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.
The Issue Whether Respondent committed the violations alleged in the Amended Administrative Complaint? If so, what disciplinary action should be taken against him?
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Agency is a state government licensing and regulatory agency. Respondent is now, and has been since approximately 1968 or 1969, a physician licensed to practice medicine in the State of Florida. He holds license number ME 0014162. 3/ Since the completion of his residency in December of 1971, Respondent has specialized in orthopedics. He currently is chief of orthopedics at Broward General Hospital. Respondent has not had any training in psychotherapy other than that which he received in a psychiatry class that he was required to take in medical school. His training in biofeedback is limited to that which he received during his residency over a period of three or four years as a result of his involvement in the treatment, with biofeedback, of approximately 15 or 20 patients. Deborah F. Cowart has a M.S. degree in counseling/guidance that she received from Nova University in 1981 and a Ph.D. degree in clinical psychology that she received from Kensington University in California in 1985. Although she is now, and has been since January 31, 1991, licensed as a mental health counselor in the State of Florida, at no time material to the instant case did Dr. Cowart hold a license to engage in mental health counseling or any profession regulated by the state. In 1986, Dr. Cowart opened the Center for Psychological and Diagnostic Services (hereinafter referred to as the "Center") in Fort Lauderdale. The Center provided pain management counseling and biofeedback services to those suffering from chronic pain. (Biofeedback is recognized in the medical community as an acceptable therapeutic modality for the treatment of chronic pain.) Dr. Cowart was the operator and sole owner, through a professional association, of the Center. In addition to her administrative duties, she worked at the Center as a therapist directly providing pain management counseling and biofeedback services to patients. At all times material to the instant case, Respondent was the Center's medical director. Initially, he served in this capacity pursuant to an oral agreement that he had with Dr. Cowart. In or around the latter part of 1990, the agreement was reduced to writing. As medical director, Respondent was a member of the Center's pain management team. He did orthopedic consultations. In addition, he conferred with the Center's two therapists, Dr. Cowart and Philip Schmidt, concerning the progress of their patients and, based upon the information they furnished him, determined, with regard to each patient discussed, whether the course of treatment and therapy the patient was receiving was medically appropriate and necessary and should continue. In this respect, Respondent "supervised" Dr. Cowart and Schmidt. At no time, however, did Respondent ever advise Dr. Cowart or Schmidt as to how they should perform the pain management counseling and biofeedback services they provided their patients, nor was he physically present when these services were rendered. Respondent himself never provided such services to any of the Center's patients. In his role as the Center's medical director, Respondent was not required to, nor did he, perform any task he was not qualified to perform. When Dr. Cowart first approached Respondent about becoming the Center's medical director, she offered to pay him a "stipend" of $1,000.00 a month for his services. Dr. Cowart, however, subsequently determined that she was not able to pay Respondent that large a stipend. She and Respondent thereafter agreed that she would pay him whatever she deemed to be appropriate, given the number of hours Respondent devoted to his medical director duties and her ability to pay him. 4/ In 1988 and 1989, Dr. Cowart paid Respondent $2,970.00 and $7,475.00, respectively, for serving as the Center's medical director. During the time that he was the Center's medical director, Respondent referred orthopedic patients of his to the Center. He did not receive a kickback from Dr. Cowart for making these referrals. While Dr. Cowart made payments to Respondent, these payments were made to compensate Respondent for performing his duties as the Center's medical director, not for referring patients to the Center. One of the patients that Respondent referred to the Center was W.K., a thirty-year old man suffering from arm, neck and back pain as a result of an on- the-job injury. W.K. had been referred to Respondent by his employer's workers' compensation insurance carrier "for a second opinion." Respondent first saw W.K. on April 8, 1986. On this initial visit, he took a history from W.K. and examined him. Respondent's impression was that W.K. had an "acute cervical sprain resolving" and "acute lumbar sprain resolving." Respondent referred W.K. to the Center on May 20, 1986, after determining that W.K.'s problem was more of a "psychological" one and that there was little, if anything, that he was able to do orthopedically to help W.K. Respondent made the referral, not for his own or Dr. Cowart's personal gain, but because he reasonably believed that it was in W.K.'s best interest to receive the services that the Center provided. At the time he made the referral, as well as at all other times material to the instant case, Respondent did not know, nor did he have reason to believe, that Dr. Cowart was not qualified, by training, experience or licensure, to perform these services. 5/ Pursuant to Respondent's authorization, Dr. Cowart held a total of approximately 111 or 116 pain management counseling and biofeedback therapy sessions with W.K., for which she sought and received payment from Cigna Insurance Company. With Respondent's permission, Dr. Cowart put Respondent's Florida medical license number on the insurance claim forms she submitted to Cigna. In filling out the claim forms, Dr. Cowart used the procedure code for "psychotherapy," 90844, to bill for the pain management counseling services provided W.K. She believed that, in so doing, she was using the correct procedure code to describe these services. 6/ Respondent did not have any reason to believe that any of the information on the forms Dr. Cowart filled out was false. Throughout the period that W.K. received treatment at the Center, Dr. Cowart and Respondent conferred on a regular basis to discuss W.K.'s case. Based upon what Dr. Cowart told him about the progress W.K. was making and what he knew about W.K. as a result of his contact with the patient, Respondent authorized the continuation of the pain management counseling and biofeedback therapy W.K. was receiving at the Center.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board of Medicine enter a final order dismissing the Amended Administrative Complaint issued against Respondent in its entirety. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 23rd day of May, 1995. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of May, 1995.
