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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs KURT STEVEN DANGL, M.D., 04-002707PL (2004)
Division of Administrative Hearings, Florida Filed:Sarasota, Florida Aug. 03, 2004 Number: 04-002707PL Latest Update: Oct. 19, 2005

The Issue Whether Respondent violated Subsections 458.331(1)(d), 458.331(1)(m), 458.331(1)(t), 458.331(1)(ll), and 458.331(1)(nn), Florida Statutes (2001),1 and, if so, what discipline should be imposed.

Findings Of Fact The Department is the state agency charged with regulating the practice of licensed physicians pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. Dr. Dangl, whose address of record is 3900 Clark Road, Suite E-1, Sarasota, Florida 34233, was issued Florida license number ME 71286 to practice medicine in Florida. During all relevant periods of time, he was not board-certified by the American Board of Medical Specialties or by any agency recognized by the Board of Medicine. Dr. Dangl is the holder of a D.M.D. degree from the Washington University School of Dental Medicine in St. Louis, Missouri. He is not licensed as a dentist in Florida, but he has previously held dental licenses in Missouri, Pennsylvania, and Virginia. He is specialty certified by the American Board of Oral and Maxillofacial Surgery. This specialty is related to the practice of dentistry. During all relevant periods of time, Dr. Dangl's office was fully and properly registered as an office surgical facility. During all relevant periods of time, Dr. Dangl did not have hospital privileges. On August 17, 2001, C.S., a female who was at that time 63 years old, came to Dr. Dangl's office for a consultation regarding facial rejuvenation and body contouring. Dr. Dangl saw C.S. and recommended "that she consider cervicofacial rhytidectomy with full face carbon dioxide laser resurfacing and autogenous fat transfer to the facial area." He further determined that the "degree of liposity in the abdomen and flanks is minimal and this can also be treated at the same time with low-volume tumescent liposuction." Prior to her consultation with Dr. Dangl, C.S. had seen an advertisement for Dr. Dangl in the "Sarasota Herald-Tribune." The advertisement listed Dr. Dangl as "Kurt Dangl, M.D., FAACS" and underneath his name appeared the words "Board Certified." From reading the advertisement, C.S. assumed that Dr. Dangl was board-certified in cosmetic or plastic surgery. C.S. returned to Dr. Dangl's office on August 21, 2001, for preoperative counseling. She signed consent forms for the procedures to be performed. The consent forms listed potential risks and complications involved with the procedures. Complications included infection, wound breakdown, and skin necrosis. The consent forms stated that Dr. Dangl did not guarantee specific results and that wound healing was outside the control of the patient and Dr. Dangl. On the printed consent forms the abbreviation "D.M.D." followed Dr. Dangl's name. No evidence was presented that the consent forms were being used as advertisements. C.S.'s medical records in Dr. Dangl's files indicate a blood sample was taken from C.S. on August 21, 2001, and sent to AccuLab. An AccuLab report dated August 22, 2001, indicated that C.S. had a slightly lowered hemoglobin level of 35.5. Based on a notation on the report, it appeared that Dr. Dangl reviewed the report on August 23, 2001. There is a handwritten note on the AccuLab report that the hemoglobin count was "ok for planned procedure." Dr. Dangl did not advise C.S. prior to the surgical procedures that her hemoglobin count was low. Dr. Dangl's records indicate that C.S. gave a medical history prior to the surgery and that Dr. Dangl performed a physical examination of C.S. prior to the surgery. C.S. advised Dr. Dangl that she had had her coccyx removed about six weeks before her scheduled cosmetic surgery. On August 28, 2001, C.S. returned to Dr. Dangl's office to have Dr. Dangl perform a face and neck lift, laser resurfacing of the face, removing fat from her abdomen and flanks, and transferring some of the fat from the abdomen and flanks to specific areas in her face. Betsy Shecter, who is licensed as an advance registered nurse practitioner in Florida, was the nurse anesthetist for C.S.'s procedures. Ms. Shecter's first contact with C.S. on August 28, 2001, occurred at 13:05, when she interviewed C.S. and then escorted C.S. to the operating room. At 13:15, C.S. was given valium, and an IV infusion of propofol and Sufenta was placed in C.S.'s arm around 13:20. Propofol is an anesthetic and Sufenta is a synthetic narcotic. C.S. was prepped and draped around 13:30, and a local anesthesia was injected at 13:35. Because the local anesthesia required about 20 to 30 minutes to become active, Dr. Dangl did not make the first incision until 14:05. The liposuction procedure to harvest the fat for a fat transfer occurred between 14:05 and 15:00. After liposuction, a local anesthesia was injected in the areas where the face lift would be performed. At 15:20, a garment was applied to the areas where fat had been harvested to keep the swelling down. Sequential leg compressions were put in place to avoid blood clots. The actual face lift started around 15:30 and ended around 20:20, when Ms. Shecter put Opticane ointment and corneal shields in C.S.'s eyes for the laser procedure. The laser procedure began around 20:25. At around 21:00, Ms. Schecter turned off the propofol drip to which Demerol had been added. The actual laser surgery stopped at approximately 20:55. The eye shields were removed at 21:15. The recovery time in the operating room commenced at 21:00 when the drugs were stopped and ended around 21:45. The recovery time continued until C.S. was discharged at 22:30. At the time of her discharge, C.S.'s vital signs were stable, and she was alert and oriented. C.S. was told prior to the surgery that someone would have to stay with her overnight after the surgery. C.S. made arrangements for her daughter and C.S.'s sister to stay overnight with her. C.S.'s sister had training and experience as a certified nurse assistant. Prior to the surgery, Dr. Dangl told C.S. that she would probably be ready to go home around four or five o'clock (16:00 or 17:00). She made arrangements with her daughter to pick her up around 17:00. When her daughter inquired from Dr. Dangl's office at 17:00 whether her mother was ready to leave, she was advised that surgery had not been completed. C.S. was not discharged until over five hours after her daughter first contacted Dr. Dangl's office. C.S.'s daughter became visibly upset when she saw her mother after the surgery and wanted to have C.S. admitted to a hospital. Because of the daughter's agitation, arrangements were made for a licensed practical nurse, Ruth Schneider, to stay overnight with C.S. C.S.'s daughter and sister had some difficulty in getting C.S. into the car for the trip home because of the sequential leg compressions, which C.S. wore home. Dr. Dangl and Ms. Shecter put C.S. in the car. At the time that C.S. was put in the car, C.S. was able to stand on her own and able to walk with support. When C.S. arrived home, Ms. Schneider assisted C.S. into her home. At that time, C.S. was alert and oriented and could ambulate with assistance. When C.S. got in her home, she was able to drink and take nourishment. Ms. Schneider helped C.S. ambulate to the bathroom. C.S. sat in a recliner and slept some during the night. At the close of Ms. Schneider's eight- hour shift, she left C.S. in the care of C.S.'s sister. C.S. was scheduled for a follow-up visit with Dr. Dangl on August 29, 2001, but C.S.'s sister was unable to arouse C.S. and get C.S. up to go to the doctor's office. Dr. Dangl's office was advised that C.S. could not come to his office. Dr. Dangl came to C.S.'s home around nine or ten o'clock in the evening of August 29, 2001, for a follow-up visit. He removed the dressings from her wounds and applied an antibiotic ointment. Dr. Dangl apparently did not have bandages with him that he could place on the surface of the wounds because he asked the sister for sanitary napkins to use as a dressing. C.S.'s sister retrieved sanitary napkins from the bathroom, and Dr. Dangl, using scissors from a nearby basket, cut the napkins up and used them to dress the wounds. He reused the Ace-type bandages which he had removed and placed them over the sanitary pads. C.S. was instructed to come to Dr. Dangl's office on August 31, 2001, for her 72-hour postoperative evaluation. On August 31, 2001, C.S.'s sister took C.S. to Dr. Dangl's office. C.S.'s sister did not accompany C.S. into the treatment room. Dr. Dangl removed the dressings and inspected the wounds. There was no evidence of hematoma, seroma, or infection. He noted that there was a "small area of devascularization immediately anterior to the left tragus on the left side" and described the areas as "about the size of a quarter." His notes indicate that the area would be "followed expectantly and debrided as necessary." He was to follow up with C.S. in 48 or 72 hours. When Dr. Dangl came out of the treatment room, he saw C.S.'s sister and asked her what was wrong with her. She explained that she was tired from being up all night with C.S. Dr. Dangl asked the sister why she did not take one of the sleeping pills that he had prescribed for C.S. The sister replied, "What? Why would you tell me to do that, take someone else's medicine?" Prior to this conversation, Dr. Dangl had not examined the sister in any way, gotten her medical history, or asked her whether she was taking any other medications. Over the next several days, C.S. complained to her sister that she was burning, hurting all over, and was not able to sleep or rest. On September 3, 2001, C.S.'s daughter called Dr. Dangl's office and advised that C.S. had a foul smelling discharge in front of her left tragus. Dr. Dangl called in a prescription for antibiotics for C.S. and told C.S.'s daughter that he wanted to see C.S. the following day. Dr. Dangl saw C.S. in his office on September 4, 2001. His examination of C.S. revealed that the size of the devascularized area in front of her left tragus had increased four times. There was some foul smelling yellow-brown discharge coming from this area as well as from several areas under the mandible approximately following the locations of the previously placed drains. He debrided the devitalized area and irrigated the discharge areas with an antibiotic solution and hydrogen peroxide. An intravenous antibiotic was administered, and wound cultures were obtained from various sites. Dr. Dangl again saw C.S. in his office on the evening of September 4, 2005. There was a minimal amount of drainage and no foul smelling odor. On September 5, 2001, C.S. again presented to Dr. Dangl's office for postoperative infection evaluation and treatment. There was a mild purulent discharge in the left anterior neck and at the left post auricular area. Dr. Dangl debrided the wound area and irrigated the wound area with sterile saline. C.S.'s pain medication was increased. Dr. Dangl saw C.S. in his office on September 6, 2001, for further wound treatment. The laboratory results of the wound cultures indicated a light growth of E. coli. Dr. Dangl administered an antibiotic intravenously and removed necrotic tissue. C.S. returned to Dr. Dangl's office on September 7, 2001. Her temperature was 100.6 degrees Fahrenheit, and she was complaining of significant discomfort. Dr. Dangl debrided the wound area. He examined the abdomen and flank incisions and found no evidence of infection or other signs of untoward wound healing. C.S.'s daughter accompanied her mother to Dr. Dangl's office on September 7, 2001, and expressed her concerns about her mother's condition. The daughter felt that her mother might benefit from hospitalization. Dr. Dangl referred C.S. to Dr. Manual Gordillo for evaluation and determination of the need for hospitalization. Dr. Gordillo treated infectious diseases. Dr. Gordillo saw C.S. and advised C.S. and her daughter that the treatment for the infection could be done in the hospital or on an outpatient basis, but expressed his opinion that admission to the hospital was borderline. C.S. opted for hospitalization and was admitted to Doctors Hospital of Sarasota on September 7, 2001. After C.S. was admitted to the hospital, additional cultures were taken of the wound sites as well as the sites in the abdomen where fat had been harvested. Based on the laboratory results, C.S. had a scant growth of E. coli from her face wound culture and a moderate growth of staphylococcus aureus from abdominal wound culture. C.S. was placed in isolation because of the staph infection. C.S. was experiencing a great deal of pain from her wounds while she was in the hospital. Because of her difficulty with pain management, she was put on a PCP pump to help control the pain. While she was in the hospital, Dr. Dangl visited her several times to observe. He did not perform any treatment on C.S. while she was hospitalized. C.S. told Dr. Dangl that she wished that he would not visit her while she was in the hospital, but he continued to come. The evidence is not clear and convincing that C.S. conveyed to Dr. Dangl that she did not want his services any longer, particularly in light of C.S.'s paying office visits to Dr. Dangl for treatment after she was discharged from the hospital. However, the evidence is clear and convincing that C.S. did not want Dr. Dangl to visit her in the hospital and that she told him so. Dr. Dangl's medical records do not establish a medical basis for continuing to see C.S. in the hospital after she asked him not to do so. C.S. was discharged from the hospital on September 13, 2001. At that time, she was feeling much better, her wounds were stable, and her wounds were not clinically overtly infected. She was directed to follow up with Dr. Dangl as soon as the following day and to follow up with Dr. Gordillo within a week. After her discharge from the hospital, C.S. continued to see Dr. Dangl on September 15, 17, 19, and 21, 2001. Dr. Dangl changed the dressings and, on two of the visits, did some minimal debridement. C.S. discontinued seeing Dr. Dangl after her office visit on September 21, 2001. On September 24, 2001, C.S. began seeing Dr. John Leikensohn, a plastic and reconstructive surgeon, for wound treatment. He diagnosed C.S. as having massive skin necrosis. When C.S. began seeing Dr. Leikensohn, she was asked to sign a medical release for her medical records from Dr. Dangl, and she did so. Dr. Leikensohn's staff contacted Dr. Dangl's office by telephone to get C.S.'s records. The medical release was sent by facsimile transmission to Dr. Dangl's office with a request for C.S.'s records. By October 2, 2001, Dr. Leikensohn had not received the records from Dr. Dangl. Dr. Leikensohn asked C.S. and C.S.'s daughter to stop by Dr. Dangl's office and get a copy of the records. C.S. went to Dr. Dangl's office and personally asked his staff for her records, but was not given the records. She also submitted a written request for her records, but did not receive them pursuant to the written request. Barbie Beaver, Dr. Dangl's office coordinator, does not recall when or from whom she actually received a request for C.S.'s records, but she does remember sending C.S.'s medical records to Barbara Dame, Dr. Dangl's risk manager, for her review on September 27, 2001. When Dr. Dangl's office received a request for a patient's records, she would advise Dr. Dangl and he would decide what to do. She gave a request for C.S.'s medical records to Dr. Dangl, and he instructed her to send them to Ms. Dame for review prior to releasing the records. Ms. Beaver does not recall when she actually sent C.S.'s records to the person who requested them. During his treatment of C.S., Dr. Dangl wrote several prescriptions for C.S. The prescription scripts contained the abbreviation "D.M.D." after his name. No evidence was presented that the prescriptions were intended to be used for advertising purposes. Dr. John J. Obi, a board-certified plastic surgeon, testified as the Department's expert witness. It is Dr. Obi's opinion that it would have been good medical practice to have advised C.S. of her low hemoglobin prior to surgery, but that because the blood level was not dangerously low, he could not "say that's a complete deviation from the standard of care." Dr. Obi further opined that Dr. Dangl exceeded the eight-hour limitation on elective cosmetic surgery in a physician's office when he performed the procedures on C.S. on August 28, 2001. Dr. Obi's opinion is based on his incorrect understanding that the anesthesia was stopped at 22:00. Thus, even if the time for calculating surgical procedures ran from the time the anesthesia was first administered at 13:15 until it was stopped at 21:00, the length of time for the surgical procedures was seven hours and forty-five minutes. Dr. Obi opined that the recovery time for C.S. was insufficient. Again he based his opinion in part on his incorrect assumption that the anesthesia was discontinued at 22:00. Dr. Obi creditably testified that Dr. Dangl's continuing to see C.S. in the hospital after she told him that she did not want him to visit fell below the prevailing standard of care. Dr. William Frazier, the expert who testified on behalf of Dr. Dangl, gave no opinion on whether Dr. Dangl's continued hospital visits after being told not to visit by C.S. violated the standard of care. Dr. Obi opined that it was a violation of the standard of care for Dr. Dangl to tell C.S.'s sister to take some of C.S.'s prescription sleeping pills without examining or taking a medical history of the sister. Dr. Frazier was of the opinion that the conversation between Dr. Dangl and C.S.'s sister did not fall below the standard of care. Dr. Frazier's opinion was based on his misunderstanding that C.S.'s sister had asked Dr. Dangl if it was appropriate for her to take a sleeping medication that she already had.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Dangl violated Subsections 458.331(1)(m), 458.331(1)(t), 458.331(1)(ll), and 458.331(1)(nn), Florida Statutes; finding that Dr. Dangl did not violate Subsection 458.331(1)(d), Florida Statutes; imposing an administrative fine of $2,000 for the violation of Subsection 458.331(1)(nn), Florida Statutes; imposing an administrative fine of $3,500 for violations of Subsection 458.331(1)(t), Florida Statutes; imposing an administrative fine of $1,000 for the violation of Subsection 458.331(1)(ll), Florida Statutes; imposing an administrative fine of $1,000 for the violation of Subsection 458.331(1)(m), Florida Statutes; suspending his license for two years; and requiring Dr. Dangl to attend continuing medical education classes to be specified by the Board of Medicine. DONE AND ENTERED this 16th day of August, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 16th day of August, 2005.

