Findings Of Fact In early August of 1992, petitioner Howard D. Kline began work as a waiter for respondent, making at least $189 per week. Fearing he might be infected, he gave blood samples on September 21, 1993, at the Bay County Public Health Unit and asked that they be tested for human immunodeficiency virus (HIV). The samples were sent to Jacksonville, and one was forwarded to the Center for Disease Control in Atlanta, Georgia. On September 28, 1992, a report of diagnostic testing done on petitioner's blood in Jacksonville, Petitioner's Exhibit No. 1, was mailed to the health department in Panama City. It reached Nancy S. Nichols, who worked at the Bay County Public Health Unit, on or before October 6, 1992. She had seen the results by the time she talked to Mr. Kline on October 6, 1992, and advised him that he had tested positive. The following day Mr. Kline stopped by the Four Winds restaurant to speak to Barbara Zaleski; wife of (one of) respondent's owners (and possibly herself a co-owner.) Although the restaurant had both a manager and an assistant manager, Ms. Zaleski had authority to hire and fire staff. When Mr. Kline told her of his affliction, she wept sympathetically, then told him he could no longer work at the restaurant because it was bad for business. On October 8, 1993, word reached Mrs. Nichols that the diagnostic testing of petitioner's blood done in Atlanta confirmed the earlier, positive diagnosis. Approximately a week later petitioner stopped by the restaurant to pick up his final paycheck. Two weeks elapsed after his discharge before he found another job. During the two-week hiatus, he lost wages totalling $378. The restaurant hired a waitress to take petitioner's place. The evidence did not reveal her status as regards human immunodeficiency virus. Respondent employed (a) cook(s) and (a) bookkeeper(s) as well as serving staff, an assistant manager and a manager, until it closed, more than three months after petitioner's discharge. The total number of respondent's employees was not proven, nor the total number of people respondent employed at any one time. Services of an attorney worth $4,700 have reasonably been required in the presentation of this claim, but these services would, except for $125 have also been necessary for the presentation of the same claim in court.
Recommendation It is, accordingly, RECOMMENDED: That the FCHR dismiss the petition, without prejudice to petitioner's proceeding in circuit court on any claim not predicated on the Florida Civil Rights Act of 1992, Sections 760.01-760.11 and 509.092, Florida Statutes (1993). DONE AND ENTERED this 14th day of December, 1993, in Tallahassee, Florida. ROBERT T. BENTON, II 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 14th day of December, 1993. COPIES FURNISHED: David L. Jernigan 3020 Kingswood Drive Panama City, Florida 32405 Nancy L. Jones Post Office Box 2062 Panama City, Florida 32401 Sharon Moultry, Clerk Commission on Human Relations 325 John Knox Road Building F, Suite 240 Tallahassee, Florida 32303-4149 Dana Baird, General Counsel Commission on Human Relations 325 John Knox Road Building F, Suite 240 Tallahassee, Florida 32303-4149
Findings Of Fact Respondent is a physician licensed to practice medicine in Florida. His office is located on Sanibel Island in Lee County. A Sanibel Island tourist, Mrs. Marion Wallace, presented herself as a patient at Respondent's office on the morning of March 2, 1981. She complained of abdominal pain and swelling. Mrs. Wallace was seen by Mr. Kern Barrow, a physician's assistant employed by Respondent. Barrow conducted a physical examination of Mrs. Wallace's abdominal region and took her medical history, noting abdominal distension, abdominal pain, anorexia, nausea, vomiting and dysuria. She had not been feeling well for several days and had experienced some nausea and vomiting in the early morning hours of March 2, 1981. Barrow conducted a routine physical examination that included examination of the abdominal region, neck, mouth and throat. No medical tests were ordered or conducted by Barrow other than a urinalysis. Barrow's preliminary diagnosis was viral gastroenteritis or urinary tract infection. He administered ampicillan and prescribed donnagel for her cramping and gaviscon for the abdominal distension or gas. He administered an injection of compazine to prevent further nausea and vomiting. Barrow could not remember consulting with Respondent concerning Mrs. Wallace on March 2, but told her to come back if her condition did not improve. He described Mrs. Wallace as looking ill, but not mortally ill. Respondent did not see Mrs. Wallace on March 2, but reviewed and initialed the chart prepared by Barrow. Respondent prescribed the medication "Tagamet," but did so only because the patient requested it, claiming to have received relief for gastritus from this medication. Mrs. Wallace returned to Respondent's office on the morning of March 3, continuing to complain of abdominal pain and swelling. Respondent examined the patient at that time, but did not perform a rectal examination. He did not order a blood test, barium enema or x-ray. He noted "observe" on her chart, but did not schedule a return visit. He tentatively diagnosed her condition as diverticulitis. Mrs. Wallace, who did not testify in this proceeding, claimed that her condition had worsened between her visits to Respondent's office on March 2 and March 3. This fact was not established by direct evidence. However, on March 4 she presented herself to another Fort Myers area physician who sent her to the hospital emergency room where her condition was diagnosed as "acute abdomen" necessitating immediate surgery. During the surgery performed on March 4, it was discovered that Mrs. Wallace had a perforated gangrenous appendicitis with abscess formation, peritonitis, and a small bowel obstruction. These are serious and dangerous medical conditions. The testimony of Respondent and the other physicians who testified in this proceeding established that his tentative diagnosis was not inappropriate given the patient's symptoms. However, his failure to perform tests (such as a blood test for white blood cell count, x-ray, rectal examination or barium enema) was a serious lapse in view of her condition and his tentative diagnosis. His prescribing of Tagamet was not shown to have been improper. Respondent's use of a physician's assistant for the initial examination was likewise not shown to have been improper. However, Respondent's inability to note any progression of her symptoms between March 2 and 3 resulted from his overreliance on the physician's assistant and failure to conduct even a minimal examination of her on March 2.
Recommendation From the foregoing, it is RECOMMENDED: That petitioner enter a Final Order (1) finding Respondent guilty of failure to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances; and (2) reprimanding and fining Respondent $1,000. DONE and ENTERED this 21st day of January, 1983, in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of January, 1983. COPIES FURNISHED: J. Riley Davis, Esquire Post Office Box 1796 Tallahassee, Florida 32302 Leonard A. Carson, Esquire Post Office Box 1528 Tallahassee, Florida 32302 Dorothy Faircloth, Executive Director Board of Medical Examiners Dept. of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Samuel R. Shorstein, Secretary Dept. of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, BOARD OF MEDICAL EXAMINERS, Petitioner, vs. CASE NO. 82-815 STANLEY P. WEGRYN, M.D., License Number: 23028, Respondent. /
The Issue Whether Petitioner’s request for coverage of proton beam radiation therapy (“proton beam therapy” or “PBRT”) is a covered benefit pursuant to the State Employees’ Health Maintenance Organization (“HMO”) Plan (“Plan”), administered by AvMed.