The Issue Whether Respondent committed the violations alleged in the Administrative Complaints? If so, what disciplinary action should be taken against him?
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Parties The Department is a state government licensing and regulatory agency. Respondent is now, and has been at all times material to the instant cases, a physician licensed to practice medicine in the State of Florida. He holds license number ME 0037235. Facts Relating to Case No. 93-5861 On December 29, 1983, at Indian River Memorial Hospital, Dr. Phil Morgan performed a partial mastectomy and an axillary lymph node dissection on G.K., a female patient who was then 57 years of age. The mastectomy was performed on G.K.'s left breast. Approximately a quarter of the breast volume was removed, including a malignant tumor that was no more than two centimeters in diameter. The procedures performed by Dr. Morgan revealed no evidence of any further malignancy. In early 1984, G.K. went to the Lawnwood Oncology Center in Fort Pierce, Florida to consult with Respondent, a radiation oncologist, regarding her receiving postoperative radiation therapy. From January 17, 1984, to February 27, 1984, Respondent administered doses of external beam radiation therapy to what remained of G.K.'s left breast and the lymphatic drainage regions. The total nominal dosage administered was 5040 cGy or rads. On or about March 13, 1984, Respondent supplemented the external beam therapy treatment G.K. had received with an Iridium-192 radioisotope interstitial implant in G.K.'s left breast. The implant consisted of two layers of radioactive needles, with one layer one centimeter deeper than the other. There were ten needles, spaced one centimeter apart, in each of the two layers. In 1984, the prevailing standard of care recognized as acceptable and appropriate by reasonably prudent radiation oncologists performing multi-layer interstitial implants required that the oncologist design and structure the implant in such a manner that the radioactive sources in each of the layers were spaced at least 1.2 centimeters apart and that the oncologist use less than half the number of radioactive sources that Respondent used. The implant remained in position for 52 hours. A volume of 253 cubic centimeters of breast tissue received a dosage of 60 cGy or rads per hour. In 1984, the prevailing standard of care recognized as acceptable and appropriate by reasonably prudent radiation oncologists performing interstitial implants required that the oncologist regulate the radiation dosage rate so that it did not exceed 50 cGy or rads per hour. An additional 72 cubic centimeters of breast tissue received a dosage of 100 cGy or rads per hour, twice the maximum dosage rate. Inasmuch as these 72 cubic centimeters of breast tissue received a total dosage of 5200 cGy or rads during the time the implant remained in position, compared to the total dosage of 3120 cGy or rads that the other 253 cubic centimeters of targeted breast tissue received, the inhomogeneity of dosage distribution well exceeded 20 percent, contrary to the then prevailing standard of care recognized as acceptable and appropriate by reasonably prudent radiation oncologists performing interstitial implants, which required that the physical design of the implant be such that there was no more than 20 percent of dosage distribution inhomogeneity. Furthermore, in designing the implant, Respondent targeted a greater volume of breast tissue than was acceptable and appropriate under the prevailing standard of care. The implant and the external beam therapy combined delivered a total nominal dosage of 8160 cGy or rads, with some areas within the central region of the implanted tissue receiving in excess of 10,000 cGy or rads. Given the relatively small size of the malignant tumor that had been removed from G.K.'s breast and the absence of any apparent residual malignancy, a reasonably prudent radiation oncologist, governed by standards in effect in 1984, would have administered, in toto, a nominal dosage of no more than 6000 to 7000 cGy or rads. In or about December of 1985, G.K. presented to Respondent with breast fibrosis and skin retraction on the side that Respondent had treated in 1984. Respondent recommended conservative measures only. G.K. went to Dr. Everrett Sugarbaker, a surgical oncologist, for a second opinion. Dr. Sugarbaker initially examined G.K. and evaluated her situation in August of 1986. He noted that G.K.'s left breast was totally contracted back against the chest wall with extensive telangiectatic and fibrotic change in the area where Respondent had inserted the Iridium-192 implant. There was also a scab over a one and a half centimeter ulcer. It was apparent to Dr. Sugarbaker that G.K. was suffering from radionecrosis as a result of the radiation therapy she had received from Respondent. Dr. Sugarbaker recommended daily peroxide application to the ulcer, but added that, if the ulcer increased in size or became infected, he would consider surgical correction of the problem. G.K. visited Respondent again in October of 1986. The area of her left breast where the implant had been inserted had experienced further tissue destruction and had become infected. Respondent prescribed antibiotic therapy, which ultimately proved to be unsuccessful. In or about February of 1987, Respondent recommended that G.K. try hyperbaric oxygen therapy, but G.K. refused to follow Respondent's recommendation. On February 13, 1987, G.K. returned to Dr. Sugarbaker for reassessment. G.K. told Dr. Sugarbaker of her recurring infection. Upon his examination of G.K., he noticed that the necrotic area of her left breast was larger than when he had seen