The Issue Whether Petitioner’s request for coverage of proton beam radiation therapy (“proton beam therapy” or “PBRT”) is a covered benefit pursuant to the State Employees’ Health Maintenance Organization (“HMO”) Plan (“Plan”), administered by AvMed.
Findings Of Fact Respondent is the state agency charged with administering the state employee health insurance program pursuant to section 110.123. At all times material hereto, Petitioner was a member of the Plan. AvMed is the third-party administrator for the Plan at issue in this cause. As the third-party administrator, AvMed provides claims processing, utilization, and benefit management services. The applicable benefit document is the State Employees’ HMO Plan, Group Health Insurance Plan Booklet and Benefits Document (“Plan Document”), effective January 1, 2019. Petitioner is a 66-year-old male who was diagnosed with prostate cancer in November 2017 and underwent a prostatectomy to remove his prostate on April 12, 2018. Subsequent to his initial surgery and treatment, Petitioner experienced increasing prostate specific antigen (“PSA”) in three follow-up tests. His prostate cancer had returned. Petitioner’s physician sought to treat his condition with PBRT, a form of external beam radiation utilizing protons, rather than traditional intensity modulated radiation therapy (“IMRT”), which is, without question, covered under the Plan. Medicare, a federal healthcare insurance program, agreed to pay 80 percent of Intervenor’s charges for PBRT, leaving Petitioner responsible for the remaining 20 percent being sought to be paid by Petitioner’s Plan. On July 3, 2019, Petitioner, through his healthcare provider, Maria-Amelia Rodrigues, M.D., and Intervenor, Miami Cancer Institute, submitted a request for coverage of PBRT to AvMed. On July 10, 2019, AvMed denied the preservice request for coverage on the basis that the therapy was experimental/investigational and, therefore, not medically necessary treatment for the member’s condition. The request was reviewed by Sri Gorty, M.D., a consultant radiation oncologist at Magellan Healthcare, which is under contract with AvMed. On July 23, 2019, Petitioner submitted a request for a Level I appeal to AvMed. The appeal was reviewed by Dr. Gregg Goldin, M.D., a consultant radiology oncologist at Dane Street, which is under contract with AvMed. He filed a report dated August 19, 2019. On August 20, 2019, AvMed denied the request for Level I appeal on the basis that the therapy was experimental/investigational and, therefore, not a medically necessary treatment. On November 19, 2019, Petitioner submitted a request for an “Expedited” Level II appeal to Respondent. The Level II appeal was reviewed by Dearline Thomas-Brown, a registered nurse and Level II appeal coordinator for Respondent. On November 21, 2019, Respondent denied Petitioner’s Level II appeal on the basis that the therapy is experimental/investigational and, therefore, not medically necessary for treatment of the member’s condition. Pursuant to the Plan Document, the Plan pays its share of the cost of covered services, if the services are: Ordered by a Network Provider (a provider who is in AvMed’s network); Considered Medically Necessary for the covered person’s treatment because of accident, illness, condition or mental health or nervous disorder; Not specifically limited or excluded under this Plan; and Rendered while this Plan is in effect. Pursuant to the Plan Document, Section I. Introduction: The Plan is not intended to and does not cover or provide any Medical Services or benefits that are not Medically Necessary for the diagnosis and treatment of the Health Plan Member. AvMed determines whether the services are Medically Necessary on the basis of terms, conditions, and criteria established by the Plan as interpreted by the state, and as set forth in medical guidelines. This chart provides a description of services and supplies covered under the Plan. Coverage Access Rules are specified under the Plan as follows: Cancer Services Diagnosis and Treatment Includes both inpatient and outpatient diagnostic tests and treatment (including anti-cancer medications administered by Network providers), including cancer clinical trials as set forth in the Florida Clinical Trial Compact. Does not include Experimental or Investigational Treatment. In order to be a covered benefit, the treatment must be “medically necessary,” not “experimental or investigational,” and it must not be specifically excluded by the Plan. “Medically Necessary” is defined as follows: The use of any appropriate medical treatment, service, equipment and/or supply as provided by a Hospital, skilled nursing facility, physician or other provider which is necessary for the diagnosis, care and/or treatment of a Health Plan Member’s Illness or injury, and which is: Consistent with the symptom, diagnosis and treatment of the Health Plan Member’s condition; The most appropriate level of supply and/or service for the diagnosis and treatment of the Health Plan Member’s condition; In accordance with standards of acceptable medical practice; Not primarily intended for the personal comfort or convenience of the Health Plan Member, the Health Plan Member’s family, the physician or other health care providers; Approved by the appropriate medical body or health care specialty involved as effective, appropriate and essential for the care and treatment of the Health Plan Member’s condition; and Not experimental or investigational. The service must meet all of the above-referenced criteria in order to be medically necessary. Given the above definition, if a service is experimental or investigational, then it cannot be medically necessary. Section VI. Limitations and Exclusions in the Plan Document specifically exclude services that are “experimental/investigational or not medically necessary treatment with the exception of routine care in connection with a clinical trial in cancer, pursuant to the Florida Clinical Trial Compact and the Patient Protection and Affordable Care Act.” “Experimental and/or Investigational” is defined as follows: For the purposes of this Plan a medication, treatment, device, surgery or procedure may initially be determined by AvMed to be experimental and/or investigational if any of the following applies: The FDA has not granted the approval for general use; or There are insufficient outcomes data available from controlled clinical trials published in peer- reviewed literature to substantiate its effectiveness for the disease or injury involved; or There is no consensus among practicing physicians that the medication, treatment, therapy, procedure or device is safe or effective for the treatment in question or such medication, treatment, therapy, procedure or device is not the standard treatment, therapy procedure or device utilized by practicing physicians in treating other patients with the same or similar condition; or Such medication, treatment procedure, or device is the subject of an ongoing Phase I or Phase II clinical investigation, or Experimental or research arm of a Phase III clinical investigation, or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as comparted with the standard for treatment or diagnosis of the condition in question. If any one or more of the above-cited criteria are met, then the treatment is experimental and/or investigational and is not a covered service. In making an adverse determination as to coverage in both the Level I and Level II appeals, Edwin Rodriguez, M.D. (note the slightly different spelling of Petitioner’s expert Dr. Maria-Amelia Rodrigues versus Dr. Edwin Rodriguez), and Nurse Thomas-Brown utilized AvMed’s Medical Coverage Guideline on PBRT. This coverage guideline regarding PBRT provides AvMed’s “Exclusion Criteria” explaining “PBRT is not covered, and is considered investigational, as to all other tumors not listed” in the guideline. PBRT is not an approved treatment option for localized prostate cancer under the NIA Magellan criteria. The Medical Technology Assessment Committee at AvMed drafts clinical policy guidelines and is responsible for maintaining or changing them as technology advances. AvMed’s policy on use of PBRT for the treatment of prostate cancer states that it is not medically necessary because studies have not shown clinical outcomes to be superior to conventional radiation therapy (i.e., IMRT). This policy was developed following extensive review of studies in peer-reviewed medical literature, available guidelines, technology assessments, and opinions from experts. The policy is updated on a yearly basis in order to take into consideration any new evidence. A recent review of the policy on PBRT resulted in no change in AvMed’s position on coverage for treatment of prostate cancer. The medical coverage guidelines are meant to be used in conjunction with the Plan Document to determine whether services are medically necessary and a covered benefit. Dr. Gorty, AvMed’s external reviewer from Magellan Healthcare, who was accepted as an expert in the field of radiation oncology, testified that his recommended denial of coverage of PBRT was informed by Petitioner’s medical records, Intervenor’s Letter of Medical Necessity, clinical trials, the model policy from the American Society of Therapeutic Radiation and Oncology (“ASTRO”), and the National Comprehensive Cancer Network (“NCCN”) guidelines. PBRT PBRT is a procedure that uses protons to deliver a curative radiation dose to a tumor, while reducing radiation doses to healthy tissues and organs, which results in fewer complications and side effects than IMRT. As stated earlier, Petitioner’s prostate was removed in April 2018. Thereafter, rising PSA levels indicated that he needed further treatment, and Dr. Rodrigues, a board-certified radiation oncologist at Miami Cancer Institute, became his treating physician. Dr. Rodrigues has been treating patients for 23 years, including prostate cancer patients. She was accepted as an expert in her field for these proceedings. Dr. Rodrigues determined PBRT to be the appropriate radiation treatment for Mr. Zolfaghari given his type of prostate cancer—recurrent prostate cancer. Dr. Rodrigues testified that recurrent prostate cancer occurs when a cancer has been treated and then reoccurs. In addition to PBRT, Dr. Rodrigues recommended, and Petitioner received, androgen deprivation therapy, generally referred to as hormone therapy, to be used in conjunction with PBRT. Dr. Rodrigues testified that the androgen deprivation therapy blocks the production of testosterone. She testified that patients with recurrent prostate cancer or certain high-risk patients have better overall survival when the two treatments are used in conjunction. As an additional aggravating factor to Petitioner’s cancer treatment, Petitioner was diagnosed with colon cancer leading to surgery in January 2020. Dr. Rodrigues testified that Petitioner’s colon cancer made his need for PBRT even more necessary, because now Petitioner is at a higher risk for adverse effects from the unwanted spread of toxicity common with IMRT. Dr. Rodrigues, as a Miami Cancer Institute physician, wrote letters requesting treatment and appealing denials of treatment as set forth above, and testified at the March 9, 2020, administrative hearing in support of Petitioner’s efforts to obtain coverage through AvMed for PBRT, which she considers to be a medically necessary treatment modality. Dr. Rodrigues was asked why she had not gone forward and provided Petitioner IMRT in order to prevent any further delay due to the passage of time from unsuccessful appeals of the denial by AvMed for the PBRT treatment of his recurring prostate cancer. She replied that she was attempting to secure a less toxic treatment modality, PBRT, for her patient who was already approved by Medicare for coverage of 80 percent of the cost of the treatment. MEDICAL NECESSITY OF PBRT VERSUS IMRT There is no dispute that IMRT is an accepted treatment modality for Petitioner’s recurrent prostate cancer, even bearing in mind his complicating factor of colon cancer surgery and treatment endured following his 2018 prostatectomy. The remaining dispute here is whether PBRT is both medically necessary and not an experimental and/or investigative form of radiation treatment. IMRT is a recognized form of treatment for Petitioner’s recurrent prostate cancer. Dr. Rodrigues testified that Miami Cancer Institute considered only candidates for PBRT as those who would qualify for IMRT, such as Petitioner. Given the availability of another treatment option, IMRT, which is the most widely recognized standard of care within the medical establishment for the treatment of Petitioner’s condition, Respondent’s experts conclude that PBRT is not medically necessary because it is not the most appropriate level of service in this case. While PBRT has been accepted by AvMed, according to its Plan, for certain types of cancer, the insurer has not yet authorized it for the treatment of prostate cancer. This is where the semantics of the contract come into play. Petitioner and Intervenor argued that Respondent mistakenly based its denial upon a diagnosis of “localized prostate cancer” (Dr. Rodrigues’ reading of the proscription of the use of PBRT for Petitioner) rather than “recurrent prostate cancer” (not specifically proscribed by the Plan according to her reading), combined with the fact that Petitioner’s unique medical condition requires lower toxicity in the specific type of radiation used. PBRT, she testified, offers lower radiation toxicity, which will have less of a harmful effect on Petitioner’s colon and rectum as a survivor of colon cancer surgery. Dr. Rodriguez, the AvMed senior medical director, testified that studies comparing PBRT to 3-D confirming radiation or IMRT are limited. Overall studies have not shown clinical outcomes to be superior to conventional radiation therapy. In addition to the preservice and Level I appeal reviews by AvMed, and Respondent’s Level II appeal review, an Independent Organization Review (“IRO”) was conducted by a licensed radiation oncologist employed by Independent Medical Expert Consulting Services. As a result of this independent review, the Plan’s denial was upheld. Dr. Rodrigues presented studies in her testimony and a letter of medical necessity which cited the potential for favorable outcomes with PBRT. Dr. Gorty, Respondent’s expert in radiation oncology, contradicted her testimony in that many of the studies she cited noted a need for further study regarding the safety and efficacy of PBRT for treatment, and all of these studies were based upon “localized prostate cancer,” rather than “recurrent prostate cancer.” Dr. Gorty also testified that Petitioner's records indicated that his cancer was localized, although it could also be "recurrent." Dr. Gorty testified that clinical studies show no significant difference in the toxicity between IMRT and PBRT. Further, Dr. Rodriguez explained that localized cancer can be recurrent. “Localized” refers to where the cancer may be found, while “recurrent” refers to a repeat or re-occurrence of a cancer, which might return to the same location or reappear in a different location. Paragraph 15 lists the criteria to determine whether a treatment or procedure is “medically necessary” under the AvMed policy. PBRT does not meet the third criterion of the definition of “medically necessary,” as PBRT treatment of prostate cancer is not in accordance with standards of acceptable community practice. Dr. Gorty testified that AvMed medical guidelines utilize IMRT as the “next generation” treatment, rather than PBRT. Further, Dr. Gorty testified that he was aware of several recent clinical trials concerning PBRT and IMRT, and these studies do not reach a conclusion that PBRT is preferable to IMRT. PBRT does not meet the fifth criterion of the definition of “medically necessary,” as PBRT has not been approved by the appropriate medical body or healthcare specialty involved as effective, appropriate, and essential for the care and treatment of prostate cancer. PBRT is not essential for the treatment of prostate cancer. There are several treatment modalities that are generally available for the treatment of prostate cancer and, as discussed above, several of those treatment options were reasonable treatment options for Petitioner. While Dr. Rodrigues believes PBRT to be preferable for Petitioner in this case due to, in her opinion, fewer adverse side effects of the treatment, she admitted that Petitioner is a suitable candidate for IMRT. Therefore, PBRT does not meet the sixth criterion of the definition of “medically necessary,” as it meets the definition of “experimental and/or investigational.” Specifically, criteria 2, 3, and 4 of the definition of “experimental and/or investigational” are met, which lead to the ultimate conclusion that PBRT is not medically necessary in this case. EXPERIMENTAL AND/OR INVESTIGATIONAL TREATMENT Paragraph 18 sets forth the criteria for determining whether a treatment or procedure is “experimental and/or investigational.” The second criterion from the definition of experimental and/or investigational treatment is met in this case. Insufficient outcomes data are not available from controlled clinical trials published in peer-reviewed literature to substantiate PBRT’s safety and effectiveness for treatment of prostate cancer. Dr. Rodriguez testified that there is a lack of peer-reviewed, published, randomized studies regarding proton beam therapy. Further, PBRT treatment is not the generally accepted standard of care. Dr. Rodrigues testified that only a handful of medical centers in the United States are using PBRT to treat cancer malignancies. Only two such programs are located in Florida—the University of Florida and Intervenor. Outside of Florida, only Massachusetts General and Loma Linda offer the treatment. Prior to Intervenor offering the treatment, Dr. Rodrigues referred her patients to one of these other facilities for PBRT when she deemed it appropriate to do so. Current randomized trials are on-going and being published in peer- reviewed medical literature. PBRT treatment for prostate cancer is considered investigational and not a standard of care option and, therefore, not medically necessary. Nurse Thomas-Brown testified that a treatment considered experimental or investigational is, automatically, not medically necessary. NIA Magellan Clinical Guideline Number NIA_CG_124, which was developed in July 2018 for implementation in January 2019 to assist physicians in the application of treatment, states that both surgery and radiation therapy should be used to treat organ confined prostate cancer, as well as prostate cancers extended into adjacent tissues. This guideline finds that PBRT is not an approved treatment option for localized prostate cancer as studies comparing it to 3-D conformal radiation or IMRT are limited. Leading organizations, such as NCCN and ASTRO, have noted insufficient data outcomes and a need for more study of proton beam therapy, which these organizations have not yet accepted as the standard of care. PBRT also meets the third criterion of the definition of “experimental and/or investigational.” There is no consensus among practicing physicians that PBRT is safe or effective for the treatment of prostate cancer or that PBRT is the standard treatment utilized by practicing physicians in treating other patients with the same or similar conditions. Both Dr. Gorty and Dr. Rodriguez testified that proton beam therapy is experimental and investigational and, therefore, not medically necessary for all forms of prostate cancer; two additional radiation oncologists reviewed the appeal and reached the conclusion that PBRT is not medically necessary. Additionally, there was uncontroverted evidence that IMRT, not PBRT, is the standard form of treatment utilized by practicing physicians for treatment of prostate cancer. Dr. Gorty testified that AvMed approved the NIA Magellan clinical guidelines for prostate cancer, which are based on the peer-reviewed studies; and he explained three such studies. His testimony noted that the second study from the University of Pennsylvania at Baltimore, Maryland, specifically matched Petitioner’s medical condition. This study compared 307 men and their comparative toxicity outcomes of PBRT verses IMRT for post-operative sites. It concluded that future prospective investigation and ongoing follow-up will determine whether dosimetric differences between treatment with IMRT and proton beam therapy convert to meaningful differences in long-term outcomes. As part of the appeal process on behalf of Petitioner, Intervenor also requested a review by an IRO. The review was completed by a board-certified radiation oncologist, and a report was generated on January 9, 2020. The “List of Materials Reviewed” is extensive and includes Petitioner’s medical records and Intervenor’s supporting documentation. The independent reviewer upheld the denial and noted that medical necessity has not been established. The IRO states that “until the current randomized trials ongoing are published in peer reviewed medical literature, proton beam treatment for prostate cancer is considered investigational and not a standard of care treatment option.”