Findings Of Fact Respondent is the state agency charged with administering the state employee health insurance program pursuant to section 110.123. At all times material hereto, Petitioner was a member of the Plan. AvMed is the third-party administrator for the Plan at issue in this cause. As the third-party administrator, AvMed provides claims processing, utilization, and benefit management services. The applicable benefit document is the State Employees’ HMO Plan, Group Health Insurance Plan Booklet and Benefits Document (“Plan Document”), effective January 1, 2019. Petitioner is a 66-year-old male who was diagnosed with prostate cancer in November 2017 and underwent a prostatectomy to remove his prostate on April 12, 2018. Subsequent to his initial surgery and treatment, Petitioner experienced increasing prostate specific antigen (“PSA”) in three follow-up tests. His prostate cancer had returned. Petitioner’s physician sought to treat his condition with PBRT, a form of external beam radiation utilizing protons, rather than traditional intensity modulated radiation therapy (“IMRT”), which is, without question, covered under the Plan. Medicare, a federal healthcare insurance program, agreed to pay 80 percent of Intervenor’s charges for PBRT, leaving Petitioner responsible for the remaining 20 percent being sought to be paid by Petitioner’s Plan. On July 3, 2019, Petitioner, through his healthcare provider, Maria-Amelia Rodrigues, M.D., and Intervenor, Miami Cancer Institute, submitted a request for coverage of PBRT to AvMed. On July 10, 2019, AvMed denied the preservice request for coverage on the basis that the therapy was experimental/investigational and, therefore, not medically necessary treatment for the member’s condition. The request was reviewed by Sri Gorty, M.D., a consultant radiation oncologist at Magellan Healthcare, which is under contract with AvMed. On July 23, 2019, Petitioner submitted a request for a Level I appeal to AvMed. The appeal was reviewed by Dr. Gregg Goldin, M.D., a consultant radiology oncologist at Dane Street, which is under contract with AvMed. He filed a report dated August 19, 2019. On August 20, 2019, AvMed denied the request for Level I appeal on the basis that the therapy was experimental/investigational and, therefore, not a medically necessary treatment. On November 19, 2019, Petitioner submitted a request for an “Expedited” Level II appeal to Respondent. The Level II appeal was reviewed by Dearline Thomas-Brown, a registered nurse and Level II appeal coordinator for Respondent. On November 21, 2019, Respondent denied Petitioner’s Level II appeal on the basis that the therapy is experimental/investigational and, therefore, not medically necessary for treatment of the member’s condition. Pursuant to the Plan Document, the Plan pays its share of the cost of covered services, if the services are: Ordered by a Network Provider (a provider who is in AvMed’s network); Considered Medically Necessary for the covered person’s treatment because of accident, illness, condition or mental health or nervous disorder; Not specifically limited or excluded under this Plan; and Rendered while this Plan is in effect. Pursuant to the Plan Document, Section I. Introduction: The Plan is not intended to and does not cover or provide any Medical Services or benefits that are not Medically Necessary for the diagnosis and treatment of the Health Plan Member. AvMed determines whether the services are Medically Necessary on the basis of terms, conditions, and criteria established by the Plan as interpreted by the state, and as set forth in medical guidelines. This chart provides a description of services and supplies covered under the Plan. Coverage Access Rules are specified under the Plan as follows: Cancer Services Diagnosis and Treatment Includes both inpatient and outpatient diagnostic tests and treatment (including anti-cancer medications administered by Network providers), including cancer clinical trials as set forth in the Florida Clinical Trial Compact. Does not include Experimental or Investigational Treatment. In order to be a covered benefit, the treatment must be “medically necessary,” not “experimental or investigational,” and it must not be specifically excluded by the Plan. “Medically Necessary” is defined as follows: The use of any appropriate medical treatment, service, equipment and/or supply as provided by a Hospital, skilled nursing facility, physician or other provider which is necessary for the diagnosis, care and/or treatment of a Health Plan Member’s Illness or injury, and which is: Consistent with the symptom, diagnosis and treatment of the Health Plan Member’s condition; The most appropriate level of supply and/or service for the diagnosis and treatment of the Health Plan Member’s condition; In accordance with standards of acceptable medical practice; Not primarily intended for the personal comfort or convenience of the Health Plan Member, the Health Plan Member’s family, the physician or other health care providers; Approved by the appropriate medical body or health care specialty involved as effective, appropriate and essential for the care and treatment of the Health Plan Member’s condition; and Not experimental or investigational. The service must meet all of the above-referenced criteria in order to be medically necessary. Given the above definition, if a service is experimental or investigational, then it cannot be medically necessary. Section VI. Limitations and Exclusions in the Plan Document specifically exclude services that are “experimental/investigational or not medically necessary treatment with the exception of routine care in connection with a clinical trial in cancer, pursuant to the Florida Clinical Trial Compact and the Patient Protection and Affordable Care Act.” “Experimental and/or Investigational” is defined as follows: For the purposes of this Plan a medication, treatment, device, surgery or procedure may initially be determined by AvMed to be experimental and/or investigational if any of the following applies: The FDA has not granted the approval for general use; or There are insufficient outcomes data available from controlled clinical trials published in peer- reviewed literature to substantiate its effectiveness for the disease or injury involved; or There is no consensus among practicing physicians that the medication, treatment, therapy, procedure or device is safe or effective for the treatment in question or such medication, treatment, therapy, procedure or device is not the standard treatment, therapy procedure or device utilized by practicing physicians in treating other patients with the same or similar condition; or Such medication, treatment procedure, or device is the subject of an ongoing Phase I or Phase II clinical investigation, or Experimental or research arm of a Phase III clinical investigation, or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as comparted with the standard for treatment or diagnosis of the condition in question. If any one or more of the above-cited criteria are met, then the treatment is experimental and/or investigational and is not a covered service. In making an adverse determination as to coverage in both the Level I and Level II appeals, Edwin Rodriguez, M.D. (note the slightly different spelling of Petitioner’s expert Dr. Maria-Amelia Rodrigues versus Dr. Edwin Rodriguez), and Nurse Thomas-Brown utilized AvMed’s Medical Coverage Guideline on PBRT. This coverage guideline regarding PBRT provides AvMed’s “Exclusion Criteria” explaining “PBRT is not covered, and is considered investigational, as to all other tumors not listed” in the guideline. PBRT is not an approved treatment option for localized prostate cancer under the NIA Magellan criteria. The Medical Technology Assessment Committee at AvMed drafts clinical policy guidelines and is responsible for maintaining or changing them as technology advances. AvMed’s policy on use of PBRT for the treatment of prostate cancer states that it is not medically necessary because studies have not shown clinical outcomes to be superior to conventional radiation therapy (i.e., IMRT). This policy was developed following extensive review of studies in peer-reviewed medical literature, available guidelines, technology assessments, and opinions from experts. The policy is updated on a yearly basis in order to take into consideration any new evidence. A recent review of the policy on PBRT resulted in no change in AvMed’s position on coverage for treatment of prostate cancer. The medical coverage guidelines are meant to be used in conjunction with the Plan Document to determine whether services are medically necessary and a covered benefit. Dr. Gorty, AvMed’s external reviewer from Magellan Healthcare, who was accepted as an expert in the field of radiation oncology, testified that his recommended denial of coverage of PBRT was informed by Petitioner’s medical records, Intervenor’s Letter of Medical Necessity, clinical trials, the model policy from the American Society of Therapeutic Radiation and Oncology (“ASTRO”), and the National Comprehensive Cancer Network (“NCCN”) guidelines. PBRT PBRT is a procedure that uses protons to deliver a curative radiation dose to a tumor, while reducing radiation doses to healthy tissues and organs, which results in fewer complications and side effects than IMRT. As stated earlier, Petitioner’s prostate was removed in April 2018. Thereafter, rising PSA