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 Should Respondent be disciplined for practicing beyond the scope of his license or by accepting and performing professional responsibilities which he knows or has reason to know that he is not competent to perform? See Section 460.413(1)(t), Florida Statutes, formerly Section 460.413(1)(u), Florida Statutes.
Findings Of Fact Petitioner is charged with regulating the practice of chiropractic pursuant to Sections 20.165, 20.42, Florida Statutes and Chapters 455 and 460, Florida Statutes. Respondent is a Florida licensed chiropratic physician. His license number is No. CH-0001538. He was issued that license on September 21, 1968. Respondent practices chiropratic at the McCall Chiropractic Clinic located at 811 Grace Avenue in Panama City, Florida. Respondent is not licensed as an osteopathic or allopathic physician as recognized by the Florida Board of Osteopathic Physicians or the Board of Medicine respectively. In 1992 Respondent sent Micheal Smith, D.C., a chiropractic physician practicing in Panama City, Florida, information described as an invitation for Dr. Smith to join Respondent in clinical research "designed to test the effectiveness of Scalar E.M. Technology upon AIDS-CANCER opportunistic organisms falling within the meaning of chapter 460.403(3)(a)(b)(c)(e), and Rule 21D-1702, Florida Statutes." The correspondence went on to describe some details about the research. In particular, Respondent stated that "preliminary field data suggest that Scalar E.M. TENS Technology is effective in 47 pathological conditions including AIDS-Cancer disease." The correspondence also set forth information concerning patients who wished to contribute to the research by making financial contributions to the "Allaganey Occupational Development Foundation, 22 Floor Pacific First Center, 1425th Avenue, Seattle, Washington 98101-2333". Respondent provided Dr. Smith a sheet on the McCall Chiropractic Clinic letterhead related to purported medical research at Stanford University in 1988 studying "the Biological Interactions with the Scalar Energy Cellular Mechanisms of Action" in response to weak ELF ectromagnetic (EM) radiation and the claimed results. That sheet describes how the McCall Chiropractic Clinic would be "conducting private research into the effectiveness of Scalar E.M. Technology upon the following conditions, for a two-year period of time." Arthritis Arm Pains Angina Pectoras Arethemia Asthma Allergies Bacterial Infection of the Lung Carple Tunnel Syndrome Cancer of the: Bone, Brain, Bladder, Bowell, Lungs, Liver, AIDS Colon Polyps Cholitis Candidia Albicans Deafness Diabetes Neuropathy Emphysemia Eckcemia Ear Infection Epstine Barr Infection Exothalmic Goider Feavers Fungus of the skin Fibrosis of the Lung Gout High Blood Pressure Herniated disc Herpes B infection Hemrroids Hardening of the arteries Herpes of the Genitals Hypertrophy of the Prostate Inflimation of the joints Nectniuria Kendidia Albicans Leg Pains Multipleschlerosis Musculardistrohy Neuropathy Nose bleads Premenstral Syndrome Paracititis of digestive track Phlebitis Sinus Infection Tumors of the Eye Varicose Veines Warts Leupus Erethematosis Parkinsons Disease Dr. Smith was also provided with a copy of an advertisement which stated: ATTENTION: Aids - Cancer Patients Dr. Curtis J. McCall, Jr. Chiropractor Research program utilizing scalar tens antineoplastic technology is available through the provisions of Chapter 460.403(3)(a)(b)(c)(e) Rule 21D-1702 Florida Statutes. Patients suffering with Aids - Cancer disease who would like to participate in the research program should call 769-1708 for an appointment or come by the office: 811 Grace Ave., P.C., Fla. 32401 In the 1993 yellow pages for the Panama City, Florida, telephone book, Respondent placed an advertisement to this effect: MCCALL CHIROPRACTIC CLINIC PEOPLE HAVE TRUSTED THE HANDS OF DR. McCALL SINCE 1968 -- TENS AIDS -- CANCER THERAPY -- 811 Grace Av Panama Cy 769-1708 In the July 8, 1993 advertising service in the "Thrifty Nickel" circulated in Panama City, Florida, Respondent placed the following advertisement: NOTICE: The McCall Chiropractic Clinic has on display a 1953 classified federal document that discloses successful treatment for cancer. Patient response indicates this technology is effective in the treatment of 47 conditions. This technology is available through the provisions or Chapter 460- 1403(3), (a), (b), (c), (e). Rule 210-1702 Florida Statutes. Phone 769-1708 for appointment, 811 Grace Avenue, Panama City, Florida 32401. F24 On July 19, 1993, Respondent, on stationary from McCall Chiropractic Clinic, wrote to TCRS, Inc., in Tallahassee, Florida, asking that company to place McCall Chiropractic Clinic on its list of AIDS/Cancer Therapeutic Center listings for national referrals. That correspondence gave a brief description of the service that Respondent intended to provide. It indicated that the therapy to be provided would cost the patient $18.00 per 20 minutes. Through Respondent's activities that have been described, Respondent directly held himself out to the public as having the ability to treat persons with AIDS. In furtherance of his intentions, Respondent developed a treatment protocol consisting of approximately 55 weeks of treatment to be monitored initially by Respondent at his chiropractic facility. That protocol required the patient to receive TENS therapy for two hours each day. The TENS device is designed to deliver transcutaneous electrical nerve stimulation. Its principal chiropractic use is for pain control. However, Respondent, in his intended care, contemplated that the device would stimulate "T-Cells" in combatting AIDS. In the protocol, Respondent also required monthly blood tests to monitor the patient's "T-Cell" counts. The protocol required the patient to be free from all other drugs, in particular, the AIDS treatment medication "AZT". Under the protocol, the patient was required to receive a weekly injection of a compound identified as "chondriana", in amounts determined by Respondent. Finally, the patient was to ingest a compound identified by Respondent as "life crystals". On or about February 4, 1994, Respondent began to care for the patient C.L. That care ended on September 29, 1994. In this arrangement Respondent and C.L. had a chiropractic physician-patient relationship. Patient C.L. died on August 18, 1995. Respondent made a diagnosis, proposed a course of treatment and directly treated C.L. for AIDS. In this treatment Respondent maintained a patient record for C.L. In an effort to secure reimbursement for the services provided to C.L., Respondent prepared insurance claim forms, affixing a diagnosis of AIDS to the claim forms and had C.L. assign benefits to the Respondent from the insurance policy. In this connection Respondent had C.L. execute a sworn statement describing the services received from Respondent. It was Respondent's expectation that the claim forms would be honored by the insurance carrier and that Respondent would be paid for the services rendered to C.L. With one exception, Respondent's billings to the insurance carrier for C.L.'s visits to Respondent's office were all for the treatment of AIDS. An investigation was instituted by the State of Florida, Department of Business and Professional Regulation/ Agency for Health Care Administration to ascertain whether Respondent was offering patient treatment for AIDS. James Cooksey, an investigator with the regulator, performed that investigation in conjunction with Tom Willoughby, investigator for the Bay County, Florida, Sheriff's Office. James Cooksey is an insurance fraud/medical malpractice investigator. To conduct the investigation Mr. Cooksey assumed the fictitious name James Stark. The reason for assuming the name was to present James Stark as a patient suffering from AIDS. In furtherance of the investigation Mr. Cooksey went to the Tallahassee Memorial Regional Medical Center and obtained a fictitious positive AIDS test in the name James Stark. On May 16, 1994, Mr. Cooksey initiated contact with Respondent. The investigator traveled from Tallahassee to Panama City. When he reached Panama City he called Respondent and told Respondent that he needed to come and talk to him. Respondent invited Mr. Cooksey to come by that afternoon. On May 16, 1994, Mr. Cooksey met with Respondent at Respondent's office. At that meeting Mr. Cooksey told Respondent that the investigator understood that Respondent could possibly cure AIDS. Mr. Cooksey further stated that he had seen something in a newspaper article that Respondent was treating AIDS patients and explained to Respondent that Mr. Cooksey had contracted AIDS and was interested in being cured. Mr. Cooksey provided Respondent with the results of the fictitious blood test. When Mr. Cooksey presented to Respondent he did not complain of any condition other than AIDS. Respondent did not physically examine Mr. Cooksey. Respondent explained to Mr. Cooksey about the nature of Respondent's treatment in which the TENS unit, also known as a Rife machine, chondriana and life crystals would be used. To demonstrate the treatment Respondent took Mr. Cooksey into a room in the back of his office, a treatment room, and had Mr. Cooksey take his shoes and socks off and place his feet on a metal pad associated with the TENS unit. When the unit as turned on Mr. Cooksey could feel tingling inside his feet. On this occasion Respondent told Mr. Cooksey that, he, Mr. Cooksey could get injections of chondriana and then the machine would be turned on and Cooksey would receive stimulation to fight the infection associated with AIDS. Respondent told Mr. Cooksey that the initial treatments for AIDS would have to be done at his office where Respondent would monitor the investigator. Respondent indicated that a nurse would come to the office and give the injections of chondriana and that Mr. Cooksey would be monitored concerning those injections until Mr. Cooksey's "system built up a little". Mr. Cooksey understood that he was to receive those injections and use the TENS unit and was not to take other forms of medication during the treatment. Respondent gave Mr. Cooksey a card with the name of a blood test that would need to be obtained and the results reported to Respondent. Mr. Cooksey was responsible for paying for the blood test. Respondent told Mr. Cooksey that the life crystals were to be taken in orally as a drink and they were described as being part of the AIDS treatment. On this date Respondent gave the investigator an estimate of the costs of this treatment, constituted of $2,000 for the TENS unit and $2,925 for chondriana and life crystals. Subsequent to that date Respondent called Mr. Cooksey and left a message on Cooksey's telephone. Respondent also wrote the investigator on May 23, 1994, providing the investigator more information concerning Respondent's treatment for AIDS. The investigator then went to the state attorney's office in Panama City and informed the state attorney of the nature of the administrative investigation and the belief that the activities by Respondent might constitute a criminal law violation. The state attorney represented to the investigator that he concurred. The state attorney then had Mr. Cooksey contact the Bay County Sheriff's office. Following that contact Mr. Cooksey took up a joint investigation between Mr. Cooksey and Bay County Sheriff's investigator Tom Willoughby. On October 18, 1994, Mr. Cooksey placed a call to Respondent and told the Respondent that he was in Panama City and would like to come by and meet with the Respondent and that he would be accompanied by a friend who might be able to "come up" with the money that was required to purchase the chondriana and life crystals and TENS unit. The part of the friend was to be played by Officer Willoughby. Mr. Cooksey and Officer Willoughby then went to Respondent's office where Respondent again explained the nature of the AIDS treatment. Officer Willoughby asked the Respondent questions concerning the nature of the treatment and how much the treatment would cost. Respondent explained that the treatment involved injections of the chondriana, drinking the life crystals and using the TENS machine for two hours a day to treat James Stark for AIDS. At the October 18, 1994 meeting between the investigators and Respondent, Respondent stated that a nurse practitioner with whom he was friends would administer the chondriana and that activity would be monitored by Respondent in Respondent's office. Officer Willoughby asked Respondent if there would be side affects to the injections. Respondent indicated that there would be sweating and that Respondent would monitor Mr. Cooksey for whatever period of time would be necessary for the side affects to subside. The investigators watched a video tape explaining the treatment for AIDS which Respondent intended to employ. The injections of chondriana would be given monthly. Respondent indicated to the investigators that he would instruct Mr. Cooksey on how many of the life crystals to take. Respondent told the investigators that the cost of the TENS unit was $2,000.00 and that the unit would be used to spread the impulses through out the body. Respondent indicated to the investigators that the nature of the treatment would form new T-cells to replace T-cells containing the AIDS virus or which were cancerous. Respondent had stated in Officer Willoughby's presence that the TENS unit cost $500.00 to produce. Respondent and the two investigators then went to a local health food store, known as the Olive Leaf, to ascertain the amount of money needed to pay for chondriana which the health food store would provide. There, the attendant at the store indicated that he could arrange to provide the chondriana and life crystals for a price approximating $2,800.00. After leaving the health food store the investigators told the Respondent that they would come back with the necessary money on October 21, 1994. The investigators returned to Respondent's office on October 21, 1994, after obtaining warrants to search the office and arrest the Respondent. Before Respondent was arrested and the search made, the investigators asked Respondent to again explain the nature of the treatment that would be provided to Mr. Cooksey and paid Respondent $1,700.00 for the TENS unit from funds belonging to the Bay County Sheriff's Office. Respondent gave the investigators a receipt for the $1,700.00 payment. Respondent was then arrested for practicing medicine without a license. On one occasion Respondent explained to the investigators that the procedures that were used to treat Mr. Cooksey for AIDS were not condoned by the FDA, but that it was working in other places where it had been tried and that three patients treated in another location had gained remission from the AIDS. Based on the proof, it is found that Respondent diagnosed Mr. Cooksey as having AIDS and developed a course of treatment for that condition. Paul Doering, M.S., is a registered pharmacist in the State of Florida. He is also licensed as a consultant pharmacist in the State of Florida. He is a Distinguished Service Professor of Pharmacy Practice at the University of Florida. He is accepted as an expert pharmacist. Mr. Doering established that the drug AZT is an antiviral drug designed to address the HIV virus associated with AIDS. Mr. Doering established that AIDS is an acronym for acquired immuno- deficiency syndrome, "a disease that affects the immune system caused by a virus or different types of viruses which attack the immune system in the body rendering the body unable to effectively mount an immune response when it comes into contact with certain types of infectious organisms." Mr. Doering established that drugs are divided into two basic groups, one group which is sold without prescription and the other group requiring a doctor's prescription. The latter category of drugs are known as Federal Legend Drugs. Mr. Doering established that there is no reference to a medication known as "chondriana" in any directory of medications which he was familiar with. As he established, chondriana does not constitute a food because foods are not generally injected into the human body. Mr. Doering established that chondriana has not been approved to be used as a drug in the United States, nor is it an experimental drug, based upon his research of sources that list drugs or experimental drugs. Marianne Gengenbach, D.C., is licensed to practice chiropractic in Florida and is an expert in chiropractic practice. She established that chiropractors are limited to using proprietary drugs, and then only where the chiropractor has passed a specific exam and obtains a proprietary drug license. Proprietary drugs are "over the counter drugs" not prescription drugs. Absent such as a license to prescribe proprietary drugs chiropractors may only make recommendations, educate patients and prescribe nutritional supplements. Dr. Gengenbach established that Respondent had diagnosed C.L. for AIDS and had treated C.L. for that condition. The treatment was directly related to the condition AIDS, and Dr. Gengenbach established that the treatment was outside the accepted standard of care for chiropractic and exceeded the scope of authorized practice from the view point of a practitioner. As Dr. Gengenbach established, Respondent also exceeded the proper scope of practice in caring for C.L. by recommending that C.L. discontinue the AZT therapy. Those same perceptions were held for treatment of Mr. Cooksey and are accepted. Dr. Gengenbach established that Respondent proposed a course of treatment for Mr. Cooksey related to the condition AIDS, without reference to any other complaints by the patient. As a consequence the course of treatment which Respondent planned for Mr. Cooksey was directed solely to the HIV infection as established by Dr. Gengenbach. Dr. Gengenbach established that the use of the chondriana and life crystals was intended to treat Mr. Cooksey for AIDS. Dr. Gengenbach established that even should the substances chondriana and life crystals be considered food or nutritional supplements, there proposed use for Mr. Cooksey would not meet the prevailing standard of care for chiropractic, in that they would be employed for the treatment of AIDS. Respondent intended that the chondriana and life crystals be used in the cure, treatment, therapy and prevention of AIDS in C.L. and Mr. Cooksey. Respondent intended that those substances affect the structure and function of the bodies of those patients. In proposing and carrying out the treatment that has been described directed to AIDS, Respondent did so mindful that chiropractic physicians in Florida are prohibited from directly treating the AIDS condition. Respondent's treatment of C.L. and proposed treatment of Mr. Cooksey violated the standards of practice acceptable to a reasonably prudent chiropractic physician under similar conditions and circumstances and exceeded the scope of his chiropractic license. In the past Respondent has been disciplined by the Board of Chiropractic on three separate occasions. Two of those cases involve the receipt of a reprimand and in the third case Respondent's license was suspended and he was required to pay an administrative fine. Respondent was also required to cease and desist the activities described in these facts based upon action taken by the Board of Medicine, which was persuaded that Respondent was engaging in the treatment of AIDS without benefit of a medical license.
Recommendation Based upon the facts found and the conclusions of law reached, given the severity of the offense and the danger posed to the public, it is, RECOMMENDED: That a final order be entered which revokes Respondent's license to practice chiropractic medicine in Florida. DONE and ENTERED this 21st day of November, 1995, in Tallahassee, Florida. CHARLES C. ADAMS, 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 November, 1995. APPENDIX CASE NO. 95-2881 The following discussion is given concerning the proposed findings of fact of the parties: Petitioner's Facts: Paragraphs 1 through 4 are subordinate to facts found. Paragraphs 5 and 6 constitute conclusions of law. Paragraphs 7 through 13 are subordinate to facts found. Paragraph 14 is not necessary to the resolution of the dispute. Paragraphs 15 through 35 are subordinate to facts found. Paragraphs 36 through 40 are conclusions of law. Paragraph 41 is subordinate to facts found. Paragraphs 42 and 43 are conclusions of law. Paragraphs 44 through 51 are subordinate to facts found. Respondent's Facts: Paragraphs 1 through 5 constitute legal argument as reported at pages 2 through 5. The proposed facts 1-3 found at pages 15 and 16, Paragraph 1 is contrary to facts found. Paragraph 2 is rejected as a discussion of activities of the Probable Cause Panel, not a proper subject for consideration. Paragraph 3 constitutes a conclusion of law. COPIES FURNISHED: Jon M. Pellett, Esquire Medical Quality Assurance-Allied Health Agency For Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Curtis J. McCall, D.C. 514 North Bonita Avenue Panama City, FL 32401 Diane Orcutt, Executive Director Agency For Health Care Administration Board of Chiropractors 1940 North Monroe Street Tallahassee, FL 32399-0792 Jerome W. Hoffman, General Counsel Agency For Health Care Administration 2727 Mahan Drive Tallahassee, FL 32308
Conclusions An Administrative Law Judge with the Division of Administrative Hearings ("DOAH") submitted his Recommended Order of Dismissal to the Department of Environmental Protection ("DEP") in these consolidated administrative proceedings. The Recommended Order of Dismissal indicates that copies thereof were served upon counsel for the Co-Respondent, Escambia County Utilities Authority (“Authority”), and upon pro se Petitioners, Kerry Culligan (*Culligan’ ) Mary Pueschel Studstill (“Studstill’), and Chris Englert Cnglert. A copy. of the Recommended Ofder of Dismissal i is attached hereto as s Exhibit A The matter is now "before the Secretary o of DEP for final agency action. a | BACKGROUND The Authority owns and operates a public water system in Escambia County, Florida. These consolidated cases involve an application fi fi led with DEP seeking a permit to construct fluoridation treatment facilities at six of the Authority’s potable water a supply wells. On September 5, 2000. DEP executed an Intent to Issue and draft permit . } 4 F tor the Applicant’ fluoridation treatment construction project. The Petitioners then fi led “similar petitions with DEP contesting the issuance of the permit to the Applicant and requesting formal administrative hearings. The Petitions, which were forwarded to : r appropriate proceedings, basically questioned the safety and effi icacy of oe DOAH fc fluoridation i in their drinking water. Administrative Law w Judge, Donald R. Alexander, AL, was assigned to “~ insuffi cient to state a cause ofa action for relief f against DEP under the controling ‘provisions of Rule 62- 555. 328, Florida Administrative Code. Rule 62- 555. 325 establishes conditions and requirements for the issuance by of permits to public oO Bo yee ee water systems for the installation and operation of fluoridation treatment equipment. _ sad The ALS J recommended that DEP center a fi ina alorer dismissing, with prejudice, t the wale) eh as ed squares sas chante és antes? CONCLUSION The case law of Florida holds that parties to. formal administrative proceedings ‘must alert agencies to any perceived defects in DOAH hearing procedures or in the findings of fact of administrative law judges by filing exceptions to the DOAH recommended orders. See Couch v. Commission on Ethics, 617 So.2d 1119, 1124 (Fla. 5th DCA 1993); Florida Dept. of Corrections v. Bradley, 510 So.2d 1122, 1124 (Fla. 1st DCA 1987). The ALJ ruled in his Recommended Order of Dismissal that Petitioners’ allegations were legally insufficient to state a cause of action warranting denial of the construction permit for Applicant's proposed fluoridation treatment facilities. Nevertheless, no exceptions were filed by any of the Petitioners objecting to this critical adverse ruling or objecting to the ALJ’s ultimate recommendation that DEP enter a final order dismissing the three petitions with prejudice. Having considered the Recommended Order of Dismissal and other matters of record and faving | reviewed the applicable law, | concur with the rulings and ultimate recommendation of the ALJ. Itis therefore ORDERED: A. The ALJ’s Recommended Order of Dismissal is adopted in its entirety and is incorporated by reference herein. - B. Culligan’s amended petition for administrative hearing and the initial petitions for administrative hearings of Studstill and Englert are dismissed, with prejudice, for failure to state a cause of action upon which a final order can be entered denying the Authority’s requested permit to construct the fluoridation treatment facilities. seals Lae eee es i x A a Mk ii i ie aL C. DEP's Northwest District Office shall ISSUE to the Authority the construction permit for the fluoridation treatment facilities, subject to the terms and conditions of the draft permit issued in DEP File No. 0083021 -001 -WCIMA. Any party to these proceedings has the right to seek judicial review of this Final : pursuant “to Rife 9.110, Florida Rules of Appellate Procedure, ‘with the clerk of the Department in the Office of General Counsel, 3900 Commonwealth Boulevard, MS. 35, Tallahassee, Florida 32399-3000; and by filing a copy of the Notice of Appeal accompanied by the applicable fi iling fees with the appropriate District Court of Appeal. The Notice of ‘Appeal must be fi led within 30 days from the date ‘this Final Order is fi led ; with the clerk of the Department. -DONE AND ORDERED this Z day of January, 2001, in Tallahassee, Florida. bn STATE OF FLORIDA DEPARTMENT . OF ENVIRONMENTAL PROTECTION LS DAVID B. STRUHS Secretary Marjory Stoneman Douglas Building AOS OSU ue SAAS ai head. te 3900 Commonwealth Boulevard ; Tallahassee, Florida 32399-3000 moun i}76lo1 CERTIFICATE OF SERVICE | HEREBY CERTIFY that a copy of the foregoing Final Order has-been sent by United States Postal Service to: Kerry Culligan Mary Pueschel Studstill 814 North 13" Avenue 414 North Guillemard Street Pensacola, FL 32501 Pensacola, FL 32501 Chris Englert Robert W. Kievet, Esquire 4121 West Avery Avenue Kievet, Kelly & Odom Pensacola, FL 32501 15 West Main Street Pensacola, FL 32401 Ann Cole, Clerk and Donald R. Alexander, Administrative Law Judge David S. Dee, Esquire Division of Administrative Hearings John T. LaVia, Ill, Esquire The DeSoto Building Landers & Parsons, P.A. 1230 Apalachee Parkway Post Office Box 271 Tallahassee, FL 32399-1550 Tallahassee, FL 32302 and by hand delivery to: Craig D. Varn, Esquire Department of Environmental Protection . . 3900 Commonwealth Blvd., M.S. 35 ° “~~~ Tallahassee, FL 32399-3000 this LStkd ay of January, 2001. STATE OF FLORIDA DEPARTMENT OF ENVIRONMENTAL PROTECTION : “TERRELL WILLIAMS Assistant General Counsel ate ) Mhea 3900 Commonwealth Blvd., M.S. 35 Tallahassee, FL 32399-3000 “Telephone 850/488-9314 ce it 1a ea
The Issue Whether the Petitioner committed the violations alleged in the Administrative Complaint, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department of Health is the state agency responsible for certifying and regulating basic X-ray machine operators in Florida. Sections 468.3001-.312, Florida Statutes. On March 30, 1993, Paul Butler was issued Basic X-ray Machine Operator Certificate Number 7729. The certificate expired December 31, 1994, and Mr. Butler requested renewal by submitting a renewal form and the required fee to the Department on December 20, 1996. Mr. Butler admitted that he knew his certificate expired December 31, 1994, but that he nonetheless took numerous X-rays subsequent to that date. On January 4, 1996, Mr. Butler prepared and submitted an application for employment to Kristie Green, office manager for South Dade Orthopedic Associates. In that application, Mr. Butler signed his name and appended to his name the designation "RMA, CRT." Ms. Green interviewed Mr. Butler, and he provided her with a copy of his certificate that showed an expiration date of December 31, 1995. Ms. Green noted that his certificate had expired four days previously, and Mr. Butler told her he was short of funds and would send in his renewal application when he received his first paycheck. Ms. Green hired Mr. Butler as an X- ray technician and medical assistant. After Mr. Butler repeatedly assured her that he had sent his renewal application to the Department, Ms. Green fired Mr. Butler on June 20, 1996, because he had not obtained a current Basic X-ray Machine Operator certificate. The evidence presented by the Department is sufficient to establish that Mr. Butler took X-rays without having an active certificate, and that he identified himself in his employment application to South Dade Orthopedic Associates as a Certified Radiologic Technologist by using the letters "CRT" after his signature. The evidence presented is also sufficient to permit the inference that Mr. Butler altered his basic X-ray Machine Operator certificate by changing the expiration date from December 31, 1994, to December 31, 1995.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health issue a final order finding that Paul Butler violated Section 468.3101(h), Florida Statutes, by violating Section 468.302(1) and (2) and that he violated Section 468.3101(f). Based on the violations, the Department of Health should impose the following penalties: Suspend Mr. Butler's Basic X-ray Machine Operator certificate for a period of six (6) months; Impose an administrative fine in the amount of Six hundred twenty-five dollars ($625.00); and Condition the reinstatement of Mr. Butler's certificate on his having completed thirty (30) hours of continuing education. DONE AND ENTERED this 12th day of January, 1998, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO 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 Filed with the Clerk of the Division of Administrative Hearings this 12th day of January, 1998. COPIES FURNISHED: Morton Laitner, Esquire Department of Health 401 Northwest 2nd Avenue Suite N-1014 Miami, Florida 33128 Paul Butler, pro se 30525 Southwest 149th Court Leisure City, Florida 33033 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700 Pete Peterson, General Counsel Department of Health 1317 Winewood Boulevard Building 6, Room 102-E Tallahassee, Florida 32399-0700
The Issue The issue is whether Petitioner engaged in a pattern or practice of overutilization as alleged in the Notice of Intent to Revoke Certification and Impose Penalties Pursuant to section 440.13, Florida Statutes ("Notice of Intent") dated April 12, 2012, and, if so, what penalty should be imposed on Petitioner.
