such patients have a better survival rate than lung transplant recipients suffering from other illnesses. The first human lung transplantation was performed in 1963 at the University of Mississippi Medical Center. This initial attempt was soon followed by other attempts, all unsuccessful. Thereafter, lung transplantations were halted. Dr. Joel Cooper, M.D. is a cardiothoracic surgeon at Barnes Hospital in St. Louis, a Washington University teaching hospital. Dr. Cooper has completed and continues to do pioneer research in the field of lung transplantation. Dr. Cooper first participated in a lung transplant attempt in 1978, performed his first lung transplant in 1982, and has performed 26 lung transplants in the past year, 25 successfully. In studying the results of the early lung transplant attempts, Dr. Cooper found that, of 38 initial lung transplant recipients, only nine lived more than two weeks, and of those nine, six died in the third week. Dr. Cooper identified the critical factor in the poor success of lung transplantation surgery to be the failure of the airway connection between the patient's existing tissue and the newly implanted lung to heal properly. Dr. Cooper developed a surgical method in which the omentum, a fatty appendage in the stomach, was brought up from the stomach and wrapped around the sutured connection. Dr. Cooper's procedure resulted in vastly improved results due to the restoration of an acceptable blood supply at the airway connection. Additionally, use of a then-new antirejection medication, Cyclosporin, resulted in substantially improved survival rates. Dr. Cooper has been very active in providing the results of his work to other practitioners. The actual procedure for performing lung transplantations has changed very little since Dr. Cooper's technique was perfected in 1983. On February 21, 1989, Mrs. McNeill was examined by Dr. James W. Wynne, M.D., a Gainesville specialist in pulmonary medicine. Dr. Wynne's examination was at the request of a surgeon preparing to operate on Mrs. McNeill for a bile duct obstruction. Dr. Wynne determined that Mrs. McNeill suffers from obstructive lung disease/emphysema. Dr. Wynne referred Mrs. McNeill to the Mayo Clinic in Jacksonville, where she was examined on August 4, 1989, by Dr. Joseph Kaplan, M.D. Dr. Kaplan is a pulmonary specialist. The Mayo Clinic is a tertiary care center, based in Rochester, Minnesota, with branch facilities in Jacksonville and in Scottsdale, Arizona. Dr. Kaplan's examination determined that Mrs. McNeill suffers from advanced lung disease/emphysema. He found her emphysema to be of the non-hereditary type and premature for her age. He found no other major medical problems. Dr. Kaplan recommended to Mrs. McNeill that she consider lung transplantation at either the Mayo Clinic in Rochester or at the University of Mississippi Medical Center in Jackson. The Mayo Clinic identifies itself as available for lung transplantation surgery, but has not yet performed such surgery. Mrs. McNeill subsequently went to the University of Mississippi Medical Center, where she was examined by Dr. Seshadri Raju. Dr. Raju is a surgeon and is director of the University's transplant program. Since 1986, he has performed 11 or 12 successful lung transplants utilizing Dr. Cooper's methodology. He was unable to recall the date of Mrs. McNeill's examination other than to identify the period as five or six months prior to the hearing. A series of comprehensive diagnostic procedures were conducted at that time which confirmed the diagnosis of emphysema and identified Mrs. McNeill as an excellent candidate for lung transplantation. Following Mrs. McNeill's visit to the University of Mississippi, the McNeill's made inquiry regarding the availability of insurance coverage under Mr. McNeill's state employee plan for Mrs. McNeill's proposed lung transplantation. State employee health insurance benefits are governed by the "State of Florida Employees Group Health Self Insurance Plan Benefit Document". Excluded from coverage, as provided in section VII, paragraph W, of the Benefit Document, are "[a]ny services or procedures which are determined by the Administrator to be experimental or investigative or are not in accordance with generally accepted professional medical standards; complications of non-covered services." The Benefit Document does not define the terms "experimental", "investigative", or "generally accepted professional medical standards". The Benefit Document, at section I, paragraph C, defines the Administrator of the plan as Blue Cross and Blue Shield of Florida, Inc. (hereinafter Blue Cross) - Under the terms of the Benefit Document, Blue Cross is responsible for determining whether a procedure is experimental or investigative or not in accordance with generally accepted professional medical standards. Dr. Raphael A. Rivera is an employee of Blue Cross and is responsible for the development of medical policy and coverage decisions for Blue Cross. Dr. Rivera also performs like responsibilities for the state employee insurance plan. Dr. Rivera's role in this case was to determine, from a medical standpoint, whether lung transplantation was experimental or investigative or otherwise not in accordance with generally accepted professional medical standards. Dr. Rivera determined that the procedure was investigational and excluded from coverage under the terms of the Benefit Document. By letter to Mr. McNeill, dated December 1, 1989, Carl Ogden, Director of the Division of State Employees Insurance, stated that the insurance plan "specifically excludes experimental or investigative services or procedures." The letter further stated, "[u]nfortunately, lung transplantation treatment at the present time is an investigative treatment for end stage pulmonary disease. Therefore, your request for insurance benefits for your wife's lung transplantation must be denied." As director of the state employee insurance program, Mr. Ogden is responsible for administration of the program. Mr. Ogden is also responsible for coverage decisions. In determining whether Mrs. McNeill's request for benefits should be approved, Mr. Ogden reviewed the recommendation of the Plan Administrator. While Mr. Ogden also considered other information in reaching his decision, the primary support for his conclusion was the Plan Administrator's recommendation. Mr. Ogden determined that the Plan Administrator recommendation was appropriate. In determining whether a procedure is experimental, investigative, or otherwise not in accordance with generally accepted professional medical standards, Dr. Rivera considers whether such procedures are so widely recognized and performed as to be generally accepted professional medical practice. Dr. Rivera further considered the number of lung transplants being performed and the success rate for such transplants. Dr. Rivera concluded that lung transplantation benefits were excluded from coverage. The greater weight of evidence does not support Dr. Rivera' s determination. As to whether a procedure is generally accepted professional medical practice, Dr. Rivera considers whether the procedure has widespread recognition and is generally available to the average physician as a part of the range of options about which the primary care physician is knowledgeable. A procedure does not have to be locally available for it to be considered generally accepted professional medical practice. The procedure need only be recognized by the bulk of practitioners in a community as a treatment option for their patients. In considering whether a procedure has widespread recognition, Dr. Rivera looks to a number of medical journals. Dr. Rivera stated that the accumulation of articles on one subject by different physicians, practice groups, and sources, is indicative of the general acceptance of a procedure. The evidence establishes that as much as 24 months may pass between the completion of the research described in a journal article and the actual publication of the article. Dr. Rivera admitted that such journals do not necessarily reflect the "state of the art". The evidence establishes that practitioners utilize additional means of remaining informed of current medical practice and standards. Alternative information sources include conferences and seminars. There is no evidence that Dr. Rivera considered such programs, which are more current than the published medical journals, in determining the extent of transplant information available to practitioners. Dr. Rivera considered diagnostic and therapeutic technology assessment bulletins issued by the American Medical Association (AMA). The sole AMA material cited by Dr. Rivera relied on 1988. Dr. Rivera contacted the Public Health Service Office of Health Technology and requested information. Dr. Rivera stated at hearing that no information was available from the Public Health Service because there was so little activity in the lung transplantation field that none was warranted. Dr. Rivera testified that he took into his consideration the fact that no Florida medical facilities perform lung transplants. However, Dr. Rivera also testified that a procedure need not be locally available to be generally accepted professional medical practice. Dr. Rivera testified that, as of August 1988, Blue Cross identified lung transplantation as "investigational" and had not further reviewed the classification. Although some Blue Cross plans do provide coverage for lung transplantation, the evidence fails to establish the contractual basis for such coverage. Dr. Rivera identified another of his considerations to be the number of transplants being performed, and determined that an insufficient number were being performed. Dr. Rivera relied, at least in part, on information generated by the United Network for Organ Sharing (UNOS). UNOS operates the donor organ procurement system and maintains statistics on organ transplants. The 1988 UNOS statistics cited by Dr. Rivera, and upon which the AMA based its technological bulletin, state that 31 lung transplants were reported. Dr. Cooper maintains a registry of lung transplantation statistics which are more current than the statistics reported by UNOS in 1988. According to Dr. Cooper, prior to 1983, there were between 40-44 lung transplantations with, at best, minimal success. From November 1983 to January 1990, there have been 265 lung transplantations worldwide, 185 single lung and 80 double lung procedures. The total number of lung transplants is substantially lower than the number of most other types of transplants. While it was asserted that the low number of lung transplants was an indication that the procedure is still in the experimental or investigational phase, the evidence establishes that the number of lung transplants is lower that other types of transplants because there are far fewer lungs available for transplantation. Most donor organs are harvested from automobile accident victims. According to the testimony of Dr. Raju, the lung is rarely available because the lungs are fragile, and collapse or become filled with fluid, and are unusable. As Dr. Raju stated, "...it is slim pickings as far as lung is concerned." Dr. Raju estimated that only five to six percent of donors have lungs appropriate for transplantation, and that such does not take into account the inherent difficulties in matching donors with recipients in a timely manner. Dr. Rivera identified the success rate of the procedure as an additional factor in determining whether a procedure is investigational. Dr. Rivera was unaware of any statistics identifying the success rate for lung transplantation. The success rate for a specific treatment is measured by the statistical survival rate for the procedure. Statistics on survival generally measure the patient's condition one year after the completion of surgical recovery. The safety and effectiveness of the procedure is the primary factor in determining success rate. According to Dr. Cooper, approximately 67% of lung transplantation recipients since 1983 remain alive. Of the 80 double lung transplantation recipients since the initial procedure in 1986, 58% remain alive. Dr. Cooper's statistics do not identify post-recovery one year survival rates, but measure the continuing survival of such patients. However, Dr. Cooper stated that the survival rates have increased in recent years. Dr. Cooper estimates current one year survival rates to be upwards of 90%. The Cooper information was supported by the testimony of other physicians knowledgeable in the field. Dr. Rivera also asserts that the volume per transplant facility is relevant to his determination because the higher the number of procedures each facility completes, the greater the probability for successful results as medical personnel become more experienced. The number of facilities performing a specific operation is less important that the volume of procedures generated at each facility. Dr. Rivera stated that it is preferable for a few centers to perform a greater volume of a specified procedure, than it would be for a large number of centers to perform only a few procedures. According to Dr. Rivera, there are 250 medical facilities in the United States which are self-designated as transplant centers. Of the 250, 59 centers are designated as available for lung transplantation. The designation of a facility does not indicate that such transplants have been performed, but that the facility has indicated the ability to perform the procedure. Although some designated centers have not yet performed lung transplants, such does not indicate that the procedure is experimental, investigative, or not in accordance with generally accepted professional medical standards. It is just as likely that the large number of facilities preparing to perform lung transplantation is an indication that the procedure has become generally accepted professional medical practice. The state employees insurance plan provides coverage for heart/lung transplantation. Although there have been no recent requests for heart/lung transplant benefits, the evidence establishes that, were Mrs. McNeill an appropriate candidate for a heart/lung transplant, benefits would be provided. Dr. Rivera testified that he intended to review the situation and that benefits for heart/lung transplantation could possibly be discontinued. There is no evidence that such review was undertaken prior to the hearing. According to Dr. Cooper, 60 heart/lung transplants were performed last year. The one year survival rate in heart/lung transplant recipients is 60-65%. The three year survival rate is 30-35%. The volume of heart/lung transplants and the survival rate for such transplants is similar, and perhaps lower, than the volume and survival rates for lung transplants. Included among other transplants for which the state employees health insurance plan provides coverage, is pancreas transplantation. Under the state employee plan, the Plan Administrator (Blue Cross) has determined that pancreas transplantation is generally accepted professional medical standards. However, Blue Cross does not provide such coverage in its proprietary insurance policies