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
Findings Of Fact The Respondent, Jayaprakash Kamath, M.D., is a licensed physician in the State of Florida, having license ME 0036704. He is board certified in internal medicine and gastroenterology. He has had no prior complaints of any kind against him since he began practicing medicine in Florida in 1980, and he has a reputation for being a competent and caring physician. On the morning of August 1, 1988, while making rounds at Morton Plant Hospital in Clearwater, Florida, the Respondent was paged by one of his partners, Belur Sreenath, M.D. The Respondent returned the call and was asked to see a patient whom Sreenath had just accepted and admitted on a 23-hour basis at Morton Plant. Sreenath reported that the patient was a referral from the Morton Plant emergency room. The patient's regular physician was on vacation, and the regular physician's on-call cover had recommended to the emergency room physician that the patient be referred to the Respondent and Sreenath to treat the patient for diagnosed fecal impaction. It was reported to the Respondent, through Sreenath, that the patient had come into the emergency room at about five in the morning complaining of abdominal pain and constipation. The emergency room physician, Jerry Julius Chase, M.D., had three X-rays done and had done his own "wet reads" of the X-rays before sending them to the radiology department for a definitive interpretation. According to Chase, the X-rays showed "much fecal matter, no obstruction." Chase did not mention any other significant findings. Chase's preliminary diagnosis was "fecal impaction." Sreenath also reported that he (Sreenath) had ordered enemas for the patient. Soon after the Respondent received the call from his partner, the Respondent called Chase, who was still in the emergency room and still had the X-rays. Chase confirmed what Sreenath had told the Respondent, again not mentioning any other significant findings. After talking to Chase, the Respondent visited the patient in his hospital room. By this time it was about 10:00 a.m. The Respondent took a history from the patient, examined the patient, and read the patient's chart. The chart included the results of lab work and the "ER sheet," which included the emergency room physician's diagnosis of abdominal pain and impaction and the results of his "wet-read" of the X-rays, but it did not yet include a report from the radiology department or the X-rays themselves. The Respondent did not contact the radiology department for a definitive interpretation of the X-rays or obtain the X-rays for his own review. By the time the Respondent saw the patient, the patient already had one enema and seemed to be responding to the treatment. Based on the information he had, the Respondent made a diagnosis of fecal impaction, confirmed his partner's orders for enemas for the patient, and added a stool softener. The nursing staff was ordered to monitor the patient's progress. The patient continued to respond satisfactorily to treatment during the day. Between ten and eleven in the evening of August 1, 1988, the patient complained of some abdominal pain or cramping (symptoms that are consistent with a diagnosis of fecal impaction and enema treatments) and the nurses on duty contacted the Respondent's partner, who was on call. Sreenath ordered a combination of demerol and vistaril as an analgesic. One small dose was enough to relieve the patient's pain, and the patient slept through most of the night. He ate 80% of his breakfast the next morning and was not complaining of pain or asking to see a doctor. At approximately 9:15 a.m. on August 2, 1988, a nurse telephoned the Respondent for a decision whether the patient was being discharged or was being admitted as an inpatient. The Respondent still had not seen the patient's X- rays, seen or had reported to him the radiology report on them, or spoken to the radiologist. On questioning, the nurse reported the patient's status to the Respondent. The nurse's report satisfied the Respondent that the patient was responding to the treatment for fecal impaction and could be discharged. The nurse was given orders to have arrangements made for the patient to see his regular physician within a week and to instruct the patient on symptoms to report if they occurred between discharge and seeing his regular physician. In accordance with the Respondent's telephone instructions, the patient was discharged at approximately 9:30 a.m. on August 2, 1988. Although there were no clinical signs or symptoms of it during the patient's stay at Morton Plant, the patient had a large aortic aneurysm, approximately eight centimeters in diameter, in his abdomen just below the renal arteries. The aneurysm was readily apparent on the X-rays, yet Chase did not report it to either the Respondent or to his partner, Sreenath. The radiologist either did not contact Dr. Chase to point out to him that the report of Chases's "wet read" of the X-rays omitted the aneurysm or, if he did, Chase did not relay this information to the Respondent or his partner. The radiologist's written report, stating that the X-rays revealed the large aneurysm, was sent to Chase, not to the Respondent, and Chase did not relay the information in it to the Respondent or his partner. If the Respondent had known about the aneurysm, he would have considered the aneurysm to be the patient's most serious medical concern. He might not have accepted the patient or, if he did, he probably would have brought a vascular surgeon into the case and had the vascular surgeon, or perhaps a cardiologist, closely monitor the patient for possible leaking or dissecting or rupture of the aneurysm. The Respondent also would have had to give consideration to whether the aneurysm was a cause of the patient's abdominal pain. In addition to treating the aneurysm as the patient's most serious medical concern, giving consideration to whether the aneurysm was a cause of the patient's abdominal pain, the Respondent would have had to give consideration to altering his diagnosis for the patient had he reviewed the X-rays or the radiologist report, or had spoken with the radiologist. In addition to showing the existence of the aneurysm, the X-rays indicated that the patient technically may not have been impacted. (The gas pattern was non-specific.) With respect to this patient, the Respondent practiced medicine below that level of care, skill and treatment which is recognized by a reasonably prudent similar physicians as being acceptable under similar conditions and circumstances (below the standard of care) in that he did not either personally review the X-rays on the patient, read or have reported to him the contents of the radiologist's report, or talk to the radiologist. Instead, he relied totally on the emergency room physician's "wet read." As a result, the Respondent's diagnosis of "fecal impaction" may not have been correct, and he did not give proper consideration to the aneurysm. However, except for the failure regarding the X-rays, the DPR otherwise did not prove that it was below the standard of care for the Respondent, who was treating the patient for fecal impaction, to discharge the patient without seeing him on the morning of August 2, 1988, based on the nurse's report to the Respondent. Although it was below the standard of care for the Respondent not to either read the X-rays himself or obtain the radiologist's definitive interpretation, it was reasonable for the Respondent to expect that the emergency room physician would have told him, and noted in the "ER sheet," that the patient he was being referred had an aneurysm of the kind and size of the one the patient had in this case. Even if the emergency doctor had not initially communicated to the Respondent the existence of the aneurysm, either directly or through the "ER sheet," it was reasonable for the Respondent to expect that, in the normal course, the radiologist reviewing the X-rays would have noted that, according to the "ER sheet," the ER doctor "missed" the aneurysm and would have contacted the ER physician to bring this to his attention, and that the ER doctor then would have contacted the Respondent to advise him of the omission. The patient did not experience abdominal pain after his discharge from Morton Plant, but he began to experience back and groin pain. The aneurysm was becoming symptomatic. The patient's symptoms markedly worsened in the early morning hours of August 4, 1988. The patient's wife had him taken to the emergency room at HCA New Port Richey Hospital at approximately half past midnight. The patient was confused, and was complaining of pain in the back and groin area. His blood sugars were three times normal. He was diagnosed preliminarily in the emergency room as having out-of-control diabetes and confusion and as being near sycope. No X-rays were taken in the emergency room at New Port Richey Hospital, and no information was obtained from Morton Plant Hospital. Because the patient and his wife did not know about the aneurysm, they were unable to report it when the emergency room physician took the patient's history. The patient was admitted to New Port Richey Hospital at approximately 2:30 a.m. on August 4, 1988. However, the admitting physician did not see the patient or order diagnostic medical imaging at that time. The admitting physician saw the patient at approximately 9:00 a.m., and ordered X-rays and a CAT scan. Before the X-rays or CT scan were taken, at approximately ten o'clock, the patient suffered an acute hypotensive event while in his hospital room. An emergency abdominal sonogram was ordered, and it was determined that the patient was suffering from the rupture of the abdominal aortic aneurysm (the same one that was evident on the X-rays taken at Morton Plant). Surgery was attempted to resect the ruptured aneurysm. The patient was a poor candidate for surgery of that kind due to his age and other health factors. The patient died on August 6, 1988. If the patient knew of the aneurysm, it is likely that his treatment on August 4, 1988, would have been far different. First, when the aneurysm became symptomatic, they probably would have contacted the vascular surgeon, who would have been on the case already, either immediately or on arrival at the emergency room. The aneurysm would have been closely monitored from the time of arrival at the hospital, and the vascular surgeon would have been prepared for surgery when indicated. 2/ At the very least, the patient and his wife probably would have reported the aneurysm during the taking of a history in the emergency room at HCA New Port Richey Hospital, and the emergency room surgeon could have immediately taken appropriate steps, such as contacting a vascular surgeon and immediately ordering appropriate diagnostic medical imaging. 3/ The Respondent did not dictate admission notes for the patient until August 17, 1988. The Respondent did not dictate discharge notes. The DPR did not prove that it was below the standard of care for the Respondent to delay the dictation of admission notes or for him not to prepare a discharge summary for a patient in the hospital on a 23-hour basis. The DPR also did not prove that the Respondent failed to keep written medical records justifying the course of treatment of the patient.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order: (1) finding the Respondent, Jayaprakash Kamath, M.D., guilty of one count of violating Section 458.331(1)(t), but dismissing the other count of the Administrative Complaint; reprimanding him; and (3) fining him $2,000. RECOMMENDED this 27th day of July, 1992, in Tallahassee, Florida. J. LAWRENCE JOHNSTON 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 27th day of July, 1992.
The Issue Whether Proposed Rules 10N-6.002, 10N-6.003, 10N-6.004, 10N-6.005 and 10N- 6.006, constitute an invalid exercise of delegated legislative authority?
