Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the final hearing, the following relevant facts are found: HRS District VIII includes Sarasota, DeSoto, Charlotte, Glades, Lee, Hendry and Collier Counties. There are presently no existing and operating osteopathic hospitals within District VIII. However, there are two applications now pending for new for new osteopathic facilities within the District. One is in Sarasota and one is on behalf of the intervenor Doctors' Osteopathic Medical Center, Inc., d/b/a Gulf Coast Hospital, Inc. (Gulf Coast), which seeks to build and operate a 120-bed acute care osteopathic hospital to be located in south lee County. That application has proceeded through the administrative hearing process, received a Recommended Order for approval of 120 beds, a Final Order for approval of 60 beds and is currently on appeal. The intervenor Naples Community Hospital is an existing allopathic acute care hospital located in Collier County, which is immediately south of Lee County. The intervenor Lee Memorial Hospital is an existing allopathic acute care hospital located in Lee County and has approval to construct and operate a satellite facility in south Lee County. The petitioner Family Center Hospital Osteopathic, Inc., proposes to construct and operate a 100-bed full service, osteopathic teaching hospital in southwest Lee County. A particular site has not yet been selected or acquired. If the proposed facility was established, it would be in competition with allopathic hospitals for patients and staffing. The petitioner's original application for a Certificate of Need was submitted to HRS in the summer of 1982. That application was prepared by a health planning consulting firm, no member of which testified in this proceeding. The original application was amended prior to the hearing with regard to the need for osteopathic beds in the area, the financial projections and the architectural design of the facility. Petitioner intends to retain a full-time management firm to be responsible for managing the proposed facility. No firm commitments have been made and no tentative price quotations have been received for such an arrangement. Petitioner proposes to construct a two-story 90,000 square foot building with ancillary services on the first floor and patient areas on the second floor. The patient areas include a 15-bed obstetrical until, a 10-bed pediatrics unit, an 8-bed ICU/CCU and the remaining beds would be medical- surgical beds. The architect had no knowledge of the location of the site proposed, and thus no site plan has been developed. While the average construction cost per square foot of a health care facility in Florida is approximately $115 or $120, that cost can vary depending upon site development requirements, construction materials, floor coverings, wall coverings and the like. These details have not yet been determined The fact that the proposed facility is to be teaching hospital was not taken into account in the schematic design. An accountant, who had no prior experience with projecting financial feasibility for a health care facility was retained by the petitioner to prepare a projected financial statement for the proposed facility. His opinion that the project would be financially feasible within the second year of operation was based primarily upon occupancy projections made by a health planner, the itemization and costs associated with manpower, salaries, equipment, supplies, etc., as projected in the original application and conversations with a "Mr. Becker" relating to bond financing. He compared his estimates and projections with other Certificate of Need applications in the Lee County area. The accountant was unaware of whether nor not the applications relied upon for comparison purposes had been update or revised at some subsequent time. He also received data concerning revenues of a "select group" of hospitals as published in a Hospital Cost Containment Board report for 1984, but made no determination of that Board's grouping of hospitals for comparative purposes. No independent investigation of the accuracy of the contents of the original application was performed by the accountant or anyone on his behalf. Although the accountant adjusted the manpower requirements as originally projected to conform with his perception of the occupancy projections, he was unaware of the minimum staffing requirements imposed upon hospitals by state and/or federal regulations. The witness candidly admitted that he did not consider it within his expertise to determine the manpower or equipment requirements for the proposed facility. He is unaware of whether or not the bond financing proposed for this project is available. There was no showing that petitioner had sufficient funds available to make expenditures for project development or other pre-opening expenses, estimated to be over $400,000.00. His revenue projections did not take into account the existence of other osteopathic beds in the area. By utilizing alternative methodologies which took into account both statewide and district wide statistics regarding osteopathic utilization rates, the number and distribution of osteopathic physicians, and population projections; the petitioner's health care planner concluded that there is a gross need in the year 1991 for 144 osteopathic acute care hospital beds in District VIII. Assuming that there are no other osteopathic hospitals in District VIII, the health care planner was of the opinion that there is a net need for the same number of beds in that District. She further concludes that the proposed osteopathic hospital would obtain 90% of the osteopathic patients of Lee County, 50% of the osteopathic patients in other District VIII Counties and an occupancy rate of approximately 73% for the second year of operation. She admits that if Gulf Coast is awarded a Certificate of Need for 60 beds or 120 beds and/or if the Sarasota applicant is awarded a Certificate of Need, the net bed need of 144 would be reduced accordingly and the projected market share and occupancy rates would be affected. Petitioner presented no evidence concerning its ability to adequately staff its proposed facility. Likewise, no evidence was presented as to petitioner's ability to obtain funds for capital expenditures or for the operation of the facility. The impact of the proposed project upon the cost of providing health services was not addressed by the petitioner. There is a need for research and educational facilities to train doctors of osteopathic medicine at the student, internship and residency levels. Both Manasota Osteopathic General Hospital in Sarasota and Gulf Coast Hospital in fort Myers have indicated their desires to become teaching facilities.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that petitioner's application for a Certificate of Need be DENIED. Respectfully submitted and entered this 7th day of May 1986 in Tallahassee, Florida. DIANE D. TREMOR Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 7th day of May 1986. APPENDIX The proposed joint findings of fact submitted by Doctors' Osteopathic Medical Center, Inc., d/b/a Gulf Coast Hospital, Inc., and Naples Community Hospital have been approved and/or incorporated in this Recommended Order, except as noted below. Paragraph 7: Rejected as unnecessary to the issues in this proceeding. Many of the proposed findings of fact contain recitations of a lack of evidence regarding certain criteria. Where these have not been included in the factual findings, they are included in the Conclusions of Law, where pertinent. COPIES FURNISHED: Claude H. Tison, Jr., Esquire MCFARLANE, FERGUSON, ALLISON & KELLY Post Office Box 1531 Tampa, Florida 33601 R. Sam Power, Esquire Office of General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building 1, Room 407 Tallahassee, Florida 32301 John D. C. Newton, II, Esquire CARSON & LINN, P.A. Cambridge Centre 253 East Virginia Street Tallahassee, Florida 32301 W. David Watkins, Esquire OERTEL & HOFFMAN, P.A. Post Office Box 6507 Tallahassee, Florida 32314-6507 Ivan Wood, Jr., Esquire WOOD, LUCKSINGER & ESPTEIN One Houston Center Suite 1600 Houston, Texas 77010 William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
The Issue The issue to be resolved in this proceeding concerns whether the licensure examination taken by the Petitioner qualifies him under Section 459.007(3), Florida Statutes, for licensure as an osteopathic physician in the State of Florida.
Findings Of Fact The Petitioner, Lawrence Edward Suess, is an osteopathic physician licensed by the Boards of Medical Examiners in Texas, Alabama, and Kentucky. He seeks licensure in Florida, pursuant to Section 459.007(3), Florida Statutes. He is also licensed in Arizona and Texas as a registered nurse, holds BS and MS degrees in child development and nursing and a Ph.D. in nursing. The Respondent, the Board of Osteopathic Medicine (Board), is an agency of the State of Florida, charged with regulating the admission to practice and the practice and licensure standards of osteopathic physicians licensed or seeking to be licensed in the State of Florida. The Board issued an order, as corrected, on November 9, 1995, granting application of licensure to the Petitioner upon the condition that within one year, he successfully complete Part III of the NBOME examination for purposes of licensure in the State of Florida, and not for diplomate status. The Board found in that order that the Petitioner had not passed all three parts of the NBOME examination and had submitted certification of passage of only Parts I and II. The Board found that the “FLEX” examination was not a substantially-similar examination to the required NBOME examination since the FLEX examination did not contain an osteopathic medicine component. The Board also found that the completion by the Petitioner of a Board certification examination was not substantially similar to the NBOME examination because it tested only a single subject matter and not the broad principles contained in Part III of the NBOME examination. On November 13, 1995, a Petition for Formal Hearing was filed by the Petitioner disputing the decision of the Board which precluded him from obtaining licensure to practice medicine in the State of Florida because of failure to complete Part III of the NBOME examination. He contended that he was outside the time period in which he would be allowed to take Part III. He further contended that the FLEX examination was a substantially-similar examination to the NBOME examination. The Petitioner contends that taking the FLEX examination should be sufficient to justify licensure, although he also acknowledged that Part III of the NBOME examination tests osteopathic philosophy and principle; and he acknowledged that the FLEX examination does not, although he was attempting to testify and argue that the FLEX examination was substantially similar to the NBOME examination. He provided no testimony or evidence, however, to establish that the FLEX examination tests osteopathic philosophy and principle. The Respondent presented the testimony of Joseph Smoley, Ph.D. by deposition. Dr. Smoley holds a Ph.D. in educational measurement and has served for ten of the last eleven years as Executive Director of the NBOME. The NBOME is an organization that develops an examination that is independent of the osteopathic medical schools to evaluate osteopathic physicians who are either currently in undergraduate or in graduate medical programs. The NBOME’s main mission is to provide state licensing examinations with an independent assessment of the knowledge base of candidate osteopathic physicians. Dr. Smoley oversees NBOME policy and supervises educational measurement within the osteopathic profession. His oversight responsibilities include the examination section of the NBOME. He provides a constant review of the process of testing for the Board of Directors. The NBOME developed its examination by having questions drafted by faculty members and osteopathic physicians in independent practice. Faculty members may be D.O.’s or Ph.D.’s in the various basic sciences, and there is a multi-tiered process for preparing and reviewing questions. A copy of the bulletin of information concerning the NBOME examinations was attached to and made part of the deposition. Dr. Smoley testified that typically the candidates take Part I as a sophomore during medical school, Part II as a senior, and Part III as an intern in their first post-graduate year. He established that the purpose behind that examination is “the integration of osteopathic principles and practices as well as the philosophy of osteopathic medicine.” No allopathic physicians are involved in the grading process of that examination. Some allopathic physicians associated with osteopathic colleges may submit questions that, after the review process, may be used on the examination. The purpose of the NBOME examination, as shown by Dr. Smoley, is to make sure that each question integrates osteopathic principles and practices in some way and that the entire examination is reflective of the practice of osteopathic medicine. Dr. Smoley is also familiar with the FLEX examination, as well as the current licensure examination for allopathic physicians, the USMLE. The Federation of State Medical Boards (FSMB) does not prepare any complete examination or any additional components for its regular examination concerning manipulation or osteopathic practice and principles. According to Dr. Smoley, there has never been an official comparison or analysis between the NBOME examination and the FLEX examination. Based upon his experience and educational measurement, he has determined that if one examination, the NBOME, contains osteopathic principles and practice and the other examination, the FLEX, does not incorporate those principles and practices, then the two examinations could not be considered equivalent. The NBOME examination is more extensive because it integrates osteopathic principles and practice throughout its content. This osteopathic examination is not simply one that tests manipulation. Therefore, it is not asserted to be appropriate for chiropractors or M.D.’s who have been trained in manipulation but only for persons who have received an osteopathic medical education. The Respondent also presented the testimony by deposition of James R. Winn, M.D. He is Executive Vice President of the FSMB. The FSMB assists state medical boards in conducting their evaluation of physicians regarding their fitness to practice medicine. The FSMB developed examinations which are administered by state boards. Dr. Winn serves as the supervisor for the examination services section of the FSMB. Those examinations are developed in cooperation with the National Board of Medical Examiners. The current examination available from the FSMB is the United States Medical Licensing Examination (USMLE) used since 1992. Prior to that time, the FSMB administered the FLEX examination, which was for the evaluation of all physicians requesting licensure. The FLEX examination did not have a section on osteopathic practice, as shown by Dr. Winn. The FSMB allows all physicians seeking licensure in the United States to take that examination, including graduates of osteopathic medical schools and graduates of foreign medical schools. With the FLEX examination, unlike the NBOME examination, medical students are not eligible, only graduates of medical schools are eligible to take the examination. Dr. Winn is familiar with the examination of the NBOME and its purpose. He is not aware of any side-by-side comparison between the two examinations to determine equivalency. In his expert opinion, there would have to be such an evaluation in order to determine whether the examinations are equivalent. The testimony of Drs. Smoley and Winn was elaborated upon and corroborated by Dr. Morton Morris. Dr. Morris is a licensed osteopathic physician in the State of Florida and is board certified in osteopathic surgery by the American Osteopathic Board of Orthopedic Surgery. He is also certified by the American Board of Quality Medical Assurance and is a fellow of the American College of Legal Medicine. He is Vice-Chancellor for academic affairs in the health professions division at Nova Southeastern University, a Florida osteopathic medical school. Additionally, Dr. Morris is a licensed, practicing attorney in the State of Florida. He practices in the areas of medical malpractice, general health law and administrative law. Dr. Morris is familiar with the NBOME examination, having served as a test item writer for the NBOME. He recognizes Dr. Smoley as one who helps develop the philosophy of the examinations in question. The philosophy of the NBOME is that content concerning osteopathic practice and principles permeates the entire examination. Even when certain questions on their face are not osteopathically oriented, the evaluation and the grading of the responses is carried out from an osteopathic viewpoint and philosophy. The test item writers are directed to draft test questions which include osteopathic philosophy. In the past, the NBOME has agreed to allow a candidate to take only Part III or an equivalent examination and receive the score from the NBOME. In fact, Dr. Morris represented that person in his capacity as an attorney. He worked out the arrangements whereby that candidate could take and pass Part III of the NBOME examination in order to obtain a Florida osteopathic medical license, as the Petitioner seeks herein, even though, since he would not have taken Part III within the required seven years, he could not receive diplomate status with the NBOME. The Board’s order in this case specifically requires passage of Part III of that examination, but it does not require diplomate status. Such an arrangement would thus seem to provide a means to alleviate the Petitioner’s predicament in the instant situation. The Petitioner, in questioning Dr. Morris upon cross- examination, inquired about the possibility of a person taking all three parts of the NBOME examination, even if he had already taken Parts I and II. Dr. Morris stated that that was possible. Page 7 of the Bulletin of Information, in evidence in Respondent’s Exhibit 1, although stating that the candidate cannot take the examination “to attempt to improve his score”, states nothing to indicate preclusion of a candidate taking the entire examination for any other purpose. Dr. Morris stated that the Petitioner could take Part III of the examination and that the NBOME would make arrangements to allow him to do that, with the understanding that if he passed Part III, he would not be able to receive diplomate status from the NBOME (because of passage of time before taking Part III). In making comparisons between osteopathic medical education and allopathic medical education, Dr. Morris acknowledged that in some cases, osteopathic medical colleges use the same textbooks as used by allopathic medical schools. That does not, however, make them similar professions. Although anatomy and physiology may not be different, the philosophy of treating the whole patient is different. Responding to the Petitioner’s contention that having obtained board