Florida Laws (7) 120.569120.5720.43456.057458.331458.3312766.102
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs WALKER WHALEY, M.D., 07-004189PL (2007)
Division of Administrative Hearings, Florida Filed:Jacksonville, Florida Sep. 17, 2007 Number: 07-004189PL Latest Update: Dec. 25, 2024
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HUMANA OF FLORIDA, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 83-000932 (1983)
Division of Administrative Hearings, Florida Number: 83-000932 Latest Update: Dec. 02, 1983

Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, as well as the stipulation of facts entered into by the parties, the following relevant facts are found: Humana of Florida, Inc., a wholly owned subsidiary of Humana, Inc., is the owner of Women's Hospital in Tampa. Women's Hospital presently has 192 licensed beds, of which 96 are used for obstetrical patients and 96 are used for gynecological patients. It is dedicated to meeting the physical, psychological, educational, social and environmental needs of women and newborns and offers a total program of obstetrical, neonatal and gynecological care. Although not designated by the State as a Level III facility, Women's Hospital in Tampa has the personnel and equipment necessary to provide Level III care. It treats many high-risk obstetrical patients and their newborns, as well as premature infants. High-risk infants do not require transfer to another hospital with Level III capabilities. Every practicing obstetrical/gynecological physician in Tampa is on the staff of Women's Hospital. Petitioner submitted an application for a Certificate of Need to add a fifth floor to its existing facility and to increase its licensed obstetrical bed complement from 96 beds to 130 beds. Of the 34 additional obstetrical beds requested, 12 are to be allocated to an antepartum unit. These 12 beds would be organized as a separate self-contained unit to care for obstetrical patients experiencing or likely to experience a complicated pregnancy and/or delivery. The types of obstetrical patients who would utilize a separate antepartum unit would include diabetics, patients who experience difficulties with blood pressure, kidney disorders and conditions associated with the heart and thyroid. In many instances, the antepartum patient is ambulatory or quasi-ambulatory and is thus able to meet many of her own needs. As a result, the intensity of nursing care in an antepartum unit is lower than that which would be expected in a postpartum obstetrical unit, resulting in a cost-savings to the antepartum patient. The total proposed capital expenditure for the addition of a fifth floor and 34 obstetrical beds is approximately $2.8 million. While petitioner is licensed for 96 obstetrical beds, only 62 of those beds were in operation at the time of the final hearing in this proceeding. Based on the 62 beds in operation, the average obstetrical bed occupancy rate was 112 percent from September, 1982 through August, 1983. Due primarily to the temporary discontinuance of obstetrical services at St. Joseph's Hospital located across the street from petitioner, occupancy levels have reached 130 percent since January of 1983. Such occupancy levels create significant problems in terms of patient care and facility, physician and nursing efficiency. The difficulties associated with scheduling surgery and infection control are exacerbated with overcrowded conditions. Because newborns and postpartum mothers are more susceptible to infection, it is medically necessary to separate and segregate postpartum and gynecological patients. Petitioner had 4,600 deliveries last year and projects it will have 5,800 deliveries this year. If all 96 obstetrical beds were currently in operation, petitioner's occupancy levels would be approximately 70 percent. An indication of adequate utilization of obstetrical beds is an average annual occupancy level of 75 percent. Petitioner expects to reach the 75 percent occupancy level of its existing licensed 96 beds within the next year and a half to two years. Petitioner presently has no private obstetrical rooms at its facility. When a patient requires isolation from other patients, one of the beds in the semiprivate room is not available for use. Due to high occupancy levels, petitioner is unable to offer a private room to any of its obstetrical patients when it is not medically necessary to do so. Thus, even without the addition of 34 beds, petitioner desires to construct a fifth floor to allow it to reconfigure its units and convert a number of semiprivate rooms into private rooms by transferring existing licensed beds to the fifth floor. This would enhance the hospital's ability to utilize its bed complement in a more efficient manner. Even without additional beds, petitioner's Executive Director believes that by amortizing construction costs over a period of 20 to 25 years and reducing its operating margin, there would not be a significant impact upon patient charges as a result of the fifth floor addition. Should petitioner be granted a Certificate of Need allowing it to construct a fifth floor with no new beds, petitioner would be willing to accept conditions concerning the conversion of existing semiprivate rooms to private, such as capping over medical gas outlets, deactivating wall outlets and light fixtures for a second bed and furnishing the new rooms on the exclusive basis of a private room. The conversion of semiprivate rooms to private rooms could be a less costly alternative to the addition of new beds in some instances. To the extent that the addition of private beds provides a potentiality for greater utilization of existing services, additional patient revenues can be generated. It is not the policy if the Department of Health and Rehabilitative Services to grant approval for "shelled in" or "banking" space due to the potential competitive advantage it affords by allowing a future increase of beds without significant cost. Petitioner has the ability to adequately staff its proposed project with all necessary technical, nursing, and medical personnel, and will provide an acceptable level of patient care. Sufficient funds are available to construct and operate the project and the project has immediate and long-term financial feasibility. Its costs and methods for the proposed construction are reasonable, appropriate, and cost-efficient. The respondent HRS has promulgated Rule 10-5.11(23), Florida Administrative Code which establishes a uniform methodology for determining the number of acute care hospital beds needed five years into the future within the eleven HRS service districts throughout the State. The Rule addresses the need for general medical and surgical, intensive care, pediatric and obstetrical acute care services in hospitals and the Department will not normally approve applications for additional beds if the new beds would cause the number of beds in a particular district to exceed the number calculated to be needed under the Rule's methodology. Rule 10-5.11(23) calculates need through a series of formulas by considering the need for the various types of individual services and then adding these figures together to produce a figure indicating the total number of acute care beds which would be needed in a particular District within a five-year time frame. Then, after certain adjustments, all existing licensed and approved acute care beds are subtracted from the total bed need to determine the net bed need within the District. Subdistrict allocations by type of service are to be made by the individual Local Health Councils consistent with the District total acute care bed allocations, with certain adjustments permitted. As of the date of the hearing in this cause, the Sixth District's Local Health Council's plan for the allocation of beds on a service specific or subdistrict basis had not been adopted. The acute care bed need methodology set forth in Rule 10-5.11(23) takes into account the population for the service area projected five years into the future, the historic utilization rate for particular types of service, average lengths of stay, optimal occupancy rates for the various types of services, and, with regard to obstetrical bed projections, the fertility rate of women between the ages of 15 and 44. The Rule sets forth the manner in which the figures for these various components are to be derived. Utilizing the methodology for determining acute care bed need as set forth in the Rule, District VI presently has 950 acute care beds in excess of the beds projected to be needed in the year 1988. By applying the subportion of the Rule relating to obstetrical beds to Hillsborough County, there are presently 47 obstetrical beds in excess of the number needed for 1988. While the petitioner agrees with the basic generic form of the methodology contained in Rule 10-5.11(23), petitioner would substitute different data than that mandated under the Rule and perform certain adjustments. For example, petitioner would adjust the numbers used in the formula by increasing the statewide fertility rate for the years 1979-81 by 5 percent, by factoring in a number of 2 percent to 3 percent to represent the in-migration of obstetrical patients, by increasing the statewide average length of stay from 3.5 to 3.8 days so as to reflect the actual experience at petitioner's facility, by making an adjustment for hospital stays by an obstetrical patient which do not result in a delivery and by making a downward adjustment for those births which do not occur in a hospital setting. Petitioner would also subtract from the number of existing and/or approved beds the 15 obstetrical beds at St. Joseph's Hospital which were taken out of service on an interim basis as of December 31, 1982, pending the development of a comprehensive plan for the delivery of obstetrical services on a decentralized basis. The parties to this proceeding have stipulated that St. Joseph's Hospital contemplates that its future obstetrical service will be centered around birthing rooms, rather than actual labor, delivery and recovery rooms, and that it is reasonable to expect that, once the service is resumed, approximately 360 deliveries will occur with this number increasing over time. After making all these adjustments and utilizing different data in the formula for determining need, petitioner concludes there is a 1988 need in District VI for 26 or 27 additional obstetrical beds. Petitioner's analysis of bed need based both on an institution-specific analysis and a trend analysis resulted in a finding of from 32 to 36 additional beds needed at petitioner's facility by the year 1988.

Recommendation Based upon the findings of fact and conclusions of law recited above, it is RECOMMENDED that petitioner's application for a Certificate of Need in its entirety be DENIED. Respectfully submitted and entered this 2nd of December, 1983, in Tallahassee, Florida. DIANE D. TREMOR 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 2nd day of December, 1983. COPIES FURNISHED: John H. French, Jr., Esquire & James C. Hauser, Esquire Messer, Rhodes & Vickers P.O. Box 1876 Tallahassee, Florida 32302 Claire D. Dryfuss Assistant General Counsel 1323 Winewood Blvd. Bldg. 1, Room 406 Tallahassee, Florida 32301 David Pingree Secretary Department of Health & Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32301

Florida Laws (1) 120.56
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MEDIVISION OF MIAMI, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 84-002306 (1984)
Division of Administrative Hearings, Florida Number: 84-002306 Latest Update: Jun. 06, 1986