levels indicated that he needed further treatment, and Dr. Rodrigues, a board-certified radiation oncologist at Miami Cancer Institute, became his treating physician. Dr. Rodrigues has been treating patients for 23 years, including prostate cancer patients. She was accepted as an expert in her field for these proceedings. Dr. Rodrigues determined PBRT to be the appropriate radiation treatment for Mr. Zolfaghari given his type of prostate cancer—recurrent prostate cancer. Dr. Rodrigues testified that recurrent prostate cancer occurs when a cancer has been treated and then reoccurs. In addition to PBRT, Dr. Rodrigues recommended, and Petitioner received, androgen deprivation therapy, generally referred to as hormone therapy, to be used in conjunction with PBRT. Dr. Rodrigues testified that the androgen deprivation therapy blocks the production of testosterone. She testified that patients with recurrent prostate cancer or certain high-risk patients have better overall survival when the two treatments are used in conjunction. As an additional aggravating factor to Petitioner’s cancer treatment, Petitioner was diagnosed with colon cancer leading to surgery in January 2020. Dr. Rodrigues testified that Petitioner’s colon cancer made his need for PBRT even more necessary, because now Petitioner is at a higher risk for adverse effects from the unwanted spread of toxicity common with IMRT. Dr. Rodrigues, as a Miami Cancer Institute physician, wrote letters requesting treatment and appealing denials of treatment as set forth above, and testified at the March 9, 2020, administrative hearing in support of Petitioner’s efforts to obtain coverage through AvMed for PBRT, which she considers to be a medically necessary treatment modality. Dr. Rodrigues was asked why she had not gone forward and provided Petitioner IMRT in order to prevent any further delay due to the passage of time from unsuccessful appeals of the denial by AvMed for the PBRT treatment of his recurring prostate cancer. She replied that she was attempting to secure a less toxic treatment modality, PBRT, for her patient who was already approved by Medicare for coverage of 80 percent of the cost of the treatment. MEDICAL NECESSITY OF PBRT VERSUS IMRT There is no dispute that IMRT is an accepted treatment modality for Petitioner’s recurrent prostate cancer, even bearing in mind his complicating factor of colon cancer surgery and treatment endured following his 2018 prostatectomy. The remaining dispute here is whether PBRT is both medically necessary and not an experimental and/or investigative form of radiation treatment. IMRT is a recognized form of treatment for Petitioner’s recurrent prostate cancer. Dr. Rodrigues testified that Miami Cancer Institute considered only candidates for PBRT as those who would qualify for IMRT, such as Petitioner. Given the availability of another treatment option, IMRT, which is the most widely recognized standard of care within the medical establishment for the treatment of Petitioner’s condition, Respondent’s experts conclude that PBRT is not medically necessary because it is not the most appropriate level of service in this case. While PBRT has been accepted by AvMed, according to its Plan, for certain types of cancer, the insurer has not yet authorized it for the treatment of prostate cancer. This is where the semantics of the contract come into play. Petitioner and Intervenor argued that Respondent mistakenly based its denial upon a diagnosis of “localized prostate cancer” (Dr. Rodrigues’ reading of the proscription of the use of PBRT for Petitioner) rather than “recurrent prostate cancer” (not specifically proscribed by the Plan according to her reading), combined with the fact that Petitioner’s unique medical condition requires lower toxicity in the specific type of radiation used. PBRT, she testified, offers lower radiation toxicity, which will have less of a harmful effect on Petitioner’s colon and rectum as a survivor of colon cancer surgery. Dr. Rodriguez, the AvMed senior medical director, testified that studies comparing PBRT to 3-D confirming radiation or IMRT are limited. Overall studies have not shown clinical outcomes to be superior to conventional radiation therapy. In addition to the preservice and Level I appeal reviews by AvMed, and Respondent’s Level II appeal review, an Independent Organization Review (“IRO”) was conducted by a licensed radiation oncologist employed by Independent Medical Expert Consulting Services. As a result of this independent review, the Plan’s denial was upheld. Dr. Rodrigues presented studies in her testimony and a letter of medical necessity which cited the potential for favorable outcomes with PBRT. Dr. Gorty, Respondent’s expert in radiation oncology, contradicted her testimony in that many of the studies she cited noted a need for further study regarding the safety and efficacy of PBRT for treatment, and all of these studies were based upon “localized prostate cancer,” rather than “recurrent prostate cancer.” Dr. Gorty also testified that Petitioner's records indicated that his cancer was localized, although it could also be "recurrent." Dr. Gorty testified that clinical studies show no significant difference in the toxicity between IMRT and PBRT. Further, Dr. Rodriguez explained that localized cancer can be recurrent. “Localized” refers to where the cancer may be found, while “recurrent” refers to a repeat or re-occurrence of a cancer, which might return to the same location or reappear in a different location. Paragraph 15 lists the criteria to determine whether a treatment or procedure is “medically necessary” under the AvMed policy. PBRT does not meet the third criterion of the definition of “medically necessary,” as PBRT treatment of prostate cancer is not in accordance with standards of acceptable community practice. Dr. Gorty testified that AvMed medical guidelines utilize IMRT as the “next generation” treatment, rather than PBRT. Further, Dr. Gorty testified that he was aware of several recent clinical trials concerning PBRT and IMRT, and these studies do not reach a conclusion that PBRT is preferable to IMRT. PBRT does not meet the fifth criterion of the definition of “medically necessary,” as PBRT has not been approved by the appropriate medical body or healthcare specialty involved as effective, appropriate, and essential for the care and treatment of prostate cancer. PBRT is not essential for the treatment of prostate cancer. There are several treatment modalities that are generally available for the treatment of prostate cancer and, as discussed above, several of those treatment options were reasonable treatment options for Petitioner. While Dr. Rodrigues believes PBRT to be preferable for Petitioner in this case due to, in her opinion, fewer adverse side effects of the treatment, she admitted that Petitioner is a suitable candidate for IMRT. Therefore, PBRT does not meet the sixth criterion of the definition of “medically necessary,” as it meets the definition of “experimental and/or investigational.” Specifically, criteria 2, 3, and 4 of the definition of “experimental and/or investigational” are met, which lead to the ultimate conclusion that PBRT is not medically necessary in this case. EXPERIMENTAL AND/OR INVESTIGATIONAL TREATMENT Paragraph 18 sets forth the criteria for determining whether a treatment or procedure is “experimental and/or investigational.” The second criterion from the definition of experimental and/or investigational treatment is met in this case. Insufficient outcomes data are not available from controlled clinical trials published in peer-reviewed literature to substantiate PBRT’s safety and effectiveness for treatment of prostate cancer. Dr. Rodriguez testified that there is a lack of peer-reviewed, published, randomized studies regarding proton beam therapy. Further, PBRT treatment is not the generally accepted standard of care. Dr. Rodrigues testified that only a handful of medical centers in the United States are using PBRT to treat cancer malignancies. Only two such programs are located in Florida—the University of Florida and Intervenor. Outside of Florida, only Massachusetts General and Loma Linda offer the treatment. Prior to Intervenor offering the treatment, Dr. Rodrigues referred her patients to one of these other facilities for PBRT when she deemed it appropriate to do so. Current randomized trials are on-going and being published in peer- reviewed medical literature. PBRT treatment for prostate cancer is considered investigational and not a standard of care option and, therefore, not medically necessary. Nurse Thomas-Brown testified that a treatment considered experimental or investigational is, automatically, not medically necessary. NIA Magellan Clinical Guideline Number NIA_CG_124, which was developed in July 2018 for implementation in January 2019 to assist physicians in the application of treatment, states that both surgery and radiation therapy should be used to treat organ confined prostate cancer, as well as prostate cancers extended into adjacent tissues. This guideline finds that PBRT is not an approved treatment option for localized prostate cancer as studies comparing it to 3-D conformal radiation or IMRT are limited. Leading organizations, such as NCCN and ASTRO, have noted insufficient data outcomes and a need for more study of proton beam therapy, which these organizations have not yet accepted as the standard of care. PBRT also meets the