certification in his specialty area should count as equivalency to the entry level examination, Dr. Morris pointed out that all that the board certification accomplishes is to show that an osteopathic physician is recognized by his or her peers as competent to practice a specialty. It does not mean that the person is osteopathically oriented enough to be eligible for licensure and to be able to pass a minimum competency examination. The Petitioner contends that having passed Parts I and II of the NBOME examination, FLEX should quality him for osteopathic licensure in the State of Florida, in lieu of taking Part III of the NBOME examination, because anything of an osteopathic nature would have already been tested on Parts I and II. Dr. Morris established to the contrary, however, that Part III is the clinical testing, the testing of how the individual puts to use his clinical evaluation in treatment of patients. It is the ultimate test of whether an individual has developed and is able to apply a philosophy of practice sufficient to show that he is competent to be an osteopathic physician. Parts I and II of the NBOME examination do not test clinical skills. The FLEX does test clinical skills, but it does not test for osteopathic practices as to clinical skills. The NBOME requires that a person take Part III within seven years of having taken Part I, if that person wishes to be a diplomate of the NBOME. There is no apparent preclusion, however, in a person arranging to take only Part III, simply for purposes of state licensure. The record is not clear whether a person could take Parts I, II and III within the period of one year. It does seem apparent, however, that the Petitioner could take Part III within a one-year time period, which is all that is required in the Board’s order. Further, the statute requires that a person take all parts of the NBOME examination or a substantially-equivalent examination. What the Petitioner attempts to do is to take two parts of the NBOME examination and then substitute a different examination (FLEX) for Part III. This does not constitute a substantially-equivalent examination for the above reasons. A substantially-equivalent examination would have to be equivalent to all three parts of the NBOME examination. During discussion of the difference between osteopathic and allopathic schools of medicine, Dr. Morris pointed out that many osteopathic physicians use the same modalities that allopathic physicians use. It is just that they also use osteopathic modalities. He gave the example of a cardiac patient whom an osteopathic physician would treat just as a medical doctor would treat the basic condition with appropriate drugs but then would incorporate osteopathic philosophy, such as the “lymphatic pump”, meaning that the osteopathic physician would incorporate muscle techniques of stretching and passive manipulation in order to help the patient. The osteopathic physician would possibly use manipulative techniques on the lymphatic system and not just use drugs or other allopathic techniques. In the context of the NBOME examination, a question might reference a cardiac patient. Although the question would not mention the lymphatic pump, a proper answer might entail a clinical response that would consider that modality of treatment. In orthopedics, Dr. Morris’ specialty, an osteopathic physician can make significant use of manipulative techniques, as well as general surgery, casting and other modalities normally used by allopathic physicians. Use of the FLEX examination, rather than the NBOME examination, would not lower standards for osteopathic physicians. Rather, the FLEX examination simply embodies a different standard than the one used to test for competency in osteopathic principles and medicine. The Petitioner acknowledged that he could have taken Part III of the NBOME examination but chose not to because it was then more convenient for him to take the FLEX examination to continue his training in the State of Texas which required passage of the FLEX examination for osteopathic licensure. The Petitioner contended that if he applied for a Florida osteopathic medical faculty certificate (MFC), the FLEX examination would be acceptable and he would be eligible. That fact, he contends, by analogy, establishes that he is qualified to practice osteopathic medicine in the State of Florida. He has never applied for such a certificate nor has he been offered an osteopathic medical faculty position in the State of Florida. Thus, determination of that issue is not before this tribunal. Even if it were, there are significant differences between a full license to practice osteopathic medicine indefinitely and a medical faculty certificate. With the MFC, the Petitioner would not be allowed to be engaged in private practice of osteopathic medicine and the MFC would only allow him to practice in the academic realm for only two years. Finally, the statutory requirements for an MFC do not require the passage of any licensure examination. Accordingly, to the extent that the Petitioner’s argument and testimony implies some analogy or equivalency between eligibility for the MFC and eligibility for full licensure, such equivalency is not borne out by the greater weight of the evidence.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the application of the Petitioner, Lawrence Edward Suess, D.O., for licensure as an osteopathic physician, without conditions, is denied on the basis that the FLEX examination has not been shown to be substantially similar to the NBOME examination.DONE AND ENTERED this 28th day of February, 1997, in Tallahassee, Florida. P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 28th day of February, 1997. COPIES FURNISHED: Lawrence E. Suess, D.O., Ph.D. Owensboro Psychiatric Institute 1700 Frederica Street, Suite 106 Owensboro, Kentucky 42301 M. Catherine Lannon, Esquire Department of Legal Affairs The Capitol, Room PL-01 Tallahassee, Florida 32399-1050 William H. Buckhalt, Executive Director Board of Osteopathic Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0757 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: Each of the petitioners and intervenors are owners, operators and/or applicants for acute care hospital facilities in Florida. Prior to the challenged proposed rule, HRS had no separate rule setting forth the criteria or methodology to be utilized when reviewing applications for new or expanded osteopathic hospitals. By memorandum dated March 1, 1984, the then Deputy Assistant Secretary for Health Planning and Development for HRS informed the HRS Acting General Counsel that because there were four applications for osteopathic hospitals should be reviewed and addressed, "it would be to our advantage to have a written policy in place within the next week." An Assistant General Counsel prepared a four-page document dated March 7, 1984, which analyzed the appellate decision in Gulf Coast Hospital, Inc. v. HRS, 424 So.2d 86 (Fla. 1st DCA, 1982) and three administrative orders involving Certificate of Need applications for osteopathic hospitals. HRS rules, particularly those dealing with the Certificate of Need program, are generally prepared by the Office of Comprehensive Health Planning. In this instance, Mr. Eugene Nelson, the Administrator of the Office of Community Medical Facilities, prepared and drafted the challenged rule. Prior to the preparation and approval of the proposed rule, which, according to the notice appearing in Volume 10, No. 18 of the Florida Administrative Weekly (May 4, 1984), was accomplished on April 6, 1984, HRS held no public workshops, formed no task force to study osteopathic bed need, and did not consult with or receive any input from the Statewide Health Counsel, local health councils, existing osteopathic or allopathic facilities or professional associations. After publishing the proposed rule on May 4, 1984, HRS did hold an informal public hearing and received written comments. Neither the transcript of the hearing nor the written comments had been reviewed by Mr. Nelson as of the date of the instant rule challenge hearing. The proposed rule adds a new subsection to existing Rule 10-5.11, Florida Administrative Code, which contains the criteria for evaluating applications for Certificates of Need. Proposed rule 10-5.11(28) sets forth the criteria for evaluating osteopathic acute care need, and provides as follows: "Osteopathic acute care hospital" or "osteopathic hospital" means, for the purposes of administration of the Health Facilities and Health Services Planning Act (Sections 381.493 - 381.499, Florida Statutes), a hospital which: Has or proposes to have licensed doctors of osteopathy (D.O.s) in the capacities of Chief of Staff, Medical Director, chiefs of each medical department, and director of any residency or training program; and Has or proposes to have, on its premises, facilities and equipment to perform osteopathic manipulative therapy. Notwithstanding the above, nothing in this paragraph shall apply to osteopathic hospitals in existence prior to the effective date of this rule. Identification of such hospitals shall be consistent with the current inventory of osteopathic acute care hospitals as shown in reference material filed with the Department of State. Applications for proposed osteopathic acute care hospital beds will be reviewed according to relevant statutory and rule criteria. A favorable need determination for proposed osteopathic acute care hospitals beds will not normally be given to an applicant unless a bed need exists according to paragraph (28)(c) of this rule. A favorable need determination may be made when the criteria, other than as specified in (28)(c), as provided for in 381.494(6)(c), Florida Statutes, and the remainder of Rule 10-5.11, Florida Administrative Code, demonstrate need. The need for osteopathic acute care hospital beds shall be calculated in conjunction with Rule 10-5.11(23) and analyzed on a service district level only. The need for such beds in a service district shall be five percent of that service district's total acute care bed need as determined by Rule 10-5.11(23), notwithstanding the supply of existing and approved non-osteopathic acute care hospital beds in the service district. In determining whether a need exists for additional osteopathic acute care hospital beds, however, the department shall consider the supply of existing and approved osteopathic acute care hospital beds in the service district and shall deduct this supply from the calculation of bed need in making such determination. In addition to the methodology contained in (28)(c), the department shall consider the following criteria and standards in reviewing proposals for additional osteopathic acute care hospital beds: The historical and current utilization of all existing osteopathic acute care hospital beds in the service district; The number of licensed and approved osteopathic acute care hospital beds in the service district; The supply of licensed D.O.'s in reasonable proximity to the location of the proposed osteopathic hospital; The historical and current utilization by D.O.'s of all non-osteopathic hospitals in the service district, except in those instances where discrimination against D.O.'s has regularly occurred. An applicant who cites discrimination in the granting or denial of hospital staff membership or professional clinical privileges as a reason for the application shall include, as part of the application, evidence that the remedies provided for in s.395.006(1), Florida Statutes, have been followed. Each proposed new osteopathic hospital must be accredited by the American Osteopathic Association (AOA) within two years of initial operation. Each existing hospital proposing additional osteopathic acute care hospital beds must be AOA- accredited; and meet the requirements under sections (a)1. and 2. In no event shall historical and current utilization of all hospital beds by all physicians be used to determine need for osteopathic acute care hospital beds. All existing and approved osteopathic acute care hospital beds shall be included in the department's inventory of total existing and approved acute care beds. Subsection (a) of the proposed rule basically defines an osteopathic hospital in terms of its staff and facilities and then "grandfathers" those osteopathic hospitals which are in existence prior to the effective date of the rule. Such hospitals are to be identified by the "current inventory of osteopathic acute care hospitals as shown in reference material filed with the Department of State." According to Mr. Nelson, the inventory referred to in the proposed rule is a directory of osteopathic hospitals prepared by the Florida Osteopathic Medical Association (FOMA). Mr. Nelson had no knowledge of the criteria which FOMA utilized to develop this list, nor did he scrutinize each hospital to determine if it was, indeed, an "osteopathic" facility. At least one hospital, Humana Hospital of the Palm Beaches, was removed by HRS from the FOMA list based on a Recommended Order from a Hearing Officer in a Certificate of Need proceeding finding that Humana was no longer an osteopathic hospital. Humana was not a party to that proceeding. The FOMA list does not include those hospitals whose medical staffs are comprised of a large percentage of osteopathic physicians. Acute care hospitals are licensed by the HRS Office of Licensure and Certification as either "general" or "special" hospitals. They are not licensed as "osteopathic" or as "allopathic" hospitals. The appointment or election of medical staff positions within a hospital are internal matters for each facility and HRS has no authority to control such matters. Florida's Hospital Licensing and Regulation Law does prohibit a licensed facility from denying staff privileges to an individual based upon the individual's status as a Doctor of Osteopathy, a Doctor of Medicine, a Doctor of Dentistry or a Doctor of Podiatry. Section 395.011, Florida Statutes. Subsection (f) of the proposed rule requires accreditation by the American Osteopathic Association (AOA) within two years of initial operation of new osteopathic hospitals and before existing hospitals propose additional osteopathic acute care beds. Both Mr. Nelson and the Director of the Office of Licensure and Certification were unaware of AOA accreditation requirements. There are no statutory requirements for AOA accreditation for osteopathic hospitals. Utilizing the FOMA list of osteopathic hospitals, osteopathic beds comprising approximately five percent of the total number of licensed acute care hospital beds in Florida. The number of osteopathic physicians licensed in Florida, without regard to the nature of their practice or the location of their residence, is approximately five percent of the total number of allopathic physicians licensed in Florida. These two factors form the basis for the quantitative osteopathic bed need methodology set forth in subsections (b) and (c) of the proposed rule. The rule provides that need for osteopathic beds in a given HRS service district is five percent of the total number of acute care hospital beds shown to be needed for such District pursuant to the acute care bed need formula contained in Rule 10 5.11(23), Florida Administrative Code. The acute care bed need formula set forth in Rule 10-5.11(23) basically employs statewide utilization rates to determine each District's bed allocation and then adjusts each District's allocation based upon that District's specific historical utilization experience. The District's gross osteopathic bed need, as determined by the five percent formula contained in the proposed rule, is then to be reduced by the number of existing and approved osteopathic beds. The actual supply of existing and approved non-osteopathic acute care beds in the service district is not to be considered in determining the osteopathic bed need. Conversely, existing and approved osteopathic beds are to be included in the inventory of total existing and approved beds. Subsection (h) of the proposed rule. While historical and current utilization of both existing osteopathic beds and the utilization by osteopathic physicians of beds in non- osteopathic hospitals are factors for consideration (subsection (d)1 and 4), HRS may not consider historical and current utilization of all hospital beds by all physicians. Subsection (g) of the proposed rule. The workings of the proposed rule can be exemplified by assuming a hypothetical District with an overall acute care bed need, as determined pursuant to Rule 10-5.11(23), Florida Administrative Code, of 1,000 beds. If no osteopathic beds currently exist in the District, 50 such beds would be approvable under the proposed rule, regardless of the number of occupancy levels of non-osteopathic beds existing in that District. If the District currently has 800 beds, 50 osteopathic beds would be approvable. If the District currently has 1,400 beds, 50 osteopathic beds would still be approvable. If existing non osteopathic hospitals in the District have occupancy rates of 20 percent or 100 percent, this factor is not to be considered. Conversely, the utilization of existing osteopathic hospitals beds is a factor for consideration. Whether the number 50 in this hypothetical District is a minimum, a maximum or just a guideline for the permissible number of osteopathic beds was a subject of confusion among the witnesses who testified at the hearing. Also subject to confusion was whether the proposed rule has the effect of limiting non-osteopathic facilities to ninety five percent of the total bed need as computed under Rule 10 5.11(23), Florida Administrative Code. In determining the need for osteopathic and allopathic beds in a given area, it is the generally accepted practice of health planning experts to consider such factors as historical, current and projected utilization or occupancy rates of existing acute care beds, the average of length of patient stays, and the admission rates of physicians (recognizing the differences in admission practices among specialties and types of physicians). Another useful predictor of need for osteopathic facilities would be the use of such facilities by non-osteopathic physicians and the use of non-osteopathic beds by osteopathic physicians. No attempt was made by HRS to include these health planning techniques in its methodology for determining the need for osteopathic beds. There are eleven HRS service districts in Florida which vary in composition from one county to sixteen counties. Osteopathic hospitals, as determined by the FOMA list, are not evenly distributed throughout the State. Indeed, such hospitals are located in only 8 of Florida's 67 counties. Four of HRS's Districts have no osteopathic beds, while some 80 percent of the total number of osteopathic beds (2,020 out of 2,504) are concentrated in four Districts. There is no evidence that Florida's osteopathic physicians are evenly distributed among the District. Occupancy levels is osteopathic hospitals for the years 1982 and 1983 have, on a statewide basis, been lower than that experienced in non-osteopathic acute care hospitals. For the year 1982, the District osteopathic occupancy rates for those Districts