Findings Of Fact Petitioner South Broward Hospital District operates Memorial Hospital located in Hollywood, Florida. On March 14, 1977, Petitioner's hospital administrator, S. A. Mudano, informed the local Health Systems Agency (HSA), which is the Health Planning and Development Council for Broward County, Inc., of Petitioner's intent to acquire an 18 million electron volt linear accelerator capable of providing radiation therapy by means of both X-ray and high energy electrons for its radiation therapy department. The cost of this acquisition was to be $455,000.00 for the machine and accessories, plus approximately $150,000.00 for construction of an addition to the existing radiation therapy department to house the unit and support facilities. This notice of intent was followed by submission of an application to the HSA and Respondent on June 20, 1977. The application was reviewed by the staff of the HSA and, although it was determined that the project did not conform to certain criteria contained in the "Goals and Standards for Diagnostic Radiology, Therapeutic Radiology, and Nuclear Medicine Services" which had been adopted by the HSA after public hearings on August 18, 1977, the HSA recommended the project for approval on October 20, 1977, and so informed Respondent on October 28, 1977. By letter of November 23, 1977, Respondent informed Petitioner that its proposal was not favorably considered because it was inconsistent with the aforesaid local goals and standards for Broward County in that maximum utilization of existing and available like equipment items had not been achieved nor projected, and that such radiation therapy units were accessible within Broward County in less that sixty minutes automobile travel time. In this letter, Respondent pointed out that existing radiation therapy units in Broward County had been utilized at only some 61 percent of their capacity in 1976 and were projected as having only the utilization rate of 87 percent by 1990, and that such rates clearly indicated a lack of demonstrated need for an additional unit. The letter further stated that although the HSA had recommended approval, it had not provided justification for its deviation from its own goals and standards. Petitioner thereafter appealed Respondent's denial of its application on December 20, 1977. (Exhibits 1 - 5) Petitioner South Broward Hospital District is a special tax district created and incorporated by a legislative act of 1947. Memorial Hospital is its only facility and provides medical care on a non-profit basis to persons in the district requiring such treatment. However, individuals living outside of the tax district who require services of Memorial Hospital may utilize the same based upon medical need and criteria established by the district's Board of Commissioners. The radiation therapy department of Memorial Hospital was constructed several years ago and presently has in use a 4 MEV linear accelerator to serve the needs of South Broward cancer patients, mostly on an outpatient basis. In 1977, this machine was operated at 116 percent capacity computed on a forty-hour week and rendered 9,655 patient treatments during that period. The first quarter of 1978, 3,056 treatments were performed, which was a utilization rate of 147 percent on a forty-hour week and 98 percent on a 60-hour week. At the time the radiation therapy department was planned, it was anticipated that additional equipment would be required in the future and therefore "shell" space was reserved in the original construction plans for ease of future installation of new equipment. Construction for the proposed linear accelerator primarily will consist of construction of a concrete vault within the existing shell, plus facilities for operation of the radiation equipment. It will take approximately 18 months "lead-time" from issuance of a Certificate of Need to acquire the equipment, and complete construction. (Testimony of Mudano, Margulies, Exhibits 1, 16, 19) Radiation therapy in cancer cases is accomplished by both external therapy machines and sealed sources of radioactive material The machines include both conventional X-ray machines and the super voltage or megavoltage units which include linear accelerators, cobalt, and betatron units. The conventional machines are used primarily for superficial treatment, such as skin cancer. The megavoltage units deliver much heavier radiation to deep tumors with greater intensity so that a localized volume of tissue can be treated without the danger of damaging surrounding organs and normal tissue. They also produce less side effects such as nausea, weakness and anemia. However, the cobalt and betatron methods have certain limitations which make them less satisfactory for many patients than the linear accelerators. The linear accelerators most commonly used today are those of 4, 6, and 18 million electron volts (MEV). The 18 MEV accelerator provides deep therapy by utilizing an electron beam that is highly controllable to most effectively treat tumor tissue. Additionally, high-energy X-ray radiation can be delivered from an 18 MEV unit for deeper penetration. The 18 MEV is thus particularly effective for obese cancer patients and for those requiring treatment in the neck and head areas. Although machines of lesser voltage, such as the 4 MEV, are capable of treating all types of cancer patients, they do not protect adjoining organs and non-cancerous tissues to the degree afforded by the 18 MEV, nor can they be utilized for the variety of radiation patterns of the larger machine which has the additional flexibility of using pure electron radiation. (Testimony of Green, Margulies, Munson, Exhibits 1 - 2) At the time the HSA staff evaluated Petitioner's application, it predicated much of its data upon the utilization of existing radiation machines in Broward County at various hospitals and one private clinic. The staff report showed that there were four cobalt units, one betatron unit, and four 4 MEV units in Broward County. In addition, the report took into consideration one 18 MEV unit for which a Certificate of Need had been issued for the North Broward Hospital on March 12, 1977, and which is expected to be operational in January, 1979. At the hearing, however, it was discovered that both the HSA and the Respondent had overlooked the fact that a Certificate of Need for three MEV units had been issued to the Florida Medical Center in Broward County on June 27, 1975. It is expected that one 18 MEV unit and two 6 MEV units will be operational in that facility in July, 1978. In view of this information, the Hearing Officer determined that prior data was incomplete and required the parties to make new projections of need for presentation at a subsequent hearing session. The revised data is shown in composite Exhibit 16 and forms the basis for consideration of the need for Petitioner's requested additional 18 MEV unit. (Testimony of Chamlis, Composite Exhibits 16, 19, 21) Although the Respondent has a state medical facilities plan in existence, it does not address the question of radiation equipment. Consequently, the only general criteria issued by an agency in the state on this subject bearing on Petitioner's application is the document issued by the HSA entitled "Goals and Standards for Diagnostic Radiology, Therapeutic Radiology, and Nuclear Medicine Services." The pertinent provisions of that document which were used by the Respondent as a basis for denial of Petitioner's application read pertinently as follow: Cost -. High quality radiology and nuclear medicine services should be provided in the most efficient and effective manner, minimizing duplication of services and facilities, as well as expenses incurred. The utilization of each piece of equipment, and all services, should be maximized; services should be an effective and economical use of resources. If there are excess providers and excess capacity exists, growth or an increase in capacity should be discouraged. If an adequate number of providers exists, yet there is excess capacity, there should not be an increase in services until demand catches up. This does not exclude an allowance for new developments or techniques. If there is an adequate number of providers and sufficient capacity, providers should be encouraged to expand services only in response to an increase in demand. This does not refer to new modalities and services previously unavailable. If there are too few providers and inadequate capacity, existing providers should be encouraged to expand and/or additional qualified providers should be encouraged to offer services. Accessibility -. Quality radiology and nuclear medicine services should be reasonably accessible to all individuals in need, taking into consideration: transportation, sociological and cultural factors and relationships to all components of the health care system. B. Radiation therapy services and equipment should be accessible to the population within sixty (60) minutes travel time by automobile. D. Regardless of economic status, race and geographic location, all individuals should have access to radiology and nuclear medicine services at the most appropriate setting with the most efficient and effective use of resources. The HSA "goals and standards" are a part of its comprehensive health systems plan promulgated to comply with federal and state law and regulations, and are designed to achieve the optimum or ideal health care situation in the community. Although the governing body of the HSA determined that Petitioner's project would not meet the goals contained in paragraphs III C and IV 18, it recommended approval of the application because of "extenuating circumstances." (Testimony of Margulies, Anderson, Tupler, Marrinson, Composite Exhibit 7) Broward County has six hospitals and one private clinic where radiation therapy units are located. However, the two 18 MEV units which have been approved by Respondent will be located in the North Broward Hospital and Florida Medical Center, both of which are in the northern part of the country. Although from a mileage standpoint, each of these facilities is accessible to the county population within an hour's driving time, the large population in the area and congested highways would make it impossible for residents of the extreme southern part of the county to reach these facilities by bus or automobile in sixty minutes during normal hours. If elderly cancer patients living in South Broward County are required to expend the time necessary to journey to the facilities located in the northern part of the county for outpatient services, it would be deleterious to their mental and physical condition, and would be disruptive to the "team" concept employed at Memorial Hospital for the diagnosis, care, and cure of cancer patients. (Testimony of Margulies, Cohen, Tupler, Rodensky, Hartley, Atkin, Marrinson, Zenkel, Boyd, Nelson, Miller, Bennett, Spiegel, McPherson, Exhibits 10, 13 - 15, 17) The data compiled by the HSA and Respondent to assess the need for an additional 18 MEV linear accelerator was obtained from patient statistics in Broward County for prior years and projections of necessary equipment in the future predicated on on a variety of factors. These include population figures, incidence rate for cancer nationally and in Broward County, numbers of patients previously treated in local hospitals and numbers of treatments, estimated capabilities of existing and approved units based on a forty-hour, forty-eight hour and sixty-hour week basis, projected need in the future for radiation therapy treatments, and the percentage of past and projected therapy equipment utilization in Broward County. In its revised statistical charts, Respondent also applied similar projections solely with respect to the population and equipment located in South Broward County. Additionally, it included projections relative to the need and utilization of high-energy equipment, including the betatron machine at Broward General Hospital and the two 18 MEV's which will become operational in the future. Petitioner presented data based primarily on projected utilization of equipment in the South Broward area, and therein employed certain standards and criteria recently announced by the Department of Health, Education and Welfare as national guidelines which will govern health system plans developed after December 31, 1978, unless modified as authorized therein in certain instances. (42 CFR 121.209) The Hearing Officer took official recognition of these guidelines which provide that each megavoltage radiation therapy unit such as Cobalt 60 and linear accelerators, should serve a population of at least 150,000 persons and treat at least 300 cancer cases annually within three years after initiation, and that no additional units should be opened unless each existing unit in the health service area is performing at least 6,000 treatments per year. However, adjustments downward may be justified when travel time to an alternate unit is a serious hardship due to geographic remoteness based on analysis by the HSA. The guidelines indicate that about half of new cancer patients require megavoltage radiation therapy and that the 6,000 treatment standard reflects an average of about 25 patients or treatments per day as a reasonable standard. However, it is also stated that extra high energy machines which have "limited but important applications" may not reach such numbers of treatments and should be evaluated individually by HSA's in the development of the health systems plans. Also, it is noted that when each existing unit cannot reasonably be expected to reach the target level and a new unit is appropriate, the HSA may call for an adjustment in the standard based on pertinent local conditions. Such local conditions may include the age of the local population, seasonal population fluctuation, and access to needed care. (Exhibits 16, 19 - 20) In consideration of the foregoing facts and supporting exhibits, and in the absence of specific published state criteria, the following findings as to the actual projected need are made: Projected need should be based on the year 1980 because Petitioner will require a "lead time" of approximately 18 months from the time any Certificate of Need is issued in which to obtain equipment, construct a vault and ancillary facilities, and place the unit in operating condition. Although there are two separate hospital taxing districts in North and South Broward County that generally service the population in their respective geographic areas, projected need should be based on Broward County as an entirety because it is the designated "health service area." An 18 MEV linear accelerator can provide better treatment in a variety of types of cancer than other radiation therapy equipment presently in use in Broward County. Therefore, projected need should be based on Broward County requirements for such machines or its closest equivalent, the betatron. In 1980, there will one betatron and two 18 MEV linear accelerators in Broward County. The estimated population of Broward County in 1980 is 1,090,400. The incidence rate of cancer patients in Broward County is estimated at 490 per 100,000, which results in 4,910 projected cancer patients. Sixty percent of cancer patients are deemed to require radiation therapy and 40 percent of this number will benefit significantly from treatment by an 18 MEV linear accelerator or equivalent. Thus, 3,205 patients will require radiation therapy in Broward County and 1,282 will benefit from the specialized treatment of the higher voltage machines. At least 20 treatments will be required for the 1,282 patients. Based upon a predicted utilization rate of 3.5 patients per hour for the betatron and four patients per hour for the two projected 18 MEV's, the machines would be utilized in excess of 100 percent in 1980 for a forty-hour week. This does not make allowance for "down time" of the 18 MEV machines for maintenance or seasonal patient fluctuation. It is found from the foregoing that the extra high-voltage units that will be in operation in Broward County in 1980 will not be adequate to serve the needs of the county population and that therefore an additional 18 MEV linear accelerator to become operational during that year would not unnecessarily duplicate the existing resources. Consequently, a need will exist for an additional unit to be operational at that time.