because, according to Dr. Rivera, Blue Cross considers pancreas transplantation to be investigational. The evidence underlying the conflict is unclear, and indicates that the use of the term "investigational" is subjective and arbitrary. There is continuing study in the filed of lung transplantation. Although the practical applications for lung transplantation continue to expand as the number of recipients and quantity of related data enlarges, such does not indicate that the procedure, in Mrs. McNeill's case, is experimental or investigational or not in accordance with generally accepted professional medical standards. The evidence clearly establishes that Mrs. McNeill is an appropriate candidate for the procedure, and that the expectations for her survival following the surgery are at least as high as the survival rates for transplantations for which insurance benefits are provided. Based upon the factors cited as determinative by Dr. Rivera, the reliable data supplied by Dr. Cooper and other practitioners, and the insurance benefits provided for other organ transplants, lung transplantation is not experimental or investigative or not in accordance with generally accepted professional medical standards. The procedure is within the generally accepted professional medical standards of those physicians who practice pulmonary medicine. The volume and success rate for lung transplantation is comparable to heart/lung transplantation for which benefits are provided. Dr. Rivera, who acknowledged Dr. Cooper's accomplishments, was unable to cite any remaining problems with lung transplantation other than immunoallergic and immunosuppressive reactions common to all transplant procedures. Although there was testimony as to whether Mrs. McNeill should receive a single or double lung transplant, such is irrelevant to this proceeding. Dr. Raju testified that, although he would prefer to perform a double lung transplant, such was dependant upon the availability of two acceptable lungs. Fewer double lung transplants have been performed than single lung procedures and the success rate for double lung transplants is lower than that for single lung transplants. Yet the success rate for both is at least as high as the success rate for the heart/lung transplants for which insurance coverage is provided.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that the Department of Administration enter a Final Order granting the Petitioner's request for insurance benefits for Mildred McNeill's lung transplantation. DONE and RECOMMENDED this 29th day of May, 1990, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM 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 May, 1990. APPENDIX CASE NO. 90-0405 The following constitute rulings on proposed findings of facts submitted by the parties. Petitioner The Petitioner's proposed findings of fact are accepted as modified in the Recommended Order except as follows: 6, 8-10, 13-14, 16-18, 19, 23. Rejected, cumulative. 24-25. Rejected. Irrelevant to whether such procedure is generally accepted medical practice under the terms of the insurance contract. 26-28. Rejected, cumulative. First two sentences rejected, cumulative. Rejected, cumulative. 42. Rejected. Unsupported hearsay evidence. 49. Last sentence rejected, unsupported hearsay. Respondent The Respondent's proposed findings of fact are accepted as modified in the Recommended Order except as follows: The use of terminology "because he had no therapy for her" is rejected, unnecessary. Rejected, irrelevant. Dr. Wynne is not a surgeon. Testimony of Dr. Rivera established that a procedure need not be locally performed to be generally accepted medical practice. Rejected, irrelevant. Testimony of Dr. Rivera established that a procedure need not be locally performed to be generally accepted medical practice. 6. Accepted as to use of medical journals. Rejected as to implication that such journals are sole source of information, not supported by evidence. Rejected, not supported by weight of evidence. Dr. Kaplan further identified the Mayo clinic as a conservative institution. Rejected, irrelevant. Rejected, irrelevant. Although Dr. Kaplan did testify that the journals are most current printed material, he also identified other sources of more current information upon which a prudent practitioner would rely. 13-15. Rejected, unnecessary, irrelevant. 18-22. Rejected, irrelevant. 24-25. Rejected, irrelevant. Rejected, goes to weight accorded witness' testimony which has been determined to be reliable, unnecessary. Rejected, unnecessary. Qualifications of witness are considered in determining weight accorded testimony. 29. Rejected, unnecessary. Qualifications of witness are considered in determining weight accorded testimony. 32-33. Rejected, unsupported hearsay. Rejected, not supported by greater weight of evidence. Rejected, not supported by greater weight of evidence. The evidence establishes that lung transplants were first performed in the early 1960's and that Dr. Cooper's technique was developed in the early 1980's. Rejected, irrelevant. Evidence establishes that coverage is available for heart/lung transplantation. Rejected, not supported by greater weight of evidence. Testimony cited in support of proposed finding indicates that the problems remaining are inherent to all transplant procedures and relate to immunoallergic and immunosuppressive reactions. Rejected, not supported by greater weight of evidence. 41. Rejected, unnecessary. Qualifications of witness are considered in determining weight accorded testimony. 43. Rejected, editorial is irrelevant. Use of word "infancy" without further explanation is without meaning. Further, Mr. Ogden's cited testimony includes his statement, "[s]eems like we'll move to a time when heart/lung, double lung, single lung transplantation will become a rational alternative...", yet benefits are available for heart/lung transplants. 48. Rejected, not supported by the greater weight of evidence, which is contrary to the determination of the Plan Administrator and the Respondent. COPIES FURNISHED: Rutledge R. Liles, Esq. 2000 Florida National Bank Tower Post Office Box 4788 Jacksonville, FL 32201 Aletta Shutes Secretary Department of Administration 435 Carlton Building Tallahassee, FL 32399-1550 Carl Ogden, Director Division of State Employees Insurance 530 Carlton Building Tallahassee, FL 32399-1550 Augustus D. Aikens, Jr., Esq. General Counsel Department of Administration 435 Carlton Building Tallahassee, FL 32399-1550 William A. Frieder, Esq. Department of Administration 438 Carlton Building Tallahassee, FL 32399-1550
The Issue Whether on or about March 6, 1978, the Respondent, Ronald M. Tauber, D.O., performed an abortion on Gloria Small at the Orlando Birthing Center, Orlando, Florida; during the course of which procedure, the patient's uterus was perforated and other complications ensued and despite an agreement from a hospital staff member at Orange Memorial Hospital, Orlando, Florida, between that staff member and Respondent to allow the transfer of the patient, Small, to Orange Memorial Hospital for emergency treatment the Respondent did not transfer the patient to the hospital until March 7, 1978, and further, that notwithstanding an emergency hysterectomy operation performed at that hospital, Gloria Small died. It is alleged that should the above-stated facts be proven, the Respondent, Ronald M. Tauber, D.O., would have failed to demonstrate satisfactory professional skill, judgment or knowledge expected of him and to have exhibited an inability to practice osteopathic medicine with reasonable skill and safety and that his professional conduct departed from minimal standards of acceptable and prevailing osteopathic medical practice, in violation of Subsections 459.14 (2)(c) and (m), Florida Statutes. (The Administrative Complaint in this cause contained paragraphs 1 and 2 which were dismissed by the undersigned with leave for the Petitioner to amend. The Petitioner did not undertake such an amendment and the paragraphs 1 and 2 of the Administrative Complaint were not considered in the course of the hearing. Paragraph 5 of the Administrative Complaint was stricken and has not been considered. The phrase found in paragraph 3 of the Administrative Complaint which is constituted of the language "as well as other abortion procedures" was stricken and was not the subject of consideration in the course of the administrative hearing. Finally, the Petitioner moved to withdraw any reference to the substantive allegations found in paragraph 4 of the Administrative complaint pertaining to Subsections 459.14(2)(h), (k), and (n), Florida Statutes, and that motion was granted without opposition from the Respondent.)
Findings Of Fact This cause comes on for consideration based upon the Administrative Complaint filed by the Petitioner, State of Florida, Department of Professional and Occupational Regulation, Florida State Board of Osteopathic Medical Examiners, against Ronald M. Tauber, D.O., Respondent. The date of that Administrative Complaint is April 24, 1978. The dispute to be resolved in the hearing process is as set forth in the issue statement of this Recommended Order. To that end, a formal hearing was held in accordance with the provisions of Subsection 120.57(1), Florida Statutes, during the course of which, testimony and other evidence were presented by the parties. The Petitioner, State of Florida, Department of Professional and Occupational Regulation, Florida State Board of Osteopathic Medical Examiners, is an agency of the State of Florida whose purpose is that of licensure and regulation of those individuals who practice osteopathic medicine in the State of Florida. The Respondent, Ronald M. Tauber, D.O., is licensed by the Petitioner in the State of Florida to practice osteopathic medicine and his license number is 3430. At all times pertinent to the Administrative Complaint, Dr. Tauber was so licensed. The facts in the case reveal that the Respondent in the month of March, 1978, was practicing osteopathic medicine in a facility located at 419 North Magnolia, Orlando, Florida. This particular structure was a building with approximately 9,000 square feet of office space which Dr. Tauber used in the practice of his specialty, obstetrics and gynecology. His type facility has been referred to as a "free standing clinic" that offers among other services elective abortions, to include those performed in the late first trimester or early second trimester of the patient's pregnancy. Some of the equipment in the installation included a maternal fetal monitor, a cardiac monitor and defibulator which were part of a crash cart. The crash cart also contained items for resuscitation of adults and infants, including drugs, tubes, scopes, Laryngoscopes and Ambu bags. There was an operating room with an operating-obstetrical table. There were sources of sterilization by gas and steam. The office also contained instruments for minor gynecologic surgery, to include abortions and laparoscopy. There was an office area used by the Patient Education Coordinator- Counselor who was a member of the Respondent's staff. This Counselor conferred with prospective abortion patients concerning the pros and cons of such a procedure, to include alternatives to pregnancy termination. The office contained a laboratory which had equipment for the performance of blood counts, cultures, urine tests, other chemistry tests, blood typing and blood cross-matching. In connection with the blood work-ups, there was a blood bank refrigerator; however, no arrangements had been consummated for the storage of blood in that refrigerator prior to the abortion which was performed on the patient, Gloria Small, the subject of this complaint. In a related area, the Respondent intended to employ an anesthetist who would give Dr. Tauber the capability of utilizing general anesthesia in his operative procedures. This arrangement had not been made on or before March 6, 1978, and the abortion performed on Gloria Small was without the benefit of any form of general anesthesia. The personnel who worked in the facility in March, 1978, included a full-time registered nurse, a number of part-time registered nurses; a full-time licensed practical nurse, a number of part-time licensed practical nurses; a full-time certified operating room technician; a part-time licensed practical nurse who functioned as a LaMaze instructor and other functions associated with the maternity aspect of the facility; a medical records librarian; a receptionist; a full-time housekeeper; a part-time maintenance man and a business advisor/bookkeeper. Dr. Tauber had arranged for backup personnel in the persons of a pediatrician in the child delivery cases and a medical doctor who specialized in obstetrics and gynecology. These individuals were to assist in the procedures at the clinic and to cover for Dr. Tauber when Dr. Tauber was unavailable. However, the medical doctor in the field of obstetrics and gynecology did not have hospital privileges and neither did Dr. Tauber. There were two other physicians who had agreed to give hospital coverage for Dr. Tauber in complicated cases, but this arrangement excluded abortion procedures. On March 2, 1978, the patient, Gloria Small, was seen by Dr. Tauber and he accepted her case. Ms. Small requested a pregnancy termination and sterilization. During his initial interview and examination, the Respondent took the patient's personal history and conducted a physical examination and determined that the patient was pregnant approximately fourteen to fifteen weeks according to the gestational size. In addition to the physical examination, Dr. Tauber counseled the patient about the abortion and sterilization procedures and indicated alternatives to those procedures and the risks involved in each course that might be pursued. The patient indicated a desire to go forward with the abortion and sterilization procedures and in preparation for the procedures the Respondent ordered certain laboratory work, including hematology; type and Rh and urinalysis. This lab work was performed. Subsequent to this time, the patient was seen by the office counselor and continued to indicate her desire to have the procedures performed and the patient was scheduled for the procedures to be conducted on March 6, 1978. When the patient arrived on the morning of March 6, 1978, she was prepared for the abortion and sterilization procedures to the extent of being sterilly cleaned and having a medication administered to relax the patient. (At the time the Respondent performed the abortion and sterilization procedures on the patient, he had performed a significant number of these procedures before.) When the patient was presented in the operating room, she had been administered Nisentil in the amount of 40 milligrams. This is an analgesic drug designed to decrease the pain during the procedure. The patient was also given Atropine, a parasympathetic, to slow down the digestive track and to decrease the chance of nausea and to retard salivation. Intravenous lines were opened and the patient was given compositions of fluids which had a mineral and sugar content. The doctor