her in August of the previous year. Dr. Sugarbaker recommended surgical correction. On February 18, 1987, Dr. Sugarbaker surgically removed the remainder of G.K.'s left breast and, in connection therewith, performed other procedures to reconstruct the chest wall and improve blood supply and promote healing in the area. The necrosis from which G.K. was suffering that made these procedures necessary was caused by Respondent having overradiated her during the course of the radiation therapy he administered to her in 1984. Facts Relating to Case No. 93-5861 In September of 1982, Dr. Khalil Cassimally performed a modified radical mastectomy on V.H.'s cancerous left breast. V.H. was approximately 34 years of age at the time. Postoperatively, from approximately October 10, 1982, to November 22, 1982, V.H. received radiation therapy from Dr. Victoria Cividino at the Lawnwood Oncology Center, of which Respondent was the director. The therapy included a total nominal dosage of 5000 cGy or rads (with a 1000 cGy or rads "boost") to the left axilla. Following the therapy, V.H. was in constant pain. At some point in time, a knot or nodule developed in the area where she had had her mastectomy. V.H. told Respondent, who had assumed responsibility for V.H.'s care and treatment from Dr. Cividino, about the nodule. The nodule was biopsied on September 15, 1983, by Dr. Cassimally. No malignancy was found. The area that was biopsied did not heal properly. V.H. continued to have problems. On March 16, 1984, Respondent visited Dr. James Grossnickle, a general surgeon. She presented with a large ulcer on her left chest wall surrounded by thick elevated tissue. On April 20, 1984, Dr. Grossnickle biopsied a portion of the ulcer and surrounding tissue. The pathological diagnosis was fat necrosis and fibrosis. There was no evidence of any malignancy. V.H. eventually returned to see Respondent. From approximately April 16, 1985, to June 11, 1985, Respondent treated V.H. with further radiation therapy. The therapy included a total nominal dosage of 5000 cGy or rads to the left axilla, which was administered in 20 fractions. The dosage, when considered in light of the dosage previously administered by Dr. Cividino in 1982, exceeded the limits of normal tissue tolerance. As a result, it caused considerable tissue damage. There was no medical justification for administering additional radiation therapy to V.H., particularly in light of the results of the post- mastectomy biopsies that had been performed by Drs. Cassimally and Grossnickle. A reasonably prudent radiation oncologist, governed by standards in effect in 1985, would not have followed such a course of treatment. After receiving this additional radiation therapy, Respondent developed a large mass of scar tissue in the treated area, in the center of which was an oozing ulcer. Her condition was the result of having been overradiated. In or about October of 1986, V.H. went to Juan Carlos Giachino, a plastic and reconstructive surgeon, who performed surgery on V.H. in an effort to remedy the situation. The surgery was unsuccessful. Oozing ulcers reappeared. One such ulcer, near her left underarm, had to be irrigated and cleaned three to four times a day. Furthermore, V.H.'s left arm became unusable as it accumulated undrained lymphatic fluid and resultingly increased in size. The excessive radiation treatment that V.H. had received had resulted in the obstruction of the lymphatic drainage pathways in the arm. The problem with her left arm became so severe that amputation of the arm was required. Other corrective surgical procedures, including chest reconstruction, were performed on V.H. to improve her condition.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board enter a final order finding Respondent guilty of the violations of subsection (1)(t) of Section 458.331, Florida Statutes, alleged in the Administrative Complaints and disciplining him for having committed these violations by imposing the penalties described in Conclusion of Law 78 of this Recommended Order. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 20th day of May, 1994. STUART M. LERNER 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 May, 1994. APPENDIX TO RECOMMENDED ORDER IN CASE NOS. 93-5739 and 93-5861 The following are the Hearing Officer's specific rulings on the "findings of facts" proposed by the Department in its proposed recommended order: 1-9. Accepted and incorporated in substance, although not necessarily repeated verbatim, in this Recommended Order. To the extent that this proposed finding addresses the standard of care for single layer implants, it has not been incorporated in this Recommended Order because, even if true, it would have no bearing on the outcome of the instant case. To the extent that it addresses the standard of care for multi- layer implants, it has been accepted and incorporated in substance. Accepted and incorporated in substance. 12-13. Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer. 14-36. Accepted and incorporated in substance. First and second sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer; Third sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. To the extent that this proposed finding states that V.H. was 25 years of age at the time of the mastectomy, it has been rejected because it is contrary to the greater weight of the evidence. Otherwise, it has been accepted and incorporated in substance. 