third criterion of the definition of “experimental and/or investigational.” There is no consensus among practicing physicians that PBRT is safe or effective for the treatment of prostate cancer or that PBRT is the standard treatment utilized by practicing physicians in treating other patients with the same or similar conditions. Both Dr. Gorty and Dr. Rodriguez testified that proton beam therapy is experimental and investigational and, therefore, not medically necessary for all forms of prostate cancer; two additional radiation oncologists reviewed the appeal and reached the conclusion that PBRT is not medically necessary. Additionally, there was uncontroverted evidence that IMRT, not PBRT, is the standard form of treatment utilized by practicing physicians for treatment of prostate cancer. Dr. Gorty testified that AvMed approved the NIA Magellan clinical guidelines for prostate cancer, which are based on the peer-reviewed studies; and he explained three such studies. His testimony noted that the second study from the University of Pennsylvania at Baltimore, Maryland, specifically matched Petitioner’s medical condition. This study compared 307 men and their comparative toxicity outcomes of PBRT verses IMRT for post-operative sites. It concluded that future prospective investigation and ongoing follow-up will determine whether dosimetric differences between treatment with IMRT and proton beam therapy convert to meaningful differences in long-term outcomes. As part of the appeal process on behalf of Petitioner, Intervenor also requested a review by an IRO. The review was completed by a board-certified radiation oncologist, and a report was generated on January 9, 2020. The “List of Materials Reviewed” is extensive and includes Petitioner’s medical records and Intervenor’s supporting documentation. The independent reviewer upheld the denial and noted that medical necessity has not been established. The IRO states that “until the current randomized trials ongoing are published in peer reviewed medical literature, proton beam treatment for prostate cancer is considered investigational and not a standard of care treatment option.”
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Management Services, Division of State Group Insurance, enter a final order denying Petitioner's request for coverage for proton beam therapy. DONE AND ENTERED this 4th day of May, 2020, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 2020. COPIES FURNISHED: Erica D. Moore, Esquire Thomas E. Wright, Esquire Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399 (eServed) Abolghasem Zolfaghari 10910 Southwest 140th Avenue Miami, Florida 33186 Frank A. Florio, Esquire Maria D. Garcia, Esquire Latasha Gethers Hines, Esquire Kozyak, Tropin & Throckmorton, LLP 2525 Ponce de Leon Boulevard, Ninth Floor Coral Gables, Florida 33134 (eServed) William Chorba, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed)
Findings Of Fact Upon consideration of the oral and documentary evidence presented at the hearing, the following relevant facts are found: At all times pertinent to the matters considered here, the Respondent was a medical doctor licensed by the State of Florida under license number ME1472. He has been engaged in the practice of medicine for 50 years. While in practice in Orlando, Florida, during the period March 14, 1980, through August 8, 1980, Respondent had as a patient, and acted as treating physician for, Mary Walsh, who was at the time suffering from cancer of the lung. Respondent's treatment of Mary Walsh during the entire period she was his patient included the administering to her of laetrile, dimethylsulfoxide (DMSO) intravenously, enzymes, and megavitamins. Dr. James M. Johnstone (D.O.) had been a physician to Mrs. Walsh over a period of several years for a variety of complaints. (Her lung cancer was detected in December, 1979, however, when she went into his office on a routine visit.) Over the period of time he had treated her, she had suffered from such things as seizures, thyroid problems, and the like, but on this particular December 1979 visit, she complained of a sore throat. Dr. Johnstone referred her for consultation with a Dr. Porth, who ultimately opined she might have cancer of the epiglottis. As a result, in January, 1980, she was admitted to the hospital, where she was diagnosed as having cancer of the left lung. Exploratory surgery conducted during a second period of hospitalization in February, 1980, revealed that the cancer was inoperable and terminal, and the procedure was terminated without any surgical excision. Dr. Johnstone and several other physicians advised Mrs. Walsh and her daughter, Vicki L. Chapman, that conventional-treatments such as radiation therapy were available for, if not a cure, at least palliative treatment to reduce pain and perhaps extend life somewhat, but Mrs. Walsh was afraid of radiation therapy and refused it repeatedly. During this period of diagnoses and tests, Mrs. Walsh and her daughter, Vicki, were told by an acquaintance named Elmer Boener, of the Fairfield Medical Center in Jamaica, which offered the organic approach to cancer control, including the use of diet and vitamins. While Mrs. Walsh and her daughter were deciding whether to go to Jamaica, Mr. Boener informed them that a Dr. Wedel would be working at Respondent's clinic offering the same treatment as available in Jamaica, and they would not have to have the stress of going out of the country. They decided to go to Jamaica, however, because of the stress in this course of treatment on diet and, in March, 1980, went to the Fairfield Clinic for ten days, returning during the first week in April, 1980, at which time Mrs. Walsh took up treatment of her condition with Dr. Wedel and Respondent at the latter's clinic in Orlando. Mrs. Chapman went with her mother on almost every visit to Respondent's office and was present when Mrs. Walsh talked with either doctor or got her treatment. On one occasion, after looking at some X rays taken of Mrs. Walsh's lungs, in the presence of Mrs. Chapman, Dr. Lynn allegedly told Mrs. Walsh that her cancer was shrinking and getting better. This was not true. Dr. Lynn denies telling her this, saying he told her the amount of fluid in the lungs had reduced, but not the size of the cancer. Considering all the evidence and weighing all the factors, I find that Dr. Lynn did make the statement alleged. However, Mrs. Walsh still had pain, and Respondent would not prescribe medication for her. Because of that, she had to go to another doctor for a prescription for whatever she needed to relieve pain. During the time that Respondent treated Mrs. Walsh, he was assisted by a "Dr." Wedel, who held himself out to be a nutritionist. However, search of the records of the various licensing agencies for the medical disciplines within this state reveals that he is not licensed as a medical doctor, osteopath, naturopath, physical therapist, podiatrist, chiropractor, pharmacist, registered nurse, or licensed practical nurse. His service to Mrs. Walsh consisted of nutritional counselling as to diet, vitamins, etc., and writing prescriptions for vitamins that were subsequently signed by Respondent. Respondent's supervision of Wedel was not regular, but periodic. Wedel was recommended to Respondent by a friend in Oregon and intended to apply for a Florida license as a medical doctor. Dr. Lynn states that before offering Wedel employment, he cleared taking him on with the Orange County Medical Association, which agency interposed no objection. When Mrs. Walsh returned to Respondent's care from Jamaica, she requested that he continue the course of treatment she had been undergoing there, which included diet control and the use of vitamins, enzymes, laetrile, and DMSO. Though Dr. Lynn's medical notes were not introduced at the hearing, he indicated that they fail to reveal he counseled Mrs. Walsh on other, conventional forms of treatment for her condition, such as X-ray therapy or chemotherapy. He is satisfied, however, that she was aware of them. Respondent, due to Mrs. Walsh's request to him that he continue the use of laetrile and DMSO, had her oral consent to do so. However, he did not have, nor did he insure that, his staff secure for him her informed, written consent to treat her with either drug. Further, he did not, prior to utilizing either drug, inform her in writing that neither was approved for use in the treatment of cancer by the Federal Food and Drug Administration of the United States Department of Health and Human Services (FDA). Laetrile, DMSO, enzymes, and megavitamins, either singly or taken together, are unconventional treatments for cancer, as accepted by the medical community, and are generally recognized by that community as being experimental.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Respondent's license to practice medicine in the State of Florida be suspended for a period of one year. RECOMMENDED this 11th day of April, 1983, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 11th day of April, 10983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 William Trickel, Jr., Esquire 35 West Pine Street Orlando, Florida 32801 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether Respondent performed a wrong-site procedure in violation of section 456.072(1)(bb), Florida Statutes; if so, whether (and what) disciplinary measures should be taken against Respondent's license to practice medicine.
