The Issue Whether Respondent, Steven A. Magilen, M.D., violated Sections 458.331(1)(m) and (t), Florida Statutes, as alleged in an Administrative Complaint signed April 2, 2001, and filed with the Department of Health on April 3, 2001, and, if so, the penalty that should be imposed.
Findings Of Fact The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in Florida. Section 20.43; Chapters 456 and 458, Florida Statutes. Steven A. Magilen, M.D., is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 002082. Dr. Magilen received his medical degree from the University of Brussels in Belgium in June 1972. He received his license to practice medicine in Florida in 1973 and completed a residency in general surgery at Mount Sinai Medical Center, Miami, Florida, in June 1976. He has maintained a private practice in Florida since 1976. Dr. Magilen is board certified in general surgery. His general surgical practice focuses on colorectal surgery and proctology. He is experienced in the use of colonoscopy, having performed an average of between 250 and 300 colonoscopies per year since approximately 1979. Dr. Magilen's address is 21150 Biscayne Boulevard, Suite 400, Aventura, Florida 33180. Dr. Magilen has not previously been the subject of a disciplinary proceeding.1 D. M., a female, was initially seen by Eugene Eisman, M.D.,2 an internist, who has continued to see D. M. for at least the past ten years. As early as 1991, D. M. related a five-year history of intermittent abdominal pain. D. M. was referred by Dr. Eisman to Dr. Magilen in June 1995,3 complaining of years of constipation, which she indicated was becoming worse. She also complained of rectal bleeding. D. M. was in her mid-60's in 1995. Rectal bleeding is one of the most common problems seen by Dr. Magilen, who sees primarily older patients. Rectal bleeding can be caused by colonic (relating to the colon) disorders or anal disorders. The typical anal disorder found in adults which results in bleeding is hemorrhoids. Colonic disorders which cause rectal bleeding include polyps, colon carcinoma (cancer), inflammatory bowel disease, ulcerative colitis, Crohn's Disease, diverticulosis, diverticulitis, and appendicitis. While rectal bleeding may occur with diverticulitis, it is less likely than with only diverticulosis.4 The disorder which is most threatening to a patient of the disorders that can cause rectal bleeding is colon cancer. If not timely identified, colon cancer can spread to an extent that surgical intervention will be ineffective and the patient will ultimately die. The typical signs of colon cancer include a change in bowel pattern, such as diarrhea or constipation, rectal bleeding, abdominal pain, and, in later stages, weight loss. Because D. M. had reported rectal bleeding, Dr. Magilen first looked for signs of hemorrhoids. After finding no such signs, Dr. Magilen recommended to D. M. that she undergo a colonoscopy to explore whether she was suffering from a colonic disorder. A colonoscopy is one of the diagnostic tools available to determine whether polyps or colon cancer are present in a patient experiencing rectal bleeding. A colonoscopy allows the physician to visually evaluate subtleties of mucosal changes of the colon by visually inspecting the lumen, or inside lining of the colon. Any problematic or suspicious tissue can be collected during the colonoscopy for later biopsy. The colonoscopy is performed by inserting a flexible tube with fiber optic capabilities into the rectum and up through the colon. The colon is the lower six to eight feet of the gastrointestinal tract, which runs from the mouth to the anus. The colon consists of a muscular wall with an inner lining of mucosa and an outer layer of serosa tissue. Typically, approximately 50% of the colon is attached to the inside of the belly cavity (the abdomen) by a suspensory fibrous tissue. Colon cancer typically is found in the mucosal surface of the colon and is most prevalent in the left colon (the rectum, sigmoid colon, the descending colon, and the distal transverse colon). Because a colonoscopy is an invasive procedure, it is not without risks. Among the risks of performing a colonoscopy is the possibility that the patient's colon will be perforated. Despite Dr. Magilen's concern over D. M.'s rectal bleeding, D. M. ignored Dr. Magilen's recommendation and declined to undergo a colonoscopy in 1995. D. M. was next seen by Dr. Magilen in April 1996. D. M. complained of constipation and bright red bleeding on the toilet paper in the bowl. At Dr. Magilen's urging, D. M. agreed to and did undergo a colonoscopy on April 23, 1996. As a result of the procedure, Dr. Magilen found and removed a 3 millimeter benign sessile polyp5 and noted the presence of a small amount of diverticuli in her sigmoid colon.6 The sigmoid colon, which makes up the last portion of the colon and attaches to the rectum, is so-named because of its "S" shape. The sigmoid colon is more mobile and, therefore, has more variability in its position. It is, however, usually located on the lower left side of the abdomen. Diverticuli are "out-pockets" or bulges in the intestine. Their presence is referred to more specifically as "diverticulosis." In adults over the age of 65 years, approximately 75% have diverticuli somewhere in the colon. A finding of diverticulosis in older adults is, therefore, not an uncommon finding. D. M. next presented to Dr. Magilen on July 14, 1997. She was 68 years of age. She complained of upper and lower abdominal pain, a change in bowel habits, occasional bright red blood from her rectum, and nausea (without vomiting). The abdominal pain, which she reported had started approximately a week and a half prior to July 14th, was reported to be mainly in the upper abdomen. D. M.'s change in bowel habits were reported to be constipation despite an increase from one bowel movement a day to four to five bowel movements per day. She was considered constipated, even with the increased number of bowel movements, because she had also reported a sensation of incomplete evacuation, that her stool consisted of hard balls, and she had witnessed bright red blood on occasion. Dr. Magilen obtained D. M.'s medical history and conducted a physical examination on July 14th. D. M.'s pertinent medical history included the following: (a) she was a heavy smoker for 26 years (3 1/2 packs a day until she quit in 1981); (b) she consumed alcohol regularly (at least 3 glasses of wine per day); (c) she had previous lumpectomies of her breasts for benign tumors; (d) she had a cavernous hemangioma on her right thigh that was treated with radiation therapy and for which she suffered a recurrence and malignancy; (e) she had cancer removed from her toe; (f) she had several D & C's of her uterus; (g) she had a sessile polyp removed from her colon in 1996; and (h) she has diverticulosis. Dr. Magilen's physical examination of D. M. revealed that she had diffuse, non-localized abdominal tenderness with no masses or organomegaly. A vaginal and rectal examination of D. M. revealed uterine tenderness with no masses. An anoscopic examination of her rectum revealed internal hemorrhoids. Dr. Magilen found no indication of acute blood loss or bowel obstruction, and no signs, symptoms, or indications of acute decompensation from a colonic malignancy. Dr. Magilen's impression of D. M. on July 14th was that she was suffering from acute abdominal pain and that uterine pathology needed to be ruled out as the source of her problem. Dr. Magilen, therefore, planned to obtain a pelvic ultrasound, admit D. M. to the hospital for 23 hours, and obtain a gynecological consult. The pelvic ultrasound, which was performed outpatient on July 14th, revealed the presence of an ovarian cyst on D. M.'s left ovary and no masses in her uterus.7 No other abnormalities, malignancies, or uterine pathology were revealed by the ultrasound. At approximately 4:30 p.m. of July 14th, D. M. presented and was admitted to Aventura Hospital. A blood chemistry profile, a complete blood count, abdomen X-rays, abdomen and pelvis Computed Axial Tomography ("CAT" or "CT") Scans and a gynecological consult with Dr. Gross, a gynecologist, were ordered. A complete blood count was also ordered for July 15, 1997. D. M. was placed on "NPO" (nothing by mouth), meaning that she was allowed no food or liquids by mouth. She was also given Vistaril, a common relaxant, to help with her complaints of pain. D. M. was not suffering from fever at the time of her admission. Her blood chemistry and the complete blood count failed to reveal any increase in her white blood cell count or an increase in immature white blood cells, commonly referred to as a "shift to the left." D. M. was found to be evidencing signs of anemia, based upon a drop in her hemoglobin. D. M.'s hemoglobin as of April 1996 had been 12.7. As of her admission to Aventura in July 1997, D. M.'s hemoglobin had fallen to 11.4. D. M.'s X-rays were unremarkable. No significant distention or the presence of free air, soft tissue masses, or abnormal calcifications were indicated. The CT Scan was produced on July 14, 1997. The image of the CT Scan was transmitted to an on-call radiologist, Dr. Maria Rodriguez, for a preliminary interpretation. Although Dr. Rodriguez issued a preliminary fax report of her findings, Dr. Magilen did not receive the report. Dr. Magilen was, therefore, unaware of the findings made by Dr. Rodriguez when he made the decision at issue in this case. The CT Scan image was also reviewed by Karl Drehobl, M.D. Dr. Drehobl's findings and impressions were provided to Dr. Magilen in a written report. That written report was received and considered by Dr. Magilen. With regard to D. M.'s colon, Dr. Drehobl's report included the following findings and impression as a result of his review of the CT Scan image: . . . . THERE IS SIGMOID DIVERTICULOSIS PRESENT. THERE IS EVIDENCE OF SIGMOID WALL THICKENING. THERE IS INCREASED DENSITY IN THE REGION OF THE SIGMOID MESENTERY. NO DISCRETE FLUID COLLECTION OR ABSCESS IS NOTED. FINDINGS ARE SUGGESTIVE OF SIGMOID DIVERTICULITIS. NO FREE AIR OR FREE FLUID IS IDENTIFIED. THE REMAINDER OF THE BOWEL AND MESENTERY ARE NORMAL. IMPRESSION: FINDINGS SUSPICIOUS FOR SIGMOID DIVERTICULITIS. NO FREE AIR OR DISCRETE ABSCESS COLLECTION. . . . . Dr. Drehobl's findings8 were consistent with those reported by Dr. Rodriguez. Dr. Drehobl's finding of "increased density in the region of the sigmoid mesentery" meant that the fat adjacent to the colon was swollen or inflamed. Dr. Drehobl's finding of sigmoid wall thickening meant that there was an abnormal thickening of the wall of the colon and small bowel. Dr. Drehobl's impression of D. M., taking into account his findings from reading the CT Scan, the fact that there were diverticuli present in the same area, D. M.'s age, and her history of abdominal pain, was that there was a "strong possibility" that D. M. was suffering from "diverticulitis or inflammation of the diverticuli in that region." See page 20, lines 12-14, Petitioner's Exhibit 2. "Diverticulitis" is the inflammation of one or more diverticuli. The diverticuli become inflamed when an out-pocket becomes blocked. Fluid from the mucosal lining of the intestine becomes captured in the blocked out-pocket. Infection and/or inflammation then occurs. If untreated, in the later stages of diverticulitis, a blocked diverticuli can rupture into the pericolonic fat and/or form an abscess.9 CT Scans can be 85 to 90% accurate in diagnosing diverticulitis. Even so, the results of a CT Scan are only a guide, one of a number of tests available to the physician, which must be correlated by the treating physician with all the clinical findings concerning the patient, including the results of the physical examination, the patient's clinical symptoms and history, the results of other diagnostic tests, and the results of laboratory studies. Dr. Drehobl's findings and impression were, therefore, not dispositive. Dr. Magilen was required to take Dr. Drehobl's findings into consideration along with his clinical findings. Dr. Magilen, after speaking with Dr. Drehobl personally about his report, did just that. Dr. Magilen was not convinced that D. M. was suffering from diverticulitis. This conclusion was based upon a number of factors: Dr. Drehobl did not find any of the more specific signs of diverticulitis which CT Scans can show such as marked edema around the colon, abscesses within the mesentery, or segmental thickening. Dr. Drehobl's findings of increased density in the region of the sigmoid mesentery and sigmoid wall thickening were equivocal findings. Persons with diverticulosis, which D. M. was known to have, almost consistently evidence some thickening of the wall of the sigmoid colon; Because the results of the CT Scan were equivocal, the findings, in addition to supporting an impression of diverticulitis, also supported an impression of a number of other disorders, in and outside the colon, which Dr. Magilen had not yet been able to rule out: inflammation in another organ, such as the appendix or an adjacent loop or intestine; inflammation in a fallopian tube or an ovary; colon neoplasm, colitis, or other tumor of the colon; ischemic colitis, Crohn's disease, and inflammatory bowel disease; D. M. was not evidencing the classic symptoms of diverticulitis: Left-lower quadrant pain; Fever; and Increased white blood cells and a "shift to the left." The presence or absence of any one or more of these symptoms alone does not reasonably support a finding of diverticulitis or the absence thereof. But the absence of all three significantly reduced the possibility that D. M. was suffering from diverticulitis; and D. M.'s symptoms, including rectal pain, bright-red rectal bleeding (which is less likely to occur with diverticulitis) associated with bowel passage, vague abdominal discomfort that was not localized to any particular quadrant of the abdomen, and her sensation of incomplete evacuation could not all be explained by diverticulitis and were suggestive of other diagnosis which Dr. Magilen had not been able to rule out. D. M.'s hemoglobin, which had dropped from 12.7 in April 1996 to 11.4 upon her admission to the hospital, indicated some loss of blood which her body was not able to replace, could also have been symptomatic of the other problems suggested by the results of the CT Scan. Based upon the foregoing, and following a consult with Dr. Gross, Dr. Magilen's impression was that D. M.'s pathology was coming from her uterus and ovarian tubes. Between the evening of July 14, 1997, and the morning of July 15, 1997, D. M.'s condition improved. She exhibited minimal abdominal tenderness, she had a normal white blood cell count, she had no fever, and she was able to eat. Dr. Magilen decided to increase her diet and to discharge her home with directions to follow-up with Dr. Magilen and her gynecologist. Dr. Magilen prescribed Cipro, a broad spectrum antibiotic, to address what he believed was her pelvic inflammatory process. The day after she was released from the hospital, July 16, 1997, D. M. presented to Dr. Eisman. She complained that the abdominal pain had returned during the night of July 15th. Dr. Eisman conducted a physical examination of D. M. Dr. Eisman found an increase in pain on palpation of the cervix and generalized mild tenderness of the abdomen. Because the pain in D. M.'s abdomen was not located in the lower left- quadrant and in light of the pain on palpation of her cervix, Dr. Eisman was of the opinion that the likely cause of her pain was pelvic inflammatory disease. The etiology of her pain was, however, still unknown. Dr. Eisman had D. M. readmitted to Aventura and notified Dr. Magilen of the change in her condition. D. M. was readmitted with orders for blood chemistry and complete blood count, ultrasound of the pelvis, X-rays of the abdomen, CT Scan of the abdomen and pelvis, and NPO (except ice chips). She was given Phenergan and Demerol for pain and nausea. Dr. Magilen examined D. M. upon her admission to the hospital. He found that her abdomen was soft with minimal tenderness. A vaginal and rectal examination revealed uterine tenderness with no masses. These findings were consistent with those of Dr. Eisman and Dr. Gross. D. M. was still not experiencing fever. Flat and upright X-rays of D. M.'s abdomen revealed no significant abnormalities. D. M.'s blood chemistry studies and complete blood count indicated the presence of anemia, a significantly elevated sedimentation rate with no increase in white blood cell count and no "shift to the left." The CT Scan revealed some evidence of diverticulosis and slight edematous changes within the fat adjacent to the sigmoid colon consistent with diverticulitis. Dr. Magilen again discussed the CT Scan findings with the radiologist. Dr. Magilen was still concerned about those findings for most of the reasons indicated in Finding of Fact 41, supra. The radiologist's findings were still equivocal; the findings were still consistent with other disorders, which the radiologist acknowledged to Dr. Magilen, including a carcinoma or other inflammatory process inside or outside the colon; D. M. was not evidencing the three classic signs of diverticulitis; and her symptoms continued to support other findings. The ultrasound of D. M.'s pelvis was performed on July 17, 1997. The following findings and impressions were made as a result of the ultrasound: . . . . THERE IS A FIBROID LESION WITHIN THE LOWER UTERINE SEGMENT ADJACENT TO THE CERVIX MEASURING 2.7 X 2.3 X 2.6 CM. NORMAL ENDOMETRIAL STRIPE IS NOTED. NO ADDITIONAL UTERINE MASSES ARE NOTED. BOTH OVARIES ARE UNREMARKABLE IN APPEARANCE. THE RIGHT OVARY MEASURES 1.6 X .9 X 1.1 CM AND THE LEFT OVARY MEASURES 1.8 X 1 X 1 CM. NO ADNEXAL MASSES ARE NOTED. SMALL AMOUNT OF FREE FLUID IS NOTED