The Issue Whether Respondent committed the violations alleged in the Administrative Complaints? If so, what disciplinary action should be taken against him?
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Parties The Department is a state government licensing and regulatory agency. Respondent is now, and has been at all times material to the instant cases, a physician licensed to practice medicine in the State of Florida. He holds license number ME 0037235. Facts Relating to Case No. 93-5861 On December 29, 1983, at Indian River Memorial Hospital, Dr. Phil Morgan performed a partial mastectomy and an axillary lymph node dissection on G.K., a female patient who was then 57 years of age. The mastectomy was performed on G.K.'s left breast. Approximately a quarter of the breast volume was removed, including a malignant tumor that was no more than two centimeters in diameter. The procedures performed by Dr. Morgan revealed no evidence of any further malignancy. In early 1984, G.K. went to the Lawnwood Oncology Center in Fort Pierce, Florida to consult with Respondent, a radiation oncologist, regarding her receiving postoperative radiation therapy. From January 17, 1984, to February 27, 1984, Respondent administered doses of external beam radiation therapy to what remained of G.K.'s left breast and the lymphatic drainage regions. The total nominal dosage administered was 5040 cGy or rads. On or about March 13, 1984, Respondent supplemented the external beam therapy treatment G.K. had received with an Iridium-192 radioisotope interstitial implant in G.K.'s left breast. The implant consisted of two layers of radioactive needles, with one layer one centimeter deeper than the other. There were ten needles, spaced one centimeter apart, in each of the two layers. In 1984, the prevailing standard of care recognized as acceptable and appropriate by reasonably prudent radiation oncologists performing multi-layer interstitial implants required that the oncologist design and structure the implant in such a manner that the radioactive sources in each of the layers were spaced at least 1.2 centimeters apart and that the oncologist use less than half the number of radioactive sources that Respondent used. The implant remained in position for 52 hours. A volume of 253 cubic centimeters of breast tissue received a dosage of 60 cGy or rads per hour. In 1984, the prevailing standard of care recognized as acceptable and appropriate by reasonably prudent radiation oncologists performing interstitial implants required that the oncologist regulate the radiation dosage rate so that it did not exceed 50 cGy or rads per hour. An additional 72 cubic centimeters of breast tissue received a dosage of 100 cGy or rads per hour, twice the maximum dosage rate. Inasmuch as these 72 cubic centimeters of breast tissue received a total dosage of 5200 cGy or rads during the time the implant remained in position, compared to the total dosage of 3120 cGy or rads that the other 253 cubic centimeters of targeted breast tissue received, the inhomogeneity of dosage distribution well exceeded 20 percent, contrary to the then prevailing standard of care recognized as acceptable and appropriate by reasonably prudent radiation oncologists performing interstitial implants, which required that the physical design of the implant be such that there was no more than 20 percent of dosage distribution inhomogeneity. Furthermore, in designing the implant, Respondent targeted a greater volume of breast tissue than was acceptable and appropriate under the prevailing standard of care. The implant and the external beam therapy combined delivered a total nominal dosage of 8160 cGy or rads, with some areas within the central region of the implanted tissue receiving in excess of 10,000 cGy or rads. Given the relatively small size of the malignant tumor that had been removed from G.K.'s breast and the absence of any apparent residual malignancy, a reasonably prudent radiation oncologist, governed by standards in effect in 1984, would have administered, in toto, a nominal dosage of no more than 6000 to 7000 cGy or rads. In or about December of 1985, G.K. presented to Respondent with breast fibrosis and skin retraction on the side that Respondent had treated in 1984. Respondent recommended conservative measures only. G.K. went to Dr. Everrett Sugarbaker, a surgical oncologist, for a second opinion. Dr. Sugarbaker initially examined G.K. and evaluated her situation in August of 1986. He noted that G.K.'s left breast was totally contracted back against the chest wall with extensive telangiectatic and fibrotic change in the area where Respondent had inserted the Iridium-192 implant. There was also a scab over a one and a half centimeter ulcer. It was apparent to Dr. Sugarbaker that G.K. was suffering from radionecrosis as a result of the radiation therapy she had received from Respondent. Dr. Sugarbaker recommended daily peroxide application to the ulcer, but added that, if the ulcer increased in size or became infected, he would consider surgical correction of the problem. G.K. visited Respondent again in October of 1986. The area of her left breast where the implant had been inserted had experienced further tissue destruction and had become infected. Respondent prescribed antibiotic therapy, which ultimately proved to be unsuccessful. In or about February of 1987, Respondent recommended that G.K. try hyperbaric oxygen therapy, but G.K. refused to follow Respondent's recommendation. On February 13, 1987, G.K. returned to Dr. Sugarbaker for reassessment. G.K. told Dr. Sugarbaker of her recurring infection. Upon his examination of G.K., he noticed that the necrotic area of her left breast was larger than when he had seen her in August of the previous year. Dr. Sugarbaker recommended surgical correction. On February 18, 1987, Dr. Sugarbaker surgically removed the remainder of G.K.'s left breast and, in connection therewith, performed other procedures to reconstruct the chest wall and improve blood supply and promote healing in the area. The necrosis from which G.K. was suffering that made these procedures necessary was caused by Respondent having overradiated her during the course of the radiation therapy he administered to her in 1984. Facts Relating to Case No. 93-5861 In September of 1982, Dr. Khalil Cassimally performed a modified radical mastectomy on V.H.'s cancerous left breast. V.H. was approximately 34 years of age at the time. Postoperatively, from approximately October 10, 1982, to November 22, 1982, V.H. received radiation therapy from Dr. Victoria Cividino at the Lawnwood Oncology Center, of which Respondent was the director. The therapy included a total nominal dosage of 5000 cGy or rads (with a 1000 cGy or rads "boost") to the left axilla. Following the therapy, V.H. was in constant pain. At some point in time, a knot or nodule developed in the area where she had had her mastectomy. V.H. told Respondent, who had assumed responsibility for V.H.'s care and treatment from Dr. Cividino, about the nodule. The nodule was biopsied on September 15, 1983, by Dr. Cassimally. No malignancy was found. The area that was biopsied did not heal properly. V.H. continued to have problems. On March 16, 1984, Respondent visited Dr. James Grossnickle, a general surgeon. She presented with a large ulcer on her left chest wall surrounded by thick elevated tissue. On April 20, 1984, Dr. Grossnickle biopsied a portion of the ulcer and surrounding tissue. The pathological diagnosis was fat necrosis and fibrosis. There was no evidence of any malignancy. V.H. eventually returned to see Respondent. From approximately April 16, 1985, to June 11, 1985, Respondent treated V.H. with further radiation therapy. The therapy included a total nominal dosage of 5000 cGy or rads to the left axilla, which was administered in 20 fractions. The dosage, when considered in light of the dosage previously administered by Dr. Cividino in 1982, exceeded the limits of normal tissue tolerance. As a result, it caused considerable tissue damage. There was no medical justification for administering additional radiation therapy to V.H., particularly in light of the results of the post- mastectomy biopsies that had been performed by Drs. Cassimally and Grossnickle. A reasonably prudent radiation oncologist, governed by standards in effect in 1985, would not have followed such a course of treatment. After receiving this additional radiation therapy, Respondent developed a large mass of scar tissue in the treated area, in the center of which was an oozing ulcer. Her condition was the result of having been overradiated. In or about October of 1986, V.H. went to Juan Carlos Giachino, a plastic and reconstructive surgeon, who performed surgery on V.H. in an effort to remedy the situation. The surgery was unsuccessful. Oozing ulcers reappeared. One such ulcer, near her left underarm, had to be irrigated and cleaned three to four times a day. Furthermore, V.H.'s left arm became unusable as it accumulated undrained lymphatic fluid and resultingly increased in size. The excessive radiation treatment that V.H. had received had resulted in the obstruction of the lymphatic drainage pathways in the arm. The problem with her left arm became so severe that amputation of the arm was required. Other corrective surgical procedures, including chest reconstruction, were performed on V.H. to improve her condition.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board enter a final order finding Respondent guilty of the violations of subsection (1)(t) of Section 458.331, Florida Statutes, alleged in the Administrative Complaints and disciplining him for having committed these violations by imposing the penalties described in Conclusion of Law 78 of this Recommended Order. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 20th day of May, 1994. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of May, 1994. APPENDIX TO RECOMMENDED ORDER IN CASE NOS. 93-5739 and 93-5861 The following are the Hearing Officer's specific rulings on the "findings of facts" proposed by the Department in its proposed recommended order: 1-9. Accepted and incorporated in substance, although not necessarily repeated verbatim, in this Recommended Order. To the extent that this proposed finding addresses the standard of care for single layer implants, it has not been incorporated in this Recommended Order because, even if true, it would have no bearing on the outcome of the instant case. To the extent that it addresses the standard of care for multi- layer implants, it has been accepted and incorporated in substance. Accepted and incorporated in substance. 12-13. Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer. 14-36. Accepted and incorporated in substance. First and second sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer; Third sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. To the extent that this proposed finding states that V.H. was 25 years of age at the time of the mastectomy, it has been rejected because it is contrary to the greater weight of the evidence. Otherwise, it has been accepted and incorporated in substance. 40-56. Accepted and incorporated in substance. First and second sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer; Third sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. Rejected as a finding of fact because it is more in the nature of a summary of testimony than a finding of fact based upon such testimony First sentence: Accepted and incorporated in substance; Second sentence: Not incorporated in this Recommended Order because it has no bearing on the outcome of the instant case. First sentence: Accepted and incorporated in substance; Second sentence: Not incorporated in this Recommended Order because it has no bearing on the outcome of the instant case. COPIES FURNISHED: Francesca Plendl, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Charles H. Kent, M.D. 3605 Juan Ortiz Circle Ft. Pierce, Florida 34947-6110 Dr. Marm Harris, Executive Director Board of Medicine Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue in this case is whether disciplinary action should be taken against Gerald Greenwald, M.D., based upon the alleged violations of Chapter 458, Florida Statutes, as contained in the two Administrative Complaints filed against the Respondent on June 3, 1985.
Findings Of Fact Based upon the stipulations of the parties, on the testimony of the witnesses, and on the exhibits received in evidence at the hearing, the following facts are found. Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida having been issued license number ME 0015097. Respondent's last known address is Dadeland Medical Building, 7400 North Kendall Drive, Miami, Florida 33156. In the yellow pages effective as of May 10, 1984, in Miami, Florida, Respondent placed an advertisement wherein Respondent advertised the "Dadeland Dermatology Center," which is located at 7400 Kendall Drive, in Miami, Florida. Despite the fact that Respondent practices medicine at the Dadeland Dermatology Center, the advertisement placed by Respondent in the Miami, Florida, yellow pages and in effect on May 10, 1984, does not anywhere list Respondent's name. In December of 1978, Respondent applied pursuant to the fictitious name statute with the Secretary of State of the State of Florida to do business under the name of "Dadeland Dermatology Center." In the yellow pages for the City of Miami, Florida, effective as of May 10, 1984, Respondent also placed an advertisement under the heading "Physicians & Surgeons - M.D. - Dermatology (Skin)" under the name Gerald Greenwald, M.D., P.A. In the advertisement, Respondent advertised that Respondent provided Silicone and Collagen implants. The Silicone and Collagen implant therapy was advertised among a list of several other conditions/treatments which Respondent dealt with in his practice. The specific phrase "Silicone & Collagen implants" was italicized and set forth in larger type and in capital letters. The above-described advertisements for "Gerald Greenwald, M.D., P.A." and for "Dadeland Dermatology Center" were contained on the same page of the City of Miami, Florida, yellow pages, in effect on May 10, 1984. Pursuant to Respondent's instructions, any member of the public who called his office, pursuant to either advertisement, was immediately informed that they were calling the office of Gerald Greenwald, M.D. Despite the fact that Respondent advertises that he provides Silicone and Collagen implants in his practice, Respondent has never purchased Collagen, has never used Collagen in his practice, and has never participated in the training program sponsored by the manufacturer and distributor of Collagen. Further, despite his statements to patients that he can obtain Collagen, Respondent has never had any intention of using Collagen because he is convinced that it is an inferior product when compared to medical grade Silicone. Collagen is a purified form of cow skin that is used to stimulate the formation of scar tissue, which then raises the surface underneath which it is injected. It is used for removing and softening wrinkles and lines. Collagen is a foreign substance and as such can cause allergic reactions, as well as exacerbation of certain diseases. Because it can cause allergic reactions, Collagen may be used only after appropriate allergy reaction skin testing has been performed. Silicone is a chemical that is commonly present in the form of sand. Medical grade Silicone has been used in injectable form to correct lines, wrinkles, and depressions in the body. The primary problems which occur with administration of Silicone are the problems of lumps and bumps caused by improper administration of the substance, which should only be injected in very small or "pin head" amounts. Before providing Collagen therapy, allergy testing is necessary, as previously described above. A small amount of Collagen is injected under the skin and examined closely for a period of three days and then re-examined after one month. If no reaction occurs, Collagen may be injected in the patient for purposes of removal of facial wrinkles and lines. It is, of course, necessary to have Collagen available in order to provide the allergy testing because the substance is used in the allergy tests. Zyderm Corporation is the only corporation that manufactures Collagen for distribution in the United States. Respondent has never ordered Collagen from Zyderm Corporation and has never participated in the training program for Collagen provided by Zyderm Corporation. Furthermore, Respondent has never had in his office the Collagen necessary to perform allergy testing on those patients seeking Collagen treatments. If a Miami, Florida, physician were to place an order for Collagen with Zyderm Corporation, it would take between four to seven days to obtain the substance. Collagen therapy is not a permanent treatment. Repeated injections will be required as the Collagen is absorbed by the body. Silicone, on the other hand, is more permanent. Because Collagen is not a permanent treatment, for the most part permanent problems will not result from improper administration of the substance. If Silicone is improperly administered, lumps and bumps and sagging may occur. Respondent is of the opinion that Collagen is much inferior to Silicone and that intelligent people, when informed about the merits of Silicone and the deficiencies of Collagen, will invariably choose Silicone. It is false, deceptive, and misleading for a physician to advertise that he provides both Collagen and Silicone implants when he does not have Collagen readily available but would have to order the substance, resulting in a delay of between four to seven days, and the physician does have Silicone readily available. It is also false, deceptive, and misleading for a physician to advertise that he provides both Collagen and Silicone implants when he has never had any intention of using Collagen because he has never taken any training in the use of Collagen and thinks it is an inferior product. During the summer of 1984, DPR investigator Diane Robie, pursuant to Respondent's advertisement, telephoned the Respondent to discuss the possibility of having Collagen treatment for the lines around her eyes. Investigator Robie was informed on the telephone, prior to her visit to Respondent's office, that Respondent preferred the use of Silicone to Collagen because it was more effective and less expensive. When investigator Robie visited Respondent's office, the Respondent discussed the relative advantages and disadvantages of both Silicone and Collagen. While the Respondent did not exert any undue pressure on investigator Robie to make a decision about whether or not she would decide to be treated, Respondent made it clear that he thought that if she chose to be treated, the treatment should be Silicone. During investigator Robie's visit, the Respondent also told her that if she still wished to have Collagen treatments, Respondent could obtain Collagen for her. Investigator Robie left the Respondent's office and did not arrange for any further appointments. Investigator Robie did not pursue what the Respondent's course of conduct would have been if she had persisted in her request for Collagen treatment. At all times material hereto, Respondent was the owner of an insurance policy taken out on Paula Greenwald, Respondent's ex-wife, which would pay $1.09 million in proceeds in the event of Paula Greenwald's death. Respondent also had a $3.5 million insurance policy on himself for the care of his children in the event of Respondent's death. In 1983, Respondent went through divorce proceedings terminating his marriage to Paula Greenwald. At the time of the divorce, there were six children ranging from seven to seventeen years of age. The divorce proceedings brought out a great deal of acrimony on both sides. After the divorce, Mrs. Greenwald was to have custody of the children and Respondent perceived that Mrs. Greenwald was, on a number of occasions, denying Respondent's visitation rights. Due to those disputes and disputes about other matters, the relationship between Respondent and Mrs. Greenwald became severely deteriorated after the divorce, continually worsening until about September of 1984. In approximately September of 1984, Mrs. Greenwald sent Respondent a card which contained an anonymous death threat. There was no evidence presented to establish that this death threat was acted upon. At a time prior to September 15, 1984, the Metro-Dade County Organized Crime Bureau received information from an Eastern Airlines employee named Mr. Armstrong, indicating that Respondent was trying to put out a contract for the death of Mrs. Greenwald. Mr. Armstrong obtained the information which he provided to the Metro-Dade County Organized Crime Bureau from another Eastern Airlines employee, Thomas Young. No one from the Metro-Dade County Organized Crime Bureau ever discussed the information directly with Mr. Young until after the arrest of the Respondent. Acting on the information received from Mr. Armstrong, Detective Paul Ohanesian went to the Respondent's office undercover posing as a patient, Paul DeSantis, on or about September 15, 1984. Ohanesian had sun spots on his back and used this as the reason for visiting Respondent's office. On the same day as Ohanesian's first visit, the Respondent became engaged to be married. When the Respondent's first wife heard about the engagement, she threatened to hurt Respondent like he had never been hurt before, and also threatened to break up his relationship with his fiancée. During the course of