Findings Of Fact At all times relevant to this case, Dr. Lior, M.D., was licensed to practice medicine in the State of Florida, having been issued license number ME 74061, and was board-certified by the American Board of Dermatology. The Department has regulatory jurisdiction over licensed physicians such as Dr. Lior. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Lior committed one such offense. In the one-count Complaint, the Department charges that Dr. Lior violated section 456.072(1)(bb), "by performing or attempting to perform health care services on the wrong patient, a wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition." Dr. Akhtar's Examination On January 11, 2010, Patient S.L., a 74-year-old gentleman, presented to Asfa Akhtar, D.O., a general dermatologist employed by the Cleveland Clinic Florida, for an evaluation of a lesion inside his left ear. It was noted on that date that S.L. had a positive history for skin cancer. Dr. Akhtar performed a physical examination of S.L., and his contemporaneous note provides, in pertinent part, as follows: "Exam of the face, ears and hands reveal a pearly papule with rolled borders on the right helix."1/ On that date Dr. Akhtar's assessment included "R/O BCC-right helix." In other words, Dr. Akhtar wanted to rule out basal cell carcinoma on S.L.'s right helix. Dr. Akhtar's plan was to conduct a "shave biopsy." Prior to performing the biopsy, the location was marked with a pen and photographed. Dr. Akhtar then performed the biopsy by scraping skin cells of the surface skin of the suspicious area. The subsequent surgical pathology report provides, in pertinent part, as follows: Final Pathologic Diagnosis SKIN BIOPSY, RIGHT HELIX: NODULAR BASAL CELL CARCINOMA WITH SURFACE ULCERATION. TUMOR EXTENDS TO THE DEEP AND PERIPHERAL MARGINS OF BIOPSY. In correspondence dated January 20, 2010, Dr. Akhtar advised S.L. that the pathologic findings from the biopsy specimen of S.L.'s right helix confirmed a basal cell carcinoma. Dr. Akhtar recommended that it "be treated by a technique called Mohs Surgery to be certain as possible that it is completely removed." January 26, 2010 Consultation On January 26, 2010, S.L. presented to Dr. Lior for a Mohs surgical consultation. In addition to being board-certified in dermatology, Dr. Lior is qualified as a Mohs surgeon. On that date, Dr. Lior, who is also employed at the Cleveland Clinic, had access to the records of Dr. Aktar's office visit, the biopsy photograph, and the pathology report. Additionally, Dr. Lior's nurse, Diane Donner, LPN, obtained additional history from the patient. Specifically, Ms. Donner noted that, "[p]atient states he has surgery in the area approximately 3 years ago. It has been present for 3 YEAR(S)." Dr. Lior then performed an examination of S.L.'s right helix; however, her examination did not include the entire right helix. Specifically, Dr. Lior did not examine the top of the helix of S.L.'s ear. Instead, Dr. Lior conducted a "focused examination" on an observed scarred pearly papule on the helix of the right ear just superior to (above) the mid-line of the ear. Dr. Lior explained the methodology utilized in limiting her examination to a specific location on the helix, as follows: Q. . . . What information from those records would indicate where on that right helix that you just described that either the biopsy was taken or that there was biopsy- proven carcinoma? A. Right. So when we get that information, patient participation is expected. We ask the patient. We get a history. Then we also need to look at the area and see what looks consistent with the biopsy site as well. And so all of these things, when you actually see a cancer and you see a scar and you see the skin graft area, and the patient tells you that that's the site, you put it together with your biopsy pathology report, as well as your office notes. It's what we use all together. Based on Dr. Lior's experience, the observed papule was consistent with the clinical appearance of basal cell carcinoma. Dr. Lior credibly testified that S.L. pointed to the same area she was palpating and advised her that he had previously undergone Mohs surgery and that the cancer had returned. Dr. Lior discussed treatment options with S.L. and advised that Mohs surgery would be appropriate, to which S.L. agreed. Dr. Lior's record of the consultation provides in pertinent part, as follows: Physical Exam: Right superior helix: There is a 1 cm scarred, crusted, pearly papule. Impression: Biopsy-proven basal cell carcinoma. Patient notes this is recurrent. Plan: Therefore indicated for Mohs surgery. February 11, 2010 Mohs Surgery S.L. returned to Dr. Lior for the scheduled Mohs surgery on February 11, 2010. Upon entering the surgical room, S.L. was engaged in a conversation with Ms. Donner concerning the location of the site. Dr. Lior greeted and approached S.L., obtained the prior photograph, approached S.L.'s ear, and stated, "let's take a look." As she was attempting to match the photograph with the area of the ear, S.L. stated to Dr. Lior, "Don't you see the scar?" while simultaneously pointing to the location of the scar tissue. Dr. Lior indeed observed the scar tissue from the prior skin graft and again, like the January 26, 2010, consultation, noted the area was consistent with recurrent basal cell carcinoma. The location was noted to be just above the scar. Dr. Lior proceeded to palpate or touch the suspicious area. Thereafter, Dr. Lior proceeded to mark the intended surgical location on S.L.'s ear with a marker pen. Subsequently, a photograph of the marked location was obtained, the patient's informed consent was obtained, and an informed consent document was executed by S.L. A time-out was then performed where Dr. Lior and her assistant agreed upon the procedure and location. The surgical site was then sterilized and injected with lidocaine. At no time prior to the surgery did S.L. voice any concerns or objections related to the proposed surgical site. S.L. was not, however, provided a mirror to examine the proposed marked location. Additionally, there was no evidence that S.L. was shown a copy of the photograph obtained by Dr. Lior prior to surgery. Dr. Lior then proceeded to perform the Mohs surgery without incident. After completing the procedure, S.L.'s ear was bandaged and S.L. waited in a separate room while the excised portion of the ear was examined to determine whether there were "clear margins"--the absence of basal cell carcinoma. After completing the examination, Dr. Lior requested that S.L. return to the operating area to discuss the findings. When S.L. returned, Dr. Lior stated, "Good news, it's all clear, the margins are clear, there's no cancer, we're going to repair the area." In response, S.L. replied that, "[t]he site was not here, it was here." S.L. then bent the top of his ear down, and Dr. Lior observed--for the first time--a papule consistent with basal cell carcinoma.2/ It is undisputed that this newly-observed papule was the site of biopsy-proven basal cell carcinoma. Dr. Lior conceded that it was her plan, at the conclusion of the January 26, 2010, consultation, to perform a Mohs surgery on the site of the biopsy-proven basal cell carcinoma. She further conceded that, on February 11, 2010, she performed the Mohs surgery on a location of S.L.'s right helix different from the location that was the subject of the biopsy performed by Dr. Akhtar.3/ Dr. Lior offered to perform a Mohs surgery on the newly-observed/previously-biopsied location; however, S.L. elected to defer the procedure for a later date. Accordingly, Dr. Lior closed the existing excision site and performed a skin graft in the area. Dr. Lior provided S.L. with her contact information and informed S.L. that she would attempt to arrange for the Cleveland Clinic to withhold the charges for the surgical procedure performed. The Cleveland Clinic reversed the charges, as requested. S.L. declined to return to the Cleveland Clinic for suture removal or for any additional procedures.