Recommendation It is recommended that the Petitioner's application for Certificate of Need/Capital Expenditure Proposal be approved. DONE and ENTERED this 7th day of July, 1978, in Tallahassee, Florida. THOMAS C. OLDHAM Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Mr. Art Forehand, Administrator Office of Community Medical Facilities 1323 Winewood Boulevard Tallahassee, Florida 32301 Chester Senf, Esquire Assistant General Counsel Department of HRS 1323 Winewood Boulevard Tallahassee, Florida 32301 R. J. Fegers, Esquire 6011 Rodman Street Hollywood, Florida 33023 Clifford F. Anderson, Jr. Executive Director Health Planning and Development Council for Broward County 416 South West 1st Avenue Ft. Lauderdale, Florida 33301
The Issue This is a proceeding under Section 408.7056, Florida Statutes (2002), in which the issue is whether the denial by Health Options, Inc. (the Petitioner), of a request that it cover additional lymphedema outpatient therapy after a mastectomy to treat C.B. (the Subscriber),1 is consistent or inconsistent with the rules and laws that regulate managed care entities.2
Findings Of Fact The following facts were stipulated to at hearing by the Petitioner and AHCA: Effective April 1, 2002, the Subscriber in question was enrolled as a participant in a group HMO plan issued by the Petitioner to the Subscriber’s employer for the benefit of its employees and their eligible dependents. This plan constitutes an “employee welfare benefit plan” pursuant to the Employee Retirement Income Security Act of 1974 (ERISA). As a result of breast cancer, the Subscriber had a partial mastectomy of her left breast. Subsequent to her surgery, she required decongestic therapy due to lymphedema. The Petitioner authorized and provided coverage for decongestic physical therapy benefits for the Subscriber for services rendered from a participating provider for the authorized period of August 9, 2001, through October 18, 2001. The Petitioner denied coverage for additional decongestic physical therapy beyond the authorized period of August 9, 2001, through October 18, 2001, on the grounds that the Subscriber’s benefit had been exhausted under the terms of the Member Handbook. The Member Handbook for the Subscriber's HMO, signed by Robert I. Lufrano, M.D., the president of the Petitioner’s company, establishes the description of the rights and obligations of the Subscriber and the Petitioner with respect to the coverage and/or benefits to be provided by the Petitioner. Pages 20-23 of the Member Handbook requires the preparation and review every 30 days of a treatment plan as recommended by the Subscriber’s primary care physician or authorized provider. Further, provisions of the Member Handbook document the Petitioner's obligation to comply with state and federal laws and regulations and states that the terms of the agreement shall be interpreted to comply with those laws. Joel Mattison, M.D., is board-certified in plastic and reconstructive surgery. He holds a license in Florida and in North Carolina to practice medicine and surgery. Dr. Mattison has a specialty in plastic surgery and tropical diseases. Dr. Mattison's testimony establishes that the most common treatment form for lymphedema is a method of massage known as decongestic therapy. Lymphedema is the type of problem that will reoccur and no current treatment permanently eliminates the problem. If treatment is not received, the patient will suffer swelling of the body part located near the problem area causing trauma and infection with fungi and bacteria. The decongestic therapy is outpatient post-surgical follow-up care in keeping with the prevailing medical standard. As established by Dr. Mattison's testimony, the massage, which is the prevailing medical standard of care for lymphedemas, could be needed in excess of 62 days. Included in the therapy is the education of the patient to perform self-massage. The instruction in self-massage, however, is only part of the therapy and the other massage should not be discontinued. The evidence does not establish that the Subscriber received any instruction in self-massage or her ability to perform this function. In addition, Dr. Mattison testified that lymphedemas as a result of reconstruction and as a result of mastectomy, are indistinguishable without other indication, such as scars or patient history. Dr. Mattison testified that lymphedema pumps are available to assist in treatment. While it is hoped that the patient will learn how to use the pump, patients cannot always be depended on to learn to use them. The evidence fails to establish that the patient was offered a lymphedema pump or that using the lymphedema pump constitutes the prevailing medical standard.
Findings Of Fact Petitioner is the governmental agency responsible for issuing licenses to practice dentistry and for regulating such licensees on behalf of the state. Respondent practices general dentistry under license number DN 0002494.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Respondent guilty of violating Sections 466.028(1)(y) and (m), issuing a reprimand, imposing a fine of $6,000, and placing Respondent on probation for one year pursuant to the terms of probation prescribed in Petitioner's PRO. RECOMMENDED this 1st day of August, 1995, in Tallahassee, Florida. DANIEL MANRY 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 1st day of August 1995.
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.
Findings Of Fact Petitioners, Manasota-88, Inc. and Concerned Citizens of Citrus County, Inc., filed their petition on August 9, 1985, challenging proposed rules 10D-91.1101 through 91.1109. These proposed rules were published in Vol. 11, No. 30., Florida Administrative Weekly, on July 26, 1985. Petitioner's Exhibit 1. The proposed rules cite sections 404.051(4) and 404.056, Florida Statutes, as authority for rulemaking. These sections provide: 404.051 Powers and duties of the Department of Health and Rehabilitative Services. --For protection of the public health and safety, the department is authorized to: * * * (4) Adopt, promulgate, amend, and repeal rules and standards which may provide for licensure, registration, or regulation relating to the manufacture, production, transportation, use, possession, handling, treatment, storage, disposal, sale, lease, or other disposition of radioactive material, including naturally occurring radioactive material and low-level radioactive waste, and radiation machines as may be necessary to carry out the provisions of this chapter. The recommendations of nationally recognized bodies in the field of radiation protection shall be taken into consideration in the adoption, promulgation, amendments, and repeal of such rules and standards. Land radiation emission standards. To preserve and protect the public health, the department is authorized to establish, by rule, and enforce any environmental standards for land which, either in its natural state or subsequent to mineral extraction, emits radiation. In the establishment of such rules, the department shall consider: Existing federal standards. The recommendations of nationally recognized bodies which are expert in the field of radiation protection. The effect on private or public water supplies. The use made, or to be made, of the land. The proposed use of the land for residential dwellings, public or private schools, or commercial buildings. The availability of measures to mitigate the effect of the radiation. (E.S.) Petitioner, Manasota-88, Inc., is an environmental health organization. T. 23. It was established in 1965. Id. Though the petition alleges that this Petitioner is a nonprofit corporation, there appears to be no record evidence of this point. Apparently this Petitioner has "members," see T. 23-24, but the record does not contain evidence of the relationship of those members to the alleged corporation. Some members of Manasota-88 own reclaimed phosphate land in Polk County, and Ms. Raines knew of about five such persons. T. 23. About 150 members of Manasota-88 live on mineralized land in Sarasota County. Members of Manasota- 88 work and shop in areas where commercial structures could possibly be built on reclaimed phosphate or mineralized land. T. 24. There was no proof of the number of "members" of Manasota-88, Inc. Ms. Raines is chairperson of Manasota-88, Inc., and was a member of the Governor's phosphate-related radiation task force. T. 24. Manasota-88, Inc. participated in all of the rule making hearings with respect to the proposed rules in question in this case. T. 26. Petitioner, Concerned Citizens of Citrus County, Inc., is an environmental organization formed to protect the natural resources of Citrus County through proper planning. T. 28. Miriam Cohen is secretary and a member of the board of directors. T. 27. The organization has 1500 members, living in all sections of Citrus County. T. Some members own reclaimed phosphate land in citrus county. Some live on reclaimed phosphate lands. Id. There is no direct evidence of the numbers of such persons, or direct proof of the alleged corporate structure of this Petitioner or its relationship to its members. Proposed rule 10D-91.1104 provides a goal that radiation exposure to the public from naturally occurring radiation be maintained "as close to normal background radiation levels as reasonably achievable," which is 0.009 working levels (WL) for the annual average radon decay product concentration. T. 34. The upper limit mandated by the rule as a ceiling, and not a goal, is 0.02 WL. Id. See Petitioner's exhibit 1, proposed rule 10D-91.1104. The proposed rule, in section 10D-91.1108, requires county health departments having certain defined lands within the county to conduct educational programs to advise the public that dwellings located on such lands have the potential of exceeding the standards set forth above. Such programs must include recommendations for periodic measurement and methods to effect remedial actions. T. 116. The lands are defined by proposed rule 10D-91.1106(1) to include lands which have previously been mined or reshaped as the result of the extraction of phosphate ore and mineralized lands known to contain uranium, thorium, or their decay products in such amounts that radiation could be in excess of the above standards. The proposed rule, in section 10D-91.1106(1)(b) provides that the Department of Natural Resources shall provide HRS with a description of such lands, and that HRS will disseminate such information to building inspection offices affected. The proposed rule has a notification procedure whereby certain test results are provided to owners of newly constructed dwellings when the above standard is exceeded. See proposed rule 10D-91.1106(2)(b) and (d). Other than the foregoing, the proposed rule does not require any other notice to persons. In particular, the proposed rule does not require that sellers or lessors give notice to prospective buyers or lessees. The proposed rule provides that newly constructed dwellings which do not use a construction technique described in section 10D-91.1106(2)(a) or (b), and which exceed the standards set forth above, must be remedied by the owner to comply with the standards. No other mandatory remediation is required. Remediation in these other cases is discretionary with the owners, although, as set forth above, county health offices must publicize remediation methods. New dwelling construction that uses "ventilated crawl spaces" as defined by the rule are exempt from testing. New dwelling construction on reclaimed phosphate land that uses "improved monolithic slab" or "post- tensioned slab" techniques as defined by the rule will be tested by HRS during the first year of occupancy using a track etch device or a thermoluminscent device. If the test results show that the standard is exceeded, the owners will be advised of the result and advised of discretionary remedial action that they can take. No testing is required of existing dwellings. Preoccupancy testing is required only of newly constructed dwellings which do not use one of the three construction techniques set forth above. The International Commission on Radiological Protection (ICRP) is a group of internationally known scientists. T. 105. The IRCP, in a 1983 report on radiation protection, recommended a standard of as low as reasonably achievable not to exceed 0.027 WL, which is higher than that in the proposed rule. T. 105; HRS exhibit 4, p.7. The National Council on Radiation Protection and Measurement (NCRP) recommends a standard