the office visit which occurred on or about September 15, 1984, Respondent examined Ohanesian's (DeSantis') back, diagnosed his condition, prescribed medication for the condition, and suggested that Ohanesian (DeSantis) return in one week. At the outset of the office visit which occurred on or about September 15, 1984, Ohanesian told Dr. Greenwald that "(a) couple of guys down at the Union down at Eastern Airlines sent me (Ohanesian) here." During the course of the first office visit, Ohanesian said, "they said that ah, you had some expensive marital problems." This initiated a conversation between Respondent and Ohanesian about Respondent's marital problems. After some discussions, Ohanesian made the statement "(s)ounds to me like it's time to get rid of her." Respondent responded as follows: Greenwald - You can't deal with it Ohanesian - Yeah Greenwald - It's a. . . She 's nuts Ohanesian - Yeah Greenwald - She's nuts Greenwald - And I like, ya know, if I had the ability Ohanesian - Ya Greenwald - To commit the perfect crime I'd kill her. She deserves to be dead Ohanesian - Well Greenwald - She's a one of the few truly evil. . . Ohanesian - Ya Greenwald - People I know. But what the hell Ohanesian - Hey, sometimes there's people That will do it for you though Greenwald - Yeah but the first one they're gonna come in on look to is me. Respondent then proceeded to tell Ohanesian that if someone would kill Respondent's ex-wife and then come to Respondent a month or two later, Respondent would give the person $50,000. Respondent told Ohanesian that he (Respondent) could not make a contract because the police and the FBI would look to Respondent. Respondent informed Ohanesian that he had told Mrs. Greenwald that if Respondent thought he could get away with it, Respondent would have his wife killed. Then Respondent again told Ohanesian that if someone killed his wife and came to him afterwards, it would be worth a lot of money to Respondent. Nothing further of significance occurred during the first office visit dated September 15, 1984, which is described above. No contract was entered into. However, Ohanesian, still known to Respondent as Paul DeSantis, was directed to return to Respondent's office and an appointment was scheduled for September 22, 1984. On or about September 22, 1984, Ohanesian returned to Respondent's office still using the name Paul DeSantis. Respondent examined Ohanesian and again prescribed medication. During the course of the office visit which occurred on or about September 22, 1984, Respondent initiated a conversation about his marital problems and informed Ohanesian that he (Respondent) had received a death threat from Mrs. Greenwald. In response, Ohanesian asked Respondent if he was still serious about having Mrs. Greenwald killed. The conversation continued as follows: Greenwald - Ya know, I can't tell you that I'm serious . . . Ohanesian - Ya - Greenwald - . . . because that would be conspiracy. I don't know if you're a cop or private, ya know, I don't know that stuff. Ohanesian - Ya, ya Greenwald - Ah, but it would certainly ah, behoove the world and be of great financial benefit to me if she were gone. Then Respondent proceeded to tell Ohanesian that his wife and her friend liked to jog at Coral Reef Park at six in the morning. Respondent described the location of the park. Respondent gave Ohanesian a description of Mrs. Greenwald's vehicle. Respondent provided Ohanesian with his wife's address and a description of Respondent's wife and her friend. During the course of the above-described conversation, the method of payment came up as follows: Ohanesian - Yeah. Well, that's all right Okay, ahm. If I give a, you a post office box, ya know, if something should happen. Greenwald - Uh hum Ohanesian - Just send it in the post office box, if you can just jot it down for yourself. Okay, it's gonna go to J and M Greenwald - Uh hum Ohanesian - Box 523816. That's in Miami, 33152. Okay, well ah, I'll guess you know anyways. So, you won't need much proof. Greenwald - Whataya mean? Ohanesian - Ahm, if she dies you won't need much proof. Greenwald - No, no, I certainly won't. Ahm, Respondent, in the course of the same conversation also stated: Greenwald - So I'm not in a conspiracy. Ahm, I'm telling you like I've probably told fifty people . . . Ohanesian - Uh hum Greenwald - . . . that the world would be better better off without her. And I would be grateful. Ohanesian - Right Greenwald - And it's as simple as that. Nothing occurred during the second office visit to establish a clear-cut contract. At the conclusion of the office visit, Respondent told Ohanesian that in ten days his (Ohanesian's) spots would be gone and the treatment would be finished. Respondent did not direct Ohanesian to return to his office for another visit after September 22, 1984. On or about September 26, 1984, Ohanesian returned to Respondent's office still using the undercover name Paul DeSantis. Ohanesian told Respondent that people were always getting run over by stolen cars. Then Ohanesian asked for expense money to run over Mrs. Greenwald. The conversation was as follows: Ohanesian - Like kids that steal cars then run over joggers all the time. I can't put out any of my own money, you know? So, we need some expense money. Is there going to be any way we can do, work something out here? Greenwald - How much expense money do you need? Ohanesian - Uh! Greenwald - And how do I know you're not a cop? Ohanesian - I'm not, Doc. You know this isn't the movies, you know? What am I going to do? I mean, well? Greenwald - All right, How much expense money? Ohanesian - I'm talking about eight hundred dollars. Greenwald - Eight hundred bucks. You got a look at her? Ohanesian - I got a good look at her, she looked at me. Greenwald - All right, how do you make sure that, uh, that uh, she's run over? Ohanesian - Well, she's going to get run over real good, I mean, you know? She's going to be jogging. She didn't jog Monday and uh, I'm just going to run her over. Run the shit off of her, and that's going to be the end of it. * * * Ohanesian - When can you get me some money? Greenwald - Uhm! Greenwald - You got no recorders or microphones? Ohanesian - No, shit no, shit the only thing is the gun Greenwald - Take it, there. At that time, Respondent gave Ohanesian $800 cash out of Respondent's wallet. After discussing expenses, Respondent and Ohanesian talked about payment of the fifty thousand dollars as follows: Ohanesian - Uhm, when I'm gone, okay, I know you're scared, just send it in this envelope, okay? Greenwald - How much money do I send in? Ohanesian - After it's over? Greenwald - Yeah Ohanesian - Fifty thousand we talked about, less whatever you're going to pay me now Greenwald - All right now. Fifty thousand Ohanesian - Uh huh Greenwald - It's fine. It's a lot of money, but it's fine. I want you to know that it is from insurance that I have Ohanesian - Okay Greenwald - I don't have fifty grand that I could give you now Ohanesian - No, I don't want, we made an agreement when I first came in here. You send it after it's over with. Did you say a month? Greenwald - Whenever I get... Ohanesian - Okay Greenwald - ... the insurance check. Ohanesian and Respondent then talked about Mrs. Greenwald's schedule for the week in question. On his patient records for DeSantis, dated September 26, 1984, Respondent wrote "Improving. Finish above. . ." At the time Respondent paid the $800 cash to Ohanesian (DeSantis) it was Respondent's intent to hire Ohanesian to kill Respondent's ex-wife, Paula Greenwald, and Respondent believed that he had hired someone to accomplish that purpose. This action of hiring someone with the motive of and for the purpose of causing the death of another person demonstrates that Respondent is a person who is extremely cruel, callous, and unfeeling. Those characteristics can affect clinical judgments and therefore relate to the ability to practice medicine. Further, the act of soliciting a patient to commit murder is poor medical judgment. On or about September 27, 1984, Respondent was arrested for solicitation to commit first degree murder. John Collins, a sergeant with the Metro-Dade Organized Crime Bureau, was one of the arresting officers. Sergeant Collins, upon arresting Respondent, advised Respondent only that he was under arrest for solicitation to commit murder. No further information was provided. Respondent was not advised of his Miranda rights because no questioning was to be pursued at that time. Respondent then asked Sergeant Collins if "she" was dead. On or about October 16, 1984, under case number 84- 22607, an information was filed against Respondent in the Eleventh Judicial Circuit Court in and for Dade County, Florida, alleging that Respondent between September 14 and 28, 1984, did unlawfully and feloniously solicit Paul Ohanesian to commit murder in the first degree, and in the course of such solicitation did command, encourage, hire or request Paul Ohanesian to kill Paula Greenwald, and to effect her death with premeditated design. On or about January 23, 1985, Respondent pleaded nolo contendere to charges of solicitation to commit murder in the Circuit Court for Dade County. On or about January 23, 1985, the court accepted Respondent's plea of nolo contendere to charges of solicitation to commit murder. On or about January 23, 1985, a sentencing hearing was held in Case Number 84-22607, before the Circuit Court in Dade County, Florida. As a result of the sentencing hearing, Respondent was placed on probation for a period of ten (10) years. As a special condition of probation, Respondent was to perform 5,000 hours of community service over a ten-year period, by performing 500 hours of community service per year for specified organizations. Additionally, as a special condition of probation, Respondent was to obtain a psychiatric evaluation from one of three specified physicians.
Conclusions Based on the foregoing findings of fact and on the applicable legal principles, the following conclusions of law are made. The Division of Administrative Hearings has jurisdiction over the parties to and subject matter of this proceeding. See Section 120.57(1), Florida Statutes, and Section 455.225(4), Florida Statutes. The Board of Medical Examiners is empowered to revoke or suspend the license of, or otherwise discipline, any physician who violates any of the following provisions of Section 458.331(1), Florida statutes: Being convicted or found guilty, regardless of adjudication, of a crime in any jurisdiction which directly relates to the practice of medicine or to the ability to practice medicine. Any plea of nolo contendere shall be considered a conviction for purposes of this chapter; False, deceptive or misleading advertising; Advertising, practicing or attempting to practice under a name other than one's own; Failing to perform any statutory or legal obligation placed upon a licensed physician; and Making deceptive, untrue or fraudulent representations in the practice of medicine or employing a trick or scheme in the practice of medicine when such trick or scheme fails to conform to the generally prevailing standards of treatment in the medical community. Petitioner has the burden of proof in this license discipline case and must prove clearly and convincingly that the alleged violations of the above-cited statutory provisions occurred. Bowling v. Department of Insurance, 394 So.2d 165 (Fla. 1st DCA 1981); Robinson v. Florida Board of Dentistry, 447 So.2d 930 (Fla. 3d DCA 1984); and Sneij v. Department of Professional Regulation, 454 So.2d 795 (Fla. 3d DCA 1984). Conclusions regarding charges in DPR Case No. 0048232 Count One of the Administrative Complaint in DPR Case No. 0048232 charges the Respondent with a violation of Section 458.331(1)(e), Florida Statutes, by "[a]dvertising, practicing, or attempting to practice under a name other than his own." There is sufficient competent substantial evidence to establish that Respondent violated Section 458.331(1)(e), Florida Statutes, by advertising under the name Dadeland Dermatology Center, a name other than his own. Respondent in mitigation offered evidence that the Dade County Medical Association did not find unethical behavior in Respondent's advertising. This evidence does not negate, but only mitigates the violation of Section 458.331(1)(e), Florida Statutes. Count Two of the Administrative Complaint in DPR Case No. 0048232 charges the Respondent with a violation of Section 458.331(1)(d), Florida Statutes, which prohibits false, deceptive, or misleading advertising. There is sufficient competent substantial evidence to establish that the Respondent violated Section 458.331(1)(d), Florida Statutes, by advertising in a false, deceptive, or misleading manner that Respondent provided Collagen and Silicone treatments, when in fact the Respondent has never used Collagen in his practice, has never been trained in the use of Collagen, has never ordered Collagen, has never had any Collagen at his office, believes Collagen is an inferior product, and has no present intention of using Collagen. It is clearly false, deceptive, and misleading for the Respondent to advertise the availability of both Collagen and Silicone treatments when in fact the Collagen treatments are not available at Respondent's office and he has no intention of making them available. Count Three of the Administrative Complaint in DPR Case No. 0048232 charges the Respondent with a violation of Section 458.331(1)(u), Florida Statutes, by Performing any procedure or prescribing any therapy which, by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject, without first obtaining full, informed, and written consent. Counsel for the Department voluntarily dismissed the charges in this count at the commencement of the hearing. Accordingly, Count Three of the Administrative Complaint in DPR Case No. 0048232 should be dismissed. Count Four of the Administrative Complaint in DPR Case No. 0048232 charges the Respondent with a violation of Section 458.331(1)(t), Florida Statutes, by Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Counsel for the Department voluntarily dismissed the charges in this count at the commencement of the hearing. Accordingly, Count Four of the Administrative Complaint in DPR Case No. 0048232 should be dismissed. Count Five of the Administrative Complaint in DPR Case No. 0048232 charges the Respondent with a violation of Section 458.331(1)(1), Florida Statutes, by Making deceptive, untrue, or fraudulent representations in the practice of medicine or employing a trick or scheme in the practice of medicine when such scheme or trick fails to conform to the generally prevailing standards of treatment in the medical community. There is sufficient competent substantial evidence to establish that Respondent violated Section 458.331(1)(1), Florida Statutes, by making deceptive, untrue, or fraudulent representations that Respondent provided Collagen implants in his practice. Essentially, Respondent is advertising that he provides both Collagen and Silicone treatments, when this is not true, and in fact is deceptive in nature. Conclusions regarding charges in DPR Case No. 0052038 Count One of the Administrative Complaint in DPR Case No. 0052038 charges the Respondent with a violation of Section 458.311(1)(c), Florida Statutes, by Being convicted or found guilty, regardless of adjudication, of a crime in any jurisdiction which directly relates to the practice of medicine or to the ability to practice medicine. Any plea of nolo contendere shall be considered a conviction for purposes of this chapter. The manner in which the last sentence of the above-quoted statutory provision is to be construed and applied was addressed as follows in Ayala v. Department of Professional Regulation, 478 50.2d 1116 (Fla. 1st DCA 1985): We find that Section 458.331(1)(c) is clearly constitutional by construing the word "shall" in the last sentence of that subsection as permissive rather than mandatory in meaning. Rich v. Ryals, 212 So.2d 641, 643. As so construed, the Board of Medical Examiners may presumptively consider the nolo contendere plea as evidence of a conviction for purposes of chapter 458; however, in accordance with the Supreme Court's opinion in The Florida Bar v. Lancaster, 448 So.2d 1019, the Board must allow appellant the opportunity to rebut this presumption and assert his innocence of the underlying criminal charges by explaining the reasons and circumstances surrounding his plea of nolo contendere, and thereby attempt to convince the Board that he is not guilty of a crime in violation of the provisions of section 458.331(1)(c). The Board must consider this evidence in deciding appellant's guilt or innocence for purposes of the disciplinary charges. Such explanation may, of course, always be considered in mitigation of punishment if appellant should be adjudicated guilty by the Board. At the hearing in this case, the Respondent was allowed an opportunity to rebut the presumption which arises from his nolo contendere plea. Respondent availed himself of the opportunity and attempted to explain the reasons and circumstances surrounding his plea of nolo contendere and attempted to convince the Hearing Officer that he is not guilty of a crime in violation of the provisions of Section 458.331(1)(c), Florida Statutes. As is obvious from the findings of fact earlier in this Recommended Order, the Respondent's efforts in this regard were unsuccessful. After careful consideration of the Respondent's explanations, I have found them to be lacking in persuasiveness when considered in light of the other evidence of the Respondent's guilt of the criminal charge of solicitation of the first degree murder of his ex-wife. Section 777.04(2), Florida Statutes, reads as follows in pertinent part: Whoever solicits another to commit an offense prohibited by law and in the course of such solicitation commands, encourages, hires, or requests another person to engage in specific conduct which would constitute such offense or an attempt to commit such offense commits the offense of criminal solicitation . . . Upon consideration of the totality of the evidence in this case, there is an abundance of competent substantial evidence that the Respondent encouraged and hired Paul Ohanesian to murder Respondent's ex-wife and that Respondent did so with the motive of and for the purpose of causing the death of his ex-wife. Respondent's explanations with regard to his having had some other motive or purpose are simply unconvincing. Count Two of the Administrative Complaint in DPR Case No. 0052038 charges the Respondent with a violation of Section 458.331(1)(h), Florida Statutes, by "[f]ailing to perform any statutory or legal obligation placed upon a licensed physician." In this regard, the Respondent is alleged to have failed to comply with or to have violated the provisions of Section 455.227(1)(a), Florida Statutes, which provides for disciplinary action where "[t]he licensee has been convicted of a felony which relates to the practice of his profession." For the following reasons this charge must be dismissed. First, while Section 455.227(1)(a), Florida Statutes, authorizes disciplinary action upon conviction of certain felonies, Section 455.227(1)(a) does not impose any statutory or legal obligation upon a licensed physician (or upon any other licensee). Section 455.227(1)(a) may provide a separate basis for discipline against a licensed physician (or other licensee), but because it does not impose any duty or obligation on licensed physicians, there can be no failure to perform anything required by Section 455.227(1)(a) which could constitute the basis of a violation of Section 458.331(1)(h), Florida Statutes. Second, even if the Respondent had been charged directly with a violation of Section 455.227(1)(a) [which he was not], such a charge would fail on the facts in this case because Section 455.227(1)(a), Florida Statutes, is limited by its terms to licensees who have been "convicted," and does not contain the broadening language of Section 458.331(1)(c), Florida Statutes, which encompasses situations in which adjudication has been withheld or in which a plea of nolo contendere has been made. Therefore, no violation of Section 458.331(1)(h), Florida Statutes, can be found, and Count Two of the Administrative Complaint in DPR Case No. 0052038 must be dismissed. Conclusions regarding the appropriate penalty With regard to the violation of Section 458.331(1)(e), Florida Statutes, by advertising under a name other than his own, even though the Dade County Medical Association found nothing wrong with the Respondent 'a advertising, the fact remains that the language of the statutory prohibition is simple and clear and the Respondent should have been aware of it. Respondent did mitigate the harm caused by the improper advertising by advising all who called that they had called Respondent's office. Accordingly, for the violation of Section 458.331(1)(e), Florida Statutes, I recommend issuance of a reprimand and an administrative fine in the amount of $250. With regard to the violation of Section 458.331(1)(d) and (1), Florida Statutes, by false, deceptive, or misleading advertising and by deceptive, untrue, or fraudulent misrepresentations, I recommend an administrative fine of $1,000. With regard to the violation of Section 458.331(1)(c), Florida Statutes, by being found guilty of a crime which directly relates to the ability to practice medicine, due to the particularly heinous nature of the Respondent's crime, I recommend that Respondent's license to practice medicine be revoked.
