The Issue Whether the medical services prescribed for the Petitioner are experimental or investigative under terms of the state insurance contract, and excluded from coverage.
Findings Of Fact The Petitioner, John M. Compton, is 55 years of age, and has been an employee of the State of Florida for 21 years and 2 months. Mr. Compton is a participant in the State of Florida Employees' Group Health Self Insurance Plan (Group Plan), and entitled to coverage in accordance with the provisions of the Group Plan. The Respondent is the Division of State Employees' Insurance, Department of Management Services (Department) which is charged with the administration of the Group Plan. BCBS is the contract administrative agency for the Group Plan, and makes recommendations to the Administrator regarding covered procedures. In February 1992, the Petitioner was diagnosed by Dr. Mark Currie, a physician who specializes in treatment of diseases of the blood and cancer, with multiple myeloma, a form of cancer which attacks the blood and bone marrow. Dr. Currie treated the Petitioner using chemotherapy with good results; however, recognizing that the prescribed chemotherapy would be effective for a finite, but unknown period of time, Dr. Currie suggested intensive chemotherapy treatment with stem cell support upon relapse. Stem cell support is another term for bone marrow transplants which today includes withdrawing the blood from the donor, extracting the stem cells which form bone marrow cells, freezing these cells, and reintroducing them into the donor. This would be done after the Petitioner had had high dose chemotherapy which would kill his existing bone marrow. Chemotherapy utilizing the drugs which would be used in this procedure has been conducted for many years and the maximum dosages, maximum toxicity, and similar information have been investigated and studied in trials which have been concluded. This therapy is standardized treatment of the type administered by Dr. Currie and presumably covered by the plan. Bone marrow transplants using the procedure described above is a relatively new procedure, compared with the chemotherapy, but has been performed for four to five years and has been accepted as a standard treatment. Dr. Currie referred the Petitioner to Dr. Robert Joyce at Baptist for assessment as a subject for treatment upon relapse using a combination of the two procedures described in paragraphs 5, 6, and 7, above. Dr. Joyce is a physician experienced in bone marrow research and the treatment of diseases of the blood and bone marrow using chemotherapy and bond marrow transplants. Dr. Joyce was the principal investigator and primary physician in the program to which the Petitioner was referred. After examination, testing and an initial series of chemotherapy using the drugs used in the high dose therapy, Dr. Joyce determined that the Petitioner is an excellent candidate for this procedure because he does not have many of the diseased cells in his system and they are destroyed by the drugs used in the chemotherapy. For the maximum benefit, the procedure must be undertaken before the number of diseased cells increase in the Petitioner's system. This is what creates the urgency in these proceedings. Dr. Joyce requested a predetermination of coverage for the proposed procedure from the Group Plan's administration, BCBS, which recommended to the Group Plan's Administrator that the coverage was excluded as investigative or experimental. See Subsection G.28 of the Insurance Plan Benefit Document, Respondent's Exhibit 3. By letter dated March 15, 1995, the administrator denied coverage. The denial letter states erroneously that the proposed procedure is a Phase II investigation, which gave rise to efforts at hearing to show that the proposed procedure was not a Phase I, II or III investigation or experiment. The benefit document, Respondent's Exhibit 3, defines "Experimental or Investigative" as meaning: . . . any evaluation, treatment, therapy, or device which involves the application, admin- istration or use, of procedures, techniques, equipment, supplies, products, remedies, vaccines, biological products, drugs, pharmaceuticals, or chemical compounds if, as recommended by the Servicing Agent and determined by the Administrator: such evaluation, treatment, therapy, or device cannot be lawfully marketed without approval of the United States Food and Drug Administration or the Florida Department of Health and Rehabi- litative Services and approval for marketing has not, in fact, been given at the time such is furnished to the Insured; such evaluation, treatment, therapy, or device is the subject of an ongoing Phase I, II, or III clinical investigation or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the condition in question; that the consensus of opinion among experts is that further studies, research, or clinical investigations are necessary to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the Condition in question; that such evaluation, treatment, therapy, or device has not been proven safe and effective for treatment of the condition in question, as evidenced in the most recently published medical literature in the United States, Canada, or Great Britain, using generally accepted scientific, medical, or public health methodologies or statistical practices; there is no consensus among practicing Physicians that the treatment, therapy, or device is safe and effective for the condition in question; or such evaluation, treatment, therapy, or device is not the standard treatment, therapy or device utilized by practicing Physicians in treating other patients with the same or similar condition. The testimony of Dr. Currie and of Dr. Joyce established that this procedure was not a Phase I, II, or III investigation; that this procedure is safe and effective within the acceptable limits of such therapies; and that there is a consensus that the procedure is safe and effective for the condition. The testimony of Dr. Joyce established that under the protocols under which the Petitioner would received the proposed treatment, information would be gathered on toxicity and on the efficacy of this treatment compared with current treatments. Deposition of Dr. Joyce, Page 113, line 9. The evidence also establishes that the treatment proposed is not the "standard" treatment for this disease. See Petitioner's Exhibit 8, Letter of September 28, 1994, Dr. Joyce to Dr. McLear attached to letter dated October 13, 1994, Dr. McLear to Dr. Joyce. Although these conditions do not define the treatment as even a Phase IV investigation, it does place the treatment within the exclusions (b) and (c) cited in Paragraph 11, above.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is, RECOMMENDED: That the proposed procedure be excluded under the terms of the State Group Plan. DONE and ENTERED this 13th day of April, 1995, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of April, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's Proposed Findings Paragraphs 1-9 Adopted and subsumed in paragraphs 1-8. Paragraphs 10-15 Adopted and subsumed in paragraphs 9-11. Paragraph 16 True, the plan does not name any specific procedure. Paragraph 17,18 There is no presumption regarding the proposed procedure as experimental. Paragraph 19,20 True, but unnecessary to resolve the legal and factual dispute. Paragraph 21-37 Subsumed in paragraph 12. Paragraph 38 Subsumed in paragraph 8. Paragraph 39 The study shows that the treatment is accepted as safe and effective, but does not address the issue of whether it is experimental. Further, the exclusion is not based upon the experimental nature of the procedure, but upon the fact that it would be excluded under specific language of the benefit plan. Paragraph 40,41 See comments to Paragraph 21. Paragraph 42-43 See comments to Paragraph 39. Paragraph 44 Subsumed in paragraphs 6,7. Paragraph 45-49 True, but not required for a determination of the issue. Paragraph 50 Subsumed in paragraph 8. Paragraph 51 Rejected as contrary to best evidence. Paragraph 52 Subsumed in paragraph 12. Paragraph 53-55 Rejected as argument. Paragraph 56 0True, but not required for a determination of the issue. Respondent's Proposed Findings Paragraphs 1-5 Paragraphs 1-4. Paragraphs 6,7 Not necessary for determination of the issue. Paragraphs 8-13 Paragraphs 3-8. Paragraphs 12 Deleted by Respondent. Paragraphs 14,15,16 Paragraphs 9-11. Paragraph 17 Paragraph 8. Paragraph 18 True, but not necessary for determination of the issue. The evidence tends to show that, notwithstanding the newness of the procedure, it is rapidly being accepted as the procedure of choice in treatment of this type of disease. Paragraph 19-23 Irrelevant. Paragraph 24 The information quoted is quoted from another source attributable to Dr. Joyce. Paragraph 25 Supports finding that the treatment is not standard, but is rejected for the purpose that it was apparently offered. Paragraph 26-29 Irrelevant. Paragraph 30,31 Conclusion of Law. Paragraph 32 Subsumed in findings that proposed procedure in not the standard treatment. Paragraph 33-39 Irrelevant. Paragraph 40 See comments to paragraph 32. Paragraph 41,42 Irrelevant. COPIES FURNISHED: Robert D. Newell, Jr., Esquire 817 North Gadsden Street Tallahassee, FL 32303 Augustus D. Aikens, Jr., Chief Benefit Programs and Legal Services Division of State Employees' Insurance 2002 Old St. Augustine Road, B-12 Tallahassee, FL 32301-4876 William H. Lindner, Secretary Department of Management Services Knight Building, Suite 307 Koger Executive Center 2737 Centerview Drive Tallahassee, FL 32399-0950 Paul A. Rowell, General Counsel Department of Management Services Knight Building, Suite 312 Koger Executive Center 2737 Centerview Drive Tallahassee, FL 32399-0950
The Issue The issue is whether Respondent is guilty of departing from the applicable standard of care, failing to keep adequate medical records, or making deceptive, untrue, or fraudulent representations in the practice of medicine and, if so, what penalty should be imposed.