Findings Of Fact The applicants, MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., are wholly owned subsidiaries of MediVision Inc., which maintains its corporate offices in Boston, Massachusetts. MediVision, Inc., was incorporated in January, 1984, to promote the development of outpatient eye surgery, in part through the development and operation of outpatient eye surgery centers. MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., will each be responsible for the development and operation of the projects proposed in their respective applications. MediVision, Inc., was organized by several individuals in response to a study conducted by Bain and Company, a strategic consulting firms as part of a consulting engagement in which those persons were involved. The study disclosed several demographic and health care delivery trends which prompted MediVision management to pursue the development of outpatient eye surgery centers. Those trends are: an overall movement of all types of surgery from an impatient to an outpatient setting; the increase in the nation's elderly population, and the fact that the likelihood of a person developing cataracts increases dramatically with age; the technological improvements in the provision of cataract surgery; the growth in the number of cataract surgeries performed nationally; and, a change in the manner in which Medicare reimburses a facility for outpatient surgery performed upon Medicare recipients. Medicare, since 1982, has reimbursed licensed freestanding ambulatory surgical facilities at a flat rate for the provision of such surgery, with no cost to the patient. For the same surgical procedures performed in a hospital outpatient setting, Medicare will reimburse the facility its costs of providing the surgery; the patient is responsible to pay the Medicare deductible and 20 percent co-insurance. Various subsidiaries of MediVision Inc., presently operate eight outpatient eye surgery centers nationwide; two are located in Florida. Other MediVision subsidiaries are developing three additional centers in Florida, pursuant to certificates of need issued by the Department of Health and Rehabilitative Services. Both parties employed the same quantitative need methodology. The methodology employs the following steps: acquire data regarding number of impatient and outpatient surgical procedures performed by existing providers; using this data, calculate current overall surgical use rate and outpatient surgical use rate for county; using the projected population for the year in question and the current use rate, calculate projected number of surgeries; multiply total projected surgeries by 40 percent to establish total outpatient surgery pool for year in question; subtract from result of step 4, all outpatient surgical procedures projected to be performed in hospitals and operating freestanding ambulatory surgery centers; subtract financial break-evens of all certificate of need approved freestanding outpatient surgery centers from this pool; and, after subtractions the number of surgical procedures remaining are compared to the break-evens of certificate of need applicant at issue. If the pool is larger than break-evens the condition is satisfied. If the pool is smaller than break-evens the condition is not satisfied. The quantitative methodology provides a reasonable approach to the evaluation of need for ambulatory surgical facilities. The basic methodology has been employed by the Department since 1982; in December, 1985, the Department began to employ a "40 percent outpatient factor" in implementing the policy. Accordingly, looking toward the planning horizon of 1988, the methodology projects that 40 percent of all surgeries in Dade County will be performed on an outpatient basis. The 40 percent outpatient factor is reasonable for use in these proceedings. The prevailing literature suggests that 40 percent of all surgeries can be expected to be performed on an outpatient basis. Within Florida, many counties are already performing in excess of 30 percent of all surgeries on an outpatient basis. Trends in health care delivery and reimbursements including the growth in pre-paid health care organizations, such as health maintenance organizations; professional review organizations, which monitor the appropriateness of hospital admissions; and Medicare reimbursement incentives will contribute to an increase in the percentage of surgeries performed in an outpatient setting. While employing the same quantitative need methodology, the parties' health planning experts arrived at different conclusions as to whether the methodology projects need for the facilities at issue in these proceedings. The differences in outcome are attributable to two issues: (1) the calculation of a base-year use rate; and (2) the calculation of "break-evens" for previously approved, but non-operational, ambulatory surgical facilities. Each expert relied upon the same basic data source in calculating a base-year surgical use rate, employing data collected by HRS and reported in the most current State Agency Action Report prepared by the Department relative to Dade County. Such Action Report (CON Action No. 4095) lacked complete data regarding the total number of surgeries performed in Dade County during the base-year (1984-5), in that six of the thirty-three acute care hospitals in Dade County failed to report. Because it is necessary to have complete data in order to establish an accurate base-year surgical use rate, Mark Druash who was engaged to undertake a need analysis by the applicants, referred to earlier State Agency Action Reports to acquire surgical procedure data for the six hospitals which had failed to report. Such documents are reliable data sources upon which to base a need analysis. In calculating a county's surgical use rate, health planners take into consideration the total population within the county. Accordingly, the total number of surgeries provided within the county must also be considered. In that six Dade County hospitals failed to report data and HRS' health planner did not acquire data relative to those facilities, the surgeries performed at those hospitals were not included in his calculation of a surgical use rate. If the total population of a county is considered in calculating a surgical use rate, but something less than the total number of surgeries is considered, the calculation results in an artificially deflated use rate. As the base-year use rate drives all of the remaining calculations in the quantitative methodology, an error in the calculation of the use rate will be carried through the entire methodology. The ultimate effect of a deflated use rate is to project a smaller number of surgical procedures, as compared to a use rate calculated upon complete data. HRS calculated a base-year surgical use rate for Dade County of 78.2 surgeries/1000 population. MediVision calculated a base-year surgical use rate of 92.8/1000 population. The variance in the use rates is attributable solely to the fact that Druash acquired and employed in his calculations surgical procedure data from all Dade County hospitals previously relied upon by HRS; while HRS relied upon incomplete data. In that Druash's calculations are based on a complete data based the surgical use rate of 92.8/1000 population is found to be more accurate and reliable than the rate of 78.2/1000 population calculated by HRS from incomplete data. The parties differ in their calculation of "break- evens for previously approved, but not yet operational, ambulatory surgical facilities. The break-even calculation is an integral part of the quantitative need methodology. The purpose of subtracting from the available outpatient surgical pool the "break-evens" of approved, but not yet operational ambulatory surgical facilities is to assure that there exists need for the project proposed adequate to allow both such project and previously approved facilities to operate in a financially viable manner. The "break-even" approach is also intended to promote competition; rather than assuming that all of the procedures projected by a facility will be performed in such facility; the approach allocates to the facility only that number of procedures it needs to generate sufficient revenues to cover its expenses. Druash who participated in the development of the quantitative methodology during his tenure with HRS, testified that the "break-even" approach was selected because it would promote competition among providers by approving enough applicants so that they would be "hungry" for the residual surgeries projected by the methodology. The purpose of calculating a financial break-even is to ascertain at what point a project's cash flow will equal its expenditures. The generally accepted method for calculating a financial break-even requires that fixed costs be separated from variable costs. The concept of variable costs is the basis for the computation of a break-even. Fixed costs are those which remain constant regardless of the volume of business conducted by an entity; variable costs are those that change directly with volume. In the operation of an ambulatory surgical facility, virtually all expenses related to medical supplies are variable. If no patients are treated, no medical supplies are needed, and no expenses are incurred. If 100 patients are treated, 100 units of medical supplies are needed, with resultant expense. Certain expenses involved in the operation of an ambulatory surgical center are totally fixed, such as debt service and property taxes. All other expenses are variable to some degree e.g. salaries, utilities, and maintenance. Depreciation and amortization of property and equipment are not considered as expenses in a break-even analysis, as those items do not represent cash expenditures. As mere accounting recognitions of prior investment, depreciation and amortization should not be included in a calculation of a cash flow break-even. HRS' methodology for calculating financial break-evens for ambulatory surgical procedures treats all expenses as fixed, and includes amortization and depreciation among those expenses. By HRS' admissions the Department, "in lieu of attempting to determine what is fixed and what is variable . . . will use a somewhat more crude method". Where a financial break-even is calculated treating all costs as fixed, the resulting break-even number is artificially inflated. By the Department's reckoning, the effect of treating all expenses as fixed is to "add a cushion" to its approvals of prior applications. HRS' expert acknowledged, however, that differentiating between fixed and variable costs in performing a financial break-even analysis is the "preferred methods no question". Lovell Jones, a certified public accountant and expert in health care finance, performed revised break-even analyses for previously approved, but not yet operational, ambulatory surgical facilities. Jones first acquired expense and revenue data from the certificate of need applications submitted by previously approved applicants. Then, treating only medical supplies as variable expenses, and excluding amortization and depreciation from the list of fixed expenses, he calculated the actual financial break-even of each approved, but not yet operational, facility. Jones' analysis finds the collective break- even of all previously approved, but not yet operational, facilities to be 17,996 procedures, whereas the Department's "crude" analysis results in a collective break-even of 25,736. Jones' method of calculating break-even, which was agreed to be technically correct by both parties, is more accurate and reliable than the method employed by the Department. Using the agreed-upon quantitative methodology, the surgical use rate calculated by Druash, and the break-even numbers calculated by Jones, there is projected to exist in 1988 a pool of 5006 outpatient surgical procedures that could be provided by the applicants in these proceedings. Subtracting the break-even numbers of the two proposed facilities, there will exist a residual pool of greater than 3600 procedures. Accordingly, there exists a quantitative need for the two proposed facilities. Furthers the residual pool of greater than 3600 procedures represents an adequate "cushion" to satisfy the concerns of HRS that previously approved facilities be given the opportunity to operate in a financially viable manner. The proposed facilities will improve access to services for both Medicare and indigent patients. Medicare patients receiving surgery at the facilities will be treated free of cost, with the Medicare program having full responsibility for payment. All other patients will be treated at the facilities regardless of ability to pay. The proposed facilities will promote competition in that management intends the charges to commercial patients to be less than the prevailing charges in the community. Where an ambulatory surgical facility enters a market, hospital charges for similar services tend to decrease. The proposed facilities will promote cost containment, as it is more costly to render care in a hospital outpatient department than in a freestanding ambulatory surgical facility. Hospital outpatient departments, which are reimbursed by Medicare for their costs of providing services, do not have the same incentive to reduce costs as do freestanding ambulatory surgery facilities, which are reimbursed at a predetermined flat rate for the provision of services. Accordingly, Medicare has encouraged the use of freestanding ambulatory surgical facilities by incurring all responsibility for payments at no cost to Medicare recipients. The Department's sole concern regarding the financial feasibility of the proposed facilities arises out of its position that there exists no need for the facilities. Accordingly, the Department questions whether the facilities will enjoy utilization sufficient to generate the revenues necessary to their viable operation. In that need for the facilities has been found to exist, it follows that the facilities will be able to generate adequate numbers of surgeries to achieve break-even in their second years of operation. Several other factors indicate that the facilities will experience utilization sufficient to achieve break-even in their second years of operation: The marketing and community education activities proposed by the applicants will encourage utilization. In its existing surgical facility in Orlando, MediVision, Inc., has undertaken similar activities, which have resulted in substantial surgical referrals to the facility; There exists a residual pool of approximately 5,000,000 untreated cataracts nationally; Medicare reimbursement policies which allow Medicare recipients to receive treatment at licensed freestanding ambulatory surgical centers at no cost to the recipient will encourage utilization of the proposed facilities; The applicants' pricing structure, for both Medicare and commercial patients, will encourage utilization of the proposed facilities; and Two local ophthalmology group practices have expressed strong interest in performing surgery at the proposed facilities. Each group presently performs in excess of 1000 surgeries annually, which volume is greater than the break-even volume necessary to be achieved at each facility.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Lawn it is RECOMMENDED that a Final Order be entered approving the applications of Petitioners to establish and operate freestanding ophthalmic ambulatory surgical centers in Dade County, Florida. DONE and RECOMMENDED this 6th day of June, 1986, at Tallahassee, Florida. LINDA M. RIGOT, 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 6th day of June, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Robert A. Weiss, Esquire The Perkins House, Suite 101 118 North Gadsden Street Tallahassee, Florida 32301 Richard A. Patterson, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 =================================================================

Florida Laws (2) 120.52120.57
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HUMHOSCO, INC., D/B/A HUMANA HOSPITAL-NORTHSIDE vs DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 90-006905 (1990)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Oct. 30, 1990 Number: 90-006905 Latest Update: Apr. 15, 1992

The Issue Whether Petitioners (collectively referred to as "Humana") are entitled to exemptions from the Certificate of Need ("CON") Law, to establish certain services at their facilities, pursuant to Subsection 381.713(1)(b), Florida Statutes (1989), (a provision which was repealed by Chapter 91-282, Laws of Florida). Whether Intervenors have standing to contest the exemption requests of Humana.