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 Respondent guilty of performing a wrong-site procedure and, therefore, violating section 456.072(1)(bb); and imposing the following penalties: a $1,000.00 fine, a letter of concern, five hours of risk management education, and a one-hour lecture on wrong-site surgery. DONE AND ENTERED this 20th day of May, 2013, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE 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 May, 2013.
The Issue The issue to be resolved in this proceeding concerns whether the Respondent's medical licensure should be subjected to discipline for the reasons asserted in the Administrative Complaint, involving his alleged malpractice concerning patient, E.L.
Findings Of Fact The Respondent at all times material hereto has been a licensed physician in the State of Florida, having been issued License No. ME0030859. The Respondent practices at 1800 N.E. Street, Suite 521, Pensacola, Florida 32501. The Petitioner is an agency of the State of Florida. It is charged by the Legislature, as pertinent hereto, with enforcing the provisions of Chapter 458, Florida Statutes, and related rules, pertaining to the regulation of licensure and the quality of practice of medical doctors within the State of Florida. The Respondent is a board-certified dermatologist, practicing that specialty in the State of Florida in excess of 15 years. There is no evidence of any prior disciplinary action against the Respondent's licensure nor of any prior instance when his practice failed to conform to appropriate professional standards. In the course of his practice, the Respondent sometimes does his own microscopic pathological examination of tissue samples taken from patients (biopsies) on occasions when he deems it appropriate and that a consulting opinion is not required. It is undisputed by the parties that a dermatologist such as the Respondent, who had extensive training in dermatopathology during his medical education, can appropriately do such biopsy work within the standard of care of a reasonable physician practicing under similar conditions and circumstances. If he does so, however, he is held to the standard of a dermatopathologist in the course of his professional practice. The Respondent treated E.L. (an 80-year-old male patient at times pertinent hereto) since approximately 1982 for various problems involving pathology of the skin, including skin carcinoma. On November 21, 1991, E.L. presented as a patient of the Respondent showing a crusty area measuring approximately 1 x 2 centimeters on the vertex of his scalp or the back of his head. The lesion in question appeared on the skin with a hard crust, whitish or yellowish in color, and the Respondent diagnosed it as hypertrophic actinic keratosis. This is sometimes a pre-cancerous condition of the skin. Upon making his diagnosis, which he did clinically, without biopsy, the Respondent performed a curettage, or scraping of the tissue, to remove and destroy it. He did this by injecting the area with lidocaine as an anesthetic before performing the curettage. The Respondent had previously treated the same sort of condition on E.L. with liquid nitrogen but chose, this time, to treat the lesion with extension cautery and curettage. He did this because he was attempting to lessen the discomfort in his 80-year-old patient, who had already undergone a number of procedures to remove pre-cancerous or cancerous lesions of the skin on his head. The use of liquid nitrogen and the associated burning of the tissues involved would cause more difficult healing and discomfort for the patient. The treatment which the Respondent accorded the actinic keratosis condition, by curettage, is an acceptable, appropriate treatment for such a condition. It is undisputed by either the Petitioner's or the Respondent's expert witnesses, as well as the Respondent in his testimony, that such a clinical diagnosis and the following treatment by curettage is within the professional standard of care and practice by dermatologists practicing under similar conditions and circumstances. A biopsy is not a necessary prerequisite to such treatment. After the November 21, 1991 destruction of the skin lesion, the patient did not return for approximately one month. On December 19, 1991, he returned to the Respondent concerned about possible infection at the removal site. The Respondent, however, detected only granulation tissue, which are normal granular projections on the surface of a normally-healing wound. Consequently, there was no reason within the bounds of reasonable medical treatment standards for the Respondent to have biopsied the lesion area on that office visit occasion, either. Patient E.L. returned on January 3, 1992, at which point the Respondent noted a minor area of "dermatitis" or a non-cancerous inflammation of the skin, for which he prescribed a cortisone ointment. The Respondent did no biopsy at that time, either, and the clear and convincing evidence does not demonstrate that a biopsy was required under those conditions and circumstances within acceptable, reasonable bounds of the Respondent's professional practice. Patient E.L. returned to the Respondent on January 23, 1992 complaining of unsatisfactory progress with the healing of the lesion. The lesion by that time had become a rounded, raised growth with central cratering, characteristic of a keratoacanthoma. The Respondent examined the lesion or tumor clinically and determined that it appeared to be a keratoacanthoma. A keratoacanthoma is a rapidly-growing nodule with a central "crater", which then fills with a crusty material. It usually remains localized and most often resolves itself spontaneously, even if untreated. On very rare occasions does it become an aggressively-growing tumor. The Respondent biopsied the suspected keratoacanthoma by performing an excision of the area. He excised the nodule, taking a narrow margin of several millimeters around it and then performed a suture closure of the wound. He performed a biopsy of the tissue thus taken himself and interpreted the biopsy results approximately one week later as confirming his clinical diagnosis of a keratoacanthoma. Keratoacanthoma is regarded as a "low-grade" form of squamous cell carcinoma. The diagnosis is based upon a clinical observation with the naked eye, based upon history, as well as by pathological diagnosis. Conservative treatment is appropriate for a keratoacanthoma since they often resolve themselves spontaneously. Simple observation, surgical excision, curettage with or without electro-desiccation, radiation therapy, intra-lesional injection, and topical application of 5-fluorouracil and methotrexate are all acceptable forms of treatment for keratoacanthoma and can be reasonably expected to cure the condition. On rare occasions, keratoacanthoma can recur, even with such treatment. The diagnosis and treatment of keratoacanthoma is a matter of good- faith differences of opinion among reasonable dermatologists and pathologists, based upon their clinical judgment and experience. Some diagnose it as keratoacanthoma, which is a low-grade form of squamous cell carcinoma; and some diagnose it as squamous cell carcinoma with varying degrees of "differentiation". The photograph of the lesion as it was seen by the Respondent prior to the January 23, 1992 surgery shows a lesion consistent with the clinical appearance of a keratoacanthoma. The Respondent has been properly trained as a dermatologist in dermatopathology, and he commonly reviews biopsy and pathology slides. He is not required, under pertinent practice standards, to seek consultation when he believes that he has made a proper diagnosis. It was proper for him to read and review the pathology slide of the biopsy specimen, even though he himself acknowledges, as do the two expert witnesses, that he would be held to a dermatopathologist's professional practice standard by doing so. The Respondent opined that actinic keratosis developed into the keratoacanthoma. Dr. Breza, the Petitioner's expert witness, opined that actinic keratosis does not develop into keratoacanthoma but, rather, into squamous cell carcinoma. Even he acknowledged, however, that good pathologists have trouble making the diagnosis of keratoacanthoma and prefer generally to diagnosis such conditions as simply "low-grade" squamous cell carcinoma. Dr. Hanke, in his testimony, established that keratoacanthoma and squamous cell carcinoma are different gradients of diagnosis on the same continuum or range describing squamous cell carcinoma. That