Recommendation Consistent with all of the foregoing, it is recommended that the Board of Medical Examiners issue a Final Order in this case to the following effect: Finding the Respondent guilty of the violations charged in Counts, One, Two, and Five of the Administrative Complaint in DPR Case No. 0048232; Finding the Respondent guilty of the violation charged in Count One of the Administrative Complaint in DPR Case No. 0052038; Reprimanding the Respondent for the violation of advertising under a name other than his own; Imposing a total of $1,250 in administrative fines against the Respondent; Revoking the Respondent's license to practice medicine; and Dismissing Counts Three and Four of the Administrative Complaint in DPR Case No. 0048232 and dismissing Count Two of the Administrative Complaint in DPR Case No. 0052038. DONE AND ORDERED this 10th of April, 1986, at Tallahassee, Florida. MICHAEL M. PARRISH, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of April, 1986. COPIES FURNISHED: Stephanie A. Daniel, Esq. Senior Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Lawrence E. Besser, Esq. SAMEK AND BESSER 1925 Brickell Suite #D-207 Miami, Florida 33129 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore Carpino, General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 APPENDIX The following are my specific rulings on each of the findings of fact proposed by each of the parties. Rulings on findings proposed by the Petitioner The paragraphs referred to below are to the numbered paragraphs of the proposed findings of fact which appear at pages 3 through 13 of the Petitioner's Proposed Recommended Order. The substance of all of the findings proposed in the following paragraphs has been accepted. Some editorial modifications have been made in the interests of clarity and accuracy, as well as when integrating similar proposals by the Respondent: 1, 2, 3, 4, 5, 6. 7. 8, 9, 10, 12, 13, 14, 15, 16, 17, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32. Paragraph 11: The findings in this paragraph are accepted with the exception of the language in parentheses, which is rejected as not supported by competent substantial evidence. Paragraph 18: Accepted in substance with unnecessary details deleted. Paragraph 29: The last sentence of this paragraph is rejected as irrelevant. The remainder of this paragraph is accepted. Rulings on findings proposed by the Respondent The paragraphs referred to below are to the numbered paragraphs of the proposed findings of fact which appeared at the following pages of the Respondent's Proposed Recommended Order: 1, 2, 3, 4, 5, 6, 16 and 17, 19 and 20. Inasmuch as the paragraphs of Respondent's proposed findings are numbered in three series of numbers in which many numbers are repeated, I have also included page reference below in the interest of clarity (Findings proposed at pages 1 through 6) Paragraph 1: Accepted in substance, with deletion of some irrelevant details. Paragraph 2: Accepted in substance, with deletion of some irrelevant details. Paragraph 3: Rejected because not supported by competent substantial evidence. Paragraphs 4, 5, and 6: T he substance of these paragraphs has been accepted with the deletion of certain editorial material. Paragraph 7: Rejected as constituting either a cumulative rehash of previous findings or as argument about the significance of the findings. Paragraphs 8 and 9: The substance of these paragraphs has been accepted with the deletion of certain editorial material. Paragraph 10: Rejected as constituting an irrelevant opinion or a conclusion of law rather than a finding of fact. Paragraph 11: Accepted in substance. Paragraphs 12, 13, 14, and 15: Accepted in substance. Paragraph 16: Rejected as contrary to the greater weight of the persuasive evidence. (See other findings regarding the guilt of the Respondent. In making my findings of fact regarding Respondent's intent, motive, and purpose, I have specifically rejected as unpersuasive and unworthy of belief Respondent's testimony that he knew that Ohanesian was not a "hit man," that he believed that Ohanesian was a private detective sent by Respondent's ex-wife, that he had no intention of causing his wife's death, and that his sole reason for paying $800 to Ohanesian was to "send a message" to his ex-wife so she would believe he was serious about having her killed even though he was not.) Paragraphs 17 and 18: Accepted in substance. Paragraph 19: Rejected as contrary to the greater weight of the persuasive evidence. (See other findings regarding the guilt of the Respondent.) Paragraph 20: Accepted in substance. Paragraph 21: Rejected in part as irrelevant and in part as contrary to the greater weight of the persuasive evidence. Paragraph 22: Rejected as contrary to the greater weight of the persuasive evidence. (See other findings regarding the guilt of the Respondent.) Paragraph 23: Rejected because it constitutes a summary of testimony and argument about the testimony and does not constitute a proposed finding of fact. Paragraph 24: Rejected in part because it constitutes a summary of the testimony and opinion rather than a proposed finding of fact. Rejected primarily because it is inconsistent with the greater weight of the persuasive evidence, including some of Dr. Jacobson's testimony on cross-examination. Paragraph 25: Rejected in part because it is irrelevant. Rejected primarily because the opinions of the Board of Directors of the Dade County Medical Association are not warranted on the basis of the persuasive evidence in this record. Paragraph 26: Rejected as contrary to the greater weight of the persuasive evidence. (Findings proposed at pages 16 and 17) Paragraphs 1, 2, 3, and 5: Accepted in substance. Paragraphs 4, 6, and 7: Although essentially correct statements, these paragraphs are rejected as findings because they are irrelevant to the issues in this case. (Findings proposed at pages 19 and 20) Paragraph 1: The substance of the first sentence is accepted. The second sentence is rejected as contrary to the greater weight of the persuasive evidence or as not supported by persuasive competent substantial evidence. Paragraph 2: Accepted in substance. Paragraph 3: The first sentence of this paragraph is accepted in substance. The second sentence is rejected as contrary to the greater weight of the evidence and not supported by competent substantial evidence. Paragraphs 4, 5, 6, and 7: Accepted in substance. Paragraph 8: Accepted in substance with some additional clarification regarding the emphasis placed on the benefits of silicone. Paragraph 9: Accepted in substance. Paragraph 10: Rejected as not supported by persuasive competent substantial evidence. (See other findings on this subject.)
Findings Of Fact Thomas J. Lane, D.V.M., Respondent, at all times material to this complaint, was a veterinarian licensed by the State of Florida, license number VM0000823. Respondent practiced veterinary medicine at the Belleview Veterinary Hospital, Belleview, Florida. During the week preceding June 25, 1978 Thomas and Julia Pilcher had been on vacation and their neighbor was caring for their Doberman Pinscher, Thunder. Upon their return Sunday, June 25, the dog's legs were swollen and he could not walk. Their regular veterinarian was away on vacation and in the early evening Respondent was telephoned to ask if he would open his clinic to examine Thunder. Pilcher gave as reference a regular customer of Respondent and Respondent proceeded to his clinic. When he arrived around 8:45 p.m. Pilcher carried the dog into the examining room. Upon examination by Respondent, Thunder was found anemic, dehydrated, semi-comatose and with a temperature of 104 degrees Fahrenheit. Blood test showed heartworms although Thunder had been on anti-heartworm medication. Exhibit 4, in the description of examination of Thunder on June 25, 1978 lists "Prognosis--Poor". At this point the testimony of Pilcher and Respondent diverge upon what was said with respect to the treatment of Thunder. Pilcher's testimony is that he told Respondent he didn't want to pay more than $100 for the treatment of Thunder and that if the costs would exceed that amount, he didn't want the dog treated. Respondent recalls Pilcher had no money when he came to the clinic with Thunder, that he may have quoted Pilcher a price of $100 for treating heartworms, and that he advised Pilcher the dog was very sick and might die. That evening while Pilcher was present, Respondent performed the following services for Thunder: Four intravenous fluids, blood sample, emergency office call, administered one drug by injection and gave Thunder antibiotics intravenously. Charges for these services were $20, $4, $10, $5 and $20, respectively, for a total of $59. Pilcher left the dog with Respondent for treatment, assuming that Respondent was going to start heartworm treatment immediately. Heartworm treatment is contra-indicated for animals with high temperature and Respondent did not intend to, nor did he, commence heartworm treatment on Thunder. On June 26, Julia Pilcher called the clinic to inquire about Thunder and spoke to Respondent's wife. Mrs. Pilcher testified she asked how Thunder was doing on the heartworm treatment and was told he was doing fine. Mrs. Pilcher understood heartworm treatment to be dangerous for older dogs, hence her concern about the treatment. Mrs. Lane did not testify regarding this conversation. On Friday, June 30, Respondent's office called Pilcher to advise him Thunder could be picked up. Pilcher had planned to drive to Georgia over July 4 holidays and inquired about the cost of boarding Thunder until after July 4. He was advised the clinic charged $5 per day board. He requested the dog be boarded until after 4 July. On July 5, 1978 Pilcher went to the clinic to pick up Thunder and was presented a bill for $241 instead of the $125 he was expecting. He also learned the dog had not been treated for heartworms. Pilcher told Respondent the bill was outrageous and he left the dog at the clinic. By certified letter dated July 7, 1978 Respondent advised Pilcher that, pursuant to Florida Statutes, he would dispose of Thunder at the end of ten days unless the dog was picked up; and that this would not relieve Pilcher from his legal obligation to pay for services performed, including board for the additional ten days period, euthanasia and burial. Subsequent telephone conversations between Respondent and Pilcher led to a settlement agreement whereby Respondent agreed to subtract one-half of the bill over one hundred dollars from the amount due. The total bill for services on 11 July was $262. Pursuant to this agreement, Mrs. Pilcher picked up the dog on 11 July and paid Respondent $182.50, which was $100 + 1/2 ($262-$1OO) + $1.50 (for certified letter). Prior to paying this sum, Mrs. Pilcher had contacted Petitioner to complain about the incident and was told to get receipts for payments made. Subsequent to Pilcher getting Thunder back, Respondent learned from other customers that Pilcher was proclaiming to numerous people that Respondent had not done right by him in this incident. By letter dated July 27, 1978 (Exhibit 5) Charles Rowe, an attorney representing Respondent, advised Pilcher that it was understood Pilcher had been making slanderous remarks about Lane and that if he did not immediately cease and desist he could expect to have suit filed against him for defamation of character. Following receipt of Exhibit 5, Pilcher ceased "bad-mouthing" Respondent.
