The Issue Whether Respondent committed the violations alleged in the Administrative Complaints? If so, what disciplinary action should be taken against him?
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Parties The Department is a state government licensing and regulatory agency. Respondent is now, and has been at all times material to the instant cases, a physician licensed to practice medicine in the State of Florida. He holds license number ME 0037235. Facts Relating to Case No. 93-5861 On December 29, 1983, at Indian River Memorial Hospital, Dr. Phil Morgan performed a partial mastectomy and an axillary lymph node dissection on G.K., a female patient who was then 57 years of age. The mastectomy was performed on G.K.'s left breast. Approximately a quarter of the breast volume was removed, including a malignant tumor that was no more than two centimeters in diameter. The procedures performed by Dr. Morgan revealed no evidence of any further malignancy. In early 1984, G.K. went to the Lawnwood Oncology Center in Fort Pierce, Florida to consult with Respondent, a radiation oncologist, regarding her receiving postoperative radiation therapy. From January 17, 1984, to February 27, 1984, Respondent administered doses of external beam radiation therapy to what remained of G.K.'s left breast and the lymphatic drainage regions. The total nominal dosage administered was 5040 cGy or rads. On or about March 13, 1984, Respondent supplemented the external beam therapy treatment G.K. had received with an Iridium-192 radioisotope interstitial implant in G.K.'s left breast. The implant consisted of two layers of radioactive needles, with one layer one centimeter deeper than the other. There were ten needles, spaced one centimeter apart, in each of the two layers. In 1984, the prevailing standard of care recognized as acceptable and appropriate by reasonably prudent radiation oncologists performing multi-layer interstitial implants required that the oncologist design and structure the implant in such a manner that the radioactive sources in each of the layers were spaced at least 1.2 centimeters apart and that the oncologist use less than half the number of radioactive sources that Respondent used. The implant remained in position for 52 hours. A volume of 253 cubic centimeters of breast tissue received a dosage of 60 cGy or rads per hour. In 1984, the prevailing standard of care recognized as acceptable and appropriate by reasonably prudent radiation oncologists performing interstitial implants required that the oncologist regulate the radiation dosage rate so that it did not exceed 50 cGy or rads per hour. An additional 72 cubic centimeters of breast tissue received a dosage of 100 cGy or rads per hour, twice the maximum dosage rate. Inasmuch as these 72 cubic centimeters of breast tissue received a total dosage of 5200 cGy or rads during the time the implant remained in position, compared to the total dosage of 3120 cGy or rads that the other 253 cubic centimeters of targeted breast tissue received, the inhomogeneity of dosage distribution well exceeded 20 percent, contrary to the then prevailing standard of care recognized as acceptable and appropriate by reasonably prudent radiation oncologists performing interstitial implants, which required that the physical design of the implant be such that there was no more than 20 percent of dosage distribution inhomogeneity. Furthermore, in designing the implant, Respondent targeted a greater volume of breast tissue than was acceptable and appropriate under the prevailing standard of care. The implant and the external beam therapy combined delivered a total nominal dosage of 8160 cGy or rads, with some areas within the central region of the implanted tissue receiving in excess of 10,000 cGy or rads. Given the relatively small size of the malignant tumor that had been removed from G.K.'s breast and the absence of any apparent residual malignancy, a reasonably prudent radiation oncologist, governed by standards in effect in 1984, would have administered, in toto, a nominal dosage of no more than 6000 to 7000 cGy or rads. In or about December of 1985, G.K. presented to Respondent with breast fibrosis and skin retraction on the side that Respondent had treated in 1984. Respondent recommended conservative measures only. G.K. went to Dr. Everrett Sugarbaker, a surgical oncologist, for a second opinion. Dr. Sugarbaker initially examined G.K. and evaluated her situation in August of 1986. He noted that G.K.'s left breast was totally contracted back against the chest wall with extensive telangiectatic and fibrotic change in the area where Respondent had inserted the Iridium-192 implant. There was also a scab over a one and a half centimeter ulcer. It was apparent to Dr. Sugarbaker that G.K. was suffering from radionecrosis as a result of the radiation therapy she had received from Respondent. Dr. Sugarbaker recommended daily peroxide application to the ulcer, but added that, if the ulcer increased in size or became infected, he would consider surgical correction of the problem. G.K. visited Respondent again in October of 1986. The area of her left breast where the implant had been inserted had experienced further tissue destruction and had become infected. Respondent prescribed antibiotic therapy, which ultimately proved to be unsuccessful. In or about February of 1987, Respondent recommended that G.K. try hyperbaric oxygen therapy, but G.K. refused to follow Respondent's recommendation. On February 13, 1987, G.K. returned to Dr. Sugarbaker for reassessment. G.K. told Dr. Sugarbaker of her recurring infection. Upon his examination of G.K., he noticed that the necrotic area of her left breast was larger than when he had seen her in August of the previous year. Dr. Sugarbaker recommended surgical correction. On February 18, 1987, Dr. Sugarbaker surgically removed the remainder of G.K.'s left breast and, in connection therewith, performed other procedures to reconstruct the chest wall and improve blood supply and promote healing in the area. The necrosis from which G.K. was suffering that made these procedures necessary was