The Issue The issue for consideration is whether Respondent, Sarasota County Public Hospital Board's, (Board), Motion To Dismiss HCA of Florida, Inc.'s (Doctors), Petition For Formal Administrative Proceedings should be granted.
Findings Of Fact On June 26, 1990, the Board filed CON application No. 6347, seeking approval to construct a comprehensive outpatient center and medical office complex on the campus of Sarasota Memorial Hospital. The new facility, anticipated to have a cost of slightly in excess of $18,000,000.00, was to house several outpatient functions including: outpatient registration outpatient diagnostic radiology outpatient laboratory services outpatient rehabilitative services outpatient cardiology diagnostic center outpatient dialysis Health resources center, and an office building located adjacent to the existing ambulatory surgical center. On or about July 13, 1990, the Department of Health and Rehabilitative Services, (Department), issued its State Agency Action Report, (SAAR), in which it indicated a preliminary decision to approve the subject application in its entirety, designating the project reviewable under Section 381.706(2)(d), Florida Statutes. Notice of this decision was published in the Florida Administrative Weekly on August 3, 1990. On August 14, 1990, Doctors filed a Petition For Formal Administrative Hearing challenging the preliminary approval, claiming that components of the project are reviewable under several subsections of Section 381.706(1), Florida Statutes. Specifically, Doctors claims that the operation of a home health agency from the complex renders it reviewable under subsection (f); that as the project constitutes a substantial change in the provision of inpatient services, or establishes new inpatient services, it is reviewable under subsection (h); and that it is an additional health care facility which is reviewable pursuant to subsection (b). Doctors also claims the new facility will hurt its ability to compete for patient referrals from physicians who will be housed in the new facility and will result in a reduction of Doctors' market share. Doctors is an existing hospital that provides a full range of acute care services to residents of Sarasota County. The Board's application contends that the development of this complex will free up capacity in key ancillary areas to better accommodate patients, and it is so found. The ambulatory diagnostic and treatment space proposed for the new facility represents what would have otherwise been less efficient additions to the existing departments. There will also be a bridge connecting the main hospital to the new center which will provide convenient access to any outpatient who may need to visit the hospital. It will also provide, "... direct linkage between the acute inpatient facility with the physicians' offices thereby enhancing pertinent access to a range of diagnostic and treatment services." Doctors contends in its Petition that it is the Board's clear intention and expectation to increase its service area and market share of Sarasota County patients as a result of this project. It asserts that if the Board's project is implemented, it will be serving different patients, and a different patient mix from a different geographical area than currently served. For the purpose of resolving the limited issues at this motion hearing, these assertions are accepted as fact. Accepting the assertions in paragraph 5 through 7, above, as fact, however, does not necessarily require the conclusions be reached that the accomplishment of the Board's project would result in any significant change to the level of its patient service since what is planned deals only with outpatient services. While Doctors disputes this, its claims that inpatient services would be effected is not supported.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore RECOMMENDED that the Secretary, Department of Health and Rehabilitative Services, enter a Final Order dismissing HCA of Florida, Inc.'s Petition in opposition to the grant of CON No. 6347 to the Sarasota County Public Hospital Board. RECOMMENDED this 15th day of October, 1990, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of October, 1990. COPIES FURNISHED: Robert A. Weiss, Esq. Parker, Hudson, Rainer & Dobbs The Perkins House 118 N. Gadsden Street Tallahassee, Florida 32301 John Radey, Esq. Elizabeth McArthur, Esq. Aurell, Radey, Hinkle & Thomas Suite 1000, 101 North Monroe Street Post Office Drawer 11307 Tallahassee, Florida 32302 Edward G. Labrador, Esq. Department of Health and Rehabilitative Services 2727 Mahan Drive, Suite 103 Tallahassee, Florida 32308
Findings Of Fact Dr. Gans is a chiropractor licensed in Florida on the basis of examination. Dr. Gans prepared and filed an application for examination and licensure with the Florida State Board of Chiropractic Examiners. Dr. Gans answered the question on the application, "Do you have a chiropractic license in any state?" by stating: "Ohio - Mechanotherapy." The Ohio authorities recognized several professions whose functions would be included under the practice of chiropractic in Florida. Mechanotherapy generally would be limited to the practice of manipulation only. Dr. Gans was licensed in Ohio as a mechanotherapist. Dr. Gans answered the question on the application, "Have you ever been refused licensure in any state?" by stating, "No." Dr. Gans had applied for, taken, and failed the Ohio chiropractic examination whereupon he was not issued a license as a chiropractor by the State of Ohio. Dr. Gans was eligible to reapply to take the Ohio examination. At the time of his application to Florida, Dr. Gans had appealed the determination by the Ohio authorities that he had failed the Ohio examination.
Recommendation Based upon the foregoing findings of fact and conclusions of law, the Hearing Officer recommends that the Florida State Board of Chiropractic Examiners revoke the license of Ray E. Gans. DONE AND ORDERED this 2nd day of October, 1978 in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: John R. Sutton, Esquire 250 Bird Road, Suite 310 Coral Gables, Florida 33146 Paul Lambert, Esquire 1311 Executive Center Drive Tallahassee, Florida 32301 C. A. Hartley, Director Florida State Board of Chiropractic Examiners Suite 202, Building B 6501 Arlington Expressway Jacksonville, Florida 32211
The Issue Two issues are raised in this case. The first issue concerns the question of whether the Petitioner must seek review and permission by and from the Respondent before engaging in this project to provide inpatient radiation therapy. See Section 381.706(1)(h), Florida Statutes. If that question is answered in the affirmative, then the next question to be answered is whether Petitioner is entitled to a certificate of need to provide inpatient radiation therapy services at its hospital in Pensacola, Florida. In answering the initial question reference is made to the case of Scared Heart Hospital of Pensacola v. Department of Health and Rehabilitative Services, and Baptist Hospital, DOAH Case No. 90-3576. That reference is made because Intervenor in the present case has made a motion in limine which asserts that the Petitioner here is estopped from raising the issue of whether jurisdiction resides with the Respondent to require a certificate of need based upon the belief that DOAH Case No. 90-3576 has answered that question in the affirmative. Thus, as argued in the motion in limine, Petitioner in the present action should be barred by doctrines of collateral estoppel and res judicata from further examining that issue. Both issues are addressed in the fact finding and conclusions of law which follow, to include a ruling on the motion in limine. At the commencement of the hearing in discussing the motion in limine an examination was made of the significance, if any, of the Petitioner having failed to clearly state its opposition to the Respondent's assertion of jurisdiction over the subject matter and that party in the Petition contesting the decision on the merits to deny the application for certificate of need. Consequently, the issue of whether Petitioner has waived its right to contest the jurisdiction is also addressed in the Recommended Order.
