The Issue An amended administrative complaint, dated July 31, 1989, alleges various violations of Chapter 459, F.S., by Respondent. Counts V, VI and VII, relating to Respondent's treatment of patient, R.C., were voluntarily dismissed by Petitioner at the commencement of the hearing. The following allegations are left at issue: That Respondent violated Section 459.015(1)(u), and (y), F.S., by prescribing Percodan and Ritalin, controlled substances, to his wife, G.I., inappropriately or in excessive quantities. That in the treatment of his wife, Respondent failed to practice osteopathic medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances, in violation of Section 459.015(1)(y), F.S. That Respondent violated Section 459.015(1)(p), F.S., by failing to keep medical records justifying the course of treatment of G.I.; and that of his mother, M.I., for whom he prescribed Demerol.
Findings Of Fact Respondent, Donald Iafornaro, D.O., is and has been at all times material to the allegations of the amended administrative complaint, a licensed physician in the State of Florida, with license number OS 0001794. Dr. Iafornaro has a limited osteopathic practice which he conducts from his home at 1802 North Lakemont, Winter Park, Florida. He has about fifty patients, and also treats his large family, including his wife, mother, eleven children and grandchildren. G.I. has been a patient of Dr. Iafornaro for approximately 25 years -- since 1973, as his wife, and prior to that, from 1964, along with the rest of her family in Cleveland, Ohio. Mrs. Iafornaro has had a demanding job caring for the Iafornaro children, her mother-in-law, the house and pets, and has recently been her husband's only staff in his practice. Between May 1985, and April 1987, her husband treated her for a variety of medical problems, including severe allergies, sleep apnea (a mechanical difficulty in breathing during deep sleep), depression, fatigue, a chronic fracture of the foot bone (a fracture which failed to heal), spinal stenosis, an unstable hip, ulcers, angina and various gynecological complaints Between May 1, 1985, and April 11, 1987, Dr. Iafornaro prescribed the following drugs, among others, to his wife: 2,720 tablets of Percodan 900 tablets of Ritalin Percodan is the product name for oxycodone hydrochloride, and Ritalin is the product name for methylphenidate hydrochloride. Both are Schedule II controlled substances and are legend drugs as defined in Section 465.003(7), F.S. With the concurrence of the parties, official recognition was taken of the Physician's Desk Reference (PDR) for the years 1984-1987. Petitioner also presented the testimony of two osteopathic physicians practicing in Dr. Iafornaro's community. The evidence from these authorities established that the prescriptions of Percodan and Ritalin for G.I. were inappropriate or in excessive quantities. Dr. Iafornaro felt that Ritalin was necessary to counteract the sedative effect of the antihistamines his wife had to take for her many allergies. He also prescribed the Ritalin for her depression. Ritalin is a mild central nervous system stimulant. It is indicated for attention deficit disorders (primarily in children) and narcolepsy. It should not be used for severe depression or for the prevention or treatment of normal fatigue. The PDR warns of drug dependence. Ritalin is also contraindicated in patients, such as G.I., who have exhibited anxiety, tension, depression and agitation. Ritalin may cause reactions such as skin rashes, a common complaint of this patient, but a problem which Dr. Iafornaro attributed to her multiple allergies. The Percodan was prescribed by Dr. Iafornaro for his wife's pain in her foot and for other pain in her low back and in her wrist. The PDR warns that Percodan may be habit forming. It contains aspirin, which can aggravate ulcers. It is indicated for relief of moderate to moderately severe pain; it is a depressant; it can cause apnea and respiratory depression in an overdose. Mrs. Iafornaro's statement that she used only about a half a tablet a day is inconsistent with the volume of the drugs prescribed for her over the relevant period. Dr. Iafornaro produced all of his medical records for G.I. for the relevant period. He claims they are incomplete because he also makes notes on odds and ends, writes on the back of a medical journal and keeps a lot of records in his head. (Iafornaro Deposition, p.15) The medical records produced by Dr. Iafornaro do not justify his course of treatment,for this patient, and particularly fail to explain the long-term volume of drugs that he was prescribing. Dr. Iafornaro claims that the probable cause panel previously reviewed his records and found them acceptable. The records were produced in response to charges that he had violated certain terms of an earlier disciplinary action. The issue was resolved with a "no probable cause" finding. That finding, in 1983, was for a different time period than the period at issue in this proceeding. Dr. Iafornaro provided records to the panel covering a limited period in 1983 when he was treating his wife for her foot fracture, a slip and fall accident and other acute conditions. The 1983 records, in contrast to those at issue here, describe the condition and his treatment. The later records provide copious listings of a variety of prescriptions, including the Percodan and Ritalin, with scant examination results, explanation of the condition being treated, or diagnoses of the complaints. Complete written medical records are an essential element of prudent osteopathic practice, particularly when, as here, the physician is treating his family and his objectivity may be questioned. Between January 5, 1987, and March 1, 1987, Dr. Iafornaro prescribed 200 50 mg Demerol tablets to his 84 year old mother, M.I. Demerol is a product name for meperidine hydrocloride, a Schedule II controlled substance, and a legend drug as defined in Section 465.003(7), F.S. The basis for the prescriptions was an episode of right upper quadrant pain felt to be of gallbladder origin. It is cheaper to purchase Demerol tablets by the 100. After M.I. took a few of the first prescription of 100, she lost the bottle and Dr. Iafornaro replaced it with another prescription. The medical records make no mention of the lost prescription, but they marginally justify the use of this drug for the limited period in issue and for the purpose intended. A previous disciplinary case involving allegations of Dr. Iafornaro's improper prescriptions and record-keeping practices was resolved with a stipulation for his one-year probation with conditions. The stipulation was approved by the Board of Osteopathic Medical Examiners in a Final Order entered on December 28, 1982. (DPR Cases #0010979, 0014467, and 0015303)
Recommendation Based on the foregoing, it is hereby, RECOMMENDED That the Department of Professional Regulation, Board of Osteopathic Medical Examiners enter a Final Order which finds Donald Iafornaro, D.O., guilty of having violated the provision of Subsection 459.015(i)(p), (u) and (y), F.S. and imposing the following penalties: Suspension of license for 90 days and until such time as he appears before the Board of Osteopathic Medical Examiners and establishes that he has taken and passed the examination conducted by the National Board of Examiners for Osteopathic Physicians and Surgeons or the Special Purpose Examination (SPEX) of the Federation of State Medical Boards, as designated by the Board of Osteopathic Medical Examiners in its final order; Upon reinstatement that his license be placed on probation for two years subject to such terms and conditions deemed appropriate by the Board, including, but not limited to, restriction of practice, direct or indirect supervision of practice or prescribing of controlled substances and required additional continuing education; That he be permanently restricted from prescribing controlled substances to family members, unless under direct supervision of another osteopathic physician; That a reprimand be imposed; That a fine of $2,000. be imposed. DONE AND RECOMMENDED this 23rd day of February, 1990, in Tallahassee, Leon County, Florida. MARY CLARK 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 23rd day of February, 1990. APPENDIX TO THE RECOMMENDED ORDER IN CASE NO. 88-5277 The following constitute specific rulings on the findings of fact proposed by the parties. Petitioner's Proposed Findings Rejected as unnecessary. Adopted in paragraph 1. 3.-5. Adopted in paragraph 5. Adopted in paragraphs 6, 8 and 10. Some blood pressure monitoring is found in the records however. Adopted in paragraph 6. Adopted as a conclusion of law and in paragraph 6. Adopted in paragraph 12. Adopted in paragraph 15. Adopted in paragraph 16. Rejected as contrary to the weight of evidence. Adopted in substance in paragraph 19. Respondent's Proposed Findings Rejected as unnecessary. Adopted in paragraph l. Adopted in part in paragraphs 7-10, otherwise rejected as unnecessary. 4.-6. Rejected as contrary to the weight of evidence. 7.&8. Adopted in paragraphs 15, 17 and 18. 9. Rejected as immaterial. COPIES FURNISHED: Bruce D. Lamb, Esquire Dept. of Professional Regulation 730 S. Sterling Street Tampa, FL 33609 Sam Murrell, Jr., Esquire P.O. Box 1749 Orlando, FL 32802 Kenneth D. Easley, General Counsel Dept. of Professional Regulation 1940 N. Monroe St., Suite 60 Tallahassee, FL 32399-0792 Rod Presnell Executive Director Osteopathic Medical Examiners Dept. of Professional Regulation 1940 N. Monroe St., Suite 60 Tallahassee, FL 32399-0792
Findings Of Fact Background Manasota applied for a Certificate of Need to construct a 100-bed osteopathic acute care hospital in Sarasota County, (District VIII). Manasota did not specifically designate a site in its application and indeed has not obtained a site for its proposed hospital as yet. It intends to locate its facility in the southern part of Sarasota County, near the interchange of I- 75 and Jacaranda Boulevard. There are three existing acute care hospitals serving south Sarasota County. Memorial, which is a 788-bed acute care hospital located in the southerly portion of the City of Sarasota; Venice, which is a 312-bed acute care hospital located in Venice; and Englewood Community Hospital (ECH) which is a brand new 100-bed acute care hospital located in Englewood, also in southern Sarasota County, immediately south of the City of Venice. ECH opened its facility in early November, 1985. The proposed location of the Applicant Manasota is in the vicinity of the southerly environs of Venice, and is within the primary service areas of these existing hospitals. The Parties Venice Hospital is a not-for-profit, general, acute care hospital. It has 312 licensed beds, of which 6 are OB beds and 32 are intensive care beds. In fiscal year 1983, it enjoyed an 89.5% average annual occupancy. That occupancy declined to 83.5% in 1984 and the next fiscal year (1985) it dropped to 71%. The hospital's occupancy rate in fiscal year 1986 will decline to approximately 55.8%. That figure includes consideration of the impact of the November, 1985 opening of the Englewood Hospital but not the projected impact of Manasota. Venice's primary service area is the southerly portion of Sarasota County and northern Charlotte County, generally co-extensive with that proposed by Manasota. Memorial is a 788-bed, publicly owned, acute care hospital. Its primary service area is Sarasota County. Its publicly elected board requires it to maintain at least a 2% operating margin (profit) in order to maintain sufficient working capital and a sufficiently favorable bond rating so that its debt financing can be obtained at optimum cost. In 1984, Memorial obtained a 6.5% operating margin, but in 1985, that margin declined to approximately 2%, due to reduced utilization. Due to declines in utilization, only 590 of its licensed beds were in service in October, 1985. Memorial's total patient days for 1985 were the lowest it has experienced since 1973. Memorial is a full-service acute care hospital, offering services including obstetrics, psychiatric services, pediatrics, emergency care, cardiac catheterization and open heart surgery, neo-natal intensive care and ambulatory surgery. ECH is a 100-bed, full-service, acute care hospital located in Englewood, immediately south of Venice, in Sarasota County. It will open in November, 1985, and thus has not yet had an opportunity to obtain patients, adequate utilization, and a favorable operating experience. Its primary service area is southern Sarasota County and northern Charlotte County, substantially the same as that of Venice and that proposed by the Applicant. ECH has osteopathic physicians on its staff and provides manipulative therapy to patients of osteopathic physicians, as do the other two existing hospitals. The chief of ECH's medical staff is an osteopath. Manasota seeks approval for construction of a 100-bed osteopathic teaching hospital in southern Sarasota County in the immediate environs of Venice. The hospital would provide medical surgical services, ICU/CCU, a 24-hour physician staffed emergency room, outpatient surgery, a pharmacy, clinical laboratory, x-ray and other surgical and diagnostic services such as radiography, cardio-pulmonary and ultra-sonography. Manasota projects opening the facility in 1988 with 92 medical surgical beds and 8 intensive care beds. The hospital would be owned by Manasota, but will be operated and managed as a subsidiary of AmeriHealth, Inc., a Florida corporation. Ninety-two per cent of Manasota's stock has been purchased by AmeriHealth Systems, Inc., which is a wholly owned subsidiary of AmeriHealth Holdings, Inc., which in turn is a wholly-owned subsidiary of AmeriHealth, Inc. AmeriHealth Inc. is a publicly-held, Florida corporation. Manasota proposes to treat patients in accordance with the principles of osteopathy, supported by osteopathic specialists. Manasota will have an open medical staff, meaning it will have allopathic and osteopathic physicians on its staff. It maintains that management and control of the facility will be by osteopaths or those "sympathetic" to the osteopathic school of medicine. Although two of the four present members of Manasota's Board of Directors are osteopathic physicians, the chief executive officer of AmeriHealth, Inc., Mr. White established that in the near future that parent entity will nominate a new board of directors. Manasota proposes to affiliate with the Southeastern College of Osteopathic Medicine in Miami as an osteopathic teaching hospital and seek accreditation by the American Osteopathic Association. The facility would be located adjacent to or east of I-75 in southern Sarasota County, a minimum distance of five miles from existing hospitals. The primary service area would be southern Sarasota County (Census Tracts 20- 27). The secondary service area would include northern Sarasota County and northern Charlotte County, as well as the remainder of HRS District VIII, purportedly within a 30-60 minute driving time. In this connection, however, it is noted that osteopathic acute care hospitals have been held to be regional in nature and Manasota's health planning witness, Mr. Konrad, established that a two-hour driving time access standard is appropriate for osteopathic hospitals. District VIII is not, by rule, divided into subdistricts for health planning and CON review purposes. See, South Dade Osteopathic Medical Center v. Department of Health and Rehabilitative Services, DOAH Case No. 84-0750, Final Order at 7 FALR 5681 (November 14, 1985); Community Hospital of Collier, Inc. v. Department of Health and Rehabilitative Services, et al. and Naples Community Hospital v. Department of Health and Rehabilitative Services, et al., DOAH Case Nos. 84- 0744, 84-0907 and 84-0909 (consolidated), (Recommended Order August 16, 1985), p. 39. Although there are no operating osteopathic acute care hospitals in District VIII at the time of hearing, Gulf Coast Hospital has been approved by Final Order for a CON for 60 osteopathic beds and will be located approximately 68 miles and less than two hours driving time from the proposed location of the Manasota facility. Demoqraphics of the Proposed Service Area Sarasota County ranks second in the state in the percentage of its population which is 65 years of age or older. Projections show that by 1990 approximately 31% of its population will be 65 years of age or older, and 14% of the population will be 75 years of age or older. It will, at that time, rank first in the state as to the percentage of its population in excess of 74 years of age. Between 1980 and 1985, Sarasota County, which comprises most of the applicant's primary service area, increased in population approximately 40,000 persons. The county is expected to grow by an additional 43,000 persons between 1985 and 1990. Southern Sarasota County (above census tracts), between 1980 and 1985, grew by approximately 28,000 persons. Between 1985 and 1990, the southern portion of the county, will increase by an additional 33,000 persons, for growth rates of 33% and 32% respectively. Between 1980 and 1985, the population of southern Sarasota County in the 65 to 74 age group grew by about 5,000 persons, as did the population of the 75 and older age group. Between 1985 and 1990 it is projected that Sarasota County residents between the ages of 65 and 74 will increase by 5,700 persons and those in the county age 75 and older will increase by approximately 6,000 persons. Northern Charlotte County, adjacent to the southern Sarasota County primary service area of the applicant, increased by approximately 16,000 persons between 1980 and 1985. This same area is projected to increase by an additional 17,000 persons between 1985 and 1990. Approximately 7,000 of those additional persons will be 65 years of age or older. Much of the population growth in Sarasota County is due to in-migration from other areas. Approximately 43% of the immigrants to Sarasota County come from the midwestern area of the United States. This is somewhat significant because the greatest percentage of osteopathic medical schools and osteopathic physicians and acute care facilities are located in what is generally described as the midwestern United States. It may be expected that elderly immigrants from those areas might have somewhat more of a predisposition to use osteopathic acute care facilities and physicians in Sarasota County. It has not been proven, however, what percentage of the population growth of Sarasota County is attributable to in-migration from all areas of the state and nation. It has thus been demonstrated that the primary service area of the applicant has experienced significant population growth since 1980, but that that population growth will continue at the same or a lesser rate between 1985 and the horizon year of 1990. Indeed, it was established that the population growth rate of elderly persons age 65 and older, who tend to use acute care hospital services more intensively than other age cohorts of the population, will actually decline between the years 1985 and 1990. It has also been proven that between 1980 and 1985 (especially since 1983), the utilization rate for Sarasota County hospitals and District VIII hospitals as a whole, has declined markedly and will continue to do so through 1990, in spite of and counter to the population growth. This is a result of such factors as the advent of "DRG" methods of medic re reimbursement, professional review organizations and consequent shifts in the provision of many health care services to an "outpatient" basis. These changes in the Medicare reimbursement system, of course, are directly related to the segment of the population aged 65 and older, which provide the majority of all acute care hospital admissions from the general population. Because the population growth rate will decline for the age 65 and older age group, the trend of declining occupancy and utilization in the face of population growth will continue through l990 The Need for the Facilities Section 381.494(6)(c)(1), Florida Statutes. HRS has not adopted, by rule, a bed need methodology for determining need for osteopathic acute care hospitals. The normal bed need determination methodology embodied in Rule 10- 5.11(23), Florida Administrative Code, is not used for determination of bed need and need for osteopathic facilities because Section 381.494(2), Florida Statutes, requires that need for osteopathic facilities be determined separately from general acute care facilities. South Dade Osteopathic, supra at 5684. Thus, osteopathic bed need must be determined by development of agency policy in light of the general statutory criteria contained in Section 381.494(2), Florida Statutes, and Subsection (6) of that provision. HRS policy has been to consider whether the proposed facility will be osteopathic; whether a demonstrated need exists for additional osteopathic acute care beds; and whether similar services or facilities exist and are available in the area where the proposed facility is to be located. The court in Gulf Coast Hospital, Inc. v. Department of Health and Rehabilitative Services, 424 So.2d 86, 90 (Fla. 1st DCA 1982) defined "osteopathic facilities" as those maintained for the purpose of: . the cure and treatment of patients in accordance with the principles of osteopathy, the teaching and the study of osteopathic medicine, and the association in practice of doctors of osteopathy, including osteopathic specialists, with support from staff personnel suitably trained in the principles and philosophy of osteopathy. The management and control of the facility so as to actively further all of the above activities rather than to merely tolerate them, must be in the hands of osteopaths or those sympathetic to that school of medicine. Manasota has proposed in its application to construct and operate a 100-bed osteopathic acute care facility with patients being treated in accordance with the principles of osteopathy in a facility meeting the above definition. The preponderant evidence reveals however, that Manasota is not truly an "osteopathic" applicant. AmeriHealth's president, Mr. White, established that AmeriHealth would soon be appointing its own board of directors for Manasota, with no assurance given that osteopathic membership would be retained. None of the officers, directors or shareholders of AmeriHealth have any experience in ownership or operation of osteopathic facilities. Mr. White established that the proposed hospital would have an open staff, but it was not shown what percentage of the staff would be osteopaths and what percentage would be M.D.'s. Mr. White intends to staff the hospital from the existing medical community in Sarasota County. There would be no recruitment of physicians from outside that area unless it became impossible to staff the hospital with Sarasota County doctors. Mr. White would seek advice from "the medical community here" in establishing needed specialties and credentials. AmeriHealth intends to assure the viability of the proposed hospital by following the practice it employed at its Richmond Hospital of obtaining physicians in the community as investors in the hospital. It was not shown, however, what percentage of the investor-physicians the Applicant seeks would be D.O.'s and what percentage would be M.D.'s. In this connection, Dr. Fred Miller, M.D., testifying for Manasota, established that the promoters of the project intend that the staff physicians would be existing physicians in the Venice area. There are six or seven D.O.'s in the Venice area, and approximately 120 M.D.'s. In this regard, Dr. Norman Ross attended a meeting at Dr. Miller's office concerning organization of Manasota. All the doctors at the meeting were M.D.'s, except for the two D.O.'s who had an ownership interest in Manasota. Mr. White assured the physicians attending the meeting that the source of physicians for the new hospital would be physicians who had already developed practices in the Venice area who could "swing their admissions" to the new hospital. Dr. Ross was also assured that the vast majority of the staff physicians would be M.D.'s. Dr. Navarro attended this or a similar meeting and, was assured by a promoter and owner of Manasota that there would not be a heavy influx of osteopaths to town because they intended to get investor-physicians in the community to staff and support the hospital. When Dr. Navarro questioned Dr. Oliva, D.O., one of the directors of Manasota, concerning how he would build an osteopathic hospital without osteopaths, Dr. Oliva explained that "the rules did not require them to have a majority of osteopaths." The intent to staff the hospital largely with M.D.'s is borne out by the fact that the promoters of the hospital offered limited partnerships in the facility to Venice area M.D.'s first. Since Manasota's own witness, Dr. Snyder, D.O., showed that it would take 50 to 75 physicians to staff such a hospital, and since Manasota's principals see no need to recruit physicians from other areas, and have primarily sought support from M.D.'s who make up 95% of the physician population in the county, it is quite unlikely that the project would actually operate as an osteopathic hospital. In this regard, the four Sarasota osteopaths testifying for existing hospitals would definitely not use the proposed facility and feel it is not needed. The preponderant evidence thus establishes that the vast majority of staff physicians will be M.D.'s. The proposed facility has been promoted primarily to M.D.'s and the majority of Sarasota County D.O.'s testifying will not use the facility. Thus, Manasota has not demonstrated it is controlled or in the hands of osteopaths or those sympathetic to that school of medicine. It has not shown it can meet the definition of an osteopathic facility even as described by some of its own medical experts. Dr. Oliva, Dr. Lewis, Dr. Kudelko and Dr. David Lowery, (D.O.'s) opined that the majority of the medical staff and department heads would have to be osteopaths for it to truly be an osteopathic facility. This will clearly not be the case at Manasota. Manasota proposes to be accredited by the American Osteopathic Association (AOA), but also proposes to be accredited by the association which accredits allopathic facilities. The AOA accreditation manual requires osteopathic hospitals to identify themselves as such on buildings and letterheads, unless they are of mixed staff. Manasota proposes a mixed M.D. and D.O. staff. Likewise, nothing in the AOA accreditation requirements mandates any particular composition of the governing board or the medical staff. The Applicant has thus not proven that it will meet any record definition of an "osteopathic" hospital, nor that it will operate as such. Assuming arguendo that it would be osteopathic, the question of whether a demonstrated need exists for additional osteopathic acute care beds and an osteopathic acute care facility and the question of whether similar services or facilities exist and are available in the area of the proposed facility must be addressed. In this connection, although there are no osteopathic facilities currently operating in District VIII, Gulf Coast Osteopathic Hospital has had its Certificate of Need approved by final order of HRS for 60 beds with its request for 120 beds being currently on appeal. It will be located in Lee County, some 68 miles from the approximate location of the applicant. Mr. Konrad, having established that osteopathic hospitals are regional in nature, and that a two-hour travel time more or less is appropriate as a standard for access to an osteopathic facility, the service areas of Gulf Coast and Manasota will overlap. It is therefore found that an osteopathic acute care facility is legally in existence and will be operationally available for osteopathic physicians and patients in District VIII and Sarasota County in the near future. Over-bedded, under-utilized acute care facilities are available represented by existing hospitals whose need for more patients is discussed elsewhere in this Recommended Order. It is undisputed amongst the parties that there is no difference between the way allopathic and osteopathic physicians and hospitals practice in terms of the health care services rendered their patients, except for the emphasis, in the osteopathic realm, of manipulation therapy for patients and the increased emphasis on a holistic view of patients by osteopathic physicians in terms of determining a proper treatment regimen. In any event, acute care patients can be fungibly treated in osteopathic or allopathic hospitals by either osteopathic or allopathic physicians. It is thus found that the services rendered by the existing allopathic facilities are like and similar services to those proposed by the applicant. There was no testimony establishing that patients wishing osteopathic care from osteopathic physicians are not receiving it. Indeed, Drs. Furci and Nestor, osteopathic physicians in Sarasota, and Dr. Chirillo, who practice in southern Sarasota County, established that doctors are currently able to treat their patients with adequate quality of care, in an osteopathic manner, in existing hospitals. Sarasota County has a significant population of 20 osteopathic physicians. Their patients desiring osteopathic acute care services are currently receiving them despite the lack of an operating osteopathic hospital. Indeed, many of those physicians could accept more patients in their practices. Some close their offices at noon due to lack of patients. The number of osteopathic physicians per 1,000 persons in the District VIII population, when compared to the state and national averages for osteopaths per 1,000 population, reveals that there is no shortage of osteopathic physicians in District VIII. A number of the osteopaths practicing in Sarasota County testified on behalf of Manasota. Doctors James and Donald Blem and Dr. Chirillo are osteopaths practicing in southern Sarasota County and northern Charlotte County. Dr. James Them supports the application in that he would prefer to practice in an osteopathic hospital with osteopathic specialists on staff with whom he could consult. He prefers the continuity of care available if he had a situation where he could refer his patients upon admission to an osteopathic specialist, rather than having to refer patients to allopathic specialists. He also supports the teaching aspect of the Manasota application. Dr. Chirillo supported the application of Manasota essentially because it would be a teaching hospital and he feels that there is a need to train osteopathic physicians, but acknowledged that no additional acute care beds are needed in Sarasota County and District VIII. Dr. Donald Them supported the hospital's application for similar reasons. None of the three doctors would transfer all their patient admissions to the Manasota Hospital, should it be built, however. Indeed, Dr. James Them did not feel some of his patients would want to go to the Manasota facility because of the travel distances involved. Drs. Them and Chirillo are on the staff of Venice Hospital, and have no difficulty in getting their patients admitted to that hospital. They have full privileges and can practice osteopathic medicine there, including manipulation therapy. They know of no patients in Sarasota County going without acute care services because there is not an osteopathic hospital in the county. The osteopathic physicians in the county have no trouble getting staff privileges at existing facilities and each is generally practicing as he chooses without restriction, other than specialization. Osteopaths will practice with allopathic physicians at Englewood Community Hospital. Three osteopaths are on its charter Medical staff. One of these was chosen as the president elect of the ECH medical staff. The osteopaths at that facility are being provided with any needed equipment. Drs. Furci, Bipman, Yonkers, and Nestor, osteopaths testifying for the existing hospitals, all feel that they can treat their patients in a proper osteopathic manner. All are on the staffs of Doctors or Memorial Hospitals in Sarasota. They believe osteopaths in the area have enough acute care beds for their patients and there are always empty beds. All found no need for any additional beds, osteopathic or allopathic. In the words of Dr. Mervin Lipman, D.O., of Sarasota, "we don't need any more hospital beds period. We are up to our ears in hospital beds today." In short, the low utilization of acute care hospitals in the district and the county, among other factors, reveals that there are available, accessible mixed staff hospitals to serve the needs of patients of allopathic or osteopathic doctors. Manasota's proposal is, in part, consistent with the 1985-87 state health plan. That plan states at Volume 2, Pages 22 and 23: in short, the dynamic nature of health care calls for a planning approach which attends to overall development patterns rather than viewing specific health problems in isolation. Three interrelated policy guides were adopted as part of the 1985-87 State Health Plan: A holistic concept of health is espoused which views man's well-being as a function of the complementary interaction of mind, body, and environment. The holistic concept of health places emphasis on promotion of well- being and prevention of illness. The resources available for organized health care activities are limited and must, therefore, be utilized to their greatest effect. Given a holistic concept of health and finite health resources, priority should be placed on increasing resources for effective health promotion and primary care while containing total health care costs. In that Manasota proposes to be an osteopathic teaching hospital and the osteopathic philosophy comports with the holistic concept of health espoused above, the Manasota proposal is consistent in part with the 1985-87 State Health Plan. Neither the state nor the District VIII Health Plans specifically address need for osteopathic beds and for osteopathic hospitals and services, but rather treat all acute care services, osteopathic or allopathic, together. The State Health Plan emphasizes the growing problem and societal expense caused by excess acute care beds in the state, and states that "the combined effect of ambulatory surgery, HMO's, DRG's and other innovations could reduce acute fewer acute care beds will be needed state-wide than existed in 1984. Mr. Konrad, Manasota's own expert health planning witness, conceded that that projection may be accurate and would apply equally to allopathic and osteopathic facilities. Goal no. 3 at page 83 of the state health plan states the policy that efficient utilization of acute care services should be promoted. Objective 3.1 of that goal expresses the intent that all non federal hospitals, considered together, should attain an average occupancy rate of at least 80 per cent by 1989. District VIII currently has a district-wide occupancy rate for the last six months of 1985 of only 63.9%. Thus, approval of an additional acute care hospital would not conform with objective 3.1 of the state health plan, and, given the declining occupancy and use rates, even if the Manasota application were not approved, District VIII will not be in compliance with this objective by 1989. Due to the continuing decrease in patient days, decrease in average length of stay and decrease in admissions projected to 1989, the occupancy rate for 1989 for District VIII is likely to be less than 69%. The Department of Health and Rehabilitative Services (HRS) has not adopted a rule setting forth an osteopathic acute care bed need methodology. The policy of HRS, in this case at least, is to use the so-called "Wellington Methodology" in determining osteopathic bed need. Ms. Dudek, the sole HRS witness, collected data for this methodology from a number of·a 33 sources. She used data concerning numbers of admissions by osteopathic physicians from July, 1984 through June, 1985, and the total number of patient days by osteopathic physicians from the local health councils in Broward, Dade, Duval, Volusia, Hillsborough, Orange and Pinellas Counties. Those counties were chosen because they contain osteopathic hospitals. Ms. Dudek considers such data important when reviewing applications for acute care osteopathic beds in areas like District VIII where no such facilities exist. The department ascertained the number of licensed osteopathic physicians residing in District VIII from the Department of Professional Regulation, and used the latest population projection issued by the Governor's Office. This data was used in three formulas, the results of which were then averaged to determine the department's position as to osteopathic acute care bed need for District VIII in the horizon year of 1990. HRS used these three formulas because, by Ms. Dudek's admission, it felt no single formula was best. The first of the formulas is population based. It multiplies the number of osteopathic admissions to hospitals per 1,000 population, multiplied times the projected 1990 population for District VIII. It then multiplies that number by the average length of stay per osteopathic admission and divides the result by 365 days, further dividing that result by 80 per cent utilization to project the total number of osteopathic beds supposedly needed in 1990. Shown mathematically, that formula is as follows: [8.6 x (907, 804/1,000) 6.9]/[365 x .80] = 184 beds. The second formula is termed "physician based" and multiplies the admission rate per osteopathic physician by the number of osteopathic physicians licensed in District VIII. It then multiplies that number by the average length of stay per admission and divides the result by 365 days, once again divided by 80% utilization, to project the number of osteopathic beds putatively needed in 1990. That formula is depicted mathematically as follows: [53.1 x 67 x 6.9]/[365 x .80] = 84 beds. The third formula, also physician based, multiplies the number of osteopathic physicians in District VIII times the number of patient days per osteopathic physician (taken from the counties from which data was collected, not District VIII), divides the resulting number by 365 days; and then multiplies that by 80% utilization to project the number of beds needed in 1990. That formula is depicted mathematically as follows: [67 x369.2]/[365 x .80] = 85 beds. The Department averaged the results of these three formulas to arrive at its position that there is a gross osteopathic acute care bed need for 1990 of 118 beds. It then subtracts the 60 beds already approved for Gulf Coast Hospital, by Final Order, for a net need of 58 osteopathic beds. Formulas 2 and 3 above are essentially identical in that they are composed of the same variables and produce the same effective result, absent rounding of numbers. It is thus apparent that it is not truly valid to include both formulas 2 and 3 in the averaging calculation since they contain the same information. They would improperly weight the result (and HRS' position) in favor of the physician-based data. This is especially true in light of the fact that HRS concedes itself that no single formula used is more accurate than the other. If the results of the population based formula number 1 is averaged with only one of the other methods, the result is a gross osteopathic bed need for District VIII of 134 beds for 1990. When the 60 beds already approved for Gulf Coast Hospital are subtracted from this total, a net osteopathic bed need for 1990 of 74 beds results. Ms. Dudek acknowledged that, in reaching the agency's position she espoused at hearing, she had not considered the other applicable statutory criteria, but merely employed her "need methodology" to determine bed need results. She acknowledged however, that her data itself showed that admissions- at osteopathic facilities in the counties she surveyed were declining. Further, in employing her formula she did not determine how many physicians were available and would actually use the facility in the Sarasota County service area, nor how many of their osteopathic patients would be admitted to existing hospitals as opposed to the Applicant' s. Her formula assumed that the osteopaths would send all their patients to an osteopathic facility in District VIII. Indeed, a number of the physicians who would seek to become staff numbers at Manasota also testified that they would not necessarily refer all their patient admissions to that facility. The D.O. specialists who expressed a desire to become staff members would admit few patients because they would not have primary care practices. The evidence establishes that osteopaths as close as the City of Sarasota would not seek to use this facility. It is thus illogical to assume that physicians further away in District VIII would attempt to use it. Ms. Dudek also apparently assumed that the data regarding admissions per osteopathic physician and per one-thousand population obtained from other areas of the state would automatically apply in the service area involved in this application. There was no proof that that would be the case. Further, her formulas take into account the optimal 80% occupancy rate which the record clearly reflects does not prevail in District VIII. The average occupancy for District VIII acute care facilities is substantially less than that and will decline through 1990. In short, there is no basis in fact to support some of the HRS assumptions with regard to its bed need methodology since some of those assumptions were not shown to apply to District VIII and since it did not include in its assumptions certain data regarding osteopathic admissions which was available for District VIII. Since its formula assumptions are thus flawed and since HRS did not evaluate the remaining statutory criteria, its conclusion that there should be approval of a 60-bed osteopathic hospital (or any other number of beds) is rejected. Testifying on behalf of Manasota, Mr. Thomas Konrad, an expert in health planning, opined that a need exists for the Manasota project. Mr. Konrad believes there is no acceptable mathematical need calculation for osteopathic beds, but feels it reasonable that the district, with two large population centers in Lee County and Sarasota Counties, could support two osteopathic hospitals. He based this on his general proposition that osteopathic acute care facilities should be placed in populous areas with high acute care utilization rates based upon the age characteristics of the population. Sarasota has a relatively large population base and will be the 14th most populous county in the state in 1990, with a large percentage of elderly persons who utilize acute care services at a higher rate than the general population. Mr. Konrad performed a "reality check" to test the efficacy of his position by calculating the osteopathic acute care bed to population ratios for the populous counties in which osteopathic hospitals are located, which have similar demographic characteristics to Sarasota County. His analysis showed that the state-wide osteopathic hospital bed to population ratio is .313 beds per 1,000 population. If the 100-bed Manasota facility were approved, the ratio for Sarasota County would be .351 beds per 1,000 population. Mr. Konrad acknowledged that he has never before employed the osteopathic bed to population test used in this case. The test contains a fallacy in that Mr. Konrad did not adjust the bed to population ratio by any occupancy standard, but rather his approach necessarily embodies the assumption that either the beds are needed in those counties he surveyed, merely because they are in existence or approved, or alternatively, he failed to consider the occupancy rates in those counties vis-a- vis the present or projected occupancy rates in Sarasota County and District VIII. It is apparent from his testimony that he did not take into account the recent occupancy rates and trends for osteopathic hospitals in the counties included in his analysis. In fact, the osteopathic hospitals in the surveyed counties experienced a collective occupancy rate of approximately 43 per cent, rather than the optimal 80%, in 1984, which