Findings Of Fact Stipulated facts 2/ The Respondent is a licensed physician in the State of Florida and has been licensed in Florida at all times material herein. The Respondent is Board Certified in family practice. The patient B. M., a female born on May 18, 1934, with a history of hypertension, diabetes, and obesity, presented to the Respondent on multiple occasions between August of 1979 and November of 1990. On September 29, 1979, when she was forty-five years old, patient B. M. notified the Respondent that her periods were spreading out and that she was getting hot flashes. On February 18, 1982, patient B. M. indicated that she was having irregular periods every couple of months. The Respondent's medical records indicate that he did not see or treat the patient B. M. between October 1, 1984, and July 3, 1987. On July 3, 1987, patient B. M. presented to the Respondent with complaints of excessive vaginal bleeding for the past three (3) months. The patient indicated the bleeding had stopped approximately three weeks earlier. The Respondent diagnosed patient B. M. with vaginitis, and prescribed her medication for vaginitis, based on the patient's complaints of vaginal discharge. Respondent did not perform a pelvic examination on that day to make that diagnosis. Patient B. M. returned the following week for a pelvic examination. The Respondent did not document the medical history of the patient B. M. during the preceding three years, although she had a history of high blood pressure and diabetes, both conditions that require periodic monitoring and prescription medication. The Respondent also did not document any pertinent information relating to the patient's gynecological history, including, but not limited to, the dates of the patient's last period, how often her periods were occurring, and how much she was bleeding, despite her complaints of excessive bleeding. On August 7, 1987, after several other visits, the patient B. M. returned for an examination. A pelvic examination revealed a vaginal laceration that was bleeding. On January 18, 1988, patient B. M. presented to the Respondent with complaints of irregular bleeding for the prior month. The Respondent suggested a dilation and curettage (scraping of the uterine walls) if patient B. M.'s bleeding continued. On December 21, 1989, patient B. M. presented to the Respondent with complaints of excessive vaginal bleeding with clots since the previous night. The Respondent indicated that the patient had her regular period the previous week, and was using condoms. The Respondent performed a pelvic examination which revealed blood clots, and diagnosed patient B. M. with dysfunctional uterine bleeding and administered progesterone to patient B. M. The Respondent did not document any additional information concerning the patient's menstrual activity, such as how often she had periods, what was meant by uncontrollable vaginal bleeding, where the bleeding was coming from, or why she was using condoms. The patient B. M. continued to complain of occasional bleeding after December 21, 1989, and on January 15, 1990, the Respondent referred the patient B. M. to a gynecologist. On February 5, 1990, the patient B. M. presented to a gynecologist, who took cervical biopsies and subsequently performed a dilation and curettage on the patient B. M. on or about February 23, 1990. The patient was subsequently initially diagnosed with grade two endometrial cancer, and after biopsy was diagnosed with grade three endometrial cancer and was referred to another gynecologist at the University of Miami. 3/ On April 5, 1990, the patient B. M. underwent a total hysterectomy. The patient B. M. was then diagnosed with Stage III-C endometrial carcinoma and underwent intravenous Adriamycin chemotherapy. On December 25, 1990, the patient B. M. expired. Facts based on evidence at hearing At all times material to this case, the subject patient 4/ weighed approximately three hundred pounds. Periods spreading out and hot flashes are signs that a woman may be beginning menopause. The average length of time between the beginning of menopausal symptoms and a cessation of menstruation is six months to one year. Endometrial cancer is cancer of the uterus. It is the most common gynecological cancer in women. Endometrial cancer occurs most often in women who are post-menopausal. About 20 to 25 percent of women are diagnosed with endometrial cancer before menopause. Most patients are diagnosed with endometrial cancer after the age of 50. When diagnosed early, patients with endometrial cancer have a very high survival rate. When diagnosed late, patients with endometrial cancer have a very low survival rate. The subject patient had several of the risk factors associated with endometrial cancer. The first symptom in most cases of endometrial cancer is abnormal bleeding. Any woman with post-menopausal abnormal bleeding should be checked for endometrial cancer. The subject patient was hospitalized in 1982. During that hospitalization she was evaluated by a gynecologist who determined that there was no evidence of abnormal or irregular gynecological problems at that time. After February 18, 1982, through October 1, 1984, there are no references in the Respondent's medical records to the subject patient's menstrual history, and no indication as to whether the patient had regular or irregular menstrual periods during that period of time. The subject patient was not seen by the Respondent on any occasion between October 1, 1984, and July 3, 1987. 5/ The subject patient returned to the Respondent's office on July 3, 1987. On the occasion of that visit she gave a history to the Respondent's office staff which is recorded in the Respondent's medical records as "excessive bleeding vaginal for 3 mos. Stopped 6/13." The Respondent's records for July 3, 1987, do not contain any additional details regarding the nature of the excessive bleeding. The Respondent's medical records for the July 3, 1987, office visit also indicate that at that time the patient had a vaginal infection with a discharge. This information was obtained from the patient. On that day the Respondent did not examine the patient to confirm the condition described by the patient. The Respondent diagnosed the patient as having vaginitis and prescribed Sultrin cream and Betadine douche for the vaginitis. The medical records for the July 3, 1987, office visit note that the patient had high blood pressure. Although the records, standing alone, do not clearly show that any treatment was undertaken on that day for the patient's high blood pressure, during the course of the July 3, 1987, visit, the Respondent prescribed medication for the patient's high blood pressure, as well as syringes for her diabetes. Those prescriptions were recorded in the patient's chart on the front cover. Because the subject patient had returned for a single office visit on July 3, 1987, after an absence of almost three years, the Respondent determined at that time that he needed to do a full physical examination on her, as well as a pelvic exam. Although the Respondent did not perform either examination at the July 3, 1987, office visit, he made plans to do both shortly thereafter. The subject patient returned ten days later, on July 13, 1987, at which time the Respondent performed a complete physical examination of the patient. No pelvic examination was performed that day, because the Respondent was having her period. The Respondent asked the patient to return one week later for a pelvic examination. The subject patient returned on July 20, 1987, at which time a pelvic examination was performed. On that day there was no evidence of any irregular or unusual bleeding. The patient did have a vaginal infection that day. The vaginal infection was treated appropriately by the Respondent. In view of the vaginal infection, the patient was advised to return to the office one week later, at which time she would be examined again. The subject patient returned to the Respondent's office on August 7, 1987, for a follow-up pelvic examination, at which time the Respondent identified a small superficial laceration in the patient's vagina. The laceration was causing some slight bleeding. The Respondent noted that there was no bleeding from the cervical os, which indicated that the small laceration was the sole source of the patient's bleeding that day. As an additional follow-up, the Respondent ordered a sonogram. The sonogram was ordered in part because, due to the patient's obesity, the Respondent was unable to palpate her internal organs. The Respondent did not document any details concerning the vaginal laceration, such as the size of the laceration, the amount the laceration was bleeding, or the precise location of the laceration, because it was a very small laceration with very slight bleeding which was of very little medical significance. The Respondent did not refer the patient to a gynecologist after learning the results of the sonogram he ordered on August 7, 1987. The Respondent concluded that the 1987 sonogram results were not significantly different from the 1982 sonogram results. Such conclusion was reasonable under the