caused by Respondent having overradiated her during the course of the radiation therapy he administered to her in 1984. Facts Relating to Case No. 93-5861 In September of 1982, Dr. Khalil Cassimally performed a modified radical mastectomy on V.H.'s cancerous left breast. V.H. was approximately 34 years of age at the time. Postoperatively, from approximately October 10, 1982, to November 22, 1982, V.H. received radiation therapy from Dr. Victoria Cividino at the Lawnwood Oncology Center, of which Respondent was the director. The therapy included a total nominal dosage of 5000 cGy or rads (with a 1000 cGy or rads "boost") to the left axilla. Following the therapy, V.H. was in constant pain. At some point in time, a knot or nodule developed in the area where she had had her mastectomy. V.H. told Respondent, who had assumed responsibility for V.H.'s care and treatment from Dr. Cividino, about the nodule. The nodule was biopsied on September 15, 1983, by Dr. Cassimally. No malignancy was found. The area that was biopsied did not heal properly. V.H. continued to have problems. On March 16, 1984, Respondent visited Dr. James Grossnickle, a general surgeon. She presented with a large ulcer on her left chest wall surrounded by thick elevated tissue. On April 20, 1984, Dr. Grossnickle biopsied a portion of the ulcer and surrounding tissue. The pathological diagnosis was fat necrosis and fibrosis. There was no evidence of any malignancy. V.H. eventually returned to see Respondent. From approximately April 16, 1985, to June 11, 1985, Respondent treated V.H. with further radiation therapy. The therapy included a total nominal dosage of 5000 cGy or rads to the left axilla, which was administered in 20 fractions. The dosage, when considered in light of the dosage previously administered by Dr. Cividino in 1982, exceeded the limits of normal tissue tolerance. As a result, it caused considerable tissue damage. There was no medical justification for administering additional radiation therapy to V.H., particularly in light of the results of the post- mastectomy biopsies that had been performed by Drs. Cassimally and Grossnickle. A reasonably prudent radiation oncologist, governed by standards in effect in 1985, would not have followed such a course of treatment. After receiving this additional radiation therapy, Respondent developed a large mass of scar tissue in the treated area, in the center of which was an oozing ulcer. Her condition was the result of having been overradiated. In or about October of 1986, V.H. went to Juan Carlos Giachino, a plastic and reconstructive surgeon, who performed surgery on V.H. in an effort to remedy the situation. The surgery was unsuccessful. Oozing ulcers reappeared. One such ulcer, near her left underarm, had to be irrigated and cleaned three to four times a day. Furthermore, V.H.'s left arm became unusable as it accumulated undrained lymphatic fluid and resultingly increased in size. The excessive radiation treatment that V.H. had received had resulted in the obstruction of the lymphatic drainage pathways in the arm. The problem with her left arm became so severe that amputation of the arm was required. Other corrective surgical procedures, including chest reconstruction, were performed on V.H. to improve her condition.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board enter a final order finding Respondent guilty of the violations of subsection (1)(t) of Section 458.331, Florida Statutes, alleged in the Administrative Complaints and disciplining him for having committed these violations by imposing the penalties described in Conclusion of Law 78 of this Recommended Order. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 20th day of May, 1994. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of May, 1994. APPENDIX TO RECOMMENDED ORDER IN CASE NOS. 93-5739 and 93-5861 The following are the Hearing Officer's specific rulings on the "findings of facts" proposed by the Department in its proposed recommended order: 1-9. Accepted and incorporated in substance, although not necessarily repeated verbatim, in this Recommended Order. To the extent that this proposed finding addresses the standard of care for single layer implants, it has not been incorporated in this Recommended Order because, even if true, it would have no bearing on the outcome of the instant case. To the extent that it addresses the standard of care for multi- layer implants, it has been accepted and incorporated in substance. Accepted and incorporated in substance. 12-13. Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer. 14-36. Accepted and incorporated in substance. First and second sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer; Third sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. To the extent that this proposed finding states that V.H. was 25 years of age at the time of the mastectomy, it has been rejected because it is contrary to the greater weight of the evidence. Otherwise, it has been accepted and incorporated in substance. 40-56. Accepted and incorporated in substance. First and second sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer; Third sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given certain evidence adduced at hearing. Rejected as a finding of fact because it is more in the nature of a summary of testimony than a finding of fact based upon such testimony First sentence: Accepted and incorporated in substance; Second sentence: Not incorporated in this Recommended Order because it has no bearing on the outcome of the instant case. First sentence: Accepted and incorporated in substance; Second sentence: Not incorporated in this Recommended Order because it has no bearing on the outcome of the instant case. COPIES FURNISHED: Francesca Plendl, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Charles H. Kent, M.D. 3605 Juan Ortiz Circle Ft. Pierce, Florida 34947-6110 Dr. Marm Harris, Executive Director Board of Medicine Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Respondent committed the violations alleged in the Administrative Complaint? If so, what disciplinary action should be taken against him?