Findings Of Fact MOTION IN LIMINE (DOAH Case No. 92-3576) On the prior occasion described in DOAH Case No. 90-3576, Petitioner had applied to Respondent for a certificate of need to institute radiation therapy services and to construct a radiation therapy facility at the campus of its hospital in Pensacola, Florida. That center was to serve inpatients and outpatients. The projected capital expenditure for that project approximated 3.7 million dollars. Petitioner contended that the radiation therapy center that would be constructed would be an extension to an existing oncology program as contrasted with the establishment of a "new service." Consistent with that position Respondent asserted that the basis for requiring a certificate of need was found in the language at Section 381.706(1)(c), Florida Statutes, which states: A capital expenditure of $1 million or more by or on behalf of a health care facility or hospice for a purpose directly related to the furnishing of health services at such facility; provided that a certificate of need shall not be required for an expenditure to provide an outpatient health service, or to acquire equipment or refinance debt, for which a certificate of need is not otherwise required pursuant to this subsection. The department shall, by rule, adjust the capital expenditure threshold annually using an appropriate inflation index. By resort to Section 381.706(1)(c), Florida Statutes, as the basis for declaring jurisdiction, the Respondent in its preliminary position did not perceive that the proposed project constituted establishment of new institutional health services or a substantial change to the existing health services, rather, it was believed to be constituted of construction costs as a capital expenditure related to the existing oncology program which expenditure met the $1 million threshold. If the basis for jurisdiction was found within Section 381.706(1)(c), Florida Statutes, then the would-be intervenor in that case, the same intervenor here, would be denied intervention. The basis for denial is found within the limitations placed upon those persons who may participate in a decision involving certificate of need for a capital expenditure as identified in Section 381.706(1)(c), Florida Statutes. That contest is between the Respondent and an applicant for the certificate. Third parties have no right to participate. On the other hand, if the basis for jurisdiction is as argued by the petition for intervention in the prior case, that basis being the jurisdiction established by Section 381.706(1)(h), Florida Statutes, then a third party health care provider in competition with the applicant seeking a certificate of need could participate in that decision. The language in Section 381.706(1)(h), states: The establishment of inpatient institutional health services by a health care facility, or a substantial change in such services, or the obligation of capital expenditures for the offering of, or a substantial change in, any such services which entails a capital expenditure in any amount, or an annual operating cost of $500,000 or more. The department shall, by rule, adjust the annual operating cost threshold annually using an appropriate inflation index. The Hearing Officer in DOAH Case No. 90-3576, heard the matter and entered his Recommended Order to resolve the right of the present intervenor to intervene in that cause. In doing so the Hearing Officer generally addressed the jurisdictional basis upon which the agency could review the application. Nothing in that process attempted to distinguish between inpatient and outpatient costs by way of a discrete analysis and allocation of those costs. Observations were made in passing concerning the aggregate amount of inpatient and outpatient costs. In particular reference was made to the capital expenditure of approximating 3.7 million dollars. No attention was given the issue of the threshold amount associated with annual operating costs identified in Section 381.706(1)(h), Florida Statutes. Factual reference to that jurisdictional amount associated with annual operating costs was left for some other occasion. The thrust in DOAH Case No. 90-3576 was to determine whether the appropriate basis for the jurisdictional claim would be found in Section 381.706(1)(c), Florida Statutes, as initially contended by the Respondent or upon resort to Section 381.706(1)(h), Florida Statutes, as contended by the petition for intervention, without a more complete analysis concerning the jurisdictional amount set out in Section 381.706(1)(h), Florida Statutes, should the hearing officer be persuaded that the latter provision constituted the grounds for review generally stated. In the factual and legal conclusions by the hearing officer in DOAH Case No. 90-3576, he determined that the project in question for inpatient and outpatient radiation therapy services constituted the establishment of new inpatient institutional health services or at least constituted a substantial change in the services that were being provided by the applicant. Thus the petition for intervention was deemed appropriate and the motion to dismiss that petition was recommended for denial. Through the Final Order which followed, with some minor modifications which have no influence on the present case, the Respondent adopted the findings of fact of the hearing officer in DOAH Case No. 90-3576, and granted the petition to intervene. The Recommended Order was entered on April 3, 1991, and the Final Order on May 21, 1991. The parties in DOAH Case No. 90-3576 did not proceed to hearing before the present case was heard. The decision by the hearing officer in DOAH Case No. 90-3576 was to defer consideration of the matter pending hearing in the present case. That choice was upon a request by all parties in DOAH Case No. 90-3576. PARTIES STIPULATIONS CONCERNING REVIEW CRITERIA The parties agree that Petitioner's Certificate of Need Application No. 6772, the present application, meets the following statutory criteria: Section 381.705(1)(c), (h), except for the third clause which is not applicable and the fourth clause which is at issue, (i), (m), except that Intervenor contends that the project costs were not properly allocated to Petitioner's Certificate of Need Application No. 6772, and (n) to Section 381.705(1). The parties also agree that the following statutory criteria are not applicable to Petitioner's application: Section 381.705(1)(e), (f), (g) and (j), Florida Statutes. Within the context of the stipulation as to criteria, the parties agree that the following issues are to be litigated: The need for the proposed project in relation to the applicable district plan and state health plan. The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care services in the service district. The availability of and adequacy of other health care facilities and services in the service district, which may serve as alternatives for the services proposed to be provided by Scared Heart Hospital. The impact of the proposed project on the cost of providing health services proposed by Scared Heart Hospital. Whether less costly, more efficient, or more appropriate alternatives to the proposed services are available. Whether existing inpatient facilities, providing inpatient services similar to those proposed are being used in an appropriate and efficient manner. Whether patients will experience serious problems in obtaining inpatient care of the type proposed, in the absence of the proposed new service. The need that the population served or to be served has for the health services proposed to be offered, and the extent to which residents in the district are likely to have access to those services. The contribution of the proposed service in meeting the health needs of members of such medically underserved groups. BACKGROUND FACTS On August 22, 1991, Petitioner gave notice that it intended to apply for the September 19, 1991, batch review cycle to initiate inpatient radiation therapy services at its Pensacola, Florida facility. That notification referred to the fact that the Petitioner was presently constructing an outpatient cancer center to provide radiation therapy services and that the anticipated opening date for that outpatient facility was December, 1991. Petitioner did apply for the September 19, 1991 batch review for initiation of inpatient radiation therapy services. At that time the construction of the outpatient radiation therapy services was proceeding. Petitioner had received a letter of non-reviewability for the construction of the outpatient cancer treatment facility on a prior date. The completion of the outpatient radiation therapy services center at the Petitioner's facility was completed and Petitioner began to provide outpatient radiation treatment in April, 1992. The cancer treatment program at Petitioner's facility is a comprehensive cancer center providing radiation therapy, chemotherapy, IV. hydration, blood transfusion, nutrition counseling, social work counseling and a library. The outpatient facility for radiation therapy is fully staffed and supplied. It was placed on the books of the Petitioner as an active asset in the year 1991. Before submitting the application for review in September, 1991 review cycle, Petitioner conferred with Respondent and was instructed to submit an application for