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Management Services, Division of State Group Insurance, enter a final order denying Petitioner's request for coverage for proton beam therapy. DONE AND ENTERED this 4th day of May, 2020, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 2020. COPIES FURNISHED: Erica D. Moore, Esquire Thomas E. Wright, Esquire Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399 (eServed) Abolghasem Zolfaghari 10910 Southwest 140th Avenue Miami, Florida 33186 Frank A. Florio, Esquire Maria D. Garcia, Esquire Latasha Gethers Hines, Esquire Kozyak, Tropin & Throckmorton, LLP 2525 Ponce de Leon Boulevard, Ninth Floor Coral Gables, Florida 33134 (eServed) William Chorba, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed)
The Issue The issue in this case is whether the Board of Medicine should discipline the Respondent, Carlos C. Soriano, M.D., on allegations contained in an Administrative Complaint filed against the Respondent in DPR Case No. 89-05941: namely, allegations that the Respondent practiced medicine below the acceptable level of care, skill and treatment, in violation of Section 458.331(1)(t), Fla. Stat. (1993), by failing to offer one of his patients the option of radiation therapy or chemotherapy for cancer of the rectum and by inappropriately delaying treatment for the condition.
Findings Of Fact The Respondent, Carlos C. Soriano, M.D., is a physician licensed in the State of Florida, holding license number ME 0024149. In late 1988 and early 1989, the Respondent, Carlos C. Soriano, M.D., was the medical director of a health maintenance organization called Gold Plus. On or about October 24, 1988, a physician at Gold Plus examined the patient in question, a 90 year-old female in apparent good health for her age, and made a preliminary diagnosis of suspected cancer of the rectum. She referred the patient to the Respondent, a surgeon, for further evaluation and treatment. The Respondent examined the patient on October 31, 1988. He confirmed his associate's preliminary diagnosis of cancer of the rectum but pointed out that a flexible sigmoidoscopy with biopsy would be necessary to make a final diagnosis and to determine the kind of cancer involved. The diagnostic procedure was scheduled for November 17, 1988. The Respondent also discussed with the patient that, due to her age and the size and extent of the tumor, surgical removal of the tumor may not be appropriate. The Respondent suggested that the best course might be to perform a palliative colostomy, if necessary, and "let nature take its course." The patient was not pleased with the Respondent's attitude and consulted a nephew, who was a physician, for advice. The nephew referred the patient to another physician, who was a gastroenterologist, for a second opinion. The gastroenterologist examined the patient on or about November 8, 1988, prepared a report for the referring physician, with copies also sent to the patient and to the Respondent. The gastroenterologist's report recommended: a colonoscopy and biopsies like those already scheduled by the Respondent; a complete work-up preliminary to surgical removal of the tumor (including CEA levels, a liver/spleen scan, chest X-ray, and CT scan of the pelvis) to determine whether the cancer had metastasized; and (3) radiation therapy if there was no evidence of metastasis, or palliative radiation prior to snare polypectomy or laser fulguration, to avoid the necessity of a colostomy in the future if there was evidence of metastasis. The Respondent performed the flexible sigmoidoscopy and three biopsies as scheduled on November 17, 1988. He told the patient he would discussed the results with her as soon as they were received from the pathology laboratory. The Respondent received the pathology report and scheduled an appointment to discuss the results with the patient and her family (another nephew, and his wife) on November 30, 1988. The pathology report on the biopsies confirmed that the tumor was malignant. The report stated that the cancer was coacogenic. At the time, and to this day, radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinomas. Assuming the accuracy of the report, the only course of possible effective curative treatment for the patient was surgical removal. Whether or not the cancer had spread, the Respondent did not think surgical removal was appropriate for the patient, due to her age and the size and extent of the tumor. He did not think she would tolerate the kind of surgery that would be required. The decision whether to perform a particular surgery on a particular patient requires the exercise of the physician's professional medical judgment. Such a judgment cannot be made without a knowledge of the patient, through history and physical examination. It is found that, based on all of the evidence, including the Respondent's knowledge of the patient, through history and physical examination, the Respondent's medical judgment not to recommend surgical removal of the patient's tumor was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. During the meeting with the patient and her family on November 30, 1988, the Respondent explained the results of biopsies and what he considered to be the treatment alternatives. He told them that he would not recommend surgical removal, due to the patient's age and the size and extent of the tumor. He mentioned but did not elaborate on the possibility of radiation therapy because he did not know much about it. He suggested that the patient consider a colostomy to bypass the tumor and to "let nature take its course." He informed the patient and her family that he would be out of the country on vacation for the next four weeks but that she should make an appointment to see him after the holidays. Meanwhile, he would have someone research for him whether radiation or other alternative treatment modes were appropriate. It is found that the Respondent's failure to recommend radiation therapy or chemotherapy was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinoma. Assuming the accuracy of the pathology report on the biopsy, the only course of possible effective curative treatment for the patient was surgical removal. Subsequent events revealed that the patient's cancer was not coacogenic but rather squamous cell carcinoma. (It is not uncommon for biopsy reports to make such an error due to the relatively small size of the biopsy sample.) But even if the biopsy report had shown that the patient suffered from squamous cell carcinoma, it could not be found that the Respondent's failure to recommend radiation therapy or chemotherapy was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. In 1988 and 1989, the medical community did not recognize radiation therapy or chemotherapy as an acceptable curative treatment for squamous cell carcinoma of the anus. Once again, the patient became anxious that the Respondent was not offering any curative treatment plan. She asked whether the Respondent should not at least have a liver/spleen scan done to see if the cancer had metastasized. Since the Respondent was not recommending surgery (the only possible curative treatment), he did not think a liver/spleen scan would serve any useful purpose. But to satisfy the patient, and because it was one of the gastroenterologist's recommendations, he agreed to schedule one for the patient before he left for vacation. The patient scheduled a follow-up appointment for January 9, 1989. Meanwhile, the Respondent left for vacation, and the liver/spleen scan was performed on December 8, 1988. In the Respondent's absence, Gold Plus delayed giving the patient the results of the scan. She became more and more anxious as time went by. When the patient called for the results, she initially was told that Gold Plus could not give her the results until the Respondent returned. It took an angry telephone call from the wife of the patient's nephew on the day before Gold Plus closed for the Christmas holiday for Gold Plus to agree to allow another of its physicians discuss the results of the scan. The patient was promised that the physician would call the next day. Still, no call came, and the wife of the patient's nephew called again just hours before the office closed for Christmas. The patient and her family were told that the results of the scan were negative. This distasteful experience further soured the patient's relationship with Gold Plus and, by extension, with the Respondent, and they lost faith in the Respondent and his medical practice. Instead of seeing the Respondent on January 9, 1989, as scheduled, the patient cancelled the appointment and made another appointment to see the gastroenterologist again. By this time, the tumor had grown to some extent and, along with it, the patient's discomfort. It was difficult to even examine the patient's rectum either digitally or by flexible sigmoidoscopy. The gastroenterologist agreed to refer the patient to another surgeon for possible surgical removal of the tumor. The patient initiated disenrollment from Gold Plus so that her Medicare could be reinstated to cover the anticipated surgery. The gastroenterologist asked the Respondent for the patient's medical records. The Respondent's care of the patient and responsibility for the care of the patient effectively ended when the patient cancelled her appointment on January 9, 1989. Another appointment with the gastroenterologist was scheduled for February 1, 1989, in anticipation of imminent surgery. Surgery was scheduled for February 14 but, after the patient's admission, was postponed to February 17, 1989. Initially, the patient's recovery from surgery was slow, and she remained hospitalized until March 14, 1989. Subsequent events raise questions whether the surgery was effective or worth the trauma. It is debatable how well the patient tolerated the surgery. It appears that she did not ever recover the level of physical vigor and energy she had before surgery. During the summer of 1989, the cancer reappeared on her coccyx and had to be treated by radiation. By the fall of 1989, another abdominal perineal resection was necessitated by the reappearance of the cancer in her rectum. Based on the best expert testimony available at the hearing, it cannot be found that the time that went by during the Respondent's treatment of the patient was "substantial," i.e., that it contributed to the spread of the patient's cancer. Notwithstanding the results of the liver/spleen scan, which was not definitive or even very useful in evaluating the patient's cancer for metastasis, it is probable that the patient's cancer already had metastasized by the time the Respondent first saw the patient. The Respondent clearly did not inordinately delay the flexible sigmoidoscopy with biopsy or his discussion of the results and treatment alternatives with the patient. The only questionable delay was the four-week delay caused by the Respondent being out of the country on vacation; by the time he was scheduled to see the patient on his return, she had terminated his care and treatment. There was no evidence on which it could be found that this delay was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing the Administrative Complaint against the Respondent. RECOMMENDED this 21st day of March, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON 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 21st day of March, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5068 To comply with the requirements of Section 120.59(2), Fla. Stat. (1991), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5.-6. The date of the procedure was November 17, not November 11. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 7.-10. Accepted and incorporated to the extent not subordinate or unnecessary. "[A]pproximately four (4) weeks after the Christmas holidays" rejected as not proven and as contrary to the greater weight of the evidence. (He said "in four weeks, i.e., after the Christmas holidays.") Accepted and incorporated. Rejected as not proven and as contrary to the greater weight of the evidence that it was just "for a second opinion." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 14.-15. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven and as contrary to the greater weight of the evidence that the gastroenterologist made such a determination; rather, the subsequent surgeon did. Also, rejected as not proven and as contrary to the greater weight of the evidence that the surgery was "successful." In some senses it was, in other senses it was not. Rejected as not proven and as contrary to facts found. 18.-19. Accepted but subordinate to facts contrary to those found, and unnecessary. 20. Both as to the growth of the tumor and as to the evidence of metastasis, rejected as not proven and as contrary to the greater weight of the evidence. (The liver/spleen scan was negative, but the best expert testimony presented as the hearing indicated that subsequent events showed prior metastasis.) 21.-22. Rejected as not proven and as contrary to facts found. (The evidence was that those treatments were not alternative curative treatments. The Respondent was not given an opportunity to use them palliatively.) 23. Rejected as not proven and as contrary to facts found. Respondent's Proposed Findings of Fact. For purposes of these rulings, the Respondent's unnumbered paragraphs of proposed findings of fact are assigned consecutive numbers. 1.-3. Accepted but subordinate and unnecessary. 4.-6. Accepted and incorporated to the extent not subordinate or unnecessary. 7. As to the second sentence, a "transverse colostomy" was discussed, not a "transverse colonoscopy." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 8.-9. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to facts found and to the greater weight of the evidence that there was no delay. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. Subordinate and unnecessary. COPIES FURNISHED: Barbara Makant, Esquire Steven A. Rothenburg Senior Attorney Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Hugh Smith, Esquire P. O. Box 3288 Tampa, Florida 33601 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire Acting General Counsel Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue for consideration is whether Respondent, Sarasota County Public Hospital Board's, (Board), Motion To Dismiss HCA of Florida, Inc.'s (Doctors), Petition For Formal Administrative Proceedings should be granted.
Findings Of Fact On June 26, 1990, the Board filed CON application No. 6347, seeking approval to construct a comprehensive outpatient center and medical office complex on the campus of Sarasota Memorial Hospital. The new facility, anticipated to have a cost of slightly in excess of $18,000,000.00, was to house several outpatient functions including: outpatient registration outpatient diagnostic radiology outpatient laboratory services outpatient rehabilitative services outpatient cardiology diagnostic center outpatient dialysis Health resources center, and an office building located adjacent to the existing ambulatory surgical center. On or about July 13, 1990, the Department of Health and Rehabilitative Services, (Department), issued its State Agency Action Report, (SAAR), in which it indicated a preliminary decision to approve the subject application in its entirety, designating the project reviewable under Section 381.706(2)(d), Florida Statutes. Notice of this decision was published in the Florida Administrative Weekly on August 3, 1990. On August 14, 1990, Doctors filed a Petition For Formal Administrative Hearing challenging the preliminary approval, claiming that components of the project are reviewable under several subsections of Section 381.706(1), Florida Statutes. Specifically, Doctors claims that the operation of a home health agency from the complex renders it reviewable under subsection (f); that as the project constitutes a substantial change in the provision of inpatient services, or establishes new inpatient services, it is reviewable under subsection (h); and that it is an additional health care facility which is reviewable pursuant to subsection (b). Doctors also claims the new facility will hurt its ability to compete for patient referrals from physicians who will be housed in the new facility and will result in a reduction of Doctors' market share. Doctors is an existing hospital that provides a full range of acute care services to residents of Sarasota County. The Board's application contends that the development of this complex will free up capacity in key ancillary areas to better accommodate patients, and it is so found. The ambulatory diagnostic and treatment space proposed for the new facility represents what would have otherwise been less efficient additions to the existing departments. There will also be a bridge connecting the main hospital to the new center which will provide convenient access to any outpatient who may need to visit the hospital. It will also provide, "... direct linkage between the acute inpatient facility with the physicians' offices thereby enhancing pertinent access to a range of diagnostic and treatment services." Doctors contends in its Petition that it is the Board's clear intention and expectation to increase its service area and market share of Sarasota County patients as a result of this project. It asserts that if the Board's project is implemented, it will be serving different patients, and a different patient mix from a different geographical area than currently served. For the purpose of resolving the limited issues at this motion hearing, these assertions are accepted as fact. Accepting the assertions in paragraph 5 through 7, above, as fact, however, does not necessarily require the conclusions be reached that the accomplishment of the Board's project would result in any significant change to the level of its patient service since what is planned deals only with outpatient services. While Doctors disputes this, its claims that inpatient services would be effected is not supported.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore RECOMMENDED that the Secretary, Department of Health and Rehabilitative Services, enter a Final Order dismissing HCA of Florida, Inc.'s Petition in opposition to the grant of CON No. 6347 to the Sarasota County Public Hospital Board. RECOMMENDED this 15th day of October, 1990, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of October, 1990. COPIES FURNISHED: Robert A. Weiss, Esq. Parker, Hudson, Rainer & Dobbs The Perkins House 118 N. Gadsden Street Tallahassee, Florida 32301 John Radey, Esq. Elizabeth McArthur, Esq. Aurell, Radey, Hinkle & Thomas Suite 1000, 101 North Monroe Street Post Office Drawer 11307 Tallahassee, Florida 32302 Edward G. Labrador, Esq. Department of Health and Rehabilitative Services 2727 Mahan Drive, Suite 103 Tallahassee, Florida 32308
The Issue Whether Respondent committed the violations alleged in the Amended Administrative Complaint? If so, what disciplinary action should be taken against him?