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Agency is a state government licensing and regulatory agency. Respondent is now, and has been since February 27, 1990, licensed to practice nutrition counseling in the State of Florida. His license number is NC 0000165. Respondent represents that he specializes in treating patients with natural remedies and that he is a homeopathic physician. Homeopathy is a school of medical thought in which diseases are treated with minute doses of drugs that are capable of producing in healthy persons symptoms like those of the disease to be treated. Respondent has neither a license to practice medicine in the State of Florida, nor a medical degree from a medical school. He does have, however, a Master of Herbology diploma that he received from a college of herbology in Canada. In addition, on August 15, 1985, Respondent received a certificate of completion from the American School of Oriental and Homeopathic Therapy certifying that he had completed the schools's "course of homeopathic therapy which includes homeopathic diagnosis, herbalism, nutrition and homeopathic therapeutic methods." Respondent also has an honorary doctor of divinity degree that he received from the World Christian Ministries. In or around October of 1993, Respondent disseminated by mail, for the purpose of soliciting business, an advertisement that was prepared under his direction 1/ and read as follows: NEW LIFE AND HEALTH DR. JANUSZ KALUSOWSKI Are you looking for a natural doctor that cares? One that listens to you and targets the origin of your ailments? Look no more! Help is on its way! New Life and Health would like to welcome Dr. Janusz Kalusowski, internationally renowned HOMEOPATH, IRIDOLOGIST and NUTRITIONIST to Broward County. For 32 years Dr. K. (as he is commonly known) has been devoting himself to conducting self-help seminars reflecting his belief that when people are properly informed, they can help themselves achieve and maintain health and happiness. For 14 years, Dr. K. was located in Dade County and recently he has relocated to Ft. Lauderdale. Dr. K. is introducing BIO-MAGNETIC THERAPY to South Florida. This therapy is least costly and it is one that the client can do at home. The therapeutic magnets are tiny and can be worn on the body all day to energize the metabolism and work on building the immune system. The result! Your body becomes increasingly capable of fighting off various diseases. To learn more about bio-magnetics and how they work, Dr. K. is presently holding free seminars on Saturdays at 11:00 A. M. Seminars are held at the doctor's new location on: 1750 E. COMMERCIAL BLVD. SUITE NUMBER 3 FORT LAUDERDALE, FLA. 33334 (305)772-1665 Note: Dr. K. is available for private consultations. If you would like Dr. K. to appear as a guest lecturer for your group/organization please call: "Leila" at (305)772-1665 Learn how to self-heal yourself with bio-magnets. You owe it to your health! Respondent had sought to obtain the prior approval of the Agency's predecessor, the Department of Business and Professional Regulation (hereinafter referred to as the "Department"), before disseminating the advertisement. The Department did not respond to Respondent's request for approval as quickly as Respondent had hoped. Unwilling to wait any further, Respondent disseminated the advertisement without having received a response from the Department. Bio-magnetism is used in the medical field for diagnostic purposes. It provides no medically recognized therapeutic benefit, however. The use of bio-magnetism as a therapeutic modality may indirectly harm a patient inasmuch as it may result in the patient not timely seeking the medical treatment the patient needs. Respondent's advertising bio-magnetism as a treatment for human ailments was beyond the scope of his practice as a nutrition counselor.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board of Medicine enter a final order: dismissing Counts One and Two of the Administrative Complaint; finding Respondent guilty of the violation of subsection (1)(j) of Section 468.518, Florida Statutes, alleged in Count Three of the Administrative Complaint; and disciplining him for having committed this violation of subsection (1)(j) of Section 468.518, Florida Statutes, by suspending his nutrition counseling license for a period of one year and requiring him to serve one year of probation, subject to those terms and conditions the Board deems appropriate, commencing immediately after the end of his suspension. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 6th day of October, 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 6th day of October, 1995.
The Issue Whether or not Respondent administered a legend drug other than in the course of his professional practice as a dentist, failed to maintain written dental and medical history records justifying the course of treatment, and failed to practice dentistry within the minimum standards of performance in diagnosis and treatment when measured against the prevailing peer community in violation of Subsections 466.028(1)(y), (m) and (q), Florida Statutes and, if so, what if any, administrative penalty should be imposed.
Findings Of Fact During times material hereto, Respondent, Kleyn B. Russell, Jr., held a license as a dentist in Florida, having been issued license number DN 0008401 by Petitioner, Department of Professional Regulation. During times material hereto, Respondent practiced dentistry in Florida. Bethany Morris (Bethany), a three year old female patient of Respondent, weighed 34 pounds when she was treated by Respondent. Bethany was born with hemangiomas (port wine scars) on the majority of her body. Cheryl Morris, the mother of Bethany, brought Bethany to Florida to undergo laser surgery treatment to remove hemangiomas, following consultation with laser surgery experts in California, Duke University in North Carolina and with several practitioners in the Midwest and in Florida. Bethany Morris' first laser surgery was performed by Dr. Massad on March 9, 1990. Between March 9, 1990 and May 15, 1990, Cheryl Morris had discussions with Dr. Massad and Jeffrey Waterer, a business representative for the laser equipment which was used in the surgical procedures for Bethany, regarding possible alternatives to general anesthesia, specifically a dental nerve "block". On or about May 15, 1990, Respondent was consulted and retained by Dr. Massad to provide a trigeminal facial nerve block to Bethany's face to alleviate any discomfort she may experience during laser surgery to remove the port wine scars on her face and lips. Respondent produced a trigeminal facial nerve block on Bethany on three separate occasions by using local anesthesia. Local anesthesia is the loss of sensation of pain in a specific area of the body, generally produced by a topically applied agent or injected agent without causing loss of consciousness. Rule 21G-14.001, Florida Administrative Code. 1/ On May 15, 1990, Respondent administered 12.5 carpulets of 2% Lidocaine with 1:100,000 Epinephrine to Bethany. On or about July 11, 1990, Respondent administered 11 carpulets of 2% Lidocaine with 1:100,000 Epinephrine to Bethany. On or about August 22, 1990, Respondent administered 8.5 carpulets, 280-306 mg., of 2% Lidocaine with 1:100,000 Epinephrine to Bethany within a one- hour period. Lidocaine is a medicinal drug. Section 465.003(7), Florida Statutes. On or about August 22, 1990, Bethany began to experience seizures, respiratory difficulty and respiratory arrest shortly after Respondent administered the last injection of local anesthetic to her. Bethany stopped breathing and Dr. Massad and Respondent began cardiopulmonary resuscitation. These efforts were unsuccessful and "911" was called and Bethany was transported to Mease Hospital in Dunedin, Florida. Bethany Morris died on August 25, 1990, and the cause of her death was anoxic encephalopathy due to cardiac arrest due to Lidocaine toxicity. Prior to her death, Bethany exhibited symptoms indicating that Respondent injected Lidocaine to her facial area in an amount in excess of the manufacturer's recommended dosage for a patient of her age/size. Specifically, on the first occasion that Respondent administered the nerve block, Bethany had to be repeatedly slapped in the face to avoid slipping into a coma. On the second occasion following Respondent's administration of Lidocaine to effect a nerve block, Bethany had to be carried to her car and slept from Respondent's office in Tampa to her temporary residence in the Brandon area. On three separate occasions, specifically May 15, 1990, July 11, 1990 and August 22, 1990, Respondent administered 2% Lidocaine with 1:100,000 Epinephrine to his patient, Bethany Morris, in an amount that exceeded the manufacturer's maximum recommended dosage. Respondent failed to recognize that special calculations were required when administering local anesthetics to children. During the administration of local anesthetics to Bethany, Respondent admitted that he failed to comprehend the correct amount of anesthetic that could be safely administered to her. Respondent's admission was borne out by his calculations of the amount of Lidocaine he administered to Bethany. Respondent's administration of 280 mg. - 306 mg. of 2% Lidocaine with 1:100,000 Epinephrine to Bethany on August 22, 1990, was an amount in excess of the recommended maximum dosage for a patient of Bethany Morris' size. Respondent failed to maintain records in his office indicating his administration of anesthesia to Bethany Morris. Respondent failed to properly recognize, diagnose and treat Bethany Morris once she began exhibiting signs of respiratory depression which led to cardiac failure due to Lidocaine toxicity. Respondent has recently been the subject of prior disciplinary action by Petitioner.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that Petitioner enter a Final Order suspending Respondent's license to practice dentistry in Florida for a period of five (5) years and prior to his reinstatement to practice dentistry, Respondent take and successfully complete continuing education courses in the administration of legend drugs in the course of his professional practice of dentistry under such terms and conditions as the Board of Dentistry may impose. RECOMMENDED this 29th day of August, 1991, in Tallahassee, Leon County, Florida. JAMES E. BRADWELL 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 29th day of August, 1991.