is, in lay terms, a keratoacanthoma is a "low-grade" squamous cell carcinoma. They are not precisely the same diagnosis, but both diagnoses describe the same general type of cells. As shown by Dr. Breza, squamous cell carcinoma tumors or lesions generally tend to appear somewhat flatter than that characteristic of a keratoacanthoma. Squamous cell carcinomas tend to be more indurated or firm on the outer edges and to have more inflammation on the outer edges, including occasional ulceration. The Respondent's description in E.L.'s medical record seems more consistent with squamous cell carcinoma, but the photographic images of the growth or lesion at issue, made at the time the biopsy and excision was performed, appear also consistent with keratoacanthoma. Based upon the information, including clinical appearance, that the Respondent had to consider in making his diagnosis and given that reasonable pathologists can differ concerning the gradients of diagnosis of squamous cell carcinoma (which includes keratoacanthoma), as shown by the expert testimony, the Respondent's diagnosis does not constitute a departure from appropriate, professional standards. The deficiency in the Respondent's practice in this instance began with the excision made on January 23, 1992. The Respondent took the tissue material from the excision for biopsy and, after pathological examination of the sample, diagnosed the nodule as keratoacanthoma. The Respondent, however, did not establish a "negative margin" for the excision. That is, the tissue removed had positive margins, especially the deep margin, which means that carcinoma cells could be observed on the surface of the piece of tissue removed. This means that the Respondent could not be assured that carcinoma cells did not remain in the tissue area surrounding the walls of the excision site because the margin of the excision around the nodule to be removed was not wide enough. The same slide and tissue sample which the Respondent used for biopsy in January 1992 was examined by a dermatopathologist, but not until some six months later, in July 1992. The dermatopathologist reported his opinion that the biopsy showed an "infiltrating squamous cell carcinoma with involvement of the lateral and deep margins." An infiltrating carcinoma implies that it is a more aggressive tumor than would be the case with a normal keratoacanthoma. The Respondent did not report those positive margins from the results of his excision and biopsy in January 1992. His testimony indicates that he may have seen them or been aware of them but did not make a larger incision in order to achieve a negative margin because of his concern about the complicated closure techniques that would be necessary. He was concerned with attendant additional discomfort to this elderly patient, as might be entailed with the possible use of grafting in order to make closure of the wound. He also seemed to discount the need to excise a larger margin because of his belief that he was dealing with a non-aggressive keratoacanthoma. In fact, however, the clear and convincing evidence shows that a larger margin wound could have been excised without the necessity for more elaborate techniques of closure and attendant discomfort to the patient. Moreover, it was established that even this elderly patient, with his attendant heart problems, could have tolerated a more elaborate excision of the tumor in question, since the procedure could still be done under low-risk local anesthesia in the Respondent's office. An infiltrating carcinoma is one which is more aggressive. It can move from its original location and infiltrate the skin and blood vessels, which can, in some cases, result in the tumor spreading via the blood stream or by infiltrating the lymphatic system, with migration to regional lymph nodes. The squamous cell carcinoma is not known for being a readily metastasizing form of cancer. It is known on some occasions to metastasize, however. The finding of positive margins on the pathological examination in July 1992 means that the tumor extended to the cut surface of the excision at the time of the January excision procedure from which that biopsy sample was taken. Thus, tumor cells remained in the patient's scalp after the January 1992 excision procedure. The finding of a positive margin requires that another margin be established, meaning that the physician must cut another level of tissue until normal skin (a negative margin) is revealed. This can be done by conventional surgery, by just a larger excision area being removed, or by "MOHS" surgery, which involves freezing sections of the excision area, with small portions of the suspicious area removed at a time and with attendant pathology examinations so that each "thread" of cancer cells can be removed with minimal damage to surrounding tissues and less attendant discomfort and healing problems associated with the resulting surgical wound. The patient could have tolerated either type of procedure in January 1992. The Respondent did not establish a negative margin, however. He only excised the carcinoma once. He stated that he was really seeking only a biopsy sample and that he considered the treatment by excision of the nodule itself and attendant scraping of the wound to be adequate as conservative treatment, to take care of what he believed to be a non-aggressive keratoacanthoma. This may be a correct assessment if the physician is certain that he is confronted with a non-aggressive, non-infiltrating keratoacanthoma. However, if positive margins to the excisional wound result, the patient is better served, and a successful treatment result much more likely, if all suspected carcinoma cells are removed at that time. If the Respondent knew of the positive margins to the excision and had made an additional excision to remove all positive margins, the provision of additional, more elaborate treatment techniques would not have been delayed for nearly six months and likely would have been unnecessary. The determination of the existence of positive margins, after the January 1992 excision procedure, should have caused him to remove additional tissue to obtain a safe, negative margin. That failure of care, in his capacity as a dermatopathologist, resulted in a six-month delay before the dermatopathologist, at Sacred Heart Hospital, identified the positive margins. He identified them on the Respondent's same January 1992 pathological slide, when he examined it in July 1992, after which radiation and further more radical treatment was attempted. Thus, the delay in treatment action, resulting from the delay in acting on the existence of positive margins by the Respondent, resulted in a six-month delay in appropriate treatment being provided the patient, which is a deviation from the accepted standard of care, as established by the testimony of Dr. Breza, which is accepted in this regard. Earlier determination (or acting on a determination) of the positive margins, after the January 1992 excision procedure would have alerted the Respondent that the excision procedure was unsuccessful and that further treatment was necessary. The patient's lesion occurred on a sun-damaged scalp. The Respondent had treated the patient repeatedly for sun-damaged skin problems, including carcinomas, in the past. Squamous cell carcinomas can be susceptible to mestastases, either regional or systemic when they are located on the scalp, although they are much less susceptible to such mestastases than if they are located on the lip or possibly the dorsal surface of the hand. The Respondent, as a board-certified dermatologist, knew or should have known that the scalp is an area of the body that can be susceptible to metastatic disease such as squamous cell carcinoma. The patient, as even acknowledged by the Respondent's expert, Dr. Hanke, was one with a high risk for developing skin cancer. In any event, after the excision procedure on January 23, 1992, the patient was seen on February 10, 1992 for removal of sutures and examination of the wound. It appeared to be healing nicely at the time, and the patient was advised to return to the Respondent in three months, unless a problem developed. The Respondent next saw the patient on April 6, 1992, when he complained of persistent pain at the excision and tumor site. This was treated by the Respondent by drainage, antibiotics, narcotic pain medications, and sleep- inducers. Later during the treatment regimen, in approximately May 1992, the Respondent felt that chemotherapy was indicated because apparently, the lesion had not been completely