Findings Of Fact Respondent has been a licensed physician in Florida continuously since August 30, 1983. His license number is ME 0042770. Respondent has never been disciplined and has, since the events described below, attended a course on the preparation of medical records. Respondent has been Board Certified in Family Practice since 1995. He specializes in the area of family practice and maintains his office in the Naples Medical Center in Naples. T. M., who was born on June 13, 1951, presented to Respondent for the first time on April 3, 1991. She had seen other physicians at the Naples Medical Center, but not Respondent. She had last visited the Naples Medical Center on February 25, 1988. T. M. had several purposes in her first visit with Respondent. First, she wanted to establish herself as a patient of Respondent following the retirement of her previous physician. Second, she wanted a prescription for Premarin following an earlier hysterectomy. Third, she wanted to determine if she had any need for a PAP smear. T. M. completed a patient questionnaire during the April 3 office visit. In her answers, T. M. affirmed that she had had "hemorrhoids or rectal bleeding," but she underlined only "hemorrhoids." She denied any colitis or other bowel disease, constipation or diarrhea, or recent change in bowel action or stools. T. M.'s testimony that she was experiencing a feeling of pressure in her bowels and felt the need to have a bowel movement when she did not need to have one is not credited. It is inconsistent with the history, as discussed below, that T. M. related to Respondent's office on her second office visit and later to Dr. Cooper. In the medical records for the April 3 office visit, Respondent noted that he reviewed T. M.'s chart and discussed her physical, "etc." The notes state that Respondent found no need for a PAP smear due to prior hysterectomy and bilateral salpingo- oophorectomy. The notes add that T. M. daily uses Premarin, which replaces estrogen, that she is not cycling, and that she will return to the office as needed. The notes report that T. M. will return to the office as needed. The notes record that T. M. will need a mammogram this year and that Respondent is refilling her Premarin prescription. These are Respondent's original medical records for T. M. As noted below, following Respondent's discovery that another physician had detected colo-rectal cancer in T. M. in January 1992, Respondent made additions to his notes. He did not date the additions to show that they were added months after the original notes. At the top of the notes, Respondent added: "Needs prescription--refill Premarin." After "etc.," Respondent added: "Family history of cancer + preventative care." Immediately preceding "RTO PRN" (which means return to office as needed), Respondent added: "Wants to." Immediately after this shorthand notation, Respondent added: "+ will call to reschedule." Adding the number 1 to the mammogram note and the number 3 to the refill Premarin note, Respondent also inserted a number 2, which states: "labs + physical this year." Within a few weeks of this initial office visit, T. M. began to experience problems with her bowels in the form of rectal bleeding and the feeling of pressure, as though she had to have a bowel movement or urinate when she did not. In June 1991, T. M. set up an appointment for June 28. By this time, T. M. was finding red blood in her stool and when she wiped her rectum with toilet paper. She told the nurse that she had been experiencing this problem for two months. The nurse recorded T. M.'s report of blood in her stool and the feeling of needing to move her bowels when she did not really need to do so. Respondent noted in the medical records: "Tenesmus." "Tenesmus" is the sensation of an urge to have a bowel movement. Under "tenesmus," Respondent wrote: "Bleeding + urgency urination." At this point, Respondent correctly commenced the process of diagnosis, rather than screening which is the performance of a test on an asymptomatic population. T. M. presented with specific complaints and symptoms that required diagnosis; by the second visit, she had self-screened. T. M.'s relevant history was that family members had had cancer, but not colon cancer. She had had hemorrhoids, but only during her two pregnancies. Respondent performed a focused examination to determine the source of T. M.'s complaints. Respondent conducted a urinalysis to rule out a urinary tract infection. The urinalysis was negative. Respondent next performed an anoscopy. An anoscope is a funnel-like instrument 4-6 inches long that is inserted into the anus. A separate light source allows the physician to observe the anus and rectum, just past the anal verge, for a total distance of about 6 centimeters. Respondent placed his finger into T. M.'s anus, but not for the purpose of conducting a digital rectal examination. A physician conducting an anoscopic examination first inserts a finger into the anus in order to relax the sphincter and confirm the absence of any blockages that would prevent the insertion of the anoscope. Consistent even with Respondent's augmented records, Respondent performed no separate digital examination of T. M.'s rectum. The purpose of the digital rectal examination is to feel the contour of the rectal wall for bumps, irregularities, or areas of unusual consistency. Although the location of T. M.'s cancerous lesion would have been within reach of a digital examination, the record does not establish that that anything would have been discoverable at the time of the June 28 office visit. Testimony to this effect from Petitioner's expert witness, Dr. Thomas Hicks, did not establish clear and convincing proof because, despite Dr. Hicks' evident competence, of his expertise in family medicine, rather than oncology, and the difficulty of determining, in hindsight, the likely size of cancerous lesions based on their condition months later after surgical intervention. The parties discuss in their proposed recommended orders Respondent's failure to document a digital rectal examination, but their shared assumption--that one took place--is unwarranted. The failure to perform a digital rectal examination raises a question as to Respondent's conformance with the applicable standard of care, but the real standard-of-care issue is Respondent's handling of the preparation of a treatment plan. As Dr. Hicks' testified, the timely preparation of a treatment plan would have satisfied all standard-of-care issues, despite the failure to perform a digital rectal examination. The situation is similar as to the performance of a hemocult blood test. Respondent's testimony that he performed one is rejected as a fabrication. The records reflect no such test. The failure of the medical records to document the hemocult blood test is thus explained by the failure of Respondent to conduct this test. The anoscopy was negative. Respondent recorded in his medical records: "Anoscope + Hemorrhoids. No clots." Following the anoscopy, Respondent tentatively diagnosed T. M. as suffering from hemorrhoids. However, Respondent set up an appointment for T. M. to return to the office for a sigmoidoscopy, which would allow examination of the lower intestine above the area examined by the anoscope. Respondent made undated additions to the medical records for the June 28 office visit. Below the recorded findings from the anoscopy, Respondent later added: "Wall color looks OK." In the original record, Respondent concluded the entries with documentation that he prescribed Anusol and stool softener and would perform a "Sigmoid to [check mark] higher up." The relevant changes were to write "Plan" beside these notes, number the three steps, and add "for malignancy" after "higher up." On July 2, 1991, T. M. visited Respondent's office so that he could conduct a sigmoidoscopy. This examination involves the insertion of a flexible tube, with its own light source, through the anus and rectum and into the sigmoid colon up to 60 centimeters for observation of the rectum and sigmoid colon. Respondent was able to insert the sigmoidscope 45 centimeters, which was adequate. He detected a spastic colon, hemorrhoids, and diverticuli, but no lesions or strictures. The absence of lesions or strictures is an indicator of the absence of precancerous or cancerous conditions. The findings of the sigmoidoscopy were thus consistent with Respondent's working diagnosis of hemorrhoids. Respondent again made undated additions to T. M.'s medical records, but the additions are unremarkable augmentations to the original notes, which adequately described the findings of the sigmoidoscopy. Following the June and July office visits, T. M.'s symptoms worsened. She began bleeding between bowel movements and was losing more blood. She felt tired all the time. She continued to feel pressure in the area of her rectum. Respondent discussed with T. M. her symptoms. He learned that she experienced some constipation, but no spasms, no feeling of a foreign body in her anus, and no abdominal or urinary tract pain. Respondent noted these findings in T. M.'s medical records. For the September 24 office visit, the medical records reflect the above-described discussion together with Respondent's recommendation that T. M. take a stool softener. Respondent later added notes showing that he reviewed the findings of the sigmoidoscopy. In the space between two lines in the original records, Respondent added: "She may need colonoscopy + referred to GI." Other additions immaterially expanded on the original notes. At the bottom of the note for this office visit, Respondent added: "To GI soon if not resolved. She will call." Respondent produced a "super bill" for the September 24 office visit. The bottom of the bill contains a block for the next appointment. The lower left-hand corner of the block states "wait." The remainder of the block states: "Appt. Dr. K. Hussey. Reason: rectal bleeding. Needs colonoscopy." Beneath this block at the very bottom of the page is the following statement: "(She will call us)." T. M. did not have her copy of this super bill. Nothing in the record suggests that, when requested to provide T. M.'s medical records to the New York physician, Respondent's office sent a copy of the super bill, which Respondent unsuccessfully contends is part of T. M.'s medical records. While notations on super bills that do not functionally assist in the process of ensuring continuity of care do not qualify as medical records, the other question concerning the super bill is whether it serves as contemporaneous documentation of Respondent's recommendation that T. M. consult a gastroenterologist. Respondent's readiness to add undated entries to T. M.'s medical records inspires no confidence in the self- serving note contained at the bottom of the super bill. To the contrary, given the succinctness of Respondent's unaltered medical records, it is unlikely that Respondent would take the time, on a bill, to write in the reason for the appointment with Dr. Hussey and the need for a colonoscopy. The parenthetical comment that T. M. will call Respondent's office renders these entries even more suspicious. A preponderance of the evidence, but not clear and convincing evidence, suggests that these entries on the super bill are also undated additions following Respondent's discovery that T. M. had rectal cancer. T. M. did not return to Respondent. Instead, while visiting her brother-in-law, who is a physician, in New York over Christmas, she scheduled an appointment on December 27, 1991, with a gastroenterologist who practiced with the brother-in-law. The physician performed a digital rectal examination and found a firm irregular area on the anterior wall of the rectum. A sigmoidoscopy revealed a large ulcerated lesion approximately 2 to 3 centimeters above the anal verge. After additional diagnostic work, a surgeon removed the lesion and performed a permanent colostomy in early January 1992. Petitioner contends in its Proposed Recommended Order that Respondent deviated from the applicable standard of care when he did not order a complete blood count during the September 24 office visit. However, Dr. Hicks accurately defined the issue when he testified that the complete blood count, as was the case with the omission of a digital rectal examination on the June 28 office visit, would not have represented a departure from the applicable standard of care if Respondent had timely prepared a treatment plan. The issue of the timeliness of the preparation of a treatment plan arises as of the September 24 office visit. Dr. Hicks' testimony precludes a finding that the failure to develop a treatment plan to pursue an alternative to the working diagnosis of hemorrhoids was a departure from the applicable standard of care any earlier than the September 24 office visit. As of the September 24 office visit, though, Respondent had three alternatives. He could either perform sufficient diagnostic tests to explore T. M.'s ongoing symptoms, he could refer her to a gastroenterologist, or he could briefly continue treatment of hemorrhoids. There is no dispute that Respondent attempted further diagnostic tests after the September 24 office visit; he did not do so. Respondent contends that he continued treatment of the hemorrhoids. There is a brief note on December 2, 1991, that T. M. received a prescription to control bowel spasms. However, Respondent's nurse evidently prescribed this medication on her own, and the spasms were not shown to be linked to hemorrhoids. To the contrary, Respondent testified that he felt that her problem at the September 24 office visit was likely constipation, which could aggravate the hemorrhoids. There is no evidence that Respondent elected, at the end of the September 24 office visit, to briefly continue treating hemorrhoids; if nothing else, Respondent's contentions about a gastroenterological referral tend to undermine further treatment by him of hemorrhoids. There is no dispute that Respondent could have met the applicable standard of care by referring T. M. to a gastroenterologist at the end of the September 24 office visit. However, the evidence is clear and convincing, despite Respondent's testimony and other evidence to the contrary, that he did not do so. This finding is based partly on the testimony of T. M., whose recall of her visits with Respondent and her visit with Dr. Cooper is obviously imprecise and sometimes inaccurate. This finding is also based on a close assessment of the evidence offered by Respondent to support his contention that he made a referral. Assessment