The Issue Whether Petitioner's proposed treatment, fluoroscopic radiofrequency thermoneurolysis, is experimental.
Findings Of Fact Petitioner, Douglas J. Phillips, Jr., D.D.S. (Dr. Phillips), is a licensed dentist in the State of Florida. Sometime in January, 1993, Dr. Phillips proposed using the procedure, fluoroscopic radiofrequency thermoneurolysis to treat a patient. This procedure involves destruction of tissue by the application of high heat, at approximately two hundred degrees Fahrenheit. A probe or cannula (insulated needle) is placed through skin, subcutaneous tissue and muscle to reach into where the tendon or ligament inserts to the bone or to where there is a small nerve root. An electrode goes through the insulated needle. Heat is then applied at approximately two hundred degrees. The treatment causes a small scar on the bone or destroys the nerve. The purpose of the procedure is to treat head and facial pain. The patient has been diagnosed with the degeneration of the temporomandibular joint on the left side, advanced degenerative osteoarthritis, and fibrous ankylosis with osteroarthritis of the left temporomandibular joint. She experiences head and facial pain. Dr. Phillips had performed fluoroscopic radiofrequency thermoneurolysis on the patient in September, 1991. CIGNA approved and paid for the procedure. The patient experienced relief from the pain for almost two years after the procedure was done. The patient is now experiencing pain again, and Dr. Phillips proposes to treat her again with fluoroscopic radiofrequency thermoneurolysis. By letter dated January 29, 1993, Intervenor CIGNA, informed Dr. Phillips that his request to perform the proposed treatment was not authorized. CIGNA'S basis for denial of approval was that the procedure was experimental and was not recognized by the American Dental Association. On or about August 27, 1993, Dr. Phillips requested that Respondent, the Department of Labor and Employment Security, Division of Workers' Compensation (Division), review the procedure pursuant to Section 440.13(1)(d), Florida Statutes (1993) and Rule 38F-7.0201, Florida Administrative Code. On November 22, 1993, the Division issued a determination that fluoroscopic radiofrequency thermoneurolysis was experimental. Dr. Phillips was taught the proposed procedure eight years ago by Dr. Ernst, a dental practitioner in Alabama. Dr. Phillips spent four days observing Dr. Ernst in Dr. Ernst's office and one week of training in a hospital under the direction of Dr. Ernst. The first procedure performed by Dr. Phillips was two years after his training with Dr. Ernst. Prior to performing the procedure, Dr. Phillips also attended a one hour lecture on the procedure given by another dentist. No other dentist in Florida practices this procedure. The American Dental Association has not endorsed the procedure. Radiofrequency thermoneurolysis is not on the American Dental Association's list of approved dental therapeutic modalities. It is not taught in any dental school or school of oral surgery. Dr. Phillips is not aware of any mention of the proposed procedure in any dental or oral surgical textbooks. Only four other dentists in the United States practice this procedure. There is no published written protocol regarding this procedure except for an article written by Dr. Wilk, which consists of a two paragraph treatment of the subject. Fluoroscopic radiofrequency thermoneurolysis is not listed in the American Dental Association's Current Dental Terminology, nor does the proposed treatment have a code assigned to it. Donna M. Reynolds is a supervisor of the policy section in the Rehabilitation and Medical Services Unit of the Division. When she received the request from Dr. Phillips to review the proposed procedure, she contacted three consultants for the Division: Dr. Richard Joseph, Dr. Martin Lebowitz and Dr. Davis. She received responses from Drs. Joseph and Lebowitz indicating that they considered the procedure to be experimental. Dr. Davis did not respond to her request. Dr. Joseph is a board certified oral and maxillofacial surgeon. When asked by the Division to review the proposed treatment, he reviewed all the documentation submitted by the Division, which included the documentation that Dr. Phillips had submitted in support of his request. Dr. Joseph also did a medline search. Medline is a computerized medical library search that is commonly performed by physicians to research or review all of the current medical literature. The medline search of 301,000 articles revealed only two or three articles relating to the use of radiofrequency thermoneurolysis. Dr. Joseph also consulted with Dr. Gremillion, the chairman of the Department of Facial Pain at the University of Florida, College of Dentistry. Based on his research, Dr. Joseph opined that the proposed procedure was experimental. It was Dr. Joseph's opinion that radiofrequency thermoneurolysis was outside the practice parameters in the general practice of dentistry. Dr. Lebowitz, an oral and maxillofacial surgeon and former co-director of the Facial Pain Clinic at the University of Florida, reviewed the documentation sent by the Division with its request to review the proposed treatment. The documentation included articles which had been supplied by Dr. Phillips to the Division. It was Dr. Lebowitz's opinion that none of the articles submitted by Dr. Phillips were scientifically acceptable based on the lack of blind studies, the quantity of patients being