40-56. Accepted and incorporated in substance. First and second sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer; Third sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. Rejected as a finding of fact because it is more in the nature of a summary of testimony than a finding of fact based upon such testimony First sentence: Accepted and incorporated in substance; Second sentence: Not incorporated in this Recommended Order because it has no bearing on the outcome of the instant case. First sentence: Accepted and incorporated in substance; Second sentence: Not incorporated in this Recommended Order because it has no bearing on the outcome of the instant case. COPIES FURNISHED: Francesca Plendl, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Charles H. Kent, M.D. 3605 Juan Ortiz Circle Ft. Pierce, Florida 34947-6110 Dr. Marm Harris, Executive Director Board of Medicine Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Respondent violated Subsection 456.072(1)(aa), Florida Statutes (2003),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with the regulation of medicine pursuant to Chapters 20, 456, and 458, Florida Statutes. Dr. Weiner, is and was at all times material to this proceeding, a licensed physician in the State of Florida, having been issued license number ME76902. He has been practicing medicine for 23 years and has not previously been the subject of a disciplinary proceeding. Dr. Weiner is board-certified in anesthesiology. S.M. has been a patient of Dr. Weiner since 1999. S.M. sought treatment from Dr. Weiner for his lower back pain that he suffered as a result of a golf cart injury. Over the course of his care under Dr. Weiner up until the date of the incident, S.M. received numerous treatments for his back pain, including radiofrequency ablation and epidural steroids. Radiofrequency ablation uses a specific frequency of radio waves to help put specific pain nerves that go to the joints of the spine to sleep for a period of time. In this procedure a steroid is deposited inside the epidural space outside the spine. The procedure can help to treat back pain as well as pain extending down the legs of the patient. On January 29, 2005, S.M. presented to Dr. Weiner with complaints of lower back pain. After examining S.M., Dr. Weiner recommended that S.M. undergo a radiofrequency ablation procedure. Dr. Weiner ordered the radiofrequency ablation procedure and instructed his office to coordinate with the Center for Digestive Health and Pain Management (Center), to have the procedure scheduled. The Center, which is a separate facility from Dr. Weiner's office, scheduled S.M.'s treatment for February 19, 2004. The Center scheduled S.M. for a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, rather than the radiofrequency ablation procedure. A Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, involves placing a needle down near the tailbone. A catheter is inserted through the needle into the space around the spine. A steroid medication is injected through the catheter. The purpose of the procedure is to decrease irritation and inflammation of the nerves as well as the discs. S.M. could have derived some benefit from the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach. Patient charts at the Center are separate from the patient charts at Dr. Weiner's office. The Center's charts are made up by the Center staff and consist of forms for the specific procedure, a template of the procedure for the specific procedure, the nursing notes, billing sheets, and other administrative paperwork. When the Center erroneously scheduled S.M. for a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, the Center prepared paperwork necessary for the provision of that technique, including consent forms. On February 19, 2004, S.M. went to the Center with the belief that he was going to receive the radiofrequency ablation procedure. During this visit, S.M. was in a lot of pain and was eager to receive treatment for his back. Upon arrival to the Center, S.M. signed a consent form that referenced a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach procedure. The nurse then confirmed with S.M., the technician, and Dr. Weiner that S.M. understood this procedure. Dr. Weiner also explained the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, to S.M before administering the treatment and also told S.M. that this was the first time he had undergone this procedure while under Dr. Weiner's care. Subsequent to signing the consent form, S.M. got undressed and was hooked up to an IV. He was then moved to another bed, and Dr. Weiner started to perform the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, on S.M. Dr. Weiner administered a local anesthesia and began to insert the tip of a needle into S.M.'s back. After partially inserting the needle in S.M.'s back, Dr. Weiner stopped the procedure and reviewed S.M.'s chart. He requested that S.M.'s chart that was in Dr. Weiner's office be brought to the Center. The chart revealed that the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, was not the procedure that was originally ordered at S.M.'s appointment on January 29, 2004. Once he realized the discrepancy, Dr. Weiner apologized to S.M. and explained that he began to do the wrong procedure. S.M. was then taken to the recovery room, and Dr. Weiner ordered the radiofrequency ablation procedure for a later date. S.M. did not receive the complete Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, procedure on February 19, 2005. In or about March 2004, S.M. returned to the Center and had the radiofrequency ablation procedure completed.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that James P. Weiner, M.D., violated Subsection 456.072(1)(aa), Florida Statutes; issuing a reprimand; imposing a $1,000 fine; requiring 25 hours of community service; and requiring five hours of risk management education. DONE AND ENTERED this 31st day of March, 2006, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of March, 2006.