of Respondent's contention of a referral begins with close examination of the already-noted entry, "She may need colonoscopy + referral to GI." This entry does not evidence a recommendation of a consultation, but rather mentions the possibility that a consultation might take place in the future. On January 10, 1992, T. M.'s mother called Respondent and informed him of T. M.'s rectal cancer surgery. At this time, Respondent, who was unaware that his office had already supplied a copy of T. M.'s original medical records to her New York physician, made all of the above-described changes in the medical records, plus another, properly dated entry, which states: "I recommended GI at last visit for a check-up or a colonoscopy but she did not schedule." However, despite the fact that Respondent made these two notes on the same date, they reveal a significant discrepancy. Unlike the added note for September 24, which refers to a future referral, the note for January 10 refers to an actual referral. In a deposition taken four years after the surgery, Respondent gave a more elaborate version of whether he made a referral during the September 24 office visit and reveals the same variation between an actual referral and a possible referral in the future. Taken for a pending medical malpractice action that T. M. had brought against Respondent, the deposition testimony states: Q. You would agree with me, sir, if you failed to get her to see a doctor other than yourself to get this problem checked out that that would have been a breach in the standard of care? A. If I failed to what? Q. If you failed to send her to a doctor--if you said, T[.], you need to get somebody to check this out, I want you to go get this checked out, then you would have breached the standard of care, wouldn't you, sir? A. If I told her to go somewhere? Q. If you failed to tell her. A. I would agree. * * * Q. All right. Did you suspect in your differential diagnosis on 9-24-91 when she came in that could be rectal cancer? Was that in your differential diagnosis? A. Yes, it could have been. Q. Okay. When you told her that you--I assume that you told her then--it's your contention you told her at that time you could have rectal cancer; correct? A. No. Q. You didn't tell her that? A. No. Q. Why not? A. Because--I mean, I told her that she needed to have this evaluated. That doesn't mean she has rectal cancer, to get it evaluated. Q. Well, what did you tell her if you suspected that she could have that and that was properly in your differential diagnosis to impress upon her the need to follow through, if anything? A. You mean to scare her into getting--into making an appointment? Q. Well, not to scare her. You didn't need to scare her to do it, did you? A. No. Q. Well, what did you say to her to get her to make the appointment? A. That she should--if this doesn't resolve, she should get an opinion from a gastroenterologist. Q. If this doesn't resolve; is that right? A. If this continues. Q. Okay. So if I understand what you're saying now, you didn't tell her you definitely need today to go get this. You told her, well, if it doesn't resolve, then you should see somebody--see a gastroenterologist? A. That why the-- Q. Am I correct? A. Well, I sort of let it--well, I didn't leave it at that, but it was--it was problem enough to get some other opinion. Q. Why was it problem enough to get some other opinion? A. Because it's been so persistent. * * * Q. What do you mean, because it's been so persistent? A. Well, the complaint has been going on for months. Q. Okay. And what about that persistency that this complaint's been going on for months made it difficult to have her go see somebody else? A. Well, it wasn't that. It was--I think it was her hesitance to make an appointment, whether to have something done or not or to have an operation or to have, you know, the hemorrhoids looked at. It wasn't that type of thing that she was looking forward to, so we sort of put a wait on it. We didn't go through with making the appointment. Q. Okay. When you say we put a wait on it, then this was something you discussed? A. Right. Q. And she—what did she say that gave you the impression that she wanted to wait? A. Well, she was--you know, she was upset about the whole thing. Q. Okay, because it had been going on so long? A. Right. Q. And you said-- A. Then--then about the other--then going to another physician, of having a specialist-- specialist look at her to do a procedure, you know, the same type of procedure except it would be more thorough, more--you know, a colonoscopy and possibly some procedure like a surgical procedure. Q. Well, was it your belief on 9-24-91 that it could, in fact, be just simply hemorrhoids? A. It was possible, but that--that wasn't--I mean, there was hemorrhoids, but that might not have been the reason for all her problems. Q. Did you ever say to her, T[.], the persistence of this problem leads me to believe that it might be something other than hemorrhoids? Did you ever say anything like that to her? A. Yes. But I did not mention malignancy or anything like that. Q. Were you trying to convince her to go get another opinion or another examination? A. No. I mean, I didn't. Q. Why not? A. Right now I don't recall why not, but-- Q. Okay. (Petitioner Exhibit 5, pages 117-22.) Each of Respondent's recountings of his discussion with T. M. on September 24 varies with regard to whether he recommended a referral or merely discussed the possibility of a referral in the future. The thrust of the deposition testimony is essentially is that Respondent was concerned about the possibility of rectal cancer and wanted T. M. to see a gastroenterologist, that T. M. resisted this recommendation, and that, in the face of this resistance, Respondent did not voice his concern about the need to rule out rectal cancer. This testimony is simply not credible. If he were making a firm recommendation of a referral, he would have voiced his explicit concerns, even if only as to the necessity at this time to rule out these more serious possibilities. If Respondent discussed a referral with T. M. at all, he mentioned nothing more than the possibility of a referral at some point in the future; interestingly, this is consistent with the additions to the September 24 medical records. Thus, the evidence is clear and convincing that Respondent did not refer T. M. to a gastroenterologist at the end of the September 24 office visit. The evidence is clear and convincing that Respondent did not prepare any other form of treatment plan, besides a referral, that would meet the applicable standard of care. As for the fraudulent alteration of medical records, the first question is whether Respondent discussed even a future referral with T. M. during her September 24 office visit. It is a close question, but the evidence is less than clear and convincing that Respondent did not discuss even the possibility of a future referral, just as the evidence is less than clear and convincing that Respondent fabricated the note on the super bill. However, the evidence is clear and convincing that the January 10 note fraudulently claims that Respondent recommended a gastroenterological consultation for a check-up and colonoscopy, but T. M. did not schedule an appointment. As for whether the medical records justify the scope and course of treatment, this issue is subsumed in the standard- of-care and fraudulent-records issues. To the extent that the records (i.e., September 24 entry) fail to reflect a clear referral to a gastroenterologist or alternative treatment plan, they do not justify the scope and course of treatment, but this issue is covered by the standard-of-care issue. To the extent that the records (i.e., January 10 entry) are fraudulent, this issue is covered by the fraudulent-record issue.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of one violation of Section 458.331(1)(t) and 458.331(1)(k), but not Section 458.331(1)(m), and imposing the following penalties for these two violations: 30 days' suspension followed by two years' probation, ten hours of continuing medical education in ethics, and a $10,000 fine. DONE AND ENTERED this 2nd day of April, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of April, 1999. COPIES FURNISHED: Kristina L. Sutter John Terrel Senior Attorneys Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Grover C. Freeman Jon M. Pellett Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether osteochondral autograft transplant surgery should be authorized for Petitioner pursuant to Workers' Compensation Law.
Findings Of Fact In 1998, Jackson fell at work and sustained an injury to her left knee. Jackson made a workers' compensation claim for the treatment of the injuries. She underwent treatment for her injuries, and her treating physician requested authorization from Jackson's Employer/Carrier to perform a surgical procedure commonly referred to by the trade name of OATS, but also known as mosaicplasty. The Employer/Carrier denied the authorization on the ground that OATS was investigative or experimental within the meaning of Rule 59B-11.002, Florida Administrative Code, and referred the request to the Agency for a determination under Section 440.13(1)(m), Florida Statutes, and Rule 59B-11.002(4), Florida Administrative Code. The Agency requested Dr. B. Hudson Berrey, the Chair of the Department of Orthopedics and Rehabilitation at Shands Hospital and Clinic at the University of Florida, to review Jackson's case to determine whether the procedure was investigative and whether the procedure would provide significant benefits to the recovery and well-being of Jackson. Dr. Berrey has been board certified in orthopedic surgery since 1982. After three years of practice, he took a fellowship in orthopedic oncology at Massachusetts General Hospital in Boston, Massachusetts. He then served as Chief of Orthopedic Oncology and, later, as Chief of Orthopedic Surgery at Walter Reed Army Medical Center in Washington, D. C. After his retirement in 1993, he served on the faculty of the University of Texas Southwestern Medical Center. He has been the Chair of the Department of Orthopedics and Rehabilitation at the University of Florida College of Medicine since 1996. In addition to his teaching duties, he continues to see patients weekly and to perform orthopedic surgery twice a week. His duties require him to keep abreast of developments in the field of orthopedic surgery. In preparation for rendering his opinion for the Agency, Dr. Berrey reviewed the medical literature, seeking articles discussing clinical trials of OATS. A clinical trial is an investigation in which patients with a certain condition may receive a treatment under study if they meet certain objective standards for inclusion. The treatment parameters are defined and outcomes are assessed according to objective criteria. Dr. Berrey found very little in peer-reviewed literature discussing clinical trials of OATS or mosiacplasty. Instead he found retrospective reviews and case reports. Based on his review of the medical literature, Dr. Berrey formed the opinion that mosaicplasty may be safe and efficacious; however, because the procedure has not been subjected to clinical trials, the procedure remains investigative. OATS involves the transfer of a patient's cartilage from one portion of the knee that is not considered weight- bearing or that is considered as having a minimal weight-bearing load to an area that receives greater force or is more weight- bearing. Dr. Berrey is of the opinion that OATS may be effective to treat isolated chondral defects on the weight- bearing surface of the knee. He describes the type of injury for which the procedure is effective as a focal lesion in an otherwise normal knee. Three components comprise the knee: the patella, the femoral articulating surface, or femoral condyle, and the tibial articulating surface or tibial plateau. The femoral condyle and tibial plateau are bony structures lined with articular cartilage that provide the gliding surface of the knee. The patella articulates with the femur at the patellar femoral joint, and the tibia articulates with the femur at the tibial femoral joint. The tibial femoral joint is made up of medial and lateral components. Other structures present in and about the knee include the menisici, the cruciate ligaments, and the collateral ligaments. Jackson's medical records, including the MRI report, show that there is a subchondral cyst and/or osteochondral defect on the anterior articular margin of the mid-media femoral condyle. There are subchondral cysts along the posterior portion of the mid-tibial plateau. In addition, there is a prominent osteochondral defect involving the patella. Jackson has articular damage to all three compartments of the knee: the femoral condyle, the patella, and the tibial plateau. Based on the degenerative changes in all three compartments of the knee, Jackson's changes are probably generalized. She does not have a focal defect of the articular cartilage of the knee. Her symptoms relate primarily to the patellar femoral joint. Her medical records describe her injuries as including chondromalacia of the patella. The term "chondromalacia" applies to a continuum of deterioration of the articular cartilage of the patella, from softening to frank fraying to fibrillation where the cartilage may be worn down to the bare bone. OATS or mosiacplasty is designed to address a localized, focal lesion. Because of the generalized nature of the diseased condition of Jackson's knee and the probability that her symptoms are related to the deterioration of her patellar femoral joint, the proposed procedure is not likely to improve her condition or to enable her to return to work.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying authorization for the OATS or mosaicplasty to be performed on Virginia Jackson. DONE AND ENTERED this 14th day of June, 2000, 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 14th day of June, 2000. COPIES FURNISHED: Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Building 3, Suite 3421 Tallahassee, Florida 32308-5403 Virginia Jackson 5555 Northwest 17th Avenue Apartment 2 Miami, Florida 33142 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403 Julie Gallagher, General Counsel Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue The issue to be resolved in this proceeding concerns whether the Respondent's medical licensure should be subjected to discipline for the reasons asserted in the Administrative Complaint, involving his alleged malpractice concerning patient, E.L.