circumstances. Accordingly, the 1987 sonogram results did not suggest any need for further investigation. The subject patient returned to the Respondent's office on August 24, 1987, at which time she had no complaints of any type of vaginal bleeding. She was being seen in order to follow up on her other complaints, notably her diabetes and her high blood pressure. The Respondent assumed that the vaginal laceration had healed and did not conduct a pelvic examination of the patient during that visit. After August 24, 1987, and before January 18, 1988, the Respondent saw and treated the subject patient once a month on four more occasions. The medical records for those four office visits do not mention the patient's menstrual history or whether she was bleeding on any of those occasions. During the four monthly visits between August of 1987 and January of 1988, the subject patient did not complain of any episodes of irregular vaginal bleeding. On January 18, 1988, the subject patient returned to the Respondent's office with complaints of irregular vaginal bleeding since having been the victim of a mugging during the previous month. The Respondent did not record any detailed information about the bleeding, such as her current menstrual condition, how much she was bleeding, or how often she was bleeding. The Respondent concluded that the bleeding was probably due to the patient's anxiety about the recent mugging incident. Nevertheless, he wanted to follow up on the irregular bleeding if it did not resolve on its own. To that end he discussed the matter with the patient and told her that if the irregular bleeding did not get better, she should come back and he would do a D & C. The Respondent noted in his record for that visit: "May need D & C if bleeding continues." In view of the patient's intelligence, the Respondent fully (and reasonably) expected she would tell him if she had any further irregular bleeding. The procedure known as D & C, or dilation and curretage, is a procedure wherein a physician obtains a sample of the lining of the uterus to evaluate it for possible abnormalities. The D & C procedure is commonly used to diagnose, or to rule out, endometrial cancer. Following the office visit on January 18, 1988, the subject patient presented to the Respondent's office on three other visits during each of which she did not have any complaints of irregular bleeding. The subject patient did not have any further gynecological complaints until December 21, 1989. On that day she returned to the Respondent's office with complaints of uncontrollable vaginal bleeding since 7:30 p. m. of the previous evening. During the course of the December 21, 1989, office visit, the subject patient told the Respondent that she had had her last regular menstrual period the week before. She also told him she was using condoms. During the course of the December 21, 1989, office visit the Respondent performed a pelvic examination of the patient and made a provisional or working diagnosis of dysfunctional uterine bleeding. He administered an injection of progesterone and instructed the patient to return in three days. He also instructed the patient to have another pelvic sonogram performed. Dysfunctional uterine bleeding is abnormal uterine bleeding not related to or caused by an organic problem such as cancer, polyps, fibroids, or infections. It is usually caused by an hormonal imbalance. In the case of a woman who is not post- menopausal and who presents with complaints of irregular vaginal bleeding, one of the differential diagnoses can be dysfunctional uterine bleeding. In such a case it is appropriate to administer progesterone prior to embarking on additional studies. In such a case the administration of progesterone is useful for two reasons: (1) if the progesterone is successful in stopping the irregular bleeding its success tends to confirm the differential diagnosis of dysfunctional uterine bleeding, and (2) if the progesterone is unsuccessful in stopping the irregular bleeding it tends to rule out the diagnosis of dysfunctional uterine bleeding and confirm the need for further investigation. Under the circumstances that existed on December 21, 1989, it was reasonable and appropriate for the Respondent to administer progesterone on the basis of a provisional or working diagnosis of dysfunctional uterine bleeding, because if the treatment was successful it would tend to confirm the provisional or working diagnosis and it the treatment was not successful it would rule out the provisional or working diagnosis. 6/ The fact that dysfunctional uterine bleeding was only a provisional or working diagnosis is illustrated by the fact that the Respondent at the same time ordered a sonogram in order to investigate other possible causes of the abnormal bleeding. A verbal report of the results of the sonogram ordered on December 21, 1989, was given to the Respondent's office by telephone on December 26, 1989. 7/ A written report of the results was provided shortly thereafter. The report of the sonogram ordered on December 21, 1989, indicated that the subject patient had an enlarged uterus measuring 18.8 x 9.3 x 10.8 centimeters. The 1989 sonogram report revealed that the patient's uterus was substantially larger than it had been at the time of the 1987 sonogram. The report of the December 21, 1989, sonogram included a recommendation for follow up examination of the uterus and the endometrial canal. The subject patient returned to the Respondent's office on December 26, 1989, at which time she told the Respondent that the bleeding had stopped. He asked her to return again in two weeks. When she returned twenty days later on January 15, 1990, she had started to again have occasional episodes of bleeding and spotting. The Respondent thereupon referred the patient for a gynecological consult. The subject patient was seen by a gynecologist, Dr. William Shure, on February 5, 1990. The patient provided Dr. Shure with a history that her last menstrual period had been on December 19, 1989. This last menstrual period history is the same history that was recorded by the Respondent on December 21, 1989. On February 5, 1990, Dr. Shure took cervical biopsies from the subject patient, and subsequently performed a D & C on the patient on February 23, 1990. The patient was then diagnosed with Stage II-B endometrial cancer. Following a total hysterectomy on April 5, 1990, the patient was diagnosed with Stage III-C endometrial cancer. Stage II-B endometrial cancer is cancer of the uterus with extension into the cervix. Stage III-C endometrial cancer is an advanced stage of cancer of the uterus which extends into the cervix and has metastasis to pelvic lymph nodes. The patient underwent chemotherapy for the cancer. The chemotherapy was unsuccessful and the patient expired on December 25, 1990. At all times material to this case the Respondent used a record- keeping methodology in his medical practice known as the SOAP method. This is an appropriate methodology for record- keeping in a medical practice. The Respondent's records regarding the subject patient demonstrate that he kept a running list of all medications prescribed for the patient. The Respondent's records regarding his care and treatment of the subject patient were sufficient to justify his course of treatment of the patient. 8/ The care, skill, and treatment applied by the Respondent in the treatment of the subject patient from July of 1987 through January of 1990 (the only time period at issue here) was reasonable under the circumstances and did not depart from the level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The Respondent's treatment of the subject patient did not constitute gross or repeated malpractice. 9/ The Respondent has not been the subject of any prior disciplinary proceedings.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Board of Medicine enter a Final Order in this case dismissing all charges in all three counts of the Amended Administrative Complaint. DONE AND ENTERED this 17th day of May 1996 at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, 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 17th day of May 1996.