WITHIN THE CUL-DE-SAC. IMPRESSION: LOWER UTERINE FIBROID LESION MEASURING 2.7 X 2.3 X 2.6 CM. NO ADNEXAL MASSES. SMALL AMOUNT OF FREE FLUID. The July 17, 1997, ultrasound found that the cyst which had been disclosed by the July 14, 1997, ultrasound was now gone. This fact, coupled with the fluid found in D. M.'s cul-de-sac (located in the rectal-uterine space, between the rectum and the posterior wall of the uterus and the vagina), could mean that the cyst had ruptured. The ultrasound also indicated that the uterus was 20 percent larger and that there was a two to three centimeter myoma or tumor in the lower uterine segment. These changes, which apparently took place over a two to three day period, and the results of D. M.'s physical examination (uterine tenderness and tenderness in the cul-de-sac), are consistent with pelvic inflammatory disease. The findings of the July 17, 1997, ultrasound could also explain the findings of edema and the change in sigmoid mesentery found by the CT Scan. Both Dr. Gross10 and Dr. Magilen concluded that it was likely that D. M. was, at least in part, exhibiting signs of pelvic inflammatory disease. Dr. Gross also concluded that, if her condition did not soon improve, a laproscopy11 would probably be required to determine the specific cause of D. M.'s complaints. Dr. Magilen was still concerned about the possibility of colon cancer or some other colonic disorder which the CT Scan and the ultrasound did not explain. Dr. Magilen's concern was based upon the following factors, which his conclusion about pelvic inflammatory disease and the CT Scans of July 14th and July 16th had not ruled out: The findings of the CT Scans and the impressions of the radiologists concerning diverticulitis had not ruled out the possibility that D. M. was suffering from some other colonic disorder, as explained in findings of fact 41 and 52; D. M. had undergone at least some treatment with antibiotics upon her release from the hospital on July 15th and undergone some bowel rest while in the hospital between July 14th and July 15th, and yet her complaints had persisted; and D. M.'s history (she is at some risk of cancer) and her complaints: she had unexplained or undefined abdominal and pelvic pain that had lasted for a week or two; she had been bleeding from the rectum and had rectal pain; she had had a change in her bowel pattern; and she had shown signs of anemia. Dr. Magilen decided to perform a colonoscopy on D. M. to be sure that D. M. was not suffering from a colonic disorder in addition to what he suspected was a pelvic inflammatory disease. The procedure was performed on July 18, 1997. It was performed easily and without apparent complication at the time. Dr. Magilen found uncomplicated diverticulosis but no other pathology, including colonic neoplasm, lesions, or malignancy. Subsequent to the completion of the colonoscopy on July 18th, D. M.'s condition rapidly deteriorated. D. M. experienced an acute abdomen, which is consistent with a possible perforation of the colon as a result of the colonoscopy. An abdominal X-ray, however, failed to reveal a perforation or the presence of free air in D. M.'s abdomen. D. M.'s condition did not improve on July 19th. Therefore, on July 20, 1997, Dr. Magilen performed exploratory surgery on D. M.'s abdomen. Dr. Magilen observed inflammation and abscesses on the outside of D. M.'s colon. Dr. Magilen also reported observing two perforations of her sigmoid colon. Dr. Magilen also found inflammation of the right ovary and tube and the presence of pus in the cul-de-sac. The pus was sampled for culture. Because of the two perforations Dr. Magilen believed he had observed, Dr. Magilen removed a large portion of the colon; he resected and placed a colostomy. Pathology of the resected portion of D. M.'s colon determined that the colon evidenced focal fibrinous hemorrhagic exudate, numerous deep diverticuli, and no neoplasm. Culture of the pus did not produce bacteria that would be expected from ruptured diverticuli. The culture was, however, consistent with a gynecologic origin. Pathology also failed to confirm Dr. Magilen's belief that there were two perforations in D. M.'s colon. These findings suggest that D. M. was suffering from a pelvic inflammatory disease, in particular, a tube and ovary on the right side; and that the inflammation may have adhered the tube and ovary to the sigmoid colon causing the symptoms evidenced by D. M. as opposed to diverticulitis. Conducting a colonoscopy in a patient with diverticulitis is generally considered counterindicated and may under certain circumstances constitute a deviation from the standard of care. A colonoscopy is counterindicated because it poses a greater risk of perforation by mechanical trauma-- disruption of the inside of the bowel wall by the scope used to perform the colonoscopy--for a patient suffering from diverticulitis. The colonoscopy also requires the injection of air into the colon which results in the colon being firmer and, thus, more prone to damage, especially if the patient is suffering from diverticulitis. A perforation of the colon can result in serious complications and can lead to death. Under normal circumstances, the preferred treatment of diverticulitis is to prescribe antibiotics, serial clinical examinations, and bowel rest. Absent some reasonable basis for deviation, the most prudent treatment of a patient suffering from acute diverticulitis who may also be suffering from a colonic disorder would be to treat the patient for the diverticulitis first and then, if deemed medically necessary, perform a colonoscopy after the diverticulitis has been resolved. Usually, the four to days it takes for antibiotics to be effective in treating diverticulitis, will not make any difference in a patient's oncologic situation. Even where it is suspected that there is another pathology in the colon, it may be prudent to calm the bowel and address the diverticulitis first before performing a colonoscopy. Despite the foregoing, if it is questionable whether a patient is in fact suffering from diverticulitis as opposed to some other process, the need for additional information concerning the patient must be weighed against the risk of performing a colonoscopy. Under these circumstances, clinical judgment concerning whether the colonoscopy should be performed must be exercised. The evidence in this case failed to prove that Dr. Magilen did not have a reasonable basis for proceeding with a colonoscopy of D. M. on July 18, 1997, despite the "suspicion" of diverticulitis reported as a result of the CT Scans of July 14th and July 16th. The normal course of treatment for diverticulitis was not followed in D. M.'s case by Dr. Magilen because Dr. Magilen was not convinced that D. M. was suffering from diverticulitis. As found, supra, Dr. Magilen concluded that D. M.'s clinical picture was unclear at best. In light of D. M.'s unclear clinical picture and Dr. Magilen's conclusions concerning the CT Scan findings, the evidence failed to prove that Dr. Magilen failed to realize that D. M.'s history, physical examination, and radiologic studies were consistent with a diagnosis of probable diverticulitis. In addition to D. M.'s unclear clinical picture and Dr. Magilen's reasonable conclusions concerning the CT Scan findings, Dr. Magilen was faced with the knowledge that Dr. Gross would in all probability perform a laproscopy on D. M. It was, therefore, reasonable for Dr. Magilen to proceed with the colonoscopy on July 18th without first treating D. M. with antibiotics and bowel rest. Dr. Magilen reasonably decided that it would be better to determine if there was any colonic disorder before the laproscopy was performed. Dr. Magilen wanted to avoid D. M. being placed under a general anesthesia and having some surprise problem with her colon discovered after the laproscopy was begun. The evidence, therefore, failed to prove that Dr. Magilen failed to practice medicine with the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances because Dr. Magilen failed to treat D. M. for diverticulitis with intravenous antibiotics and serial clinical examinations before performing the colonoscopy on July 18, 1997. Finally, the evidence failed to prove that Dr. Magilen failed to document justification for proceeding to perform a colonoscopy on D. M. on July 18, 1997.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered dismissing the Administrative Complaint against Steven A. Magilen, M.D. DONE AND ENTERED this 29th day of October, 2001, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 29th day of October, 2001.
The Issue The issue in this case is whether the Board of Medicine (Board) should revoke or otherwise discipline the Respondent’s medical license for violating section 458.331(1)(t) and (u), Florida Statutes (2011), by using experimental stem cell therapy that did not meet the standard of care and by not getting the patient’s informed consent.
Findings Of Fact The Respondent is licensed to practice medicine in Florida. He holds license ME 45186. He is a board-certified anesthesiologist. In mid-2011, the Respondent began working at Jouvence Medical in Sarasota and was offered the opportunity to take over the stem cell medicine practice of Dr. Feinerman, who was treating patients with lung disease using an intravenous autologous stem cell procedure. The Respondent had no formal training in stem cell medicine, which is not normally practiced by anesthesiologists, but the Respondent observed Dr. Feinerman perform his stem cell procedure and correctly concluded that he was fully capable of performing it himself. In addition, the Respondent had strong interest in stem cell medicine and gained some knowledge of it from studying literature while seeking stem cell therapy for his elderly father, who has chronic obstructive pulmonary disease. On September 14, 2011, patient J.F. presented to the Respondent at Jouvence with a number of medical issues, including post-polio syndrome and end-stage idiopathic pulmonary fibrosis (IPF). The standard of care for end-stage IPF is supportive management, including oxygen, which was offered and being provided by the patient’s primary physician and pulmonologist, who referred the patient to Jouvence for a stem cell treatment that might provide additional health benefits and possibly extend the patient’s life, or even cure him. On seeing the patient on September 14, 2011, the Respondent appropriately took his history, reviewed his medical records and various test results, and offered the autologous stem cell procedure he learned from Dr. Feinerman. The Respondent adequately explained to the patient how the procedure would be performed and how much it would cost. He told the patient that results were not guaranteed, but that some patients reported receiving benefits from the treatment. The patient signed a consent form acknowledging and documenting what the Respondent told him. It certainly was true that the procedure’s hoped-for results were not guaranteed, but just saying that was inadequate to inform the patient. The procedure proposed by the Respondent essentially consisted of: a 60 cubic centimeter (cc) blood draw, and intravenous infusion of 150 micrograms (mcg) of Neupogen; concentration of the drawn blood in a centrifuge; and, the next day, peripheral intravenous infusion of 10 cc’s of the patient’s concentrated blood, together with 100 cc’s of saline solution. According to the Respondent, the treatment would confer maximum benefits by delivering mesenchymal stem cells directly into the patient’s fibrotic lungs and also by stimulating the patient’s bone marrow to produce additional mesenchymal stem cells that would migrate to and concentrate in the lungs. Once in the lungs, the mesenchymal stem cells theoretically would differentiate and regenerate healthy, non-fibrotic lung tissue to replace fibrotic tissue. Mesenchymal stem cell treatments to regenerate heart tissue have been successful, and it is hoped that these treatments increasingly will replace heart transplants and surgeries. The similar use of mesenchymal stem cells for lung disease is being studied in vigorously regulated and controlled FDA-approved trials, which are experiments on human subjects. Safety trials were held in 2015 and 2016. So far, the trials have not progressed beyond safety trials; trials to determine efficacy have not begun. The FDA-approved trials of stem cell treatments for lung disease are much different from the procedure performed by the Respondent. They involve the extraction, concentration, and characterization of tens or hundreds of millions of mesenchymal stem cells from human donors and the use of those stem cells to treat human subjects. The Respondent’s treatment was so different from these trials that it did not even require FDA approval. It was unrealistic for the Respondent to think it likely that the procedure he performed on J.F. would result in regeneration of lung tissue. Blood contains a minimal number of mesenchymal stem cells. Neupogen is a granulocyte colony- stimulating factor that is administered (usually in multiple doses over a relatively long period of time, especially when administered through the peripheral veins, as done in the Respondent’s procedure) to chemotherapy patients to amplify the development of white blood cells called neutrophils. Neutrophils are hematopoietic stem cells, which do not differentiate as mesenchymal stem cells do. The two injections of Neupogen administered in the Respondent’s procedure would not be expected to increase the production of mesenchymal stem cells significantly. There was no reasonable expectation that the procedure performed by the Respondent would introduce a significant amount of mesenchymal stem cells into the patient’s lungs so as to achieve the maximum hoped-for benefit of regenerating lung tissue. There had been anecdotal reports that patients have benefited from the treatment offered to J.F. by the Respondent. Since the functioning of stem cells in the body was not well known at the time, it was possible that some of the reported benefits are real. It is possible that the introduction of even a small number of stem cells, either mesenchymal or hematopoetic, could reduce inflammation in the lungs and stimulate the production of additional stem cells in the bone marrow. (There also could have been benefits from a placebo effect, even if not intended by the Respondent.) The procedure performed by the Respondent was fairly benign. Since the patient’s own blood was being used, there was little or no risk of rejection. There is a risk of infection from any blood draw and infusion. While the risk of infection was relatively small, the harm to a patient in J.F.’s condition from any infection would be significant and could result in the loss of lung tissue. Loss of consciousness was another risk from the procedure that was small but serious for a patient in J.F.’s condition. There also was some risk of pulmonary emboli, albeit small. The patient survived the procedure performed on September 14 and 15, 2011. The evidence was not clear, but it suggested that the patient was neither harmed nor benefited. About a month later, the patient’s condition worsened and he died, which was not unexpected given his dire medical condition. After J.F. died, his life partner R.C. asked the Respondent to return the $5,000 he had paid for J.F.’s procedure. The Respondent referred him to Jouvence, which declined to return the money. R.C. filed a complaint with the Department of Health, which investigated and filed the pending Administrative Complaint. Shortly after J.F. died, the Respondent decided to discontinue offering the procedure to similar patients because the small chance of benefits did not outweigh the risk of infection. As to the charge that the Respondent practiced below the standard of care, the standard of care for the patient J.F. was supportive management, which the patient’s other doctors already were providing. The Respondent offered the patient the possibility of a health benefit beyond the standard of care. Although the chances of complete success were extremely small to nonexistent, there was a chance of some health benefits, and the concomitant risks were not clearly unreasonable. The procedure was performed in an appropriate manner in all other respects. As to the charge of experimentation without giving informed consent, the Respondent should have been more forthright in disclosing to the patient that his chances of receiving a medical benefit were very small and that the chances of a cure or an appreciable lengthening of his life were extremely small. It was not enough to say “results are not guaranteed.”
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 the Respondent guilty of a violation of section 458.331(1)(u); placing him on probation for one year; and fining him $1,000. DONE AND ENTERED this 20th day of December, 2016, in Tallahassee, Leon County, Florida. S J. LAWRENCE JOHNSTON 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 20th day of December, 2016. COPIES FURNISHED: Chad Wayne Dunn, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399 (eServed) Augustine Smythe Weekley, Esquire Weekley Schulte Valdes, LLC Suite 100 1635 North Tampa Street Tampa, Florida 33602 (eServed) Sarah E. Corrigan, Esquire Department of Health Prosecution Services Unit, Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 23299 (eServed) Claudia Kemp, JD, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed)
The Issue Whether the Certificate of Need (“CON”) Application No. 10490 submitted by Baptist Hospital of Miami, Inc. (“Baptist Hospital” or “Baptist”), to establish a new adult autologous and allogeneic bone marrow transplant program in Florida’s Organ Transplant Service Area 4 (“TSA 4”) should be approved.