was assisted by a scrub technician and there was a circulating registered nurse available. The procedures began at approximately 12:00 noon and were concluded at 1:25 p.m. The patient was dialated and the suction cannula was placed in the uterus and the suction machine turned on, at which point the materials in the uterus began to flow into the suction machine. In view of the advanced stage of the pregnancy, it was then necessary to place various instruments, ring forceps, to withdraw the pregnancy tissue. In the course of the manipulations, placental tissue was observed being brought down. At that point, the patient began to bleed heavily. Dr. Tauber placed the ring forceps into the uterus and the ring forceps went beyond normal depths expected in such an examination of the uterus. This preliminary procedure led to the eventual verification that a perforation had occurred. At this juncture, the doctor was working in the cervical canal. The doctor's response to the apparent perforation was to place the laparoscope and attendant instrument into the abdomen, setting up the procedure with a local anesthesia. When this action was taken, the Respondent, using a fallopian applicator (which was to be used in the sterilization procedure) lifted the uterus and saw a perforation two to four centimeters in length in the right posterior aspect of the lower uterine segment. At this point of observation, the perforation was not bleeding. There was a certain amount of blood in the lower dependent portion of the abdomen which did not measure more than 25 cc and this was consistent with a perforation that was not bleeding. The operating room technician was allowed to visualize the perforation through the laparoscope and the medical doctor who specialized in obstetrics and gynecology was called to assist. While the Respondent was waiting for the arrival of the backup physician, he allowed the operating room technician to assist him by viewing through the laparoscope while the Respondent turned to the vaginal aspect of the procedure and entered the uterus. During the process of the evacuation of the remaining placental tissue, the Respondent placed an instrument through the performation a second time; however, no additional bleeding was observed at that point. The bleeding which had been observed initially had slowed to a continuous ooze and this amount of bleeding caused the Respondent to observe the area of the perforation for an additional period of thirty minutes or more to confirm that the bleeding was not increasing in volume. The backup physician also observed the area of the perforation and consulted with the Respondent about the complication. The dialation and evacuation procedure was completed and the fallope rings applied and when the Respondent was convinced that he didn't have bleeding intra-abdominally, the patient was packed by placing gauze-type material in the vagina, thereby promoting pressure against the bleeding area. (The sequence of observations through the laparoscope that have been mentioned before occurred after the packing had been placed.) During the pendency of the observation, no blood was observed to be coming through the packing. Contemporaneous to the observations, fluids were used to replace the high blood loss. That amount of blood loss was believed to be in the amount of 1500 cc. When the complications occurred in the course of the operation, there was a drop in blood pressure and an increase in the pulse rate. In addition, the pre-operative hemoglobin was 13.5 g.m. as compared to 9.5 g.m. post- operative, and the hemoglobin ranged from around 8.2 g.m. through the higher 8.0 g.m. and lower 9.0 g.m., from the period immediately following the operation until around 5:00 p.m.., March 7, 1978. A more complete detail of the change in blood pressure, pulse rate and hemoglobin count may be found in Petitioner's Composite Exhibit No. 1, which is a copy of the Respondent's case records on the patient, Gloria Small. From an examination of all the vital signs, the patient was hypovolemic to the extent of being in hypovolemic shock following the aforementioned procedures. At the conclusion of the operation, Dr. Tauber instructed his staff to monitor the patient closely, and she remained on the cardiac monitor which had been employed during the operative procedures and the patient's vital signs, to- wit, blood pressure and pulse, were checked frequently. In addition, the staff was instructed to catherize the patient after six hours if the patient did not void and to record the amount of fluid intake and output and to observe the patient for vaginal bleeding. The patient was also given fluids to include dextrose and water and Normasol M, together with certain medication. These instructions were carried out by the staff. Dr. Tauber continued to give the patient fluids and to consider whether the patient should be transfused with whole blood. Around 3:00 p.m. on March 6, 1978, Dr. Tauber decided to infuse the patient with whole blood. He contacted the managing director of the Central Florida Blood Bank to attempt to gain the permission of that organization to provide whole blood for the benefit of the patient, Gloria Small. There had been some preliminary contact with the blood Bank about providing blood for patients of Dr. Tauber, but that arrangement had not been finalized prior to Gloria Small's operation. The managing director conferred with the medical director of the blood bank and a decision was made to honor Dr. Tauber's request for blood. Some delay ensued due to a mix-up on the part of Dr. Tauber's staff on the question of labeling the samples; nonetheless, this problem was rectified and at 6:10 p.m., and again at 7:25 p.m., blood was delivered for the benefit of the patient, Gloria Small, and that blood was infused into the patient. Contrary to the recollection of the Respondent, there is no record of further units of blood being requested by the Respondent, Dr. Tauber, for the benefit of the patient, Gloria Small, and, therefore, officially no such request was made of the blood Bank during the pendency of Dr. Tauber's treatment of the patient. As a consequence, the further treatment which Dr. Tauber gave the patient, Gloria Small, was without the benefit of the immediate availability of further units of blood. As previously stated, Dr. Tauber did not have hospital privileges and had not made any prior arrangement for the patient to be turned over to a physician with hospital privileges, in the event a medical emergency arose which required the hospitalization of the patient, Gloria Small. His first effort at making such an arrangement occurred between 5:00 and 5:30 on March 6, 1978, when he contacted a Dr. Lassiter, a resident in obstetrics and gynecology at the Orange Memorial Hospital, Orlando, Florida. The purpose of such conversation was to arrange for the patient to transfer if her condition worsened. Dr. Lassiter was unable to make this arrangement and it was only after the physician in charge had been conferred with that it was arranged for the patient, Gloria Small, to be accepted at Orange Memorial Hospital. This agreement was reached by the Respondent and the physician in charge, one Dr. Herran. Dr. Herran then confirmed this agreement with Dr. Lassiter, the resident, and instructed Dr. Lassiter to accept the patient, Gloria Small, if she were transferred and to immediately notify Dr. Herran if such transfer did occur. Dr. Tauber left his clinic around midnight of the morning of March 7, 1978, and left the patient in charge of a staff nurse. He returned to the hospital on the morning of March 7, 1978, and the patient's condition remained stabilized until approximately 5:00 p.m. on March 7, 1978. Up until that point, the bleeding that had been experienced following the initial hemorrhage was slight, and it was decided to remove the packing which had been placed at the conclusion of the operation. Most of the packing had been removed and there was no sign of bleeding, when a substantial hemorrhage took place in the cervical canal. At that point, Dr. Tauber repacked and made arrangements for an emergency ambulance, to transfer the patient to the hospital, and to notify Dr. Herran. The patient's vital signs began to deteriorate and during the transportation of the patient from Dr. Tauber's facility to Orange Memorial Hospital, the patient began to show marked signs of hypevolemic shock. Upon arriving at the Orange Memorial Hospital, the patient became the charge of that hospital staff and Dr. Tauber was no longer responsible, although he stayed with the patient and offered assistance, which was declined. The events which transpired at the Orange Memorial Hospital evidenced an inordinate delay on the part of the staff in properly administering to the needs of the patient. Whether this significantly contributed to the patient's ultimate demise is unresolved, but having arrived at the hospital in a condition where her body was already at a low ebb and unable to tolerate further insult, the patient died following a hysterectary performed in the Orange Memorial Hospital. The principal factor in that death was hypovolenic shock. Out of these events, the Petitioner has charged Dr. Tauber with a failure to demonstrate satisfactory professional skill, judgment or knowledge in the treatment of the patient, Gloria Small, and the accusation that Dr. Tauber has exhibited an inability to practice osteopathic medicine with reasonable skill and safety and that his professional conduct departed from minimal standards of acceptable and prevailing osteopathic medical practice. The particular substantive allegations which remain to be considered at this time are found in Subsections 459.14(2)(c) and (m), Florida Statutes, which state the following: 459.14 Refusal, revocation and suspension of license, etc.-- (c) Gross malpractice or the inability to practice osteopathic medicine with reasonable skill and safety. In enforcing this paragraph the board shall, upon just cause shown, have authority to compel a physician to submit to a mental or physical examination to be conducted by physicians designated by the board, such examination to be at the expense of the board. Failure or refusal of a physician to submit to such an examination when so directed by the board shall constitute an admission of his inability to practice osteopathic medicine with reasonable skill and safety. (m) A finding by the board that the indivi- dual is guilty of immoral or unprofessional conduct. Unprofessional conduct shall include any departure from, or failure to conform to, the minimal standards of acceptable and prevail- ing osteopathic medical practice, without regard to the injury of a patient, or the committing of any act contrary to honesty, whether the same is committed in the course of practice or not. In addressing the question of the application of these substantive standards set forth above to the facts reported in this case, the parties have offered the testimony of a number of persons within the profession of osteopathic medicine and other physicians who are medical doctors. An analysis of their testimony in view of the accusations in this cause establishes that the Respondent has evidenced an inability to practice ostepathic medicine with reasonable skill and safety within the meaning of Subsection 459.14(2)(c), Florida Statutes, and is likewise guilty of unprofessional conduct for departing from minimal standards of acceptable and prevailing osteopathic medical practice within the community where he practiced as required by Subsection 459.14(2)(m), Florida Statutes. The facts that led to these conclusions are those which show that the Respondent went forth with the dialation and evacuation and sterilization procedures of Gloria Small at a time when he did not have hospital privileges and at a time when he was unassociated with those persons who would have the necessary hospital privileges to address complications which might occur during these procedures, which complications might need immediate and well-defined access to a hospital facility. In addition, the possibility existed that the patient would need whole blood and other products associated with fluid replenishment and the Respondent had failed to make adequate arrangements for such eventuality, which failure caused undue delay in the infusion of the whole blood in the patient, Gloria Small. The problem in this case concerning the lack of readily available blood or blood products constituted a violation of the aforementioned standards on the part of Dr. Tauber and the very fact that Dr. Tauber had not made the prior arrangements to have available such blood or blood products constituted a further violation of the aforementioned standards. In a related area, that condition which would cause a necessity of the infusion of blood, to-wit, hypovolemic shock, had not adequately been anticipated, in violation of the necessary standards, even if you assume that Dr. Tauber made a sufficiently prompt response to the patient's hypovolemic condition which occurred following Dr. Tauber's operative procedures. Had the blood been needed more promptly, the Respondent was not prepared. There was considerable debate on the question of the necessity to transport the patient, Gloria Small, to a hospital following the substantial hemorrhage which occurred in the dialation and evacuation and sterilization procedures. After close scrutiny, it does not appear that the Respondent was remiss for not transferring the patient to Orange Memorial Hospital as opposed to the occasion when he did transfer her, remiss within the meaning of a violation of a standard set forth in Chapter 459, Florida Statutes. The procedures which Dr. Tauber used in discussing the case with his patient, Gloria Small, and providing other counseling do not violate provisions of Chapter 459, Florida Statutes, nor is the act of perforation itself and the contemporaneous management of that perforation in violation of Chapter 459, Florida Statutes. Likewise, the response which Dr. Tauber made in the second emergency on March 7, 1978, when the bleeding occurred did not violate the provisions of Chapter 459, Florida Statutes. Finally, it cannot be determined from this record whether Dr. Tauber could have avoided the confusion which took place after the patient was transferred to Orange Memorial Hospital, by earlier coordination with Dr. Herran; and in view of the fact that the patient was no longer his charge once she had been admitted to Orange Memorial Hospital, there can be no responsibility, within the meaning of Chapter 459, Florida Statutes, for those events which transpired when the patient was admitted to Orange Memorial Hospital. The parties have availed themselves of the opportunity to submit findings of fact, conclusions of law and recommendations and these offerings have been reviewed prior to the rendition of this Recommended Order and to the extent that they are not inconsistent with the Recommended Order, they have been utilized in aid of the preparation of this Recommended Order. To the extent that these proposals are inconsistent with the Recommended Order, they are hereby specifically rejected.