studied, and the lack of studies performed in different locations. In researching the issue, Dr. Lebowitz contacted Dr. Jim Ruskin, the head of the residency program in the Oral Maxillofacial Surgery Department at the College of Dentistry, University of Florida. Dr. Ruskin is considered a world authority on the management of facial pain. Dr. Lebowitz also spoke with Dr. John Gregg, a Virginia dental practitioner who previously ran the facial pain clinic at Chapel Hill at the University of North Carolina. Additionally, Dr. Lebowitz spoke with Dr. Castellano, an oral and maxillofacial surgeon in Tampa, Florida. Based on his research, Dr. Lebowitz concluded that radiofrequency thermoneurolysis was experimental. Dr. John Roland Westine is board certified in oral maxillofacial surgery and is a licensed dentist. He has studied the use of electrical energy in destroying tissue and has used electro-surgical equipment for thirty years. Dr. Westine is familiar with radiofrequency thermoneurolysis. Prior to the final hearing, he had reviewed the records of forty patients who had been treated with radiofrequency thermoneurolysis. It was his opinion that the proposed procedure was not safe and could cause the following problems: irreparable damage to vision, stroke, motor deficiencies, damage to facial nerves, nerve deficits, sensory deficits, abscess formations and parotid fistulas. Based on the preponderance of the evidence, Dr. Phillips has not demonstrated that the fluoroscopic radiofrequency thermoneurolysis is widely accepted by the practicing peer group, that the procedure is based on scientific criteria, or that the procedure is reasonably safe. Radiofrequency thermoneurolysis, including fluoroscopic radiofrequency thermoneurolysis, is an experimental procedure.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered determining that fluoroscopic radiofrequency thermoneurolysis is experimental and denying approval for the procedure. DONE AND ENTERED this 29th day of August, 1995, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND 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 29th day of August, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-762 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1. Petitioner did not designate which portion of his proposed recommended order contained the proposed findings of fact and which portion contained the proposed conclusions of law; thus, I am unable to address the paragraphs which Petitioner may contend are his proposed findings of fact. Respondent's Proposed Findings of Fact. Paragraphs 1-5: Accepted in substance. Paragraphs 6-7: Accepted that that is what the statutes and rule say. Paragraph 8: The first sentence is accepted in substance. The second sentence is accepted to the extent that the Division does submit the documentation to consultants. The evidence established that the proposed treatment is not for use in the aid or confirmation of a diagnosis; therefore, the Division would not be required to submit the documentation to four consultants based on Rule 38F-7.0201, F.A.C. Paragraph 9: Accepted in substance. Paragraph 10: Accepted. Paragraph 11: Rejected as unnecessary. Paragraphs 12-15: Accepted in substance. Paragraph 16: Rejected as constituting argument. Intervenors Proposed Findings of Fact. Paragraphs 1-2: Accepted in substance. Paragraph 3: Rejected as unnecessary detail. Paragraphs 4: Accepted. Paragraph 5: The last sentence is rejected as unnecessary. The remainder is accepted in substance. Paragraph 6: Accepted in substance. Paragraph 7: Rejected as unnecessary detail. Paragraphs 8-9: Accepted to the extent that Dr. Phillips desires to use the proposed treatment. The remainder is rejected as unnecessary. Paragraph 10: Rejected as not supported by the greater weight of the evidence. Paragraph 11: Rejected as unnecessary. Paragraphs 12-15: Accepted in substance. Paragraph 16: Rejected as unnecessary. Paragraph 17: The first sentence is rejected as unnecessary. The second sentence is accepted in substance. Paragraph 18: Accepted in substance. Paragraph 19: The first four sentences are accepted in substance. The remaining is rejected as unnecessary. Paragraphs 20-21: Accepted in substance. Paragraphs 22-31: Rejected as unnecessary. Paragraphs 32-35: Accepted in substance. Paragraph 36: Rejected as unnecessary. Paragraphs 37-39: Accepted in substance. Paragraphs 40-41: Rejected as unnecessary. COPIES FURNISHED: Robert R. Johnson, Esquire Post Office Box 3466 West Palm Beach, Florida 33402 Michael Moore, Esquire Office of the General Counsel Department of Labor & Employment Security 2012 Capitol Circle Southeast, Suite S-307 Tallahassee, Florida 32399-2189 Nancy Lehman, Esquire Neil J. Hayes, P.A. 224 Datura Street, Suite 601 West Palm Beach, Florida 33401 Douglas L. Jamerson, Secretary Department of Labor and Employment Security 303 Hartman Building 2012 Capital Circle Southeast Tallahassee, Florida 32399-2152 Edward A. Dion Department of Labor and Employment Security General Counsel Department of Labor and Employment Security 303 Hartman Building 2012 Capital Circle Southeast Tallahassee, Florida 32399-2152
The Issue The issue for determination in this case is whether Respondent's license to practice medicine in the State of Florida should be disciplined for disseminating, or causing the dissemination of an advertisement that was false, deceptive or misleading in violation of Rule 59R-11.001, Florida Administrative Code, and Section 458.331(1)(x), Florida Statutes.