Findings Of Fact Background Facts The Department is the state agency responsible for certifying health care providers who provide injured workers with medical services pursuant to section 440.13, Florida Statutes. Petitioner, Harry M. Koslowski, M.D., is a Florida- licensed physician. Dr. Koslowski is a neurologist and is board certified in neurorehabilitation. He is the admitting neurologist at Brooks Rehabilitation Hospital in Jacksonville, is affiliated with Specialty Hospital in Jacksonville, and lectures to residents at Shands Hospital Jacksonville. Dr. Koslowski's practice focuses on rehabilitation and pain management for difficult patients. Dr. Koslowski stated, "I see the worst of the worst where other doctors have given up." Dr. Koslowski is a "certified health care provider" as defined in section 440.13(1)(d), meaning that the Department has certified him to provide treatment to injured workers. As a certified health care provider, Dr. Koslowski is eligible to receive reimbursement for authorized medical services rendered to injured workers. Section 440.13(8) requires workers' compensation carriers to report all instances of overutilization to the Department. Upon receipt of such a report, the Department must make a determination whether a pattern or practice of overutilization exists. Section 440.13(11)(c) places exclusive jurisdiction with the Department "to decide any question concerning overutilization under subsection (8)." Upon a determination of overutilization (or any other violation of chapter 440), the Department is authorized to impose an array of penalties, including administrative fines and the decertification of the health care provider. § 440.13(8)(b) & (13), Fla. Stat. In a letter to Eric Lloyd, the Department's program administrator, dated March 5, 2010, Mark S. Spangler, the attorney for Memorial Medical Center ("Memorial") and its workers' compensation carrier USIS, reported overutilization by Dr. Koslowski in regard to his treatment of P.T., a registered nurse employed by Memorial Medical Center. Mr. Spangler's letter described four peer-review opinions obtained by USIS, all of which agreed that the services provided by Dr. Koslowski to P.T. constituted overutilization. The Department conducted an investigation of the reported overutilization. Mr. Lloyd testified that when a carrier's peer-review reports contradict the reports or opinions of a health care provider rendering medical services, the Department requests an opinion from an expert medical advisor ("EMA"). Section 440.13(9) authorizes the Department to contract with an EMA to provide peer review or expert medical consultation, opinions, and testimony in connection with resolving disputes concerning "reimbursement, differing opinions of health care providers, and health care and physician services rendered under this chapter, including utilization issues." The Department hired Michael Yaffe, M.D., to provide an expert advisory opinion. Dr. Yaffe is a board-certified neurologist and a certified EMA. Dr. Yaffe completed a records review and issued a written report to the Department. Dr. Yaffe's report, dated September 11, 2011, concluded that aspects of Dr. Koslowski's treatment of P.T. were not medically necessary and appropriate. On April 12, 2012, the Department issued the Notice of Intent, quoted at length in the above Preliminary Statement. The injured worker, P.T., is a registered nurse who has retired since the events relevant to this proceeding. She worked for many years at Memorial. P.T. sustained a work- related injury by accident when she developed a non-healing ulceration on her right forearm related to a tuberculosis ("TB") tine test administered on November 14, 1985. USIS accepted compensability of the accident and has provided extensive remedial care and medical treatment pursuant to section 440.13. Medical treatment of P.T.‘s right arm P.T.'s medical history subsequent to the November 14, 1985, incident has been complex. She has received treatment from dozens of health care providers, including mental health professionals. Earl H. Eye, M.D., an internist who is board certified in infectious diseases, took over as P.T.'s primary physician in December 1991 and coordinated her treatment until August 2006. Dr. Eye maintained an infectious disease practice from 1975 to 2009. Dr. Eye testified that P.T. "just about gave me gray hair trying . . . to get the wound on her arm healed." Dr. Eye "tried virtually all the approaches that I could think of." He further described his multiyear treatment of P.T. as follows: This is one of the most difficult cases that I can ever recall taking care of. I spent more time and more effort on this -- this young woman -- than virtually all the other patients that have been through my practice. P.T. gave physicians a history that included her having been treated for renal TB, but nothing in the written medical record confirmed that treatment. Cultures of her urine indicated sterile pyuria, which are associated with TB but also have other causes. Dr. Eye testified that he could never confirm that P.T. had TB in the past, and that he was certain she did not have active TB while he was treating her. Though there was no indication of active TB, the skin on P.T.'s forearm at the site of the tine test broke down and would not completely heal. Dr. Eye's treatment of P.T. was extensive and exhaustive. He met with P.T. in his office roughly once a month for many years. Dr. Eye and the physicians to whom he referred P.T. attempted many treatments for her wound: intravenous antibiotics, steroids, excision, multiple skin grafts, more than 30 debridements, nerve graft surgery, whirlpool therapy, hyperbaric chamber treatment, the application of platelet-derived growth factors, fungal and yeast treatments, sleep apnea treatments, pedicle flap surgery, physical therapy and occupational therapy. Dr. Eye's records indicate a frustrating pattern of improvement in the wound until it was nearly healed, followed by setbacks. Dr. Eye concluded that the reaction to the TB tine test had sensitized the affected area of P.T.‘s arm, causing her immune system to attack and kill the cells, defeating all efforts to heal the wound.2/ The failure of the wound to heal over a period of years led to suspicions that P.T. might be self-inflicting harm by introducing bacteria into the wound. In 1994, Dr. Eye noted, "Hopefully [P.T.] is not inducing these types of problems in her arm." However, Dr. Eye ultimately was convinced that P.T. presented a complex, perplexing problem rather than a case of self-inflicted damage. On March 4, 2004, Dr. Eye noted, ?Some have tried to blow her off as a self-inflicted but we have never seen evidence of that.? Dr. Eye testified that he sent P.T. to Dr. Atul Shah, a board-certified psychiatrist, to "make sure" that there was not a psychological component to P.T.'s condition. Dr. Shah reported back to Dr. Eye that in his opinion P.T. was not causing injury to herself. In an August 6, 1991, report to a claims examiner, Dr. Shah stated that he "entertained the possibility of malingering," but concluded that "I have strong doubts that the wound is caused intentionally or perpetuated by conscious factors " The medical records indicate that Dr. Shah saw P.T. more than 150 times from February 1991 through February 1998. P.T. also treated with psychologist Kelly M. Boswell 269 times from April 1997 through January 2008. Though P.T. was diagnosed with numerous psychological problems, including pain and depression caused by her forearm wound, neither Dr. Shah nor Dr. Boswell believed that there was any self-inflicted harm involved in the case. In June 1998, Dr. Boswell referred P.T. to Ron Kirsner, M.D., a psychiatrist, for Meridia therapy. Dr. Kirsner's notes from his initial meeting with P.T. indicate that she told him her initial consultation with Dr. Shah was for "Munchausen's like syndrome" in relation to the unhealing ulcer on her right arm. Dr. Kirsner saw P.T. 72 times between June 1998 and December 2007. In a note dated March 9, 2001, summarizing his coordinated care meeting with a nurse case manager from USIS, Dr. Kirsner wrote: "I mentioned that I do not suspect Munchausen's." Indeed, though the concern was raised at times during more than twenty years of treatment, neither Dr. Eye nor any of the 40 other treating providers listed in the records ever concluded that P.T. was engaged in self-inflicted harm. In light of subsequent opinions offered by physicians who reviewed only the paper record, it is important to keep in mind that no physician who met with and treated P.T. believed that she was sabotaging her wound treatment. Dr. Eye testified that the possibility of self-harm was not overlooked in P.T.'s treatment, and that appropriate steps were taken. In a December 19, 1994, note, Dr. Eye stated that a referring physician at Duke University told him that ?after discussion and evaluation they feel that there is very likely a component of self-induced problems with this.?3/ The Duke physician recommended a psychiatric evaluation. Dr. Eye‘s note acknowledged that a ?more aggressive stance? might be called for and that factitious involvement ?has to be explored as one of the options.? Dr. Eye testified that in light of the Duke consultation, Dr. Francis Ong, who performed several surgical procedures on P.T., placed a cast on her arm following one skin graft in order to prevent any possibility of her tampering with the wound or retarding the healing process. Dr. Eye testified that ?when the cast came off, this graft had broken down and it opened back up again.? It should be noted that Dr. Eye was testifying from memory and that there is no documentary evidence indicating that the wound worsened while in the cast. On April 5, 1995, Dr. Ong performed a skin graft on P.T.‘s right forearm and applied a short arm cast to the arm. On April 18, 1995, Dr. Ong debrided the wound and reapplied the cast. On April 24 and May 10, 1995, Dr. Ong debrided the wound and applied grafts. Dr. Eye‘s notes for an April 24, 1995, visit with P.T. state that ?[P.T.] had her cast taking [sic] off by Dr. Ong. There is an area about the size of a dime that looks necrotic. The rest of the graft looks like it has taken.? On June 22, 1995, Dr. Ong noted, ?She has finally healed. We took out some sutures trying to come out. She is healing pretty well. We will see her as needed.? When asked why he did not believe that P.T. was engaging in factitious behavior, Dr. Eye testified as follows: I never saw evidence, and I‘m pretty familiar with people who, shall we say, are trying to fake it and I‘m very familiar with the signs and P.T. never showed any of that. Here was a woman who was trying to go on with her life, who was trying to continue to work every day, who was trying to take care of her family, who was trying to get back, and just all she wanted was to resume her life and not have to fool with this. And –- and we tried every way we could to help her achieve that goal, but I never sensed at any point in time that she was doing this. Plus we -– we kind of tested it a couple times, if you recall. We -- we did a graft and put a cast on her. Now, there‘s no way in hell because there‘s no sign she drilled through the cast that she could have gotten to the wound to break it down. We sent home care to her home for I think a month and a half and dressed it every day or whatever day their interval was. They didn‘t see any evidence that she had done anything to it. It didn‘t -- it didn‘t heal. So we made concerted efforts both -- you know, while I didn‘t believe, I said, okay, let‘s -- let‘s be skeptical. Let‘s -- let‘s go for the benefit of the doubt. We‘ll check it out, see, and even when we checked it out, it didn‘t matter. * * * The wound that we‘re seeing is -- is a very, I‘d have to say almost unique. I‘m not sure I‘ve ever seen a wound like this before.4/ Now, I‘m familiar with people who are faking it, I‘m familiar with people who induce wounds, and when they scratch, they leave scratch marks around the wound, the end of the wound is a tapered down, smooth edge. They dig underneath. You see -- you see irregularities in the -- underneath it. This wound was heaped up, it was gray around the margin, it was undermined. You could pick up the edge of the skin. So if you‘re trying to do it like this (demonstrating), you would have torn that edge off. Okay. And the bottom was -- was flat. You saw tendons, you saw muscle, you saw stuff down there, and -- and, you know, I don‘t care how -- how dedicated you are, you don‘t stick your finger in those structures. . . Because that would hurt like a -- that would be very painful. In conclusion, Dr. Eye agreed with the statement that ?physically . . . there was no conceivable way that she could have self-inflicted this wound.? Bruce Steinberg, M.D., an orthopedic surgeon who specializes in treating the upper extremity, treated P.T. for approximately one year, from July 1995 through August 1996. Dr. Steinberg testified extensively concerning his findings of clawing and spasticity in P.T.‘s right small and ring fingers, and his decision to refer P.T. to Dr. Koslowski5/ for Botox injections that might ease the spasms sufficiently to allow for tendon transfer surgery or, perhaps, ease them enough to forego surgery altogether. Dr. Steinberg noted that he has performed over 10,000 surgeries and seen over 60,000 patients, and P.T. was the only one he has seen in her condition. When asked whether the condition he observed could have been self-produced by the patient, Dr. Steinberg responded: I‘m insulted by even the question. This lady was the real deal. She went through multiple surgeries before seeing me. She had flaps performed. I don‘t think she faked any of this. I don‘t think it‘s possible to do so, and the posture that she‘s maintaining is not one you can do without having a deficit of some sort. As noted above, Dr. Eye was the physician who coordinated the care of P.T. among many doctors and through many courses of diagnostic testing and treatment. Dr. Eye referred to himself as the ?quarterback,? the necessary central observer of what all the other health care providers were doing for P.T. On March 17, 1995, Dr. Eye noted the possibility of sending P.T. to a ?physiotherapist? such as Dr. Koslowski for an evaluation of the pain and spasms in her fingers. Dr. Eye testified that he sent P.T. to Dr. Koslowski ?for treatment, not for diagnosis.? Dr. Eye was supervising all the testing on P.T., and did not want Dr. Koslowski to order duplicative blood work. Dr. Eye testified that ?all I asked him to do was do the treatment.? Dr. Eye did want Dr. Koslowski to determine whether to continue P.T. on baclofen for her spasms, because P.T. had reported the medication made her drowsy. On March 29, 1995, Dr. Koslowski first saw P.T., noting ?right ulnar neuropathy? as the reason for the consultation. On March 30, 1995, Dr. Koslowski performed electromyography (?EMG?) and nerve conduction studies on P.T., finding ?signs of Wallerian degeneration involving the right ulnar nerve distal to the ulcer with the proximal part of the nerve also starting to be affected, with evidence of denervation potentials and decreased recruitment at the flexor carpi ulnaris.? He concluded that the study was consistent with right ulnar neuropathy and noted that it was ?much worse? than a study conducted by another doctor in 1993. Dr. Koslowski prescribed Ativan (lorazepam) 5 mg three times per day ?as tolerated,? and told P.T. to discontinue the baclofen. Dr. Koslowski next saw P.T. on May 10, 1995, which was the same date as one of Dr. Ong‘s debridements following the placing of the cast on P.T.‘s arm. Dr. Koslowski noted that P.T.‘s skin graft appeared to be taking well and that P.T. reported the spasm was much better since she started on the Ativan. Dr. Koslowski noted that P.T. was referred to Dr. Steinberg for a surgical evaluation to determine whether she could have a ?nerve transposition of the median nerve to the ulnar nerve.? Dr. Koslowski increased P.T.‘s Ativan to 1 mg twice per day. Dr. Koslowski‘s records indicate that he did not see P.T. again until May 22, 1996. In the intervening year, the wound on P.T.‘s right arm completely healed for the first time. On September 11, 1995, Dr. Eye wrote the following note, in relevant part: [P.T.]‘s arm has healed, has been so for a month. No breakdown. The wound looks good. There is contraction scarring in the area. She has lost some use of the lateral portion of her hand and weakness. There is consideration for possible tendon transfer. My thoughts are in this particular situation I would be extremely reluctant to do anything to break the integrity of the skin, particularly if it is anywhere close to the area where we have had such a terrible time trying to get it to heal. We will go ahead and symptomatically treat for other problems as they occur. The next record of P.T. visiting Dr. Eye‘s office is dated May 20, 1996. During the interim, P.T. continued to see Dr. Shah, the psychiatrist. Dr. Shah or his associate treated P.T. 45 times in 1997 and 36 times in 1996. In June 1995, P.T. went to the Hand Clinic at Methodist Medical Center to obtain a protective splint for her right forearm. On July 26, 1995, P.T. paid her first visit to Dr. Steinberg, the orthopedic surgeon, who noted that P.T. presented with a complaint poor function of her right hand secondary to weakness and clawing, as well as decreased sensation in the small and ring fingers. Following a physical examination, Dr. Steinberg recorded the following impression: ?Right upper extremity ulnae nerve paralysis with clawing of the small and ring fingers. In addition she has spasticity and contracture of the flexor tendons to the ring and small fingers of the right hand.? He recommended the following plan: I recommend first a thorough course of therapy to see if the spasms and adhesions of her flexor tendons to the small and ring fingers could be overcome. After a through [sic] discussion with [P.T.], I have indicated to her that if with therapy, the spasms and clawing of the small and ring fingers could be passively corrected, then an intrinsic mechanism reconstruction using the extensor carpi radialis longus would benefit to regain active extension at the PIP and DIP joints of the ring and small fingers while also maintaining flexion block at the metacarpal phalangeal joints. In addition to tendon transfer for adductor function would also be a secondary consideration to increase strength of her pinch. Certainly I would not consider a tenolysis of these flexion tendons since this would need to be done at the level of the flap which in the last 2 months has for the first time healed over the last few years. P.T.‘s first follow-up visit with Dr. Steinberg was on September 18, 1995. Following an examination, Dr. Steinberg recommended that P.T. continue ?aggressive therapy? and return for reevaluation in two months, at which time Dr. Steinberg would consider ?surgical intervention in the form of tendon transfer.? P.T. returned on November 17, 1995, at which time Dr. Steinberg noted improvement but also noted ?evidence of quite a bit of spasm.? He wrote that P.T. was still not ready for the tendon transfer procedure. Dr. Steinberg again advised P.T. to continue therapy and return in two months for reevaluation. P.T. returned to Dr. Steinberg‘s office on February 12, 1996 for her reevaluation. Dr. Steinberg noted that she was still having ?marked spasms of the right ring and small fingers.? He wrote that he could not recommend a surgical procedure with the level of spasms she was experiencing. Dr. Steinberg referred P.T. to Dr. Koslowski to recommend an antispasmodic medication, and concluded as follows: She will follow up with us in two months. At that point, depending on how she is doing with both therapy and also with medication she is taking will determine if, in fact, treatment with a tendon transfer is warranted. P.T. returned to Dr. Steinberg‘s office for reevaluation on April 17, 1996. In the notes for this visit, Dr. Steinberg wrote: ?Dr. Koslowski has been attempting to obtain approval for a bio-tox injection to see if this will resolve her spasms. I am in full agreement with [P.T.] receiving this treatment.?6/ Dr. Steinberg testified that his initial objective in the therapies he ordered for P.T. was to determine whether the condition in P.T.‘s hand was contracture or spasm. After several months of therapy, during which P.T. showed limited progress, Dr. Steinberg was nearly convinced that the condition was spasm. He recommended the Botox treatment in order to definitively establish that P.T. had spasm and, if so, whether the spasm could be overcome sufficiently to permit the long-term solution of a surgical procedure. Dr. Steinberg explained the Botox strategy as follows: Well, we know Botox is a temporary treatment, and the idea here was to do a Botox injection to see if indeed there was [neurological stimulation] that was causing the muscles to fire. And if you can arrest that by basically paralyzing that or turning off that input of electrical stimulation or nerve stimulation, you may resolve the spasm. And if that were the case, you either have an approach to go after the nerve itself or you could go after muscles, and/or if it relaxed in a long-range process the muscle spasm, and sometimes we see that, then you can do tendon transfers. And/or lastly, the injection itself may lead to the ability for the patient to overcome the spasms and actually have better function and not require any surgery. On May 20, 1996, P.T. visited Dr. Eye‘s office for the first time since September 1995. Dr. Eye noted that P.T.‘s arm wound continued to be completely healed, but that she had severe nerve damage in the hand. Dr. Eye wrote the following concerning P.T.‘s proposed course of treatment: Dr. Koslowski would like to inject botulism and to paralyze the nerve and then have her see Dr. Steinberg who will do some tendon grafting. She brings with her some articles about this. She has done some research and she wanted to get our opinion. She was advised that this had been used in cases in the past, mostly with torticollis and some with multiple sclerosis and some lazy eye syndrome of the eye. There has never been cases [sic] where there has been a systemic infection of the botulism. She was advised that we have no problems with her undergoing this. Although we would not like them to inject directly into the wound or make an incision directly into the old [illegible]. She is aware of this. She is going to go along with the procedure and will keep us post [sic] as to the outcome. On May 22, 1996, P.T. returned to Dr. Koslowski‘s office. Dr. Koslowski noted that P.T. was still experiencing spasms and rated her pain at 3-4 on a scale of 10. He ordered her to continue taking her present medications: Dantrium, a muscle relaxant, 400 mg per day; Valium, 5 mg at bedtime; and Lortab (acetaminophen and hydrocodone), 7.5 mg per day. Dr. Koslowski also noted that P.T. would return in two weeks for a Botox injection over the flexor aspect of the flexor ulnaris. On June 5, 1996, P.T. returned to Dr. Koslowski‘s office with right ulnar nerve neuropathy with spasms in the small and ring fingers. She rated her pain at 7 on a scale of 10, and had discontinued all her medications except Lortab. Dr. Koslowski noted as follows: Under EMG guidance, I inserted a needle into the flexor carpi ulnaris, and flexor digitorum profundis and after the injection, the EMG activity decreased dramatically. I injected approximately 15 units in each muscle. She tolerated the procedure well. Dr. Koslowski instructed P.T. to report her condition in two days, and to set a follow-up visit in three months. She was to hold off on any medications and to contact Dr. Steinberg for future treatment. On June 19, 1996, P.T. returned to Dr. Steinberg‘s office for an evaluation. Dr. Steinberg found that the Botox injections ?improved her spasms tremendously and now she is able to fully extend her digits.? He also noted that P.T. had some underlying weakness of the digits. Dr. Steinberg instructed P.T. to return after she had been off the toxin for at least six weeks for an evaluation of possible tendon transfer surgery. Dr. Steinberg next saw P.T. on August 28, 1996, nearly three months after her Botox injection. Dr. Steinberg noted that the spasm in P.T.‘s hand had improved considerably but seemed to be recurring. He recommended that she continue with occupational therapy to strengthen the hand. Dr. Steinberg‘s notes concluded as follows: I am concerned that her hand spasm is a dynamic changing event, and I am unable to predict exactly where it will end up. Therefore, timing tendon transfers is difficult. She will be seeing Dr. Koslowski and consideration of another botulism toxin will be undertaken. I will see her back in three months, and I will still be attempting to time the tendon transfer procedure. Despite the anticipatory tenor of Dr. Steinberg‘s note, P.T. never returned to Dr. Steinberg‘s office. P.T. returned to Dr. Koslowski‘s office on September 4, 1996. She told Dr. Koslowski that the first Botox injection lasted for two months, leading him to conclude that he had not given her enough of the Botox. Dr. Koslowski wrote that the drug representative told him that he should have administered 120 total units instead of the 30 units that he used on P.T. On September 11, 1996, Dr. Koslowski dispersed 200 units of Botox between the carpi ulnaris and flexor digitorum profundus muscles. He directed P.T. to follow up in three months or sooner if she found no significant relief from the injections. The medical records indicate that P.T. did not visit any medical provider other than Dr. Shah, the psychiatrist, between September 11, 1996, and February 25, 1997. On February 25, 1997, P.T. returned to Dr. Eye‘s office. Dr. Eye noted: ?[P.T.] comes in today after 18 months of arm healing, looking good. She developed the onset of vesicles followed by the breakdown and now approximately 5 to 6 mm ulcer with necrotic tissue and eschar. This appears to be almost similar to her previous problems, interestingly it occurred in the grafted area.? Dr. Eye decided to immediately treat this ulcer aggressively, ?to head this off before it gets large.? He planned to treat P.T. with a hyperbaric oxygen sleeve and Vibratabs (doxycycline), and to ramp up to debridement and full hyperbaric if she did not respond rapidly. P.T. was initially unable to obtain hyperbaric treatment due to equipment problems at the medical facility. On April 1, 1997, Dr. Eye noted that P.T. had commenced the hyperbaric treatment and was on Vibratabs but that the ulcer had enlarged and looked ?angry and undermined.? Dr. Eye wrote: ?We are very distraught that after all of the work and time and the final healing, we now have a breakdown that appears to be enlarging again and resuming her previous course.? He suspected ?some sort of autoimmune phenomenon we are not able to identify at this time.? Throughout the remainder of 1997, Dr. Eye continued to treat P.T.‘s wound. As in the previous rounds of treatment, the wound would appear to be healing but then would refuse to completely close. On July 16, 1997, P.T. returned to Dr. Koslowski complaining of pain at a score of 8 on a scale of Dr. Koslowski prescribed medications and said that he would consider doing a Botox injection once the ulcer was healed. In November 1997, P.T. returned to Dr. Ong, who began performing debridements and skin grafts. P.T. began complaining of pain in the arm. On January 16, 1998, Dr. Ong performed an abdominal pedicle flap, which became infected. By March 1998, the infection appeared to be under control and the flap was beginning to heal. However, by April, the progress of the infection had reversed and the wound was enlarging. Dr. Ong performed debridements of the necrotic skin on the wound on May 5 and 26, June 16 and 30, July 8 and 28, and August 5, 1998. On July 21, 1998, P.T. had her first appointment with Shirley Hartman, M.D., a Jacksonville family-practice physician. The record is unclear as to who referred P.T. to Dr. Hartman. P.T. continued to see Dr. Hartman until at least early 2008, receiving acupuncture and medications for arm pain and other treatments designed to improve her diet and general health. P.T. saw Dr. Hartman very frequently, twice per week at times over her long course of treatment. Dr. Eye‘s medical records do not mention Dr. Hartman by name but do clearly indicate Dr. Eye‘s awareness that P.T. was receiving acupuncture, noting several times that the acupuncture appeared to work well in conjunction with the Botox treatments to control P.T.