Recommendation In view of all the facts and circumstances, it is recommended that the Respondent, Ronald M. Tauber, D.O., have his license to practice osteopathic medicine in the State of Florida suspended for a period of two (2) years. DONE AND ENTERED this 10th day of May, 1979, in Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings Room 101, Collins Building 530 Carlton Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Ronald C. LaFace, Esquire Post Office Box 1752 Tallahassee, Florida 32302 Michael Sigman, Esquire Suite 1515 CNA Tower Orlando, Florida 32801 Roy Lucas, Esquire 1055 Thomas Jefferson Street, N.W. Suite 604 Washington, D.C. 20007 Samuel Weiss, Esquire 1180 Hartford Building 200 East Robinson Street Orlando, Florida 32801
The Issue Whether Certificate of Need application (Number 9078) for an adult kidney transplantation program, filed by St. Luke's Hospital Association, meets the statutory and rule criteria for approval.
Findings Of Fact The Agency for Health Care Administration (AHCA) is the state agency authorized to administer the Certificate of Need (CON) program for health care facilities and services in Florida. Pursuant to Rule 59C-1.044, Florida Administrative Code, AHCA requires applicants to obtain separate CONs for the establishment of each adult or pediatric organ transplantation program, including heart, kidney, liver, bone marrow, lung, lung and heart, pancreas and islet cells, and intestines transplantations. For purposes of determining the need for organ transplantation services, the State of Florida is divided, by rule, into four service planning areas, corresponding generally with the northern, western central, eastern central and southern regions of the state. St. Luke's and Existing Providers St. Luke's Hospital Association operates St. Luke's Hospital (St. Luke's), a 289-bed, non-for-profit hospital with 17 beds for skilled nursing care and 272 acute care beds. St. Luke's is located on Belfort Road in Jacksonville, Duval County, Florida, AHCA, District 4, organ transplantation service planning area one. Available services at St. Luke's include obstetrics, open heart surgery, neurosurgery, adult bone marrow, and adult liver transplantation. The transplant services have been added during the last six or seven years. The severity of the illnesses and diseases treated at St. Luke's is represented by its relatively high Medicare case weight of 1.7 in 1997, after the addition of relatively low intensity obstetrics services. In 1998, St. Luke's applied for CONs to establish adult pancreas and islet cell, and adult kidney transplant programs. St. Luke's received the CON to establish the pancreas and islet cell transplant program. The application for a CON to establish an adult kidney transplant program is at issue in this proceeding. The parties stipulated that the letter of intent and application, for CON Number 9078, to establish the adult kidney transplant program, were timely filed. Methodist Medical Center, Inc., d/b/a Methodist Medical Center (Methodist) is a 244-bed acute care hospital, serving primarily adults, with special units for diabetes, hospice, and occupational medicine programs. The services do not include either obstetrics or pediatrics. In 1989, Methodist received a CON allowing its establishment of kidney transplant services. Methodist is located approximately one and a half miles north of downtown Jacksonville. Methodist's representatives contend that an additional kidney transplant program in Jacksonville, at St. Luke's, is not needed and will be detrimental to Methodist. St. Luke's, it was argued, will draw from a limited supply of organs and increase Methodist's financial losses. Those losses at Methodist were expected to range between $5 million and $8 million in 1999. Methodist's accountant described the hospital's financial health as poor to critical. The kidney transplant program provides a positive financial contribution at Methodist, largely due to Medicare reimbursements. At the time of the final hearing, Methodist was managed by Shands-Jacksonville, an affiliate of Shands Teaching Hospital and Clinics (Shands) at the University of Florida in Gainesville, and of University Medical Center in Jacksonville (University Hospital). Shands is also located in organ transplant service area one, but Gainesville is in AHCA District 3, not in 4 like Jacksonville. University Hospital is located across the street from Methodist and serves essentially the same inner-city, lower socio-economic population. St. Luke's was first established in the late 1800's. Previously located directly across the street from Methodist, St. Luke's was relocated near the intersection of J. Turner Butler Boulevard at Interstate 95, south of downtown Jacksonville in 1984. In 1987, St. Luke's became affiliated with the Mayo Clinic in Jacksonville (Mayo-Jacksonville). The two facilities share an administrator. St. Luke's receives approximately three- fourths of its admissions from Mayo-Jacksonville physicians. The Mayo-Jacksonville clinic is located approximately 12 miles from St. Luke's at J. Turner Butler Boulevard and Highway A-1-A. The multi-specialty and multi-subspecialty clinic, is staffed by 230 full-time salaried physicians. The governing board of Mayo-Jacksonville reports to the executive committee of its sole corporate member, the Mayo Foundation for Medical Education and Research (Foundation) in Rochester, Minnesota. The Foundation is the parent organization for the original Mayo Clinic in Rochester (Mayo-Rochester) and its affiliated hospitals, St. Mary's Hospital (with 1100 beds) and Methodist Hospital (with 700 to 800 beds), both in Rochester, Minnesota. In addition to the one in Jacksonville, the Foundation has also established a clinic in Scottsdale, Arizona (Mayo-Scottsdale). The Mayo-Scottsdale clinic is affiliated with a local inpatient hospital. Other related organizations include the Mayo Medical School and the Mayo Graduate School of Medicine. Issues Related to Need St. Luke's contends that its transplant surgeons would increase the total number of kidney transplants in Florida, by using less than ideal donor organs and by expanding waiting lists to enhance the possibility of donor/recipient matches. St. Luke's expects to overcome some of the usual limitations on available cadaveric organs because living donors can also be used to provide kidneys. Finally, St. Luke's maintains that a need exists for dual transplant programs, particularity the combination of kidney and pancreas programs. St. Luke's proposes to provide adult kidney transplants as an alternative to life-long dialysis or death for patients suffering from end-stage renal disease. Nationally, the number of dialysis patients increased from 123,822 in 1987 to 287,000 in 1996. The number of patients waiting for kidney transplants increased from 13,000 in 1987 to 41,000 in 1999. The mortality for patients on waiting lists also increased from over 1700 in 1996 to over 2000 in 1997. Due to the large and growing demand for organs, the federal government contracts with the United Network for Organ Sharing (UNOS) to coordinate the allocation of cadaveric organs. UNOS has designated five organ procurement organizations (OPOs) in Florida, one at the University of Florida in Gainesville (the UF OPO), and the others at centers in Orlando, Tampa, Fort Myers, and Miami. When cadaveric organs become available and are retrieved by surgeons from the nearest OPO, UNOS governs the priority in offering the organs. Organs are offered first to the United States military transplant centers, second to potential recipients who are six antigen or "perfect matches," then as paybacks to OPOs who have provided "perfect matches," and finally to various categories of other high-grade matches. After the organ is offered but not taken in the mandatory UNOS sharing hierarchy, the organ becomes available to local programs within the procuring OPO. St. Luke's will participate in the UNOS program for kidneys as it currently does for other organs, and expects to follow the medical protocols established at Mayo-Rochester, where kidney transplants have been performed for 30 years. St. Luke's has included $100,000 in start-up costs for Mayo-Rochester staff to train the St. Luke's staff. In establishing its successful liver transplant program, St. Luke's allocated $75,000 for comparable start-up costs. Rule 59C-1.044(8)(d), Florida Administrative Code, provides for the determination of the need for new programs, in part, based on the number of transplants performed at existing providers, which must exceed 30. An applicant must also provide a reasonable projection of volume, in excess of 15 a year by the second year of the proposed new program. Currently, two adult kidney transplant programs are approved or operational in each of the four service planning areas of Florida: at Shands in Gainesville and Methodist in Jacksonville in the north, which is service planning area one and coincides with the UF OPO; at Southwest Florida Regional in Fort Myers and Tampa General in western central Florida, which is service planning area two; at Florida Hospital in Orlando and Bert Fish Memorial in Volusia County in eastern central Florida, in service planning area three; and at the Cleveland Clinic Florida in Broward County and Jackson Memorial in Miami in the south, in service planning area four. At the time of this hearing, Bert Fish Memorial and the Cleveland Clinic were approved but not operational. The six operational Florida programs increased in volume from 442 transplants in 1994 to 641 in 1997, or an average increase of 13.2% a year. However, recent growth has been less dramatic. Using one year longer to establish a trend, from 1994 to 1998 data, the average annual increase was 9% a year. Kidney transplant volumes ranged, in 1997, from a low of 45 at Southwest Florida to highs of 150 at Jackson Memorial and 162 at Tampa General. From 1994 to 1997, the volume of kidney transplants within service planning area one increased from 35 to 52 at Methodist, and from 106 to 127 at Shands. As the parties stipulated, that volume exceeds the required minimum of 30 transplants at each provider in the service planning area. As also required by rule and stipulated by the parties, there are no new approved but not yet operational providers within service planning area one. Methodist notes that St. Luke's would be the first Florida program approved in a city which already has an existing kidney transplant service. The United States Renal Disease System (USRDS) is a national organization which collects and reports statistics on patients with end-stage renal disease (ESRD). USRDS is divided into regional networks, including Network Seven which is the ESRD Network of Florida, Inc. The Board of Directors of Network Seven adopted the following motion: The Network Seven Board of Directors reviewed the report of the Network's task force regarding the need for additional renal transplant resources for Service Area 1. After a lengthy discussion, the Board unanimously agreed that the Standardized Transplantation Ratio for Florida's Service Area 1 would not justify the establishment of a new stand-alone renal transplant program in this area. However, it agreed that the availability of a multi-organ transplant service (ie: pancreas and kidney) would be beneficial to those ESRD patients in residing [sic] Service Area 1. Two dual organ kidney and pancreas transplant programs are currently located in Florida, at Shands in Gainesville and at Jackson Memorial in Miami. Methodist notes that both are associated with medical schools at teaching hospitals, and are geographically well-suited to serve north and south Florida. Methodist's transplant surgeon who is the medical director of its program, and served on the Network 7 task force, agreed that a kidney/pancreas program is desirable. Apparently, most pancreas transplants are also done with kidneys but not vice versa. Relatively, few kidney/pancreas transplants are performed, although the number has doubled nationally since 1991. In 1997, there were 3 kidney/pancreas transplants at Shands, 3 at Mayo- Rochester and 33 at Jackson Memorial. The low volume of the dual transplant procedures reflected both medical skepticism and the absence of insurance reimbursement for the procedure when it was considered experimental. Having performed six dual transplants for no charge in 1998, Shands has been able to convince a majority of its third-party payors in Florida to pay for the procedure. The federal government, through the Medicare program, also changed its policy and now reimburses for kidney/pancreas transplants. As a result, the number of dual transplants is reasonably expected to increase. No CON is issued, under the Florida system, to authorize the dual kidney/pancreas program only. As Methodist noted, St. Luke's did not offer to condition its CON by limiting itself to a dual transplant program. The standardized transplantation ratio (STR), on which the Network Seven Board relied, is the ratio of first kidney transplants to the expected number based on the estimated national rate adjusted for age. For the four Florida organ transplant service planning areas, the STRs reported by Network Seven are as follows: Region 1 (North) 1.00 Region 2 (West Central) 1.35 Region 3 (East Central) 1.19 Region 4 (South) .66 A STR of 1.0 indicates generally, that a region is performing transplants as expected based on the national average. Therefore, the suggestion that the performance is mediocre is rejected. Methodist supports its argument that no need exists for an additional kidney transplant program at St. Luke's, based on Network Seven's finding that the STR for the region is roughly what should be expected. St. Luke's, however, asserted that the STR could be raised to the level of region two with the approval of a new program. In fact, the approval of a program at the Cleveland Clinic in Broward County, in region four, was supported by Methodist's expert health planner, among others, in part, by the desire to raise the STR. That situation can be distinguished based on geography and the failure in region four to meet expectations, while a better performance than the national average is not to be expected necessarily from the approval of another program in the same city