Findings Of Fact Petitioner, AGENCY FOR HEALTH CARE ADMINISTRATION (AHCA), is the agency of the State of Florida vested with the statutory authority under Chapter 458, Florida Statutes, to regulate the practice of medicine. Respondent, JONATHAN M. FRANTZ, M.D., is and at all material times has been, a licensed physician in the State of Florida, having been issued license number ME 0054884. Respondent graduated from the University of Miami School of Medicine in 1983, and thereafter entered a residency program in Opthamology at the Louisiana State University Eye Center in New Orleans, Louisiana, where from 1987 to 1989 Respondent was a Fellow in Cornea, External Disease, and Refractive Surgery. During his Fellowship at the Louisiana State University Eye Center, Respondent participated in the initial research projects involving the Excimer Laser Procedure, which at that time was exclusively an investigational device. The term "investigational device" is a technical term used by the Food and Drug Administration (FDA) and medical researchers. The term means that a device has yet to be approved for treatment of human patients by the FDA and that its use is limited by the FDA to research investigations. The Excimer Laser is a device that projects a wavelength of light over the surface of the cornea to treat nearsightedness and astigmatism. The wavelength of light removes irregularities on the surface of the cornea or anterior corneal tissue in order to change the refraction of the eye and improve the patient's eyesight. At all material times, the Excimer Laser was an investigational device. Radial Keratotomy is, and at all material times was an FDA approved procedure for the treatment of nearsightedness and astigmatism. The Excimer Laser procedure differs from Radial Keratotomy in that Radial Keratotomy is a procedure in which incisions are made to the corneal tissue itself. The incisions allow for the flattening of the center of the cornea, and thus, unlike the Excimer Laser, actually change the structure of the cornea. During his Fellowship, Respondent participated in primate and human research involving the Excimer Laser, and assisted in the development of protocols for use in the first treatment of human patients with the device. Respondent received a research award from the National Eye Institute for his investigative work with the Excimer Laser. Respondent has published several articles in medical literature relating to the Excimer Laser. Respondent is certified by the American Board of Opthamology, and is a member of the American Academy of Opthamology. After completion of his Fellowship, Respondent entered private practice in Ft. Myers, Florida. While in private practice, Respondent continued his research work with the Excimer Laser. In 1990, Respondent was selected as one of a small group of physicians to conduct Excimer Laser investigational treatments on patients. As a principal investigator, Respondent treated patients with all degrees of nearsightedness and astigmatism. In May of 1993 Respondent was employed by Eye Centers of Florida located in Ft. Myers, Florida. Respondent performed Excimer Laser investigational procedures while so employed. At this time, the Excimer Laser procedure was also being performed by Dr. James J. Rowsey, Jr., Chairman of the Department of Opthamology at the University of South Florida in Tampa, Florida. The Excimer Laser procedure performed at the University of South Florida offered a different protocol than that offered by Respondent at the Eye Centers of Florida. Respondent was the only Opthamologist in Florida offering Excimer Laser procedures for patients with all degrees of nearsightedness and astigmatism, as well as offering Radial Keratotomy. In addition to his expertise in Opthamology, Dr. Rowsey has extensive expertise in the area of ethical medical advertising. On May 23, 1993, the following advertisement was published in the Charlotte Sun Herald, a Florida newspaper: Jonathan M. Frantz, M.D., corneal specialist with the Eye Centers of Florida, invites you to join him for an exciting lecture on the newest breakthroughs in eye surgery - the Excimer laser and Radial Keratotomy (RK). Eye Care Centers of Florida is the only eye care center in Florida that offers both options. Come to our free seminar and find out how you can reduce your need for glasses or contact lenses. EXCIMER LASER RADIAL KERATOTOMY THE CORRECTION OF NEARSIGHTEDNESS AND ASTIGMATISM FREE ADMISSION AND SCREENING FOR EXCIMER LASER AVAILABLE PLEASE BRING GLASSES AND/OR CURRENT EYE GLASS PRESCRIPTION WEDNESDAY, MAY 26 7:00 PM FIRST FEDERAL BANK BUILDING 3524 D TAMIAMI TRAIL (SECOND FLOOR) PORT CHARLOTTE RESERVATIONS 1-800-226-3377 OR 1-813-939-3456 EYE CENTERS OF FLORIDA Helping You See Your Best 4101 Evans Avenue Fort Myers, Florida (Caution: The Excimer Laser is an Investigational Device. Limited by Federal Law to Investigational Use.) The advertisement also contained Respondent's picture, and the logo for the Eye Centers of Florida. The advertisement was composed by a marketing agency retained by the Eye Centers of Florida. Respondent was generally aware of the contents of the advertisement, but did not give specific approval for the placement of the advertisement. Respondent was aware that the advertisement of the Excimer Laser required cautionary language stating that the procedure was an investigational device limited by the FDA. The advertisement clearly states that the Excimer Laser is an investigational device limited by the FDA. The advertisement is a public invitation to attend a lecture given by Respondent concerning the Excimer Laser and Radial Keratotomy. At the lecture, Respondent explained that the Excimer Laser was an investigational device. Thereafter a person seeking Excimer Laser treatment was given a consent form that explained in detail the investigatory nature of the procedure. As a principal investigator Respondent was limited in the number of patients he could treat with the Excimer Laser. Respondent received an economic benefit from the treatment of patients with the Excimer Laser. As a result of the investigational efforts of Respondent and other medical researchers, the Excimer Laser was proved to have beneficial results in the treatment of nearsightedness and astigmatism. Subsequent to the publication of the advertisement, the Excimer Laser received FDA approval. The advertisement was reviewed by Norman S. Levy, M.D., Ph.D., an Opthamologist, and Director of the Florida Opthamologic Institute in Gainesville, Florida. As an expert in Opthamology, Dr. Levy opined that the advertisement published in this case was deceptive in that the advertisement implied that the Excimer Laser and Radial Keratotomy procedures were equally available, and the experimental nature of the Excimer Laser procedure was not clear from the advertisement. The advertisement was also reviewed by Dr. Rowsey, who opined that the advertisement was not misleading or deceptive, that the advertisement clearly contained cautionary language stating that the Excimer Laser was at that time an investigational device, and that the advertisement was merely a public invitation to a lecture to obtain more information regarding these procedures. In this respect, Dr. Rowsey has specific and extensive experience with the Excimer Laser, as well as in medical ethics, and his opinion on this issue is deemed more credible. There is no evidence that a patient of the Respondent's was deceived or mislead by the advertisement.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that Petitioner, the AGENCY FOR HEALTH CARE ADMINISTRATION, enter a final order dismissing the Administrative Complaint filed against Respondent JONATHAN M. FRANTZ, M.D., in the above-styled case. RECOMMENDED in Tallahassee, Leon County, Florida, this 24th day of January, 1996. RICHARD HIXSON, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of January, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-3773 Petitioner's Proposed Findings of Fact. 1.-6 Accepted and incorporated. Rejected to the extent that Respondent personally approved the advertisement. Rejected to the extent that a lay person could be misled. Rejected as not supported by the weight of evidence. Respondent's Proposed Findings of Fact. 1.&2. Accepted and incorporated. 3. Rejected as irrelevant. 4.-.7. Accepted and incorporated. 8.&9. Rejected as not necessary. 10.-12. Accepted and incorporated. 13. Rejected as not necessary. 14.-16. Accepted and incorporated. 17. Rejected as not necessary. 18.-26. Accepted and incorporated. COPIES FURNISHED: Joseph S. Garwood, Esquire AHCA - Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 John Lauro, Esquire Barnett Plaza, Suite 3950 101 East Kennedy Boulevard Tampa, Florida 33602