of as low as reasonably achievable not to exceed 0.004 WL. T. 106-07; HRS exhibit 5, pp. 88-89; Petitioner's exhibit 25H, p. 13. The Governor's Phosphate Radiation Task Force of 1982 recommended 0.027 WL. Petitioner's exhibit 25F, p. 15. Other states have either considered or adopted the same standard as adopted in this proposed rule: as low as reasonably achievable not to exceed 0.02 WL. T. 98. In February, 1979, in a letter from the Environmental Protection Agency (EPA) to the Governor of Florida, the EPA recommended several standards for radiation levels on Florida phosphate lands. These recommendations were summarized on pp. 38665 and 38666 of Petitioner's exhibit 5. The first recommendation is that remedial action "should be taken" in all residences in which "the initial indoor air concentration of radon decay products exceeds 0.02 Working Level (WL), including normal indoor background." The second recommendation provides: II. When annual average air concentrations of radon decay products are less than 0.02 WL, remedial action required to reduce such concentrations to as low as reasonably achievable levels should be taken. Among the factors to be considered in determining the appropriate degree of reduction are the cost and effectiveness of available remedial measures, the health risk averted, the normal background level, the life expectancy of the structure, and measurement uncertainties. The third recommendation is that remedial action is not warranted in existing residences solely to reduce the indoor gamma radiation exposure rate. The fourth and final recommendation is that development sites for new residences be selected and prepared and the residences designed and sited so that the annual average indoor air concentration of radon decay products and gamma radiation does not exceed average normal background levels (indoor) plus uncertainties of normal background variation and measurement capability. The average normal indoor background level of radiation is about 0.004 WL for annual indoor air concentration of radon decay products, and 6 microroentgens per hour for gamma and x rays. Petitioner's exhibit 5, p. 38666. Uncertainties due to normal variations and measurement capability add 0.005 WL and 6 microroentgens, thus making the EPA "as low as reasonably achievable" standards to be 0.009 WL and 11 microroentgens per hour. Id.; T. 34. The supporting text of Petitioner's exhibit 5 makes it clear that the EPA did not recommend mandatory remediation below 0.02 WL. The technical information section states an attempt to achieve the "as low as reasonably achievable" standard would impose unreasonable costs in 15 percent of the cases. The technical information section further shows that costs and practicality are factors to be considered in trying to achieve lower levels: In order to provide flexibility to bring about remediation when costs are reasonable, remediation is recommended whenever responsible authorities determine that it is practicable to do so in the range between 0.02 WL (including normal indoor background) and 0.005 WL above normal background. (E.S.) Petitioner's exhibit 5, p. 38668. The technical information section describes the recommended standard for radon daughter product level below 0.02 WL as being "discretionary" with respect to remediation: The recommendations provide that when the radon daughter product level in existing homes is less than 0.02 WL (including normal background indoors) action be taken to reduce the radon concentration to as low as reasonably achievable levels. It is recognized that a discretionary policy such as this may complicate implementation of the recommendations since decisions must be made regarding which exposure level can be considered as low as reasonably achievable for each structure. To assist in making such decisions several factors should be considered: * * * 3. The cost to reduce the level should be evaluated . . . . * * * 5. The social and economic inconvenience to the to the inhabitants should be considered. Some inhabitants may find expenditures to install control technology prohibitive and a major disruption to their life styles. (E.S.) Petitioner's exhibit 5, p. 38669. On September 20, 1984, Richard J. Guimond, Director, Criteria and Standards Division, Office of Radiation Programs for the EPA, characterized the 0.02 WL as "a remedial action level," specifically referring to the letter which is Petitioner's exhibit 5, and characterized the reduction of radiation levels to a point not "significantly above normal background levels for Florida" as the goal of construction methods for new housing. In the next paragraph he stated: "We do not believe it is appropriate to establish a remedial action level for new housing different from that for existing housing." Attached to his letter were what Mr. Guimond referred to as "our comments" on the draft of the Governor's phosphate Related Task Force standards. In the last sentence on the first page of those comments, the EPA comments state: The difficulties in enforcement may discourage the incorporation of the ALARA [as low as reasonably achievable] principle in regulations, but the practice should, at a minimum, be encouraged in the text that accompanies the standards. (E.S.) In summary none of the EPA recommendations above explicitly recommend mandatory remediation. Even where more than 0.02 WL is present, the EPA recommendation only says that remediation "should" be taken. See Recommendation I above. Below 0.02 WL, EPA Recommendation II expressly lists factors to be considered in determining whether or not remediation should be taken. Moreover, the EPA did not specifically consider in any great detail what might be needed to achieve Working Levels below 0.02, and saw this as within the discretion of the state. Petitioner's exhibit 25A, p. 12. See findings of fact 21 through 24. By letter dated March 22, 1985, Sheldon Meyers, Acting Director, Office of Radiation Programs for the EPA, wrote to the Respondent to comment on the proposed rules for radiation levels in newly constructed houses. Mr. Meyers stated that "we . . . concur in the numerical standards you have proposed." Petitioner's exhibit 8. Mr. Meyers further praised the Respondent for using design criteria rather than direct radiation standards. Id. Mr. Meyers was critical, however, of the automatic exemption of testing of new houses using monolithic slabs or ventilated crawl spaces. Mr. Meyers stated that they were not aware of any data demonstrating that monolothic slabs have long- term effectiveness in preventing radon entry, that cracks are likely to appear over the normal lifetime of a house, and that there was not enough data to justify using a monolithic slab alone to prevent radon entry. He recommended that the monolithic slab be used only in conjunction "with other radon resistant techniques, such as well-sealed polymer barriers and sub-slab ventilation systems." He also questioned the use of crawl spaces, saying his data was "incomplete." He concluded by recommending that a testing program be used to certify construction techniques, and that while crawl space certification may be easy, that monolithic slab performance may take longer. Mr. Meyers did not expressly state that "all structures be subjected to preoccupancy and long term monitoring," as proposed by the Petitioners in proposed finding of fact 32. The rule requires both types of slab construction to have a polyethylene (or equivalent) soil gas barrier. Petitioner's exhibit 1; Petitioner exhibit 25G, pp. 37-38. Use of ventilated crawl spaces, monolithic slabs, or post-tensioned slabs, is expected to reduce radiation levels to the "as low as reasonably achievable" levels set forth in the rule, based upon current understanding of these building techniques. Petitioner's exhibit 25F, p. 33-34; T. 36-40. It is reasonable, however, for there to be some continued data collection to see how these building techniques perform in future years. Petitioners exhibit 25A, pp. 13-19, 57; T.40 It would not be reasonable to set the mandatory upper limit at the background level of 0.09 WL because as the background level is approached, one cannot tell whether the level of radiation is due to normally expected background or is due to the phosphate caused excess. Petitioner's exhibit 25H, pp. 22, 15; Petitioner's exhibit 25F, pp.35-36. Setting the mandatory upper limit that close to the normal background level would make the rule manageable and difficult to enforce. Id. The problem is not that monitoring devices are inaccurate, but that the readings from such devices, at the background level, increasingly run the risk of overregulation. Id. The "track etch" radon decay products detection device is a simple detection device, without moving parts, that has been almost universally accepted over the past ten years as a measuring device in uranium mines, and is a widely accepted measuring device. T. 109. A second detection device, using a thermoluminscent detector, is the "RPISU," or the radon progency integrating sampling units. The RPISU is widely accepted and used. T. 110. Both devices are recommended by the EPA and by most of the measuring standards organizations, including the Bureau of Standards. T. 111; Petitioner's exhibit 25H, pp.37-38. The Respondent anticipates that it will use the track etch detection device to monitor radon daughter levels when new construction involves either an improved monolithic slab or a post-tensioned slab. T. 113. The Respondent contemplates using the RPISU for monitoring radon levels for newly constructed dwellings tested pursuant to proposed rule 10D-91.1106(2)9(d). Id. Various agents and employees, as well as other persons, expressed varying opinions as to the legal question of whether the Respondent has legal authority to require more rigorous forms of public notification, and the Respondent appears to have considered these various opinions. See HRS exhibit 7; Petitioner's exhibit 10, 17, 25E (p. 4), and 15. Evaluation of problems of enforcement, cost off enforcement, and economic inconvenience to persons regulated are consistent with EPA guidelines. See findings of fact 23 and 24 above. Lifetime residency (75 percent) occupancy of a residence with an air concentration of 0.02 WL is predicted to result in a 70 percent increase in lung cancer, from 2 per 100 to 5 per 100. Petitioner's exhibit 5, p. 38668. If 80 percent reduction of all cases above 0.02 WL is achieved, 60 percent of the excess risk of lung cancer will be eliminated; if 80 percent reduction of all cases above 0.005 WL (plus 0.004 WL background) is achieved, 75 percent of the excess risk of lung cancer will be eliminated. Ibid. Thus, the benefit of going all the way to the as low as reasonably achievable level is to eliminate another 15 percent of the excess risk of lung cancer, or 0.45 cases per 100 persons. The proposed rule does not place any mandatory duties upon local building inspection offices. The proposed rule states: 10D-91.1107 Inspection and Notification of Test Results. (1) Following an evaluation of the test data for dwellings specified in 10D-91.1106(2)(d), the Department shall send the appropriate building inspection office a letter recommending approval or denial of occupancy no later than 5 working days after evaluating the test data. * * * (2) Each building inspection office . . . should give written notice of the prospective building or owner of the dwelling of the requirements of this part and should assure that occupancy of the dwelling is not permitted until confirmation is received from the Department that the dwelling has met the standards contained in 10D-91.1104(2), or until inspection has verified that the dwelling is constructed in accordance with 10D-91.1106(2)(a) or (2)(b). Thus, the County building inspector will receive the recommendations of the Respondent, but has no mandated duties. The proposed rule only suggests what the county building inspector "should" do. The testimony was not in conflict with the proposed rule. The witness who testified on this point stated that "we really would expect" the building office to refuse to issue a certificate of occupancy. He did not testify that the local building inspector was required to withhold the certificate of occupancy. T. 64-65. The Hearing Officer officially recognizes that intervenor, Polk County, is a political subdivision of this state. Findings of fact adopted by reference in the Appendix, as well as explicit findings of fact made in the Appendix, are incorporated herein by reference.