the initiation of inpatient services and to allocate costs to the project based upon a percentage of the total facility which would be devoted to inpatient services. Through the application Petitioner noted that the total cost of the establishment of the radiation therapy services projected to open in December, 1991, was $4,124,475. Pursuant to the instruction by the Respondent $618,671 was allocated as an estimate of capital expenditures for inpatient radiation therapy services. This approximates 15 percent of patients being treated as inpatients of the total number of patients treated by radiation therapy. Generally stated, the experience of most providers is that 10 to 15 percent of radiation therapy is delivered on an inpatient basis with the balance of the radiation therapy being delivered on an outpatient basis. The allocation of capital expenditures to inpatient therapy was an artificial device mandated by the Respondent. It does not reflect the actual experience. In actuality the incremental project costs related to capital expenditures for the inpatients receiving radiation therapy are zero. The reason for this finding is based upon the fact that the equipment for providing the inpatient radiation therapy is already in place, the facility for providing that care had been constructed, there is no associated incremental depreciation for inpatient care, the project has been fully paid for from funded depreciation cash and has been placed upon the books of the facility at 100 percent of that total. In essence, the capital costs have been incurred before the advent of the inpatient radiation therapy services. Additional costs promoted by the provision of care for inpatients who receive radiation therapy at the facility would be supply expenses attributable to those inpatients and the possibility of additional salaries attributable to overtime work done by staff to serve the inpatients. These are minimal costs. Operating costs were also artificially allocated to inpatients in the application. For the first year of operation, salaries allocated to inpatient care were estimated at $64,950.00, with associated benefits at $9,898.00, other patient care expenses at $17,925.00 and depreciation in the amount of $51,135.00. Even when resort is made to this certificate the proposal to institute inpatient radiation therapy does not reach the $500,000.00 threshold in annual operating costs, in addition to having no fiscal impact by way of capital expenditures. Petitioner is a 391 bed acute general hospital located in Pensacola, Florida. The services that it provides are available to inpatients and outpatients. Among those services are an open heart facility, neonatal intensive care Level II and Level III units, and freestanding 50 bed children's hospital. The patients receiving care for cancer are provided screening programs, risk assessments, preventative education programs, diagnostic services, surgery, chemotherapy and radiation therapy on an outpatient basis. The application for inpatient radiation therapy was not favorably reviewed in the State Agency Action Report issued on or about January 8, 1992. This led to the present hearing when Petitioner contested the decision to deny the application. Intervenor and West Florida Hospital, both of Pensacola, Florida, and the same planning district where Petitioner is located, have certificates of need to provide inpatient radiation therapy. They also provide outpatient radiation therapy. The other two hospitals treat patients referred by Petitioner for radiation therapy needs. The inpatients of the Petitioner requiring radiation therapy must be transported to the other two hospitals to receive that care. The majority of those patients who are being transported are referred to the Intervenor. Pediatric cancer patients from Petitioner's facility are transported to West Florida. The patients who are transported from Petitioner's facility to the Intervenor's facility are received by the Intervenor as outpatients. When they return to the Petitioner's facility they are perceived as inpatients. Each of the other two facilities who offer radiation therapy pursuant to certificates of need have two linear accelerators to provide inpatient and outpatient radiation therapy. Petitioner seeks to have its single linear accelerator which now provides outpatient radiation therapy made available to provide inpatient radiation therapy. There are also two non-hospital based radiation therapy centers which have single linear accelerators to provide outpatient radiation therapy services. Those non-hospital based providers are located in Ft. Walton Beach and Crestview, Florida, within the same planning district that is associated with this application. REVIEW CRITERIA 1/ Section 381.705(1)(a), Florida Statutes, requires that an application be reviewed for its consistency with the state and district health plans. Neither of those plans addresses the provision of radiation therapy services. As a consequence, neither plan sets forth need allocation factors that would address this type application. In view of the silence of the state and local health plans concerning inpatient radiation therapy, the application cannot be seen as inconsistent with those plans. Section 381.705(1)(b), Florida Statutes, speaks in terms of the availability, quality of care, efficiency, appropriateness, accessibility, and extent of utilization and adequacy of like and existing health care services in the service district to be served by the applicant. As stated before inpatient radiation therapy is being delivered by two other providers. Those providers make available and could continue to make availability the quality of care, which is efficient, appropriate, accessible and adequate in delivering inpatient radiation therapy to those patients which Petitioner would serve if granted the certificate of need to do so. The inpatient radiation therapy services offered by those two providers are not over-utilized at present nor would they be in the foreseeable future. The exception to these findings would be related to a quality of care issue not pertaining to the actual delivery of radiation therapy to patients referred from the Petitioner to the other two providers but related to the inconvenience in preparing those patients for transport for delivery of therapy and the transport itself. For some patients who are required to undergo the preparation for transport and transport, that process can be quite painful. Patients have refused to be transported to receive radiation therapy and this has complicated their treatment. It would be a less uncomfortable process if the patients were undergoing the radiation therapy at the Petitioner's facility. Physician's practice patterns in this community where some physicians choose to practice in a single hospital notwithstanding their admission privileges in multiple hospitals complicates the issue in that a patient may be admitted to Petitioner's facility because the admitting physician chooses to practice there alone. Once a diagnosis is made and a decision reached that the patient in that hospital needs to undergo radiation therapy, the need to transport for those treatment ensues. Moreover, as suggested, the decision to utilize radiation therapy in the treatment is not ordinarily made at the initial moment of admission when health care professionals are trying to make the initial diagnosis concerning the patients complaints in deciding whether they are associated with cancer or not and if radiation therapy would benefit the patient or even in the instance where the patient is known to have a history of that illness whether radiation therapy is indicated. Therefore, there might not be a reason to try and place the patient in a facility that has inpatient radiation therapy available if that treatment regime upon evaluation does not seem indicated. The issue concerning the ability to transfer a patient from one facility to another for the overall hospitalization to include provision of inpatient radiation therapy such that a patient who has been determined to need radiation therapy could be transferred from Petitioner's facility to Intervenor's facility for overall care, while theoretically possible does not seem practicable. Additionally, the patients who receive outpatient radiation therapy through Petitioner's facility who would need at some future point in treating the condition to be transferred to another facility to receive radiation therapy once admitted as an inpatient in Petitioner's facility breaks the continuity of the management of the care by requiring the patient to undergo an evaluation by two different radiation therapists, disrupting the patient- physician relationship in a setting which is complicated by the patient's condition. Nonetheless, the quality of care is not so compromised by the need to transport for the inpatients at the Petitioner's facility to receive radiation therapy to conclude that it constitutes a reason standing alone to grant the certificate of need. In a similar vein, as contemplated by Section 381.705(1)(d), Florida Statutes, the availability and adequacy of other health care facilities and services and hospices in the service district of the applicant, such as outpatient care and home care services, which might serve as alternatives for the applicant's proposal have been