which had osteopathic facilities ranged from 36.4 percent to 88.5 percent, with a statewide average of 54.1 percent. The allopathic occupancy rate for the same year ranged from 66.8 percent to 74.4 percent among all Districts, with a statewide average of 70.2 percent. The range for osteopathic occupancy rates in 1983 was from 33.9 percent to 85.7 percent, with a statewide average of 50.9 percent. The corresponding allopathic occupancy rates were 64.7 percent to 77.7 percent, with a statewide average of 68.2 percent. The optimal occupancy level for acute care hospitals is generally considered to be 80 percent. Pursuant to Rule 10-5.11(23), Florida Administrative Code, the statewide total acute care bed need for the year 1988 is 49,278 beds. Under proposed rule 10-5.11(28), the total osteopathic bed need for 1988 is 2,463 beds. As of March 15, 1984, there were 51,256 licensed and approved allopathic beds and 2,504 licensed and approved osteopathic beds, for a total acute care bed count of 53,760. Thus, under the operation of both rules, for the 1988 planning year, Florida is overbedded by over 4,400 allopathic beds and over 40 osteopathic beds on a statewide basis. Yet, the net result of applying the proposed rules 5 percent formula to each District is to allow the approval of an additional 896 new osteopathic acute care beds. Adding this number to the number of existing osteopathic beds would result in a ratio of osteopathic to allopathic beds of over 6 percent. The operational effect of the proposed rule on a District basis would be to allow an additional 85 osteopathic beds in District 6 (a District already overbedded by 1,029 beds), even though that District already has 193 osteopathic beds operating at occupancy levels of 35.3 percent. Yet, District 7, which shows a surplus of only 170 beds, would received only 64 osteopathic beds in spite of the fact that its osteopathic occupancy level in 1983 was 85.7 percent. District 11 would show a need under the proposed rule for 120 additional osteopathic beds, even though that District is currently overbedded by over 1,500 beds and experienced an osteopathic occupancy level of 56.5 percent and an allopathic occupancy level of 64.7 percent in 1983. The proposed rule would allow 323 osteopathic beds to be established in 3 of the 4 Districts lacking such beds, even though those 3 Districts are currently overbedded by almost 500 beds. Under the proposed rule, an application for osteopathic acute care beds will not normally be granted unless the 5 percent criterion is met. The rule then command HRS to also consider additional criteria: the number of and utilization of existing osteopathic beds, the supply of licensed D.O.s in "reasonable proximity" to the proposed osteopathic hospital and the historical and current utilization by D.O.s of non-osteopathic hospitals, unless discrimination against D.O.s has regularly occurred. The rule contains no indicia of quantification of these additional criteria. The manner in which these factors are to be treated in the Certificate of Need process is not disclosed. Mr. Nelson candidly admitted that at least two of these factors could work either in favor of approval or in favor of disapproval of an application for new osteopathic acute care beds. The Economic Impact Statement (EIS) prepared by HRS for this proposed rule quantifies the publication, printing and mailing costs of the proposed rule for HRS. In the section entitled "Cost or Economic Benefit to Persons Directly Affected," the EIS notes that the rule is "expected to promote an orderly development" of osteopathic hospitals throughout the state and that applicants proposing osteopathic facilities will be able to determine the number of beds available for Certificate of Need approval. The EIS concludes that the additional criteria "are expected to help contain health care costs" and that the rule is expected to provide more equitable access to osteopathic beds for both applicants and patients. As to the impact on competition and the open market for employment, the EIS concludes that applicants, while competing for fewer beds than those that may be available under Rule 10-5.11(23), would not be able to compete on a more equal basis. Finally, the EIS points out that osteopathic physicians able to document discrimination would stand a better chance of a favorable decision on their application. The only data and method listed for making these conclusions was a review and comparison of Rule 10- 5.11(23) and a review of Certificate of Need applications for osteopathic acute care beds. Experience with the Certificate of Need process illustrates that once a bed need is quantified and announced, those beds are rapidly applied for and approved. It is also an accepted principle that decreased occupancy levels in existing facilities generally result in increased health care costs. This is because a hospital's fixed costs must be spread over relatively fewer patients. No attempt was mad in the EIS to assess the impact which the proposed rule may have on acute care bed surpluses sin Florida or on existing allopathic facilities which currently have osteopathic physicians on their medical staffs. No consideration was given to the effect which the propose rule may have upon competition for patients between existing allopathic and osteopathic facilities. Existing utilization or occupancy levels of either osteopathic or allopathic facilities were not considered by the person who prepared the EIS. The economic impact of giving osteopathic beds a preference over allopathic beds (in the sense that the supply of allopathic beds are not to be considered while the supply of osteopathic beds are to be included in the total bed inventory) was not discussed in the EIS.
The Issue Whether Respondent, Alexandra Konowal, D.O., violated Subsections 459.015(1)(x) and (o), Florida Statutes, and, if so, what penalty should be imposed.
Findings Of Fact Respondent is a licensed osteopathic physician in the State of Florida, having been issued license number OS 7169. Petitioner is the state agency charged with regulating the practice of osteopathic medicine pursuant to Section 20.42, Florida Statutes. On July 20, 1998, Respondent first saw Patient B. M., a 75-year-old female, at Eye Health of Fort Myers, for a complaint of poor vision and cataracts. Respondent scheduled cataract surgery for July 30, 1998, at an outpatient surgery center. On Thursday, July 30, 1998, at approximately 10:30 a.m., Respondent performed the surgery, removing the lens of Patient B. M.‘s left eye and replacing it with an implant. Patient B. M. was discharged from the surgery center at 11:17 a.m., with instructions to go to Eye Health of Fort Myers for follow-up examination that afternoon. On Saturday, August 1, 1998, Patient B. M. telephoned Eye Health early in the morning complaining of inability to see from the left eye and severe pain in the left eye. At about 9:00 a.m., August 1, 1998, Patient B. M. was examined at Eye Health of Fort Myers by James Campbell, an optometrist with Eye Health. Dr. Campbell found residual cortex in the left eye, with corneal edema, but observed no pus in the eye. Dr. Campbell changed the antibiotic eye drops for the patient. At approximately 10:00 a.m., on August 1, 1998, Dr. Campbell had a telephone conference with Respondent and Dr. Franz to discuss the symptoms of Patient B. M. At approximately 4:45 p.m., on August 1, 1998, Patient B. M. again called Eye Health complaining of unbearable pain. Dr. Campbell, in turn, called Respondent at approximately 5:00 p.m. to advise her of Patient B. M.’s complaints. During the 5:00 p.m. telephone call from Dr. Campbell to Respondent, Dr. Campbell discussed the possible diagnosis of endophthalmitis. At 5:36 p.m., August 1, 1998, Respondent spoke with Patient B. M. on the telephone for nine minutes. During the 5:36 p.m. telephone call, Patient B. M. reported shooting pains in her eye and that her vision was bad. During the 5:36 p.m. telephone call, Respondent advised Patient B. M. that she needed to be evaluated. When Patient B. M. said she could not come in, Respondent advised of the possible risks including damage to the optic nerve from excessive pressure and infection. Respondent suggested going to the emergency room and offered to provide transportation, but Patient B. M. refused. During the 5:36 p.m. telephone call, Respondent recommended that Patient B. M. take Percocet that the Patient already had for the pain; Respondent would call in a prescription for erythromycin ointment and told the patient to call back if the eye didn’t improve. Following the 5:36 p.m. telephone call, Respondent did phone in a prescription for erythromycin to a Walgreens Pharmacy near Patient B. M.'s residence. It appears the patient did not pick up this prescription. The "standard of care" expert witness offered by Petitioner found it "difficult to answer" a hypothetical question directed to the "standard of care" of Respondent's care of Patient B. M., incorporating all relevant facts set forth hereinabove in these Findings of Facts and, essentially, failed to render an opinion incorporating all relevant facts; therefore, Petitioner has failed to prove by clear and convincing evidence that 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 as alleged in this matter. Respondent prepared an office note dated August 1, 1998, 7:30 p.m., as a record of Respondent’s telephone call to Patient B. M. This note was, in fact, prepared on the morning of August 3, 1998. The note reads in its entirety: 8/1/98 7:30 PM Spoke with patient. States having pain in left eye. Recommended artificial tears for shooting pain, and continue using Ocuflox and Pred Forte. Patient states she has been taking Percocet every four hours with no relief, but she takes Percocet regularly for neuropathy. Told to use two every four hours and call if no improvement. While the August 1, 1998, office note records a great deal of relevant information, Respondent's testimony revealed it does not reflect Patient B. M.'s refusal to come in for evaluation, Respondent's warnings regarding the risks of not being evaluated, an offer of transportation to an emergency room, or a prescription order for Erythromycin. Petitioner's expert witness testified on deposition that, "I'm not sure what the standard of care is" for charting weekend telephone calls. When he receives a telephone call at home from a patient, he makes notes on "a scrap of paper" and later records the note in the patient's record. Respondent testified that she now keeps a book at home in which she records every conversation when patients call her at home; she then brings the book to her office for reference in recording the entire conversation in the patient's record. However, she does not believe that anyone in her practice does it the way she now does. There is no standard procedure in the practice of osteopathic medicine for memorializing conversations in the patient's record between a physician and patient which occur outside the office or hospital setting. On August 3, 1998, Patient B. M. returned to Respondent’s office complaining of no vision and sharp pain. Respondent’s examination revealed Patient B. M.’s left eye to be swollen and with hypopyon (internal pus). Respondent diagnosed endophthalmitis and immediately referred Patient B. M. to a retinal specialist. On August 3, 1998, Patient B. M. was seen by the retinal specialist who found near total hypopyon, so that neither the iris nor any posterior detail could be visualized. Ultrasound showed dense mobile vitreal opacities, primarily anteriorly. The specialist recommended a vitrectomy with injection of antibiotics, and discussed at length the possibility of loss of vision, loss of the eye and uncertainty of any visual benefit. He performed the surgery for Patient B. M. the night of August 3, 1998. Endophthalmitis is a recognized complication of cataract surgery that occurs in less than one percent of patients, but does not presumptively indicate a departure from the standard of care. The standard of care required Respondent see Patient B. M. and treat her for endophthalmitis on August 1, 1998, or to warn Patient B. M. on August 1, 1998, of the serious consequences of endophthalmitis if Patient B. M. did not have an examination. The evidence revealed that Respondent warned Patient B. M. of the serious consequences of her failure to go to the clinic or an emergency room for treatment.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED, that the Department of Health, Board of Osteopathy, enter a final order finding that Respondent, Alexandra Konowal, D.O., is not guilty of violating Subsections 459.015(1)(x) and (o), Florida Statutes, and dismissing the Administrative Complaint filed in this matter. DONE AND ENTERED this 18th day of December, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of December, 2001. COPIES FURNISHED: Bruce A. Campbell, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 39A Tallahassee, Florida 32399-0450 Bruce M. Stanley, Jr., Esquire Henderson, Franklin, Starnes & Holt 1715 Monroe Street Post Office Box 280 Fort Myers, Florida 33902-0280 William H. Buckhalt, Executive Director Board of Osteopathic Medicine Department of Health 4052 Bald Cypress Way, Bin C06 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact Petitioner, OMCO, is a corporation formed by Basic American Medical, Inc.(BAMI), to apply for a certificate of need (CON) to construct and operate a 120-bed acute care osteopathic hospital in Ocala, Florida. Petitioner is incorporated with 1,000 authorized shares with a par value of $1.00 per share. All shares of OMCO are controlled by BAMI pending issue. To obtain local support for the application, BAMI has offered local investors, principally doctors, the opportunity to purchase ten shares each at par value conditioned upon the issuance of a CON to OMCO. Up to 20 percent of the stock is proposed to be issued to 20 such investors (Exhibit 3). At the time of the hearing 10 percent of the stock had been issued to ten doctors, each of whom paid BAMI $10.00. Financing of the project is to be arranged by BAMI and, although BAMI is prepared to provide in excess of $1 million for initial construction and $1 million for start-up operating expenses, the entire cost of the project is intended to be funded with long-term financing. Arrangements for this financing is to be handled by Century Mortgage Corp., a wholly owned subsidiary of BAMI. Century Mortgage Corp. offered to provide $9 million at 12.5 percent for 25 years and $3.6 million at 13.5 percent for 8 years, for equipment, but proposes to serve only as a broker between OMCO and the investors who advance the money. BAMI corporate officers testified that Marion County was selected as the site for the proposed hospital because the state acute care bed methodology rule indicates there is a need for additional acute care beds in Marion County. No need for osteopathic hospital beds was determined but the application was submitted for an osteopathic hospital because, under Florida law, it was believed easier to get a CON for an osteopathic hospital than for an allopathic hospital. One of these investors, Sheldon Katanick, D.O., is a resident of Michigan who is contemplating a move to the Ocala area. Dr. Katanick is a radiologist but is currently on the staff at no hospital. He would prefer to practice at an osteopathic hospital rather than at an allopathic hospital because "There are procedures I might want that wouldn't be carried out at an allopathic hospital." No further identification of these procedures was given. As a radiologist Dr. Katanick would admit fewer patients than he would if he were in general practice. He estimates that he would admit five to ten patients per month if the application is approved and he moves to Ocala and establishes a practice. Arthur Paraiso, M.D., lives in Bellview, some ten miles south of Ocala, and is also an investor in OMCO. He has never served on the staff of an osteopathic hospital but would have no objection to serving on such a staff and will serve if the hospital is built. Paraiso is currently on the staff of no hospital. He recently resigned from the staff of Munroe Regional Medical Center because he "didn't like the atmosphere." He was told to resign from the staff of another hospital which was not identified. He has approximately 1,000 active patients but has no idea how many of these patients he would admit to the proposed hospital. Ronald E. Shelley, D.O., has operated the Bellview Medical Center for 16 years as sole practitioner. Although he has served on the staff of allopathic hospitals in the past, he is currently on the staff of no hospital. He considers the commuting from Bellview to Ocala (ten miles) to be difficult and prefers to refer his patients needing hospitalization to a doctor admitted to the staff at one of the Ocala hospitals. Also, he considers it difficult for a sole practitioner to serve on the staff of a hospital without being covered by another practitioner in his office. Shelley sees up to 60 patients per day in the winter season and approximately 40 patients per day during the summer. Most of the patients he has hospitalized go to an Ocala hospital but occasionally he sends patients to an osteopathic hospital in Orlando. Dr. Shelley is also a stockholder in OMCO and is on the board of directors. He is president of District Twelve Osteopathy Group, which has 25 members located throughout District Three, the health planning district in which Marion County is located. Robert M. Corbett, D.O., supports the application to construct an osteophathic hospital at Ocala. He operates two emergency walk-in clinics, one at Crystal River, Florida, and one at Ocala, Florida. He holds staff privileges at Seven Rivers Community Hospital in Crystal River and consulting privileges at Marion Community Hospital, which authorizes him to admit a limited number of patients to this hospital each year. Emergency clinics are staffed with four DO's and two MD's. Generally, the clinics treat emergency patients, and if one of these patients needs to be hospitalized the clinic refers the patient to a doctor on the staff of the appropriate hospital for admission. Dr. Corbett and the other doctors manning the emergency walk-in clinics do not have time to run the clinics and monitor patients in the hospital at the same time; hence, the referrals to another doctor for admission. Dr. Corbett did not testify he would change his mode of operation of referring patients for hospitalization and personally admit patients if an osteophathic hospital opened in Ocala. Robert Panzer, D.O., testified by deposition submitted after the final hearing date. Dr. Panzer has been practicing osteopathy in the Ocala area for approximately eight years and has about 5,000 active patients, of which six to ten are normally hospitalized. He admits all of his patients through M.D. specialists. He applied for and was accepted on the staff of Munroe Regional Medical Center, but never exercised the privileges granted. Panzer testified that he was told by a staff member at an Ocala hospital that he could not do manipulation of patients in the hospital; but, on cross-examination, he could not recall who told