Findings Of Fact Respondent, Santiago F. Suarez (Suarez), was at all times material hereto licensed as a physician in the State of Florida, and held license number ME 0030132. Suarez is a family practitioner, and has no specialized training relating to the human eye. He has never performed a refraction or prescribed eyeglasses during his medical career, nor has he had any training or experience in prescribing and fitting contact lenses.1 Commencing in the latter part of 1983 and continuing through the early part of 1984, Suarez acted as the supervising physician for Reynaldo Avello (Avello) when he performed refractions or fit contact lenses on clients of the Optical Medical Center; a business owned by Avello. During this time period, Avello routinely refracted the vision of his clients; measured the eyes of clients who desired contact lenses; prescribed eyeglasses and contact lenses; and prepared, dispensed or fit eyeglasses and contact lenses for his clients as well as clients of optometrists and ophthalmologists. Avello is not, and never has been, a licensed optician or optometrist, and he has no formal education or training beyond high school. Consequently, his activities were proscribed by law unless they were appropriately delegated and supervised by a medical doctor.2 Chapter 463 and 484, Part I, Florida Statutes. In this case Avello, not Suarez, prescribed eyeglasses and contact lenses. Avello conducted the eye examination, but limited his practice to refracting the eye and, when appropriate, to measuring the eye for contact lenses. Although Avello was ostensibly practicing under Suarez' supervision, Suarez was not competent to perform a refraction, or to prescribe and fit eyeglasses and contact lenses. In fact, Suarez took no active part when client's eyes were refracted, but deferred to Avello's "expertise." Suarez limited his involvement to securing a brief medical history from the client, and being available in case an emergency arose.3 Suarez' reliance on Avello's "expertise," without inquiring as to his training and experience, was a serious error in judgment. The only training Avello had in refracting the human eye occurred while he was employed part-time by the Union Latina clinic in Hialeah, immediately before he opened the Optical Medical Center. During his employment at the clinic, Avello was shown how to do a refraction by a board qualified ophthalmologist, but he never performed any refractions under that ophthalmologist's supervision. In March 1980, Avello opened the Optical Medical Center. With the exception of the period during which Suarez supervised Avello, the center has always had in its employ a board qualified or certified ophthalmologist. During those times, all eye examinations were performed by the ophthalmologist, and Avello did no refracting. While Avello considers himself qualified to do refracting, the proof regarding his training and experience renders his opinion unpersuasive. At no time was he shown to have worked under the supervision of a qualified practitioner, and no qualified practitioner was shown to be familiar with the quality of his work. Further, Avello was not shown to have had any qualified training or experience in measuring the human eye; prescribing eye glasses and contact lenses; or preparing, dispensing, and fitting eyeglasses and contact lenses. Accordingly, the proof established that Suarez accepted and performed professional responsibilities which he knew he was not competent to perform, that he assisted an unlicensed person to practice medicine contrary to law, and that he delegated professional responsibilities to a person he should have known was not qualified to perform them. The proof further established that the existent community standard required that a complete eye examination be performed before eyeglasses or contact lenses could be prescribed, and that such standard was breached. Suarez' failings could have resulted in profound adverse consequences to those patrons who were ostensibly refracted and fitted under his supervision. Improperly fit eyeglasses can result in blurred vision and nausea. More importantly, improperly fit contact lenses can result in permanent visual damage to the eye. In mitigation, Suarez avers that he agreed to supervise Avello out of a sense of personal obligation, not profit; that his employment was to be for the limited time it took Avello to secure the services of another physician; and, that when he undertook to supervise Avello he believed such activity to be legal. Suarez also offered for consideration in mitigation the fact that he cooperated in the investigation of the Optical Medical Center, and the fact that he had never previously been disciplined. Suarez' plea in mitigation is largely unpersuasive. While he may have undertaken Avello's supervision out of a sense of personal obligation, it was not without the expectation of compensation. Suarez and Avello had agreed, that if their association proved profitable, he would be compensated for his services. Notably, while Suarez' desire to fulfill a personal obligation is admirable, its priority is far below that owed to those to whom he professed to render a professional service. In this case, Suarez' supervision permitted an unqualified person to render professional services that he, as a medical doctor, was not qualified to perform, and therefore not qualified to supervise. No physician could reasonably believe such conduct was appropriate.4 Suarez' assertion that his association with Avello was to be of limited duration is not only irrelevant, but contrary to the proof. Suarez supervised Avello for 1 1/2 years, and there was no showing that Avello or Suarez made any effort during that period to hasten his replacement. Notably, during his association with Avello's business, the front of the store proclaimed in bold guilding "Optical Medical Center, Santiago F. Suarez, M.D." Under the circumstances, the proof does not suggest that their association was to be casual or of short duration.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that: The medical license of Respondent, Santiago F. Suarez, be suspended for a period of one (1) year, and that during the period of such suspension Respondent be required to complete such courses as the Board of Medicine may require to demonstrate an adequate comprehension of professional ethics, scope of practice for a family practitioner and delegation of professional responsibility; and An administrative fine in the sum of $2,000.00 be ~ assessed against Respondent, Santiago F. Suarez. DONE and ORDERED this 15th day of September, 1987, in Tallahassee, Florida. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of September, 1987.