considered. Out of that list, only the possibility of the use of outpatient care provided by the existing facilities who offer outpatient radiation therapy would arguably have pertinence to this inquiry. They would not constitute an available and adequate substitute for inpatient radiation therapy for reason that patients who are admitted to a hospital are distinguished from those who come to the facility from other places for purposes of receiving outpatient radiation therapy. That distinction has to do with the gravity of the condition of the patient which caused the patient to be admitted to the hospital in the first instance, and to receive, together with medical attention and other therapies, the provision of radiation therapy. Concerning that portion of Section 381.705(1)(h), Florida Statutes, which describes the applicant's need to address the availability of alternative uses of resources for the provision of other health services, that clause was referred to as an issue in the prehearing stipulation but was not advanced at the hearing. Through the prehearing stipulation the parties did not include reference to Section 381.705(1)(k), Florida Statutes, as a provision about which there was an agreement concerning compliance or the need to comply with its terms. The record reveals that the applicant and the existing providers address the need for radiation therapy of individuals who are not residing in the service district. This project does not appear to have a pronounced influence in improving or diminishing health care for persons not residing in the service district. Section 381.705(1)(l), Florida Statutes, addresses the probable impact of the project on the cost of providing health services proposed by the applicant and it takes into consideration the effects of competition on the supply of health services being proposed and any improvements or innovations in the financing and delivery of health services which foster competition and serve as a promotion of quality assurance and cost effectiveness. Whether the applicant delivers services to the inpatients that it would gain with recognition of its application or some other entity serves the needs of those patients, the basic costs of providing health services would be relatively the same. The exception is the improvement in the circumstance of health care costs related to the transport of the patients from the Petitioner's facility to the two other facilities for provision of the radiation therapy of inpatients in the Petitioner's facility and the attendant costs of duplication of patient charges and professional fees charged by the physician therapist potentially associated with having a patient move from the status of an outpatient at the Petitioner's facility to an admitted patient at that facility who receives radiation therapy at one of the other two facilities while undergoing inpatient care in the Petitioner's facility. These additional costs in transport and potential for patient charges associated with procedures in the other two hospitals and physicians fees in those other two hospitals which are duplicative of efforts made by the Petitioner's outpatient radiation program in its procedures and the physician's fees associated with those outpatient radiation therapy procedures could be done away with if the project were approved. There is no indication of any significant improvements or innovations in the financing and delivery of health services associated with this application which might foster competition and serve to promote quality assurance and cost effectiveness. The cost improvements that are discussed here standing alone do not justify the applicant being granted a certificate of need. The advent of an inpatient radiation therapy service will not be so adverse in its impact that it will cause the Intervenor or any other existing facility to lose financial viability concerning the ability to maintain an appropriate level of utilization of existing facilities. There are no costs of construction and the method of proposed construction need not be considered in that the construction has been concluded as previously discussed. Consequently, the necessity to address the costs and methods of the proposed constructions as described in Section 381.705(1)(m), Florida Statutes, is not relevant to the inquiry. Nor are the references within Section 381.705(2), Florida Statutes, having to do with capital expenditures pertinent to the outcome in examining the review criteria. LACK OF A VIABLE NEEDS FORMULA Respondent does not have a rule which calculates the need for inpatient radiation therapy by resort to a formula which derives need. Neither does the Respondent have an emergent policy which it is developing to formulate the amount of inpatient radiation therapy services needed in a given review cycle. Respondent and the private litigants have attempted to examine the need for inpatient radiation therapy contemplated by this application by devising various mathematical formulas to determine need. Each explanation is fundamentally flawed in that they fail to address the discrete issue contemplated for examination by the review process, that is the need for inpatient radiation therapy. Instead, these methods look at all radiation therapy both inpatient and outpatient. The statute does not contemplate that form of evaluation. It is the 10 to 15 percent of all radiation therapy patients that constitute the inpatients. It is the provision of care to those persons that is subject to examination. If need is to be derived by use of a formula, a knowledge of the circumstances existing for outpatients, a category of patient for whom no certificate of need must be obtained to serve them, should not enter in to the analysis. The formulas exercised by the parties in measuring the overall need for inpatient and outpatient radiation therapy services derive the answers by identifying the number of linear accelerators needed in the district or in one instance for the applicant's facility alone. In that exercise a count is made of the four linear accelerators in the district belonging to the two hospitals which have been granted certificates of need which would allow inpatient radiation therapy to be delivered as well as outpatient therapy and the three programs that serve outpatients on three additional linear accelerators. The total number of linear accelerators is seven counting the linear accelerator the Petitioner has to serve outpatients. No attempt by formula has been made to ascertain whether more than four linear accelerators found within the two hospitals who have certificates of need to provide inpatient radiation therapy service are warranted. Thought provoking questions have been raised by the several parties in critiquing the needs calculation made by an opponent or opponents. However, it is not necessary to choose among these competing theories because in selecting any theory one cannot derive the amount of inpatient radiation therapy services needed in the district. Furthermore, case law does not allow the trier of fact to utilize the basic information provided by the parties to construct a formula for determining need for inpatient radiation services independent of the efforts of the parties in the person of their experts whom they have consulted with on this subject. This means that the decision here must be made by a review of applicable criteria without resort to a preliminary determination of numeric needs. This has been done. On balance, when taking into account the combination of improvements to quality of care for a patient being transported from the Petitioner's facility to receive radiation therapy and the improvement concerning the removal of the cost of that transport and duplication of charges and fees for certain patients who move from an outpatient posture under treatment by the Petitioner and into an inpatient status with Petitioner receiving radiation therapy at one of the two other hospitals which has been discussed in preceding paragraphs, the project is justified and the application should be granted.