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Agency is a state government licensing and regulatory agency. Respondent is now, and has been since approximately 1968 or 1969, a physician licensed to practice medicine in the State of Florida. He holds license number ME 0014162. 3/ Since the completion of his residency in December of 1971, Respondent has specialized in orthopedics. He currently is chief of orthopedics at Broward General Hospital. Respondent has not had any training in psychotherapy other than that which he received in a psychiatry class that he was required to take in medical school. His training in biofeedback is limited to that which he received during his residency over a period of three or four years as a result of his involvement in the treatment, with biofeedback, of approximately 15 or 20 patients. Deborah F. Cowart has a M.S. degree in counseling/guidance that she received from Nova University in 1981 and a Ph.D. degree in clinical psychology that she received from Kensington University in California in 1985. Although she is now, and has been since January 31, 1991, licensed as a mental health counselor in the State of Florida, at no time material to the instant case did Dr. Cowart hold a license to engage in mental health counseling or any profession regulated by the state. In 1986, Dr. Cowart opened the Center for Psychological and Diagnostic Services (hereinafter referred to as the "Center") in Fort Lauderdale. The Center provided pain management counseling and biofeedback services to those suffering from chronic pain. (Biofeedback is recognized in the medical community as an acceptable therapeutic modality for the treatment of chronic pain.) Dr. Cowart was the operator and sole owner, through a professional association, of the Center. In addition to her administrative duties, she worked at the Center as a therapist directly providing pain management counseling and biofeedback services to patients. At all times material to the instant case, Respondent was the Center's medical director. Initially, he served in this capacity pursuant to an oral agreement that he had with Dr. Cowart. In or around the latter part of 1990, the agreement was reduced to writing. As medical director, Respondent was a member of the Center's pain management team. He did orthopedic consultations. In addition, he conferred with the Center's two therapists, Dr. Cowart and Philip Schmidt, concerning the progress of their patients and, based upon the information they furnished him, determined, with regard to each patient discussed, whether the course of treatment and therapy the patient was receiving was medically appropriate and necessary and should continue. In this respect, Respondent "supervised" Dr. Cowart and Schmidt. At no time, however, did Respondent ever advise Dr. Cowart or Schmidt as to how they should perform the pain management counseling and biofeedback services they provided their patients, nor was he physically present when these services were rendered. Respondent himself never provided such services to any of the Center's patients. In his role as the Center's medical director, Respondent was not required to, nor did he, perform any task he was not qualified to perform. When Dr. Cowart first approached Respondent about becoming the Center's medical director, she offered to pay him a "stipend" of $1,000.00 a month for his services. Dr. Cowart, however, subsequently determined that she was not able to pay Respondent that large a stipend. She and Respondent thereafter agreed that she would pay him whatever she deemed to be appropriate, given the number of hours Respondent devoted to his medical director duties and her ability to pay him. 4/ In 1988 and 1989, Dr. Cowart paid Respondent $2,970.00 and $7,475.00, respectively, for serving as the Center's medical director. During the time that he was the Center's medical director, Respondent referred orthopedic patients of his to the Center. He did not receive a kickback from Dr. Cowart for making these referrals. While Dr. Cowart made payments to Respondent, these payments were made to compensate Respondent for performing his duties as the Center's medical director, not for referring patients to the Center. One of the patients that Respondent referred to the Center was W.K., a thirty-year old man suffering from arm, neck and back pain as a result of an on- the-job injury. W.K. had been referred to Respondent by his employer's workers' compensation insurance carrier "for a second opinion." Respondent first saw W.K. on April 8, 1986. On this initial visit, he took a history from W.K. and examined him. Respondent's impression was that W.K. had an "acute cervical sprain resolving" and "acute lumbar sprain resolving." Respondent referred W.K. to the Center on May 20, 1986, after determining that W.K.'s problem was more of a "psychological" one and that there was little, if anything, that he was able to do orthopedically to help W.K. Respondent made the referral, not for his own or Dr. Cowart's personal gain, but because he reasonably believed that it was in W.K.'s best interest to receive the services that the Center provided. At the time he made the referral, as well as at all other times material to the instant case, Respondent did not know, nor did he have reason to believe, that Dr. Cowart was not qualified, by training, experience or licensure, to perform these services. 5/ Pursuant to Respondent's authorization, Dr. Cowart held a total of approximately 111 or 116 pain management counseling and biofeedback therapy sessions with W.K., for which she sought and received payment from Cigna Insurance Company. With Respondent's permission, Dr. Cowart put Respondent's Florida medical license number on the insurance claim forms she submitted to Cigna. In filling out the claim forms, Dr. Cowart used the procedure code for "psychotherapy," 90844, to bill for the pain management counseling services provided W.K. She believed that, in so doing, she was using the correct procedure code to describe these services. 6/ Respondent did not have any reason to believe that any of the information on the forms Dr. Cowart filled out was false. Throughout the period that W.K. received treatment at the Center, Dr. Cowart and Respondent conferred on a regular basis to discuss W.K.'s case. Based upon what Dr. Cowart told him about the progress W.K. was making and what he knew about W.K. as a result of his contact with the patient, Respondent authorized the continuation of the pain management counseling and biofeedback therapy W.K. was receiving at the Center.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board of Medicine enter a final order dismissing the Amended Administrative Complaint issued against Respondent in its entirety. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 23rd day of May, 1995. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of May, 1995.
The Issue Whether Respondent violated Subsections 458.331(1)(d), 458.331(1)(n), and 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact Hammesfahr is a licensed physician in the State of Florida, having been issued Florida License ME 52212 on February 8, 1988. He is board-certified in neurology and pain management. Hammesfahr's office is located in Clearwater, Florida, where he maintains a practice treating patients who have had strokes. A stroke is a blockage of an artery in the brain that causes damage to the brain. As a result of the stroke certain cells within the brain will die, and the victim will develop a multitude of deficits, including paralysis, loss of vision, sensory loss, and memory problems. Between 1998 and 2000, Hammesfahr advertised his treatment for stroke patients and included the following statements in some of his advertisements: Using advanced technology, Dr. Hammesfahr has developed a sophisticated method to help restore blood flow to the damaged areas of the brain after a stroke. With increased blood flow to these areas, the brain can heal. Dr. Hammesfahr is the first physician to treat and successfully reverse the effects of stroke using vasodilators. These advertisements have appeared in Florida and in airline magazines, which travel throughout the country. In some of his advertisements, Hammesfahr indicated that based on an evaluation of the first 67 patients who went through the therapy 82 percent had major improvement, 11.9 percent had minor improvement, and 6 percent had no improvement. He further indicated that the study showing these results was peer-reviewed. Generally, Hammesfahr's treatment protocol is based on the concept of dilating blood vessels in the brain to optimize neurological function and neurological recovery. He uses vasodilator medications to dilate blood vessels in the brain and to increase blood flow into the brain. Various methods are used to monitor the therapy and improvement, including ultrasound, physical examinations, neuropsychological and physical therapy testing, EEG, transcranial Doppler, and blood pressure monitoring. Medications used to dilate the blood vessels include ACE inhibitors, calcium channel blockers, nitrates, alpha and beta blockers, and sympatholytics. After a stroke has occurred, brain cells in the center of the stroke are destroyed and cannot be revived. The area next to the stroke center is called the penumbra and consists of brain cells that are damaged and might recover. Hammesfahr does not claim that his treatment protocol can restore the brain cells that have been destroyed. He does claim that by using his protocol there may be some recovery in the damaged areas, where the blood vessels have restricted and narrowed. The medications dilate the vessels and increase the blood flow to the damaged areas. The recovery of a stroke patient consists of three phases: acute, subacute, and chronic. The acute phase occurs from the onset of the stroke to the next few days or weeks thereafter. The subacute phase starts at the end of the acute phase and lasts for approximately six weeks to three months. However, in certain cases it might last as long as 18 months. The chronic phase is the last phase, which commences at the end of the subacute phase and lasts for an indefinite period. Hammesfahr usually treats stroke patients who are in the chronic phase, but has also treated patients in the other phases of stroke recovery. When a patient contacts Hammesfahr concerning his stroke treatment, the patient will be sent a new patient package, which describes the phases of treatment, contains articles written by Hammesfahr concerning his treatment, and includes a fee schedule. Hammesfahr has different treatment plans from which the patient may choose to participate. The costs for the treatment vary according to the plan; the longer the patient is seen in Clearwater by Hammesfahr, the more costly the treatment. The average patient seen by Hammesfahr opts for the three-week plan. If a patient decides that he wants to be treated by Hammesfahr, the patient is required to see his primary care physician, provide the physician with the articles contained in the new patient package, and obtain his medical records from the physician. The primary care physician is to perform certain tests on the patient and give a medical clearance for the patient to travel to Clearwater, Florida, for treatment by Hammesfahr. The patient is also sent a package of materials, which includes a medical history form to be filled out by the patient and brought to Hammesfahr when the patient comes to Clearwater for treatment. When the patient initially presents for treatment at Clearwater, the patient is given an explanation of the treatment by Hammesfahr and his staff. Patients are advised that there are no guarantees that the treatment will be successful. An intake is performed to make sure that the needed forms are properly completed, including a history of the patient to determine that the patient's primary care physician has given the patient a clearance to come to Hammesfahr for treatment, and to review the medical records of the patient. A physical examination is performed on the patient. The patient is given a schedule for the time that the patient will be in treatment in Clearwater, and Hammesfahr's staff reviews the schedule with the patient. Tests are performed on the patient in Hammesfahr's office such as the transcranial Doppler ultrasound to generally determine the blood velocity. The patient is sent to Diane Hartley, a physical therapist, for testing of gross motor function, and to Dr. Alexander Gimon for neuropsychological testing. The tests given by Ms. Hartley and Dr. Gimon are standardized tests, for which the patient normally pays additional fees. The initial tests by Ms. Hartley and Dr. Gimon are given to form a baseline for a comparison with later test results. Those patients who are three-week patients will also have examinations by Ms. Hartley and Dr. Gimon at the end of their treatment period. The test results are compared with the test results taken at the beginning of the treatment period. The patient receives an orientation session in which the patient is informed of the responsibilities that the patient has during the course of treatment. Such responsibilities include taking blood pressure measurements at prescribed times of the day, charting the results of the blood pressure test, and seeing and providing the patient's primary care physician with the blood pressure readings. The patient must drink eight glasses of water a day, unless the patient has a heart disease, and must avoid certain types of foods that are vasoconstrictors. Once the patient completes the treatment at Hammesfahr's office, the primary care physician will take over the medical management of the patient's treatment. Hammesfahr's office will confer with the patient's primary care physician after the patient leaves Hammesfahr's office to discuss the monitoring of the patient and the altering of the patient's medication. One week after returning from treatment in Clearwater with Hammesfahr, the patient must see his primary care physician. In October 1999, a friend of M.T. mailed M.T. one of Hammesfahr's advertisements. As result of receiving the advertisement, M.T. contacted Hammesfahr's clinic and sought treatment from him for a stroke which she suffered in May 1999. Hammesfahr sent M.T. an information package and a videotape. The package contained articles written by Hammesfahr, a description of the different programs available, and a price list for the programs. M.T. decided that she would try a three-day program for $3,000. There was a dispute as to exactly which program M.T. received when she went to Clearwater. The only two programs which Hammesfahr listed as costing $3,000 were the Executive Stroke Prevention Program and the One-Week Evaluation and Treatment Program. The Executive Stroke Prevention Program was described as follows: This is a three (3) day program in which patients will undergo CAT scan and MRI at our facility, state of the art computerized EEG, and transcranial ultrasound to look at the blood vessels of the brain. They will undergo a comprehensive medical review and family review, as well as recommendations for lowering one's chances of a stroke or to treat if there has been a stroke in the past. This program is not covered by insurance. The One-Week Evaluation and Treatment Program was described as follows: This program is designed for those who want to start the stroke program and have the program advanced to a level which makes it significantly easier for the family physicians at home and neurologists to continue the program safely and rapidly. The first days [sic] involved in the initial evaluation, as well as any testing such as EEG and ultrasound testing, if necessary, and CT scans and MRIs as well as blood tests, followed by days two through five being involved in the initiation of medical treatment in that either treating the previous stroke or preventing future strokes. Recommendations are then made to the family physician or neurologists for caring through on this program. There was an additional three-day program, Initial Evaluation and Treatment, which listed for $2,000 and provided the following: This is a three (3) day consultation and evaluation with recommendations for treatment. This program is designed for patients who are interested in treatment of their stroke by their family physicians at home. A comprehensive evaluation will be made by our physicians as well as treatment recommendations. This evaluation will include review of CAT scans or MRIs and blood tests, and when appropriate, computerized EEG testing, neuropsychological testing, and ultrasound evaluations. The program is approximately three days. Prior to traveling to Hammesfahr's clinic, M.T. was directed by Hammesfahr to obtain medical tests from her primary care physician, which she did. The tests included a CT scan of the brain, a CMP, liver profile, CBC with different platelets, Westergren's sed rate, EEG, CVA, and EKG. She was also required to take and write down her blood pressure two times a day for a week before going to Hammesfahr's clinic. M.T. also filled out a medical history form and a system review checklist prior to her visit to Hammesfahr. In a letter dated February 12, 2000, to M.T. on Hammesfahr's letterhead, his office staff described the treatment that M.T. would receive as follows: Your first visits with us will be quite long. So, plan accordingly. On your first day, you will have a consultation with the doctor. The second day you will have diagnostic testing in our office, and an appointment with Dr. Gimon for a neuro- psychological evaluation and Diane Hartley for a physical therapy evaluation. Both of these doctors will be calling you to set up these appointments. The neuro-psychological testing will help us to evaluate any memory changes. You will probably see Dr. Gimon again towards the end of your treatment. On Tuesdays and Thursdays there is an orientation session outlining what we will be doing here in the office and [sic] explaining our treatment program will be given out. Each new patient must attend one of these sessions. Every day thereafter, your visit will be at least two (2) hours long. As you know, our treatment consists of sessions in this office each day Monday through Friday for the duration of your therapy. Please note: No warranties or guarantees can be made regarding the time, the degree, or the duration of improvement with this therapy. On February 20, 2000, M.T. signed a Waiver for Use of Medications, which stated: I am, or my caregiver is, aware that I have had a neurological disease and have failed to respond to other types of medications used in the conservative management of my condition. . . . Options available to me at this time are those now used at the Florida Neurological Institute. I am aware that the medications used in this therapy are medications that have FDA approval. However, I am also aware that the FDA has not approved these medications in the doses and number of medications used here at the Institute. I am aware that Dr. Hammesfahr has published many articles on his therapy. I am aware of the fact that, during the past two years, the Institute has treated many patients with similar conditions and that most have had at least some improvement in the symptoms associated with their problem. I have, and my caregiver has, been counseled regarding this theory under which this therapy is being promulgated. Upon arrival at the Florida Neurological Institute, I and my caregiver, will see and listen to the videotapes available regarding this therapy. I have, or my caregiver has, read this waiver and understands its contents. I am, and my caregiver is, aware that there is no indicated use for this therapy now. I have had all questions I may have concerning the use of these medications answered, I agree to undergo the use of these medications as outlined in the material presented to me. As stated above, I am fully aware of the fact that this therapy probably will not be covered by my insurance, but I wish to continue with this therapy as outlined to me in my training and information sessions. I also understand that no physician, or any other person in this office, can make any guarantees of success from this therapy. (Emphasis in the original) On February 28, 2000, M.T., accompanied by her husband, presented to Hammesfahr's clinic in Clearwater, Florida, for treatment. On her first day at the clinic, she received an orientation. She was required to pay $3,000 for her treatment. A staff member at Hammesfahr's clinic took M.T.'s blood pressure and directed M.T. to take her own blood pressure readings thereafter. On the second day of treatment, February 29, 2000, M.T. was sent to Dr. Alexander Gimon, a neuropsychologist, for a 30-minute evaluation. A staff member of Hammesfahr's clinic gave M.T. a transcranial Doppler, a carotid artery ultrasound, and an electrocardiogram. A Physician's Office Visit History and Physical Examination Form was filled out with a date of "2-28-00" struck through at the top of the form and the date of "2-29-00" placed next to it. At the end of the form appeared a physician's statement signed by Hammesfahr and dated February 22, 2000, a week before M.T. presented for treatment, stating that he had "examined this patient, reviewed his/her history, and consulted with him/her and the caregiver regarding the treatment planned here at Florida Neurological Institute." An Objective (Physical Examination) form was filled out, again with the date of "2-28-00" struck through at the top of the form and the date "2-29-00" placed next to it. The form does not indicate who performed the physical examination. The form does indicate that M.T.'s blood pressure and pulse readings were taken. M.T. met with Hammesfahr, who observed her gait and told her that he would send her back home and would work with her physicians. He did not prescribe any medications at that time and did not give M.T. any medications during her treatment at his clinic. On March 1, 2000, M.T. was supposed to meet with the physical therapist, Diane Hartley, for evaluation at 8:00 a.m. When she arrived at