represented a 10% decrease since 1982. Between 1983 and 1985 the patient days per osteopathic physician in those counties decreased by almost 28%. The test used by Mr. Konrad does not present a true picture of need for District VIII since it does not take into account whether the figures upon which it is based represent excess osteopathic bed capacity and does not take into account the utilization rates in those counties, much less the presently existing and projected utilization rate for Sarasota County and District VIII as that might relate to an appropriate bed to population rates. The utilization rate at Gulf Coast is unknown because it has not had an opportunity to get into operation and the utilization rate at the allopathic hospitals which are like, existing facilities and services, is substantially lower than 80% and declining. Manasota will admittedly compete for the same declining patient day pool with those existing allopathic facilities. Thus, Mr. Konrad's general opinion that the two populous centers of District VIII involved could support two minimum-sized osteopathic hospitals, as tested by his osteopathic bed to population ratio method of analysis, was not established to be a valid test for osteopathic acute care bed need for District VIII and Sarasota County. In light of this and in consideration of the other above findings, there has been shown to be no need for additional osteopathic (or other) acute care beds or facilities in Sarasota County or District VIII. Availability, Quality of Care, Efficiency, Appropriateness, Accessibility, Extent of Utilization and Adequacy of Like and Existing Health Care Facilities in the District There presently are no acute care osteopathic hospitals operating in District VIII nor do any have dedicated portions of their facilities devoted solely to the practice of osteopathic medicine, although each of the acute care hospitals involved have varying numbers of osteopaths on their staffs. Gulf Coast Hospital, however, will construct and operate its approved facility in the immediate future and thus, at least 60 osteopathic beds are approved and not yet utilized as available osteopathic services in the district. Gulf Coast Hospital has not had the opportunity to get into operation, attain its market share and a favorable utilization experience so as to become available as yet. Given that Gulf Coast will be constructed 68 miles from Manasota in Lee County, much closer than the two-hour regional travel time standard established above, it is obvious that an osteopathic acute care hospital will soon be available and accessible to District VIII patients. Osteopathic acute care services are presently available in District VIII, notwithstanding the fact that the Gulf Coast facility is not yet open. Sarasota County osteopathic physicians have staff privileges at area hospitals and by their own testimony, are able to treat their patients in a fully osteopathic manner at existing Sarasota County acute care facilities. Venice Hospital is supportive of the practice of osteopathic medicine. Dr. James Them, D.O., is on the staff at Venice with full privileges and has no difficulty in getting his patients admitted. He can practice osteopathic medicine there in an unimpeded way, including the use of manipulation tables provided by the hospital. He acknowledged that the patients in Sarasota County are not denied acute care services because of the lack of an osteopathic hospital. Drs. Donald Them, D.O., and Joseph Chirillo, D.O., of the Venice staff are of a similar opinion. The other area D.O.'s testifying are able to treat their patients in a proper osteopathic manner at existing facilities and they would not seek staff privileges at Manasota. Although several osteopaths testified that they desired the availability of osteopathic specialists in an osteopathic facility to render consultation and referral of their patients with attendant continuity of care more facile, and to avoid, in some instances, duplication of tests in the referral process with allopaths, they did not demonstrate that their patients suffer from any lack of adequate care in existing facilities. The advent of the Manasota facility would not necessarily alleviate this "physician inconvenience" purportedly caused by referring patients to allopathic specialists, inasmuch as Manasota will be a mixed staff hospital, such that many of the specialists on its staff are likely to be allopathic physicians anyway. All of the Sarasota County osteopathic physicians can handle additional patients and have had osteopathic patients adequately cared for in existing facilities, at which they have full privileges. Osteopathic physicians have no difficulty gaining staff privileges and admitting patients at existing facilities. Indeed, at the new Englewood facility, three osteopaths are on the staff and one was chosen by his peers as president-elect of the medical staff. Osteopaths at Englewood will be provided with any needed equipment. In short, with the advent of the 100-bed Englewood facility, the 60-120 bed Gulf Coast facility, together with the existing hospitals which have substantial unused capacity, osteopaths practicing in Sarasota, Charlotte County, and District VIII have enough beds between now and 1990 for their patients at facilities at which they may freely practice osteopathic medicine. These like and similar services are available because both allopathic and osteopathic physicians and hospitals draw from the same limited patient pool. There is no essential difference between the way allopathic and osteopathic primary care physicians, surgeons, and specialists practice in terms of the services rendered acute care hospital patients. The primary difference only lies in the use of manipulative therapy, with attendant manipulation tables which are used in the osteopathic setting. This service is already available at the existing hospitals. The difference in philosophy between osteopathic and allopathic practice is manifested more at the out-patient primary care level. At the primary treating physician level the patient is looked at holistically in the sense that, in addition to treating the illness or condition the patient is presented with, the osteopath seeks to ascertain and correct causes of the illness rooted in other systems of the body or the patient's environment or family circumstance. The allopathic physician tends to be oriented toward treating the specific problem by dealing with the involved bodily system only. There is, at any rate, very little difference in the way allopathic and osteopathic physicians practice at the acute care hospital level, in caring for their patients. Thus, all persons desiring osteopathic acute care services are able to receive them in District VIII, despite the lack of an additional osteopathic hospital. In view of the number of osteopaths per thousand population in District VIII, as compared to state and national averages in evidence, there is no shortage of osteopathic physicians in District VIII. Given the low utilization of existing acute care hospitals in the district and in Sarasota County, including Gulf Coast, which has not had the opportunity to fill any of its beds, there are like, existing, available, accessible, mixed staff hospitals in Sarasota County and in District VIII providing adequate acute care services, including osteopathic of the type proposed. The quality of existing hospitals in the district has not been placed at issue. No testimony or evidence concerning quality of care about Memorial or Doctors Hospitals has been adduced. The Englewood Hospital, as of the time of the hearing, had not yet opened. Dr. Raymond McDearmott, M.D., was presented to criticize quality of care at the Venice Hospital. Dr. McDearmott, however, did not have admitting privileges and was limited in his experience to working in the emergency room at Venice. He has been engaged in a dispute with Venice's administration concerning his operation of the emergency room, which may culminate in litigation. This adversarial attitude toward Venice, together with his failure to describe specific instances of inadequate care, entitles his testimony to scant consideration. There is no competent evidence to indicate that existing hospitals are not providing adequate quality care. Likewise, the efficiency of existing facilities was largely not addressed, with the exception of Venice Hospital. Manasota contended that Venice Hospital was not operating efficiently because of an alleged excessive amount of administrative expenses. That contention was predicated upon data submitted to the Hospital Cost Containment Board by Venice Hospital which was reported by the board and indicated that administrative expenses at Venice exceeded those of other hospitals in the cost containment board "reporting group" of which Venice is a member. It was established, however, that that information had either been filed with or reported by the Hospital Cost Containment Board in error, and that indeed, the error was corrected on the Board's own volition. The administrative expenses at Venice Hospital for the reporting period in question, were at approximately the mid-point for hospitals-in its reporting group. Thus, it has not been established that Venice or any of the other hospitals in Sarasota County or District VIII, are operating inefficiently, aside from their problems with under-utilization and unused capacity. It has also been proven that the existing hospitals are "like" facilities which are accessible. Indeed, 95% of the population of District VIII is within 20-miles or less of an existing acute care hospital. The Gulf Coast osteopathic facility will be well within the proven two hour accessibility standard for osteopathic hospitals, since it will be 68 miles from the proposed location of the Manasota facility. The existing hospitals are underutilized. There has been no showing that existing hospitals are inaccessible to residents of the county and the district. Concerning the issue of extent of utilization of like and existing facilities, witnesses Konrad, Beechey, Shanika, Zaretsky, Schwartz and Porter acknowledged the declining utilization of acute care hospitals in Sarasota County and District VIII, and the continuing nature of that decline. In District VIII, occupancy of acute care hospitals has decreased significantly from 1983 through 1985, such that the composite occupancy rate for the district was 67.2% in 1983, 60.9% in 1984 and 52.4% for 1985. The dramatic changes occurring in the health care industry since 1983 have caused the severe declines in inpatient utilization. The primary reason has been the change, beginning in 1983, to the Medicare prospective payment system as opposed to the former cost-based reimbursement system. The new system is otherwise known as the "DRG" system. Thus, Medicare reimbursement is now based on a Fla. rate reimbursement based upon the type of illness, diagnosis or treatment. The effect of this change has been to sharply decrease the average length of stay of Medicare patients in hospitals, as well as to decrease Medicare admissions. Medicare admissions are decreasing through increased emphasis on utilization review by professional review organizations mandated by the Medicare system. This results in more procedures, such as some surgery, being performed on an outpatient basis. Inpatient utilization concomitantly declines. These factors, coupled with the growth of home health services, and the imminent impact of preferred provider organizations (PPO's) and health maintenance organizations (HMO's) in Sarasota County and District VIII, have and will impact hospital occupancy rates significantly to an increasing degree. Mr. Conrad and Mr. Schwartz both showed that these factors which depress hospital utilization impact utilization of osteopathic and allopathic facilities in the same way. In fact, since osteopathic facilities have historically experienced higher average lengths of stay than allopathic facilities, the DRG method of prospective reimbursement has and will have a greater impact on osteopathic hospitals. Hospital utilization in District VIII is still declining. Even though the population is increasing significantly, hospital occupancy is decreasing. During 1980 the population of Sarasota County was 205,846 from which 292,500/ patient days were generated. In 1985 the projected population for Sarasota County was 242,875 and the projected number of patient days was down to 273,486. Thus, the population of the county increased by 37,000 during that five year period, yet the number of patient days decreased by approximately 19,000. Thus, the hospital use rate is decreasing more rapidly than the population is increasing, and it has not been shown that patient days will increase in relation to the population through the year 1990. The increasing influence of the above-mentioned alternatives to inpatient care will continue to cause a drop in the hospital use rate for Sarasota County in the future. Indeed, the 1985-87 state health plan, in evidence, predicts that the combined effect of outpatient surgery and other delivery systems will result in an additional 15 per cent decline in hospital admissions by 1989. The current decline in utilization rate in Sarasota County hospitals has not yet been affected by the advent of HMO's and PPO's, but those prepaid health insurance organizations are in the offing and will cause further declines in utilization. If present trends continue, as has been proven to be likely, and the Manasota Hospital application is approved with its proposed 100 beds, hospital occupancy in Sarasota County will decline to approximately 40% in 1990. Approval of the applicant's facility would result in occupancy rates as low as 35 to 38% for Venice, Englewood and Manasota Hospitals, since Manasota, with a large number of M.D.'s on its staff will draw its patients and patient days from the same pool as the existing hospitals and thus share an insufficient number of patients with them. In order for all hospitals in District VIII to operate at the optimum of 80% utilization, as many as 1,344 acute care beds would have to be eliminated from the existing licensed and approved beds. Even if no additional beds are approved, the most realistic projection of hospital utilization in District VIII for 1990 is 44.6%. The average occupancy for acute care beds in District VIII during 1983 averaged 67.2%. By 1985 the occupancy rate was down to 52.4%. Accordingly, in view of the significantly low district-wide and county occupancy and the continuing downward trend, the legislatively mandated goal of hospital cost containment underlying Section 381.494, Florida Statutes, will not be furthered by the approval of additional hospital facilities in District VIII and Sarasota County, including that proposed by Manasota. Manasota's Abilitv to Provide Qualitv CareSection 381.494(6)(C)(3), Florida Statutes Inasmuch as the Manasota facility has not been found needed for a variety of reasons enunciated herein, the issue of its ability to provide quality health care will not be addressed in depth. It is quite likely that Manasota, if it got into operation, overcoming the operational and legal impediments discussed herein, could provide quality health care. Its management team is made up of Mr. Gerald White and other former managers of Health Corporation of America, all of whom have substantial health care managerial expertise. The Availability of Alternative Sources of Care -Section 381.494(6) (c)4, Florida Statutes There are less costly, more efficient and appropriate alternatives to the proposed Manasota project for District VIII and Sarasota County. The existing acute care hospitals are like and existing facilities offering similar health care services which are severely under-utilized. The osteopaths testifying both for and against the Manasota application acknowledge that there are plenty of hospital beds to admit their patients in Sarasota County, and that they can be satisfactorily, osteopathically treated at existing hospitals. Those D.O.'s supporting the application of Manasota acknowledged that they will continue to send their patients to existing facilities as well. Thus the existing acute care hospitals (as well as the future Gulf Coast facility), are appropriate alternatives to the Manasota facility, and since they are greatly under-utilized, or in the case of ECH and Gulf Coast, not yet utilized, they need more patients and more revenue to become more efficient, enabling them to deliver health care services in a less costly manner the public. If Manasota's hospital were approved, utilization would decline still further, generating even more excess acute care capacity. Unused capacity has a significant fixed cost increment which will have to be borne by the health care consuming public. This is wholly aside from the capital expenditure in excess of fifteen million dollars needed to place the Manasota facility in operation. This would be an unnecessary cost for the consumers of District VIII to bear in view of the lack of need for it. Probable Economies in Service Derived from Joint or Shared Resources-Section 381.494(6)(c)5, Florida Statutes Manasota does not propose to operate joint, cooperative or shared health resources in conjunction with its proposed hospital. This criteria is not really at issue in this case and no party offered proof with regard thereto. Need in the District for Special Equipment and Services not Accessible in Adjoining Areas-Section 381.494(6)(c)6, Florida Statutes This criterion is not applicable in this proceeding. Manasota will not offer specialized equipment or services of a type not already available in Sarasota County or the district. The Need for Research and Educational Facilities Including Institutional and Community Training Programs for Practitioners and for Doctors of Osteopathy and Medicine at the Internship and Residency Training Level-Section 381.494(6)(c)7, Florida Statutes Manasota proposes an osteopathic teaching hospital. It called Dr. Arnold Melnick to testify regarding the need for additional osteopathic teaching hospitals in Florida. Dr. Melnick is the Dean of the Southeastern College of Osteopathic Medicine (SECOM) in North Miami Beach. He was accepted as an expert in the fields of medical education and osteopathic medicine. Dr. Melnick established that the emphasis in osteopathic medical education is to train general or family practitioners. This aspect of medical education and practice comports with the holistic philosophy of osteopathic medicine which emphasizes treatment of a patient by looking at the patient's entire physical and environmental circumstance, rather than being specific disease, condition or system oriented. Because of the emphasis on training for ability to diagnose and treat all aspects of a patient's medical circumstance, osteopaths tend to be in general practice and family practice rather than specializing such that approximately 87% of osteopaths are in general. Only 4% of the osteopathic profession are primary care specialists in the areas of pediatrics, obstetrics and internal medicine. Dr. Melnick established that because of the holistic philosophy, there is not a significant need for more osteopathic specialists. This is also the reason that internships for osteopaths are required to be one year "rotating" internships. Osteopathic interns in teaching hospitals must rotate for a month or more through each of a teaching hospital's medical departments, such as pediatrics, obstetrics, and the like so that their training will be designed to give them a broad knowledge of many areas of medical practice. Contrastingly, with allopathic internships, interns concentrate in the area of their chosen specialty with a view toward moving on toward a residency in that specialty. It is for this reason that osteopathic teaching hospitals must offer a sufficient number of different medical practice departments so that interns may be given broad training in all the medical practice fields they will be required to know to be competent general or family practitioners, in keeping with the osteopathic philosophy of medical practice. Thus, although osteopathic practice is characterized by a vast majority of family practitioners, specialists are required· to train osteopathic physicians. The AOA accreditation requirement dictates that certified osteopathic trainers must be present in the various departments. Dr. Melnick established that an osteopathic teaching hospital should not be smaller than l00 beds, must have at least three outstanding osteopathic internists, at least two osteopathic surgeons, an osteopathic pediatric specialist, as well as an obstetrics-gynecology specialist. Manasota presented testimony of osteopathic specialists consisting of a surgeon, a pathologist and an opthamologist from Suncoast Hospital in Largo, Florida who are willing to move to Sarasota County and become staff members if the hospital is built. Manasota, however, has not established that it will have the specialists required for an appropriate quality osteopathic teaching hospital. It did not show how it would obtain the required number of internal medicine specialists, surgeons, a pediatrician nor a specialist in obstetrics and gynecology. In fact, Manasota will not have an obstetrics department. Both Dr. Melnick and Mr. White established that a teaching hospital needs more FTE staff members than a non- teaching hospital. The proposed 3.4 FTE's will be less than necessary for a teaching hospital to adequately operate. There is currently a shortage of nurses and other technical staff employees in Sarasota County, as evidenced by the difficulty Venice has had hiring and retaining people in these positions due to the advent of the Englewood facility and its competing recruitment. There is a substantial likelihood that Manasota will have difficulty obtaining sufficient staff members to be a bona fide quality teaching hospital, especially since it proposes to hire osteopathically trained nurses and technicians. It did not establish where it intends to recruit them. In view of the fact that Manasota