Findings Of Fact Bone Marrow Transplants Bone marrow transplantation is performed after a patient has received very high doses of chemotherapy in order to eradicate cancer. High doses of chemotherapy can cure cancerous cells or cause remission, but chemotherapy can also damage healthy cells. Damage may be done to progenitor cells that create the components for blood, including white blood cells. If progenitor cells are damaged by chemotherapy, the patient may succumb to infection and bleeding. To avoid this problem, physicians remove blood-producing progenitor cells from the patient's blood and bone marrow, and store them while the patient receives chemotherapy. The patient is then reinfused with progenitor blood cells, allowing the patient to make normal blood and recover. This infusion of progenitor cells is commonly referred to as bone marrow transplantation ("BMT"). BMT has become an essential method of fighting blood cancers. BMT is offered in hospital settings, and most transplants are performed on an inpatient basis. However, certain types of BMT services are more frequently being offered on an outpatient basis. BMTs are categorized as either autologous or allogeneic. In autologous BMTs, the patient's own blood and bone marrow cells are removed and then reinfused after chemotherapy. The process begins with apheresis to collect the patient's bone marrow and blood cells. The patient's blood is processed through a machine that separates progenitor cells and stores them. The process of apheresis may take up to five hours. The cells are frozen for later use. The process of freezing blood product is referred to as cryopreservation. The patient then receives chemotherapy and is then reinfused with the patient's own blood and bone marrow cells. Some cancer patients, such as acute leukemia patients, have malignant or compromised blood progenitor cells. In those cases, autologous transplantation is not an option. Instead, progenitor cells must be obtained from an alternative donor, such as a family member or a compatible nonrelative. Allogeneic transplants carry a higher risk of complications, primarily because the introduction of another person's progenitor cells may cause "graft vs. host" disease, which involves the patient’s rejection of the infused cells. Histocompatibility tests help determine whether donated progenitor cells will successfully match with the patient and reduce the chances of graft vs. host disease. BMT is a relatively rare procedure. In 2014, there were 17,303 BMT procedures in the United States involving patients over the age of 21. In 2016, there were 1,026 cases in Florida involving patients over the age of 15. The Regulatory Framework Section 408.032(17), Florida Statutes (2018),1/ defines a “tertiary health service” as a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost-effectiveness of such service. Examples of such service include, but are not limited to, pediatric cardiac catheterization, pediatric open-heart surgery, organ transplantation, neonatal intensive care units, comprehensive rehabilitation, and medical or surgical services which are experimental or developmental in nature to the extent that the provision of such services is not yet contemplated within the commonly accepted course of diagnosis or treatment for the condition addressed by a given service. As a tertiary health service, inpatient BMT may only be offered once a hospital has obtained a CON. See §§ 408.032(17), 408.036(1)(f), Fla. Stat.; Fla. Admin. Code R. 59C-1.044. The statutory review criteria for CONs are set forth in section 408.035. The criteria include factors such as: (a) the need for the health service proposed; (b) the applicant’s ability to provide quality care; (c) the extent to which the proposed service will enhance access to healthcare for residents in the applicable service district; and (d) the immediate and long-term financial feasibility of the proposal. AHCA has published Florida Administrative Code Rule 59C-1.044 governing CON review for transplantation services. Subsections (3), (4), (5) set forth criteria that applicants for several different types of transplant programs must satisfy. Subsections (9) and (10) set forth criteria that BMT applicants must "normally" meet before a new transplant program will be approved. AHCA may approve a CON for BMT services when an applicant demonstrates that not-normal circumstances are present. For many CON-regulated services, AHCA predicts the future need for additional beds or services by announcing a "fixed need pool," establishing a numerical need for new programs around the state. See, e.g., Fla. Admin. Code R. 59C-1.0355 (establishing fixed need pool methodology for hospices); 59C-1.036 (pertaining to nursing facility beds), 59C-1.039 (pertaining to comprehensive medical rehabilitation beds). The establishment of a fixed need pool creates a rebuttable presumption that a new service is or is not needed. Balsam v. Dep’t. of HRS, 486 So. 2d 1341 (Fla. 1st DCA 1986); Humhosco, Inc. v. Dep’t. of HRS, 476 So. 2d 258 (Fla. 1st DCA 1985). However, there is no fixed need pool for organ transplantation services such as BMT. With regard to need, a BMT CON applicant must reliably project that it will annually perform 10 autologous and 10 allogeneic transplants. See Fla. Admin. Code R. 59C-1.044(9)(b)1. (pertaining to adult allogeneic BMT programs and stating such applicants “shall be able to project that at least 10 adult allogeneic transplants will be performed each year. New units shall be able to project the minimum volume for the third year of operation.”); Fla. Admin. Code R. 59C-1.044(9)(c)1. (pertaining to adult autologous BMT programs and stating that such applicants “shall be able to project that at least 10 adult autologous transplants will be performed each year. New units shall be able to project the minimum volume for the third year of operation.”). Rule 59C-1.044(2)(f) provides that “[p]lanning for organ transplantation programs shall be done on a regionalized basis.” Accordingly, the rule establishes four transplant service areas (“TSA”), and each one corresponds to an area containing approximately 25 percent of Florida’s population. The TSA relevant to the instant case is TSA 4, which consists of Broward, Miami-Dade, Monroe, Collier, and Palm Beach Counties. The Parties Baptist Hospital Baptist Health South Florida (“BHSF”) is a not-for- profit, faith-based community healthcare organization that operates nine hospitals, approximately 50 outpatient centers, and a medical group serving South Florida, from the Keys to the Palm Beaches. Though each is separately incorporated, all of BHSF's hospitals report to BHSF leadership and represent an integrated hospital system. BHSF has traditionally offered cancer treatment throughout its hospitals. BHSF sought to create a comprehensive cancer institute to serve South Florida, the Caribbean, and Latin America. The cancer institute would offer complete cancer care, from screening and diagnosis, to treatment, and psychosocial support, all the way to palliative care. BHSF created the Miami Cancer Institute (“MCI”) to consolidate the cancer services it offered at many of its hospitals into a single location at Baptist Hospital. The goal was to offer integrated care, so that everything a cancer patient might need could be offered at one location. Though separately incorporated, MCI is an outpatient department of Baptist Hospital in Miami-Dade County, Florida.2/ All of MCI's services are billed through Baptist Hospital, and MCI’s management reports to Baptist Hospital’s administration.3/ MCI sees between 800 and 1,000 cancer patients a day. Because BMT is required to cure most hematological malignancies, including leukemia, myelodysplastic syndrome, pyelolymphatic disorders, myeloma, and lymphoma, BMT services are essential to MCI becoming a comprehensive cancer care center. Consultants and leaders at MCI also concluded that MCI must offer inpatient BMT in order for MCI to offer the full range of care needed by cancer patients. Therefore, Baptist applied to obtain the CON at issue in this proceeding. Baptist recently completed the process of becoming an affiliate of the Memorial Sloan Kettering (“MSK”) Cancer Center in New York. That alliance has now been formed and is operational. MSK is the United States’ leading center for cancer treatment and BMT. The alliance between Baptist and MSK is a strong, integrated linkage between the clinical and research efforts of both organizations. The alliance provides Baptist’s patients with the latest BMT protocols and techniques. MSK and its cancer research will now be able to add a genomic database of Hispanic cancer patients that may result in improved treatment for patients not of European descent. The University of Miami The University of Miami (“UM”) was established in 1925 and is one of Florida’s preeminent universities. The University of Miami Hospital and Clinics (“UMHC”), the Sylvester Comprehensive Cancer Center (“Sylvester”), and the Miller School of Medicine are all part of UM and are all located in Miami-Dade County, Florida. UM’s medical facilities (the Miller School of Medicine, the University of Miami Hospital, Sylvester, and Anne Bates Leach Eye Center) are located on a medical campus shared with Jackson Memorial Hospital in Miami. Sylvester is a 40-bed specialty care center hospital, and the care offered to the residents of South Florida has achieved significant statewide and national prominence. UM is recognized as a Prospective Payment System (“PPS”) exempt institute, which allows it special reimbursement treatment from Medicare for purposes of reimbursement for cancer care provided at Sylvester. There are only 11 such centers in the country. According to AHCA’s discharge database, 147 residents of TSA 4 received BMT treatment in calendar year 2016 at UM.4/ In 2016, UM performed the second highest number of BMTs in Florida.5/ AHCA AHCA is the state agency charged with administering Florida’s CON program. A CON is required before a hospital may offer inpatient BMT. A CON is not required to establish and operate an outpatient BMT program because outpatient services are exempt from CON review. The Non-Parties H. Lee Moffitt Cancer Center (“Moffitt”) is located in Hillsborough County, Florida. Moffitt is the largest BMT program in Florida, performing more than 400 BMT procedures annually. Moffitt is a recognized cancer hospital, and its physicians are recognized cancer researchers. Fifty to 60 residents of TSA 4 travel outside of South Florida each year in order to receive BMT, and the majority receive that treatment at Moffitt. Because the distance from Miami to Moffitt is 250 to 280 miles and a course of treatment can take two to three months, it is a substantial burden for patients in TSA 4 with limited resources to receive BMT treatment at Moffitt. Memorial Hospital West (“Memorial West”) is located in Broward County. Memorial West and UM are the only operational CON-approved adult service providers of BMT services in TSA 4. Memorial West has been a low volume provider of BMT. According to AHCA’s State Agency Action Report(“SAAR”), Memorial West performed nine inpatient BMT procedures in 2012, 15 in 2013, 20 in 2014, 15 in 2015, and four in 2016. Shortly before the final hearing in this matter, Memorial West affiliated with Moffitt in hopes of reinvigorating its largely inactive program. Moffitt has fully staffed and assumed all clinical operations in the Memorial West program. Under Moffitt leadership and clinical management, the Memorial West program performed eight allogeneic and 19 autologous BMTs between July 1, 2017, and January 26, 2018. Good Samaritan Hospital (“Good Samaritan”) is located in Palm Beach County. For many years, Good Samaritan reported to AHCA that it provided a moderately large volume of inpatient BMT. For instance, Good Samaritan reported doing 42 BMTs in 2016. However, it was recently discovered that Good Samaritan had been incorrectly reporting bone marrow biopsies as bone marrow transplants. All parties now acknowledge that Good Samaritan does not have a BMT program. The Prior Proceeding During the October 2015 Other Beds and Programs CON Batching Cycle, Baptist Hospital filed an application to establish a new adult inpatient autologous and allogeneic BMT program in TSA 4. On February 19, 2016, AHCA issued a SAAR preliminarily approving the application. On March 11, 2016, UM filed a petition challenging AHCA’s preliminary decision, and the petition was assigned DOAH Case No. 16-1698CON. After a nine-day hearing in September 2016, Administrative Law Judge (“ALJ”) James H. Peterson, III, issued a Recommended Order on March 30, 2017, recommending that AHCA deny Baptist’s CON application. AHCA rendered a Final Order on June 13, 2017, adopting ALJ Peterson’s recommendation.6/ The Current CON Application Baptist’s current application seeks to establish an adult inpatient autologous and allogeneic bone marrow transplant program located in TSA 4. On August 18, 2017, AHCA issued a SAAR preliminarily approving Baptist's CON application. Baptist has self-imposed three conditions on its application. The first condition is that the proposed BMT program will be located at Baptist Hospital. The second condition is that 12 acute-care beds will be delicensed so as to convert an 18-bed unit to a 6-bed inpatient BMT unit. The third condition is that Baptist will provide at least 10 percent of its inpatient BMT case volume on an annual basis to Medicaid (including managed Medicaid), charity, or self-pay payments. AHCA is requiring that Baptist establish an on-site cryopreservation lab as a condition of approval for its CON. Outpatient BMT has already begun at Baptist because a CON is not required for outpatient services. It is assumed that Baptist will achieve accreditation from the Foundation for the Accreditation of Cellular Therapy (“FACT”) for autologous BMT before the first inpatient procedures are performed. FACT accreditation is the key to receiving reimbursement from federal payors and private insurers. Baptist does not plan to perform any inpatient BMTs until it has completed a year of outpatient autologous procedures. AHCA received letters from several Florida state legislators and local government officials expressing support for Baptist’s application. The Statutory Review Criteria Section 408.035(1)(a) – The Need for BMT in TSA 4 Because the rule governing applicants for autologous and allogeneic BMT programs requires applicants to demonstrate the ability to perform 10 autologous and 10 allogeneic BMTs a year, a forecast of the future need for BMT by TSA 4 residents is necessary in order to evaluate whether Baptist can satisfy that requirement. AHCA’s discharge database includes inpatient treatments and excludes outpatient treatments because outpatients are not admitted. That database indicates that 215 TSA 4 residents received BMTs at a CON-approved hospital in Florida for the 12 months ending September 2016. Sixty-two TSA 4 residents received their treatment at a facility outside TSA 4 during the 12 months ending in December 2016. The number of outmigration cases has remained relatively constant over the last 10 years despite the fact that UM has entered the BMT market and steadily increased the number of BMTs it performs. Baptist’s current application projects the increase in TSA 4's adult inpatient BMT case volume for 2019 (year one of operation) and 2020 (year two of operation) using three different annual growth rates (five percent, seven percent, and nine percent). This analysis forecasts increases of 34 to 63 BMT cases in 2019 and 46 to 88 cases in 2020, depending on the growth rate applied. In other words, Baptist projects that inpatient BMT need in 2019 for TSA 4 will be between 249 and 278 cases, and Baptist projects that inpatient BMT need for TSA 4 in 2020 will be between 261 and 303 cases. UM predicts that the need for adult inpatient BMT in TSA 4 in 2020 will be 277 cases. Both parties’ need projections are reasonable. Even if the demand for BMT by TSA 4 residents only grows by five percent a year, the resulting number of BMT cases will be higher than Baptist's projected volumes of 22 cases in year one and 30 cases in year two. This indicates that there will be adequate growth to support Baptist's BMT program and the existing providers. With regard to the need for BMT in TSA 4, Baptist’s health planning expert testified that: the number of adult inpatient bone marrow transplant cases that will be performed on residents of TSA 4 will grow by more than the 22 and 30 cases that are forecasted for Baptist Hospital. In other words, the market is growing enough that Baptist can achieve its volume and existing providers can maintain at least their current level of service. There are circumstances indicating that a five percent annual growth rate for inpatient BMT is conservative and likely to underestimate the actual need among TSA 4 residents. For instance, national volume data for BMT from the Center for International Blood and Marrow Transplant Research (“the CIBMTR”) shows that there has been strong and continuous growth in autologous and allogeneic BMT over the last 10 years in the United States. In 2010, there were 16,668 BMTs in the United States. By 2014, that number had grown to 19,862, which represents a five percent average annual growth rate. More recent data from the CIBMTR indicates that there were 21,292 BMTs performed in the United States during 2015, which represents a seven percent growth rate from 2014 to 2015. The number of BMT procedures is reliably growing every year, and that is partially due to slight increases in population. This increase is also due to the fact that additional types of patients might benefit from BMT. There has also been an increase in the number of BMTs performed in Florida. Total adult inpatient BMT cases performed in all Florida hospitals have grown from 671 procedures for the 12 months ending September 2012, to 917 procedures for the 12 months ending September 2016. That amounts to an increase of 246 inpatient cases over a four-year period, or an average annual increase of 62 cases each year. In percentage terms, that is a 37 percent increase from 2012 to 2016 and an annual average percentage growth of nine percent per year. A review of the most recent yearly increase, from 2015 to 2016, demonstrates there were 68 new cases and a percentage growth of eight percent. As for circumstances specific to TSA 4, the total population in South Florida is increasing at a rate of approximately one percent per year. The segment of the population over the age of 15 is growing at a slightly higher rate than the total population. People over the age of 61 are receiving more BMTs than in the past. Because the elderly (65+) show the highest percentage population growth in TSA 4, the increased volume for this population will impact the overall volume growth forecasted for TSA 4. There is additional room for BMT use to increase in TSA 4 because that area’s utilization of BMT is low in comparison to other geographic areas. AHCA discharge data shows an overall adult BMT use rate for TSA 4 residents of 4.12 cases per 100,000 people, and the use rate for all of Florida is 5.07 cases per 100,000 people. The greater weight of the evidence demonstrates that the number of inpatient BMT cases in TSA 4 will increase to at least 249 cases in 2019 and to at least 261 cases in 2020. The greater weight of the evidence also demonstrates that the aforementioned forecasts are conservative and that the actual increases are likely to be higher. Section 408.035(1)(b) – The Existing Health Services in the Service District of the Applicant Section 408.035(1)(b) requires AHCA to evaluate “[t]he availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the service district of the applicant.” (emphasis added). Section 408.032(5) divides Florida into 11 health service planning districts. District 11 consists of Miami-Dade and Monroe Counties. UM is the only BMT provider in District 11. Memorial West is located in District 10, which encompasses Broward County. Therefore, section 408.032(5) excludes Memorial West from this analysis. Good Samaritan does not have a BMT program. While UM is the only authorized and operational provider of inpatient BMT services in Miami-Dade County, UM did not provide BMT to a single charity care patient between 2014 and 2016, despite committing to do so. UM's lack of service to charity BMT patients is consistent with its financial reports to the state. UM has the ability to provide charity care. In 2016, UMHC reported a net income of approximately $175 million. As the only existing local BMT provider in the community, UM's failure to provide any charity care presents an access limitation for charity patients. The lack of outpatient BMT presents another access issue. UM does not plan to perform any outpatient BMT procedures even though the medical trend is that more and more of the less complicated autologous BMT procedures are being performed on an outpatient basis. Some countries in Europe are even experimenting with autologous transplantation performed in the patient's home. For some patients that live in the Miami area, outpatient BMT presents a more convenient alternative than a long hospital stay. The inability to access a BMT provider willing to perform outpatient BMT is an access issue. Another access issue involves the utilization of UM’s BMT capacity. The number of BMT procedures performed at UM has steadily increased over time and jumped by more than 70 procedures in 2017 alone. UM's physicians predicted that the number of BMT procedures would grow by 65 in the current year, allowing UM to reach volumes it has never achieved before. Those volumes have allowed UM to conduct research and educational activities. As a result of increasing volumes, UM's BMT program has used a progressively higher number of beds within the hospital. UM's BMT program is on