Ms. Hartley's facility, no one was there to let M.T. in the building. When M.T. went into the facility, she did not like the looks of the building, describing it as "shoddy looking." She decided that she did not want to stay for an evaluation and left. The fee Hammesfahr charged M.T. included the fees for Dr. Gimon and Ms. Hartley. On March 1, 2000, M.T. and her husband returned home with the understanding that Hammesfahr would be contacting her doctors in Alabama to arrange for the administering of the medications. M.T. was told to make an appointment with her primary care physician for the week after she returned from Clearwater. Hammesfahr first communicated with M.T.'s physicians by letter, dated April 5, 2000, asking them to administer the vasodilators and magnesium sulfate I.V.'s. M.T.'s physicians in Alabama refused to administer the medications. M.T. did not take the vasodilators, which Hammesfahr wanted her physicians to administer; nevertheless, M.T. improved. Based on the rate schedule presented to M.T. for Hammesfahr's various treatment programs, she should have received either the Executive Stroke Prevention Program or the One-Week Evaluation and Treatment Program. Hammesfahr was adamant that M.T. did not sign up for the Executive Stroke Prevention Program, and the evidence established that she did not receive this program. M.T. was given an itinerary that indicated that she would be treated by Hammesfahr for a week; however the evidence established that she did not receive the treatment that was supposed to be given in the One-Week Evaluation and Treatment Program, which promised that the initiation of medical treatment would be done on days two through five. Hammesfahr did not administer any medications or prescribe any medications for M.T. during her stay in Clearwater. The evidence does show that M.T. received the three-day Initial Evaluation and Treatment Program, for which she should have been charged only $2,000. Hammesfahr presented the expert testimony of Dr. Jacob Green, who is a board-certified neurologist, practicing in Jacksonville, Florida. He has been practicing for over 35 years. Dr. Green has written papers on the use of transcranial Doppler, and he is experienced in the treatment of acute and chronic stroke patients. Dr. Green is familiar with the protocol and procedure utilized by Hammesfahr in treating stroke patients. He has read articles written by Hammesfahr, reviewed patients' records, and spent a day in Hammesfahr's office observing Hammesfahr's practice and treatment protocol which is at issue in this case. While he was at Hammesfahr's clinic, Dr. Green observed Hammesfahr treat patients, reviewed medical records of patients when they first came to Hammesfahr for treatment, and compared the findings in those records to his observations of the patients' abilities. Dr. Green discussed the treatment and protocol with Hammesfahr. Based on his deposition testimony, Dr. Green had a good understanding of the treatment and protocol used by Hammesfahr for stroke patients. Dr. Green described the standard of care for a stroke patient as "to do good by the patient, do no harm." According to Dr. Green, Hammesfahr's care and treatment and protocol complied with the standard of care. Hammesfahr presented the expert testimony of Dr. William Scott Russell, Jr., a retired neurologist with 33 years of experience. In his practice, he had treated thousands of stroke patients. Dr. Russell retired in October 1998. Dr. Russell had first-hand knowledge of the protocol used by Hammesfahr when he treated Dr. Russell for an acute stroke. Prior to Dr. Russell's being treated by Hammesfahr, Dr. Russell had reviewed a paper written by Hammesfahr concerning Hammesfahr's treatment protocol for stroke victims using vasodilators. Dr. Russell considered the treatment protocol espoused by Hammesfahr to not be below the standard of care as of 1998. In 1996, Dr. Russell experienced a stroke. When he awoke one morning, he was confused. He went to work and had difficulty with his abilities to speak and write. Dr. Russell realized that he was experiencing a stroke and had a technician in his office run an EEG. He had peer-reviewed some of Hammesfahr's papers prior to his stroke and was impressed with Hammesfahr's work. So, he contacted Hammesfahr and presented at Hammesfahr's clinic for treatment the day he experienced the stroke. Hammesfahr performed a transcranial Doppler on Dr. Russell and administered nitroglycerine to dilate Dr. Russell's blood vessels. Ten minutes after the nitroglycerine was administered, Dr. Russell's symptoms disappeared. Within a reasonable degree of medical probability, the cause of his recovery was the use of the nitroglycerine. Nitrates are used for acute stroke patients when the patient has an extremely high blood pressure. The nitrates lower the blood pressure and are given intravenously so that the medication can be discontinued immediately if the blood pressure should fall too low. There was no evidence presented to determine whether at the time that Hammesfahr administered nitroglycerine to Dr. Russell that Dr. Russell's blood pressure was high. At the time of the final hearing, Dr. Russell felt that he had total recovery from the stroke deficits. He has reduced his intake of medications prescribed by Hammesfahr and has not had a return of the deficits. The Department presented the testimony of four expert witnesses concerning the standard of care for treatment of stroke victims: Dr. Harold Charles Friend, Dr. Steven Novella, Dr. David F. Scales, and Dr. Thomas Hoffman. Dr. Hoffman has been practicing neurology in Melbourne, Florida, since 1982. Approximately five to ten percent of his patients have had a stroke or a cerebral vascular disease. He has read some of Hammesfahr's advertisements and viewed Hammesfahr's article on Hammesfahr's Internet web site. Dr. Hoffman understands Hammesfahr's protocol to be the use of medications to increase the cerebral blood flow and the use of the transcranial Doppler to direct the medication treatment by measuring the cerebral blood flow. Dr. Hoffman does not agree that the use of vasodilators increases the blood flow to the brain. There is a loss of cerebral autoregulation when a stroke occurs. According to Dr. Hoffman, the use of vasodilators can decrease the blood flow to the brain and worsen neurological functioning in acute stroke patients. It is the opinion of Dr. Hoffman that Hammesfahr's treatment of stroke patients falls below the standard of care for acute, subacute, and chronic stroke patients. Dr. Steven Novella is a neurologist and an assistant professor at Yale University. He received his medical license in Connecticut in 1993 and obtained his board certification in neurology in 1998. He treats stroke patients and is familiar with the appropriate treatment for stroke patients. Dr. Novella understands that the treatment for stroke patients which Hammesfahr advocates is the administration of vasodilators to expand blood vessels which have an insufficient blood supply due to constriction. He disagrees with Hammesfahr's theory, espousing that the blood vessels in the area of the brain that is not receiving enough blood flow will dilate as far as they can go and that the blood vessels will not respond to the vasodilators because the blood vessels are already maximally dilated. Dr. Novella is of the opinion that vasodilators may be used for stroke patients to reduce the risk of another stroke when the patient is hypertensive, but that the vasodilators should not be used as a method of reversing deficits caused by stroke. Dr. Harold Charles Friend is a board-certified neurologist, who has been practicing neurology for 26 years. He practices in Boca Raton, Florida. Approximately five to eight percent of his practice is dedicated to treating stroke patients. He is currently treating in excess of 500 stroke patients. Dr. Friend has reviewed the charts of two patients of Hammesfahr, an article written by Hammesfahr, some of Hammesfahr's advertisements, some newspaper articles, and an article authored by Hammesfahr, which appeared on an Internet site. Dr. Friend also saw a patient in his office that had previously been treated by Hammesfahr. Based on the information from these sources, Dr. Friend incorrectly understood that Hammesfahr's methodology was to basically lower the blood pressure of his patients in an attempt to restore dead cells. He also concluded that the patients seen by Hammesfahr were also receiving physical therapy at the time of treatment. Dr. Friend opined that Hammesfahr's treatment of chronic stroke victims did not comport with the standard of care recognized in the medical community. He further concluded that given the medications that Hammesfahr administers to his patients, that one would expect some adverse effects or no effect on the patients. The only mention in the record of a patient's being harmed by Hammesfahr's treatment was by Dr. Friend. Dr. Friend reviewed a medical chart of a patient who had worsened after treatment by Hammesfahr and had to go to another physician, Dr. Nassar Elmansoury, to correct the problem. The patient had been prescribed Accupril, ten milligrams four times a day, and nitroglycerine cream. Both medications are vasodilators. When the patient presented to Dr. Elmansoury, the patient was feeling worse and experiencing chest pain, dizziness, and disequilibrium. Dr. Elmansoury eliminated the nitroglycerine cream and reduced the amount of Accupril. Within two weeks, the patient was improved. Dr. David F. Scales is a board-certified neurologist, who has been practicing for 34 years. He currently practices in the Jacksonville, Florida, area at the Jacksonville Neurological Clinic. About 50 percent of his in-patient practice consists of stroke patients. Stroke patients comprise about 20 to 25 percent of the entire practice. Dr. Scales has reviewed the medical records of two of Hammesfahr's patients, articles written by Hammesfahr, literature provided by Hammesfahr to his patients, and Hammesfahr's Internet web site. Dr. Scales understands Hammesfahr's theory to be that vasodilators are administered to dilate the blood vessels in the brain so that more blood flows through the penumbra, reactivating neurons that were in a suspended state of activation. He does not agree with Hammesfahr's theory because the blood vessels in the penumbra would be dilated to the maximum and the medications would dilate blood vessels in other parts of the body, which would in turn take away or steal the blood flow from the blood vessels in the penumbra. After reviewing the medical records of two of Hammesfahr's patients, M.T. and M.S., Dr. Scales was of the opinion that the treatment provided by Hammesfahr did not meet the standard of care for the treatment of stroke patients. Having considered the testimony of the experts presented by the parties, it is determined that the standard of care for the treatment of stroke patients varies according to the stage, type, and severity of the stroke. In the acute stage, the patient is admitted to the hospital. A medical history is taken and a physical exam is given, followed by appropriate laboratory and imaging studies to determine the site and cause of the stroke. For patients seen within three hours of the onset of the stroke, certain intravenous medications may be given in an attempt to break up the blood clot. For patients seen beyond the three-hour point, the treatment is maintenance of their blood pressure, monitoring of their vital signs, and treating any complications that may occur such as pneumonia and urinary tract infections. Patients may be given blood thinners to improve the flow of the blood, and medication to increase the blood pressure in the event the blood pressure is too low. Patients with severe hypertension, generally a blood pressure over 220 systolic or 120 diastolic, are given medications to lower their blood pressure. Patients with asymptomatic hypertension are treated judiciously during their hospital stay with anti-hypertensive medications, and the blood pressure is gradually lowered. The standard of care for subacute stroke patients is a continuation of the treatment given in the acute phase. Patients will be started on rehabilitation therapy, which may include speech, occupational, and physical therapy. The standard of care for chronic stroke patients, whom the physician is seeing for the first time, would be to take a history to determine what happened, review the medical records and any imaging studies that may have been done, and review the treatment they have had. The physician should assess the patients' risk factors for stroke such as hypertension, hyperlipidemia, diabetes, and smoking and manage those factors aggressively. Treatment with antiplatelets such as aspirin or an anticoagulation medication might be indicated. An assessment of their neurological functional abilities should be done to determine whether aids, braces, further therapy, or home care could be beneficial. Based upon the evidence presented, the treatment advocated by Hammesfahr is not within the generally accepted standard of care. However, the evidence is not clear and convincing that the treatment used by Hammesfahr is harmful to his patients. There is literature in the medical community that vasodilators can be used in the treatment of stroke as a measure to prevent future strokes. There is evidence that in over 200 patients seen by Hammesfahr that a large percentage improved after being treated by Hammesfahr. Dr. Gimon tested a group of 168 stroke patients seen at Hammesfahr's clinic during the period of November 1999 to May 2000 and another group of 163 stroke patients seen during October 2000 through February 2001. The same battery of tests was administered to both groups. Dr. Gimon evaluated these patients on nine separate neurological evaluations that are standard instruments recognized in neuropsychology. The tests measured identified areas of brain function, including verbal, visual, visual motor, and conceptual thinking. Both groups of patients were tested prior to the treatment by Hammesfahr. The patients were tested again approximately 18 to 21 days after they began treatment at Hammesfahr's clinic. The test results showed that many patients showed improvements in the areas tested. The improvements noted were measured as to a statistical difference so that the findings could not be attributable to testing error. Some patients showed no improvement in all areas. The test results revealed that there was no neuropsychological deterioration of the patients tested. Diane Hartley tested two groups of Hammesfahr's patients, who were treated at his clinic during the period of January to December 2000. Her tests were designed to measure functional motor improvement from a gross motor standpoint. She performed tests on the patients prior to their beginning treatment with Hammesfahr and again approximately two and one half to three weeks after the patients had begun treatment. Of the 242 patients tested by Ms. Hartley, 221 patients demonstrated improvement in one or more of the areas tested and 21 patients showed no improvement. Of the patients tested, ten received physical therapy from Ms. Hartley while they were being treated by Hammesfahr. These ten patients demonstrated a significant amount of improvement, which Ms. Hartley could not attribute solely to the physical therapy they received. The evidence establishes that Hammesfahr informed his patients by the use of videos, orientation sessions, literature, and a web site on the Internet of the nature of the therapy and did not guarantee that the patients would improve as a result of the treatment. Patients were able to make an informed decision on whether to try Hammesfahr' treatment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Hammesfahr did not violate Subsections 458.331(1)(d) and 458.331(1)(t), Florida Statutes; finding that Hammesfahr did violate Subsection 458.331(1)(n), Florida Statutes; placing Hammesfahr on probation for six months; and imposing a $2,000 administrative fine. DONE AND ENTERED this 20th day of November, 2002, in Tallahassee, Leon County, Florida. _____ SUSAN B. KIRKLAND 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 20th day of November, 2002.
Findings Of Fact The allegations against Petitioner in the underlying proceeding were all connected with his use of Grenz Ray therapy, a safe, rapid, and painless procedure for the patient. It has been used for the treatment of benign skin diseases for more than sixty years. The National Academy of Sciences in 1980 affirmed the safety factor inherent in the use of Grenz Rays and strongly endorsed the concept that it remained the prerogative of the physician to use any form of therapy in which the benefits accruing to the patient from its use are considered to outweigh the risks inherent in its use. The American Academy of Dermatology at its 1991 annual meeting offered lectures and a symposium on the beneficial use of Grenz Ray therapy. Medical schools have taught dermatologists the beneficial use of Grenz Ray therapy for many decades. Many doctors use Grenz Ray therapy as a modality of treatment. Until the underlying proceeding arose, Dr. Altman's use of Grenz Ray therapy had never been questioned by any federal or state regulatory agency. Until the underlying proceeding arose, no claim for Grenz Ray therapy rendered by Dr. Altman had ever been declined by any third-party payor, and all claims submitted by him to the Department for Grenz Ray therapy had been paid for the two years that Dr. Altman had been participating as a provider in the Florida Medicaid Program prior to the Department's Emergency Termination Order. There is no statute or rule on either the federal or the state level which prohibits the use of Grenz Ray therapy. Moreover, the Department has no policy against the use of Grenz Ray therapy. Grenz Ray therapy as utilized by Dr. Altman is conservative. The Department offered no evidence in the underlying proceeding that Grenz Ray therapy as utilized by Dr. Altman is similar to utilizing the drug Thalidomide or causing exposure to asbestos, as alleged in the Department's Administrative Complaint. No patient has complained regarding the treatment provided to that patient by Dr. Altman. The investigation into Dr. Altman's use of Grenz Ray therapy was triggered by a computer search. The matter was then assigned to an investigator who had been employed by the Department for approximately one year who held herself out to have special training in radiation therapy as a certified oncology nurse. She based her investigation upon experts that began with the use of an expert personally known to her--her own dermatologist who also uses Grenz Ray therapy. Thereafter, one expert recommended another. At about the same time, she was investigating the use of Grenz Ray therapy by another dermatologist in the Broward County area, the same area in which Petitioner practices. Related to that investigation, the investigator was presented with articles strongly advocating the use of Grenz Ray therapy authored by yet another dermatologist utilizing Grenz Ray therapy in the Broward County area. At the same time, the investigator was also provided with information showing that training in Grenz Ray therapy was a requirement for completing a medical residency in dermatology. The investigator ignored those articles presented to her and failed to even speak to the author of the articles. On the other hand, the scientific studies, medical textbook chapters, and other medical articles relied upon by the investigator to show that Dr. Altman's use of Grenz Ray therapy was excessive, inferior, or inappropriate did not support that conclusion, but rather supported the opposite conclusion. The investigator did not understand that some of the articles she was reading related to higher levels of ionizing radiation than the ultra-soft Grenz Rays. Prior to initiating the Emergency Termination Order and the Administrative Complaint, the investigator never spoke to Dr. Altman concerning the services that he was providing. Instead, she went to Dr. Altman's office, advised him that Grenz Ray therapy was an outdated and antiquated modality, and picked up his medical records for the patients in question so that she could make copies of them to have them reviewed by her experts. Although she had no preconceived list of experts when she started her investigation, the investigator spoke to no practitioner who used Grenz Ray therapy on children and contacted no professional dermatologist associations regarding the use of Grenz Ray therapy by their members. Similarly, although her own dermatologist uses Grenz Ray therapy, the investigator "built a case" which alleged, essentially, that when Dr. Altman utilized Grenz Ray therapy, it was inappropriate. The investigator specifically made no attempt to contact any expert who would be favorable to Petitioner's use of Grenz Ray therapy. The investigator formed a mental impression that Petitioner's use of Grenz Ray therapy was inappropriate for children and excessive for adults when she reviewed the computer report of Dr. Altman's claims which had, up to that moment, been paid by the Department without question. Her investigation was thereafter dictated by her personal beliefs, and she ignored all evidence to the contrary. Based upon her investigation, the Department determined that it would take action. Although it could have simply terminated its contract with Petitioner without cause, it did not do so. Similarly, the Department did not request that Petitioner reimburse the Department for claims already paid by the Department. Rather, the Department issued an Emergency Termination Order followed by an Administrative Complaint seeking to terminate Dr. Altman from the Medicaid Program for five years and seeking to fine him the amount of $20,000. Although the Department was justified in conducting its investigation, it was not substantially justified at the time that the underlying action was initiated by the issuance of its Emergency Termination Order and Administrative Complaint.