Recommendation Based upon the consideration of the facts, and in view of the conclusions of law, it is, RECOMMENDED: That a Final Order be entered which declines jurisdiction to require a certificate of need for inpatient radiation therapy services or in the alternative grants a certificate of need for inpatient radiation therapy services. DONE and ENTERED this 20th day of August, 1992, in Tallahassee, Florida. CHARLES C. ADAMS, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of August, 1992.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The petitioner, Michael Selinsky, was a candidate for the chiropractic examination given in November of 1987. The practical examination is composed of three portions, X-ray interpretation, technique and physical diagnosis, and a score of 75% must be achieved on all three subject areas in order to pass. The petitioner received a score of 77.1 on the X-ray interpretation area, a score of 77.5 on the technique area and a score of 72.5 on the physical diagnosis area. In this proceeding, petitioner challenges two of the scores he received on the examination in the area of physical diagnosis. The physical diagnosis portion of the examination consists of oral questions posed to the candidate by two examiners. The answers are graded on a scale of 1 to 4, with 4 being the highest grade. Petitioner challenges the grade of 3 one of the examiners gave him for the "neurological" portion of the exam and the grade of 2 another examiner gave him for the "X-ray technique & diagnosis" portion of the examination. On these two areas of the examination, Examiner number 14 awarded petitioner a grade of 3 on both areas. Examiner number 23 awarded petitioner a grade of 4 on the "neurological" portion anal a grade of 2 on the "x-ray technique & diagnosis" portion. During the neurological section of the oral examination, petitioner was requested to demonstrate upon a live model how he would test the extensor hallicus longus muscle for the L-5 mytome. In response, he extended the great toe in the wrong direction. In responding to a question concerning an upper motor neuron lesion and a lower motor lesion, petitioner's answers were very incomplete. During the X-ray technique portion of the oral examination, petitioner was requested to demonstrate with a live model how he would position a patient for a lateral shoulder x-ray. The petitioner responded that he had never heard of such a position, but then attempted to position the patient. In fact, there is no way to take an x-ray of the lateral shoulder view because two bones would be superimposed. While this might be viewed as a "trick" question, petitioner should have been aware that no such x-ray could be taken. During another x-ray positioning question, petitioner failed to turn the patient's head. Also, during the X-ray technique portion of the oral examination, petitioner was asked to identify three factors that affected his exposure to radiation as an operator. The petitioner's answer included such things as lead- lined booths, lead-lined walls in the x-ray room and proper film developing to decrease the number of retakes. Several times, the examiners asked him questions regarding his answers, and the petitioner responded that he was not sure. When considering an operator's safety with regard to radiation exposure, there are three fundamental and established factors to take into account: time of exposure, distance and shielding. The petitioner's answers had relevance to patient safety, but not to the safety of the operator. In spite of prodding and grilling by the examiners with regard to operator safety, petitioner was unable to elucidate the three fundamental factors of radiation safety.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that the petition be DISMISSED. Respectfully submitted and entered this 17th day of October, 1988, 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 17th day of October, 1988. COPIES FURNISHED: Copies furnished: William A. Leffler, III, Esquire Bruce D. Lamb, General Counsel Department of Professional Department of Professional Regulation Regulation 130 North Monroe Street 130 North Monroe Street Tallahassee, Florida 32399-0750 Tallahassee, Florida 32399-0750 Michael Selinsky Pat Guilford, Executive 5259 Wayside Court Director Spring Hill, Florida 34606 Board of Chiropractic Examiners Lawrence A. Gonzalez, Secretary Department of Professional Department of Professional Regulation Regulation 130 North Monroe Street 130 North Monroe Street Tallahassee, Florida 32399-0750 Tallahassee, Florida 32399-0750
Findings Of Fact Rubin Klein, M.D., dispenses radiation therapy treatments at his office in Hollywood, Broward County, Florida, just north of the Dade County line. He uses two cobalt machines for this purpose. Cobalt's radioactivity fades at an approximate rate of one percent per month, and at least one of Dr. Klein's machines has deteriorated to the point that it cannot be used much longer. Dr. Klein would like to see the failing machine replaced by a linear accelerator, but he does not want to bear the expense of acquiring a linear accelerator, particularly since his practice fell off sharply two or three years ago with the opening of a radiation therapy department at Hollywood Memorial Hospital. Dr. Klein has offered to donate his equipment to petitioner, and petitioner proposes to accept Dr. Klein's donation of his better cobalt unit, to bear the expense of moving the cobalt unit, to acquire a linear accelerator, to construct an appropriate facility, and to install the equipment. Petitioner estimates that it would cost approximately eight hundred twenty-three thousand dollars ($823,000.00) to accomplish this. On the other hand, Dr. Klein estimates that it would cost approximately two hundred five thousand dollars ($205,000.00) to acquire a linear accelerator and to install it in his office. Once the physical changes which it proposes have been accomplished, petitioner proposes to hire Dr. Klein's office staff, including a full-time radiation physicist and two radiation therapy technicians. In August of 1977, petitioner submitted its application for certificate of need, joint exhibit No. 1, receipt of which was acknowledged by Mr. Robert E. Straughn on behalf of the Office of Community Medical Facilities, on August 29, 1977. Joint exhibit No. 2. The staff of the Health Systems Agency of South Florida, Inc. prepared an analysis of petitioner's application, which concluded with a recommendation against approval of the application. Joint exhibit No. 4, p. 31. Because of petitioner's proximity to Broward County, the Health Systems Agency of South Florida, Inc. solicited the views of the Health Planning and Development Council for Broward County on petitioner's application, but these views were never made known. A review committee of the Health Systems Agency of South Florida, Inc. voted against granting petitioner's application. In a memorandum from the review committee's chairperson to the Health Systems Agency's Board of Directors, the committee's reasons were stated as follows: Although this is a transfer and upgrade of existing equipment, it still represents excess capacity for the total community. The project does not foster cost containment since construction costs represent the expense of building a new unit. (The committee felt that such expense would be asking the community to absorb unnecessary costs.) Joint exhibit No. 7. On October 18, 1977, the Board of Directors of the Health Systems Agency of South Florida, Inc. adopted the staff's analysis and voted to recommend denial of petitioner's application because, inter alia, "[i]t is less costly to maintain the facility in its present location." Joint exhibit No. 8. On November 16, 1977, Mr. Art Forehand wrote petitioner that the Office of Community Medical Facilities had also reviewed the application and had also concluded that it should be denied. Joint exhibit No. 9. Petitioner's hospital is located in Dade County on Biscayne Boulevard one fifth of a mile south of the Broward County line. Petitioner has six or seven oncologists on its medical staff and 20 percent of its beds are filled by cancer victims, half of whom receive radiation therapy. The demographic data suggest that cancer patients will continue to occupy petitioner's beds in like or greater numbers. Seventy-eight percent of petitioner's patients are 65 years old or older, an age group three or four times more vulnerable to cancer than the general population. As things now stand, petitioner's patients must leave the hospital in order to receive radiation therapy. This ordinarily necessitates transportation by ambulance. The cost for such transportation to Dr. Klein's office and back is sixty-five dollars ($65.00). Dr. Klein's office is four and one half miles from petitioner's hospital. Approximately three percent of Dr. Klein's patients are hospitalized at Biscayne Medical Center, Inc., and travel to and from his office by ambulance. The practice of radiation medicine occurs more and more in hospitals rather than in radiologists' offices, and this trend is generally believed to be desirable. Tumors may be treated surgically or chemically instead of or in addition to being treated with radiation. Physicians sometimes disagree among themselves as to whether surgery, medicine or radiation is indicated in a given case. Petitioner's cancer patients would benefit from examination by a radiation oncologist as well as by other medical specialists. A cancer victim who presents himself at a radiologist's office may not have been examined beforehand by a medical oncologist or by a surgical oncologist; a cancer patient who has been admitted to a hospital is perhaps more likely to be examined by these specialists before a course of treatment is settled on. Chemotherapy and various heat treatments, which are more readily administered in a hospital setting, may enhance the beneficent effects of radiation in some cases. Hospitalization facilitates observation of patients and detection of untoward side effects. In practice, however, nine outpatients for every one inpatient "tends to be the normal spread for a radiation therapy department." (R326) Radiation emitted from a linear accelerator can be focussed more sharply than radiation emitted from a cobalt unit. For Hodgkin's disease, certain pituitary and other disorders, a linear accelerator is a much better means of treatment than a cobalt unit is. Since radiation tends to destroy human tissue, whether diseased or healthy, the linear accelerator's relative precision can be a significant advantage in a wide range of