track to treat 240 patients and will have to utilize other beds in addition to the 12 beds originally set aside for BMT. Another access issue pertains to the types of cases that outmigrate from TSA 4. Baptist’s application contained data indicating that a disproportionate amount of the outmigration cases are complex in nature, and the SAAR states the following: the applicant notes that the highest level of outmigration was observed in allogeneic BMT patients which accounted for 41 percent of outmigration cases. [Baptist] states that these patients require the longest post-discharge treatment regimen and for this reason high levels of outmigration are evidence of a significant problem. Autologous cases with complications account for 23 percent of outmigration cases and autologous patients without complications account for four percent of outmigration cases. The applicant reiterates that the proposed project is expected to target these patients as a local alternative to care outside of OTSA 4. The fact that Good Samaritan does not have a BMT program may be the most significant access issue in this particular service district, and that amounts to a substantial change in circumstances since the prior proceeding. ALJ Peterson’s Recommended Order indicates that he evaluated the existing provision of BMT in District 11 based on the premise that Good Samaritan had an operational BMT program. The greater weight of the evidence demonstrates that access to BMT in District 11 is less than optimal, especially given that all parties now accept that Good Samaritan does not have a BMT program. Section 408.035(1)(c) – The Applicant’s Ability and History Regarding Quality of Care Baptist offers high quality healthcare. Evidence of past quality is demonstrated by Baptist's numerous accreditations and quality awards. U.S. News and World Report studied patient safety and mortality rates in U.S. hospitals and surveyed 30,000 physicians in 5,000 hospitals across the country. The publication ranked BHSF as the highest performing healthcare organization in South Florida, and eighth best in Florida. Since the CON application was filed, BHSF has risen to sixth best in the state. Baptist is one of only eight hospitals in the world, and the first hospital in Florida, to receive the Magnet Award, an award for nursing practice from the American Nursing Association. The American Nursing Association reviews quality metrics and nursing performance in all departments of the hospital to determine merit for the Magnet Award. Baptist has achieved high marks for patient satisfaction. Consumer Reports ranked Baptist highly for patient safety and quality. Consumer Reports rated Baptist Hospital the safest hospital in Miami-Dade County. Baptist assures that a high quality of care is maintained by implementing robust performance improvement plans. Baptist has a board-level quality committee that reviews outcome data on a bi-monthly basis. Baptist also has a medical executive committee where performance improvement peer review results are presented on a monthly basis. Baptist also has a number of collaborative teams over particular areas such as surgery, stroke, and tumors. These teams review outcomes in their particular areas and present them to the performance improvement steering council. Baptist's performance improvement plan will be applied to a BMT program. There will be a BMT group to monitor outcomes in the same way as other groups. Baptist has already developed extensive policies and procedures for its BMT program. These policies and procedures were developed by the recruited staff and will be reviewed for final approval by the BMT program’s new director, Dr. Gunther Koehne. Baptist expects Dr. Koehne to implement standards of care consistent with MSK's in order for Baptist's patients to participate in MSK's clinical trials. Baptist’s outpatient BMT unit is brand new and is equipped for patient needs. The outpatient and apheresis BMT units had already been constructed, equipped, and staffed by the time of the final hearing in this matter. Dr. Koehne testified that the facilities are both attractive and highly functional. Baptist has provided the space and equipment necessary to operate a BMT program. Baptist's CON application included plans for the renovation of a portion of the hospital where inpatient BMT patients will be served. The parties stipulated that the costs and methods of that construction were reasonable. Baptist has an age-appropriate intensive critical care unit which includes facilities for prolonged reverse isolation. Evidence was presented regarding the correlation of low volume BMT hospitals or doctors and their outcomes. The studies suggest that higher volumes and experience for physicians and their teams lead to better outcomes for patients. However, Dr. Hugo Fernandez, the Chair of the Department of Malignant Hematology and Cellular Therapies at Moffitt, testified that a volume of 10 allogeneic transplants and 10 autologous transplants is above the volume at which research shows lower volumes may affect quality. Dr. Fernandez testified that Memorial West began safely performing allogeneic transplants one year after receiving its CON. Dr. Claudio Anasetti, the Chair of the Blood and Marrow Transplantation Department at Moffitt, agreed that 20 transplants is a sufficient volume to ensure good outcomes. The aforementioned findings, and those yet to be discussed, demonstrate that Baptist will be able to offer high quality care to patients of an adult inpatient BMT program. Section 408.035(1)(d) – The Availability of Resources Section 408.035(1)(d) pertains to a review of the applicant’s resources for project accomplishment and operation. The statute expressly mentions “health personnel, management personnel, and funds for capital and operating expenditures.” Findings regarding Baptist’s current ability to provide the health and management personnel necessary for autologous and allogeneic BMT will be discussed below in relation to Baptist’s ability to satisfy the criteria of rule 59C-1.044 applicable to BMT centers. Baptist’s ability to fund the proposal will be discussed below in relation to the immediate and long-term financial feasibility of the proposal. Section 408.035(1)(e) – The Extent to Which the Proposed Services Will Enhance Access to Health Care for Residents of the Service District Baptist has a history of providing health care services to Medicaid and indigent/charity patients. Baptist Health System hospitals, including Baptist Hospital, provide 4.3 percent of its services to charity care patients, which is well above the average of 3.4 percent for hospitals in Miami- Dade County. Baptist Hospital also exceeds the county average. As noted in a previous section, the access to care in District 11 is less than optimal given: (1) UM’s lack of inpatient charity care; (2) the fact that UM performs no outpatient BMT; (3) the fact that Good Samaritan does not have a BMT program; and (4) the fact that a very high percentage of the outmigration cases are complex in nature, i.e., allogeneic and autologous with complications. The greater weight of the evidence indicates that a BMT program at Baptist is likely to alleviate issues pertaining to access to care in the service district. However, given that Baptist will likely be a relatively small program for the foreseeable future, those issues will not be resolved in their entirety in the short-term. Section 408.035(1)(f) – The Immediate and Long-Term Financial Feasibility of the Proposal Section 408.035(1)(f) refers to “financial feasibility” rather than “profitability.” The cost for Baptist's proposed BMT program is $7,624,433, and the greater weight of the evidence demonstrates that Baptist will be able to finance the completion of the BMT program along with its other planned capital projects. Baptist has a capital budget of $20,414,000 to finance routine items such as the replacement of outdated equipment and renovations of nursing units. This budget also covers additional clinical equipment that might be needed to begin a new service line. Baptist identified other capital commitments that it had planned or were underway at the time of application. Along with the BMT program, Baptist’s other significant capital projects include construction of a new medical tower at a cost of $125 million and relocation of a helipad at a cost of $5 million. In total, Baptist disclosed $195.8 million in capital projects in its application. Rather than using debt to finance the initiation of the BMT program, Baptist will use cash on hand. The application included a letter from BHSF's Chief Financial Officer committing to pay for the project’s start-up costs and to cover any operational losses that may be incurred as the BMT program ramps up: BHSF intends to make available the required funds to Baptist Hospital of Miami, Inc. for the purpose of establishment of the project described in CON Application No. 10490, through startup and project stabilization, including but not limited to the project costs identified on Schedule 1 of CON Application No. 10490. BHSF intends to fund this project from internal sources. BHSF’s ability to fund the project is documented in the attached BHSF audited financial statements. Baptist provided audited financial statements which demonstrate the wherewithal to afford this project. BHSF’s net income for 2016 was $162,640,710. BHSF had $263 million in cash flow in 2016 and possesses over $2.4 billion in cash and investments. While the audited financial statements state that the cash and other investments are “limited,” the explanatory notes to those statements state that “[a]ssets whose use is limited include assets set aside by the Board of Trustees for future capital improvements and education, over which the Board retains control and may at its discretion subsequently use for other purposes . . . .” This supports Baptist’s assertion that the unrestricted cash and investments can be used for any purpose. BHSF’s financial statements indicate that its current liabilities exceed its current assets by $100,470,725. While this is cause for concern, that is substantially ameliorated by the fact that BHSF’s total assets exceeded its total liabilities by $3,165,081,911 in 2016. Even if BHSF’s application understated (or even omitted) some expenses associated with initiating the BMT unit, those expenses are insignificant for an entity with the financial resources available to Baptist through BHSF. In short, the greater weight of the evidence demonstrates that Baptist can afford to initiate the proposed project and cover any operational losses during the first years of operation. With regard to long-term financial feasibility, Baptist expects to get little or no revenue from allogeneic transplants in year one because it plans to perform 10 cases in order to become FACT accredited. None of the managed payors such as Medicare HMO and Medicaid HMO will pay until there is FACT accreditation. Accordingly, the per case revenue is expected to be $88,000 in year one, but that amount is expected to increase to $175,000 in year two. After accounting for anticipated expenses, Baptist forecasts a $2.9 million loss in year one of the application and a $577,000 loss in year two of the application. During the final hearing, Baptist’s financial expert testified that the BMT program was projected to turn a small profit of $25,000 in year three of the application. Given how substantially the net loss from the BMT program narrowed from year one to year two by adding only eight patients, it is reasonable to infer that the program will come close to breaking even by adding an additional 10 patients at some point after year two of the application. Baptist’s projected expenses differ from its previous application because Baptist previously estimated both inpatient and outpatient revenues and expenses. The current application is for inpatient services only. Outpatient BMT services have already been established at Baptist, and the expenses for those facilities and staff are considered sunk costs when compared to the project at issue, inpatient BMT services. Those sunk costs include research facilities, staffing, nurses, and doctors, and they were appropriately excluded from the pro forma financial statements associated with this application. Existing hospital staff can absorb the additional demand for dietary and other services. Even if it were to be assumed that this project will never be a positive contributor to Baptist’s net income, that would not be a basis, by itself, for finding that the BMT program is not financially feasible over the long-term. UM’s healthcare planning expert testified that BMT programs are not profit centers, but healthcare institutions operate such programs in order to fulfill a “mission” and to help people. That testimony was convincing and is accepted. The evidence clearly and convincingly demonstrates that Baptist and BHSF are committed to having a BMT program. As noted above, Baptist considers a BMT program to be an integral component of its goal to have MCI be a full service cancer treatment center. Baptist and BHSF’s commitment to the project is further demonstrated by the fact that MCI has already begun treating patients via an outpatient BMT program. Baptist has incurred substantial expenses (such as construction and staffing) in preparing to have a BMT program at MCI. In short, the preponderance of the evidence demonstrates that this project is financially feasible in the long-term. Even if it is not ultimately profitable, Baptist is committed to funding the program's losses, and Baptist demonstrated the ability to cover operational losses indefinitely.7/ Section 408.035(1)(g) – The Extent to Which the Proposal Will Foster Competition that Promotes Quality and Cost-Effectiveness AHCA concluded in the SAAR that “[t]his project is not likely to have a material impact on competition to promote quality and cost-effectiveness.” Nevertheless, the SAAR presented the following regarding the implications of UM’s PPS-exempt status: In addition, the reviewer notes that the applicant will not be a PPS-exempt cancer hospital, as UMHC is designated, and therefore reimbursement to the two proposed Miami-Dade providers from Medicare will be different. The reviewer notes that according to the U.S. Government Accountability Office (GAO), in 2012, Medicare payments received by the 11 PPS- exempt cancer hospitals were, on average, 42 percent more per discharge than what Medicare would have paid a local PPS teaching hospital to treat cancer beneficiaries with the same level of complexity. The GAO also found that the PPS-exempt cancer hospital’s payment methodology lacks strong incentives for cost containment and has the potential to result in substantially higher total Medicare expenditures. The GAO concludes that until Medicare pays PPS-exempt cancer hospitals to encourage efficiency, Medicare remains at risk for overspending. According to FloridaHealthFinder.gov, based on data submitted to the Agency through the inpatient database, UMHC had 160 bone marrow transplants with charges ranging from (on average) $403,740 (25th percentile) to $662,662 (75th percentile) with an ALOS of 25.0 days for CY 2016 for all adults 18+. The statewide total charges, for the same time period, ranged (on average) from $188,363 to $458,097 with an ALOS of 22.8 days. While a BMT program at Baptist is unlikely to promote competition that will increase quality and cost-effectiveness, it appears that a BMT program at Baptist serving Medicare recipients would be less costly than the same service at UM, a PPS-exempt provider. However, given the relatively small size of the program at Baptist, it would probably be many years before any substantial savings could be achieved by shifting Medicare BMT patients from UM to Baptist. Section 408.035(1)(h) – The Costs and Methods of the Proposed Construction The parties stipulated that the costs and methods of construction were reasonable. Section 408.035(1)(i) – Baptist’s Past and Proposed Provision of Health Care Services to Medicaid Patients and the Medically Indigent As found above, Baptist Hospital has a significant record of providing more than the average level of service to Medicaid recipients and the indigent. Rule Review Criteria General Requirements for Organ Transplantation Programs Rule 59C-1.044 is entitled “Organ Transplantation” and sets forth additional criteria by which AHCA reviews applications for organ transplantation programs such as a BMT program. Subsection (1) of the rule provides that “[a]pplicants for each type of transplantation program shall meet the requirements specified in subsections (3), (4) and (5).” Rule 59C-1.044(3)(a) requires applicants to have staff and other resources necessary to care for the patient’s chronic illness before, during, and after transplantation. The rule also requires that “[s]ervices and facilities for inpatient and outpatient care shall be available on a 24-hour basis.” Findings regarding Baptist’s physician staff are set forth below during the discussion of requirements pertaining specifically to allogeneic BMT programs. Nevertheless, it is found here that Baptist can provide a comprehensive range of physician specialty support services on a 24-hour basis. These include (but are not limited to) services such as intensive care physicians, cardiologists, infectious disease specialists familiar with the care of severely immune-compromised patients, and interventional radiologists. Rule 59C-1.044(3)(c) requires a transplant services applicant to have “[a]n age-appropriate (adult or pediatric) intensive care unit which includes facilities for prolonged reverse isolation when required.” Baptist’s application satisfies this requirement. Baptist proposes utilizing its existing adult critical care resources when necessary for BMT patients. Baptist plans to transfer BMT patients from the six-bed adult BMT unit to the intensive care unit (“ICU”) when the ICU team determines the patient needs additional critical care support. Examples include patients who become hemodynamically unstable or those who need mechanical ventilation. Baptist’s application notes that it is developing a “Protective Environment” room to support BMT patients who may require critical care services. Rule 59C-1.044(3)(d) requires a transplant services applicant to have “[a] clinical review committee for evaluation and decision-making regarding the suitability of a transplant candidate.” Baptist satisfies this requirement in that Baptist has specifically identified eight physicians to serve on its clinical review committee and will place subsequently recruited BMT physicians on the committee. Baptist has also identified 17 other medical professionals (including many from the BMT Team Support staff) who will be placed on its clinical review committee. Rule 59C-1.044(3)(e) requires an applicant to have: [w]ritten protocols for patient care for each type of organ transplantation program including, at a minimum, patient selection criteria for patient management and evaluation during the pre-hospital, in- hospital, and immediate post-discharge phases of the program. Rule 59C-1.044(3)(f) requires an applicant to have “[d]etailed therapeutic and evaluative procedures for the acute and long term management of each transplant program patient, including the management of commonly encountered complications.” Baptist’s application states that: [t]he protocols, policies, treatment plans and guidelines for selection, evaluation, treatment and management of the BMT patients are currently being finalized under the direction of the BMT Medical Director, Lyle Feinstein, MD. Drafts of these [] protocols, policies, treatment plans and guidelines are presented in Appendix 5. The draft documents received in evidence and other information presented in Baptist’s application are sufficient to satisfy the required patient selection criteria established by rule. As for the evaluative procedures, the application states “[w]ritten protocols/policies defining therapeutic and evaluative procedures for the acute and long term management of each BMT patient are being finalized for the Fall 2017 initiation of the outpatient BMT program and for the development of this proposed inpatient BMT program.” The application includes examples of those final drafts. The draft documents received in evidence are sufficient to meet the required therapeutic and evaluative procedures established by rule. Rules 59C-1.044(3)(h), (i), and (j) require an applicant to have: (a) an onsite tissue-typing laboratory or a contractual arrangement with an outside laboratory within Florida meeting the requirements of the American Society of Histocompatibility; (b) pathology services; and (c) blood banking facilities. In the current application, Baptist states that it has contracted with the Laboratory Corporation of America (“LabCorp”) for tissue typing services. The application includes a certificate from the American Society of Histocompatibility and Immunogenetics indicating that LabCorp is accredited in the area of “Histocompatibility Testing for Other Clinical Purposes.” The application also demonstrates that LabCorp is licensed to operate within the State of Florida. The contract with LabCorp is sufficient to meet the criteria in rule 59C-1.044(3)(h). As for pathology services, Baptist explains in its application that its laboratory department has the technical resources and expertise necessary to fully support the proposed BMT program and provide the necessary information to best manage[] each BMT patient’s care. This in-house expertise and infrastructure, combined with the OneBlood and LabCorp external resources, will ensure that all BMT patients will have the required laboratory support to optimally meet their medical needs. The application specifies that Baptist’s laboratory department can provide the following services: chemistry, coagulation, cytology, flow