‘s pain. In his deposition for this case, Dr. Eye indicated that he was aware of Dr. Hartman as P.T.‘s ?family physician.? Dr. Hartman‘s medical notes indicate an awareness of the treatments being undertaken by Dr. Eye, Dr. Koslowski, and Dr. Ong. In her initial visit, P.T. gave Dr. Hartman a lengthy history, including that of the wound on her right arm and her spasms. Dr. Hartman outlined a plan to boost P.T.‘s immune system and correct her reported chronic constipation through diet modifications. By July 13, 1998, Dr. Eye was concerned with the regression in P.T.‘s wound, and again voiced the belief that P.T. was suffering from ?some sort of autoimmune reaction.? On September 15, 1998, Dr. Eye conferred with Dr. Ong concerning P.T.‘s lack of progress. Dr. Eye noted that P.T. ?continues to be an enigma as to the reason for the failure to respond and heal.? On September 22, 1998, Dr. Ong performed another debridement. On September 24, 1998, P.T. returned to Dr. Koslowski complaining of the severe pain in her arm. Dr. Koslowski noted that P.T. was developing flexor spasms in her wrists. He agreed to perform Botox injections and did so on September 29, 1998. Dr. Koslowski‘s notes described the procedure as follows: After isolating each muscle via EMG needle reading, the patient had the following muscles injected with botulinum toxin: right flexor carpi ulnaris, right flexor digitorum, right profundus, right flexor digitorum superficialis, right third and fourth lumbricales, right deep muscle of the abductor pollicis brevis and right abductor digiti minimi with a total amount of 300 units utilized. The patient tolerated the procedure well. Relaxation of the right thumb and first right three digits was immediately apparent to visual exam. Patient stated her ?right forearm area felt much less heavy and tense.? P.T. visited Dr. Eye‘s office on September 30, 1998. Dr. Eye noted that the Botox injections had given her relief from spasms.7/ His note was otherwise despairing as to the condition of the wound itself, which had an enterococcus infection that was proving resistant to antibiotics. Dr. Eye noted, ?We will await the results of her current attempts at therapy and make modifications if appropriate, since we have tried almost everything. I do not have a specific thing to try. We suggest she might consider watching [sic] with detergent solution which would kill the organisms.? P.T. had a follow-up visit with Dr. Koslowski on October 13, 1998. Dr. Koslowski noted that she was having less spasticity in her hand but that she was feeling ?a neural-type of pain going into her pinkie along the ulnar aspect of the hand? that she rated 8 on a scale of 10. He noted decreased tone in the small and ring fingers, though she was able to move the ring finger almost completely in extension. The small finger remained flexed but could be extended slightly. He continued P.T.‘s Neurontin prescription with an increased dosage, and started her on Darvocet as needed for pain. On October 21, 1998, Dr. Ong performed an excision and abdominal rotation flap on P.T.‘s right forearm that included some repair of a nerve that had been damaged in a previous debridement. On October 27, 1998, Dr. Koslowski saw P.T. She stated that she was not having spasms and was having minimal pain.8/ Dr. Koslowski made no changes in her medications. On November 9, 1998, Dr. Eye expressed some encouragement at the results of Dr. Ong‘s surgery, noting that the nerve repair had lessened the pain and that the wound itself appeared ?much improved.? On December 2, 1998, Dr. Eye wrote that the graft ?did not take? and was removed. The wound was 2.5 by 2 cm in diameter. Dr. Koslowski saw P.T. on December 11, 1998. P.T. reported that the spasms were beginning to increase but that she was ?doing pretty well? overall.9/ He noted increased tone in the flexor of the small and ring fingers and that P.T. was able to extend it passively and ?slightly actively.? On December 22, 1998, Dr. Ong reported that the wound was healing well. On January 11, 1999, Dr. Eye wrote that P.T.‘s wound was ?doing great? and that the area was completely healed. However, Dr. Eye also noted that P.T. was having night sweats and that her weight had gone from 123 pounds to 109 pounds since March 1998.10/ P.T. denied any other new symptoms or any changes that occurred when the night sweats began two months previously. Dr. Eye ordered labs, a chest x-ray and an abdominal CT scan to find the cause of the night sweats.11/ On January 4, 1999, P.T. reported to Dr. Hartman that her spasms were ?okay.? Dr. Hartman was trying P.T. on Flexeril (cyclobenzaprine), a muscle relaxant, and noted that it appeared to work for P.T. without causing daytime drowsiness. Dr. Koslowski saw P.T. again on January 12, 1999, and noted that she was still receiving significant relief from the Botox. He advised P.T. to return for Botox injections ?when she needs it or if the spasticity gets severe.? Dr. Koslowski anticipated a follow-up visit in three months. On February 1, 1999, P.T. returned to Dr. Eye to go over the lab work he ordered on her last visit. The labs and the CT scan indicated nothing irregular, but P.T. continued to complain of night sweats in which her temperature would spike as high as 102 degrees. Her arm remained completely healed, and Dr. Eye advised against Dr. Ong performing a proposed ulnar nerve graft while she was running fevers. Dr. Eye noted that P.T.‘s weight had stabilized. By February 19, 1999, Dr. Eye found much improvement in P.T., both as to her hand and the night sweats. The wound was healing, her symptoms were improving, and Dr. Ong was beginning to plan a nerve transplant. Dr. Eye continued to express pessimism as to P.T.‘s overall prognosis, noting that ?we had this wound heal in the past only to have it break down later, so I do not feel comfortable that we have a cure at this time.? Dr. Eye advised P.T. to return in two months. On March 31, 1999, Dr. Ong performed the nerve transplant, harvesting the sural nerve from P.T.‘s right leg and transferring it to the ulnar nerve. Dr. Ong reported that P.T. tolerated the procedure well. In a follow-up visit on April 6, 1999, Dr. Ong noted only minimal bruising and no infection. P.T. visited Dr. Hartman on April 7, 1999. Dr. Hartman noted spasms in P.T.‘s right hand, especially on the ulnar side. P.T. reported that the Flexaril helped with the spasms. On April 12, 1999, P.T. returned to Dr. Koslowski‘s office. Dr. Koslowski noted that P.T. now had a splint on her arm following the nerve graft. Upon examination, Dr. Koslowski noted some decreased tone in the ulnar distribution of the hand.12/ Dr. Koslowski advised P.T. to follow up in six months unless otherwise necessary, and at that time they would consider a new round of Botox injections. He prescribed 30 Valium, 5mg, one tablet at bedtime. P.T. saw Dr. Hartman on April 14, 1999, and reported the results of her appointment with Dr. Koslowski on April 12. Dr. Hartman noted that P.T.‘s spasms were less severe than she had seen them in the past, but still threatened to injure the nerve during her post-operative recovery. P.T. visited Dr. Eye on April 30, 1999. He remarked that everything was healed from the surgery ?except for one small area that is a little less than a cm in diameter.? P.T. understood that it would take a long time for the nerve to regenerate. After visits to both Dr. Ong and Dr. Eye in early June 1999, P.T. did not visit either of them again until November 1999. P.T. continued to see Dr. Hartman for acupuncture and electrical stimulation on a regular basis during this period. On September 28, 1999, P.T. visited Dr. Koslowski and requested a repeat of the Botox treatment in her right hand. Dr. Koslowski noted that P.T. reported spasm in the right hand in the distribution of the median nerve. Dr. Koslowski performed a physical examination, noting increased hypertonicity in the small and ring fingers, and scheduled P.T. to return in two weeks for Botox injections. On October 12, 1999, Dr. Koslowski administered 400 units of Botox to the following muscles: the right flexor digitorum superficialis, right flexor digitorum profundus, flexor carpi ulnaris, opponens digiti minimi, third and fourth lumbricales, third and fourth volar interossei, third and fourth dorsal interossei, adductor pollicis, and abductor digiti minimi. He advised P.T. to follow up on an as-needed basis. On October 28, 1999, P.T. reported to Dr. Hartman that she had experienced no significant spasms since her most recent Botox treatment. In the notes from a visit with P.T. on November 9, 1999, Dr. Eye stated that P.T. reported ?significant pain relief with the Botulism injections.? He also noted that P.T. had recently been diagnosed with Lyme disease and Bell‘s palsy. On November 16, 1999, P.T. reported to Dr. Hartman that she was still doing well on the Botox. She was having spasms but they were much milder than before the treatment. P.T. reported that she was now able to sleep through the night. On December 21, 1999, P.T. reported an increase in the severity of the spasms after she had put her arms out to break a fall. On January 26, 2000, Dr. Hartman noted that the spasms were doing better through the use of a combination of Flexaril and Baclofen, a muscle relaxer. On February 11, 2000, P.T. presented to Dr. Eye having gone through a series of stressful personal events (the death of her father-in-law and of a good friend, and her adopted daughter giving birth to a child with deformities) and with the wound on her arm having increased in size. Dr. Eye called for the wound to be cultured, but remained convinced that ?the underlying problem is not bacterial. She gets secondary bacterial infections but there is still something that causes the beginning of the breakdown. Stress certainly could have affected it this time.? On February 23, 2000, P.T. visited Dr. Koslowski and reported to him that the spasms were much better thanks to the Botox injections. P.T. requested pain medications. Dr. Koslowski prescribed 75 tablets of Darvocet-N 100, one tablet three to four times a day as needed for pain, with three refills. This was the last time Dr. Koslowski saw P.T. until January 12, 2001. Dr. Eye continued to treat the wound through March and April 2000, with poor results. On April 4, 2000, he wrote, ?I am at a loss at this point as to further procedures.? Despite continuous antibiotic treatment, bacteria remained in P.T.‘s wound. On April 24, 2000, ?the arm suddenly got much worse. The ulcer spread.? Dr. Eye noted, ?I have tried all measures, this ulcer essentially defies simple solutions. We have tried almost everything and sent her to 3 referral centers with no suggestions.? On May 1, 2000, Dr. Eye noted that despite treatment with Cipro, the ulcer was rapidly enlarging. Dr. Eye discussed with P.T. the possibility of arm amputation, as all concerned were ?becoming very discouraged about trying to salvage the arm.? P.T.‘s condition continued to wax and wane in this fashion through the remainder of 2000. Certain treatments such as intravenous antibiotics would arrest the growth of the ulcer or even commence healing. By July 27, Dr. Eye reported that the wound was nearly healed. On August 8, he wrote that it was ?completely healed.? By September, however, the wound had relapsed and Dr. Eye was resigned that treatment would have to continue ?probably indefinitely.? The wound again improved through November and December, but never quite healed. P.T. consistently complained of pain in the arm. P.T. also saw Dr. Hartman on a regular basis through the remainder of 2000, continuing the electrical stimulation and acupuncture. Through most of the year, P.T.‘s spasms seemed to be more or less controlled by the combination of Flexaril and Baclofen. On October 28, 2000, Dr. Hartman received the results of P.T.‘s thyroid testing, which indicated hypothyroidism. Dr. Hartman prescribed a thyroid extract. In September and October, P.T. regularly complained to Dr. Hartman about pain in the arm. Dr. Hartman prescribed a transcutaneous electrical nerve stimulation (?TENS?) unit for P.T.‘s home use. P.T. reported that it was effective in alleviating the pain from spasms that woke her up at night in October and November. However, on December 4, P.T. complained to Dr. Hartman of ?knife-like? pain shooting down her forearm. On January 2, 2001, Dr. Hartman noted that the spasms were ?pretty intense.? The TENS unit was helpful but not enough to alleviate the pain. On January 16, 2001, Dr. Hartman noted that the ?spasms [are] back with a vengeance.? P.T. returned to Dr. Koslowski on January 12, 2001, complaining of the spasms in her right arm. P.T. reported ?that the injections worked for approximately one year.? P.T. mentioned that she was also given acupuncture treatments and believed they helped in conjunction with the Botox. P.T. reported that she was not taking any pain medication and requested that Dr. Koslowski prescribe something for pain. Dr. Koslowski‘s examination indicated increased spasm in the flexor aspect of the right hand. He prescribed Lortab for pain and scheduled a follow-up visit for administration of Botox. On February 3, 2001, P.T. told Dr. Hartman that the Botox treatment had been delayed pending approval by USIS. P.T. told Dr. Hartman that the spasms were so bad they woke her up at night and she could do nothing but pace the floor. P.T. stayed home from work one day because she could not use her right arm. On February 14, 2001, Dr. Koslowski performed the Botox procedure on P.T. The amount of Botox used and the placement of the injections were identical to those of the October 12, 1999, procedure. See Finding of Fact 68, supra. P.T. did not return to Dr. Koslowski‘s office until June 3, 2003. On February 14, 2001, Dr. Ong performed a debridement of the wound on P.T.‘s right arm. Vacuum Assisted Closure (?VAC?) therapy was used on P.T.‘s arm in the effort to promote healing and reduce infection. She showed some improvement, but the therapy was not entirely successful. On March 27, 2001, Dr. Eye noted a new infection and the possibility of returning to the IV antibiotic regime. He wrote, ?We are puzzled how she can continue to get organisms in the wound in the face of sterile technique in VAC.? He also noted that her ?arm spasm and pain continue,? though this was only six weeks after her Botox injections. Dr. Eye finally noted some improvement on April 23, 2001, but only after a course of IV Rocephin (ceftriaxone) in addition to the VAC therapy. On May 23, 2001, in noting continued improvement, Dr. Eye wrote that in the future, ?we will simply just give the antibiotics as our first course of therapy to resolve it.? In visits to Dr. Hartman on February 28, March 29, and April 9, 2001, P.T. reported that the spasms were gone since her most recent Botox treatment. On April 23, 2001, P.T. told Dr. Hartman that the spasms had returned but were ?not too bad.? P.T. conceded that the spasms were waking her up at night. The spasms improved somewhat during May, but by June 4, 2001, P.T. was reporting that the Botox was ?wearing off fast.? Through the remainder of 2001, Dr. Hartman was able to control the spasms fairly well with Klonopin (clonazepam), an antianxiety/anticonvulsant medication with muscle-relaxant properties. On August 24, 2001, Dr. Ong performed an excision and skin graft on the ulcer. On September 4, 2001, Dr. Eye reported that the graft showed degeneration and appeared infected. Dr. Ong‘s reports indicated his opinion that P.T. was showing improvement, but Dr. Eye disagreed. On September 18, Dr. Eye noted that the wound appeared larger than it was before the graft. By September 25, Dr. Eye was coming to agree with Dr. Ong that the wound was healing, though his notes during this period also reference concerns about the overall condition of P.T.‘s arm. After a November 2, 2001, appointment, Dr. Eye noted ?further signs of nerve damage with loss of function of the hand. She has thenar eminence wasting consistent with an ulnar neuropathy.? Dr. Eye‘s notes in November and December 2001 make reference to P.T.‘s inability to get in to see Dr. Koslowski for further Botox injections. On January 17, 2002, Dr. Hartman noted that P.T.‘s spasms were becoming ?bothersome.? On January 24, 2002, Dr. Eye noted that P.T.‘s condition is getting worse and that amputation of the arm would be the likely outcome. Though Dr. Eye noted that P.T. was ?seeing Dr. Koslowski for injection,? P.T. in fact continued to be unable to get the injection from Dr. Koslowski for reasons not made clear in the record. Dr. Eye referred P.T. to Michael T. Pulley, M.D., Ph.D., a board-certified physician in the fields of neurology and clinical neurophysiology who was an associate professor of neurology at the University of Florida and Shands in Jacksonville. On January 28, 2002, Dr. Pulley performed an initial neurological examination on P.T. and concluded she was ?an excellent candidate for continued botulinum toxin injections since these have worked well in the past. I will see her back to do those injections and plan to use a total of 200 units.? On February 4, 2002, Dr. Pulley performed the Botox injections. He injected the following muscles in her right arm: flexor digitorum profundus ulnar head, 50 units; flexor digitorum superficialis, 20 units; flexor digitorum profundus median head, 10 units; lumbrical #2, 10 units; flexor carpi ulnaris, 30 units; and abductor pollicis brevis, 15 units. Dr. Pulley‘s notes stated that he would see P.T. in a follow-up visit in one month to assess the effectiveness of the injections, but his records do not indicate that such a visit occurred. On February 12, 2002, Dr. Hartman noted that the Botox treatment had resolved the spasms that were keeping P.T. awake at night. On February 15, 2002, Dr. Eye noted that P.T. reported improvement in the pain she was feeling in the arm. On March 14, 2002, Dr. Eye noted remarkable improvement in the healing of the wound, which he attributed to hyperbaric treatments accompanied by IV Rocephin. His plan was to continue periodic hyperbaric treatments even after the wound healed, in order to keep it healed. Dr. Eye also noted that P.T. reported that when working, she was forced to leave the hospital and change her dressings and take her IV antibiotics in her car because ?some woman there fears that it is =catching.‘? On April 4, 2002, Dr. Eye noted that the healing process was proceeding well but that P.T.‘s arm pain was so bad it woke her up at night. He also noted a significant decrease in the size of her right arm. Dr. Eye stated that P.T. would be continued on IV antibiotics until the wound healed. On June 20, 2002, Dr. Eye wrote the following: Someone recently indicated she was at maximal medical benefit. This is completely erroneous. We have even had her healed in the past only to break down and continue to have problems. She is developing progressive nerve damage in the arm. In my view there may be no date of maximal medical improvement for [P.T.] with a chronic persistent problem. In our opinion this will be a lifelong remaining problem. Ultimately the solution may well be an amputation at which point she would have reached maximal medical improvement but only then. She voices no other new complaints. The pain in the arm continues to be present. On July 11, 2002, P.T. returned to Dr. Pulley for a repeat Botox injection.13/ This time, Dr. Pulley injected 135 units into the following muscles of P.T.‘s right arm: flexor digitorum profundus ulnar head, 95 units; flexor carpi ulnaris, 50 units; flexor digitorum superficialis, 50 units. On this occasion, the anticipated follow-up visit occurred, on August 7, 2002. P.T. reported that things were going very well and she was able to sleep through the night.14/ Dr. Pulley performed an examination and concluded that P.T. had ?definite weakness? in her right arm. He noted: ?It is not clear how much of this is due to the ongoing ulnar nerve injury and how much is due to the botulinum toxin. In any event, she feels that this is a very good outcome.? This was P.T.‘s final visit to Dr. Pulley. After seeing P.T. on September 26, 2002, Dr. Eye noted that the ulcer was not healing and that P.T. was now beginning to lose functional use of the hand. Dr. Eye raised the possibility of amputation with prosthesis, but P.T. did not want to discuss the subject. P.T. voiced that she had only ?modest? pain in the arm. Dr. Eye continued to see P.T. once or twice per month for the rest of 2002 and early 2003 with the same pattern of improvement on the margins, then setbacks, such that the wound never completely healed.15/ On November 11, 2002, Dr. Eye remarked on the ?waxing and waning of the ulcer? and on his constant search on the internet for some new treatment he might try to resolve P.T.‘s case. On January 6, 2003, Dr. Hartman noted that the Botox appeared to be wearing off and the spasms were back in P.T.‘s right arm. On January 21, 2003, Dr. Hartman noted that the spasms were not yet ?terrible? and that the plan was to wait until the spasms worsened to get the Botox treatment. On March 3, 2003, Dr. Eye noted that his own recommendation would be to amputate the arm, but that P.T. wanted to keep it. Dr. Eye‘s notes on several occasions speak approvingly of the Botox injections P.T. received for the pain in her arm. His notes of May 15, 2003, state that P.T. plans to return to Dr. Koslowski for treatment. On June 3, 2003, P.T. returned to Dr. Koslowski for the first time since February 14, 2001. P.T. reported that she had received Botox injections from Dr. Pulley during the interim, and that the most recent injection had ?lasted? for about eleven months. Dr. Koslowski‘s physical examination found ?the intrinsics of her hand were spastic with finger flexion, especially in the ulnar aspect of the hand.? He found that the flexion was severe enough to cause ?spasticity? and that she had a very difficult time opening her hand. Dr. Koslowski prescribed Lidoderm patches; 60 Oxycontin, 5 mg, one tablet twice a day as needed, and a follow-up visit after his office obtained the Botox for P.T.‘s injections. Through May and early June, Dr. Hartman noted that the spasms had been worsening. On June 12, 2003, Dr. Hartman noted that P.T.‘s spasms were ?outrageous,? affecting her night and day. She noted that P.T.‘s wound seemed a little deeper than on her previous visit, and that the spasms ?seem to rip it up.? On June 18, 2003, Dr. Koslowski performed the Botox injections on P.T. The amount of Botox used and the placement of the injections were identical to those of the October 12, 1999, and February 14, 2001, procedures. See Findings of Fact 68 and 75, supra. Dr. Koslowski‘s notes indicate that P.T. was to come in for a follow-up in one month, but in fact she did not return until October 30, 2003. P.T. visited Dr. Eye on July 3, 2003. Dr. Eye noted that the wound was down 4-5 mm but that P.T. intended to stop the hyperbaric treatments because she could no longer stand being in the confined space. Dr. Eye further noted that P.T.‘s pain had ?dramatically improved with the Botox injections.? P.T. visited Dr. Hartman on July 29, 2003, and reported some spasms in her right, small finger. Dr. Hartman noted that the finger was apparently ?not touched by Botox.? The three adjacent fingers were not spasming. On August 25, 2003, Dr. Hartman noted that P.T.‘s wound had re-opened for ?no particular reason.? On October 26, 2003, Dr. Eye noted that P.T. was having more muscle spasms than before and that she was scheduled to receive Botox from Dr. Koslowski. He wrote, ?It has been 3 months since her last Botox injection. Usually they last a little longer.? On October 27, 2003, Dr. Hartman noted that the spasms were ?awful today. Back with a vengeance.? She found that the spasms had broken down two areas of the wound. On October 28, 2003, Dr. Hartman wrote, ?Needs spasm relief!? On October 30, 2003, P.T. returned to Dr. Koslowski‘s office. She told him that the Botox injections only worked for a couple of months this time. Dr. Koslowski‘s physical examination revealed some spasms in the ulnar nerve distribution with a claw hand.16/ Dr. Koslowski‘s notes indicate a plan to increase the amount of Botox to 600 units for the next series of injections. On November 14, 2003, Dr. Hartman noted that the Botox was still not available to P.T. She therefore performed a series of trigger-point injections of lidocaine with the goal of preventing the spasms from further breaking down the wound. On November 18, 2003, Dr. Eye noted that the wound had almost completely healed, but the spasms had broken it down again. The pain from the spasms was such that P.T. could not sleep at night. Dr. Eye indicated that he had spoken to Dr. Koslowski, who had said there was a delay in obtaining Botox. Dr. Eye prescribed Percocet for the pain until she could receive the Botox injection that would ?resolve the symptoms.? On November 20, 2003, Dr. Koslowski injected 600 units of Botox into the muscles of P.T.‘s right arm. Though the amount was increased, the placement of the injections was the same as in the immediately previous three sessions. See Finding of Fact 68, supra, for a list of the muscles injected. Dr. Koslowski noted that follow-up would be done on an as-needed basis. On December 15, 2003, Dr. Hartman noted that P.T.‘s pain was better since the Botox injection. P.T. also reported ?amazing pain relief? from the trigger-point injections of lidocaine. P.T. visited Dr. Eye on January 6, 2004. She reported to Dr. Eye that the Botox was helping to keep the arm pain somewhat in check, and that she was still able to use the hand. At this point, Dr. Eye had given up on a lasting solution for the wound on P.T.‘s arm: ?Clearly it waxes and wanes on its own parameters. Nothing we are doing seems to be making any difference. I think symptomatic treatment is the only solution for now. We still have not run across a previous description of a similar wound.? On February 10, 2004, Dr. Eye noted that the ulcer had grown and had purulent drainage. The type of pain P.T. was reporting was more consistent with infection than the type of neuropathic pain addressed by Dr. Koslowski‘s Botox treatments. P.T. had been using detergent soaks on the wound, and Dr. Eye now suggested raw honey, ?which has been reported to have a dramatic antibacterial property.? Dr. Eye told P.T. that he had heard of ?some type of special grafting procedure in Boston? for which he would be happy to send her. On February 17, 2004, Dr. Hartman performed a series of trigger-point injections with bupivacaine. On March 4, 2004, P.T. presented to Dr. Eye with a clean wound, which he attributed to ?antibacterial? and ?osmotic? effects of the honey. P.T. reported pain in the arm, described by Dr. Eye as ?neuropathic.? She is still taking Percocet to sleep and reported that the pain was so bad she could not use the computer at work. P.T. was to make an appointment to see Dr. Koslowski. On April 1, 2004, P.T. saw Dr. Koslowski. P.T. rated her pain as a 5, ?where 0 is no pain and 10 is the worst pain imaginable.? P.T. told Dr. Koslowski that the pain had started within the last week. She also stated that Botox was working very well on her. Dr. Koslowski gave P.T. samples of Trileptal (oxcarbazepine), an anti-seizure medication that has been used off-label for neuropathic pain. He instructed P.T. to let him know if it helped. If it did, his office would call in a prescription for her. Dr. Koslowski also signed a medical authorization for P.T. to be excused from work from March 29 until April 5, 2004. A nurse‘s note in Dr. Eye‘s records, dated April 6, 2004, states that P.T. reported that she was told by Dr. Koslowski that he could not perform a nerve block due to the open wound on P.T.‘s arm. Dr. Eye told P.T. that Dr. Koslowski may consider Botox instead. P.T. stated that she would discuss the matter with Dr. Koslowski. On April 12, 2004, P.T. saw Dr. Eye, who noted that she had been ?in severe pain for the last several weeks. Her husband says she is up almost all night. She can‘t sleep. The Percocet is not doing the job. We are going to add Fentanyl patch. She got Botox but it has not made a significant difference.? In fact, P.T.