Recommendation Based upon the findings of fact and conclusions of law recited above, it is recommended that the respondent's determination to deny petitioner's application for a certificate of need to institute radiation therapy facilities at its hospital be AFFIRMED. Respectfully submitted and entered this 9th day of June, 1977, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Art Forehand, Administrator Office of Community Medical Facilities 1323 Winewood Boulevard Tallahassee, Florida 32301 Richard R. Paige, Esquire Paige and Catlin Alfred I. DuPont Building Miami, Florida 33131 Eric J. Haugdahl, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Sheldon M. Simons, Esquire Professional Building 3661 South Miami Avenue Miami, Florida 33133 Alex Hofrichter, Esquire Carey, Dwyer, Cole, Selwood and Bernard Post Office Box 450888 Miami, Florida 33145
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Parties The Agency is a state government licensing and regulatory agency. Respondent is now, and has been since 1962, a physician licensed to practice medicine in the State of Florida, holding license number ME 0010545. He is also licensed to practice medicine in the States of New Jersey and New York. From 1948 to 1952, Respondent attended the Chicago Medical School, from which he graduated with a M.D. degree. From 1952 to 1953, he had a rotating internship in a Newark, New Jersey hospital. After receiving his license to practice medicine in the State of New Jersey, Respondent started a general medical practice there. He closed his practice in 1955 to begin training in his current primary specialty, psychiatry. He received such training from 1955 to 1960. He trained at Essex County Hospital in Cedar Grove, New Jersey, the New Jersey State Diagnostic Center in Menlo Park, New Jersey, the Veterans Administration Hospital in Lyons, New Jersey, Mount Sinai Hospital in New York, New York, and the Neuropsychiatric Institute in Princeton, New Jersey. From 1960 to 1971, Respondent had his own psychiatric practice in Woodcliff, New Jersey. During the earlier portions of this period he also authored the following three articles which were published in the American Journal of Psychiatry: "Improving Insulin Therapy in Schizophrenia with Neostigmine" (May, 1961); "Improving Insulin Therapy with Calcium Gluconate" (February, 1962); and "Resistant Psychosis Treated Successfully by Indoklon" (February, 1962). In 1971, Respondent moved his psychiatric practice to Florida, specifically 9145 Northwest 27th Avenue in Miami. He practiced psychiatry at this location in Miami until the early 1980's. In addition to his private practice, in 1972, Respondent was the Director of the Methadone and Alcohol Unit at Reed Memorial Hospital in Miami. In October of 1973 and May of 1975, respectively, two articles that Respondent had written, "Rapid Treatment of Opiate Addiction" and "The Post- Opiate Syndrome," were published in the Florida Journal of Medicine. Furthermore, from 1982 to 1984, he taught a "Fundamentals of Medical Science" course at Florida International University's Bay Vista Campus in North Miami, Florida. From July of 1983 to April of 1984, Respondent was a staff psychiatrist at the Broward County Crisis Center in Pembroke Pines, Florida. Since leaving the staff of the Broward County Crisis Center in April of 1984, Respondent has been practicing psychiatry and, to a lesser extent, family medicine at his office located at 17122 West Dixie Highway in North Miami Beach, Florida. In addition to his private practice, since approximately 1991, Respondent has taught psychiatry courses at Nova Southeastern University in Miami. Although he teaches and practices psychiatry, he is not board certified in this specialty. Respondent's Care and Treatment of Patient C.R. Overview From on or about October 2, 1984, to on or about July 8, 1985, (hereinafter referred to as the "treatment period") Respondent provided medical care and treatment to patient C.R., a 35-year old overweight female with suicidal thoughts. C.R. initially presented to Respondent with complaints of melancholia, irritability, nervousness and inability to control her weight. She explained that in the recent past her boyfriend had shot himself to death in her presence, her mother had passed away, and she had to put two of her cats to sleep, which events had led her to attempt to commit suicide by cutting her wrists. She further informed Respondent that she expected to die and join her dead boyfriend in the near future. Respondent diagnosed C.R. as having agitated depression with neurotic, not psychotic, features. He also concluded that she was suffering from obesity. Depression is a disorder with a predominant complaint of melancholia and depressed affect. A patient with agitated depression has features of melancholia, superimposed with anger and irritability. Agitated depression is more difficult to treat clinically than simple depression. During subsequent visits C.R. also complained of diarrhea, headaches, coughing spells, and pain associated with a fissure in her anal canal. Although C.R. made certain comments to Respondent during the treatment period indicating that she used cocaine and consumed excessive amounts of alcohol, Respondent reasonably believed, based upon the totality of circumstances, including other statements C.R. made to him and her appearance, demeanor and conduct during her visits to his office, that C.R.'s claims of cocaine and excessive alcohol use were "attention-getting" fabrications and that she did not have an addictive or abusive personality or a history of drug or alcohol abuse 12/ and he treated her accordingly. In doing so, Respondent did not act in a manner that was inconsistent with what a reasonably prudent psychiatrist at the time would have done under similar circumstances. In the medical records that he maintained on C.R., Respondent noted that C.R. had made claims of cocaine and excessive alcohol use, but he did not indicate that he disbelieved these claims. C.R.'s condition gradually improved during the treatment period. She lost weight, maintained a neater and cleaner appearance and became more outgoing. Overall Drug Regimen During the treatment period, Respondent prescribed the following legend drugs for C.R.: Plegine, which contains Phendimetrazine, a Schedule III controlled substance; Didrex, a Schedule III controlled substance; Sinequan; Elavil; Valium, which contains Diazepam, a Schedule IV controlled substance; Librium, which contains Chlordiazepoxide, a Schedule IV controlled substance; Xanax, which contains Alprazolam, a Schedule IV controlled substance; Inderal; Ativan, which contains Lorazepam, a Schedule IV controlled substance; Placidyl, which contains Ethchlovynol, a Schedule IV controlled substance; Hycodaphen, which contains Hydrocodone, a Schedule III controlled substance; Darvocet, which contains Propoxyphene, a Schedule IV controlled substance; Percocet, which contains Oxycodone, a Schedule II controlled substance; Percodan, which also contains Oxycodone; Sudafed; Gantrisin; Paregoric; and Xylocaine (in ointment form). Respondent also administered the legend drug Lasix to C.R. In addition, he administered to C.R. the following legend drugs as adjuncts to psychotherapy: Ketamine Hydrochloride (hereinafter referred to simply as "Ketamine"), which is sold under the brand name of Ketalar; Brevital, a barbiturate containing Methohexital, a Schedule IV controlled substance; and, on a single occasion, Seconal, another barbiturate, which contains Secobarbital, a Schedule II controlled substance. He further administered to C.R. Brevital and the legend drugs Atropine and Anectine in conjunction with non-convulsive electric current therapy. That Respondent prescribed or administered the legend drugs specified in the preceding four paragraphs is reflected in the medical records that Respondent maintained on C.R. Respondent further indicated in these medical records the amounts of these drugs that were prescribed and administered. Respondent's polypharmacy approach to treat the symptom clusters with which C.R. presented (and which were noted in the medical records that Respondent maintained on C.R.) was not inappropriate and did not produce any significant, unwanted drug interactions. Furthermore, Respondent did not prescribe or administer any drugs to C.R. 13/ in excessive amounts and he carefully monitored C.R.'s use of the drugs that he prescribed for her during her frequent office visits. Antidepressant Drug Therapy In the ordinary case, where time is not of the essence, a tricyclic antidepressant, such as Sinequan or Elavil, which Respondent prescribed for C.R. on her second visit on October 9, 1984, is the medication of choice in attempting to combat depression. Sympathomimetic amines, such as Plegine and Didrex, are also used in treating depression. 14/ (In addition to helping fight depression, these amphetamine-like 15/ "mood elevators" also function as anorexic agents.) Unlike tricyclic antidepressants, which produce no immediate effect, sympathomimetic amines are very rapid acting. Therefore, if a patient suffering from depression is suicidal and in the throes of a life threatening crisis, as was C.R. when she presented to Respondent, treatment with sympathomimetic amines is warranted because of the quick relief it provides. Because of C.R.'s desperate situation, Respondent prescribed both Plegine and Didrex to treat her depression. That these sympathomimetic amines might also help C.R. lose weight was, in Respondent's mind, an added bonus, but it was not the primary reason that he prescribed them. Neither Plegine nor Didrex should be prescribed for an individual who has an addictive or abusive personality or a history of drug or alcohol abuse. Respondent, however, as noted above, reasonably believed that, in the case of C.R., he was not dealing with someone who had drug or alcohol problems. While there were occasions that Respondent prescribed both Plegine and Didrex for C.R. on the same date, he never prescribed them for concomitant use. When he gave C.R., during the same visit, prescriptions for both Plegine and Didrex, he specifically instructed her to use them, not at the same time, but rather sequentially, for minimum periods of a week each. That he gave these instructions, however, is not reflected in the medical records he maintained on C.R. It is an acceptable practice to alternate the use of Plegine and Didrex in such a manner to determine which produces the best results for the patient. Respondent found that Plegine was more effective than Didrex in combatting C.R.'s depression. He therefore stopped prescribing Didrex for C.R. The last time he prescribed Didrex for her was November 27, 1984. He continued to prescribe Plegine until June 18, 1985. Antianxiety Drug Therapy To reduce the anxiety that C.R. was experiencing, Respondent appropriately prescribed the benzodiazepines Valium and Xanax and other antianxiety agents and sedatives, including Inderal, which he prescribed after C.R. reported having a "panic attack," and Placidyl, a strong hypnotic sedative or sleeping pill. These antianxiety agents were prescribed for concomitant use with antidepressant medication. Such concomitant use is appropriate where the patient is both depressed and anxious, as was C.R. in the instant case. Drug-Assisted Psychotherapy On approximately 40 separate occasions, from November 10, 1984, to June 11, 1985, Respondent administered Ketamine to C.R. intravenously prior to a psychotherapy session in order to reduce her resistance to psychotherapy. 16/ Ketamine is a commonly used, 17/ relatively safe, 18/ FDA-approved 19/ anesthetic that is structurally similar to PCP. 20/ It is a legend drug. Unlike traditional anesthetics, which are general central nervous system depressants, Ketamine depresses some parts of the brain and stimulates others. In sufficient dosage, it provides anesthesia quickly. Its anesthetic effect lasts a relatively short period of time (approximately ten minutes) and there is generally rapid recovery, although postoperatively, some patients may hallucinate. While Ketamine remains in the bloodstream for approximately 24 hours, a patient who has received an anesthetic dose of Ketamine 21/ and suffered no complications, as a general rule, may be released two hours after having been anesthesized, provided instructions are given that the patient is not to operate a motor vehicle or other dangerous machinery or to make any major decisions immediately upon the patient's release. Aside from hallucinations, other possible side-effects from the use of Ketamine, according to the Physician's Desk Reference (hereinafter referred to as the "PDR"), include delirium, confusion, amnesia, tonic and clonic movements sometimes resembling seizures, anorexia, nausea and vomiting. Furthermore, because it tends to raise blood pressure, it should be used with caution where the patient is hypertensive. 22/ There is no evidence in the anesthesia literature that even the repeated use of Ketamine causes psychosis in normal patients. The impact that Ketamine has on the psyche induces an abreactive or dissociative effect in the patient and results in the patient becoming more verbal and expressive. Furthermore, like all anesthetics, Ketamine can be used as a tranquillizer to allay anxiety if administered in a dosage and manner that does not achieve an anesthetic outcome. 23/ Because of these features, there is reason to believe that Ketamine may help as an adjunct to psychotherapy. There are a number of authoritative, scientific articles, some dating as far back as the 1940's, which support such a view. Among them is a 1973 article, "The Use of Ketamine in Psychiatry," written by E. Khorramzadeh and A.O. Lofty (Respondent's Exhibit 11) and a 1979 article, "Ketamine-Facilitated Induced Anxiety Therapy and Its Effect upon Clients' Reactions to Stressful Situations," written by A.A. Sappington, G. Corssen, A.T. Becker and M. Tavakoli (Respondent's Exhibit 10). Respondent reviewed these two articles before deciding to use Ketamine as an adjunct to C.R.'s psychotherapy. Notwithstanding the foregoing, Ketamine-assisted psychotherapy is not now, nor was it at any time material to the instant case, recognized as a standard or conventional treatment in the mainstream psychiatric community. It is not even mentioned in either the PDR or the American Psychiatric Association's four volume work on the treatment of psychiatric disorders. Furthermore, the FDA-approved labeling and package insert for Ketamine make no mention of the drug having any use in the practice of psychiatry. It is not necessarily inappropriate, however, for a physician to use a drug that has been approved as safe by the FDA for a purpose other than that which is indicated on the FDA-approved label and package insert. Before he used Ketamine in his treatment of C.R. as an adjunct to psychotherapy, Respondent discussed the matter with C.R. and obtained her full, informed written consent. Such consent was given in a handwritten statement that C.R. signed on November 6, 1984. The statement, which Respondent retained as part of his medical records on C.R., read as follows: Permit to Dr. Royce I, [C.R.], have been suffering from painful depression and nervousness. I have learned that Pentothal and Amytal (AMYTAL) Interviews, also known as TRUTH SERUM, have helped persons with symptoms such as mine. Dr. Royce who has been using Amytal interviews since 1957, has also had experience with the same technique using ketamine, a much safer drug than Amytal or Pentothal. The effect of ketamine (also known as KETALAR), wears off in less than 15 to 20 minutes. Therefore, a patient is able to leave the doctor's office hours sooner than would be possible with Amytal. Ketamine is also safer because it does not depress the cough or gag reflexes or respiration, as Amytal and Pentothal do. Because of these facts, I am now writing this statement with Dr. Royce's help to give permission to IRVING D. ROYCE, M.D. to treat me with psycho- therapy including intra-venous injections of ketamine. I expect that the ketamine will help me to feel less depressed and less agitated, at least for the 10 to 15 minutes during which time it will have an effect on me. If I am less distracted by my physical nervousness and my depression, I will at least be able to participate better in therapy with Dr. Royce. Also Dr. Royce has discussed with me studies involving persons who have shown improvement during psychotherapy using ketamine at the start of the therapy sessions. Since Dr. Royce will be using lower doses than described in the Physicians Desk Reference ("P.D.R.") to help control my physical agitation I do not expect that these added psychiatric benefits will positively occur. However, if my psychotherapy should happen to show some benefit because of the ketamine, then I shall be grateful for that. In my mind there is a narrow line dividing whether or not I can expect to evolate (EVOLATE) in time to be with David Clark in Heaven for New Year's Eve. I doubt that my fate can be changed. I already have some first-hand knowledge of the value and safety of ketamine because I used it quite a few times to clip the claws of my cats. Dr.Royce and I have discussed alternate treatments for overcoming my expectation to be dead before the end of this year. He favors electroshock treatments in a hospital but I don't want to go through those seizures. We also discussed more frequent office visits and/or a higher dose of drugs for me, but I'd rather not change our pattern of having Dr. Royce evaluate my medications from one week to the next. We discuss how I feel each time and Dr. Royce adjusts the dose or changes medicines accordingly. I have told Dr. Royce that I expect to patch things up with David Clark as soon as I can get to him. I have to evolate (EVOLATE) as soon as possible to be with him before he returns to this life as some- body else. After his reincarnation (REINCARNATION), I may not be able to recognize who he really is. With or without any medication such as ketamine, I'm running out of time. The discussion of KETALAR in the P.D.R. says, "Ketalar has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients from 105 separate studies." Also, "Ketalar has a wide margin of safety." I feel confident now that Ketalar is a safe medication for me. In addition, Dr. Royce demonstrated to me how his Oxygen Resuscitator works in case he has to use it on me by breathing through it himself. Even when he held his breath, I could hear the machine cycling on and off, doing the breathing for him. Finally for thoroughness Dr. Royce and I made the following notes by referring to the P.D.R.: I will not become pregnant during the time when I am being treated. I will not take anything by mouth after midnight of the day before each Ketalar treatment. I will always bring some adult with me when I come here for the Ketalar treatments. I will take Valium 5 mg orally 45 minutes before the Ketalar instead of the 2 mg to 5mg intra- venously described in the P.D.R. The valium is to help prevent "an EMERGENCE REACTION." I understand this reaction to be a period of emotional excitement which can occur in some instances when higher doses of Ketalar are used such as during surgery and where the prophylactic dose of Valium or some other sedative is not given to the patient before Ketalar. 24/ The initial does of Ketalar will be "from 0.5 mg to 2.0 mg per pound.