Findings Of Fact Standing. The Petitioners, Medivision, Inc., and Tampa Surgi-Center, d/b/a Ambulatory Surgery Center, have standing to challenge the proposed rules at issue in these cases. See the affidavits of Larry Cyment and Donna McMillan. Intervenor, Florida Hospital Association, Inc., has standing to participate in these cases. See the affidavit of Pat Haines. The following Intervenors have established their standing to participate as intervenors in these cases through testimony or affidavit: Cataract Surgery Center, Cortez Foot Surgery Center, Ambulatory Surgery Center of Bradenton, Tampa Outpatient Surgical Facility, Naples Day Surgery, Ambulatory Surgical Center, Specialty Surgical Center and Tallahassee Single Day Surgery. Eye Surgery Center, The Eye Associates, FW Associates and Cordova Ambulatory Surgical Center have failed to prove their standing to participate in these cases. The Proposed Rules; Purpose and Adoption. The Health Care Cost Containment Board (hereinafter referred to as the "Board"), published Rules 10N-6.002, 10N-6.003, 10N-6.004, 10N-6.005 and 10N- 6.006 (hereinafter referred to as the "Proposed Rules"), in Volume 16, Number 12, of the Florida Administrative Weekly (March 23, 1990). The purpose of the Proposed Rules is to collect data concerning the provision of ambulatory surgery services in the State of Florida. Data collected by the Board will allow a comparison of patient charges and will create an additional bases for the analysis of trends in the health care field. In particular, data collection will promote the analysis of shifts in the provision of health care from inpatient to outpatient settings. Data concerning patient identity, geographic location, diagnosis, procedures performed and charges for services is required to be collected and submitted to the Board pursuant to the Proposed Rules. In June of 1989, the staff of the Board presented a study to the Board concerning the growth of ambulatory health care services. Staff recommended that the Board direct that steps be taken to explore the possibility of collecting ambulatory surgery data. The Board accepted the recommendation and appointed a Technical Advisory Panel. The Technical Advisory Panel appointed by the Board consisted of nine representatives of various interested groups. Two members were from freestanding ambulatory surgery centers and two members were from hospitals providing ambulatory surgery services. At meetings of the Technical Advisory Panel in July, August, September and October, 1989, the collection of ambulatory surgery services data was considered. The Technical Advisory Panel discussed collection costs, the type of data to be collected, implementation dates, legislative authority, methods of submitting data and the scope of data collection. The Board was made aware of the Technical Advisory Panel's efforts through minutes of the Panel's meetings and other materials provided to the Board. The collection of ambulatory surgery services data was considered by the Board at its October, November and December, 1989, meetings. The Proposed Rules were approved by the Board at its December, 1989, meeting. There is no statutory authority which specifically provides that data may be collected by the Board from "freestanding ambulatory surgical centers." The Board cited Section 407.03, Florida Statutes (1989), as the specific authority for the Proposed Rules. The Board cited Sections 407.003, 407.03 and 407.08, Florida Statutes (1989), as the laws implemented by the Proposed Rules. Scope of the Proposed Rules. Ambulatory surgery services are provided in a variety of settings: hospitals (e.g., acute care, psychiatric and rehabilitation), licensed freestanding ambulatory surgery centers, physician offices and other unlicensed health care facilities. The Proposed Rules provide that all licensed hospitals included in Groups 1 through 10 and Group 14 of the HCCCB Florida Hospital Uniform Reporting System Manual which provide outpatient surgery services and all licensed ambulatory surgery centers in Florida are required to collect and submit 45 data elements to the Board. Psychiatric hospitals and rehabilitation hospitals are not subject to the Proposed Rules. Physicians' offices and other unlicensed health care providers are also not subject to the Proposed Rules. The Proposed Rules are limited to licensed providers of ambulatory surgery services so that the Board's staff can insure that all members of the groups selected data actually collect and report data. The Board cannot insure that all unlicensed providers of ambulatory surgery services, such as physicians' offices, comply with the Proposed Rules. Therefore, if data was required to be collected and submitted by unlicensed providers, the data would be less reliable. The weight of the evidence failed to prove that the requirement of the Proposed Rules that only hospitals included in Groups 1 and 10 and Group 14 of the HCCCB Florida Hospital Uniform Reporting System Manual and licensed freestanding ambulatory surgery centers collect and submit data constitutes an invalid exercise of delegated legislative authority. Specific Data vs. Aggregate Data. The Proposed Rules require the collection and reporting of 45 specific data elements. Aggregate data concerning ambulatory surgery services could be obtained from insurance companies and used by the Board as an alternative to the more specific data required to be collected pursuant to the Proposed Rules. Aggregate data is a compilation of specific data. Aggregate data can be used to comply with the Board's statutorily required functions. If aggregate data is used, however, it is likely that reporting will be incomplete. Not all information is reported to insurance companies concerning outpatient activity. Therefore, aggregate data obtained from insurance companies would not cover 100% of ambulatory surgery services provided by reporting entities, resulting in the potential for presenting an incomplete or inaccurate picture of ambulatory surgery services. The recommendations and conclusions which can be reached from aggregate data are limited. Specific data allows more flexibility for research purposes. Specific data will assure greater accuracy and comparability of data. Recommendations and conclusions reached from specific data should be more accurate. In order to insure comparability of data, specific data concerning patients, geographic location, diagnoses, procedures and charges must be collected. The Board collected aggregate data concerning ambulatory surgery services through a special study. The Board collected the data from hospitals and, on a voluntary basis, from licensed ambulatory surgery centers. "Typical" charges for specified ambulatory surgery procedures was collected. This collection effort was flawed by the lack of specific data. The accuracy of the reports based upon the aggregate data was criticized publicly. The reports were even criticized by one of the witnesses called to testify by Intervenors, Cataract Surgery Center, et. al. The weight of the evidence failed to prove that the requirement of the Proposed Rules that specific data be collected and submitted instead of aggregate data constitutes an invalid exercise of delegated authority. Confidential Patient Data. Some of the data elements to be reported pursuant to the Proposed Rules constitute confidential patient information. Disclosure of confidential patient information is prohibited by Florida law. The Proposed Rules do not require or authorize disclosure of confidential patient information. The manner in which the data collected will be distributed has not yet been decided upon by the Board. The evidence failed to prove that the Board will not comply with prohibitions against disclosure of confidential patient information. The weight of the evidence failed to prove that the requirement of the Proposed Rules that confidential patient information be reported to the Board constitutes an invalid exercise of delegated authority. Computer Use. The Proposed Rules require that data be submitted by computer tape or computer diskette. Therefore, data will have to be input into a computer system. The Proposed Rules specify the format data must be in when submitted. Most of the language of the Proposed Rules is computer terminology. The terminology of the Proposed Rules will require some knowledge of computers to carry out the requirements of the Proposed Rules. The language of the Proposed Rules is intentionally designed to convey technical information. The general purpose and requirements of the Proposed Rules does not take any special knowledge to understand. Requiring the submission of data by electronic means is designed to assure the accuracy and confidentiality of the data. The requirement of the Proposed Rules that data be reported in computer form and the use of computer terminology does not constitute an invalid exercise of delegated legislative authority. Errors in the Proposed Rules. Proposed Rule 10N-6.002(2) defines "Ambulatory Surgery Services" as procedures "provided in a hospital in its dedicated ASC ..." [Emphasis added]. Instead of "ASC" the Board intended to use the terms "operating room." Proposed Rule 10N-6.005 contains a list of the data elements to be collected and reported to the Board. This Proposed Rule contains the following errors or unclear language: Item 20 is "Facility Fee - Pri. Proc." "Pri. Proc." is an abbreviation for primary procedure. Items 21-24, similar to Item 20, contains the abbreviation "Sec. Proc." instead of secondary procedure. Items 25-27 contain a reference to "Page 3". As published in the Florida Administrative Weekly, there is no page 3. Item 35, which deals with expected methods of payment, refers to "Comm. Ins. (incl. BCBS)." This reference is an abbreviation for commercial insurance (Blue Cross Blue Shield). Item 44, patient birth date, uses the abbreviation "MMYYYY." This abbreviation should be "MMDDYY." Proposed Rule 10N-6.006 refers to "Primary Diagnosis Code" and "Secondary Diagnosis Code." The Rule should refer to Primary and Secondary "Procedure" Code. The mistakes identified in findings of fact 38-40 are not significant enough to characterize the rule as vague. Nor are these mistakes sufficient enough to otherwise conclude that the Proposed Rules constitute an invalid exercise of delegated legislative authority. Economic Impact. The Economic Impact Statement (hereinafter referred to as the "EIS"), issued with the Proposed Rules provided the following concerning the economic impact of the Proposed Rules on the Board: ESTIMATE OF THE COST OF IMPLEMENTATION: The agency will be affected by the costs of rule promulgation and by the demands placed upon staff time to assure compliance with the rules and to analyze the data collected. Costs for these activities are estimated to be approximately $85,000 per year. The weight of the evidence failed to prove that this portion of the Board's EIS is unreasonable. The EIS provided the following concerning the economic impact of the Proposed Rules on persons affected by the Proposed Rules: ESTIMATE OF THE COST OF IMPLEMENTATION: Implementation by affected facilities will cost approximately $2.9 to $3.1 million. These funds will be used to develop the programs necessary to collect and submit the data required. On-going compliance will have a much less significant impact. . . . . ESTIMATE OF COST TO ALL PERSONS DIRECTLY AFFECTED BY THE RULE: The initial cost to Florida hospitals and freestanding ambulatory surgery centers (ASC) would be from approximately $2.9 to $3.1 million to develop the reporting system necessary to generate the necessary data elements. On-going annual cost to the hospitals and free standing ASCs would be substantially less after the first year's start-up procedures are adopted. . . . . The EIS is insufficient because it does not adequately discuss the costs (implementation and ongoing costs) to affected persons or the impact of the Proposed Rules on small business. The weight of the evidence proved that the Proposed Rules will have an economic impact on affected persons. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of the implementation cost affected persons can be expected to incur as a result of the Proposed Rules. As indicated in the EIS, the Board's determination of the estimate of the economic impact on affected persons was based upon surveys the Board distributed to licensed ambulatory surgery centers, an estimate of costs that hospitals incurred in implementing the Board's detailed patient data collection rule, the Board staff's experience with computer costs (including the collection and entry of data) and consultation with a computer expert familiar with the Proposed Rules. The surveys relied upon by the Board were distributed to all licensed freestanding ambulatory surgery centers. A total of 91 surveys were distributed. The Board requested that the surveys be returned within one week. Forty-one responses to the surveys were received by the Board from licensed freestanding ambulatory surgery centers. The responses constitute hearsay. Findings of fact concerning whether the information contained in the responses is correct, therefore, have not been made. The responses to the surveys have, however, been relied upon to make findings of fact concerning what information the Board based its EIS on. The Board received the following pertinent responses to the surveys from licensed freestanding ambulatory surgery centers: (1) 26 of the responders use computers, 12 have no computer capacity and 3 have some computer capacity; 17 or 18 different software programs are in use; and, (3) the costs to implement the proposed collection of data ranged from $0 to $50,000.00. Twenty- six responders indicated that they did not know how long it would take for them to implement the proposed collection of data. The Board determined that the average implementation cost for licensed freestanding ambulatory surgery centers reported in the responses to its survey was $18,975.00 and that the average implementation time was 13 weeks. The Board rounded up the average cost reported to it in the surveys and estimated that the cost of implementing the Proposed Rules at licensed freestanding ambulatory surgery centers would be $20,000.00. Based upon the existence of 85 licensed facilities, the Board estimated the total implementation cost for licensed freestanding ambulatory surgery centers to be $1,700,000.00 ($20,000.00 x 85). The Board estimated that the maximum cost of implementing the Proposed Rules at affected hospitals would be $2.00 per patient record. This estimate was based upon the Board's estimate of the cost of hospital compliance with the Board's detailed patient discharge data rule. Based upon an estimate of 600,000 patient records a year which will have to processed as a result of the Proposed Rules, the Board estimated the total cost of implementation in affected hospitals to be $1,200,000.00. The Board concluded that the total minimum cost of implementing the Proposed Rules will be $2,900,000.00 ($1,700,000.00 cost for freestanding ambulatory surgery centers plus $1,200,000.00 cost for affected hospitals). The Board discussed the cost of implementing the Proposed Rules with J. Thomas Solano, an expert in computers. Mr. Solano estimated that the cost of modifying an existing computer system (small to mid-range computer) to comply with the Proposed Rules would be $4,000.00 to $10,000.00. The Board used the highest estimate, $10,000.00, and multiplied this cost by the number of affected persons (85 freestanding ambulatory surgery centers and 220 hospitals x $10,000.00). This resulted in a rounded-up estimated implementation cost of $3,100,000.00. The Board concluded that the total maximum cost of implementing the Proposed Rules will be $3,100,000.00. Some of the data to be collected and reported pursuant to the Proposed Rules is already being collected by affected persons. Therefore, the primary cost of complying with the Proposed Rules will be associated with modifying existing computer software and/or hardware. The cost of modifying an existing computer system can fluctuate widely. As a general rule, computer users with existing software must rely upon their existing software provider to make modifications. The cost of modifying software can, therefore, be much higher than Mr. Solano estimated. As an alternative to modifying existing systems, affected persons can acquire a freestanding personal computer and software which can be used to comply with the Proposed Rules. The cost of such an acquisition should be approximately $2,500.00 to $5,600.00. Intervenor, T.S.D.S., Inc., d/b/a Tallahassee Single Day Surgery Center, estimated that it will have to spend approximately $14,000.00 to $20,000.00 to implement the Proposed Rules. This estimate is based upon a letter purportedly from the Intervenor's computer company. The information contained in the letter is hearsay. The estimated implementation costs are, therefore, not supported by admissible evidence. The estimate, even if supported by competent substantial evidence, is within the Board's estimated implementation costs and, therefore, fail to prove that the Board's EIS is unreasonable or that the Board failed to fully consider the economic factors or impact. Intervenor, Cataract Surgery Center, estimated implementation costs of $1,900.00. This amount is limited to additional maintenance fees, supplies and personnel costs. Cataract Surgery Center believes there will no charge from its computer vendor to modify its software. Cataract's estimated costs are reasonable and within the Board's estimates. Ambulatory Surgical Center of Lake County (hereinafter referred to as "Lake"), does not own a computer. It uses the computer system of its physician owners. Lake considered more than one method of complying with the Proposed Rules. It considered buying a personal computer and estimated it would cost $5,000.00. This cost is consistent with the estimates of the Board. Lake also considered purchasing an integrated hardware and software package. It estimated that such a system would cost $40,000.00 to $50,000.00. The estimate is based upon hearsay. Even if the evidence concerning the cost of an integrated system is accepted as correct, the evidence fails to prove that such costs are necessary to comply with the Proposed Rules. The estimate for this system is based upon Lake's decision that it would perform other functions with the computer system, including storing management information and performing billing functions. These functions are not required in order to comply with the Proposed Rules. Lake currently treats approximately only 300 patients annually. The weight of the evidence failed to prove that the Proposed Rules constitute an invalid exercise of delegated authority because of the implementation cost which will be incurred by affected persons. The weight of the evidence also failed to prove that the inadequate treatment of implementation costs in the EIS was fully considered by the Board. Therefore, the treatment of implementation costs in the EIS constitutes harmless error. Although the primary costs to affected persons caused by the Proposed Rules will be associated with implementation of the Proposed Rules, there will also be certain costs associated with ongoing compliance with the Proposed Rules. There will be ongoing costs for the collection of data, entry of the data into a computer and reporting data to the Board. Ongoing costs caused by the Proposed Rules will be greater if an affected person with an existing computer system acquires a freestanding computer system instead of using the existing system. The Board's statement in the EIS concerning ongoing costs was not based upon information from affected persons. The statement concerning ongoing costs does not indicate what the ongoing costs of compliance with the Proposed Rules will be. It only indicates that it will be less than the initial implementation costs associated with the Proposed Rules. Although the weight of the evidence did not prove the estimated total amount of ongoing costs to affected persons from the Proposed Rules, the weight of the evidence failed to prove that ongoing costs will be greater than the estimated total amount of implementation costs. T.S.D.S., Inc., d/b/a Tallahassee Single Day Surgery Center, estimated that it would incur ongoing costs of approximately $6,000.00. This estimate is reasonable. Cataract Surgery Center estimated that it would incur ongoing costs of $41,600.00, or $20.00 per case, to comply with the Proposed Rules. Cataract Surgery Center's estimated costs include the following costs: reel purchase; handling; reel preparation; collection of billing data; process of sending information to the Board; clarification of errors; additional record production; and response to public inquiries. Cataract Surgery Center's estimated costs are not reasonable. The estimated time to comply with the Proposed Rules is excessive and some of the tasks, i.e., collection of billing data, are not required by the Proposed Rules. Cataract Surgery Center's conclusion that it may have an increase in maintenance fees is reasonable. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of the ongoing costs affected persons can be expected to incur as a result of the Proposed Rules. Therefore, the treatment of ongoing costs in the EIS was harmless error. The weight of the evidence also failed to prove that the Proposed Rules constitute an invalid exercise of delegated authority because of the ongoing cost which will be incurred by affected persons. The EIS contains a statement that the Proposed Rules should have no economic impact on small business. In reaching this conclusion the Board failed to take into account the legal definition of "small business" contained in Florida Statutes. The Board did, however, actually consider the impact the Proposed Rules would likely have on small ambulatory surgery centers subject to the Proposed Rules. The Board attempted to reduce the economic impact on small ambulatory surgery centers by allowing affected persons to file data on computer tape or on diskette. By allowing the use of diskettes for reporting data, the Board made it possible for affected persons to use personal computers to comply with the Proposed Rules. Delayed submission of some data elements was also allowed in order to reduce the impact on small facilities. It is unlikely that the Board would have made further modifications of the Proposed Rules had the legal definition of "small business" been considered. The weight of the evidence failed to prove what, if any, reasonable modifications should have been taken by the Board to accommodate any economic impact on small business. The weight of the evidence failed to prove whether any of the entities that participated in the proceeding were small businesses. Those entities, although meeting the definition of small business with regard to the number of employees they have and their net worth, failed to prove whether they are "independently owned and operated." See Section 288.703(1), Florida Statutes (1989). The weight of the evidence failed to prove if any person affected by the Proposed Rules is a small business. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of small business which can be expected to incur as a result of the Proposed Rules. Therefore, the treatment of the impact on small business in the EIS was harmless error. The weight of the evidence also failed to prove that the Proposed Rules constitute an invalid exercise of delegated legislative authority because of the impact on small business. The Petitioners and Intervenors presented evidence concerning a number of actions which the Board did not take during its consideration of the economic impact and factors of the Proposed Rules and its preparation of the EIS. This evidence proved only that there were other steps which the Board could have taken during its preparation of the EIS. The Petitioners and Intervenors failed to prove, however, that the steps which the Board did take were not sufficient. The Petitioners and Intervenors therefore failed to prove that the steps which the Board did not take were required or necessary.
The Issue The issues are whether Petitioner has sufficiently completed the requirements necessary to receive a license to practice orthotic fitting from the Board of Orthotists and Prosthetists and whether the Petitioner has violated section 468.809, Florida Statutes, by practicing orthotics without a license or registration.
Findings Of Fact 1. The two rules governing the requirements for licensure as on orthotic fitter in the state of Florida are found in section 469.803(5)(c), Florida Statutes (2010), and Florida Administrative Code Rule 64B14-4.110(1)(b). Section 468.803(5)(c) requires: (c) to be licensed as an orthotic fitter the applicant must pay a license fee not to exceed $500 and must have: A high school diploma or its equivalent; A minimum of 40 hours of training in orthotics education, as approved by the board; Two years of supervised experience in orthotics acquired after completion of the required education, as approved by the board; and Completed the mandatory courses. Petitioner requested information from the Board regarding the requirements for licensure and received a publication containing both chapter 468, Florida Statutes, Part XIV, and rule 64B14. He completed the prerequisite education required by section 468.803(5)(c), on June 22, 2009. However, Petitioner testified that he only reviewed the requirements identified in section 468.803(5)(c) and did not consider the definition of "experience" contained in rule 64B14-4.110(1), for applicants for licensure as an orthotic fitter. Florida Administrative Code Rule 64B14-4.110(1)(b) construes supervised "experience" to require an applicant to complete two years of experience in orthotics under the supervision of a Florida licensed orthotist. The two years of experience may only begin accruing after the applicant has successfully completed the requisite education courses. Petitioner applied for a license in orthotic fitting on November 22, 2010, only 17 months after the completion date of his educational courses. Assuming Petitioner started gaining experience immediately upon completion of his education courses, Petitioner was still seven months shy of the two years of experience required to obtain a license as an orthotic fitter. Petitioner testified at hearing regarding the orthotic experience gained prior to applying for licensure. According to his testimony, his experience consisted of activity more accurately described as assistance than experience. The experience described was limited to helping patients stand up, holding a measuring stick, assisting with paperwork, and explaining paperwork to the patient. Petitioner’s role involved little more than observing and occasionally assisting a licensed physical therapist. This is surely not what is meant by “experience in orthotics under the direct supervision of a Florida licensed orthotist,” as contemplated by rule 64B14- 4.110(1)(b). The assistance provided by Petitioner was performed under the supervision of a licensed physical therapist. While his actions, as described at hearing, did not meet the requirements for supervision specified by rule 64B14-9.110, they also did not rise to the level of unlicensed activity.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered by the Board of Orthotists and Prosthetists denying Petitioner’s application for licensure as an orthotic fitter. DONE AND ENTERED this 2nd day of August, 2011, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of August, 2011. COPIES FURNISHED: Frank Edward Maloney, Jr., Esquire Macclenny City Attorney 445 East Macclenny Avenue, Suite 1 Macclenny, Florida 32063-2217 Lee Ann Gustafson, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-6536 Bruce Deterding, Executive Director Board of Orthotists and Prosthetists Department of Health 4052 Bald Cypress Way, Bin C07 Tallahassee, Florida 32399-1701 Nicholas Romanello, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
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 =================================================================
The Issue The issues for determination are whether Respondent Lucien Armand, M.D., violated Section 458.331(1)(v), Florida Statutes (2006); Section 458.331(1)(nn), Florida Statutes (2006), by violating Florida Administrative Code Rule 64B8-9.009(2) and (4), and Section 458.351, Florida Statutes (2006); Section 458.331(1)(m), Florida Statutes (2006); and Section 458.331(1)(t), Florida Statutes (2006), as alleged in an Amended Administrative Complaint filed by the Department of Health before the Board of Medicine on June 20, 2008; and, if so, what disciplinary action should be taken against his license to practice medicine in the State of Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Lucien Armand, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 33997. Dr. Armand is board-certified in general surgery by the American Board of Surgery. Dr. Armand’s mailing address of record at all times relevant to this matter was 2071 Southwest 52nd Way, Plantation, Florida 33317. At the times relevant, Dr. Armand practiced medicine at 4100 South Hospital Drive, Suite 108, Plantation, Florida 33317. The office at which Dr. Armand practiced medicine was located very close to Plantation General Hospital (hereinafter referred to as “Plantation”). Dr. Armand has been the subject of three prior disciplinary matters arising out of five separate cases. Penalties were imposed in those three disciplinary matters. The Department summarized those disciplinary matters in paragraph 37 of its Proposed Recommended Order: In DPR Case Numbers 0019222, 0019123 and 0091224, Respondent was fined, received a reprimand, and was required to complete 30 hours of Continuing Medical Education (CME) in general vascular surgery and risk management within the surgical practice. In Case Number 94-10100, Respondent was required to submit to and comply with an evaluation at the University of Florida, to pay a fine, was reprimanded, was required to complete twenty hours of CME in general surgery in performing Laparoscopic Cholecystectomy, and was placed on Probation for two (2) years. In Case Number 1999- 58474, Respondent was restricted from performing Level II or above office surgery as defined in Rule 64B8-9.009(1)(d), Florida Administrative Code, until the Respondent demonstrated to the Board that he had successfully completed the University of Florida Comprehensive Assessment and Remedial Education Service (UF C.A.R.E.S.) course and complied with all recommendations, was reprimanded, was placed on probation for two (2) years, was required to attend the Florida Medical Association “Quality Medical Record Keeping for Health Care