‘s most recent Botox treatment had been on November 20, 2003. Dr. Eye noted that he would try to get P.T. in to see Dr. Ong the next day. On April 13, 2004, P.T. visited Dr. Ong, who noted the ulcer with ?a lot of necrosis? and a need for debridement. P.T. was in a great deal of pain from the infection. Also on April 13, 2004, P.T. visited Dr. Hartman, who noted that the nerve was exposed under the ulcer and that P.T. was ?in awful pain.? Her ring and small fingers ?feel like in a vat of boiling oil.? P.T. reported that she had not been able to work for two weeks. Dr. Hartman administered a series of trigger-point injections with bupivacaine. On April 16, 2004, Dr. Ong performed a debridement and rotation skin flap on P.T.‘s wound, and applied a wrist splint. On April 22, 2004, Dr. Eye placed her on IV antibiotics, in light of the failure of previous skin flaps. On May 10, 2004, P.T. visited Dr. Eye, who noted that ?her arm looks better than it has in years.? P.T. reported that the pain was gone as soon as the surgery was performed. Dr. Eye decided to keep P.T. on IV antibiotics ?until this thing is pretty much healed.? By early June, the ulcer again appeared to be increasing in size, though P.T. still reported dramatic improvement in her pain since the graft. On July 27, 2004, Dr. Eye noted that the wound ?almost appears to have healed and filled in. The pain in the arm is dramatically better.? Dr. Eye‘s prognosis remained guarded, however, because the medical team had healed the wound in the past only to have it break down once treatment stopped. P.T. saw Dr. Koslowski on August 12, 2004. P.T. rated her pain at a 2 or 3 on a scale of 10. Dr. Koslowski noted hypalgesia at the ulnar distribution of the right hand and severe spasms in the flexor aspect of the hand. He discussed the treatment options with P.T. and they agreed that Botox was the preferred choice. Dr. Koslowski ordered 600 units of Botox and hoped to administer it to P.T. within the next three weeks. On August 18, 2004, Dr. Hartman noted that P.T.‘s Botox was on order. P.T. reported that her spasms were not ?horrible,? but the botox will be a ?welcome relief.? On September 14, 2004, Dr. Koslowski injected 600 units of Botox into the muscles of P.T.‘s right arm. The placement of the injections was the same as in the immediately previous four sessions, except that on this occasion Dr. Koslowski did not inject the adductor pollicis. See Finding of Fact 68, supra, for a list of the muscles injected. Dr. Koslowski noted that follow-up would be done on an as-needed basis. On October 4, 2004, Dr. Eye noted continued improvement in the wound. He noted that P.T. had continued to work through almost all of her illness, which he found ?somewhat amazing.? Dr. Eye also noted the following: I spoke with Dr. Koslowski who is taking a more aggressive approach to keeping the area botulized to resolve the pain. There is some data that this may improve wound healing and in fact appears to be somewhat effective to this point. We remain skeptical, however, if it shows long term affects [sic] but certainly I am willing to try. We have tried every measure known without significant improvement or results. P.T.‘s wound continued to progress toward healing until her arm was injured in a car accident in December 2004, or January 2005. On January 18, 2005, Dr. Eye noted a ?small breakdown? in the wound. On January 25 and February 14, 2005, Dr. Hartman performed a series of trigger-point injections for pain. The wound remained open as of March 17, 2005, and Dr. Eye advised P.T. to resume the application of raw honey and to protect the wound as much as possible. Dr. Eye noted, ?The peripheral neuropathy is under much better control with the Botox. She is able to use her hand to some degree.? Dr. Eye advised P.T. to ?continue to follow up with her necessary Botox to control the pain neuropathy.? On May 11, 2005, P.T. returned to Dr. Koslowski to request Botox injections. Dr. Koslowski‘s physical examination revealed spasms in the right flexor on the ulnar aspect of the hand, as well as some spasm in the medial aspect. He indicated that he would order 600 units of Botox, ?to be injected at a later date when payment is received.? On June 1, 2005, Dr. Hartman noted that P.T.‘s arm had been spasming for two weeks. On June 2, 2005, Dr. Hartman performed a series of trigger-point injections with bupivacaine. On June 8, 2005, Dr. Koslowski injected 600 units of Botox into the muscles of P.T.‘s right arm. The injections were placed in the following muscles: flexor digitorum superficialis; flexor digitorum profundus; flexor carpi ulnaris; opponens digiti minimi; third and fourth lumbricales; third and fourth volar interossei; third and fourth dorsal interossei; adductor digiti minimi; and ?the deeper version of the flexor pollicis brevis muscle and adductor pollicis.? Dr. Koslowski advised P.T. to call in one week to tell him the benefit of the injections and to follow-up in six months to repeat the procedure. Dr. Eye‘s notes for visits from P.T. on June 28 and October 3, 2005, indicate that P.T.‘s wound is doing relatively well and that the Botox treatments have been effective in helping to control the pain in her right arm. On December 27, 2005, Dr. Eye noted that the wound had broken open again. He wrote that multiple attempts to treat it with antibiotics had failed and he would not pursue that route again. P.T. was to continue the program of topical treatment and return in three months or sooner if the problem worsened. On January 24, 2006, P.T. visited Dr. Koslowski‘s office along with her USIS case manager. After Dr. Koslowski explained the purpose and preferred frequency of the Botox treatments, they decided that P.T. would receive Botox treatments every six months. Dr. Koslowski injected 600 units of Botox into the muscles of P.T.‘s right arm. The placement of the injections was the same as in the session of June 8, 2005. See Finding of Fact 138, supra. P.T. visited Dr. Eye‘s office on March 27, 2006. Dr. Eye noted that P.T.‘s ulcer had relapsed and was ?now as big as ever despite all the efforts put into it.? He suggested that P.T. consider natural alternatives to treating the wound because ?conventional treatment of all types has failed.? Dr. Eye suggested that P.T. return in two to three months. On May 18, 2006, P.T. visited Dr. Koslowski. She stated that the spasms had not yet increased but that she wanted to set up the next Botox treatment in order to preempt their onset. Dr. Koslowski conducted an uneventful physical examination and instructed P.T. to return in one month unless otherwise necessary. On June 13, 2006, P.T. visited Dr. Eye, who noted that the ulcer continued to increase in size. They debated whether to resume hyperbaric treatments or skin grafts, but P.T. expressed a preference to ?hang on? with the topical treatments. On July 7, 2006, P.T. called in to Dr. Koslowski‘s office complaining of spasms in her little finger that had been ongoing for about one week. Dr. Koslowski told P.T. that he would advise the case manager of the need to order Botox for injections ?in the very near future.? On August 16, 2006, Dr. Koslowski injected 600 units of Botox into the muscles of P.T.‘s right arm. The placement of the injections was the same as in the session of June 8, 2005. See Finding of Fact 138, supra. Dr. Koslowski advised P.T. that he would follow up with further Botox injections in six months. On August 22, 2006, P.T. reported to Dr. Hartman that the Botox injections had greatly decreased the spasms. Dr. Hartman recommended that trigger-point injections be performed for neuropathic pain a few months after the administration of Botox. On August 24, 2006, P.T. visited Dr. Eye, who noted that the ulcer has been ?quiet? and well controlled with topical medications. He noted that P.T. had not needed IV antibiotics in two years and was off all oral antibiotics as well. Dr. Eye also noted that the recent Botox injection for pain helped her. He advised P.T. to continue with the current program and to return in four months. This was P.T.‘s last visit with Dr. Eye. She was formally discharged from his practice in January 2007. On October 26, 2006, Dr. Hartman performed a series of trigger-point injections in P.T.‘s right upper arm and forearm. On March 13, 2007, P.T. returned to Dr. Koslowski‘s office complaining of spasms in her right hand and requesting Botox injections. Dr. Koslowski agreed to perform the injections as soon as he could obtain 600 units of Botox. Two months passed before the Botox could be obtained. On April 16, 2007, P.T. asked Dr. Hartman to take over as her primary care physician for her workers‘ compensation-related injury. Dr. Hartman agreed to do so. On May 14, 2007, Dr. Koslowski injected 600 units of Botox into the muscles of P.T.‘s right arm. The placement of the injections was the same as in the session of June 8, 2005. See Finding of Fact 138, supra. Dr. Koslowski advised P.T. that he would follow up with further Botox injections in six months, unless otherwise necessary. He also told her that he would like to order the Botox now so that he would have it by the time P.T. was ready for her next series of injections. On November 26, 2007, Dr. Hartman noted that the spasms were beginning again and that sufficient time had passed to initiate the process of obtaining Botox injections.17/ On February 11, 2008, P.T. presented to Dr. Koslowski with spasms in the ulnar distribution of her right hand. She stated that she had begun experiencing the spasms within the past week or two. She rated her pain at 7 or 8 on a scale of Dr. Koslowski‘s physical examination noted spasms, but not as bad as P.T. had experienced in the past. Dr. Koslowski planned to inject P.T. with Botox as soon as it could be obtained. Dr. Koslowski performed the Botox injections on March 26, 2008. The placement of the injections was the same as in the session of June 8, 2005. See Finding of Fact 138, supra. On February 5, 2009, P.T. presented to Dr. Koslowski with spasms in her right hand and rated her pain at 6 to 7 on a scale of 10. Dr. Koslowski‘s physical examination noted ulnar nerve malformation with spasm in the index finger and flexion spasm in the ring finger, which P.T. reported as having started about a week and a half ago. On March 17, 2009, Dr. Koslowski performed Botox injections on P.T. The placement of the injections was the same as in the session of June 8, 2005, see Finding of Fact 138 supra, except that on March 17, 2009, Dr. Koslowski did not record an injection into the flexor digitorum superficialis. The March 17, 2009, visit was P.T.‘s last recorded visit to Dr. Koslowski‘s office. P.T.‘s treatment by Dr. Boswell and Dr. Kirsner As noted at Finding of Fact 17, supra, P.T. saw psychiatrist Dr. Atul Shah from February 1991 through February 1998. In April 1998, P.T. began seeing Kelly M. Boswell, Ph.D., a psychologist practicing in Atlantic Beach. P.T. continued to see Dr. Boswell throughout the time period relevant to this proceeding. Dr. Boswell‘s treatment is dealt with separately because it did not bear directly on Dr. Koslowski‘s treatment and because the record does not indicate that there was any coordination between Dr. Boswell and Dr. Eye or the other physicians working in conjunction with Dr. Eye. To the contrary, Dr. Boswell‘s records indicate that P.T. insisted that Dr. Boswell not share with her other health care providers certain information P.T. confided in their sessions. P.T. was referred to Dr. Boswell by Donna Spanzo, an ARNP associated with Dr. Shah whom P.T. had been seeing for about one year. On April 27, 1998, P.T. reported to Dr. Boswell a history of bulimia nervosa since age seven and daily purging at the present time. P.T. felt obsessed with her weight, which Dr. Boswell observed to be within normal limits. P.T. reported that she had taken Prozac ?for years.? She reported ?bad memories? of domestic abuse or violence that she was not ready to discuss. Dr. Boswell gave P.T. a provisional DSM-IV Axis I diagnosis of eating disorder NOS and dysthymic disorder secondary to the eating disorder. In June 1998, Dr. Boswell referred P.T. to a Jacksonville psychiatrist, Dr. Ron Kirsner, for the purpose of commencing Meridia therapy in conjunction with her treatment with Dr. Boswell. Meridia (sibutramine) is an appetite suppressant (since withdrawn from the U.S. market) used in the treatment of obesity. In his medical notes, Dr. Kirsner wrote that both P.T. and Dr. Boswell believed that P.T.‘s depression was ?probably secondary to or at least contributed significantly to her inability to control her bulimia.? Dr. Kirsner explained that Meridia would be used in P.T.‘s case ?to help her experiment with the feeling of satiety.? On July 8, 1998, P.T. reported to Dr. Boswell that she had vomited blood during the last week. At Dr. Boswell‘s insistence, P.T. agreed to undergo a physical. Dr. Boswell recommended Dr. Graciela Diez-Hoeck, a Jacksonville internist.18/ On July 15, 1998, P.T. reported to Dr. Boswell that she was ?down to purging every other day.? Dr. Boswell noted that P.T. ?still refuses to let me? consult with Dr. Eye. On August 25, 1998, P.T. admitted to Dr. Boswell that she had canceled her appointment with Dr. Diez-Hoeck. P.T. did agree to tell Dr. Hartman about her bulimia. One of the chief issues raised by P.T. with Dr. Hartman during this early part of her treatment was chronic constipation, for which Dr. Hartman tried a number of approaches. However, there is no mention of bulimia in Dr. Hartman‘s medical records for this time period. In her September 1998 sessions with Dr. Boswell, P.T. expressed her ?grief and anger? over the loss of function in her arm. She also expressed her inability to directly communicate her fears to her treating physician regarding proposed surgical procedures, and her fear of being perceived as a ?wimp.? P.T. promised to be more open with her physicians. On October 4, 1998, P.T. discussed her frustration at the failure of her wound to heal, as well as her tendency to be hard on herself and not reach out to others for comfort. On October 5, 1998, Dr. Kirsner suggested that P.T. start taking an antidepressant to ?elevate [her] mood and restore hope.? He prescribed Serzone (nefazodone) twice daily in increasing dosages over three weeks. On October 13, 1998, P.T. complained of her struggle with chronic pain. Dr. Boswell reiterated her insistence that P.T. tell her physician the status of her eating disorder. Dr. Boswell noted that P.T. was very resistant but understood that she needed to make a decision before her next weekly session or Dr. Boswell would stop seeing her. At the next session, P.T. reported that she had made an appointment to see Dr. Diez-Hoeck on the day before Thanksgiving, and P.T. gave permission for Dr. Boswell to communicate with Dr. Diez-Hoeck about her case. Through November 1998, P.T. was reporting progress in the healing of her arm and the fact that she was purging much less. However, her wound began to worsen in early December. On December 15, 1998, P.T. expressed her frustration at the failure of her arm to heal and reported to Dr. Boswell that she had purged four times in the last week. They discussed the idea that purging was a way of expressing distress and anger toward her body as well as a way to discharge anxiety. Also on December 15, Dr. Kirsner noted that he had spoken with Dr. Boswell and they were both concerned that P.T. was losing too much weight on Meridia, that blood work needed to be done, and that P.T. had still not told her other physicians about her bulimia. Dr. Kirsner wrote that he had ?set a limit today? by telling P.T. that he would not refill her Serzone or Meridia until he had seen blood studies for her. On December 30, 1998, Dr. Boswell noted that P.T.‘s blood work was done and her values were within normal limits. On January 7, 1999, Dr. Kirsner began hypnotherapy with P.T., which P.T. reported to Dr. Boswell was proving helpful. P.T. continued to receive hypnotherapy from Dr. Kirsner throughout his treatment of her, and she began practicing self-hypnosis and positive visualization techniques that Dr. Kirsner taught her during their sessions. Starting on December 30, 1998, and continuing through later sessions, Dr. Boswell began exploring with P.T. the stresses of her job and P.T.‘s fear of leaving it. P.T. complained repeatedly of fatigue, and Dr. Boswell stressed the importance of resting rather than constantly trying to fight through the fatigue. On January 27, 1999, P.T. reported to Dr. Boswell that her wound was doing better but that she was having painful spasms in her right arm. Dr. Boswell continued to press the importance of taking in sufficient calories and maintaining a balanced diet. Dr. Boswell laid out a specific eating plan for P.T. to follow. P.T. indicated receptiveness, but appeared to Dr. Boswell to be generally resistant to eating a sufficient amount of protein and fat. Over the next month, P.T. reported that she followed the diet and felt less fatigued, though she also commented that she felt like ?the doughboy.? Dr. Boswell weighed her to demonstrate that P.T. had actually lost weight. On February 17, 1999, Dr. Boswell noted that P.T.‘s arm was completely healed and that P.T. was beginning to make the ?mind-body connection? and to feel empowered as regards her own health. On February 24, 1999, Dr. Boswell noted that P.T. was ?very upset due to receiving news that infection in arm is back. Getting advice to reopen wound and go on IV antibiotics.? This note is odd because nothing in Dr. Eye‘s notes for this time period indicate any problem with the healing of P.T.‘s arm. See Dr. Eye‘s note for February 19, 1999, discussed at Finding of Fact 66, supra. In fact, P.T. was doing so well that Dr. Eye and Dr. Ong were beginning to plan a nerve transplant. Also on February 24, 1999, P.T. reported to Dr. Kirsner that a Gallium scan showed an infection in her arm and that she was going to undergo an incision and drainage procedure. On February 16, 1999, Dr. Hartman had noted, ?Arm wound really good!? Dr. Eye‘s note for February 19, 1999, states: ?We did a Gallium scan, nothing could be found. At this point we are not going to pursue further. We feel that antibiotics on an empirical basis is not further indicated.? On this date, P.T. was clearly misleading Dr. Boswell and Dr. Kirsner as to the condition of her arm. On March 22, 1999, P.T. reported to Dr. Boswell that she was apprehensive about ?upcoming surgery to address signs of infection -- graft nerve.? The surgery performed on March 31, 1999, by Dr. Ong was a nerve transplant, unrelated to any infection. On April 14, 1999, P.T. gave Dr. Kirsner a description of the surgery that included the excision of ?infected pockets? in the arm. Dr. Ong‘s surgical notes make no mention of infection and specifically state that P.T. was not given any kind of antibiotic at the time of surgery. On April 27, 1999, P.T. reported to Dr. Boswell that her arm was worse and an ulceration was developing. This concern was not reflected in the medical notes of Dr. Eye or Dr. Ong. On April 26, 1999, Dr. Hartman did note that P.T.‘s wound looked ?weepy? and her suspicion of a yeast infection, but she did not prescribe anything more than a change in the method of dressing the wound. On May 5, 1999, P.T. reported to Dr. Boswell that her arm was infected. Dr. Eye‘s medical notes for April 30, 1999, note that the surgical site ?looks clean. There is no purulent drainage.? On May 17, 1999, Dr. Hartman noted that the wound was draining a bit but she did not prescribe an antibiotic. By June 2, 1999, Dr. Hartman noted that the wound ?looked good.? On June 9, 1999, P.T. reported to Dr. Kirsner that she was taking Sporanox (itraconazole) for the yeast infection in the wound. In fact, Dr. Hartman had prescribed Sporanox for P.T.‘s night sweats on March 17, 1999. On April 14, 1999, P.T. also reported to Dr. Kirsner that she had recently been binging and purging. On April 21, 1999, P.T. reported to Dr. Boswell that she felt ?sluggish and fat.? On May 5, 1999, P.T. reported to Dr. Kirsner that she had a hard time controlling her bulimia because it provided ?stress relief.? On May 12 and 19, 1999, P.T.‘s sessions with Dr. Boswell focused on her need to seek less stressful work. P.T. described herself as in a ?funk? because of her job, her husband‘s poor health, and her frustration with the healing process of her arm. On June 2, 1999, P.T. reported to Dr. Boswell that she felt depressed due to her arm getting worse. Dr. Eye‘s notes of the same date state the wound looked clean, with ?just a superficial ulceration at the area of the graft site.? Dr. Eye wrote that he would see P.T. ?in a few months? if nothing changed for the worse. In response to P.T.‘s reported depression, Dr. Boswell told P.T. that she needed to reduce her hours or quit her job altogether because it required her to get up at 3 or 4 a.m. and work late. P.T. was still struggling with the idea of being thought a ?wimp? if she could not maintain her work schedule. On June 9, 1999, P.T. discussed with Dr. Boswell the connection between her exhaustion from overwork and her purging. On June 9, 1999, P.T. reported to Dr. Kirsner that she was getting her work assignment changed from triage to the less stressful position of anesthesia screening. On June 22, 1999, P.T. told Dr. Boswell that the change in job positions should be accomplished by mid-July. P.T. reported starting the new position on July 15, 1999. On July 20, 1999, P.T. reported to Dr. Boswell that work was going well but that her arm wound was getting larger and draining. The records give no indication that P.T. reported her concerns to Dr. Eye. Dr. Boswell noted the connection between sleep and nutrition, and stated that she wanted to get P.T. on to a more normal sleep pattern before aggressively ?pushing? on food. On August 4, 1999, P.T. reported to Dr. Boswell that the pain in her arm woke her up every night, and she would get up and take a shower to relieve the pain. They discussed P.T.‘s options for dealing with pain, and P.T. expressed her fear of becoming addicted to narcotics. On August 18, 1999, P.T. and Dr. Boswell discussed going to Dr. Koslowski to ask about a TENS unit or a nerve block for her pain. On September 1, 1999, P.T. reported that she had made an appointment with Dr. Koslowski. On September 8, 1999, P.T. reported to Dr. Boswell that Dr. Hartman had prescribed Klonopin for the pain from the spasms. On September 13, 1999, Dr. Hartman prescribed dicloxacillin and Diflucan (fluconazole) for an infection in P.T.‘s arm wound. P.T. reported to Dr. Boswell on September 9, 1999, that the arm had developed pseudomonas and that she then had an allergic reaction to the antibiotic. Dr. Hartman‘s medical notes do not mention an adverse reaction to the antibiotic. On September 29, 1999, P.T. discussed with Dr. Boswell her depression and anxiety regarding her fears that her arm would never get better. On October 5, 1999, P.T. reported to Dr. Boswell that her arm was getting worse. She was now having spasms during the day as well as at night, but felt hopeful because she would be getting Botox injections from Dr. Koslowski on October 12. P.T. also reported that she was binging more, which Dr. Boswell related to exhaustion from the constant struggle to sleep through the night. On October 13, 1999, P.T. reported to Dr. Boswell that she received the Botox injections on the previous day, that they should take effect within one week, and that they should provide some level of relief from spasm for the next seven months. Dr. Boswell was hopeful that the injections would help P.T.‘s insomnia. On October 29, 1999, P.T. reported to Dr. Kirsner that the Botox injections had taken away 80 percent of the arm spasms and that she was now sleeping through the night. On January 2, 2000, P.T. reported to Dr. Boswell that her arm had worsened and that her work environment ?is quite stressful.? P.T.‘s sleep was becoming inconsistent again. Dr. Boswell directed P.T. to observe her home environment for causes of stress. On February 22, 2000, P.T. reported to Dr. Boswell that her arm was infected again and she was now purging daily. Dr. Boswell‘s notes do not mention any of the obvious stressors set forth in Dr. Eye‘s note of February 11, 2000: P.T.‘s father-in-law and a good friend had died, and P.T.‘s adopted daughter had given birth to a child with deformities. See Finding of Fact 78, supra. On February 23, 2000, P.T. related all of these traumatic events to Dr. Kirsner.19/ On April 6, 2000, Dr. Boswell noted that P.T. was sleeping better thanks to resuming her Klonopin prescription and had succeeded in reducing her purging to five days per week. P.T.‘s immediate goal was to maintain the regimen of not purging two days per week. P.T. continued to struggle with ?feeling fat? and with maintaining her morale regarding the condition of her arm. On May 31, 2000, P.T. reported to Dr. Boswell that her wound ?looks better, but it hurts like crazy.? P.T. spoke to Dr. Boswell about her continuing reluctance to take any sort of addictive substance. On June 14, 2000, P.T. told Dr. Boswell that she was sleeping better and had not purged in a week. P.T. resolved that she would not purge until her arm healed. On June 28, 2000, Dr. Boswell noted that P.T. was still not purging and had progressed sufficiently to commence a nutritional rehabilitation program to be medically overseen by Dr. Hartman. Dr. Hartman‘s contemporaneous medical notes make no mention of such a plan, even though Dr. Hartman continued to treat P.T.‘s constipation via diet. Dr. Boswell‘s medical notes indicate an ongoing discussion with P.T. about contacting Dr. Hartman for consultation on diet and related areas such as P.T.‘s adrenal insufficiency. By August 2, 2000, Dr. Boswell appeared to be in contact with Dr. Hartman, if not directly then using P.T. as an intermediary. Dr. Boswell understood that Dr. Hartman believed P.T.‘s chronic constipation was a major source of her wound- healing difficulty. Dr. Boswell noted that she would send some suggested articles on constipation to Dr. Hartman and would suggest some further tests to run on P.T. Again, Dr. Hartman‘s notes are silent as to consultations with Dr. Boswell. As noted at Finding of Fact 81, supra, P.T.‘s wound relapsed in September 2000. On September 5, 2000, she complained to Dr. Boswell of spasms in her arm and a sense of fatigue from the lack of sleep caused by the pain.20/ On September 19, 2000, P.T. reported to Dr. Boswell that Klonopin was not helping as much as it used to, and that she was very concerned about becoming dependent on analgesic or anxiolytic drugs. They discussed how P.T.‘s fear of developing a ?disability persona? was keeping her from taking the steps necessary to heal. Dr. Boswell discussed the matter with Dr. Kirsner, relaying her concern that P.T. was being ?stoic.? Dr. Kirsner discussed with P.T. the criteria for addiction, which include the continued use of the drug despite negative consequences. P.T. told Dr. Kirsner that she had a prescription for Lortab from Dr. Eye, but that it ?hypes me up.? Dr. Kirsner started P.T. on MS Contin, time-released morphine sulfate. On September 26 and again on October 3, 2000, P.T. reported to Dr. Boswell that she was unable to take MS Contin during the workweek because she had to wake up early. After obtaining a medical work-release note from Dr. Hartman, P.T. was able to take the MS Contin. On October 10, 2000, P.T. reported to Dr. Boswell that she felt much better after taking time off and being able to sleep through the night on the MS Contin. However, when she went back to work in early December 2000, P.T. reported that the pain was an 8 on a scale of 10 by the end of the day because she was unable to take the MS Contin. On December 5, 2000, P.T. reported to Dr. Kirsner that she was ?in a fog? when she took MS Contin and so could only take it when she went home from work. Dr. Kirsner believed that the dosage prescribed could not cause the effects described by P.T. and that she was just ?squirrely? about taking it while working for fear of making a mistake. They discussed various clinical options before settling on adding Provigil (modafinil) to the MS Contin in order to improve P.T.