him that.; Dr. Panzer also has patients from outside Marion County. If this osteophathic hospital is authorized, Fanzer would join the staff and admit patients. He is one of the ten local investors and has been elected to the board of directors of the proposed hospital by the other investors. Other than the testimony of Dr. Panzer that he could not practice manipulation at a local hospital, no testimony was presented that any osteopathic patient is unable to obtain adequate treatment at existing facilities in Marion County, that existing hospitals refuse to admit osteopathic physicians to their staffs, or that there is any unmet need for osteophathic treatment in Marion County. There is no osteopathic hospital in District Three, which includes Marion County and 15 other surrounding counties. In District Three there are approximately 25 osteopathic physicians; in Marion County there are eight, of which only two, including Panzer, have applied for staff privileges at a Marion County hospital. Considerable testimony was presented that once an osteopathic hospital is built additional osteopathic physicians will move to the area, will build up practices, and utilize the facilities provided. Only general historical data from other counties was presented to support this position. In those counties cited the population is more urban than is Marion County and District Three population. Except for one hospital in Palm Beach County, osteopathic hospitals in Florida have a lower occupancy rate than do allopathic hospitals. Most DO witnesses emphasize the holistic approach to the patient taken by the osteophathic physician in his treatment as compared to the treatment of the specific illness used by an allopathic physician and to the fact that greater use of manipulative therapy is used in the practice of osteopathic medicine than in the practice of allopathic medicine. Otherwise, all witnesses generally agreed that the physical facilities provided at an acute care hospital are identical at allopathic and osteopathic hospitals. A bed in an allopathic hospital is indistinguishable from a bed in an osteopathic hospital and the primary difference between the two practices results from the philosophical approach to medicine each takes. As a result, patients of osteopathic physicians receive more physical therapy treatment than do patients of allopathic physicians albeit by use of identical equipment. Plans and cost estimates for the proposed hospital, including equipment, are taken largely from an allopathic hospital recently opened by BAMI at Kissimmee, Florida. The implementation of the Diagnostic Related Groups (DRG's) by the Federal Government for Medicare patients and greater emphasis and growth of Health Maintenance Organizations (HMO's) and Preferred provider Organizations (PPO's) which have occurred during the past year have coincided with a major reduction in the usage rate of hospital beds in the subdistrict of Marion County as well as throughout the State of Florida and the United States. For reasons generally attributed to actions intended to reduce the cost of medical treatment, patient days and hospital occupancy rates have been materially reduced and if current trends continue substantial rate increases will be needed to keep many hospitals solvent. This factor is affecting the existing 15 osteopathic hospitals in Florida at the same or greater rate than it is affecting the allopathic hospitals. Although Gulf Coast Hospital v. DHRS, 420 So.2d 86 (Fla. 1st DCA 1982), indicates the acute care bed need rule, 10 5.11(23), F.A.C., is not applicable to determining need for osteopathic hospital beds, Petitioner uses this rule to show a need for acute care beds exists in Marion County. Because the acute care bed rule is partly based on a 1978 statewide use rate to determine need, the methodology overstates the need for new beds. Since 1978 the use rate has decreased throughout the state but the rule has not been modified to reflect this reduction in use rate. District Three, the 16-county area including Marion County, has a need for acute care beds in 1990 (the target year for this application) of 191. Using the 1984 use rate, Marion County will have a need for 87 acute care beds in 1990. The Health Planning council for District Three has recommended that 15 percent of the district bed need should be set aside for Levy, Dixie, and Gilchrist Counties, which have been determined to be underserved. This reduces the potential allocation of beds to Marion County to 74. As a general rule CON's for less than 100 bed hospitals are not granted because those hospitals tend to be less cost-effective than are larger hospitals offering the same services. Absent a bed need methodology for osteopathic hospitals, DHRS developed two methodologies to determine need for osteopathic hospital beds. The first methodology divides the number of admissions to osteopathic hospitals in each county in 1984 by the number of doctors of osteopathy in the county to arrive at an admission rate per DO. This is multiplied by the average length of stay (ALOS) to arrive at the number of patient days per DO. Averaging the patient days per 1,000 population for these osteopathic hospitals in the southern Florida counties in which osteopathic hospitals are located gives an average of 63.3 patient days per 1,000 population in these counties. Applying this figure to the population of Marion County in 1990, the five year planning horizon used to determine the hospital bed need, shows approximately 41 osteopathic beds will be needed in Marion County in 1990 (Exhibit 9). The second approach which is not really a bed need methodology as much as a check on the requested beds is to determine from the same historical data the number of DO's needed to support a 120-bed hospital. That figure is calculated to be 91 (Exhibit 9). Methodologies proposed by OMCO's expert witnesses rely heavily on the acute care bed need methodology established by Rule 10-5.11(23), F.A.C. although the courts have held that this methodology is not applicable to osteopathic hospitals because of the language of Section 381.494(2), Florida Statutes, which requires "The need for such facilities shall be determined on the basis of the need for and the availability of osteopathic services and facilities in the community." Further, Petitioner attempts to justify the need for an osteopathic facility in District Three, which has no osteopathic hospital, on the basis of the population of the district as a whole despite the long distances involved in this 16-county area. Obviously, people in the extreme northwestern part of this district are unlikely to use the proposed facility in Ocala in view of much nearer acute care hospital beds. Only a hospital offering those services provided by a regional medical center can expect to have a districtwide service area. Here, OMCO proposes to provide only basic acute care facilities and few patients could be expected from beyond the primary service area of Marion County. With the current decline in hospital occupancy rate, the introduction of a new hospital in Marion County will have an adverse impact on existing hospitals since patients that would be admitted at OMCO would generally come from those patients that otherwise would use MCH or MRMC. This would serve to reduce even further those hospital occupancy rates and adversely affect the ability of MRMC to serve indigent patients. Because of the declining occupancy rates in all hospitals and the generally lower occupancy rates at osteopathic hospitals in Florida, the financial feasibility of the project is questionable despite OMCO's witnesses who attested to the financial feasibility of the project. The estimates on which these opinions of financial feasibility are based are not realistic and do not incorporate the latest data on occupancy rates for the calendar year 1984 which were available, albeit not in final published form, at the time of the hearing. Evidence presented for those completed months of 1985 indicates the occupancy rates are further declining in the Marion County hospitals in 1985. OMCO proposes to serve as a teaching hospital and presented witnesses who so testified. Before a hospital can serve as a teaching hospital, it must meet certain qualifications, such as having as heads of all departments DO's who meet specific requirements, and thereafter be certified as a teaching hospital by the American Osteopathic Association. While it is certainly possible for OMCO to meet these requirements and be so certified, it is speculative to say at the present time that such certification will be obtained. Evidence of need for additional teaching hospitals was submitted only by objected-to hearsay testimony not corroborated by admissible evidence. Accordingly, need for additional osteopathic teaching hospitals was not shown. None of the other criteria of Section 381.494(6)(c)1 13, Florida Statutes, are of sufficient comport to justify denial of this application if a need for the proposed facility had been demonstrated. Absent a showing of need, further discussion of these criteria is not deemed warranted or necessary to the findings.
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 Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: By an application filed in late 1981, Sun Coast Hospital, in partnership with Metropolitan General Hospital, sought approval from the respondent HRS for a Certificate of Need to construct an 86-bed acute care hospital facility in the Countryside area of North Pinellas County. The facility is to be known as the Palm Harbor Hospital and is to be located on State Road 584, some 18 to 20 miles from the existing Sun Coast Hospital. The proposed facility is to be a free-standing hospital with 80 medical/surgical beds and 6 intensive care beds. Twenty-six of the beds are to be transferred from Sun Coast Hospital. The total project cost is $10,066,533 to be financed by a bond issue at 15 percent interest for 30 years. It is anticipated that Sun Coast and Metropolitan General will split the initial costs of the Palm Harbor facility. It is proposed that the new facility will have a radiology department, a laboratory, a surgical department and an emergency room. Metropolitan and Sun Coast will serve as back-up facilities for the more complicated procedures. The medical staff at the new facility will be oriented to osteopathic specialties. It is anticipated that the new Palm Harbor Hospital will be a teaching facility for osteopathic medicine. Petitioners project an 80 percent occupancy rate at the proposed facility for its second year of operation. The respondent HRS conducted a comparative analysis of petitioners' application along with four other applications for Certificates of Need for hospitals in North Pinellas County. HRS denied petitioners' application, but granted a Certificate of Need to Mease Hospital and Clinic to construct a 100- bed satellite acute care hospital in North Pinellas County. The Certificate of Need issued to Mease is not being challenged in this proceeding. The petitioners' proposed facility is to be located approximately 2.5 miles from the new Mease facility. Sun Coast and Metropolitan General Hospitals are nonprofit corporations accredited by the American Osteopathic Association (AOA). Metropolitan is located in Pinellas Park and Sun Coast is located in Largo, just north of Ulmerton Road. Sun Coast is one of the largest teaching facilities for osteopathic physicians in the South, and it is the largest teaching facility in Florida. It trains about 30 osteopaths at any given time, and at the time of the hearing, it had 14 interns, 15 externs and 8 residents. Some 95 percent of the physicians on its staff are Doctors of Osteopathy (D.O.). Sun Coast Hospital has 314 licensed beds, with 248 beds staffed and in operation. It intends to transfer 26 beds to the new Palm Harbor facility. The average monthly occupancy at Sun Coast is 180 beds, or 57 percent of its licensed bed capacity. Out of its 248 operating beds, there are generally 68 open and available beds at all times. Sun Coast presently receives approximately 10 percent of its patient census from the Palm Harbor area. Teaching hospitals attract primary care physicians to an area. As part of their education, DOs are required to serve a one-year rotating internship at an AOA accredited hospital. This includes rotating service and training in the areas of general medicine, surgery, OB/GYN, pediatrics, pathology and radiology. In the United States, there are 15 Colleges of Osteopathic Medicine, 8 of which have been established in the last 10 years. While there were only 400 osteopathic graduates five to seven years ago, there are presently 1100 graduates per year. There are approximately 16,000 medical doctors graduating each year. Nationally, approximately 4 percent of all physicians are Doctors of Osteopathy. In Florida, 13 percent of all physicians are Doctors of Osteopathy. In Pinellas County, there are three AOA accredited hospital facilities with a total of 534 beds, or 12 percent of the total licensed beds. In North Pinellas County (north of Ulmerton Road), there are approximately 439 MDs and 92 DOs, or 17.33 percent of all the physicians. The DOs in North Pinellas have 2.27 AOA accredited beds per D.O., as compared to 3.5 non-AOA available beds per M.D. Based upon total licensed bed capacity, the occupancy levels in Pinellas County for allopathic beds is 69 percent and is 56.2 percent for osteopathic beds. In North Pinellas County, the occupancy levels for total allopathic beds is 73.1 percent and for total osteopathic beds is approximately 55 percent. In North Pinellas County, osteopathic patients account for about 12 percent of all hospital admissions. Osteopathic beds account for approximately 18 percent of the total number of licensed beds in North Pinellas County. Pinellas County has more osteopathic beds than other areas in this State. Approximately 30 percent of all osteopathic beds in Florida are in Pinellas County, which has about 7.5 percent of the State's population. HRS has no promulgated or established definition of an osteopathic facility. Some experts testified that a facility had to be AOA accredited to be designated a true "osteopathic" facility, while others were of the opinion that only the "concept" of the facility must be osteopathic. While osteopathic physicians receive somewhat different training and education than allopathic physicians, there was no dispute that there is no major difference between an osteopathic and an allopathic hospital with regard to necessary equipment or technical staff. The main equipment difference is a table upon which manipulative therapy is performed in the osteopathic facility. Also, a structural examination of osteopathic patients is performed and, therefore, space is needed on the hospital chart to record the structural evaluation. There are currently three AOA accredited osteopathic hospitals in Pinellas County--Sun Coast, Metropolitan and Harborside Hospital. University Hospital, which is largely staffed by DOs, but is not AOA certified, also exists in Pinellas County. Located about 25 minutes north of the Countryside or Palm Harbor area is Riverside Hospital in Pasco County. Riverside is owned by American Health Care Enterprises, which also owns Harborside Hospital in St. Petersburg. Riverside was purchased from Pasco County in 1982 and, in the contract of sale, American Health Care made a commitment of its desire to be accredited by the AOA, become an osteopathic teaching facility and be affiliated with the Southeastern College of Osteopathic Medicine in Miami. Riverside has 102 licensed beds, with 100 beds open. Of its total admissions, 56 percent are osteopathic patients. It is operated by a seven member Board of Directors, three of whom are physicians. Two of the three physicians are osteopaths. One of the osteopathic Board members is a trustee of the Southeastern College of Osteopathic Medicine. Riverside's Chief of Medicine is a D.O., as is its Vice- Chief of Staff. Of the 18 family physicians on the staff at Riverside, 14 are DOs. The opening and operation of a new osteopathic facility within a 25 minute drive from Riverside Hospital would harm Riverside financially and would hinder its plans to become an osteopathic teaching facility. The local health systems plan found a need for 95 additional hospital beds in North Pinellas County. Insufficient evidence was presented by the parties that the need for hospital beds, osteopathic or allopathic, in North Pinellas County was any greater than 95. The applicable standard for accessibility is that hospital beds located within 30 minutes driving time be available for 90 percent of an area's population. In determining the bed needs for an area, it is the policy of HRS to consider community needs in terms of historical utilization and shifts in population. Neither physician opinion, beds per physician nor the needs of a limited proposed primary service area (as opposed to community need) are given controlling consideration. The recently approved 100-bed facility of Mease Hospital and Clinic is located about two miles north and 1.5 miles west of the central point of the petitioners' proposed primary service area. The new Mease facility is to be a satellite of the Mease Hospital in Dunedin, which operates at an occupancy level of 74 percent. Mease is not accredited by the AOA and has no separate manipulative therapy department, but it does have 8 osteopathic physicians on its staff. The new Countryside Mease facility plans to have an emergency room, and offer services in radiology, physical therapy and surgery. It is anticipated that two osteopathic physicians will staff the Mease Countryside emergency room. Local law requires that critically ill, emergency patients be transported to the nearest emergency room. The opening and operation of a new osteopathic hospital within two and one half miles of the new Mease Hospital would harm it financially, would divert emergency room patients and inpatients derived there from, and would make it difficult for Mease to adequately staff its new facility.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that the application of Sun Coast/Metropolitan General Hospital for a Certificate of Need to construct an 86-bed acute care osteopathic hospital in North Pinellas County be DENIED. Respectfully submitted and entered this 29th day of June, 1983, in Tallahassee, Florida. DIANE D. TREMOR Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 29th day of June, 1983. COPIES FURNISHED: Cynthia S. Tunnicliff, Esquire Carlton, Fields, Ward, Emmanuel, Smith & Cutler, P.A. P.O. Drawer 190 Tallahassee, Florida 32302 Robert A. Weiss, Esquire Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32301 John P. Frazer, Esquire Frazer & Hubbard, P.A. P.O. Box 1178 Dunedin, Florida 33528-1178 Kenneth Hoffman, Esquire Oertel & Hoffman, P.A. 646 Lewis State Bank Bldg. Tallahassee, Florida 32301-1879 David Pingree Secretary Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32301
The Issue The issue in the case is whether the allegations of the Administrative Complaint, filed by the Petitioner against the Respondent, are correct, and, if so, what penalty should be imposed.