Findings Of Fact At all times material, Respondent was licensed as an osteopathic physician in the state of Florida, having been issued license number 050004170. Respondent practices in the field of general surgery, and at all times material to this action, Respondent was on staff as Chief of Surgery at the University Hospital, Holly Hill, Florida. The incident which gave rise to the charges herein arose on August 5, 1987 when Respondent inserted a chest tube into patient W.T.'s right chest wall so as to relieve a pneumothorax which had actually occurred in W.T.'s left lung. A pneumothorax is a pocket of air in the cavity surrounding the lung which causes the lung to contract upon itself. At all times material, Patient W.T. had a subcutaneous pacemaker on the left side of her chest. However, the evidence from all credible witnesses is consistent that pacemakers are routinely placed on either the right or left side and that there is no reasonable medical presumption that pacemakers are always placed in someone's left chest area. The subcutaneous pacemaker did not enter significantly into W.T.'s case management at University Hospital. It operated on "automatic" and since it did its job, none of the University Hospital physicians involved in W.T.'s care paid much attention to it. W.T. was admitted to University Hospital for treatment of a drug overdose on July 9, 1987. As a part of her treatment, an Ewald tube was inserted into her stomach by a physician other than the Respondent. Patient W.T. was discharged from the hospital on July 18, 1987 with a portion of the tube inadvertently left in her stomach and her esophagus. On July 21, 1987, W.T. was readmitted to University Hospital. She was suffering from septicemia and bilateral pneumonia. X-rays revealed that a portion of the tubing had not been removed. This tubing was removed by the Respondent via successful gastroesophagoscopy on July 23, 1987. At Respondent's order, W.T. was placed in the Intensive Care Unit (ICU) following the removal of the tube. Dr. Desai was called in as a pulmonologist. When W.T. had been admitted to University Hospital on July 21, 1987, she already had been in a "guarded" condition. Despite successful removal of the Ewald tube, W.T.'s overall condition continued to deteriorate. Prior to the night of August 4, 1987, W.T. had developed adult respiratory distress syndrome (ARDS) which involves a breakdown in the capillary barriers within the lung itself, resulting in a diffuse leakage of fluid throughout all of the air space of the patient's lung. Because of the patient's serious lung condition, Dr. Desai placed her on a volume respirator, and the respirator pressure (PEEP) was progressively increased during her admission until it was set at 20 PEEP at the time of the incident. Twenty PEEP is an unusually high level of respirator pressure which was necessary in this case because of the patient's severe lung problem. The volume respirator essentially breathed for the patient and involved a tube being secured in her mouth. Often, between her admission to the ICU and the date of the incident, W.T. had torn the respirator tube out of her mouth, so she had been continuously restrained and sedated to keep this from happening again. Each time W.T. had extubated herself she had been "blue coded," meaning she had suffered either cardiac arrest or shock. Whether or not W.T. weighed between 225 and 250 pounds or weighed 350- plus pounds cannot be determined with any reasonable degree of accuracy since there is equally credible evidence over the entire foregoing range of poundage. It is material, however, that by all accounts of all witnesses, W.T. was markedly and grossly obese to the extent that her size, shape, and weight contributed to her several health problems and rendered her a patient more difficult to diagnose, more difficult to x-ray, more difficult to move, and more difficult to nurse and medically attend than she would have been otherwise. The evidence as to whether W.T.'s obesity impeded medical personnel from correctly interpreting her breath sounds on August 5, 1987, the date of the incident, is divided, as is the evidence as to whether or not on that date W.T.'s pacemaker was visible to the naked eye, but upon the greater weight of the credible evidence as a whole, it is found that on August 5, 1987, W.T.'s obesity, generally deteriorated condition, and left pneumothorax rendered the presence, volume, and location of breath in each lung subject to interpretation and "judgment call," and that unless one were specifically looking and feeling for a pacemaker, one would not necessarily have been able to detect the pacemaker in W.T.'s left chest due to the extraordinarily heavy pad of fat and the absence of scarring in that location. The foregoing finding of fact has been reached because with the exception of the complaining witness, Nurse Counihan, all factual witnesses either testified that they did not notice a pacemaker scar or they specifically noticed there was no scarring on W.T.'s chest. Also, with regard to breath sounds, both Mr. Starr and Respondent listened for W.T.'s breath sounds on the morning of the incident and within a very few minutes of each other. Mr. Starr described W.T.'s breath sounds when he entered her room as decreased on the right and absent on the left. His findings were consistent with a left pneumothorax but he never informed Respondent what he had found. Respondent arrived only a few minutes later and could not get any breath sounds from either side. Dr. O'Leary, accepted as an expert in pulmonology and the insertion of chest tubes, opined persuasively that one could not rely on breath sounds to locate which side the pneumothorax was on in the face of a recent x-ray. Also, the use of the respirator could have been misleading to either or both Mr. Starr or Respondent. X-rays taken of W.T.'s chest at least ten times between July 23, 1987 and July 31, 1987 clearly depict that the pacemaker was on the left side of W.T.'s chest. These x-rays were reviewed by Respondent with a radiologist the day before the events which are the focus of these charges took place. The radiology reports of W.T.'s chest x-rays dated July 25, 1987, July 28, 1987, and July 31, 1987 specifically mention the pacemaker but only the report dated July 28, 1987 states that the pacemaker overlies the left thorax. Respondent did not review any narrative reports when he and the radiologist were reviewing the actual x-rays together. There is no evidence that this procedure was outside the appropriate standard of care. Dr. Dworkin, expert in radiology and quality assurance and review, Dr. O'Leary, and Dr. Rosin, Petitioner's internal medicine expert, all testified that it is not below the professional standard of care for a treating physician to forget within a day after such an x-ray review which side a pacemaker is on unless the pacemaker enters significantly into his treatment of the patient, which in this case it did not. By the early morning hours of August 5, 1987, W.T. had become even more critically ill with multiple system failures, including a failure in the cardiopulmonary systems, a neurological deficit, and failure of her renal functions. The mortality rate of a patient suffering from ARDS, without considering the other conditions from which W.T. was suffering, exceeds 50%, and responsible medical retrospective estimates made at formal hearing of W.T.'s specific survival chances in the early morning hours of August 5, 1987 fall in the 10-50% range. During the early morning hours of August 5, 1987, the nurses on duty in ICU were having trouble maintaining W.T.'s blood pressure. They began telephoning Dr. Desai and Respondent at approximately 4:00 a.m. One of those doctors, most probably Dr. Desai, ordered a portable chest x-ray of W.T., which was accomplished at 6:30 a.m. by Josephine Christnagel, R.T., who is a registered x-ray technologist. At the time this x-ray was performed, W.T. was already in critical condition and could not speak or respond. W.T.'s condition was such that she probably was not salvageable when Respondent arrived on the scene at 7:00 a.m. on August 5, 1987. Unbeknownst to anyone at this point in time, the 6:30 a.m. x-ray had been inadvertently mislabeled by Ms. Christnagel so that the left side of the patient's chest appeared on the x-ray with a lead marker, "R" (for "right") , on it. This chest x-ray revealed that W.T. had a pneumothorax, and because it was mislabeled, the pneumothorax appeared to be on the right side. If a chest tube is properly inserted from the outside chest wall on the side of the pneumothorax, into the chest cavity, the air can be released and the lung can re-expand, delivering oxygen to the patient and raising blood pressure to normal. At all times material on August 4-5, 1987, the ranking ICU nurse on W.T.'s case was Carey Beninger ne' Counihan, R.N. The ICU nurses notified Dr. Desai by phone of the pneumothorax and he, in turn, notified Respondent. Because Respondent was more nearly ready to go to the hospital, Respondent rushed to the hospital to insert a chest tube into W.T., treatment which he and Dr. Desai, the attending pulmonologist, had agreed was the appropriate treatment for W.T.'s pneumothorax. For the reasons given infra with regard to the time the nurses' notes were compiled and Nurse Counihan's confusion over the x-ray itself, the evidence is not clear and convincing that Respondent was ever told by Dr. Desai or by the nurses by phone that the pneumothorax was on W.T.'s left side (the correct side). Even if Respondent had been so informed by Dr. Desai, since Dr. Desai had never seen the x-ray, it still would have been appropriate for Respondent to rely on the x-ray itself once he got to the hospital, unless at the hospital, something or someone clearly alerted him to the fact that the pneumothorax was actually on the left side. At approximately 7:00 a.m., just prior to the arrival of Respondent, Dr. Michael Danzig, D.O., who was the day-shift emergency room doctor, and Wesley Starr, R.P.T., a respiratory therapist, arrived at ICU and entered W.T.'s room. At approximately the time they arrived, the night-shift emergency room doctor, Dr. Haas, left the room. By all accounts, there was a continuing "commotion," a "ruckus," or "an emergency situation" in progress with at least two nurses, including Nurse Counihan, and other personnel providing various therapies to W.T. who had no palpable blood pressure and was in shock. This atmosphere continued after Respondent arrived shortly thereafter, with the nurses' and Mr. Starr's attention directed to care of the patient. When Respondent arrived, Dr. Danzig became, essentially, an observer. Upon arrival at W.T.'s room, Respondent examined the 6:30 a.m. x-ray against a window with daylight showing through. The x-ray, as it was mismarked, showed a massive tension pneumothorax on W.T.'s right side and a pacemaker on the same side, the right. After review of the x-ray, Respondent examined W.T., including listening for breath sounds. He heard nothing significant from either lung. Dr. O'Leary's opinion that such a finding was not unusual and that Respondent could not rely on either his own examination of breath sounds or that of Mr. Starr (had he even known of Mr. Starr's hearing breath sounds on the right but not the left) at that point is persuasive. Under these circumstances, breath sounds would not have alerted Respondent to a mislabeled x-ray. Respondent relied on the mislabeled x-ray and began to prep the right side of the patient for the chest tube. As Respondent began to prep W.T.'s right side, a dispute arose between himself and Nurse Counihan. Having weighed and evaluated all the testimony and the documentary evidence and exhibits, having reconciled that evidence which can be reconciled, and having eliminated that evidence which is not credible, it is found that the most credible version of this dispute is that Nurse Counihan asked Respondent why he was prepping the right side if W.T. had a left pneumothorax, and Respondent replied, "No, it isn't. Look at the x-ray." To this, Nurse Counihan said, "Yes, it is. I'm sure of it," and pointed to the lung on the x-ray which did not show a pneumothorax (the side next to the nameplate and the side without either a pacemaker or a pneumothorax). Respondent said, "No, it isn't. Look at the damn x-ray!" Respondent then proceeded to intubate on the right side while referring frequently to the mislabeled x-ray. In making the foregoing finding, it is noted that there were significant differences between the testimony of Nurse Counihan and all other witnesses, both factual and expert. Nurse Counihan deposed/testified that both she and another nurse had pointed out to Respondent that the patient's pacemaker was on the patient's left side and so was the pneumothorax. The other three factual witnesses, Starr, Danzig, and Respondent, all testified that they have no recollection whatsoever of anyone mentioning a pacemaker. Even Wesley Starr, called by the Petitioner, and who was present in W.T.'s room at the head of the patient's bed throughout the time of these discussions, testified that, to the best of his recollection, no one mentioned a pacemaker and that he did not recall anyone except Nurse Counihan challenging the Respondent's prepping W.T.'s right side. Also, Dr. Danzig, who was present in the room during the argument, and who testified that he had placed over 200 chest tubes during the course of his medical residency training, testified that if Nurse Counihan had, indeed, mentioned a pacemaker, he would have intervened in order to assist Respondent in determining the correct side of the pneumothorax. Although Petitioner asserted that Dr. Danzig is not credible due to his friendship with Respondent, that argument is not persuasive both due to the remoteness and degree of the friendship and Dr. Danzig's insistence that if Respondent should say that Nurse Counihan pointed to the side of the x-ray showing the pacemaker, then Respondent would be wrong. Respondent apparently did not review W.T.'s records either before or after the dispute with Nurse Counihan. These records were either in her room or elsewhere in the ICU unit, but since, at that point, the nurses' notes had not been compiled from their scratch pads to the patient's chart since before 4:00 a.m., there was nothing in W.T.'s chart/records to alert Respondent that the x- ray was mislabeled or that the patient had a pneumothorax on the left side even if he had reviewed the record. Also, he would have had to go back to the July 31 x-ray or the July 28 radiology narrative before he could have discovered that the pacemaker was on the left. This would have been very time consuming. Also, Dr. Danzig, who actually had made a cursory review of the patient's records when he first arrived in the room, was not alerted by Nurse Counihan's words or her pointing to the x-ray to any reason to search the records for information about the pacemaker. In further assessing Nurse Counihan's testimony, the undersigned has weighed in her favor the consistency of her recent deposition testimony with her notes and the incident report which she completed within five hours after the intubation incident on August 5, 1987. However, weighing against her credibility with regard to her statements then and now that she told Respondent that the pacemaker was on W.T.'s left side is the fact that even her August 5, 1987 report and notes were prepared in the glow of a hindsight favorable to her position and that her deposition shows that she is confused about how a pneumothorax appears on an x-ray. Reconciling all the testimony one can, it is remotely possible that Nurse Counihan said, "It is a left pneumothorax," while pointing to the lung shown on the x-ray as not having a pneumothorax and which, due to the "R" marker on the other lung could be inferred to be the left lung. It is even remotely possible (although not probable or persuasive given the three other factual witnesses' testimony that she had never mentioned a pacemaker) that Nurse Counihan could have told the Respondent, "The pneumothorax is on the same side as the pacemaker," which also was consistent with the x-ray as mislabeled. However, upon the credible evidence as a whole, the only reasonable conclusion is that if Nurse Counihan did mention a pacemaker at the time of her dispute with Respondent, she was ineffective in clearly conveying to Respondent or to anyone else in the room that the pacemaker and the pneumothorax were on the patient's left side or that there was any reason to further search the records or the patient's body to resolve the dispute. It is uncontroverted that, prior to the insertion of the chest tube in W.T.'s right side, absolutely no one, including Nurse Counihan, was aware that the x-ray was reversed, and that Ms. Counihan never informed the Respondent that the x-ray was reversed. Respondent's testimony is accepted that upon placement of the chest tube in W.T.'s right side (the side without the pneumothorax) he heard an immediate audible gush of air. That others in the room did not hear this rush of air is understandable due to the noise and confusion in the room, particularly the respirator sounds. Also, it is uncontroverted that upon placement of the chest tube in W.T.'s right side, the patient's blood pressure, which had been zero, immediately rose into normal range. A dramatic and rapid reestablishment of the patient's blood pressure is the expected result of a proper placement of a chest tube with a tension pneumothorax. All health care personnel present seem to have regarded the blood pressure stabilization as proof that the Respondent had placed the chest tube on the correct side of the patient, because no one, including Nurse Counihan, thereafter protested that a misplacement had occurred. Release of pressure and a return in blood pressure is not normally associated with placement of a chest tube in the wrong side of a patient and there is no definitive medical explanation of why it occurred in this instance, despite Dr. O'Leary's speculation that the gush of air could have been a leak of air across the Mediastrum. After placement of the chest tube in the patient's right side, Respondent ordered an immediate repeat chest x-ray to be certain the tube was placed in the correct lung and was placed correctly. After the patient's blood pressure had been reestablished, Dr. Danzig left the intensive care unit because he believed that the pneumothorax had been relieved completely and because the patient was now stable. If W.T. had not been stable, Dr. Danzig would have remained in the room since he was the day- shift emergency room doctor and he did not know if any physicians other than Respondent and himself were even in the hospital yet. After securing the chest tube and dressing the chest, Respondent left the floor and went to the operating room (OR) to notify the OR staff that there would be a delay before he could begin previously scheduled surgery. Thereafter, on his way to check the new x-ray he had just ordered, Respondent met Ms. Christnagel, who was bringing it to him. Ms. Christnagel then informed Respondent that she had mislabeled the 6:30 a.m. preintubation x-ray. Respondent simultaneously reviewed the new, postintubation x-ray and discovered that he had placed the chest tube in the wrong side of W.T.'s chest. At approximately the same time, W.T.'s blood pressure again dropped and a "code blue" was called. Dr. Gloria Mikula, M.D., who happened to be in the ICU at the time W.T. coded, "ran the code" to attempt to reestablish the patient's blood pressure. Throughout the time in which Dr. Mikula was running the code on this patient, no one, including Nurse Counihan, said anything to the effect that W.T. may have had a chest tube placed in the wrong side. In fact, the nursing staff did not even inform Dr. Mikula that this patient had had a pneumothorax and chest tube insertion prior to the code being called. Such information would have been important from a medical standpoint because it would have allowed Dr. Mikula to act immediately to relieve the tension in the patient's chest. Immediately upon reviewing the repeat chest x-ray and upon hearing the announcement of the code blue at the same time, Respondent rushed back to W.T.'s room, placed a chest tube in the patient's left side, and the patient's blood pressure was again reestablished. However, some time later in her hospitalization, W.T. expired. Nurse Counihan's failure to say anything to Dr. Mikula about the pneumothorax is further indicative of her immediate satisfaction that Respondent's intubation on the right side had been acceptable and that it was only after he discovered his error through the new x-ray and correctly intubated W.T. on the left side that Nurse Counihan completed her notes and incident report describing his error for the chart. The notes were transposed from her scratch pad and memory at approximately noon, August 5, 1987. Dr. Rosin, Petitioner's expert in internal medicine, criticized Respondent's performance as below the professional standard of care because he felt that once Respondent was made aware in the patient's room by Nurse Counihan that the pneumothorax could be on the patient's left side, Respondent had an obligation to make further inquiry or investigation before inserting the chest tube in the patient's right side. In Dr. Rosin's opinion, Respondent's investigation could have taken several routes: review of earlier x-rays and the patient's record, further conversation with the nurse, further hands-on examination of the patient for signs of the pacemaker, and/or ordering a new x- ray. Although Dr. Rosin testified that Respondent should have ordered a repeat x-ray so as to resolve the dispute with Nurse Counihan before inserting the chest tube on W.T.'s right side, he also conceded that the only possible adverse effect of the decision Respondent made was the delay in relieving W.T.'s condition. The chest intubation involved is not a benign or casual procedure, but no actual harm occasioned by misplacement of the chest tube was demonstrated in this case, and the maximum amount of time which would have been saved, under Dr. Rosin's approach, would have been that short period of time it took for the Respondent to place the chest tube and dress the wound. Under the circumstances, if Respondent had delayed intubation, W.T. would probably have "coded blue" before the correctly labelled chest x-ray could have been performed anyway. In light of the confused state of the patient's breath sounds, obesity, and lack of scarring, the fact that no nurses' notes had been codified since before 4:00 a.m., Nurse Counihan's own confusion about the mismarked x-ray, and how far back in the patient's chart Respondent would have had to look before he would have been able to locate anything useful about the pacemaker, it is found that Respondent behaved reasonably in an emergency situation, and Dr. O'Leary's and Dr. Dworkin's expert opinions that he did not violate the professional standard of care in the first insertion of the chest tube are accepted. It is also found that the Respondent's procedure in ordering the new chest x-ray and leaving the room after the first intubation without further search of the records or further conversation in the room was reasonable and appropriate under the circumstances.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Physicians enter a Final Order dismissing all charges against Respondent. DONE and ENTERED this 25th day of July, 1991, at Tallahassee, Florida. ELLA JANE P. DAVIS 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 25th day of July, 1991.