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 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 Whether Petitioner’s request for coverage of proton beam radiation therapy (“proton beam therapy” or “PBRT”) is a covered benefit pursuant to the State Employees’ Health Maintenance Organization (“HMO”) Plan (“Plan”), administered by AvMed.
Findings Of Fact Respondent is the state agency charged with administering the state employee health insurance program pursuant to section 110.123. At all times material hereto, Petitioner was a member of the Plan. AvMed is the third-party administrator for the Plan at issue in this cause. As the third-party administrator, AvMed provides claims processing, utilization, and benefit management services. The applicable benefit document is the State Employees’ HMO Plan, Group Health Insurance Plan Booklet and Benefits Document (“Plan Document”), effective January 1, 2019. Petitioner is a 66-year-old male who was diagnosed with prostate cancer in November 2017 and underwent a prostatectomy to remove his prostate on April 12, 2018. Subsequent to his initial surgery and treatment, Petitioner experienced increasing prostate specific antigen (“PSA”) in three follow-up tests. His prostate cancer had returned. Petitioner’s physician sought to treat his condition with PBRT, a form of external beam radiation utilizing protons, rather than traditional intensity modulated radiation therapy (“IMRT”), which is, without question, covered under the Plan. Medicare, a federal healthcare insurance program, agreed to pay 80 percent of Intervenor’s charges for PBRT, leaving Petitioner responsible for the remaining 20 percent being sought to be paid by Petitioner’s Plan. On July 3, 2019, Petitioner, through his healthcare provider, Maria-Amelia Rodrigues, M.D., and Intervenor, Miami Cancer Institute, submitted a request for coverage of PBRT to AvMed. On July 10, 2019, AvMed denied the preservice request for coverage on the basis that the therapy was experimental/investigational and, therefore, not medically necessary treatment for the member’s condition. The request was reviewed by Sri Gorty, M.D., a consultant radiation oncologist at Magellan Healthcare, which is under contract with AvMed. On July 23, 2019, Petitioner submitted a request for a Level I appeal to AvMed. The appeal was reviewed by Dr. Gregg Goldin, M.D., a consultant radiology oncologist at Dane Street, which is under contract with AvMed. He filed a report dated August 19, 2019. On August 20, 2019, AvMed denied the request for Level I appeal on the basis that the therapy was experimental/investigational and, therefore, not a medically necessary treatment. On November 19, 2019, Petitioner submitted a request for an “Expedited” Level II appeal to Respondent. The Level II appeal was reviewed by Dearline Thomas-Brown, a registered nurse and Level II appeal coordinator for Respondent. On November 21, 2019, Respondent denied Petitioner’s Level II appeal on the basis that the therapy is experimental/investigational and, therefore, not medically necessary for treatment of the member’s condition. Pursuant to the Plan Document, the Plan pays its share of the cost of covered services, if the services are: Ordered by a Network Provider (a provider who is in AvMed’s network); Considered Medically Necessary for the covered person’s treatment because of accident, illness, condition or mental health or nervous disorder; Not specifically limited or excluded under this Plan; and Rendered while this Plan is in effect. Pursuant to the Plan Document, Section I. Introduction: The Plan is not intended to and does not cover or provide any Medical Services or benefits that are not Medically Necessary for the diagnosis and treatment of the Health Plan Member. AvMed determines whether the services are Medically Necessary on the basis of terms, conditions, and criteria established by the Plan as interpreted by the state, and as set forth in medical guidelines. This chart provides a description of services and supplies covered under the Plan. Coverage Access Rules are specified under the Plan as follows: Cancer Services Diagnosis and Treatment Includes both inpatient and outpatient diagnostic tests and treatment (including anti-cancer medications administered by Network providers), including cancer clinical trials as set forth in the Florida Clinical Trial Compact. Does not include Experimental or Investigational Treatment. In order to be a covered benefit, the treatment must be “medically necessary,” not “experimental or investigational,” and it must not be specifically excluded by the Plan. “Medically Necessary” is defined as follows: The use of any appropriate medical treatment, service, equipment and/or supply as provided by a Hospital, skilled nursing facility, physician or other provider which is necessary for the diagnosis, care and/or treatment of a Health Plan Member’s Illness or injury, and which is: Consistent with the symptom, diagnosis and treatment of the Health Plan Member’s condition; The most appropriate level of supply and/or service for the diagnosis and treatment of the Health Plan Member’s condition; In accordance with standards of acceptable medical practice; Not primarily intended for the personal comfort or convenience of the Health Plan Member, the Health Plan Member’s family, the physician or other health care providers; Approved by the appropriate medical body or health care specialty involved as effective, appropriate and essential for the care and treatment of the Health Plan Member’s