The Issue Whether Respondent violated Subsection 456.072(1)(aa), Florida Statutes (2003),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with the regulation of medicine pursuant to Chapters 20, 456, and 458, Florida Statutes. Dr. Weiner, is and was at all times material to this proceeding, a licensed physician in the State of Florida, having been issued license number ME76902. He has been practicing medicine for 23 years and has not previously been the subject of a disciplinary proceeding. Dr. Weiner is board-certified in anesthesiology. S.M. has been a patient of Dr. Weiner since 1999. S.M. sought treatment from Dr. Weiner for his lower back pain that he suffered as a result of a golf cart injury. Over the course of his care under Dr. Weiner up until the date of the incident, S.M. received numerous treatments for his back pain, including radiofrequency ablation and epidural steroids. Radiofrequency ablation uses a specific frequency of radio waves to help put specific pain nerves that go to the joints of the spine to sleep for a period of time. In this procedure a steroid is deposited inside the epidural space outside the spine. The procedure can help to treat back pain as well as pain extending down the legs of the patient. On January 29, 2005, S.M. presented to Dr. Weiner with complaints of lower back pain. After examining S.M., Dr. Weiner recommended that S.M. undergo a radiofrequency ablation procedure. Dr. Weiner ordered the radiofrequency ablation procedure and instructed his office to coordinate with the Center for Digestive Health and Pain Management (Center), to have the procedure scheduled. The Center, which is a separate facility from Dr. Weiner's office, scheduled S.M.'s treatment for February 19, 2004. The Center scheduled S.M. for a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, rather than the radiofrequency ablation procedure. A Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, involves placing a needle down near the tailbone. A catheter is inserted through the needle into the space around the spine. A steroid medication is injected through the catheter. The purpose of the procedure is to decrease irritation and inflammation of the nerves as well as the discs. S.M. could have derived some benefit from the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach. Patient charts at the Center are separate from the patient charts at Dr. Weiner's office. The Center's charts are made up by the Center staff and consist of forms for the specific procedure, a template of the procedure for the specific procedure, the nursing notes, billing sheets, and other administrative paperwork. When the Center erroneously scheduled S.M. for a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, the Center prepared paperwork necessary for the provision of that technique, including consent forms. On February 19, 2004, S.M. went to the Center with the belief that he was going to receive the radiofrequency ablation procedure. During this visit, S.M. was in a lot of pain and was eager to receive treatment for his back. Upon arrival to the Center, S.M. signed a consent form that referenced a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach procedure. The nurse then confirmed with S.M., the technician, and Dr. Weiner that S.M. understood this procedure. Dr. Weiner also explained the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, to S.M before administering the treatment and also told S.M. that this was the first time he had undergone this procedure while under Dr. Weiner's care. Subsequent to signing the consent form, S.M. got undressed and was hooked up to an IV. He was then moved to another bed, and Dr. Weiner started to perform the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, on S.M. Dr. Weiner administered a local anesthesia and began to insert the tip of a needle into S.M.'s back. After partially inserting the needle in S.M.'s back, Dr. Weiner stopped the procedure and reviewed S.M.'s chart. He requested that S.M.'s chart that was in Dr. Weiner's office be brought to the Center. The chart revealed that the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, was not the procedure that was originally ordered at S.M.'s appointment on January 29, 2004. Once he realized the discrepancy, Dr. Weiner apologized to S.M. and explained that he began to do the wrong procedure. S.M. was then taken to the recovery room, and Dr. Weiner ordered the radiofrequency ablation procedure for a later date. S.M. did not receive the complete Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, procedure on February 19, 2005. In or about March 2004, S.M. returned to the Center and had the radiofrequency ablation procedure completed.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that James P. Weiner, M.D., violated Subsection 456.072(1)(aa), Florida Statutes; issuing a reprimand; imposing a $1,000 fine; requiring 25 hours of community service; and requiring five hours of risk management education. DONE AND ENTERED this 31st day of March, 2006, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of March, 2006.
Findings Of Fact Upon consideration of the oral and documentary evidence presented at the hearing, the following relevant facts are found: At all times pertinent to the matters considered here, the Respondent was a medical doctor licensed by the State of Florida under license number ME1472. He has been engaged in the practice of medicine for 50 years. While in practice in Orlando, Florida, during the period March 14, 1980, through August 8, 1980, Respondent had as a patient, and acted as treating physician for, Mary Walsh, who was at the time suffering from cancer of the lung. Respondent's treatment of Mary Walsh during the entire period she was his patient included the administering to her of laetrile, dimethylsulfoxide (DMSO) intravenously, enzymes, and megavitamins. Dr. James M. Johnstone (D.O.) had been a physician to Mrs. Walsh over a period of several years for a variety of complaints. (Her lung cancer was detected in December, 1979, however, when she went into his office on a routine visit.) Over the period of time he had treated her, she had suffered from such things as seizures, thyroid problems, and the like, but on this particular December 1979 visit, she complained of a sore throat. Dr. Johnstone referred her for consultation with a Dr. Porth, who ultimately opined she might have cancer of the epiglottis. As a result, in January, 1980, she was admitted to the hospital, where she was diagnosed as having cancer of the left lung. Exploratory surgery conducted during a second period of hospitalization in February, 1980, revealed that the cancer was inoperable and terminal, and the procedure was terminated without any surgical excision. Dr. Johnstone and several other physicians advised Mrs. Walsh and her daughter, Vicki L. Chapman, that conventional-treatments such as radiation therapy were available for, if not a cure, at least palliative treatment to reduce pain and perhaps extend life somewhat, but Mrs. Walsh was afraid of radiation therapy and refused it repeatedly. During this period of diagnoses and tests, Mrs. Walsh and her daughter, Vicki, were told by an acquaintance named Elmer Boener, of the Fairfield Medical Center in Jamaica, which offered the organic approach to cancer control, including the use of diet and vitamins. While Mrs. Walsh and her daughter were deciding whether to go to Jamaica, Mr. Boener informed them that a Dr. Wedel would be working at Respondent's clinic offering the same treatment as available in Jamaica, and they would not have to have the stress of going out of the country. They decided to go to Jamaica, however, because of the stress in this course of treatment on diet and, in March, 1980, went to the Fairfield Clinic for ten days, returning during the first week in April, 1980, at which time Mrs. Walsh took up treatment of her condition with Dr. Wedel and Respondent at the latter's clinic in Orlando. Mrs. Chapman went with her mother on almost every visit to Respondent's office and was present when Mrs. Walsh talked with either doctor or got her treatment. On one occasion, after looking at some X rays taken of Mrs. Walsh's lungs, in the presence of Mrs. Chapman, Dr. Lynn allegedly told Mrs. Walsh that her cancer was shrinking and getting better. This was not true. Dr. Lynn denies telling her this, saying he told her the amount of fluid in the lungs had reduced, but not the size of the cancer. Considering all the evidence and weighing all the factors, I find that Dr. Lynn did make the statement alleged. However, Mrs. Walsh still had pain, and Respondent would not prescribe medication for her. Because of that, she had to go to another doctor for a prescription for whatever she needed to relieve pain. During the time that Respondent treated Mrs. Walsh, he was assisted by a "Dr." Wedel, who held himself out to be a nutritionist. However, search of the records of the various licensing agencies for the medical disciplines within this state reveals that he is not licensed as a medical doctor, osteopath, naturopath, physical therapist, podiatrist, chiropractor, pharmacist, registered nurse, or licensed practical nurse. His service to Mrs. Walsh consisted of nutritional counselling as to diet, vitamins, etc., and writing prescriptions for vitamins that were subsequently signed by Respondent. Respondent's supervision of Wedel was not regular, but periodic. Wedel was recommended to Respondent by a friend in Oregon and intended to apply for a Florida license as a medical doctor. Dr. Lynn states that before offering Wedel employment, he cleared taking him on with the Orange County Medical Association, which agency interposed no objection. When Mrs. Walsh returned to Respondent's care from Jamaica, she requested that he continue the course of treatment she had been undergoing there, which included diet control and the use of vitamins, enzymes, laetrile, and DMSO. Though Dr. Lynn's medical notes were not introduced at the hearing, he indicated that they fail to reveal he counseled Mrs. Walsh on other, conventional forms of treatment for her condition, such as X-ray therapy or chemotherapy. He is satisfied, however, that she was aware of them. Respondent, due to Mrs. Walsh's request to him that he continue the use of laetrile and DMSO, had her oral consent to do so. However, he did not have, nor did he insure that, his staff secure for him her informed, written consent to treat her with either drug. Further, he did not, prior to utilizing either drug, inform her in writing that neither was approved for use in the treatment of cancer by the Federal Food and Drug Administration of the United States Department of Health and Human Services (FDA). Laetrile, DMSO, enzymes, and megavitamins, either singly or taken together, are unconventional treatments for cancer, as accepted by the medical community, and are generally recognized by that community as being experimental.