Recommendation Upon consideration of the foregoing, it is ORDERED Petitioner, Concerned Citizens of Citrus County, Inc., have failed to prove standing, and therefore are DISMISSED as a Petitioner in this case. The remaining Petitioner and Intervenor have failed to prove that proposed rules 10D-91.1101 through 10D-91.1109 are an invalid exercise of delegated legislative authority. DONE and ORDERED this 20th day of December, 1985, in Tallahassee, Florida. Hearings Hearings 1985. WILLIAM C. SHERRILL, JR. Hearing Officer Division of Administrative The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative this 20th day of December, APPENDIX TO RECOMMENDED ORDER, CASE NO. 85-2813RP RULINGS UPON ALL PROPOSED FINDINGS OF FACT A. The following, using the same numbers as used by the Petitioners in their proposed findings of fact, pages , are the specific rulings of the Hearing Officer as to each proposed finding of fact. If "adopted," the finding as proposed becomes a finding of fact in this recommended order. If adopted or rejected with qualifying statements, the qualifying statements, to the extent that facts are involved, are additional findings of fact. Adopted. Petitioners fail to give any page reference for the conclusions of fact proposed. The Hearing Officer cannot find any reference to the national average, and therefore rejects the second and third sentences of this proposed finding of fact. The fourth sentence is also incorrect. The report cited, HRS exhibit 3B, states in several places that the mean WL for undisturbed nonmineralized land to be 0.004 WL. The rest of the proposed finding of fact is adopted. Rejected. Petitioners have failed to cite any portion of the record where this fact has been proven, and the Hearing Officer does not recall any such testimony. Further, the policy of the United States with respect to VA and FHA loans has not been shown to be relevant to this rule challenge. Adopted. Additionally, the report noted that in some cases, application of a standard of 0.009 WL to a new structure might not be feasible or reasonable. Footnote 2 is rejected as legal argument. Adopted. The first sentence is adopted. Petitioners fail to cite the portion of the record supportive of the second sentence, and the Hearing Officer has no recollection of any such evidence in the record, and therefore, the proposed finding in the second sentence is rejected. Adopted. Table 12, page 57, of attachment A to Petitioner's exhibit 25A does not establish the proposed fact that use of crawl spaces and monolithic slabs at a cost of $550 will reduce radiation to 0.09 WL and 11 microroentgens/hour; section 5.0 implies this result, but does not state it with sufficient precision for a finding of fact to be made. Only the following statement of fact can be made: that the EPA estimated that it would cost $550 for ventilated crawl spaces, and for improved slab construction to reduce radon radiation by 80 percent, using 1977 dollars. Adopted. The first sentence is adopted. The second sentence is rejected since the record is closed for new exhibits. Adopted. Adopted. There is no citation to the record for the last sentence of this proposed finding, and the Hearing Officer has no recollection of evidence on this point, and therefore the last sentence is rejected. The next to last sentence overstates the text of paragraph 4, page 38665, Petitioner's exhibit 5. The correct statement is as follows: Residents who live a lifetime in these homes [homes having radon levels from 0.03 to 0.1] could experience a risk of lung cancer which is 2-4 times the average risk to a member of the U.S. population. The rest of the proposed finding is adopted. Adopted, including the footnote. As discussed more completely in the findings of fact above, the EPA recommendations I through IV found on pages 38665 66, Petitioner's exhibit 5, do not recommend mandatory remedial action. Proposed finding of fact 15 is adopted, except the word "mandatory." There is no citation to the record to support proposed finding of fact 16, and the Hearing Officer is unable to find record support for this proposed finding, and therefore must reject it. Adopted. Petitioner's proposed finding of fact 18 is rejected for several reasons. First, the citation to Petitioner's exhibit 24 does not support the proposed finding, and the Hearing Officer has no recollection of any other record evidence to support this proposed finding. Second, the finding is not relevant. The task force did not adopt this apparently preliminary standard. Petitioner's proposed finding of fact 19 is rejected in part because there is no citation to the record to support the finding that revisions were made due to "vigorous lobbying by the Florida Phosphate Council and the Florida Home Builders Association." The finding is further rejected because the proposals of the subcommittee are irrelevant. The finding that the task force ultimately adopted a 0.027 WL standard has already been made. Adopted, except the parenthetical "[to the public health]" is rejected. The EPA did not limit its consideration of costs to only the public health, but consistently evaluated the costs to home owners and land owners as well. See e.g. Petitioner's exhibit 5, p. 38669, numbered paragraph 3 and 5; Petitioner's exhibit 25A, attachment A, pages 56-75. Adopted. Rejected because prior drafts rules are not at issue in this case, and have no relevancy or weight as to what the proper standards should be. Rejected for the same reasons as stated in 22 above. Adopted. Rejected because irrelevant. The issue in this case is not whether the Respondent has legal authority to adopt more stringent notice requirements, but whether a rule that fails to do so is an invalid exercise of delegated legislative authority. Adopted. Adopted with the following exception. Petitioner's exhibit 15 does not state that the Office of General Counsel stated any legal opinion as to notice. The exhibit fails to identify "OSLS," and the Hearing Officer cannot make a finding as to what that means. Moreover, the legal opinion stated in the exhibit by the OSLS, is not a fact, but is relevant only argument as to conclusions of law. Adopted. While this proposed finding of fact contains a number of statements that are accurate, if adopted as phrased, the record would be incomplete. "Public health benefits" were not specifically analyzed as such for the construction options for new housing, but it would be incorrect to find that the Respondent did not consider such benefits, given all of the other record evidence that ventilated crawl space or slab construction are reasonably expected to reduce radiation levels to the "as low as reasonably achievable" standard. By limiting options to these construction standards, with the alternative of variance from these construction standards coupled with testing and remediation, the Respondent de facto, has followed a path toward improving public health based upon the 0.02 WL standard. Moreover, with respect to option 1, the the exhibit recommended adoption for three reasons, not just the one proposed by Petitioners. Finally, the last sentence of footnote 6 is rejected for lack of evidence. Petitioner's exhibit 4 does not explain how the thermoluminscent device is proposed to be used, and lacking evidence on the point, the Hearing Officer cannot conclude that the $30,000 cost is an estimate of the cost of preoccupation monitoring of 3,700 new houses. The $30,000 cost only reflects the purchase cost of 100 devices at $300 each. With these exceptions, the proposed finding is adopted. Adopted, except the footnote 7 is rejected. There is no evidence of the expense to the Department of Agriculture to conduct its testing program, or the relevance to this proceeding. Adopted. Adopted, except the last sentence is rejected because Mr. Meyers did not expressly say that in his letter. Adopted. Adopted. Adopted, except proposed finding 36d. The standard proposed is contained in proposed rule 10D- 91.1104, and is "normal background radiation levels as reasonably achievable." The normal background is 0.004 WL and 6 microroentgens per hour. The maximum standard stated in the proposed rule is 0.02 WL and 20 microroentgens per hour. Adopted, except that the second sentence is rejected because irrelevant. The legal authority of the Respondent to do something is a legal question, not a factual question. Rejected. There is no evidence that Dr. Cox's opinions, elicited on cross examination, were intended to state the intentions of the Respondent with respect to testing devices and number and extent of use. The first sentence is rejected. Mr. Guimond stated: "But you'd probably use a number of track etch cups, and you might do them in a various placement within the structure." By qualifying his opinion with "probably" and "might," Mr. Guimond made it clear that he was not expressing a rule. The remainder of the proposed finding is adopted. Adopted, with the addition that Ms. Trott also testified that her duties include processing, development, and coordination of all parts of the rule package other than the rule itself. Adopted, with the following exceptions. Ms. Trott did not testify that she obtained cost figures from a "lobbyist," or from any person of a particular profession other than the "Polk County Association of the Florida Homebuilders Association." The last two sentences are rejected because beyond the expertise of the witness as he himself testified, T. 127, and beyond the expertise certified by the Hearing Officer, T. 91. Adopted. Adopted. Adopted. Adopted. Secretary Pingree made it clear that he deferred to the advice of legal counsel on the notification issue. Otherwise, the proposed finding is adopted. Rejected. The relevance of this proposed finding is not shown by the record. Adopted, except that Dr. Howell, is currently the Deputy Secretary. Rejected. The record cited by Petitioners from these proposed findings of fact do not support the findings in the form proposed. The first sentence of proposed finding 50 is rejected. Dr. Howell simply testified that it would be very hard to subject public health programs to a cost/benefit analysis. The second sentence is adopted. Dr. Howell testified that exposure to 0.02 WL for 70 years would cause a risk of 2 additional lung cancer fatalities per 100 persons, and that that was a high risk. The proposed finding as worded is rejected. Adopted. Rejected. Dr. Howell vaguely testified that "if you had a good building technique, a good informed consent, you actually may allay a lot of fear." Petitioner's exhibit 25B, p. 40. He did not tie this opinion to the proposed rule. Adopted. Adopted. The first sentence is rejected because Dr. King did not make it clear what kind of "standard" he was referring to. All that Dr. King said was "there was no evidence in that literature to support a level other than what could be in fact detected in food, which was again, detection limit was then one per billion." Petitioner's exhibit 25F, p. 13. It is not at all clear that Dr. King was describing a ceiling, and since he was talking about detection thresholds, he was probably only talking about the practical limits of designing a standard. The second sentence is rejected because it is a distortion of what Dr. King said. Dr. King testified: "predominately the issue was the level of risk, but the integral part of balancing was whether or not it was practical to eliminate from the food supply, whether it was possible to technologically, as we understood it, to eliminate from the food supply ethylene dibromide." Id. The last sentence is adopted, but with the addition that such 1,000 persons have been exposed to average levels of EDB for a lifetime. Adopted, except that the goal is one "adverse health effect" per one million, not "one lifetime fatality." Rejected. The citation to the record does not support the proposed finding in the form proposed. Adopted. Adopted. Adopted, with the following exceptions. The record cited does not support a finding that Dr. King recommended 0.02 WL because 1/3 of existing homes would violate 0.01 WL, and does not support the proposed fact that 1/3 of existing homes would violate 0.01 WL. The record further does not support the finding that Dr. King made his recommendation based upon precedential value for other states. What Dr. King said was that he relied upon the precedent of the use of 0.02 WL by the Environmental Protection Agency. Petitioners exhibit 25F, p. 25. The first sentence is adopted. The second sentence is rejected. Petitioner's exhibit 25F, p. 23, 1. 