proposes to recruit its medical staff locally, it has failed to establish where it will obtain the required number of D.O. specialists as certified trainers for each of its departments. There are eight osteopathic teaching hospitals in Florida. The most recent graduating class from SECOM consisted of 40 osteopathic physicians. All of them were placed in suitable intern programs in and out of Florida. It was not shown that all of these 40 interns would have remained in Florida even had there been an additional osteopathic teaching hospital. The college will be graduating 100 osteopathic physicians per year by 1987. It was not established that all of the internships they will require must be at Florida hospitals. In this connection it was shown that a 100-bed osteopathic teaching hospital could accommodate eight interns, but only if that hospital was operating at 80% capacity. If the same hospital had only a 57% occupancy it could accommodate 5.7 interns. Thus by Manasota's own utilization projections it could accommodate only about five interns, even if it could obtain the required number of osteopathic specialists as trainers. Further, such interns typically receive stipends of from $18,000 to $20,000 per year. Although Manasota could obtain approximately $3,000 per year per intern from a grant program established by the legislature, it did not demonstrate in its financial evidence that it has provided for the necessity of $75,000 per year for intern salaries. In short, it has not been proven that Manasota genuinely can establish its facility as an osteopathic teaching hospital in accordance with Dean Melnick's own, requirements. Availabilitv of Resources, Manpower, Management Personnel and Funds for Operating and Capital Expenditures; Effects on Clinical Needs of Training in the District for Health Care Professionals; Accessibility to Schools in the District for Health Care Training; Alternative Uses of Resources for Other Health Services; Accessibility of the Facility to all Residents of the District; Section 381.494(6)(c)8, Florida Statutes In terms of manpower availability, the Applicant intends to have an open staff of M.D.'s and D.O.'s, purportedly recruited from the existing medical community in Sarasota County. Manasota will only seek to recruit physicians from outside that area if unable to staff the hospital from existing physicians with practices in Sarasota County who could "swing" their patients from existing hospitals to Manasota's facility, discussed above. The potential physician-investors, referenced above, were assured by Manasota's principals, that the vast majority of the 20 or 30 physicians needed to staff the facility would be M.D.'s from the Venice and Sarasota area. The doctors attending these promotional meetings were told there would not be a heavy influx of osteopathic physicians to Venice to staff the hospital. There are between 100 and ll0 M.D. physicians in the Venice area. There are 20 osteopathic physicians in Sarasota County. Three support the application and would seek privileges at Manasota, four of them would not and do not feel the hospital is needed. The remainder did not testify nor indicate any interest in staff privileges. The testimony of the osteopathic physicians from other areas (Dade City and Pinellas County), as well as Dr. Melnick, as found above, established that for a hospital to be osteopathic in philosophy and operation, at least 52% of its governing body should be osteopathic physicians, as well as the majority of its department heads and staff. Only four of these doctors expressed a desire to join Manasota's staff. There is therefore simply no competent, substantial evidence of record to establish that a majority of the staff physicians will be osteopathic physicians, nor that the majority of the department heads will be osteopaths. In fact, the evidence does not reflect clearly how many staff positions Manasota proposes to obtain to operate the hospital, nor that a sufficient number of M.D.'s and D.O.'s can be obtained locally in the face of the staff privileges offered at existing hospitals. If an influx of physicians will be required from outside areas to staff the hospital, while this might provide adequate physicians to staff the hospital, it would not serve to increase hospital utilization, they would bring no patients with them. In fact, with the utilization rate decreasing, the pool of patient days available to render the hospital and medical practices feasible is continuing to shrink and if more physicians are added to the Sarasota County market, health care costs can only rise as doctors and the hospitals must raise charges in order to render their practices financially feasible when there are not enough patients in relation to the number of doctors or beds available. Better alternative uses of the resources represented by the increased charges would involve not building such a facility in such a shrinking patient market, but rather allowing existing hospitals a chance to improve their utilization experience first with their already constructed and financed excess capacity. The 3.4 full time staff equivalents (FTE's) per occupied bed based upon witness Sucher's projections are insufficient to staff an acute care hospital such as this. Indeed, as shown by Mr. White, a teaching hospital may require up to 5.6 FTE's. A minimum of 3.8 FTE's per occupied beds would be needed to staff an acute care facility such as that proposed by Manasota as shown by Mr. Schwartz, and as a teaching hospital an even higher staff ratio would be necessary. If Manasota adjusted its FTE staff to meet only the minimum 3.8 FTE standard, its costs for staffing would be $450,000 more than that proposed in its pro forma expense statement. Indeed, if it actually proposes to be a teaching hospital, its staffing requirements and concomitant expense would increase on the order of one million dollars more than that proposed in its pro forma. In connection with this, the staff proposed to be needed in certain departments was understated. For instance, 16 to 18 employees would be needed to staff a laboratory in a 100-bed hospital and Manasota only allocated 8. Similarly, it only proposes to have 3 FTE's to staff its pharmacy. This is an insufficient number of employees to staff a pharmacy seven days a week, 24 hours a day as Manasota proposes to do. Finally, although Manasota proposes to have an osteopathically trained staff of nurses and other technicians, it did not demonstrate where it would be able to recruit such staff members trained in osteopathic principles of nursing and other disciplines. Thus the Applicant has not proven the availability of sufficient manpower and related resources to feasibly operate the project. The issue of availability of funds for capital and operating expenditures for accomplishment and operation of this project is treated with more specificity infra., however, it should be pointed out that Manasota has significantly understated land purchase, site development, working capital and other capital costs by more than two million dollars, and otherwise understated the magnitude of resources the project will require. Although the facility will be readily accessible to the population of south Sarasota County, in view of the above findings there is no accessibility difficulty for acute care patients, both allopathic and osteopathic, at the present time, in the county and District VIII, especially with the advent of the Gulf Coast Osteopathic Hospital and the recently opened Englewood facility. The considerations in the above statutory criteria regarding health care training and education needs are dealt with to the extent they are relevant in this proceeding in the findings concerning Manasota's proposed posture as an osteopathic teaching hospital. Financial Feasibility Mr. Randy Sucher and Dr. Elton Scott, testified as financial experts on behalf of Manasota. Mr. Sucher testified that the projected utilization of a proposed facility is the "cornerstone" of a financial feasibility study, and financial forecast. Mr. Sucher conceded that the financial feasibility study done in this case was much less detailed and thorough than had been done in his experience when he was employed by an accounting firm to perform feasibility studies for hospital clients, especially in the area of evaluating patient demand. Mr. Sucher largely relied on the demand and utilization study performed by Dr. Scott. The frailty in the study lies in the method employed by Dr. Scott to study demand and project utilization, which lacks specificity. He determined his position regarding patient demand for Manasota's project largely by attending meetings and interviewing physicians, most of whom are M.D.'s in Sarasota County. He then projected utilization by determining the admission rate per 1,000 population in south Sarasota County which is Manasota's primary service area. He arrived at a figure of 102 admissions per 1,000 population, determined by merely considering the admissions to Venice Hospital as reported in the 1983 hospital cost containment board data. He applied that admission figure to the population figures for south Sarasota County for 1985. He performed no patient origin studies for Venice Hospital, so it was not established whether all of those admissions originated from the same south Sarasota County origin area represented by his population figure. The results of his interviews with physicians do not indicate hat all the patients admitted by those physicians to Venice Hospital, came from the south Sarasota County service area proposed for Manasota. There is thus no way to determine from this record if the patient admission figures relied upon by Dr. Scott correlate with the actual admissions to Venice and from the relevant primary service area population. Thus, even though Dr. Scott's data showed 102 admissions for Venice per 1,OO0 population, when only looking at the census tract population areas for south Sarasota County, it was not established that those admissions were not drawn from a much larger population base representing more of Sarasota County and possibly north Charlotte County. If so, that would result in a much lower admissions per 1,000 population figure for Venice Hospital, as that relates to the number of patient admissions Manasota could expect to capture from Venice. Dr. Scott's utilization assumptions were not verified by any patient origin studies for Venice Hospital, which might show, for instance, that significant numbers of its admissions come from areas from which Memorial and Englewood will draw patients. Thus, the 22 per cent share of Venice's admissions that Scott opines Manasota will attract, have not been verified by a showing that those patients are from origin areas or physicians more likely to be attracted to Manasota as opposed to Venice, Englewood or Memorial, if Manasota is built. In this connection, no in-depth physician analysis study or market analysis study was done by Dr. Scott or Mr. Sucher. Instead, they relied upon general discussions at interviews with three local osteopathic physicians and 12 to 15 M.D.'s as well as three or four out-of-district D.O.'s and, according to Mr. Sucher,: "from that, we just kind-of got a composite feeling that we could generate 'x'." Dr. Scott and Mr. Sucher also relied in part upon a 1983 informal survey conducted by a Manasota shareholder of an indefinite number of Sarasota County physicians. Some of these, including the four Sarasota D.O.'s discussed above, now have privileges at other Sarasota area hospitals and will not admit patients to Manasota. The three D.O.'s who support the application will not refer all their patients to Manasota and the osteopathic physicians from the St. Petersburg area, who indicated a desire to join Manasota's staff, are not all "admitting physicians," some of them being specialists who only engage in hospital practice and would provide no patient admissions. As found above, Manasota did not prove that it could adequately staff the hospital with M.D.'s and D.O. s. If it obtains doctors from other areas, they will not have a local patient base from which the hospital can gain the admissions necessary to achieve a feasible revenue posture. Neither Dr. Scott or Mr. Sucher took into account the market share that Englewood would obtain, including its share of admissions from Venice Hospital. Englewood is a new, 100-bed acute care facility located in Sarasota County, closely proximate to the Manasota proposed location and to Venice's location. A significant portion of its staff physicians are located in Venice. The primary service areas of all three hospitals substantially overlap. It is not reasonable to conclude that Manasota will not compete with Englewood for patients, as well as with Venice. Thus, Dr. Scott and Mr. Sucher's estimate that 22% of its admissions could be obtained from the patient pool enjoyed by Venice at the present time, is over-stated as that relates to Manasota's projected patient utilization and revenue. All three hospitals will compete for the same pool of patients, as will Memorial. Englewood is likely to claim a substantial number of the patient admissions originating in this area, and thus it is unrealistic to ignore the market share that Englewood is likely to obtain. Manasota is not likely to realize the admissions it projects obtaining from the Venice area and thus its utilization will be significantly lower than projected, as will its revenues. Patient days will continue to drop through 1990 because the use rate is dropping more rapidly than the population is increasing. Manasota will thus have to obtain most of its patient days from the admissions enjoyed by existing hospitals, which already have low and declining utilization. It has simply not been established that Manasota will be able to capture sufficient patient days from them to ensure its financial feasibility. Assuming arguendo, that its utilization projections are accurate, the revenue and expense projections based thereon are inaccurate and not supportive of finanical feasibility. "Contractual adjustments" represent the differences between what the hospital charges and what is actually reimbursed by Medicare and other reimbursement schemes. The contractual adjustment represents a deduction from gross revenue. A significant issue was raised by all parties through their financial experts, concerning the portion of the contractual adjustment related to capital cost pass-through. Mr. Beachey, and other witnesses for existing hospitals, opined that capital cost pass-through, whereby a hospital is reimbursed for its cost of capital through the DRG reimbursement system, will be eliminated entirely phased out in steps such that the increment of DRG reimbursement represented by capital cost pass-through should be eliminated from Nanasota's revenue figures. Mr. Beachy feels the ultimate federal regulations enacted will call for a phased reduction in capital cost pass-through. All experts, both for the Applicant and the protestants, agreed that the capital cost pass-through is very likely to be reduced or eliminated in future years. The dispute amongst the experts concerned whether new facilities, either CON approved, under construction, or opening in the year the regulation becomes effective, will have their capital cost pass-through reimbursement entirely eliminated. Because all the opinions are based upon conjecture and speculation regarding what the Congress will do in this regard, they are rejected. The Applicant's pro forma statement of revenues (in evidence) is predicated, in part, upon the assumption that DRG Medicare reimbursement will increase five per cent a year through fiscal year 1989-1990. This assumption is rejected in favor of Mr. Beachey's expert testimony. Mr. Beachey established that the Medicare reimbursement increase for 1986 will only be one-half of one per cent, and that for 1987 one house of congress has agreed to a one half per cent increase in the reimbursement rate, and the other to a one per cent increase. While the ultimate 1987 rate is speculative, Mr. Beachey established that for that and future years it is not likely to be on the order or magnitude of 5%. Mr. Beachey, in an abundance of caution (favorable to the Applicant), opined that at best there might be a 3% annual increase in Medicare reimbursement after 1986, rather than the 5% postulated by the Applicant (even though the 1986 increase is only one-half per cent. His opinion is clothed with substantial probability of reliability and is accepted. The Applicant projects a 5% deduction to revenue for bad debts. Mr. Beachey established that this is more likely to be 8%. That was indeed the figure used by the Applicant in its own application, also in evidence. Mr. Sucher's pro forma statement also projected Manasota providing 3% Medicaid, while the application itself, in evidence, indicates Manasota will obtain 5% of its revenue based upon reimbursement for Medicaid care. These resulting contractual adjustments, which are deductions from revenue, coupled with the necessary adjustment for the increased increment for bad debt, which was established, reveal that, because of these adjustments alone, the Applicant will experience a loss of $414,000 for its first year of operation, and a $1,012,000 loss for the second year. These loss figures do not reflect Mr. Beachey's opinion that an increased number of FTE's are necessary over the 3.4 FTE's projected by Mr. Sucher, which would reduce revenue by $512,000, nor his opinion that declines in "capital cost pass-through" would reduce revenue by $700,000 the first year and $430,000 the second year. This latter opinion was rejected for the reasons mentioned above, and his opinion regarding the additional FTE staff required is rejected because of Mr. Beachey's lack of expertise regarding adequate staffing patterns and levels. The Applicant failed to account for indigency tax assessments of $155,000 and $188,000 for 1988-1990. That assessment is designed to enhance reimbursement for indigent care for hospitals in the state. Although Mr. Sucher and Dr. Scott opined that the amount of the assessment would be reimbursed, an accounting "wash," the preponderant, expert testimony reveals that there is no direct reimbursement payment related to the amount paid into that fund. In any event, the amounts of such possible reimbursements are not proven. Additionally, the Applicant did not account in its expenses for real estate taxes which will amount to $155,000 per year. These expense increases and concomitant revenue deductions are reflected in the above found loss figures. The Applicant will have to increase its charges by a substantial amount to offset these net losses. The revenues would have to be increased on the order of 36% the first-year of operation and 35.9% the second year. It is important to remember that only 26% of the Applicant's patient mix would be private paying or insurance reimbursed patients, who could absorb these increased charges. Concerning staff salaries and benefit expense, the Applicant proposes 3.4 FTE's per occupied bed. A number of the expert witnesses, both for the protestant hospitals and the Applicant, established that that is an insufficient level of staffing for a 100-bed hospital. Mr. Sucher acknowledged that he had no personal experience in determining staffing patterns and staffing a hospital, although in his capacity as an expert in hospital finance, he had dealt with the financial implications of staffing. Mr. Sucher admitted that his 3.4 FTE figure was a rough estimate, which primarily included only nursing and administrative staff, and did not take into account laboratory staff and other technical positions. Mr. White himself finds that teaching hospitals, require a range of from 3.7 to 5.6 FTE's per occupied bed. Mr. Schwartz established that the non-teaching hospitals in the area have a minimum of 3.8 FTE's per occupied bed which is the minimum accepted for a facility such as Manasota's. Indeed, the testimony of Dr. Melnick and Mr. White shows that a higher staffing rate would be needed since Manasota proposes to be an osteopathic teaching hospital. Thus, the appropriate staff ratio (and concomitant salary and benefit expense) for Manasota would have to be substantially higher than 3.8 FTE's per occupied bed. If the FTE ratio were, however, raised to the minimum level of 3.8 FTE's, the expense figure for salaries and benefits would increase by $450,000. Given Mr. White's, Mr. Schwartz's and Dr. Melnick's testimony that a higher level of staffing is needed at a teaching facility, this expense figure might be much higher. If, for example, a modest increase in staffing to account for Manasota's obligations as a teaching hospital operation necessitated a raise in the FTE ratio to only 4.2 FTE's per occupied bed, the total additional expense over that attributable to the projected 3.4 FTE's would be on the order of $900,000. Even that figure would be on the lower end of the range normal for teaching hospitals. These additional staffing expense adjustments would increase the above loss figures by a minimum of $450,000 and likely much more. In addition to the above understated expense items, the Applicant failed to account for payment of federal income tax. The Applicant also failed to provide for payment of insurance which Mr. Sucher acknowledged would cost between $400,000 and $600,000 per year. Payments for utility expense were also not accounted for and Mr. Sucher acknowledged those would cost approximately S300,000 per year. Payments for sales taxes and contract services such as laundry service, which will be a substantial expense, were not accounted for, nor were principal payments on the approximate 14 million dollar debt. The Applicant did not allow for marketing expenses, even though Mr. Sucher and Mr. White acknowledged that an aggressive marketing strategy would be used to obtain a feasible level of admissions. Mr. Sucher testified that a great deal of these expenses generally fell under the heading "supply and other" in the pro- forma statement but, in consideration of these and many other