in region one. While the STR is helpful in an analysis of need, Rule 59C-1.044(8)(d), Florida Administrative Code, requires consideration of the projected transplant volume based on the number of end-stage renal disease patients. Basically, these are patients whose kidneys have ceased to function. From June to December 1998, Network Seven estimated that the number of patients with kidney failure in service planning area one increased from approximately 2800 to 3000. Using expected population growth only, not the historical growth rate, St. Luke's conservatively estimated in its CON that number of patients would reach approximately 2900 by the end of the year 2000. Because some patients are not medically appropriate transplant candidates or will, for other reasons, never receive the service, St. Luke's used a ratio of patients to project transplant cases. Using only 20% of patients between ages 14 and 65, St. Luke's reasonably projects a need for over 300 kidney transplant surgeries in service planning area one in the year 2000. Using population increase and the lower historical growth rate of 9.5%, St. Luke's established a need for up to 450 kidney transplants in 2000 in service planning area one. Either number is sufficient to document St. Luke's ability to perform at least 15 kidney transplants by the end of the second year of operation, as required by rule. Methodist's expert further reduced by 40% the number of potential transplant patients to get what the projected to be the actual number of surgeries. This number is intended to take into consideration the limited number of cadaveric organs. The result is, however, unrealistically lower numbers, in the range of the actual number of surgeries currently performed in area one and is, therefore, rejected. In fact, despite the limitations on cadaveric organs, the number of kidney transplants has continued to increase. St. Luke's experience with liver transplants is also evidence of its ability to exceed the minimum number of 15 kidney transplants in the second year of operation. Specifically, St. Luke's expects to perform 15 kidney transplants in the first year, and 30 in the second year. More than double the projected number of Florida residents received liver transplants, 25 or 26 as compared to 12 or 13 cases in the first seven months of that program at St. Luke's. Compared to projections of 15 liver transplants in year one, 30 in year two, St. Luke's transplant surgeons actually performed 113 after 18 months. Significantly, the volume at Shands has also increased based on the annualized volume for the first quarter of 1999. St. Luke's also demonstrated that it is successfully transplanting livers which were rejected by other Florida programs. Currently, the same team of transplant surgeons harvests all abdominal organs, livers, kidneys, and pancreases, but can use only the livers at St. Luke's. The surgeons who perform the liver transplants at St. Luke's will also perform kidney transplants. As a result of the team's aggressive use of organs and recent changes in federal government requirements for notice of potential donors and reimbursement policies, St. Luke's is reasonably expected to assist in expanding the available supply of cadaveric organs and in increasing the number of transplant surgeries. Subsection 408.035(1)(a) - need in relation to district plan The District 4 health plan, developed by the Health Planning Council of Northeast Florida, Inc., includes preferences applicable to the evaluation of St. Luke's application. Preference one applies to applicants who will meet identified needs with acceptable quality in an economical manner. St. Luke's expert conceded that its proposal will be more costly and require longer average lengths of stay when compared to that at Methodist but not as compared to other Florida programs. St. Luke's projected an average length of stay of 7.6 days at $50,123 per case, but the Florida average is 10.5 days at $81,048. No construction is required for implementation of the project which has a total cost of $238,450. Therefore, St. Luke's proposal generally meets the requirements of preference one. Preference two, for applicants who will alleviate a geographic access problem, is not met by St. Luke's. One argument advanced by St. Luke's and rejected is that the existing providers are not using organs at the appropriate rate. Considering 1997 data, Shands and Methodist appear not to accept and use kidneys at the expected rate, as calculated and assigned by UNOS. The reported expected acceptance rate for Methodist is 30.7% in contrast to an actual rate of 11.5%. Shand's assigned expected rate is reported to be 53.8% but its actual rate of acceptance is shown as 37.4%. Corrected UNOS data shows the opposite result, that acceptance rates are higher than expected. UNOS data is inconsistent and inconclusive. In general, the data is so unreliable as to have no significant probative value. St. Luke's meets preference three by caring for HIV positive patients. St. Luke's also demonstrated its access to adequate staff for a kidney transplant program, meeting the requirement of preference four. Methodist questioned St. Luke's failure to list a certified transplant nephrologist on its staff, but physician services are provided by salaried employees of Mayo-Jacksonville. Preference five favors applicants who demonstrate that a new service will not have a significant negative impact on similar facilities. Even though there may be sufficient numbers of kidney disease patients who qualify for and have access to transplants in service area one, the geographic overlap of the programs is an issue of concern related to impact. Methodist primarily serves transplant service area one patients. St. Luke's draws 50% of its patients from Duval and the five surrounding counties, 35% from other areas of Florida, and 15% from elsewhere, primarily Georgia and the southeastern United States, but that also includes 3% of international origin. It is reasonable to expect St. Luke's to maintain approximately the same patient origin mix in a kidney program. This mix will require St. Luke's to perform only 8 kidney transplants on patients from service area one in order to reach the minimum volume requirement of 15 in the second year, which is actually projected for the first year. Currently, 16 Mayo-Jacksonville patients who are on the waiting list for kidney transplants at Methodist would likely receive transplants at St. Luke's if it had a program. Taking into consideration growth and applying a traditional impact analysis, Methodist will lose two to four cases, and Shands will lose nine cases in the first year of a competing program at St. Luke's. With that level of impact, both programs remain substantially above the minimum required by AHCA rule. One expert equated the loss of ten cases from Methodist, to a financial loss of $100,000, after reimbursement deductions and reduced expenses. The overall magnitude of Methodist's financial losses is so great that the loss of the contribution from the kidney transplant program is insufficient to affect the hospital's profitability. Similarly, the loss of nine cases from Shands leaves volume significantly above the minimum required. Methodist and St. Luke's differ in their reliance on cadaveric and living donors, which also should help alleviate any impact of competition for cadaveric organs on the existing program at Methodist. While Methodist uses 50% living donors, St. Luke's projects a more traditional mix of 30% living. It is reasonable to expect that the growth in transplants, and the differences in patient and organ origins will allow Methodist to avoid any detrimental effect from the establishment of a program at St. Luke's. Methodist suggested that the approved program in Volusia County, and to a lesser extent, that in Broward County will also be unable to achieve minimum volumes if a program is established at St. Luke's. Methodist's support for the Volusia County program, however, lends credence to St. Luke's assertion that the geographic overlap is minimal. St. Luke's demonstrated that the number of projected transplants, taking into consideration the approved programs, is considerably lower than the expected numerical increase in surgeries. Projections of 30 at St. Luke's, six at the Cleveland Clinic, and 25 at Bert Fish during the year 2000 are achievable from the projected growth in kidney transplants. The data also indicates that the Florida waiting lists for transplant candidates could and should be expanded. Separate transplant provider lists are coordinated into the organ sharing list maintained by UNOS. Nationally, 150 people for every one million are on waiting lists for kidney transplants. That number, even adjusted to exclude older patients, is double the ratio for the Florida waiting list. Some expansion is reasonably expected as a result of the establishment of a new Florida program. The numbers needed and projected at each program, the differences in projected patient origins, the ability to expand the waiting list and the absence of an adverse impact from the establishment of the liver transplant program at St. Luke's provide some assurance that a kidney transplant program will not be detrimental to the existing providers. Preference six, for applicants who will maximize services to rural county residents, is met by St. Luke's service to surrounding rural areas. In addition to the general health plan preferences for CON applicants, the District 4 health plan includes specific preferences for transplant services. The parties stipulated that preferences one and five for applicants in major population areas (over 250,000) and for pediatric services are not at issue. Specific preference two applies to applicants with relationships with a broad spectrum of other health care providers, including agreements for patient transfers and organ procurement. In response, St. Luke's refers to its active participation in the UF OPO. As Methodist notes, however, a continuation of the existing relationship, with Mayo physicians performing kidney transplants at Methodist, is the most cost- effective and non-duplicative alternative. St. Luke's transplant surgeons will continue to provide coverage for the surgeons at Methodist. Transplant-specific preference three favors applicants who have a significant role in regional and national research efforts, including by government contracts or research grants. Methodist insists that a distinction be made between the well- known work of the Mayo Foundation and that of St. Luke's. The Mayo Foundation divides its services into three major segments - medical care, medical research, and medical education. Research is supported by over $100 million from government agencies and $80 million from the Foundation. Over a thousand residents and fellows are enrolled in Mayo educational programs. Over 75 transplant-specific research projects within the Mayo system are coordinated by a single institutional review board. Admittedly, a non-university facility, St. Luke's does participate in Mayo educational and research activities. Over 60 Mayo-Rochester physicians, residents, and fellows were rotating through Mayo-Jacksonville and practicing at St. Luke's at the time the CON application was filed. St. Luke's separate budget for basic science research also exceeded $10 million for over 200 active research protocols. The medical research building at Mayo-Jacksonville exceeds 80,000 square feet in size. For these reasons, St. Luke's demonstrated that its participation in educational and research activities satisfies the preference. Transplant preference four favors applicants with a specific commitment to provide charity care. In its application, St. Luke's commits to providing 6% of total kidney transplants to Medicaid or charity patients. One expert witness noted that St. Luke's commitment exceeds the statewide volume of 4% Medicaid/charity kidney transplant patients, which was the condition for approval of the Bert Fish CON. Most patients with end-stage renal disease are covered by Medicare. In calendar years 1996-1998, Shands provided over 30% Medicaid and from 4 to 8% charity care. Methodist provided from 9 to 11% Medicaid and approximately 2% charity care. By contrast, St. Luke's provided from .7% to 1.2% Medicaid and just over 2% charity case. St. Luke's meets the preferences by specifying a reasonable commitment for the kidney transplant program, although it has historically provided comparatively insignificant Medicaid and charity care. Since organ transplant service area one includes Districts 1, 2, and 3, as well as 4, St. Luke's and AHCA also considered the local health plans for those districts. Both noted that District 3 has a preference for organ transplant applicants which are teaching hospitals, as defined by Florida Statutes. St. Luke's does not meet that preference. It is not a statutory teaching hospital. On balance, St. Luke's does meet the intent of local health plans preferences and, therefore, the requirements of Subsection 408.035(1)(a), Florida Statutes. Subsection 408.035(1)(b) - increase/improve availability, access, quality of care, efficiency, utilization, and adequacy of like and existing facilities in the district In its application, St. Luke's illustrated the concern for renal patients as follows: End-stage renal disease is a large and growing problem in Florida and north Florida. with 14,168 ESRD patients in Florida and 2,822 ESRD patients in service planning area one during 1998, with 787 Florida residents added to the kidney waiting list during 1997, and with Florida resident deaths due to diabetes growing to 3,828 deaths by 1997, the magnitude of the ESRD problem is evident. St. Luke's Exhibit 1 at p. 96. St. Luke's plans to serve an increasing pool of patients within the District and the service planning area. With its aggressive use of organs, St. Luke's can also increase available cadaveric organs, thus increasing numerically, the accessibility, availability and utilization of kidney transplant services in the district. The efficiency of all providers is also reasonably expected to be enhanced due to the introduction of competition into the market. Currently, the relationship between Methodist and Shands is not competitive. Subsection 408.035(1)(c) - quality of