cytometry, hematology, histology, microbiology, phlebotomy, serology, transfusion service, and urinalysis. The aforementioned services are available 24 hours a day, seven days a week. In addition, laboratory tests can be completed in approximately one hour on a STAT basis. The application states that the laboratory department has seven pathologists who are board certified in anatomic and clinical pathology and that those pathologists: are eminently qualified and [] can diagnose the spectrum of complications that may occur in the immunocompromised bone marrow transplant patient population. They are able to diagnose the different pathogens that may effect this population. Similarly, they are able to identify and diagnose the histologic features of graft vs. host disease. The record evidence is sufficient to meet the criteria for pathology services in rule 59C-1.044(3)(i). The application also states that: [t]he existing blood banking and transfusion facilities and services currently in existence at Baptist Hospital are appropriate for supporting the blood requirements associated with the proposed new BMT program. Combining these existing Hospital capacities with the support of OneBlood, acting as the area’s centralized blood collection, storage and distribution hub, all necessary blood banking services are available and supported. Further, with OneBlood providing the specialty BMT blood/marrow processing and storage services, the blood and blood banking needs of the BMT patients will be fully met. The application contains a June 6, 2017, letter from a OneBlood representative to Marisol Fitch of AHCA describing OneBlood’s capabilities and indicating OneBlood will be servicing Baptist’s BMT program. The record evidence is sufficient to meet the criteria for blood banking facilities and services in rule 59C-1.044(3)(j). Rule 59C-1.044(3)(k) calls for an applicant to have a “program for the education and training of staff regarding the special care of transplantation patients,” and Baptist’s current application demonstrates it has such a program. Rule 59C-1.044(3)(l) refers to “[e]ducation programs for patients, their families and the patient’s primary care physician regarding after-care for transplantation patients.” UM does not challenge Baptist’s ability to satisfy this criterion. Rules 59C-1.044(4)(a) and (b) set forth general requirements for the physician staff and the program director. These topics will be addressed in the discussion pertaining to the specific rule-based requirements for an adult allogeneic BMT program. Rule 59C-1.044(4)(d) sets forth general requirements for nurses and nurse practitioners. This topic will be addressed in the discussion pertaining to the specific rule-based requirements for an adult allogeneic BMT program. Rule 59C-1.044(4)(e) calls for an applicant to have “[c]ontractual agreements with consultants who have expertise in blood banking and are capable of meeting the unique needs of transplant patients on a long term basis.” Baptist’s current application demonstrates that OneBlood, as its provider of “specialty BMT blood/marrow processing and storage services,” meets the criteria established in that rule. Rules 59C-1.044(4)(f), (g), and (h) call for an applicant to have appropriately trained nutritionists, respiratory therapists, social workers, psychologists, and psychiatrists. Baptist has “clinical registered dieticians who are Certified Specialists in Oncology Nutrition, having the expertise of meeting the needs of patients with immunocompromised patients.” As for respiratory therapists, the application states that Baptist’s respiratory therapists “are experienced in providing respiratory support to BMT patients who develop pulmonary complications post-transplant such as pulmonary edema, bronchiolitis obliterans with organizing pneumonia and other complications seen post-transplant.” The application also states that Baptist’s respiratory therapists “will receive structured education about current standards of respiratory and pulmonary care for bone marrow patients by an expert in the field.” As for the requirements pertaining to social workers, psychologists, and psychiatrists, Baptist’s application states that it has a full complement of such professionals and four social workers assigned to the inpatient oncology unit. Baptist plans to have social workers “specifically trained and assigned to support bone marrow transplant patients and families.” Those “BMT social workers will be knowledgeable in the spectrum of community services and assets available to support bone marrow transplant patients and their families throughout the full continuum of bone marrow care, including pre- and post-transplant care.” Moreover, MCI is building a “Cancer Patient Support Center” that will be staffed by multidisciplinary teams of specialists and clinicians who will provide a wide array of support services such as Psycho-Oncology, Psychosocial Services, Integrative Medicine, Exercise Physiology, and Oncology Rehabilitation. Baptist’s application and the evidence of record is sufficient to meet the criteria established in rules 59C- 1.044(4)(f), (g), and (h). Rule 59C-1.044(5) pertains to data reporting requirements for facilities with organ transplant programs and is not at issue in this proceeding. As discussed above and in subsequent findings set forth below, Baptist’s application satisfies the requirements set forth in rules 59C-1.044(3) and (4). Requirements Specific to Bone Marrow Transplant Applicants Rule 59C-1.044 sets forth requirements specific to bone marrow transplant applicants. For instance, subsection (1) states that a bone marrow transplant applicant must be a teaching or research hospital. See Fla. Admin. Code R. 59C-1.044(1) (mandating in pertinent part that “[t]he following organ transplantation programs shall be restricted to teaching or research hospitals: liver, adult allogeneic bone marrow, pediatric allogeneic and autologous bone marrow ”). See also Fla. Admin. Code R. 59C-1.044(9)(b)(mandating that “[a]dult allogeneic bone marrow transplantation programs shall be limited to teaching and research hospitals.”); Fla. Admin. Code R. 59C-1.044(9)(c)(providing that “[a]dult autologous bone marrow transplantation programs can be established at teaching hospitals or research hospitals; or at community hospitals having a research program, or who are affiliated with a research program, as defined in this rule.”). Rule 59C-1.044(9)(b)9. pertains specifically to adult allogeneic BMT programs and requires an applicant to have “[a]n ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital. The program must include monitoring and long-term patient follow-up.” Rule 59C-1.044(9)(b)10. requires “[a]n established research-oriented oncology program.” The Research Criteria Rule 59C-1.044(2)(d) defines a “research hospital” as “[a] hospital which devotes clearly defined space, staff, equipment, and other resources for research purposes, and has documented teaching affiliations with an accredited school of medicine in Florida or another state.” Rule 59C-1.044(2)(d) defines a “research program” as “[a]n organized program that conducts clinical trial research, collects treatment data, assesses outcome data, and publishes statistical reports showing research activity and findings.” The evidence presented at final hearing demonstrated that Baptist Hospital has a robust research program and a good research team. Dr. Miguel Villalona-Calero was recognized as an expert in medical oncology and clinical and translational research. Dr. Villalona-Calero has been involved with cancer research his entire career. Dr. Villalona-Calero has served as principal investigator on numerous clinical trials, including National Cancer Institute ("NCI") clinical trials. In 1999, Dr. Villalona-Calero moved to Ohio State University where he became a full tenured professor and conducted many clinical trials with early therapeutics. By the time Dr. Villalona-Calero left Ohio State, the research he was conducting had become nationally and internationally known. Dr. Villalona-Calero has approximately 111 original publications resulting from his research. Dr. Villalona-Calero has been involved in approximately 21 grants from NCI related to translational research work. Dr. Villalona-Calero left Ohio State to join Baptist in September of 2015. Dr. Villalona-Calero was one of the first physicians Baptist recruited toward the goal of building the research component of Baptist's comprehensive cancer center. Dr. Villalona-Calero leads Baptist's research program with Dr. Jeffrey Boyd, Dr. Minesha Mehta, and Dr. Michael Zinner. Among the other clinical trials personnel on the fourth floor of MCI are coordinators, research nurses, and data managers. Dr. Villalona-Calero has recruited infusion nurses with the experience to respond to any emergencies that may occur during the clinical trials on the fourth floor. In addition to Dr. Villalona-Calero, Dr. Zinner, Dr. Boyd and Dr. Minesh Mehta, there are other investigators at Baptist who conduct research, including a radiation oncologist and a neuro-oncologist. Baptist's application contained the biographies of 13 additional investigators conducting research at Baptist. Dr. Koehne will also conduct research at Baptist, similar to the research he conducted at MSK. Dr. Koehne is well recognized in the bone marrow transplant field, specifically in the area of T-cell immunology and T-cell immunotherapy. The clinical trials office at Baptist is almost fully staffed. The only area for which Dr. Villalona-Calero is still recruiting is in the expanding area of early therapeutics. Staffing is complete for clinical research services, regulatory quality assurance, clinical trials administration, and finance. Dr. Villalona-Calero formed the clinical scientific review committee to review the scientific merit of all the cancer clinical trials to be performed at MCI. The clinical scientific review committee works in conjunction with the Institutional Review Board ("IRB"). The IRB rules on ethical issues such as informed consent. While the clinical scientific review committee is composed of MCI faculty, the IRB is an independent higher authority that must approve clinical trials before they may commence. Since the 2015 CON application, Baptist has constructed MCI, and it includes a research wing. Baptist now has its clinical trials personnel on the fourth floor of the research wing. The new research wing also houses the Center for Genomic Medicine and a Phase One Therapeutics Unit. Dr. Villalona-Calero designed the therapeutics unit that contains advanced cardiology equipment that permits printing of EKGs directly from the equipment. The unit also contains ten infusion areas, a centralized nursing station, and a centralized investigational pharmacy. Adjacent to the unit are the facilities to house the clinical trials personnel. Near the clinical trials personnel are a protocols support lab and a biorepository. The fourth floor of the research wing also contains treatment rooms. These rooms have monitoring capabilities not available in normal hospital rooms. Because a patient's condition can change quickly and unexpectedly during clinical trials, these rooms are also designed so that emergency procedures can be activated more quickly than in a normal hospital room. The fourth floor rooms are similar to ICU rooms. The clinical treatment rooms and their equipment are fully operational and open to patients. Dr. Villalona-Calero and Dr. Boyd also have laboratories at Florida International University (“FIU”). The labs at FIU allow for trials not suitable in a hospital, such as trials involving animals. BHSF funded the labs at FIU. Baptist has outcome monitoring and long-term patient follow-up as part of its research program. Additionally, Baptist's Center for Genomic Medicine is conducting cutting edge research at Baptist. Dr. Boyd was accepted as an expert in translational research and genomic medicine. Dr. Boyd is the Vice-President for Translational Research and Genomic Medicine, as well as the Deputy Director at MCI. Dr. Boyd is also employed by FIU as a tenured professor and chair of the Department of Human and Molecular Genetics, and associate dean for basic research and graduate programs. He has held both positions since July 2015. As founding director of the Center for Genomic Medicine at MCI, Dr. Boyd has created three operation units within MCI. First is the division of clinical genetics, a group of medical professionals whose function is to counsel and advise appropriate genetic testing – and in some cases treatment – for individuals at substantially increased risk for inherited cancer susceptibility. Second is a biobanking operation consisting of two discrete entities: the biospecimen repository facility ("BRF") and the protocol support lab ("PSL"). The BRF is charged with acquiring the consent of MCI patients for permission to bank excess tissue, blood and other fluids, annotate them, store them and ultimately distribute them for generic research purposes, as they may arise in the translational cancer research universe. The PSL obtains these biospecimens, processes them, and distributes them to laboratories that may be conducting a test associated with the clinical trial. Third is the molecular diagnostics laboratory ("MDL"), which is the clinical testing facility. The MDL performs targeted therapy, precision therapy, and precision medicine by obtaining DNA from patient tumors and manipulating that DNA with the goal of finding "druggable targets." The MDL contains a research and development division that carries out translational cancer research, primarily genetic and genomic type research using existing technology, and research to develop new types of testing that may become appropriate as the field evolves. The Center for Genomic Medicine at MCI conducts significant clinical research. This clinical research is specifically focused on cancer research. Baptist and FIU share a very close and expanding relationship related to medical school research and clinical care. FIU's medical school has 480 students (120 students per class). Most of these students' clinical experience during their four-year education period takes place at Baptist. Baptist has funded research laboratories for numerous faculty on the college of medicine staff. Baptist's research program has changed substantially since the 2015 CON application. For example, Baptist has ramped up its clinical trials program through its association with MSK, and the completion of the construction of the physical plant has allowed the opening of the Center for Genomic Medicine, where the above mentioned genomic research takes place. Baptist also conducts investigator-initiated trials that were not yet begun during the last CON application. The Teaching Criteria Rule 59C-1.044(2)(g) provides that a “teaching hospital” means “[a]ny hospital which meets the conditions specified in Section 408.07(45), F.S.” The statute defines teaching hospitals as hospitals that are officially affiliated with an accredited Florida medical school with at least seven accredited, graduate medical educational programs and the presence of at least 100 full time resident physicians. Baptist does not offer seven accredited graduate medical educational programs to at least 100 residents, and therefore does not meet the definition of a teaching hospital as set forth in section 408.07. However, Baptist engages in teaching activities. BHSF coordinates all of the clinical rotations for FIU medical students across the Baptist Health system. There are approximately 500 students participating in rotations at BHSF. Approximately 3,000 physicians are credentialed at BHSF. More than 500 of those physicians have faculty appointments at FIU. They serve as precepting physicians for the medical students who participate in clinical rotations. Baptist offers training to first and second year medical school students, including rotations in emergency medicine. After moving into their third and fourth years, students move into their core elective rotations which occur across the entire BHSF system. There are approximately two dozen elective rotations available to third and fourth year medical school students at Baptist, including general surgery and internal medicine. There are approximately 500 medical students rotating in a typical year at Baptist. Baptist provides accredited graduate medical education programs in family medicine, family sports medicine, and orthopedic sports medicine. Baptist also offers fellowships in radiology and minimally invasive surgery. Baptist offers a robust clinical training program in nursing and allied health. Baptist has between 3,500 and 4,000 nursing allied health students credentialed to rotate through all of BHSF. Despite the fact that Baptist does not meet the technical requirements to be a teaching hospital, it does satisfy the standards associated with a research hospital. Therefore, Baptist satisfies rules 59C-1.044(1) and (9). Volume Requirements When considered together, rules 59C-1.044(9)(b)1. and (c)1. require that an applicant for an adult autologous and allogeneic BMT program be able to project that at least 10 autologous and 10 allogeneic transplants will be performed each year.8/ As found in a previous section, a conservative estimate indicates that the number of BMT procedures should grow by at least five percent a year in TSA 4. Given the forecasted growth in BMT and the fact that Baptist refers approximately 70 patients a year to other facilities for BMT treatment, Baptist should have no difficulty satisfying the volume requirement. It is reasonable to expect that a substantial number of patients who begin their cancer treatment at Baptist will elect to stay with Baptist if their course of treatment leads to BMT. The greater weight of the evidence demonstrates that Baptist satisfies the volume requirements. Program Director Requirements 253. Rules 59C-1.044(9)(b)2. and (c)2. have virtually identical requirements for a program director. Rule 59C-1.044(9)(b)2. requires an applicant to have program director who is a board certified hematologist or oncologist with experience in the treatment and management of adult acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The program director must have formal training in bone marrow transplantation. Baptist has recruited Dr. Koehne to serve as the program director for its BMT program. After obtaining his medical degree and PhD in Germany, Dr. Koehne worked at MSK. MSK is one of the leading institutions for cancer and bone marrow transplant in the world. While at MSK, Dr. Koehne focused his research on post-transplant complications following allogeneic BMTs, including the reactivation of certain viruses. After undergoing clinical trials, a method developed by Dr. Koehne to treat such viral reactivations became the nationally recognized standard for treatment and has been licensed by biopharmaceutical companies. In addition to his appointment as a member at MSK, Dr. Koehne was a professor of medicine at Weill Cornell Medical College. Prior to coming to MCI, Dr. Koehne was the medical director of the BMT laboratory and associate attending physician at MSK. As medical director, Dr. Koehne oversaw the processing of bone marrow and gained familiarity with the equipment and processes for blood processing. Dr. Koehne has done extensive work in the field of BMT research. Before leaving MSK, Dr. Koehne served as principal investigator of three clinical research trials and co-investigator on three or four more trials. Dr. Koehne plans to continue these clinical trials at MCI, the results of some of which have already been published. Dr. Koehne has personally performed many BMTs throughout his career. MSK Cancer Center does 450 transplants a year. Approximately 250 of those cases are autologous and the rest are allogeneic. The greater weight of the evidence demonstrates that Baptist has satisfied the program director requirement. Nursing Requirements Rule 59C-1.044(4)(d) requires all transplant applicants to have a staff of nurses and nurse practitioners “with experience in the care of chronically ill patients and their families.” Rule 59C-1.044(9)(b)3., which specifically pertains to adult allogeneic BMT programs, requires an applicant to have “[c]linical nurses with experience in the care of critically ill immune-suppressed patients. Nursing staff shall be dedicated full time to the program.” UM does not contest the fact that Baptist has a nursing staff experienced in the care of chronically ill patients and their families. As for the requirements of rule 59C-1.044(9)(b)3., Baptist has approximately 130 critical care, clinical nurses experienced in the care of critically ill immunosuppressed patients within the critical care unit. Baptist has a history of effectively staffing specialty areas that require specialty education. Baptist's ICU is also appropriately staffed. This nursing expertise will be available to the BMT program. Baptist has developed a program for the education and training of staff regarding special care of BMT patients. Baptist included the 306-page plan in its CON application. This plan addresses the care requirements for providing bone marrow transplant care. The greater weight of the evidence demonstrates that Baptist satisfies the nursing requirements. Interdisciplinary Transplant Team Rule 59C-1.044(4)(a) pertains to all transplant applicants and requires them to have a “staff of physicians with expertise in caring for patients with end-stage disease requiring transplantation.” Furthermore, that staff “shall have medical specialties or sub-specialties appropriate for the type of transplantation program to be established.” Rule 59C-1.044(9)(b)4. applies specifically to adult allogeneic BMT programs and requires an applicant to have: [a]n interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoetic and lymphopoietic malignancies, and non-neoplastic disorders. The