Findings Of Fact The Respondent at all times material hereto has been a licensed physician in the State of Florida, having been issued License No. ME0030859. The Respondent practices at 1800 N.E. Street, Suite 521, Pensacola, Florida 32501. The Petitioner is an agency of the State of Florida. It is charged by the Legislature, as pertinent hereto, with enforcing the provisions of Chapter 458, Florida Statutes, and related rules, pertaining to the regulation of licensure and the quality of practice of medical doctors within the State of Florida. The Respondent is a board-certified dermatologist, practicing that specialty in the State of Florida in excess of 15 years. There is no evidence of any prior disciplinary action against the Respondent's licensure nor of any prior instance when his practice failed to conform to appropriate professional standards. In the course of his practice, the Respondent sometimes does his own microscopic pathological examination of tissue samples taken from patients (biopsies) on occasions when he deems it appropriate and that a consulting opinion is not required. It is undisputed by the parties that a dermatologist such as the Respondent, who had extensive training in dermatopathology during his medical education, can appropriately do such biopsy work within the standard of care of a reasonable physician practicing under similar conditions and circumstances. If he does so, however, he is held to the standard of a dermatopathologist in the course of his professional practice. The Respondent treated E.L. (an 80-year-old male patient at times pertinent hereto) since approximately 1982 for various problems involving pathology of the skin, including skin carcinoma. On November 21, 1991, E.L. presented as a patient of the Respondent showing a crusty area measuring approximately 1 x 2 centimeters on the vertex of his scalp or the back of his head. The lesion in question appeared on the skin with a hard crust, whitish or yellowish in color, and the Respondent diagnosed it as hypertrophic actinic keratosis. This is sometimes a pre-cancerous condition of the skin. Upon making his diagnosis, which he did clinically, without biopsy, the Respondent performed a curettage, or scraping of the tissue, to remove and destroy it. He did this by injecting the area with lidocaine as an anesthetic before performing the curettage. The Respondent had previously treated the same sort of condition on E.L. with liquid nitrogen but chose, this time, to treat the lesion with extension cautery and curettage. He did this because he was attempting to lessen the discomfort in his 80-year-old patient, who had already undergone a number of procedures to remove pre-cancerous or cancerous lesions of the skin on his head. The use of liquid nitrogen and the associated burning of the tissues involved would cause more difficult healing and discomfort for the patient. The treatment which the Respondent accorded the actinic keratosis condition, by curettage, is an acceptable, appropriate treatment for such a condition. It is undisputed by either the Petitioner's or the Respondent's expert witnesses, as well as the Respondent in his testimony, that such a clinical diagnosis and the following treatment by curettage is within the professional standard of care and practice by dermatologists practicing under similar conditions and circumstances. A biopsy is not a necessary prerequisite to such treatment. After the November 21, 1991 destruction of the skin lesion, the patient did not return for approximately one month. On December 19, 1991, he returned to the Respondent concerned about possible infection at the removal site. The Respondent, however, detected only granulation tissue, which are normal granular projections on the surface of a normally-healing wound. Consequently, there was no reason within the bounds of reasonable medical treatment standards for the Respondent to have biopsied the lesion area on that office visit occasion, either. Patient E.L. returned on January 3, 1992, at which point the Respondent noted a minor area of "dermatitis" or a non-cancerous inflammation of the skin, for which he prescribed a cortisone ointment. The Respondent did no biopsy at that time, either, and the clear and convincing evidence does not demonstrate that a biopsy was required under those conditions and circumstances within acceptable, reasonable bounds of the Respondent's professional practice. Patient E.L. returned to the Respondent on January 23, 1992 complaining of unsatisfactory progress with the healing of the lesion. The lesion by that time had become a rounded, raised growth with central cratering, characteristic of a keratoacanthoma. The Respondent examined the lesion or tumor clinically and determined that it appeared to be a keratoacanthoma. A keratoacanthoma is a rapidly-growing nodule with a central "crater", which then fills with a crusty material. It usually remains localized and most often resolves itself spontaneously, even if untreated. On very rare occasions does it become an aggressively-growing tumor. The Respondent biopsied the suspected keratoacanthoma by performing an excision of the area. He excised the nodule, taking a narrow margin of several millimeters around it and then performed a suture closure of the wound. He performed a biopsy of the tissue thus taken himself and interpreted the biopsy results approximately one week later as confirming his clinical diagnosis of a keratoacanthoma. Keratoacanthoma is regarded as a "low-grade" form of squamous cell carcinoma. The diagnosis is based upon a clinical observation with the naked eye, based upon history, as well as by pathological diagnosis. Conservative treatment is appropriate for a keratoacanthoma since they often resolve themselves spontaneously. Simple observation, surgical excision, curettage with or without electro-desiccation, radiation therapy, intra-lesional injection, and topical application of 5-fluorouracil and methotrexate are all acceptable forms of treatment for keratoacanthoma and can be reasonably expected to cure the condition. On rare occasions, keratoacanthoma can recur, even with such treatment. The diagnosis and treatment of keratoacanthoma is a matter of good- faith differences of opinion among reasonable dermatologists and pathologists, based upon their clinical judgment and experience. Some diagnose it as keratoacanthoma, which is a low-grade form of squamous cell carcinoma; and some diagnose it as squamous cell carcinoma with varying degrees of "differentiation". The photograph of the lesion as it was seen by the Respondent prior to the January 23, 1992 surgery shows a lesion consistent with the clinical appearance of a keratoacanthoma. The Respondent has been properly trained as a dermatologist in dermatopathology, and he commonly reviews biopsy and pathology slides. He is not required, under pertinent practice standards, to seek consultation when he believes that he has made a proper diagnosis. It was proper for him to read and review the pathology slide of the biopsy specimen, even though he himself acknowledges, as do the two expert witnesses, that he would be held to a dermatopathologist's professional practice standard by doing so. The Respondent opined that actinic keratosis developed into the keratoacanthoma. Dr. Breza, the Petitioner's expert witness, opined that actinic keratosis does not develop into keratoacanthoma but, rather, into squamous cell carcinoma. Even he acknowledged, however, that good pathologists have trouble making the diagnosis of keratoacanthoma and prefer generally to diagnosis such conditions as simply "low-grade" squamous cell carcinoma. Dr. Hanke, in his testimony, established that keratoacanthoma and squamous cell carcinoma are different gradients of diagnosis on the same continuum or range describing squamous cell carcinoma. That is, in lay terms, a keratoacanthoma is a "low-grade" squamous cell carcinoma. They are not precisely the same diagnosis, but both diagnoses describe the same general type of cells. As shown by Dr. Breza, squamous cell carcinoma tumors or lesions generally tend to appear somewhat flatter than that characteristic of a keratoacanthoma. Squamous cell carcinomas tend to be more indurated or firm on the outer edges and to have more inflammation on the outer edges, including occasional ulceration. The Respondent's description in E.L.'s medical record seems more consistent with squamous cell carcinoma, but the photographic images of the growth or lesion at issue, made at the time the biopsy and excision was performed, appear also consistent with keratoacanthoma. Based upon the information, including clinical appearance, that the Respondent had to consider in making his diagnosis and given that reasonable pathologists can differ concerning the gradients of diagnosis of squamous cell carcinoma (which includes keratoacanthoma), as shown by the expert testimony, the Respondent's diagnosis does not constitute a departure from appropriate, professional standards. The deficiency in the Respondent's practice in this instance began with the excision made on January 23, 1992. The Respondent took the tissue material from the excision for biopsy and, after pathological examination of the sample, diagnosed the nodule as keratoacanthoma. The Respondent, however, did not establish a "negative margin" for the excision. That is, the tissue removed had positive margins, especially the deep margin, which means that carcinoma cells could be observed on the surface of the piece of tissue removed. This means that the Respondent could not be assured that carcinoma cells did not remain in the tissue area surrounding the walls of the excision site because the margin of the excision around the nodule to be removed was not wide enough. The same slide and tissue sample which the Respondent used for biopsy in January 1992 was examined by a dermatopathologist, but not until some six months later, in July 1992. The dermatopathologist reported his opinion that the biopsy showed an "infiltrating squamous cell carcinoma with involvement of the lateral and deep margins." An infiltrating carcinoma implies that it is a more aggressive tumor than would be the case with a normal keratoacanthoma. The Respondent did not report those positive margins from the results of his excision and biopsy in January 1992. His testimony indicates that he may have seen them or been aware of them but did not make a larger incision in order to achieve a negative margin because of his concern about the complicated closure techniques that would be necessary. He was concerned with attendant additional discomfort to this elderly patient, as might be entailed with the possible use of grafting in order to make closure of the wound. He also seemed to discount the need to excise a larger margin because of his belief that he was dealing with a non-aggressive keratoacanthoma. In fact, however, the clear and convincing evidence shows that a larger margin wound could have been excised without the necessity for more elaborate techniques of closure and attendant discomfort to the patient. Moreover, it was established that even this elderly patient, with his attendant heart problems, could have tolerated a more elaborate excision of the tumor in question, since the procedure could still be done under low-risk local anesthesia in the Respondent's office. An infiltrating carcinoma is one which is more aggressive. It can move from its original location and infiltrate the skin and blood vessels, which can, in some cases, result in the tumor spreading via the blood stream or by infiltrating the lymphatic system, with migration to regional lymph nodes. The squamous cell carcinoma is not known for being a readily metastasizing form of cancer. It is known on some occasions to metastasize, however. The finding of positive margins on the pathological examination in July 1992 means that the tumor extended to the cut surface of the excision at the time of the January excision procedure from which that biopsy sample was taken. Thus, tumor cells remained in the patient's scalp after the January 1992 excision procedure. The finding of a positive margin requires that another margin be established, meaning that the physician must cut another level of tissue until normal skin (a negative margin) is revealed. This can be done by conventional surgery, by just a larger excision area being removed, or by "MOHS" surgery, which involves freezing sections of the excision area, with small portions of the suspicious area removed at a time and with attendant pathology examinations so that each "thread" of cancer cells can be removed with minimal damage to surrounding tissues and less attendant discomfort and healing problems associated with the resulting surgical wound. The patient could have tolerated either type of procedure in January 1992. The Respondent did not establish a negative margin, however. He only excised the carcinoma once. He stated that he was really seeking only a biopsy sample and that he considered the treatment by excision of the nodule itself and attendant scraping of the wound to be adequate as conservative treatment, to take care of what he believed to be a non-aggressive keratoacanthoma. This may be a correct assessment if the physician is certain that he is confronted with a non-aggressive, non-infiltrating keratoacanthoma. However, if positive margins to the excisional wound result, the patient is better served, and a successful treatment result much more likely, if all suspected carcinoma cells are removed at that time. If the Respondent knew of the positive margins to the excision and had made an additional excision to remove all positive margins, the provision of additional, more elaborate treatment techniques would not have been delayed for nearly six months and likely would have been unnecessary. The determination of the existence of positive margins, after the January 1992 excision procedure, should have caused him to remove additional tissue to obtain a safe, negative margin. That failure of care, in his capacity as a dermatopathologist, resulted in a six-month delay before the dermatopathologist, at Sacred Heart Hospital, identified the positive margins. He identified them on the Respondent's same January 1992 pathological slide, when he examined it in July 1992, after which radiation and further more radical treatment was attempted. Thus, the delay in treatment action, resulting from the delay in acting on the existence of positive margins by the Respondent, resulted in a six-month delay in appropriate treatment being provided the patient, which is a deviation from the accepted standard of care, as established by the testimony of Dr. Breza, which is accepted in this regard. Earlier determination (or acting on a determination) of the positive margins, after the January 1992 excision procedure would have alerted the Respondent that the excision procedure was unsuccessful and that further treatment was necessary. The patient's lesion occurred on a sun-damaged scalp. The Respondent had treated the patient repeatedly for sun-damaged skin problems, including carcinomas, in the past. Squamous cell carcinomas can be susceptible to mestastases, either regional or systemic when they are located on the scalp, although they are much less susceptible to such mestastases than if they are located on the lip or possibly the dorsal surface of the hand. The Respondent, as a board-certified dermatologist, knew or should have known that the scalp is an area of the body that can be susceptible to metastatic disease such as squamous cell carcinoma. The patient, as even acknowledged by the Respondent's expert, Dr. Hanke, was one with a high risk for developing skin cancer. In any event, after the excision procedure on January 23, 1992, the patient was seen on February 10, 1992 for removal of sutures and examination of the wound. It appeared to be healing nicely at the time, and the patient was advised to return to the Respondent in three months, unless a problem developed. The Respondent next saw the patient on April 6, 1992, when he complained of persistent pain at the excision and tumor site. This was treated by the Respondent by drainage, antibiotics, narcotic pain medications, and sleep- inducers. Later during the treatment regimen, in approximately May 1992, the Respondent felt that chemotherapy was indicated because apparently, the lesion had not been completely