care Modeled after that of the Mayo Clinic Rochester, St. Luke's kidney transplant program will be emulating a program with the nation's best survival rates despite its use of organs which have been rejected by others. St. Luke's is licensed by the AHCA, certified to participate in the Medicare and Medicaid programs, accredited by the Joint Commission on the Accreditation of Health Care Organizations (JCAHO), and certified by UNOS to perform transplants. The parties stipulated that St. Luke's has a history of providing a high quality of care. The evidence also supported a finding that St. Luke's will also provide the same high quality of care in kidney transplantation services, using the same physical spaces, by essentially the same staff. St. Luke's staff will require only specialized kidney transplant training and equipment. Subsection 408.035(1)(d) - available and adequate alternatives An alternative to a new kidney transplant provider is the expansion of the volume of cases performed at existing providers. There are no physical constraints to the alternative, only the need for additional staff and supplies. Methodist and Shands can absorb the projected increase in kidney transplant surgeries in the service planning area. Given that lack of constraint, the minimum volume established for existing providers by rule, gives the guidance to determine whether it is appropriate to expand volumes at existing providers or to introduce a new provider. Because there is no competition in the service area in which the existing providers are well above the minimum volume, and the projected volumes for the new programs are exceeded by the projected additional transplants, the establishment of an additional program is appropriate. Subsection 408.035(1)(e) - economies and improvements from joint operative or shared resources The advantages of developing a kidney transplant program at St. Luke's include: the ability to utilize the existing infrastructure which supports the liver and bone marrow transplant programs; and the ability to adopt Mayo Rochester's treatment protocols, standards, and training resources, and to participate in its research projects. The only clearly identified disadvantage is the risk of undermining the cooperation of Mayo-Jacksonville transplant surgeons with Methodist and the loss of some transplant surgeries from Methodist and Shands. On balance, the introduction of a kidney program in Florida, emulating the Mayo-Rochester program, offers a valuable sharing of Mayo resources. Subsection 408.035(1)(f) - need for equipment or services not accessible in adjoining areas St. Luke's proposal will not result in the introduction of any special equipment or services which are not reasonably or economically accessible in adjoining areas. Subsection 408.035(1)(g) - need for research and educational facilities; (1)(h) - needs of training programs and schools for health professionals Mayo-Jacksonville has active research, medical residency, and fellowship training programs in Jacksonville. Most of the inpatient care associated with the research and educational programs is provided at St. Luke's. A new program at St. Luke's offers new educational opportunities for Mayo- Jacksonville physicians. Subsection 408.035(1)(h) - availability of personnel for project accomplishment (see also Rule 59C-1.044) While the statutory criteria generally, considers whether CON proposals include plans to employ the necessary personnel, the organ transplant rule gives much greater detail. As required by rule, St. Luke's has the staff needed to care for the transplant patients. It offers 24-hour on-site dialysis, and is staffed by renal care and dialysis nurses, nutritionists, respiratory therapists, social workers, psychologists, dialysis laboratory workers and administrators. Physicians include board and UNOS certified transplant surgeons, anesthesiologists, pathologists, psychiatrists, nephrologists, endocrinologists, and immunologists and infectious disease specialists. In addition to the health care professionals needed for operation of a kidney transplant program, St. Luke's has significant experience with the data collection process necessary to evaluate adequately a transplant program. Among the requirements of the Rule are a 24-hour shared call system for organ procurement, and clinical review committees, which already exist. St. Luke's operates a 17-bed intensive care transplant unit capable of prolonged reverse isolation, if required. Equipment is available and in operation for cooling, flushing, and transporting organs, as are an on-site tissue typing laboratory and an in-house blood bank, as the parties stipulated. Subsection 408.035(1)(h) - availability of funds for project accomplishment and Subsection 408.035(1)(i) - immediate and long-term financial feasibility The total project cost is $238,450, which covers filing fees, staff training, and equipment. No renovation or construction costs are anticipated because St. Luke's has adequate capacity to implement the kidney program in existing spaces. Methodist's expert testified that the financial feasibility of the project cannot be determined due to errors on Schedule 2 of the CON application and the lack of reliable utilization projections. As previously determined, the utilization projections are supported by the projected number of area one patients with kidney failure who ultimately have transplant surgeries. Schedule 2 of the CON application lists the capital project commitments of the applicant. St. Luke's listed projects which total $35.9 million taken from a "1998 Capital Budget Request Summary." The total, in excess of $35 million, represents the budget request summary of just over 34 million, minus approximately $4 million that had already been spent, plus a little over $5 million for the two pending CONs and expansion of an intensive care unit (ICU). The ICU expansion cost of $500,000, was understated by $766,000. At the hearing, however, St. Luke's expert testified that he mistakenly listed St. Luke's "wish list," when he used $34 million, which exceeded "approved" projects by $17 to $18 million. That total would have been approximately $16,974,000. The available cash and investments for St. Luke's, approximately $80 million, is sufficient to cover the project costs and other capital projects at either $35 million or $16 million, or $21 million if, as asserted at hearing, the $16 million is understated by $5 million. The proposal is financially feasible in the short-term, even considering the decline in available cash and investments to $65 million at the time of the final hearing. In terms of long-term financial feasibility, the experts considered profits or losses from operations. St. Luke's experienced losses from operations of $4.5 million, $4 million, and $12.9 million in the years 1996, 1997, and 1998, respectively. When investment income is considered, however, St. Luke's had a positive income figure of $5.2 million in 1997 and losses reduced to $.7 million in 1998. St. Luke's explained the losses as temporary due to the initiation of costly new services, the enhancement of information systems, and an increase in charity care. The charges for kidney transplants at St. Luke's are expected to equal $57,200 a case, or $1.7 million in gross revenue for 30 cases at the end of the second year of operations. The expected charges are reasonable when compared to charges, in 1996, of $50,000 at Mayo-Rochester, $42,000 at Shands, $38,000 at Methodist, and a Florida average of $81,000. Kidney transplants continue to receive cost-based reimbursements from Medicare. From the $1.7 million in gross revenue, St. Luke's expert projected an incremental profit of approximately $100,000. In addition, the audited financial statements of the Foundation were submitted with St. Luke's CON, with a statement of the Foundation's willingness to fund the project. With over $1 billion in cash and investments and, for 1997, net income over $31 million, the Foundation is able to assure the short and long- term financial feasibility of the kidney transplant program at St. Luke's. Subsection 408.035(1)(j) - needs of a health maintenance organization (HMO) Although the Mayo organization includes a licensed Florida HMO, the proposal is not intended to serve its needs any more than those of any other potential patients. Mayo- Jacksonville and St. Luke's have contracts to provide services to a number of other HMOs. Subsection 408.035(1)(k) - substantial services to non-resident of the district or adjacent districts Currently, St. Luke's attracts 51% of its patients from Duval County, another 21% from the other counties in District 4, 16% from the rest of Florida, and the remaining 12% from outside of Florida. The patient origin for Mayo-Jacksonville is even more geographically dispersed than that of St. Luke's, with 22% of from outside of Florida. By comparison, nearly 99% of Methodist's patients come from North Florida. St. Luke's patient origin data indicates the reasonableness of its expectation that 15% of kidney transplant patients will come from outside Florida. St. Luke's, therefore, meets the criterion for substantial service to non-residents. Subsection 408.035(1)(l) - impact on costs, effects of competition on improvements or innovations in financing and delivering services with quality assurance and cost-effectiveness St. Luke's expects expanded transplant services to reduce its overall fixed cost per transplant. The introduction of a Mayo-affiliated medical program is reasonably expected to introduce beneficial competition to the market which currently has no competition. The fact that competition will come from a nationally-known, very successful program is expected to have a positive impact on existing programs. Subsection 408.035(1)(m) - costs and methods of construction Methodist contends that St. Luke's omission of architectural drawings or floor plans in the CON makes it impossible to consider the statutory criteria related to construction. While St. Luke's failed to include any architectural drawings, it did include descriptions of the existing spaces and in-house services which will support the program. Schedule 1 and 9 of the application show that no costs are associated with construction, expansion, remodeling or demolition. Architectural drawings were not submitted and not required by AHCA for CONs filed by the Cleveland Clinic (kidney transplant), Tampa General (lung transplant), and University Medical Center (heart transplant). In each instance, the facility proposed using existing spaces for the new programs. Based on AHCA's past practices in comparable circumstances, St. Luke's application is not flawed due to the absence of architectural plans. Subsection 408.035(1)(n) - history of and proposed services to Medicaid and medically indigent patients St. Luke's has historically provided limited Medicaid and charity care. See Findings of Fact 39 and 40. St. Luke's proposal to perform 3% Medicaid and 3% charity kidney transplants in the second year of operation is the equivalent of one Medicaid and one charity case. That commitment, however, exceeds the Florida average and the commitment AHCA required of Bert Fish program. The commitment made by St. Luke's is adequate for kidney transplant services. Subsection 408.035(1)(o) - past and proposed continuum of care in multi-level system St. Luke's affiliation with Mayo physicians' practices and the Mayo-Jacksonville clinic allow it to incorporate kidney transplant services into a multi-level system which includes home health and outpatient care. Subsection 408.035(2)(a) - capital expenditures proposals (a) less costly alternatives; (b) utilization of similar services; (c) alternatives to new construction; and (d) serious access problems Subsection 408.032(2), Florida Statutes, defines capital expenditures as follows: "Capital expenditure" means an expenditure including an expenditure for a construction project undertaken by a health care facility as its own contractor, which, under generally accepted accounting principles, is not properly chargeable as an expense of operation and maintenance, which is made to change the bed capacity of the facility, or substantially change the services or service area of the health care facility, health service provider, or hospice, and which includes the cost of the studies, surveys, designs, plans, working drawings, specifications, initial financing costs, and other activities essential to acquisition, improvement, expansion, or replacement of the plant and equipment. In this project, St. Luke's proposes to incur the cost for kidney transplant equipment to establish the new service. The least costly alternative is enhanced Mayo participation in the program at Methodist. Methodist is, however, sufficiently utilized, well in excess of the rule minimum. No new construction is required at St. Luke's to implement the kidney transplant service. Patients will not, however, experience serious problems with access to kidney transplant services if St. Luke's is not approved. There are no physical constraints on the expansion of services at Shands or Methodist. In the absence of physical constraints at existing providers, but in consideration of their volumes which are well in excess of that required, the introduction of competition of the Mayo quality at such low cost is, on balance, desirable for the health care system.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED That a final order be entered issuing CON 9078 to establish a new adult kidney transplant program at St. Luke's Hospital in Jacksonville. DONE AND ENTERED this 17th day of February, 2000, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 17th day of February, 2000. COPIES FURNISHED: Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Richard A. Patterson, Esquire Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308 F. Philip Blank, Esquire R. Terry Rigsby, Esquire Geoffrey D. Smith, Esquire Blank, Rigsby & Meenan, P.A. 204 South Monroe Street Tallahassee, Florida 32301 Michael J. Cherniga, Esquire Seann M. Frazier, Esquire Greenberg Traurig, P.A. Post Office Drawer 1838 Tallahassee, Florida 32302
The Issue Whether Respondent Cleveland Clinic Florida Hospital's Motion to Dismiss the Petition in this case, for lack of standing, should be granted.