Findings Of Fact Petitioners, Manasota-88, Inc. and Concerned Citizens of Citrus County, Inc., filed their petition on August 9, 1985, challenging proposed rules 10D-91.1101 through 91.1109. These proposed rules were published in Vol. 11, No. 30., Florida Administrative Weekly, on July 26, 1985. Petitioner's Exhibit 1. The proposed rules cite sections 404.051(4) and 404.056, Florida Statutes, as authority for rulemaking. These sections provide: 404.051 Powers and duties of the Department of Health and Rehabilitative Services. --For protection of the public health and safety, the department is authorized to: * * * (4) Adopt, promulgate, amend, and repeal rules and standards which may provide for licensure, registration, or regulation relating to the manufacture, production, transportation, use, possession, handling, treatment, storage, disposal, sale, lease, or other disposition of radioactive material, including naturally occurring radioactive material and low-level radioactive waste, and radiation machines as may be necessary to carry out the provisions of this chapter. The recommendations of nationally recognized bodies in the field of radiation protection shall be taken into consideration in the adoption, promulgation, amendments, and repeal of such rules and standards. Land radiation emission standards. To preserve and protect the public health, the department is authorized to establish, by rule, and enforce any environmental standards for land which, either in its natural state or subsequent to mineral extraction, emits radiation. In the establishment of such rules, the department shall consider: Existing federal standards. The recommendations of nationally recognized bodies which are expert in the field of radiation protection. The effect on private or public water supplies. The use made, or to be made, of the land. The proposed use of the land for residential dwellings, public or private schools, or commercial buildings. The availability of measures to mitigate the effect of the radiation. (E.S.) Petitioner, Manasota-88, Inc., is an environmental health organization. T. 23. It was established in 1965. Id. Though the petition alleges that this Petitioner is a nonprofit corporation, there appears to be no record evidence of this point. Apparently this Petitioner has "members," see T. 23-24, but the record does not contain evidence of the relationship of those members to the alleged corporation. Some members of Manasota-88 own reclaimed phosphate land in Polk County, and Ms. Raines knew of about five such persons. T. 23. About 150 members of Manasota-88 live on mineralized land in Sarasota County. Members of Manasota- 88 work and shop in areas where commercial structures could possibly be built on reclaimed phosphate or mineralized land. T. 24. There was no proof of the number of "members" of Manasota-88, Inc. Ms. Raines is chairperson of Manasota-88, Inc., and was a member of the Governor's phosphate-related radiation task force. T. 24. Manasota-88, Inc. participated in all of the rule making hearings with respect to the proposed rules in question in this case. T. 26. Petitioner, Concerned Citizens of Citrus County, Inc., is an environmental organization formed to protect the natural resources of Citrus County through proper planning. T. 28. Miriam Cohen is secretary and a member of the board of directors. T. 27. The organization has 1500 members, living in all sections of Citrus County. T. Some members own reclaimed phosphate land in citrus county. Some live on reclaimed phosphate lands. Id. There is no direct evidence of the numbers of such persons, or direct proof of the alleged corporate structure of this Petitioner or its relationship to its members. Proposed rule 10D-91.1104 provides a goal that radiation exposure to the public from naturally occurring radiation be maintained "as close to normal background radiation levels as reasonably achievable," which is 0.009 working levels (WL) for the annual average radon decay product concentration. T. 34. The upper limit mandated by the rule as a ceiling, and not a goal, is 0.02 WL. Id. See Petitioner's exhibit 1, proposed rule 10D-91.1104. The proposed rule, in section 10D-91.1108, requires county health departments having certain defined lands within the county to conduct educational programs to advise the public that dwellings located on such lands have the potential of exceeding the standards set forth above. Such programs must include recommendations for periodic measurement and methods to effect remedial actions. T. 116. The lands are defined by proposed rule 10D-91.1106(1) to include lands which have previously been mined or reshaped as the result of the extraction of phosphate ore and mineralized lands known to contain uranium, thorium, or their decay products in such amounts that radiation could be in excess of the above standards. The proposed rule, in section 10D-91.1106(1)(b) provides that the Department of Natural Resources shall provide HRS with a description of such lands, and that HRS will disseminate such information to building inspection offices affected. The proposed rule has a notification procedure whereby certain test results are provided to owners of newly constructed dwellings when the above standard is exceeded. See proposed rule 10D-91.1106(2)(b) and (d). Other than the foregoing, the proposed rule does not require any other notice to persons. In particular, the proposed rule does not require that sellers or lessors give notice to prospective buyers or lessees. The proposed rule provides that newly constructed dwellings which do not use a construction technique described in section 10D-91.1106(2)(a) or (b), and which exceed the standards set forth above, must be remedied by the owner to comply with the standards. No other mandatory remediation is required. Remediation in these other cases is discretionary with the owners, although, as set forth above, county health offices must publicize remediation methods. New dwelling construction that uses "ventilated crawl spaces" as defined by the rule are exempt from testing. New dwelling construction on reclaimed phosphate land that uses "improved monolithic slab" or "post- tensioned slab" techniques as defined by the rule will be tested by HRS during the first year of occupancy using a track etch device or a thermoluminscent device. If the test results show that the standard is exceeded, the owners will be advised of the result and advised of discretionary remedial action that they can take. No testing is required of existing dwellings. Preoccupancy testing is required only of newly constructed dwellings which do not use one of the three construction techniques set forth above. The International Commission on Radiological Protection (ICRP) is a group of internationally known scientists. T. 105. The IRCP, in a 1983 report on radiation protection, recommended a standard of as low as reasonably achievable not to exceed 0.027 WL, which is higher than that in the proposed rule. T. 105; HRS exhibit 4, p.7. The National Council on Radiation Protection and Measurement (NCRP) recommends a standard of as low as reasonably achievable not to exceed 0.004 WL. T. 106-07; HRS exhibit 5, pp. 88-89; Petitioner's exhibit 25H, p. 13. The Governor's Phosphate Radiation Task Force of 1982 recommended 0.027 WL. Petitioner's exhibit 25F, p. 15. Other states have either considered or adopted the same standard as adopted in this proposed rule: as low as reasonably achievable not to exceed 0.02 WL. T. 98. In February, 1979, in a letter from the Environmental Protection Agency (EPA) to the Governor of Florida, the EPA recommended several standards for radiation levels on Florida phosphate lands. These recommendations were summarized on pp. 38665 and 38666 of Petitioner's exhibit 5. The first recommendation is that remedial action "should be taken" in all residences in which "the initial indoor air concentration of radon decay products exceeds 0.02 Working Level (WL), including normal indoor background." The second recommendation provides: II. When annual average air concentrations of radon decay products are less than 0.02 WL, remedial action required to reduce such concentrations to as low as reasonably achievable levels should be taken. Among the factors to be considered in determining the appropriate degree of reduction are the cost and effectiveness of available remedial measures, the health risk averted, the normal background level, the life expectancy of the structure, and measurement uncertainties. The third recommendation is that remedial action is not warranted in existing residences solely to reduce the indoor gamma radiation exposure rate. The fourth and final recommendation is that development sites for new residences be selected and prepared and the residences designed and sited so that the annual average indoor air concentration of radon decay products and gamma radiation does not exceed average normal background levels (indoor) plus uncertainties of normal background variation and measurement capability. The average normal indoor background level of radiation is about 0.004 WL for annual indoor air concentration of radon decay products, and 6 microroentgens per hour for gamma and x rays. Petitioner's exhibit 5, p. 38666. Uncertainties due to normal variations and measurement capability add 0.005 WL and 6 microroentgens, thus making the EPA "as low as reasonably achievable" standards to be 0.009 WL and 11 microroentgens per hour. Id.; T. 34. The supporting text of Petitioner's exhibit 5 makes it clear that the EPA did not recommend mandatory remediation below 0.02 WL. The technical information section states an attempt to achieve the "as low as reasonably achievable" standard would impose unreasonable costs in 15 percent of the cases. The technical information section further shows that costs and practicality are factors to be considered in trying to achieve lower levels: In order to provide flexibility to bring about remediation when costs are reasonable, remediation is recommended whenever responsible authorities determine that it is practicable to do so in the range between 0.02 WL (including normal indoor background) and 0.005 WL above normal background. (E.S.) Petitioner's exhibit 5, p. 38668. The technical information section describes the recommended standard for radon daughter product level below 0.02 WL as being "discretionary" with respect to remediation: The recommendations provide that when the radon daughter product level in existing homes is less than 0.02 WL (including normal background indoors) action be taken to reduce the radon concentration to as low as reasonably achievable levels. It is recognized that a discretionary policy such as this may complicate implementation of the recommendations since decisions must be made regarding which exposure level can be considered as low as reasonably achievable for each structure. To assist in making such decisions several factors should be considered: * * * 3. The cost to reduce the level should be evaluated . . . . * * * 5. The social and economic inconvenience to the to the inhabitants should be considered. Some inhabitants may find expenditures to install control technology prohibitive and a major disruption to their life styles. (E.S.) Petitioner's exhibit 5, p. 38669. On September 20, 1984, Richard J. Guimond, Director, Criteria and Standards Division, Office of Radiation Programs for the EPA, characterized the 0.02 WL as "a remedial action level," specifically referring to the letter which is Petitioner's exhibit 5, and characterized the reduction of radiation levels to a point not "significantly above normal background levels for Florida" as the goal of construction methods for new housing. In the next paragraph he stated: "We do not believe it is appropriate to establish a remedial action level for new housing different from that for existing housing." Attached to his letter were what Mr. Guimond referred to as "our comments" on the draft of the Governor's phosphate Related Task Force standards. In the last sentence on the first page of those comments, the EPA comments state: The difficulties in enforcement may discourage the incorporation of the ALARA [as low as reasonably achievable] principle in regulations, but the practice should, at a minimum, be encouraged in the text that accompanies the standards. (E.S.) In summary none of the EPA recommendations above explicitly recommend mandatory remediation. Even where more than 0.02 WL is present, the EPA recommendation only says that remediation "should" be taken. See Recommendation I above. Below 0.02 WL, EPA Recommendation II expressly lists factors to be considered in determining whether or not remediation should be taken. Moreover, the EPA did not specifically consider in any great detail what might be needed to achieve Working Levels below 0.02, and saw this as within the discretion of the state. Petitioner's exhibit 25A, p. 12. See findings of fact 21 through 24. By letter dated March 22, 1985, Sheldon Meyers, Acting Director, Office of Radiation Programs for the EPA, wrote to the Respondent to comment on the proposed rules for radiation levels in newly constructed houses. Mr. Meyers stated that "we . . . concur in the numerical standards you have proposed." Petitioner's exhibit 8. Mr. Meyers further praised the Respondent for using design criteria rather than direct radiation standards. Id. Mr. Meyers was critical, however, of the automatic exemption of testing of new houses using monolithic slabs or ventilated crawl spaces. Mr. Meyers stated that they were not aware of any data demonstrating that monolothic slabs have long- term effectiveness in preventing radon entry, that cracks are likely to appear over the normal lifetime of a house, and that there was not enough data to justify using a monolithic slab alone to prevent radon entry. He recommended that the monolithic slab be used only in conjunction "with other radon resistant techniques, such as well-sealed polymer barriers and sub-slab ventilation systems." He also questioned the use of crawl spaces, saying his data was "incomplete." He concluded by recommending that a testing program be used to certify construction techniques, and that while crawl space certification may be easy, that monolithic slab performance may take longer. Mr. Meyers did not expressly state that "all structures be subjected to preoccupancy and long term monitoring," as proposed by the Petitioners in proposed finding of fact 32. The rule requires both types of slab construction to have a polyethylene (or equivalent) soil gas barrier. Petitioner's exhibit 1; Petitioner exhibit 25G, pp. 37-38. Use of ventilated crawl spaces, monolithic slabs, or post-tensioned slabs, is expected to reduce radiation levels to the "as low as reasonably achievable" levels set forth in the rule, based upon current understanding of these building techniques. Petitioner's exhibit 25F, p. 33-34; T. 36-40. It is reasonable, however, for there to be some continued data collection to see how these building techniques perform in future years. Petitioners exhibit 25A, pp. 13-19, 57; T.40 It would not be reasonable to set the mandatory upper limit at the background level of 0.09 WL because as the background level is approached, one cannot tell whether the level of radiation is due to normally expected background or is due to the phosphate caused excess. Petitioner's exhibit 25H, pp. 22, 15; Petitioner's exhibit 25F, pp.35-36. Setting the mandatory upper limit that close to the normal background level would make the rule manageable and difficult to enforce. Id. The problem is not that monitoring devices are inaccurate, but that the readings from such devices, at the background level, increasingly run the risk of overregulation. Id. The "track etch" radon decay products detection device is a simple detection device, without moving parts, that has been almost universally accepted over the past ten years as a measuring device in uranium mines, and is a widely accepted measuring device. T. 109. A second detection device, using a thermoluminscent detector, is the "RPISU," or the radon progency integrating sampling units. The RPISU is widely accepted and used. T. 110. Both devices are recommended by the EPA and by most of the measuring standards organizations, including the Bureau of Standards. T. 111; Petitioner's exhibit 25H, pp.37-38. The Respondent anticipates that it will use the track etch detection device to monitor radon daughter levels when new construction involves either an improved monolithic slab or a post-tensioned slab. T. 113. The Respondent contemplates using the RPISU for monitoring radon levels for newly constructed dwellings tested pursuant to proposed rule 10D-91.1106(2)9(d). Id. Various agents and employees, as well as other persons, expressed varying opinions as to the legal question of whether the Respondent has legal authority to require more rigorous forms of public notification, and the Respondent appears to have considered these various opinions. See HRS exhibit 7; Petitioner's exhibit 10, 17, 25E (p. 4), and 15. Evaluation of problems of enforcement, cost off enforcement, and economic inconvenience to persons regulated are consistent with EPA guidelines. See findings of fact 23 and 24 above. Lifetime residency (75 percent) occupancy of a residence with an air concentration of 0.02 WL is predicted to result in a 70 percent increase in lung cancer, from 2 per 100 to 5 per 100. Petitioner's exhibit 5, p. 38668. If 80 percent reduction of all cases above 0.02 WL is achieved, 60 percent of the excess risk of lung cancer will be eliminated; if 80 percent reduction of all cases above 0.005 WL (plus 0.004 WL background) is achieved, 75 percent of the excess risk of lung cancer will be eliminated. Ibid. Thus, the benefit of going all the way to the as low as reasonably achievable level is to eliminate another 15 percent of the excess risk of lung cancer, or 0.45 cases per 100 persons. The proposed rule does not place any mandatory duties upon local building inspection offices. The proposed rule states: 10D-91.1107 Inspection and Notification of Test Results. (1) Following an evaluation of the test data for dwellings specified in 10D-91.1106(2)(d), the Department shall send the appropriate building inspection office a letter recommending approval or denial of occupancy no later than 5 working days after evaluating the test data. * * * (2) Each building inspection office . . . should give written notice of the prospective building or owner of the dwelling of the requirements of this part and should assure that occupancy of the dwelling is not permitted until confirmation is received from the Department that the dwelling has met the standards contained in 10D-91.1104(2), or until inspection has verified that the dwelling is constructed in accordance with 10D-91.1106(2)(a) or (2)(b). Thus, the County building inspector will receive the recommendations of the Respondent, but has no mandated duties. The proposed rule only suggests what the county building inspector "should" do. The testimony was not in conflict with the proposed rule. The witness who testified on this point stated that "we really would expect" the building office to refuse to issue a certificate of occupancy. He did not testify that the local building inspector was required to withhold the certificate of occupancy. T. 64-65. The Hearing Officer officially recognizes that intervenor, Polk County, is a political subdivision of this state. Findings of fact adopted by reference in the Appendix, as well as explicit findings of fact made in the Appendix, are incorporated herein by reference.