Findings Of Fact The Petitioner is the agency responsible for licensure and regulation of osteopathic physicians practicing in the State of Florida. At all times material to this case, the Respondent has been a Florida licensed osteopathic physician, holding license number OS 005726. The Respondent is board-certified in family medicine and emergency medicine. On February 23, 2000, the Respondent was working in the emergency room at Health Central medical facility in Ocoee, Florida. On February 23, 2000, a patient, herein identified as Patient D.S., arrived at the Health Central emergency room. According to the triage notes, Patient D.S. presented with "intermittent chest & upper back pain" occurring over a two-week period. Patient D.S. had been brought to the emergency room by a friend. The triage nurse's notes indicate that he was interviewed at about 2:05 p.m. The patient's vital signs were taken. As recorded in the triage nurse's notes, the patient's pulse was slightly elevated at 110. His blood pressure was 139/96. Patient D.S. presented at the emergency room with several cardiac risk factors. He was a smoker and over 40 years of age. The fact that he is a male is alleged as an additional risk factor although the evidence fails to establish that gender alone is a significant risk factor. At about 2:28 p.m., the Respondent met Patient D.S. for evaluation. The Respondent noted the patient's chief complaint to be "intermittent r[ight] upper back discomfort and chest tightness" of two weeks' duration. The patient indicated that the pain radiated across the upper back. There was no shortness of breath, no nausea or vomiting, and no diaphoresis noted. The patient identified the pain as a three on a one-to-ten scale. The Respondent observed that the patient was curt in his responses to questions and did not appear interested in remaining in the emergency room. The patient indicated that he had no personal or family history of coronary artery disease, hypertension or diabetes (additional coronary risk factors). The patient admitted to smoking a pack of cigarettes daily. The patient denied any prior cardiac event. The Respondent performed a physical examination of the patient. The patient did not exhibit any of the classical signs of a heart attack, such as sharp lateral left chest pain, substernal chest pressure or pain, pallor, sweating, nausea, vomiting, severe indigestion, or loss of blood pressure. Based on the triage protocol, a "12 lead" EKG was ordered for Patient D.S. and was performed at about 2:52 p.m. According to the EKG (also known as an ECG), Patient D.S. exhibited normal sinus rhythm, but the EKG was classified as "abnormal" and displayed possible left atrial enlargement and an anterolateral infarct of undetermined age. The EKG measures different heart functions including ischemia, infarction, enlargement, arrhythmias and irregularities in conduction patterns. Patient D.S.'s EKG showed poor "R wave" progression, which is indicative of prior myocardial injury. Patient D.S.'s EKG exhibited the presence of "QS complexes" from V1 to V6 with no "R wave" progression, which is indicative of prior myocardial injury. Patient D.S.'s EKG showed evidence of an anterolateral infarct, indicating the existence of prior myocardial injury. According to the EKG analysis, Patient D.S. had experienced a cardiac injury at some time prior to his arrival at the emergency room on February 23, 2000, or was experiencing a cardiac injury during his visit to the emergency room. The fact that the EKG exhibited evidence of prior myocardial injury places Patient D.S. at higher-risk for subsequent cardiac injury. The Respondent documented that he evaluated the triage assessment and reviewed the EKG results. The Respondent did not admit the patient to the hospital for observation. The Respondent did not consult with a cardiologist on staff at the hospital. The Respondent did not order cardiac enzyme testing for the patient. The patient told the Respondent that the patient had an appointment on February 24, 2000, with his primary physician. The Respondent discharged the patient with a diagnosis of right shoulder and back pain, concluding the symptoms were of a musculoskeletal origin. The Respondent provided a copy of the EKG to the patient and instructed him to give it to his primary care physician on the next day. By deposition, Dr. Steven M. Schwartz testified as a medical expert on behalf of the Petitioner. At the hearing, Todd M. Husty testified as a medical expert on behalf of the Respondent. Based upon a review of the testimony, the testimony of Dr. Schwartz is persuasive and is credited. Based on the circumstances of this case and on Dr. Schwartz testimony, the Respondent has failed to practice osteopathic medicine with the level of care, skill, and treatment recognized as being acceptable under similar conditions and circumstances. The symptoms exhibited or reported by Patient D.S. during his visit to the emergency room on February 23, 2000, are consistent with ischemic heart disease which is the result of insufficient blood circulation to the heart muscle tissue. A reasonable and prudent physician under similar circumstances would have considered Patient D.S. to be at high risk for ischemic heart disease, and would have admitted the patient to the hospital for further diagnostic testing and evaluation including consultation with a staff cardiologist. Patients experiencing cardiac infarction can present with atypical symptoms almost as frequently as with classical symptoms. Atypical presentations can include pain in areas other than those identified as classical pain patterns. The pain can be dull instead of sharp. The pain can be reproducible on manipulation. Patient D.S. was experiencing atypical dull and reproducible pain. The absence of classical symptoms does not rule out the possibility of infarction or ischemia. Symptoms of musculoskeletal chest pain are similar to symptoms exhibited by a person who has experienced or is experiencing a myocardial infarction. The standard of care requires that potential myocardial infarction be ruled out. A reasonable and prudent physician would proceed to perform appropriate tests to rule out cardiac cause of the symptoms before concluding they were of musculoskeletal origin. The day after leaving the emergency room, the patient was evaluated by his primary care physician and was transported from the physician's office to Florida Hospital for further treatment. On February 25, 2000, Patient D.S. underwent a left heart catheterization and coronary arteriogram, which revealed 90 percent stenosis of the left anterior, and atherosclerotic plaquing of the right coronary artery and circumflex. On February 29, 2000, Patient D.S. underwent a percutaneous transluminal coronary angioplasty and stenting. The patient's recovery from the incident and procedure was satisfactory.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a Final Order finding that William H. Weaver, D.O., violated Section 459.015(1)(x), Florida Statutes, and imposing a reprimand and a fine of $2,500.00. It is further recommended that William H. Weaver, D.O., be required to complete within six months of the Final Order, a continuing medical education course related to proper diagnosis and treatment of cardiac-related presentations in an emergency room setting. DONE AND ENTERED this 7th day of February, 2003, in Tallahassee, Leon County, Florida. WILLIAM F. QUATTLEBAUM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 7th day of February, 2003. COPIES FURNISHED: Matthew P. Bartolomei, Esquire Hill, Adams, Hall & Schieffelin, P.A. Post Office Box 1090 Winter Park, Florida 32790-1090 James W. Earl, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265 Kim Kluck, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265 William H. Buckhalt, Executive Director Board of Osteopathic Medicine Department of Health 4052 Bald Cypress Way, Bin C06 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4025 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4025 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact THE APPLICANT Petitioners Osteophathic Medical Hospitals, Inc. (OMHI), proposes to build a 120-bed acute care osteopathic teaching hospital in the Hobe Sound area of Martin County. Hobe Sound is located in the south-central portion of the county, along the eastern seaboard. The hospital is intended to serve the needs of both osteopathic and allopathic physicians and their patients but will be openly identified and administered as an osteopathic institution. Osteopathic physicians, under the guidance of the current principals of OMHI, will be responsible for recruitment and organization of the professional staff, along with the development and administration of an osteopathic intern and residency training program. OMHI's application was filed on August 15, 1983, and was deemed complete by Respondent, Department of Health and Rehabilitative Services (DHRS), on October 15, 1983. DHRS reviewed the application and, in January 1984, denied the application. This administrative proceeding followed. OMHI revised its application twice during the pendency of these administrative proceedings, the most recent revision occurring on October 18, 1985. The most outstanding revision is the involvement of Hospital Corporation of America (HCA) in the proposed hospital and HCA's backing and eventual takeover of the project. The revision also based the need for the project on need projected for January 1, 1991. OMHI is a Florida corporation, the shareholders of which are three osteopathic physicians practicing in District IX: Dr. Harold Kirsh, Dr. Michael Longo, and Dr. Albert LaTorra. 0MHI is party to a binding contract with Hospital Corporation of America (HCA), under which HCA has agreed that, if the certificate of need is granted, HCA shall acquire the stock of OMHI and, thereafter, shall construct the proposed hospital and operate it as an osteopathic institution, consistent with the representations included in the CON application. HCA had no such interest in this project when the original CON application was filed in August 1983. OMHI had not intended to involve HCA in this project and, indeed, would have preferred to have proceeded autonomously with development of the hospital. At the time the original application was denied, OMHI had entered into an agreement with a large commercial developer whereby the latter had agreed to finance and construct the hospital if the application were granted. OMHI's original intention was then to employ a professional management company to operate the hospital. When the application was denied, it became necessary to seek another joint venturer to underwrite the anticipated financial burden of the administrative hearing. OMHI representatives contacted various proprietary health care chains to ascertain whether any would agree to underwrite the cost of an administrative proceeding in return for the opportunity to own and operate the new osteopathic facility. OMHI had such discussions with Universal Health Services, Inc. and American Medical International, Inc., in addition to Hospital Corporation of America. Further, Dr. Kirsh inquired whether Martin Memorial would be interested in a joint venture in connection with Martin Memorial's then pending application to construct a satellite hospital in central Martin County on the condition that this latter proposed facility be open to all licensed osteopathic physicians. Ultimately, OMHI elected to enter into the relationship with Hospital Corporation of America. In addition to acquiring the stock of OMHI should this application be granted, HCA has agreed to operate the facility as an osteopathic institution, to insure that the professional staff by-laws comport with the requirements of the American Osteopathic Association, to seek accreditation by the AOA, and to implement an osteopathic intern and residency program. For their part, the principals of OMHI agree to assume responsibility for recruitment and staff of the new facility and for supervision and administration of the proposed osteopathic intern and residency programs. The principals of OMHI already have had such experience in connection with their role in the development of the new osteopathic hospital in Wellington, as well as the development of Community (now Humana) Hospital of the Palm Beaches when it was an osteopathic facility. The principals of OMHI also are parties to the contract and would have a continuing right of enforcement. OSTEOPATHIC MEDICINE AND OSTEOPATHIC TRAINING. The osteopathic profession emphasizes the delivery of primary care. Approximately 80 percent of practicing osteopathic physicians today are engaged in general/family practice. Although there may be increasing numbers of osteopathic students who seek specialty training, more than 70 percent of the osteopathic students graduating today still go into family practice. Because of the profession's commitment to the emphasis upon primary care, the curriculum at osteopathic colleges varies significantly from the course of study at allopathic medical schools. Osteopathic schools require all students to take a broad range of clinical and didactic courses, so that the student is exposed to all medical subject matter. Further, during upper class years, each student is required to take rotating "externships" during which he or she concentrates, for months at a time, on different medical specialities at various osteopathic hospitals. By contrast, the allopathic student typically elects his or her specialty during the medical school years and begins to concentrate on a narrower range of medical subject matter during that time. Upon graduation, the allopathic student continues this specialty training with two or more years of postgraduate training in that particular area. As a result, many allopathic students may complete their entire education without exposure to the broader medical subject matter with which every family physician must have a working familiarity. Osteopathic postgraduate education is also quite different from the allopathic model. Unlike the allopathic student, who continues his specialty training during his postgraduate years, the osteopathic graduate is required to take a one year "rotating internship" at an osteopathic hospital. Again, the emphasis and point of this internship is to prepare the student for family practice because that preparation is the profession's mission. During the internship, the student is required to serve in all of the major hospital departments, including surgery, internal medicine, OB/GYN, family practice and the ancillary departments. Allopathic training and postgraduate programs are accredited by the AMA through the Liaison Committee on Graduate Medical Education. The Liaison Committee has no connection with osteopathic postgraduate programs, which are accredited by the AOA. As a result of this training in general medicine, the osteopathic physician is fully qualified to enter family practice following his or her one- year rotating internship. Florida grants licensure to osteopathic students at that time. In essence, the profession's emphasis on general practice during the student's early medical school years commences his or her "specialty" training in family practice well before graduation and the postgraduate internship. Osteopathic medicine differs from the allopathic school not only in philosophy, but also in the clinical approach to the musculoskeletal system. Osteopathic physicians are trained not only to treat the symptoms of disease through drug therapy but to view disease as dysfunction in a patient's system as a whole. Thus, osteopathic physicians stress a "holistic" approach to the healing arts with emphasis on nutrition and preventive medicine. The distinctiveness of osteopathic medicine arises from its emphasis upon osteopathic manipulative therapy. Manipulative therapy is taught in osteopathic medical schools and is practiced clinically at osteopathic hospitals as an element of the osteopathic focus on preventive medicine and on treating the body's symptoms as an integrated whole. HISTORY OF OSTEOPATHIC DISCRIMINATION. Martin Memorial Hospital is a 336 bed allopathic acute care hospital located in Stuart, Florida. Martin Memorial is located in the northeast section of Martin County and is within the proposed service area of OMHI's planned hospital. Jupiter Hospital is an allopathic acute care hospital located in northern Palm Beach County, just south of the Martin County line. Jupiter Hospital is located approximately 8 to 10 miles from the proposed site of OMHI's planned hospital. Growth of the osteopathic profession in Martin County has been impeded by the policies of Intervenors, Martin Memorial Hospital, Inc. (Martin Memorial), and Jupiter Hospital, Inc. (Jupiter Hospital). To some extent, Martin Memorial and Jupiter Hospital are responsible for the shortage of D.O.S (osteopaths) in Martin County and, if OMHI's facility were opened, more osteopathic physicians soon would move to the area. Both Martin Memorial and Jupiter Hospital had adopted medical staff policies and by-laws intended to preclude osteopathic physicians from qualifying for staff privileges. As Florida law has changed to prohibit this direct discrimination, both adopted new policies which comply with the law but have had the continuing effect of excluding the majority of osteopathic physicians from their respective medical staffs. Martin Memorial. In the early 1970's, the Martin Memorial by-laws seemed to permit privileges for osteopathic physicians by allowing an applicant to offer "equivalent training" as a means of satisfying the educational criteria. Nevertheless, when a fully credentialed osteopathic physician applied for privileges in 1973 that application was denied despite the fact that the applicant presented three letters from allopathic physicians offering "unhesitating" recommendations and documenting his professional skills. In response to that application, the Martin Memorial by-laws