21-25. The third sentence is rejected because it is irrelevant. The proposed finding is a misstatement of the testimony. Dr. King said he looked at the EPA study, but could not remember what it said. Petitioner's exhibit 25F, p.29, 1. 12-13. Rejected as irrelevant. Dr. King's inability to remember this fact at this deposition is not relevant. Dr. King explicitly stated that he "heard a number of numbers," but that he could not recall any. Petitioner's exhibit 25F, p. 31, 32. Rejected as misleading. Dr. King testified that in choosing the Working Level standard, he was more concerned about normal distribution, reliability of monitoring, and the ability to enforce effectively at the chosen standard. Petitioner's exhibit 25F, p. 33, 1. 7-18. Adopted. Rejected. Dr. King did not say that. He only said that the concern about remediation in existing homes was one that "we all felt needed to be addressed." Petitioner's exhibit 25F, p. 44 1. 10-11. He then said "I felt that at sometime soon we would have to deal with that issue. "Dealing with an issue, or "addressing" an issue can mean that it was discussed, encouraged, rejected, mandated, or ultimately ignored after discussion. It does not mean adoption of a mandatory program of remediation. Adopted. Adopted. Rejected. This is a misstatement of the testimony. Dr. King did not testify that he believed lands should be quarantined. Dr. King testified that "maybe" a Mr. Herron with the IMC said that, and "Again, that would have been an ideal situation to be able to make that recommendation, I don't believe that that was within the preview of the charge that we had, however, to make that recommendation." Petitioner's exhibit 25F, p. 51, 1. 17- 20. Adopted. Adopted Rejected. The testimony is equivocal and contains too many qualifications for this categorical proposed fact to be adopted. Petitioner's exhibit 25F, pp. 66, 1. 20-25, to 67, 1. 1-14. Adopted. Adopted. Rejected. The testimony is unclear, and does not support the statement as proposed by Petitioners. Petitioner's exhibit 25H, p. 17, 1.6-12. Rejected. The portion of the record cited for this statement of fact contains comments of counsel, but does not contain clear testimony of the witness to prove this point Adopted. Rejected. The witness did not say anything about "notification of buyers and lessees." He stated: "I think it would be a good idea to let people know in existing structures, which most of them already do." A buyer is not a person in an existing structure, and the issue of notice to buyers or prospective lessees is quite different from general notice to persons residing in structures. Petitioner's exhibit 25H, p. 32, 1. 2-3. Adopted. The first sentence is adopted. The second sentence is misleading. The persons named were clearly not intended by the witness to be the only persons. Petitioner's exhibit 25G, p. 6, 1. 18-21. The second sentence is rejected because it is false as proposed. Rejected. Gordon Nifon did not testify that one of the "principle" considerations of "this group" was the economic impact of the standard on real estate values. He said that he felt that the 0.02 WL standard offered a significant degree of protection to people not now protected and yet it does not bring undue economic hardship to a lot of people. Petitioner's exhibit 25G, p. 5, 1. 1- He was then examined closely about his opinion regarding economic impact, and finally stated that just about everyone who any impact upon the rule standard discussed how to balance economic impact with the public health. Id., p. 6, 1. 13-21. A finding can be made that economic impact was a consideration, but the record fails to support Plaintiff's suggestion that it was one of the principle considerations. As proposed, the finding is rejected. A finding is made that there was some concern that at the 0.01 WL that too many houses would be affected, but the influence of that concern upon the final outcome of the proposed rule is not clear in the record. Petitioner's exhibit 25G, p. 12, 1. 1-3. The first sentence is rejected. The witness was not certain. The second, third and fourth sentences are adopted. Adopted. The first sentence is adopted. The second sentence is rejected as proposed. The witness said that to do a "definitive study of any one home, there might be some reason to use more than one detector." He testified further: "I will only say that it wouldn't hurt, I suppose, to have two or more detectors. But I'm not sure if it would be a great value." Petitioner's exhibit 25G, p. 15, 1. 14-16 and 20-22. This is not sufficient to adopt the proposed finding. The first sentence is rejected. The witness made no representations as to what HRS had done with respect to testing. Petitioner's exhibit 25G, p. 12, 1. 6. The second sentence is adopted. Adopted. Adopted. Adopted, with the addition that "lifetime risk" means exposure at a given number of Working Levels for a lifetime. Rejected as phrased. The following statement is adopted as an alternative: Due to lack of complete data, some data collection was recommended by Mr. Guimond with respect to new construction on phosphate lands. Petitioner's exhibit 25A, pp. 13, 1. 25 to 19, 1. 17. Rejected. The answer is unintelligible, the testimony is that of counsel rather than the witness, no predicate was laid for the witness's degree of familiarity with the study, the levels mentioned in the question are not identified or explained, the witness was not qualified as an expert, the study is hearsay, and the cited passage is otherwise not the sort of evidence that is sufficiently reliable for the purpose proposed by Petitioners. Rejected as irrelevant. Rejected. The N.C.R.P. standards are for both types of structures. Petitioner's exhibit 25A, p. 27, 1. 22-25. Rejected in the form proposed. The following is adopted: (another space) Mr. Guimond thought that the I.R.C.P. document was "pretty confusing," and had "quite a bit of caveats in there which would enable Governments to move the values they use either direction " Petitioner's exhibit 25A, p. 28. The testimony is insufficient to conclude that the I.R.C.P. document is "useless." Adopted. Rejected as phrased. The following is adopted: Mr. Guimond implied that the EPA often tries to get a higher degree protection than it did in these standards, but they felt it was a reasonable compromise based on trying to weigh risk and the absolute need of people for housing. Petitioner's exhibit 25A, p. 30. Adopted. Mr. Guimond was further of the opinion that it would be a "legitimate approach" for HRS to make the suggestion to the Legislature that its authority to give such notice be given consideration. Petitioner's exhibit 25A, p. 34. Adopted. Adopted. Adopted. Rejected as stated. Dr. Jerrett testified that notification was desirable, not that it was "necessary." T. 58, 1. 2-7. The following statements of fact are erroneously included in the Petitioners' "Argument" section, and are ruled upon as if they were proposed findings of fact: Paragraph 103B is adopted only to the extent stated in findings of fact 2 through 9. Paragraph 103C is adopted. Paragraph 103D, is adopted except there was no evidence of the participation of Concerned Citizens of Citrus County in the rule-making public hearings as parties. The following, using the same numbers as used by the Respondent in its proposed findings of fact, pages 1-4, are the specific rulings of the Hearing Officer as to each proposed finding of fact. If "adopted," the finding as proposed becomes a finding of fact in this recommended order. If adopted or rejected with qualifying statements, the qualifying statements, to the extent facts are involved, are additional findings of fact: Adopted. Adopted. Adopted, except the last sentence, which is not fact. Adopted. Petitioner's exhibit 25H, p. 6, 31. Rejected as proposed. HRS is considering amendment to the proposed rule to include schools and public buildings. T. 59, 77-78, 80; Petitioner's exhibit 25E, p. 8. Adopted, except the fifth sentence is rejected. The Hearing Officer cannot conclude from the testimony of Stephen King, M.D., that an upper limit less than 0.02 WL would be unmanageable, unrealistic, or unenforceable. Dr. King was specifically referring to the setting of a ceiling standard at background, and simply indicated that it be both unrealistic and unmanageable to require ideal background when the background number is in fact only a point of distribution on a bell curve that is expected to have some values higher than the standard. Petitioner's exhibit 25F, pp. 35-36. The first sentence is adopted. The second sentence is rejected as proposed. The rule speaks for itself, stating that counties which have lands "within their borders identified in 10D-91.1106(1) shall conduct . . . educational programs to advise the public that dwellings located on such lands have the potential of exceeding the standard . . . ." Proposed rule 10D 91.1108. The testimony is insufficient to conclude that in fact the educational program will include letters, brochures, or that HRS will have a full-time health educator. That was only the vision of the witness, and the full-time health educator was only a "budget issue," which means something HRS intends to ask the Legislature to fund. T. 63. Adopted. Adopted. Rejected because it is a conclusion of law. The Intervenor, Polk County, proposes only two findings of fact, designated paragraphs 7 and 8. Proposed finding of fact 7 is rejected, as more fully explained in the findings of fact, because the proposed rule does not impose any "duty" on the local building inspector since it uses the word "should." Proposed fending of fact 8 has been adopted in the findings of fact, although worded differently. HRS does expect that local building inspectors will follow their recommendations and the suggestion of the proposed rule and withhold the certificate of occupancy. COPIES FURNISHED: Richard A. Patterson, Esquire Department of HRS 1323 Winewood Blvd Building One, Suite 407 Tallahassee, Florida 32301 Thomas W. Reese, Esquire 132 Eight Street North St. Petersburg, Florida 33701 Mark F. Carpanini, Esquire Office of County Attorney Post Office Box 60 Bartow, Florida 33830 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32301 Liz Cloud, Chief Bureau of Administrative Code 1802 The Capitol Tallahassee, Florida 32301 Carroll Webb, Executive Director Administrative Procedures Committee 120 Holland Building Tallahassee, Florida 32301 A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW PURSUANT TO SECTION 120.68, FLORIDA STATUTES. REVIEW PROCEEDINGS ARE GOVERNED BY THE FLORIDA RULES OF APPELLATE PROCEDURE SUCH PROCEEDINGS ARE COMMENCED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF THE DIVISION OF ADMINISTRATIVE HEARINGS AND A SECOND COPY, ACCOMPANIED BY FILING FEES PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL, FIRST DISTRICT, OR WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE PARTY RESIDES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED.