‘s alertness on the job. On December 13, 2000, P.T. reported to Dr. Boswell that she was sleeping much better thanks to the new drug regime. On January 9, 2001, Dr. Boswell noted that P.T. had stopped taking her pain medications due to her husband‘s concerns about addiction.21/ P.T. admitted to Dr. Boswell that she had not told her husband ?the whole story? regarding the rationale for taking pain control medications. P.T. agreed to bring her husband in to meet with Dr. Boswell. On January 16, 2001, P.T. told Dr. Kirsner that taking the MS Contin twice a day was helping her a lot. Dr. Kirsner queried as to why she waited until 3 p.m. to take her first dose, and P.T. replied that ?it would be too easy to fall into? taking three doses per day and that she considered sticking to twice per day a ?victory.? Dr. Kirsner attempted to explain that taking three doses per day would increase her functioning and free up her mental energy for pursuits ?more fruitful than fighting pain off.? He further told her that her current dosage of MS Contin was the lowest available and that she could not become sedated on a 15 mg dose of MS Contin taken with Provigil. P.T. also told Dr. Kirsner that her husband was not supportive regarding her need to take chronic pain medications, and that she had been purging three times per week since Christmas. On January 23, 2001, P.T. reported to Dr. Boswell that taking the pain meds three times per day as prescribed made her feel better and did not adversely affect her performance at work. P.T. committed to maintaining her medication regime for at least one week. P.T. also indicated that she was planning to get a Botox injection for the spasms in her right arm. On January 30, 2001, P.T. reported to Dr. Boswell that her wound had grown and deepened, and that the spasms were ?very bad.? Her pain was improved by following her established medication regime, but the spasms continually woke her up at night. Dr. Boswell suggested that P.T. consult with another neurologist because of Dr. Koslowski‘s apparent difficulty in securing Botox. On February 6, 2001, P.T. reported to Dr. Boswell that Dr. Eye believed the wound was ?gangrenous.? Dr. Eye‘s medical note for February 3, 2001, does not mention ?gangrene? but certainly shows alarm, describing the wound as having become more necrotic, widened, looking ?meaner? and in need of debridement. P.T. reported to Dr. Boswell that Dr. Koslowski‘s office was still unable to schedule the Botox injections. P.T. agreed to Dr. Kirsner‘s suggestion that the dosage of her MS Contin should be increased to a level sufficient to address her increased pain without causing sedation. On February 13, 2001, P.T. reported to Dr. Boswell that the pain was so bad that she had to leave work. She reported that the MS Contin helped her sleep at night but did not control the pain during the day because P.T. reduced the dose because she was determined to stay alert. Dr. Koslowski performed the Botox procedure on February 14, 2001. One week later, P.T. reported to Dr. Boswell that the Botox had stopped the spasms but not the pain. The pain in P.T.‘s forearm was at its worst when she was changing the dressing on the wound. P.T. was unable to return to work because of the protocol regarding changing dressings on the wound with the VAC device. Dr. Kirsner prescribed immediate- release morphine sulfate for use during dressing changes. The complaints of pain and difficulty sleeping persisted through March 2001. On April 3, 2001, P.T. confided to Dr. Boswell that some of her episodes of ?purging? were actually uncontrolled vomiting from nausea. On March 9, 2001, Dr. Kirsner recorded notes from his meeting with Joelle Crahay, the independent nurse case manager coordinating care with USIS. Dr. Kirsner told Ms. Crahay that P.T. was reluctant to increase the dosage of her pain medications as recommended. He described how P.T.‘s wound had closed in December 2000, then returned from a vacation with the wound infected and much worse. Dr. Kirsner ?mentioned that I do not suspect Munchausen‘s?22/ and doubted the existence of any kind of dissociative disorder. Dr. Kirsner noted that he supported P.T. working. In a medical note written on March 14, 2001, Dr. Kirsner again stated that he recommended ?return to work!? In another note on the same date, he indicated that he had told Ms. Crahay that it would be psychologically healthy for P.T. to go back to work. On March 27, 2001, Dr. Kirsner noted that P.T. was motivated and wished she could go back to work. Dr. Kirsner agreed that working would be psychologically helpful, but only if P.T. were placed in a position that did not stress her right hand. On April 17, 2001, P.T. reported to Dr. Boswell that she was ?confused? by messages she was getting from Ms. Crahay to the effect that Dr. Kirsner was recommending that she return to work. Dr. Boswell noted that she felt strongly that working was interfering with P.T.‘s healing and that her mental status on MS Contin was ?questionable.? P.T. feared losing workers‘ compensation and was apprehensive about challenging Ms. Crahey‘s decisions despite her fears of working while in a great deal of pain and/or under sedation from pain medications. P.T. agreed to have Ms. Crahay call Dr. Boswell to discuss the issue of returning to work. In mid to late April 2001, P.T. returned to work. On April 24, she reported to Dr. Boswell that she was having a hard time juggling the demands of work with having to arrange for dressing changes and taking IV antibiotics. The pain of the dressing changes in particular made it hard for her to function. P.T. expressed ambivalence because she wanted to work but was struggling to heal and feared she would lose her workers‘ compensation benefits if she stopped working. On May 1, 2001, P.T. told Dr. Boswell that she was being moved to a more stressful job when she already felt overstressed. On May 24, 2001, P.T. reported to Dr. Kirsner that going back to work helped her mental health at first, but now she felt she was carrying the stress home with her. In June and July 2001, dietary, purging and fatigue issues were at the forefront of Dr. Boswell‘s concerns. P.T.‘s medications appeared to be holding her pain mostly in check, though Dr. Boswell remained concerned about sedation. P.T. was anxious and demoralized over Dr. Eye‘s recommendation that she have further surgery on her arm. P.T. reported to Dr. Kirsner that her bulimia was worse. She felt out of control, craved sweets, and reported on July 9 that she was purging four or five times per week. P.T. felt guilty about her lack of control over her bulimia, but also confessed to Dr. Kirsner that she felt a sense of relief when she purged. On September 7, 2001, two weeks after Dr. Ong performed an excision and skin graft, P.T. told Dr. Kirsner that she wanted to find and consult with a ?national expert? on wound care. Dr. Kirsner agreed that she should undertake the research to find such an expert, both in the interest of healing her arm and to give P.T. a sense of control over her treatment. They discussed how she should go about finding the expert. After her August 24, 2001, surgery, P.T. was out of work for the remainder of the year due to the healing process of her arm followed by health complications from the heavy doses of IV antibiotics that Dr. Eye prescribed. P.T. expressed to Dr. Boswell her anxiety, guilt, and depression over not working. She understood that she felt better when not working, but felt that she was letting people down by staying at home. On November 6, 2001, P.T. reported to Dr. Boswell that Dr. Eye had suggested total disability. P.T. was reluctant to give up on working because she feared a loss of identity and lack of structure in her life. P.T.‘s husband, M.T., accompanied her to Dr. Boswell‘s office on December 4, 2001. M.T. told Dr. Boswell he believed P.T. was overmedicated. P.T. seemed clumsy, ?out of it,? and had extreme difficulty sleeping at night. They discussed referring P.T. to a pain specialist. On January 25, 2002, P.T. reported to Dr. Kirsner that M.T. objected to her use of narcotics to manage her pain. P.T. was tearful and asked Dr. Kirsner, ?What else can I do?? Dr. Kirsner offered to meet with M.T. to discuss his fears and educate him on the proper use of opioids. Dr. Kirsner also discussed the fact that P.T.‘s functional capacity was greater when she was taking MS Contin than when she wasn‘t, and the fact that the opposite is usually true for addicts. On February 28, 2002, P.T. reported to Dr. Kirsner that M.T. had ?backed off? his objections to opiate analgesics. P.T. returned to work on February 25, 2002, three weeks after her initial Botox treatment with Dr. Pulley. See Finding of Fact 96, supra. She started by working five hours per day, three to four days per week. Dr. Kirsner was required to send a letter to P.T.‘s nurse manager at Memorial certifying that the medications he was prescribing would not interfere with P.T.‘s job performance. P.T. reported to both Dr. Boswell and Dr. Kirsner, as she did to Dr. Eye, that some of her coworkers objected to her changing her dressings and taking IV antibiotics in the hospital. She therefore had to go to her car to perform these activities, which added to her stress. Through late March and early April, P.T. and Dr. Boswell discussed her need to find a new job. In May 2002, Dr. Boswell noted that P.T. continued to struggle with binging and purging. Dr. Boswell urged, not for the first time, that P.T. get inpatient treatment for her eating disorder. There were two perpetual obstacles to such a plan. First, P.T.‘s other medical problems prevented her from taking such a single-minded approach to her bulimia. Some facilities would not accept a patient who was taking IV antibiotics or having hyperbaric treatments. Second, P.T. blanched at the expense of an inpatient program out of fear that her workers‘ compensation probably would not cover it. On July 1, 2002, P.T. told Dr. Boswell that she felt very anxious about Dr. Eye‘s suggestion that her arm might need to be amputated. On July 2, 2002, Dr. Kirsner prescribed Neurontin for spasms in P.T.‘s right hand. On July 11, 2002, P.T. received her second set of Botox injections from Dr. Pulley. There is no indication in the medical notes that she discussed the Botox injections with either Dr. Boswell or Dr. Kirsner. On July 22, 2002, P.T. reported to Dr. Kirsner that her pain was much better than on her last visit in June. On September 2, 2002, P.T. reported to Dr. Boswell that the wound in her arm was growing again and she did not know why. On September 6, 2002, Dr. Boswell noted P.T.‘s anxiety over Dr. Eye‘s once more suggesting amputation to P.T. On September 10, 2002, P.T. expressed her distress over the reversal in the condition of her arm. On September 19, 2002, P.T. told Dr. Boswell that she was considering giving up the hyperbaric treatments because of the extreme claustrophobia she felt in the chamber. P.T.‘s condition remained more or less unchanged through the remainder of 2002. She worked on her eating disorder, showing some amenability to Dr. Boswell‘s suggestion of inpatient treatment but continuing to find logistical reasons not to pursue it. P.T. had pain in the arm, especially during dressing changes, but expressed to Dr. Boswell her reluctance to use narcotic medications. P.T.‘s problems with the hyperbaric chamber increased to ?overwhelming dread,? which Dr. Kirsner attempted to address with clinical hypnosis from December 2002 through January 2003. During the first quarter of 2003, Dr. Boswell pushed the idea of P.T.‘s seeing a clinical nutritionist, as she continued to believe that many of P.T.‘s health problems were nutrition related. P.T. resisted seeing a nutritionist or a new physician because she feared the idea of being weighed. Dr. Boswell promised to ?run interference? for P.T. on this issue. On May 14, 2003, P.T. reported to Dr. Kirsner that she had discontinued the hyperbaric treatments. P.T. was frustrated by the feeling that ?my arm was becoming my life.? On May 22, 2003, P.T. complained to Dr. Boswell that she felt overwhelmed by the lack of progress with the arm wound. On June 5, 2003, P.T. reported to Dr. Boswell that the pain was worsening and she was attempting to arrange a Botox treatment with Dr. Koslowski. On June 12, 2003, P.T. reported to Dr. Boswell ?distress due to significant pain.? P.T. reported that she was ?still unable to get Botox -- due to trouble with paperwork.? Dr. Boswell urged P.T. to communicate the urgency of her situation to Dr. Koslowski‘s office, rather than ?minimizing the level of her distress (as she tends to do).? On June 26, 2003, P.T. and Dr. Boswell continued to discuss her pain and the difficulty of getting Botox. (P.T. had received Botox injections from Dr. Koslowski on June 18, 2003.) Dr. Boswell broached the idea of P.T.‘s seeing an ARNP associated with Dr. Boswell‘s practice who specialized in non-narcotic pain management. Dr. Boswell‘s notes for her sessions with P.T. from July 3, 2003, through September 24, 2003, were accidentally destroyed by her transcriptionist. The following is Dr. Boswell‘s summary of her recollection of those sessions: In the beginning of July [P.T.] experienced significant relief from receiving Botox injections to the injured arm. The focus of therapy remained on lifestyle issues: getting enough sleep, eating well, and avoiding stress as much as possible. These efforts were in the interest of keeping pain and eating disorder symptoms under control. The summer was relatively uneventful, and [P.T.‘s] eating disorder symptoms were well- contained (i.e., no purging, but persistent body-image disturbance and dissatisfaction). In the beginning of September, [P.T.] was still doing well, continuing with her studies at UNF, and went to Puerto Rico with her husband. She returned in the middle of September. Around that time, [P.T.] began to focus on the weight she had gained (about 10-15 lbs), which still left her well within a healthy range, but was distressing to her. In addition, the pain in her arm again became significantly worse, although not as bad as in the early summer. On October 1, 2003, P.T. reported to Dr. Boswell that she had been purging twice a day, after a significant period of being asymptomatic with bulimia. P.T. stated that she felt ?clearer and a little euphoric.? Dr. Boswell noted that she was working on obtaining clearance from USIS to enroll P.T. in the eating disorders program with her nutritionist. On November 13, 2003, P.T. reported to Dr. Boswell that she had been approved for one session with the nutritionist and could be approved for more depending on the nutritionist‘s recommendations. On December 17, 2003, P.T. reported feeling ?very comfortable? with Jeanne Montross, the ARNP pain specialist. On January 23, 2004, P.T. reported that her treatment with Ms. Montross was going very well ?in that the Lidocaine patches are providing quite a bit of analgesic relief during the daytime, but not so much at night.?23/ However, on January 12, 2004, P.T. had reported to Dr. Kirsner that she found it difficult to distract herself from the ?ever present? pain in her arm. Through February and early March 2004, P.T. complained to Dr. Boswell of her difficulty in following the nutritionist‘s recommendations because the plan entailed ?too much food.? On March 16, 2004, Dr. Boswell noted that P.T. was ?beside herself with pain.? On March 23, 2004, Dr. Boswell noted her concern that P.T. ?may be becoming worn out by chronic pain syndrome? and thus become demoralized regarding the other aspects of her care. On April 5, 2004, P.T. reported that she was very down due to disabling pain. She denied suicidal ideations, but admitted to feeling despondent. Dr. Boswell urged P.T. to take some time off work to rest and recuperate, because in her current state she was ?too exhausted to see things clearly.? On May 4, 2004, two weeks after Dr. Ong performed a debridement, P.T. reported to Dr. Boswell that she felt somewhat better but was still struggling with the pain. In May and June 2004, Dr. Boswell‘s notes indicate that P.T.‘s main preoccupation was with her husband, who had open heart surgery. From August through September, Dr. Boswell‘s notes indicate that her sessions with P.T. mainly focused on dietary concerns. On October 6, 2004, P.T. reported to Dr. Boswell that her pain was better since her September Botox injections, but that it still sometimes woke her up at night. In October and November 2004, P.T.‘s chief preoccupation was dealing with a subpoena she had received from the attorney for the workers‘ compensation carrier. She and her husband argued over whether she should hire an attorney. Dr. Boswell urged P.T. to disregard her husband‘s advice and obtain counsel. In November, P.T. was reporting that she was purging about once a week. By December 9, she was purging four times per week and refusing to go further with the dietary program. Dr. Boswell contemplated terminating P.T. as a patient but decided such an action would be counterproductive to P.T.‘s health. In December 2004, P.T. was reporting that her pain was ?extreme? and ?debilitating.? In January 2005, P.T. reported to Dr. Boswell a general worsening in her arm without an apparent cause. The conflict with her husband over whether to hire a lawyer was a stressor on P.T. during January and February 2005. Dr. Boswell offered to speak with M.T. about the question. Dr. Boswell also continued to press P.T. on the need to address her dietary program. On March 17, 2005, P.T. agreed to see the nutritionist again. P.T. met with the nutritionist on March 31. On April 14, 2005, P.T. reported that she was doing well with the nutrition plan. Dr. Boswell discussed with her the importance of not giving in to denial about her problem and noted that P.T. felt a lot of shame about being a woman over 50-years old with bulimia. P.T. continued working on the program through the summer of 2005 and seemed to be gaining control over her eating disorder. On October 24, 2005, P.T. complained to Dr. Boswell that her arm was getting worse and the wound was increasing in size. On November 7, 2005, P.T. complained of painful spasms, and that P.T. was attempting to ?get Botox worked out for pain relief.? P.T. continued to complain of spasms on November 21, 2005, and Dr. Boswell noted that she ?needs to get Botox.? On December 19, 2005, Dr. Boswell noted that P.T. was ?very stressed due to pain.? P.T. received Botox injections from Dr. Koslowski on January 24, 2006. On January 31, 2006, P.T. reported to Dr. Boswell that the pain was better and that she was beginning to plan for her imminent retirement. By March 28, 2006, P.T. was reporting to Dr. Boswell that the pain in her arm had increased significantly. On May 9, 2006, P.T. reported that her arm wound was deeper and wider. The pain was ?not unbearable? but was sufficient to ?take all the fun out of life.? On June 1, 2006, Dr. Kirsner noted his agreement with Dr. Boswell that P.T. should be taking opiates for her arm, and prescribed immediate release morphine (?MSIR?), 15 mg, two to five per day as needed. P.T. reported that she used the MSIR mainly when dressing the wound. On June 21, 2006, P.T. reported to Dr. Boswell that she was doing much better overall since her retirement, but the pain in her arm was still significant. P.T. received Botox injections from Dr. Koslowski on August 18, 2006. P.T.‘s reports to Dr. Boswell indicate that her arm remained more or less stable for the remainder of 2006. By early 2007, P.T. was feeling stress caused by subpoenas served by the lawyer for USIS to her health care providers, exacerbated by Dr. Eye‘s decision, under pressure from USIS, to terminate her as a patient in his practice. Her arm wound appeared to Dr. Boswell to be deteriorating. On March 7, 2007, Dr. Boswell noted her concern that P.T.‘s arm needed medical care but USIS had yet to assign a new doctor. On March 28, 2007, Dr. Boswell noted that P.T. was going to the Mayo Clinic for care but was not certain the physician would take the case. On March 30, 2007, P.T. saw Dr. Richard J. Presutti at the Mayo Clinic. After examining P.T., Dr. Presutti saw no evidence of an active infection and recommended that P.T. continue with her current medications and seek care at a chronic wound care facility, a service not offered by Mayo. On April 4, 2007, Dr. Boswell noted that P.T. was in pain and attempting to set up an appointment with Dr. Koslowski to receive Botox injections, as well as trying to find a new doctor to take the place of Dr. Eye. On May 10, 2007, P.T. reported to Dr. Boswell that she was having pain from nerve spasms but that she would be getting Botox soon. On May 14, 2007, Dr. Koslowski administered his last series of Botox injections to P.T. On May 23, 2007, Dr. Boswell noted that P.T. was doing well and that the spasms had subsided since she received the Botox injections. Utilization Review Medical Summary Before addressing directly the peer reviews that USIS commissioned as to Dr. Eye‘s treatment of P.T., it is necessary first to examine the ?Utilization Review Medical Summary? (the ?Summary?), a 218-page document prepared by Mr. Spangler, the attorney for USIS. This examination is necessary because at least one of the peer reviewers, Mark J. Upfal, M.D., M.P.H., expressly stated his partial reliance on the contents of the Summary. Other reviewers such as Fernando Miranda, M.D., and Brian D. Wolff, M.D., also appear to have primarily relied on the Summary without stating as much in their reports. The medical record in this case is daunting, as one might suspect given that the Summary alone runs to 218 single- spaced pages. There are 41 listed providers who treated P.T. at some point between 1985 and 2008. There are 1,826 pages of provider medical records (many of which are handwritten and some of which are virtually illegible), 878 pages of reports from home health visits, and 551 pages of diagnostic reports. These numbers do not include billing records, patient ledgers, and prescription records, all of which are also included in the record. It is understandable that busy physicians engaged to provide peer review reports would wish to read a reliable summary rather than wade through the mass of documents forming the medical record in this case. However, if the summary proves to be unreliable, then the basis of the peer review report is also called into question. In this case, the Summary has proven to be a seriously flawed document, riddled with errors of commission and omission. Without speculating as to the reasons for these errors, the undersigned will note those most pertinent to this case, i.e., the many times that statements about Botox treatment appearing in provider medical notes have failed to survive the transition into the Summary or have been garbled in translation, and the many times that P.T.‘s complaints of pain and spasm in her right arm are not mentioned in the Summary.24/ The errors in the Summary have the effect of minimizing the severity of the pain and spasms in P.T.‘s right arm and the apparent effectiveness of the Botox treatments in addressing that pain and allowing P.T. to use her right hand. No expert relying solely on the Summary could come away with a complete picture of P.T.‘s condition and treatment. Dr. Eye‘s note of May 20, 1996, regarding Dr. Koslowski‘s proposed course of treatment is quoted at Finding of Fact 38, supra. The Summary states that ?Dr. Eye opined that there was no documented case of a tendon transfer in this situation,? where the note is clearly dealing with P.T.‘s concerns regarding Botox. Dr. Eye was actually telling P.T. that there has never been a case in which a patient was systemically infected by Botox injections. The Summary continues in the following bizarre fashion: ?Tendon transfer was used to treat multiple sclerosis, torticollis and lazy eye syndrome.? Again, it is plain that Dr. Eye‘s reference was to Botox treatments, not the proposed tendon transfer. On January 27, 1999, P.T. reported to Dr. Boswell that she was experiencing painful spasms in her right arm. The Summary entry for this date does not mention the spasms. On August 18, 1999, Dr. Boswell noted that P.T. had returned from vacation feeling better, though still troubled by arm pain. Dr. Boswell suggested that P.T. ask Dr. Koslowski about a TENS unit or a nerve block. The Summary entry for this date mentions nothing about arm pain or Dr. Koslowski. Dr. Boswell and P.T. again discussed obtaining a TENS unit from Dr. Koslowski on August 25, 1999. Again, the Summary entry ignored this note. On September 8, 1999, P.T. reported to Dr. Boswell that the spasms in her arm were waking her up at night and that Dr. Hartman had prescribed Klonopin for the pain. The entire Summary entry for this date reads as follows: ?On 09/08/99, the claimant discussed her job stresses and sleep interruptions.? The Summary entry for September 22, 1999 reads, ?On 09/22/99, the claimant discussed her diet.? Dr. Boswell‘s notes for that date deal solely with P.T.‘s discouragement over the status of her wound. Dr. Boswell‘s notes for September 29, 1999, state that P.T. discussed her fear that her arm would never get better. Dr. Boswell noted that P.T. was going to Dr. Koslowski for Botox and felt that the Klonopin was helping. P.T. discussed her sleep cycles and dealing with the chronic pain that kept her awake. Dr. Boswell noted dysphoria and anxiety regarding the status of her arm, as well as some concern P.T. had about a small weight gain due to an increase in her caloric intake. The Summary entry for this date reads as follows, in its entirety: ?On 9/29/99, the claimant weight [sic] 111 pounds and was concerned about her weight gain.? Dr. Boswell‘s notes for October 13, 1999, include the following: ?Got Botox injections -- should be working [within] 1 wk, lasts for 7 mos. Feels hopeful [about] it. This should help [with] insomnia.? The Summary entry for this date reads as follows, in full: ?On 10/13/99, the claimant discussed her anxieties.? Dr. Hartman‘s notes for October 28, 1999, state that P.T. had experienced only rare, light spasms since her Botox injections on October 12. The Summary entry for this date makes no mention of this portion of the notes. Dr. Hartman‘s notes for November 16, 1999, state as follows: ?Still doing well on Botox. Spasms still but nothing like they were. No longer wakens her in nite.? The Summary entry for this date makes no mention of this portion of the notes. In her note for September 5, 2000, Dr. Boswell recorded three bullet points: ?1. =My arm has been bothering me a lot.‘ Spasms – neural -- could be nerve regeneration; 2. Started yoga -- enjoying it a lot; 3. Struggling [with] weight gain.? The Summary entry for this date reads as follows, in full: ?On 09/05/00, the claimant reported she went to yoga class and struggled with her weight gain.? For unexplained reasons, the Summary included the second and third bullet points but not the first. On January 18, 2001, Dr. Eye noted as follows: ?She‘s been to see Dr. Koslowski because of the increased pain and spasm and he does want to do another Botox injection. She‘s had a good response from those in the past, so that‘s certainly a consideration.? The Summary entry for this date does not mention this note. On February 20, 2001, Dr. Kirsner noted that P.T. had Botox injections within the past week, and that the injections had eliminated her spasms but not the pain in her right forearm. The Summary entry for this date does not mention the Botox treatment. On February 28, 2001, Dr. Hartman noted, ?No spasms!? since P.T.‘s February 14 Botox treatment. The Summary entry for this date makes no mention of Botox treatment or spasms. On March 29, 2001, Dr. Hartman noted, ?Spasms gone since Botox.? (Emphasis added.) The Summary entry for this date states that P.T. ?had fewer spasms after the Botox injection.? (Emphasis added.) On April 9, 2001, Dr. Hartman continued to note the absence of spasms since P.T.‘s most recent Botox treatment. The Summary for this date is silent on that point. On December 5, 2001, Dr. Eye emphatically noted, ?She needs to get back with Koslowski for her Botox injection.? The Summary entry for this date does not mention this statement. On February 12, 2002, Dr. Hartman noted that the Botox injections P.T. received from Dr. Pulley on February 4 had ?resolved nite spasm.? The Summary entry for this date states that P.T. recently had Botox but does not mention the result. On July 29, 2002, Dr. Hartman noted that P.T. had received Botox injections two weeks ago, resulting in decreased spasms. The Summary entry for this date is silent as to the injections or the result. On October 17, 2002, Dr. Eye noted that P.T. ?continues to get her Botox injections for the pain and spasms of the hand.? On November 11, 2002, Dr. Eye again noted that P.T. ?continues to get her Botox for pain and spasm control.? The Summary entries for these dates make no mention of these statements. On June 12, 2003, Dr. Hartman noted that P.T. was suffering from ?outrageous spasms? and had seen Dr. Koslowski the previous week. Dr. Hartman further noted that P.T.