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Respondent's license to practice medicine in the State of Florida be suspended for a period of one year. RECOMMENDED this 11th day of April, 1983, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 11th day of April, 10983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 William Trickel, Jr., Esquire 35 West Pine Street Orlando, Florida 32801 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether Respondent, a licensed physician, violated the applicable standard of care by diagnosing prostate cancer in four patients, and recommending and participating in a course of treatment for these patients, without confirming prostate cancer through tissue biopsy results; and, if so, what is the appropriate penalty?
Findings Of Fact Petitioner is responsible for the investigation and prosecution of complaints against medical doctors licensed in the state of Florida, who are accused of violating chapters 456 and 458 of the Florida Statutes. Respondent is licensed as a medical doctor in Florida, having been issued license number ME 46625. Respondent is not board-certified in any specialty recognized by the Florida Board of Medicine. Respondent has never had disciplinary action against his license to practice medicine. Respondent's Practice Since his residency concluded in 1985, Respondent has practiced urology. For more than 20 years, the focus of his practice has been prostate disease, its diagnosis, and treatment. In 2006, Respondent became the lead investigator for a General Electric study regarding its 3-Tesla magnetic resonance spectroscopy imaging machine (3T MRI-s) as part of an Institutional Review Board measuring the heat generated by the machine to ensure the safety of patients. Between 2006 and 2010, 1,600 prostates were scanned with a 3T MRI-s as part of the study. Respondent reviewed the results of each radiology report associated with these scans and compared them to the clinical data he had for each patient. Respondent also completed a double-blind study of 200 of these patients who had prostate biopsies during 2008 and 2009, as well as the 3T MRI-s, correlated the results of the biopsies and the scans, and became convinced that the 3T MRI-s technology alone is a positive predictor of prostate cancer 95 percent of the time. According to both parties' experts, as well as Respondent, the standard of care in Florida and throughout the United States is to use a needle tissue biopsy to identify prostate cancer. As admitted by Respondent, medical schools teach that needle biopsy is "the way" to diagnose prostate cancer. Absent a biopsy showing malignant tissue, it is not possible for a reasonably prudent physician to diagnose or treat prostate cancer. Biopsies are usually performed to diagnose prostate cancer if a man has a combination of risk factors, such as family history, an abnormal digital rectal exam, and/or increasing levels of Prostate Specific Antigen (PSA). However, needle biopsies for prostate cancer carry a false negative rate of 20 to 50 percent, which means that a standard 12-point needle biopsy (where 12 samples of tissue from different locations in the prostate are sampled) often misses cancerous tissue. Prostate needle biopsies are sometimes painful and carry a risk of complications, including common complications such as bleeding and infection, and the unlikely complications of septic shock and death. Respondent is convinced that there is a significant risk from a prostate needle biopsy to spread prostate cancer cells outside the prostate capsule, which is referred to as "seeding" or "needle tracking." Respondent's belief is founded upon a one-page 2002 article published in the American Urological Association, Inc.'s Journal of Urology (Journal), which refers to two cases in which a tumor was discovered in the rectal wall after prostate biopsies and cryoblation.1/ The tumors were suspected of being the result of needle tracking from prostate cancer biopsies. Significantly, this article makes clear that needle tracking resulting from prostate biopsies are rare and "exceedingly uncommon." Respondent's concern, regarding prostate biopsies spreading prostate cancer, is also in part founded upon a one-paragraph 1991 Journal abstract reporting a Johns Hopkins University School of Medicine study of 350 patients in which needle tracking was suspected in seven patients (two percent).2/ According to Respondent, his belief that prostate biopsies spread prostate cancer is "intuitive," although he acknowledges this is not the prevailing view in Florida. Respondent argues that doctors do not want to believe needle tracking takes place with prostate biopsies and suggests there is a financial motivation for doctors to require a positive biopsy before definitively diagnosing prostate cancer. Respondent is so convinced of the dangers of needle biopsies for prostate cancer that he published a book, Men at Risk: the Dirty Little Secret – Prostate Biopsies Really Do Spread Prostate Cancer Cells, in 2012, which he provides to all his patients. In his book, Respondent states: For me, a 3T MRI scan is the best objective marker to a diagnosis of prostate cancer. To summarize, patients must answer one question. Should I agree to a prostate biopsy procedure where it has been proven to spread prostate cancer cells or do I keep my fingers and toes crossed, hoping for the best? In two words, . . . "absolutely not." To me, the decision is easy – the literature validates avoiding random biopsies and supports imaging with a 3 T magnet. There is no other organ in the human body where diagnosis is dependent on sticking needles randomly and blindly into a delicate organ in an attempt to find cancer. This practice is archaic, patently barbaric, unacceptable and preferentially favored by virtually all urologists. Beyond the obvious benefit to being able to see a cancer and its pattern of invasion with the 3.0 Tesla MRI scan, there is no other exam or scan that competes in terms of diagnostic accuracy or predictability. The discerning patient will soon recognize that guessing where cancer is located, through random biopsies, is for the less informed.[3] Respondent refers to the use of 3T MRI-s as the "truth serum" of prostate cancer diagnosis. During all times material hereto, Respondent held himself out as a urologist who could diagnose and treat prostate cancer without a needle biopsy. In fact, the four patients at issue in this case found Respondent through an Internet search. Respondent defines his office, the Diagnostic Center for Disease (DCD) as, "A comprehensive prostate cancer diagnostic center in Sarasota, Florida specializing in non-invasive diagnostics (MRI/MRIS) without biopsy as an integral part of the diagnostic evaluation of prostate cancer."4/ Respondent also advertised himself as "a world expert in High Intensity Focused Ultrasound (HIFU), having diagnosed and treated more patients for prostate cancer from more countries than any other treating doctor in the world."5/ HIFU is a treatment alternative to brachytherapy (the insertion of radioactive seeds into the prostate), radiation, and prostatectomy (the surgical removal of the prostate gland) for prostate cancer and uses highly focused ultrasound waves in a small area to create intense heat, which destroys prostate cancer tissue. HIFU was not an approved treatment for prostate cancer in the United States until October 9, 2015, at which time the Food and Drug Administration (FDA) approved the use of the Sonablate machine for prostate tissue ablation. Prior to that time, Respondent referred his patients to treatment facilities in Mexico and the Caribbean where he performed HIFU treatments. The standard of care in Florida precludes treating prostate cancer with HIFU in the absence of a tissue biopsy confirming the presence of cancer. In order to be eligible for HIFU treatment, in addition to a positive diagnosis, the patient's prostate gland must be less than 40 grams. HIFU is not appropriate on patients with multiple calcifications in their prostate because they interfere with the treatment. Because a smaller prostate gland is easier to work with, prior to undergoing HIFU treatment, patients are often prescribed Bicalutamide (also known by its brand name, Casodex) and Trelstar. Bicalutamide suppresses the uptake of testosterone and Trelstar suppresses