["] Therefore at my present weight of 167 lbs., no more than 334 mg will be used. After the Ketalar Therapy, I will wait one hour in the office discussing whatever seems to be important to me with Dr. Royce's assistants (Mrs. Royce and/or their daughter Jacki.) After the one-hour period, I will be examined by Dr. Royce who will dismiss me if he sees that I have recovered completely from the Ketalar Treatment. I will not drive an automobile or operate electrical or hazardous machinery for at least 24 hours after each Ketalar treatment. I will report to Dr. Royce anything unusual which occurs to me in the interval between Ketalar Treatments, such as fever, rash, nausea, infection, or unusual thoughts, dreams, or daydreams. No guarantee of results has been given to me by Dr. Royce, Mrs. Royce or Jacki. The Ketamine-assisted psychotherapy sessions began on C.R.'s next visit, which was on November 10, 1984. On that same date, she signed another handwritten statement in which she acknowledged that she was borrowing copies of nine different "scientific" articles dealing with or related to Ketamine use and agreed to return these borrowed materials to Respondent after she had "had time to read them." At no time during the treatment period did Respondent administer Ketamine in a dosage or manner that was calculated to, or did in fact, anesthesize C.R. or subject her to undue risk or harm. On only two occasions, toward the end of the treatment period, did he administer more than 100 milligrams of Ketamine during a session: the April 26, 1985, session, when he administered 112.5 milligrams; and the June 6, 1985, session when he administered 125 milligrams. 25/ On each and every occasion, Respondent administered the Ketamine slowly over a period of time to avoid anesthesizing C.R. There was no reason for Respondent to believe that the interaction between the Ketamine and any of the other drugs he had administered to C.R. or prescribed for her would result in any adverse consequences. At no time did Respondent teach C.R. how to self-administer Ketamine, nor did he ever approve or sanction such self-administration. Following each Ketamine-assisted psychotherapy session, which generally lasted at least an hour, C.R. remained in Respondent's office, in the company of Respondent's wife and/or his daughter Jacqueline, for a minimum of another hour to an hour and a half. C.R. was not permitted to leave until it was determined that it was safe for her to do so. The last Ketamine-assisted psychotherapy session was on June 11, 1985. Respondent stopped using Ketamine as an adjunct to psychotherapy because he reasonably believed that, in light of the progress C.R. had made, she no longer needed to rely on the drug's abreactive or dissociative effect in order to engage in effective psychotherapy. Instead of Ketamine, he used Brevital for C.R.'s last seven drug- assisted psychotherapy sessions. The final drug-assisted psychotherapy session was held on July 9, 1985, which was the last time Respondent saw C.R. Electric Current Therapy Electroconvulsive therapy is an accepted treatment for serious depression involving the delivery, to electrodes placed on the patient's skull, of a measured amount of electric current (on the average 350 millilamps) sufficient to produce a seizure or convulsion. Ordinarily, the patient is premedicated with an anesthetic and medication to modify the convulsion and its impact. Respondent recommended that C.R. be hospitalized and receive in- hospital electroconvulsive therapy. C.R.'s reaction to the recommendation was a "very negative" one. She did agree, however, to undergo non-convulsive electric current therapy, which is helpful in treating anxiety and in facilitating effective psychotherapy. She gave her consent in two signed, handwritten statements, one dated November 13, 1984, and the other dated January 31, 1985. C.R.'s November 13, 1984, statement read as follows: Permit for a Series of Electric-shock Treatments This is to give permission to Irving D. Royce, M.D. and to members of his office staff to administer a series of Electric Shock Treatments to me to treat my mental illness. These treatments will be given to me in addition to the Psychotherapy and medica- tions prescribed for me. The treatment procedure will include having electrodes placed on my head. Then an electric current will flow through the electrodes. There will be no pain or danger of a convulsion because of the very low amount of amperes that will flow. Medications which may be used during the series of electric treatments may include Atropine, Anectine, Brevital or Pentothal, and/or oxygen. I understand that these treatments are frequently effective (especially in regard to anxiety and/or depression) because they theoretically modify the chemical reactions within the brain. Other possible therapies have been discussed with me by Dr. Royce, including anti-depressant medication, psychotherapy, behavior modification, and convulsive electro-shock treatments (plus combination of these techniques.) However, I prefer at this time to start a series of the electro-shock treatment described in the second paragraph above, anywhere from five to twelve in number to comprise the series. I also understand that these treatments are not effective 100 percent of the time. Dr. Royce has also warned me that there have been side-effects reported in the literature but that patients he has known have not had any persistent complaints. Adverse reactions which have been reported included excitement and sedation. The injections may also cause local irritation of the skin. I am not pregnant and shall wait until the treat- ments are completed before considering becoming pregnant, although pregnancy is not in my plans at this time or in the near-future. Also, I agree to wait in Dr. Royce's office for at least an hour after each treatment, until he advises me that I may safely allow a responsible person to drive me home. I have been advised not to drive an automobile, not to operate any machinery, and to stay at home for the remainder of the day after each treatment. The actions and possible side-effects of each medication listed above has been described to me by Dr. Royce. In addition, I have been advised of the antidepressant and other actions of TOFRANIL, ELAVIL, MARPLAN, NARDIL, PARNATE, AMPHETAMINE, PLEGINE, AND DIDREX. No guarantees have been given to me as to the results which may be achieved by this course of treatment. C.R.'s January 31, 1985, statement read as follows: Permission for Electro-shock Treatment I, [C.R.], hereby give permission to Irving D. Royce, M.D., and his assistants to give me a series of electro-shock treatments, using Anectine, Brevital, Pentothal, and/or Atropine and any related medication. I have occasional back pain from a previous injury. Respondent retained C.R.'s November 13, 1984, and January 31, 1985, statements as part of his medical records on C.R. On seven different occasions, from January 31, 1985, to March 15, 1985, Respondent administered non-convulsive electric current therapy to C.R. using a Reiter Electrostimulator (Model CW47). Before doing so he did not consult with any other physician. In administering non-convulsive electric current therapy to C.R. without consulting with and obtaining the agreement of another physician, Respondent did not act in a manner that was inconsistent with what a reasonably prudent psychiatrist at the time would have done under similar circumstances. Given C.R.'s symptomatology, such therapy was not inappropriate. Rather, it was indicated. Some time after leaving Respondent's office following the fifth non- convulsive therapy session on February 22, 1985, C.R. returned to the office for a second visit, during which she received Ketamine-assisted psychotherapy. Following the sixth non-convulsive electric therapy session on March 8, 1985, C.R. appeared to be disturbed about something and delayed leaving Respondent's office. To help reduce her anxiety, Respondent decided to have a Ketamine- assisted psychotherapy session with her before she left the office that day. These were the only occasions that Respondent administered both non-convulsive electric current therapy and Ketamine to C.R. on the same date. 26/ In doing so on these two occasions, Respondent did not act in a manner that was inconsistent with what a reasonably prudent psychiatrist at the time would have done under similar circumstances. The Reiter Electrostimulator that Respondent used to administer electric current therapy had three different settings, only one of which, Setting 3, was designed to generate a current sufficient to produce a seizure or convulsion. Respondent never used Setting 3 in treating C.R. He only used Settings 1 and 2, which produced non-convulsive stimulation. Although it was always Respondent's intention to comply with C.R.'s wishes and administer non-convulsive, not convulsive, electric current therapy, Respondent took the prudent precautionary measure before each electric current therapy session of premedicating C.R. with Brevital, Atropine and Anectine in the highly unlikely event that there was a mishap resulting in C.R. suffering a seizure or convulsion during a session. Such a mishap never occurred. At no time during any electric current therapy session did C.R. have a seizure or convulsion. Furthermore, she suffered no adverse reaction of any kind to the therapy. Nonetheless, the non-convulsive electric current therapy was discontinued because Respondent felt that, in light of the improvement C.R. had made, his time with her would be better spent pursuing other treatment alternatives. Although the electric current therapy administered to C.R. was at all times non-convulsive in nature, Respondent did not so indicate in the medical records that he maintained on C.R. In these records, Respondent used the abbreviation "ECT" to refer to the non-convulsive electric current therapy he was administering to C.R. "ECT" was then, as it is now, understood by most practitioners to refer to electrconvulsive therapy, although it has also been used by some practitioners to indicate electric current therapy of any type. Therefore, at best, Respondent's medical records convey that Respondent administered some form of electric current therapy in treating C.R., but leave the reader to speculate whether the therapy was convulsive or non-convulsive in nature. 27/ At worst, they inaccurately suggest that Respondent administered electroconvulsive therapy to C.R. C.R.'s Rectal Fissure Respondent never treated C.R.'s rectal fissure. Rather, he insisted that she be treated by a specialist. He provided her with medication for the pain she was experiencing as a result of the fissure only after she had made an appointment to see a specialist. In providing C.R. with such pain medication, Respondent was not practicing outside the scope of his competence or expertise. In January and February of 1985, David Ornstein, M.D., an internist and gatroenterologist, provided C.R. with treatment for her rectal fissure. Following such treatment, Dr. Ornstein instructed C.R. to follow-up with her psychiatrist for psychiatric care. C.R.'s Death On July 11, 1985, C.R. was found dead on the floor in the kitchen of her apartment. She was sitting with her legs crossed and her upper body bent forward. Her head was almost touching the floor. Next to her, lying on the floor, was a telephone receiver. A search by police of the apartment and its contents revealed, among other things: hypodermic needles; syringes; two empty vodka bottles; a large number of empty, partially filled, and filled, labelled 28/ and unlabelled medication vials and containers; 29/ and labelled audio cassette tapes. 30/ An autopsy was conducted on C.R.'s body by the Dade County Medical Examiner's Office. The autopsy revealed the presence of neither alcohol, cocaine or Ketamine in C.R.'s bloodstream. Phenobarbital 31/ and Placidyl, however, were detected. The amount of the former, but not the latter, was in the fatal range. Other drugs, such as Valium, were determined to be present, but merely in insignificant trace amounts. C.R.'s lungs were congested. Such congestion is common in drug- related deaths. Small linear marks, which appeared to be needle track scars, were discovered on C.R.'s left arm. 32/ After the autopsy was performed, the Dade County Medical Examiner's Office determined that C.R.'s death was accidental, that the immediate cause of her death was acute "polydrug [to wit: Phenobarbital and Placidyl 33/ ] intoxication," and that "positional asphyxia" was a secondary contributing factor. There was no evidence that C.R.'s death was the result of chronic substance abuse.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board enter a final order finding Respondent guilty of the violations of former subsection (1)(n) of Section 458.331, Florida Statutes, noted above, disciplining him for having committed these violations by issuing him a reprimand, and dismissing the remaining charges against him. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 18th day of January, 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 18th day of January, 1995.
Findings Of Fact South Miami Hospital's proposed findings of fact: The following proposed findings where adopted and found as fact in the body of this recommended order, or if not explicitly found therein, are hereby adopted as findings of fact: 1, 2, 3, 4, 6 (except the first and last sentences), 7(A) through (E), 8(A) through (J)(except sentences 4 and 5 of (B) and sentence 3 of (F)), 10(except the first sentence), and 11 (except the first sentence). The following proposed findings have been rejected because the Hearing Officer has concluded as a matter of law that the rules exceed statutory authority because they preclude balanced consideration of statutory criteria, and thus the Hearing Officer has not reached the question of whether the rules are reasonably related to the purposes of the statute or appropriate to the ends specified in the statute. These proposed findings are also rejected because they are conclusions of law: 5, 6 (first and last sentences), 10 (first sentence), and 11 (first sentence). The following proposed finding has been rejected because the state agency action report for certificate of need 1244 is not in evidence, and the testimony is not adequate or not adequately supported on the point: 8(B)(sentences 4 and 5). The third sentence of proposed finding of fact 8(F) is rejected because the state agency action report was in error when it stated that seven of eleven units in Dade County were performing 6,000 procedures per year. Proposed finding of fact 9 is rejected as legally irrelevant pursuant to conclusion of law 19. The Department of Health and Rehabilitative Services's proposed findings of fact: The following proposed findings of fact were adopted and found as fact in the body of this recommended order, or if not explicitly found therein, are hereby adopted as findings of fact: 1,2,3(except the second sentence), 4, 5, 6, 8, 9, 10, 11, and 12. The following proposed finding of fact is rejected because in those instances where the 6,000 treatments threshold is not met, the existing and proposed rules preclude consideration of any other rule criteria: 7. The following proposed finding of fact is rejected because the order of consolidation only permits the record in the section 120.57 hearing to be considered in the rule challenge cases, and not vice versa: 3(second sentence). Baptist Hospital of Miami, Inc.'s proposed findings of fact: The following proposed findings of fact were adopted and found as fact in the body of this recommended order, or it not explicitly found therein, are hereby adopted as findings of fact: 1, 2 (except the last sentence), 4, 5, 6, 7(except sentences 2 and 3), 8, 9, 10, 12, 17, 18, and 19. The last sentence of proposed finding 2 is rejected. There is only perhaps one (1) free standing outpatient radiation unit in District XI, and 15 hospital-based units. TR. 72. Thus, the 90 percent of outpatient treatments must in fact be occurring in the 15 hospital based units rather than in outpatient units. Consequently, although there is no evidence of fraudulent or improper suppression of treatments in this record, the hospitals in District XI which have radiation units certainly are in a position to suppress the number of treatments if they choose to do so. Proposed finding of fact 3 is rejected. Evidence Which was presented contrary to this finding has been found in findings of fact 49, 51, 52 and 53. The second and third sentence of proposed findings of fact 7 are rejected. The Hearing Officer needed only 10 to 15 minutes to read through a state agency action report to discover to what extent HRS mentioned or considered the rule, and all of the findings herein pertaining to specific state agency action reports were compiled in that length of time per report. Further, the few mistakes made by Mr. Cushman have been discussed in findings of fact 85- 101, and the totality of those mistakes, hopefully not compounded by mistakes of the Hearing Officer, did not change the conclusions that are inescapable when from finding of fact 101. The decisional history by HRS under the rule has been arbitrary given the fact that the rule is absolute and has no exceptions. Proposed finding of fact 11 is irrelevant since the state agency action reports themselves are in evidence, and is rejected on that basis. Proposed findings of fact 13, 15, and 16 are true but misleading since the analysis in each case by HRS was not based upon consideration of the entire District, but was a finding based solely upon a subarea in the district. The essentials of these proposed findings of fact have been dealt with in findings of fact 95B and 97B, C, and D. Proposed finding of fact 14 is rejected because lacking a basis of fact in the record to make it relevant. The record contains no evidence as to any local health systems agency having subdivided a district, except for District XI, and it further contains no evidence as to why that might be relevant in evaluation of certificate of need decisions in districts other than District XI. Mercy Hospital, Inc.'s proposed findings of fact: Proposed finding of fact 1 is rejected as a proposed finding of fact because it is a conclusions of law and has been discussed in that section, to the extent relevant. The following proposed findings of fact were adopted and found as fact in the body of his recommended order, or if not explicitly found therein, are hereby adopted as findings of fact: 2(except the last sentence), 3, 5, and 6. The last sentence of proposed finding of fact 2 is rejected. The fact that the state agency action reports in some cases, as noted in finding of fact 100, mentioned that utilization rates of some or all of the units in the district does not compel the conclusion proposed that "it was in fact one of the criteria that had to be met." The Hearing Officer has read each state agency action report, and although a utilization rate may have been mentioned in the state agency action report in some cases, HRS did not state in the report that the 6,000 treatments threshold "had to be met" or that the rule was satisfied, unless mentioned in the findings above. Proposed finding of fact 4 has been dealt with in conclusions of law 18 and 19. A number of the facts contained in this proposed finding have in fact been found. But the arguments of law contained in this proposed finding of fact are either contained in the conclusions of law or are irrelevant in view of those conclusions of law. COPIES FURNISHED: John Gilroy, Esquire Dept. of Health and Rehabilitative Services Building 1, Suite 407 1323 Winewood Boulevard Tallahassee, Florida 32301 Jean Laramore, Esquire G. Steven Pfeiffer, Esquire LARAMORE & CLARK, P.A. 325 North Calhoun Street Tallahassee, Florida 32301 Lewis W. Fishman, Esquire 9400 South Dadeland Blvd. Suite 420, Dadeland Towers South Miami, Florida 33156 Kyle R. Saxon, Esquire Catlin, Saxon, Tuttle & Evans 800 Alfred I. duPont Building Miami, Florida 33131 Steven Huss, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee Florida 32301 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Liz Cloud, Chief Bureau of Administrative Code 1802 The Capitol Tallahassee, Florida 32301 Carroll Webb, Executive Director Administrative Procedure Committee 120 Holland Building Tallahassee, Florida 32301
The Issue Whether Petitioner’s request for coverage of proton beam radiation therapy (“proton beam therapy” or “PBRT”) is a covered benefit pursuant to the State Employees’ Health Maintenance Organization (“HMO”) Plan (“Plan”), administered by AvMed.