were amended to require specifically that an applicant have training approved by the American Medical Association and the Association of American Medical Colleges. Because osteopathic physicians are trained in schools approved by the American Osteopathic Association, all osteopathic graduates were precluded from staff membership by this provision. Martin Memorial similarly relied upon its by-law provisions to deny the applications of Drs. Equi and Shefter, two osteopathic physicians who applied for staff privileges in 1976. In October 1976, Dr. Equi notified Martin Memorial that he had obtained legal counsel and served notice that he intended to challenge the hospital's blanket prohibition of staff privileges for graduates of AOA-approved medical schools. In reaction, the medical staff several months later (January 1977) voted to amend the staff by-laws to permit applications from osteopathic physicians. As with the previous by-laws, however, the new provision had the effect of excluding most osteopathic physicians from the medical staff, since it additionally required all applicants to have two years of postgraduate training recognized by the American Medical Association. As stated above, osteopathic physicians take their postgraduate training at AOA- approved medical schools and hospitals. Although an osteopathic physician may qualify to attend AMA postgraduate programs, in fact few D.O.s choose to do so for example, approximately one percent of the graduating class of SECOM, the Southeastern College of Osteopathic Medicine. In 1979 a new Florida law was enacted, effective January 1, 1980, requiring all hospitals to accord equal treatment to osteopathic and allopathic applicants for staff privileges. Section 395.0653, Florida Statutes (1979). Accordingly, in February 1980, Martin Memorial amended its by-laws to permit training accredited by the American Osteopathic Association as an acceptable credential for privileges at the hospital. Nevertheless, the hospital retained its prior requirement that all applicants have two years of postgraduate education in order to qualify for privileges. The practical effect of the two-year postgraduate education requirement was to exclude the majority of osteopathic physicians from staff positions at Martin Memorial. As stated above, approximately 70 percent to 80 percent of all osteopathic physicians enter general practice, and the AOA requires only a one-year postgraduate internship for licensure because of the concentration on general practice during medical school. The exclusionary effect of the two year postgraduate education requirement is reflected in the experience of Martin Memorial itself. Since the by-law provisions seemingly were amended to permit equal treatment in February 1980, only three osteopathic physicians have obtained admitting privileges, and one of those (Dr. Equi) obtained privileges only as a result of litigation. By contrast, there are approximately 170 allopathic physicians on the Martin Memorial staff, of whom 140 are active and associate members. The earlier discrimination against osteopathic physicians practiced by Martin Memorial, together with the effective exclusion of most osteopathic physicians from the hospital staff today, has caused an undersupply of osteopathic physicians in the Martin County area. Hospital privileges are essential to the establishment of a medical practice in a community today. Privileges are important not only to provide access to hospital facilities, but also to convey to the public that the physician is "good enough to be on a hospital staff." Jupiter Hospital. The first set of medical staff by-laws adopted by Jupiter Hospital in 1979 prohibited osteopathic physicians from staff membership by requiring graduation from a school approved by the AMA's Liaison Committee on Graduate Medical Education and by requiring similar postgraduate training, Like Martin Memorial, Jupiter Hospital agreed to amend its by-laws to permit hospital privileges for D.O.s only when required to do so by changes in Florida law. Nevertheless, when Jupiter Hospital amended those by-laws in 1980, the new provisions relating to osteopathic applications retained the requirement that D.O. applicants have postgraduate training approved by the Liaison Committee on Graduate Medical Education, and those provisions continue to exist today. (Although HCA provides financial management services at Jupiter Hospital, that corporation has no involvement with the hospital's staff by-laws or the granting and denial of staff privileges.) Dr. Harold Kirsh, who lives in the northern Palm Beach County area, has encountered difficulty because he is unable to obtain staff privileges at Jupiter Hospital. Although Dr. Kirsh received two years of postgraduate training in his specialty, he was denied privileges at Jupiter because that training was approved by the American Osteopathic Association rather than the allopathic Liaison Committee on Graduate Medical Education. As a result, Dr. Kirsh has been unable to treat friends, neighbors, and patients in the northern Palm Beach County area who prefer to seek treatment at a hospital near their homes. Proximity to a hospital is a critical factor in a patient's selection of a physician. Osteopathic specialists, although they receive more than one year of postgraduate training, similarly are discouraged from applying for allopathic hospital staff privileges by the two year postgraduate requirement. Because osteopathic specialists rely upon osteopathic general practitioners for referrals, osteopathic specialists are not likely to locate in areas in which the existing hospitals limit access by osteopathic general practitioners. The effect of Jupiter Hospital's past discrimination against osteopathic applicants, and current by-laws indicating that osteopathic physicians who do not have two years of postgraduate training approved by the Liaison Committee on Graduate Medical Education will not be admitted to the staff, is reflected in the fact that only four or five osteopathic physicians have privileges at Jupiter on a medical staff of approximately 140 allopathic physicians (including at least one Bonnie Hubicz, D.O. whose post-graduate training was not approved by the Liaison Committee despite provisions in the By- Laws requiring Liaison Committee approval.) Even if the many osteopathic general practitioner graduates in Florida today desired to obtain more than one year of postgraduate training in family practice, only three or four residency slots offering two years of such postgraduate family practice training are available in the entire state. DHRS. OMHI did not prove that DHRS discriminates against osteopaths or has been purposefully obstructionist in the face of applications for certificates of need for osteopathic facilities. The evidence only proves: (1) that, from its enactment in 1972 as Chapter 72-391, Laws of Florida (1972), DHRS interpreted Section 381.494(2), Florida Statutes, contrary to the interpretation ultimately given by the District Court of Appeal, First District, by its decision in the Gulf Coast case on December 16, 1982; (2) that DHRS has not yet promulgated a rule methodology for determining osteopathic bed need; and (3) that, on a case- by-case basis, DHRS recently has changed the utilization assumptions it has used in determining osteopathic bed need in the face of declining average length of stay and occupancy rates for osteopathic (as well as allopathic) hospitals. No discriminatory intent or effect is inferred from these facts. NEED FOR FACILITY. State Health Plan and District Health Plan. The 1985 Florida State Health Plan provides little guidance with regard to an osteopathic hospital, whether or not a teaching hospital. Page 22 of the Plan establishes the policy guide that "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." As was previously discussed, osteopathic medicine is founded on the holistic concept of medicine. The development of additional osteopathic facilities and training for osteopathic physicians advances this policy guide of the 1985-87 State Health Plan. Additionally, the State Health Plan notes the applicability of Section 381.494(2), Florida Statutes (1979), and its distinction between allopathic and osteopathic medical practices. Neither the State nor the District IX Health Plan specifically address numerical need for osteopathic hospitals and services. But both address the problem of acute care overbedding and optimal occupancy rates for such facilities. Those portions of the Plans apply equally to osteopathic and allopathic hospitals. The acute care section of Volume II of the 1985-87 State Health Plan emphasizes the ever growing problem and societal expense caused by excess acute care beds in the State. It states that "the combined effect of ambulatory surgery, HMOs, DRGs, and other innovations could reduce acute care bed need for (1989) by 15 percent or more," with the result being fewer acute care beds needed statewide than existed in 1984. The State Health Plan also contains the goal that all acute care hospitals in each district of the state attain an average annual occupancy rate of 80 percent by 1989. The Acute Care Section of the 1985 District IX Health Plan states that the overall annual licensed bed occupancy rate for acute care general hospitals in District IX should equal 80 percent. The local health plan also states that before needed new beds may be approved, the average annual occupancy rate of the applying facility for the most recent calendar year, and the corresponding subdistrict average, should equal or exceed 80 percent. Although this section of the local health plan only addresses "needed beds," as determined by Rule 10- 5.11(23), Florida Administrative Code, its minimum required average occupancy should apply equally before any new acute care beds, including new osteopathic beds, are approved. In 1985, The District IX Local Health Council raised its recommended occupancy levels for medical surgical beds (and its required minimum occupancy before "needed" new beds may be approved) from 75 percent to 80 percent. Citing the Florida Hospital Bed Utilization and Distribution Study, the 1985-87 State Health Plan notes that the concentration of surplus beds occurs primarily in four geographical areas: District IV (Jacksonville), District VI (Tampa), District x (Ft. Lauderdale), and District XI (Miami). The study notes that Districts VI and XI alone accounted for 57.1 percent of the total projected surplus in the state in 1983. The four districts cited accounted for 87.9 percent of the state's bed surplus. The Existing Osteopathic Facilities and Services. Wellington Medical Center is an approved, 120 bed osteopathic hospital in Palm Beach County. Humana Hospital Palm Beaches is listed as an osteopathic hospital in the 1985-86 Yearbook and Directory of the Florida Osteopathic Medical Association. Humana Hospital Palm Beaches is listed as an accredited osteopathic hospital in the American Osteopathic Association's 1984-85 Yearbook of Osteopathic Physicians. The American Osteopathic Association, Division of Accreditation, on October 15, 1985, directed a letter to Jennings, Ryan, Federa & Co. which stated: The institution Humana Hospital Palm Beaches 3 was surveyed and examined by a survey team earlier this year. The Committee on Hospital Accreditation examined the survey report and made a recommendation for continuing approval of the institute that was acted upon by our Board of Trustees at its July, 1985 meeting. The Humana Hospital Palm Beaches is accredited by the American Osteopathic Association and has an internship program that is also accredited by that organization. Approximately 22 percent of the admitting medical staff at Humana Hospital Palm Beaches is composed of osteopaths. Of 150 total on the staff in 1983, 50 were osteopaths. Now 50 of approximately 200 on the staff are osteopaths. Humana Hospital Palm Beaches' governing board has one D.O. member and one M.D. member. Approximately 44 percent of Humana Hospital Palm Beaches' patient admissions in February 1985 were by D.O.s. The hospital's D.O. admissions are "approximately 50/50." The medical staff by-laws of Humana Hospital Palm Beaches provide that the position of chairman of each department be held by an osteopath every other year. The chairman and vice- chairman, one of whom is an allopath and one of whom is an osteopath, rotate positions annually. Similarly, the office of chief of staff is alternated between an allopathic and an osteopathic physician. Humana Hospital Palm Beaches has an Osteopathic Methods and Concepts Committee which meets regularly. It has an organized Department of Osteopathic and Family Medicine. There is also an Accreditation Committee whose duties include assuring "that the hospital is presently, and in the future, in compliance with the accreditation standards of the American Osteopathic Association." Humana Hospital Palm Beaches (Humana) has numerous attributes of an osteopathic hospital. Based on the testimony and record of this proceeding, there is little difference between the osteopathic attributes of Humana Hospital Palm Beaches and the osteopathic attributes proposed for OMHI's proposed hospital. From a health planning standpoint, osteopathic services rendered at Humana Hospital Palm Beaches should be counted among the available osteopathic services in District IX. Humana has always had osteopathic manipulation tables. The hospital's osteopathic internship program is currently training eleven interns. The reason Humana responded to OMHI's interrogatories stating that it is not an osteopathic facility was its administrator's understanding that "osteopathic hospital" meant totally osteopathic with no allopathic participation. Although the Humana Hospital's obligations to maintain AOA accreditation and to operate an intern program for osteopathic physicians are the result of a law suit settlement Humana has no plans to discontinue the AOA accreditation or the intern training program. There is no basis to assume that Humana will discontinue the osteopathic services now offered. Under the terms of that settlement agreement, Humana's compulsion to operate an intern program lapses this year. Similarly, Humana's obligation to refrain from any effort to amend the medical staff by-laws, which provide for the rotation of department chairmanships between M.D.'s and D.O.'s, terminates five years after the settlement date (1987). In addition to the Humana and Wellington facilities, osteopathic services are offered at other area acute care hospital that have osteopaths on their staffs, including Martin Memorial and Jupiter. Bed Need. In part, OMHI proposes two supply-based methods for use in projecting the number of osteopathic beds needed in District IX. A supply-based method attempts to project bed need by multiplying a physician use rate by the number of physicians projected to be practicing in an area in the future. For several reasons, the statewide supply-based methods OMHI proposes are unreliable. First, in general it is more appropriate to base need projections on population use rates and projected population. It is the sick portion of the population represented by the population use rates and population that generates bed need, not the supply of physicians (whether allopathic or osteopathic.) Generally, it should be assumed that physicians follow the sick population, not vice versa. Second, it is more accurate to project population than it is to project the number of physicians expected to be practicing in an area. Being a much smaller group than the population as a whole, projections of the number of osteopaths expected to be practicing in an area in the future are more affected by variables other than passing of time than are population projections. In addition, because the current number of osteopaths in District IX is significantly influenced by the variables of past allopathic hospital staff privilege policies, as discussed above, it is even more difficult to project the number of osteopaths expected to be practicing in District IX in the future. Adding to this inherent unreliability, OMHI's expert witness may not have plotted the data points correctly in performing his regression analysis, a significant error when one has only ten data points with which to work. Third, a statewide supply-based method must assume that the percentage of physicians who do not actively practice in the area in question is the same as the percentage of physicians who do not practice in the area used to obtain the physician use rates. For example, as of November 1985, there were approximately 121 osteopaths in Districts IX, but only 88 were practicing. The use rate used by OMHI in its statewide supply-based method is a use rate for osteopathic hospitals throughout Florida. There was no evidence that the same percentage of active osteopaths in District IX, i.e., approximately 73 percent, obtains statewide. Fourth, the osteopath use rate incorporated in OMHI's statewide supply-based method includes both osteopath and allopath admissions at osteopathic hospitals throughout the state. The method must therefore assume that there is one osteopath admission at an allopathic hospital for each allopath admission included in the admission statistics of the osteopathic hospitals. There is no evidence supporting the validity of this assumption, but the assumption is reasonable given the limitations of the available data. OMHI also, in part, proposes a type of supply-based method for determining osteopathic bed need referred to as the "Wellington rate." The "Wellington rate," so called because it was used by OMHI to support its application to construct the Wellington osteopathic hospital in Palm Beach County, actually uses the statistics generated at Humana Hospital Palm Beaches. The Wellington rate isolates osteopath admissions at the Humana Hospital and applies the resulting use rate to the projected number of osteopaths expected to be in District IX in the future. It therefore does not suffer from the weakness noted in paragraph 53(d.) above. But it does share the other weaknesses of a supply-based method set-out in paragraph 53., plus one. The problem referred to in paragraph 53.