team shall direct permanent follow-up care of the bone marrow transplantation patients, including the maintenance of immunosuppressive therapy and treatment of complications. Baptist has substantially augmented its existing physician staff through the hiring of Dr. Koehne. Baptist will also rely on Dr. Feinstein to provide BMT services. Dr. Feinstein has experience starting a new BMT program and in achieving FACT accreditation. Dr. Feinstein has experience with both autologous and allogeneic transplantations. Dr. Feinstein has a strong background in BMT. MCI was also successful in recruiting Dr. Paba-Prada, who is experienced in autologous transplantation and treating patients with myeloma and lymphoma from Dana-Farber Cancer Center. Baptist’s application states the following regarding its physician staffing: Essential to the success of the proposed BMT program is the experienced team of 27 board certified hematologists and oncologists currently on staff at the Hospital, with three of these physicians currently trained and experienced to care for the adult BMT patients. With this large group of hematologists and oncologists currently on staff, providing patient care in the inpatient and outpatient settings, these physicians create a strong and experienced medical team to support the existing 9 multidisciplinary tumor site teams, including a team for Hematological Malignancies and BMT. To whatever extent that Baptist needs to recruit additional physicians in order to satisfy the rule-based requirements, it is noted that the program will not heavily taxed at the outset. There will probably never be more than two to three patients in the BMT unit at any one time during the first two years of operation. The greater weight of the evidence demonstrates that Baptist satisfies the physician staffing requirements. Laboratory Requirements Rule 59C-1.044(9)(b)7. calls for an applicant to have: [a] laboratory equipped to handle studies including the use of monoclonal antibodies, if this procedure is employed by the hospital, or T-cell depletion, separation of lymphocyte and hematological cell subpopulations and their removal for prevention of graft versus host disease. This requirement may be met through contractual arrangements. Rule 59C-1.044(9)(b)8. calls for an applicant to have “[a]n onsite laboratory equipped for the evaluation and cryopreservation of bone marrow. Baptist proposed to contract with OneBlood for laboratory services required to offer BMT. The application also indicated that Baptist would establish an onsite lab if required by AHCA. When AHCA approved Baptist's application, the approval was conditioned upon the establishment of an onsite laboratory for cryopreservation at Baptist. Since that requirement was announced, Baptist identified space, budgeted, and has now equipped a cryopreservation lab at the hospital. OneBlood offers services used in BMT at hospitals. OneBlood provides processing for allogeneic and autologous transplants. OneBlood provides blood processing services for other BMT programs in Florida. OneBlood provides services for both Miami Children's Hospital's BMT program and Memorial West's BMT program. Neither hospital has its own cryopreservation lab. OneBlood provides all processing required of – and has all the equipment needed for – an autologous BMT procedure including cryopreservation. OneBlood also provides all the processing required for an allogeneic BMT procedure. OneBlood has agreed to provide the processing required for Baptist's BMT program, as it does for Miami Children's Hospital and Memorial West. OneBlood offers cryopreservation and storage, thawing of stem cell collections, and CD 34 cell counts. OneBlood will offer T-Cell subset characterization (also referred to as "T-cell depletion") in 2018. To begin offering T-cell depletion, OneBlood only needs to acquire a cell separator. The cell separator is an automatic machine. OneBlood will have little difficulty gaining the additional accreditation to perform T-cell depletion because performing T-cell depletion only requires the acquisition of the cell separator. The OneBlood contract accommodates requests for services after hours and on weekends because OneBlood is available on call if products arrive during off hours. UM has used OneBlood for stem cell processing in the past. UM has successfully transferred blood product from OneBlood to UM for use in transplantation. UM has also successfully shipped blood products that were harvested at UM from UM to OneBlood. UM has successfully transferred blood product to OneBlood for use in a transplantation in Broward County. The greater weight of the evidence demonstrates that Baptist satisfies the laboratory requirements. Other Criteria Baptist satisfies the requirements in rules 59C- 1.044(9)(b)5. and 6. pertaining to inpatient transplantation units and a radiation therapy division. Rule 59C-1.044(9)(b)11. calls for an applicant to have a “patient convalescent facility to provide a temporary residence setting for transplant patients during the prolonged convalescence.” Baptist’s application notes that it “works cooperatively with a number of local hotels to ensure that patients and their families have accessible housing resources during extended hospital stays or extended recuperative stays." Baptist also has several apartments that can be used by patients, caregivers and/or family members. The application states that Baptist is in the process of constructing a new hotel facility that will be located on the northwest corner of the Baptist Hospital campus. This hotel will have 184 rooms and will house BMT patients and their families during post-transplant monitoring and evaluation. Rule 59C-1.044(9)(b)12. calls for an applicant to have an “outpatient unit for close supervision of discharged patients.” The application states that Baptist anticipated completing an outpatient unit on the third floor of MCI by the Fall of 2017. The greater weight of the evidence demonstrates that Baptist satisfies standards for convalescent housing and outpatient facilities. Not Normal Circumstances A prospective provider of a tertiary health service such as BMT can apply by satisfying all of the statutory and rule requirements or by demonstrating that not-normal circumstances exist. Ms. Fitch, the CON and commercial managed care unit manager for AHCA, explained the not-normal circumstances AHCA relied on to preliminarily approve Baptist’s CON: Q: What abnormal circumstances were presented within this application? A: Well, there were a couple of them. There was the utilization of the existing programs. Essentially the – there are three programs in OTSA 4. The first one, Good Sam, is essentially defunct. We had condition compliance reports; we noted it in the SAAR, that, through condition compliance reports, we found out that what Good Sam had been reporting were biopsies, because they reported zero inpatient or outpatient bone marrow transplants in calendar year 2016. So that program is essentially defunct. We also had Memorial West, which is significantly underutilized and not producing enough bone marrow transplants to be considered much of a viable program in the latter half of 2015 and certainly in 2016. We also have the overutilization of the one program at University of Miami Hospital and Clinics. They applied for a 12-bed unit. They advertised on their website for a 12-bed unit. They’re obviously doing more than what an average daily census of 12 beds would be. So that program seemed to be overutilized. So the utilization patterns that we were seeing [were] one not-normal circumstance for the population. Another not-normal circumstance is the charity care or lack of charity care within this OTSA 4, not seeing that charity care is being provided by the existing program, and so there [are] questions as to financial accessibility to the residents of OTSA 4. In addition to that, looking at the cost- effectiveness criteria under 408.035, looking at the data that is at Florida Health Line for charges amongst the – statewide for the exact same procedure, and then looking at the charges at University of Miami Hospital and Clinics, the charges at University of Miami Hospital and Clinics are significantly higher than the charges for the statewide average. And by “significantly higher,” it’s approximately $200,000 plus, both in the charges low category, which is the 25th quartile; and in the charges high category, which is the 75 quartile. So that cost- effectiveness issue is concerning. In addition to that, on the cost- effectiveness, University of Miami pointed out in their opposition statement that they are a PPS-exempt facility. And kind of exploring what that means, they’re one of only 11 PPS-exempt facilities in the nation, and how they get reimbursed by Medicare – of course Medicare is the bar in which all rates are set – and so how that affects cost-effectiveness within the OTSA 3 – 4, sorry. Q: Were previous programs approved by the agency applying this rule under not normally approved? A: Yes. The last two bone marrow transplant programs in OTSA 4 that were approved, both the University of Miami Hospital and Clinics and Memorial West, were approved under not-normal circumstances, because they did not meet all the rule criteria; specifically, both of those facilities were not statutory teaching hospitals. The fact that Good Samaritan does not have a BMT program, despite the previous reports to AHCA that it performed 42 BMTs in 2016, by itself, is significant enough to justify Baptist not strictly complying with the requirements of rules 59C-1.044(9)(b) and (c). The greater weight of the evidence demonstrates that not-normal circumstances are present in TSA 4. Adverse Impact If the CON at issue is granted, there is no persuasive evidence demonstrating that UM’s ability to conduct research or to maintain the proficiency of its physicians will be adversely impacted. However, it is very likely that patients who would have received their BMT treatment at UM will instead receive that treatment at Baptist. While the greater weight of the evidence demonstrates that UM should not experience any meaningful decline in volume, UM is very likely to be adversely impacted by the fact that its patient volumes (and the resulting increase in revenues) will not be growing as quickly if the CON at issue were not granted. As Baptist moves to recruit additional staff with experience with BMT and/or allogeneic procedures, it is possible that Baptist may hire UM employees. In sum, the greater weight of the evidence demonstrates that UM will be adversely impacted to a minor degree if the CON at issue is granted. Changed Circumstances To the extent the outcome of DOAH Case No. 16-1698CON is determined to have any relevance in this de novo proceeding, the evidence establishes that conditions have sufficiently changed such that conclusions regarding issuance of a CON to Baptist for an adult autologous and allogeneic BMT program in TSA 4 in DOAH Case No. 16-1698CON have no applicability to the new application at issue herein. Such changed circumstances include, but are not limited to, the following. Ms. Fitch testified that it was unknown during the prior proceeding that Good Samaritan was a defunct program. Multiple findings in ALJ Peterson’s Recommended Order corroborate Ms. Fitch’s testimony. The alliance between Baptist and MSK is another changed circumstance. Mr. Richardson described the significance of that alliance as follows: The Memorial Sloan Kettering alliance linkage is just not marketing and branding and saying you are a part of us. It actually appears to be a much stronger integrated linkage between Memorial Sloan Kettering and the Baptist Hospital Miami Cancer Institute operation. Basically the last go around, Baptist was in a six- to nine-month evaluation process, where they were providing policies, procedures, outcomes, just a huge amount of information to Sloan Kettering to basically see whether they would be accepted as part of the alliance. That all went through, and now as described here, it’s a real linkage; they basically, in terms of the – you have linkage between the clinical side and you have linkage between the research sides. So you have the ability for Baptist to tap into the expertise that is available at Sloan Kettering. So it’s not just a marketing name, Baptist Hospital linked with somebody else. It’s a true integrated operational linkage. Another changed circumstance is that MCI is now operational, and Baptist is performing outpatient autologous procedures. At the time of the 2015 CON application, MCI was aspirational and was being constructed. The current Baptist application is substantially better than the prior one. Baptist has gone to great lengths to improve its research capacity, and all of the available evidence indicates that Dr. Koehne is exceptionally well-qualified to be Baptist’s program director.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order approving the Certificate of Need Application No. 10490 submitted by Baptist Hospital of Miami, Inc. to establish a new adult autologous and allogeneic bone marrow transplant program in Florida’s Organ Transplant Service Area 4. DONE AND ENTERED this 15th day of August, 2018, in Tallahassee, Leon County, Florida. S G. W. CHISENHALL 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 15th day of August, 2018.
The Issue The issue is whether Respondent is guilty of departing from the applicable standard of care, failing to keep adequate medical records, or making deceptive, untrue, or fraudulent representations in the practice of medicine and, if so, what penalty should be imposed.
Findings Of Fact Respondent has been a licensed physician in Florida continuously since August 30, 1983. His license number is ME 0042770. Respondent has never been disciplined and has, since the events described below, attended a course on the preparation of medical records. Respondent has been Board Certified in Family Practice since 1995. He specializes in the area of family practice and maintains his office in the Naples Medical Center in Naples. T. M., who was born on June 13, 1951, presented to Respondent for the first time on April 3, 1991. She had seen other physicians at the Naples Medical Center, but not Respondent. She had last visited the Naples Medical Center on February 25, 1988. T. M. had several purposes in her first visit with Respondent. First, she wanted to establish herself as a patient of Respondent following the retirement of her previous physician. Second, she wanted a prescription for Premarin following an earlier hysterectomy. Third, she wanted to determine if she had any need for a PAP smear. T. M. completed a patient questionnaire during the April 3 office visit. In her answers, T. M. affirmed that she had had "hemorrhoids or rectal bleeding," but she underlined only "hemorrhoids." She denied any colitis or other bowel disease, constipation or diarrhea, or recent change in bowel action or stools. T. M.'s testimony that she was experiencing a feeling of pressure in her bowels and felt the need to have a bowel movement when she did not need to have one is not credited. It is inconsistent with the history, as discussed below, that T. M. related to Respondent's office on her second office visit and later to Dr. Cooper. In the medical records for the April 3 office visit, Respondent noted that he reviewed T. M.'s chart and discussed her physical, "etc." The notes state that Respondent found no need for a PAP smear due to prior hysterectomy and bilateral salpingo- oophorectomy. The notes add that T. M. daily uses Premarin, which replaces estrogen, that she is not cycling, and that she will return to the office as needed. The notes report that T. M. will return to the office as needed. The notes record that T. M. will need a mammogram this year and that Respondent is refilling her Premarin prescription. These are Respondent's original medical records for T. M. As noted below, following Respondent's discovery that another physician had detected colo-rectal cancer in T. M. in January 1992, Respondent made additions to his notes. He did not date the additions to show that they were added months after the original notes. At the top of the notes, Respondent added: "Needs prescription--refill Premarin." After "etc.," Respondent added: "Family history of cancer + preventative care." Immediately preceding "RTO PRN" (which means return to office as needed), Respondent added: "Wants to." Immediately after this shorthand notation, Respondent added: "+ will call to reschedule." Adding the number 1 to the mammogram note and the number 3 to the refill Premarin note, Respondent also inserted a number 2, which states: "labs + physical this year." Within a few weeks of this initial office visit, T. M. began to experience problems with her bowels in the form of rectal bleeding and the feeling of pressure, as though she had to have a bowel movement or urinate when she did not. In June 1991, T. M. set up an appointment for June 28. By this time, T. M. was finding red blood in her stool and when she wiped her rectum with toilet paper. She told the nurse that she had been experiencing this problem for two months. The nurse recorded T. M.'s report of blood in her stool and the feeling of needing to move her bowels when she did not really need to do so. Respondent noted in the medical records: "Tenesmus." "Tenesmus" is the sensation of an urge to have a bowel movement. Under "tenesmus," Respondent wrote: "Bleeding + urgency urination." At this point, Respondent correctly commenced the process of diagnosis, rather than screening which is the performance of a test on an asymptomatic population. T. M. presented with specific complaints and symptoms that required diagnosis; by the second visit, she had self-screened. T. M.'s relevant history was that family members had had cancer, but not colon cancer. She had had hemorrhoids, but only during her two pregnancies. Respondent performed a focused examination to determine the source of T. M.'s complaints. Respondent conducted a urinalysis to rule out a urinary tract infection. The urinalysis was negative. Respondent next performed an anoscopy. An anoscope is a funnel-like instrument 4-6 inches long that is inserted into the anus. A separate light source allows the physician to observe the anus and rectum, just past the anal verge, for a total distance of about 6 centimeters. Respondent placed his finger into T. M.'s anus, but not for the purpose of conducting a digital rectal examination. A physician conducting an anoscopic examination first inserts a finger into the anus in order to relax the sphincter and confirm the absence of any blockages that would prevent the insertion of the anoscope. Consistent even with Respondent's augmented records, Respondent performed no separate digital examination of T. M.'s rectum. The purpose of the digital rectal examination is to feel the contour of the rectal wall for bumps, irregularities, or areas of unusual consistency. Although the location of T. M.'s cancerous lesion would have been within reach of a digital examination, the record does not establish that that anything would have been discoverable at the time of the June 28 office visit. Testimony to this effect from Petitioner's expert witness, Dr. Thomas Hicks, did not establish clear and convincing proof because, despite Dr. Hicks' evident competence, of his expertise in family medicine, rather than oncology, and the difficulty of determining, in hindsight, the likely size of cancerous lesions based on their condition months later after surgical intervention. The parties discuss in their proposed recommended orders Respondent's failure to document a digital rectal examination, but their shared assumption--that one took place--is unwarranted. The failure to perform a digital rectal examination raises a question as to Respondent's conformance with the applicable standard of care, but the real standard-of-care issue is Respondent's handling of the preparation of a treatment plan. As Dr. Hicks' testified, the timely preparation of a treatment plan would have satisfied all standard-of-care issues, despite the failure to perform a digital rectal examination. The situation is similar as to the performance of a hemocult blood test. Respondent's testimony that he performed one is rejected as a fabrication. The records reflect no such test. The failure of the medical records to document the hemocult blood test is thus explained by the failure of Respondent to conduct this test. The anoscopy was negative. Respondent recorded in his medical records: "Anoscope + Hemorrhoids. No clots." Following the anoscopy, Respondent tentatively diagnosed T. M. as suffering from hemorrhoids. However, Respondent set up an appointment for T. M. to return to the office for a sigmoidoscopy, which would allow examination of the lower intestine above the area examined by the anoscope. Respondent made undated additions to the medical records for the June 28 office visit. Below the recorded findings from the anoscopy, Respondent later added: "Wall color looks OK." In the original record, Respondent concluded the entries with documentation that he prescribed Anusol and stool softener and would perform a "Sigmoid to [check mark] higher up." The relevant changes were to write "Plan" beside these notes, number the three steps, and add "for malignancy" after "higher up." On July 2, 1991, T. M. visited Respondent's office so that he could conduct a sigmoidoscopy. This examination involves the insertion of a flexible tube, with its own light source, through the anus and rectum and into the sigmoid colon up to 60 centimeters for observation of the rectum and sigmoid colon. Respondent was able to insert the sigmoidscope 45 centimeters, which was adequate. He detected a spastic colon, hemorrhoids, and diverticuli, but no lesions or strictures. The absence of lesions or strictures is an indicator of the absence of precancerous or