the production of testosterone, with both drugs having the effect of shrinking the prostate gland. Side effects of these drugs include hot flashes, weakness, and a sense of a loss of well-being. Facts Related to Patient G.P. Patient G.P., a 69 year-old retiree, had a prostate biopsy performed in December 2005 after a rise in his PSA level. This biopsy was negative for prostate cancer, but Patient G.P. was diagnosed with an enlarged prostate and benign prostate hyperplasty (BPH). In May 2008, Patient G.P. learned through a physical exam for a life insurance policy that his PSA level was elevated. After another check of his PSA level in November 2008, Patient G.P. was advised to undergo another prostate biopsy. Because his first prostate biopsy was painful, Patient G.P. searched the Internet for alternatives to biopsy and learned of Respondent and his use of the 3T MRI-s at the DCD in Sarasota for diagnosing prostate cancer. Patient G.P. traveled to Florida from Michigan to meet with Respondent on January 5, 2009. Patient G.P. underwent a 3T MRI-s scan at Respondent's office. Respondent told Patient G.P. that he was unsure of the results because they were consistent with BPH and not prostate cancer. However, Respondent advised Patient G.P. was considered "high risk" because his father died from prostate cancer in 2002. Rather than undergoing any treatment at that time, Patient G.P. was prescribed Avodart for his BPH and agreed to active surveillance (A.S.) whereby he would receive regular PSA screening. When Patient G.P.'s December 2009 PSA level went up after being on Avodart for most of the year, he was concerned and telephoned Respondent's office. Respondent prescribed Casodex based upon his telephone call with Patient G.P. on January 15, 2010. By February 2010, G.P.'s PSA level decreased significantly, but not as much as he believed it should have after taking Casodex for several weeks. Patient G.P. also experienced urinary frequency problems and pain. He returned to Respondent's office where Respondent performed an ultrasound and digital rectal exam. Respondent told Patient G.P. it was likely he had prostate cancer, but that he could not be sure without a biopsy. However, Respondent's medical records reflect that Respondent diagnosed Patient G.P. as having prostate cancer without a tissue biopsy.6/ Respondent offered to do a targeted biopsy based on an MRI scan. Respondent also discussed his concerns regarding needle tracking from biopsies with Patient G.P. Patient G.P. made it clear he did not want a biopsy, and he wanted to proceed to HIFU. Respondent advised Patient G.P. of the risk of erectile dysfunction following HIFU, but did not discuss the possibility of urinary stricture problems. In April 2010, Patient G.P. traveled to Mexico where the HIFU procedure was performed by Respondent. In March 2011, Patient G.P. saw a urologist in Michigan about his diminished urinary stream and pain. The urologist used a reamer to open Patient G.P's urethra, but on April 15, 2011, he went to the emergency room because he was completely unable to urinate. Patient G.P. was catheterized and subsequently underwent electro-vaporization on April 25, 2011, to relieve the urinary stricture. In August 2011, Patient G.P. also underwent hydro- dilating in an attempt to relieve the symptoms of his urinary stricture. In September 2011, Patient G.P. saw board-certified urologist Dr. Joel Gelman, who specializes in urethral reconstruction. At that time, Patient G.P. was advised that his urinary stricture, caused by the HIFU treatment, was a significant problem because his urethra was closed off almost to the bladder neck. Dr. Gelman performed a transurethral resection of the prostate (TURP). As part of the TURP procedure, Dr. Gelman took samples of Patient G.P.'s prostate tissue and no evidence was found of prostate cancer. Although Patient G.P. had no complaints regarding his course of treatment from Respondent, Dr. Gelman filed a complaint against Respondent because he was concerned that Respondent prescribed medications and performed HIFU on Patient G.P. for prostate cancer without a tissue biopsy. Facts Related to Patient J.W. Patient J.W., a 74 year-old retired dentist, had two biopsies performed in 2005 and 2007 ordered by his urologist in Alabama in response to elevated PSA levels. No evidence of malignancy was found. Patient J.W.'s PSA level was again elevated when tested in March 2012. He was reluctant to have another biopsy because the first two were painful. Patient J.W. was told about Respondent by a friend, and he viewed Respondent's website. Patient J.W. was interested in consulting with Respondent because Respondent advertised he had an MRI machine that could detect cancer cells, and Respondent believed prostate biopsies spread cancer. Patient J.W. traveled from Alabama to meet with Respondent at the DCD on May 14 and 15, 2012. After a sonogram and MRI, Respondent diagnosed Patient J.W. with prostate cancer. Respondent discussed a treatment plan which included what Respondent called "chemical castration" for a period of six months, to be followed with a trip to Mexico for HIFU treatment at the cost of $32,000.00. Respondent did not suggest any other treatment options to Patient J.W. or recommend a tissue biopsy. The idea of "chemical castration" scared Patient J.W., who sought a second opinion in June 2012 from another urologist, Dr. M. Eric Brewer. Dr. Brewer told J.W. that HIFU was not an accepted treatment in the United States for prostate cancer. Patient J.W. declined to go forward with treatment by Respondent. Dr. Brewer recommended A.S. and, as recommended by Dr. Brewer, Patient J.W. has his PSA level checked every six months. Patient J.W.'s PSA levels have decreased without any treatment. Dr. Brewer discussed Patient J.W.'s case with his partners, the tumor board, the president of the Southeastern Urological Association, and the president of the American Board of Urology, who unanimously advised Dr. Brewer to file a complaint with Petitioner against Respondent for cancer diagnosis and recommending treatment in the absence of a pathologic specimen. Facts Related to Patient K.S. Patient K.S. is a 62-year-old video producer and editor from Tennessee. He has no family history of prostate cancer. Patient K.S. had his PSA level tested in 2005 and 2009, at which time it was considered elevated. Patient K.S. was referred to a urologist by his primary care physician. After again showing elevated PSA levels, Patient K.S. underwent a prostate biopsy in 2011 and 2012. Neither biopsy was positive for prostate cancer. However, Patient K.S. and his wife were concerned about his rising PSA level and sought a second opinion. Patient K.S.' wife was concerned that if her husband had prostate cancer, his local urologist would recommend removal of the prostate. She researched alternative treatments on the Internet and found Respondent's website. On October 15, 2012, Patient K.S. and his wife traveled to the DCD in Sarasota to meet with Respondent. Respondent initially performed an ultrasound on Patient K.S. and then told Patient K.S. he was "concerned" Patient K.S. had prostate cancer. He recommended HIFU treatment to Patient K.S. Respondent made it clear to Patient K.S. that Respondent would not perform a needle biopsy because it pushes cancer further into the prostate. Respondent told Patient K.S. that the MRI would make it clear whether Patient K.S. had prostate cancer. Later that same day, Patient K.S. had an MRI performed at the DCD. Approximately a week later, Patient K.S. received a telephone call from Respondent with the MRI results who told Patient K.S. that based on the MRI, he had Gleason 7 prostate cancer, a fairly aggressive form of prostate cancer that could be treated with HIFU in Mexico the following month. This was followed up with an e-mail from the DCD to Patient K.S. demanding a payment of $32,000.00 within three days to schedule the HIFU procedure in Mexico. Patient K.S.' wife immediately secured a bank loan for the $32,000.00 Due to the seriousness of the diagnosis and the rush for payment for HIFU, Patient K.S. visited his primary care doctor for another opinion. Patient K.S' primary care doctor, Dr. Jeffrey Jump, told him that no one can diagnose prostate cancer as a Gleason 7 without a tissue biopsy. Further, it was a "red flag" to Dr. Jump that a cash payment of $32,000.00 was expected in such a short time frame to schedule treatment. After speaking to Dr. Jump, Patient K.S. decided not to have HIFU and instead opted for A.S. Subsequent PSA level tests for Patient K.S. have shown a decrease in his PSA level. Patient K.S.' wife filed a complaint with the Petitioner against Respondent. Facts Related to Patient V.P. Patient V.P. is a 63-year-old construction worker and guide from Alaska. He has no family history of prostate cancer. In August 2013, at age 60, Patient V.P. had his first physical examination. As part of the exam, he took a PSA test, which showed an elevated PSA level of 6.3. As a result, Patient V.P. was referred to a urologist who recommended a biopsy. Patient V.P. heard from friends that prostate biopsies are painful, so he