‘s wound had become a little deeper and that the ?spasms seem to rip it up.? The Summary entry for this date mentions the spasms but not their apparent effect on P.T.‘s wound. On July 3, 2003, Dr. Eye noted as follows: ?The pain has dramatically improved with the Botox injections . . . She is doing better with the Botox injections, which are done very [sic] 4 to 8 months.? The Summary entry for this date merely states that ?the claimant continued Botox injections.? Dr. Boswell‘s summary of her recollections of the sessions between July 3 and September 24, 2003, the notes of which were lost by the transcriptionist, are set forth in Finding of Fact 219, supra. The first item noted in the summary was P.T.‘s having experienced ?significant relief? from receiving Botox injections on June 18, 2003. The Summary entry for the lost sessions does not mention the Botox treatment. The Summary entry for Dr. Kirsner on December 1, 2003, states that ?the claimant reported spasms, requests for Botox injections.? In fact, P.T. told Dr. Kirsner that it had been difficult getting Botox, but now that she had had the injections on November 20, 2003, the spasms in her right arm were better. On April 6, 2004, Dr. Eye‘s nurse noted that P.T. called to say that Dr. Koslowski could not perform a nerve block because of the open wound in her arm. Dr. Eye told P.T. that Dr. Koslowski might consider Botox instead of the nerve block, and P.T. stated that she would discuss it with Dr. Koslowski. The Summary entry for this date states as follows: ?Dr. Koslowski called to report he was unable to do nerve blocks due to the open wound. Dr. Eye advised him to use Botox.? The Summary misconstrues a conversation between P.T. and Dr. Eye as one between Dr. Koslowski and Dr. Eye, and further misconstrues a suggestion made by Dr. Eye to P.T. as direct advice from Dr. Eye to Dr. Koslowski. On April 12, 2004, Dr. Eye noted that P.T. had been in severe pain for several weeks and the Botox ?has not made a significant difference.? See Finding of Fact 125, supra, for details. In fact, P.T. had not received Botox since November 20, 2003. The Summary entry for this date notes Dr. Eye‘s statement that Botox had not made a significant difference, but fails to note that it had been nearly five months since P.T.‘s last Botox treatment. On October 4, 2004, Dr. Eye noted at some length a discussion he had with Dr. Koslowski about taking a ?more aggressive approach? to using the Botox. The note is quoted at Finding of Fact 134, supra. The Summary entry for this date is entirely silent as to Dr. Eye‘s notes on this discussion. On December 7, 2004, Dr. Eye noted that P.T.‘s pain was ?much better controlled? with the regular Botox injections. The Summary entry for this date does not mention this note. On March 17, 2005, Dr. Eye noted, ?The peripheral neuropathy is under much better control with the Botox. She is able to use her hand to some degree... She is to otherwise protect the wound as much as possible, continue to follow up with her necessary Botox to control the pain neuropathy.? The Summary entry for this date makes no mention of Botox treatments. On June 28, 2005, Dr. Eye noted, ?Recently she has had increasing pain in the arm. Botox has helped.? The Summary entry for this date mentions the arm pain but not the Botox. On December 27, 2005, Dr. Eye noted, ?[P.T.] comes in today. She had done relatively well. Recently she has had more pain with the arm. She is working with Dr. Koslowski for possible Botox. This seems to be very effective.? The Summary entry for this date makes no mention of Dr. Koslowski or Botox. On August 24, 2006, Dr. Eye noted that P.T. had recently received a course of Botox injections that helped her pain. The Summary entry for that date is silent as to the Botox injection. The above 30 instances of the Summary‘s failure to mention P.T.‘s Botox treatments, her physicians‘ clear endorsement of the continued treatments, or the positive effects of those treatments are not intended to be inclusive. These were simply examples noted by the undersigned while reviewing the medical record in this case. There were, of course, many physician notes concerning pain, spasms, and Botox treatments that were accurately recounted by the corresponding Summary entries. However, the pervasiveness of the errors and omissions leads to the finding that the Summary is not a reliable document, and could not serve as the basis for an expert opinion regarding Dr. Koslowski‘s level of care. Peer reviews of Dr. Eye‘s treatment The large financial outlay for P.T.‘s workers‘ compensation care led to the utilization review investigation by Mr. Spangler on behalf of Memorial and USIS. The investigation initially focused on Dr. Eye, the ?quarterback? of the team of physicians who treated P.T.‘s wound over the years. The record contains four peer review reports that Mr. Spangler obtained from physicians as to whether Dr. Eye‘s treatment was reasonable and medically necessary as it related to the November 14, 1985, accident, and whether Dr. Eye‘s treatment was excessive in frequency and duration as it related to the accident. These reviews were based on medical records provided to the physicians by Mr. Spangler. There is no indication in the record as to how many physicians Mr. Spangler solicited in order to obtain the four reports that he included in his submission to the Department. Mark J. Upfal, M.D., submitted a medical record review dated September 16, 2005. The review was updated on May 30, 2007. Dr. Upfal was a fellow of the American College and Occupational and Environmental Medicine, had a master‘s degree in public health, and was board certified in occupational medicine. Dr. Upfal worked at Detroit Receiving Hospital in Michigan. The stated purpose of Dr. Upfal‘s review was ?to address the relationship between [P.T.‘s] employment at Memorial . . . and her development of a chronic ulcer of the right forearm, with failure of wound healing and chronic infection.? Dr. Upfal stated that his report was based on a review of the Summary, as well as additional documents provided by the workers‘ compensation carrier ?per my request for additional documentation.? In his report, Dr. Upfal states as follows: Numerous physicians who have evaluated and treated [P.T.] over the years have been unable to explain the two decade persistence of this lesion on the basis of pathophysiological mechanisms. Many physicians have opined that this is likely the result of a factitious disorder in which [P.T.] has caused a failure to heal through self-inflicted manipulation of the wound. This kind of interference with healing has been known to occur in the face of psychiatric disturbances. In fact, this is by far the most likely explanation. The preponderance of evidence supports this explanation, and it is my opinion that within a reasonable degree of medical certainty, there is no other viable medical explanation. (Emphasis added.) As noted at Finding of Fact 19, supra, none of the 40 or so providers who treated P.T. over the years ever ?opined that this is likely the result of a factitious disorder.? Some providers naturally suspected that P.T. may have been manipulating her wound, and some such as Dr. Shah were consulted to confirm or rule out that hypothesis. Invariably, the providers came to the conclusion that P.T. was, as Dr. Steinberg put it, ?the real deal.? The underscored statement by Dr. Upfal is at variance with the medical record. At other places in his report, Dr. Upfal more accurately states that physicians ?have wondered whether or not this might be a factitious disorder,? and that ?there is suspicion articulated by some physicians? regarding P.T.‘s possible manipulation of the wound. Dr. Upfal does not mention that those physicians concluded that their suspicions were unfounded. He credits the suspicions but not the subsequent inquiries that laid those suspicions to rest. Dr. Upfal concluded that a factitious disorder was ?the most viable explanation in the absence of a systemic or specific dermatological disorder, and in the absence of other widespread disease or other non-healing wounds, to explain the decades of failed healing.? He recommended a consultation with a plastic surgeon and an independent psychiatric evaluation ?to assess her overall tendency toward self-inflicted health problems? and to provide an opinion as to the adequacy of the psychiatric treatment P.T. had received to date. Eugene Truchelut, M.D., submitted a peer review report dated January 16, 2006. Dr. Truchelut‘s report indicates that he was a Diplomate of the American Board of Internal Medicine and practiced in Orlando. Dr. Truchelut stated that he reviewed ?seven bound volumes of extensive records,? and his recitation of the history of Dr. Eye‘s treatment of P.T. indicates that he thoroughly reviewed at least those medical records and notes pertaining directly to Dr. Eye. Dr. Truchelut came to the following conclusions: fter review of the aforementioned records from Dr. Eye, it appears that treatment of the claimant by him would be considered both reasonable and medically necessary as related to the incident of November 1985, from the initial visit in December 1991, until August 1995, when the claimant‘s wound was described as completely healed. Subsequent treatment of the claimant by him would not be reasonable and medically necessary, but would be excessive in frequency and duration, as related to the incident of November 1985. Dr. Eye‘s records in August 1995 and 1996 document that the original skin ulcer was healed, and not present until a new lesion was seen in February 1997. There is no evidence from these records that whatever caused the skin injury at that time (and intermittently, again at future dates) was related to the alleged incident after the tine test in November 1985. While there is some evidence that the claimant suffered from a long-term eating disorder and had chronic issues of nutritional deficiencies, there is no clear evidence of an underlying systemic disease as a result of the incident in 1985. In addition, I note that healing of the wound in 1995 was confirmed by Dr. Francis Ong, a plastic surgeon who treated the claimant concurrently. Crucial to Dr. Truchelut‘s conclusion is the fact that P.T.‘s wound was completely healed in August 1995, and that any further treatments to P.T. were therefore unrelated to her workers‘ compensation injury. He apparently disregarded, or found irrelevant, the ?severe nerve damage? noted by Dr. Eye on May 20, 1996, the hand weakness and clawing for which P.T. first sought treatment from Dr. Steinberg on July 26, 1995, and the neuropathic pain for which P.T. was treated by Dr. Koslowski during the interim when the wound‘s surface was healed. Edward M. Neff, M.D., a Miami physician, submitted a peer review report dated February 28, 2006. Dr. Neff‘s credentials are stated to be board certification in internal medicine and cardiology. Dr. Neff also states that he is a Fellow of the American College of Cardiology. Dr. Neff‘s report is problematic in several respects. The report is short, sketchy, and includes factual statements that have no apparent support in the record. Dr. Neff writes, ?In May 1989, [P.T.] was diagnosed with a =factitial ulcer.‘? Dr. Neff does not state who made this diagnosis. A diligent search of the medical records reveals no such statement. However, such a statement is found in Mr. Spangler‘s Summary, without attribution to a physician or other documentary support. This indicates that Dr. Neff was relying on the flawed Summary rather than the actual medical records. Dr. Neff also states, ?At various times during her illness, several physicians thought that the ulcer was factitious in origin.? Here, Dr. Neff merely a restates Dr. Upfal‘s misstatement of the medical record. Physicians expressed suspicions, but no physician who treated P.T. ever concluded that her ulcer was factitious in origin. Dr. Neff concludes that the initial treatments provided by Dr. Eye were appropriate, reasonable, and medically necessary ?until June of 1987.? This is an interesting statement, given that Dr. Eye did not begin treating P.T. until December 1991. Dr. Neff states, ?From a medical standpoint, there is no reason why [P.T.‘s] ulcer should not have healed by June of 1987.? Dr. Neff provides no reason for his selection of June 1987. Prior to stating his conclusion, Dr. Neff did not mention June 1987 in his report. Because Dr. Neff was not a witness in this proceeding, there was no opportunity to ask him why he selected June rather than April, May, or July 1987. Nothing about Dr. Neff‘s peer review report inspires confidence in the reader that this physician seriously examined the medical record or arrived at an independent conclusion regarding Dr. Eye‘s treatment of P.T. Finally, Charles M. Callahan, M.D., of Vero Beach filed a peer review report that was undated but bears a fax date of November 14, 2006. Dr. Callahan‘s report states that he is board certified in infectious disease and tropical medicine. Dr. Callahan‘s report is dense, detailed, and indicates a serious engagement with the complexities of P.T.‘s case. Following a lengthy, meticulous examination of P.T.‘s treatment, focusing on Dr. Eye but not neglecting the work of various other medical providers, Dr. Callahan reached the following conclusions: It is my belief that Dr. Eye‘s treatments from 1991 until 1995 were reasonable. The patient had multiple episodes of wound infection, and the pathogens that were isolated were appropriately treated. There were several biopsies made, imaging studies performed, and serial cultures taken. Unfortunately, the patient was managed with prolonged courses of IV antibiotics complicated by bacterial overgrowth, candidiasis, lymphocytopenia, anemia, vertigo and dizziness, and renal insufficiency. The patient also had complications of IV catheter infections requiring their removal. Almost without exception, these pathogens (that were isolated) could have been treated with oral antibiotic therapy. Furthermore, restrictive treatment methods were only utilized twice (the cast in 1995 and the VAC in 2001). Further attention to the patient‘s weight loss (especially in 1999) would have been extremely important. Further attention to the patient‘s psychiatric diagnosis, anemia, bingeing and purging, and suppressed TSH [thyroid- stimulating hormone] would have also been important in wound healing. The patient‘s chronic smoking and the implications of a non-healing wound would have been extremely important. The patient also received IVIG [intravenous immunoglobulin] with questionable indication and benefit. There are serial documentations in the chart (over seven times) regarding the possibility of factitious disorder. Multiple outside consultants addressed this as a significant possibility. It would have been appropriate and expedient to have either hospitalized the patient or limited the access of the patient to the wound to see of the patient‘s wound would heal with appropriate therapy. With regards to the question of medically necessary and reasonable, up until 1995 the treatments were mostly medically necessary and reasonable. There were a few exceptions which I have previously listed, but these are probably not relevant in the overall context of a very difficult and chronic wound in a very difficult patient. However, when the patient‘s wound recurred in 1997 (for very unclear reasons almost 18 months after closure), the possibility of a factitious disorder must have been employed. Furthermore, the patient‘s continued smoking, dietary issues, psychiatric issues (bulimia and bingeing and purging), as well as her prior history would have required addressment. Failure to address and acknowledge these multiple documented episodes in a patient with no clinical explanation for her recurrent wound is not reasonable and most likely led to overutilization. . . . The most likely reasons for the patient‘s failure to heal were a combination of chronic tobacco use, malnutrition secondary to self-infliction from bingeing and purging, and a propensity for manipulation of the wound through a factitious disorder that remained undiagnosed. Therefore, the ongoing treatment rendered by Dr. Eye would not be considered reasonable or medically necessary as it relates to the November 14, 1985, accident. Dr. Callahan‘s review fairly criticizes several aspects of Dr. Eye‘s treatment. In a portion of his report not quoted above, Dr. Callahan notes that P.T.‘s arm was placed in a cast for two months in 1995 and that during that time the wound decreased in size to less than 2 cm. Dr. Eye took the wound‘s failure to heal completely as an indication that P.T. was not manipulating it; Dr. Callahan seems to take the opposite view that the marked improvement in the wound while casted indicates at least grounds to suspect that P.T. was engaged in self-harm. Dr. Callahan is correct that hospitalization of P.T. would have definitively answered the question of wound manipulation. Dr. Callahan reasonably doubts Dr. Eye‘s medical judgment that there was insufficient cause to further pursue the issue. In some respects, Dr. Callahan‘s opinion is unfair to Dr. Eye. Dr. Callahan, in reviewing the entire medical record, is charging Dr. Eye with a level of omniscience that Dr. Eye did not in fact possess. Dr. Callahan does not take into account the fact that P.T. actively prevented Dr. Eye from obtaining a complete and accurate understanding of her eating disorder by forbidding Dr. Boswell to consult with Dr. Eye. P.T.‘s weight fluctuations were clues that Dr. Callahan rightly suggests that Dr. Eye should have pursued more aggressively. However, Dr. Eye‘s failure to thoroughly investigate P.T.‘s weight fluctuations does not equate to a failure to act on actual knowledge of P.T.‘s eating disorders, which Dr. Callahan‘s critique seems to imply. The Werner report Apparently based on Dr. Upfal‘s suggestion that P.T. undergo an independent psychiatric evaluation, USIS hired Tonia Werner, M.D., an assistant professor in the Division of Forensic Psychiatry at the University of Florida‘s Department of Psychiatry, to perform a review of P.T.‘s medical records followed by an in-person evaluation of P.T.25/ Dr. Werner wrote that the purpose of her evaluation was to ?determine what role, if any, mental illness plays in preventing [P.T.‘s] ulcer from healing.? Dr. Werner‘s report attested to having reviewed the entire medical record, but it naturally focused on P.T.‘s mental health providers. The report listed 47 providers ?sources of data,? but expressly discussed only 15 of those, presumably because they were considered the most significant sources of information. As one would expect, the report went into some detail regarding the medical records of Dr. Shah, Dr. Boswell, and Dr. Kirsner, the mental health providers who treated P.T. over the course of a number of years. However, the report also discussed the peer-reviews of Dr. Upfal, Dr. Neff, Dr. Truchelut, and Dr. Callahan. None of these physicians had first-hand knowledge of P.T. They had merely reviewed the medical records, with varying degrees of completeness and comprehension. Dr. Werner‘s report also appears to cherry-pick notes from other providers that are consistent with the notion that P.T. was engaging in self-harm. Providers who noted suspicions of factitious disorders receive special attention in Dr. Werner‘s report, whereas the records of Dr. Eye, Dr. Steinberg, Dr. Ong, Dr. Pulley, and Dr. Koslowski do not merit mention. In discussing Dr. Kirsner‘s records, the Werner report states, ?Dr. Kirsner documented [P.T.] has having [sic] a =Munchausen‘s-like‘ syndrome for an unhealed arm ulcer.? This is a misrepresentation of Dr. Kirsner‘s records. The passage that the Werner report references is Dr. Kirsner‘s recitation of P.T.‘s medical history, in which Dr. Kirsner stated that P.T. was initially sent to Dr. Shah because there were suspicions of a ?Munchausen‘s like syndrome.? Dr. Kirsner did not ?document? that P.T. had such a syndrome. In fact, Dr. Kirsner expressly stated that he did not suspect P.T. of having such a syndrome. See Findings of Fact 18 and 202, supra. Dr. Werner concludes with a DSM-IV Axis I psychiatric diagnosis that includes ?Malingering? and ?Factitious Disorder with combined psychological and physical signs and symptoms,? in addition to ?Major Depressive Disorder, moderate, recurrent, currently in remission,? ?Eating Disorder NOS,? ?Anxiety Disorder NOS,? and ?Nicotine Dependence.? Interestingly, a neuropsychological evaluation undertaken by psychologists at the University of Florida at Dr. Werner‘s request found that P.T.‘s results on the Minnesota Multiphasic Personality Inventory, Second Edition, were ?essentially normal with no elevations on any of the clinical scales.? Peer reviews of Dr. Koslowski‘s treatment Dr. Eye was not reported to the Department by USIS because he agreed to withdraw from the case. Dr. Eye testified, ?I was threatened would be a nice way to put it. Somebody came and said if I didn‘t voluntarily withdraw from this case, they were going to challenge all our charges. And while I would have been willing to go ahead with it, I had partners who voted not to do so, and being part of a group, it didn‘t leave me much choice.? No action was taken against Dr. Eye or any of his physician partners who provided treatment to P.T.26/ After securing Dr. Eye‘s withdrawal from P.T.‘s case, USIS focused its attention on Dr. Koslowski‘s treatment and sought opinions from neurologists concerning the appropriateness of the Botox treatments administered by Dr. Koslowski. John R. McCormick, M.D., submitted a records review dated May 29, 2008, and an addendum dated December 19, 2009. Dr. McCormick also testified via deposition in this proceeding. He is board certified in neurology, licensed to practice in the state of Florida, and is a fellow of the American Academy of Neurology. Dr. McCormick testified as an expert in neurology, without objection. Following the pattern of the previous reports, Dr. McCormick‘s review of the record emphasized the suspicions of various physicians that P.T.‘s injury was factitious, and mostly failed to note when a physician opined that P.T. was not engaged in manipulative or Munchausen‘s-like behavior.27/ Regardless of his choices of emphasis, Dr. McCormick‘s recitation of the record is mostly accurate. In one notable exception, Dr. McCormick states that Dr. Eye ?was quite concerned about the idea of [Botox] injections and warned [P.T.] about this. Nonetheless, she elected to go along with the procedure, in his words.? Dr. McCormick here grossly mischaracterizes Dr. Eye‘s medical notes from May 20, 1996. See Finding of Fact 38, supra. Dr. Eye was actually assuaging P.T.‘s concerns about systemic infection from the Botox injections. Dr. Eye expressly stated to P.T. that he had ?no problems with her undergoing this.? His only concern was that the Botox injections not be made directly into the ulcer site on P.T.‘s right arm. Dr. McCormick is critical of Dr. Koslowski‘s examination methods and the completeness of his records. He seems convinced that P.T. is manipulating the September 24, 1998, examination, because Dr. Koslowski‘s description of her symptoms suggests a ?factitious attempt to produce the appearance of paralysis in all muscles of the hand.? Rather than commence Botox injections, Dr. Koslowski should have gotten an occupational therapist involved in his treatment to manage the nerve injury with exercise. Most damningly, Dr. McCormick concludes that Dr. Koslowski does not understand ?the clinical and pharmacologic features of Botox.? This conclusion is based on two notes entered by Dr. Koslowski on September 29, 1998, and February 14, 2001. In the earlier note, Dr. Koslowski wrote that after the Botox injections, ?Relaxation of the right thumb and first right three digits was immediately apparent to visual exam.? In the later note, Dr. Koslowski stated that P.T. ?almost had complete relaxation as well, with the injections.? Dr. McCormick states: ?This medication is a toxin which acts at the neuromuscular function level and takes several weeks to produce a response. Not only is he treating a condition that would not be expected to respond to Botox, but he is getting a response which is physiologically and pharmacologically impossible to attain under any circumstances.? After completing his record review, Dr. McCormick stated the following opinion in concluding his report: The diagnosis of an ulnar nerve injury defines a lower motor neuron event, and as such does not induce spasm, spasticity or dystonia. The repair of an ulnar nerve does not induce any of the above either. When the nerve is damaged, the fibers cease to function, and with that the nerve supply to the muscles decreases. In other words, it is a denervation of the supplied muscles and they become wasted, atrophic and weak. The tone in these muscles, by definition, MUST be decreased, since it is a lower motor neuron injury. Only an upper motor neuron lesion can produce ?spasticity? as Dr. Koslowski described. She does not have an upper motor neuron injury and, hence, does not have spasticity. Botulinum toxin works at the level of the nerve and muscle junction to produce a ?chemical denervation? of the nerve, essentially mimicking nerve damage producing motor deficit. The administration of botulinum toxin to muscles supplied by a nerve which is already denervated has absolutely no pathophysiologic basis. The effect is only to produce additional weakness. Another extremely important observation in this case is the alleged response time from the time of injection to the benefit of relaxation as reported by the claimant and observed by Dr. Koslowski. On at least two occasions Dr. Koslowski described an immediate effect of relaxation following the injections. This response is impossible to achieve from any known mechanism of action of botulinum toxin. The toxin requires at least a couple of weeks to produce the effect of denervation and has absolutely no immediate effects. This response should have set off immediate ?red flags.? Since there is no physiologic mechanism to describe her bizarre response to the toxin, she clearly was actively distorting her examination in order to obtain invasive treatment. Dr. Koslowski‘s failure to provide adequate neurologic examination, never accurately recording the motor function in her hands muscles [sic] he was injecting, is a huge oversight. Furthermore, over the many years he treated her, he used various terms, including spasms and spasticity interchangeably, it seems. This is totally inappropriate and represents an egregious variance from accepted neurologic practice, but does provide some insight into his lack of precision when describing her neurologic condition. Whether he was ever aware of the circumstances and concerns regarding the failure of her ulcer to heal, and the numerous references to possible factitious, self-induced injury is not reflected in any of his notes. These notes are all cursory and inadequate as far as describing her neurologic status. I have extensively reviewed the neurologic literature seeking any indication for the use of botulinum toxin to treat an ulnar neuropathy and have failed to find any references to such. I have spoken to neurologists who administer botulinum toxin seeking answers to this same question and have been told that there is no indication at all for the use of botulinum toxin in a peripheral nerve injury, for it only serves to denervate the nerve further and produce additional weakness. It is important to recognize that a flexion contracture will not respond to botulinum toxin, and it would seem that [P.T.] may have developed some degree of flexion contracture. By the same token, she may have been fabricating the appearance of a flexion contracture. The treatment of this type of nerve injury is to continue home stretching and strengthening exercises to maintain the range of motion of the muscles. As a registered nurse, she was well aware of this, yet she continued to ignore the essentials of care. I have reviewed the IME reports of the physicians, and find them extremely well- documented and appropriate. This lady has, in my opinion, classic Munchausen‘s syndrome in many, if not all aspects. She has duped the medical profession over and over and has managed to obtain extensive medical care for what in all probability began as a relatively minimal condition. She has two MMPI studies which are reported as not particularly abnormal, and this, again, is a manipulated response. She has extensive medical experience and knows what answers MMPI testing requires, in all likelihood. Munchausen‘s features of manipulation and care-seeking will continue, but it is important to recognize that it is not related to the industrial accident, and in my opinion, will probably require aggressive psychiatric management. These individuals are extremely refractory to treatment, and in her case this has gone on so long that it has become part of her daily life. Beginning with the last quoted paragraph, it is important to keep in mind that Dr. McCormick is a neurologist, not a psychiatrist. Dr. McCormick himself testified that ?I‘d sooner defer that to the psychiatrists? when the implications of P.T.