Findings Of Fact Petitioners Humhosco, Inc. d/b/a Humana Hospital Brandon (Humana Brandon) in Hillsborough County applied for CON exemption to initiate open heart surgery services. Humhosco, Inc. d/b/a Humana Hospital Northside (Humana Northside) in St. Petersburg, Pinellas County, applied for a CON exemption to initiate open heart surgery and inpatient MRI services. Humana of Florida, Inc. d/b/a Humana Hospital St. Petersburg (Humana St. Petersburg), in Pinellas County applied for a CON exemption to establish a Level II neonatal intensive care unit (NICU). Humana of Florida, Inc. d/b/a Humana Hospital Pasco (Humana Pasco) in Dade City, Pasco County, applied for CON exemption to initiate inpatient cardiac catheterization. Humana of Florida, Inc. d/b/a Humana Hospital Bennett (Humana Bennett) in Plantation, Broward County applied for a CON exemption for a Level II NICU. Community Hospitals of Humana, Inc. d/b/a Humana Hospital Cypress (Humana Cypress) in Pompano Beach, Broward County applied for CON exemption to perform inpatient cardiac catheterization procedures, and for substance abuse and psychiatric beds. Community Hospital of The Palm Beaches, Inc. d/b/a Humana Hospital Palm Beaches (Humana Palm Beaches) in Palm Beach County applied for a CON exemption to perform inpatient cardiac catheterization procedures. Humana Hospital Pembroke Pines, Inc. d/b/a Humana Hospital Pembroke Pines (Humana Pembroke) in Broward County applied for CON exemptions for open heart surgery, inpatient cardiac catheterization, Level II NICU, psychiatric and comprehensive rehabilitation beds. Intervenors Adventist Health System/Sunbelt, Inc. (Adventist) filed a Notice of Voluntary Dismissal on June 3, 1991. Florida Hospital Association (FHA) is a trade association of approximately 225 hospitals in the State of Florida. The Association of Voluntary Hospitals of Florida, Inc. (AVHF) is a not-for-profit corporation representing approximately 90 private and public not- for-profit hospitals in the State of Florida. All Children's Hospital (ACH), a 144-bed children's specialty hospital with Level II and Level III NICU beds, is a Regional Perinatal Intensive Care Center (RPICC) located in St. Petersburg in HRS District 5 for Pinellas/Pasco Counties. Florida Medical Center, Ltd. (FMC) is a 459-bed acute care hospital in HRS District 10, Broward County, at which services include inpatient cardiac catheterization, open heart surgery, and short term psychiatric services. Lakeland Regional Medical Center (LRMC) is an 897-bed acute care hospital, located in Polk County in HRS District 6, with a range of cardiac services, including open heart surgery. Plantation General Hospital (Plantation), a general acute care hospital in HRS District 10, Broward County, offers cardiac catheterization and Level II NICU among its procedures and programs. South Broward Hospital District (SBHD), a legislatively-created special taxing district, operates a 737-bed Memorial Hospital in HRS District 10, Broward County, at which its services include open heart surgery, inpatient cardiac catheterization, Level II and III neonatal intensive care, short-term inpatient psychiatric treatment, and inpatient comprehensive rehabilitation. St. Anthony's Hospital is a 434-bed community hospital in St. Petersburg, Pinellas County, which is in HRS District 5, and offers inpatient cardiac catheterization. St. Joseph's Hospital is a 649-bed facility in Tampa, Hillsborough County, which is in HRS District 6, and provides inpatient cardiac catheterization and open heart surgery. St. Mary's Hospital, a 378-bed general, acute-care hospital in West Palm Beach, Florida, offers Level II and III NICU, and inpatient cardiac catheterization. Hillsborough County Hospital Authority, operates Tampa General Hospital (Tampa General) in HRS District 6, with 1,024 beds and a range of cardiac services, including open heart surgery. University Community Hospital (UCH) is located in HRS District 6, and is an existing provider of open heart surgery. Standing Adventist failed to present evidence of standing. FHA members include all of the petitioners and intervenors in this case. AVHF members include at least one member providing the same service in the same HRS District as the services which the eight Humana hospitals seek to establish by the exemption requests. ACH is an existing provider of Level II NICU in HRS District 5, the same service in the same area as proposed in the exemption request of Humana St. Petersburg. FMC provided 10% of its cardiac services in 1990 to HMP enrollees and is an existing provider of inpatient cardiac catheterization, open heart surgery, and short term psychiatric services in HRS District 10, which are, in part, the subjects of the Humana Cypress and Pembroke exemption requests. At LRMC, from October 1, 1989 through September 30, 1990, 163 open heart surgeries, 215 cardiac catheterizations, 22 angioplasties, and 1,434 other cardiology procedures were performed on patients discharged to zip codes included by Humana Brandon in its service area for its exemption request for open heart surgery. Plantation is an existing provider in HRS District 10 of inpatient cardiac catheterization, for which Humana Cypress requested exemption, and Level II NICU, for which Humana Bennett requested exemption, and both of which services are included in the Humana Pembroke exemption request. SBHD estimates the range of patients lost, as a result of approval of the exemption requests of Humana Pembroke and Humana Bennett, at between 25-344 cardiac catheterizations, 58-434 open heart surgeries, up to 232 substance abuse treatments, between 8-352 comprehensive rehabilitations, 25-1933 short-term inpatient psychiatric, and 58-1354 neonatal patients. St. Anthony's provides inpatient cardiac catheterization in St. Petersburg and Southern Pinellas County, the same service in an overlapping service area as proposed in the Humana Pasco exemption request. St. Joseph's service areas for inpatient cardiac catheterization and open heart surgery overlap those in the exemption requests of Humana Pasco for cardiac catheterization, and overlap those of Humana Brandon and Humana Northside for open heart surgery. St. Mary's is a Humana Care Plan provider for inpatient cardiac catheterization, in a service area overlapping that proposed for inpatient cardiac catheterization by Humana Palm Beaches, and for NICU at Humana Bennett, since St. Mary's is one of the designated statewide Regional Perinatal Intensive Care Centers. Tampa General is under contract to Humana HMO, PPO and insurance subscribers, and provided 116 open heart surgeries to patients included within the service area of the Humana Brandon exemption request, and projects its loss of gross revenue at $1.5 million from the approval of the Humana Brandon exemption request for open heart surgery. At UCH, which has a service area within the area proposed for open heart surgery at Humana Brandon, twenty open heart surgeries in fical year 1990, and forty open heart surgeries in the first six months of 1991 were performed on HMP enrollees, the latter generating approximately $2 million in gross revenues. Amendment of Applications for Exemption (Costs) The June 1990 Humana exemption requests failed to include the costs of the services proposed, as required by Florida Administrative Code 10- 5.005(2)(a). HRS reviewed the requests, failed to notify Humana of the omission of cost data, and failed to cite the absence of that data as a basis for its decisions. The cost of services is included implicitly within the statutory criterion for review of exemption requests, because cost may be a factor in distinguishing between services which are or are not available by exemption. Tertiary and Inpatient Institutional Health Services or Beds Subsection 381.702(20), Florida Statutes, defining "tertiary health services" was enacted subsequent to the HMO exemption in Subsection 381.713(1), Florida Statutes, without any concurrent, material amendment of the latter. NICU and comprehensive rehabilitation are included in Subsection 381.702(2), Florida Statutes, as examples of tertiary health services. Open heart surgery is included within the definition of tertiary health services in Florida Administrative Code Rule 10-5.002(66). Inpatient cardiac catheterization is an inpatient institutional health service. Short-term inpatient psychiatric and substance abuse services are included in "alcohol treatment, drug abuse treatment and mental health services" as defined in Subsection 381.702(9), Florida Statutes. Because they are within the definition of "health services" but not within the definition of "tertiary services", short-term inpatient pschiatric and substance abuse are also included within the definition of "institutional health services" which may be exempt from CON regulation if all other provisions of the HMO exemption provision are met. Certain inpatient institutional health services, such as substance abuse and psychiatric services are authorized by the issuance of licenses designating the number of approved beds which may be used in offering the service. Need methodology and physical plant requirements are factors which differ in the requirements for services offered in approved licensed beds. The HMO exemption provision encompasses inpatient services provided in licensed bed inventories, in the phrase "inpatient institutional health services." Nature and Control of Facilities Each of the eight Humana hospitals are health care facilities, as defined in Subsection 381.702(7), Florida Statutes. Each of the eight Humana hospitals are licensed acute care hospitals which primarily provide inpatient health services, as required by Subsection 381.713(1)(b)1., Florida Statutes (1989). Humana Pembroke Humana Pembroke Pines, Inc. was incorporated in December 1989. It acquired the assets of Pembroke Pines General Hospital, pursuant to an asset sale and purchase agreement, the performance of which was guaranteed by Humana, Inc. Humana Medical Plan, Inc. (HMP), an HMO, is a wholly-owned subsidiary of Group Health Insurance, Inc., which in turn is a wholly-owned subsidiary of Humana, Inc. Although HMP acquired 100% of the stock in Humana Pembroke Pines, Inc., documents filed with state and federal agencies, other than HRS and the Department of Insurance, continued to list Humana, Inc. as the insured or controlling entity. Humana first indicated to HRS that the acquisition of Pembroke Pines General Hospital would be made by Humana Hospital Pembroke Pines, Inc., with a possible change of ownership to another Humana subsidiary, and subsequently notified HRS that the acquiring subsidiary would be HMP. Based on Humana's notice that the acquisition would not result in a change in beds or services, HRS determined that the acquisition of Pembroke Pines was not reviewable under CON requirements. An internal memorandum dated February 1, 1990, indicates that Humana planned to take advantage of the HMO exemption request prior to the acquisition of Pembroke Pines General Hospital, but did not report its plans to HRS. On March 2, 1990, HRS issued a license to Humana Hospital Pembroke Pines, Inc. There is no evidence to support the assumption that HRS would not have approved the acquisition of Humana Pembroke, or that Humana's plans to utilize the HMO exemption would have invoked CON review of the acquisition and resulted in a denial of the acquisition. Humana Pembroke is controlled directly or indirectly by HMP, the Humana HMO, as required by Subsection 381.713(1)(b)2. Enrollment of 50,000 Individuals Within the Service Area Subsection 381.713(1)(b)2., Florida Statutes, required the enrollment of at least 50,000 enrollees within the HMO's service area. The term "service area" is not used in the statute on CON application review criteria. Rather that statute, in Section 381.705, Florida Statutes, uses the term "service district", which is defined in Subsection 20.19(7), Florida Statutes, as the organizational components of HRS. The term "service area" is also not used in Subsection 641.47(3), Florida Statutes; that statute defines the area in which an HMO does business as an approved "geographic area". The HMO service area, under the exemption provision, is the HMO's geographic area, because the requirement in subsection (2), that the HMO have 50,000 enrollees, otherwise would be indistinguishable from the requirement in subsection (3), that the facility's access area have 50,000 enrollees. HMP's appoved service area includes Broward, Dade, Flagler, Hillsborough, Orange, Osceola, Palm Beach, Pasco, Pinellas, Seminole and Volusia Counties, and approximates 400,000 enrollees. Facility Geographically Located So That Service Is Reasonably Accessible To The 50,000 Enrollees Accessibility standards for various services are established for CON applications by rules. There is no reason to distinguish between the standards used for the determination of accessibility to health services within the CON application process and the standards applicable to making that same determination within the CON exemption request process. Florida Administrative Code Rule 10-5.011(1)(o)6. establishes a standard of 45 minutes maximum ground travel time under average travel conditions for access to inpatient psychiatric services, which is the equivalent of a 15-mile radius for Humana Pembroke. Humana Pembroke's exemption request, filed in June 1990, as up-dated in July, identified 55,592 enrollees within a 15-mile radius of the hospital. This enrollment data was given by zip code in Attachment 3B for inpatient cardiac catheterization and in Attachment 3D for short term inpatient psychiatric services. 1/ In its September 1990 CON application for inpatient cardiac catheterization, which has the slightly longer travel time of one hour, Humana Pembroke identified a service area with zip codes which would include only 21,375 of the 55,592 enrollees. When compared to enrollment data for the same zip codes in Humana's Exhibit 41, the most recent data available, enrollment in Humana Pembroke's zip codes for inpatient cardiac catheterization services and short term inpatient psychiatric services equals 27,083 HMP members, although one zip code, 33154, does not appear on Exhibit 41. Even accepting Humana's assertion that 321 enrollees reside in zip code 33154, total enrollment would equal 27,404. Humana has failed to demonstrate that Humana Pembroke is geographically located so as to be reasonably accessible to provide either inpatient cardiac catheterization or short term inpatient psychiatric services to 50,000 HMP enrollees. Limitation of Service to HMO Enrollees HRS preliminarily determined that Humana Pembroke's exemption request for inpatient cardiac catheterization services should be granted but that the service should only be available to HMP members. The text of subsection 381.713(1)(b), Florida Statutes, does not however restrict the provision of services to HMO enrollees, and the fact that a minimum number of enrollees must be in the service area to maximize the utilization of the service by enrollees does not compel such a conclusion. Subsection 381.713(1)(a), Florida Statutes, is a similar exemption provision which requires the enrollment of 50,000 individuals in an HMO's service area and a reasonably accessible facility, but also requires that 75% of reasonably expected patients be HMO enrollees. The Legislature was, therefore, obviously aware of the issue, yet in the applicable subsection failed to include any provision conditioning CON exemption approved upon provision of services only to HMO enrollees. Exemption Requests Based On Voting Trust Agreements Humana Pasco, Humana Palm Beaches, and Humana Cypress requested exemption approval to establish various inpatient institutional health services based on the control of those facilities by HMP by virtue of a voting trust agreement. The license-holder of Humana Pasco, Humana of Florida, Inc., is a wholly owned subsidiary of Humana, Inc. The license-holder of Humana Palm Beaches, Community Hospital of the Palm Beaches, Inc., is a wholly owned subsidiary of Humana, Inc. The license-holder of Humana Cypress, Community Hospitals of Humana, Inc., is a wholly owned subsidiary of Humana, Inc. On behalf of Humana Pasco, Humana Palm Beaches, and Humana Cypress, Humana, Inc., entered into Voting Trust Agreements (Agreements) designating HMP, the Humana HMO, as trustee, but did not report the change of control to state and federal agencies. The Agreements, dated May 29, 1990, have identical substantive provisions. The term of the Agreements is ten years, terminating May 28, 2000, with a provision that Humana, Inc. may not unilaterally terminate the Agreements, although Humana, Inc. subsequently offered to terminate one of the agreements. Each Agreement authorizes HMP to hold and vote the shares of stock of the respective Humana, Inc. subsidiary. Each Agreement obligates HMP to vote the shares in the best interest of Humana, Inc. and the applicable wholly-owned subsidiary. Each Agreement requires HMP to pay over all profits and dividends to Humana, Inc., with all convenient speed. Each Agreement provides that without the consent of Humana, Inc., HMP shall not increase or reclassify capital stock; sell, lease or exchange all or substantially all property or assets; or vote to consolidate, merge, or dissolve the Humana, Inc. subsidiaries. The Agreements provide that the trustee accepts the specified responsibilities, but recite no compensation. The Humana hospitals, including Humana Pasco, Humana Palm Beaches, and Humana Cypress, have chief operating officers who are known as executive directors, who report to HMP Vice-Presidents, but the executive directors receive incentive compensation for maximizing hospital utilization, as do all their superiors throughout the chain of command, up to and including the president of Humana Inc. Humana Pasco, Humana Palm Beaches, and Humana Cypress pay management fees to Humana, Inc., as does HMP, and are directly owned by corporate entities which have the same officers and directors as HMP. By virtue of the voting trust agreement, HMP votes the shares of stock in Humana Pasco, Humana Palm Beaches, and Humana Cypress, but no operational changes in the facilities have resulted from the establishment of the voting trust agreements. HMP, as voting trustee, has control of the assets of Humana Pasco, Humana Palm Beaches, and Humana Cypress. HMP is an HMO with in excess of 50,000 enrollees in its service area. See, Findings 60 and 61, above. The standard for determining if a proposed service is geographically accessible for 50,000 enrollees is the same as that established in the rules for CON applications for the same service. See, Findings 62 and 63, above. Humana Pasco. Humana Pasco's exemption request for inpatient cardiac catheterization asserted that 74,225 HMP enrollees reside within one hour's travel time of the facility. The applicable travel time standard for inpatient cardiac catheterization subject to CON review is one hour, under Florida Administrative Code Rule 10-5.032. Areas within a forty-mile radius of Humana Pasco are within one-hour average travel time of the facility. The zip codes for enrollees in the Humana Pasco exemption request are substantially different from those included within its service area in a 1987 CON application and from Hospital Cost Containment Board data on actual utilization of the facility. Humana failed to demonstrate that 50,000 HMP enrollees have geographic accessibility for inpatient cardiac catheterization services to Humana Pasco, based on the applicable travel time standard of one hour. 2/ Humana Palm Beaches. In the June 7, 1990 Humana Palm Beaches' exemption request for inpatient cardiac catheterization services, Humana asserted that there were 58,268 HMP enrollees within a 40-mile radius, or one-hour average travel time of the facility. In the July 31, 1990 submission of corrected information, Humana's attachment 3a asserts that 50,592 HMP enrollees reside in areas within 45 miles of Humana Palm Beaches. 3/ Humana's Exhibit 41, a computer printout of enrollees for May 1990, demonstrates that the enrollees in the zip codes listed on attachment 3a of the July submission equal 49,894 HMP members. Although not determinative of enrollment in the service area, HMP's reports to the Department of Insurance on enrollment in Palm Beach County and the Hospital Cost Containment Board data on zip codes with greater than 5% actual utilization of Humana Palm Beaches also show fewer than 50,000 enrollees. Humana attempted to assert that its enrollment figures are constantly increasing. Because the number of HMP members is so close to 50,000, that assertion becomes significant. A comparative review of the individual zip code enrollments asserted in Attachment 3A to the Humana Palm Beaches' July submission to those in Humana Exhibit 41 demonstrates that some zip codes lost members, presumably due to changing residential patterns. Therefore, it is impossible to make a general assumption that HMP's growth in membership is evenly distributed across zip codes within an area geographically accessible to a hospital. Humana has failed to establish that 50,000 enrollees have geographic access to Humana Palm Beaches for inpatient cardiac catheterization services using the one-hour travel time standard for CON review. Humana Cypress. Humana asserted that 50,962 HMP enrollees are geographically accessible to Humana Cypress for inpatient cardiac catheterization, or within the one-hour travel time or 15 miles, although its September 1990 CON application for the same service defines an area including approximately half that number. Humana asserted that 68,412 HMP enrollees are geographically accessible to Humana Cypress for inpatient substance abuse and short term inpatient psychiatric services, or within the 45-minute travel time or a 15-mile radius, although its September 1989 CON applications for the same services encompass an area with approximately 41,000 of the enrollees. When zip codes in the exemption requests are compared to Humana's exhibit 41, a computer printout of enrollees for May 1990, 4/ the enrollees in the zip codes submitted in the exemption request for inpatient cardiac catheterization total 50,581 and those submitted in the exemption requests for inpatient substance abuse and short term inpatient psychiatric services total 67,812. 5/ Humana has established that Humana Cypress is geographically accessible to provide inpatient cardiac catheterization to 50,000 HMP enrollees under the one-hour travel time requirement. Humana has established that Humana Cypress is geographically accessible to 50,000 HMP enrollees under the 45 minute travel time requirement for short term inpatient psychiatric and inpatient substance abuse services.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that a Final Order be entered Dismissing the Petition to Intervene filed by Adventist based on its Notice of Voluntary Dismissal; Denying the exemption requests of Humana Brandon for open heart surgery, Humana Northside for open heart surgery, Humana St. Petersburg for Level II NICU, and Humana Bennett for Level II NICU, Humana Pembroke for open heart surgery and Level II NICU, because those services are tertiary services, not institutional health services. Denying the exemption request for inpatient cardiac catheterization and short-term inpatient psychiatric services at Humana Pembroke for failure to establish geographic accessibility to 50,000 HMP enrollees. Denying the exemption requests of Humana Pasco and Humana Palm Beaches for failure to establish that 50,000 HMO enrollees have reasonable access to inpatient cardiac catheterization services at these facilities. Granting the exemption request of Humana Cypress for inpatient cardiac catheterization, short term inpatient psychiatric services, and inpatient substance abuse services, without limiting the provision of services to HMP enrollees. RECOMMENDED this 14th day of October, 1991, at Tallahassee, Florida. Eleanor M. Hunter Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of October, 1991.

Florida Laws (3) 120.5720.19641.47
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SAN MARCO SURGICAL CENTER, LTD. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 84-003712 (1984)
Division of Administrative Hearings, Florida Number: 84-003712 Latest Update: Apr. 03, 1986

The Issue This proceeding was initiated when HRS proposed to deny San Marco's application for Certificate of Need No. 3304 for an ambulatory surgical center in Jacksonville, Duval County, Florida. San Marco filed a timely petition for formal hearing. Initially four intervenors were involved: Baptist, Memorial, Surgical Services of Jacksonville, Inc. and Medivision of Duval County, Inc. Surgical Services filed its Notice of Voluntary Dismissal on March 7, 1985, and Medivision withdrew on October 28, 1985. At the hearing, San Marco offered evidence through eight witnesses and 28 exhibits; HRS presented one witness and one exhibit; and the two intervenors presented nine witnesses and 26 exhibits. Certain exhibits, by stipulation of the parties, were entered as "Hearing Officer Exhibits." Those four exhibits included the state agency action plan, the petitioner's application for CON, a three-volume state health plan and the District IV health plan The primary issue is whether San Marco is entitled to Certificate of Need No. 3304 for an ambulatory surgical center which will include two operating rooms. During the course of the proceeding several ancillary issues developed; those issues are summarized here and are addressed in the body of this recommended order: In determining need for a free-standing ambulatory surgery center, is it appropriate to consider evidence of out- patient surgical services provided by hospitals? (Petitioner's Motion in Limine, T-9). Is the project proposed by San Marco an "ambulatory surgical center" as defined in subsection 381.493(3)(a), Florida Statutes? (Respondent's Motion to Dismiss, T-500). Should the intervenors, Baptist and Memorial be dismissed for failure to establish standing? (Petitioner's Motion for directed verdict, T-1182). The briefs, memoranda and proposed orders of the parties have been carefully considered in the preparation of this Recommended Order. A specific ruling on each proposed finding of fact is included in the Appendix attached hereto. On March 25, 1986, Petitioner filed a Motion for Restricted Reopening of Record. Basis for the motion is Medivision's withdrawal of its application for certificate of need. The motion is denied.