looked on the Internet for alternatives. Patient V.P. found Respondent's website, which claimed Respondent could diagnose prostate cancer without a biopsy by using new MRI technology. Patient V.P. traveled to Sarasota to meet Respondent on September 11, 2013. Respondent performed a digital rectal exam and told Patient V.P. that his prostate was much enlarged. Respondent next performed a prostate ultrasound on Patient V.P. Immediately after the ultrasound, Respondent told Patient V.P., "I'm telling you right now you have prostate cancer." Respondent provided Patient V.P. with a prescription for Bicalutamide and Trelstar, which Respondent said would wipe out Patient V.P.'s testosterone and slow the growth of the cancer. Respondent told Patient V.P. that prostate biopsies are dangerous and metastasize cancer cells. Respondent said that even though he knew Patient V.P. had cancer, he wanted an MRI to see the amount of cancer. Respondent also offered Patient V.P. the opportunity to participate in a private placement offering for a HIFU company he was forming for a minimum investment of $50,000.00. The following day, Patient V.P. had an MRI and then met with Respondent to review the results. Respondent showed Patient V.P. his MRI images and pointed to areas of concern. Respondent told Patient V.P. he had extensive prostate cancer and that Patient V.P. did not have much time to decide whether to have HIFU because the cancer was about to metastasize. Respondent told Patient V.P. to take the Bicalutamide for ten days and then return for an injection of Trelstar to atrophy his prostate and make him ready for HIFU in 90 days. At Respondent's direction, Patient V.P. began the Bicalutamide and then returned to the DCD on September 20, 2013, for a three-month injection of Trelstar. During this visit, Patient V.P. questioned the cost if the HIFU was not successful in getting all the cancer and he needed further treatment. Respondent told Patient V.P. that he "doesn't miss," but an additional treatment of HIFU would cost another $10,000.00 to $12,000.00, in addition to the $32,000.00 for the initial treatment. Concerned about these costs, Patient V.P. asked about going to Loma Linda, California, for proton therapy as an alternative. Respondent told Patient V.P. that proton therapy would cause bladder cancer and any alternative to HIFU would require a needle biopsy first. Respondent actively discouraged Patient V.P. from any non-HIFU treatment for prostate cancer. As soon as Patient V.P. questioned Respondent about alternatives to HIFU, he was suddenly fast-tracked for HIFU scheduled October 24 through 26, 2013. He was told he needed to make a $10,000.00 deposit to hold the date and the total cost was $32,000.00. Despite his concerns regarding the expedited scheduling of his procedure and the cost of the HIFU treatment, Patient V.P. returned to the office with a check for $10,000.00 to cover the cost of the deposit to hold the October treatment date. While waiting to hand the check to Respondent's receptionist, Patient V.P. overheard Respondent on a speakerphone arguing with a radiologist concerning an MRI report. Respondent was insisting the radiologist include the word "cancer" on MRI reports and the radiologist insisted it was not possible for him to make such a diagnosis. After hearing this conversation, Patient V.P. immediately left Respondent's office with his check. Patient V.P. subsequently discussed his experience with a trusted friend who practiced as a nurse in a cancer clinic. She, too, expressed concerns about diagnosing and treating prostate cancer without a biopsy. Patient V.P. was referred by this friend to Dr. Vipul Patel, a physician specializing in urologic cancer in Orlando. Patient V.P. met with Dr. Patel on October 18, 2013. Dr. Patel advised Patient V.P. that it was not possible to diagnose prostate cancer without a biopsy. Dr. Patel also disputed that prostate biopsies can spread prostate cancer. Dr. Patel performed a digital rectal exam and found Patient V.P.'s prostate to be slightly enlarged (which is not abnormal for a man of Patient V.P.'s age), normal, and smooth. Dr. Patel told Patient V.P. that he doubted he had prostate cancer. Patient V.P. then underwent a prostate biopsy by Dr. Patel, which was negative for prostate cancer. This was surprising to Patient V.P. because Respondent led him to believe, based on the MRI, that his prostate was full of cancer. Patient V.P. experienced significant side effects as a result of taking the medications ordered by Respondent. The Bicalutamide caused Patient V.P. to experience overwhelming depression, shakes, hot flashes, tunnel vision, and headaches. The Trelstar caused erectile dysfunction, increased frequency of hot flashes, night sweats, and made Patient V.P. so weak he was unable to work for eight months. Standard of Care As discussed above, the experts who provided depositions or live testimony in this case were unanimous in their conclusions that the standard of care in Florida from 2008 through 2013 precluded diagnosis or treatment of prostate cancer in the absence of a tissue biopsy. A reasonably prudent physician would not tell a patient he had prostate cancer based upon an ultrasound and/or MRI. A reasonably prudent physician would not prescribe medication, suggest treatment, or participate in treating a patient for prostate cancer, based upon an ultrasound or MRI. Respondent claims that in each of these cases, he advised the patient that a needle biopsy was the definitive test for prostate cancer, but it was a method he did not favor due to the possibility of needle tracking. Respondent's testimony in this regard is not credible in light of the credible testimony of the three patients that Respondent made clear he would not perform a needle biopsy and actively discouraged them from anything other than diagnosis by MRI and subsequent HIFU treatment. Respondent's suggestion, that he offered needle biopsy as an option, is wholly inconsistent with the title, theme, and contents of his own book, and the manner in which he defined his method of diagnosing prostate cancer at the DCD in his book and on his website. It is self-evident that a patient's perceptions regarding the safety and efficacy of needle biopsies for prostate cancer detection are at least, in part, influenced by the discussion with the physician. Respondent's active efforts to dissuade these patients from having the one definitive test for prostate cancer, by dramatically over-inflating the infinitesimally small possibility of needle tracking, were wholly inconsistent with the standard of care. Respondent claims that these four patients insisted they did not want a needle biopsy, therefore, it was appropriate to diagnose them on the basis of "a preponderance of the evidence and concordance of data" and move forward with a treatment plan, including medications and HIFU. The standard of care in Florida during 2008 through 2013, for a situation in which a patient suspected of having prostate cancer refused a needle biopsy, was to prescribe a course of A.S., including regular and frequent PSA testing, and to offer no other treatment.7/ Ultimate Factual Determinations Petitioner established by clear and convincing evidence that Respondent committed medical malpractice in his treatment of Patients G.P., J.W., K.S., and V.P. by the following violations of the standard of care: failing to obtain and review prostate biopsy results before confirming the patient had, or diagnosing the patient with, prostate cancer (Patients G.P., J.W., K.S., and V.P.); prescribing Bicalutamide/Casodex to a patient without first confirming through a prostate tissue biopsy that the patient has prostate cancer (Patients G.P. and V.P); prescribing, injecting, or authorizing the injection of Trelstar to a patient without first confirming through biopsy results that the patient has prostate cancer (Patient V.P); recommending and/or attempting to facilitate HIFU treatment without first confirming through biopsy results that the patient has prostate cancer (Patients G.P., J.W., K.S., and V.P.); and participating in, and/or assisting with the performance of HIFU treatment for a patient without first confirming through biopsy results that the patient has prostate cancer (Patient G.P.). Accordingly, Respondent is guilty of the offense defined in section 458.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent violated section 458.331(1)(t), Florida Statutes, as charged in Amended Administrative Complaints; imposing a fine of $30,000.00; revoking Respondent's medical license; and imposing costs of the investigation and prosecution of this case. DONE AND ENTERED this 24th day of February, 2017, in Tallahassee, Leon County, Florida. S MARY LI CREASY 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 24th day of February, 2017.
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 The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what sanctions should be imposed against him, if any.