non-itemized expenses such as kitchen or food service, supply purchases, and drug purchases which were not depicted in the pro- forma statement as to amount, it was not established that the general category for supply and other expenses was sufficient to cover all of these expenditures. Capital Costs The Applicant has additionally understated some of the capital costs involved in the project. Foremost among these, as Mr. Sucher admitted, the proposed $15,587,000 capital cost attributable to the project did not include a required 1.5 million dollars in working capital. Manasota also included only $500,000 for land acquisition. One of the sites under consideration however, would cost approximately $1,250,000. Manasota's own witness regarding real estate values established that the required 7 to 10 acre site in south Sarasota County, would cost on the order of a million dollars, exclusive of real estate commissions, legal fees, and other preliminary site costs. Although Manasota has proposed to be an osteopathic hospital, no provision was made in its proposed equipment costs for manipulative therapy tables. Ms. Usher, Manasota's equipment expert, opined that such a table would cost from $150 to $8,000. Indeed, Dr. Snyder, D.O., established that equipping a department of manipulative therapy could cost as much as $100,000. The equipment list does not provide for other items of equipment normally present in operating an acute care hospital, such as an incinerator or two-way radio communication equipment. Some items, such as televisions and a computer system, are optional to some extent, and the record does not reflect whether some items such as a telephone system might be included in the overall capital costs for the facility, even though not listed on the equipment list. It is noteworthy, however, that Manasota has not provided for any expenditure for kitchen or dining room equipment, which could cost as much as $250,000 to $350,000. This unprovided for equipment is essential for functioning as an acute care hospital. The inclusion of these items would boost the capital costs of the project to approximately $17,837,000, without considering the cost of the osteopathic manipulation tables and unknown construction contingencies, dependent on site selection, such as acceleration and deceleration traffic lanes, extension of utility lines and service, and, potentially, a package sewage treatment plant. The contingency fund of $400,000 described by Mr. Henry, was not shown to be adequate to cover these costs. Short-Term Financial Feasibility Manasota retained Morgan, Schiff and Company, Inc. as its financial adviser and broker for this project approximately three months prior to hearing. Mr. Thaddeus Jaroszewicz represented that corporation in testifying regarding financiability of the project. Neither Mr. Jaroszewicz nor Morgan Schiff have participated in the financing of a health care facility prior. Mr. Jaroszewicz stated that it was necessary to have an understanding of the health care industry in which a client operates in order to evaluate the reasonableness of cash flow projections provided to him by the client. Although Mr. Jaroszewicz has some understanding of the economics of the health care industry, due to his lack of experience with health care clients, his expertise is somewhat limited. Given his experience in the financial markets, Mr. Jaroszewicz is confident he can raise the 90% debt financing, probably through banking institutions. However, he based his opinion on the financial projections provided him by Manasota, which for reasons expressed in the other findings herein, have been shown to be inaccurate in projecting financial feasibility. The capital costs, for reasons found herein, are understated as well, such that the true capital costs of the project will approach 18 million dollars, instead of $15,587,000 which Mr. Jaroszewicz assumed. All of these factors, coupled with the fact that AmeriHealth, Inc., through its purchase of Richmond Metropolitan Hospital, the pending purchase of Antauga Medical Center and Smith Hospitals in Alabama from HCA, the Savannahs Hospital Project in Indian River County, Florida, together with its pending half-million dollar lease of a facility in Lockhart, Texas, has committed all its resources and indeed is heavily "leveraged" in seeking to accomplish these purchases. AmeriHealth owes in excess of 11.3 million dollars on the 14 million dollar Richmond Hospital purchase. Regarding the HCA Alabama facilities purchase, AmeriHealth will assume 5 to 6 million dollars in HCA debt and incur new debt totaling 8 million dollars. Additionally, it will give 2.3 million dollars in subordinated notes back to HCA for the remainder of the financing. Upon completion of an expansion project at the Antauga Hospital there will be an additional 8 million dollars in debt assumed by AmeriHealth. The Savannahs Hospital Project in Indian River County will involve an additional 9.5 million dollars in debt. That financing has not closed. AmeriHealth is additionally involved in purchasing Ambulatory Surgical Centers which will cost $450,000 to $750,000 each. AmeriHealth's net worth is approximately 4.7 million dollars. As of September 11, 1985, the HCA acquisitions had not closed because AmeriHealth was unable to secure acceptable financing. Citibank, the proposed lender, was requiring strict liquidity requirements and capital expenditure requirements on AmeriHealth before it would finance the project. AmeriHealth found these requirements unworkable so that it was unable to close the HCA transaction and had to ask for extensions of time on the closing date. AmeriHealth has not yet been able to obtain acceptable financing for that purchase. AmeriHealth is thus a fledgling company which has leveraged all its assets. It will likely have substantial difficulty obtaining financing for the Manasota project. In view of the fact that Mr. Jaroszewicz had not had the benefit of doing his own analysis of the Applicant's proposed financial projections, and in view of the other evidence that has shown that revenues have been overstated and expenses and capital costs understated, it must be concluded that if a lender was aware of this negative cash posture, obtaining of satisfactory financing would be quite doubtful. In this regard it is understood that if a CON were actually granted financing might be arranged. It must be proven that the financial projections are indeed accurate and that indeed, the project will be financially feasible on a short and long term basis for that to happen, however. Such has simply not been proven to be the case. Special Needs of Health Maintenance Organizations (HMO's)-Section 381.494(6)(c)10, Florida Statutes This provision is not at issue in this proceeding. There is no evidence regarding special needs of HMO's. Needs and Circumstances of Entities Which Provide a Substantial Portion of Services to Individuals Not in the District or Adjacent Districts-Section 381.494(6)(c)11, Florida Statutes If Manasota were approved and could feasibly operate as a teaching hospital, it would be available to provide internship and residency programs to students from SECOM and other medical schools. Additionally, Manasota would be available to provide osteopathic health care services to individuals in adjacent districts. However, the preponderant evidence of record does not reveal that osteopathic health care services in adjacent districts are not already being met, especially given the under utilization of osteopathic hospitals in Pinellas and Hillsborough Counties, approximately an hour's drive to the north. Probable Impact of Project on Cost of Providing Health Services, Effects of Competition on Innovations in Financing and Delivery of Health Services which Foster Competition Section 381.494(6)(c)12, Florida Statutes. That portion of this criterion concerning innovations in financing and delivery of health services which foster competition, etc., is not truly at issue. There was no evidence to indicate that any innovations in financing and delivery of health services are proposed other than that Manasota proposes to be an osteopathic teaching hospital, and proposes to charge 10% lower rates. As found above, the Gulf Coast Osteopathic Hospital will be substantially less than two hour's travel time from Manasota's site, and thus Manasota will not truly be an innovative health service in the district. Even if Manasota were approved, it is highly unlikely, in view of the above findings, that it can deliver its health services more cost-effectively. The probable impact of the project on cost of health services and the effects of resultant competition on the supply of health services, must be addressed. In this regard, Memorial is a full-service, acute care hospital, competing for the pool of patients in the primary service areas of Venice, Englewood and the proposed Manasota facility. Memorial is licensed for 788 beds, but as of October, 1985, only 590 beds were in service and staffed, due to a steady decline in utilization. Memorial's total patient days for 1985 were the lowest it has experienced since 1973, 15% less than its peak year of 1982. Memorial would experience substantial adverse financial impact if the Manasota project were approved. Memorial, in 1984, obtained 1,458 patients from the south Sarasota County area, including the cities of Osprey, Venice, Nokomis and Northport, in the primary service area proposed by Manasota and also served by Venice and Englewood. If the Manasota Hospital is approved, Memorial will lose approximately half of those patients. This would result in a reduction of gross revenues of approximately $3,579,000 and a concomitant reduction in its net operating revenue margin of $1,382,000. A reduction of this magnitude would reduce Memorialt's overall operating margin to 1.2%. A 2% operating margin, which Memorial will experience for 1985, is the absolute minimum safe level at which a hospital can operate in a financially viable manner. With a 1.2% operating margin, Memorial will be unable to maintain necessary working capital, nor maintain favorable bond financing ratings with bond rating agencies. If its bond rating worsens, its cost of bonded indebtedness will correspondingly rise. In order for Memorial to maintain its 2% operating margin, it would have to increase prices by at least 2.6%. The only other alternative would be to raise its tax levy as a public hospital board by approximately 28%. Either eventuality would result in a significant increase in health care costs to the Sarasota County community. Venice Hospital has 312 licensed beds. Its average annual occupancy was 71% in 1985, but will decline to 55.8% for the 1986 fiscal year. The declining utilization will be caused by the continuing effects of the DRG reimbursement system, and the other factors enumerated above. The average length of stay and projected utilization at Venice will continue to decline at least until 1990. The 55.8% occupancy rate projected for 1986 includes only the impact on Venice's utilization of the opening of the ECH, not Manasota. Even so, its projected operating revenue for 1986 will be only $589,150. The patients that Manasota will obtain will come from the same pool of patients served by Venice and the declining utilization rate, even in the face of increasing population, reveals that there are not enough patients for Venice to operate cost-effectively, especially if Manasota is opened. The loss of patients to Manasota will cause a loss of gross revenues for Venice of $10,287,200, strictly from inpatient revenues, not taking into account outpatient losses. Venice has already laid off personnel and will have to continue to do so to compensate for revenue losses from the downturn in its utilization. Venice will have to close additional nursing units and beds and further reduce staff on account of the competitive effects of the ECH opening. Even after reducing a reasonable percentage of such variable costs, Venice will suffer a net operating revenue loss of approximately $4,020,119 if Manasota is opened. If this eventuality occurs, Venice will be forced to face either bankruptcy or likely closing of entire wings and drastic reductions of present services. This would diminish access to health care services in the area, and quite likely result in declination of quality care. Dr. Scott acknowledged that Manasota would take a significant number of patients from Venice, but minimized its effect by opining that Venice could make up for the loss by operating more efficiently, believing that its recent bond refinancing resulted in unnecessary additional financing costs to Venice, that Venice had an excessive amount of administrative expenses. The above findings reflect, however, that the bond refinancing did not result in any significant increase in debt cost to Venice, and yielded several million dollars more capital funds for Venice. Dr. Scott's figures for Venice's purportedly high administrative costs was shown by Mr. Shanika to be in error. Thus, if Manasota Hospital meets its own projections, which are over-stated, it will draw approximately 2,415 patients from Venice, causing it to operate at a loss, and destroying the feasibility of its programs and endangering its quality of care. Since Venice is already operating as a relatively efficient hospital, it cannot make up those losses by becoming more efficient. Venice's operating revenue would fall to the break even point if it only lost 309 patients. If Manasota drew anywhere near 2,415 patients from Venice, charges would have to be increased on the order of 40% to compensate for the loss. Englewood is a fledgling 100-bed acute care facility scheduled to open in November, 1985, and has thus not yet had an opportunity to obtain adequate utilization of its beds and services and to secure a positive operating ratio. Dr. Scott recognized the potential impact on Englewood of the Manasota opening, particularly with respect to physicians located in the Englewood area who might swing all or part of their admissions to Manasota. If any of Englewood's staff physicians, such as Dr. Chirillo, who testified in support of Manasota, swung all or part of their patient bases to Manasota, it would have a substantial deleterious effect on the patient days and revenue for Englewood. This would result in a diminution of service at Englewood or in some cases a discontinuance of certain services. Under present projections, Englewood will not realize profit for approximately 5 years, but if the Manasota facility is built, that time will be significantly extended. Manasota will have a significant adverse impact on Englewood's utilization and financial viability by taking patients away from it before it has an opportunity to reach a profitable operating situation. Englewood has already experienced problems in hiring sufficient qualified staff members. It has experienced counter offers to prospective staff members made by other hospitals, such that in order to obtain qualified staff, Englewood has had to raise the salaries it offers. If Manasota opened, the additional competition for staff members would likely cause salaries for staff to be bid upwards still further, as well as causing technically trained staff members to become even scarcer. This situation could cause significant cost increases to all facilities involved and to the health care consuming public. Manasota seeks to staff its facility largely with physicians in Sarasota County who could swing their admissions to the new hospital. There is only one pool of patients and patient days for the four contending facilities to divide amongst them, however. Osteopathic patients come from the same patient pool as those treated by M.D.'s, in that all are acute care patients. Since there is no unserved need for more acute care beds in Sarasota County, or District VIII, inpatient utilization of the three existing facilites will necessarily decrease by the advent of Manasota. Manasota also projects 1,200 outpatient surgeries its first year. These patients must come from Venice, Englewood or Memorial. These facilities depend on outpatient surgeries as an important source of revenue and profit which is used to offset areas of service which do not operate as favorably. The loss of these patients to Manasota by the existing facilities, which are already competing for a shrinking patient market in terms of declining patient days and utilization, will inevitably lead to higher patient charges and to shrinking availability of services. The cost to the community will be significant. Under- utilized facilities are more costly to the community. As utilization declines due to the above-found causes, future patients will be forced to absorb the cost of excess beds. The more patients who utilize a service which represents a capital expenditure, the lower the unit cost will be to the health care consumer. The construction of unneeded facilities, representing excess capacity, results in capital expenses borne by the public increasing at a greater rate than the numbers of patients or patient days from which off-setting revenues must come. The patients and the community will then have to bear a higher unit cost for health care services represented by this excess capacity. While Manasota contended, as partial justification for its facility, that there are a number of hospitals-in the state with occupancy rates in the low forty percentile range, which still generate significant profits, this point ignores the high cost the health consuming public must pay for 50 to 60% unused capacity at such hospitals. Hospitals can only reduce their variable costs attributable to unused bed capacity and typically, 40% of the costs of unused capacity are fixed costs which are not covered by any revenue and which cannot be reduced by staff and service reductions. Such fixed costs must be passed on to the public through higher rates and through the government reimbursement systems. Indeed, as established by Dr. Zaretsky, the cost of 100 excess beds to the Sarasota County community would amount to $3,674,349 in aggregate added annual costs, expressed in 1983 dollars. Even without the advent of the Manasota facility, there are already considerably more than 100 excess beds in Sarasota County. If the capital cost "pass through" scheme is eliminated in whole or in part, the hospitals would have to absorb or pass on to consumers more costs through inFla.ed rates and possible increases in Medicare and Medicaid reimbursement. To the extent that existing facilities are unable to raise charges sufficiently, they will have to absorb the differences, incur losses or cut back on services and quality of care. If a hospital is approved for an area that is not currently a monopoly, with existing hospitals already competing for patients, especially if the hospitals are operating below capacity, than the added competition is destructive. It dilutes the patient volume each hospital depends upon for adequate revenue coverage of costs. This results in inefficiency in the health care system since hospitals have fewer patients to spread the fixed costs among. Thus it has been established that approval of Manasota as an additional competitor in this market will result in significant added health care costs to the community. Cost and Methods of Construction, Etc.-Section 381.494(6)(c)13, Florida Statutes Aside from the capital cost understatements reflected in the above findings, the construction costs, methods of construction and provisions for energy conservation dictated by the south Florida environment where the hospital will be built, have been shown by the Applicant to be reasonable and appropriate. Because of the indefinite site location in the south Sarasota County area, however, the funds set aside in the pro forma of $35,000 for site preparation costs, and the $400,000 contingency fund related to construction, have not been established to be adequate to cover all site preparation work and such potential offsite construction costs as additional traffic lanes, signals and utility service extensions. Available, Less Costly, More Efficient Alternatives Section 381.494(6)(d)(1), Florida Statutes. There are available less costly, more efficient alternatives to the acute care inpatient services proposed by the Applicant. The existing inpatient facilities, including Gulf Coast Osteopathic Hospital, can or will provide, inpatient services similar to those proposed. The existing facilities are providing them in an appropriate, efficient manner to the extent they are able, given their under-utilization. Existing Facilities Are Being Used in an Appropriate, Efficient Manner-Section 381.494(6)(d)2, Florida Statutes It has not been established that existing inpatient facilities are being used in an efficient manner, in terms of adequate use of their present capacity. Rather, the record reflects that existing hospitals are under-utilized with the added health care costs and inefficiencies that entails, which Manasota would aggravate. Alternatives to New Construction such as Modernization and Sharing-Section 381.494(6)(d)3, Florida Statutes The Applicant has not established that alternatives to the proposed construction have been considered and implemented to the maximum extent possible. The existing facilities are viable alternatives to the proposed new construction, in that they have substantial amounts of unused capacity and can provide additional acute care services as needed without expansion. Many of the osteopathic physicians testifying acknowledged that their patients can be treated in an appropriate, efficient manner in existing facilities. Patients Will Experience Serious Problems Obtaining Inpatient osteopathic Care in the Absence of the Proposed Facility-Section 381.494 (6)(d)4, Florida Statutes. The Applicant has not established that patients will experience serious problems in obtaining inpatient care of the type proposed in the absence of Manasota. Osteopathic acute care services are available in District VIII, notwithstanding the absence of another identifiable osteopathic facility, for the reasons delineated above.