Practitioners” course, was required to perform 100 hours of community service, and was required to reimburse the Department for costs. Dr. Armand, who is 70 years of age, has been practicing medicine for 46 years. He has practiced medicine in Florida since 1979. During the eight months prior to the final hearing of this matter, Dr. Armand was working in South Sudan pursuant to contract with the United States State Department. October 6, 2006, Surgery on Patient W.C. On September 14, 2006, Patient W.C. presented to Dr. Armand and was diagnosed as having a slow-growing left inguinal hernia. Dr. Armand scheduled Patient W.C. for surgical repair of the inguinal hernia. The surgery was scheduled for October 6, 2006, at Dr. Armand’s office and, at the request of Patient W.C., under local sedation. At approximately 9:30 a.m., October 6, 2006, Patient W.C. arrived as scheduled at Dr. Armand’s office, accompanied by his wife and child. Patient W.C., who was not asked to execute any paperwork concerning the operation, was taken into a room where he was directed to lie down. There were two nurses in the room. Patient W.C. was given one shot of some form near the site of the procedure. This shot is the only medication he remembers receiving. He denied any recollection of having received medication intravenously, intramuscularly, or rectally. According to Dr. Armand, Patient W.C. was given “local anesthesia, Xylocaine 1% and ½% during the procedure and I gave some oral sedation, 10mg. of Valium, by mouth.” Page 171, Lines 19-21, Vol. II, Transcript of Final Hearing. At some point during the surgery, Patient W.C.’s intestines eviscerated, pushed themselves out through the hernia, making the hernia impossible to repair in the office. Due to the evisceration of Patient W.C.’s intestines, Dr. Armand eventually closed the incision and decided to transport Patient W.C. to Plantation to complete the procedure. Dr. Armand’s testimony that he closed and took patient W.C. to Plantation because Patient W.C. began “fidgeting” is not credited. While Patient W.C. did not have any clear recollection of the surgery while at Dr. Armand’s office, he did recall that “I was shaking myself and one of the nurses put something on my head and I went to sleep.” Page 40, Lines 20-22, Vol. I, Transcript of Final Hearing. Patient W.C. later indicated that “[o]ne of the ladies sprayed something on my face,” at which point Patient W.C. “went to sleep.” Page 41, Lines 23-24, and Page 42, Line 8, Vol. I, Transcript of Final Hearing. Patient W.C. did not remember anything else from this point in the surgery until he awoke at approximately 2:00 p.m., October 6, 2006, in a room at Plantation. Patient W.C. was transported to Plantation after he “fell asleep” by Dr. Armand. When Patient W.C. arrived at the Plantation emergency room, he was noted to be “sleepy” and, based upon Dr. Armand’s representation to the emergency room physician, Cornell Calinescu, M.D., was described as “somewhat sedated secondary to Valium and Clonidine.” Patient W. C. was also described by Dr. Calinescu and an emergency room nurse as able to speak. Upon admission to Plantation, Dr. Armand performed emergency surgery on Patient W.C. under general anesthesia, completing the procedure he had begun in his office. The surgery was completed without further complication. As noted above, Patient W.C. has no recollection of arriving at the Plantation emergency room, how he got to the hospital, or anything else that took place after falling asleep in Dr. Armand’s office, until he awoke in a hospital room later in the afternoon. Dr. Armand’s Medical Records for the October 6, 2006, Surgery. Dr. Armand’s office notes for Patient W.C. lack any documentation as to what took place in his office on October 6, 2006. Dr. Armand did not record the date of the procedure; the type of procedure performed; pre-operative care; any drugs that were prescribed, dispensed, and/or administered; the type and dosage of anesthetic sedation used; or post-operative care. Dr. Armand’s medical records for Patient W.C. also failed to include any informed consent for the procedure performed on October 6, 2006. As noted above, Dr. Armand did complete an operative report after the emergency surgery performed on Patient W.C. at Plantation. Office Surgery; Level of Anesthesia. Florida Administrative Code Rule 64B8-9.009 (hereinafter referred to as the “Office Surgery Rule”) prescribes standards for the performance of office surgery. In providing those standards, the Office Surgery Rule defines three levels of sedation and the conditions under which each level may be achieved and must be performed. Level II and Level III office surgery require registration of the physician’s office to perform. Dr. Armand’s office was not registered to perform Level II or Level III office surgery at the times relevant to this proceeding. Only the first and second levels of office surgery are relevant to this case. Florida Administrative Code Rule 64B8-9.009(3) describes the types of procedures appropriate for “Level I” office surgery, which Dr. Armand has argued he performed on Patient W.C., as follows: Minor procedures such as excision of skin lesions, moles, warts, cysts, lipomas and repair of lacerations or surgery limited to the skin and subcutaneous tissue performed under topical or local anesthesia not involving drug-inducted alteration of consciousness other than minimal pre- operative tranquilization of the patient. Liposuction involving the removal of less than 4000cc supernatant fat is permitted. Incision and drainage of superficial abscesses, limited endoscopies such as proctoscopes, skin biopsies, arthrocentesis, thoracentesis, paracentesis, dilation of urethra, cysto-scopic procedures, and closed reduction of simple fractures or small joint dislocations (i.e., finger and toe joints). . . . . 5. Chances of complication requiring hospitalization are remote. Florida Administrative Code Rule 64B8-9.009(4) describes the types of procedures appropriate for “Level II” office surgery, which the Department argues Dr. Armand utilized on Patient W.C., as follows: Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, thus making intra and post- operative monitoring necessary. Such procedures shall include, but not be limited to: hemorrhoidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000cc supernatant fat. Level II Office surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. [Emphasis added]. While the Department relies in part upon the language of Florida Administrative Code Rule 64B8-9.009(4) that “[s]uch procedures shall include, but not be limited to . . . hernia repair . . .” to support its argument that the procedure performed by Dr. Armand on Patient W.C. was in fact performed as Level II surgery, this reliance is misplaced. Regardless of the proper interpretation of this language of the Rule (whether it clearly puts physicians on notice that all hernia repair surgery must be conducted as Level II surgery or not), at best it establishes a proscription. Such a proscription, cannot, however, be relied upon to establish the “fact” that Level II surgery was performed or not. The question of whether Dr. Armand performed the procedure defined as “Level II” office surgery is the disputed issue of fact in this case. Resolving this factual dispute requires an ultimate factual determination, which involves the application of a legal standard (the Rule) to the historical facts (what Dr. Armand actually did) as found by the trier-of-fact based upon the evidence. The Rule is not evidence of what Dr. Armand did; rather it is the yardstick against which Dr. Armand’s conduct must be measured and, ultimately, judged. The evidence either way concerning the level of surgery performed by Dr. Armand consisted of his testimony denying that Level II surgery was performed, the testimony of Patient W.C. concerning his condition, the description of Patient W.C.’s condition by emergency room personnel, and the opinion of the Department’s expert witness, Christian Brikedal, M.D., as to the level of surgery. Dr. Armand’s denial that he performed Level II surgery was not convincing because it was inconsistent with the patient’s description of his condition on October 6, 2006, and the description of his condition by emergency room staff when arrived at Plantation. Patient W.C. had no recollection of going to the hospital or anything that transpired there until he awoke at about 2:00 p.m. the afternoon of October 6, 2006. Emergency room staff noted that Patient W.C. was able to talk when he arrived. These facts, convincingly proved, are more consistent with what constitutes Level II surgery: “the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining . . . the ability to respond purposefully to verbal command and/or tactile stimulation.” This finding is further supported by Dr. Brikedal opinion that Patient W.C.’s condition was consistent with having undergone Level II sedatopm. Dr. Brikedal, whose testimony was convincing and uncontroverted, was asked the following question and gave the following answer at Page 22, Lines 7-14, Vol. I, Transcript of Final Hearing: Q Assuming W.C. is going to testify that as soon as the complication occurred that he was put to sleep and didn’t wake up until he was in the hospital, are you able to reach any conclusions about the level of sedation that occurred? A He would have to have been given a sedative I.V. or I.M. to be that sleepy. This opinion, as to Patient W.C.’s condition on October 6, 2006, supports a finding that Patient W.C. was under Level II anesthesia while surgery was being performed in Dr. Armand’s office. Having found that Patient W.C. was under the level of sedation described in the definition of “Level II” office surgery, leads inescapably to the finding that Dr. Armand administered Level II sedation to Patient W.C. The foregoing finding is further supported by the portion of the Office Surgery Rule quoted, supra, in finding of fact 24. Dr. Brikedal explained during the hearing why it is “appropriate and necessary to do an inguinal hernia repair” as Level II surgery: “Sedation to the point that the patient’s comfortable so they’re able to or they’re not pushing against you, inhibiting you from performing this very safely.” Page 24, Lines 20-22, Vol. I, Transcript of Final Hearing. As a board- certified general surgeon who has previously registered and had his office accredited as an office at which Level II surgery could be performed, Dr. Armand must have been aware of why it is prudent to perform hernia repairs as Level II surgery. While Dr. Armand may have begun the surgery as Level I, when Patient W.C.’s intestines eviscerated, Dr. Armand must have realized that taking Patient W.C. to Level II sedation would give him a better opportunity to correct the problem. Unfortunately for Dr. Armand, it was too late. Office Surgery Rule Procedures. Florida Administrative Code Rule 64B8-9.009(2) prescribes requirements for conducting “office surgery,” taking into account of the level of sedation utilized during a procedure. The hernia repair performed by Dr. Armand on Patient W.C. constituted “surgery” as defined in Florida Administrative Code Rule 64B8-9.009(1). Performance of the surgery in Dr. Armand’s office constituted “office surgery” as those terms are defined in Florida Administrative Code Rule 64B8-9.009(1)(d). The “office surgery” performed by Dr. Armand on Patient W.C. failed to comply, as required, with all the requirements of Florida Administrative Code Rule 64B8-9.009(2), applicable to conducting Level II office surgery and, in some instances, Level I office surgery: Dr. Armand failed to “maintain complete records” of the surgical procedure as required by Florida Administrative Code Rule 64B8-9.003, or a written informed consent from the patient as required by Florida Administrative Code Rule 64B8- 9.009(2)(a)(applicable in part to Level I and Level II surgery); No log of Level II surgery was kept as required by Florida Administrative Code Rule 64B8-9.009(2)(c); No adverse incident report was filed as required by Florida Administrative Code Rule 64B8-9.009(2)(k). This portion of the rule requires that “[t]he surgeon shall report to the Department of Health any adverse incidents that occur within the office surgical setting. . . .” (Emphasis added). This requirement is separate from any requirement that a hospital report adverse incidents and the burden of reporting is put directly on the surgeon; and Dr. Armand did not have an established risk management program as required by Florida Administrative Code Rule 64B8- 9.009(2)(j). The Standard of Care. Dr. Birkedal provided an opinion to the Department and testified at the final hearing as to whether Dr. Armand’s treatment of Patient W.C. met the “level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers ” (Hereinafter referred to as the “Standard of Care”). In his original opinion dated December 22, 2007, Dr. Birkedal indicated that he did not believe that Dr. Armand’s care of Patient W.C. violated the Standard of Care. There were caveats or assumptions, however, which Dr. Birkedal recognized in his written opinion could change his opinion if not correct. In particular, at the time of his original opinion, Dr. Birkedalk had incorrectly assumed that the procedure performed on Patient W.C. was a Level I procedure. Dr. Birkedal recognized in his original opinion that, if his assumption were incorrect, that his opinion would change: “[i]f he did give an IV sedative, then he may have violated the standard of care if his office is not licensed to give IV sedatives.” At hearing, Dr. Birkedal was of the opinion that Dr. Armand had not simply performed Level I surgery and, therefore, opined that he had violated the Standard of Care because his office was not a properly licensed office surgery suite. Dr. Birkedal also offered other opinions at hearing concerning what he perceived were violations of the Standard of Care, but those “violations” were not alleged by the Department in the Amended Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Lucien Armand M.D., has violated Section 458.331(1)(v), Florida Statutes (2006); Section 458.331(1)(nn), Florida Statutes (2006), by violating Florida Administrative Code Rule 64B8-9.009 and Section 458.351, Florida Statutes (2006); Section 458.331(1)(m), Florida Statutes (2006); and Section 458.331(1)(t), Florida Statutes, to the extent found in this Recommended Order; and indefinitely suspending his license to practice medicine in Florida, but allowing him to continue to practice medicine outside the United States through his relationship with the United States Department of State after full disclosure of the Board’s final order to the United States Department of State. Should a medical license not be a condition of employment by the United States Department of State, his license should be revoked. DONE AND ENTERED this 17th day of June, 2009, in Tallahassee, Leon County, Florida. LARRY J. SARTIN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 17th day of June, 2009. COPIES FURNISHED: Diane Kiesling Assistant General Counsel Robert A. Milne Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Sean Ellsworth, Esquire Ellsworth Law Firm, P.A. 1501 Collins Avenue, Suite 208 Miami Beach, Florida 33139 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
The Issue Whether the Petitioner is qualified for licensure as a medical doctor in Florida by examination.