Findings Of Fact Petitioner is the State agency responsible for the administration of Medicaid funds in Florida. Respondent is a physician licensed in the State of Florida and practicing in Sunrise, Broward County, Florida. He is a Board-certified dermatologist. Until the Department issued its emergency termination order, Respondent participated in the Medicaid program by treating Medicaid recipients and receiving reimbursement from the Department. He was one of only several Broward County dermatologists who accepted Medicaid patients. As part of his medical practice, Respondent employs a device known as a grenz ray machine to treat certain dermatologic conditions from which his patients, including his Medicaid patients, suffer. Grenz rays (also known as ultra-soft x-rays and Bucky rays) have been used for more than sixty years for the treatment of benign skin diseases. Grenz rays are radiations of very low energy. They are closely related to conventional x-rays but possess very limited penetration abilities. Conventional x-rays and grenz rays are part of the electromagnetic spectrum, with grenz rays bordering the very short wavelength ultraviolent light. The word Grenz is derived from a German word meaning "border." As part of the electromagnetic spectrum, grenz rays are a form of ionizing radiation. Further up the electromagnetic spectrum from the very low energy of grenz rays are the higher energy levels of superficial x-rays and then the higher levels of diagnostic x-rays through such intense ionizing radiation equipment as the linear accelerator. Grenz rays do not penetrate the skin as deeply as even superficial radiation. As grenz rays pass through the outer layer of skin, their energy drops off rapidly. Grenz rays are almost entirely absorbed within the first 1-2 millimeters of skin. Accordingly, grenz rays do not have an energy level capable of penetrating so as to constitute a real risk of biological damage. Grenz ray therapy is a safe, rapid, and painless procedure for the patient. The risk of malignancy from grenz ray therapy appears to be quite small and then only in a few cases involving massive overdoses. Further, the risk factor of grenz rays in the development of non-melanoma skin tumors is small, if any. Any relationship between grenz ray therapy and skin cancer in humans is far from evident as opposed to conventional x-rays further up the electromagnetic spectrum which can be carcinogenic. Long-term studies of substantial numbers of people who have received grenz ray therapy have not documented risk. Although cautions against unnecessary use of ionizing radiation have been issued, the cautions against indiscriminate use of ionizing radiation relate to the use of superficial x-rays and/or higher levels of radiation. Those same recommendations suggest the use of less penetrating grenz rays which offer a wider margin of safety. Those recommendations, such as those issued by the National Academy of Sciences in 1980, in addition to affirming the safety factor inherent in grenz rays, also strongly endorse the concept that it remains the prerogative of the physician to use any form of therapy in which the benefits accruing to the patient from its use are considered to outweigh the risks inherent in its use. For many decades, medical schools have taught dermatologists about the beneficial uses of grenz ray therapy in alleviating benign dermatologic conditions. Medical schools have uniformly included lectures and required reading on grenz ray therapy in their curricula. Although not all have provided their students with "hands-on" experience as part of their studies, by the time dermatologists have completed their residencies, however, most of them have been given "hands-on" training. Respondent was taught the use of grenz ray therapy in medical school. Over the last several decades, the use of grenz ray therapy by dermatologists has declined as antibiotics and topical medications have increased in availability. However, grenz ray therapy has remained an effective weapon in the arsenal of therapeutic modalities available in the treatment of dermatologic conditions. The American Academy of Dermatology is the national organization for Board-certified dermatologists. Its 1991 annual meeting took place during the course of the final hearing in this cause. At its annual meeting, the Academy offered two lectures and a symposium on the beneficial use of grenz ray therapy for many benign conditions. Respondent attended the symposium and one of the lectures. He did not attend the lecture which was a basic introduction to grenz ray therapy. Whether the emphasis placed on grenz ray therapy during the Academy's last annual meeting indicates a resurgence in the use of grenz ray therapy is unknown; however, it is clear that doctors still use that therapeutic modality and are still teaching it to each other. The standard dose of grenz ray therapy ranges from 50 rads to 200 or 300 rads. It is a small dose and requires only a few seconds to administer. The dosimetry cannot be scientifically or logically compared to the dosimetry of diagnostic x-rays, such as a chest x-ray, since such diagnostic x-rays require a much higher level of ionizing radiation than grenz rays. Similarly, grenz rays are not used for the purpose of obtaining x-rays of a human body. They are simply used to treat diseases and conditions of the skin. Some dermatologists use grenz rays to treat benign skin disorders. Respondent is one of them. Some dermatologists do not use grenz rays. Some of the ones who do not use grenz rays refer their patients who would benefit from grenz ray therapy to dermatologists who administer that modality. One of the Department's witnesses does not use grenz ray therapy; one of the Department's witnesses does but for fewer skin disorders than the variety of skin disorders which Respondent treats with grenz ray therapy; and the Department's third witness does not use grenz ray therapy but rather uses superficial therapy, a stronger form of ionizing radiation, to treat at least one of the same conditions that Respondent treats with grenz ray therapy. Until this case arose, Respondent's use of grenz ray therapy had never been questioned by any federal or state regulatory agency. Likewise, no claim for grenz ray services rendered by Respondent had been declined by any third- party payor, and, specifically, all claims for grenz ray therapy which Respondent had submitted to the Department over the years that he had been a Medicaid provider had been paid. There is no statute or rule on the federal or state level prohibiting the use of grenz ray therapy, and the Department has no policy against such use. The Department had been paying Respondent on all claims submitted by him in accordance with the reimbursement schedule utilized by Medicaid, with the current rate being $11 for a grenz ray therapy treatment. Respondent has four grenz ray machines in the medical office which he shares with another dermatologist. Those machines are calibrated annually by a radiation physicist, and they have been inspected and licensed every year by the Department. Respondent's machines are calibrated to deliver the standard minimum dose of 50 rads per treatment. Respondent's use of the minimum dosimetry for grenz ray therapy is conservative. The Department's computer does random utilization audits of services by Medicaid providers in the State of Florida. The computer "flagged" Respondent, one of only several dermatologists providing Medicaid services in Broward County, as having been paid for an "excessive" number of grenz ray treatments. The Department's investigator who received that computer file had never heard of grenz ray therapy. She began a search of the literature to learn about grenz ray therapy. She misunderstood the scientific studies, medical textbook chapters, and other medical articles which she obtained. She did not understand that the biological risks of ionizing radiation discussed in the writings she collected related to higher levels of ionizing radiation than the ultra-soft grenz rays. She also misunderstood the conclusions of the scientific studies specifically related to grenz rays. She did not speak to Respondent regarding the medical services he was providing. Instead, she went to Respondent's office, copied medical records of some of his Medicaid patients, and advised him that his use of grenz ray therapy was an outdated, antiquated modality. She further advised him that grenz ray therapy should never be used on children. The Department then issued an emergency termination order terminating Respondent's Medicaid provider status due to the danger which his use of grenz ray therapy posed to his patients. No one on behalf of the Department contacted Respondent to discuss those patients or his use of grenz ray therapy prior to the Department entering its emergency termination order. As required by Chapter 120, Florida Statutes, the emergency termination order was followed by this Administrative Complaint. There are no statutes, rules, policies or guidelines issued by any federal or state regulatory agency specifying the order in which physicians may select a particular treatment modality, and that decision is properly left to each physician. Although some physicians use grenz ray therapy as the treatment of last resort, some use