excised. Consequently, he prescribed injections of intralesional cortisone methotrexate and 5-fluorouracil. These, however, did not produce satisfactory healing or control of the pain. During April and May 1992, the Respondent saw the patient for complaints of persistent pain, poor healing, and drainage of the wound. On May 18, 1992, the Respondent performed a drainage of the lesion which had begun to show an abscess formation. An abscess formation is an indicator of squamous cell carcinoma, which should have been recognized by the Respondent. This should have alerted him that his diagnosis of simply keratoacanthoma was not correct, at least by that time. With the presence of these continuing and exacerbated problems with the wound site, the Respondent did not seek or perform further biopsy of the tumor site, despite continued complaints of persistent pain and further growth of the lesion between April and July 1992. The patient made 16 visits to the Respondent between April 1992 and July 14, 1992 for treatment and pain relief. During this time, little improvement occurred in the patient's condition, but no additional biopsy or consultation was requested or performed by the Respondent. The lack of improvement in E.L.'s condition during the period of April through July 1992 should have alerted the Respondent that something was incorrect about the patient's condition and that more extensive radical treatment would be necessary. In fact, the Respondent did respond to the continued complaints by, in addition to prescribing antibiotics and pain medication, prescribing the above- referenced intralesional injections of cortisone, methotrexate, and 5- fluorouracil. On July 9, 1992, another curettage procedure was performed and the pathology of the scrapings was sent for evaluation by a pathologist. The Respondent's interpretation of this tissue at the time apparently was a keratoacanthoma; well-differentiated squamous cell carcinoma. This was ultimately described by the pathologist to whom it was referred as a moderately- differentiated squamous cell carcinoma. Subsequently, after the C&D procedure, the patient was referred to Baptist Hospital in Pensacola, Florida, for radiation therapy. He received a full-course of radiation therapy with some booster therapy afterward and then, on his own volition, went for a second opinion to the University of South Alabama Medical Center in Mobile, Alabama. Five physicians at that facility recommended more extensive surgery, which ultimately the patient refused. There is no clear and convincing evidence that, at least at that point in the patient's progress, the persistent tumor had actually mestastized, although it was apparently growing locally. The fact that the lesion at issue was failing to heal and producing persistent pain by the visit of April 6, 1992 should have been interpreted so as to set in motion further investigative procedures, including an additional biopsy, to find out the reason for that condition and its persistence. Although a proper procedure involving excision and biopsy was done in January of 1992, the frozen sections of the lesion could have been interpreted to show that the tumor was an infiltrating carcinoma extending to the lateral and deep margins of the excision and something more aggressive could have been done to treat it at that time. It could have either been re-excised with frozen section control of the margins, referred to a "MOHS'" surgeon for a similar type of surgery or referred to a general surgeon. Radiation therapy could have been tried, at least by the time the persistence of the problem was determinable in April of 1992. The resultant reduction of delay in securing more extensive treatment of the lesion would have certainly benefited the patient. The persistence of the pain in the six-month period of time after the January 1992 excision of the tumor, until just before the time the patient was referred for radiation therapy indicates there was probably perineural invasion by the tumor (infiltration of the nerves), which produced pain. This should have alerted the Respondent that something more than a non-aggressive keratoacanthoma was involved, as well. In summary, it has been demonstrated that the Respondent failed to practice medicine within that level of care, skill and treatment recognized by reasonably prudent, similarly-situated physicians as acceptable under the circumstances, by failing to make an additional biopsy after the patient re- presented with problems associated with persistent pain and improper healing in April 1992; by failing to recognize and act on the presence of positive margins to the excision material taken in January 1992, to effect an additional excision at that time, so as to secure a safe, negative margin to the tumor. The failure to obtain consultation on the biopsy taken from a dermatopathologist was not in itself evidence of falling below appropriate professional levels of care, skill and treatment, but the Respondent, by doing his own interpretation of the biopsies was, as he agrees, creating a situation in which he would be held to the same standard as a dermatopathologist. The failure to correctly interpret the biopsy he took in January 1992, by failing to recognize the positive margins to the excised material and failing to act to remove those indicia of the continued presence of the tumor, at a time when it was thus easily excised, likely prevented an easily-effected cure.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is RECOMMENDED that the Respondent be found guilty of a violation of Section 458.331(1)(t), Florida Statutes, in the manner concluded above, and that the Respondent receive a private reprimand, a $2,000.00 fine, and that he be required to attend 20 additional hours of Category I continuing medical education in the area of diagnosis and treatment of skin cancer. DONE AND ENTERED this 30th day of October, 1995, in Tallahassee, Florida. P. MICHAEL RUFF, 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 30th day of October, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3531 Petitioner's Proposed Findings of Fact 1-8. Accepted. 9-10. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not itself materially dispositive. Rejected, as contrary to the clear and convincing evidence. The evidence does not reflect that one biopsy sample only showed one part of the lesion at issue but, rather, several parts were represented. Accepted. Accepted, but not itself materially dispositive. 15-21. Accepted. 22-24. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 25-26. Accepted. 27. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 28-36. Accepted. 37-41. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 42-44. Accepted. 45. Rejected, as contrary to the clear and convincing evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. 46-53. Accepted, but not in their entirety materially dispositive. 54. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 55-56. Accepted. Rejected, as not in its entirety supported by clear and convincing evidence of record. Accepted. Accepted, to the extent of failing to practice medicine within the appropriate standard of care by not making earlier and more frequent biopsies only. Respondent's Proposed Findings of Fact 1-17. Accepted. 18. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 19-20. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter, and as not entirely in accord with the clear and convincing evidence of record. Accepted. Accepted, but not necessarily as to its material import and subordinate to the Hearing Officer's findings of fact on this subject matter, which contain additional findings of fact not contained in Proposed Finding of Fact No. 23 and which are material, relevant, and necessary to a clear picture of the patient's progress and treatment rendered during the period of April 6, 1992 through July 14, 1992. Accepted, but not as to its purported material import. Rejected, as contrary to the clear and convincing evidence of record, and as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not as to its purported material import. 27-31. Accepted. COPIES FURNISHED: Britt Thomas, Senior Attorney Mary Anne Davies, Certified Legal Extern Agency for Health Care Administration 1940 North Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Donald Partington, Esq. CLARK, PARTINGTON, ET AL. Post Office Box 13010 Pensacola, FL 32591-3010 Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, FL 32399-0770 Jerome W. Hoffman, Esq. General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, FL 32309