Recommendation Accordingly, having considered the foregoing Findings of Fact, Conclusions of Law, the competent, substantial evidence of record, the candor and demeanor ot the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED: That the application of Manasota Osteopathic General Hospital, Inc. for a Certificate of Need authorizing establishment and operation of a 100-bed osteopathic teaching hospital in HRS District VIII and Sarasota County, Florida be DENIED. DONE and ENTERED this 26th day of June, 1986 in Tallahassee, Florida. P. MICHAEL RUFF, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 26th day of June, 1986. COPIES FURNISHED: John D. C. Newton, II, Esquire CARSON & LINN, P.A. 253 East Virginia Street Tallahassee, Florida 32301 William E. Williams, Esquire FULLER & JOHNSON, P.A. Post Office Box 1739 Tallahassee, Florida 32302 Robert A. Weiss, Esquire 118 North Gadsden Street Suite 101 Tallahassee, Florida 32301 Ken Davis, Esquire DAVIS, JUDKINS & SIMPSON Post Office Box 10368 Tallahassee, Florida 32302 E. G. Boone, Esquire Robert Klingbeil, Esquire Post Office Box 1596 Venice, Florida 34284 W. David Watkins, Esquire OERTEL & HOFFMAN, P.A. Post Office Box 6507 Tallahassee, Florida 32314-6507 Theodore C. Eastmore, Esquire WILLIAMS, PARKER, HARRISON, DIETZ & GETZEN Post Office Box 3258 Sarasota, Florida 33578 Harden King, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= STATE OF FLORIDA DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES VENICE HOSPITAL, INC., Petitioner, vs. CASE NO. 85-0045 DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, and MANASOTA OSTEOPATHIC GENERAL HOSPITAL, INC., Respondents. / HCA OF FLORIDA, INC., d/b/a DOCTORS-HOSPITAL OF SARASOTA, Petitioner, vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, CASE NO. 85-0047 Respondent, and MANASOTA OSTEOPATHIC GENERAL HOSPITAL, INC. AND ENGLEWOOD COMMUNITY HOSPITAL, Intervenors. / DOCTORS' OSTEOPATHIC MEDICAL CENTER, INC. d/b/a GULF COAST HOSPITAL, INC., Petitioner, vs. CASE NO. 85-0050 DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, Respondent. / SARASOTA COUNTY PUBLIC HOSPITAL BOARD d/b/a, MEMORIAL HOSPITAL, SARASOTA, Petitioner, vs. CASE NO. 85-0051 DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES and MANASOTA OSTEOPATHIC GENERAL HOSPITAL, Respondent. /
Findings Of Fact Carl Sylvester Roberts, Jr. is an osteopathic physician registered with the Florida State Board of Osteopathic Medical Examiners and holds license number 0001470. Roberts first treated J. C. Duncan on March 31, 1975. Thereafter Duncan visited Roberts for treatment periodically. In the latter part of 1976 Roberts advised Duncan that he was strapped for cash and Duncan suggested he could make some extra money by prescribing drugs which Duncan could sell and split the profit. Duncan proposed to provide Roberts with patients who had a bona fide need for drugs, have them visit Roberts for examination and thereafter Roberts could legitimately prescribe drugs for them. This agreement resulted in Duncan producing at least 4 patients in early December, 1976 whom Roberts examined. The modus operandi for these patients was for Duncan to bring the patients to Roberts' office where they were examined and, after finding medical evidence of a valid need for pain killers, Roberts would prescribe Dilaudid for these patients. Duncan then accompanied these patients to a pharmacy where the prescriptions were filled. Thereafter the patients gave the pills to Duncan who paid them $250 each. Duncan normally took the pills to Tampa where they were given to a contact who peddled same and reimbursed Duncan $1200 for 100 Dilaudid tablets. Duncan thereafter reimbursed Roberts at the rate of $7 per tablet. Prior to taking the patients to Roberts, Duncan explained the procedure to be followed and, in effect offered these patients a physical examination plus $250 for their participation. The charts for the four patients presented into evidence as Exhibits 2, 7, 9 and 11 showed they paid $30 for this visit (except Parker who was charged $20). Other patients were normally charged $10, $12 or $14 for a first visit. Narcotics agents in Ocala received street information that Roberts was illegally dispensing drugs and approximately one year before this hearing, started an investigation. In December, 1976 the Ocala police arrested Roberts but apparently had insufficient evidence to prosecute. However, while Roberts was accompanying the police back to his office to pick up some tapes, he told them that he had been prescribing drugs for J. C. Duncan to sell to repay a gambling debt he owed Duncan. Duncan was subpoenaed by the State Attorney for a deposition and given immunity from prosecution for his testimony and assistance in obtaining evidence against Roberts. Duncan advised the police of the plan that he and Roberts had been using. On January 27, 1977 Duncan was wired for sound by having a small transmitter placed under his clothes and sent by the police to Roberts' office while police monitored the conversation on the street below. When Duncan left Roberts' office the narcotics investigators met him outside and received from Duncan Exhibits 1, 3, and 4. Exhibit 1 is the prescription made out to Mabel Butler for 50 Dilaudid tablets with the patient's name scratched out. Exhibits 3 and 4 were prescriptions made out to J. C. Duncan for 35 Dexedrene capsules and 50 Dilaudid tablets respectively. Duncan was overweight and the Dexedrene was prescribed to help him lose weight. He has a long history of pains stemming from back problems for which the Dilaudid was prescribed. However, Duncan testified that he could get relief from a handfull of Aspirin, Bufferin or Excedrin as well as from Dilaudid. With respect to the prescription on Exhibit 1, when the name of Mabel Butler was scratched out, the prescription became void and unfillable at any pharmacy. On the night of February 1, 1977 Roberts visited Duncan at the latter's home and gave him 120 Dilaudid tablets to sell. These tablets were turned over to the narcotics investigator the following morning and a laboratory examination of these tablets (Exhibit 19) showed them to be a derivative of Morphine, viz. Dilaudid. On February 2, 1977 Duncan was again wired for sound and given $450 in marked bills and sent to Roberts office. The conversation between Roberts and Duncan was taped and the tape of that conversation was received into evidence as Exhibit 17. A transcript of that tape was offered as Exhibit 18. Having listened to the tape while following the transcript I find that the transcript is reasonably close to being an exact transcription of the conversation recorded on Exhibit 17. While in Roberts' office Duncan discussed with Roberts payment for the pills received the previous evening as well as those received on previous prescriptions for which he, Roberts, had not been paid. During this visit Roberts prepared prescriptions for Dilaudid in the names of the 4 patients previously brought in by Duncan, namely John Stewart, 16 tablets (Exhibit 6), Eddie Parker, 30 tablets (Exhibit 8), Marcia Marshall, 50 tablets, (Exhibit 10) and Robert Pennington 50 tablets (Exhibit 12). The latter two prescriptions were dated February 3, 1977. The charts for these patients all indicated the patients were seen by Roberts on the dates shown on the prescriptions, that is, on February 2 and February 3. During this visit Duncan advised Roberts that he, Duncan, owed Roberts additional money but had only $450 to give him at the time. Just as Duncan completed counting out the $450 on Roberts' desk the narcotics investigator knocked on the door, was let in, arrested Roberts and took the money and the prescriptions that had been prepared. In addition, other papers on Roberts' desk were taken. One, Exhibit 14, shows what appears to be a column of numbers of the tablets prescribed that evening with an abbreviation of the patient's name along side the number. Thus 16 St, 30 Pa, 50 Pe, and Marcia 50 correspond to the number of Dilaudid tablets on Exhibits 6, 8, 10 and 12 prescribed for Stewart, Parker, Pennington and Marcia Marshall for a total of 146. Testifying in his own behalf Respondent denied any wrong doing or that he had ever had any Dilaudid pills in his possession. He accounted for the $450 on his desk by claiming it to be the result of a $120 investment (or loan he made to Duncan) to participate in a lumber operation proposed by Duncan. When read quotes from his taped conversation with Duncan Roberts testified he had no recollection of the conversation. On the other hand, during his taped conversation with Duncan on February 2, 1977 Roberts acknowledged receipt of the tablets he had given Duncan from a "woman" who delivered them to his residence. Roberts' explanation of the prescriptions and chart entries dated February 3, 1977 which were seized February 2, 1977 was that he had prepared these prescriptions for the following day to save time. His explanation for the chart entry was that the patients must have called in and described their symptoms. Neither explanation is credible. His explanation for the February 2 prescriptions was that these patients had also called in, however, the police witness contacted three of the four and each advised he had not communicated with Roberts on February 2. Duncan's testimony that none of the pills prescribed for him by Roberts was ever sold by Duncan was unrebutted. Exhibit 20, a certified copy of the Judgment of Circuit Court dated June 27, 1977 recorded in Minutes Book 61, Page 33, shows that Carl Sylvester Roberts, Jr. pleaded nolo contendere to Count I pursuant to plea bargaining, was adjudicated guilty by the court of sale of a derivative of opium and was placed on probation for two years. Counts II and III were nolle prossed.
The Issue Respondent is charged, pursuant to Count I with a violation of Section 459.015(1)(h) in that he allegedly failed to perform any statutory or legal obligation placed upon a licensed physician by his alleged violation of Section 459.0154 Florida Statutes, which statute sets forth requirements of physicians who treat with the substance dimethyl sulfoxide ("D.M.S.O."), pursuant to Count II, with a violation of Section 459.015(1)(o) in that he allegedly exercised influence on a patient in such a manner as to exploit the patient for financial gain, pursuant to Count III, with a violation of Section 459.015(1)(t) in that he allegedly committed gross or repeated malpractice or failed to practice medicine with that level of care; skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances, pursuant to Count IV, with a violation of Section 459.015(1)(u) in that he allegedly performed a procedure or prescribed a therapy which, by the prevailing standards of medical practice in the community would constitute experimentation on human subjects; pursuant to Count V, with a violation of Section 459.015(1)(n), in that he allegedly failed to keep written medical records justifying the course of treatment of a patient, including but not limited to patient histories, examination results and test results; and pursuant to Count VI, with a violation of Section 459.015(1)(1); in that he allegedly made deceptive untrue or fraudulent representations in the practice of osteopathic medicine or employed a trick or scheme in the practice of osteopathic medicine when such trick or scheme fails to conform to the generally prevailing standards of treatment. Counts VII and VIII, were severed, to remain pending in the instant action until such time as Petitioner should file a voluntary dismissal thereof or a notice that same were ready for hearing. Petitioner had every opportunity to resolve this state of the pleadings and did not do so. PROCEDURAL AND EVIDENTIARY MATTERS At formal hearing, Respondent and Gregory D. Seeley, Esquire, were examined pursuant to Rules 22I-6.05 and 28-5.1055 F.A.C. and Gregory D. Seeley, an Ohio attorney, was determined to be a qualified representative of Respondent for purposes of this cause only. Respondent thereafter attempted to file a formal written answer, which request was denied pursuant to Rules 22I- 6.04 (5) and 25- 5.203 F.A.C. Petitioner presented the live testimony of Frank R. Laine, Lloyd D. Gladding, D.O., Jeffrey Erlich, M.D., William Pawley, Respondent Wilfred Mittlestadt, D.O., Mark Montgomery, Ph.D., and the deposition testimony of Wilbur Blechman, M.D. Petitioner offered 12 exhibits, all of which were admitted in evidence. Deposition of Dr. Blechman is Petitioner's Exhibit 4 and Petitioner's Requests for Admission with extensive Answers thereto are Petitioner's Composite Exhibit 1, within the twelve. A request of Petitioner for judicial notice was denied. Respondent testified on his own behalf. Respondent also was permitted to late-file the depositions of Garry Gordon, M.D., and Stanley Jacobs, M.D. Inasmuch as the transcripts of those depositions were timely filed, they are admitted in evidence as Respondent's Exhibits 4 and 5 respectively. Respondent offered 3 exhibits in evidence; all were excluded. Exhibits not admitted or at least proffered were not retained as part of the record. A number of requests for judicial notice by Respondent were also denied. In the course of formal hearing, Respondent also made several motions for mistrial and/or recusal of the undersigned due to admission in evidence of what Respondent characterized as "prejudicial material." None of these motions was meritorious and all were denied, but a discussion of these rulings is also incorporated within this recommended order. By agreement at hearing and without subsequent objection, copies of those matters actually judicially noticed by the undersigned were attached by the parties to their respective post-hearing proposals. The parties' pre-hearing stipulation (H.O. Exhibit 2 as interlineated) also included stipulations as to many facts and has been extensively utilized in preparation of this recommended order. At the close of Petitioner's case in chief Respondent moved to dismiss the pending charges as unproved. This motion was taken under advisement for resolution within this recommended order. The motion was renewed within Respondent's post-hearing proposals with written argument. The Motion to Dismiss within Respondent's post-hearing proposals also renews all previous motions to dismiss, incorporating by reference what may be read as previous arguments concerning procedural and pleading irregularities as to Counts VII and These issues are also disposed of within this recommended order. Transcript of formal hearing was provided by Petitioner, who filed its proposed findings of fact and conclusions of law beyond the 10 day limitation. Respondent's proposed findings of fact and conclusions of law were timely filed. The late-filing of Petitioner's proposals without objection by Respondent are deemed a waiver of the 30 days for entry of this recommended order pursuant to Rule 22I-6.31 F.A.C., but all proposals have been considered and Petitioner's proposed findings of fact and Respondent's proposed findings of fact are ruled on in the appendix hereto.