Findings Of Fact The Parties San Marco is a limited partnership. The owners are Stuart Yachnowitz, individual general partner and sole limited partner; Surgi-Centers of America, Inc., (SCA), a Florida corporation, corporate general partner; and Jacksonville Women's Health Organization, Inc., a Florida corporation, (JWHO), corporate general partner. The sole shareholders of SCA are Stuart Yachnowitz, his father, Joseph Yachnowitz and Susan Hill. The owners of JWHO are Joseph and Stuart Yachnowtiz. (T-47, 48, CON application pp. 20-23). San Marco intends to include local physicians in the ownership of the surgicenter. (CON application p. 40) The surgieenter will be managed by Y and S Management Corporation, the company now providing management services to JWHO. Y and S Management Corporation is owned by Joseph and Stuart Yachnowitz. Including JWHO, it manages eight licensed abortion clinics throughout the country as well as two free-standing ambulatory surgery centers (FSACs) which primarily perform abortions. Susan Hill, the chief operating officer for Y and S for the past ten years, prepared the CON application for the surgicenter. (T-47-49, 108-111). The building at 1561 San Marco Boulevard in Jacksonville, currently occupied by JWHO for its licensed outpatient abortion clinic, will be renovated and occupied by San Marco. The facility will be expanded from approximately 3000 square feet to 4700 square feet. Two operating rooms (ORs) will be added along with ancillary facilities necessary for licensure as an ambulatory surgical center. (Petitioner's Exhibit #1, CON application p. 4, T-52, 54, 55). Abortions will continue to be performed at the facility at an estimated rate of 168 procedures a month. (Petitioner's Exhibit #2, T-102, 103). Other surgical procedures will be added in the categories of gynecology, general surgery, and plastic surgery at the projected rate of 15 per month for the first month of operation to 90 per month after a little over a year's operation. The 90 additional procedures per month is anticipated to continue through the second year of operation. (Petitioner's Exhibit #2, CON application p. 40, T- 102, 103). San Marco anticipates drawing some patients for the additional procedures from its existing caseload and utilizing some physicians who currently practice at the abortion center. (T-62, 63, 101, 102, 247). Memorial is a not-for-profit acute care hospital, located in Duval County in close proximity to the San Marco facility. Since May 1985, Memorial has been providing outpatient surgery services in a dedicated outpatient facility adjacent to the acute care hospital. The same day surgery" facility contains two laser rooms and four operating rooms. (T-854, 913, 914). Baptist is a not-for-profit acute care general hospital also located within close proximity to the San Marco facility. It currently provides outpatient surgical services in twelve ORs and 3 cystoscopy rooms in its main facility. Sometime around August 1987, its new adjacent 17-story structure, The Pavillion, is anticipated to open. The fourth floor of that facility will be dedicated to outpatient surgery and will include four operating rooms and two cystoscopy rooms. (T-939, 984, 987, 988, 1045, 1047). HRS reviewed San Marco's application and determined that it should be denied on the following basis: "There appears to be an insufficient projected number of outpatient procedures to allow this facility to be viable." (State Agency Action Report, September 6, 1984). The State and Local Health Plans The 1985-1987 State Health Plan does not directly address the need for additional ambulatory surgical centers. It adopts as an objective that ". . . By 1989, 30 percent of all surgical operations should be performed on an outpatient basis." (Vol. II p. 81). It addresses ambulatory surgical centers as an alternative delivery system which lowers costs by substituting less costly services. (Vol. II p. 76). And, it outlines a brief history of the increase of ambulatory surgical centers in Florida during the decade of the 1980s. It acknowledges, "As in the case of hospitals, saturation of the marketplace for outpatient surgery has caused new entrants into the field to be more highly specialized in order to attract sufficient business. (Vol. II p. 27). HRS District IV includes Duval, Nassau, Baker, Clay, St. Johns, Flagler and Volusia counties. The 1985 District IV Local Health Plan adopts sub-area boundaries in planning for certain specialized services, including ambulatory surgery. Sub-area A is comprised of Baker, Nassau, Duval, Clay and St. Johns counties. (p. 112). In contrast to the State Health Plan, it makes specific recommendations: that sub-area boundaries should be used for planning purposes; that no additional units should be approved prior to the adoption of state rules; and that no ambulatory surgery units should be added to the district through 1986, when the agency will review the matter again. (p. 20). Utilizing 1983 data to base its projections and the need methodology of a challenged draft state rule, it concludes that Sub-area A has a surplus of 14 ambulatory surgical units. (p 143). Existing Like Facilities and Other Alternatives to the Proposed Service. Ambulatory surgery is typically performed in three types of facilities: general hospitals which mix inpatient and outpatient surgery in main operating rooms; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in adjacent buildings; and free-standing surgical centers which are unassociated physically or administratively with a hospital. (T. 387-390). Testimony in this proceeding was virtually unanimous as to the distinct disadvantages of serving surgical outpatients in a non-dedicated operating room setting. The mingling of' less ill or well outpatients with seriously ill inpatients increases the opportunity for contagion, heightens patient anxiety, deprives patients of access to their families, presents scheduling problems (including the bumping of outpatients in emergencies), and generally increases the cost of the service to the outpatient consumer. (T-386, 388-392, 1125- 1128). Both Baptist and Memorial have recognized the need for separate, dedicated operating rooms. The comparison of hospital-based dedicated ambulatory surgery rooms with free-standing ambulatory surgery rooms stirs somewhat more controversy. There are advantages and disadvantages to both. A hospital-based unit may or may not be more accessible to the physicians. While doctor's offices are often near hospitals, parking still is a problem. While some patients might prefer to avoid a hospital setting altogether, some are comforted by the proximity in the event of an emergency or decision to recuperate overnight. While costs are generally lower in a free-standing facility, there may be an advantage to having the expensive equipment immediately available in some cases (T-241-246, 392, 758-760,996, 1000-1001). If comparing non-dedicated ORs to free-standing ambulatory centers is comparing apples to oranges, then comparing hospital-based ambulatory centers to free-standing ambulatory centers is comparing red apples to green apples. Personal preferences often dictate the choice, but either one will make a pie. There exists no adopted rule governing methodology for determining need for ambulatory surgery centers. In this proceeding, each party presented its own methodology through an expert witness. Those methodologies are described as follows: Petitioner's Need Methodology Howard Fagin, PhD, was qualified as an expert in Health Planning and Health Economics without objection. (T-377) In his opinion there is a need for additional ambulatory surgery rooms. His opinion is based on a four-step process which includes: Analysis of the service area and population within that service area; Review of existing facilities providing comparable or related services; Examination of the utilization of those services within the existing facilities; and Analysis of the need for new health care facilities based upon population and need for new services in the area. 393, 394) Dr. Fagin identified Duval County as the primary service area, and Nassau, Baker, Clay and St. Johns counties as the secondary service area. The surrounding counties depend on Duval for their medical care in many cases. Together, the primary and secondary service areas comprise HRS District IV, Sub- area A (Local Health Plan, p. 112). Population figures are taken from those compiled and projected by the Executive Office of the Governor. (T.-396) For several reasons it is difficult to obtain data on out-patient surgical procedures in Florida. Out-patient surgery is a relatively new phenomenon; some hospitals do not separate in-patient from out-patient procedures in reporting; other hospitals count cases rather than procedures. (T-398) Dr. Fagin felt comfortable with data obtained from the state and from the N. E. Florida Health Planning Council, as adjusted with the use of data obtained from Baptist and Memorial for 1982, 1983, and 1984. (Petitioner's exhibits #11, 12 and 13) For 1984, he figured 31.1 percent of the surgical cases in Duval County were out-patient cases, with the trend increasing. (T-403) Petitioner's Exhibit #15 is the summary of Dr. Fagin's need analysis with two columns, one assuming an out-patient surgery rate of 35 percent of total surgeries, and the other assuming a rate of 40 percent. The number of available ambulatory surgery rooms (24) is based upon the availability of four rooms in one recently opened free-standing ambulatory center (AMI) and twenty other free-standing or dedicated (used only for out-patients) operating rooms in Duval County hospitals. The analysis assumes that the rooms will be operated five days a week, two hundred and fifty days a year (5 days x 52 weeks, minus 10 days for holidays and "down-time"). The figure of 960 cases per year, per room, is further derived from the assumptions the room will be operated 6 hours a day, an average case (including preparation, surgery, and cleanup) will take 1.25 hours, and the rooms will be utilized 80 percent of the time. In addition to the number of cases described to dedicated and free-standing rooms through that process, 3000 cases are presumed to be done each year in non-dedicated operating rooms. This figure is derived from rounding off the reported 3030 out-patient cases in non-dedicated units in 1983. The rationale for including those cases is that due to lack of sufficient free-standing units, the out-patient services must be provided in the regular hospital OR environment. The number of such cases, according to Dr. Fagin, should decrease as the number of free-standing units increases. (T. 414-415). Dr. Fagin's methodology applied to various hypothetical fact situations yields the following conclusions as to need for (+), or excess of (- ), free-standing ambulatory surgery operating rooms: Assuming a service area including all of HRS District IV, Sub-area A, 24 currently available rooms; and 960 cases per room per year: (Petitioner's Exhibit #15) 35 percent 40 percent + 6 rooms + 10 rooms Same assumptions as A, above: (intervenor`s Exhibit #16) 30 percent rate + 1 room Same assumptions as A, above, except limited to Duval County: (Intervenor Exhibit #17) 30 percent 35 percent 40 percent -4 rooms -1 room +2 rooms Same assumptions as A, above, except 31 existing rooms, instead of 24: (Intervenor Exhibit #18) 30 percent 35 percent 40 percent not calculated -2 rooms +3 rooms Same assumptions as A, above, except 31 existing rooms and service area limited to Duval County: (Intervenor Exhibit #19) 30 percent 35 percent 40 percent -11 rooms -8 rooms -5 rooms Same assumptions as A., above, except 1200 cases per room per year, instead of 960: (Intervenor Exhibit #20) 30 percent 35 percent 40 percent -4 rooms -1 room +3 rooms Same assumptions as A, above, except 1200 cases per room and 31 existing available rooms: (Intervenor Exhibit #21) 30 percent 35 percent 40 percent -11 rooms -8 rooms -4 rooms Same assumptions as A, above, except 1200 cases per room, 31 existing available rooms and Duval County only: (Intervenor Exhibit #22) 30 percent 35 percent 40 percent -15 rooms -13 rooms -10 rooms HRS Need Methodoloy Reid Jaffe, Medical Facilities Consultant for the Office of Community Medical Facilities, was qualified as an expert in health care planning with emphasis on certificate of need. (T-533) He explained the ambulatory surgical center need methodology as summarized in DHRS Exhibit #1. The Department typically uses a single county as its planning area for ambulatory surgery applications. (T-556). Therefore, the data is based on Duval County population and services provided by Duval County facilities. To obtain the volume of surgical procedures in Duval County hospitals, letters were written requesting the break-out for the period February 1984-January 1985. While the process is not an exact science, Mr. Jaffe feels that since the Department asks for the same type of information over a period of time, the anomalies in the figures will become obvious. (T-569). Based upon the returns to the questionnaire, the Duval total surgery rate, (out-patient and in-patient) was determined as 97.7 per 1000 population; the out- patient surgery rate was determined to be 30.2 per 1000 population. The July, 1987 population projection was 623,091. Need was projected at both 30 percent out-patient to total surgeries and 40 percent out-patient to total surgeries. The out-patient surgical potential (number of procedures) is derived from subtracting the hospital out-patient surgical volume from the projected number of procedures needed at a 30 percent and 40 percent rate. From that line was deducted the projected breakeven procedures for each of three free-standing ambulatory surgery centers in various stages of development in Duval County. The 30 percent rate yielded a bottom line of 5,922 excess procedures, and the 40 percent rate yielded a bottom line of 165 procedures remaining for some other facility to perform (unmet need). Since HRS considers the facility breakeven point to be considerably more than 165 procedures per year, it concludes that no additional facilities are required at this time. HRS did not explain its assumption that the rate of surgeries performed on an out-patient basis at hospitals would remain constant (30.2 per 1,000 population), while the overall percentage of out-patient surgeries to total surgeries would increase to 40 percent. (DHRS #1, T-569-576). Intervenor's Need Methodology Michael Swartz testified for Memorial and Baptist as an expert in health care planning and hospital administration. (T-704) He rejected the second-hand data utilized by both Petitioners' and HRS' experts. He devised a poll that was sent to all area hospitals and attempted to verify the responses through direct contacts and, in some instances, a walk-through of the facilities and review of hospital records. Information reported in State Agency Action reports was used for St. Luke's, since that one hospital failed to respond. (T- 704-707, 711-713). Like the other need methodology experts in this proceeding, Mr. Swartz relied on population projections from the Executive Office of the Governor. (T- 711). The geographical service area was considered Duval County, because that is what the state considers and in Mr. Swartz' opinion an ambulatory surgery center draws from a less than 30-minute driving period. (T-712). Mr. Swartz found in his data gathering that, while the number of surgeries per 1000 population has fluctuated only slightly, the mix of surgeries (in-patient to out-patient) has shown a dramatic increase in out-patient procedures. (Intervenor's Exhibit #5, T-722). After determining what he considered were the actual numbers of surgeries performed in 1983 and 1984, the actual number of operating rooms in Duval County, and the actual amount of time spent for each case, including clean-up, he determined that the bottom line showed a utilization rate of only 27.8 percent of existing surgical suites in Duval County in 1984. (Intervenor's Exhibit #6, T-729). Utilizing a fixed use rate of 103.3 surgery cases per thousand, Mr. Swartz projected an excess capacity of 109,214 cases in hospitals in 1986 and 1987, and an excess capacity for 19,279 cases in free-standing surgical centers (including AMI, Surgicare III and Medivision) in 1986 and 1987. (Intervenor's Exhibit #12 and #14, T-749, 750). The most fatal flaw in Mr. Swartz' ultimate conclusion, that there is a current and projected excess of surgery suites in Duval County, is that after his painstaking data-gathering process he lumped together all types of existing operating rooms and assumed they were all equally appropriate to handle in- patient and out-patient surgeries. This assumption is contrary to the weight of evidence in this proceeding. Of the three methodologies presented, I find Dr. Fagins most reasonable. It requires some adjustments, however, to conform to the evidence. Proceeding from Petitioner's Exhibit #15, I find the 40 percent out-patient surgery rate reasonable and consistent with credible expert testimony from all sides in this case. (Howard Fagin - T-413; Reid Jaffe - T-573; Rena Blackmer - T-106l; Carol Whittaker-T- 990: Eileen Fullernveider, T- 1125). Utilization of Subdistrict A as the service area is also 4 appropriate here. It is consistent with the District IV local health plan and recognizes the fact that Jacksonville draws from outlying counties for the sophisticated range of medical services it provides. (T-254, 255) while ordinarily free-standing surgery centers might be more neighborhood oriented and draw from a closer geographical area, it is noted that Duval is the only county in Subdistrict A with free-standing or dedicated operating rooms and for that reason patients could be expected to travel into Jacksonville. (Petitioner's Exhibit #14) The one-hour travel time addressed in the CON application, p. 226, would include some travel from the outlying counties. Reid Jaffe, the HRS expert, does not agree with the local health plan because it would be unlikely that a resident of a county that has a hospital or multiple hospitals in it and that have ambulatory surgical programs, to bypass those closer facilities just to go to Jacksonville." (T-554, 555). In the absence of dedicated ambulatory surgical programs, however, some patients very likely would travel to Jacksonville. The continued projection of 3000 cases in non-dedicated operating rooms is reasonable, since not all ambulatory surgery patients would travel to Jacksonville. Further, even when it completes its new ambulatory center, Baptist anticipates continuing to conduct approximately 2096 of its out-patient surgeries in the main ORs. (T-1063, 1064, 1085). Patient and physician loyalty would also account for some continued out-patient surgeries in those hospitals without dedicated ORs. The population projection for 1988 is appropriate, given a two-year planning horizon and the fact that the final hearing in this proceeding was continued until the end of 1985. The surgical rate of 102.94 per 1000 population is slightly higher than the 97.7 rate utilized by HRS but, just under the 103.3 rate utilized by Intervenor's expert, Howard Swartz. (Intervenor's Exhibit #14). Petitioner's Exhibit #15 understates the available ambulatory surgery rooms projected for 1988. A second free- standing ambulatory surgery center has been approved for Jacksonville and has completed its legal proceedings: Surgicare III, with 3 operating rooms. (T-562, Surgical Services of Jacksonville v. HRS, 479 So.2d 120, Affirmed 11/18/85). The record in this proceeding does not clearly reveal the status of a third surgical center, Medivision, with two rooms dedicated to opthomologieal surgery. Since that facility may still be in legal limbo, its rooms are not being counted. While Intervenor, Baptist, on cross examination posited a hypothetical application of Petitioner's methodology which included seven additional available rooms, no competent evidence followed up to substantiate any more than three additional beds. The available ambulatory surgery rooms factor in the methodology is therefore adjusted to 27. Petitioner's methodology also understates "available capacity" by understating the number of cases which could be handled per room, per year. While Dr. Fagin's methodology utilized 960 cases per room, per year, the weight of evidence and expert opinion established that at least 1300 cases per room, per year is a more realistic approximation. Intervenor's need expert, Michael Swartz, determined capacity based on ten available hours per day, five days a week, at 75 percent effici-ency (American College of Surgeons Standard) to be 2,077 cases per room, per year. (Intervenor's Exhibit #9, T-735- 737). The Hill-Burton standard utilized to determine the need for construction funds in the 1970's was 1200 cases per year, based upon data collected in the 1960s when the average time for a ease was 2 hours. (T-740, 741). Average time today is far less. (T-149, 240, 1064) Petitioner's own projected utilization assumes a capacity for 2 operating rooms, with evening and Saturday scheduling to be 300 procedures a month. (Petitioner's Exhibit #2). This translates into 1800 procedures per year, per-room. while recognizing that counting procedures rather than cases yields a higher number, San Marco never asserted that it anticipates performing two procedures for almost every case it handles. Yet this ratio is the only means of reconciling the difference between its expert's projection and that of its administrator. The above-described adjustment to Petitioner's need methodology results in the following adaptation of Petitioner's Exhibit #15: 40 percent Am. Surg. Subdistrict A 1988 Population Surgical Rate Total Surgery 861,120 102.94/1000 pop. 88,644 Ambulatory Surgery 35,457 Available Am. Surg. rooms 27 Available capacity (1300 cases) 35,100 Am. Surg. in Hospitals 3,000 Net Need Cases -2,643 Net Need Rooms - 2 Quality Of Care San Marco will occupy a building presently occupied by the Jacksonville Women's Health Organization, a licensed abortion clinic. If the certificate of need is granted, the existing building will be remodeled to provide two operating rooms and ancillary facilities required for licensure as an ambulatory surgical facility. HRS witness Reid Jaffe does not question the ability of the structure to meet requirements for licensure and does not question the ability of the proposed center to provide quality care. (T-584). The center will develop bylaws and protocols to maintain quality of care. To practice at the center, a physician must be licensed in Florida and must have privileges in good standing at a local hospital (T-59, 60). Jaroslav Fabian Hulke, M.D., was accepted as an expert in obstetrics and gynecology. He has had extensive experience in teaching and conducting out- patient surgery. (Petitioner's Exhibit #7). He has become personally familiar with Y & S Management's facilities and with their staff through his work at the center in Raleigh, North Carolina. He has also observed the facility in Jacksonville and assisted Susan Hill in developing the equipment list for the facilities. His high commendation of Miss Hill, her facilities and the planned equipment was without equivocation; his testimony as to the anticipated quality of care to be offered by this facility is most credible. (T-351, 353, 355). Anesthesia classifications range from I to IV depending on the condition of the patient. Class I and II are relatively healthy. The San Marco center will handle class I and II; some hospital out-patient units handle class III patients on a selected basis. (T-114, 141, 1120). Statistics on emergencies and deaths in free-standing ambulatory centers are not available now. The Free-standing Ambulatory Surgical Association (FASA) is in the process of gathering data. (T-1129, 1153, 1154). Depending on how they are run, equipped and staffed, the free-standing centers are considered extremely safe. (T-1128). Nothing in this proceeding would hint that the proposed administration, staffing or equipment for San Marco is less than high quality. Staffing By their Prehearing Stipulation filed on October 25, 1985, the parties agreed that there exists in Duval County an adequate labor pool of health manpower and management personnel to staff an ambulatory surgical facility. San Marco has the ability, experience and intention to obtain adequate, well- trained personnel to provide staffing for the proposed center. (T-72-75, 232- 236, 351-352). Physical and Economic Accessibility The parties have stipulated that the proposed facility is geographically available to all residents of Duval County. (Prehearing Stipulation, filed October 25, 1985). While the center will focus on the Duval County area, it also will likely draw from surrounding counties to a lesser degree. The existing abortion center already serves the wider area and as found in paragraph 12 above, no free-standing ambulatory center or dedicated out- patient ORs exist in Subdistrict A outside Duval County. For that reason, patients could be expected to drive as much as an hour to get to the facility. (CON application, p. 226). San Marco claims that it will serve 15 percent medicaid and 5 percent medicare patients. (CON application pp. 91-136). The Raleigh-Surgi-Center was used as a model since it is the one facility that receives medicaid reimbursement for non-abortion procedures. (T-89,160). However, while Medicaid does not reimburse for abortions, the State of North Carolina provides state funds and apparently those patients are computed in Raleigh's 21.6 percent figure. (T-89,90). The validity of the model is undermined by the fact that no such reimbursement occurs in Florida. (T-161). Even though the 20 percent Medicaid and Medicare projection is overstated, economic accessibility is enhanced by the willingness of the center to reduce fees for abortion procedures for otherwise Medicaid eligible patients by $50.00 or $60.00, which sum represents the management fee portion of the procedure cost. (T-158-160). More significantly, the projected standard fee for other than abortion procedures, $300.00 - 400.00, is substantially lower than fees at hospitals, including hospitals with separate ambulatory units. (T- 57, 81-82, 907, 1070, 1071, Petitioner's Exhibits #19, 20, 21, 22). Capital Costs and Financial Feasibility The total anticipated project cost for the proposed center is $246,000.00, including $80,000.00 for renovation of the building and approximately $133,000.00 for the purchase of equipment. (T-94-98, 172-173, 327). Capital is available for project start-up through the personal funds of millionaires, Stuart and Joseph Yachnowitz. (T-172). In its review of the application, HRS concluded: "There appears to be an insufficient projected number of out- patient procedures to allow this facility to be viable." (State Agency Action Report, Hearing Officer Exhibit #1). At hearing, HRS witness Reid Jaffe testified that because of the co-mingling of revenues from the abortion center and the proposed ambulatory surgery center, the financial feasibility of the project could not be determined. (T. 588, 589). On the other hand, if the revenues are co-mingled and if the projections in the applicant's pro formas are accurate, then the facility ought to do better than break even. (T-600-601). Christopher Fogel, Petitioner's expert accountant, represents Y & S Management and the ten out-patient facilities owned by Joseph and Stuart Yachnowitz. (T-182, 183) His financial projections for the proposed facility are found in Petitioner's Exhibits #5 and #6. The first projection is based upon the fee of $300.00 per procedure, for one hour of OR time, and the second is based upon $400.00, for 1.3 hours of OR time. The projections presume the facility would continue to offer its existing services (abortions) at its current level and expand to 250, 500 or 1000 procedures per year. At the $300.00 per procedure level, the facility would begin to make money with 500 additional procedures a year. However, by adding back 50 percent of the management fees (profit in the fees available to the Yachnowitz') and adding back depreciation and amortization, a positive cash flow results without any additional procedures, and increases substantially for 250, 500 and 1000 procedures at both the $300.00 and $400.00 per procedure rate. (T-198-206). Given the worst case scenario (no additional procedures), the owners are losing money only for tax purposes, but are actually increasing cash flow through the legitimate tax deduction of a loss which is not a loss of cash. (T-206). H. Impact on Competition The introduction of a free-standing ambulatory center in Duval County had a positive dynamic effect on existing traditional providers of surgical care in Duval County. Prices were lowered and more hospitals began out-patient surgery programs of their own. While the changes in costs and methods of surgical services is also attributable to pressure and incentives from insurers, no one disputes that the competition from AMI (the one free-standing facility in Duval County that is currently operational) was healthy. (T-639, 640, 1132, 893-894, 1061, 996- 997, 239). HRS health care planning expert, Reid Jaffe is of the opinion that currently the four ORs at AMI, the two opthalomological ORs at Medivision, and the 3 general ORs of Surgicare III (approved but not yet opened) are sufficient competition to the hospitals and to each other (T-564- 565, 643). No one seriously contends that the addition of San Marco's 2 ORs would put an existing facility out of business. Memorial's Chief Financial Officer, Earl Winston Lloyd, expects his facility's new out-patient unit to continue to be profitable with or without San Marco. Memorial's out-patient facility has exceeded Memorial's expectations in its productivity and profitability (T. 871- 874). John Anderson, Chief Financial Officer at Baptist, is concerned that Baptist will lose at least 35 procedures per month which are currently being performed at Baptist by physicians who have indicated an interest in practicing at San Marco. (Intervenor's Exhibit #23, T-943-945). However, he doesn't know whether those same doctors are performing out-patient surgeries in other facilities or whether those surgeries might be the ones that are taken to San Marco. (T-976). Rena Blackmer, Director of Surgical Services at Baptist, testified that when competing out-patient units opened at A.M.I., Memorial and St. Lukes, she felt initially that Baptist was losing a share of the market, but there has not been a continuing adverse effect. (T-1062). In 1985, Memorial`s excess revenue over expenses was approximately $2.5 million, with gross patient revenues of $80-82 million. (T. 863, 864). In 1985, excess revenue over expenses for Baptist was approximately $10 million. A $4.6 million loss on refinancing a debt is not included in that total; however, the $4.6 million is a balance sheet entry which impacts the income statement and is not a cash item. (T-956, 957) Total operating revenue in 1985 was $96 million. (T-955) David Mobley M.D. is a plastic surgeon who has been medical director of the Jacksonville Womens Health Organization since 1976. He practices at Baptist Medical Center, and his name appears on Intervenor's Exhibit #23 as one of the doctors whose out-patient surgeries the hospital is concerned about losing to San Marco. Dr. Mobley performs in his private office approximately ten surgeries a week that he would like to transfer to San Marco. Among as those cases are performed in his office, he is reimbursed only the fee that he receives for the same procedure done in a hospital. He absorbs the cost for his operating room at his office, his staff and supplies. (T- 247, 248). For the patient or his insurer however, the cost for the procedure would be at least twice as much in a free-standing surgery center as in the physician's office. (T-268). San Marco: Abortion Clinic or Ambulatory Surgical Center? From all the evidence in this proceeding the uncontrovertible fact emerges that when and if it is approved, San Marco Surgi-Center will merge with the Jacksonville Women's Health Organization and the two entities will make up a single health care facility: the building is the same; the equipment is the same; the owners are primarily the same; the managers are the same; and for purposes of predicting financial success, the revenue and expenses of the two entities have been considered one and the same. San Marco projects that even after two years of operation as a surgical center, a majority of its procedures will remain abortions. (Petitioner's Exhibit #2). Abortions are accomplished in health care facilities through a variety of surgical techniques, the most common of which is dilation and evacuation (D & E). (T-346, 347). Even though D & E's are expected to predominate at the facility in terms of projected number of procedures (168 per month, compared to 90 other surgical procedures per month, by June 1988), the D & E's will not predominate either in gross revenue from fees or in the anticipated OR time. San Marco anticipates the average patient charge for surgeries other than abortions to be $400.00 per case and the average OR time to be 1.3 hours. (T-93, 149). The non-medicaid patient charge for a D & E is $185.00, and the time in the OR room is generally about twenty minutes. (T-148, 158). Taking the same month, June 1988, and multiplying the number of abortions first by fee, then by OR time, yields a total of $31,080 in fees and 55.4 hours in the OR room. The same process for the 90 other surgical procedures yields $36,000.00 in fees and 119.7 hours OR time.