Findings Of Fact Respondent is the state agency charged with administering the state employee health insurance program pursuant to section 110.123. At all times material hereto, Petitioner was a member of the Plan. AvMed is the third-party administrator for the Plan at issue in this cause. As the third-party administrator, AvMed provides claims processing, utilization, and benefit management services. The applicable benefit document is the State Employees’ HMO Plan, Group Health Insurance Plan Booklet and Benefits Document (“Plan Document”), effective January 1, 2019. Petitioner is a 66-year-old male who was diagnosed with prostate cancer in November 2017 and underwent a prostatectomy to remove his prostate on April 12, 2018. Subsequent to his initial surgery and treatment, Petitioner experienced increasing prostate specific antigen (“PSA”) in three follow-up tests. His prostate cancer had returned. Petitioner’s physician sought to treat his condition with PBRT, a form of external beam radiation utilizing protons, rather than traditional intensity modulated radiation therapy (“IMRT”), which is, without question, covered under the Plan. Medicare, a federal healthcare insurance program, agreed to pay 80 percent of Intervenor’s charges for PBRT, leaving Petitioner responsible for the remaining 20 percent being sought to be paid by Petitioner’s Plan. On July 3, 2019, Petitioner, through his healthcare provider, Maria-Amelia Rodrigues, M.D., and Intervenor, Miami Cancer Institute, submitted a request for coverage of PBRT to AvMed. On July 10, 2019, AvMed denied the preservice request for coverage on the basis that the therapy was experimental/investigational and, therefore, not medically necessary treatment for the member’s condition. The request was reviewed by Sri Gorty, M.D., a consultant radiation oncologist at Magellan Healthcare, which is under contract with AvMed. On July 23, 2019, Petitioner submitted a request for a Level I appeal to AvMed. The appeal was reviewed by Dr. Gregg Goldin, M.D., a consultant radiology oncologist at Dane Street, which is under contract with AvMed. He filed a report dated August 19, 2019. On August 20, 2019, AvMed denied the request for Level I appeal on the basis that the therapy was experimental/investigational and, therefore, not a medically necessary treatment. On November 19, 2019, Petitioner submitted a request for an “Expedited” Level II appeal to Respondent. The Level II appeal was reviewed by Dearline Thomas-Brown, a registered nurse and Level II appeal coordinator for Respondent. On November 21, 2019, Respondent denied Petitioner’s Level II appeal on the basis that the therapy is experimental/investigational and, therefore, not medically necessary for treatment of the member’s condition. Pursuant to the Plan Document, the Plan pays its share of the cost of covered services, if the services are: Ordered by a Network Provider (a provider who is in AvMed’s network); Considered Medically Necessary for the covered person’s treatment because of accident, illness, condition or mental health or nervous disorder; Not specifically limited or excluded under this Plan; and Rendered while this Plan is in effect. Pursuant to the Plan Document, Section I. Introduction: The Plan is not intended to and does not cover or provide any Medical Services or benefits that are not Medically Necessary for the diagnosis and treatment of the Health Plan Member. AvMed determines whether the services are Medically Necessary on the basis of terms, conditions, and criteria established by the Plan as interpreted by the state, and as set forth in medical guidelines. This chart provides a description of services and supplies covered under the Plan. Coverage Access Rules are specified under the Plan as follows: Cancer Services Diagnosis and Treatment Includes both inpatient and outpatient diagnostic tests and treatment (including anti-cancer medications administered by Network providers), including cancer clinical trials as set forth in the Florida Clinical Trial Compact. Does not include Experimental or Investigational Treatment. In order to be a covered benefit, the treatment must be “medically necessary,” not “experimental or investigational,” and it must not be specifically excluded by the Plan. “Medically Necessary” is defined as follows: The use of any appropriate medical treatment, service, equipment and/or supply as provided by a Hospital, skilled nursing facility, physician or other provider which is necessary for the diagnosis, care and/or treatment of a Health Plan Member’s Illness or injury, and which is: Consistent with the symptom, diagnosis and treatment of the Health Plan Member’s condition; The most appropriate level of supply and/or service for the diagnosis and treatment of the Health Plan Member’s condition; In accordance with standards of acceptable medical practice; Not primarily intended for the personal comfort or convenience of the Health Plan Member, the Health Plan Member’s family, the physician or other health care providers; Approved by the appropriate medical body or health care specialty involved as effective, appropriate and essential for the care and treatment of the Health Plan Member’s condition; and Not experimental or investigational. The service must meet all of the above-referenced criteria in order to be medically necessary. Given the above definition, if a service is experimental or investigational, then it cannot be medically necessary. Section VI. Limitations and Exclusions in the Plan Document specifically exclude services that are “experimental/investigational or not medically necessary treatment with the exception of routine care in connection with a clinical trial in cancer, pursuant to the Florida Clinical Trial Compact and the Patient Protection and Affordable Care Act.” “Experimental and/or Investigational” is defined as follows: For the purposes of this Plan a medication, treatment, device, surgery or procedure may initially be determined by AvMed to be experimental and/or investigational if any of the following applies: The FDA has not granted the approval for general use; or There are insufficient outcomes data available from controlled clinical trials published in peer- reviewed literature to substantiate its effectiveness for the disease or injury involved; or There is no consensus among practicing physicians that the medication, treatment, therapy, procedure or device is safe or effective for the treatment in question or such medication, treatment, therapy, procedure or device is not the standard treatment, therapy procedure or device utilized by practicing physicians in treating other patients with the same or similar condition; or Such medication, treatment procedure, or device is the subject of an ongoing Phase I or Phase II clinical investigation, or Experimental or research arm of a Phase III clinical investigation, or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as comparted with the standard for treatment or diagnosis of the condition in question. If any one or more of the above-cited criteria are met, then the treatment is experimental and/or investigational and is not a covered service. In making an adverse determination as to coverage in both the Level I and Level II appeals, Edwin Rodriguez, M.D. (note the slightly different spelling of Petitioner’s expert Dr. Maria-Amelia Rodrigues versus Dr. Edwin Rodriguez), and Nurse Thomas-Brown utilized AvMed’s Medical Coverage Guideline on PBRT. This coverage guideline regarding PBRT provides AvMed’s “Exclusion Criteria” explaining “PBRT is not covered, and is considered investigational, as to all other tumors not listed” in the guideline. PBRT is not an approved treatment option for localized prostate cancer under the NIA Magellan criteria. The Medical Technology Assessment Committee at AvMed drafts clinical policy guidelines and is responsible for maintaining or changing them as technology advances. AvMed’s policy on use of PBRT for the treatment of prostate cancer states that it is not medically necessary because studies have not shown clinical outcomes to be superior to conventional radiation therapy (i.e., IMRT). This policy was developed following extensive review of studies in peer-reviewed medical literature, available guidelines, technology assessments, and opinions from experts. The policy is updated on a yearly basis in order to take into consideration any new evidence. A recent review of the policy on PBRT resulted in no change in AvMed’s position on coverage for treatment of prostate cancer. The medical coverage guidelines are meant to be used in conjunction with the Plan Document to determine whether services are medically necessary and a covered benefit. Dr. Gorty, AvMed’s external reviewer from Magellan Healthcare, who was accepted as an expert in the field of radiation oncology, testified that his recommended denial of coverage of PBRT was informed by Petitioner’s medical records, Intervenor’s Letter of Medical Necessity, clinical trials, the model policy from the American Society of Therapeutic Radiation and Oncology (“ASTRO”), and the National Comprehensive Cancer Network (“NCCN”) guidelines. PBRT PBRT is a procedure that uses protons to deliver a curative radiation dose to a tumor, while reducing radiation doses to healthy tissues and organs, which results in fewer complications and side effects than IMRT. As stated earlier, Petitioner’s prostate was removed in April 2018. Thereafter, rising PSA levels indicated that he needed further treatment, and Dr. Rodrigues, a board-certified radiation oncologist at Miami Cancer Institute, became his treating physician. Dr. Rodrigues has been treating patients for 23 years, including prostate cancer patients. She was accepted as an expert in her field for these proceedings. Dr. Rodrigues determined PBRT to be the appropriate radiation treatment for Mr. Zolfaghari given his type of prostate cancer—recurrent prostate cancer. Dr. Rodrigues testified that recurrent prostate cancer occurs when a cancer has been treated and then reoccurs. In addition to PBRT, Dr. Rodrigues recommended, and Petitioner received, androgen deprivation therapy, generally referred to as hormone therapy, to be used in conjunction with PBRT. Dr. Rodrigues testified that the androgen deprivation therapy blocks the production of testosterone. She testified that patients with recurrent prostate cancer or certain high-risk patients have better overall survival when the two treatments are used in conjunction. As an additional aggravating factor to Petitioner’s cancer treatment, Petitioner was diagnosed with colon cancer leading to surgery in January 2020. Dr. Rodrigues testified that Petitioner’s colon cancer made his need for PBRT even more necessary, because now Petitioner is at a higher risk for adverse effects from the unwanted spread of toxicity common with IMRT. Dr. Rodrigues, as a Miami Cancer Institute physician, wrote letters requesting treatment and appealing denials of treatment as set forth above, and testified at the March 9, 2020, administrative hearing in support of Petitioner’s efforts to obtain coverage through AvMed for PBRT, which she considers to be a medically necessary treatment modality. Dr. Rodrigues was asked why she had not gone forward and provided Petitioner IMRT in order to prevent any further delay due to the passage of time from unsuccessful appeals of the denial by AvMed for the PBRT treatment of his recurring prostate cancer. She replied that she was attempting to secure a less toxic treatment modality, PBRT, for her patient who was already approved by Medicare for coverage of 80 percent of the cost of the treatment. MEDICAL NECESSITY OF PBRT VERSUS IMRT There is no dispute that IMRT is an accepted treatment modality for Petitioner’s recurrent prostate cancer, even bearing in mind his complicating factor of colon cancer surgery and treatment endured following his 2018 prostatectomy. The remaining dispute here is whether PBRT is both medically necessary and not an experimental and/or investigative form of radiation treatment. IMRT is a recognized form of treatment for Petitioner’s recurrent prostate cancer. Dr. Rodrigues testified that Miami Cancer Institute considered only candidates for PBRT as those who would qualify for IMRT, such as Petitioner. Given the availability of another treatment option, IMRT, which is the most widely recognized standard of care within the medical establishment for the treatment of Petitioner’s condition, Respondent’s experts conclude that PBRT is not medically necessary because it is not the most appropriate level of service in this case. While PBRT has been accepted by AvMed, according to its Plan, for certain types of cancer, the insurer has not yet authorized it for the treatment of prostate cancer. This is where the semantics of the contract come into play. Petitioner and Intervenor argued that Respondent mistakenly based its denial upon a diagnosis of “localized prostate cancer” (Dr. Rodrigues’ reading of the proscription of the use of PBRT for Petitioner) rather than “recurrent prostate cancer” (not specifically proscribed by the Plan according to her reading), combined with the fact that Petitioner’s unique medical condition requires lower toxicity in the specific type of radiation used. PBRT, she testified, offers lower radiation toxicity, which will have less of a harmful effect on Petitioner’s colon and rectum as a survivor of colon cancer surgery. Dr. Rodriguez, the AvMed senior medical director, testified that studies comparing PBRT to 3-D confirming radiation or IMRT are limited. Overall studies have not shown clinical outcomes to be superior to conventional radiation therapy. In addition to the preservice and Level I appeal reviews by AvMed, and Respondent’s Level II appeal review, an Independent Organization Review (“IRO”) was conducted by a licensed radiation oncologist employed by Independent Medical Expert Consulting Services. As a result of this independent review, the Plan’s denial was upheld. Dr. Rodrigues presented studies in her testimony and a letter of medical necessity which cited the potential for favorable outcomes with PBRT. Dr. Gorty, Respondent’s expert in radiation oncology, contradicted her testimony in that many of the studies she cited noted a need for further study regarding the safety and efficacy of PBRT for treatment, and all of these studies were based upon “localized prostate cancer,” rather than “recurrent prostate cancer.” Dr. Gorty also testified that Petitioner's records indicated that his cancer was localized, although it could also be "recurrent." Dr. Gorty testified that clinical studies show no significant difference in the toxicity between IMRT and PBRT. Further, Dr. Rodriguez explained that localized cancer can be recurrent. “Localized” refers to where the cancer may be found, while “recurrent” refers to a repeat or re-occurrence of a cancer, which might return to the same location or reappear in a different location. Paragraph 15 lists the criteria to determine whether a treatment or procedure is “medically necessary” under the AvMed policy. PBRT does not meet the third criterion of the definition of “medically necessary,” as PBRT treatment of prostate cancer is not in accordance with standards of acceptable community practice. Dr. Gorty testified that AvMed medical guidelines utilize IMRT as the “next generation” treatment, rather than PBRT. Further, Dr. Gorty testified that he was aware of several recent clinical trials concerning PBRT and IMRT, and these studies do not reach a conclusion that PBRT is preferable to IMRT. PBRT does not meet the fifth criterion of the definition of “medically necessary,” as PBRT has not been approved by the appropriate medical body or healthcare specialty involved as effective, appropriate, and essential for the care and treatment of prostate cancer. PBRT is not essential for the treatment of prostate cancer. There are several treatment modalities that are generally available for the treatment of prostate cancer and, as discussed above, several of those treatment options were reasonable treatment options for Petitioner. While Dr. Rodrigues believes PBRT to be preferable for Petitioner in this case due to, in her opinion, fewer adverse side effects of the treatment, she admitted that Petitioner is a suitable candidate for IMRT. Therefore, PBRT does not meet the sixth criterion of the definition of “medically necessary,” as it meets the definition of “experimental and/or investigational.” Specifically, criteria 2, 3, and 4 of the definition of “experimental and/or investigational” are met, which lead to the ultimate conclusion that PBRT is not medically necessary in this case. EXPERIMENTAL AND/OR INVESTIGATIONAL TREATMENT Paragraph 18 sets forth the criteria for determining whether a treatment or procedure is “experimental and/or investigational.” The second criterion from the definition of experimental and/or investigational treatment is met in this case. Insufficient outcomes data are not available from controlled clinical trials published in peer-reviewed literature to substantiate PBRT’s safety and effectiveness for treatment of prostate cancer. Dr. Rodriguez testified that there is a lack of peer-reviewed, published, randomized studies regarding proton beam therapy. Further, PBRT treatment is not the generally accepted standard of care. Dr. Rodrigues testified that only a handful of medical centers in the United States are using PBRT to treat cancer malignancies. Only two such programs are located in Florida—the University of Florida and Intervenor. Outside of Florida, only Massachusetts General and Loma Linda offer the treatment. Prior to Intervenor offering the treatment, Dr. Rodrigues referred her patients to one of these other facilities for PBRT when she deemed it appropriate to do so. Current randomized trials are on-going and being published in peer- reviewed medical literature. PBRT treatment for prostate cancer is considered investigational and not a standard of care option and, therefore, not medically necessary. Nurse Thomas-Brown testified that a treatment considered experimental or investigational is, automatically, not medically necessary. NIA Magellan Clinical Guideline Number NIA_CG_124, which was developed in July 2018 for implementation in January 2019 to assist physicians in the application of treatment, states that both surgery and radiation therapy should be used to treat organ confined prostate cancer, as well as prostate cancers extended into adjacent tissues. This guideline finds that PBRT is not an approved treatment option for localized prostate cancer as studies comparing it to 3-D conformal radiation or IMRT are limited. Leading organizations, such as NCCN and ASTRO, have noted insufficient data outcomes and a need for more study of proton beam therapy, which these organizations have not yet accepted as the standard of care. PBRT also meets the third criterion of the definition of “experimental and/or investigational.” There is no consensus among practicing physicians that PBRT is safe or effective for the treatment of prostate cancer or that PBRT is the standard treatment utilized by practicing physicians in treating other patients with the same or similar conditions. Both Dr. Gorty and Dr. Rodriguez testified that proton beam therapy is experimental and investigational and, therefore, not medically necessary for all forms of prostate cancer; two additional radiation oncologists reviewed the appeal and reached the conclusion that PBRT is not medically necessary. Additionally, there was uncontroverted evidence that IMRT, not PBRT, is the standard form of treatment utilized by practicing physicians for treatment of prostate cancer. Dr. Gorty testified that AvMed approved the NIA Magellan clinical guidelines for prostate cancer, which are based on the peer-reviewed studies; and he explained three such studies. His testimony noted that the second study from the University of Pennsylvania at Baltimore, Maryland, specifically matched Petitioner’s medical condition. This study compared 307 men and their comparative toxicity outcomes of PBRT verses IMRT for post-operative sites. It concluded that future prospective investigation and ongoing follow-up will determine whether dosimetric differences between treatment with IMRT and proton beam therapy convert to meaningful differences in long-term outcomes. As part of the appeal process on behalf of Petitioner, Intervenor also requested a review by an IRO. The review was completed by a board-certified radiation oncologist, and a report was generated on January 9, 2020. The “List of Materials Reviewed” is extensive and includes Petitioner’s medical records and Intervenor’s supporting documentation. The independent reviewer upheld the denial and noted that medical necessity has not been established. The IRO states that “until the current randomized trials ongoing are published in peer reviewed medical literature, proton beam treatment for prostate cancer is considered investigational and not a standard of care treatment option.”
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Management Services, Division of State Group Insurance, enter a final order denying Petitioner's request for coverage for proton beam therapy. DONE AND ENTERED this 4th day of May, 2020, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 2020. COPIES FURNISHED: Erica D. Moore, Esquire Thomas E. Wright, Esquire Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399 (eServed) Abolghasem Zolfaghari 10910 Southwest 140th Avenue Miami, Florida 33186 Frank A. Florio, Esquire Maria D. Garcia, Esquire Latasha Gethers Hines, Esquire Kozyak, Tropin & Throckmorton, LLP 2525 Ponce de Leon Boulevard, Ninth Floor Coral Gables, Florida 33134 (eServed) William Chorba, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed)
The Issue Two issues are raised in this case. The first issue concerns the question of whether the Petitioner must seek review and permission by and from the Respondent before engaging in this project to provide inpatient radiation therapy. See Section 381.706(1)(h), Florida Statutes. If that question is answered in the affirmative, then the next question to be answered is whether Petitioner is entitled to a certificate of need to provide inpatient radiation therapy services at its hospital in Pensacola, Florida. In answering the initial question reference is made to the case of Scared Heart Hospital of Pensacola v. Department of Health and Rehabilitative Services, and Baptist Hospital, DOAH Case No. 90-3576. That reference is made because Intervenor in the present case has made a motion in limine which asserts that the Petitioner here is estopped from raising the issue of whether jurisdiction resides with the Respondent to require a certificate of need based upon the belief that DOAH Case No. 90-3576 has answered that question in the affirmative. Thus, as argued in the motion in limine, Petitioner in the present action should be barred by doctrines of collateral estoppel and res judicata from further examining that issue. Both issues are addressed in the fact finding and conclusions of law which follow, to include a ruling on the motion in limine. At the commencement of the hearing in discussing the motion in limine an examination was made of the significance, if any, of the Petitioner having failed to clearly state its opposition to the Respondent's assertion of jurisdiction over the subject matter and that party in the Petition contesting the decision on the merits to deny the application for certificate of need. Consequently, the issue of whether Petitioner has waived its right to contest the jurisdiction is also addressed in the Recommended Order.