The Issue The issue in this case is whether the Board of Medicine should discipline the Respondent, Carlos C. Soriano, M.D., on allegations contained in an Administrative Complaint filed against the Respondent in DPR Case No. 89-05941: namely, allegations that the Respondent practiced medicine below the acceptable level of care, skill and treatment, in violation of Section 458.331(1)(t), Fla. Stat. (1993), by failing to offer one of his patients the option of radiation therapy or chemotherapy for cancer of the rectum and by inappropriately delaying treatment for the condition.
Findings Of Fact The Respondent, Carlos C. Soriano, M.D., is a physician licensed in the State of Florida, holding license number ME 0024149. In late 1988 and early 1989, the Respondent, Carlos C. Soriano, M.D., was the medical director of a health maintenance organization called Gold Plus. On or about October 24, 1988, a physician at Gold Plus examined the patient in question, a 90 year-old female in apparent good health for her age, and made a preliminary diagnosis of suspected cancer of the rectum. She referred the patient to the Respondent, a surgeon, for further evaluation and treatment. The Respondent examined the patient on October 31, 1988. He confirmed his associate's preliminary diagnosis of cancer of the rectum but pointed out that a flexible sigmoidoscopy with biopsy would be necessary to make a final diagnosis and to determine the kind of cancer involved. The diagnostic procedure was scheduled for November 17, 1988. The Respondent also discussed with the patient that, due to her age and the size and extent of the tumor, surgical removal of the tumor may not be appropriate. The Respondent suggested that the best course might be to perform a palliative colostomy, if necessary, and "let nature take its course." The patient was not pleased with the Respondent's attitude and consulted a nephew, who was a physician, for advice. The nephew referred the patient to another physician, who was a gastroenterologist, for a second opinion. The gastroenterologist examined the patient on or about November 8, 1988, prepared a report for the referring physician, with copies also sent to the patient and to the Respondent. The gastroenterologist's report recommended: a colonoscopy and biopsies like those already scheduled by the Respondent; a complete work-up preliminary to surgical removal of the tumor (including CEA levels, a liver/spleen scan, chest X-ray, and CT scan of the pelvis) to determine whether the cancer had metastasized; and (3) radiation therapy if there was no evidence of metastasis, or palliative radiation prior to snare polypectomy or laser fulguration, to avoid the necessity of a colostomy in the future if there was evidence of metastasis. The Respondent performed the flexible sigmoidoscopy and three biopsies as scheduled on November 17, 1988. He told the patient he would discussed the results with her as soon as they were received from the pathology laboratory. The Respondent received the pathology report and scheduled an appointment to discuss the results with the patient and her family (another nephew, and his wife) on November 30, 1988. The pathology report on the biopsies confirmed that the tumor was malignant. The report stated that the cancer was coacogenic. At the time, and to this day, radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinomas. Assuming the accuracy of the report, the only course of possible effective curative treatment for the patient was surgical removal. Whether or not the cancer had spread, the Respondent did not think surgical removal was appropriate for the patient, due to her age and the size and extent of the tumor. He did not think she would tolerate the kind of surgery that would be required. The decision whether to perform a particular surgery on a particular patient requires the exercise of the physician's professional medical judgment. Such a judgment cannot be made without a knowledge of the patient, through history and physical examination. It is found that, based on all of the evidence, including the Respondent's knowledge of the patient, through history and physical examination, the Respondent's medical judgment not to recommend surgical removal of the patient's tumor was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. During the meeting with the patient and her family on November 30, 1988, the Respondent explained the results of biopsies and what he considered to be the treatment alternatives. He told them that he would not recommend surgical removal, due to the patient's age and the size and extent of the tumor. He mentioned but did not elaborate on the possibility of radiation therapy because he did not know much about it. He suggested that the patient consider a colostomy to bypass the tumor and to "let nature take its course." He informed the patient and her family that he would be out of the country on vacation for the next four weeks but that she should make an appointment to see him after the holidays. Meanwhile, he would have someone research for him whether radiation or other alternative treatment modes were appropriate. It is found that the Respondent's failure to recommend radiation therapy or chemotherapy was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinoma. Assuming the accuracy of the pathology report on the biopsy, the only course of possible effective curative treatment for the patient was surgical removal. Subsequent events revealed that the patient's cancer was not coacogenic but rather squamous cell carcinoma. (It is not uncommon for biopsy reports to make such an error due to the relatively small size of the biopsy sample.) But even if the biopsy report had shown that the patient suffered from squamous cell carcinoma, it could not be found that the Respondent's failure to recommend radiation therapy or chemotherapy was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. In 1988 and 1989, the medical community did not recognize radiation therapy or chemotherapy as an acceptable curative treatment for squamous cell carcinoma of the anus. Once again, the patient became anxious that the Respondent was not offering any curative treatment plan. She asked whether the Respondent should not at least have a liver/spleen scan done to see if the cancer had metastasized. Since the Respondent was not recommending surgery (the only possible curative treatment), he did not think a liver/spleen scan would serve any useful purpose. But to satisfy the patient, and because it was one of the gastroenterologist's recommendations, he agreed to schedule one for the patient before he left for vacation. The patient scheduled a follow-up appointment for January 9, 1989. Meanwhile, the Respondent left for vacation, and the liver/spleen scan was performed on December 8, 1988. In the Respondent's absence, Gold Plus delayed giving the patient the results of the scan. She became more and more anxious as time went by. When the patient called for the results, she initially was told that Gold Plus could not give her the results until the Respondent returned. It took an angry telephone call from the wife of the patient's nephew on the day before Gold Plus closed for the Christmas holiday for Gold Plus to agree to allow another of its physicians discuss the results of the scan. The patient was promised that the physician would call the next day. Still, no call came, and the wife of the patient's nephew called again just hours before the office closed for Christmas. The patient and her family were told that the results of the scan were negative. This distasteful experience further soured the patient's relationship with Gold Plus and, by extension, with the Respondent, and they lost faith in the Respondent and his medical practice. Instead of seeing the Respondent on January 9, 1989, as scheduled, the patient cancelled the appointment and made another appointment to see the gastroenterologist again. By this time, the tumor had grown to some extent and, along with it, the patient's discomfort. It was difficult to even examine the patient's rectum either digitally or by flexible sigmoidoscopy. The gastroenterologist agreed to refer the patient to another surgeon for possible surgical removal of the tumor. The patient initiated disenrollment from Gold Plus so that her Medicare could be reinstated to cover the anticipated surgery. The gastroenterologist asked the Respondent for the patient's medical records. The Respondent's care of the patient and responsibility for the care of the patient effectively ended when the patient cancelled her appointment on January 9, 1989. Another appointment with the gastroenterologist was scheduled for February 1, 1989, in anticipation of imminent surgery. Surgery was scheduled for February 14 but, after the patient's admission, was postponed to February 17, 1989. Initially, the patient's recovery from surgery was slow, and she remained hospitalized until March 14, 1989. Subsequent events raise questions whether the surgery was effective or worth the trauma. It is debatable how well the patient tolerated the surgery. It appears that she did not ever recover the level of physical vigor and energy she had before surgery. During the summer of 1989, the cancer reappeared on her coccyx and had to be treated by radiation. By the fall of 1989, another abdominal perineal resection was necessitated by the reappearance of the cancer in her rectum. Based on the best expert testimony available at the hearing, it cannot be found that the time that went by during the Respondent's treatment of the patient was "substantial," i.e., that it contributed to the spread of the patient's cancer. Notwithstanding the results of the liver/spleen scan, which was not definitive or even very useful in evaluating the patient's cancer for metastasis, it is probable that the patient's cancer already had metastasized by the time the Respondent first saw the patient. The Respondent clearly did not inordinately delay the flexible sigmoidoscopy with biopsy or his discussion of the results and treatment alternatives with the patient. The only questionable delay was the four-week delay caused by the Respondent being out of the country on vacation; by the time he was scheduled to see the patient on his return, she had terminated his care and treatment. There was no evidence on which it could be found that this delay was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing the Administrative Complaint against the Respondent. RECOMMENDED this 21st day of March, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of March, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5068 To comply with the requirements of Section 120.59(2), Fla. Stat. (1991), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5.-6. The date of the procedure was November 17, not November 11. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 7.-10. Accepted and incorporated to the extent not subordinate or unnecessary. "[A]pproximately four (4) weeks after the Christmas holidays" rejected as not proven and as contrary to the greater weight of the evidence. (He said "in four weeks, i.e., after the Christmas holidays.") Accepted and incorporated. Rejected as not proven and as contrary to the greater weight of the evidence that it was just "for a second opinion." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 14.-15. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven and as contrary to the greater weight of the evidence that the gastroenterologist made such a determination; rather, the subsequent surgeon did. Also, rejected as not proven and as contrary to the greater weight of the evidence that the surgery was "successful." In some senses it was, in other senses it was not. Rejected as not proven and as contrary to facts found. 18.-19. Accepted but subordinate to facts contrary to those found, and unnecessary. 20. Both as to the growth of the tumor and as to the evidence of metastasis, rejected as not proven and as contrary to the greater weight of the evidence. (The liver/spleen scan was negative, but the best expert testimony presented as the hearing indicated that subsequent events showed prior metastasis.) 21.-22. Rejected as not proven and as contrary to facts found. (The evidence was that those treatments were not alternative curative treatments. The Respondent was not given an opportunity to use them palliatively.) 23. Rejected as not proven and as contrary to facts found. Respondent's Proposed Findings of Fact. For purposes of these rulings, the Respondent's unnumbered paragraphs of proposed findings of fact are assigned consecutive numbers. 1.-3. Accepted but subordinate and unnecessary. 4.-6. Accepted and incorporated to the extent not subordinate or unnecessary. 7. As to the second sentence, a "transverse colostomy" was discussed, not a "transverse colonoscopy." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 8.-9. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to facts found and to the greater weight of the evidence that there was no delay. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. Subordinate and unnecessary. COPIES FURNISHED: Barbara Makant, Esquire Steven A. Rothenburg Senior Attorney Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Hugh Smith, Esquire P. O. Box 3288 Tampa, Florida 33601 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire Acting General Counsel Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792
The Issue Should Respondent be disciplined for practicing beyond the scope of his license or by accepting and performing professional responsibilities which he knows or has reason to know that he is not competent to perform? See Section 460.413(1)(t), Florida Statutes, formerly Section 460.413(1)(u), Florida Statutes.