(c) above is exacerbated in OMHI's "Wellington rate method" because it uses only 33 heavy admitting osteopaths to generate its osteopath use rate but multiplies the resulting use rate by all osteopaths expected to be in District IX in the future, whether admitting, active or inactive. OMHI'S Wellington rate method therefore assumes that all the osteopaths expected to be in District IX in the future will be active and just as heavy admitters as the 33 heavily admitting osteopaths now on the staff of the Humana Hospital, the only osteopathic hospital in District IX at this time. Such an assumption is unreasonable. It is more reasonable to assume that, if the Wellington rate is used, future osteopathic bed need will be the product of the Wellington rate and the number of admitting osteopaths projected to be actively practicing in District IX on the relevant planning horizon. As alluded to earlier, a population-based method for determining bed need generally is preferable to a supply- based method. But because of the limitations of available data, the population-based method used in part by OMHI to project osteopathic bed need has weaknesses, too. Because there is only one hospital in District IX that has a substantial number of osteopath admissions, the choice of population-based use rates is between a "Wellington" population-based rate and a statewide osteopath admission rate. If the statewide rate is used, it assumes that the statewide use rate "fits" District IX. There was no evidence supporting this assumption. To the contrary, the evidence was, e.g., that use rates in 1984 at osteopathic hospitals in the state (excluding irrelevant obstetrical and psychiatric admissions where possible) varied from a low of approximately 12.5 patient days per 1,000 population in District VI to a high of 113 in District V, with an average of approximately 45. Because the statewide osteopathic use rate is obtained from the use rates at osteopathic hospitals, as is the rate for the statewide supply-based method, it shares with that supply-based method the weakness of requiring an assumption that there is one osteopath admission at an allopathic hospital for each allopath admission counted among the admissions at the osteopath hospital. Finally, population-based methods share with supply-based methods the difficulty of trending declining use rates forward to the relevant planning horizon. Each of three methods statewide supply-based, the Wellington rate, and statewide population-based have weaknesses which make it unwise to determine osteopathic bed need exclusively-on any one of them. The most rational approach is to average the three in the hopes of obtaining the best projection. There was insufficient evidence on which to conclude that the average should be weighted in any way. The best population-based approach available from the evidence in the record would use a statewide use rate of 42.39 patient days per 1,000 population. This use rate is derived by taking twice the total patient days at all AOA accredited hospitals in Florida, excluding irrelevant obstetrical and psychiatric admissions to the extent possible, for the first half of 1985 and dividing the total by the total population of the districts in which those hospitals are located. Using Tampa Bay Community Hospital, not AOA accredited, as part of the data base to generate the use rate is specifically rejected as unreasonable; likewise, not using Humana Hospital Palm Beaches, under the facts of this case, is specifically rejected as unreasonable. In addition, it is not reasonable to include irrelevant obstetrical and psychiatric admissions in the numbers generating the use rate. On these points, the testimony of Martin Memorial's expert, Judy Horowitz, is accepted, and the contrary testimony of OMHI's expert, Phillip Taylor, and HRS' expert, Elizabeth Dudek, is rejected. The formula for using the statewide population-based use rate of 42.39 to projection bed need is: Bed Need = 42.39 patient days x Population divided by 1, 000 365 days/yr divided by 80 percent occupancy standard Population for District IX is projected to be: 1,145,423 on July 1, 1988 1,218,311 on July 1, 1990 1,235,361 on January 1, 1991 Using the formula, osteopathic bed need under the statewide population-based method would be: 166 on July 1, 1988 177 on July 1, 1990 179 on January 1, 1991 For comparison purposes, if the use rate were obtained by dividing the total patient days by the population only of the counties, instead of districts, in which the hospitals are located, the bed need would be: 233 on July 1, 1988 248 on July 1, 1990 251 on January 1, 1991 The "old" Wellington rate first suggested by OMHI for use in projecting osteopathic bed need is obsolete and should not be considered. The "new" and more appropriate Wellington rate is 618 patient days per osteopath. But OMHI proposes to multiply that rate by the total of all osteopaths projected to be in District IX on the relevant planning horizon although the "new" Wellington rate is generated by dividing total osteopathic patient days at the Humana Hospital only by the admitting osteopaths. This methodology is rejected. It results in an unreasonably high bed need projection. Instead, the "new" Wellington rate should be multiplied only by the number of admitting osteopaths expected to be practicing in District XI on the relevant planning horizon. No party explicitly offered a method of projecting the number of admitting osteopaths expected to be practicing in District IX in the future. However, there was evidence that, of the 121 osteopaths registered by the Department of Professional Regulation as residing in District IX on November 1, 19B5, only 33 were the heavily admitting osteopaths whose admissions from January to June 1985 resulted in the "new" Wellington rate. Using Horowitz' linear regression analysis, which is specifically accepted as more reliable than Taylor's (since Taylor could not testify whether he plotted the ten data points correctly), the number of admitting osteopaths expected to be practicing in District IX in the future can be projected by the formula: Y 33 + 0.756 X where Y number of osteopaths And X number of months after January 1985 Using that formula: Y on July 1, 1988 33 + 0.756(42) 65 Y on July 1, 1990 33 + 0.756(66) 83 Y on January 1, 1991 33 + 0.756(72) 87 Multiplying the "new" Wellington rate of 618 by the number of admitting osteopaths expected to be practicing in District IX yields the following bed need projections: Bed Need 7/1/88 618 patient days x 65 D.O.s divided by D.O. 365 days/yr 80 percent occupancy standard = 138 Bed Need 7/1/90 618 patient days x 83 D.O.s divided by D.O. 365 days/yr 80 percent occupancy standard = 176 Bed Need 1/1/91 618 patient days x 87 D.O.s divided by D.O. 365 days/yr 80 percent occupancy standard = 184 Finally, there is evidence supporting a statewide supply-based method of projecting osteopathic bed need. The statewide use rate of 313.24 admissions per osteopath suggested by Horowitz is specifically accepted as more reasonable than the use rate of 369.2 suggested by Taylor and Dudek. See paragraphs 61 and 62 above. Since the statewide use rate is obtained by dividing total osteopathic admission by total osteopaths registered with the Department of Professional Regulation, it is appropriate to multiply the statewide use rate by the total number of osteopaths Horowitz' linear regression analysis projects will be in District IX on the relevant planning horizon. Again, Horowitz' linear regression analysis is preferred as more reliable than Taylor's. The statewide supply-based method described in paragraph 70 yields the following results: Bed Need 7/1/88 313.24 patient days x 141 D.O.s divided by D.O. 365 days/yr 80 percent occupancy standard = 151 Bed Need 7/1/90 313.24 patient days x 159 D.O.s divided by D.O. 365 days/yr 80 percent occupancy standard = 171 Bed Need 1/1/91 313.24 patient days x 164 D.O.s divided by D.O. 365 days/yr 80 percent occupancy standard = 176 The results of the three applicable osteopathic bed need methods population-based, statewide supply-based, and Wellington rate supply-based, as revised based on the evidence in this case can be summarized: Population- Statewide Supply- Revised Wellington Average Based Based Rate Supply-Based 7/1/88 166 151 138 152 7/1/90 177 171 176 175 1/1/91 179 176 184 180 Since there already are 120 approved osteopathic beds at Wellington and approximately 81 of the Humana Hospital's 162 beds are used to render osteopathic services, there is no raw bed need for OMHI's proposed 120-bed osteopathic hospital. Area hospitals have a high seasonality factor of approximately 122 percent of average. Occupancy in a hospital above 90 percent at any time created quite a few problems with regard to a patient's ability to receive inpatient care. Any time one deals with an occupancy rate above 90 percent, particularly when some rooms are semi-private, one must be concerned about the type of patients, infectious disease control, and other serious problems that can arise in terms of ability to admit a patient. But the peak season high utilization still does not justify the addition of 120 beds in District IX. It would be more accurate to subtract beds at an osteopathic facility filled by allopathic physicians from osteopathic bed inventory. But it is impossible to do this from the evidence in this case. The only osteopathic hospital in District IX (excluding Humana) is not yet operating. In addition, it would logically follow that a pro rated portion of all osteopathic admissions at all allopathic hospitals in District IX also would have to be added to the inventory, an impermissible result under the law. Consideration of the beds at the Humana Hospital serving osteopathic patients is based on the uniqueness of the Humana Hospital, as more fully described above. Health Planning Horizon. Because of the length of lead time necessary to plan new construction of a 120-bed hospital facility and to open the facility to the public, it is reasonable from a health planning viewpoint to determine whether a new hospital is needed based upon the need for the facility projected five years from the completion date of the application or, if there are formal administrative proceedings, five years from the final hearing in the administrative proceedings. DHRS has in the past followed a non-rule policy of projecting need for all acute care hospitals, allopathic and osteopathic, five years into the future from the completion date of the application or, if there are formal administrative proceedings, from the final hearing in the administrative proceeding. There was no evidence that DHRS has decided whether or how to re- formulate its policy in light of the recent decision in Gulf Court Nursing Center vs. Department of Health and Rehabilitative Services, 10 FLW 1983 (Fla. 1st DCA 1985), clarified on rehearing, 11 FLW 437 (February 14, 1986.) Other Need Considerations. Although the evidence was that only approximately 10 percent of the population as a whole prefers to use osteopathic physicians, the evidence demonstrates a shortage of osteopaths in Martin County. Past history of discrimination and current staff privilege policies at area hospitals have contributed to the shortage, as previously explained in more detail. Only three osteopaths are on Martin Memorial's staff of approximately 173 physicians, and Jupiter Hospitals's staff of approximately 145 physicians includes only 4 or 5 osteopaths. There are only two osteopaths in all of St. Lucie County. OMHI's proposed osteopathic hospital would attract osteopaths to the area and help alleviate the shortage. There also is a shortage of osteopathic internship and residency programs. Only eight of the fifteen osteopathic hospitals in Florida have internship programs. (In addition, the osteopathic Wellington hospital being built by OMHI will have an internship program with the Southeastern College of Osteopathic Medicine.) Those programs cannot accommodate Florida graduating osteopaths, much less the net influx of out-of-state graduates who desire to intern in Florida. Only three to four osteopathic hospitals in the country offer residency programs for osteopaths, one of which fortunately is located in Florida. OMHI's proposed teaching hospital with internship and residency programs might help meet the need for such programs. However, low and declining utilization at existing osteopathic facilities will adversely impact the viability of osteopathic intern programs already existing in Florida. A hospital with a low utilization rate would have difficulty supporting such a program. Stated conversely, a hospital with adequate utilization of 75 percent or more would have more opportunity to train students. Currently, only eight of the fifteen osteopathic hospitals in Florida are able to offer such programs. Given the decline in osteopathic utilization which will be discussed below, the approval of OMHI's proposed hospital could further decrease utilization at existing and approved osteopathic facilities and jeopardize the existing program at Humana and the proposed program at Wellington, as well as OMHI's own proposed program. OMHI did not prove that it has studied and found not practicable less costly and less efficient alternatives for meeting the need for osteopathic internship and residency programs in Florida. Those alternatives include the expansion or formation of internship and residency programs at the existing Florida osteopathic hospitals, especially the seven which have no such programs at this time. The other alternative would be for HCA to operate one or more of its existing allopathic hospitals in manner similar to the way in which Humana Hospital Palm Beaches is operated. If, for example, HCA's Port St. Lucie or Lawnwood Memorial Hospital, both in St. Lucie County, could be operated as Humana Hospital Palm Beaches is, HCA could help meet the need for osteopathic hospital beds and internship and residency programs in District IX in a less costly and more efficient manner. ACCESSIBILITY. The only substantial and persuasive evidence on accessibility to osteopathic services and hospitals was that most of Martin and all of St. Lucie and Indian River Counties would be more than a thirty minute drive from Humana Hospital Palm Beaches and the proposed Wellington Hospital. This would be more than 10 percent of the total population of District IX. However, OMHI did not prove that a thirty minute drive time is the appropriate standard for geographic accessibility to osteopathic services and hospitals. Nor did OMHI prove that such accessibility to 90 percent of the total population of the district is the appropriate standard in this case. Although DHRS has by rule made geographic accessibility within a 30 minute drive time in urban areas for 90 percent of a district's population the standard for all acute care hospitals under Rule 10-5.11(23)(i), Florida Administrative Code, those standards cannot logically be used to measure osteopathic accessibility since only approximately 10 percent of the population prefers to use osteopathic physicians. There was no competent proof what osteopathic geographic accessibility standard should be applied in this case. Nor was there proof that there are no osteopathic facilities or services in adjoining districts that are accessible to remote parts of District IX. Finally, there was no proof how accessible OMHI's proposed hospital would be to the most northern parts of District IX. Nor was there proof that the Rule 10-5.11(23)(I) standard for accessibility to acute care hospitals (either allopathic or osteopathic) is not satisfied in District IX. The evidence suggested that the standard is satisfied. OMHI estimates that 2.5 percent of its patients will be Medicaid patients. UTILIZATION. Utilization of acute care hospitals is declining. The reasons for the decline are the dramatic changes which the health care industry has undergone since 1983. The primary reason has been the shift in 1983 to the Medicare prospective payment system, otherwise known as DRGs. The DRG system changed Medicare reimbursement from cost base to a set reimbursement based on type of illness. The effect of this change has been primarily to sharply decrease the average length of stay of Medicare patients. Other causes of decline in utilization include an increased emphasis on utilization review and the use of outpatient services such as outpatient surgery and home health services. In many areas of the country, preferred provider organizations (PPO's) and health maintenance organizations (HMO's) also have impacted hospital occupancy rates significantly, lowering lengths of stay and admission rates. As specifically recognized by the State Health Plan, "the emergence of these alternative delivery systems ... have exacerbated declining occupancy rates." In District IX, average lengths of stay have declined in acute care hospitals as follows: 1983 6.9 First half of 1984 6.5 1984 6.2 First half of 1985 6.2 During the same time periods, occupancy rates in District IX acute care hospitals have declined as follows: 1983 73.7 First half of 1984 72.3 1984 65.8 First half of 1985 64.7 Statewide, average lengths of stay in osteopathic hospitals have declined as follows: 1983 7.9 First half of 1984 7.1 July 1, 1984 thru June 30, 1985 6.9 During the same time periods, occupancy rates at osteopathic hospitals throughout the state have declined as follows: 1983 50.4 1984 43.3 July 1, 1984 thru June 30,1985 39.9 Meanwhile, at Humana Hospital Palm Beaches, the only hospital in District IX with significant osteopathic admissions, average lengths of stay declined as follows: 1983 7.7 1984 6.8 First half of 1985 7.4 Occupancy rates at Humana Hospital Palm Beaches declined as follows: 1983 82.9 1984 76.9 First half of 1985 67.2 