Findings Of Fact The facts necessary for disposition of the Motion to Dismiss are not in dispute. The Public Health Trust of Miami-Dade County operates Jackson Memorial Hospital ("JMH") in Dade County (AHCA District 11). In its Petition for Formal Administrative Hearing, certified to have been served on August 19, 1998, the Trust alleged that JMH is the only provider of adult kidney transplantation services within Florida Transplant Service Planning Area 4, which includes AHCA Districts 8, 9, 10 and 11. The Trust described itself in both the Petition and an amended Petition which followed as: [A]n agency and instrumentality of Miami-Dade County, which is organized and operated pursuant to Chapter 154, Part II, Florida Statutes, and Chapter 25A of the Code of Miami-Dade County. It governs and operates Jackson Memorial Hospital and other designated health care facilities. Its address is 1611 N.W. 12th Avenue, Miami, Florida 33136. Amended Petition, paragraph 2, p. 2. The Trust and Jackson Memorial Hospital are both in Dade County, AHCA District 11. With regard to CCFH, the Petition alleged the following. CCFH is located in Fort Lauderdale, Broward County (AHCA District 10). CCFH has CON approval to construct a new facility in Weston, also in Broward County. It submitted an application for an adult kidney transplantation program at the new Broward County facility which was awarded preliminary CON approval as noticed in the Florida Administrative Weekly on July 31, 1998. It is the application for the adult kidney transplantation program at the Weston facility in AHCA District 10 which the petition seeks to have denied contrary to AHCA's preliminary approval. The Petition's allegations with regard to standing are contained in paragraphs seven and eight: As the sole provider of adult transplantation services in Transplant Area 4, Petitioner has standing to file this petition because its substantial interests will be directly affected by the Agency action for which this petition seeks review. The adverse affects to the PHT if the preliminary approval of CON No. 9026 is upheld include but are not limited to: A decrease in the number of procedures performed at JMH, which may impair research objectives and medical proficiency; A loss of needed revenue to JMH, the largest provider of indigent hospital care in Florida; An increase in the competition for professional staffing, thereby driving up the costs of performing these hospital services; and An increase in the cost to the health care system for performing transplant services through he unnecessary duplication of services. Petition for Formal Administrative Hearing, p. 3 and 4. CCFH moved to dismiss the Petition on the basis that the Trust had not alleged facts sufficient to meet the standing requirement in CON proceedings found in Section 408.039(5), Florida Statutes. In essence, CCFH asserted that the Trust had failed to allege that its adult kidney transplantation program in District 11 was within the same district as the challenged kidney transplant program of CCFH approved by AHCA for District 10. In response, the Trust informed the Agency that it had on the same date filed an Amended Petition which, differs substantively from the original petition only in paragraphs 4 and 8, concerning the issue of standing. By filing its Amended Petition, the Trust adds an additional basis for standing, and does not in any manner retreat from the basis for standing asserted in its original Petition. Public Health Trust's Response to Cleveland Clinic Florida Hospital's Motion to Dismiss, p. 2, paragraph 2. The new paragraphs four and eight in the Amended Petition, state: PHT's medical staff (including its transplantation physicians) is provided by the university of Miami School of Medicine, doing business as the University of Miami Medical Group (UMMG), under an affiliation agreement between the PHT and the University of Miami. Through the UMMG, JMH conducts various activities in Broward County as part of its adult kidney transplantation program, including but not limited to the following: UMMG sees approximately one third of all its post transplant patients at two satellite clinics in Fort Lauderdale; and UMMG through the University of Miami's Organ Procurement Organization maintains agreements with various Broward donor hospitals and provides in-service training to hospital personnel involved in organ procurement, including kidney procurement. * * * As the sole provider of adult transplantation services in Transplant Area 4, as an existing health care facility with an established adult kidney transplant program operating in both Districts 10 and 11, Petitioner has standing to file this petition because its substantial interests will be directly affected by the Agency action for which this petition seeks review. Amended Petition, pages 2 and 3. The Amended Petition was filed with the Department Clerk for AHCA on September 4, 1998, prior to the case's referral by AHCA to DOAH. Argument on the Motion to Dismiss was heard on September 28, 1998. Ruling was reserved until entry of this order.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that the Agency for Health Care Administration enter a final order dismissing the amended petition in this case of the Public Health Trust of Miami-Dade County, Florida. DONE AND ENTERED this 14th day of October, 1998, in Tallahassee, Leon County, Florida. DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 14th day of October, 1998. COPIES FURNISHED: Jack P. Hartog, Esquire Assistant County Attorney Jackson Memorial Hospital West Wing 109 1611 Northwest 12th Avenue Miami, Florida 33136 Robert A. Weiss, Esquire Karen A. Putnal, Esquire Parker, Hudson, Rainer & Dobbs LLP 118 North Gadsden Street, 2nd Floor Tallahassee, Florida 32301 Richard A. Patterson, Esquire Agency for Health Care Administration 2727 Mahan Drive, Building 3 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3 Suite 3431 Tallahassee, Florida 32308
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Petitioner, Lakeland Regional Medical Center (LRMC), is a 897-bed private, not-for-profit, general acute care hospital located at 1324 Lakeland Hills Boulevard, Lakeland, Florida. It is considered a major regional referral hospital and provides a wide range of tertiary services, including open heart surgery. The facility is located in District 6 and is one of six facilities in the district having an existing open heart surgery program. Respondent, Department of Health and Rehabilitative Services (HRS), is the state agency charged with the responsibility of administering the Health Facility and Services Development Act, also known as the Certificate of Need (CON) law. On September 26, 1988 intervenor, Winter Haven Hospital, Inc. (WHH), filed with HRS an application for a CON seeking authority to establish an open heart surgery program at its facility in Winter Haven, Florida. After reviewing the application, on February 3, 1989, HRS published notice of its intent to issue the requested CON. If approved, this program would be in competition with similar programs operated by LRMC and intervenor, Hillsborough County Hospital Authority d/b/a Tampa General Hospital (TGH). Those two parties have initiated formal proceedings in Case Nos. 89-1286 and 89-1287 to contest the proposed grant of authority. Intervenor, Venice Hospital, Inc. (Venice), has a pending application for authority to establish an open heart surgery program in a separate administrative proceeding and has intervened in opposition to LRMC's rule challenge. It is noted that LRMC, WHH and TGH are located in District 6 while Venice is located in an adjoining, but separate, district. All parties have standing in this proceeding. In order for HRS to grant a certificate of need, it is necessary for an applicant to satisfy all relevant rule and statutory criteria. In this vein, the agency has promulgated Rule 10-5.011(1)(f), Florida Administrative Code (1987), which contains certain criteria pertaining to open heart surgery programs. That rule provides in relevant part as follows: (f)2. Departmental Goal. The Department will consider applications for open heart surgery programs in context with applicable statutory and rule criteria. The Department will not normally approve applications for new open heart surgery programs in any service area unless the conditions of Sub-paragraphs 8. and 11., below, are met. * * * 11.a. There shall be no additional open heart surgery programs established unless: (1) the service volume of each existing and approved open heart surgery program within the service area is operating at and is expected to continue to operate at a minimum of 350 adult open heart surgery cases per year or 130 pediatric heart cases per year, (Emphasis added) * * * The requirements of this rule, which are unambiguous, and other pertinent statutory and rule criteria, are to be applied by HRS to all applicants, including WHH, during the CON review process. Although the rule itself is not being challenged by LRMC, subparagraph 11.a. of the rule is at the heart of this controversy. Petitioner and TGH contend that the clear language of the rule requires that, absent the existence of not normal circumstances, HRS may not award a CON unless each existing and approved open heart surgery program in the service area is operating at and is expected to continue to operate at 350 procedures per year. Because there are now six approved and existing open heart surgery programs in the district, petitioner argues that the rule mandates that, before a new program can be authorized, each of the six programs must meet the required level of 350 procedures per year. They contend further that the particular policy applied by HRS to WHH's application is not apparent on the face of rule 10-5.011(1)(f)2. and thus it constitutes an unpromulgated rule. In preliminarily approving WHH's application, HRS admits that it used a so-called averaging policy which it agrees may be described in the following manner: HRS has formulated and is applying in reviews of Certificate of Need ("CON") applications for new open heart surgery services a policy of general applicability that is uniformly and consistently applied, which calls for the averaging of the utilization of existing and approved adult open heart surgery programs in the applicable service area, and which deems subparagraph 11.a.(I) of Rule 10-5.011(1)(f), Fla. Admin. Code, to be met if the average utilization of all such existing and approved programs in that service area is at least 350 cases (the "Averaging Policy"). Pursuant to its Averaging Policy, HRS will approve a CON application for a new adult open heart surgery program under Rule 10- 5.011(1)(f), Fla. Admin. Code, even if each existing and approved program in the proposed service area is not operating at a minimum of 350 adult cases per year, and even if no "not normal" circumstances are presented in the application or found to exist in the State agency Action Report. Stated another way, HRS deemed subparagraph 11.a. to have been met in WHH's case because, after dividing the total number of procedures performed district wide by the number of existing and approved programs, there were an average number of procedures in excess of 350 for each program in the district. It used this averaging process even though two programs were not operational at the time the review process took place, and only two (LRMC and TGH) of the six programs had actually performed more than 350 procedures during the specified time period being measured. 1/ Thus, the averaging policy used by HRS allows approval of a CON application for open heart surgery even if only some programs in a district, rather than each, have the required 350 case volume. The averaging technique has not been reduced to writing in a memorandum, manual or agency policy directive, and it has not been formally adopted as a rule. In this regard, HRS, but not WHH and Venice, has admitted that the policy is indeed a rule. The results of applying that "rule" are contained in the state agency action report issued by HRS and made a part of this record. HRS has consistently and uniformly applied this averaging technique in every open heart surgery case except one since the rule was adopted in substantially its present form on February 14, 1983. 2/ It has been applied without discretion by those HRS personnel who have the responsibility of administering the CON law and regulations. The proponents of the averaging policy argued first that the language in subparagraph 11.a. authorized its use. However, nothing in the language of the existing rule expressly refers to an averaging process. They also contended that when other provisions within the rule are read, the use of the policy becomes apparent. More particularly, they pointed to subsection (7) of the rule which requires that the provision of open heart surgery be consistent with the state health plan. That plan provides in part that one of its objectives is to maintain an average volume of 350 procedures at all programs in the state. However, the state health plan is not mentioned in subparagraph 11.a., subsection (7) does not track or mirror the averaging technique, and the same subsection does not alert the user of the rule to the fact that an averaging process will be applied.
The Issue Whether respondent should grant petitioner's application for a certificate of need for a ten-station chronic hemodialysis center in Broward County?