cases. Treatment takes more time with a cobalt unit, especially one with a failing source of radiation. Dr. Klein estimates he could treat a fifth again as many people in the same time, with a linear accelerator. What constitutes optimum utilization of radiotherapy equipment is a matter of debate. Dr. Richard Johnson testified that six to seven thousand patients annually constitute "the maximum you can give good treatment," (R153) apparently on the basis of a 35 hour work week. (Rl54) On the other hand, the staff of the Health Systems Agency of South Florida, Inc. used a 48 hour work week in its calculations and concluded that both Dade and Broward County have substantial excess capacity in radiotherapy equipment. Both Dade and Broward Counties do, in fact, have excess capacity in radiotherapy equipment. On the assumption that Dr. Klein's practice would grow, if removed to petitioner's hospital, and on the assumption that Dr. Klein would charge (in addition to the hospital's charges) twenty dollars per procedure (which he indicated was the very minimum he might charge), Mr. Donald Dahlfues testified that the federal government might be billed less for the same number of treatments if Dr. Klein performed them in petitioner's hospital than if he performed them in his present office. The foregoing findings of fact should be read in conjunction with the statement required by Stuckey's of Eastman, Georgia v. Department of Transportation, 340 So.2d 119 (Fla. 1st DCA 1976), which is attached as an appendix to the recommended order.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That respondent deny petitioner's application for certificate of need. DONE and ENTERED this 17th day of April, 1978, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of April, 1978. APPENDIX Paragraphs one, two, three, four, five, six, seven, eight, nine, ten, eleven, fourteen, fifteen, and nineteen of petitioner's proposed findings of fact are generally supported by the evidence and have largely been adopted, in substance, insofar as relevant. Paragraph thirteen of petitioner's proposed findings of fact recites an "optimum accepted utilization rate" which was not established by the evidence. Paragraph sixteen of petitioner's proposed findings of fact is not supported by the evidence and has not been adopted for that reason. One of petitioner's witnesses indicated that 90 percent of the anticipated use of the equipment would be on an outpatient basis. While another of petitioner's witnesses claimed that hospital bed time would be reduced in some cases, petitioner's administrator is looking to "increased inpatient days as a result of having the equipment" (R43) to help defray the cost of the equipment. Paragraph seventeen of petitioner's proposed findings of fact states a debatable policy conclusion rather than a fact established by the evidence at the hearing. Paragraphs eighteen, twenty and twenty-one of petitioner's proposed findings of fact are not supported by the evidence as a whole and have not been adopted for that reason. Paragraphs one, three, four, five, six, seven, eight, nine, ten, thirteen, fourteen, sixteen, seventeen, eighteen, nineteen and twenty-one of respondent's proposed findings of fact are generally supported by the evidence and have largely been adopted, in substance. COPIES FURNISHED: Edward R. Rumin, Esquire Adams and Adams 2870 East Oakland Park Boulevard Fort Lauderdale, Florida 33306 Milton E. McRay, Esquire 6502 Powers Ferry Road, N. W. Atlanta, Georgia 30339 Steven W. Boss, Esquire 1323 Winewood Boulevard Room 309 Tallahassee, Florida 32301
The Issue Whether the Petitioner committed the violations alleged in the Administrative Complaint, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department of Health is the state agency responsible for certifying and regulating basic X-ray machine operators in Florida. Sections 468.3001-.312, Florida Statutes. On March 30, 1993, Paul Butler was issued Basic X-ray Machine Operator Certificate Number 7729. The certificate expired December 31, 1994, and Mr. Butler requested renewal by submitting a renewal form and the required fee to the Department on December 20, 1996. Mr. Butler admitted that he knew his certificate expired December 31, 1994, but that he nonetheless took numerous X-rays subsequent to that date. On January 4, 1996, Mr. Butler prepared and submitted an application for employment to Kristie Green, office manager for South Dade Orthopedic Associates. In that application, Mr. Butler signed his name and appended to his name the designation "RMA, CRT." Ms. Green interviewed Mr. Butler, and he provided her with a copy of his certificate that showed an expiration date of December 31, 1995. Ms. Green noted that his certificate had expired four days previously, and Mr. Butler told her he was short of funds and would send in his renewal application when he received his first paycheck. Ms. Green hired Mr. Butler as an X- ray technician and medical assistant. After Mr. Butler repeatedly assured her that he had sent his renewal application to the Department, Ms. Green fired Mr. Butler on June 20, 1996, because he had not obtained a current Basic X-ray Machine Operator certificate. The evidence presented by the Department is sufficient to establish that Mr. Butler took X-rays without having an active certificate, and that he identified himself in his employment application to South Dade Orthopedic Associates as a Certified Radiologic Technologist by using the letters "CRT" after his signature. The evidence presented is also sufficient to permit the inference that Mr. Butler altered his basic X-ray Machine Operator certificate by changing the expiration date from December 31, 1994, to December 31, 1995.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health issue a final order finding that Paul Butler violated Section 468.3101(h), Florida Statutes, by violating Section 468.302(1) and (2) and that he violated Section 468.3101(f). Based on the violations, the Department of Health should impose the following penalties: Suspend Mr. Butler's Basic X-ray Machine Operator certificate for a period of six (6) months; Impose an administrative fine in the amount of Six hundred twenty-five dollars ($625.00); and Condition the reinstatement of Mr. Butler's certificate on his having completed thirty (30) hours of continuing education. DONE AND ENTERED this 12th day of January, 1998, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 12th day of January, 1998. COPIES FURNISHED: Morton Laitner, Esquire Department of Health 401 Northwest 2nd Avenue Suite N-1014 Miami, Florida 33128 Paul Butler, pro se 30525 Southwest 149th Court Leisure City, Florida 33033 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700 Pete Peterson, General Counsel Department of Health 1317 Winewood Boulevard Building 6, Room 102-E Tallahassee, Florida 32399-0700
The Issue The issue for determination in this case is whether Respondent's license to practice medicine in the State of Florida should be disciplined for disseminating, or causing the dissemination of an advertisement that was false, deceptive or misleading in violation of Rule 59R-11.001, Florida Administrative Code, and Section 458.331(1)(x), Florida Statutes.
Findings Of Fact Petitioner, AGENCY FOR HEALTH CARE ADMINISTRATION (AHCA), is the agency of the State of Florida vested with the statutory authority under Chapter 458, Florida Statutes, to regulate the practice of medicine. Respondent, JONATHAN M. FRANTZ, M.D., is and at all material times has been, a licensed physician in the State of Florida, having been issued license number ME 0054884. Respondent graduated from the University of Miami School of Medicine in 1983, and thereafter entered a residency program in Opthamology at the Louisiana State University Eye Center in New Orleans, Louisiana, where from 1987 to 1989 Respondent was a Fellow in Cornea, External Disease, and Refractive Surgery. During his Fellowship at the Louisiana State University Eye Center, Respondent participated in the initial research projects involving the Excimer Laser Procedure, which at that time was exclusively an investigational device. The term "investigational device" is a technical term used by the Food and Drug Administration (FDA) and medical researchers. The term means that a device has yet to be approved for treatment of human patients by the FDA and that its use is limited by the FDA to research investigations. The Excimer Laser is a device that projects a wavelength of light over the surface of the cornea to treat nearsightedness and astigmatism. The wavelength of light removes irregularities on the surface of the cornea or anterior corneal tissue in order to change the refraction of the eye and improve the patient's eyesight. At all material times, the Excimer Laser was an investigational device. Radial Keratotomy is, and at all material times was an FDA approved procedure for the treatment of nearsightedness and astigmatism. The Excimer Laser procedure differs from Radial Keratotomy in that Radial Keratotomy is a procedure in which incisions are made to the corneal tissue itself. The incisions allow for the flattening of the center of the cornea, and thus, unlike the Excimer Laser, actually change the structure of the cornea. During his Fellowship, Respondent participated in primate and human research involving the Excimer