excised. Consequently, he prescribed injections of intralesional cortisone methotrexate and 5-fluorouracil. These, however, did not produce satisfactory healing or control of the pain. During April and May 1992, the Respondent saw the patient for complaints of persistent pain, poor healing, and drainage of the wound. On May 18, 1992, the Respondent performed a drainage of the lesion which had begun to show an abscess formation. An abscess formation is an indicator of squamous cell carcinoma, which should have been recognized by the Respondent. This should have alerted him that his diagnosis of simply keratoacanthoma was not correct, at least by that time. With the presence of these continuing and exacerbated problems with the wound site, the Respondent did not seek or perform further biopsy of the tumor site, despite continued complaints of persistent pain and further growth of the lesion between April and July 1992. The patient made 16 visits to the Respondent between April 1992 and July 14, 1992 for treatment and pain relief. During this time, little improvement occurred in the patient's condition, but no additional biopsy or consultation was requested or performed by the Respondent. The lack of improvement in E.L.'s condition during the period of April through July 1992 should have alerted the Respondent that something was incorrect about the patient's condition and that more extensive radical treatment would be necessary. In fact, the Respondent did respond to the continued complaints by, in addition to prescribing antibiotics and pain medication, prescribing the above- referenced intralesional injections of cortisone, methotrexate, and 5- fluorouracil. On July 9, 1992, another curettage procedure was performed and the pathology of the scrapings was sent for evaluation by a pathologist. The Respondent's interpretation of this tissue at the time apparently was a keratoacanthoma; well-differentiated squamous cell carcinoma. This was ultimately described by the pathologist to whom it was referred as a moderately- differentiated squamous cell carcinoma. Subsequently, after the C&D procedure, the patient was referred to Baptist Hospital in Pensacola, Florida, for radiation therapy. He received a full-course of radiation therapy with some booster therapy afterward and then, on his own volition, went for a second opinion to the University of South Alabama Medical Center in Mobile, Alabama. Five physicians at that facility recommended more extensive surgery, which ultimately the patient refused. There is no clear and convincing evidence that, at least at that point in the patient's progress, the persistent tumor had actually mestastized, although it was apparently growing locally. The fact that the lesion at issue was failing to heal and producing persistent pain by the visit of April 6, 1992 should have been interpreted so as to set in motion further investigative procedures, including an additional biopsy, to find out the reason for that condition and its persistence. Although a proper procedure involving excision and biopsy was done in January of 1992, the frozen sections of the lesion could have been interpreted to show that the tumor was an infiltrating carcinoma extending to the lateral and deep margins of the excision and something more aggressive could have been done to treat it at that time. It could have either been re-excised with frozen section control of the margins, referred to a "MOHS'" surgeon for a similar type of surgery or referred to a general surgeon. Radiation therapy could have been tried, at least by the time the persistence of the problem was determinable in April of 1992. The resultant reduction of delay in securing more extensive treatment of the lesion would have certainly benefited the patient. The persistence of the pain in the six-month period of time after the January 1992 excision of the tumor, until just before the time the patient was referred for radiation therapy indicates there was probably perineural invasion by the tumor (infiltration of the nerves), which produced pain. This should have alerted the Respondent that something more than a non-aggressive keratoacanthoma was involved, as well. In summary, it has been demonstrated that the Respondent failed to practice medicine within that level of care, skill and treatment recognized by reasonably prudent, similarly-situated physicians as acceptable under the circumstances, by failing to make an additional biopsy after the patient re- presented with problems associated with persistent pain and improper healing in April 1992; by failing to recognize and act on the presence of positive margins to the excision material taken in January 1992, to effect an additional excision at that time, so as to secure a safe, negative margin to the tumor. The failure to obtain consultation on the biopsy taken from a dermatopathologist was not in itself evidence of falling below appropriate professional levels of care, skill and treatment, but the Respondent, by doing his own interpretation of the biopsies was, as he agrees, creating a situation in which he would be held to the same standard as a dermatopathologist. The failure to correctly interpret the biopsy he took in January 1992, by failing to recognize the positive margins to the excised material and failing to act to remove those indicia of the continued presence of the tumor, at a time when it was thus easily excised, likely prevented an easily-effected cure.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is RECOMMENDED that the Respondent be found guilty of a violation of Section 458.331(1)(t), Florida Statutes, in the manner concluded above, and that the Respondent receive a private reprimand, a $2,000.00 fine, and that he be required to attend 20 additional hours of Category I continuing medical education in the area of diagnosis and treatment of skin cancer. DONE AND ENTERED this 30th day of October, 1995, in Tallahassee, Florida. P. MICHAEL RUFF, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of October, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3531 Petitioner's Proposed Findings of Fact 1-8. Accepted. 9-10. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not itself materially dispositive. Rejected, as contrary to the clear and convincing evidence. The evidence does not reflect that one biopsy sample only showed one part of the lesion at issue but, rather, several parts were represented. Accepted. Accepted, but not itself materially dispositive. 15-21. Accepted. 22-24. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 25-26. Accepted. 27. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 28-36. Accepted. 37-41. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 42-44. Accepted. 45. Rejected, as contrary to the clear and convincing evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. 46-53. Accepted, but not in their entirety materially dispositive. 54. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 55-56. Accepted. Rejected, as not in its entirety supported by clear and convincing evidence of record. Accepted. Accepted, to the extent of failing to practice medicine within the appropriate standard of care by not making earlier and more frequent biopsies only. Respondent's Proposed Findings of Fact 1-17. Accepted. 18. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 19-20. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter, and as not entirely in accord with the clear and convincing evidence of record. Accepted. Accepted, but not necessarily as to its material import and subordinate to the Hearing Officer's findings of fact on this subject matter, which contain additional findings of fact not contained in Proposed Finding of Fact No. 23 and which are material, relevant, and necessary to a clear picture of the patient's progress and treatment rendered during the period of April 6, 1992 through July 14, 1992. Accepted, but not as to its purported material import. Rejected, as contrary to the clear and convincing evidence of record, and as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not as to its purported material import. 27-31. Accepted. COPIES FURNISHED: Britt Thomas, Senior Attorney Mary Anne Davies, Certified Legal Extern Agency for Health Care Administration 1940 North Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Donald Partington, Esq. CLARK, PARTINGTON, ET AL. Post Office Box 13010 Pensacola, FL 32591-3010 Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, FL 32399-0770 Jerome W. Hoffman, Esq. General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, FL 32309
The Issue The issue in this case is whether the license of Allen B. Erde, M.D., should be disciplined by the Florida Board of Medicine based upon actions he is alleged to have taken, or failed to have taken, between August and November, 1986, in the care and treatment of his patient, C.W.
Findings Of Fact At all times material hereto, Respondent has been licensed as a physician in the State Of Florida, having been issued license number ME-0008625. Respondent was C.W.'s obstetrician during her pregnancy in 1986, and initially examined her on August 26, 1986, when she was six weeks pregnant. During this initial visit, C.W. was informed by Respondent that her pregnancy was progressing normally. At her second visit, on September 23, 1986, Respondent detected no fetal heartbeat. However, he informed C.W. that this was not a problem. He requested that she bring her husband with her for her third visit so that they both could hear the heartbeat. Prior to her third visit, C.W. saw Respondent in his office on October 6, 1986, complaining of urinary problems, and a stiff neck and back. Respondent treated her for a urinary tract infection. Later that same day she began to bleed vaginally, passed clots and experienced cramping pains. She then saw Respondent at the Winter Haven Hospital emergency room, but was told that nothing seemed wrong. Respondent advised her simply to go home, put her feet up, and rest. There were several other occasions during October, 1986, when C.W. experienced cramping and vaginal bleeding. She called Respondent each time to express her concerns, but was told simply to lie down, and keep her feet up. On October 22, 1986, C.W. and her husband visited Respondent for her third scheduled visit. No heartbeat was heard. Respondent again told C.W. that there was no cause for concern, the baby was just small and probably behind her pelvic bone. C.W. was presumably 14 weeks pregnant at this time, but Respondent's office records indicate that the fetus was decreasing in size, there was no weight gain, and no heartone. C.W. continued to experience pain and bleeding, sometimes accompanied by clots. She was not gaining weight, and had none of the other indications of pregnancy which she had experienced in her prior pregnancies. C.W. continued to express concern to Respondent, but his advice remained simply to lie down, and keep her feet up. In response to a five day episode of bleeding, C.W. saw Respondent in his office on November 12, 1986. Although she was 17 weeks pregnant at that time, Respondent's office records indicate a fetus 14 weeks in size. Respondent did not order any fetal viability tests, and there is no evidence in his office record that he considered any testing of the fetus. C.W. saw Respondent for her fourth scheduled visit on November 19, 1986, and, again, no fetal heartbeat was detected. She was still experiencing vaginal bleeding. Her uterus was only 10-12 weeks in size, although she was presumably 19 weeks pregnant at this time. C.W. was distraught, and expressed great concern to Respondent that she was presumably almost five months pregnant and no fetal heartbeat had ever been detected. C.W. demanded that Respondent do something. He then ordered a quantitative Beta-subunit Human Chorionic Gonadotropin blood test to determine her hormone level. On November 2l, 1986, Respondent called C.W. at her place of employment, and informed her that her hormone levels were extremely low, and that she might not have a viable pregnancy. He told her she should keep her next regularly scheduled appointment with him, but if she experienced any severe bleeding or cramping to call him. C.W. left work and became increasingly upset. She contacted him later on that same day for a more complete explanation of what she should expect. Respondent told her that the fetus was "reversing itself and was losing weight instead of gaining." C.W. was not informed by Respondent that the fetus was not viable, and she took his advice to mean that if she was extremely careful there was still a chance of carrying the pregnancy to term. Respondent admitted to the Petitioner's investigator, Jim Bates, that he knew the fetus was dead at this time, but he was trying to let nature take its course, and if she did not abort in two or three months, he would take the fetus. Because she was extremely upset and her friends were concerned about the advice she was receiving from the Respondent, an appointment with another obstetrician, Dr. Vincent Gatto, was made for C.W. by one of her friends. Dr. Gatto saw C.W. on or about November 21, 1986, and after examining her he immediately diagnosed her as having had a missed abortion. A sonogram confirmed this diagnosis. A dilation and curettage was performed on C.W., and subsequent pathological reports revealed remnants of an 8-week fetus. The medical records which Respondent maintained of his care and treatment of C.W. are incomplete and contain discrepancies concerning his evaluation of the patient. They do not reflect C.W.'s numerous telephone calls, or that she was increasingly upset over the course of her pregnancy. There is no delineation of a plan of treatment in these records, or any explanation of the type of treatment he was pursuing for her. There is no explanation or justification in these records of Respondent's failure to order a sonogram or test, other than the one Beta-subunit Human Chorionic Gonadotropin, for C.W., although she repeatedly reported vaginal bleeding and cramping, and there was a continuing inability to detect a fetal heartbeat. Respondent failed to carry out the correct tests on C.W., and therefore, he failed to make a correct diagnosis of missed abortion, or to treat her correctly. He allowed her to carry a dead fetus for almost two months. Retention of the products of a non-viable pregnancy can lead to several complications, including infection, blood clotting and psychological trauma. In fact, this experience caused C.W. severe emotional anguish. In his care and treatment of C.W., Respondent failed to meet the standard of care that is required of a physician practicing under similar conditions and circumstances.
Recommendation Based upon the foregoing, it is recommended that Florida Board of Medicine enter a Final Order suspending Respondent's license to practice medicine for a period of five years, and imposing an administrative fine of $3,000. DONE AND ENTERED this 21st day of August, 1989 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 21st day of August, 1989. APPENDIX (DOAH CASE NO. 88-4785) Rulings on the Petitioner's Proposed Findings of Fact: Adopted in Finding l. Adopted in Finding 2. Adopted in Finding 3. Adopted in Finding 4. Adopted in Finding 5. 6-7. Adopted in Finding 6. Adopted in Finding 7. Adopted in Finding 8. Adopted in Finding 9. Adopted in Finding 10. Adopted in Finding 11. Rejected as irrelevant. 14-17. Adopted in Finding 13. 18-21. Adopted in Finding 12. 22. Adopted in Finding 14. The Respondent did not file Proposed Findings of Fact. COPIES FURNISHED: Mary B. Radkins, Esquire Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Allen B. Erde, M.D. P. O. Box 1817 Winter Haven, FL 33883-1817 Allen B. Erde, M.D. 198 First Street, South Winter Haven, FL 33880 Dorothy Faircloth Executive Director Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792 Kenneth Easley, General Counsel Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0729
The Issue The issues to be determined in this proceeding are whether Respondent, John L. Lentz, Jr., M.D., committed the disciplinary violations charged with respect to seven patients in three Administrative Complaints that have been consolidated for the purpose of hearing. If the facts demonstrate that any of the charged violations have been committed, then the appropriate penalty to be imposed for such violations must be recommended.