Findings Of Fact At the time petitioner's application was originally submitted, an unmet need for hemodialysis facilities appeared to exist in Broward County. The project review committee and the board of directors of the Health planning and Development Council for Broward County, Inc., recommended denial of petitioner's application and of all applications for new facilities, however. Competing applicants seeking to expand and establish a satellite were awarded certificates of need because their personnel had proven track records. Petitioner's application was tentatively denied, not because it was deficient, but because competing applications were deemed stronger. With the approval and addition of hemodialysis units since that time, Broward County has become saturated with dialysis centers, and now has significant excess capacity. As of January 1, 1981, there were eight dialysis centers in Broward County, which is coterminous with the jurisdiction of the Health Systems Agency for respondent's District VIII, the Health Planning and Development Council for Broward County, Inc. These eight dialysis facilities had, in the aggregate, 125 approved stations, as of January 1, 1981. Five free-standing stations have since been approved for Plantation Artificial Kidney Center. Respondent's Exhibit No. 3. Countywide, the 125 hemodialysis stations then existing had a utilization rate of 67 percent in January and February of 1981, winter months in which Broward County experiences an influx of seasonal residents. On January 31, 1981, there were 29 seasonal hemodialysis patients in Broward County and, on February 28, 1981, there were 38. Respondent's Exhibit No. 1. Broward County has a population of approximately one million persons. Using the formula prescribed in respondent's rules, Florida End Stage Renal Disease Network 19 projected that 353 patients would require in-center dialysis in 1980, while in fact only 339 patients required dialysis outside their homes. This need could have been met with 106 stations, on the basis of 3.2 patients per station, instead of the 125 stations that existed in Broward County in fact in 1980. For December of 1981, the projection is that 349 patients will require 109 stations; for December of 1982, it is projected that 359 patients will require 112 stations; and for December of 1983, it is projected that 371 patients will require 116 stations, on the basis of 3.2 patients per station. Respondent's Exhibit No. 3. Customarily, dialysis centers are open for business six days a week, with each machine available for two shifts daily. Dialysis usually entails three sessions weekly for the patient so that, if fully utilized, one machine could service four patients. Approximately ten hemodialysis stations in Broward County are set aside for patients with hepatitis positive antigens. These isolation stations are not ordinarily fully utilized. On this account and because of seasonal changes in the numbers of hemodialysis patients in Broward County, the health systems plan looks to an 80 percent utilization rate (on the basis of two shifts a day, even though the machines could he used for three shifts daily in an emergency). This utilization rate translates into 3.2 patients per machine. Another objective of the health system plan is that 95 percent of patients be within 30 minutes of a hemodialysis center. The annual implementation plan calls for 132 stations by December of 1982, without adding any new centers. Dialysis patients in south Florida are older than dialysis patients in north Florida, on the average. Most dialysis patients in Broward County are more than 50 years old. In 1978, Broward County's increase in patients with end stage renal disease was the highest among [Florida's] HSA areas. Petitioner's Exhibit No. 4. Historically, Broward County has had the highest acquisition rate in Florida, although the rate has fallen recently. In 1978, the acquisition rate in Broward County was approximately 138 per million population. By 1980, it had dropped to 119 per million persons. The state average for 1980 was between 105 and 110 per million. In September of 1979, 122 of the 305 persons receiving chronic hemodialysis treatments in Broward County came from Dade County and ten postal zones in the south end of Broward County. Petitioner's Exhibit No. 5. Residential growth in Broward County is occurring principally in the western part of the county. Petitioner proposes to build a ten-station hemodialysis facility at 4175 Southwest 84th Street, in Davie, Broward County, Florida. Dr. Herold, a nephrologist, would refer patients to petitioner's facility, if it is built, and if the South Broward Artificial Kidney Center fills up. Although not an expert in making such projections, Dr. Herold "would say ten [of his] patients, as a guesstimate, Deposition, p. 6, would be referred to petitioner's proposed facility annually. Dr. Zeig, another nephrologist, said three of his patients were in imminent need of dialysis, as were six patients of a former associate of his, a Dr. Levinson. Dr. Zeig testified that he would refer his patients, "upwards of eight to ten . . . in the coming year," Deposition, p. 10, to petitioner's facility, if built. In his deposition, Dr. Rose testified on April 20, 1981, that he could refer "in the range of five to maybe seven" patients to the proposed facility within "the next year." These projected patients are among the 122 persons forecast to develop end stage renal disease in Broward County in 1981 or the 125 expected to be afflicted in 1982. Respondent's Exhibit No. 3. Petitioner projects that the proposed facility could break even with eight patients. Medicare pays for about 95 percent of renal dialysis treatments, nationally. Three or four dialysis centers are within 20 minutes driving time of the site petitioner proposes. The proposed facility would be approximately six miles from Plantation Artificial Kidney Center (15 approved stations 80 percent utilized as of February 28, 1981), and only three or four miles from the Nephrology Associates' satellite facility in Pembroke Pines (four approved stations 44 percent utilized as of February 28, 1981). Located in Broward County south and east of petitioner's proposed facility are South Broward Artificial Kidney Center in Hollywood (30 approved stations 80 percent utilized as of February 28, 1981) and Nephrology Associates' main facility, which is also in Hollywood (10 approved stations 65 percent utilized as of February 28, 1981). Petitioner's Exhibit No. 5; Respondent's Exhibit No. 1. Petitioner's facility would be next north of the southernmost of what would be five hemodialysis centers in the western part of Broward County. Petitioner proposes to offer patients "free" transportation to and from the proposed facility. At present, only one hemodialysis facility in Broward County, Plantation Artificial Kidney Center, provides transportation for patients. There was testimony, however, that Broward County would provide transportation "through coordination with each of the dialysis facilities, if needed." Block Deposition, p. 19. Some patients requiring dialysis perform dialysis themselves at home. This practice is likely to increase significantly as a result of recent advances in continuous ambulatory peritoneal dialysis techniques. Projections that 35 persons in Broward County would elect this method of dialysis in 1981, 30 in 1982, and 40 in 1983 were not shown to be unrealistic, even though Broward County's home dialysis rates have historically been extremely low. On February 28, 1981, 13 of the 350 hemodialysis patients in Broward County underwent dialysis at home. In 1978, there was only one such patient in Broward County. Eighty-seven hemodialysis patients or approximately 19 percent of the total in Broward County died in 1980. Half of the four attempts to transplant kidneys in Broward County failed in 1980. As a practical matter: patients are likely to follow their physicians' advice about which dialysis center to go to. Dr. Herold testified that he choose[s] not to use, Deposition, p. 9, Nephrology Associates' satellite facility for some unspecified medical reason. Dr. Zeig expressed similar sentiments, but also testified that "all our patients were dialysized there, Deposition, p. 8, during the time that he himself had been associated with Nephrology Associates. Dr. Zeig also testified that he had a letter from Nephrology Associates' board of directors advising him he was unwelcome there. Dr. Rose testified that he would not refer patients to Nephrology Associates' satellite facility because of "strong feelings based on medical conditions that exist that I, too, choose not to discuss." Deposition, p. 5. There was hearsay testimony to the effect that Nephrology Associates reused chemical dialyzers, but absolutely no evidence tending to show that this was not good medical practice or that any formal complaint about Nephrology Associates had been filed anywhere on any ground. Nephrology Associates is fully certified for Medicare purposes. In preparing the foregoing findings of fact, the hearing officer had the benefit of respondent's memorandum, petitioner's memorandum of law, and petitioner's proposed recommended order. To the extent petitioner's proposed findings of fact have not been adopted in substance, they have been rejected as unsupported by or contrary to the evidence; or have been deemed irrelevant.
Recommendation It is, accordingly, RECOMMENDED: That respondent deny petitioner's application for certificate of need. DONE AND ENTERED this 7th day of July, 1981, in Tallahassee, Florida. ROBERT T. BENTON, II 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 7th day of July, 1981. COPIES FURNISHED: Guyte P. McCord, III, Esquire and Cynthia S. Tunnicliff, Esquire Post Office Box 82 Tallahassee, Florida 32302 Eric J. Haugdahl, Esquire 1317 Winewood Boulevard Tallahassee, Florida 32301 Richard Baron, Esquire Suite 500 444 Brickell Avenue Miami, Florida 33131 =================================================================
Findings Of Fact At all times relevant hereto Respondent was licensed to practice medicine in the State of Florida and was issued License No. ME 0027980 (Exhibit 6). During the period 1984-86 Respondent operated Tampa Family Practice Center as Gold Plus HMO. He owned the clinic or at least totally controlled the clinic by closely supervising the doctors who worked for him at the clinic, requiring his approval of all medications prescribed for patients, for any referrals of patients to a consultant, or for hospitalization, all in an attempt to keep costs down. This clinic operated as a family practice clinic, and doctors were required to schedule up to 40 patients per day. No nephrologist or internal medicine specialists worked at the clinic. L. M. received a kidney transplant in 1983 through the aegis of the Tampa Transplant Clinic and, following the transplant, was monitored by the clinic for several months on a routine basis. In 1984, L. M. applied to join Respondent's Gold Plus HMO and was accepted as a patient by Respondent, after L. M. disclosed that he had received a kidney transplant in 1983. L. M.'s reason for joining the HMO was to save money on his medications. L. M. was told by Respondent that the clinic would not normally accept kidney patients, but because L. M. had received a transplant he was no longer considered a renal patient. L. M. was treated at Respondent's clinic for approximately twenty months during which period he was never referred to a nephrologist, nor were L. M.'s medical records requested from the doctors who had treated L. M. following his kidney transplant. At his clinic visits, his temperature, blood pressure and weight were taken, and his prescriptions for the drugs he was taking when he enrolled in Gold Plus were renewed. During the final three months L. M. was treated at Respondent's clinic he lost approximately 40 pounds and started to feel poorly with nausea and lowering of his blood pressure. Despite the lowering of L. M.'s blood pressure, his medication to combat high blood pressure was continued. L. M. also suffered from diabetes and required insulin. Had L. M. been referred to a nephrologist before his condition became critical, blood tests would have shown that the kidneys were not functioning normally and that some of the medications he was receiving were contra- indicated. It would also have shown he needed additional medication. L. M.'s condition deteriorated rapidly, and he "crashed". He was transported to Carrollwood Community Hospital by ambulance as Respondent's patient, but he was not seen at the hospital by Respondent. However, a representative from Respondent's clinic went to the hospital to induce L. M. to sign a paper disenrolling himself from Gold Plus. Despite, or because of, his serious illness at this time, L. M. did not sign the release. As L. M.'s condition appeared critical to the nurses at Carrollwood Community Hospital, the head nurse called Dr. Goldstein, a nephrologist who had treated L. M. before his transplant, to advise him L. M. was a patient in critical condition, and Respondent wasn't providing any help. Dr. Goldstein telephoned Respondent to tell him L. M. should not be at a community hospital where renal patients cannot be adequately treated without dialysis facilities and that L. M. should be transferred to Tampa General Hospital to the care of the renal transplant team. Respondent said he would try to arrange for the transfer of L. M., but needed to work out some financial arrangements. When Dr. Goldstein learned a few hours later that L. M.'s transfer to Tampa General had not been ordered, he again called Respondent to demand that L. M. be transferred to Tampa General. Shortly thereafter L. M. was transferred, and upon his arrival an acute hemodialysis was done. At this time, L. M. had fluid in his lungs, a pulmonary infection, a blood count showing no kidney function and liver damage. Without dialysis L. M. would not have survived. Following his discharge from Tampa General L. M.'s transplanted kidney is working but not as well as it had before the inadequate treatment led to his crash. Because of this setback, L. M. will likely require a regrafting of another kidney in the future. Another patient of Respondent was E. J., an end stage renal patient who, once he enrolled in Gold Plus, was never referred to a nephrologist for consultation, nor were E. J.'s records obtained by the clinic from the nephrologist who had earlier treated E. J. E. J. had been admitted to Carrollwood Community Hospital several times before May, 1985 when he was admitted by Respondent suffering from kidney disease. Shortly after admission, E. J.'s condition deteriorated to the point the nurse became apprehensive for his survival. On the morning of May 22, 1985, the floor nurse was very concerned about E. J. and called in her supervisor. The only treatment that had been ordered by Respondent for E. J. was oxygen to help his breathing. The head nurse observed E. J. to be short of breath and afraid he was dying. She called Respondent to relay the patient's condition and requested Respondent's presence. Respondent repeated this order for oxygen and told the nurse to put Johnson on "no code". The nurse told Respondent that "no code" would not be accepted by the hospital over the phone and that he would have to personally sign the order at the hospital. Respondent told the nurse to call E. J.'s family and have them come to the clinic. When the nurse called Respondent again shortly thereafter, he hung up on her. "No code" is the status reserved for terminally ill patients with no hope of recovery and a very short time to live. "No code" means that emergency measures will not be adopted to keep the patient alive and is ordered only after the doctor has discussed the patient's condition with the family and with the patient if he is capable of understanding, and all agree that is best for the patient. Fearing the patient would die, the nurse then called Dr. Goldstein and requested he look in on E. J. A few minutes later, the nurse again called Dr. Goldstein to request he come as soon as possible. Dr. Goldstein arrived at Carrollwood Community Hospital shortly thereafter. Upon his arrival, Dr. Goldstein found E. J. short of breath but sufficiently alert to say he didn't want to die. Dr. Goldstein recognized that E. J. needed dialysis as soon as possible and arranged to have the patient transferred to St. Joseph Hospital where hemodialysis was performed. E. J. recovered. E. J.'s medical records showed that while under the care of Respondent he had been admitted several times to Carrollwood Community Hospital with the same symptoms, but no nephrologist had ever been consulted on this patient. The patient had been given treatment and prescriptions to treat the symptoms of his problem, but was never referred to a dialysis center for the hemodialysis he needed until the intervention of Dr. Goldstein. No competent evidence was submitted that Respondent told L. M. that he could use no other physician while a member of Gold Plus. The hearsay testimony to this effect was not corroborated by the testimony of L. M. or any other witness who heard such instruction given. Competent evidence was presented regarding Respondent's reluctance to admit patients to hospitals, even for emergencies, and his close monitoring and approving of prescriptions that the doctors working at Gold Plus issued to patients. This evidence clearly demonstrates that Respondent exercised influence on the patients in such a manner as to exploit them for financial gain. A physician trained in family practice only is not competent to treat an end stage renal patient without referring the patient to a nephrologist for consultation. No evidence was submitted that Respondent had training in nephrology other than what he received while in medical school or as an intern. A nephrologist who does not work frequently, if not exclusively, with renal transplant patients is not competent to treat a transplant patient without consultation with a transplant specialist. Changes in the field of transplant and immunosuppressant medications are occurring so rapidly that a physician needs to work in this field almost daily to remain current and qualified to safely treat and monitor such patients.