Laser, and assisted in the development of protocols for use in the first treatment of human patients with the device. Respondent received a research award from the National Eye Institute for his investigative work with the Excimer Laser. Respondent has published several articles in medical literature relating to the Excimer Laser. Respondent is certified by the American Board of Opthamology, and is a member of the American Academy of Opthamology. After completion of his Fellowship, Respondent entered private practice in Ft. Myers, Florida. While in private practice, Respondent continued his research work with the Excimer Laser. In 1990, Respondent was selected as one of a small group of physicians to conduct Excimer Laser investigational treatments on patients. As a principal investigator, Respondent treated patients with all degrees of nearsightedness and astigmatism. In May of 1993 Respondent was employed by Eye Centers of Florida located in Ft. Myers, Florida. Respondent performed Excimer Laser investigational procedures while so employed. At this time, the Excimer Laser procedure was also being performed by Dr. James J. Rowsey, Jr., Chairman of the Department of Opthamology at the University of South Florida in Tampa, Florida. The Excimer Laser procedure performed at the University of South Florida offered a different protocol than that offered by Respondent at the Eye Centers of Florida. Respondent was the only Opthamologist in Florida offering Excimer Laser procedures for patients with all degrees of nearsightedness and astigmatism, as well as offering Radial Keratotomy. In addition to his expertise in Opthamology, Dr. Rowsey has extensive expertise in the area of ethical medical advertising. On May 23, 1993, the following advertisement was published in the Charlotte Sun Herald, a Florida newspaper: Jonathan M. Frantz, M.D., corneal specialist with the Eye Centers of Florida, invites you to join him for an exciting lecture on the newest breakthroughs in eye surgery - the Excimer laser and Radial Keratotomy (RK). Eye Care Centers of Florida is the only eye care center in Florida that offers both options. Come to our free seminar and find out how you can reduce your need for glasses or contact lenses. EXCIMER LASER RADIAL KERATOTOMY THE CORRECTION OF NEARSIGHTEDNESS AND ASTIGMATISM FREE ADMISSION AND SCREENING FOR EXCIMER LASER AVAILABLE PLEASE BRING GLASSES AND/OR CURRENT EYE GLASS PRESCRIPTION WEDNESDAY, MAY 26 7:00 PM FIRST FEDERAL BANK BUILDING 3524 D TAMIAMI TRAIL (SECOND FLOOR) PORT CHARLOTTE RESERVATIONS 1-800-226-3377 OR 1-813-939-3456 EYE CENTERS OF FLORIDA Helping You See Your Best 4101 Evans Avenue Fort Myers, Florida (Caution: The Excimer Laser is an Investigational Device. Limited by Federal Law to Investigational Use.) The advertisement also contained Respondent's picture, and the logo for the Eye Centers of Florida. The advertisement was composed by a marketing agency retained by the Eye Centers of Florida. Respondent was generally aware of the contents of the advertisement, but did not give specific approval for the placement of the advertisement. Respondent was aware that the advertisement of the Excimer Laser required cautionary language stating that the procedure was an investigational device limited by the FDA. The advertisement clearly states that the Excimer Laser is an investigational device limited by the FDA. The advertisement is a public invitation to attend a lecture given by Respondent concerning the Excimer Laser and Radial Keratotomy. At the lecture, Respondent explained that the Excimer Laser was an investigational device. Thereafter a person seeking Excimer Laser treatment was given a consent form that explained in detail the investigatory nature of the procedure. As a principal investigator Respondent was limited in the number of patients he could treat with the Excimer Laser. Respondent received an economic benefit from the treatment of patients with the Excimer Laser. As a result of the investigational efforts of Respondent and other medical researchers, the Excimer Laser was proved to have beneficial results in the treatment of nearsightedness and astigmatism. Subsequent to the publication of the advertisement, the Excimer Laser received FDA approval. The advertisement was reviewed by Norman S. Levy, M.D., Ph.D., an Opthamologist, and Director of the Florida Opthamologic Institute in Gainesville, Florida. As an expert in Opthamology, Dr. Levy opined that the advertisement published in this case was deceptive in that the advertisement implied that the Excimer Laser and Radial Keratotomy procedures were equally available, and the experimental nature of the Excimer Laser procedure was not clear from the advertisement. The advertisement was also reviewed by Dr. Rowsey, who opined that the advertisement was not misleading or deceptive, that the advertisement clearly contained cautionary language stating that the Excimer Laser was at that time an investigational device, and that the advertisement was merely a public invitation to a lecture to obtain more information regarding these procedures. In this respect, Dr. Rowsey has specific and extensive experience with the Excimer Laser, as well as in medical ethics, and his opinion on this issue is deemed more credible. There is no evidence that a patient of the Respondent's was deceived or mislead by the advertisement.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that Petitioner, the AGENCY FOR HEALTH CARE ADMINISTRATION, enter a final order dismissing the Administrative Complaint filed against Respondent JONATHAN M. FRANTZ, M.D., in the above-styled case. RECOMMENDED in Tallahassee, Leon County, Florida, this 24th day of January, 1996. RICHARD HIXSON, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of January, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-3773 Petitioner's Proposed Findings of Fact. 1.-6 Accepted and incorporated. Rejected to the extent that Respondent personally approved the advertisement. Rejected to the extent that a lay person could be misled. Rejected as not supported by the weight of evidence. Respondent's Proposed Findings of Fact. 1.&2. Accepted and incorporated. 3. Rejected as irrelevant. 4.-.7. Accepted and incorporated. 8.&9. Rejected as not necessary. 10.-12. Accepted and incorporated. 13. Rejected as not necessary. 14.-16. Accepted and incorporated. 17. Rejected as not necessary. 18.-26. Accepted and incorporated. COPIES FURNISHED: Joseph S. Garwood, Esquire AHCA - Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 John Lauro, Esquire Barnett Plaza, Suite 3950 101 East Kennedy Boulevard Tampa, Florida 33602
The Issue The ultimate issue is whether the State's insurance program should pay for physical therapy provided to its insured, the Petitioner; however, this is dependent only upon a determination of what is medically necessary.
Findings Of Fact At all times pertinent to the issues contained herein, Petitioner was an eligible dependent of E. P. J. Gibbs, #F266-87-2492, an insured employee under the State of Florida Employees' Group Health Self Insurance Plan, provided for in Section 110.123, Florida Statutes. Eligible dependents are entitled to participate and obtain the identical level of benefits as are available to insured employees. Petitioner first injured her right knee while jogging in September or October 1983. (Petitioner Exhibit 1 - letter of Dr. Peter Indelicato.) Petitioner was first examined by Dr. Peter A. Indelicato, an Orthopedic Physician specializing in sports medicine, on October 10, 1983, for evaluation and treatment of pain in her right knee. Dr. Indelicato diagnosed Petitioner's condition as patellofemoral pain syndrome (PPS). PPS is a condition which causes pain in the area surrounding the patella (knee cap) and the femur (bone of the thigh). This condition may be treated surgically or non-surgically (conservatively) by strengthening the leg and knee through physical therapy. Dr. Indelicato treated Petitioner's condition conservatively, referring Petitioner to the Physical Therapy and Rehabilitation Center (PTRC) on October 11, 1983, for evaluation and treatment in the quadricep strengthening program in accordance with Anterior Cruciate Ligament Protocol (ACL Program). See Page 22 of Hearing Officer Exhibit 1. This protocol started at the same point as the post operative protocol in the 7-8 weeks after surgery and ran until the 16-18 weeks after surgery. See Page 20 of Hearing Officer Exhibit 12 On her referral to the PTRC, the Petitioner was observed by staff members. The Petitioner was unable to ambulate without difficulty; did not have full range of movement in her leg; the pain in Petitioner's knee made pedaling the stationary bicycle uncomfortable; and work out with the Cybex, another exercise machine, was totally precluded because of pain. Following Petitioner's admission to the program, Petitioner's condition improved. Within one week of her admission into the program, Petitioner lost the "catch" in her patella. By October 28, 1983, Petitioner was able to tolerate the stationary bicycle. By November 9, 1983, Petitioner was able to exercise using the Cybex. On November 18, 1983, the charting for the Petitioner by the physical therapist reflected that she continued to do well and concluded: "She is scheduled to return to see Dr. Indelicato next week and I think we can discharge