Findings Of Fact Petitioner graduated from the School of Medicine at the University of Pennsylvania in 1955, following which he did a rotating internship at Abington Memorial Hospital before reporting for active duty in the U.S. Navy. Upon release from active duty in the Navy in 1959 he entered a residency program in general surgery at Hospital of University of Pennsylvania followed by thoracic surgery which he completed in 1965. Petitioner was certified by the American Board of Surgery in 1965 and by the Board of Thoracic Surgery in 1966. From 1965 to 1986 Petitioner was engaged in the practice of general, cardiac, thoracic and vascular surgery. In the latter part of this period, he headed a cardiothoracic surgery team at Lankenau Hospital, Philadelphia, which performed some 700-800 open-heart surgeries per year. It was during this period that most of the malpractice suits were filed against Petitioner, the hospital and other doctors on his team. As head of the surgical team Petitioner did the definitive surgery (bypass grafts) while other members of the team opened and closed the chest cavity. Petitioner is currently licensed to practice medicine in Pennsylvania, New York, New Jersey, Delaware and Arizona. At the time he first applied for licensure in Florida in 1988, he was licensed in Pennsylvania, New Jersey and Arizona. No licensing agency has brought any charges against Petitioner's license. Petitioner took and passed the FLEX examination in 1988 scoring 84 and 83 on the two parts of the exam. In the past twenty years, 19 malpractice suits have been filed against Petitioner. Of those suits 9, have been dismissed by Plaintiffs without any recovery from Petitioner, and two were settled on behalf of Petitioner, one in 1979 for $50,000 and one in 1989 for $25,000. Those settlements represented little more than nuisance value. The hospital defendant settled one case for $225,000 and another for $2,500. Of the remaining eight suits the complete medical records of those cases were reviewed by another cardiothoracic and vascular surgeon who opined that five are without merit. For the remaining three, additional evidence is needed to fairly appraise the merits of those suits. This additional information will not be available until discovery is completed. Petitioner's testimony, that these remaining three cases did not involve a failure on his part to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, corroborates the Affidavit of the risk manager (Exhibit 3) and letters in the file (Exhibit 1) stating those cases are deemed to be without merit and will be vigorously defended. All of these suits were brought in Pennsylvania where the backlog of civil cases is such that civil cases are not scheduled for trial until approximately seven years after the suit is filed. Furthermore, the complaints filed in these cases contain general allegations that the Respondent's negligence, inattention, failure to adequately apprise the plaintiff of possible complications of the surgery, along with the negligence of the hospital and others involved with the surgery, directly resulted in the plaintiff's death, injury, etc. These are catch- all allegations and the specific nature of the malpractice claim cannot be discerned from these pleadings. Cardiothoracic and vascular surgery is a high risk field of medicine in that the patients are frequently very sick and elderly. Accordingly, the success rate for this type surgery is lower than for most surgeries, and this leads to a higher incidence of suits alleging malpractice. Many of these earlier suits were brought before the doctors began paying attention to documenting that they fully explained the risks of the surgery to the patient and thereafter the patient gave informed consent to the operation. Petitioner has been more assiduous in this regard in recent years than he was several years ago. This practice will have the effect of reducing the incidence of malpractice suits against surgeons. It is noted that several of the suits alleged the plaintiffs were not adequately advised regarding the risks involved and, therefore, they did not give informed consent to the surgery.
Recommendation It is RECOMMENDED that Horace MacVaugh III be granted a license to practice medicine in Florida. DONE and ENTERED this 19th day of December, 1990, in Tallahassee, Leon County, Florida. K. N. AYERS 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 19th day of December, 1990. APPENDIX Petitioner's proposed findings are accepted, except: 8. Accepted only insofar as consistent with HO #5 and 6. 15. Rejected. No evidence was presented in this regard. Respondent's proposed findings are accepted except: 17. Second and third sentences rejected as not supported by any competent evidence. COPIES FURNISHED: Roger Lutz, Esquire Robin Uricchio, Esquire HOLLAND & KNIGHT Post Office Box 1526 Orlando, Florida 32802 Allan Grossman, Esquire The Capitol, Suite 1602 Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Florida Board of Medicine Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth E. Easley, Esquire General Counsel Department of Professional Regulation Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792
The Issue The issue for consideration in this hearing is whether the Intervenor, St. Joseph Hospital of Port Charlotte, should be issued Certificate of Need #6202 for the establishment of a cardiac catheterization laboratory at its facility in Port Charlotte, Florida.
Findings Of Fact At all times pertinent to the issues herein, the Department was the state agency responsible for the regulation and certification of health care facilities in this state and charged with the responsibility of issuing Certificates of Need, (CON), under the criteria set forth in Section 381.705 Florida Statutes and the Department's Rules. St. Joseph Hospital is a 212 bed general acute care hospital located in Port Charlotte, Florida, within the jurisdiction of the Department's District VIII. It is a not for profit, tax exempt corporation owned by Bon Secours Health Systems, a multi-hospital system. It offers varied medical and surgical services, including obstetrics and pediatrics, and operates a 24 hour emergency room. The facility is accredited by the Joint Commission on Accreditation and Health care Organization, and its laboratory is accredited by the American College of Pathology. Because St. Joseph opened a nursing home in Port Charlotte in 1975, Chapel Manor Nursing Home, Fawcett's predecessor, and at that time, the only nursing home in Port Charlotte, applied for and was issued a CON to convert from a nursing home to an acute care hospital and began operation as Fawcett Memorial Hospital that year. Fawcett is now a 254 bed general medical surgical acute care hospital providing a broad range of services with the exception of obstetrics and pediatrics, and is located directly across the street from St. Joseph. It offers diagnostic cardiac catheterization service only, implementing that service in August, 1989. Both Fawcett and St. Joseph have the same service area and utilize the same physicians on their medical staffs, which are practically identical. St. Joseph offers a full array of cardiology services with the exception of cardiac catheterization. As a result, any St. Joseph patient requiring cardiac catheterization must be discharged from St. Joseph and transferred to another hospital in the area which provides that service. Between January 1989 and February, 1990, approximately 97 St. Joseph patients required transfer because of the fact that St. Joseph had no pertinent program. Because of this fact, and recognizing that the Department had determined there was a numeric need for an additional cardiac catheterization lab within the district, specifically based on the under-served indigent and Medicaid patients, in February, 1990, St. Joseph submitted a letter of intent to file a CON application for the establishment of an adult inpatient cardiac catheterization laboratory at its facility in District VIII. This letter of intent was based on proper Board Resolution, and was filed not only with the District but also with the local Health Council, and the required notice was published in a local paper. Thereafter, in March, 1990, St. Joseph filed its CON application for the facility, along with the appropriate fee, with the Department, at the same time filing a copy with the local Health Council. The Department responded with an omissions letter, the requirements of which were met by St. Joseph in a timely manner, and the Department thereafter deemed the application complete. Notwithstanding Fawcett's allegations in the post hearing submission that St. Joseph's application was not complete, there was no evidence presented at hearing to so establish, and the Department deemed it both timely and ultimately complete. On on about July 17, 1990, the Department issued its State Agency Action Report and notified St. Joseph of its decision to approve the application. Approximately one month later, in a timely fashion, Fawcett filed its Petition challenging the Department's approval of St. Joseph's application. St. Joseph projects implementation of service by the unit in December, 1992. The unit will encompass approximately 3,800 square feet and will be part of and companion to a larger construction project designed to expand St. Joseph's surgical capacity. It will be located in a proposed two-story addition to the south side of the existing hospital. Total cost of the project, including construction of the building and equipment, is estimated to be approximately $2.6 million, one hundred percent of which will be financed by debt. It is estimated that interest costs over the term of the financing will be an additional $2.25 million. St. Joseph anticipates the charge for a cardiac catheterization will be $6,657.48 in 1993, and $7,123.50 in 1994. This is the same as the average charge for the procedure by existing providers in the district, adjusted for inflation in later years. The facility will be open routinely from 7:00 AM to 2:30 PM, Monday through Friday. An on-call team will, however, be available 24 hours a day although cardiac catheterization, usually an elective procedure, should not require much in the way of emergency services. Dr. Victor Howard, a Board certified internist and cardiologist, who is already on staff at St. Joseph, is projected to be the medical program director for the new facility without additional compensation. Cardiac catheterization is a relatively new diagnostic and therapeutic invasive procedure which involves the insertion of an extremely fine hollow tube through a blood vessel in the groin, up into the patient's heart. Because the patient faces danger from collateral problems such as bleeding, stroke, congestive heart failure and medication reactions, at least three staff members are required to assist the physician performing the catheterization. As with most procedures, the more it is done, the more proficient the individuals doing it become. By the same token, the medical staff assistants to the physician in charge must have specialized skills and training, and the Department rules require that in order to properly provide for therapeutic catheterization patients, an open heart surgery facility must be available within thirty minutes of the facility where the catheterization is being carried out. St. Joseph intends to rely on Medical Center Hospital in Punta Gorda, approximately ten miles away, as the required backup open heart facility. Medical Center is within the maximum thirty minute drive time criteria. It provides not only an open heart surgery program but also both diagnostic and therapeutic cardiac catheterizations. Diagnostic catheterizations, as opposed to therapeutic catheterizations, can be done on an outpatient basis. Experience has indicated that staff assistant technicians, nurses and others, are frequently not reasonably available. As a result, there is continuing competition between hospitals providing the services requiring these individuals, and this competition is often severe. Nonetheless, Fawcett has, up to the present, been able to recruit and retain adequate numbers of experienced personnel without the necessity for paying a bonus over and above normal salary. By the same token, St. Joseph believes it, too, will be able to attract and retain sufficient numbers of qualified personnel to successfully operate its laboratory as approved. At the present time, St. Joseph has ten registered nurses on staff who have cardiac catheterization laboratory experience. The laboratory, if approved, will not open at St. Joseph until the second half of 1992. At that time, manpower requirements for the project call for 3.36 full time employees, (FTE's), and that number appears capable of being satisfied by the current staff, though a cardiovascular technician, (CVT), has not yet been hired for the lab. In addition, St. Joseph appears to have on hand adequate management and supervisory personnel. It projects salary and benefits expense of almost $140,000.00 in 1993 and almost $150,000.00 in 1994. Maintenance expense is expected to approximately $65,000.00 the second year of operation. The proposed project has been enthusiastically received by the medical community in the service area. Because, in that area, the treating physician determines where the patient will be treated, support for the project by the area cardiologists is important as a positive factor for consideration. Because it has both the financial and personnel resources to provide the service, access to the service will be improved for the medically indigent and the facility's current cardiology program will be enhanced. The Florida legislature has, by its passage of Section 381.705, Florida Statutes, laid the basic analytical framework to be used in determining whether the facility here in question is needed. Consistent with the terms of the enabling statute, the Department has promulgated Rule 10-5.011, F.A.C., to implement the provisions of the statute. The rule formula provides a showing of "need" if at least 300 procedures could be performed by the new program, based on the total number of catheterizations, diagnostic and therapeutic, projected for the District. Projections for Charlotte County alone indicate 180 additional catheterizations between 1989 and 1994. Consistent therewith, the Department has determined that within DHRS District VIII, the pertinent service district, there is a numeric need for one additional cardiac catheterization laboratory. Need, however, goes beyond the question of numeric need. It is also a factual issue that requires an analysis of health planning principles and standards used within the ultimate goal of providing the best quality medical care for the citizens of this state in a sound, economically justified manner. In that regard, it