Recommendation Based on the foregoing, it is recommended that Certificate of Need #3304 be denied. DONE and ORDERED this 2nd day of April, 1986, in Tallahassee, Florida. MARY CLARK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of April, 1986. APPENDIX TO RECOMMENDED ORDER, CASE NO. 84-3712 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. Rulings on Proposed Findings of Fact Submitted by the Petitioner Adopted in substance in paragraph 3. Adopted in paragraph 1. Adopted in substance in paragraph 2. The surgical procedures are summarized by category in paragraph 3. Adopted in substance in paragraphs 2, 16 and 24. Rejected as cumulative and unnecessary. Adopted in substance in paragraphs 16 and 19. Adopted in substance in paragraphs 25 and 26. The statement of John Anderson's testimony is unnecessary, Rejected as cumulative and unnecessary. Adopted in substance in paragraph 26. Rejected as cumulative and unnecessary. Substantially adopted as summarized in paragraph 26. Adopted in part in paragraph 23, otherwise rejected as unnecessary. Adopted in part in paragraph 23, otherwise rejected as unnecessary. Adopted in part in paragraph 23, otherwise rejected as unnecessary. Adopted in substance in paragraph 12 and 21. Adopted in substance in paragraph 12, 13 and 21. Adopted in substance in paragraph 13. Adopted in substance in paragraph 13. Adopted in substance in paragraph 4. Adopted in substance in paragraph 5. Adopted in part in paragraph 5, otherwise rejected as unnecessary. Rejected as irrelevant and unnecessary. Adopted in paragraph 20. Rejected as irrelevant. Rejected as explained in paragraph 22. Rejected as unnecessary. Policy memorandum #7 is addressed in Conclusion of Law No. 3; otherwise this is rejected as a finding of fact. Rejected as unnecessary. Rejected as repetitive. Adopted in substance in paragraph 24 and 26. Adopted in substance in paragraph 21. Adopted in paragraph 9. Rejected as cumulative. Adopted in paragraph 9, otherwise rejected as contrary to the weight of evidence or unnecessary. Adopted in part in paragraph 29, otherwise rejected as unnecessary. Adopted in substance in paragraph 28. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in substance in paragraph 28. Adopted in paragraph 28. Adopted in part in paragraph 28, otherwise rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in paragraph 29 as to the profit of $10 million dollars, otherwise rejected as unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. As addressed in conclusions of law #10 and #11, the impact on Baptist was found to be minimal and insufficient to support "standing". Adopted in paragraph 10. Rejected as unnecessary. Rejected as unnecessary. Adopted in substance in paragraphs 10 and 11. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in substance in paragraph 11. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary, except as to the apples/oranges analogy, which is adopted in paragraph 9. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in paragraph 11. Adopted in paragraph 10, as to the characterization of Dr. Fagin's testimony. Otherwise, rejected as summary of testimony rather than findings of fact. The adoption of 40 percent as reasonable is found in paragraph 12. Rejected as contrary to the weight of the evidence. HRS Need Methodology is rejected in paragraph 10.(b) and paragraph 12 as being less reasonable than Petitioners' experts methodology. Rejected as essentially argument, rather than findings of fact. Rejected as contrary to the weight of evidence. Rejected as repetitive. Adopted in substance in paragraph 33 and Conclusion of Law #3. Rejected as argument unsupported by the weight of evidence. Rejected. See paragraph 7 for discussion of State Health Plan. Rejected as argument, rather than finding of fact. No paragraph of this number is found in Petitioner's Proposed Findings of Fact. Adopted in Conclusions of Law, paragraph 4. Rulings on Joint Proposed Findings of Fact Submitted by the Respondent and Intervenors. (Note, the numbers in the left column conform to the numbering of the joint proposed findings) 1. Adopted in substance in paragraph 1, 2 and 3. Adopted in paragraph 6. Adopted -In paragraph 4. Adopted in paragraph 5. 1. Adopted in paragraph 7. Adopted in paragraph 8. Rejected as irrelevant. Adopted in part in paragraph 8, otherwise rejected as unnecessary. Rejected as irrelevant. Adopted in substance in paragraph 10(b). Rejected as contrary to the weight of the evidence. Adopted in part in paragraph 10, otherwise rejected as unnecessary. Rejected as a re-statement of testimony, rather than finding of fact 10.c. Description of Mr. Swartz' methodology is provided in paragraph Rejected as irrelevant. Rejected as irrelevant. 13 - 21. Rejected as unnecessary. Adopted in substance in paragraph 10. Rejected as unnecessary. Rejected as contrary to the weight of evidence, except as reflected in paragraph 10. Adopted in part in paragraph 10.b., otherwise rejected as unnecessary. 25A. Adopted in part in paragraph 10, otherwise rejected as unsubstantiated by competent substantial evidence. Adopted in part in paragraph 10, otherwise rejected as unnecessary. Adopted in part in paragraph 22 and 23, otherwise rejected as unnecessary. 1. Adopted in substance in paragraph 31. Adopted in substance in paragraph 31. Rejected as contrary to the evidence by considering all uncontroverted testimony and evidence describing the facility. Adopted in part in paragraph 32 and 33, otherwise rejected as irrelevant. Adopted in part in paragraph 32 and 33, otherwise rejected as irrelevant. Rejected as contrary to the weight of the evidence. Adopted in part in paragraph 31, 32 and 33, otherwise rejected as irrelevant. Rejected as irrelevant. Rejected as contrary to the weight of the evidence. 1. Rejected as unnecessary. Rejected as argument that is unnecessary or unsupported by competent substantial evidence. Adopted in substance in paragraph 27. 1. Rejected as cumulative. Rejected as cumulative. Rejected as unnecessary. Adopted in part in paragraph 4, 5 and 10, otherwise, rejected as unnecessary. Adopted in substance in paragraph 9. Adopted in substance in paragraph 9. Adopted in part in paragraph 4 and 5, otherwise rejected as unnecessary. Rejected as cumulative. Addressed in Conclusion of Law 6. 1. Adopted in paragraph 17. Rejected as irrelevant. Rejected as irrelevant. 1. Rejected as cumulative. 2. Rejected as mere re-statement of testimony rather than a finding of fact. 1. 1. 1. 1. Adopted in paragraph 20. Adopted in part in paragraph 24, otherwise rejected as irrelevant or contrary to the weight of evidence. Rejected as irrelevant. 1. Adopted in part in paragraph 26, otherwise rejected as irrelevant. Adopted in paragraph 24. Rejected as irrelevant. 1. Addressed in Conclusion of Law 4. 1. Addressed in Conclusion of Law 4. 1. Rejected as unnecessary argument. Adopted in part in paragraph 27, otherwise rejected as unnecessary. Rejected as the description of an exhibit and characterization of testimony. Adopted in part in paragraph 30, otherwise rejected as unnecessary. 1. Adopted in paragraph 24. COPIES FURNISHED: William J. Page, Jr., Secretary Department of HRS 1323 Winewood Blvd. Tallahassee, Florida 32301 Steve Huss, Esquire General Counsel Department of HRS 1323 Winewood Blvd. Tallahassee, Florida 32301 Chris H. Bentley, Esquire William E. Williams, Esquire Jeannette Andrews, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Richard Power, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 Michael J. Dewberry, Esquire Christopher Hazelip, Esquire 1300 Gulf Life Drive Jacksonville, Florida 32207 Robert Meek, Esquire Post Office Box 240 Jacksonville, Florida 32201 =================================================================