Findings Of Fact Based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and on the entire record of this proceeding, the following findings of fact are made: Petitioner is the state agency charged with the licensing and regulation of the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to these proceedings, Respondent was a licensed physician in the State of Florida, having been issued license number ME 82437. Respondent’s address of record is 15200 Emerald Coast Parkway, St. Marten Unit 506, Destin, Florida 32541. Respondent was board-certified by the Academy of Family Physicians until 2009. He currently holds no board certification in any specialty area, and did not complete any residency other than his residency in family medicine. Respondent went to medical school at the University of South Carolina and initially practiced in that state. He moved to Florida in 2001 and since that time, has worked in a variety of practice settings, including working as an emergency room physician in several hospitals in areas such as Phenix City, Alabama; Panama City, Florida; and Defuniak Springs, Florida. At some point, Respondent became interested in the diagnosis and treatment of Lyme disease, and in approximately 2007, he opened a clinic in Destin named the Lentz Lyme Clinic. Respondent attended four continuing medical education courses that focused on the diagnosis and treatment of Lyme disease. Each of the courses he attended was three to four days long. Diagnosis and Treatment of Lyme Disease Lyme disease is an infectious disease caused by the bacteria Borrelia burgdorferi. Lyme disease is typically transmitted by a tick bite from what is often referred to as a deer tick, more formally known as the Ixodes scapularis tick. The tick is usually very small, and must remain on the person’s skin for approximately 36 hours or more in order for the disease to be transmitted. Lyme disease is generally considered to be endemic to the Northeastern United States, in states such as the New England states, Pennsylvania, upstate New York, Delaware, and northern Virginia. While it is not impossible to contract Lyme disease in Florida, the more persuasive evidence established that it is not prevalent in this state. The most credible, compelling evidence presented established that most people who are diagnosed in Florida with Lyme disease were most likely infected while traveling in a part of the country that is endemic for the disease, and that states in the Southeastern United States are in a low-risk area for Lyme disease. There was some conflict in the testimony concerning the stages and symptoms of Lyme disease, and what factors should be considered in diagnosing the disease at the various stages. The more credible and persuasive descriptions of Lyme disease and its stages describe the disease as having three stages: early localized Lyme disease; early disseminated Lyme disease; and late Lyme disease. The probable stage of the disease at the time a patient presents for diagnosis and treatment determines what is necessary for a diagnosis. Early localized Lyme disease is the disease as it typically presents within the first four weeks of the tick bite. The patient often, but not always, presents with a rash called an erythema migrans, which is generally over five centimeters wide (and can be as large as 19 centimeters) and is sometimes clear in the center, leading to the term “bull’s-eye rash” to describe it. In addition to the erythema migrans, a patient may present with virus-like symptoms, such as fatigue, malaise, fever, chills, myalgia (muscle aches), and/or headache. Often the symptoms at this stage, or any stage, for that matter, are non-specific symptoms that are common to a variety of conditions, including ALS and MS. According to Respondent’s expert, Dr. Cichon, these are conditions that a physician should also consider when diagnosing Lyme disease, Babesiosis, or Bartonellosis. In other words, when a patient presents with symptoms that do not include the erythema migrans, but are vague and non-specific, Lyme disease and co-infections related to Lyme disease should not be the only diagnoses considered. In order to diagnose Lyme disease a thorough history is required, including information on a patient’s travel locations, whether travel included states that are typically endemic for Lyme disease; the time of year the travel occurred; whether the patient engaged in the type of activity (such as hunting, fishing, hiking, or other outdoor activities) that would expose him or her to the possibility of a tick bite; any history of rashes; and whether the patient remembers a tick bite. The history should also include any symptoms the patient is experiencing and when the symptoms began. If the patient reports travel to an endemic area, and presents with an erythema migrans that the physician can examine, a diagnosis of early Lyme disease can be made without confirmatory laboratory tests. At that early stage, laboratory tests would not be particularly useful because they detect antibodies to the Borrelia burgdorferi, as opposed to detecting the bacteria itself. At that early stage of the disease, there is not sufficient time for the body to develop the antibodies necessary for detection through laboratory testing. The second stage of Lyme disease is called early disseminated Lyme disease, which may be characterized by multiple erythema migrans lesions; cardiac symptoms, such as atrioventricular block; arthralgia (joint pain); myalgia; or neurologic involvement, such as lymphocytic meningitis, facial nerve Palsy (Bell’s palsy), or encephalitis. If a patient presents with some combination of these symptoms, along with a history indicating travel to an endemic area and activities in that area consistent with tick exposure, a reasonable prudent physician would seek confirmatory laboratory tests to reach a diagnosis of Lyme disease, assuming the patient presents four weeks or more after possible exposure to a tick bite. The type of test to use is discussed below. Late Lyme disease is characterized by neurological symptoms, such as encephalomyelitis, peripheral neuropathy; and arthritis and arthralgia, usually in a single joint, such as a knee. As with early disseminated Lyme disease, a thorough history and physical is required for a diagnosis, as well as a confirmatory laboratory test. There was a great deal of testimony presented regarding the type of testing that is appropriate for the diagnosis of Lyme disease. Petitioner advocated the use of the ELISA test, followed by the Western blot test, commonly referred to as the two-tiered approach. ELISA and Western blot will be discussed in more detail below. Respondent contends that this two-tiered approach is inaccurate and that other tests are more definitive. His argument regarding the testing to use is consistent with his claim that there are two “standards of care,” one recognized by the Infectious Disease Society of America (IDSA), and one recognized by the International Lyme and Associated Diseases Society (ILADS). The tests recognized as standard for diagnosis of Lyme disease by Drs. Robbins, Anastasio, Robertson, Rosenstock, and Powers, are the two-tiered approach ELISA and Western blot tests. The ELISA is an enzyme-linked immunosorbent assay screening test. If the screening test is positive or equivocal for enzymes indicative of Lyme disease, a Lyme Western blot test is performed to confirm the presence of antibodies to Borrelia burgdorferi. For patients with early Lyme disease, the two-tier testing process may produce false negatives because the patient has not had sufficient time to develop antibodies in response to the bacteria. For those with late Lyme disease, the test is highly sensitive and specific because late Lyme disease patients have ample time to develop antibodies. The two-step approach is recommended by the Centers for Disease Control (CDC) because it provides for both sensitivity and specificity. Usually lab tests are either sensitive or specific, but not both. For a test to be considered “sensitive,” there are no false negatives. ELISA is considered a sensitive test. Specificity refers to the specific antibody bands being evaluated. With Western blot, there is an examination of different specific antibody bands. A Western blot IgM test looks for antibodies that are created initially from white blood cells that specifically attach to the infectious organism. A Western blot IgG looks for a different set of antibodies that continue to persist long after the infection is gone. A Western blot IgG is considered positive if five of the ten antibody bands are positive, while an IgM is considered positive if two of three bands are positive. The ILADS guidelines criticize use of the ELISA and Western blot tests because in the organization’s view, the two- tiered testing lacks sensitivity. The guidelines state that several studies “showed that sensitivity and specificity for both the IgM and IgG western blot range from 92 to 96% when only two [as opposed to five] specific bands are positive.”2/ While the ILADS guidelines criticize the two-tiered approach represented by ELISA and Western blot and indicate that other testing has been evaluated, “each has advantages and disadvantages in terms of convenience, cost, assay standardization, availability and reliability.” The ILADS guidelines do not expressly advocate not using the ELISA and Western blot, and note that while other tests remain an option to identify people “at high risk for persistent, recurrent, and refractory Lyme disease,” the tests have not been standardized. Dr. Michael Cichon, testifying for Respondent, opined that the ELISA and Western blot tests had little value and that Respondent’s failure to use them was not a departure from the standard of care. However, while at hearing he denied that he would order either test, in his deposition he indicated that he would order both tests, as a guide to diagnosis. His testimony that the ELISA and Western blot tests are not useful in the diagnosis of Lyme disease is rejected as not credible. Clear and convincing evidence at hearing established that a reasonable, prudent physician who is presented with a patient having possible exposure to Lyme disease occurring four weeks or more before seeing the physician would order the two- tier testing of ELISA and Western blot if it was appropriate to test for Lyme disease. While performing other tests in conjunction with the two-tier tests is not per se a departure, the standard of care requires either ordering the ELISA and where necessary, the Western blot, or reviewing any test results for these tests previously obtained by the patient. Treatment of Lyme disease also depends on the stage at which the condition is diagnosed. If a patient is diagnosed with early localized Lyme disease, a single course of doxycycline for 14 to 28 days is generally appropriate. Early disseminated Lyme disease and late Lyme disease may be treated with IV antibiotics, for a similar period of time. In summary, the standard of care in the diagnosis and treatment of Lyme disease requires a physician to take an appropriate medical history, perform a physical examination, obtain objective laboratory test results in the absence of an erythema migrans rash, and refer patients who do not improve after an initial course of antibiotic treatment to an infectious disease specialist for further evaluation. An appropriate history must include the information described in paragraph nine, and the testing to be ordered should include an ELISA and, where positive or equivocal, a Western blot test. Diagnosis and Treatment of Babesiosis Babesiosis is a parasitic disease of the blood caused by infection with Babesia. Babesiosis, like Lyme disease, is typically transmitted by a tick bite, and can be transmitted by the same tick that carries Lyme disease. There are occasions when a patient properly diagnosed with Lyme disease also will have Babesiosis as a co-infection. It is, however, not a common diagnosis, and even infectious disease specialists may go an entire career without diagnosing it. If a family practice physician suspects Babesiosis, the better approach would be to refer the patient to an infectious disease specialist. However, failure to refer a patient to a specialist, assuming that the family physician performs the appropriate testing and treatment, is not necessarily a departure from the standard of care. At all times material to the allegations in the Administrative Complaints, the standard of care for the diagnosis and treatment of Babesiosis included the physician taking an appropriate medical history, performing a physical examination of the patient, and obtaining objective laboratory test results in order to make an evidence-based diagnosis. As with Lyme disease, the patient’s medical history should contain information regarding the patient’s travel; whether they had exposure to a tick bite; whether they recall being bitten by a tick; as well as what symptoms the patient is experiencing. Babesiosis typically presents with virus-like symptoms, fever, sweats, and the identification of Babesia parasites in the patient’s blood. The tests that a reasonably prudent similar physician would order to determine whether a patient had Babesiosis are either a blood smear to identify Babesial parasites or a polymerase chain reaction (PCR) amplification