Findings Of Fact Petitioner is charged with regulating the practice of chiropractic pursuant to Sections 20.165, 20.42, Florida Statutes and Chapters 455 and 460, Florida Statutes. Respondent is a Florida licensed chiropratic physician. His license number is No. CH-0001538. He was issued that license on September 21, 1968. Respondent practices chiropratic at the McCall Chiropractic Clinic located at 811 Grace Avenue in Panama City, Florida. Respondent is not licensed as an osteopathic or allopathic physician as recognized by the Florida Board of Osteopathic Physicians or the Board of Medicine respectively. In 1992 Respondent sent Micheal Smith, D.C., a chiropractic physician practicing in Panama City, Florida, information described as an invitation for Dr. Smith to join Respondent in clinical research "designed to test the effectiveness of Scalar E.M. Technology upon AIDS-CANCER opportunistic organisms falling within the meaning of chapter 460.403(3)(a)(b)(c)(e), and Rule 21D-1702, Florida Statutes." The correspondence went on to describe some details about the research. In particular, Respondent stated that "preliminary field data suggest that Scalar E.M. TENS Technology is effective in 47 pathological conditions including AIDS-Cancer disease." The correspondence also set forth information concerning patients who wished to contribute to the research by making financial contributions to the "Allaganey Occupational Development Foundation, 22 Floor Pacific First Center, 1425th Avenue, Seattle, Washington 98101-2333". Respondent provided Dr. Smith a sheet on the McCall Chiropractic Clinic letterhead related to purported medical research at Stanford University in 1988 studying "the Biological Interactions with the Scalar Energy Cellular Mechanisms of Action" in response to weak ELF ectromagnetic (EM) radiation and the claimed results. That sheet describes how the McCall Chiropractic Clinic would be "conducting private research into the effectiveness of Scalar E.M. Technology upon the following conditions, for a two-year period of time." Arthritis Arm Pains Angina Pectoras Arethemia Asthma Allergies Bacterial Infection of the Lung Carple Tunnel Syndrome Cancer of the: Bone, Brain, Bladder, Bowell, Lungs, Liver, AIDS Colon Polyps Cholitis Candidia Albicans Deafness Diabetes Neuropathy Emphysemia Eckcemia Ear Infection Epstine Barr Infection Exothalmic Goider Feavers Fungus of the skin Fibrosis of the Lung Gout High Blood Pressure Herniated disc Herpes B infection Hemrroids Hardening of the arteries Herpes of the Genitals Hypertrophy of the Prostate Inflimation of the joints Nectniuria Kendidia Albicans Leg Pains Multipleschlerosis Musculardistrohy Neuropathy Nose bleads Premenstral Syndrome Paracititis of digestive track Phlebitis Sinus Infection Tumors of the Eye Varicose Veines Warts Leupus Erethematosis Parkinsons Disease Dr. Smith was also provided with a copy of an advertisement which stated: ATTENTION: Aids - Cancer Patients Dr. Curtis J. McCall, Jr. Chiropractor Research program utilizing scalar tens antineoplastic technology is available through the provisions of Chapter 460.403(3)(a)(b)(c)(e) Rule 21D-1702 Florida Statutes. Patients suffering with Aids - Cancer disease who would like to participate in the research program should call 769-1708 for an appointment or come by the office: 811 Grace Ave., P.C., Fla. 32401 In the 1993 yellow pages for the Panama City, Florida, telephone book, Respondent placed an advertisement to this effect: MCCALL CHIROPRACTIC CLINIC PEOPLE HAVE TRUSTED THE HANDS OF DR. McCALL SINCE 1968 -- TENS AIDS -- CANCER THERAPY -- 811 Grace Av Panama Cy 769-1708 In the July 8, 1993 advertising service in the "Thrifty Nickel" circulated in Panama City, Florida, Respondent placed the following advertisement: NOTICE: The McCall Chiropractic Clinic has on display a 1953 classified federal document that discloses successful treatment for cancer. Patient response indicates this technology is effective in the treatment of 47 conditions. This technology is available through the provisions or Chapter 460- 1403(3), (a), (b), (c), (e). Rule 210-1702 Florida Statutes. Phone 769-1708 for appointment, 811 Grace Avenue, Panama City, Florida 32401. F24 On July 19, 1993, Respondent, on stationary from McCall Chiropractic Clinic, wrote to TCRS, Inc., in Tallahassee, Florida, asking that company to place McCall Chiropractic Clinic on its list of AIDS/Cancer Therapeutic Center listings for national referrals. That correspondence gave a brief description of the service that Respondent intended to provide. It indicated that the therapy to be provided would cost the patient $18.00 per 20 minutes. Through Respondent's activities that have been described, Respondent directly held himself out to the public as having the ability to treat persons with AIDS. In furtherance of his intentions, Respondent developed a treatment protocol consisting of approximately 55 weeks of treatment to be monitored initially by Respondent at his chiropractic facility. That protocol required the patient to receive TENS therapy for two hours each day. The TENS device is designed to deliver transcutaneous electrical nerve stimulation. Its principal chiropractic use is for pain control. However, Respondent, in his intended care, contemplated that the device would stimulate "T-Cells" in combatting AIDS. In the protocol, Respondent also required monthly blood tests to monitor the patient's "T-Cell" counts. The protocol required the patient to be free from all other drugs, in particular, the AIDS treatment medication "AZT". Under the protocol, the patient was required to receive a weekly injection of a compound identified as "chondriana", in amounts determined by Respondent. Finally, the patient was to ingest a compound identified by Respondent as "life crystals". On or about February 4, 1994, Respondent began to care for the patient C.L. That care ended on September 29, 1994. In this arrangement Respondent and C.L. had a chiropractic physician-patient relationship. Patient C.L. died on August 18, 1995. Respondent made a diagnosis, proposed a course of treatment and directly treated C.L. for AIDS. In this treatment Respondent maintained a patient record for C.L. In an effort to secure reimbursement for the services provided to C.L., Respondent prepared insurance claim forms, affixing a diagnosis of AIDS to the claim forms and had C.L. assign benefits to the Respondent from the insurance policy. In this connection Respondent had C.L. execute a sworn statement describing the services received from Respondent. It was Respondent's expectation that the claim forms would be honored by the insurance carrier and that Respondent would be paid for the services rendered to C.L. With one exception, Respondent's billings to the insurance carrier for C.L.'s visits to Respondent's office were all for the treatment of AIDS. An investigation was instituted by the State of Florida, Department of Business and Professional Regulation/ Agency for Health Care Administration to ascertain whether Respondent was offering patient treatment for AIDS. James Cooksey, an investigator with the regulator, performed that investigation in conjunction with Tom Willoughby, investigator for the Bay County, Florida, Sheriff's Office. James Cooksey is an insurance fraud/medical malpractice investigator. To conduct the investigation Mr. Cooksey assumed the fictitious name James Stark. The reason for assuming the name was to present James Stark as a patient suffering from AIDS. In furtherance of the investigation Mr. Cooksey went to the Tallahassee Memorial Regional Medical Center and obtained a fictitious positive AIDS test in the name James Stark. On May 16, 1994, Mr. Cooksey initiated contact with Respondent. The investigator traveled from Tallahassee to Panama City. When he reached Panama City he called Respondent and told Respondent that he needed to come and talk to him. Respondent invited Mr. Cooksey to come by that afternoon. On May 16, 1994, Mr. Cooksey met with Respondent at Respondent's office. At that meeting Mr. Cooksey told Respondent that the investigator understood that Respondent could possibly cure AIDS. Mr. Cooksey further stated that he had seen something in a newspaper article that Respondent was treating AIDS patients and explained to Respondent that Mr. Cooksey had contracted AIDS and was interested in being cured. Mr. Cooksey provided Respondent with the results of the fictitious blood test. When Mr. Cooksey presented to Respondent he did not complain of any condition other than AIDS. Respondent did not physically examine Mr. Cooksey. Respondent explained to Mr. Cooksey about the nature of Respondent's treatment in which the TENS unit, also known as a Rife machine, chondriana and life crystals would be used. To demonstrate the treatment Respondent took Mr. Cooksey into a room in the back of his office, a treatment room, and had Mr. Cooksey take his shoes and socks off and place his feet on a metal pad associated with the TENS unit. When the unit as turned on Mr. Cooksey could feel tingling inside his feet. On this occasion Respondent told Mr. Cooksey that, he, Mr. Cooksey could get injections of chondriana and then the machine would be turned on and Cooksey would receive stimulation to fight the infection associated with AIDS. Respondent told Mr. Cooksey that the initial treatments for AIDS would have to be done at his office where Respondent would monitor the investigator. Respondent indicated that a nurse would come to the office and give the injections of chondriana and that Mr. Cooksey would be monitored concerning those injections until Mr. Cooksey's "system built up a little". Mr. Cooksey understood that he was to receive those injections and use the TENS unit and was not to take other forms of medication during the treatment. Respondent gave Mr. Cooksey a card with the name of a blood test that would need to be obtained and the results reported to Respondent. Mr. Cooksey was responsible for paying for the blood test. Respondent told Mr. Cooksey that the life crystals were to be taken in orally as a drink and they were described as being part of the AIDS treatment. On this date Respondent gave the investigator an estimate of the costs of this treatment, constituted of $2,000 for the TENS unit and $2,925 for chondriana and life crystals. Subsequent to that date Respondent called Mr. Cooksey and left a message on Cooksey's telephone. Respondent also wrote the investigator on May 23, 1994, providing the investigator more information