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
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
The Issue The issue for decision herein is whether or not Respondent exhibited fraud, deceit, negligence, incompetence, or misconduct in the examination and fitting of a patient for contact lenses in violation of Subsection 463.016(1)(g) and (h), Florida Statutes, and, if so, what, if any, administrative penalty should be imposed.
Findings Of Fact Petitioner, Department of Professional Regulation, Board of Optometry, is the state agency charged with regulating the practice of optometry in Florida, pursuant to Section 20.30 and Chapters 455 and 463, Florida Statutes. Respondent is, and has been at all times material hereto, a licensed optometrist who holds license number 0000437, and his last address of record is Zodiac Optical, 1211 South Dale Mabry Highway, Tampa, Florida 33 On February 21, 1987, Respondent examined and fitted Patricia Gama for hard contact lenses and Ms. Gama paid $154.00 for the lenses. On that date, Respondent obtained an initial refraction for the right eye of -1.25 and for the left eye of -1.00 (eye glass prescription only) and by use thereof, fitted Gama with contact lenses. At the time, Gama was employed as a cashier at a commercial retail establishment. Gama immediately began experiencing discomfort with the contacts, specifically blurred vision, red eyes and headaches. Gama found it difficult to read the cash register keys and function as a cashier. Gama advised Respondent of her discomfort on February 25, 1987, and at that time, Respondent fitted Gama with another set of contact lenses. Gama continued to experience discomfort with the contact lenses and after advising Respondent of such, Respondent on February 27, 1987, fitted Gama with a third set of contact lenses. Gama's discomfort with the contact lenses continued and she again advised Respondent of his discomfort. On March 18, 1987, Respondent fitted Gama with a fourth set of contact lenses. Through it all, Respondent used eleven different lenses in an effort to properly fit Gama; however, she continued to experience discomfort. Throughout Respondent's endeavor to properly fit Gama with contact lenses, he did so in a courteous and professional manner. However, Gama's husband insisted that she seek a second opinion from another optometrist, obtain a refund from Respondent and discontinue using the lenses Respondent prescribed. On April 22, 1987, Respondent's partner, Dr. William Hunter, refunded $74.00 of the total purchase price of $154.00 that Gama paid. He also gave Gama the prescription prepared for her by Respondent. Respondent works in a group practice which is owned by Dr. Hunter. Dr. Hunter has a policy of giving only a 50% refund within thirty days of purchase if the patient is not satisfied. On the following day, April 23, 1987, Gama was examined and fitted for contact lenses by Dr. Julian Newman. Respondent's initial refraction was twice as strong as Dr. Newman's refraction. It is not uncommon for patients, such as Gama, to test differently for glasses on different days which can result in different refraction readings on different days. Likewise, it is not unusual for an optometrist to note different refractions for the same patient on different days, or to make an error in the refraction readings for the same patient. When this is done however, the optometrist should try to correct the mistake if, in fact a mistake is made. Here, Respondent strived to satisfy Gama and never ceased efforts to comfortably fit her with contact lenses. Respondent made a refund to Gama in keeping with office policy which appeared reasonable under the circumstances considering the time spent with Gama before she decided to seek another opinion from another optometrist. (Testimony of Drs. Julian D. Newman, O.D. and Joel Marantz, O.D. both of whom were expert witnesses in this proceeding.) Respondent's receptionist, Beatrice Franklin, paid $100.00 to Gama on or about December 11, 1987, in exchange for Gama signing a request to drop her charges against Respondent at the Department of Professional Regulation. Respondent had no knowledge of Ms. Franklin's actions, and in fact, Sharon Hosey, a receptionist employed by Respondent, corroborated Respondent's testimony respecting lack of knowledge on his part as to any payments to Gama other than the $74.00 refund in exchange for her withdrawal of the complaint with Petitioner or to otherwise obtain Gama's signature on a release. Respondent was conscientiously attempting to comfortably fit Gama with contact lenses when Gama decided to seek a second opinion. He did so by changing the prescriptions on several occasions, including changing to lenses made by a different manufacturer. In the process, Respondent tried eleven different contact lenses. Respondent was willing to continue treating Ms. Gama and provide the required follow-up care.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that: The Board of Optometry enter a Final Order dismissing the Administrative Complaint filed herein in its entirety. DONE and ENTERED this 16th day of February, 1990, in Tallahassee, Leon County, Florida. JAMES E. BRADWELL 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 16 day of February, 1990. COPIES FURNISHED: Elizabeth R. Alsobrook, Esquire Department of Professional Regulation 1940 North Monroe, Suite 60 Tallahassee, Florida 32399-0792 Jack L. Hargraves, O.D. 1211 South Dale Mabry Highway Tampa, Florida 33629 Patricia Guilford, Executive Director Florida Board of Optometry Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0792 Kenneth E. Easley, Esquire General Counsel Department of Professional Regulation 1940 North Monroe, Suite 60 Tallahassee, Florida 32399-0792 =================================================================