her on a home program at that time." See Hearing Officer's Exhibit 1 Page 25. Dr. Indelicato examined the Petitioner on November 21, 1983. The doctor found visible atrophy or wasting away of the quadricep and that the strength of Petitioner's quadricep muscle could not be tested because of pain. Based upon these findings, Dr. Indelicato referred Petitioner back to therapy at the PTRC for an additional 4-6 weeks. See Gibbs Exhibit 1. The charting for the physical therapist for November 27, 1983 stated: "Pt. returned to see Dr. Indelicato this week and in light of her diminished Cybex results it was decided to continue her on a further quadricep strengthening program. She is working terminal extension on the Cybex, stationary cycling and SLR (Straight Leg Raise) and not having any difficulty." See Hearing Officer Exhibit 1, page 26. Dr. Indelicato's order for continued therapy was consistent with the ACL Protocol which calls for 9-10 weeks of therapy. See Hearing Officer's Exhibit 1, page 20. Petitioner continued to receive physical therapy treatments until January 13, 1984. All total, Petitioner received 39 days of treatment from October 11, 1983 to January 13, 1984, or approximately eight weeks of therapy. The following is a list of treatments by date with costs. DATE AMOUNT 1. October 11, 1983 $30.00 2. October 12, 1983 30.00 3. October 14, 1983 30.00 4. October 17, 1983 30.00 5. October 19, 1983 30.00 6. October 21, 1983 30.00 7. October 24, 1983 30.00 8. October 26, 1983 30.00 9. October 28, 1983 30.00 10. October 31, 1983 30.00 11. November 2, 1983 35.00 12. November 4, 1983 32.50 13. November 7, 1983 32.50 14. November 9, 1983 32.50 15. November 11, 1983 32.50 16. November 14, 1983 32.50 17. November 16, 1983 32.50 18. November 18, 1983 45.00 19. November 21, 1983 35.00 20. November 23, 1983 35.00 21. November 28, 1983 35.00 22. November 30, 1983 35.00 23. December 2, 1983 35.00 24. December 5, 1983 35.00 25. December 7, 1983 35.00 26. December 9, 1983 32.50 27. December 16, 1983 27.50 28. December 19, 1983 35.00 29. December 22, 1983 32.50 30. December 23, 1983 40.00 31. December 27, 1983 35.00 32. December 28, 1983 35.00 33. December 30, 1983 35.00 34. January 3, 1984 35.00 35. January 5, 1984 35.00 36. January 6, 1984 35.00 37. January 9, 1984 35.00 38. January 11, 1984 35.00 39. January 13, 1984 35.00 TOTAL NOT PAID $622.50 The Department of Administration contracts with Blue Cross Blue Shield of Florida, Inc. (BCBS) to be its Administrative Services Only Agent pursuant to Section 110.123(5), Florida Statutes. Dr. Richard C. Dever, Medical Director at BCBS, testified BCBS uses certain screens which allow a certain number of medical services to be paid simply on the basis of the submitted claim. The number of physical therapy sessions which triggers screening is 21 within a six month period. On November 30, 1983, the Petitioner's total visits to the therapist exceeded 21 visits within 6 months of October 11, 1983. (Deposition testimony of Dr. Richard Dever, page 6.) When the Petitioner's treatment exceed 21 visits, documentation was requested by letter dated March 29, 1984. See Hearing Officer Exhibit 1, page 18. This data was provided the first time by the physical therapist shortly after it was requested. The record of the reviews, page 29 of Hearing Officer Exhibit 1, reflects a request for review by "RBB" on March 6, 1984. On April 12, 1984, M. Kunie, R.N., determined that maximum benefits had been paid and no additional payment should be made. No basis for this determination is stated in the BCBS records except that the number of visits exceeded the set number, 21. On March 16, 1984, according to Composite Exhibit 1, page 2, Rhonda Brannon of BCBS advised the PTRC by letter as follows: The above claim, along with all supporting documents, was forwarded to our Medical Review Department. They have advised us that this claim was paid correctly, under the terms of this contract, and no further payment is due. Brannon's letter gave no basis for denying the claim, was not addressed to Petitioner, and did not mention the Petitioner's right to an administrative hearing to controvert this administrative determination of her rights. On May 22, 1984 Petitioner wrote to Nevin Smith, Secretary of the Department of Administration, requesting a formal administrative hearing on the denial of her claim pursuant to Chapter 120, Florida Statutes. See Composite Exhibit 1, Page 1. On May 30, 1984, Daniel C. Brown, General Counsel for the Department of Administration, replied to Petitioner in care of the PTRC. In summary, Mr. Brown advised Petitioner that her request for a hearing was rejected because her letter was insufficient to permit the Department to determine whether a formal hearing is appropriate or whether the controversy may be resolved without a formal hearing. Mr. Brown's letter also stated that if Petitioner would provide a statement stating the nature of treatment rendered by the rehabilitation center, the date of service, the amount of payment that was made by BCBS for such service, and the reasons given Petitioner by BCBS for no further payment the Department would institute administrative proceedings. See Composite Exhibit 1, Page 4. On June 8, 1984, Susan Gardner, Office Manager of PTRC, replied to Mr. Brown advising him that Petitioner was in Europe for six weeks, and forwarded to him the information which he requested. See Composite Exhibit 1, Page 5. On June 14, 1984, Mr. Brown replied to Ms. Gardner advising her that Ms. Gibbs would have to submit a petition containing the information which he had earlier outlined in his May 30, 1984 letter. See Composite Exhibit 1, Page 6. On June 25, 1984, the professional therapists at PTRC wrote Governor Bob Graham regarding the pending claims of the Petitioner and others outlining their difficulties in obtaining relief or a hearing. See Composite Exhibit 1, Page 7. The next correspondence was from Petitioner on March 13, 1985, when she again wrote Nevin Smith, Secretary of the Department of Administration. Her letter references a telephone conversation with Mr. Smith in which he had represented that Petitioner's claim would be reviewed by a qualified person. See Composite Exhibit 1, Page 10. Gilda Lambert, the new Secretary of Administration, replied to Petitioner on March 27, 1985. Lambert's letter reflects that BCBS had purged the file and that Petitioner's records were no longer on file. Ms. Lambert advised Petitioner to send copies of her file to Customer Service, Bureau of Insurance, Department of Administration to enable the Department to request BCBS to review Petitioner's claim to determine if the service was medically necessary. See Composite Exhibit 1, Page 11. On April 12, 1985, Susan Gardner of PTRC wrote Ms. Lambert forwarding to her the records of Petitioner and all their patients with similar problems. See Composite Exhibit 1, Page 12. On June 24, 1985, Dennis E. Nye, Chief of the Bureau of Insurance, wrote Petitioner advising her that guidelines limited treatment to four treatments per day for 21 days unless documentation is provided showing additional days of treatment are medically necessary. This was the first time the term "medically necessary" was used in explaining the agency's action. On February 17, 1984, PTRC had provided documentation for the treatment, which in the opinion of the Medical Review department did not support more than 21 days of treatment. Mr. Nye's letter did advise Petitioner of her right to a hearing within 21 days pursuant to Chapter 120, Florida Statutes. Dr. Richard C. Dever, M.D., an employee of BCBS gave a deposition clarifying the review procedures of BCBS of Petitioner's file. Petitioner's file was subjected to Level II review of the documentation. Level II review is by nurses in the medical review area. According to their assessment, there was no further medical improvement after 21 treatments. According to Dr. Dever, if a patient does not show any improvement, their treatment is considered "maintenance therapy," is not considered medically necessary, and is not covered. See Dever Deposition, Page 7, Line 24 to Page 8, Line 5. There is no evidence introduced that Petitioner's file was reviewed by a physician, much less one specializing in orthopedics. On July 23, 1985, Ms. Gibbs requested a hearing asserting that the treatment she received was medically necessary. According to the Department, the contract for coverage provides as follows regarding medical-surgical expenses: III. COVERED MEDICAL-SURGICAL EXPENSES A. 100 percent of the actual charge for medically necessary inpatient/outpatient physician or physical therapist expenses shall be paid when ordered by a physician for the treatment of an insured as a result of a covered accident or illness subject to the one hundred dollar ($100.00) deductible per insured; however, such payment shall not exceed the maximum amount permitted under the AFS (approved fee schedule).
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is Recommended that the Department of Administration pay the Petitioner's claim and carefully assess the existing program to prevent a reoccurrence of the many problems revealed in this case. DONE and ORDERED this 3rd day of December, 1986, in Tallahassee, Florida. STEPHEN F. DEAN 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 3rd day of December, 1986.