is appropriate to evaluate need with an eye that looks toward avoiding unnecessary and costly duplication of services that are unnecessary. Fawcett contends there is no need for an additional lab in District VIII, based on the underutilization of existing programs. The Department's rule, the use of which resulted in a determination of need for one additional unit, does not regulate capacity. District VIII consists of Sarasota, DeSoto, Glades, Hendry, Charlotte, Lee, and Collier Counties. Sarasota and Lee Counties each have three cardiac catheterization programs while Collier has one in its only hospital. Charlotte County has two, Fawcett and Medical Center. It has already been noted that Fawcett and St. Joseph are located across the street from one another. Medical Center, which is used for therapeutic catheterizations, is located not far from the other two, and all three are Medicaid providers. All three also serve generally the same service area and use, essentially, the same medical staff. Moreover, the three facilities' cardiology staffs are essentially identical. When evaluating the service availability, however, it must be noted that Charlotte County experienced the highest relative increase in population among all the District VIII counties during the decade of the 1980's, and projections are that it will continue to lead up through 1995. At the present time, Charlotte County has the highest percentage of residents over age 65, (34%), of any of the District VIII counties. Looking at the proposed service in light of the pertinent State Health Plan, that for 1989, four preferences should be considered when evaluating the need for the proposed service. One deals with giving preference to those who propose to establish both cardiac catheterization and open heart surgical services. Since there is no established need for an open heart surgery service in the District, St. Joseph could not and does not plan to provide for one. Consequently, this preference is not pertinent here. The second preference is for those applicants who propose to establish a cardiac catheterization program in a county without any existing program. Again, this is not pertinent to the current situation. The third preference is toward applicants with a history of providing a disproportionate share of Medicaid and charity care. Here, St. Joseph is not a disproportionate Medicaid share provider, a point made by Fawcett. By the same token, however, neither is Fawcett. Fawcett did not, over the years, keep an accurate record of the number of patients to whom it provided free medical services, or of the value of those services. It claims it did not realize the importance of those numbers, concerning itself more with the provision of the service rather than with the recording of it. It was not, for most of its existence, however, a Medicaid provider, applying for and gaining that certification as of September l, 1989. Yet, during those non-certified, unrecorded years, it claims to have provided care to patients regardless of their ability to pay. While this claim is accepted as true, it is impossible to quantify it. The fourth preference is given to applicants who agree to provide services to all patients regardless of ability to pay. St. Joseph has agreed to do so and has a history of providing care to the medically indigent. So does Fawcett, but Fawcett is not an applicant, so the preference issue does not, necessarily, apply. It is clear, however, that neither the existing providers nor the applicant are precluded or disqualified as a result of the application of these preferences. Turning to the local, (District) Health Plan, which is also to be considered in the evaluation of the projects, the 1989 update of the District VIII Plan, that pertinent here, also provides for applicants to be evaluated in light of several preferences. One calls for an applicant to provide certain services, all of which are provided currently by St. Joseph. The second preference calls for the laboratory to be open no less than 40 hours a week and to provide a maximum waiting time of one month for simple, elective cases. The evidence presented indicates that the currently operating facilities meet this criteria, but also that St. Joseph will likely do the same if approved. Another preference relates to the proposed program's impact on existing providers in the area. It is here that the parties disagree radically on whether or not such an impact exists. St. Joseph has taken the position that its program will have only minimal impact on the ability of Fawcett and other existing providers to continue to provide quality economic service. On the other hand, Fawcett projects a major negative impact on its services, and claims the Department apparently failed to consider, at the time it did its initial evaluation, whether or not St. Joseph's program would adversely impact on it's existing service. Fawcett contends that its presently improving financial posture will be definitely impacted adversely by St. Joseph's implementation of the new service, if approved, in that its anticipated positive financial improvement will be reduced, if not destroyed, by the opening of St. Joseph's proposed program. Evidence produced by Fawcett tends to indicate that by 1994, if current projections hold true, Charlotte County will experience an increase of only 180 diagnostic catheterizations per year. St. Joseph's projections indicate that in that timeframe it expects to perform 509 diagnostic catheterizations per year. Simple arithmetic, then, would reveal that if those figures are correct, 329 of the 509 projected diagnostic procedures would have to come from the number of procedures performed by both Fawcett and Medical Center. Since approximately 75% of the current cardiac catheterizations performed in Charlotte County are performed at Fawcett, by far the greatest impact would be on that institution. The figures projected indicate a loss by Fawcett, then, of 232 procedures in 1993 and 318 in 1994. Medical Center's projected losses would be somewhat less, but nonetheless, such a reduction, if realized, would result in a loss of revenue to each of the existing providers from current income levels. Fawcett experienced severe financial problems during the past several years prior to the incumbency of the present CEO. In 1987 and 1988, it had financial losses which were improved in 1989 to a result showing a marginal excess of revenue over expenses. For 1990, Fawcett expects to show a profit for the first time in several years. Its prior negative operating result, however, has had a negative impact on its debt to equity ratio which, itself, is significant in that it is used by lenders as an index or flag regarding the financial health of an institution which seeks to borrow money. Because of its poor financial condition in the past, Fawcett was unable recently to borrow money needed for 1990 capital projects, and it is the increasing profit margin, which Fawcett hopes will make it more competitive in the borrowing market, that is most threatened by the proposed initiation of St. Joseph's project. The improved financial picture which Fawcett experienced in the most recent financial years has been directly attributed to the revenue earned by its cardiac catheterization program. In 1989, Fawcett determined that each cardiac catheterization patient contributed $1,927.00 to the hospital's financial health, and Fawcett contends that each patient taken from it by the opening of St. Joseph's proposed program will result in a financial loss to it. Utilizing the 1989 contribution margin projected to 1993 and 1994 reflects that if St. Joseph's program is approved, and if the anticipated numerical patient load is lost, the net financial loss to Fawcett would be in excess of $446,000.00 in 1993 and in excess of $612,000.00 in 1994. If these figures are inflated to 1993 and 1994 dollars, the loss could well be greater. Fawcett contends that it is currently experiencing a healthy improvement in its financial position which it anticipates would be substantially and adversely affected by the loss of cardiac catheterization patients to St. Joseph if that facility's project were approved as proposed. No doubt there would be a negative impact, but the degree thereof is speculative. Both the statute and the rule mentioned previously set forth criteria for the evaluation of these projects. One is the existence of an alternative to the service provided. Whereas St. Joseph contends there is no alternative diagnostic procedure preferable to cardiac catheterization, Fawcett contends there are several alternatives to St. Joseph's proposed project. Nonetheless, prior to its application, St. Joseph considered some alternatives. One was the setting up of a mobile laboratory on an interim basis. Since this could be used only by outpatients, it was determined not to meet the need of those patients requiring an inpatient procedure or of the physicians who would perform in it, and the anticipated $1.3 million cost was considered excessive for a short term fix. It is so found. Another was the possibility of establishing the lab somewhere within the hospital's existing space, but a survey of the facility quickly revealed there is no available existing space. However, since a part of the service proposed by St. Joseph would include outpatient catheterization, this part of the need could be met by the laboratory established in Charlotte County by several cardiologists who practice on the staff of St. Joseph, and who recently established a facility in the county. By the same token, if a need for outpatient procedures is demonstrated, the existing inpatient program could, Fawcett contends, provide it. Finally, is the existence of under-utilized programs at Fawcett and the Medical Center which have existing excess capability which could be considered an adequate and available alternate to the St. Joseph program. Turning to the question of financial feasibility, another evaluation criteria, there is no doubt that St. Joseph has the ability to borrow the capital to make the project financially feasible in the immediate future. St. Joseph's financial condition is sound. As might be expected, there is substantial difference in opinion as to the reasonableness of the pro forma projections submitted by St. Joseph's as evaluated by the Department. In fact, the parties agree to very little. St. Joseph contends that the patient mix estimated in the application is reasonable and based on its experience and that of Lee Memorial Hospital, and that the staffing level is appropriate and reasonable, and there is little to contest. The major difference in positions is in the area of supply costs and the percentage of patients accounted for by Medicare. St. Joseph estimated a supply cost of $248.00 per admission in 1989 dollars, inflated by 7% per year up to 1993 and 1994, but Fawcett contends the actual supply cost in 1989 dollars is $492.00 per admission. Assuming, arguendo, that Fawcett is correct, the projected supply costs would then be increased by in excess of $85,000.00 in 1993 and almost $126,000.00 in 1994, and this would result in a reduction of projected income for the service in both years. Fawcett's evidence and argument here are not persuasive, however. Fawcett also contends that St. Joseph's assumption that 58.9% of the cardiac catheterization patients would be Medicare, a figure which assumes that the Medicare patient utilization for catheterization would be the same as the facility as a whole, is not reasonable. Fawcett relies on the fact that St. Joseph is the sole obstetrics provider in Charlotte County and the majority of these obstetric patients are not Medicare patients. Considering that along with the fact that cardiac catheterization is a service which has a higher level of Medicaid utilization than St. Joseph presently provides, a more likely and reasonable predictor of the Medicare utilization of St. Joseph's program would be the Medicare utilization for the two existing catheterization programs. Fawcett's utilization in that regard is 64.6% and Medical Center's is 70.5%. Extrapolating from those figures, Fawcett contends a reasonable financial projection for St. Joseph's program would be 65% Medicare utilization. Since that type of service is reimbursed on the basis of DRG, the amount of income to the hospital is less, and the resultant contractual allowances, deductions from revenue, would be in excess of $61,000.00 in 1993 and more than $87,000.00 in 1994. Therefore, combining both the increase in projected supply costs and the decrease in projected income from Medicare, Fawcett contends that the projected number of catheterizations in 1994 and 1994, as modified using Fawcett's figures would result in a net reduction of approximately $210,000.00 in the former year and in excess of $126,000.00 in the latter. If those figures prove correct, St. Joseph's proposed program , it is suggested, would apparently not be feasible in the long term. On the other hand, St. Joseph contends its utilization figures for 1993 and 1994 are reasonable in that it projects a volume slightly greater than one-half of the number of procedures accomplished by Fawcett in its first year of operation. St. Joseph's expert evaluated the use projections for the first two complete years of operation and the costs assumptions and found both to be reasonable. Nonetheless, he also accomplished calculations of profitability utilizing Fawcett's suggested increased costs figures, and utilizing three different approaches, ultimately concluded that even looking at the worst case scenario, St. Joseph's proposal would be financially feasible both in the short and the long term. Independent analysis of the evidence leads to the conclusion that the projected staffing level and the salaries and benefits for that staff are reasonable. The anticipated reimbursements on the basis of the DRG's are reasonable. The projected utilization in the first and second years of operation are reasonable, and taken together, the evidence supports the conclusions drawn by St. Joseph's expert. It is so found. Another area for consideration is the impact St. Joseph's program would have on Fawcett's existing program. Fawcett's program has now been in operation for several years and even with approval of St. Joseph's, will continue to operate without competition until the second half of 1992, after which St. Joseph's program would be in a start-up configuration for at least a year. As such, it will be well into 1993 and possibly into 1994 before St. Joseph's program can be considered to have its full impact vis-a-vis the Fawcett program. Fawcett's expert, who concluded that St. Joseph's program would have a serious adverse effect on Fawcett's ability to contribute to its improving financial picture did not consider the fact that Fawcett does not