Generally, utilization of medical/surgical beds have declined faster than overall hospital bed utilization. For example, occupancy rates at Humana, Jupiter and Martin Memorial have declined as follows: 1983 1984 Semiannual 1984 1985 Semiannual Jupiter 71.4 67.8 58.2 59.9 Martin Memorial 74.8 71.2 66 68.3 Humana 82.7 85.8 76.9 66.9 The low average occupancy rates for District IX do not include over 700 beds in District IX which have been approved but have not yet been licensed (120 of which are at the Wellington facility). Underlying part of OMHI's need and utilization projections has been the contention that an osteopathic hospital will attract new osteopathic physicians to an area in sufficient numbers to adequately utilize a facility. However, the utilization evidence in this case does not support this "magnet effect". If this magnet effect were a valid principal upon which to base need or utilization projections, one would expect the existing osteopathic facilities in Florida to have attracted sufficient osteopaths to support reasonable utilization of those facilities. The fact of low and falling osteopathic utilization in Florida, rather than supporting such a contention, casts serious doubts on the ability of any osteopathic facility to achieve adequate utilization. It is probable that utilization will decline somewhat more before the decline bottoms out. It is highly unlikely that utilization will increase in the next five years. OMHI's ABILITY TO PROVIDE QUALITY CARE. OMHI and HCA possess the ability to provide quality care at the proposed acute care hospital. Several doctors of osteopathy have expressed an interest in practicing in the area if an osteopathic hospital is located there and others would be attracted. HCA owns approximately 35 hospitals in Florida. It owns or operates 420 hospitals throughout the world. It has assets of 4 billion dollars and has committed the approximately 23 million dollars that will be necessary to construct and begin operation of this facility. It has a one billion dollar line of credit as a part of its general debt capability. It can attract the manpower and other resources necessary to operate OMHI's proposed hospital. The principals of OMHI have the credentials and experience to recruit a qualified staff of osteopathic physicians. The staffing of the hospital would be accomplished in part by interns who will be a part of the hospital's teaching program. The American Osteopathic Association has no particular staffing requirements for osteopathic teaching facilities. Over the years, it is likely that students who receive internship, externship and residency training at OMHI's proposed hospital will remain in the vicinity. There is ample medical staff personnel available to support OMHI's proposed hospital. METHOD OF CONSTRUCTION. OMHI proved that the cost and methods of construction of the proposed hospital can be expected to be reasonably energy-and-cost-efficient. I. FINANCIAL FEASIBILITY. As previously mentioned, HCA has the financial ability to construct and begin operating OMHI's proposed hospital in the short term. However, OMHI did not prove the long-term financial feasibility of its proposed hospital. The evidence presented by OMHI's experts on the long- term financial feasibility of the proposed hospital were dependent upon the accuracy of the osteopathic bed need projections of Dr. Philip Taylor. As previously discussed, Dr. Taylor's need projections erroneously inflated the osteopathic bed need. For these and other reasons, the testimony of OMHI's financial experts was based upon erroneous assumptions and did not prove long- term financial feasibility. The Site Of OMHI's Proposed Hospital. OMHI does not yet know exactly where the proposed location of the hospital is. Hobe Sound, where the proposed OMHI hospital is to be located, is near the northern border of Jonathan Dickinson State Park. Jonathan Dickinson State Park is a large, unpopulated park area. There is no evidence that either HCA or OMHI can purchase property in or around Hobe Sound that is appropriate for a proposed hospital for a price at or below 1.5 million dollars. Zoning Considerations. To construct an acute care hospital in the vicinity of Hobe Sound, the property must be designated "institutional" under the Martin County Comprehensive Plan. According to the Zoning Administrator of Martin County, the lands in the vicinity of Hobe Sound that are designated "institutional" are south of Bridge Road along U.S. 1 somewhat adjacent to Jonathan Dickinson State Park. This property was so designated because the Hobe Sound Company, which owns the "institutional" designated lands, wanted to keep residential development off of the property. This would insure that their well fields would not be encroached upon by small subdivisions. No evidence was adduced that any of this property is for sale, could be purchased by HCA within its budget, or is appropriate for a hospital. The only other "institutional" land near Hobe Sound is owned by Martin County for park sites, fire halls, and uses of that nature. No applications are pending to designate other lands "institutional" in the Hobe Sound area. The only time such applications can be made is between September 1 and October 31 of each year. The earliest OMHI could apply for such a designation, therefore, is September 1, 1986. Typically, it would take at least until April, 1987 to approve a change in designation to "institutional." Other building and zoning approvals necessary to construct a hospital would take until approximately the middle of 1987. OMHI's CON application projects that "continuous" construction would be underway in October, 1986. According to existing zoning and land use requirements in Martin County, it is likely that construction of the proposed hospital could not begin until at least mid-1987, some nine months behind schedule, assuming necessary approvals are successfully obtained. If construction of OMHI's proposed hospital was delayed longer than six months, HCA would have to rebudget the project. Forecasted Utilization. OMHI's forecasted utilization for its proposed hospital suffers from several flaws. OMHI's forecasted utilization at its proposed hospital is based upon OMHI's need analysis. In forecasting 1988 utilization, OMHI did not consider the timing difference between the need projection it issued (July, 1990) and the proposed opening date of the hospital (January, 1988). Because the need for osteopathic beds is less in 1988 than in 1990, basing a utilization forecast on 1990 need would result in an overestimate of patient days. OMHI assumed an average length of stay of 6.9 days in its bed need calculation, yet the projected average length of stay used by OMHI's financial expert at the proposed hospital is 5.8 days. If the average length of stay in January 1988 is 5.8 days, use of 6.9 will have resulted in an overestimate of need and, thus, an overestimate of utilization. OMHI projects a first year of occupancy at the proposed hospital of 51.7 percent which is greater than the average experienced in 1984 by all existing Florida osteopathic hospitals. The 15 AOA accredited hospitals in Florida experienced an aggregate acute care occupancy rate of 42.5 percent in 1984. None of those 15 hospitals is a start-up facility like OMHI proposes. None of the occupancy levels of other existing osteopathic hospitals even approached OMHI's 75 percent estimate of occupancy for the second year at the proposed new hospital. The aggregate acute care occupancy for all existing District IX hospitals in 1984 was 65.8 percent. Only 3 of 18 existing hospitals experienced occupancies greater than 75 percent in 1984. There will not be a sufficient number of osteopaths in the Martin-St. Lucie primary service area in 1988 and 1989 to reach OMHI's projected occupancy levels. Even if all the growth in the supply of osteopaths projected for 1988 or 1989 by OMHI for District IX occurred in only Martin and St. Lucie Counties, OMHI's utilization forecast is not supported. All of this goes to show that OMHI's need analysis was faulty and over-estimated the need for osteopathic beds in District IX, as previously discussed. Financial Feasibility Of The Proposed Hospital To evaluate the financial feasibility of OMHI's proposed project, OMHI's expert used a computer model. The computer model used by OMHI's financial expert incorrectly includes all insurance costs, including malpractice insurance costs and liability insurance, rather than just insurance that is rightfully associated with capital costs, to determine capital cost reimbursement by Medicare. The impact of including all insurance in allowable capital costs depends upon the Medicare payor mix. If that Medicare payor mix is about 60 percent, the impact of including all insurances would erroneously increase the bottom line of OMHI's pro forma. OMHI's financial expert used three different hospitals in the development of payor mix assumptions: Lawnwood Medical Center, Port St. Lucie Hospital, and Doctors General Hospital in Lake Worth. In assuming a 55 percent payor mix of Medicare patients, OMHI's financial expert did not know the percent of persons that are 65 and over in either the Hobe Sound area, Martin County, or District IX. One of the hospitals that OMHI's financial expert considered in assuming a 55 percent Medicare payor mix was Lawnwood, which has an obstetric/gynecology department. OMHI's application does not propose OB/GYN. Using Lawnwood's experience in determining the payor mix for the proposed hospital without making any adjustment is unreliable because people 65 and over do not use obstetric programs. Assuming a 55 percent Medicare payor mix for OMHI's proposed hospital was inappropriate. A Medicare payor mix of between 60-65 percent would be more in keeping with the demographics of the Hobe Sound area and Stuart and to the south. OMHI's financial expert failed to include emergency room physician fees in his analysis even though the proposed hospital will offer a 24 hour a day emergency room. The hospital is unlikely to generate sufficient emergency room revenues in its first 2 years of operation to cover the total expense of having emergency room physicians. OMHI's assumption of physician fees is understated. Staffing an emergency room with qualified physicians could cost $500,000 a year, $125,000 to $250,000 of which would have to be subsidized by OMHI. OMHI's financial expert inappropriately assumed that annual inflation would be 5 percent on both the expense side and the revenue side of his analysis. Rate Controls, a publication relied upon by financial professionals, shows all expense inflation rates above 5 percent. A higher inflation rate for expenses should have been used by OMHI's financial expert, recognizing the different components of inflation. Very few expense components will experience rates less than 5 percent. HCA's acquisition costs of the project are not included in the analysis performed by OMHI's financial expert. These costs should have been accounted for under generally accepted accounting principles. OMHI's financial expert erroneously assumed the same fixed amounts of $559,000 for deductions from revenue for 1988 and 1989 Medicaid and outpatient Medicare contractual allowances. Using fixed amounts in this manner illustrates a lack of understanding of the reimbursement system or an inability of OMHI's computer model to properly reflect how the system works. To assume these amounts would be fixed is totally erroneous. The bottom line profitability projected by OMHI's financial experts, approximately $3,000,000 before taxes after the second year, is not believable. Martin Memorial's financial feasibility expert, Robert Smith, prepared an alternative financial statement which reflects estimates and assumptions that more appropriately reflect the financial outcome of the proposed OMHI hospital in its first 2 years of operation. Mr. Smith's alternative assumptions reflect that the OMHI hospital will lose approximately $1.8 million dollars in its first year and $1.9 million dollars in its second year. The break-even analysis performed by OMHI's financial expert is not a valid analysis of the projected break- even point of OMHI's proposed hospital. OMHI's financial expert assumed in his break-even analysis that many of the projected expenses at the proposed hospital would be 100 percent variable. For example, physician fees and other fees, supply expenses, leases, rentals and repairs. It is inappropriate and erroneous to treat such items as totally variable. OMHI's financial expert's break-even analysis concludes that that proposed hospital will break-even with an average daily census of 35 or an occupancy of about 29 percent. A hospital, and particularly a 120-bed teaching hospital, is unlikely to break even at an average daily census of 35. Over a five-year period, using the more reasonable assumptions employed by Martin Memorial's expert, OMHI's hospital is not financially feasible. The hospital probably would lose a significant amount of funds in its fifth year of operation. IMPACT OF THE OMHI HOSPITAL ON COMPETITION. OMHI'S original CON application, on page 18, contained a discussion about HCA's impact on the market in the area of its proposed hospital to the north and west through its Lawnwood and Port St. Lucie Hospitals in St. Lucie County and H. H. Raulerson Hospital in Okeechobee County. OMHI stated in that initial application that its application would "bring competition to a health care market now dominated exclusively by Hospital Corporation of America and Martin Memorial Hospital." This discussion was omitted from the application after HCA became involved as a future owner of OMHI. Approval of the OMHI hospital would give HCA the opportunity to increase its impact on the health care market in and near the Martin-St. Lucie metropolitan statistical area. HCA would own three out of the four hospitals in Martin and St. Lucie Counties. In addition, Raulerson Hospital in Okeechobee County is owned by HCA. (Jupiter is managed by HCA but is not owned by HCA and HCA does not control policy there.) But approval of the OMHI hospital would not enable HCA to set prices and salaries in the area or take away the charge-paying patients, leaving the nonpaying patients. Only the primary service areas of Martin Memorial and Port St. Lucie overlap with OMHI's proposed service area. Even with OMHI's additional 120 beds, Martin Memorial still would have more beds than OMHI and Port St. Lucie. The OMHI Hospital would further HCA's advantage over Martin Memorial in the CON process. For example, Lawnwood and Martin Memorial are at present competing for an open-heart and cardiac catherization CON in the same batch. Martin Memorial faces an uphill battle because Lawnwood can draw upon a network of referral base hospitals, such as Port St. Lucie, Raulerson in Okeechobee, and perhaps others to the south. Given the lack of need for 120 osteopathic beds and the current under-utilization of allopathic hospitals in District IX, it should not be expected that OMHI's additional competition will promote quality assurance or cost effectiveness. To the contrary, the additional hospital services probably would result in duplication of services, higher costs and economic pressures to sacrifice quality assurance for cost considerations. MORE COST-EFFECTIVE ALTERNATIVES. HCA owns the Port St. Lucie, Lawnwood Memorial and H. H. Raulerson hospitals. Virtually no osteopaths practice at any of them. If HCA would operate those hospitals as Humana Hospital Palm Beaches is operated, the future need for osteopathic services and hospitals and internship and residency programs in District IX could be met more efficiently and at a lower cost. OMHI did not prove that it explored those alternatives and found them not to be practicable. There are now approximately 15 osteopathic hospitals in Florida, but only eight have internship or residency programs. If such teaching programs could be established at those hospitals, any additional need for them in Florida could be met in a more efficient and less costly manner than by building a hospital that is not otherwise needed. OMHI did not prove that it has explored those alternatives and found them not to be practicable. IMPACT OF THE PROPOSED HOSPITAL ON MARTIN MEMORIAL, JUPITER, AND NME. If the proposed hospital succeeds and fills with patients, it will negatively impact both Martin Memorial and Jupiter Hospitals. It would introduce another 120 beds, which are not physically any different from available beds. Jupiter Hospital has received 15 percent of its patients from the Hobe Sound area for the last few years. Jupiter Hospital is a fifteen minute drive from Hobe Sound. The OMHI hospital would have a substantial effect on Jupiter's market in the Hobe Sound area. It would impact substantially on Jupiter's financial viability. The OMHI hospital could result in Jupiter Hospital eliminating some services that it now makes available to the community. The OMHI hospital would probably result in another reduction of staff at Jupiter. The OMHI hospital probably would cause an increase in patient charges at Jupiter Hospital. National Medical Enterprises, Inc., d/b/a West Boca Raton Medical Center (NME), applied for a certificate of need to add 15 allopathic obstetrical beds at its hospital. The NME application was reviewed in the same batching cycle as the OMHI application. Approval of the OMHI application would decrease the net need for acute-care allopathic beds under Rule 10-5.11(23), Florida Administrative Code, and substantially impact NME's application.
Recommendation Based on the foregoing Findings Of Fact and Conclusions Of Law, it is recommended that Respondent, Department of Health and Rehabilitative Services, deny the application of Osteopathic Medical Hospitals, Inc., for a Certificate of Need for an osteopathic hospital in Martin County, CON Action No. 2842. RECOMMENDED this 8th day of April, 1986, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 8th day of April, 1986.