of Babesial DNA. Should a patient be diagnosed with Babesiosis, the normal and customary treatment is a ten-day course of clindamycin and atovaquone. Diagnosis and Treatment of Bartonellosis Bartonellosis is an infectious disease caused by bacteria of the genus Bartonella. It is generally transmitted by lice or fleas on a person’s body, coming off of other animals, such as rats. It also can be transmitted through a cat scratch, as the cat gets fleas under its claws by scratching itself. As is the case with Babesiosis, a family practice physician is unlikely to diagnose Bartonellosis. It is not a common diagnosis, and even infectious disease specialists may go an entire career without diagnosing it. If a family practice physician suspects Bartonellosis, the better approach would be to refer the patient to an infectious disease specialist. However, failure to refer a patient to a specialist, assuming that the family physician performs the appropriate testing and treatment, is not necessarily a departure from the standard of care. In order to make a diagnosis, a thorough history and physical is required, along with objective laboratory test results. A physician should inquire about exposure to animals that could carry fleas, ticks, or lice, and whether there had been any recent instances where the patient has been scratched by a cat. The symptoms of Bartonellosis are nonspecific and include fever, headaches, myalgia, and arthralgia. The generally accepted test used to confirm a diagnosis of Bartonellosis would be a PCR amplification of Bartonella DNA, or paired blood serologies. DOAH Case No. 15-2888PL; DOH Case No. 2011-15106 (Patient C.C.) From approximately September 28, 2010, through approximately February 28, 2012, Respondent provided medical care and treatment to patient C.C. At the time of her original presentation to Respondent, C.C. was 27 years old. Prior to seeing Dr. Lentz, C.C. had a series of orthopedic injuries. For example, in 1998, C.C. was involved in a serious car accident, resulting in multiple broken bones and internal injuries requiring a two-week stay in the hospital. C.C. joined the Air Force in 2006, where she served as an aircraft mechanic. During basic training she suffered an injury to her shoulder, which caused problems with her neck, back, and shoulder. While in the military, C.C. was involved in two additional accidents: she broke her wrist in a motorcycle accident at some point, and on March 31, 2009, she had a second accident where the car she was driving was struck by another vehicle. While C.C. denied any injuries as a result of this second accident, shortly thereafter in July 2009, she had neck surgery because of discs impinging on the nerves in her neck. C.C.’s work as an aircraft mechanic required her to work in the fuel tanks of an airplane, which is a very confined space. C.C. is approximately 5’10” tall, and the work she performed required her to become contorted in a very small space for approximately 13 hours at a time. After her neck surgery, she started having increasing amounts of pain in her back and hips, to the point where she could no longer perform her job duties and in August of 2010, resorted to a wheelchair because of her inability to walk. Although she consulted multiple doctors both in the military and through referrals to outside physicians, she did not discover the cause of her pain. On or about September 28, 2010, Respondent evaluated C.C. for complaints of severe back, buttock, and right leg pain. When she presented for her first office visit, Dr. Lentz’s review of symptoms indicated that C.C. had a frontal headache with pain at a level of 10 out of 10; sensitivity to light and sound; loss of hearing and buzzing; nausea but no vomiting; withdrawal symptoms described as sweats when she did not take Ultram or Lortab; and feelings of hopelessness and emotional lability. His physical examination reported that C.C. was in a wheelchair, and documented “soles of feet painful, SKIN: rashes, soles of feet red, NEURO: paresthesia, pain, tender extremity.” At that time, Respondent diagnosed C.C. as having chronic fatigue syndrome and chronic pain syndrome. In C.C.’s history, Respondent noted that she “grew up in Texas/Arkansas-hunting, forests, etc. There is no notation of recent travel on this first visit. Dr. Lentz asked her about any flu-like symptoms, which she denied having. Many of the symptoms listed by C.C. are general symptoms that are common to a variety of ailments. Respondent, however, focused only on chronic fatigue, chronic pain, Lyme disease, Babesiosis, and lupus. On this first office visit, Respondent prescribed CD57, C3a, C4a, and eosinophilic cationic protein (ECP) laboratory tests of C.C.’s blood. With respect to the order for CD57, Respondent listed Lyme disease as a diagnosis. For the C4a and C3a, he listed Lyme disease and Lupus as the diagnoses, and for the ECP he listed a diagnosis of Babesia infection. Respondent did not prescribe an immunoassay (ELISA) test or Western blot test for Borrelia burgdorferi for C.C. The ECP test result for C.C. collected on October 6, 2010, was 20.8. The reference range for a normal test result is 1-10. The notation for the test on the lab result states: This test uses a kit/reagent designated by the manufacturer as for research use, not for clinical use. The performance characteristics of this test have been validated by Advanced Diagnostic Laboratories at National Jewish Health. It has not been cleared or approved by the US Food and Drug Administration. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. On or about October 15, 2010, Respondent diagnosed C.C. with Lyme disease. He based his diagnosis of Lyme disease on the results of the CD57 blood test. The CD57 test is a cluster designation test that measures a marker found on lymphocytes, which are a type of white blood cell that are sometimes referred to as natural killer cells. Although Respondent claimed at hearing that he did not consider the test to be definitive, in his deposition he indicated that he believed that it was in fact definitive. Dr. Cichon, on the other hand, testified that the CD57 test used by Dr. Lentz is not a definitive test for Lyme disease, but is useful for measuring the progress of treatment. At least one test result for C.C. reflecting the results for a CD57 panel has the following notation from the laboratory: This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Results of this test are for investigational purposes only. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. On or about October 15, 2010, Respondent also diagnosed C.C. with Babesiosis. Respondent did not prescribe a blood smear examination for Babesial parasites or PCR amplification for Babesial DNA for C.C. He based his diagnosis on the ECP test. On October 15, 2010, Dr. Lentz received an e-mail from C.C.’s roommate, M.B., informing him that C.C. had visited the emergency room over the weekend because of the level of her pain. The e-mail asked whether C.C. could begin with her treatment before her next appointment. In response, Dr. Lentz called in prescriptions for doxycycline and Cleocin, both of which are oral antibiotics. On or about October 18, 2010, Respondent described C.C. as being in no acute distress, with a gait that is within normal limits. He also noted some wheezing, pain all over, tears, and cramps in her muscles. Respondent prescribed long-term IV antibiotic therapy and referred C.C. to a specialist for venous port placement for the administration of intravenous (IV) antibiotic therapy. The specific medications prescribed at this visit are acetaminophen-oxycodone 300 mg - 7.5 mg oral tablets to be taken three times daily; Cymbalta 30 mg oral, once a day; Flagyl 500 mg oral tablets, to be taken three weeks on, one week off; heparin 5000 units/ml injectable solution, once a day; Omnicef 300 mg oral capsules, once a day; Interfase Plus Prothera, a supplement; and boluoke lumbrokinase, also a supplement. At the October 18, 2010, visit, he also ordered a Fry test for Bartonellosis and prescribed intravenous vancomycin, with weekly vancomycin trough levels. Dr. Lentz testified at hearing that the prescription for vancomycin was to treat Bartonellosis.3/ However, at this juncture, no diagnosis for Bartonellosis had been made. Heparin is an anticoagulant that is used for a variety of issues, such as blood clots, pulmonary emboli, and Berko emboli. It is also used in coronary heart disease if a patient has a myocardial infarction. The more persuasive and credible testimony established that it was below the standard of care to use heparin in the treatment of Lyme disease, Babesiosis, or Bartonellosis. Not only did heparin have no efficacy, it had the potential to be very dangerous for C.C., or any other patient. On October 28, 2010, Respondent noted that the vancomycin was at 1.5 grams and still not therapeutic, and ordered that the medication be changed to Primaxin and that the Omnicef and vancomycin troughs be stopped. On November 10, 2010, Respondent noted that C.C. was experiencing flu-like symptoms, but was now resting fewer hours each day. For the first time, he noted “past 4 years in military=Virginia, Canada, Honduras, as sites for exposure to Lyme.” He also noted “no wheelchair, but slow to move, pain to rt LS-hip-leg.” He continued to list her diagnoses as Lyme disease, Babesiosis, chronic pain syndrome, and chronic fatigue syndrome. Respondent also saw C.C. in the office on December 8, 2010, and January 10, 2011. At the December 8, 2010, visit, he discontinued the use of Flagyl because of her nausea and switched to Tindamax (one tablet daily for three weeks, then off one week) instead. On January 19, 2011, Dr. Lentz received an e-mail from C.C.’s roommate regarding a fall C.C. had over the weekend. As a result, he wrote an e-mail to C.C. and told her to stop the Tindamax and “add the neurotoxins to remove the neurologic toxins that are being created by the antibiotics.” He also directed her to stop the heparin injections, as she needed to be off of heparin before having some hand surgery to remove a cyst. C.C. returned for an office visit on February 9, 2011. At that time, Respondent’s notes indicate that she was ambulatory but still significantly fatigued and still falling. He noted, “rt hip. sciatic nerve still #1 symptom, can not stand or walk for long periods of time, not sure if neurologic/Lyme or degenerative nerve dis.” In his assessment, he stated she “needs CT lumbar sacrum to r/o orthopedic issue with back pain.” During the course of treatment, Respondent was consistently prescribing OxyContin at 10 mg, three times daily. On March 16, 2011, he referred C.C. to Dr. Beach at Andrews Institute to detox off the OxyContin. He also noted that she had been given 100 percent disability through the military, and would take approximately four months to process out of the military. He also noted “electrical ablation at T9, T10 for chronic back pain per Dr. Nyguen.” Dr. Lentz continued to see C.C. on April 12, 2011; May 4, 2011; and May 13, 2011. Throughout her treatment with IV antibiotics, C.C. experienced problems with nausea, rashes, and diarrhea, but claims that over time, her symptoms began to improve so that she could walk and eventually was able to hold down part-time employment. Toward the end of her military tenure, C.C. needed a referral in order to continue to see Dr. Lentz. To that end, on June 8, 2011, she saw Dr. Janelle Robertson, M.D., a board certified infectious disease specialist at Eglin Air Force Base. Dr. Robertson evaluated C.C. for Lyme disease, and documented her history, including travel history and history of tick bites. She reviewed prior records from Eglin Air Force base that indicated C.C. had an ELISA screening on June 10, 2010 (approximately two and a half months before seeing Dr. Lentz), that was negative. The ELISA test was not only performed before C.C. saw Dr. Lentz, but well after C.C. began suffering the symptoms that led her to seek out Dr. Lentz. Accordingly, the ELISA test was administered at a time at which C.C. would have developed sufficient antibodies for the test to be useful. Dr. Robertson also noted that while C.C. had a history of tick bites in Florida, Texas, and Alabama, she did not report any rashes or illness at or near the time of the tick bites. She also had no history of migratory arthralgia or Bell’s palsy. Dr. Robertson testified credibly that C.C. was having no night sweats, weight loss, changes in vision, palpitations, difficulty breathing, or gastrointestinal problems, and that her primary complaint was back and hip pain. C.C.’s pain remained in the same locations and persisted without resolution since 2009. Dr. Robertson concluded that C.C. did not have Lyme disease, and that her prior negative ELISA test conclusively established that she did not have the disease. She opined that, given that C.C.’s symptoms had persisted since 2009, if she had actually had Lyme disease, she would have developed antibodies that would have been detected with the ELISA test. She also determined that Respondent did not have Babesiosis and recommended to C.C. that she immediately stop the therapy prescribed by Dr. Lentz, because in Dr. Robertson’s view, the therapy was unsafe. C.C. has since transitioned out of the military into civilian life. Although she believes that the treatment by