currently perform outpatient cardiac catheterization procedures, and any of that nature done by St. Joseph should have no impact on Fawcett. The expert also did not consider in his analysis of impact any population growth beyond 1990 or growth in the demand for diagnostic catheterization procedures. Fawcett listed approximately $13.7 million in proposed capital expenses over the next five years which, it claims, will be adversely impacted by the effect of St. Joseph's proposed program on its cash picture. Many of the line items within this figure are much the same as normal routine replacement items, and only $3.5 million represent the cost of items specifically identified as needed to meet existing life safety code violations or for accreditation purposes. No doubt there will be some impact on Fawcett's operation by the opening of St. Joseph's program, yet Fawcett has not demonstrated clearly that the impact will result in a return to the pre-1990 negative cash position which was shown to now be reversing. Even accepting Fawcett's expert's assumptions, the likelihood is great that Fawcett's equity balance would increase by over $900,000.00 from 1992 to 1993 and by over $800,000.00 from 1993 to 1994. So long as Fawcett's cardiac catheterization program performs more than 182 procedures per year, its current break-even point, no negative impact to the hospital's overall financial picture is likely to occur. Assuming that Fawcett's procedures were no more than one-half its 1990 admissions, at current rates, its program would render a positive contribution of more than $650,000.00 to the hospital's financial picture. This figure could not be considered as other than a viable financial contribution. What is more, the implementation of the program at St. Joseph should not exert any upward pressure on the cost of other services rendered by St. Joseph, and should, by competition, moderate future price increases for this procedure at the two competing facilities. As regards Medicaid and indigent care, St. Joseph has been a Medicaid provider since 1965 and has a history of providing service to indigent patients and under-served groups. In fact, the value of care rendered without cost to patients by St. Joseph has climbed from $418,000.00 in 1988 to a projected $1.5 million in 1991. By the same token, its commitment to Medicaid has increased to almost 4% in 1990, in addition to approximately 2% of uncompensated care that same year. The obstetric unit has been shown to operate $500,000.00 a year in the red because of the volume of indigent care provided. Nonetheless, St. Joseph agrees to accept a condition to its CON requiring it to provide 1.5% Medicaid and 2% charity care. In comparison, Fawcett was not certified for Medicaid until late 1989 and its experience since that time has not been substantiated. This tends to underscore the Department's contention that Medicaid and charity patients are under-served within the Charlotte County area. Other criteria outlined within the statute have not been shown by evidence presented, as being significantly affected one way or the other by the implementation of St. Joseph's proposed program. Several of the statutory criteria are, in fact, not applicable to the proposed project in this case. Much the same can be said for the criteria outlined in Rule 10-5.011(1), F.A.C., which tend to overlap to a substantial degree with the statutory review criteria. Fawcett claims that the application filed with the Department by St. Joseph is "very incomplete" in that it omits significant information regarding project costs, capital expenses, source of funds, and a litany of other required information. It claims, therefore, that the Department could not have conducted any meaningful review of the application based upon the information provided. The Department's representative, Ms. Dudek, admits that most, if not all applications omit some information. That is the purpose of the omissions letter which is sent to an applicant after initial review. Not all information called for by the statute is deemed essential however. If an omission is considered immaterial, it will not cause the application to be denied, all other essential material being provided. There are primarily two criteria called for by the statute which are essential to Departmental approval. The first deals with the applicant's access to resources to develop and operate the project, and the second is that the applicant offer quality care. In this case, both were deemed to have been met as was stipulated to by Fawcett. In the instant case, the Department's representative concluded that St. Joseph's application was one of the most thorough and comprehensive, in terms of presentation and backup, to have been filed within the past few years.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered by the Department approving St. Joseph's application for an inpatient cardiac catheterization laboratory, (CON #6202) for District VIII. RECOMMENDED in Tallahassee, Florida this 4th day of April, 1991. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of April, 1991. APPENDIX TO RECOMMENDED ORDER CASE NO. 90-5815 The following constitutes my specific rulings pursuant to Sec 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. & 4. Accepted. 5. & 6. Accepted. 7. - 10. Accepted and incorporated herein. 11. & 12. Accepted. 13. & 14. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted. & 19. Accepted and incorporated herein. 20. & 21. Accepted and incorporated herein. 22. - 26. Accepted and incorporated herein. 27. - 34. Accepted. Rejected. - 39. Accepted. 40. - 42. Accepted and incorporated herein, except for the first sentence of Finding 41. Rejected. Accepted and incorporated herein. & 46. Accepted. Rejected. Rejected. - 51. Accepted and incorporated herein. Accepted. Accepted. Not proven. - 59. Accepted and incorporated herein. Accepted that the loss of revenue will have an impact but the loss has not been shown to be substantial. - 65. Accepted and incorporated herein. 66. & 67. Accepted. 68. - 76. Accepted incorporated herein in substance. Rejected that the loss of revenue would "cripple" the health trend. It would adversely affect it but not cripple it. - 83. Accepted and incorporated herein. 84. - 90. Accepted. Accepted. Accepted and incorporated herein. - 97. Accepted that there are alternatives, but rejected that they are acceptable or adequate. Rejected as too broad a statement. Rejected as to the conclusion of waste. & 101. Accepted. Ultimate conclusion rejected. Need for level of education and experience accepted. Accepted. Underlying fact accepted. Balance is editorialization. - 108. Accepted. Accepted. Not an appropriate Finding of Fact. Accepted. & 113. Accepted and incorporated herein. 114. - 116. Rejected. Accepted. & 119. Rejected. 120. & 121. Accepted and incorporated herein. Rejected. - 126. Accepted. 127. & 128. Accepted. 129. & 130. Rejected. 131. & 132. Accepted. 133. & 134. Rejected. Not a Finding of Fact but a comment of the state of the evidence. Accepted. & 138. Accepted. Accepted. Rejected. & 142. Accepted. Rejected. St. Joseph was a Hill-Burton hospital. Accepted. Accepted that St. Joseph receives funds from taxes and other sources, but the conclusions that aid to Medicaid an the indigent "is to be expected" is an unjustified conclusion. 146. Accepted. 147. Accepted but probative value questionable. 148. Accepted that it is less costly. 149. First two sentences accepted. Remainder not proven. 150. Rejected. 151. & 152. Accepted in the short term. 153. Accepted. 154. Not proven. 155. Rejected. 156. - 158. Rejected. 159. & 160. Accepted. FOR THE RESPONDENT AND INTERVENOR: 1. - 3. Accepted and incorporated herein. Accepted. - 8. Accepted and incorporated herein. Accepted. - 13. Accepted. 14. - 16. Accepted and incorporated herein. Accepted. & 19. Accepted and incorporated herein. 20. & 21. Accepted. 22. - 24. Accepted and incorporated herein. Accepted and incorporated herein. - 28. Accepted and incorporated herein. Accepted and Incorporated herein. - 35. Accepted and incorporated herein. 36. - 41. Accepted and incorporated herein. Accepted. - 45. Accepted and incorporated herein. 46. & 47. Accepted. 48. & 49. Accepted and incorporated herein. 50. & 51. Accepted. 52. - 54. Accepted and incorporated herein. 55. - 58. Accepted. 59. & 60. Accepted and incorporated herein. Accepted. Accepted. & 64. Not Findings of Fact but a comment on the state of the evidence. 65. & 66. Accepted and incorporated herein. Not a Finding of Fact but a statement of party position. Not a Finding of Fact but a comment on the evidence. & 70. Accepted and incorporated herein. 71. & 72. Accepted and incorporated herein. Accepted. Accepted. Not a Finding of Fact but a comment on the evidence. Accepted. - 80. Accepted and incorporated herein. Accepted but irrelevant to the issues here. Accepted but considered more a statement of party position and a comment on the evidence. & 84. Accepted and incorporated herein. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted and noted in the Conclusions of Law portion of the Recommended Order. - 100. More proper as Conclusions of Law than as Findings of Fact, but accepted where pertinent. COPIES FURNISHED: John D. C. Newton, II, Esquire Aurell, Radey, Hinkle & Thomas Suite 1000, Monroe-Park Tower P.O. Drawer 11307 Tallahassee, Florida 32302 Richard Patterson, Esquire DHRS 2727 Mahan Drive Tallahassee, Florida 32308 R. Terry Rigsby, Esquire Philip Blank, P.A. P.O. Box 11068 Tallahassee, Florida 32302 Linda K. Harris Acting General Counsel Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32399-0700 Sam Power Agency Clerk DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700
Findings Of Fact Petitioner, Peter P. McKeown, is a graduate of the University of Queensland Medical School in Brisbane, Australia. He holds the degrees of Bachelor of Medicine and Bachelor of Surgery. Doctorates of Medicine, under the British system, are reserved for specialists. Nonetheless, the medical training Petitioner received equates to that leading up to the award of the degree of Doctor of Medicine in the United States, and he is a physician and licensed as such in several states. He has completed residencies in general and thoracic surgery in Australia and the United States and has taken advanced training in cardiovascular and thoracic surgery at Emory University. Immediately before coming to the University of South Florida, (USF), Dr. McKeown was an Assistant Professor of Surgery at the University of Washington. In mid to late 1988, Dr. McKeown responded to an advertisement USF had placed in the Journal of the American Medical Association seeking applicants qualified for appointment at the Associate Professor level "... to join the Department of Surgery at the University of South Florida College of Medicine as the Chief of Cardiothoracic Surgery." He was selected for the position and joined the faculty effective May 1, 1989. All the correspondence leading up to Petitioner's joining the University faculty referred not only to his appointment as Associate Professor but also his assignment as Chief of the Cardiothoracic Surgery Division. Only the actual state employment contract described his employment exclusively as Associate Professor and made no mention of the Chief position. Under these circumstances, Petitioner did not gain any proprietory interest in the position of Chief of the Cardiothoracic Surgery Division. Dr. McKeown held the position of Chief of the Cardiothoracic Surgery Division until April, 1994, when, as a result of a decision made by the Chairman of the school's Department of Surgery, he was replaced as Chief and that position was filled, on a temporary basis, by the Department Chair. Petitioner claims that when he arrived at USF to assume the directorship, an administrative position, he saw an opportunity to develop the position into something significant. He contends he would not have come to USF unless he was to be the Chief of the Division as there was no appeal to him in a position as a general faculty member. He wanted an opportunity to budget, hire people, and develop plans and programs, and in order to advance in academic medicine, one must, at some point, hold an administrative position. Apparently the Department of Surgery had experienced a rapid turnover in faculty. It is not clear whether this caused or was the result of a dispute with administrators and medical staff at Tampa General Hospital, (TGH), where much of the clinical medical school activity is carried on. However, the program was recognized as being weak in cardiothoracic surgery, and this condition offered Petitioner the challenge he wanted. In his five years as Chief, Petitioner increased both the number and quality of personnel and revenues considerably. He developed affiliations with several foreign universities and recruited qualified people, built up the laboratory, secured more grants, developed a program of continuing medical education and raised the examination scores of the school's graduates. He opened new clinical programs and built up both billings and collections to the point where the program revenues were increased at least 2 to 5 times. By 1992- 1993, the Division was making money and generating a surplus and still used clinic funds to support research. During his tenure as Chief of the Division, Petitioner served under two Department of Surgery chairmen. The first was Dr. Connar, the individual who recruited him; and the incumbent is Dr. Carey, the individual who removed him. Petitioner asserts that at no time during his tenure in the position of Chief of the Cardiothoracic Surgery Division was he ever told, by either Department Chairman, that his performance was unsatisfactory. All Division heads within the Department were, from time to time, counseled about personnel costs, and Petitioner admits he had some differences with Dr. Carey about that subject and some other financial aspects of the job, but nothing different than anywhere else in academia. Petitioner was removed by Dr. Carey based in part upon his alleged inability to get along with people. Though he claims this is not true, he admits to three areas of conflict. The first related to his objection to transplants being accomplished by unqualified surgeons which, he alleges, Dr. Carey permitted to further his own ends. The second related to the pediatric heart transplant program for which Petitioner supported one candidate as chair and Dr. Carey supported another. The third related to Petitioner's reluctance to hire a physician whom Dr. Carey wanted to hire but to whom Petitioner purportedly objected. Of the three areas of dispute, only the first two came before his removal, but he contends at no time was he advised his position was a problem for the Department. By the same token, none of Petitioner's annual performance