Findings Of Fact MOTION IN LIMINE (DOAH Case No. 92-3576) On the prior occasion described in DOAH Case No. 90-3576, Petitioner had applied to Respondent for a certificate of need to institute radiation therapy services and to construct a radiation therapy facility at the campus of its hospital in Pensacola, Florida. That center was to serve inpatients and outpatients. The projected capital expenditure for that project approximated 3.7 million dollars. Petitioner contended that the radiation therapy center that would be constructed would be an extension to an existing oncology program as contrasted with the establishment of a "new service." Consistent with that position Respondent asserted that the basis for requiring a certificate of need was found in the language at Section 381.706(1)(c), Florida Statutes, which states: A capital expenditure of $1 million or more by or on behalf of a health care facility or hospice for a purpose directly related to the furnishing of health services at such facility; provided that a certificate of need shall not be required for an expenditure to provide an outpatient health service, or to acquire equipment or refinance debt, for which a certificate of need is not otherwise required pursuant to this subsection. The department shall, by rule, adjust the capital expenditure threshold annually using an appropriate inflation index. By resort to Section 381.706(1)(c), Florida Statutes, as the basis for declaring jurisdiction, the Respondent in its preliminary position did not perceive that the proposed project constituted establishment of new institutional health services or a substantial change to the existing health services, rather, it was believed to be constituted of construction costs as a capital expenditure related to the existing oncology program which expenditure met the $1 million threshold. If the basis for jurisdiction was found within Section 381.706(1)(c), Florida Statutes, then the would-be intervenor in that case, the same intervenor here, would be denied intervention. The basis for denial is found within the limitations placed upon those persons who may participate in a decision involving certificate of need for a capital expenditure as identified in Section 381.706(1)(c), Florida Statutes. That contest is between the Respondent and an applicant for the certificate. Third parties have no right to participate. On the other hand, if the basis for jurisdiction is as argued by the petition for intervention in the prior case, that basis being the jurisdiction established by Section 381.706(1)(h), Florida Statutes, then a third party health care provider in competition with the applicant seeking a certificate of need could participate in that decision. The language in Section 381.706(1)(h), states: The establishment of inpatient institutional health services by a health care facility, or a substantial change in such services, or the obligation of capital expenditures for the offering of, or a substantial change in, any such services which entails a capital expenditure in any amount, or an annual operating cost of $500,000 or more. The department shall, by rule, adjust the annual operating cost threshold annually using an appropriate inflation index. The Hearing Officer in DOAH Case No. 90-3576, heard the matter and entered his Recommended Order to resolve the right of the present intervenor to intervene in that cause. In doing so the Hearing Officer generally addressed the jurisdictional basis upon which the agency could review the application. Nothing in that process attempted to distinguish between inpatient and outpatient costs by way of a discrete analysis and allocation of those costs. Observations were made in passing concerning the aggregate amount of inpatient and outpatient costs. In particular reference was made to the capital expenditure of approximating 3.7 million dollars. No attention was given the issue of the threshold amount associated with annual operating costs identified in Section 381.706(1)(h), Florida Statutes. Factual reference to that jurisdictional amount associated with annual operating costs was left for some other occasion. The thrust in DOAH Case No. 90-3576 was to determine whether the appropriate basis for the jurisdictional claim would be found in Section 381.706(1)(c), Florida Statutes, as initially contended by the Respondent or upon resort to Section 381.706(1)(h), Florida Statutes, as contended by the petition for intervention, without a more complete analysis concerning the jurisdictional amount set out in Section 381.706(1)(h), Florida Statutes, should the hearing officer be persuaded that the latter provision constituted the grounds for review generally stated. In the factual and legal conclusions by the hearing officer in DOAH Case No. 90-3576, he determined that the project in question for inpatient and outpatient radiation therapy services constituted the establishment of new inpatient institutional health services or at least constituted a substantial change in the services that were being provided by the applicant. Thus the petition for intervention was deemed appropriate and the motion to dismiss that petition was recommended for denial. Through the Final Order which followed, with some minor modifications which have no influence on the present case, the Respondent adopted the findings of fact of the hearing officer in DOAH Case No. 90-3576, and granted the petition to intervene. The Recommended Order was entered on April 3, 1991, and the Final Order on May 21, 1991. The parties in DOAH Case No. 90-3576 did not proceed to hearing before the present case was heard. The decision by the hearing officer in DOAH Case No. 90-3576 was to defer consideration of the matter pending hearing in the present case. That choice was upon a request by all parties in DOAH Case No. 90-3576. PARTIES STIPULATIONS CONCERNING REVIEW CRITERIA The parties agree that Petitioner's Certificate of Need Application No. 6772, the present application, meets the following statutory criteria: Section 381.705(1)(c), (h), except for the third clause which is not applicable and the fourth clause which is at issue, (i), (m), except that Intervenor contends that the project costs were not properly allocated to Petitioner's Certificate of Need Application No. 6772, and (n) to Section 381.705(1). The parties also agree that the following statutory criteria are not applicable to Petitioner's application: Section 381.705(1)(e), (f), (g) and (j), Florida Statutes. Within the context of the stipulation as to criteria, the parties agree that the following issues are to be litigated: The need for the proposed project in relation to the applicable district plan and state health plan. The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care services in the service district. The availability of and adequacy of other health care facilities and services in the service district, which may serve as alternatives for the services proposed to be provided by Scared Heart Hospital. The impact of the proposed project on the cost of providing health services proposed by Scared Heart Hospital. Whether less costly, more efficient, or more appropriate alternatives to the proposed services are available. Whether existing inpatient facilities, providing inpatient services similar to those proposed are being used in an appropriate and efficient manner. Whether patients will experience serious problems in obtaining inpatient care of the type proposed, in the absence of the proposed new service. The need that the population served or to be served has for the health services proposed to be offered, and the extent to which residents in the district are likely to have access to those services. The contribution of the proposed service in meeting the health needs of members of such medically underserved groups. BACKGROUND FACTS On August 22, 1991, Petitioner gave notice that it intended to apply for the September 19, 1991, batch review cycle to initiate inpatient radiation therapy services at its Pensacola, Florida facility. That notification referred to the fact that the Petitioner was presently constructing an outpatient cancer center to provide radiation therapy services and that the anticipated opening date for that outpatient facility was December, 1991. Petitioner did apply for the September 19, 1991 batch review for initiation of inpatient radiation therapy services. At that time the construction of the outpatient radiation therapy services was proceeding. Petitioner had received a letter of non-reviewability for the construction of the outpatient cancer treatment facility on a prior date. The completion of the outpatient radiation therapy services center at the Petitioner's facility was completed and Petitioner began to provide outpatient radiation treatment in April, 1992. The cancer treatment program at Petitioner's facility is a comprehensive cancer center providing radiation therapy, chemotherapy, IV. hydration, blood transfusion, nutrition counseling, social work counseling and a library. The outpatient facility for radiation therapy is fully staffed and supplied. It was placed on the books of the Petitioner as an active asset in the year 1991. Before submitting the application for review in September, 1991 review cycle, Petitioner conferred with Respondent and was instructed to submit an application for the initiation of inpatient services and to allocate costs to the project based upon a percentage of the total facility which would be devoted to inpatient services. Through the application Petitioner noted that the total cost of the establishment of the radiation therapy services projected to open in December, 1991, was $4,124,475. Pursuant to the instruction by the Respondent $618,671 was allocated as an estimate of capital expenditures for inpatient radiation therapy services. This approximates 15 percent of patients being treated as inpatients of the total number of patients treated by radiation therapy. Generally stated, the experience of most providers is that 10 to 15 percent of radiation therapy is delivered on an inpatient basis with the balance of the radiation therapy being delivered on an outpatient basis. The allocation of capital expenditures to inpatient therapy was an artificial device mandated by the Respondent. It does not reflect the actual experience. In actuality the incremental project costs related to capital expenditures for the inpatients receiving radiation therapy are zero. The reason for this finding is based upon the fact that the equipment for providing the inpatient radiation therapy is already in place, the facility for providing that care had been constructed, there is no associated incremental depreciation for inpatient care, the project has been fully paid for from funded depreciation cash and has been placed upon the books of the facility at 100 percent of that total. In essence, the capital costs have been incurred before the advent of the inpatient radiation therapy services. Additional costs promoted by the provision of care for inpatients who receive radiation therapy at the facility would be supply expenses attributable to those inpatients and the possibility of additional salaries attributable to overtime work done by staff to serve the inpatients. These are minimal costs. Operating costs were also artificially allocated to inpatients in the application. For the first year of operation, salaries allocated to inpatient care were estimated at $64,950.00, with associated benefits at $9,898.00, other patient care expenses at $17,925.00 and depreciation in the amount of $51,135.00. Even when resort is made to this certificate the proposal to institute inpatient radiation therapy does not reach the $500,000.00 threshold in annual operating costs, in addition to having no fiscal impact by way of capital expenditures. Petitioner is a 391 bed acute general hospital located in Pensacola, Florida. The services that it provides are available to inpatients and outpatients. Among those services are an open heart facility, neonatal intensive care Level II and Level III units, and freestanding 50 bed children's hospital. The patients receiving care for cancer are provided screening programs, risk assessments, preventative education programs, diagnostic services, surgery, chemotherapy and radiation therapy on an outpatient basis. The application for inpatient radiation therapy was not favorably reviewed in the State Agency Action Report issued on or about January 8, 1992. This led to the present hearing when Petitioner contested the decision to deny the application. Intervenor and West Florida Hospital, both of Pensacola, Florida, and the same planning district where Petitioner is located, have certificates of need to provide inpatient radiation therapy. They also provide outpatient radiation therapy. The other two hospitals treat patients referred by Petitioner for radiation therapy needs. The inpatients of the Petitioner requiring radiation therapy must be transported to the other two hospitals to receive that care. The majority of those patients who are being transported are referred to the Intervenor. Pediatric cancer patients from Petitioner's facility are transported to West Florida. The patients who are transported from Petitioner's facility to the Intervenor's facility are received by the Intervenor as outpatients. When they return to the Petitioner's facility they are perceived as inpatients. Each of the other two facilities who offer radiation therapy pursuant to certificates of need have two linear accelerators to provide inpatient and outpatient radiation therapy. Petitioner seeks to have its single linear accelerator which now provides outpatient radiation therapy made available to provide inpatient radiation therapy. There are also two non-hospital based radiation therapy centers which have single linear accelerators to provide outpatient radiation therapy services. Those non-hospital based providers are located in Ft. Walton Beach and Crestview, Florida, within the same planning district that is associated with this application. REVIEW CRITERIA 1/ Section 381.705(1)(a), Florida Statutes, requires that an application be reviewed for its consistency with the state and district health plans. Neither of those plans addresses the provision of radiation therapy services. As a consequence, neither plan sets forth need allocation factors that would address this type application. In view of the silence of the state and local health plans concerning inpatient radiation therapy, the application cannot be seen as inconsistent with those plans. Section 381.705(1)(b), Florida Statutes, speaks in terms of the availability, quality of care, efficiency, appropriateness, accessibility, and extent of utilization and adequacy of like and existing health care services in the service district to be served by the applicant. As stated before inpatient radiation therapy is being delivered by two other providers. Those providers make available and could continue to make availability the quality of care, which is efficient, appropriate, accessible and adequate in delivering inpatient radiation therapy to those patients which Petitioner would serve if granted the certificate of need to do so. The inpatient radiation therapy services offered by those two providers are not over-utilized at present nor would they be in the foreseeable future. The exception to these findings would be related to a quality of care issue not pertaining to the actual delivery of radiation therapy to patients referred from the Petitioner to the other two providers but related to the inconvenience in preparing those patients for transport for delivery of therapy and the transport itself. For some patients who are required to undergo the preparation for transport and transport, that process can be quite painful. Patients have refused to be transported to receive radiation therapy and this has complicated their treatment. It would be a less uncomfortable process if the patients were undergoing the radiation therapy at the Petitioner's facility. Physician's practice patterns in this community where some physicians choose to practice in a single hospital notwithstanding their admission privileges in multiple hospitals complicates the issue in that a patient may be admitted to Petitioner's facility because the admitting physician chooses to practice there alone. Once a diagnosis is made and a decision reached that the patient in that hospital needs to undergo radiation therapy, the need to transport for those treatment ensues. Moreover, as suggested, the decision to utilize radiation therapy in the treatment is not ordinarily made at the initial moment of admission when health care professionals are trying to make the initial diagnosis concerning the patients complaints in deciding whether they are associated with cancer or not and if radiation therapy would benefit the patient or even in the instance where the patient is known to have a history of that illness whether radiation therapy is indicated. Therefore, there might not be a reason to try and place the patient in a facility that has inpatient radiation therapy available if that treatment regime upon evaluation does not seem indicated. The issue concerning the ability to transfer a patient from one facility to another for the overall hospitalization to include provision of inpatient radiation therapy such that a patient who has been determined to need radiation therapy could be transferred from Petitioner's facility to Intervenor's facility for overall care, while theoretically possible does not seem practicable. Additionally, the patients who receive outpatient radiation therapy through Petitioner's facility who would need at some future point in treating the condition to be transferred to another facility to receive radiation therapy once admitted as an inpatient in Petitioner's facility breaks the continuity of the management of the care by requiring the patient to undergo an evaluation by two different radiation therapists, disrupting the patient- physician relationship in a setting which is complicated by the patient's condition. Nonetheless, the quality of care is not so compromised by the need to transport for the inpatients at the Petitioner's facility to receive radiation therapy to conclude that it constitutes a reason standing alone to grant the certificate of need. In a similar vein, as contemplated by Section 381.705(1)(d), Florida Statutes, the availability and adequacy of other health care facilities and services and hospices in the service district of the applicant, such as outpatient care and home care services, which might serve as alternatives for the applicant's proposal have been considered. Out of that list, only the possibility of the use of outpatient care provided by the existing facilities who offer outpatient radiation therapy would arguably have pertinence to this inquiry. They would not constitute an available and adequate substitute for inpatient radiation therapy for reason that patients who are admitted to a hospital are distinguished from those who come to the facility from other places for purposes of receiving outpatient radiation therapy. That distinction has to do with the gravity of the condition of the patient which caused the patient to be admitted to the hospital in the first instance, and to receive, together with medical attention and other therapies, the provision of radiation therapy. Concerning that portion of Section 381.705(1)(h), Florida Statutes, which describes the applicant's need to address the availability of alternative uses of resources for the provision of other health services, that clause was referred to as an issue in the prehearing stipulation but was not advanced at the hearing. Through the prehearing stipulation the parties did not include reference to Section 381.705(1)(k), Florida Statutes, as a provision about which there was an agreement concerning compliance or the need to comply with its terms. The record reveals that the applicant and the existing providers address the need for radiation therapy of individuals who are not residing in the service district. This project does not appear to have a pronounced influence in improving or diminishing health care for persons not residing in the service district. Section 381.705(1)(l), Florida Statutes, addresses the probable impact of the project on the cost of providing health services proposed by the applicant and it takes into consideration the effects of competition on the supply of health services being proposed and any improvements or innovations in the financing and delivery of health services which foster competition and serve as a promotion of quality assurance and cost effectiveness. Whether the applicant delivers services to the inpatients that it would gain with recognition of its application or some other entity serves the needs of those patients, the basic costs of providing health services would be relatively the same. The exception is the improvement in the circumstance of health care costs related to the transport of the patients from the Petitioner's facility to the two other facilities for provision of the radiation therapy of inpatients in the Petitioner's facility and the attendant costs of duplication of patient charges and professional fees charged by the physician therapist potentially associated with having a patient move from the status of an outpatient at the Petitioner's facility to an admitted patient at that facility who receives radiation therapy at one of the other two facilities while undergoing inpatient care in the Petitioner's facility. These additional costs in transport and potential for patient charges associated with procedures in the other two hospitals and physicians fees in those other two hospitals which are duplicative of efforts made by the Petitioner's outpatient radiation program in its procedures and the physician's fees associated with those outpatient radiation therapy procedures could be done away with if the project were approved. There is no indication of any significant improvements or innovations in the financing and delivery of health services associated with this application which might foster competition and serve to promote quality assurance and cost effectiveness. The cost improvements that are discussed here standing alone do not justify the applicant being granted a certificate of need. The advent of an inpatient radiation therapy service will not be so adverse in its impact that it will cause the Intervenor or any other existing facility to lose financial viability concerning the ability to maintain an appropriate level of utilization of existing facilities. There are no costs of construction and the method of proposed construction need not be considered in that the construction has been concluded as previously discussed. Consequently, the necessity to address the costs and methods of the proposed constructions as described in Section 381.705(1)(m), Florida Statutes, is not relevant to the inquiry. Nor are the references within Section 381.705(2), Florida Statutes, having to do with capital expenditures pertinent to the outcome in examining the review criteria. LACK OF A VIABLE NEEDS FORMULA Respondent does not have a rule which calculates the need for inpatient radiation therapy by resort to a formula which derives need. Neither does the Respondent have an emergent policy which it is developing to formulate the amount of inpatient radiation therapy services needed in a given review cycle. Respondent and the private litigants have attempted to examine the need for inpatient radiation therapy contemplated by this application by devising various mathematical formulas to determine need. Each explanation is fundamentally flawed in that they fail to address the discrete issue contemplated for examination by the review process, that is the need for inpatient radiation therapy. Instead, these methods look at all radiation therapy both inpatient and outpatient. The statute does not contemplate that form of evaluation. It is the 10 to 15 percent of all radiation therapy patients that constitute the inpatients. It is the provision of care to those persons that is subject to examination. If need is to be derived by use of a formula, a knowledge of the circumstances existing for outpatients, a category of patient for whom no certificate of need must be obtained to serve them, should not enter in to the analysis. The formulas exercised by the parties in measuring the overall need for inpatient and outpatient radiation therapy services derive the answers by identifying the number of linear accelerators needed in the district or in one instance for the applicant's facility alone. In that exercise a count is made of the four linear accelerators in the district belonging to the two hospitals which have been granted certificates of need which would allow inpatient radiation therapy to be delivered as well as outpatient therapy and the three programs that serve outpatients on three additional linear accelerators. The total number of linear accelerators is seven counting the linear accelerator the Petitioner has to serve outpatients. No attempt by formula has been made to ascertain whether more than four linear accelerators found within the two hospitals who have certificates of need to provide inpatient radiation therapy service are warranted. Thought provoking questions have been raised by the several parties in critiquing the needs calculation made by an opponent or opponents. However, it is not necessary to choose among these competing theories because in selecting any theory one cannot derive the amount of inpatient radiation therapy services needed in the district. Furthermore, case law does not allow the trier of fact to utilize the basic information provided by the parties to construct a formula for determining need for inpatient radiation services independent of the efforts of the parties in the person of their experts whom they have consulted with on this subject. This means that the decision here must be made by a review of applicable criteria without resort to a preliminary determination of numeric needs. This has been done. On balance, when taking into account the combination of improvements to quality of care for a patient being transported from the Petitioner's facility to receive radiation therapy and the improvement concerning the removal of the cost of that transport and duplication of charges and fees for certain patients who move from an outpatient posture under treatment by the Petitioner and into an inpatient status with Petitioner receiving radiation therapy at one of the two other hospitals which has been discussed in preceding paragraphs, the project is justified and the application should be granted.