condition; and Not experimental or investigational. The service must meet all of the above-referenced criteria in order to be medically necessary. Given the above definition, if a service is experimental or investigational, then it cannot be medically necessary. Section VI. Limitations and Exclusions in the Plan Document specifically exclude services that are “experimental/investigational or not medically necessary treatment with the exception of routine care in connection with a clinical trial in cancer, pursuant to the Florida Clinical Trial Compact and the Patient Protection and Affordable Care Act.” “Experimental and/or Investigational” is defined as follows: For the purposes of this Plan a medication, treatment, device, surgery or procedure may initially be determined by AvMed to be experimental and/or investigational if any of the following applies: The FDA has not granted the approval for general use; or There are insufficient outcomes data available from controlled clinical trials published in peer- reviewed literature to substantiate its effectiveness for the disease or injury involved; or There is no consensus among practicing physicians that the medication, treatment, therapy, procedure or device is safe or effective for the treatment in question or such medication, treatment, therapy, procedure or device is not the standard treatment, therapy procedure or device utilized by practicing physicians in treating other patients with the same or similar condition; or Such medication, treatment procedure, or device is the subject of an ongoing Phase I or Phase II clinical investigation, or Experimental or research arm of a Phase III clinical investigation, or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as comparted with the standard for treatment or diagnosis of the condition in question. If any one or more of the above-cited criteria are met, then the treatment is experimental and/or investigational and is not a covered service. In making an adverse determination as to coverage in both the Level I and Level II appeals, Edwin Rodriguez, M.D. (note the slightly different spelling of Petitioner’s expert Dr. Maria-Amelia Rodrigues versus Dr. Edwin Rodriguez), and Nurse Thomas-Brown utilized AvMed’s Medical Coverage Guideline on PBRT. This coverage guideline regarding PBRT provides AvMed’s “Exclusion Criteria” explaining “PBRT is not covered, and is considered investigational, as to all other tumors not listed” in the guideline. PBRT is not an approved treatment option for localized prostate cancer under the NIA Magellan criteria. The Medical Technology Assessment Committee at AvMed drafts clinical policy guidelines and is responsible for maintaining or changing them as technology advances. AvMed’s policy on use of PBRT for the treatment of prostate cancer states that it is not medically necessary because studies have not shown clinical outcomes to be superior to conventional radiation therapy (i.e., IMRT). This policy was developed following extensive review of studies in peer-reviewed medical literature, available guidelines, technology assessments, and opinions from experts. The policy is updated on a yearly basis in order to take into consideration any new evidence. A recent review of the policy on PBRT resulted in no change in AvMed’s position on coverage for treatment of prostate cancer. The medical coverage guidelines are meant to be used in conjunction with the Plan Document to determine whether services are medically necessary and a covered benefit. Dr. Gorty, AvMed’s external reviewer from Magellan Healthcare, who was accepted as an expert in the field of radiation oncology, testified that his recommended denial of coverage of PBRT was informed by Petitioner’s medical records, Intervenor’s Letter of Medical Necessity, clinical trials, the model policy from the American Society of Therapeutic Radiation and Oncology (“ASTRO”), and the National Comprehensive Cancer Network (“NCCN”) guidelines. PBRT PBRT is a procedure that uses protons to deliver a curative radiation dose to a tumor, while reducing radiation doses to healthy tissues and organs, which results in fewer complications and side effects than IMRT. As stated earlier, Petitioner’s prostate was removed in April 2018. Thereafter, rising PSA levels indicated that he needed further treatment, and Dr. Rodrigues, a board-certified radiation oncologist at Miami Cancer Institute, became his treating physician. Dr. Rodrigues has been treating patients for 23 years, including prostate cancer patients. She was accepted as an expert in her field for these proceedings. Dr. Rodrigues determined PBRT to be the appropriate radiation treatment for Mr. Zolfaghari given his type of prostate cancer—recurrent prostate cancer. Dr. Rodrigues testified that recurrent prostate cancer occurs when a cancer has been treated and then reoccurs. In addition to PBRT, Dr. Rodrigues recommended, and Petitioner received, androgen deprivation therapy, generally referred to as hormone therapy, to be used in conjunction with PBRT. Dr. Rodrigues testified that the androgen deprivation therapy blocks the production of testosterone. She testified that patients with recurrent prostate cancer or certain high-risk patients have better overall survival when the two treatments are used in conjunction. As an additional aggravating factor to Petitioner’s cancer treatment, Petitioner was diagnosed with colon cancer leading to surgery in January 2020. Dr. Rodrigues testified that Petitioner’s colon cancer made his need for PBRT even more necessary, because