concerning Respondent's treatment for AIDS. The investigator then went to the state attorney's office in Panama City and informed the state attorney of the nature of the administrative investigation and the belief that the activities by Respondent might constitute a criminal law violation. The state attorney represented to the investigator that he concurred. The state attorney then had Mr. Cooksey contact the Bay County Sheriff's office. Following that contact Mr. Cooksey took up a joint investigation between Mr. Cooksey and Bay County Sheriff's investigator Tom Willoughby. On October 18, 1994, Mr. Cooksey placed a call to Respondent and told the Respondent that he was in Panama City and would like to come by and meet with the Respondent and that he would be accompanied by a friend who might be able to "come up" with the money that was required to purchase the chondriana and life crystals and TENS unit. The part of the friend was to be played by Officer Willoughby. Mr. Cooksey and Officer Willoughby then went to Respondent's office where Respondent again explained the nature of the AIDS treatment. Officer Willoughby asked the Respondent questions concerning the nature of the treatment and how much the treatment would cost. Respondent explained that the treatment involved injections of the chondriana, drinking the life crystals and using the TENS machine for two hours a day to treat James Stark for AIDS. At the October 18, 1994 meeting between the investigators and Respondent, Respondent stated that a nurse practitioner with whom he was friends would administer the chondriana and that activity would be monitored by Respondent in Respondent's office. Officer Willoughby asked Respondent if there would be side affects to the injections. Respondent indicated that there would be sweating and that Respondent would monitor Mr. Cooksey for whatever period of time would be necessary for the side affects to subside. The investigators watched a video tape explaining the treatment for AIDS which Respondent intended to employ. The injections of chondriana would be given monthly. Respondent indicated to the investigators that he would instruct Mr. Cooksey on how many of the life crystals to take. Respondent told the investigators that the cost of the TENS unit was $2,000.00 and that the unit would be used to spread the impulses through out the body. Respondent indicated to the investigators that the nature of the treatment would form new T-cells to replace T-cells containing the AIDS virus or which were cancerous. Respondent had stated in Officer Willoughby's presence that the TENS unit cost $500.00 to produce. Respondent and the two investigators then went to a local health food store, known as the Olive Leaf, to ascertain the amount of money needed to pay for chondriana which the health food store would provide. There, the attendant at the store indicated that he could arrange to provide the chondriana and life crystals for a price approximating $2,800.00. After leaving the health food store the investigators told the Respondent that they would come back with the necessary money on October 21, 1994. The investigators returned to Respondent's office on October 21, 1994, after obtaining warrants to search the office and arrest the Respondent. Before Respondent was arrested and the search made, the investigators asked Respondent to again explain the nature of the treatment that would be provided to Mr. Cooksey and paid Respondent $1,700.00 for the TENS unit from funds belonging to the Bay County Sheriff's Office. Respondent gave the investigators a receipt for the $1,700.00 payment. Respondent was then arrested for practicing medicine without a license. On one occasion Respondent explained to the investigators that the procedures that were used to treat Mr. Cooksey for AIDS were not condoned by the FDA, but that it was working in other places where it had been tried and that three patients treated in another location had gained remission from the AIDS. Based on the proof, it is found that Respondent diagnosed Mr. Cooksey as having AIDS and developed a course of treatment for that condition. Paul Doering, M.S., is a registered pharmacist in the State of Florida. He is also licensed as a consultant pharmacist in the State of Florida. He is a Distinguished Service Professor of Pharmacy Practice at the University of Florida. He is accepted as an expert pharmacist. Mr. Doering established that the drug AZT is an antiviral drug designed to address the HIV virus associated with AIDS. Mr. Doering established that AIDS is an acronym for acquired immuno- deficiency syndrome, "a disease that affects the immune system caused by a virus or different types of viruses which attack the immune system in the body rendering the body unable to effectively mount an immune response when it comes into contact with certain types of infectious organisms." Mr. Doering established that drugs are divided into two basic groups, one group which is sold without prescription and the other group requiring a doctor's prescription. The latter category of drugs are known as Federal Legend Drugs. Mr. Doering established that there is no reference to a medication known as "chondriana" in any directory of medications which he was familiar with. As he established, chondriana does not constitute a food because foods are not generally injected into the human body. Mr. Doering established that chondriana has not been approved to be used as a drug in the United States, nor is it an experimental drug, based upon his research of sources that list drugs or experimental drugs. Marianne Gengenbach, D.C., is licensed to practice chiropractic in Florida and is an expert in chiropractic practice. She established that chiropractors are limited to using proprietary drugs, and then only where the chiropractor has passed a specific exam and obtains a proprietary drug license. Proprietary drugs are "over the counter drugs" not prescription drugs. Absent such as a license to prescribe proprietary drugs chiropractors may only make recommendations, educate patients and prescribe nutritional supplements. Dr. Gengenbach established that Respondent had diagnosed C.L. for AIDS and had treated C.L. for that condition. The treatment was directly related to the condition AIDS, and Dr. Gengenbach established that the treatment was outside the accepted standard of care for chiropractic and exceeded the scope of authorized practice from the view point of a practitioner. As Dr. Gengenbach established, Respondent also exceeded the proper scope of practice in caring for C.L. by recommending that C.L. discontinue the AZT therapy. Those same perceptions were held for treatment of Mr. Cooksey and are accepted. Dr. Gengenbach established that Respondent proposed a course of treatment for Mr. Cooksey related to the condition AIDS, without reference to any other complaints by the patient. As a consequence the course of treatment which Respondent planned for Mr. Cooksey was directed solely to the HIV infection as established by Dr. Gengenbach. Dr. Gengenbach established that the use of the chondriana and life crystals was intended to treat Mr. Cooksey for AIDS. Dr. Gengenbach established that even should the substances chondriana and life crystals be considered food or nutritional supplements, there proposed use for Mr. Cooksey would not meet the prevailing standard of care for chiropractic, in that they would be employed for the treatment of AIDS. Respondent intended that the chondriana and life crystals be used in the cure, treatment, therapy and prevention of AIDS in C.L. and Mr. Cooksey. Respondent intended that those substances affect the structure and function of the bodies of those patients. In proposing and carrying out the treatment that has been described directed to AIDS, Respondent did so mindful that chiropractic physicians in Florida are prohibited from directly treating the AIDS condition. Respondent's treatment of C.L. and proposed treatment of Mr. Cooksey violated the standards of practice acceptable to a reasonably prudent chiropractic physician under similar conditions and circumstances and exceeded the scope of his chiropractic license. In the past Respondent has been disciplined by the Board of Chiropractic on three separate occasions. Two of those cases involve the receipt of a reprimand and in the third case Respondent's license was suspended and he was required to pay an administrative fine. Respondent was also required to cease and desist the activities described in these facts based upon action taken by the Board of Medicine, which was persuaded that Respondent was engaging in the treatment of AIDS without benefit of a medical license.
Recommendation Based upon the facts found and the conclusions of law reached, given the severity of the offense and the danger posed to the public, it is, RECOMMENDED: That a final order be entered which revokes Respondent's license to practice chiropractic medicine in Florida. DONE and ENTERED this 21st day of November, 1995, 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 21st day of November, 1995. APPENDIX CASE NO. 95-2881 The following discussion is given concerning the proposed findings of fact of the parties: Petitioner's Facts: Paragraphs 1 through 4 are subordinate to facts found. Paragraphs 5 and 6 constitute conclusions of law. Paragraphs 7 through 13 are subordinate to facts found. Paragraph 14 is not necessary to the resolution of the dispute. Paragraphs 15 through 35 are subordinate to facts found. Paragraphs 36 through 40 are conclusions of law. Paragraph 41 is subordinate to facts found. Paragraphs 42 and 43 are conclusions of law. Paragraphs 44 through 51 are subordinate to facts found. Respondent's Facts: Paragraphs 1 through 5 constitute legal argument as reported at pages 2 through 5. The proposed facts 1-3 found at pages 15 and 16, Paragraph 1 is contrary to facts found. Paragraph 2 is rejected as a discussion of activities of the Probable Cause Panel, not a proper subject for consideration. Paragraph 3 constitutes a conclusion of law. COPIES FURNISHED: Jon M. Pellett, Esquire Medical Quality Assurance-Allied Health Agency For Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Curtis J. McCall, D.C. 514 North Bonita Avenue Panama City, FL 32401 Diane Orcutt, Executive Director Agency For Health Care Administration Board of Chiropractors 1940 North Monroe Street Tallahassee, FL 32399-0792 Jerome W. Hoffman, General Counsel Agency For Health Care Administration 2727 Mahan Drive Tallahassee, FL 32308