cancerous conditions. The findings of the sigmoidoscopy were thus consistent with Respondent's working diagnosis of hemorrhoids. Respondent again made undated additions to T. M.'s medical records, but the additions are unremarkable augmentations to the original notes, which adequately described the findings of the sigmoidoscopy. Following the June and July office visits, T. M.'s symptoms worsened. She began bleeding between bowel movements and was losing more blood. She felt tired all the time. She continued to feel pressure in the area of her rectum. Respondent discussed with T. M. her symptoms. He learned that she experienced some constipation, but no spasms, no feeling of a foreign body in her anus, and no abdominal or urinary tract pain. Respondent noted these findings in T. M.'s medical records. For the September 24 office visit, the medical records reflect the above-described discussion together with Respondent's recommendation that T. M. take a stool softener. Respondent later added notes showing that he reviewed the findings of the sigmoidoscopy. In the space between two lines in the original records, Respondent added: "She may need colonoscopy + referred to GI." Other additions immaterially expanded on the original notes. At the bottom of the note for this office visit, Respondent added: "To GI soon if not resolved. She will call." Respondent produced a "super bill" for the September 24 office visit. The bottom of the bill contains a block for the next appointment. The lower left-hand corner of the block states "wait." The remainder of the block states: "Appt. Dr. K. Hussey. Reason: rectal bleeding. Needs colonoscopy." Beneath this block at the very bottom of the page is the following statement: "(She will call us)." T. M. did not have her copy of this super bill. Nothing in the record suggests that, when requested to provide T. M.'s medical records to the New York physician, Respondent's office sent a copy of the super bill, which Respondent unsuccessfully contends is part of T. M.'s medical records. While notations on super bills that do not functionally assist in the process of ensuring continuity of care do not qualify as medical records, the other question concerning the super bill is whether it serves as contemporaneous documentation of Respondent's recommendation that T. M. consult a gastroenterologist. Respondent's readiness to add undated entries to T. M.'s medical records inspires no confidence in the self- serving note contained at the bottom of the super bill. To the contrary, given the succinctness of Respondent's unaltered medical records, it is unlikely that Respondent would take the time, on a bill, to write in the reason for the appointment with Dr. Hussey and the need for a colonoscopy. The parenthetical comment that T. M. will call Respondent's office renders these entries even more suspicious. A preponderance of the evidence, but not clear and convincing evidence, suggests that these entries on the super bill are also undated additions following Respondent's discovery that T. M. had rectal cancer. T. M. did not return to Respondent. Instead, while visiting her brother-in-law, who is a physician, in New York over Christmas, she scheduled an appointment on December 27, 1991, with a gastroenterologist who practiced with the brother-in-law. The physician performed a digital rectal examination and found a firm irregular area on the anterior wall of the rectum. A sigmoidoscopy revealed a large ulcerated lesion approximately 2 to 3 centimeters above the anal verge. After additional diagnostic work, a surgeon removed the lesion and performed a permanent colostomy in early January 1992. Petitioner contends in its Proposed Recommended Order that Respondent deviated from the applicable standard of care when he did not order a complete blood count during the September 24 office visit. However, Dr. Hicks accurately defined the issue when he testified that the complete blood count, as was the case with the omission of a digital rectal examination on the June 28 office visit, would not have represented a departure from the applicable standard of care if Respondent had timely prepared a treatment plan. The issue of the timeliness of the preparation of a treatment plan arises as of the September 24 office visit. Dr. Hicks' testimony precludes a finding that the failure to develop a treatment plan to pursue an alternative to the working diagnosis of hemorrhoids was a departure from the applicable standard of care any earlier than the September 24 office visit. As of the September 24 office visit, though, Respondent had three alternatives. He could either perform sufficient diagnostic tests to explore T. M.'s ongoing symptoms, he could refer her to a gastroenterologist, or he could briefly continue treatment of hemorrhoids. There is no dispute that Respondent attempted further diagnostic tests after the September 24 office visit; he did not do so. Respondent contends that he continued treatment of the hemorrhoids. There is a brief note on December 2, 1991, that T. M. received a prescription to control bowel spasms. However, Respondent's nurse evidently prescribed this medication on her own, and the spasms were not shown to be linked to hemorrhoids. To the contrary, Respondent testified that he felt that her problem at the September 24 office visit was likely constipation, which could aggravate the hemorrhoids. There is no evidence that Respondent elected, at the end of the September 24 office visit, to briefly continue treating hemorrhoids; if nothing else, Respondent's contentions about a gastroenterological referral tend to undermine further treatment by him of hemorrhoids. There is no dispute that Respondent could have met the applicable standard of care by referring T. M. to a gastroenterologist at the end of the September 24 office visit. However, the evidence is clear and convincing, despite Respondent's testimony and other evidence to the contrary, that he did not do so. This finding is based partly on the testimony of T. M., whose recall of her visits with Respondent and her visit with Dr. Cooper is obviously imprecise and sometimes inaccurate. This finding is also based on a close assessment of the evidence offered by Respondent to support his contention that he made a referral. Assessment of Respondent's contention of a referral begins with close examination of the already-noted entry, "She may need colonoscopy + referral to GI." This entry does not evidence a recommendation of a consultation, but rather mentions the possibility that a consultation might take place in the future. On January 10, 1992, T. M.'s mother called Respondent and informed him of T. M.'s rectal cancer surgery. At this time, Respondent, who was unaware that his office had already supplied a copy of T. M.'s original medical records to her New York physician, made all of the above-described changes in the medical records, plus another, properly dated entry, which states: "I recommended GI at last visit for a check-up or a colonoscopy but she did not schedule." However, despite the fact that Respondent made these two notes on the same date, they reveal a significant discrepancy. Unlike the added note for September 24, which refers to a future referral, the note for January 10 refers to an actual referral. In a deposition taken four years after the surgery, Respondent gave a more elaborate version of whether he made a referral during the September 24 office visit and reveals the same variation between an actual referral and a possible referral in the future. Taken for a pending medical malpractice action that T. M. had brought against Respondent, the deposition testimony states: Q. You would agree with me, sir, if you failed to get her to see a doctor other than yourself to get this problem checked out that that would have been a breach in the standard of care? A. If I failed to what? Q. If you failed to send her to a doctor--if you said, T[.], you need to get somebody to check this out, I want you to go get this checked out, then you would have breached the standard of care, wouldn't you, sir? A. If I told her to go somewhere? Q. If you failed to tell her. A. I would agree. * * * Q. All right. Did you suspect in your differential diagnosis on 9-24-91 when she came in that could be rectal cancer? Was that in your differential diagnosis? A. Yes, it could have been. Q. Okay. When you told her that you--I assume that you told her then--it's your contention you told her at that time you could have rectal cancer; correct? A. No. Q. You didn't tell her that? A. No. Q. Why not? A. Because--I mean, I told her that she needed to have this evaluated. That doesn't mean she has rectal cancer, to get it evaluated. Q. Well, what did you tell her if you suspected that she could have that and that was properly in your differential diagnosis to impress upon her the need to follow through, if anything? A. You mean to scare her into getting--into making an appointment? Q. Well, not to scare her. You didn't need to scare her to do it, did you? A. No. Q. Well, what did you say to her to get her to make the appointment? A. That she should--if this doesn't resolve, she should get an opinion from a gastroenterologist. Q. If this doesn't resolve; is that right? A. If this continues. Q. Okay. So if I understand what you're saying now, you didn't tell her you definitely need today to go get this. You told her, well, if it doesn't resolve, then you should see somebody--see a gastroenterologist? A. That why the-- Q. Am I correct? A. Well, I sort of let it--well, I didn't leave it at that, but it was--it was problem enough to get some other opinion. Q. Why was it problem enough to get some other opinion? A. Because it's been so persistent. * * * Q. What do you mean, because it's been so persistent? A. Well, the complaint has been going on for months. Q. Okay. And what about that persistency that this complaint's been going on for months made it difficult to have her go see somebody else? A. Well, it wasn't that. It was--I think it was her hesitance to make an appointment, whether to have something done or not or to have an operation or to have, you know, the hemorrhoids looked at. It wasn't that type of thing that she was looking forward to, so we sort of put a wait on it. We didn't go through with making the appointment. Q. Okay. When you say we put a wait on it, then this was something you discussed? A. Right. Q. And she—what did she say that gave you the impression that she wanted to wait? A. Well, she was--you know, she was upset about the whole thing. Q. Okay, because it had been going on so long? A. Right. Q. And you said-- A. Then--then about the other--then going to another physician, of having a specialist-- specialist look at her to do a procedure, you know, the same type of procedure except it would be more thorough, more--you know, a colonoscopy and possibly some procedure like a surgical procedure. Q. Well, was it your belief on 9-24-91 that it could, in fact, be just simply hemorrhoids? A. It was possible, but that--that wasn't--I mean, there was hemorrhoids, but that might not have been the reason for all her problems. Q. Did you ever say to her, T[.], the persistence of this problem leads me to believe that it might be something other than hemorrhoids? Did you ever say anything like that to her? A. Yes. But I did not mention malignancy or anything like that. Q. Were you trying to convince her to go get another opinion or another examination? A. No. I mean, I didn't. Q. Why not? A. Right now I don't recall why not, but-- Q. Okay. (Petitioner Exhibit 5, pages 117-22.) Each of Respondent's recountings of his discussion with T. M. on September 24 varies with regard to whether he recommended a referral or merely discussed the possibility of a referral in the future. The thrust of the deposition testimony is essentially is that Respondent was concerned about the possibility of rectal cancer and wanted T. M. to see a gastroenterologist, that T. M. resisted this recommendation, and that, in the face of this resistance, Respondent did not voice his concern about the need to rule out rectal cancer. This testimony is simply not credible. If he were making a firm recommendation of a referral, he would have voiced his explicit concerns, even if only as to the necessity at this time to rule out these more serious possibilities. If Respondent discussed a referral with T. M. at all, he mentioned nothing more than the possibility of a referral at some point in the future; interestingly, this is consistent with the additions to the September 24 medical records. Thus, the evidence is clear and convincing that Respondent did not refer T. M. to a gastroenterologist at the end of the September 24 office visit. The evidence is clear and convincing that Respondent did not prepare any other form of treatment plan, besides a referral, that would meet the applicable standard of care. As for the fraudulent alteration of medical records, the first question is whether Respondent discussed even a future referral with T. M. during her September 24 office visit. It is a close question, but the evidence is less than clear and convincing that Respondent did not discuss even the possibility of a future referral, just as the evidence is less than clear and convincing that Respondent fabricated the note on the super bill. However, the evidence is clear and convincing that the January 10 note fraudulently claims that Respondent recommended a gastroenterological consultation for a check-up and colonoscopy, but T. M. did not schedule an appointment. As for whether the medical records justify the scope and course of treatment, this issue is subsumed in the standard- of-care and fraudulent-records issues. To the extent that the records (i.e., September 24 entry) fail to reflect a clear referral to a gastroenterologist or alternative treatment plan, they do not justify the scope and course of treatment, but this issue is covered by the standard-of-care issue. To the extent that the records (i.e., January 10 entry) are fraudulent, this issue is covered by the fraudulent-record issue.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of one violation of Section 458.331(1)(t) and 458.331(1)(k), but not Section 458.331(1)(m), and imposing the following penalties for these two violations: 30 days' suspension followed by two years' probation, ten hours of continuing medical education in ethics, and a $10,000 fine. DONE AND ENTERED this 2nd day of April, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE 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 2nd day of April, 1999. COPIES FURNISHED: Kristina L. Sutter John Terrel Senior Attorneys Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Grover C. Freeman Jon M. Pellett Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
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 Based upon the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made: At all time pertinent to this proceeding, Respondent, Jules G. Minkes, was licensed as an osteopathic physician in the State of Florida having been issued license No. OS 001516. There is no evidence that Respondent has ever been the subject of prior disciplinary action by the Petitioner, Department of Professional Regulation, and/or the Board of Osteopathic Medical Examiners. Respondent is certified by the American College of Osteopathic Internists, the American College of Osteopathic Board of Cardiology, the American Osteopathic Board of Nuclear Medicine and the American Board of Nuclear Medicine. Respondent has no advanced or specialized training in dermatology, however, he did complete courses in dermatology as a student and, as part of his primary care practice, he does provide some minor dermatological treatments. At all pertinent times, Respondent was the medical director of South Dade Osteopathic Medical Center d/b/a Suburban Medical Center ("Suburban"). Suburban was a primary care provider facility with International Medical Center ("IMC"), a health maintenance organization ("HMO"). Suburban contracted to become part of the IMC HMO system beginning in June of 1981. Under the IMC system, a patient's primary care physician was the "gatekeeper" four medical services. In the absence of an emergency, a patient was required to first see his primary care physician in order to be referred to other specialized medical care. Conflicting evidence was presented regarding the operation of the IMC program and the procedures for referring patients to specialized medical care and/or physicians who were not part of the HMO network. The IMC referral procedures and the manner of allocating the costs of specialized treatment were not the same at all IMC facilities and were changed several times during the early and mid 1980's. (Certain pertinent aspects of the referral process are explored in more detail in Findings of Fact 37 below.) IMC developed a network of physicians to whom primary care physicians could refer patients for specialized medical treatment. In accordance with its IMC contract, Suburban was expected to provide all primary medical care for all IMC patients assigned to the center. Respondent and Suburban agreed to refer IMC patients to specialists, hospitals, etc. within the IMC network "unless approval for a nonparticipating facility or a professional is specifically approved by the medical director or executive director of IMC." At all times pertinent to this proceeding, Respondent referred his HMO patients to the IMC specialist network with the expectation that those specialists would either treat the patient or further refer them as necessary. Some IMC affiliated providers entered into "risk" contracts with IMC and were responsible for paying specialists and/or directly negotiating arrangements for those specialists to be compensated. The evidence established that, during the time that the Patient was treated at Suburban, Suburban did not have a "risk" contract with IMC. As set forth on page 4 paragraph 23 of the contract between Suburban and IMC (Respondent's Exhibit 3) IMC paid the specialists attending to Suburban's HMO Medicare patients. In accordance with Suburban's contract, IMC allocated a specific amount per member per month to be deposited into an account and applied towards payments of the specialists. At the end of each quarter of the calendar year, IMC was supposed to distribute any sums remaining in the specialists' account to Respondent. However, during the time the contract was in effect, there were never any funds remaining in the specialists' account at the end of any calendar quarter. Therefore, no funds from this account were ever distributed to Respondent. IMC developed a plan for treating Medicare eligible patients. This program was known as the Gold Plus Plan and required the patient to essentially assign their Medicare benefits to the HMO. All patients who enrolled in the Gold Plus Plan executed an agreement acknowledging that all non-emergency medical treatment had to be provided or arranged for by IMC and that they would be limited to seeing doctors within the IMC network. All patients were advised that they could see a specialist at their own expense or could disenroll from the HMO at any time and return to their prior Medicare status. The Patient, T.G., enrolled in the IMC Gold Plus Plan in July of 1982 and executed the standard agreement. At the time she was first seen at Suburban, T.G. was approximately 68 years old. She was a somewhat difficult patient who frequently complained of numerous minor ailments. In approximately 1978, while she was living in New York, T.G. had a basal cell carcinoma removed from her forehead by a dermatologist. T.G. and her husband, C.G., moved to Florida in approximately 1978. Shortly thereafter, additional lesions appeared on her forehead. The Patient's family physician at the time, Dr. Kenneth Hertz, referred T.G. to a dermatologist, Dr. Darrell Blinski, who biopsied the lesions in August of 1981. The pathology report from the biopsy contained a diagnosis of "basal cell carcinoma; both side margins are involved. The deep margin is clear." Involvement of the surgical margins of a biopsy indicates the basal cell carcinoma has spread to the limits of the biopsy and perhaps beyond. On August 22, 1981, T.G. was admitted to coral Reef General Hospital where Dr. Blinski attempted to excise the basal cell carcinoma and performed a Limberg flap procedure to cover the skin defect on her forehead. As a result of the procedure, the Patient had a noticeable scar in the middle of her forehead. Dr. Blinski's admission notes in connection with this August 22, 1981 procedure indicate T.G. had: ... a history of multiple recurrences of basal cell carcinoma of the forehead under treatment in New Jersey and down here... incisional biopsy of a central forehead lesion was done and returned as a basal cell carcinoma, margins involved. The area in question wad in the central forehead. The physical examination revealed an ulcerated lesion measuring 2 mm x 5 mm in the central forehead with a scarred area to the left of that measuring 4 mm in diameter. Involved skin is within 1 cm. Examination of the rest of the facial skin was negative for lesions. A pathology report dated August 27, 1981 on tissue removed during the procedure performed by Dr. Blinski revealed basal cell carcinoma with the "left lateral margin free of tumor, all others surgical margins involved with tumor." In other words, not all of the tumor was removed during the surgery by Dr. Blinski. Dr. Blinski referred the Patient to Dr. Henry Menn for consultation. Dr. Menn was a professor of dermatology and head of the Mohs chemosurgery unit at the University of Miami. In a letter dated September 21, 1981, Dr. Menn advised Dr. Blinski that he thought: It would be best to initiate Mohs Chemosurgery excision of the residual basal cell carcinoma discovered by you in the surgical margins of your excised specimen performed on 27th of August, 1981, from