Florida Laws (3) 120.56120.57395.002
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs JOHN CHRISTOPHER CHAUVIN, M.D., 99-003723 (1999)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Sep. 01, 1999 Number: 99-003723 Latest Update: Jul. 06, 2004

The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine, based on alleged violation of Section 458.331(1)(t), Florida Statutes.

Findings Of Fact Respondent is a licensed physician in the State of Florida. He has been licensed in Florida at all times material to this proceeding. He currently holds license no. ME 0063272. Respondent has been practicing medicine for 20 years. He is certified by the American Association of Physician Specialist in Emergency Room Medicine. He has spent over 50,000 hours working in an emergency room setting and has never had his license suspended, revoked, or otherwise sanctioned. For approximately six to nine months in 1995-1996, Respondent was employed by a company which provided emergency room physicians to hospitals in the Central Florida region. On May 14, 1996, Respondent was providing services through that company at Glades General Hospital's emergency room. S.A.R. is a 69-year-old male. On May 14, 1996, S.A.R.'s wife called Emergency Medical Services (EMS), in connection with her husband, S.A.R. He was experiencing chest and epigastric pains. S.A.R. wore a nitroglycerin patch and had a history of heart disease. In response to the wife's call, EMS arrived at S.A.R.'s home. The emergency medical technicians (EMTs) noted that patient S.A.R. complained of severe chest pain and that he was cool and moist. The EMT's placed S.A.R. on a heart monitor. The heart monitor showed that S.A.R. was experiencing multifocal premature contractions (PVC's). Multifocal PVC's are a sign of an irritated heart. They are a risk factor for sudden cardiac death. S.A.R. was also experiencing abnormal, ectopic heartbeats consistent with heart disease. EMS gave S.A.R. Lidocaine and oxygen to reduce the irritability in his heart muscle and to suppress the abnormal heartbeats. At approximately 9:10 p.m., EMS transported S.A.R. to the emergency room at Glades General Hospital in Belle Glade, Florida. The Emergency Service Record concerning S.A.R. contains the following findings by the nurse who received the patient into the emergency room: Current medications: Axid 150 mg, Minitran 10 mg patch. Heart disease (Myocardial Infarction 20 years prior). Hernia. Patient complaining of epigastric pains since Friday (May 14 was Thursday). Pains come and go and are non-radiating. Skin is warm and dry, lungs are clear, and there is no respiratory distress. Oxygen is at 98 percent and there is strong pulse. Multifocal PVC "noted on cardiac monitor." Respondent was among the admitting team who evaluated the patient. Respondent noted that S.A.R. was experiencing severe pains located in the epigastric area with some radiation to the chest. The pains would last approximately five minutes and then fade away. Respondent also learned that S.A.R. had experienced the pain for approximately one week long and had gone to see his regular physician about the chest pain the day before he came to the hospital. His physician had prescribed Axid. Axid is a medication for indigestion. It takes some amount of time to become effective. Therefore it was not surprising to Respondent that S.A.R. had not gotten any relief 25 hours after he had begun taking the indigestion medication. Respondent took patient S.A.R. off the Lidocaine and ordered a GI Cocktail and a cardiac work-up. A GI Cocktail coats the stomach lining and reduces stomach spasms. It is intended to act quickly. A cardiac work- up consists of placing a patient on a heart monitor, monitoring vital signs, observing for arrhythmias, performing an EKG, and drawing blood tests for abnormal electrolytes and cardiac enzymes. A GI Cocktail will relieve chest pain. However, it will not normally alleviate cardiac pain in the chest area. In this case, all of S.A.R.'s pain and discomfort was relieved by the GI Cocktail, indicating that the epigastric pain was the reason for S.A.R.'s distress. The nurses notes indicate that at approximately 10:15 p.m., S.A.R. was experiencing multifocal PVC's on the monitor. The nurses notes indicate a more serious heart condition. The blood tests showed normal electrolytes and cardiac enzymes, indicating that S.A.R.'s heart was not the problem. Respondent did not find any evidence of a possible cardiac problem from his review of the patient's symptoms, from the test results, or by way of his personal observation of the patient. Respondent did not observe any multifocal PFC. He did observe that S.A.R.'s heart was not normal due to heart disease. Respondent diagnosed the patient with Gastritis, and released patient S.A.R. at approximately 10:30 p.m. The heart strips introduced into evidence did not show multifocal PVCs. They did show an abnormal heart beat consistent with heart disease. However, S.A.R. had numerous risk factors for a heart attack, including: Patient S.A.R. was a 69-year-old male. Patient S.A.R. suffered from coronary artery disease. Patient S.A.R. suffered a myocardial infarction approximately twenty years earlier. Patient S.A.R. was taking nitroglycerin for his heart condition as evidenced by a patch on his arm. Patient S.A.R. experienced multifocal PVC's on the cardiac monitor in the ambulance. Patient S.A.R.'s EKG taken in the hospital displayed unifocal PVC's and was abnormal, showing damage to two of the three electrical conduction bundles. Patient S.A.R. was cold and clammy when EMS first arrived. In this case, there is no way to know if S.A.R.'s pain was related to his heart. However, there is no way to rule out S.A.R.'s pain was caused by his heart. Approximately sixteen hours later, patient S.A.R. returned to the emergency room in full cardiac arrest. On May 15, 1996, seven and one-half hours later, he had another heart attack and died, of a myocardial infarction. There is no evidence that S.A.R.'s earlier emergency room visit was the cause of his later demise or that admission to the hospital would have prevented S.A.R.'s later demise. Petitioner's expert witness found that Respondent's treatment of S.A.R. was appropriate. That is, he ordered the proper test and treated the epigastric pain properly. In fact, his diagnosis that the problem was "GI in origin" was, according to Dr. Edelberg, statistically correct. Petitioner's expert concluded that Respondent could not rule out coronary ischemia and therefore should have tried to admit S.A.R. to the hospital for observation. The standard of care is for an emergency physician to evaluate a patient based on the worst case suggested by the symptoms even if statistically not the most probable. Based on patient S.A.R.'s past history and his current symptoms, the standard of care required Respondent to admit this type of patient into the hospital for observation. In failing to admit patient S.A.R. into the hospital for observation, the Respondent deviated from the standard of care required by a reasonably prudent similar physician under similar circumstances and conditions. Other than this one violation there is no evidence that Respondent is incompetent to practice medicine.

Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That Petitioner Department of Health, Board of Medicine enter a final order finding Respondent John Christopher Chauvin, M.D., guilty of violating Section 458.331(1)(t), Florida Statutes, and imposing upon the Respondent the following penalty: A Reprimand from the Board of Medicine and that Respondent, within two years take twenty-five hours of continuing education in the treatment of myocardial infarction in addition to any hours required for license renewal. DONE AND ENTERED this 12th day of May, 2000, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER 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 12th day of May, 2000. COPIES FURNISHED: James Morrison, Certified Legal Intern Albert Peacock, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 R. Bruce McKibben, Jr., Esquire 1301 Miccosukee Road Tallahassee, Florida 32308 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1703 William Langue, General Counsel Department of Health 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750

Florida Laws (4) 120.57455.225458.331766.102
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TAMPA SURGI CENTRE, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 83-000472 (1983)
Division of Administrative Hearings, Florida Number: 83-000472 Latest Update: May 08, 1984

Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: Surgical Services of Tampa, Inc. (SST) is a wholly owned subsidiary of Surgical Services, Inc., (SSI) located in Orlando, Florida. Eighty percent of SSI is owned by American Medical International, Inc. (AMI), the third largest health care provider in the United States. The remaining twenty percent ownership of SSI is held by Randall M. Phillips, who also serves as the president of SST. AMI owns and operates some 70 acute care hospitals in the United States and abroad, a nursing home and 7 or 8 ambulatory surgery centers around the country. Two of these centers are located in Florida, one in Clearwater and one in Tallahassee, and SSI has the responsibility for these centers. SSI also holds several Certificates of Need for other free standing ambulatory surgery centers to be constructed in Florida. AMI has made a commitment to provide financial support for the total development of the applicant's proposed ambulatory surgery facility in Tampa. This support includes the purchase of the land, construction of the building, equipping the facility and working capital. The financing is to be in the form of a fifty percent equity contribution and a 28-year loan at 12 percent interest to SST for the remaining funds. AMI has sufficient financial resources to fulfill its commitment to the proposed project. The total projected cost for the proposed facility is $2,240,800.00. The parties have stipulated that the proposed costs associated with construction, equipment and land acquisition and preparation are reasonable. The parties have also stipulated that the proposed staffing pattern is adequate and that the applicant SST will have the ability to adequately staff the proposed facility. While SST had not made a firm site selection at the time of the hearing, it has plans to locate its facility somewhere near the vicinity of St. Joseph's Hospital and the Human Women's Hospital in Tampa, Florida. Its service area includes all of Hillsborough County. The center will consist of four operating rooms or surgical suites, and laboratory, x-ray and administrative areas for a total of 15,000 square feet. SST plans to handle all types of surgical procedures which can be performed on an outpatient basis. Its medical staff will be open to all doctors qualified to perform the types of surgeries that can be accomplished on an ambulatory, outpatient basis. The facility will admit any patient a surgeon schedules for surgery, and will accept Medicare and Medicaid patients. SST plans to invoke an aggressive marketing effort to inform and educate consumers, insurance companies, employers, physicians and other health care facilities in the market area as to the benefits and cost- effectiveness of using its facility to perform surgery on an outpatient basis. It has budgeted some $20,000.00 to effect such a marketing program. Professional accreditation with the Joint Commission on Accreditation of Hospitals will be sought after the proposed facility completes its first year of operation. Based upon a 15 percent Medicare utilization or patient mix and using the lowest Medicare reimbursement level and a projected number of procedures of 2,234 and 2,681 for the first and second years of operation, SST projects that it will have a loss of $17,426 in its first year of operation and a profit of $22,173 in its second year of operation. Using the highest payment level in the amount of contractual allowances, SST's pro forma statement shows a net income in both years of $689 and $41,444, respectively. The projected Medicare utilization percentage of 15 percent was not demonstrated to be erroneous and approximates the Medicare mix experienced at the petitioner's ASC facility in the preceding year. The projection of 2,234 procedures to be performed in the first year of operation was derived by estimating the number of potential ambulatory surgeries in the proposed service area (approximately 30 percent of all surgeries) and subtracting therefrom the number currently being performed in hospitals (approximately 15 percent), leaving a projected unmet caseload of 2,234. The salary projections, which were adjusted for inflation under the assumption that the proposed facility would begin operations in August of 1984, appear to be reasonable and adequate. In the 1981-82 reporting period, approximately 58,000 total surgical procedures were reported in Hillsborough County. Of this number, approximately 82 percent were performed on an inpatient basis, while 18 percent were performed on an outpatient basis. The literature on the subject, as well as some other states, predicts that between 28 percent and 48 percent of all surgeries could be performed in ambulatory settings. In Salt Lake City, Utah, 38.2 percent of all surgeries are performed on an outpatient basis. A wider acceptance on the part of patients, consumers and physicians of the concept of performing surgery on an outpatient basis, as well as changes in third party reimbursement (including the new Medicare reimbursement system of payment based on diagnostic related groupings as opposed to lengths of hospital stay), should result in the performance of an increased percentage of surgeries on an outpatient basis. The applicant's expert ambulatory surgical facilities health planner utilized four different methodologies to evaluate the need for additional ambulatory surgery facilities in Tampa. The first methodology utilized was use rate-based and took into account population and historical surgery utilization data. Using the assumption that 30 percent of all surgeries performed can be performed in an ambulatory setting, projecting the number of surgeries expected in 1984 and subtracting the number performed on an outpatient basis in the last reporting period (1981-82), it was determined that the remaining unmet need in 1984 would be 8,226 ambulatory surgeries, and the respective figures for 1985 and 1986 would he 8,596 and 8,955. A flaw in this methodology is the assumption that existing facilities will not increase their usage of outpatient surgical procedures. The second methodology is also use rate-based, but predicts an increased performance of outpatient procedures by existing facilities, said increase approximating the percentage of population growth, assumes a 30 percent to 40 percent outpatient to inpatient ratio and produces a range of unmet need in 1984 of 7,586 to 13,753, in 1985 of 7,737 to 14,028, and in 1986 of 7,885 to 14,295. The third method is a use rate and capacity-based methodology. It also uses the 30 percent to 40 percent range as the potential ambulatory surgery market and then designates a number of dedicated operating rooms which would be appropriate to fill that need. Assuming that an average capacity is 1,200 procedures per room per year and that all current ambulatory surgeries are performed in dedicated ambulatory surgery suites, and then dividing that capacity figure into the number of expected ambulatory surgeries in 1984, the required number of dedicated operating rooms ranges from 16 to 21 in 1984 and 1985 and from 17 to 22 in 1986. Assuming 9 current dedicated ambulatory surgery operating rooms, the net need is determined as a range from 7 to 12 additional dedicated rooms in 1984 and 1985 and from 8 to 13 in 1986. The fourth methodology is similar to the first, but is based on patient day utilization. It uses a 30 percent outpatient to inpatient ratio, and yields an unmet need, after subtracting current procedures performed at existing facilities, of 8,221 procedures in 1984, 8,591 in 1985 and 8,950 in 1986. Each of the methodologies results in a sufficient number of outpatient surgical procedures to support the applicant's proposed surgery center. The respondent HRS has no promulgated rule prescribing the methodology to be utilized to determine the need for additional ambulatory surgical centers in an area. Its non-rule methodology, utilizes a use rate per 1,000 population for a given year, applies that to a projected population two and three years into the future and then multiplies that figure by 29 percent. The 29 percent represents a midrange between 18 percent and 40 percent, the range suggested by the literature as representing the percentage of total surgeries that can be performed on an ambulatory basis. Taking into account the existing outpatient use rate being experienced, the projected population and the projected number of outpatient procedures which will be provided by existing facilities, a total number of outpatient procedures that could be performed by an applicant is produced. The Department also considers the number of procedures an applicant would have to perform in order to break even financially in its second year of operation. This methodology relates need to financial feasibility, but does not consider capacity or optimum utilization factors. In this case, the use of HRS's methodology results in a total figure of 7,569 outpatient procedures that need to be provided in 1986 beyond those that would be provided by the existing outpatient facilities of the area hospitals. The HRS calculations do not consider those procedures being performed at the petitioner's ASC facility. HRS calculated that SST would have to perform 2,463 procedures by the year 1986 in order to break even financially, and therefore that there were a significant number of procedures available to support the need for an additional ambulatory surgery facility. Existing hospitals in Hillsborough County currently perform surgery on an outpatient basis. As indicated above, some 18 percent of all surgeries, or 10,276 procedures, were reported as outpatient in the 1981-82 reporting period by Hillsborough County facilities, including the petitioner. With the exception of the petitioner's four dedicated operating rooms and two more at an area hospital, the remaining existing operating rooms are not used exclusively for outpatient surgeries, but are available for such surgery. Many existing hospitals are currently in the process of expanding their outpatient services. These expansion efforts generally involve new pre-admission, pre-operative and recovery room beds and reception areas for ambulatory surgical patients, and not new dedicated operating rooms for outpatients. Among those receiving recent Certificates of Need to expand their outpatient services are Tampa General Hospital, St. Joseph's Hospital, Brandon Community Hospital and Humana's Women's Hospital. University Community Hospital is also active in the performance of outpatient surgical procedures. Depending upon the sufficiency and efficiency of management and staff, a freestanding ambulatory surgery center offers some advantages over outpatient surgery performed in a hospital operating room utilized for both inpatients and outpatients. The freestanding facility may have staff surgeons and anesthesiologists with specialized outpatient surgery training. Total overhead costs are likely to be less, thus resulting in reduced patient costs. Since the operating room staff effort is continually focused on outpatient surgery only, management problems may be reduced, thus making the experience more pleasant for the patient, his family and the surgeon. Patients will experience less waiting times as there will not be as many emergencies as in a hospital setting or as much "bumping" of an elective surgery outpatient in an ambulatory center. If properly and efficiently managed, there may be less danger of cross-infection in the freestanding facility. The petitioner ASC is a freestanding facility built in 1979 and located adjacent to the University of South Florida in Tampa. It occupies 14,350 square feet, has four operating rooms, a special procedures room, several examination rooms, 12 recovery beds, 8 pre- and post-operative beds, waiting rooms and administrative and business office areas. Staff privileges are held by 157 surgeons from the Tampa area. At the time of the hearing, 15 more surgeons had applied for staff privileges. Its total caseload for the first eleven months of operation was 257. Cases performed in 1980 increased to 420. In 1981 and 1982, ASC performed 1,172 and 1,217 procedures, respectively. For the first seven months of 1983, 1,191 procedures were performed, for a utilization rate of approximately 25 percent. ASC has no formal, regular budgeted marketing program. It has received accreditation from the Joint Commission on Accreditation of Hospitals.

Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that HRS issue a Certificate of Need to Surgical Services of Tampa, Inc. to construct and operate a freestanding, four operating room ambulatory surgery center in Hillsborough County. Respectfully submitted and entered this 22nd day of March, 1984, in Tallahassee, Florida. DIANE D. TREMOR, 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 22nd day of March, 1984. COPIES FURNISHED: F. Phillip Blank and Robert A. Weiss, Esquires 241 East Virginia Street Tallahassee, Florida 32301 Claire D. Dryfuss, Esquire Assistant General Counsel 1323 Winewood Blvd. Tallahassee, Florida 32301 Fred W. Baggett and Michael J. Cherniga, Esquires 101 East College Avenue P.O. Drawer 1838 Tallahassee, Florida 32301 David Pingree Secretary Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32301

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LEESBURG REGIONAL MEDICAL CENTER, INC. vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 83-000156 (1983)
Division of Administrative Hearings, Florida Number: 83-000156 Latest Update: Jan. 30, 1984

Findings Of Fact Introduction Petitioner, Leesburg Regional Medical Center ("Leesburg"), is a 132-bed acute care private, not-for-profit hospital located at 600 East Dixie Highway, Leesburg, Florida. It offers a full range of general medical services. The hospital sits on land owned by the City of Leesburg. It is operated by the Leesburg hospital Association, an organization made up of individuals who reside within the Northwest Taxing District. By application dated August 13, 1982 petitioner sought a certificate of need (CON) from respondent, Department of Health and Rehabilitative Services (HRS), to construct the following described project: This project includes the addition of 36 medical/surgical beds and 7 SICU beds in existing space and the leasing of a CT scanner (replacement). The addition of the medical/surgical beds is a cost effective way to add needed capacity to the hospital. Twenty-four (24) beds on the third floor will be established in space vacated by surgery and ancillary departments moving into newly constructed space in the current renovation project. A significant portion of this area used to be an obstetric unit in the past; and therefore, is already set up for patient care. The 7 bed SICU unit will be set up on the second floor, also in space vacated as a result of the renovation project. Twelve additional beds will be available on the third and fourth floors as a result of changing single rooms into double rooms. No renovation will be necessary to convert these rooms into double rooms. It is also proposed to replace the current TechniCare head scanner with GE8800 body scanner. Based on the high demand for head and body scans and the excessive amount of maintenance problems and downtime associated with the current scanner, Leesburg Regional needs a reliable, state-of-the-art CT scanner. The cost of the project was broken down as follows: The total project cost is $1,535,000. The construction/renovation portion of the project (24 medical/surgical and 7 SICU beds) is $533,000. Equipment costs will be approximately $200,000. Architectural fees and project development costs total $52,000. The CT scanner will be leased at a monthly cost of $16,222 per month for 5 years. The purchase price of the scanner is $750,000 and that amount is included in the total project cost. The receipt of the application was acknowledged by HRS by letter dated August 27, 1982. That letter requested Leesburg to submit additional information no later than October 10, 1982 in order to cure certain omissions. Such additional information was submitted by Leesburg on October 5, 1982. On November 29, 1982, the administrator for HRS's office of health planning and development issued proposed agency action in the form of a letter advising Leesburg its request to replace a head CT scanner (whole body) at a cost of $750,000 had been approved, but that the remainder of the application had been denied. The basis for the denial was as follows: There are currently 493 medical/surgical beds in the Lake/Sumter sub-district of HSA II. Based upon the HSP for HSA II, there was an actual utilization ratio of existing beds equivalent to 2.98/1,000 population. When this utilization ratio is applied to the 1987 projected population of 156,140 for Lake/Sumter counties, there is a need for 465 medical/surgical beds by 1987. Thus, there is an excess of 28 medical/surgical beds in the Lake/Sumter sub-district currently. This action prompted the instant proceeding. At the same time Leesburg's application was being partially denied, an application for a CON by intervenor-respondent, Lake Community Hospital (Lake), was being approved. That proposal involved an outlay of 4.1 million dollars and was generally described in the application as follows: The proposed project includes the renovations and upgrading of patient care areas. This will include improving the hospital's occupancy and staffing efficiencies by reducing Med-Surg Unit-A to 34 beds and eliminating all 3-bed wards. Also reducing Med-Surg Units B and C to 34 beds each and eliminating all 3-bed wards. This will necessitate the construction of a third floor on the A wing to house the present beds in private and semi-private rooms for a total of 34 beds. There is also an immediate need to develop back-to-back six bed ICU and a six-bed CCU for shared support services. This is being done to fulfill JCAH requirements and upgrade patient care by disease entity, patient and M.D. requests. Another need that is presented for consideration is the upgrading of Administrative areas to include a conference room and more Administrative and Business office space. However, the merits of HRS's decision on Lake's application are not at issue in this proceeding. In addition to Lake, there are two other hospitals located in Lake County which provide acute and general hospital service. They are South Lake Memorial Hospital, a 68-bed tax district facility in Clermont, Florida, and Waterman Memorial Hospital, which operates a 154-bed private, not-for-profit facility in Eustis, Florida. There are no hospitals in Sumter County, which lies adjacent to Lake County, and which also shares a subdistrict with that county. The facilities of Lake and Leesburg are less than two miles apart while the Waterman facility is approximately 12 to 14 miles away. South Lake Memorial is around 25 miles from petitioner's facility. Therefore, all three are no more than a 30 minute drive from Leesburg's facility. At the present time, there are 515 acute care beds licensed for Lake County. Of these, 493 are medical/surgical beds and 22 are obstetrical beds. None are designated as pediatric beds. The Proposed Rules Rules 10-16.001 through 10-16.012, Florida Administrative Code, were first noticed by HRS in the Florida Administrative Weekly on August 12, 1983. Notices of changes in these rules were published on September 23, 1983. Thereafter, they were filed with the Department of State on September 26, 1983 and became effective on October 16, 1983. Under new Rule 10-16.004 (1)(a), Florida Administrative Code, subdistrict 7 of district 3 consists of Lake and Sumter Counties. The rule also identifies a total acute care bed need for subdistrict 7 of 523 beds. When the final hearing was held, and evidence heard in this matter, the rules were merely recommendations of the various local health councils forwarded to HRS on June 27, 1983 for its consideration. They had not been adopted or even proposed for adoption at that point in time. Petitioner's Case In health care planning it is appropriate to use five year planning horizons with an overall occupancy rate of 80 percent. In this regard, Leesburg has sought to ascertain the projected acute care bed need in Lake County for the year 1988. Through various witnesses, it has projected this need using three different methodologies. The first methodology used by Leesburg may be characterized as the subdistrict need theory methodology. It employs the "guidelines for hospital care" adopted by the District III Local Health Council on June 27, 1983 and forwarded to HRS for promulgation as formal rules. Such suggestions were ultimately adopted by HRS as a part of Chapter 10-16 effective October 16, 1983. Under this approach, the overall acute care bed need for the entire sixteen county District III was found to be 44 additional beds in the year 1988 while the need within Subdistrict VII (Lake and Sumter Counties) was eight additional beds. 2/ The second approach utilized by Leesburg is the peak occupancy theory methodology. It is based upon the seasonal fluctuation in a hospital's occupancy rates, and used Leesburg's peak season bed need during the months of February and March to project future need. Instead of using the state suggested occupancy rate standard of 80 percent, the sponsoring witness used an 85 percent occupancy rate which produced distorted results. Under this approach, Leesburg calculated a need of 43 additional beds in 1988 in Subdistrict VII. However, this approach is inconsistent with the state-adopted methodology in Rule 10- 5.11(23), Florida Administrative Code, and used assumptions not contained in the rule. It also ignores the fact that HRS's rule already gives appropriate consideration to peak demand in determining bed need. The final methodology employed by Leesburg was characterized by Leesburg as the "alternative need methodology based on state need methodology" and was predicated upon the HRS adopted bed need approach in Rule 10-5.11(23) with certain variations. First, Leesburg made non-rule assumptions as to the inflow and outflow of patients. Secondly, it substituted the population by age group for Lake and Sumter Counties for the District population. With these variations, the methodology produced an acute care bed need of 103 additional beds within Lake and Sumter Counties. However, this calculation is inconsistent with the applicable HRS rule, makes assumptions not authorized under the rule, and is accordingly not recognized by HRS as a proper methodology. Leesburg experienced occupancy rates of 91 percent, 80 percent and 73 percent for the months of January, February and March, 1981, respectively. These rates changed to 86 percent, 95 percent and 98 percent during the same period in 1982, and in 1983 they increased to 101.6 percent, 100.1 percent and 95.1 percent. Leesburg's health service area is primarily Lake and Sumter Counties. This is established by the fact that 94.4 percent and 93.9 percent of its admissions in 1980 and 1981, respectively, were from Lake and Sumter Counties. Although South Lake Memorial and Waterman Memorial are acute care facilities, they do not compete with Leesburg for patients. The staff doctors of the three are not the same, and there is very little crossover, if any, of patients between Leesburg and the other two facilities. However, Lake and Leesburg serve the same patient base, and in 1982 more than 70 percent of their patients came from Lake County. The two compete with one another, and have comparable facilities. Leesburg has an established, well-publicized program for providing medical care to indigents. In this regard, it is a recipient of federal funds for such care, and, unlike Lake, accounts for such care by separate entry on its books. The evidence establishes that Leesburg has the ability to finance the proposed renovation. HRS's Case HRS's testimony was predicated on the assumption that Rule 10-16.004 was not in effect and had no application to this proceeding. Using the bed need methodology enunciated in Rule 10-5.11(23), its expert concluded the overall bed need for the entire District III to be 26 additional beds by the year 1988. This calculation was based upon and is consistent with the formula in the rule. Because there was no existing rule at the time of the final hearing concerning subdistrict need, the witness had no way to determine the bed need, if any, within Subdistrict VII alone. Lake's Case Lake is a 162-bed private for profit acute care facility owned by U.S. Health Corporation. It is located at 700 North Palmetto, Leesburg, Florida. Lake was recently granted a CON which authorized a 4.1 million dollar renovation project. After the renovation is completed all existing three-bed wards will be eliminated. These will be replaced with private and semi-private rooms with no change in overall bed capacity. This will improve the facility's patient utilization rate. The expansion program is currently underway. Like Leesburg, the expert from Lake utilized a methodology different from that adopted for use by HRS. Under this approach, the expert determined total admissions projected for the population, applied an average length of stay to that figure, and arrived at a projected patient day total for each hospital. That figure was then divided by bed complement and 365 days to arrive at a 1988 occupancy percentage. For Subdistrict VII, the 1988 occupancy percentage was 78.2, which, according to the expert, indicated a zero acute care bed need for that year. Lake also presented the testimony of the HRS administrator of the office of community affairs, an expert in health care planning. He corroborated the testimony of HRS's expert witness and concluded that only 26 additional acute care beds would be needed district-wide by the year 1988. This result was arrived at after using the state-adopted formula for determining bed need. During 1981, Lake's actual total dollar write-off for bad debt was around $700,000. This amount includes an undisclosed amount for charity or uncompensated care for indigent patients. Unlike Leesburg, Lake receives no federal funds for charity cases. Therefore, it has no specific accounting entry on its books for charity or indigent care. Although Leesburg rendered $276,484 in charity/uncompensated care during 1981, it is impossible to determine which facility rendered the most services for indigents due to the manner in which Lake maintains its books and records. In any event, there is no evidence that indigents in the Subdistrict have been denied access to hospital care at Lake or any other facility within the county. Lake opines that it will loose 2.6 million dollars in net revenues in the event the application is granted. If true, this in turn would cause an increase in patient charges and a falling behind in technological advances. For the year 1981, the average percent occupancy based on licensed beds for Leesburg, Lake, South Lake Memorial and Waterman Memorial was as follows: 71.5 percent, 58.7 percent, 63.8 percent and 65.7 percent. The highest utilization occurred in January (81 percent) while the low was in August (58 percent). In 1982, the utilization rate during the peak months for all four facilities was 78 percent. This figure dropped to 66.5 percent for the entire year. Therefore, there is ample excess capacity within the County even during the peak demand months.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the application of Leesburg Regional Medical Center for a certificate of need to add 43 acute care beds, and renovate certain areas of its facility to accommodate this addition, be DENIED. DONE and ENTERED this 15th day of December, 1983, in Tallahassee, Florida. DONALD R. ALEXANDER 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 15th day of December, 1983.

Florida Laws (1) 120.57
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