ratings reflected any University dissatisfaction with his performance. At no time was he ever rated unsatisfactory in any performance area; and prior to his removal, he had no indication his position as Chief of the Division was in jeopardy. Dr. Carey indicates he did counsel with Petitioner often regarding his attitude but did not rate him down because he hoped the situation would improve. Dr. McKeown was called to meet with Dr. Carey in his office on April 12, 1994. At that meeting, Dr. Carey was very agitated. He brought up the "Norman" incident and indicated he was going to remove Petitioner as Chief of the Division. Dr. McKeown admits to having made an inappropriate comment regarding Dr. Norman, another physician, to a resident in the operating room while performing an operation. He also admits that it was wrong to do this and apologized to Dr. Norman both orally and in writing shortly thereafter. Dr. Norman accepted his apology and Petitioner asserts that after his removal, Dr. Norman called him and assured him he, Norman, had not prompted the removal action. Dr. Norman did not testify at the hearing. Dr. Carey removed Petitioner from his position as Chief because of the comments he had made regarding Dr. Norman. Almost immediately after the meeting was concluded, Dr. Carey announced in writing his assumption of the Chief's position, in which position he remained until he hired Dr. Robinson as Chief in April, 1995. Petitioner found out that Carey's threat to remove him had been carried out the following day when his nurse told him his removal had been announced at the Moffett Cancer Center. He thereafter heard other reports of his removal from other sources, and based on what had happened, concluded his removal was intended to be and constituted a disciplinary action for his comment regarding Dr. Norman. He was not advised in advance of Carey's intention to impose discipline nor given an opportunity to defend himself before the action was taken. He claims he was not given any reason for his removal before or at the time of his dismissal. It is found, however, that the removal was not disciplinary action but an administrative change in Division leadership. Dr. McKeown at first did nothing about his removal, believing it would blow over. However, after he heard his removal had been publicized, he called several University officials, including a Vice-President, the General Counsel and the Provost, to see how the matter could be handled. He claims he either got no response to his inquiries or was told it was a Medical College problem. He then met with the Dean of the College of Medicine who indicated he could do nothing. After he was removed as Division Chief, Petitioner's salary remained the same as did his supplement from his practice. He claims, however, his removal has had an adverse effect on his reputation in the medical and academic communities. It is his belief that people now feel something is wrong with him. Dr. Carey's blunt announcement of his assumption of the Chief's position, without any reasons being given for that move or credit being given to Petitioner for his past accomplishments has had an impact on his ability to work effectively. After his removal, he received calls from all over the world from people wanting to know what had happened. The removal has, he claims, also made it more difficult for him to get grants and has, thereby, adversely impacted his ability to do productive research. In addition, his removal made it difficult for him to carry out his academic duties. His specialty is still presented in student rotations, only in a different place in the medical curriculum. Dr. McKeown has sought reinstatement to the administrative position of Chief of the Division. He is of the opinion that Dr. Carey's action in removing him from his position as Division Chief was capricious and damaging to the University as well as to his career. Petitioner admits he could have been less confrontational in the performance of his duties as Division Chief, but he knows of no complaints about him from TGH, All Children's Hospital or the VA Hospital. There are, however, letters in the files of the Department Chairman which indicate some dissatisfaction with Petitioner's relationships in some quarters and, as seen below, there were signs of dissatisfaction from both TGH and All Children's Hospitals. Petitioner admits he may have been somewhat overbearing or abrasive, but neither his alleged inability to properly steward finances nor his alleged inability to get along with people were mentioned to him at the time of dismissal or before. After Dr. Carey assumed the Chairmanship of the Department of Surgery in July, 1990, he saw Dr. McKeown frequently on an official basis at first. A Chief, as Petitioner was, has many and varied functions such as administration, teaching, fiscal, research, clinic administration and the like. People skills are important because of the necessary interface with colleagues, faculty, administrators and the public. When Dr. Carey came to USF, Dr. McKeown had not been in place very long, and the Division of Cardiothoracic Surgery was not doing well financially. There were contract negotiations going on with the VA Hospital which were not going well, at least partly because, Dr. Carey asserts, Dr. McKeown had made some major unacceptable demands. As a result, Dr. Carey stepped in, along with Dr. Benke, who was very effective in dealing with the VA, and as a result, an agreement was reached which resulted in somewhere between $275,000 and $300,000 per year coming in which put the Division in the black. Dr. Carey recalls other instances indicating Dr. McKeown's inability to get along with others. One related to the relationship with TGH previously mentioned. TGH had made a decision to use a particular physician as head of its transplant program because, allegedly, Dr. McKeown had so angered private heart patients they would not let him be appointed even though Dr. McKeown was Dr. Carey's choice. As it turned out, Dr. Carey convinced the TGH Director and another physician to agree to a plan whereby Dr. McKeown would be head of the program 50 percent of the time. This would have been good for the University, but Dr. McKeown refused indicating that if he could not be in charge all of the time, he would not be in charge at all. Another incident relates to All Children's Hospital. That institution wanted to initiate a pediatric heart transplant program and a meeting was set up to which Dr. McKeown was invited. Petitioner so infuriated the community surgeons attending that meeting they would not work with him, and without his, Carey's, efforts, Dr. Carey claims the program was doomed to failure. As a result, Carey asked Dr. Nevitsky to help get the program started. This gave the USF an opportunity to participate in the program, but when Nevitsky left, they lost it. Still another example, according to Dr. Carey, is the fact that some surgeons on staff have called to complain about Dr. McKeown's attitude and unwillingness to compromise and negotiate and about his demands for service and staff, all of which creates friction among the hospital staff. A few days before Dr. Carey removed Petitioner as Chief, he spoke with the Dean of the College of Medicine, a Vice-president of the University, and others who would be impacted, about his concern regarding the Cardiothoracic Surgery Division and, in fact, he had had discussions with other officials even before that time. Long before making his decision to remove Petitioner, Carey spoke of his consideration of possibly shifting the emphasis within the Division to non-cardiac thoracic surgery in place of the cardiac program which Dr. Carey felt was not very successful. He believed the program did not do enough procedures to support the medical school affiliation. Dr. Carey chose to dismiss Dr. McKeown as Chief of the Division on April 12, 1994, after learning of McKeown's destructive attack on another surgeon before a junior physician in a public place, an operating room, (the Norman incident). He notes that over the years there was a building concern regarding Dr. McKeown's abilities as an administrator, and this incident with Dr. Norman was the last straw. Dr. Carey had received complaints about Petitioner from other physicians, all of which he discussed with Dr. McKeown. Finally, with the Norman incident, it became abundantly clear that Dr. McKeown's capabilities as a leader had diminished to the point where a change was necessary. Before he dismissed Petitioner, and during the investigation which led up to the dismissal, Dr. Carey admits, he did not give Dr. McKeown any opportunity to give any input to the decision. By the time Carey met with McKeown on April 12, 1994, his mind was made up. The Norman incident was demonstrative of what Carey perceived as McKeown's lack of supervisory ability, and it was that factor which led Carey to the ultimate decision to remove McKeown. He felt it necessary to act then and not leave Dr. McKeown in place during the search for a replacement. Petitioner cites alleged comments made by Carey to others that he would have relieved anyone for doing what Petitioner did in the Norman incident. Dr. Carey cannot recall having made such a statement. He claims he considered disciplinary action against Petitioner for the Norman comments but decided against it. However, it was the last in a series of incidents which caused him to question the propriety of McKeown's placement in the Chief's position, and which ultimately cemented his decision to replace him. Dr. Carey met with Dr. McKeown several times before the dismissal and counseled him about administrative deficiencies in his performance, but he never told Dr. McKeown that unless he improved, he would be dismissed. This is consistent with Petitioner's testimony that he was not warned of his shortcomings or of the administration's dissatisfaction with his performance. Disagreements in conversations between superior and subordinate, meant by the former to be corrective in nature, are not always taken as such by the latter. Dr. Carey did not document any of this in Dr. McKeown's personnel files but put some of the information he received by way of communications from others in the files. These are the letters submitted by the University, pursuant to agreement of the parties, subsequent to the hearing. They contributed to Carey's increasing concern about Dr. McKeown's ability to lead the Division. At no time, however, though he questioned Dr. McKeown's leadership, did Dr. Carey ever question his good faith and sincerity, nor does he do so now. When he finally decided action was necessary, on April 12, 1994, Dr. Carey wrote a memorandum to the Medical College faculty concerning his assumption of the position as Chief of the Cardiothoracic Surgery Division. He also advised Dr. McKeown of his removal. Dr. Carey remained in the Chief's position, holding that title in an administrative capacity and not from a clinical standpoint, for approximately one year, intending to stay in the position only until he could find a fully qualified thoracic surgeon to take the job. After Carey removed Petitioner, he was contacted by the Medical College Dean who asked that he get with McKeown and try to work something out. He thereafter offered Dr. McKeown the position of Chief of the cardiac section of the Division but McKeown declined. Dr. Carey also, on April 26, 1994, wrote to TGH recommending that Dr. McKeown be allowed to have more impact on the hospital's transplant program, pointing out that the change in McKeown's position at the University was occasioned by a need for a change in leadership. According to Dr. Tennyson J. Wright, Associate Provost of the University, disciplinary action against nonunion faculty members is governed by Rule 6C4-10.009, F.A.C., and requires notice of proposed action be given before such disciplinary action is taken. The contract which Dr. McKeown holds and has held since the inception of his tenure at the University, is a standard USF/State University System contract. It reflects Petitioner was hired as an Associate Professor, which is one of the three types of personnel classifications used within the system. These are faculty, administration and support. Petitioner's contract does not refer to his holding the Division Chief position and it is not supposed to. Such a position is an administrative appointment within a Department and a working title used to define the holder's duties, and service in such a position is at the pleasure of the Department Chair. Appointment to or removal from a Chief position is an administrative assignment. The position of Department Chairperson, on the other hand is a separate position and subclassification within the University classification system and is different.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Petitioner, Peter P. McKeown's, grievance against the University of South Florida School of Medicine arising from his removal as Chief, Cardiothoracic Surgery Division in the Department of Surgery be denied. DONE AND ENTERED this 19th day of January, 1996, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of January, 1996. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 95-1832 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. FOR THE PETITIONER: 1. - 7. Accepted and incorporated herein. Though the documents in question refer to appointment, in actuality the personnel action was an appointment to the faculty with an administrative assignment to the position of Director of the Division. & 10. Accepted. 11. & 12. Accepted and incorporated herein. 13. & 14. Accepted and incorporated herein. - 19. Accepted and incorporate herein. Accepted and incorporated herein. Accepted. Rejected as inconsistent with the better evidence of record. Accepted. Accepted and incorporated herein. Rejected as inconsistent with the better evidence of record. & 27. Accepted. & 29. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. 32. - 34. First sentence accepted. Second sentence rejected as inconsistent with the better evidence of record. 35. - 37. Accepted. 38. Rejected as argument. 39. Accepted. FOR THE RESPONDENT: - 9. Accepted and incorporated herein. Accepted. - 14. Accepted and incorporated herein. 15. & 16. Accepted and incorporated herein. COPIES FURNISHED: Benjamin H. Hill, III, Esquire William C. Guerrant, Jr., Esquire Danelle Dykes, Esquire Hill, Ward & Henderson, P.A. Post Office Box 2231 Tampa, Florida 33601 Thomas M. Gonzalez, Esquire Thompson, Sizemore & Gonzalez 109 North Brush Street, Suite 200 Post Office Box 639 Tampa, Florida 33601 Olga J. Joanow, Esquire University of South Florida 4202 East Fowler Avenue, ADM 250 Tampa, Florida 33620 Noreen Segrest, Esquire General Counsel University of South Florida 4202 East Fowler Avenue, ADM 250 Tampa, Florida 33620-6250