Findings Of Fact At all times material, Respondent was licensed as an osteopathic physician in the State of Florida having been issued license number 05 0001510. He has practiced approximately 40 years. On April 4, 1983 Frank R. Laine went to Bio-Equilibrium Testing located in Ft. Lauderdale, Florida. Laine complained of pain in his hands, feet, knees, and shoulders. On five different visits, Laine saw a Diane La Berge. At all times material hereto, Diane La Berge was not licensed to practice either medicine or osteopathic medicine in the State of Florida but held herself out as a homeopathic physician and Director of Bio-Equilibrium Testing. She conducted a series of "tests" and made "evaluations" regarding Laine's condition. Among the tests performed was a metal analysis based on a cutting of Laine's hair sent to Biochemical Concepts, a testing laboratory. Based on her evaluation of the results of the hair analysis for metal La Berge diagnosed Laine as suffering from "heavy or acute copper poisoning". As treatment therefore La Berge recommended chelation therapy, acupuncture, and numerous "supplements", presumably vitamins. Laine understood, based on his conversations with La Berge, that chelation therapy would "cure" his condition. Laine attempted, on a couple of occasions, to obtain chelation therapy from a physician recommended by La Berge; however, there was never anyone at that physician's office. Therefore, Laine went to Respondent's office after being referred by Dr. Harvey Frank, Laine's personal chiropractor. There is absolutely no proof of any connection or relationship of any kind between La Berge or Bio-Equilibrium Testing and Respondent. About two months prior to his seeking out Bio- Equilibrium, Laine, a boat captain, had sanded the hull of a boat coated with a copper-based paint. He performed this type of work approximately once a year, always outdoors with adequate ventilation. Laine informed Respondent that he had been scraping the hull of a copper boat and brought a copy of the hair analysis to their initial office consultation on May 16, 1983. Laine initially presented himself to Respondent seeking chelation therapy on May 16, 1983. He complained of constant pain in his hands, feet, knees, and shoulders. Respondent obtained a medical history based in part on responses to a Cornell Medical Index Health Questionnaire (CMI), a health questionnaire on Respondent's stationery, and another history form, which contained a description of symptoms, family history, and personal history. Some of these responses were filled in, not by Laine, but by his wife. Respondent also got a brief verbal history from Laine but did no extensive one-on-one questioning of Laine or verification of prior physicians and diagnoses listed by Laine and/or his wife. He did no questioning concerning all of the responses or even significant relevant responses. The significant relevant responses include a "yes" response to the question: "Are you crippled with severe rheumatism (arthritis)?" Laine's symptoms were consistent with a diagnosis of rheumatoid arthritis but Respondent only recorded "inflamed joints onset following scraping copper bottom of boat." There is no recorded physical examination of Laine by Respondent at this initial office visit or at any time thereafter. On May 16, 1983, Respondent diagnosed Laine as having "Copper poisoning as told by hair analysis," wrote this in his records, and administered intravenous chelation with 5cc. dimethyl sulfoxide (D.M.S.O.), intramuscular injections of zinc; and an intravenous injection of Phillpott's formula and sulfur cyl. Apparently, an oral dose of zinc was also prescribed. Respondent also obtained a urine specimen for analysis by tests which would be helpful in determining kidney function. Although there is clear evidence that Laine specifically requested chelation therapy of Respondent, there is no evidence that he ever requested administration of D.M.S.O. or any other substance specifically. Chelation therapy in general involves the use of certain chemicals called chelation agents to bind, immobilize, and in some instances to increase the excretion of a target molecule, in most cases heavy metals, so that the free amount in the blood is decreased more rapidly than the body would do absent the chelation therapy. Vitamin C and D.M.S.O. are not generally recognized as effective chelation agents. Both Vitamin C and D.M.S.O. have only weak binding properties. Phillpott's formula is an I.V. for allergies and a nutritional supplement containing Vitamin C and other vitamins and minerals. Among those testifying, only Dr. Gordon and Respondent, members of the American Academy of Medical Preventics, even recognized its name, absent a list of ingredients. Sulfur cyl is a salycilate useful in the treatment of inflamed joints and arthritis. D.M.S.O. is an organic solvent with the potential to dissolve the vascular system. At no time did Respondent obtain a written release from Laine, releasing Respondent from any liability for the administration of D.M.S.O. intravenously through chelation therapy. At a May 17, 1983 office visit, Respondent administered intravenous chelation with 5cc. D.M.S.O. and an intravenous injection of sulfur cyl to Laine. No further testing was done by Respondent on that day. On this date Laine indicated that he was subjectively feeling better. On May 19, 1983, Respondent administered intravenous chelation with D.M.S.O. and an intravenous injection of Phillpott's formula and sulfur cyl to Laine. D.M.S.O. was also prescribed topically for skin and shoulders as needed. Respondent also ordered copper levels to be obtained from blood and urine specimens. Laine provided a 24 hour urine specimen which Respondent had tested. The specimen analyzed at 74.8 micrograms per liter. The normal copper values for the laboratory in question were .00-60.00 micrograms per liter. The greater weight of the direct credible expert testimony is that Laine's test showed a mild elevation not diagnostically significant for acute copper poisoning, however some rheumatoid arthritis sufferers show elevated copper levels. Respondent received the results of this urine test on May 22, 1983. On May 23, 1983 Respondent administered chelation with D.M.S.O. and intravenous injection of sulfur cyl to Laine. D.M.S.O. 99.9 was prescribed topically for shoulders. No further testing was performed on that date. On May 24, 1983, Laine was administered intravenous chelation with D.M.S.O. and an intravenous injection of sulfur cyl by Respondent. A blood sample was drawn for testing. On May 25, 1983, Respondent administered an intravenous injection of sulfur cyl to Laine. At this visit, Respondent used a plethysmograph to study Laine's entire body. Plethysmography is used to measure pulse pressure, usually in the venous system, for determining impeded blood flow in the veins and was apparently done because of a response on Laine's medical history involving angina and prior myocardial infarctions and because of a protocol or teaching of the American Academy of Medical Preventics. The blood sample drawn on May 24, 1983 was tested. The tests performed included serum copper levels, a SMAC profile, and r.a. latex titer results. The results showed a serum copper level of 135 micrograms per deciliter (normal values 70-155) and an r.a. latex titer of 1/1280. The greater weight of the direct credible expert testimony is that these results are not indicative of significant copper poisoning but were one significant indicator of rheumatoid arthritis. The results were reported to Respondent on May 26, 1983. On May 26, 1983, Respondent administered intravenous chelation with D.M.S.O. with sulfur cyl and calcium disodium edetate (E.D.T.A.) added. Chelin was also prescribed, apparently orally. Blood urea nitrogen (BUN) levels were also obtained that day. E.D.T.A. is most often used in the treatment of mild to severe lead poisoning. Although E.D.T.A. will chelate other heavy metals, including copper, it is not the treatment of choice by the majority of medical and osteopathic physicians for treatment of either copper poisoning or rheumatoid arthritis. D- penicillamine is preferred over E.D.T.A. because it is more effective and because E.D.T.A. has significant side effects, including primarily kidney failure. E.D.T.A. also has a problem permeating cell membranes. On May 27, 1983, Respondent administered intravenous chelation with D.M.S.O. and sulfur cyl to Laine. In Respondent's discussions with Laine between May 16 and May 27, 1983, Respondent suggested that a reduction of Laine's copper level would improve his symptoms. Respondent did not fully inform Laine of any of the potential side effects of E.D.T.A. chelation therapy or intravenous D.M.S.O. Respondent told Laine that his treatment was not completely accepted in the general medical community but he believed in it and it would be acceptable. This falls far short of fully informing Laine as to alternative methods of treatment and their potential for cure of his condition. In total, Respondent billed Laine $1,350.00 for office visits, various tests, examinations, and treatments. At each visit, Respondent provided Laine with bills and health insurance claim forms. These do not reflect a diagnosis until May 26 and then only the single diagnosis of "toxic metal poisoning". The bills were never paid by Laine whose wife complained to the Department of Professional Regulation concerning Respondent's treatment of Laine when Laine's insurance declined to pay for Respondent's treatment of him. Despite Respondent's oral testimony to the contrary, the patient records do not reflect that Respondent diagnosed Laine as having rheumatoid arthritis or cardiovascular disease, they show only copper poisoning of various degrees as reflected in the above findings of fact. Respondent maintains that the many tests were necessary and conservative for the purpose of confirming or rejecting his initial diagnosis of copper poisoning, to determine the presence of rheumatoid arthritis, and to guard against potential kidney failure before E.D.T.A. chelation was attempted. Since Respondent never performed any "hands on" physical examination and did no one-on-one questioning of Laine concerning the medical history forms, the tests may appear excessive, particularly in light of the probability that E.D.T.A. was used on Laine before Respondent received the final test results, but the characterization of Dr. Blechman is accepted that the type and spectrum of tests including plethysmography actually ordered by Respondent do not demonstrate significant fault. Respondent's office staff regularly took readings of Laine's bloodpressure and pulsed and measured his height and weights but the patient records do not reflect any "hands on" physical examination by Respondent of Laine on any of the eight office visits. The greater weight of the expert testimony is that a minimal physical examination for a new patient with unverified complaints should entail a complete hands-on physical which palpates the head, eyes, ears, nose, throat, neck, chest, abdomen, and the extremities and joints, listening to the heart and lungs and examining the skin, plus a rectal examination. If only joint diseased arthritis, or rheumatoid arthritis were suspected or being investigated for treatment, a minimal physical examination should emphasize evaluating all joints (including peripheral joints) by palpation, determining the range of motion of affected joints, listening to the heart and lungs, taking blood pressure, and evaluating length and duration of symptoms. According to physicians board- certified or with a majority of their practices in rheumatology or internal medicine, it is particularly important in joint disease cases for the physician to feel the joint to determine which element thereof is swollen and to see if it is warm to the touch i.e. inflamed. Respondent admits his initial physical examination of Laine was merely observation of Laine's movements and his general ambulatory motion with his clothes on, examination of tophi in his ears, and listening to his heart and lungs. Respondent is vague about whether he observed Laine's hands. Respondent's type of initial physical examination, if it can be called that, and lack of follow-up examinations fall short of the level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as acceptable under similar conditions and circumstances. On May 27, 1983 Laine also went to see Jeffrey Erlich, M.D. He was in pain and getting no relief from Respondent. On that date Dr. Erlich took a history from Laine, performed a complete "hands on" physical examination, reviewed laboratory data provided him by Laine from Respondent and tentatively diagnosed Laine as having rheumatoid arthritis. Laine's condition was such that, at formal hearing, Dr. Erlich characterized Laine as "the second sickest rheumatoid arthritis patient" he had seen. Because of the severity of Laine's condition Dr. Erlich began Laine on oral predisone which is the conservative treatment of choice among the majority of medical physicians and osteopathic physicians for the treatment of rheumatoid arthritis. Laine was subsequently hospitalized for what may have been side effects of the predisone itself or aggravation of a pre-existing ulcer by the predisone. From this hospitalization, Respondent desires that the inference be drawn that Dr. Erlich was less close to prevailing standards of treatment than was Respondent because Erlich's prescription for predisone constituted an error of Erlich based on failed physical examination and history-taking, which error Respondent knowingly avoided by electing chelation therapy over the predisone treatment. Respondent's argument is not persuasive, and that leap of the imagination cannot be made upon the credible competent substantial evidence in the record. Faulty judgment calls of Dr. Erlich, even if any existed, are non-issues advanced by Respondent to draw attention from relevant and material issues. Further, while in the hospital, Laine was seen by a rheumatologist and a gastroenterologist who essentially confirmed Erlich's diagnosis of rheumatoid arthritis. Laine has since been administered several types of treatment for rheumatoid arthritis, including but not limited to D-Penicillamine, by both Erlich and the rheumatologist without much success, but Laine continues to tolerate predisone and to receive some pain relief therefrom. In light of the foregoing, it is found that Laine had rheumatoid arthritis which Respondent failed to diagnose principally because of Respondent's persistent reliance on the previous hair analysis and his failure to use "hands-on" physical examination contrary to the prevailing level of care, skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as acceptable under similar conditions and circumstances. Respondent's reliance on hair analysis performed by a non-physician was misplaced and did not conform to the practice of medicine with that level of care, skill and treatment which is recognized by a reasonably prudent osteopathic physician under similar facts and circumstances. Not only is the greater weight of all credible expert evidence that hair analysis has little or no clinical value in diagnosing elevated copper levels or anything else because hair analysis indicates not only endogenous (internal or ingested) but also exogenous (external) sources of copper, but Respondent's own testimony further reveals that he merely assumed that the hair sample had been properly taken from the nape of Laine's neck and properly washed prior to testing. In making this finding of fact, the undersigned has not overlooked the testimony of Respondent's expert, Dr. Garry Gordon, who considers hair analysis to be a valuable diagnostic tool when laboratories meet all protocols. However, even Dr. Gordon admits that hair analysis is only relied on by a "distinct clear cut minority" nationwide; it is not required by the American Academy of Preventics; and the particular hair analysis of Laine in this case would probably show his most recent exogenous exposure to the copper boat hull. Respondent is a member of the American Academy of Medical Preventics and considers himself a holistic practitioner and an expert in the use of chelation therapy for prevention and cure of disease. /1 He administers chelation therapy to an average of 32 persons per week for one ailment or another. The American Academy of Medical Preventics is a group with a nationwide membership of 500-1000; of whom perhaps 100 are certified physicians. A protocol of this group requires extensive testing to verify the presence of various diseases, commends the least invasive approaches to testing and treatment, and favors chelation therapy for a number of ailments as well as hair analysis as a testing device. According to Respondents the D.M.S.O. was administered for the purpose of aiding the cell permeability of the vitamin C and later to aid the cell permeability of the E.D.T.A., E.D.T.A. was administered one time for the purpose of treating rheumatoid arthritis; the Phillpott's formula (primarily vitamin C) was for chelation of copper allergies and improving nutrition; and sulfur cyl was for inflammed joints. This treatment conforms to the American Academy of Preventics' protocol. It is stipulated by the parties that Respondent did not use D.M.S.O. as a treatment or cure for copper poisoning or as a treatment or cure for rheumatoid arthritis. (Pre-Hearing Stipulation paragraphs 33 and 34; H.O. Exhibit 2). Expert testimony was permitted to be elicited from Lloyd D. Gladding, D.O., Jeffrey Erlich M.D., Mark Montgomery, Ph.D., Wilbur Blechman, M.D., Garry Gordon, M.D., and Stanley Jacobs, M.D. Respondent objected to any testimony by Petitioner's witnesses, Dr. Gladding, D.O. (the only Florida licensed osteopathic physician other than Respondent to testify), Jeffrey Erlich, M.D., Mark Montgomery, Ph.D. in toxicology and instructor of both medical and osteopathic physicians, and Wilbur Blechman, M.D. because they were not "similar health care providers" in that none were physicians specializing in holistic and preventive medicine upon grounds that only reasonably prudent similar physicians may properly evaluate Respondent's performance. Dr. Blechman's testimony by deposition was further objected to by Respondent upon the ground that a medical physician may not testify to the statutory standard required of a "reasonably prudent similar osteopathic physician as acceptable under similar conditions and circumstances" as specified in Section 459.015(1)(t) F.S. This position was not consistent with Respondent's relying heavily on the testimony of Dr. Jacob, also a medical physician (M.D.) or Dr. Gordon, trained as an osteopath but accredited through a merger of schools as an M.D. Upon authority of Wright v. Schulte 441 So.2d 660 (Fla. 2d DCA 1983) 2/ upon the definition of "physician" contained in Section 459.0514(1) embracing both medical physicians and osteopathic physicians, upon the statutory language contained in Section 459.015(1)(t), specifying "The board shall give great weight to the provisions of Section 768.45 when enforcing this paragraph," and upon each witness' specialized education, training, and experience as evident from the records the undersigned overruled Respondent's objections and qualified the witnesses as experts pursuant to their respective qualifications. This ruling is also in accord with the history of Chapter 21R F.A.C., of which judicial notice has been taken, and which shows holistic and preventive medicine has never been recognized as a sub-speciality by the Board of Osteopathic Medical Examiners. This evidentiary ruling is here reaffirmed and reiterated as clarification of the weight and credibility of the experts' opinions accepted, relied upon, or rejected in this recommended order. The Food and Drug Administration (F.D.A.) is the federal agency charged with the enforcement of the federal Food and Drug Acts which includes the regulation of the manufacture and distribution of drug products. As part of its regulatory powers, the F.D.A. approves or disapproves drugs for human consumption. It does not approve or disapprove uses or treatments of drugs. Once the drug has been approved as a prescriptive agent, physicians are not limited by the F.D.A. in their utilization of approved drugs to the specific indications set forth in the F.D.A. package inserts. D.M.S.O. has been approved for human consumption. The package insert for D.M.S.O. as reported in the Physician's Desk Reference (PDR), a standard reference used by practicing physicians, recognizes it as indicated for treatment of the condition of interstitial cystitis only, a condition Laine did not have. E.D.T.A. has also been approved by the F.D.A. for human consumption. Its package insert as reported in PDR recognizes it as indicated for treatment of the conditions of digitalis toxicity, hypercalcemia, lead, and other heavy metal toxicities. The undersigned has considered the testimony of all the experts qualified in this case subject to differing weight and credibility considerations of their education, training, and experience. The definition of "experimental treatment" as that type of treatment which has not been shown to be effective or safe under clinical studies conducted after F.D.A. approval of the drug involved is accepted. With some minor variation of choice of words, that is the definition advanced by Dr. Gladding, D.O., Dr. Blechman, M.D. and by toxicologist Mark Montgomery, even though clinical tests also precede F.D.A. approval. D.M.S.O. and E.D.T.A. in the quantities and treatments used by Respondent are experimental and not approved or recognized as acceptable for treatment of either copper poisoning or rheumatoid arthritis by a respectable minority of the medical profession. The opinions of the Florida physicians board certified or with a majority of their practices in rheumatology or internal medicine and of Mark Montgomery, who teaches both medical physicians and osteopathic physicians the physical and physiological operation of various drugs, are considered more credible on this issue than that of Dr. Gordon, drafter of the American Academy of Preventics' protocol using E.D.T.A. and D.M.S.O. together in chelation. Dr. Gordon admits that in many ways all D.M.S.O. and E.D.T.A. treatments are practiced only by members of the American Academy of Medical Preventics, which has not yet been recognized by the American Medical Association and which represents a minority of physicians nationwide. Even by the construction of the evidence most favorable to Respondent, that is, the testimony of Dr. Jacob, Respondent's expert in D.M.S.O., the small quantities of D.M.S.O. administered by Respondent in the course of eight treatments would not have been therepeutically effective in reducing the copper levels in Laine's body and would not have been therepeutically effective in treatment of rheumatoid arthritis. A stronger solution than that used by Respondent would have been necessary to have either a positive or negative effect upon Laine. Dr. Jacob does not use D.M.S.O. for chelation but when using it by intravenous injection requires a release be signed. Laine was not physically harmed by the treatments administered by Respondent. The most that can be said is that the Respondent's misdiagnosis and useless treatments delayed his obtaining appropriate treatment. There is no recognized cure for rheumatoid arthritis and it has been shown that any of the numerous treatments utilized for rheumatoid arthritis will work on some individuals while not working on others. The symptoms of rheumatoid arthritis may alleviate without any treatments or conversely may get progressively worse regardless of any treatment utilized or they may clear up for no apparent reason.
Recommendation That the Board of Osteopathic Medical Examiners enter a final order finding Respondent guilty of violations of Count I [sections 459.015(h) and 459.0154], Count III [Section 459.015(1)(t)], Count IV [Section 459.015(1)(u)], Count V [Section 459.015(1)(n)], and Count VI, (section 459.015(1)(1)], suspending Respondent's license for a total period of one year therefor, and dismissing Count II [Section 459.015(1)(o)] with prejudice and dismissing Counts VII and VIII without prejudice. DONE and ORDERED this 14th day of May, 1986, in Tallahassee, Florida. ELLA JANE P. DAVIS 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 14th day of May, 1986.