Recommendation Based upon the consideration of the facts, and in view of the conclusions of law, it is, RECOMMENDED: That a Final Order be entered which declines jurisdiction to require a certificate of need for inpatient radiation therapy services or in the alternative grants a certificate of need for inpatient radiation therapy services. DONE and ENTERED this 20th day of August, 1992, in Tallahassee, Florida. CHARLES C. ADAMS, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of August, 1992.
The Issue This is a bifurcated proceeding in which the sole issue before the hearing officer at this present stage of the proceeding concerns whether the construction of a radiation therapy center and the institution of Radiation Therapy Medical Services by Sacred Heart Hospital should be considered a "new institutional health service" pursuant to Section 381.706(1)(h), Florida Statutes, as that relates to the right of Baptist Hospital to intervene in this proceeding. If the project is deemed to be merely a capital expenditure of a million dollars or more and reviewable only for that reason pursuant to Section 381.706(1)(c), Florida Statutes, then the Intervenor would have no standing as stated in Section 381.709(5)(b), Florida Statutes.
Findings Of Fact Radiation oncology is a therapeutic process in which external radiation beams are utilized to treat cancerous tumors to effect a cure or a palliation. Radiation therapy is provided by board certified radiation oncologists in specialized facilities which house radioactive materials and specialized equipment, such as linear accelerators. The provision of radiation therapy requires specialized medical personnel such as technicians certified to operate linear accelerators to provide radiation treatments, as well as physicians and dosimetrists to calibrate machines and insure that radiation treatments are properly delivered. Radiation therapy is a medical specialty which deals with the utilization of radiation for the treatment of cancerous tumors and sometimes benign diseases. Radiation oncology or radiation therapy involves the use of consultative services, the knowledge of clinical, biological and pathological characteristics of the disease process, the evaluation of patients, the localization of tumors, the planning of radiation, the delivery of radiation treatments, and subsequent evaluation of the effects of treatment on the tumor and the patient. Sacred Heart provides cancer therapy through surgery and medical oncology. The various aspects of those cancer treatment services do not include the provision of radiation therapy, although in the past, in several isolated instances, radiation oncology trained physicians have provided brachytherapy involving the implanting of radioactive materials in the tissues or body cavities of the patients involved. These instances did not involve a regular program of radiation therapy provided by Sacred Heart, however, and in the typical instance, any cancer patients needing radiation therapy, including brachytherapy, are and have been referred out to facilities offering such services, including the Intervenor. The present cancer therapy services offered by Sacred Heart are delineated on pages 55-60 of the transcript of this proceeding. Sacred Heart filed an application for a certificate of need (CON) for a radiation therapy center on its campus to serve inpatients and outpatients. The total project costs for constructing the building and equipping as a radiation therapy center is estimated to be approximately 3.7 million dollars. The applicant proposes that the radiation therapy center would be an adjunct or extension of the hospital's existing oncology program and would not constitute a "new service" as defined in Chapter 10-5, Florida Administrative Code. The Department also takes the position that the initiation of radiation oncology or therapy services is not the establishment of a "new institutional health service" or a "substantial change" in health services. The Department takes the position that the project and application is reviewable only for the construction costs portion of the project as a capital expenditure in excess of one million dollars. HRS maintained at hearing that it has consistently taken the position that radiation therapy is not considered to be a new inpatient institutional health service pursuant to subsections 381.702(8)(13), Florida Statutes (1989). The Department's representative who testified was unable to explicate the reason for the alleged determination by the Department that radiation therapy is not a new institutional health service. She was unable to relate when such a supposed policy of treating radiation therapy only as a capital expenditure was adopted by the Department. It is noteworthy when reviewing her testimony, appearing at page 88 through 126 of the transcript of this proceeding, that repeated references are made by the HRS witness, the overall tenor or theme of which is that the purchase of linear accelerators is not regarded as the effectuation of a new institutional health service according to her view of the Department's policy regarding radiation therapy. Thus it may be that the Department views the addition of radiation therapy as involving simply the purchase of capital equipment, i.e., a linear accelerator. The evidence reflects otherwise however. The institution of radiation therapy at a hospital involves much more than the mere purchase of a linear accelerator device. It involves the purchase of the accelerator, the construction of a shielded space or building in which to house it and operate it, the employment of physicists, dosemetrists, qualified radiation therapy oncologists, and even the institution of a machine shop to make repairs and repair parts. The institution of radiation therapy at a hospital involves much more than the mere purchase and installation of a linear accelerator and the instant application seeks to institute such a comprehensive therapy service and not merely the capital expenditure required to purchase a linear accelerator solely. Thus, the Department's purported policy of viewing the institution of radiation therapy service as merely a capital expenditure (if, indeed, a policy, which was not proven in this case) is misplaced because the evidence in this record reveals that institution of radiation therapy at a hospital involves much more in the way of equipment and services than the mere purchase and capital expenditure related to acquisition of a linear accelerator. The Department has reserved Rule 10-5.011(1)(g), Florida Administrative Code, for a radiation therapy methodology. The remainder of that rule contains methodologies reserved for other services which HRS regulates as new institutional health services as well. These include such services as medicare, certified home health agencies, cardiac catheterization programs, and open heart surgery services. The reservation of a radiation therapy methodology in the rules is significant because of its indication of what the Department's intent with regard to the regulation of this service is or might be, because the Department has deleted references in its rules to reservations for services it has since chosen to deregulate, such as computerized tomography and chronic renal dialysis (see former Rules 10-5.011(1)(c) and (1)(h). The elimination of these rule reservations was published in the Florida Administrative Weekly, Vol. 15, No. 27, July 7, 1989. The Department in the past has had a rule governing need methodology for radiation therapy services. That rule was in effect until late in 1985 when it was invalidated in a 120.56 Florida Statutes rule challenge proceeding in South Miami Hospital v. Department of Health and Rehabilitative Services, 7 FALR 5491 (DOAH Nov. 1985). After that rule methodology for radiation therapy services was invalidated, the Department's witness in this proceeding, in her supervisory capacity, signed a memorandum regarding reconsideration of certificate of need #2682 involved in the South Miami Hospital case wherein South Miami Hospital sought to initiate radiation therapy services. That memo stated: The Department does not currently have a rule in place to determine the need for radiation therapy, as such the reconsideration of CON #2682, utilizing statutory criteria, will consider an applicant's specific justification for the purchase of major medical equipment and the initiation of a new service (emphasis added). The Department subsequently reiterated that the establishment of a radiation therapy service would be reviewed as a new institutional health service in the case of Bayfront Medical Center v. Department of Health and Rehabilitative Services, DOAH Case No. 87-2029 (Final Order entered September 1988). In adopting the hearing officer's conclusions of law from the recommended order in that case concerning the need for review of St. Anthony's Hospital's CON application for a radiation therapy service the Department determined that, as did the hearing officer: A certificate of need is required when a hospital proposes a capital expenditure over a threshold amount to provide inpatient health services or proposes a substantial change of inpatient institutional health services. Section 381.706(1)(c) and (h), Florida Statutes, (1987). Since the application under consider- ation in this proceeding proposes radiation therapy services to inpatients, as well as outpatients for a total project cost of almost 4.2 million dollars, a CON is required. The Department failed to explain any reasonable basis for any proposed change in the policy explicated in the May 22, 1986 policy memorandum, quoted above, and in the final order in Bayfront Medical Center supra. The Department's position may be summed up to the effect that its policy has changed from one of considering radiation therapy to be a new institutional health service to the current alleged policy of considering it to be a capital expenditure. It did not explicate why that policy had changed or a rational, factual or legal basis for it however and in view of the totality of Ms. Dudek's testimony it seems that the Department witness was emphasizing the policy of referring to the addition of radiation therapy as reviewable as merely a capital expenditure because of the Department's view, apparent from her testimony, that it in essence involves purchase of a linear accelerator. In the face of the unrefuted evidence to the effect that much more in the way of equipment, services and staff is involved in adding radiation therapy to the range of services offered by a hospital, it is apparent that the Department has failed to explicate a rational basis for the putative policy of regarding the institution of such a health service as merely a capital expenditure. Baptist Hospital operates a radiation therapy center of its own of approximately 10,000 square foot space. This area contains shielded space for linear accelerators, examination rooms, physicians offices, as well as a machine shop for repair and maintenance of the linear accelerators and space for dosimetry computers. This department at Baptist is organized and operated separated from other oncology services. Radiation therapy is primarily used to treat cancer patients and the patients are seen, evaluated, and treated within the confines of the radiation therapy facility. Policies and procedures unique to the radiation therapy department are utilized. Staff members include, physicians, technicians, physicists, and dosimetrists who are dedicated only to the provision of the radiation therapy service at the hospital. Thus from a clinical perspective, therapy is not merely an extension or an adjunct of the existing oncology program but rather is a separate therapeutic service in and of itself to which oncology patients may be referred when the services are deemed needed. Indeed, oncology involves different forms of curative and palliative treatment, including surgery and chemotherapy, with much different protocols, differently trained specialized staff members, differently trained and/or certified physicians with different methods, therapies and protocols for treating cancer. The commonality between the two types of service is that they have the ultimate goal of treating cancer patients, but the evidence shows that they are clearly two different medical specialties and institutional health services. There is little relationship between radiation oncology and the field of diagnostic radiology. Diagnostic radiology services are utilized almost exclusively to diagnose illnesses, conditions, while radiation oncology or radiation therapy is used to therapeutically treat patients with radiation to effect a cure or palliation. Radiation oncologists consult with and exchange patients with general surgeons, ear, nose and throat specialists, and other specialists as they do with medical oncologists. Therefore medical oncology and radiology are separate and distinct services. Although there is a relationship between radiation oncology and other cancer services such as chemotherapy and surgical therapy, the relationship is different in terms of the unique services, equipment and specially trained personnel required to provide radiation therapy as opposed to differently trained personnel, different equipment, therapy and procedure protocols required for other types of cancer services. Thus from a health planning perspective it does not logically follow that because a hospital provides medical or surgical oncology services, that it should also provide radiation therapy. The issue of the need for the service in terms of patient demand, availability of the specially trained personnel, the costs of providing the service, including the financial feasibility of constructing the facilities and buying the equipment needed, as well as the impact on other providers in terms of diversion of available patient days must be considered. It is noteworthy, as a corroborative aside concerning the evidence that establishes that radiation therapy is a separate and distinct institutional health service, that 29 of the 33 states which have certificate of need programs for the regulation of acute care facilities require a separate certificate of need in order to establish a radiation therapy service program. Sacred Heart does not currently have a radiation therapy service. It does have oncology services and surgical services that includes surgical therapy for cancer patients. Patients who need radiation therapy currently are referred out to other facilities including Baptist Hospital. Sacred Heart attempted, in its case in support of the HRS position treating this as merely a capital expenditure situation, to analogize the provision of radiation therapy services to the acquisition of a lithotripter. Sacred Heart contends that lithotripsy which is a form of treating kidney stones is an extension of the urology program of a hospital and that radiation therapy, a form of treating cancer tumors is merely an extension of an overall integrated cancer treatment program. However, whereas the residency requirement for radiation therapy or oncology is four years, after at least one year of post-doctoral work, the specialized training necessary to perform lithotripsy is a specialty training course of only several weeks duration. Further, hospitals requiring lithotripters typically have urologists treating kidney stones on the hospital staff. Sacred Heart in this instance has no radiation oncologist on its staff acting with admitting privileges who could provide radiation therapy services at the present time. Although it may have medical oncologists and surgeons on staff who treat cancer patients, Sacred Heart lacks the specialized policies and protocols, equipment, shielded physical space, specially trained medical personnel such as radiation oncologists, dosemetrists and physicists necessary to provide radiation therapy absent to the establishment of a new service. The list of institutional health services for which there is a specific need methodology includes, among others, inpatient cardiac catheterization, open heart surgery, neonatal intensive care units and transplant programs. The Department's attempt to distinguish between the establishment of an inpatient cardiac cath service and an inpatient radiation therapy service by stating that HRS had a rule methodology for the establishment of inpatient cardiac cath services whereas it didn't for inpatient radiation therapy services is a distinction without any logical basis. This is because the establishment of a service such as radiation therapy as a distinct and separate institutional health service depends upon the factual uniqueness or differences in the equipment, staff, protocols and policies required to institute such a service, as compared to other existing services at such a hospital, rather than the mere fact that the Department in the past has chosen to have a rule methodology for one type of service and not for another one. This distinction cannot serve as the basis for establishment of HRS's intent or policy in this regard in any event, however, because HRS has at least reserved Rule 10-5.011(1)(g), Florida Administrative Code for a radiation therapy methodology in any event, it simply has not enacted one yet, thus belying any distinction in terms of its body of rules, regarding different institutional health services based upon the mere fact that it has enacted a rule methodology for determining need for one type of institutional health service and not for another as yet. In summary, although the Department and Sacred Heart attempt to distinguish between radiation therapy and other institutional inpatient health services such as open heart surgery and cardiac catheterization by contending that radiation therapy is not a specialized service, in reality it has been established that radiation therapy requires a separate facility with specialized equipment, specially trained medical personnel with different training from personnel devoted to other types of cancer services, different protocols and procedures. It thus cannot be found to merely be an adjunct or extension of other cancer services, but rather is a separate and distinct institutional inpatient health service, just as open heart surgery, cardiac catheterization, diagnostic radiology or medical oncology for instance.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the candor and demeanor of the witnesses and the pleadings and arguments of the parties it is therefore recommended that the motion to dismiss the petition to intervene filed by Baptist Hospital be denied, that Baptist Hospital be accorded standing in this proceeding and that the case proceed to hearing on the substantive merits of the application. RECOMMENDED this 3rd day of April, 1991, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of April, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 90-3576 Petitioner's proposed findings of fact: Accepted. Accepted, but subordinate to the Hearing Officer's findings of fact on the subject matter. 3-6 Accepted. Rejected as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted. Rejected as immaterial in this de novo proceeding. 10-20 Accepted. 21-22 Accepted, but not itself dispositive of material issues. 23-24 Accepted. 25-26 Accepted, but not materially dispositive. Accepted, but subordinate to the Hearing Officer's findings of fact. Accepted, but not materially dispositive. Accepted, but not material. Rejected as subordinate to the Hearing Officer's findings of fact. Rejected as irrelevant. Rejected as immaterial. Rejected as subordinate to the Hearing Officer's findings of fact and as immaterial. Rejected as subordinate to the Hearing Officer's findings of fact on the subject matter. Accepted, but not materially dispositive. Rejected as subordinate to the Hearing Officer's 'findings of fact and as contrary to the preponderant weight of the evidence. 37-41 Rejected as a discussion and recitation of testimony and not fact finding and as subordinate to the Hearing Officer's findings of fact. Intervenor's proposed findings of fact: 1-18 Accepted. COPIES FURNISHED: Stephen Ecenia, Esquire Katz, Kutter, Haigler, Alderman, Davis, Marks & Rutledge, P.A. 215 S. Monroe Street Suite 400 First Florida Bank Building Tallahassee, FL 32301 Karen O. Emmanuel, Esquire Emmanuel, Sheppard & Condon 30 South Spring Street Post Office Drawer 1271 Pensacola, FL 32596 Richard A. Patterson, Esquire Department of Health and Rehabilitative Services 2727 Mahan Drive, Suite 103 Fort Knox Executive Center Tallahassee, FL 32308 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Linda Harris, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700