Recommendation Upon consideration of the foregoing, it is ORDERED Petitioner, Concerned Citizens of Citrus County, Inc., have failed to prove standing, and therefore are DISMISSED as a Petitioner in this case. The remaining Petitioner and Intervenor have failed to prove that proposed rules 10D-91.1101 through 10D-91.1109 are an invalid exercise of delegated legislative authority. DONE and ORDERED this 20th day of December, 1985, in Tallahassee, Florida. Hearings Hearings 1985. WILLIAM C. SHERRILL, JR. Hearing Officer Division of Administrative The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative this 20th day of December, APPENDIX TO RECOMMENDED ORDER, CASE NO. 85-2813RP RULINGS UPON ALL PROPOSED FINDINGS OF FACT A. The following, using the same numbers as used by the Petitioners in their proposed findings of fact, pages , are the specific rulings of the Hearing Officer as to each proposed finding of fact. If "adopted," the finding as proposed becomes a finding of fact in this recommended order. If adopted or rejected with qualifying statements, the qualifying statements, to the extent that facts are involved, are additional findings of fact. Adopted. Petitioners fail to give any page reference for the conclusions of fact proposed. The Hearing Officer cannot find any reference to the national average, and therefore rejects the second and third sentences of this proposed finding of fact. The fourth sentence is also incorrect. The report cited, HRS exhibit 3B, states in several places that the mean WL for undisturbed nonmineralized land to be 0.004 WL. The rest of the proposed finding of fact is adopted. Rejected. Petitioners have failed to cite any portion of the record where this fact has been proven, and the Hearing Officer does not recall any such testimony. Further, the policy of the United States with respect to VA and FHA loans has not been shown to be relevant to this rule challenge. Adopted. Additionally, the report noted that in some cases, application of a standard of 0.009 WL to a new structure might not be feasible or reasonable. Footnote 2 is rejected as legal argument. Adopted. The first sentence is adopted. Petitioners fail to cite the portion of the record supportive of the second sentence, and the Hearing Officer has no recollection of any such evidence in the record, and therefore, the proposed finding in the second sentence is rejected. Adopted. Table 12, page 57, of attachment A to Petitioner's exhibit 25A does not establish the proposed fact that use of crawl spaces and monolithic slabs at a cost of $550 will reduce radiation to 0.09 WL and 11 microroentgens/hour; section 5.0 implies this result, but does not state it with sufficient precision for a finding of fact to be made. Only the following statement of fact can be made: that the EPA estimated that it would cost $550 for ventilated crawl spaces, and for improved slab construction to reduce radon radiation by 80 percent, using 1977 dollars. Adopted. The first sentence is adopted. The second sentence is rejected since the record is closed for new exhibits. Adopted. Adopted. There is no citation to the record for the last sentence of this proposed finding, and the Hearing Officer has no recollection of evidence on this point, and therefore the last sentence is rejected. The next to last sentence overstates the text of paragraph 4, page 38665, Petitioner's exhibit 5. The correct statement is as follows: Residents who live a lifetime in these homes [homes having radon levels from 0.03 to 0.1] could experience a risk of lung cancer which is 2-4 times the average risk to a member of the U.S. population. The rest of the proposed finding is adopted. Adopted, including the footnote. As discussed more completely in the findings of fact above, the EPA recommendations I through IV found on pages 38665 66, Petitioner's exhibit 5, do not recommend mandatory remedial action. Proposed finding of fact 15 is adopted, except the word "mandatory." There is no citation to the record to support proposed finding of fact 16, and the Hearing Officer is unable to find record support for this proposed finding, and therefore must reject it. Adopted. Petitioner's proposed finding of fact 18 is rejected for several reasons. First, the citation to Petitioner's exhibit 24 does not support the proposed finding, and the Hearing Officer has no recollection of any other record evidence to support this proposed finding. Second, the finding is not relevant. The task force did not adopt this apparently preliminary standard. Petitioner's proposed finding of fact 19 is rejected in part because there is no citation to the record to support the finding that revisions were made due to "vigorous lobbying by the Florida Phosphate Council and the Florida Home Builders Association." The finding is further rejected because the proposals of the subcommittee are irrelevant. The finding that the task force ultimately adopted a 0.027 WL standard has already been made. Adopted, except the parenthetical "[to the public health]" is rejected. The EPA did not limit its consideration of costs to only the public health, but consistently evaluated the costs to home owners and land owners as well. See e.g. Petitioner's exhibit 5, p. 38669, numbered paragraph 3 and 5; Petitioner's exhibit 25A, attachment A, pages 56-75. Adopted. Rejected because prior drafts rules are not at issue in this case, and have no relevancy or weight as to what the proper standards should be. Rejected for the same reasons as stated in 22 above. Adopted. Rejected because irrelevant. The issue in this case is not whether the Respondent has legal authority to adopt more stringent notice requirements, but whether a rule that fails to do so is an invalid exercise of delegated legislative authority. Adopted. Adopted with the following exception. Petitioner's exhibit 15 does not state that the Office of General Counsel stated any legal opinion as to notice. The exhibit fails to identify "OSLS," and the Hearing Officer cannot make a finding as to what that means. Moreover, the legal opinion stated in the exhibit by the OSLS, is not a fact, but is relevant only argument as to conclusions of law. Adopted. While this proposed finding of fact contains a number of statements that are accurate, if adopted as phrased, the record would be incomplete. "Public health benefits" were not specifically analyzed as such for the construction options for new housing, but it would be incorrect to find that the Respondent did not consider such benefits, given all of the other record evidence that ventilated crawl space or slab construction are reasonably expected to reduce radiation levels to the "as low as reasonably achievable" standard. By limiting options to these construction standards, with the alternative of variance from these construction standards coupled with testing and remediation, the Respondent de facto, has followed a path toward improving public health based upon the 0.02 WL standard. Moreover, with respect to option 1, the the exhibit recommended adoption for three reasons, not just the one proposed by Petitioners. Finally, the last sentence of footnote 6 is rejected for lack of evidence. Petitioner's exhibit 4 does not explain how the thermoluminscent device is proposed to be used, and lacking evidence on the point, the Hearing Officer cannot conclude that the $30,000 cost is an estimate of the cost of preoccupation monitoring of 3,700 new houses. The $30,000 cost only reflects the purchase cost of 100 devices at $300 each. With these exceptions, the proposed finding is adopted. Adopted, except the footnote 7 is rejected. There is no evidence of the expense to the Department of Agriculture to conduct its testing program, or the relevance to this proceeding. Adopted. Adopted, except the last sentence is rejected because Mr. Meyers did not expressly say that in his letter. Adopted. Adopted. Adopted, except proposed finding 36d. The standard proposed is contained in proposed rule 10D- 91.1104, and is "normal background radiation levels as reasonably achievable." The normal background is 0.004 WL and 6 microroentgens per hour. The maximum standard stated in the proposed rule is 0.02 WL and 20 microroentgens per hour. Adopted, except that the second sentence is rejected because irrelevant. The legal authority of the Respondent to do something is a legal question, not a factual question. Rejected. There is no evidence that Dr. Cox's opinions, elicited on cross examination, were intended to state the intentions of the Respondent with respect to testing devices and number and extent of use. The first sentence is rejected. Mr. Guimond stated: "But you'd probably use a number of track etch cups, and you might do them in a various placement within the structure." By qualifying his opinion with "probably" and "might," Mr. Guimond made it clear that he was not expressing a rule. The remainder of the proposed finding is adopted. Adopted, with the addition that Ms. Trott also testified that her duties include processing, development, and coordination of all parts of the rule package other than the rule itself. Adopted, with the following exceptions. Ms. Trott did not testify that she obtained cost figures from a "lobbyist," or from any person of a particular profession other than the "Polk County Association of the Florida Homebuilders Association." The last two sentences are rejected because beyond the expertise of the witness as he himself testified, T. 127, and beyond the expertise certified by the Hearing Officer, T. 91. Adopted. Adopted. Adopted. Adopted. Secretary Pingree made it clear that he deferred to the advice of legal counsel on the notification issue. Otherwise, the proposed finding is adopted. Rejected. The relevance of this proposed finding is not shown by the record. Adopted, except that Dr. Howell, is currently the Deputy Secretary. Rejected. The record cited by Petitioners from these proposed findings of fact do not support the findings in the form proposed. The first sentence of proposed finding 50 is rejected. Dr. Howell simply testified that it would be very hard to subject public health programs to a cost/benefit analysis. The second sentence is adopted. Dr. Howell testified that exposure to 0.02 WL for 70 years would cause a risk of 2 additional lung cancer fatalities per 100 persons, and that that was a high risk. The proposed finding as worded is rejected. Adopted. Rejected. Dr. Howell vaguely testified that "if you had a good building technique, a good informed consent, you actually may allay a lot of fear." Petitioner's exhibit 25B, p. 40. He did not tie this opinion to the proposed rule. Adopted. Adopted. The first sentence is rejected because Dr. King did not make it clear what kind of "standard" he was referring to. All that Dr. King said was "there was no evidence in that literature to support a level other than what could be in fact detected in food, which was again, detection limit was then one per billion." Petitioner's exhibit 25F, p. 13. It is not at all clear that Dr. King was describing a ceiling, and since he was talking about detection thresholds, he was probably only talking about the practical limits of designing a standard. The second sentence is rejected because it is a distortion of what Dr. King said. Dr. King testified: "predominately the issue was the level of risk, but the integral part of balancing was whether or not it was practical to eliminate from the food supply, whether it was possible to technologically, as we understood it, to eliminate from the food supply ethylene dibromide." Id. The last sentence is adopted, but with the addition that such 1,000 persons have been exposed to average levels of EDB for a lifetime. Adopted, except that the goal is one "adverse health effect" per one million, not "one lifetime fatality." Rejected. The citation to the record does not support the proposed finding in the form proposed. Adopted. Adopted. Adopted, with the following exceptions. The record cited does not support a finding that Dr. King recommended 0.02 WL because 1/3 of existing homes would violate 0.01 WL, and does not support the proposed fact that 1/3 of existing homes would violate 0.01 WL. The record further does not support the finding that Dr. King made his recommendation based upon precedential value for other states. What Dr. King said was that he relied upon the precedent of the use of 0.02 WL by the Environmental Protection Agency. Petitioners exhibit 25F, p. 25. The first sentence is adopted. The second sentence is rejected. Petitioner's exhibit 25F, p. 23, 1. 21-25. The third sentence is rejected because it is irrelevant. The proposed finding is a misstatement of the testimony. Dr. King said he looked at the EPA study, but could not remember what it said. Petitioner's exhibit 25F, p.29, 1. 12-13. Rejected as irrelevant. Dr. King's inability to remember this fact at this deposition is not relevant. Dr. King explicitly stated that he "heard a number of numbers," but that he could not recall any. Petitioner's exhibit 25F, p. 31, 32. Rejected as misleading. Dr. King testified that in choosing the Working Level standard, he was more concerned about normal distribution, reliability of monitoring, and the ability to enforce effectively at the chosen standard. Petitioner's exhibit 25F, p. 33, 1. 7-18. Adopted. Rejected. Dr. King did not say that. He only said that the concern about remediation in existing homes was one that "we all felt needed to be addressed." Petitioner's exhibit 25F, p. 44 1. 10-11. He then said "I felt that at sometime soon we would have to deal with that issue. "Dealing with an issue, or "addressing" an issue can mean that it was discussed, encouraged, rejected, mandated, or ultimately ignored after discussion. It does not mean adoption of a mandatory program of remediation. Adopted. Adopted. Rejected. This is a misstatement of the testimony. Dr. King did not testify that he believed lands should be quarantined. Dr. King testified that "maybe" a Mr. Herron with the IMC said that, and "Again, that would have been an ideal situation to be able to make that recommendation, I don't believe that that was within the preview of the charge that we had, however, to make that recommendation." Petitioner's exhibit 25F, p. 51, 1. 17- 20. Adopted. Adopted Rejected. The testimony is equivocal and contains too many qualifications for this categorical proposed fact to be adopted. Petitioner's exhibit 25F, pp. 66, 1. 20-25, to 67, 1. 1-14. Adopted. Adopted. Rejected. The testimony is unclear, and does not support the statement as proposed by Petitioners. Petitioner's exhibit 25H, p. 17, 1.6-12. Rejected. The portion of the record cited for this statement of fact contains comments of counsel, but does not contain clear testimony of the witness to prove this point Adopted. Rejected. The witness did not say anything about "notification of buyers and lessees." He stated: "I think it would be a good idea to let people know in existing structures, which most of them already do." A buyer is not a person in an existing structure, and the issue of notice to buyers or prospective lessees is quite different from general notice to persons residing in structures. Petitioner's exhibit 25H, p. 32, 1. 2-3. Adopted. The first sentence is adopted. The second sentence is misleading. The persons named were clearly not intended by the witness to be the only persons. Petitioner's exhibit 25G, p. 6, 1. 18-21. The second sentence is rejected because it is false as proposed. Rejected. Gordon Nifon did not testify that one of the "principle" considerations of "this group" was the economic impact of the standard on real estate values. He said that he felt that the 0.02 WL standard offered a significant degree of protection to people not now protected and yet it does not bring undue economic hardship to a lot of people. Petitioner's exhibit 25G, p. 5, 1. 1- He was then examined closely about his opinion regarding economic impact, and finally stated that just about everyone who any impact upon the rule standard discussed how to balance economic impact with the public health. Id., p. 6, 1. 13-21. A finding can be made that economic impact was a consideration, but the record fails to support Plaintiff's suggestion that it was one of the principle considerations. As proposed, the finding is rejected. A finding is made that there was some concern that at the 0.01 WL that too many houses would be affected, but the influence of that concern upon the final outcome of the proposed rule is not clear in the record. Petitioner's exhibit 25G, p. 12, 1. 1-3. The first sentence is rejected. The witness was not certain. The second, third and fourth sentences are adopted. Adopted. The first sentence is adopted. The second sentence is rejected as proposed. The witness said that to do a "definitive study of any one home, there might be some reason to use more than one detector." He testified further: "I will only say that it wouldn't hurt, I suppose, to have two or more detectors. But I'm not sure if it would be a great value." Petitioner's exhibit 25G, p. 15, 1. 14-16 and 20-22. This is not sufficient to adopt the proposed finding. The first sentence is rejected. The witness made no representations as to what HRS had done with respect to testing. Petitioner's exhibit 25G, p. 12, 1. 6. The second sentence is adopted. Adopted. Adopted. Adopted, with the addition that "lifetime risk" means exposure at a given number of Working Levels for a lifetime. Rejected as phrased. The following statement is adopted as an alternative: Due to lack of complete data, some data collection was recommended by Mr. Guimond with respect to new construction on phosphate lands. Petitioner's exhibit 25A, pp. 13, 1. 25 to 19, 1. 17. Rejected. The answer is unintelligible, the testimony is that of counsel rather than the witness, no predicate was laid for the witness's degree of familiarity with the study, the levels mentioned in the question are not identified or explained, the witness was not qualified as an expert, the study is hearsay, and the cited passage is otherwise not the sort of evidence that is sufficiently reliable for the purpose proposed by Petitioners. Rejected as irrelevant. Rejected. The N.C.R.P. standards are for both types of structures. Petitioner's exhibit 25A, p. 27, 1. 22-25. Rejected in the form proposed. The following is adopted: (another space) Mr. Guimond thought that the I.R.C.P. document was "pretty confusing," and had "quite a bit of caveats in there which would enable Governments to move the values they use either direction " Petitioner's exhibit 25A, p. 28. The testimony is insufficient to conclude that the I.R.C.P. document is "useless." Adopted. Rejected as phrased. The following is adopted: Mr. Guimond implied that the EPA often tries to get a higher degree protection than it did in these standards, but they felt it was a reasonable compromise based on trying to weigh risk and the absolute need of people for housing. Petitioner's exhibit 25A, p. 30. Adopted. Mr. Guimond was further of the opinion that it would be a "legitimate approach" for HRS to make the suggestion to the Legislature that its authority to give such notice be given consideration. Petitioner's exhibit 25A, p. 34. Adopted. Adopted. Adopted. Rejected as stated. Dr. Jerrett testified that notification was desirable, not that it was "necessary." T. 58, 1. 2-7. The following statements of fact are erroneously included in the Petitioners' "Argument" section, and are ruled upon as if they were proposed findings of fact: Paragraph 103B is adopted only to the extent stated in findings of fact 2 through 9. Paragraph 103C is adopted. Paragraph 103D, is adopted except there was no evidence of the participation of Concerned Citizens of Citrus County in the rule-making public hearings as parties. The following, using the same numbers as used by the Respondent in its proposed findings of fact, pages 1-4, are the specific rulings of the Hearing Officer as to each proposed finding of fact. If "adopted," the finding as proposed becomes a finding of fact in this recommended order. If adopted or rejected with qualifying statements, the qualifying statements, to the extent facts are involved, are additional findings of fact: Adopted. Adopted. Adopted, except the last sentence, which is not fact. Adopted. Petitioner's exhibit 25H, p. 6, 31. Rejected as proposed. HRS is considering amendment to the proposed rule to include schools and public buildings. T. 59, 77-78, 80; Petitioner's exhibit 25E, p. 8. Adopted, except the fifth sentence is rejected. The Hearing Officer cannot conclude from the testimony of Stephen King, M.D., that an upper limit less than 0.02 WL would be unmanageable, unrealistic, or unenforceable. Dr. King was specifically referring to the setting of a ceiling standard at background, and simply indicated that it be both unrealistic and unmanageable to require ideal background when the background number is in fact only a point of distribution on a bell curve that is expected to have some values higher than the standard. Petitioner's exhibit 25F, pp. 35-36. The first sentence is adopted. The second sentence is rejected as proposed. The rule speaks for itself, stating that counties which have lands "within their borders identified in 10D-91.1106(1) shall conduct . . . educational programs to advise the public that dwellings located on such lands have the potential of exceeding the standard . . . ." Proposed rule 10D 91.1108. The testimony is insufficient to conclude that in fact the educational program will include letters, brochures, or that HRS will have a full-time health educator. That was only the vision of the witness, and the full-time health educator was only a "budget issue," which means something HRS intends to ask the Legislature to fund. T. 63. Adopted. Adopted. Rejected because it is a conclusion of law. The Intervenor, Polk County, proposes only two findings of fact, designated paragraphs 7 and 8. Proposed finding of fact 7 is rejected, as more fully explained in the findings of fact, because the proposed rule does not impose any "duty" on the local building inspector since it uses the word "should." Proposed fending of fact 8 has been adopted in the findings of fact, although worded differently. HRS does expect that local building inspectors will follow their recommendations and the suggestion of the proposed rule and withhold the certificate of occupancy. COPIES FURNISHED: Richard A. Patterson, Esquire Department of HRS 1323 Winewood Blvd Building One, Suite 407 Tallahassee, Florida 32301 Thomas W. Reese, Esquire 132 Eight Street North St. Petersburg, Florida 33701 Mark F. Carpanini, Esquire Office of County Attorney Post Office Box 60 Bartow, Florida 33830 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32301 Liz Cloud, Chief Bureau of Administrative Code 1802 The Capitol Tallahassee, Florida 32301 Carroll Webb, Executive Director Administrative Procedures Committee 120 Holland Building Tallahassee, Florida 32301 A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW PURSUANT TO SECTION 120.68, FLORIDA STATUTES. REVIEW PROCEEDINGS ARE GOVERNED BY THE FLORIDA RULES OF APPELLATE PROCEDURE SUCH PROCEEDINGS ARE COMMENCED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF THE DIVISION OF ADMINISTRATIVE HEARINGS AND A SECOND COPY, ACCOMPANIED BY FILING FEES PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL, FIRST DISTRICT, OR WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE PARTY RESIDES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED.