‘s psychiatric condition was broached. Nonetheless, he is able to diagnose Munchausen‘s syndrome in P.T. from a review of the medical records, without ever laying eyes on P.T., whereas Dr. Shah and Dr. Kirsner, both psychiatrists, and Dr. Boswell, a psychologist, extensively treated P.T. for nearly 20 years and were somehow unable to reach that diagnosis. Similarly, the University of Florida Ph.D. psychologists who administered the MMPI to P.T. in July 2007 were unable to detect her manipulation of the test, but Dr. McCormick, without benefit of any of the testing data aside from the one and one-half page final evaluation, was able to sniff out P.T.‘s fakery. Dr. McCormick knows that P.T. manipulated a May 5, 1989, MMPI test, though the medical record contains only a scoring sheet with some conclusory descriptions and does not indicate who administered and/or interpreted the test. Indeed, it appears that P.T. was able to ?dupe? the entire medical profession for decades, but she could not fool Dr. McCormick.28/ Dr. McCormick‘s diagnosis of Munchausen‘s syndrome conveniently allows him to disregard contrary information in the medical record. All of P.T.‘s subjective reports of pain in her arm or relief from the Botox injections may be ignored as manipulations of her duped medical providers. P.T.‘s essentially normal MMPI testing would appear to constitute evidence contrary to a conclusion of a mental disorder, but Dr. McCormick assumes that P.T.‘s normal MMPI is actually additional evidence of Munchausen‘s. Dr. McCormick‘s testimony raises a question as to the extent to which his opinion was based on his own independent review of the medical record and how much was based on the earlier reports discussed at Findings of Fact 268-291, supra. Dr. McCormick testified that ?so many of her physicians and her psychiatrists have felt that this problem is a self-generated problem and is psychiatric in origin. It‘s factitious.? As has been discussed at length in this Recommended Order, none of P.T.‘s regular medical providers ever concluded that her wound was factitious.29/ Only the experts employed by USIS to review the paper record have stated as fact that P.T.‘s physicians concluded that her problem was factitious. Dr. McCormick could not have come by his statement from the medical record alone. In his testimony, Dr. McCormick was hesitant to opine that Dr. Koslowski‘s alleged failure to consider P.T.‘s psychiatric condition and the possibility of self-harm constituted a violation of the standard-of-care. Dr. McCormick stated that it was difficult to make such a judgment because P.T. ?was not forthcoming as far as what she was doing.? He stated that the ?bottom line is that it is our responsibility as a provider to get this information; however, we need to get it,? but Dr. McCormick offered no real strategies for how a practitioner goes about obtaining a complete and accurate history from a recalcitrant patient who has instructed her other providers not to cooperate. Like Dr. Callahan‘s critique of Dr. Eye, Dr. McCormick‘s report criticizes Dr. Koslowski for failing to act on information that was not available to him. Dr. McCormick conceded that Dr. Koslowski could not simply ignore P.T.‘s persistent complaints of pain, but he then stated that the pain had to be considered ?in the perspective of her underlying psychiatric problems and not treat her for a purported physical problem without addressing the underlying, huge underlying psychiatric problem.? Like Dr. Eye, Dr. Koslowski was intentionally kept in the dark by P.T. as to the extent of her psychiatric difficulties and treatment. More pertinent to his area of expertise, Dr. McCormick opined that Botox therapy was not indicated for ulnar neuropathy, which should not produce muscle spasms. Dr. Koslowski initially performed a ?poor examination of the hand,? focusing only on the peripheral nerve without detailed muscle testing. Even if the focus is on the ulnar nerve, it‘s ?only normal? to also examine the radial and medial nerves in order to verify they are not also problematic.30/ ?[T]he impression was ulnar neuropathy with spasm, rule out some type of dystonia, although he didn‘t describe any dystonic symptoms.? Dr. McCormick stated that it was unusual to find muscle spasms associated with ulnar neuropathy, and concluded as follows: I have no idea why Botox would be given for an ulnar neuropathy. There‘s no rationale for it. You have a neuropathy, you have decreased tone. Really, it doesn‘t justify the use of botulinum toxin. I went to the American Academy of Neurology Guidelines for the use of Botox, and nowhere in there is Botox indicated for any type of a peripheral neuropathy. I mean, the way Botox works is it‘s a toxin. It works at the neuromuscular junction and it interferes with the transmission of nerve impulses from the nerve to the muscle so that it weakens the muscle. We use to in dystonia. He was —- he did mention dystonia, which she doesn‘t have dystonia, from all the rest of his reports. You can use it to weaken the muscle. For example, if you have a violinist who has dystonic fingers in his left hand or her left hand so that when she goes to play the violin, she gets writer‘s cramp or violinist‘s cramp. That can be treated with Botox. That‘s the purpose of it, is to treat an overactive muscle. The purpose of Botox is not to treat a muscle that is weak because of damage to the nerve. It can only make it weaker and it can only aggravate the problem. The objection that Dr. Koslowski was injecting the Botox not so much to treat the muscle as to provide pain relief was of no moment to Dr. McCormick because he clearly did not believe her subjective reports of pain, did not believe she was actually suffering muscle spasms, and did not believe the reported relaxation she experienced immediately after receiving the injections on two occasions. Dr. McCormick did not believe that Botox would be a proper treatment for any pain that P.T. may have been experiencing. Dr. McCormick gave special critical attention to Dr. Koslowski‘s use of the term ?spasticity? to describe P.T.‘s symptoms: There‘s nothing here to indicate —- anywhere in this history to indicate that this is a lady who has spasticity . . . Spasticity is abnormal motor function due to increased tone in the muscles . . . [I]n her case, it would be an upper spinal cord problem or a problem with the brain . . . [H]er problem is a peripheral problem. It‘s a peripheral nerve problem. It‘s not a spinal cord problem, it‘s not a brain problem, and I‘m not sure why he chose that terminology of spasticity because it‘s just not consistent with the way a neurologist thinks. . . [S]pasticity is the central nervous system. It‘s the brain with the spinal cord. Once your nerve leaves the spinal cord, it becomes a peripheral nerve, and damage to the peripheral nerve cannot be accompanied by spasticity. It‘s caused by weakness. . . If you think of cerebral palsy, for example, in which the hand and the arm are drawn up and the leg is stiff, that‘s a classic example of spasticity. Dr. McCormick pointed out that American Academy of Neurology and FDA guidelines for the use of Botox apply only to spasticity, not to any other condition, and that by definition P.T. could not have been suffering from spasticity. Dr. McCormick conceded that another board-certified neurologist, Dr. Pulley, had also treated P.T. with Botox. He ?was surprised to see that? in the medical record, but otherwise did not offer an opinion on Dr. Pulley‘s treatment. Dr. McCormick conceded that Dr. Pulley also used the term ?spasticity? in describing P.T.‘s symptoms. Dr. McCormick conceded that Dr. Eye was the primary treating physician, that Dr. Eye conducted all manner of tests and treatments on P.T. concurrent with Dr. Koslowski‘s treatment, and that Dr. Eye was also concerned about the spasms in P.T.‘s fingers. Dr. McCormick conceded that other physicians, including Dr. Eye, consistently referred to P.T.‘s ?spasms? as a problem in her treatment. Finally, Dr. McCormick conceded that Dr. Eye was well aware of the Botox treatments P.T. was obtaining from Dr. Koslowski. Fernando Miranda, M.D., submitted a records review dated May 19, 2008, and an addendum dated June 16, 2008. Dr. Miranda also testified via deposition in this proceeding. Dr. Miranda is board certified in neurology and licensed to practice in the state of Florida. Dr. Miranda testified as an expert in neurology, without objection. Dr. Miranda‘s May 19, 2008, records review provides as follows: In this review of records, the patient appears to have been working for Memorial Hospital Medical Center as a nurse, when she was exposed to tuberculosis. There are extensive narratives in the chart describing how many specialists have thought that this exposure could not have resulted in some of the claims by this worker, who states not only an ulcerated lesion on the right forearm but also a kidney abscess, which she states was secondary to tuberculosis as well. This particular wound on the right upper extremity has been opined by many individuals to be secondary to self- infliction opposed to tuberculosis. However, the patient, on March 29, 1995, presented as a referral from Dr. ?Ay [sic] to Dr. Koslowski, who noted that the patient had developed ?tuberculosis, blisters, and ulcerations of the right forearm.? Dr. Koslowski also opines that she has an ulnar nerve paresis. Dr. Koslowski sent her for a graft of the ulnar nerve and Dr. Steinberg on the opined [sic] on the nerve transposition of the median to the ulnar nerve. She was treated with muscle relaxants, including Dantrium, Valium, and pain medication, which was Lortab. The patient was given a Botox injection as early as 06-05-96 and this was to the flexor carpi ulnaris and flexor digitorum profundus, in the territory of the ulnar nerve. This was secondary to spasms of these muscles. Since then, the patient has received as many as 13 injections at 13 separate sites. The injections go through 2007, according to records. The predominant complaint was one of pain and spasm, and the patient was described as having a claw-hand. However, which sounds interesting, is the fact that claw-hand is usually caused by weakness of the flexor carpi ulnaris, flexor digitorum profundus, of the ring and little fingers, as well as the intrinsic hand muscles. These are apparently the muscles that Dr. Koslowski is injecting. It is also unclear why this patient has the spasms. Spasticity is certainly a central nervous system phenomenon and not a peripheral nervous system phenomenon. As far as the Neurological opinion goes, I would feel not at ease in having one of the basic concepts clear, which is, what is it that Dr. Koslowski is actually treating? Dr. Miranda‘s June 16, 2008, addendum reads as follows: This is further clarification of my opinion rendered on May 19, 2008. As I stated on page two, spasticity is a central phenomenon of the brain, and no [sic] a peripheral nervous system phenomenon. Claw-hand is usually caused by weakness of the flexor carpi ulnaris and flexor digitorum profundus. Further weakness would be caused by Botox injection. It is my opinion, given the records reviewed by me, that Dr. Koslowski‘s treatment is not in accordance with the diagnoses offered and previously described, which are consistent with an ulnar nerve impairment. The spelling of Dr. Eye‘s name in the May 19, 2008, report leads to the inference that Dr. Miranda dictated the report and never read the finished product. In any event, these reports are brief, conclusory, and of little assistance to the fact finder. When read in light of Dr. Miranda‘s deposition testimony, his reports become useless. In his testimony, Dr. Miranda stated that he spent one and one-half hours reviewing the medical records in this case. This was not enough time to do more than skim the 218-page Summary prepared by Mr. Spangler, let alone read the thousands of pages in the actual record. The opinions he offered were based only on broad generalities regarding spasticity and claw-hand; they could not have been based on any genuine understanding of P.T.‘s condition.31/ In reading whatever portion of the record he bothered with, Dr. Miranda came away with the idea that Dr. Koslowski billed USIS $1.5 million for the Botox injections he administered to P.T. When counsel for Dr. Koslowski presented him with an opportunity to correct himself, Dr. Miranda instead dug the hole deeper: Q. Okay. Approximately how many —- I‘m not asking you to count all the instances, but approximately how many times did Dr. Koslowski administer Botox? A. I don‘t remember right now offhand. I would have to re-review the records for that. Q. Well, if it was $1.5 million, I mean, we would be talking about literally hundreds of administrations of Botox, wouldn‘t we? A Well, it depends. The Botox, I don‘t remember how much it was in 2008, but I can tell you that right now it‘s about $500 for a hundred units. And so, if he administered a hundred units times two, that would that would be a thousand dollars, plus the administration fee that he charged was $2,400. So we‘re talking about $3,500. So the way to do the math is divide, you know, $1.5 million by 3,500. $1.5 million was actually the total workers‘ compensation payout to all of P.T.‘s medical providers over the course of twenty-plus years of treatment, according to Mr. Spangler‘s cover letter to Dr. Miranda. Only the most careless misreading of that letter would lead one to attribute all of those costs to Dr. Koslowski, whose actual share of the total, according to Mr. Spangler‘s Summary, was $54,200, including $24,230 in charges for Botox injections. The Summary states that Dr. Koslowski made a total of 89 Botox injections to P.T.‘s right hand between June 5, 1996, and May 14, 2007. P.T. received two more series of injections from Dr. Koslowski after May 14, 2007. Assuming that each session involved a dozen injections,32/ then the total number of injections would be 113.33/ If one indulges in Dr. Miranda‘s math, dividing $1.5 million by $3,500 to arrive at a total of 428.57 injections, one would conclude that in the course of the fourteen occasions in which Dr. Koslowski administered Botox to P.T. between 1996 and 2009, he made an average of 35.7 injections per session. That the numbers cited in his testimony did not immediately strike Dr. Miranda as ludicrous renders his credibility as an expert witness nugatory.34/ Dr. Miranda‘s substantive medical testimony generally followed that of Dr. McCormick, including the criticism of Dr. Koslowski‘s use of the term ?spasticity? to describe a condition not proceeding from the central nervous system. There was one notable exception: Dr. Miranda opined that Dr. Koslowski would have been medically justified in administering Botox on one or two occasions, but not for the ten or so years that he continued to treat P.T. in this fashion. Dr. Miranda explained his reasoning as follows: [F]or a peripheral nerve damage, most peripheral nerve damages are recoverable in a period —- and this is the piece of information that you may not know, that the peripheral nerves grow at a rate of one millimeter to three millimeters per day. The younger the patient, the more likelihood that the peripheral nerve is going to regenerate, unless there is an underlying disorder like diabetes in which it becomes very abnormal, sometimes low growth, and sometimes not particularly in an organized fashion. When I say it‘s reasonable to assume that this patient, if she were to have had an ulnar problem causing her claw hand, for a peripheral —- let me underline the word ?peripheral? nervous system involvement because there is no evidence again of a brain involvement —- one would postulate that it would take about a year to grow from the elbow down into the hand, the ulnar nerve. So if that were the case, knowing that each Botox injection lasts between four and eight months, it would be reasonable to assume by the time you‘re giving the second injection, that would be all that one needs. Based on a reading of the entire medical record, it is apparent that Dr. Miranda‘s general statements as to the regeneration rate of the ulnar nerve would likely be overly optimistic in P.T.‘s case.35/ In any event, Dr. Miranda‘s reasoning seems to assume that the Botox injections did offer relief to P.T.‘s claw-hand condition and were therefore an acceptable treatment until such time as the ulnar nerve could be expected to regenerate and naturally relieve P.T.‘s symptoms. However, the undersigned is hesitant to give any credit to the opinions expressed by Dr. Miranda in his testimony, given the casual sloppiness of his reports. Finally, Brian D. Wolff, M.D., submitted a records review dated June 24, 2008, and an addendum dated November 22, 2009. Dr. Wolff‘s letterhead states that he is a board- certified neurologist practicing in Naples. Dr. Wolff did not testify at the hearing, and his report is being considered as a hearsay document over the objection of Dr. Koslowski. Dr. Wolff‘s report essentially repeats the opinion of Dr. McCormick, though he also appears to labor under the false impression that Dr. Koslowski36/ billed some exorbitant amount of money for the Botox injections. It is unclear how long Dr. Wolff spent reviewing the medical records. His report goes into very little detail regarding the records of any provider other than Dr. Koslowski, and his notations regarding Dr. Koslowski indicate primary reliance on Mr. Spangler‘s Summary rather than Dr. Koslowski‘s actual medical notes. Like Dr. McCormick, this neurologist is able to make the psychiatric diagnosis of ?factitious disorder/Munchausen syndrome? within a reasonable degree of medical certainty based upon an online medical dictionary definition of the term37/ and a few citations from the record regarding provider suspicions of wound manipulation. Dr. Wolff went farther than any other reviewer in stating his opinion that P.T. never suffered a work- related injury at all. Given that Dr. Wolff did not testify and his opinions could not be subjected to cross-examination, Dr. Wolff‘s report is of little assistance to the undersigned‘s ultimate determination in this case.38/ Expert Medical Advisor‘s report As part of its own investigation in this case, the Department hired Michael Yaffe, M.D., to provide an expert advisory opinion. As noted at Finding of Fact 7, supra, Dr. Yaffe is a board-certified neurologist and a certified EMA who completed a record review and issued a written report to the Department. Dr. Yaffe's report, dated September 11, 2011, concluded that aspects of Dr. Koslowski's treatment of P.T. were not medically necessary and appropriate. Dr. Yaffe testified via deposition as an expert in neurology and as an EMA under chapter 440, Florida Statutes, without objection. Dr. Yaffe‘s written report is puzzling. It is less a narrative than a seemingly random stroll through P.T.‘s medical record followed by a general description of the proper uses of Botox. Dr. Yaffe‘s report dwells the longest on Dr. John Drewniany, a hand surgeon whom USIS hired to perform a consultation in March 2002, and who examined P.T. once. The long first paragraph of Dr. Yaffe‘s report recites Dr. Drewniany‘s history and physical examination of P.T. in detail, which would not be remarkable except for the fact that Dr. Yaffe‘s report includes no more than two sentences about any other medical provider. Dr. Drewniany concluded that the prognosis for P.T.‘s right arm was poor and recommended against surgical options. He also mentioned that ?one must consider the fact of a possible factitious problem? as regards the failure of the right arm wound to heal. Dr. Yaffe included this statement in his report. As to P.T.‘s other medical providers, the discussion portion of Dr. Yaffe‘s report mentioned only Dr. Steinberg, Dr. Kirshner, and Dr. Boswell. As to Dr. Steinberg, the report noted only that on June 26, 1996, he ?commented that Botox injection helped the spasms of the claimant. She was able to extend her fingers.? As to Drs. Kirsner and Boswell, the report noted only that they ?had been involved in assessing this patient for a long-term eating disorder (bulimia).? Dr. Yaffe‘s report also contains the following paragraph: Dr. Mark J. Upfal, M.D., Occupation Health [sic] in his note of September 16, 2005, having reviewed records again raised the question of probably self-inflicted interference with the wound-healing process. Dr. Upfal stated that he believed that Botox injections should be discontinued as they would be of no benefit and possibly potentially harm the claimant. This quote is curious on two counts. First, it appears designed to leave the impression that Dr. Upfal was a treating physician making a ?note? in the chart after reviewing the records, rather than a physician hired by USIS to perform a peer review. Second and more critical, the peer review that Dr. Upfal conducted was of Dr. Eye, not Dr. Koslowski. The words ?Botox? or ?botulinum? do not appear in Dr. Upfal‘s report; it states not a word regarding Dr. Koslowski‘s treatment of P.T. Based on the evidence of record, the opinion Dr. Yaffe attributes to Dr. Upfal regarding discontinuation of the Botox injections is imaginary.39/ This is not the end of Dr. Yaffe‘s creativity. In his review of Dr. Koslowski‘s medical notes, Dr. Yaffe states, ?September 4, 2006, the claimant reported to Dr. Koslowski of the effectiveness of the Botox lasting two months.? P.T. actually made this report to Dr. Koslowski on September 4, 1996, after her first series of Botox injections. This report led Dr. Koslowski to conclude that he had not used enough Botox. See Finding of Fact 45, supra. After Dr. Koslowski increased the dosage, P.T. routinely reported the effects of the injections as lasting much longer than two months. Dr. Yaffe also states, ?July 9, 2007, Dr. Koslowski reported that the Botox lasted three months and was causing a steady improvement in the patient‘s condition.? Dr. Koslowski made no note in P.T.‘s medical record on July 9, 2007, and never in any of his notes made such a categorical statement about Botox causing ?steady improvement? in P.T.‘s condition. Dr. Koslowski always understood the tenuousness of P.T.‘s medical status and that the effects of the Botox injections were ameliorative and temporary. Dr. Yaffe‘s report lists twelve ?conclusions,? some of which bear directly on Dr. Koslowski‘s treatment and some of which are general statements regarding such matters as FDA approval of Botox for focal dystonia and who is allowed to inject Botox in the state of Florida. In summary, Dr. Yaffe concluded that Dr. Koslowski‘s medical records were insufficient to document his objective exam findings or to correlate the exam findings with P.T.‘s symptoms. Dr. Yaffe concluded that Botox was not indicated for P.T.‘s peripheral nerve condition and that Dr. Koslowski‘s evaluation and treatment of P.T. were not medically necessary and appropriate. He stated that the duration of treatment was excessive. However, Dr. Yaffe also stated, ?The response to this treatment as represented by the patient‘s subjective complaints and examinations by a number of physicians involved with this case shows that there has been some benefit with less spasm and pain.? He stated that this ?might be a placebo effect.? In his conclusions, Dr. Yaffe also mentioned once again the ?suspicion? that the problems with P.T.‘s right forearm may have been self-inflicted. Finally, the following ?conclusion? of Dr. Yaffe is set out in full: 3. Dr. Koslowski quoted ?Dr. Michael Pulley? (see Shands) that he injected. . . ?the claimant‘s arm twice, which lasted eleven and twelve months.? However, there are no additional documented information available from Shands or Dr. Koslowski‘s to support these comments regarding Botox effectiveness in this regard. The quote is a reference to Dr. Koslowski‘s medical note of June 3, 2003, when P.T. returned to his office for the first time in over two years. See Finding of Fact 107, supra. However, the language that Dr. Yaffe placed in quotation marks is actually his summary of Dr. Koslowski‘s note. The placement of Dr. Pulley‘s name in quotation marks implies some level of suspicion, presumably as to whether Dr. Koslowski is concocting an endorsement for his treatment from another physician. Dr. Yaffe‘s report includes a ?summary of records reviewed? that lists 36 sources but does not list Dr. Pulley or Shands in Jacksonville, which may explain Dr. Yaffe‘s failure to recognize Dr. Pulley‘s name.40/ However, the inclusion of the parenthetical ?see Shands? indicates some level of awareness of Dr. Pulley‘s identity. Dr. Yaffe‘s deposition testimony did little to clarify his level of information as regards to Dr. Pulley. When first questioned, Dr. Yaffe had no recollection of Dr. Pulley. There followed a colloquy in which Dr. Yaffe stated that he ?reviewed the records of everything that was presented to me in the envelope? provided by the Department,41/ but had no recollection of Dr. Pulley‘s providing any Botox injections to P.T. Dr. Yaffe agreed that it would be relevant for him to evaluate why a second physician chose to administer Botox to P.T., but he could not recall making such an evaluation in his report. Dr. Yaffe attempted to minimize the absence of Dr. Pulley‘s records in his report by stating that, if he had reviewed them, he would have concluded that Dr. Pulley had made ?another mistake.? Either Dr. Yaffe was not provided Dr. Pulley‘s medical records, or he ignored them in his report. In either case, this omission constitutes a significant flaw in Dr. Yaffe‘s analysis of Dr. Koslowski‘s treatment of P.T. Dr. Yaffe failed to consider Dr. Pulley‘s supportive opinion while giving full credit to the negative peer review reports of Drs. Miranda, McCormick, and Wolff, not to mention the negative opinion he invented for Dr. Upfal. Dr. Yaffe testified that he had no recollection of the peer reviews of Dr. Eye‘s treatment of P.T., despite his report‘s emphasis on the peer review of Dr. Upfal. Dr. Yaffe had no real recollection of Dr. Eye‘s medical records or of how those records correlated with those of Dr. Koslowski. Dr. Yaffe could not recall the interaction between Drs. Eye and Koslowski or the testing performed on P.T. by Dr. Eye. Dr. Yaffe stated that it ?wasn‘t my function? to examine internal medicine issues, regardless of their relevance to an evaluation of Dr. Koslowski‘s treatment. Dr. Yaffe testified that he has never used Botox in his practice. Before arriving at his opinion, Dr. Yaffe did not consult with any neurologist who uses Botox. Dr. Yaffe claimed to have received some training during his residency in the use of Botox by watching other physicians administer it. This claim seems unlikely given that Dr. Yaffe completed his residency in 1974 and all available data indicate that Botox was not used on humans even experimentally before 1977.42/ The undersigned credits Dr. Yaffe with having observed physicians administer Botox to patients, and assumes that he was merely confused as to when this occurred. Dr. Yaffe stated that P.T.