it as a treatment of first choice, and others use it in an adjunctive manner, i.e., in conjunction with other treatment modalities. Respondent uses grenz ray therapy with other treatments to expedite those other treatments. During the final hearing, the Department was given leave to strike the allegations in the Administrative Complaint as to many of Respondent's patients. What remained were allegations as to improper treatment of 39 children and 4 adults. Although the use of ionizing radiation on children is generally discouraged because of the potential biological effect, such restrictions do not apply to the use of grenz ray therapy. There are no apparent clinical limitations on the use of grenz ray therapy based upon age or sex. The physiological process and the way tissue reacts to grenz rays are the same for adults as for children, including infants. Because the quantity of grenz rays capable of penetrating below the top 1 to 2 millimeters of skin is small and no risk therefrom has been documented, children can benefit from the use of grenz ray therapy as much as adults can. Respondent's use of grenz ray therapy on the 39 children and 4 adults involved herein was appropriate, was medically necessary, was neither excessive nor inferior, and was not harmful to those patients; rather, Respondent's use of grenz ray therapy benefited the patients in question. All of the dermatologic conditions for which Respondent administered grenz ray therapy to the patients involved herein are among the conditions likely to benefit from grenz ray therapy. They are also among the conditions identified during the Academy's 1991 annual meeting as being appropriate for grenz ray therapy. When utilizing ionizing radiation therapy, it is important to note in the patient's record the number of rads administered, the treatment site, and the skin target distance for two reasons. First, there is a cumulative lifetime dose above which ionizing radiation would not normally be administered. Second, the use of ionizing radiation in a particular treatment area may prohibit subsequent use of ionizing radiation in that same treatment area. The same restrictions regarding repeated doses of ultra-soft grenz rays do not appear to apply. There is no certainty that there is a maximum lifetime dose. Although researchers in Denmark have recommended a maximum of less than 2,000 rads per year and 10,000 rads per lifetime and although American literature recommends 5,000 rads as the total lifetime cumulative dose per location, Swedish researchers, who conducted the landmark long-term study of over 14,000 patients who had received ultra-soft grenz ray treatment, have indicated that a schedule of weekly treatments for a total of 800 - 1,000 rads followed by a 6-month rest before additional treatment is given can be followed ad infinitum. Further, due to the meager penetration beyond the surface by grenz rays, research has not established that the administration of grenz ray therapy would be a barrier to subsequent use of additional grenz rays or the stronger forms of ionizing radiation. Grenz ray therapy has a standard minimum protocol attendant to its use. Grenz rays appear to be ineffective at less than 50 rads or with a skin target distance of more than approximately 20 centimeters. Respondent's grenz ray machines are calibrated to deliver the minimum effective dose of 50 rads at the effective skin target distance of 20 centimeters. Respondent noted in the medical records each grenz ray treatment given to each of the patients in question herein. Although Respondent's medical records for the patients involved herein rarely specified that the dose administered was 50 rads, did not recite the skin target distance, and rarely contained a drawing of the area affected, some dermatologists include such information in their medical records, and some do not. In the absence of such detail, subsequent treating physicians would likely assume the standard protocol. In any event, the failure to specify such details does not fall below the acceptable standard of care. Respondent's records do not contain an written informed consent form for any of the patients involved herein to whom he administered grenz ray therapy. There is no federal or state statute or rule or Department policy requiring that a dermatologist obtain a written informed consent form before administering grenz ray therapy. The evidence is uncontroverted that Respondent did explain to the patient or to the patient's parent or guardian grenz ray therapy together with its benefits and risks. The evidence is uncontroverted that he obtained consent in advance of such treatments. Although some dermatologists notate in their records that the explanation was given, some do not, and some do some of the time. Respondent's failure to notate those discussions in the medical records of the patients involved herein does not fall below the acceptable standard of care. The thyroid, the eyes (particularly the cornea), and the testicles are sensitive to even low doses of radiation. Therefore, using cones to collimate the beam and/or shielding the patient are devices normally used to protect patients from receiving ionizing radiation outside the field of treatment. However, the necessity for shielding those organs from the administration of the ultra-soft grenz rays is not so clear. It is not established that there is a risk to the thyroid from grenz ray therapy to the neck or to the testicles from grenz ray therapy to the scrotum due to the lack of penetration abilities of grenz rays. It is also believed that closing the eyelids offers the cornea sufficient protection to avoid risk from grenz ray therapy. It is clear that Respondent did not always use cones or other shielding devices, but there is no evidence that Respondent wanted to limit the field of treatment during those applications of grenz ray therapy. Further, it is Respondent's practice to place his hand over the eyes of any patient receiving grenz ray therapy to the face area who is unable to close his or her eyelids. While such a practice may not be in Respondent's own best interest, there is no evidence that Respondent's use of his hand as a shielding device reduced the benefits or increased the risks of grenz ray therapy for his patients. It has not been shown that Respondent fell below acceptable standards in his use of shielding devices. Although it is well known that exposure to ionizing radiation carries a risk, no safe threshold dose has been established. A safe threshold dose for grenz rays is even more elusive since the existing literature does not document biological harm from the administration of grenz ray therapy in accordance with standard dosimetry. Although grenz rays are incapable of being used to diagnose conditions due to their inability to penetrate beyond the outer layer of skin, grenz rays and the stronger levels of ionizing radiation are used to treat conditions based on a risk/benefit ratio. Stated differently, the use of any form of ionizing radiation is acceptable when the benefit to the patient outweighs the risk. In using grenz ray therapy for the patients involved herein, Respondent determined that in his best medical judgment the benefit to the patients outweighed the risk. In sum, Respondent's treatment of the patients named in the Administrative Complaint was within acceptable standards of care. Further, his records of those treatments are within acceptable standards of care.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty of the allegations contained within the Administrative Complaint and dismissing the Administrative Complaint filed against him in this cause. DONE and ENTERED this 20th day of April, 1992, at Tallahassee, Florida. LINDA M. RIGOT 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 April, 1992. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 91-3487 Petitioner's proposed findings of fact numbered 1, 3-6, 8-15, 25, 27, 28, 31, 37, and 40 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 2, 17, 20, 21, 39, 41 and 52 have been rejected as being unnecessary for determination of the issues involved herein. Petitioner's proposed findings of fact numbered 7, 16, 18, 19, 24, 26, 29, 30, 32-36, 38, 42-47 and 53 have been rejected as not being supported by the weight of the evidence in this cause. Petitioner's proposed findings of fact numbered 22, 23 and 48-51 have been rejected as not constituting findings of fact but rather as constituting recitation of testimony, argument of counsel, or conclusions of law. Respondent's proposed findings of fact numbered 1, 2, 4-6, 10-15 and 17-28 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed findings of fact numbered 3, 7-9, and 16 have been rejected as being unnecessary for determination of the issues involved herein. COPIES FURNISHED: David G. Pius, Senior Attorney Department of Health and Rehabilitative Services Building Six, Room 234 1317 Winewood Boulevard Tallahassee, FL 32399-0700 Salvatore A. Carpino, Esquire 1 North Dale Mabry, Suite 1010 Tampa, FL 33609 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 John Slye, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700