now Petitioner is at a higher risk for adverse effects from the unwanted spread of toxicity common with IMRT. Dr. Rodrigues, as a Miami Cancer Institute physician, wrote letters requesting treatment and appealing denials of treatment as set forth above, and testified at the March 9, 2020, administrative hearing in support of Petitioner’s efforts to obtain coverage through AvMed for PBRT, which she considers to be a medically necessary treatment modality. Dr. Rodrigues was asked why she had not gone forward and provided Petitioner IMRT in order to prevent any further delay due to the passage of time from unsuccessful appeals of the denial by AvMed for the PBRT treatment of his recurring prostate cancer. She replied that she was attempting to secure a less toxic treatment modality, PBRT, for her patient who was already approved by Medicare for coverage of 80 percent of the cost of the treatment. MEDICAL NECESSITY OF PBRT VERSUS IMRT There is no dispute that IMRT is an accepted treatment modality for Petitioner’s recurrent prostate cancer, even bearing in mind his complicating factor of colon cancer surgery and treatment endured following his 2018 prostatectomy. The remaining dispute here is whether PBRT is both medically necessary and not an experimental and/or investigative form of radiation treatment. IMRT is a recognized form of treatment for Petitioner’s recurrent prostate cancer. Dr. Rodrigues testified that Miami Cancer Institute considered only candidates for PBRT as those who would qualify for IMRT, such as Petitioner. Given the availability of another treatment option, IMRT, which is the most widely recognized standard of care within the medical establishment for the treatment of Petitioner’s condition, Respondent’s experts conclude that PBRT is not medically necessary because it is not the most appropriate level of service in this case. While PBRT has been accepted by AvMed, according to its Plan, for certain types of cancer, the insurer has not yet authorized it for the treatment of prostate cancer. This is where the semantics of the contract come into play. Petitioner and Intervenor argued that Respondent mistakenly based its denial upon a diagnosis of “localized prostate cancer” (Dr. Rodrigues’ reading of the proscription of the use of PBRT for Petitioner) rather than “recurrent prostate cancer” (not specifically proscribed by the Plan according to her reading), combined with the fact that Petitioner’s unique medical condition requires lower toxicity in the specific type of radiation used. PBRT, she testified, offers lower radiation toxicity, which will have less of a harmful effect on Petitioner’s colon and rectum as a survivor of colon cancer surgery. Dr. Rodriguez, the AvMed senior medical director, testified that studies comparing PBRT to 3-D confirming radiation or IMRT are limited. Overall studies have not shown clinical outcomes to be superior to conventional radiation therapy. In addition to the preservice and Level I appeal reviews by AvMed, and Respondent’s Level II appeal review, an Independent Organization Review (“IRO”) was conducted by a licensed radiation oncologist employed by Independent Medical Expert Consulting Services. As a result of this independent review, the Plan’s denial was upheld. Dr. Rodrigues presented studies in her testimony and a letter of medical necessity which cited the potential for favorable outcomes with PBRT. Dr. Gorty, Respondent’s expert in radiation oncology, contradicted her testimony in that many of the studies she cited noted a need for further study regarding the safety and efficacy of PBRT for treatment, and all of these studies were based upon “localized prostate cancer,” rather than “recurrent prostate cancer.” Dr. Gorty also testified that Petitioner's records indicated that his cancer was localized, although it could also be "recurrent." Dr. Gorty testified that clinical studies show no significant difference in the toxicity between IMRT and PBRT. Further, Dr. Rodriguez explained that localized cancer can be recurrent. “Localized” refers to where the cancer may be found, while “recurrent” refers to a repeat or re-occurrence of a cancer, which might return to the same location or reappear in a different location. Paragraph 15 lists the criteria to determine whether a treatment or procedure is “medically necessary” under the AvMed policy. PBRT does not meet the third criterion of the definition of “medically necessary,” as PBRT treatment of prostate cancer is not in accordance with standards of acceptable community practice. Dr. Gorty testified that AvMed medical guidelines utilize IMRT as the “next generation” treatment, rather than PBRT. Further, Dr. Gorty testified that he was aware of several recent clinical trials concerning PBRT and IMRT, and these studies do not reach a conclusion that PBRT is preferable to IMRT. PBRT does not meet the fifth criterion of the definition of “medically necessary,” as PBRT has not been approved by the appropriate medical body or healthcare specialty involved as effective, appropriate, and essential for the care and treatment of prostate cancer. PBRT is not essential for the treatment of prostate cancer. There are several treatment modalities that are generally available for the treatment of prostate cancer and, as discussed above, several of those treatment options were reasonable treatment options for Petitioner. While Dr. Rodrigues believes PBRT to be preferable for Petitioner in this case due to, in her opinion, fewer adverse side effects of the treatment, she admitted that