The Issue Petitioner Department of Professional Regulation seeks to suspend, revoke, or otherwise discipline respondent's license to practice medicine on charges of professional misconduct violative of Chapter 458 Florida Statutes (1979). The issues for determination are: Whether respondent is guilty of gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, in his treatment of Verdi Hammond Burroughs ("Burroughs") and Charles Kirk ("Kirk") in violation of Section 458.331(1)(t), Florida Statutes (1979); Whether respondent's treatment of Burroughs and Kirk was fraudulent and constituted misrepresentation, and whether the treatment was medically beneficial to the exclusion of other forms of proper medical treatment and was, therefore, harmful to the patient in violation of Section 458.331(1)(1), Florida Statutes (1979); Whether respondent violated Sections 458.331(1)(1), 458.331(1)(h), Florida Statutes (1979) by failing to fully inform Burroughs and Kirk (in his prescribing and administering Amygdalin [Laetrile]) of alternative methods of treatment for their cancer, and the potential of these methods for cure; whether each patient failed to sign a written release releasing respondent from liability; and whether respondent informed each patient, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services; Whether respondent's treatment of Burroughs and Kirk, when measured by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject without first obtaining full, informed, and written consent, in violation of Section 458.331(1)(u), Florida Statutes (1979); Whether respondent failed to comply with Sections 458.333 and 458.335, Florida Statutes (1979); Whether metabolic therapy is recognized by a respectable minority of the medical profession as a treatment for cancer. Background By an eight-count administrative complaint dated March 31, 1982, petitioner Department of Professional Regulation, Board of Medical Examiners (Department), charged respondent Daniel J. Clark with multiple violations of Chapter 458, Florida Statutes (1979), the "Medical Practice Act." Respondent disputed the charges and requested a Section 120.57(1) hearing. On April 29, 1982, the Department forwarded this case to the Division of Administrative Hearings for assignment of a hearing officer. Hearing was then set for September 22 and 23, 1982. At hearing, the Department presented the testimony of Evelyn Kuhn, Daniel Clark, Alvin Edward Smith, Tammy Thompson, Brenda Kempton, and Lois Ann White. Petitioner's Exhibit Nos. 1/ 1-5 were received into evidence. The respondent testified in his own behalf and presented the testimony of Rodrigo Rodriquez, Rebecca Scholz, and Allen Bernsten. Respondent's Exhibit Nos. 1-5 were proffered but not received into evidence. The parties filed proposed findings of fact and post- hearing briefs by December 1, 1982. Those proposed findings which are incorporated herein are adopted; otherwise they are rejected as unsupported by the evidence or unnecessary to resolution of the issues. Based on the evidence presented at hearing, the following findings of fact are determined:
Findings Of Fact I. Respondent Since 1976, respondent has been licensed to practice medicine in the State of Florida, holding license number ME0026861. (Tr. 269; Prehearing Stipulation) He received a bachelor of science degree from Georgia Southwestern College and a medical degree from Medical College of Georgia. In 1975, he trained for five months with a gynecological oncologist in Americus, Georgia. In 1978, he completed a three year residency program at University Hospital in Jacksonville, Florida. (Tr. 266-268). Since 1979, he has practiced medicine in Ormond Beach, Florida. Initially, his practice included gynecology, family practice, and general nutrition. He then began to treat cancer patients with metabolic (nutritional) therapy. The purpose of such therapy is to enhance the immunological and biological capacities of a patient--nutritionally, immunologically, and physiologically--in order to improve the patients performance in combating cancer. This cancer treatment includes the administration of Amygadalin (Laetrile), vitamins, herbal teas and detoxifiers, and the application of salves and packs to cause localized hyperthermia. It is not a conventional, orthodox, or widely practiced form of cancer treatment. No other physician in Volusia County uses it. Most accredited medical schools in the United States do not teach it. The American Medical Association (AMA) considers it to be experimental. Eventually, respondent's metabolic treatment of cancer patients began to account for 15 percent to 20 percent of his practice. (Testimony of Clark, Rodriquez; P-3) II. Respondent's Treatment of Verdi Hammond Burroughs In October or November 1979, Nelson Murray, a chiropractor, asked respondent to examine Verdi Hammond Burroughs, a patient who had complained to Dr. Murray about a lump in her right breast. (The offices of Dr. Murray and respondent were close together in the same building. And, in the past, Dr. Murray had referred patients to respondent for medical treatment.) (Testimony of Clark, P-3). Respondent, who considered it an "across-the-hall consult," agreed. He went to Dr. Murray's office, examined Ms. Burroughs' right breast, and noted a small lump. He recommended that she have a biopsy or that she see a surgeon for a second opinion, to make sure that the lump was not malignant. (Subsequently, she failed to follow this recommendation.) Although he did not refer her to a particular surgeon, he looked up the names of several who might be willing to operate on her, as she was a Jehovah's Witness. (Since Jehovah's Witnesses object to blood transfusions, many surgeons refuse to operate on them.) (Testimony of Clark, P-3) During this brief examination, respondent did not perform any diagnostic tests other than to manually examine the breast. Although he kept meticulous patient medical records, he did not open a patient record on Ms. Burroughs or have her complete a patient history form. He took no progress notes during the examination. He did not consider her his patient, did not assume responsibility for her treatment, and did not charge her a fee. (Testimony of Clark; P-1, P-3). Respondent had no contact with Ms. Burroughs until Dr. Murray asked him to reexamine her in February, 1980. The circumstances were similar. Respondent examined her in Dr. Murray's office, noted the breast lump was unchanged, made no medical reports, and charged no fee. He recommended that she undergo a laboratory test, including complete blood chemistry, SMAC 22, CBC, and sedimentation rate. For this purpose, he specifically referred her to Dr. Nelson A. Murray, a medical doctor and pathologist in Jacksonville, Florida. (At that time, she lived in Jacksonville, Florida.) He also recommended, again, that she have a biopsy performed--a recommendation which she, again, failed to follow. (Testimony of Clark; P-3). On September 22, 1980, almost eight months later, chiropractor Murray again asked respondent to come to his office and examine Ms. Burroughs right breast. Respondent's subsequent examination revealed that the entire breast was severely inflamed and the nipple was inverted or sloping downward. The breast had the appearance of an inflamed carcinoma. Respondent strongly suggested that she have laboratory tests (the same tests which he had recommended earlier) done as soon as possible and that she arrange to see him immediately thereafter. He, again, told her that she needed a biopsy and gave a preliminary diagnosis of breast cancer. This time, she followed his recommendation. Two days later, she had the complete lab tests done by Dr. Murray, the Jacksonville pathologist. (Testimony of Clark; P-3). Respondent still did not consider Ms. Burroughs his patient or assume any responsibility for her treatment. During this September 22, 1980, examination, he did not open a patient file, take notes, or charge a fee. There is no evidence that Ms. Burroughs-- at that time--believed that she was his patient--or he, her doctor. Nor is there evidence that either party misunderstood or was confused about their relationship or their respective responsibilities. (Testimony of Clark; P-3). Between the February, ,1980 and September 22, 1980, examinations, respondent did not contact Ms. Burroughs and did not discuss her condition with chiropractor Murray. Between the November, 1979 and the September, 1980, examinations, respondent did not order or perform any further diagnostic tests on Ms. Burroughs and did not attempt to check with her to see if she had followed his recommendations. Neither did he expressly inform her that he was not her doctor. The Department contends that his failure to take these actions violates a generally accepted standard of medical care. (Testimony of Clark; P- 3) This contention, however, is unsubstantiated. The evidence does not demonstrate that the generally accepted standard of medical care required respondent to take such actions. Conversely, it has not been specifically shown how, and in what ways, respondent's treatment of Ms. Burroughs between November, 1979 and September, 1980, fell below an acceptable standard of medical care. 2/ Ms. Burroughs became respondent's patient on October 7, 1980, when she came to his office for medical treatment. He performed a complete work up, physical examination, and medical history, and reviewed the results of the lab blood tests. He concluded that her condition was essentially normal except for her right breast, which was severely inflamed and the nipple retracted. In addition, the lymph nodes under her right armpit' were palpable and enlarged. His initial impression was that she had inflammatory carcinoma (cancer) of the right breast with lymph gland involvement. He then scheduled her for a biopsy, which was necessary before he could determine the type of cancer involved. (Testimony of Clark; P-3) The biopsy was performed on October 9, 1980 by Dr. Kluger, a St. Augustine physician. It indicated an inflamatory intraductal adenocarcinoma of the breast, primary. Dr. Kluger, who felt that surgery was inadvisable because of the lymph node involvement, subsequently recommended to respondent that Ms. Burroughs undergo radiation and chemotherapy. (Testimony of Clark; P-1, P-3). During the October 7, 1980, office visit, respondent explained to Ms. Burroughs the alternative methods of cancer treatment, including their potential for cure. The methods discussed included surgery, radiation, chemotherapy, and metabolic therapy. She refused to undergo radiation or surgical treatment, explaining that her husband died of lung cancer after receiving surgery, radiation, and chemotherapy. She agreed however, to consider chemotherapy in conjunction with metabolic therapy. He explained to her that metabolic therapy was not a treatment against the cancer, per se, but that it would help "build up her body to where her own immune system would help her fight the cancer." (P-1). She agreed to accept this treatment--chemotherapy with metabolic therapy--then signed four separate affidavits on forms provided by respondent. The affidavits acknowledged her consent to the ordering and administration of Laetrile. Respondent, however, did not inform Ms. Burroughs in writing (by these affidavits or any other documents), that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. She also did not sign a written release, releasing him from any liability from the administration of Laetrile. (Testimony of Clark; P-1, P-3) During the October 7, 1980, visitation--after the affidavits were signed--respondent began treating her with metabolic therapy, consisting of Laetrile I.V., Vitamin C, B Vitamins, B-15, B-12, and crude liver injections. Metabolic therapy was commenced without obtaining her prior written consent. (Testimony of Clark; P-1). Several days later, on October 13, 1980, respondent began treating her with small doses of chemotherapy in conjunction with the metabolic therapy. The chemotherapy treatment plan was based on a phone call to Dr. Donald Cole, a New York oncologist. Respondent described the type and extent of Ms. Burroughs cancer and Dr. Cole recommended small 100 milligram doses of 5-FU twice weekly, two to five milligrams of Laetrile twice weekly, and 50 milligrams of Cytoxin PO orally. Respondent administered this regimen until he discontinued chemotherapy at the end of November, 1980. (Testimony of Clark; P-3). These doses and intervals of chemotherapy did not conform to the manufacturers' recommended doses contained in the Physicians Desk Reference, a standard reference used by practicing physicians. The doses administered by respondent were lower than those normally used in chemotherapy and are considered to be in the research or experimental stage. (Testimony of Clark, Smith). Chemotherapy and metabolic therapy are incompatible-- they work at cross-purposes. Chemotherapy drugs are strong immunosuppressants. They are toxic and intended to poison cancer cells; 3/ their effect is to suppress the body's immunological system. In contrast, the purpose of metabolic therapy is to enhance that same immunological system. (Tr. 215-216). For this reason, the use of chemotherapy is not included within the protocols for metabolic therapy found in International Protocols in Cancer Management. 4/ Respondent concedes that this publication is authoritative and contains the standard protocols for metabolic therapy. (Testimony of Rodriquez, Clark). Ms. Burroughs chemotherapy stopped at the end of November, 1980, but her metabolic therapy continued. By March, 1981, her right arm was beginning to swell because of enlarging lymph nodes. On the March 2, 1981, office visit, respondent told her that Laetrile was not stopping the cancer, and discussed restarting chemotherapy. He increased her Vitamin C, and began administering herbal cleaners and botanical medicines containing red clover, chapparral, myrr, goldenseal, yellow dot, juniper berries, yuva, ursaberries, conch grass, and dandelion. Respondent categorizes these medicines as blood purifiers, lymph purifiers, liver cleaners, and kidney cleaners. (P-3). By June, 1981, respondent believed the cancer had metastasized to Ms. Burroughs' right lung. During office visits in early June, he rubbed herbal ointment or liniment, Vitamins E and F, into her rib cage area. He also prescribed herbal packs and poultices to cause localized hyperthermia (heat increase). He prescribed dark and yellow herbal salves and instructed her to apply them to her right breast and underarm area, explaining that they would draw out and break down the cancer tumor. (Testimony of Clark, Kuhn; P-3). These salves--strong and painful--caused pieces of gray tissue to fall off her breast and underarm area. Respondent reacted by encouraging her, telling her that the salves were breaking down the cancerous tumor. (He now admits, however, that the herbal ointments and salves would have been ineffective in treating the cancer which had metastasized to her lungs.) He also prescribed a tea which tasted like black pepper. She forced herself to swallow it because he had told her that it would break up the cancer in her body. This representation was also untrue. (Testimony of Clark, Kuhn, Smith.) In administering metabolic therapy to Ms. Burroughs, respondent also prescribed whole-body hyperthermia for the purpose of stimulating her immune system. This required her to totally submerge herself in bath water which was as hot as she could tolerate. According to the standardized protocols for metabolic therapy, as stated in International Protocols in Cancer Management, such "whole-body hyperthermia, while successful in some cases, is dangerous and considered experimental." (Tr. 320, Testimony of Clark). Respondent's metabolic and chemotherapeutic treatment of Ms. Burroughs failed to conform to the standard of care recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. It fell below the prevailing and generally accepted standard of care recognized by his peers in the medical community: a.) After the diagnosis, respondent made an improper and incomplete staging 5/ of the disease by failing to take a liver scan, which would have revealed the existence (or nonexistence) of liver lesion. Cancer of the liver is deadly and must be dealt with immediately. (Tr. 89-92). b.) After he diagnosed Ms. Burroughs breast cancer, he failed to prescribe surgery or a combination of surgery and radiation therapy, treatment methods which likely would have been beneficial and controlled the disease. (Surgery, such as a radical mastectomy, does not cause a significant loss of blood, so blood transfusions--something Ms. Burroughs opposed--could have been avoided.) If necessary, chemotherapy--using conventional doses--could also have been administered. The chemotherapy and metabolic therapy which respondent provided Ms. Burroughs was probably worthless. The herbal salves and teas which he prescribed were incapable of drawing out or breaking up the cancerous tumor. c.) When Ms. Burroughs' cancer was diagnosed, it was in an advanced and complicated stage. Under such circumstances, a general practitioner (such as respondent) should have referred her to or obtained a consult from an oncologist, a specialist in the treatment of cancer. Respondent did neither. (Testimony of Smith). Metabolic therapy is not approved or recognized as acceptable for cancer treatment by a respectable minority of the medical profession. This finding is based on the opinion of Alvin Edward Smith, MD., board certified in oncology and internal medicine, and a Fellow of the American College of Physicians. He has treated cancer patients since 1978. His opinion on this issue is considered more credible than the contrary opinion of Rodrigo Rodriquez, M.D., who practices medicine in Tijuana, Mexico, who is not licensed to practice medicine in the United States, and who--other than acting as a guest resident at Kings County Hospital in Brooklyn, New York--has never practiced medicine in the United States. (Testimony of Smith, Rodriquez). III. Respondent's Treatment of Charles Kirk Charles Kirk became respondent's patient on August 13, 1980, and died shortly thereafter on September 9, 1980. Mr. Kirk, a 77-year-old male, was having great difficulty swallowing food and had a history of recurring choriocarcinoma of the larynx or throat. Surgery had been performed on him several times, and his larynx (voice-box) had been removed. Respondent explained to him the alternative methods of treatment, including surgery, chemotherapy, radiation, and metabolic therapy. Mr. Kirk opposed further surgery and objected to chemotherapy and radiation. He requested Laetrile. After he signed an affidavit provided by respondent (the same form which had been provided Ms. Burroughs), respondent ordered Laetrile. (Testimony of Clark; P-2). Respondent then referred him to a general surgeon for the placing of a gastrostomy feeding tube, a device which would enable him to swallow food and liquids. The tube was successfully placed surgically, after which respondent began administering Laetrile to him as part of metabolic therapy. The treatment was brief, only nine or ten days. On September 26, 1980, Mr. Kirk died. (Testimony of Clark; P-2). Mr. Kirk's condition, when he first became respondent's patient, was essentially irreversible; he was in the final stages of a fatal cancer. (Testimony of Clark, Smith; P-2). Respondent administered Laetrile to Mr. Kirk without first obtaining from him a release of liability and without informing him, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. (Testimony of Clark.)
Recommendation Based on the foregoing, it is RECOMMENDED: That respondent's license to practice medicine be suspended for one year, for violating Section 458.331(1)(h), (1), (t), (u), Florida Statutes (1979). DONE AND RECOMMENDED this 9th day of March, 1983, in Tallahassee, Florida. R. L. CALEEN, JR. 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 9th day of March, 1983.