Findings Of Fact The following Findings of Fact are based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and on the entire record of this proceeding. Petitioner is the state agency charged with regulating the practice of osteopathic medicine pursuant to section 20.43, and chapters 456 and 459, Florida Statutes. At all times material to these proceedings, Respondent was a licensed osteopathic physician within the State of Florida, having been issued license number OS 8729. Respondent's address of record at the time of filing the Administrative Complaint was 11950 County Road 101, Suites 101, 102, and 103, The Villages, Florida 32162. Respondent's current address of record is 13767 U.S. Highway 441, Lady Lake, Florida 32159. Respondent currently holds no board certification in any specialty area, and did not complete any residency other than in emergency medicine. Respondent attended Michigan State University, College of Osteopathic Medicine. In 2002, he began full-time practice as an emergency room physician at Munroe Regional Medical Center in Ocala, Florida. He worked as an emergency room physician until he opened Exceptional Urgent Care Center (“EUCC”). At all times material to this complaint, Respondent owned and operated EUCC. Treatment Provided to Patient J.K. On March 15, 2018, J.K., along with his wife, presented to EUCC with complaints of a sore throat and fever. This was the first of two visits to the clinic. J.K. reported his medications as Amlodipine, Warfarin, Tamsulosin, and Dofetilide (unless otherwise indicated, hereinafter referred to by its trade name "Tikosyn"). J.K. was prescribed these medications by his cardiologist at the William S. Middleton Memorial Veterans Hospital (“V.A. Hospital”) in Wisconsin, his home state. Relevant to this matter, Tikosyn helps patients maintain a normal heartbeat rhythm. Tikosyn was prescribed to keep J.K.'s heart in rhythm as he had atrial fibrillation. J.K. was treated by a nurse practitioner, who ordered a chest x-ray and a flu swab. The flu swab returned negative, and the chest x-ray showed no focal pneumonia. J.K. was prescribed Tamiflu and Naproxen. J.K. elected not to fill the Tamiflu due to the “expensive cost.” Respondent was not involved in J.K.'s treatment on this date. On March 16, 2018, J.K. and his wife K.K. returned to EUCC as J.K.’s symptoms had not improved. On this visit, J.K. saw Dr. Im. Dr. Im evaluated J.K. and ordered two tests. Dr. Im ordered a Prothrombin Time International Normalized Ration ("PT INR") test to determine J.K.'s coagulation and he ordered a CT scan of the chest. The PT INR results were within the therapeutic range. The CT scan showed shattered ground- glass opacification in the posterior right lower lobe and the medial left upper lobe. The CT scan findings were interpreted as "non-specific, may represent hypoventilatory change or an infectious inflammatory process (acute or chronic).” Respondent advised J.K. and K.K. that the CT scan appeared to show the start of pneumonia, and he was going to prescribe three medications: Levaquin 750 mg, Prednisone 20 mg, and Zyrtec 10 mg. K.K. testified that she asked Respondent if the Levaquin, Prednisone, or Zyrtec were contraindicated with any of J.K.'s current prescriptions, specifically Tikosyn. K.K recalls that Respondent replied that he was not familiar with Dofetilide (Tikosyn), and advised them to check with the pharmacist to see if there were any contraindications. Although Respondent initially advised J.K. and K.K. that he was not familiar with Tikosyn, Respondent testified that he advised J.K. and K.K. of the possible interactions between Levaquin and Tikosyn and told her that the interaction was very rare. He testified that he advised J.K. and K.K. that the pharmacist is a safety net, and the pharmacist would call him to discuss the prescriptions if he missed anything. K.K. credibly testified that Respondent did not counsel J.K. or K.K. on any risks regarding the medications Dr. Im prescribed or provide them with any alternatives during the visit on March 16, 2018. J.K. and K.K. left EUCC and went to Publix to fill the prescriptions. K.K. asked the pharmacist if any medications would interfere with any of J.K.'s prescribed medications. Upon advice of the pharmacist that Levaquin was contraindicated with Tikosyn, K.K. declined to fill the prescription for Levaquin. On behalf of J.K., K.K. then called EUCC and asked for a different antibiotic that would not interact with Tikosyn. However, she was instructed to contact J.K.'s cardiologist. K.K. then contacted the cardiology staff of the V.A. Hospital in Wisconsin, who instructed K.K. to follow the advice of the pharmacist and (tell J.K.) not to take the Levaquin. K.K. called EUCC a second time to confirm whether J.K. had an infection and she was told that J.K. did not have an infection. Respondent recalls that he had a personal conversation with K.K. during a courtesy telephone call placed the next day (March 17, 2018). Respondent testified that during that call, he explained Levaquin was the drug of choice, other medications would not cover J.K.'s pneumonia, the potential interactions were very rare, and J.K. needed to take the Levaquin. By his own admission and his medical records, Respondent did not provide J.K. or K.K. with any specific alternative antibiotics and insisted that J.K. needed to take the Levaquin. K.K. disputes that Dr. Im spoke with her or J.K. at any point after the March 16, 2018, visit. She clearly recalled that she spoke with a woman each time she spoke with staff at Dr. Im’s office. Overall, J.K. and K.K. clearly and convincingly testified that Respondent never advised them of the risks of using Levaquin with Tikosyn or provided any alternatives to the Levaquin. Expert Testimony Petitioner offered the testimony of Dr. Anthony Davis, who testified as an expert. Dr. Davis has been licensed as an osteopathic physician in Florida since 1995. Dr. Davis attended Kirksville College of Osteopathic Medicine and completed an internship in family practice. He has been board certified in family medicine by the American Board of Osteopathic Family Physicians since 2001, and board certified in emergency medicine by the American Association of Physician Specialists since July 2003. He is also affiliated with professional organizations including the American College of Family Practice and Florida Osteopathic Medical Association. Dr. Davis was accepted as an expert in emergency and family medicine. Dr. Davis relied upon his work experience, his training, and his review of the medical records for J.K. to render his opinion regarding the standard of care related to treating J.K. The standard of care requires an osteopathic physician treating a patient similar to J.K. to: (1) provide and document their justification for why Levaquin was the appropriate drug of choice; (2) note the patient’s acknowledgment that there are interactions with Tikosyn; (3) ensure the patient understands the risks and benefits of combining Tikosyn and Levaquin; (4) explain to the patient that there are limited alternatives to Levaquin; and (5) provide the reason for prescribing a potentially dangerous drug. Levaquin is a medication that comes with a black box warning that requires physicians to counsel patients on the risks associated. When a drug is designated as contraindicated and has a category X for interaction, the standard of care requires that the physician clearly explains to the patient why they are using the drug and defend how it is going to be safe. Tr., p. 70. Dr. Davis opined there were multiple treatment options available for J.K., such as supportive care or an antibiotic with a lower risk of interaction with J.K.'s existing medication. Moreover, Dr. Davis testified that there were safer alternatives to Levaquin that would effectively treat pneumonia, such as doxycycline, if J.K. actually had pneumonia and an antibiotic was necessary. Respondent provided literature from the Infectious Diseases Society of America related to community-acquired pneumonia in an attempt to prove that X-Ray or other imaging techniques are required for the diagnosis of pneumonia and to support his claim that Levaquin was the drug of choice for J.K. However, Dr. Davis credibly pointed out that the article, published in 2007, is no longer accurate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Medicine enter a Final Order as follows: Finding that John Joseph Im, D.O., violated section 459.015(1)(x), by committing medical malpractice, as defined in section 456.50, as alleged in the Administrative Complaint; Issue a letter of concern against Respondent’s license to practice osteopathic medicine; Requiring completion of a prescribing practices course; and Imposing an administrative fine of $2,500. DONE AND ENTERED this 16th day of December, 2019, in Tallahassee, Leon County, Florida. S YOLONDA Y. GREEN 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 16th day of December, 2019.
Findings Of Fact The Respondent is licensed by the Board to practice as an osteopathic physician in Florida. The Respondent has been licensed to practice as an osteopathic physician in the State of Pennsylvania. He was criminally charged in the State of Pennsylvania with various violations of 35 Penna. Stat. Section 780- 113(a)(14). After entering a plea of not guilty, he was tried and convicted of three counts of violating the statute. He was adjudicated guilty and sentenced. The Respondent has exhausted all direct appellate remedies in Pennsylvania. He continues to pursue available collateral remedies. The Pennsylvania State Board of Osteopathic Examiners initiated disciplinary action against the Respondent. A hearing was conducted, and the Pennsylvania board concluded that the Respondent was convicted of a crime involving moral turpitude and was guilty of unethical conduct. The Board stated: It is clear that the Respondent blatantly disregarded the health and welfare of the citizens of Pennsylvania and the Board can impose a penalty for such disregard. How- ever, the Board has taken into consideration the fact that the Respondent no longer resides or practices osteopathic medicine in Pennsylvania, and therefore, he is presently not a danger to the health, safety and welfare of Pennsylvania. Apparently disregarding the testimony of the Respondent in the record that he did intend to continue practicing osteopathic medicine in Pennsylvania if his license was not revoked, the Board imposed no penalty against the Respondent. The Respondent thus continues to be licensed to practice osteopathic medicine in Pennsylvania. The Respondent is presently engaged in the general practice of osteopathic medicine in Florida. He practices in a black area and is the only doctor who accepts Medicaid patients in the area. During 1976 he turned in his federal license to dispense controlled substances. He is thus not able to prescribe controlled substances in his practice, but he can prescribe other drugs. The Respondent has not been the subject of any other disciplinary proceedings during his many years as a practicing osteopathic physician.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I make the following relevant factual findings: At all times material hereto, Respondent was an osteopathic physician licensed by the State of Florida having been issued License Number OS 0016000. In August, 1984, one Jacob Kantor was a regular patient of both Respondent and Dr. Barry Goldberg, a chiropractor employed by Respondent. Kantor periodically came to the office for chiropractic therapy with Dr. Goldberg and for medical examination and treatment by Respondent. Kantor often showed up at Respondent's office without an appointment. On August 13, 1984, Jacob Kantor came to Respondent's medical office and discussed with Dr. Goldberg whether he could obtain reimbursement for a bill Kantor had paid to another chiropractor. Goldberg advised Kantor that, as an HMO patient, procedurally he should have first sought a referral to another chiropractor before obtaining services from a chiropractor, not affiliated with Respondent's practice, when he wished to be reimbursed by Respondent. Goldberg suggested that he talk with Respondent who perhaps would make an exception to the usual procedure in this instance. Kantor did not ask for medical treatment from Respondent on that visit although he did speak with Respondent about getting reimbursed for the fees he paid to an unaffiliated chiropractor. Respondent explained to Kantor that he was not entitled to reimbursement for chiropractic treatment received from chiropractors not associated with his office without his prior approval. Respondent then terminated the conversation with Kantor and proceeded to an examination room to treat a female patient. Kantor followed Respondent into the examination room and insisted upon continuing the conversation concerning the reimbursement. Respondent escorted Kantor out of the room and closed the door. Kantor persisted and re-entered the room, again interrupting Respondent's intended examination of the female patient and was, for a second time, escorted by Respondent out of the examining room. Debbie Lombardo, a medical assistant whose employment was terminated by Respondent five days after the alleged incident, recalled Kantor's repeated interruption of Respondent's attempt to examine the female patient. Respondent touched or pushed Kantor which resulted in his (Kantor) losing his balance and falling backwards inside the doorway of an adjoining room. Lombardo assisted Goldberg in picking up Kantor from the doorway that he fell into in losing his balance. Dr. Goldberg did not see what caused Kantor to lose his balance but he did observe Kantor back-pedalling out of an examination room, through the hallway, into an adjoining room and ultimately landing against the back wall of that room. Goldberg assisted Kantor in getting up from the floor. Lombardo was in another room assisting with a patient at that time. Kantor, who did not testify at the Final Hearing, alleged in his initial written complaints to the Petitioner that he did not fall but instead fell into the arms of Dr. Goldberg. To the contrary, both Goldberg and Lombardo denied that Goldberg prevented Kantor from falling after he lost his balance. In his statement to Investigator O'Connell during 1984, Kantor again stated that when he lost his balance, he was caught by Goldberg who prevented him from falling. Respondent denied pushing or otherwise attempting to strike or threaten Kantor. Archie Page, a former patient of Respondent, witnessed the incident in August, 1984. Page observed that Kantor appeared mad and taunted Respondent while Respondent was trying to restrain and calm him down. Page observed Goldberg coming out of his office, putting his arms around Kantor and taking him toward the waiting room following the incident, all in an effort to put him at ease. Page denied that Respondent pushed Kantor or that Kantor was ever on the floor. 1/ Resolution of the issue, concerning an alleged battery, although not charged in the complaint, requires a credibility choice between Respondent, his former patient Archie Page and Respondent's two previous employees, Debbie Lombardo and Barry Goldberg. The testimony of former patient Archie Page appears more credible as he has no personal interest in the outcome of the proceedings, his testimony was direct and he appeared most credible during the hearing. Three months after the subject incident, investigator O'Connell went to the offices of Respondent to investigate the incident and interviewed Respondent and Goldberg. During that interview, Goldberg, who was not under oath, stated that Jacob Kantor needed a lot of help as he had a bad psychological problem. Referring to the alleged incident of August 13, 1984, Goldberg stated that, "its possible that I may have seen (Kantor) that day but I don't recall it, and I'd certainly remember seeing him if I was supposed to have seen Dr. Shore strike him. Nothing of this sort ever took place to my knowledge." (T-page 121, lines 14 through page 122, line 17.) Goldberg testified under oath at a deposition in a related civil case that he did not have to lie to the DPR agent because the subject did not come up. Goldberg further testified at final hearing herein that he told the truth when questioned during the course of that deposition. Goldberg again testified under oath at the trial of the related civil case that he did not lie to the DPR agent and that he did not even discuss the incident with the agent. Goldberg, under oath at final hearing herein, again initially testified that he did not discuss the incident with the DPR agent. Finally, Goldberg claimed that he lied by means of withholding information from the DPR agent and that he did so because Respondent threatened to hurt him if he did not lie to DPR's agent. 2/ Respondent did not strike, threaten to, or attempt to strike Kantor at anytime on August 13, 1984. Kantor, as testified by all witnesses, was a demanding and overbearing patient who would show up at Respondent's office, without an appointment and would demand treatment whenever he showed up. Within one week after the subject incident, Kantor came back to Respondent's office seeking treatment for an abrasion and a cyst and wanted a referral to a proctologist. Respondent made the referral and had no further contact with Kantor. Such actions by Kantor is not indicative of a patient who was the subject of an assault and battery at the hands of Respondent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that: Petitioner enter a Final Order dismissing the Administrative Complaint filed herein in its entirety. DONE and ORDERED this 28th day of October, 1988, in Tallahassee, Florida. JAMES E. BRADWELL 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 28th day of October, 1988.
Findings Of Fact At all times relevant hereto Lawrence D. Urban was a licensed osteopathic physician in Florida having been issued license number OS 001232. From January 1983 through at least March 17, 1984, Respondent maintained offices in Clearwater and Zephyrhills. He practiced in the Clearwater office on Monday, Wednesday and Friday of each week and in the Zephyrhills office on Tuesday, Thursday and Saturday. Respondent employed Wendell Bloom to work in the Zephyrhills office as a business manager and assistant to Respondent. Bloom had no medically related license such as physician's assistant, nurse, technician, etc. As an assistant to Respondent, Bloom drew blood, performed vascular analyses, mixed IV solutions, and administered IV solutions. He worked at the Zephyrhills office Monday through Friday. Bloom had standing orders from Respondent that if a new patient came in Bloom would draw a blood sample, send it to the lab for analysis and make an appointment for the patient to see Respondent when the results of the blood analysis was received. Respondent described his practice in Zephyrhills as holistic, involving nutrition, chelation, and cancer therapy using laetril. Chelation treatment involves the intravenous injections of solutions containing EDTA (Ethylenadiaminetetracetic acid), vitamins, including B12, B complex and C, and the minerals, calcium and magnesium. On many occasions Bloom commenced IV chelation injections containing EDTA before Respondent arrived at the office and completed some of these after Respondent had left the office. On at least five (5) occasions Bloom injected patients with IV solutions containing EDTA without Respondent being present any time during the procedure. Drawing blood without a doctor present in the office constitutes the practice of medicine. Injecting IV solutions in patients constitutes the practice of medicine without a doctor present. In the Zephyrhills office Respondent referred to Bloom as Dr. Bloom in the presence of patients. No sign or disclaimer was posted in the office that Bloom had no prior medical training and was not licensed in any medically related health professional field in Florida. Respondent knew that patients might believe Bloom to be a medical doctor. In administering an IV solution to a patient there is always a danger of an allergic reaction or an anaphylactic reaction, even if a patient has previously tolerated the treatment. Respondent acknowledged that serious side affects would result to a patient receiving an IV solution containing EDTA if the patient suffered kidney failure. Bloom also operated the vascular analyzer machine in the office. As described by Bloom, by attaching clips from the machine to the fingers and toes the machine will tell you if there is any kind of clotting or obstruction any place within the cardiovascular system. Further, by putting transmission gel on the clip and holding it over an artery, transmissions from the clip with the return echo is transformed onto a chart which will denote the elasticity of the artery. This machine is not universally accepted in the medical profession. By Final Order entered August 26, 1983 (Exhibit 1) the Florida Board of Osteopathic Medical Examiners found Respondent guilty of filing false reports, fee splitting, and abetting an unlicensed person to practice osteopathic medicine. He was sentenced to a reprimand, placed on probation for six (6) months and directed to report to the Board at the end of the probationary period. If, at this time, Respondent's report on the status of his practice satisfies the Board that the financial aspects of his practice is in accordance with the law, the reprimand will be withdrawn. Terms and conditions of the probation were not delineated. Respondent appeared before the Board at its March 17, 1984 meeting. After Respondent reported that the financial aspects of his practice were poor, but in conformity with the law, one of the Board members inquired if Respondent was working with any non-osteopathic physicians in his practice, which was one of the accusations for which he was reprimanded and placed on probation. At this point Respondent told the Board that he had a helper who was a "non- anything" who was drawing blood, doing vascular analyses of patients, giving IVs to patients undergoing chelation therapy and whatever Respondent told him to do. (Exhibit 2) After hearing these disturbing facts the Board voted to extend the Respondent's probation while an investigation of his practice was conducted. The charges considered at this hearing were those resulting from that investigation.
Findings Of Fact Respondent, Eugene W. Williams, II, is an osteopathic physician licensed in Florida, and was so licensed at all times relevant to this proceeding. His address is 4394 Palm Beach Boulevard, Fort Myers, Florida 33905. On June 21, 1979, Sue Riley presented herself to Respondent for treatment of a fractured left distal radius. Respondent ordered arm elevation and ice bag treatment to reduce the swelling. The next day, he set the arm in a cast and performed a closed reduction. The injured arm was initially x-rayed at the hospital emergency room on June 21, 1979, and was not x-rayed again until July 5, 1979, when Respondent noted that the fracture was not closed. He then referred the patient to an orthopedic specialist. The testimony of Petitioner's expert witness indicated that a second X ray should have been taken after casting rather than two weeks later to insure that the fracture was, in fact, closed. Without such an X ray, Respondent could not be certain that the fracture was closed initially or that it had not reopened. Respondent's testimony and that of two other experienced physicians established that it is not uncommon to omit the X ray immediately after casting. In their view, no X ray is needed for ten days to two weeks provided the fracture appears to have been closed and properly aligned. Respondent's testimony established that all indications were favorable following casting and that he did not believe an X ray was needed for ten days to two weeks.
Recommendation From the foregoing, it is RECOMMENDED that the Second Amended Administrative Complaint be dismissed. DONE and ENTERED THIS 14th day of February, 1983, in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of February, 1983. COPIES FURNISHED: James B. Gillis, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 JulieAnn Ricco, Esquire 1655 Palm Beach Lakes Boulevard Suite 106, Forum III West Palm Beach, Florida 33401 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy J. Faircloth, Executive Director Board of Osteopathic Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