Petitioner is a suitable candidate for IMRT. Therefore, PBRT does not meet the sixth criterion of the definition of “medically necessary,” as it meets the definition of “experimental and/or investigational.” Specifically, criteria 2, 3, and 4 of the definition of “experimental and/or investigational” are met, which lead to the ultimate conclusion that PBRT is not medically necessary in this case. EXPERIMENTAL AND/OR INVESTIGATIONAL TREATMENT Paragraph 18 sets forth the criteria for determining whether a treatment or procedure is “experimental and/or investigational.” The second criterion from the definition of experimental and/or investigational treatment is met in this case. Insufficient outcomes data are not available from controlled clinical trials published in peer-reviewed literature to substantiate PBRT’s safety and effectiveness for treatment of prostate cancer. Dr. Rodriguez testified that there is a lack of peer-reviewed, published, randomized studies regarding proton beam therapy. Further, PBRT treatment is not the generally accepted standard of care. Dr. Rodrigues testified that only a handful of medical centers in the United States are using PBRT to treat cancer malignancies. Only two such programs are located in Florida—the University of Florida and Intervenor. Outside of Florida, only Massachusetts General and Loma Linda offer the treatment. Prior to Intervenor offering the treatment, Dr. Rodrigues referred her patients to one of these other facilities for PBRT when she deemed it appropriate to do so. Current randomized trials are on-going and being published in peer- reviewed medical literature. PBRT treatment for prostate cancer is considered investigational and not a standard of care option and, therefore, not medically necessary. Nurse Thomas-Brown testified that a treatment considered experimental or investigational is, automatically, not medically necessary. NIA Magellan Clinical Guideline Number NIA_CG_124, which was developed in July 2018 for implementation in January 2019 to assist physicians in the application of treatment, states that both surgery and radiation therapy should be used to treat organ confined prostate cancer, as well as prostate cancers extended into adjacent tissues. This guideline finds that PBRT is not an approved treatment option for localized prostate cancer as studies comparing it to 3-D conformal radiation or IMRT are limited. Leading organizations, such as NCCN and ASTRO, have noted insufficient data outcomes and a need for more study of proton beam therapy, which these organizations have not yet accepted as the standard of care. PBRT also meets the third criterion of the definition of “experimental and/or investigational.” There is no consensus among practicing physicians that PBRT is safe or effective for the treatment of prostate cancer or that PBRT is the standard treatment utilized by practicing physicians in treating other patients with the same or similar conditions. Both Dr. Gorty and Dr. Rodriguez testified that proton beam therapy is experimental and investigational and, therefore, not medically necessary for all forms of prostate cancer; two additional radiation oncologists reviewed the appeal and reached the conclusion that PBRT is not medically necessary. Additionally, there was uncontroverted evidence that IMRT, not PBRT, is the standard form of treatment utilized by practicing physicians for treatment of prostate cancer. Dr. Gorty testified that AvMed approved the NIA Magellan clinical guidelines for prostate cancer, which are based on the peer-reviewed studies; and he explained three such studies. His testimony noted that the second study from the University of Pennsylvania at Baltimore, Maryland, specifically matched Petitioner’s medical condition. This study compared 307 men and their comparative toxicity outcomes of PBRT verses IMRT for post-operative sites. It concluded that future prospective investigation and ongoing follow-up will determine whether dosimetric differences between treatment with IMRT and proton beam therapy convert to meaningful differences in long-term outcomes. As part of the appeal process on behalf of Petitioner, Intervenor also requested a review by an IRO. The review was completed by a board-certified radiation oncologist, and a report was generated on January 9, 2020. The “List of Materials Reviewed” is extensive and includes Petitioner’s medical records and Intervenor’s supporting documentation. The independent reviewer upheld the denial and noted that medical necessity has not been established. The IRO states that “until the current randomized trials ongoing are published in peer reviewed medical literature, proton beam treatment for prostate cancer is considered investigational and not a standard of care treatment option.”
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Management Services, Division of State Group Insurance, enter a final order denying Petitioner's request for coverage for proton beam therapy. DONE AND ENTERED this 4th day of May, 2020, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 2020. COPIES FURNISHED: Erica D. Moore, Esquire Thomas E. Wright, Esquire Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399 (eServed) Abolghasem Zolfaghari 10910 Southwest 140th Avenue Miami, Florida 33186 Frank A. Florio, Esquire Maria D. Garcia, Esquire Latasha Gethers Hines, Esquire Kozyak, Tropin & Throckmorton, LLP 2525 Ponce de Leon Boulevard, Ninth Floor Coral Gables, Florida 33134 (eServed) William Chorba, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed)