tissue removed from the forehead. In approximately four weeks inflammation and irritation normally present after a surgical flap procedure will be reduced and the chemosurgical excision will be more easily accomplished. Dr. Menn apparently changed his treatment plan for the Patient because, instead of undertaking chemosurgery, he simply followed the patient clinically until the summer of 1982. During that time period, there were no clinical signs of regrowth of the basal cell carcinoma. While primary basal cell carcinoma typically grows in little mounds of cells, recurrent basal cell carcinoma can grow in a different, infiltrative fashion. This type of growth tends to be more subtle and the skin can appear normal for extensive periods of time. T.G. returned to Dr. Menn on December 17, 1981 and, in a letter dated December 21, 1981, Dr. Menn advised Dr. Blinski that: ... about four months have now passed since you excised the large basal cell carcinoma on her forehead. There is no clinical evidence of regrowth of tumor even though the surgical excision margins were involved by tumor after your treatment. Close clinical inspection and palpation do not reveal the evidence of basal cell carcinoma at this time... I will continue to follow the patient at periodic intervals. If there is any evidence of malignancy, I will do an excisional biopsy and initiate chemosurgical treatment as indicated. On March 15, 1982, Dr. Blinski examined the patient and advised Dr. Menn by letter that "there is no recurrence as of this time. She will be followed in four months." By letter dated May 19, 1982, Dr. Menn advised Dr. Blinski "I re- examined our patient [T.G.] on the 18th of May, 1982. I am pleased to report that there is no evidence of regrowth of the skin cancer were [sic] you performed plastic surgery on her forehead... I will continue to follow the patient." On July 22, 1982, T.G. and her husband joined the IMC Gold Plus Plan. Because the Gold Plus Plan required the enrollees to assign their Medicare benefits, T.G. stopped seeing Dr. Menn at this time. T.G. had an appointment with Dr. Menn on October 7, 1982. Dr. Menn's notes indicate that the patient did not appear for her appointment and there is a notation that the "patient wishes to continue care in her HMO." Suburban was the HMO affiliate center to which T.G. was assigned. T.G.'s first visit to Suburban took place on September 3, 1982. During that visit, T.G. advised the Respondent that she had a history of skin cancer. During the physical examination of the Patient, the Respondent noted the scar on her mid-forehead. At the time of the Patient's initial visit to Suburban, the medical records of her prior treatment by Dr. Blinski and Dr. Menn were not available. At some point, those records were obtained by the Respondent. However, it is not clear when the records were received. T.G.'s second visit to Suburban was on September 17, 1982. There is no indication in the medical records of that visit that her forehead was examined. On October 4, 1982, T.G. returned to Suburban and complained to Respondent that her "forehead always feels hot." The Respondent noted a "small left papular swelling 4mm at lower portion of scar-subcut." Under the "assessment" portion of his medical form, Respondent wrote "(1) follow possible recurrence basal cell carcinoma-left lower forehead (2) 1-2mm lesion on right forehead (3) keratotic lesion-right arm." During the October 4, 1982 visit, Respondent hyfercated the lesions on the Patient's right forehead and right arm. Hyfercation is an electrocauterization that burns or desiccates skin lesions by removing the water content of skin cells. Hyfercation destroys tissues and, as a result, the tissue cannot be pathologically diagnosed unless a biopsy is first taken. No biopsy was taken prior to the hyfercation of either of the lesions. Although Respondent has no specialized training in dermatology, he regularly hyfercates skin lesions as part of his office practice. Respondent believes that he has the ability to differentiate between minor, obviously benign skin lesions and those that are more questionable and should be referred to a dermatologist. Respondent noted on the medical records from this visit to "follow for excisional biopsy." That comment was made with respect to the lesion on the Patient's lower left forehead. That lesion was not hyfercated. Instead, the Respondent decided to refer the Patient to a dermatologist in the IMC system for the treatment of that lesion. On October 14, 1982, the Respondent signed the referral form for T.G. to go to the IMC Dermatology Center at a facility known as the Westchester Clinic. An appointment with the IMC dermatologist was scheduled for October 21, 1982. On that day, the Patient was seen by Dr. Seymour Munzer, a dermatologist affiliated with IMC. The exact nature of Dr. Munzer's business relationship with IMC was not established, but he apparently traveled to various IMC Centers to treat patients. During the October 21, 1982 visit, Dr. Munzer noted the Patient's history of surgery for basal cell carcinoma with Dr. Blinski. He noted some nodular firmness above the left brow. His diagnostic impression was "(1) prob. [sic] scar tissue (2) r/o [rule out] recurrent basal cell carcinoma." Patient stated on several occasions that she did not like Dr. Munzer and wanted to see Dr. Menn, her options under the Gold Plus Plan were fully explained to her and she was advised that, under that plan, her treatment would have to be coordinated through the IMC dermatologist. She was also advised that she could see Dr. Menn at her own expense or disenroll from the program and continue her care under traditional Medicare procedures. The Respondent never completed any additional dermatological referral forms for the Patient. While Dr. Munzer claims that a written referral from the primary care physician was necessary every time a patient returned to see him, this testimony is rejected. The more creditable evidence established that Respondent was not required under the IMC system to issue a referral for each visit by a Patient to an IMC specialist. Dr. Munzer biopsied the lesion over the Patient's left brow and submitted it for pathological diagnosis. The pathology report was returned on October 26, 1982 and indicated "basal cell carcinoma, infiltrating. Surgical margins involved by the lesions." T.G. returned to Suburban on November 3, 1982. The records of that visit indicate that the Respondent was waiting for the pathology report. For his assessment, Respondent noted "r/o [rule out] basal cell carcinoma forehead." Respondent's plan was to "follow path report Westchester Center." During the November 3 visit, Respondent removed a 1mm keratotic lesion from the Patient's lower right chin. The Patient returned to Suburban on November 23, 1982. By that time, Respondent had received a copy of Dr. Munzer's report and the pathology report on the biopsy performed by Dr. Munzer. The Respondent discussed the results of the biopsy with the Patient and her husband and explained that she needed to follow up with the dermatologist. While the Patient and her husband have testified that the Respondent advised them that he could treat her basal cell carcinoma, this testimony is rejected. The more creditable evidence established that the Respondent advised the Patient of her need for follow-up by a dermatologist. The Respondent discussed the results of the biopsy with Dr. Munzer by phone and it was his understanding that Dr. Munzer would continue to follow the Patient and provide whatever additional treatment was necessary. The Respondent never received any additional reports or correspondence from Dr. Munzer regarding the Patient. Because the IMC specialists rotated between several hospitals, there was often alot of confusion regarding the paperwork for those patients referred to specialists. It was not unusual for there to be significant delays between the time an IMC specialist saw a patient and the time the specialist's report was sent to the primary care physician. In fact, in many instances such reports were never received. Thus, while Respondent did not receive any further reports from Dr. Munzer, Respondent thought Dr. Munzer and/or IMC was providing treatment for the Patient's basal cell carcinoma as diagnosed in the October 26, 1982 pathology report. No records of the treatment rendered by Dr. Munzer could be obtained from either Dr. Munzer or the Westchester Clinic where Dr. Munzer treated the Patient. It is not clear whether the Patient ever returned to Dr. Munzer for further evaluation or treatment. 1/ However, it is clear that Respondent and his office staff advised the Patient on several occasions that she needed to follow-up with the dermatologist. While the There is no evidence that Dr. Munzer ever developed a plan for treating T.G. Dr. Munzer could not specifically recall his treatment of this Patient except to review his report and the pathology report in Respondent's records. Dr. Munzer testified that he would not have attempted to treat a patient with recurrent basal cell carcinoma on the face, particularly in the area of scar tissue. Instead, he states that he would have recommended either Mohs chemosurgery, referral to a plastic surgeon or possibly radiation therapy. However, it does not appear that Dr. Munzer ever communicated his reluctance to treat such a condition to the Respondent. As far as the Respondent knew, Dr. Munzer and/or the IMC Dermatology Center were capable of treating this Patient. While Dr. Munzer claimed that he did not have authority to refer a patient from an affiliate center for further follow-up, at the very least his input and recommendation would have been essential to determine how to treat a patient with unique dermatological problems. In this case, it does not appear that he ever provided such a recommendation or opinion. Moreover, while Dr. Munzer contends that the Medical Director of an affiliate center was the only person who could make referrals outside the IMC network, Suburban's contract with IMC required such determinations to be made by the Medical Director of IMC. The evidence established that, under Suburban's contract, once a patient was referred to an IMC specialist for treatment, that specialist and IMC were responsible for determining whether to send the patient for additional consultation to a physician outside the IMC network. At no point during the treatment of this Patient did the Respondent attempt to treat the Patient's known basal cell carcinoma. The Patient was next seen by the Respondent on December 7, 1982. The Respondent noted "basal cell carcinoma left-forehead." There is no indication that the Respondent was attempting any treatment for this problem. The Patient was instructed to return in three months. The Patient was treated by the Respondent on February 1, 16, and March 7, 1983 for various ailments and complaints. There is no mention of the Patient's basal cell carcinoma in the medical records of these visits. On April 1, 1983, the Respondent excised a skin lesion on T.G.'s left shoulder. The Respondent submitted the excised lesion for biopsy and the pathology report stated that there was no evidence of malignancy. There is no evidence in the medical records of the April 1, 1983 report that Respondent treated or discussed the basal cell carcinoma on the Patient's forehead. The Patient returned to Suburban on April 4, 6, and May 2, 1983. She was seen by the Respondent during the April 4 and May 2, 1983 visits. The records of those three visits do not reflect any treatment or discussion of the Patient's forehead. The Patient's next visit to Suburban was on May 24, 1983. During that visit, Respondent noted a "2mm keratotic skin lesion, mid forehead." That lesion was high on the forehead near the hairline. It was not in the scar area or adjacent to the previously diagnosed basal cell carcinoma. The Patient wanted the lesion removed for cosmetic reasons and it was the Respondent's opinion that the lesion was not clinically related to the Patient's previous problems. The Respondent felt that the appropriate treatment was to obliterate the lesion and watch for any recurrence rather than to biopsy such a small lesion which appeared benign. His assessment was "keratosis, possible basal cell carcinoma." He hyfercated the lesion and noted to follow it for healing. Because no biopsy was done on this lesion, there is no pathology report available to establish whether or not this lesion was a basal cell carcinoma. Some of the expert witnesses in this proceeding have testified that the Respondent's failure to biopsy this lesion falls below the standard of care expected of a reasonably prudent physician under similar circumstances. However, that testimony presupposes that the lesions was contiguous or adjacent to the prior problem areas. Moreover, even Petitioner's experts admit that a primary care physician such as Respondent should be able to recognize and distinguish cosmetic skin problems from more questionable problems that need closer scrutiny. There is insufficient evidence to disregard Respondent's clinical diagnosis. Even though the Patient had a history of basal cell carcinoma, it was possible, indeed it is likely, that a patient with her history would develop unrelated cosmetic lesions. At the time that the lesion was hyfercated, the Respondent once again advised the Patient that she needed to continue seeing the dermatologist regarding the previously diagnosed basal cell carcinoma. Sometime during the Patient's visits in April or May of 1983, Respondent became aware that the Patient had not been returning to Dr. Munzer for follow-up care of the basal cell carcinoma of her forehead. Until this time, the Respondent had assumed that the Patient was being treated by Dr. Munzer. The Patient reiterated her dislike for Dr. Munzer and also indicated that she did not like the Westchester facility. The Respondent once again explained her options under the HMO plan and advised her of the need to seek specialized care for her basal cell carcinoma. The Patient did not exercise any of the options explained to her and continued to be treated at Suburban through at least March of 1984. During that time, she was treated for various ailments, but no attempt was made to treat the basal cell carcinoma. The Patient's next visit to Suburban took place on June 1, 1983. In addition to treating other unrelated complaints, the Respondent noted that the wound from the hyfercated forehead lesion was healing. The Patient was also treated at Suburban on June 16 and 21, July 7 and 25, August 1 and 9 and October 17, 1983. The Respondent saw the Patient on all of those visits except for the June 16, July 25, and October 17 visits when she was treated by other Suburban employees. There is no indication in the medical records of these visits that the Patient's forehead and/or basal cell carcinoma were treated. The Patient did not appear for scheduled appointments on June 6, July 18, and August 12, 1983. During a visit on November 1, 1983, the Respondent noted a lesion on the Patient's right forehead. This lesion was not contiguous to the Patient's scar nor was it adjacent to the area biopsied by Dr. Munzer. The Respondent hyfercated this lesion. As with the other lesions that Respondent hyfercated, the hyfercation was performed for cosmetic reasons and not because of any medical necessity. Each of the lesions that were hyfercated healed quickly and completely without any sign of regrowth. Because the lesions were hyfercated, biopsies were not possible. The absence of a pathology report precludes a conclusion that none of the hyfercated lesions were malignant. However, the Respondent's testimony that he only hyfercated lesions in areas where no previous problems had occurred and that appeared clinically benign is accepted. Therefore, there was no deviation from the standard of care expected of a reasonably prudent physician. The Patient returned to Suburban on November 8, and 28, and December 14, 1983 and January 13 and 30, 1984. There is no indication that the Respondent saw the Patient on those visits. The Patient was seen by other physicians employed by Suburban. None of those physicians attempted to treat any skin problems and/or the forehead area of this Patient. There is no indication that any of these physicians noted any abnormality on the Patient's forehead. During those visits when the Respondent saw the Patient, the Respondent would typically check her forehead to determine if there were any changes in the scar or the area that Dr. Munzer had biopsied. No changes were evident until the Patient's visit on February 6, 1984. During the February 6, 1984 visit, the Respondent noticed a slight nodularity on the Patient's forehead. Respondent did not attempt to treat that bump. He again recommended to the Patient that she see the dermatologist. The only notation in the medical records was "follow slight nodularity-forehead-hx [history] basal cell CA." The Patient was instructed to return in two weeks. The Patient returned to Suburban on February 7, 13, 27, and March 14, 1984. The Respondent only saw the patient on the February 13 visit. During these visits, she was treated for various unrelated matters and there is no notation regarding her basal cell carcinoma or the nodularity noted on February 6. On March 7, 1984, T.G. transferred to Dr. C.N. House's IMC affiliated provider center. On her first visit to Dr. House on April 6, 1984, T.G. was referred to a dermatologist, Dr. Kenneth Rosen, for a biopsy of her forehead. At the time of this visit, Dr. House did not have any of the Patient's prior records. Dr. Rosen took biopsies from three areas of the Patient's forehead: one from the "right forehead", one from the "mid-forehead", and one from the "mid-forehead above left side." The pathology reports on all three sections indicated basal cell carcinoma that had been incompletely excised. The multiple sites of carcinoma indicate that the tumor was infiltrating. Dr. Rosen advised Dr. House that he was not qualified to treat the Patient. He advised Dr. House that the Patient needed to be referred for Mohs chemosurgery. At the time, the only physician in Miami that Dr. House knew could perform that surgery was Dr. Menn. Mohs chemosurgery, now known as Mohs micrographic surgery, is the treatment of choice for recurrent basal cell carcinomas because of its high cure rate and conservation of healthy skin. Dr. House's contract with IMC was a "risk" contract. Under that contract, the fees for treatment by specialists were directly deducted from his payment from IMC. Dr. House arranged his own network of specialists to whom he would refer patients. As indicated above, the Respondent's contractual arrangement with IMC was different and, at least during the time this Patient was being treated, Respondent only referred patients to the network developed by IMC. Dr. House arranged for the Patient to be seen by Dr. Menn on May 15, 1984. In making this arrangement, Dr. House agreed to personally assume responsibility for Dr. Menn's fees. T.G. was treated by Dr. Menn at the University of Miami with the Mohs Chemotherapy technique in four stages over a period of three days, May 29, 30, and June 1, 1984. The Mohs Surgery revealed an extensive basal cell carcinoma that covered most of the Patient's forehead area. Extensive skin was removed during the surgery and, in some areas, the surgery penetrated to the underlying bone. The surgery reports indicate that all of the area was one continuous basal cell carcinoma of the forehead, the eyelids and the nasal dorsum. Dr. Garland believes that the basal cell carcinoma treated by Mohs Chemosurgery in May of 1984 was the same tumor present and growing at the time that Dr. Menn was seeing this Patient in 1981 and 1982. After the Mohs Surgery, the Patient was referred by Dr. House to Dr. Gary Zahler, an IMC Plastic Surgeon, for repair by skin grafting of the extensive wound to her forehead. After the surgery, the Patient was followed by Dr. Menn until his death in 1985. Dr. Larry Garland, a colleague of Dr. Menn at the University of Miami and a dermatologist specializing in Mohs Chemosurgery and cutaneous oncology, continued following the Patient after Dr. Menn's death. T.G. died from other causes in 1989. She had no recurrence of basal cell carcinoma following the Mohs surgery. The evidence established that the Respondent is a capable and dedicated physician. There is no evidence that the Respondent manipulated the Patient for his own financial gain. It is clear that at the time this case was initiated, there were some erroneous factual assumptions made by at least one expert retained by the Petitioner. Petitioner sent the Patient's medical records for review by Dr. Joseph Rosen. His opinion served as one of the grounds for the initial finding of probable cause in this case and the subsequent issuance of the Administrative Complaint. That opinion was premised on the erroneous assumption that the Respondent never referred the Patient to a dermatologist for treatment. At the hearing in this cause, Dr. Rosen amended his opinion and acknowledged that a referral did take place. However, he felt that the Respondent had still failed to meet the applicable standard of care because he failed to take adequate steps to ensure that the Patient's basal cell carcinoma was treated. This issue is addressed in the conclusions of law below.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Medical Examiners enter a Final Order finding the Respondent, Jules G. Minkes not guilty of the allegations contained in Count I of the Administrative Complaint and dismissing that Count, but finding Respondent guilty of Count II and III, issuing a letter of concern and imposing a fine of $500.00. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 13th day of December, 1990. J. STEPHEN MENTON 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 13th day of December, 1990.