‘s claw hand could have been caused by spasticity but was more likely the result of peripheral nerve damage. The muscles that are innervated by the ulnar nerve become impaired and cannot maintain adequate function. The antagonistic muscles take over the positioning of the fingers, resulting in clawing. Dr. Yaffe stated that he saw no point in Dr. Koslowski‘s injection of Botox into the stronger muscles: ?You are still not correcting a weakened muscle, which is the cause of the problem. You are just going to add another problem area . . . The concept is not right.? Like Dr. McCormick, Dr. Yaffe did not see the merit of using Botox to reduce pain and restore some level of functioning to P.T.‘s right hand, because the use of Botox would have the eventual result of further weakening the muscles in the hand. Given the overall poor prognosis for P.T.‘s right arm, Dr. Yaffe‘s emphasis on ?correcting a weakened muscle? seems a questionable priority compared to the increased quality of life that P.T. obtained however temporarily, from the Botox injections. Dr. Yaffe‘s opinion also mirrored that of Dr. McCormick regarding Dr. Koslowski‘s use of the term ?spasticity.? See Finding of Fact 307, supra. Dr. Yaffe scoffed at the suggestion that P.T.‘s case was particularly complex. He testified that half of P.T.‘s referrals were unnecessary and constituted ?barking up the wrong tree.? An essential basis for Dr. Yaffe‘s opinion was that Dr. Koslowski‘s use of Botox is outside the list of FDA-approved applications. Dr. Yaffe stated his categorical opposition to off-label uses of Botox by physicians. He testified that off- label use of a medication is ?speculative? and therefore violates the standard-of-care. Dr. Yaffe acknowledged that physicians often use off-label treatments by stating, ?They may be, but that doesn‘t justify them doing it, does it?? Dr. Yaffe was a truculent, evasive, and somewhat disingenuous witness. Many pages of the deposition consist of Dr. Yaffe pointlessly arguing with Dr. Koslowski‘s lawyer. At one point, Dr. Yaffe refused to answer a question because counsel was ?using words that are so vague, like =number‘ and =several.‘? The ?vague? words that counsel was using were in fact quotations from Dr. Yaffe‘s own report. Dr. Yaffe‘s report gave prominence to the possible ?psychological component? in P.T.‘s problems, but in his testimony Dr. Yaffe backpedaled from the notion that this represented his own opinion and stated that he was merely noting that ?some observers? had suggested the psychological component.43/ He also backed away from the several suggestions of ?factitiousness? in his report, again claiming that he was merely recording the observations of other practitioners. In summary, Dr. Yaffe‘s slipshod and in places factitious written report, coupled with his belligerent yet equivocal testimony, rendered him an unpersuasive witness. Testimony at the final hearing P.T. testified at the final hearing. She testified that she had retired after 40 years as a registered nurse, 25 of them spent working at Memorial. At the time of the hearing, she still had the wound on her arm and wore a bandage. P.T. testified that the wound was currently about the size of a dime and one millimeter in depth. The wound had not been infected for about five years. P.T. denied ever manipulating the wound. She testified that physicians placed casts on the wound on at least three different occasions, preventing her from accessing the wound. Once, the cast had to be removed after two weeks ?because the smell got so bad.? P.T. testified that the casting was done after surgery. The wound would be closed immediately after the surgical procedure, but would open up while it was in the cast. It would begin as a small necrotic area and then gradually become larger. P.T. testified that she was currently changing the wound dressings. For several years, a home health care service did the dressing changes for her and the dressings were ?much more elaborate.? At times, there were pumps on the wound. P.T. stated that she would not have been able to manipulate the wound during the periods when the home health care service was dressing the wound.44/ P.T. testified that no one who has experienced the kind of pain she endured would extend the agony by manipulating the wound. She recalled that at one point when the pain was unbearable, she and Dr. Eye discussed amputating her right arm. She recalled that she tried hyperbaric treatments, whirlpool treatments, acupuncture, surgery, and all manner of physical and occupational therapies, and stated that she was willing to do anything to heal the arm. P.T. testified that the Botox treatments from Dr. Koslowski helped with the pain. P.T. stated, ?[A]t first you‘d get some relaxation of the joints and I was able to open my hand, and then within a week I had total loss of the spasms. I mean, it was amazing. It was truly amazing.? She stated that she never saw anything inappropriate in Dr. Koslowski‘s technique. P.T. testified that she finally gave up on getting the Botox treatments when the ?hassle? of obtaining approval from the insurance carrier became too much. Since she stopped receiving Botox injections, P.T. has treated the pain with Klonopin prescribed by Dr. Hartman, with acupuncture, and with microcurrent treatments. P.T. discussed her treatment by Dr. Shah, Dr. Kirsner, and Dr. Boswell. She stated that it was the USIS case manager who first suggested mental health care. She stated that she didn‘t know what she would have done without Dr. Boswell to ?vent to? when she was undergoing such excruciating pain. P.T. testified that she has had an eating disorder since she was seven years old, and that she has binged and purged through the years, though she also stated that she has had those episodes ?under control? since 2007. P.T. stated that none of her psychiatric or psychological care providers ever suggested to her that the wound on her arm was related to any psychiatric condition. P.T. testified that Dr. Eye was the ?gatekeeper? for her care. She believed that Dr. Eye knew about her eating disorder, but acknowledged that she felt shame about it and did not reveal her eating disorder to physicians other than Drs. Kirsner and Boswell. P.T. had no recollection of telling Dr. Koslowski about her eating disorder or her nutritional issues. P.T. also acknowledged that she was not candid with Dr. Koslowski regarding the medications she had been prescribed by Dr. Kirsner. She denied ever taking multiple narcotics at the same time and denied being addicted to narcotics. Dr. Koslowski testified that he completed his residency in neurology at the Medical College of Pennsylvania, then did a fellowship in neurorehabilitation at the University of Maryland. While at the University of Maryland, Dr. Koslowski took elective training in regional anesthesia at Johns Hopkins University. He stated that at present he is the only neurorehabilitation specialist in Jacksonville and is the only neurologist with admitting privileges to Brooks Rehabilitation Hospital in Jacksonville. He also regularly lectures to neurology residents at Shands in Jacksonville. Dr. Koslowski is board certified in neurorehabilitation and was accepted as an expert in the fields of neurology and neurorehabilitation without objection. Dr. Koslowski explained that his training in anesthesia has been important because a large portion of his practice is pain management. He is able to perform nerve blocks that other neurologists cannot do. Dr. Koslowski explained that the Botox injections he performed on P.T. were ?a form of nerve block, but we do it to the muscle at the neuromuscular junction.? Dr. Koslowski testified that P.T. was referred to him by Dr. Eye and presented with ulnar neuropathy that resulted in pain and spasms. He stated that P.T. was having a lot of spasms in her right arm, and the spasms had the effect of breaking down the skin from the inside out. Dr. Koslowski testified that Dr. Steinberg had been planning a complex tendon transfer for P.T., but that he decided not to perform it because the Botox was effective.45/ Dr. Koslowski testified that he first started learning about Botox during his fellowship. He has since published an article and lectured on Botox. He described it as working in two ways, one neuromuscular and one nervous. Its neuromuscular function is to block the effect of acetylcholine at the junction between the nerve and the muscle. Its nerve effect is analgesic, blocking substances like glutamate, calcitonin gene-related peptides, and substance P that go from the nerve to transmit the sensation of pain. Dr. Koslowski noted that Botox was not FDA-approved until 1989, well after his experiences using it on patients during his Johns Hopkins fellowship. He further noted that in 1989 Botox was not approved for all its present-day uses. Dr. Koslowski stated that in his experience it is common for there not to be FDA approvals for treatments of rare disorders, because ?it‘s very expensive to get FDA approval, so a lot of times a drug company will get the drug on the market for one indication and will wind up using it for another indication.? Dr. Koslowski testified that it is very common for professional journals and conferences to discuss off-label uses for Botox. He stated that the upcoming meeting of the American Academy of Neurology would include the presentation of nine papers on uses for Botox that have not been approved by the FDA. Dr. Koslowski was not surprised by the length of the effects of Botox injections on P.T. He stated that he has been injecting Botox longer than anyone else in Jacksonville and that P.T.‘s results were not inconsistent with his long experience. Dr. Koslowski testified that these results were also consistent with the literature in the field, which showed responses to Botox that varied from a couple of months to a year. Dr. Koslowski testified that he reviewed all the available medical records in this case, and that it took him about 83 hours to do so. In his opinion, it would be impossible for an expert to understand P.T.‘s case by reviewing the record for only a few hours. Dr. Koslowski‘s testimony is entirely credited as to the amount of time required adequately to review the medical record in this case. Dr. Koslowski testified that he treated P.T. for about ten years. P.T. was an ?extremely complex? patient who was being treated by ?about half a dozen? other physicians at the time she started seeing Dr. Koslowski. All of these physicians were aware that Dr. Koslowski was treating P.T. with Botox, and none of them ever suggested the treatment was inappropriate. Dr. Koslowski disagreed with the reviewing physicians‘ opinions that Botox should only be used for conditions of the central nervous system. He testified as to medical literature demonstrating its use in peripheral nervous system phenomena and cited Dr. Pulley‘s agreement that Botox was appropriate in the case of P.T. Dr. Koslowski also disagreed with the opinion of Drs. Yaffe and McCormick that Botox was inappropriate for P.T. because its effect would only be to further weaken an already weak muscle. Dr. Koslowski believed that it was myopic to look at the muscle in isolation and emphasized that he and Dr. Steinberg were trying to treat P.T.‘s spasticity for function: Being a specialist in rehab, function is very, very important. It‘s more important that all the little iotas that we as neurologists tend to be fixated on. So by correcting the spasm, P.T. became functional to the point that she came to me afterwards and she —- the first time, she came to me and said: ?Wow, I can open up my hands. I can now start an IV with my right hand.? It was like a miracle, she thought. I mean, she‘s trying to help people. That‘s what I was trying to do myself. Dr. Koslowski disagreed also with the notion that ?spasticity? is never present with a peripheral nerve injury, based on his own years of experience and medical literature describing spasticity as a condition that may occur secondary to various disorders or traumas, including peripheral nerve injury. He also pointed to the fact that Botox treatment is increasingly common for focal hand dystonias such as writer‘s cramp or cramping in musicians, which are not necessarily caused by the central nervous system. As to the ?spasticity? controversy, the undersigned finds that it amounts to a tempest in a teapot. The Department‘s witnesses seized on Dr. Koslowski‘s use of the term ?spasticity? to make a debating point, i.e., that P.T. could not be suffering from ?spasticity? as that term is generally defined in the medical community because she suffered no central nervous system injury, therefore Dr. Koslowski does not understand even basic neurological principles. The undersigned finds that the following colloquy between Dr. Pulley and counsel for Dr. Koslowski adequately disposes of this issue in a common sense way: Q. Do you have any concern regarding the administration of Botox to this patient? A. No. Q. Let me just ask you this, in terms of evaluation of spasticity, do you believe that P.T. was suffering from spasticity? A. No, I don‘t. Q. Okay. Is the term spasticity sometimes used for conditions —- peripheral nerve-type conditions? A. Well, that‘s a little controversial, and I think —- I think it would be probably incorrectly applied and maybe a better term would be spasm as opposed to spasticity. Q. Is it frequent, however, that neurologists and other professionals use the term spasticity when they should really use the term spasm? A. Yes. I think it‘s not at all uncommon.46/ Q. Okay. And does-— does the use of spasticity rather than the term spasms necessarily imply that any . . . inappropriate medical treatment would be given to a patient? A. No. It doesn‘t necessarily imply that, no.47/ In short, contrary to the Department‘s implication, even if Dr. Koslowski is misusing the term ?spasticity,? such misuse does not perforce lead to the conclusion that his treatment of P.T. was inappropriate. At most, it demonstrates that his use of Botox was off-label, which Dr. Koslowski freely admitted in any event. As to another criticism by Dr. McCormick, that P.T. could not possibly have experienced immediate relaxation upon injection of the Botox, Dr. Koslowski testified that he probably injected a local anesthetic prior to administering the Botox, and that P.T. was likely feeling the effect of the anesthetic. He stated that it was his practice to inject P.T. with a local because she complained about how painful the Botox injections were. Dr. Koslowski conceded that he did not record the use of a local anesthetic. Dr. Koslowski went on to testify that he had noted signs of Wallerian degeneration in P.T., which he described as degeneration of the myelin sheaths around the nerve and then the axons caused by nerve damage. In P.T.‘s case, he believed that the ulnar nerve damage degenerated backward to her brachial plexus into her brain stem to cause the phenomenon. Dr. Koslowski based this diagnosis on EMGs and nerve conduction studies indicating a progressive degeneration of the ulnar nerve. Dr. Koslowski stated that he didn‘t aggressively pursue more EMG or nerve conduction studies after he began administering Botox because his role in P.T.‘s treatment ?was really to treat her with the Botox and the pain, to help her with the pain.? He was working with Dr. Eye, who was overseeing P.T.‘s treatment and whom Dr. Koslowski saw in the hospital almost every day. They discussed the case frequently because it was so unusual. Dr. Koslowski estimated that over the years he has received hundreds of referrals from Dr. Eye. On this point, Dr. Koslowski‘s testimony is consistent with that of Dr. Eye, who stated, ?As a matter of fact, when I sent her to Dr. Koslowski for his help with the -— with the Botox, I didn‘t want him to do the tests. We were doing the tests, and all I asked him to do was the treatment. I was doing the testing.? Dr. Eye is here specifically referencing blood testing, but the larger point remains that Dr. Koslowski‘s role in P.T.‘s treatment was very limited and circumscribed by the overall authority of Dr. Eye. See also, Finding of Fact 27, supra. Dr. Koslowski conceded that he did not always include his diagnosis or all of his test results in his written records. He also stated that at the time of the referral, he did not receive any reports or written explanation of the reason for the referral from Dr. Eye. The history provided in Dr. Koslowski‘s initial evaluation was based solely on information provided by P.T. Dr. Koslowski testified that he relied on this information to be accurate and complete. Dr. Koslowski testified that he never requested medical records from P.T.‘s other treating physicians. During the entire time he treated P.T., Dr. Koslowski was unaware that she had been treated for psychiatric problems. He was unaware that she had treated with Dr. Shah, Dr. Kirsner, or Dr. Boswell, and was also unaware of her eating disorder. Dr. Koslowski did not believe that P.T.‘s psychiatric condition was important in the context of his limited involvement in her treatment. As to possible self-injurious behavior, Dr. Koslowski testified that it ?might be a curiosity,? but also would not be relevant to his treatment. He did not pursue the issue because Dr. Eye, the physician in charge of P.T.‘s treatment, had informed Dr. Koslowski that he had considered the possibility of self-harm and had ruled it out. Dr. Koslowski could not testify as to whether anything about P.T.‘s wound suggested self-harm because he did not examine the wound. Dr. Koslowski testified that his treatment was justified because a patient such as P.T. ?has so many issues and she‘s complaining of such severe pain, it‘s worth trying these avenues . . . [Y]ou have to think out of the box a lot of times when you‘re in this field.? Dr. Koslowski‘s statement is supported by Dr. Eye‘s testimony: [Dr. Koslowski‘s] theory —- and he and I talked about this —- was that the spasticity of the -– of the muscle and the tendon, if you will, or the motion actually was having an adverse effect on the blood supply because of the continued tension. And when we relaxed that, now she could move the arm, the pain was dramatically better. I mean, it was -— if for no other reason than purely humanitarian reasons for the pain, it was worth it because this poor woman was in pain. But on top of that she got increased movement. Now she could use the arm, now she could work, and now the wound would heal. So, I mean, how can you go wrong with that. Dr. Pulley‘s deposition testimony likewise supports the testimony of Dr. Koslowski. Dr. Pulley testified that he often uses Botox for off-label treatments such as focal limb dystonias and spasticity of the leg. He stated that Botox is ?pretty much accepted as a treatment for things like writer‘s cramp? although it is not FDA-approved for that use. Dr. Pulley agreed that there were a number of conditions that occurred so infrequently that it would be impracticable to perform the kind of studies that lead to FDA approval. Dr. Pulley testified that P.T. had objective indications of a real medical condition in her hand and that the possibility she might be faking ?didn‘t enter into my thought process.? He did not perform testing beyond the physical examination because he saw no reason to doubt the existing diagnosis or to change the treatment she was receiving. The ulnar nerve problem was a clear diagnosis and the posture of P.T.‘s hand and her inability to straighten her fingers made diagnostic testing unnecessary. On examination of P.T., Dr. Pulley noted flexion of the digits of her right hand. He stated that it is usually ?too late to do much? for patients in P.T.‘s condition because they have developed a contracture of the joint, meaning that no treatment will ever improve the position of their fingers. P.T. had not reached that point and therefore was an appropriate candidate for Botox injections: I have seen other patients who‘ve had similar issues, but in those cases I have not seen patients that I thought would benefit from treatment with botulinum toxin. Either they didn‘t have the overactivity of muscles that she seemed to demonstrate, or they had permanent flexion contractures already that I didn‘t think that they would benefit from treatment with botulinum toxin. * * * [T]he goal of using that medication is to reduce muscle overactivity or perhaps to restore balance, so when you have nerve injury, some of the muscles supplied by that nerve will become weak. In certain joints there are different muscles acting across that joint, and if some muscles become weak, others will become relatively overactive and could put the joints in an abnormal posture making them less functional. So in this case the idea was to reduce the activity of some of the muscles to sort of restore that balance. Dr. Pulley testified that P.T. obtained pain relief and some relaxation of the spasms from the Botox injections. He allows the patient to determine when she requires another injection, based on her function. Because of the pain of the injection, patients sometimes put off the injection as long as possible. Dr. Pulley stated that it is not recommended to do Botox injections more frequently than every 90 days, but that there is no maximum interval between injections. The length of an injection‘s effect is dependent on ?a lot of factors? including the cause of the dysfunction, the size of the patient, other medications, and the number of injections the patient has received in the past. Dr. Pulley has had patients wait more than a year for repeat injections. As to the question of whether repeated Botox injections were inappropriate in this case because they only served to further weaken the muscle, Dr. Pulley responded as follows: [T]he goal here is to try to restore some balance between the excessive amount of flexion and sort of allowing more extension to happen, and that was the goal of her treatment. So if continually giving Botox actually in some cases can cause some permanent weakness of the muscles that you‘ve treated and may lead to some permanent, quote, dysfunction of that muscle but—but hopefully improved function for the person. Dr. Pulley stated that Botox is an effective therapy for patients with peripheral neurological disorders and that it was an effective therapy for P.T. The determination of the success of Botox treatment is always up to the patient because the goal is to improve the patient‘s function. If the patient feels that her function is better with the treatment, then the physician takes the patient at her word. Summary of findings The evidence established that there was a therapeutic purpose for the Botox injections administered by Dr. Koslowski. The initial purpose was to confirm whether P.T. had spasm in her right hand. In 1996, Dr. Steinberg wanted to confirm the presence of spasm and if possible get the spasm under control sufficiently to allow for tendon transfer surgery. Dr. Steinberg even hoped that the Botox therapy might improve P.T.‘s condition to the point that surgery would not be necessary. The Botox injections provided so much relief that P.T. continued to return to Dr. Koslowski for further periodic injections. The injections relieved P.T.‘s pain and spasms and restored a level of functionality to her right hand for periods of several months.48/ Dr. Koslowski was never P.T.‘s primary physician. Dr. Eye emphasized that he sent P.T. to Dr. Koslowski ?for treatment, not for diagnosis.? Dr. Koslowski‘s role in P.T.‘s overall treatment was extremely limited, which adequately accounts for his failure to delve deeply into P.T.‘s psychological diagnoses, eating disorder, or possible manipulation of the wound on her right arm. None of these issues were related to the very particular treatment that Dr. Koslowski was providing. As to Dr. Koslowski‘s alleged failure to inquire as to P.T.‘s psychological condition, it must be remembered that P.T. was not always the most forthcoming of patients. She kept even Dr. Eye in the dark as to her psychiatric treatment. She would not allow her mental health providers to discuss her case with the physicians who were treating her arm. It is questionable whether further inquiries by Dr. Koslowski would have provided any information of use in his treatment of P.T. The Department‘s evidence did not establish that P.T. manipulated the wound on her right arm. There was reason to suspect that she might be engaged in self-harm, but none of P.T.‘s direct providers believed that she was doing so. In any event, Dr. Koslowski‘s treatment addressed pain and spasm caused by an ulnar neuropathy that was a consequence of the wound. He did not treat the wound itself; indeed, Dr. Koslowski testified that he could not recall ever examining the wound. Whether P.T. was manipulating the wound would have been at most of tangential concern to Dr. Koslowski. The Department alleged but failed to prove that P.T. was exaggerating her reports of pain and faking the spasms in her right hand. The Department‘s only argument on this point is that pain is subjective and that P.T.‘s reports should not be believed. The unanimous testimony of her treating physicians that the pain and spasm were genuine sufficiently disposes of this argument. The Department‘s EMA and peer reviewers were far less than convincing. Faced with the clear evidence that the Botox injections provided pain relief and restoration of function to P.T., the Department‘s experts were reduced to focusing on Dr. Koslowski‘s use of the term ?spasticity,? on Dr. Koslowski‘s reports of relaxation after the injections, and on the fact that Dr. Koslowski‘s use of Botox was off-label. None of the Department‘s experts adequately addressed the fact that P.T.‘s other treating providers unanimously supported Dr. Koslowski‘s treatments, or the fact that Dr. Pulley also performed the Botox injections. This is not even to mention the careless misreading and non-reading of the medical records or the misstatements of fact in which the Department‘s experts engaged, which alone were sufficient to disqualify the testimony of Dr. Miranda and to significantly impair the credibility of Dr. Yaffe. As indicated in the discussion of the self-harm issue, much of the evidence presented at the hearing would have been more appropriate to a proceeding against Dr. Eye or the other providers involved in direct treatment of P.T.‘s wound, rather than a proceeding against Dr. Koslowski, a bit player in the P.T. saga whose chief mistake appears to have been not agreeing to settle with USIS. The Department‘s investigation appears to have consisted of little more than accepting at face value the materials provided by the attorney for USIS, then hiring Dr. Yaffe to render an expert advisory opinion based on those materials. Nothing prevented the Department from undertaking a critical review of the USIS materials and discovering for itself the manifold errors that are set forth in the above findings. USIS clearly had business reasons for seeking to punish Dr. Koslowski while declining to pursue action against other physicians who were much more deeply involved in P.T.‘s treatment. The Department, however, should have better reasons for prosecuting a case than the fact that a physician would not accept an insurance company‘s settlement offer.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Financial Services, Division of Workers‘ Compensation, enter a final order dismissing the Notice of Intent. DONE AND ENTERED this 15th day of November, 2013, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON 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 15th day of November, 2013.
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.
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.
Recommendation Based upon the findings of fact and conclusions of law recited above, it is recommended that the respondent's determination to deny petitioner's application for a certificate of need to institute radiation therapy facilities at its hospital be AFFIRMED. Respectfully submitted and entered this 9th day of June, 1977, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Art Forehand, Administrator Office of Community Medical Facilities 1323 Winewood Boulevard Tallahassee, Florida 32301 Richard R. Paige, Esquire Paige and Catlin Alfred I. DuPont Building Miami, Florida 33131 Eric J. Haugdahl, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Sheldon M. Simons, Esquire Professional Building 3661 South Miami Avenue Miami, Florida 33133 Alex Hofrichter, Esquire Carey, Dwyer, Cole, Selwood and Bernard Post Office Box 450888 Miami, Florida 33145
The Issue 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