Dr. Lentz was effective in treating her condition, the events since she stopped treatment for Lyme disease suggest otherwise. For example, C.C. testified in her deposition that her treatment ended in mid-May 2011 because Dr. Lentz determined that she did not need more treatment, yet it appears that the military would no longer authorize treatment by Dr. Lentz once C.C. saw Dr. Robertson. Moreover, she continues to have some of the same pain that led her to treatment with Dr. Lentz. In approximately October 2014, she had hip surgery because her “hips are pretty much shot.” She has had three surgeries for kidney stones, steroid injections for temporary relief from her back pain, and acupuncture treatments for her back pain. At least one physician attributed her problem to the kind of work she performed as an aircraft mechanic, and at deposition she indicated that a recent MRI indicated that she has some lumbar narrowing. In short, it appears that the months-long IV antibiotic therapy she endured has provided no lasting solution to her pain. Respondent’s care and treatment of C.C. was a departure from the standard of care in that he diagnosed Lyme disease based upon an inadequate history and no objective laboratory test results from an ELISA test and Western blot. Specifically, Respondent failed to obtain C.C.’s travel history or any history of rashes, possible tick bites, including the size of the tick, and in fact obtained a history devoid of any flu-like symptoms characteristic of Lyme disease. C.C.’s primary symptoms were related to her back pain. Respondent’s own expert, Dr. Cichon, testified that the key to a diagnosis of Lyme disease is the patient’s history.4/ With this inadequate history in mind, Respondent did not obtain an ELISA test or Western blot, but instead relied on a test that, on its face, indicates that it is for investigational use only and should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically-established diagnostic product or procedure. The more persuasive and compelling testimony established that the failure to obtain objective laboratory confirmation of Lyme disease through the use of the ELISA and Western blot tests is a departure from the standard of care recognized by a reasonably prudent similar physician. The more persuasive and compelling evidence also established that C.C. did not actually have Lyme disease, despite Respondent’s diagnosis of the disease. Respondent also departed from the appropriate standard of care by his failure to use the appropriate tests for the diagnoses of Babesiosis and Bartonellosis. His test of preference, the ECP test, is by its own terms, not intended to be used as the sole means for clinical diagnosis or patient management decisions. As stated by Dr. Robbins, it has no clinical relevance and is diagnostic of nothing. Likewise, his credible testimony indicated that use of the Fry test was not appropriate, as it is a proprietary test of the laboratory and not FDA approved.5/ Respondent’s care and treatment of C.C. also departed from the applicable standard of care by prescribing surgery for placement of a venous port for administration of intravenous medication, and by prescribing both intravenous and oral antibiotic therapy in inappropriate and excessive amounts. The more credible and persuasive testimony demonstrated that C.C. did not have Lyme disease, Babesiosis, or Bartonellosis, and therefore did not need any of the antibiotic therapy prescribed. Even had C.C. received a correct diagnosis, the more persuasive evidence demonstrated that the amounts and duration of the antibiotics prescribed were not only unwarranted, but potentially dangerous for the patient. C.C. had the possibility of negative reactions from the many antibiotics prescribed, but also the very real possibility that she has built up a resistance to the antibiotics such that they will be ineffective should she actually need them in the future. Finally, Respondent’s care and treatment of C.C. departed from the applicable standard of care by the prescription of heparin. There was no medical justification for the prescription of an anticoagulant for the treatment of Lyme disease, even if appropriately diagnosed (which did not happen here), and as with the prescription of multiple long-term antibiotics, was potentially dangerous and harmful to the patient. DOAH Case No. 15-2889PL; DOH Case No. 2011-18613 (Patients D.H., S.L., J.L., W.L., and D.D.) Patient D.H. Respondent provided care and treatment to patient D.H. from approximately November 24, 2010, to approximately October 14, 2011. D.H. was previously seen by a physician’s assistant, Thomas Gregory Roberts, who at various times worked under Respondent’s supervision, including the period from April 29, 2009, to May 26, 2010, and again from September 21, 2010, through December 18, 2010.6/ Mr. Roberts had ordered a previous CD57 test for D.H., and had prescribed doxycycline for him on a long-term basis. Mr. Roberts’ office was closing and his records were no longer available, so on November 24, 2010, D.H.’s wife, J.H., e-mailed Dr. Lentz to request laboratory tests and to schedule an appointment for D.H. She stated in part: Dear Dr. Lentz: Both my husband and I have been to you before, but not at your current office. [D.H.] went to Tom Roberts at Village Health Assoc. and was sent for blood work. His CD57 counts were off, so he put him on Doxycycline [sic] and was on it for several months. His last blood work was done in July and by the sound of it showed some improvement, but he told him to stay on the antibiotics. Tom Roberts gave him an order for follow up bloodwork which reads CD57 + NK Cells Dx2793. Since he is currently not practicing that we know of, we are requesting that you please write an order so that [D.H.] can have blood work done and come to you for the results. Based upon this e-mail, Respondent ordered a CD57 test, using the diagnostic code for and reference to Lyme infection, and an ECP test using the diagnostic code for and reference to Babesia infection. He did so without actually seeing D.H., taking a history, or performing a physical examination. Respondent diagnosed D.H. as having Lyme disease and Babesiosis. He communicated the diagnoses to D.H. on December 25, 2010, via e-mail, stating, “CD57 is positive for Lyme and ECP positive for Babesia. Call Amy at 424-6841 for an appointment. Dr. Lentz.” It does not appear from the record that he considered or ruled out any other condition for D.H.’s complaints. Respondent did not prescribe or order for D.H. an ELISA or Western blot test, PCR amplification of Bartonella or Babesial DNA, or blood smear tests at any time during D.H.’s care and treatment. Respondent did not refer D.H. to a specialist in the diagnosis and treatment of infectious diseases, such as Lyme disease, Bartonellosis, and Babesiosis at any time during Respondent’s treatment and care of D.H. D.H.’s first office visit was January 17, 2011. At that time, J.H., D.H.’s wife, who attended the majority of his doctor’s visits with him, testified that his only complaint at that point was fatigue, and ongoing diarrhea she attributed to the lengthy time he had already been on antibiotics. She acknowledged that he checked off those items on a form at the doctor’s office, but was not going to see Dr. Lentz complaining about those: he went simply because of his fatigue. He had no rash at that point, and never complained of a tick bite. Dr. Lentz’s records, however, indicate that he complained about exhaustion; face-neck, jaw, and orbital pain; diarrhea; cramping; stiff and painful joints; mood swings; irritability; explosive [sic]; and poor concentration. From what J.H. could remember, the physical examination Respondent performed on D.H. was very brief. Respondent took D.H.’s blood pressure, possibly looked in his mouth, palpated his abdomen, and did a knee reflex test. She did not remember him doing anything else, except having D.H. fill out a long form. Dr. Lentz’s medical records for this visit contain no prior medical history, no pulse, and no respiration rate. Respondent diagnosed D.H. with Lyme disease. When J.H. asked him if he was sure, Respondent said, absolutely. J.H. had done some research and knew that Respondent had only ordered a CD57 for D.H. She asked him about ordering the Western blot, but he did not order it. She could not remember Respondent’s exact response, but was led to believe that he did not think that the Western blot test was as accurate in diagnosing Lyme disease. At this first visit, Respondent also ordered the Fry test. Results from the Fry test are dated January 25, 2011, and indicate: Based on the accompanying test results for the sample for listed patient and accession number is suggested for follow up confirmation of the putative organism(s). Protozoan: The Special Stains (100x magnification) or the Advanced Stains (magnification listed) for this sample is suggestive of a protozoan. PCR testing for putative FL1953 is suggested for follow-up confirmation. EPierythrozoan/Hemorbartonella: The Special Stains (100x magnification) or the Advanced Stains (magnification listed) for this sample is suggestive of epierythrozoan/ hemobartonella. PCR or serology testing for the putative epierythrozoan/hemobartonella (Bartonella spp.) is suggested for follow up confirmation and speciation. (emphasis added). The records do not indicate that Respondent ordered any of the follow-up testing recommended by the Fry laboratory which, ironically, is the very testing for Bartonellosis that a reasonably prudent similar physician should order for this condition. His records also do not indicate that he ever added Bartonellosis as a diagnosis for D.H. During the course of his treatment, Respondent prescribed for D.H. the antibiotics Omnicef, azithromycin, and Cleocin, as well as Interface Plus Prothera (an enzyme supplement formulation), boluoke lumbrokinase (a fibrinolytic supplement), atenolol (a beta blocker used primarily in cardiovascular disease, added March 7, 2011), heparin injections (an anticoagulant, also added March 7), artemisinin (an antimalarial, added June 14), Mepron (an antiparasitic, added June 14), Tindamax (added June 14), Plaquenil (an antimalarial), and Vermox (an anthelmintic)(both added August 21). J.H. understood that, based upon Respondent’s explanations, the heparin was prescribed to help other medicines be absorbed into the cells, or something along those lines. She was concerned about D.H. being on the heparin, in part because as a result of him injecting the heparin in his abdomen, D.H. had a lot of bruising and knots all over his belly. She was also concerned because D.H. worked as a boat captain on the Mississippi River, which required him to be away from home for weeks at a time. She was concerned about the ramifications should he have an accident at work when he had no access to medical care. Her concerns were warranted. The couple also had concerns about the number of medications D.H. was taking while under Respondent’s care. He developed blurred vision, did not sleep well, and had chronic diarrhea. When D.H. came home from his last visit, which J.H. apparently did not attend, he reported that Dr. Lentz had said something about having a port placed for the administration of more antibiotics. That shocked her, so before he would go through with port placement, they sought a second opinion. Dr. Patrick Anastasio is an osteopathic physician who is a board-certified infectious disease specialist. During all times relevant to these proceedings, he was a solo practitioner in private practice at Emerald Coast Infectious Diseases in Fort Walton Beach, Florida. He has worked in the area for approximately 12 years. D.H. sought a second opinion from Dr. Anastasio regarding his Lyme disease and Babesiosis diagnoses. To that end, he saw Dr. Anastasio for the first time on September 29, 2011. Dr. Anastasio did not believe that D.H. had the symptoms initially to place him in a high risk group for Lyme disease. During his examination, he looked for signs that would be consistent with Lyme disease, such as arthritis, cognitive problems, or neurological problems, but did not discover any. Dr. Anastasio did not believe that D.H. had either Lyme disease or Babesiosis, but ordered a blood smear, and a Western blot and a Babesia PCR test to rule out the conditions. All tests came back negative.7/ Dr. Anastasio recommended to D.H. that he stop taking all of the medications prescribed by Dr. Lentz, and D.H. did so. It still took months for the diarrhea, most likely caused by the long-term antibiotic therapy, to subside. However, D.H. began to feel better once he stopped taking the antibiotics. Dr. Charles Powers, M.D., testified that Dr. Lentz’s medical records for D.H. were not adequate for the evaluation of whether D.H. had Lyme disease. He also believed that it was below the standard of care to use the CD57 for the diagnosis of Lyme disease as opposed to the ELISA and Western blot tests, and that it was below the standard of care not to order the ELISA and Western blot tests in the absence of an erythema migrans rash that Dr. Lentz could physically observe. Dr. Powers believed that there was no basis upon which to diagnose D.H. with Lyme disease, and therefore any treatment based on this faulty diagnosis would be below the standard of care. Even assuming the diagnosis was correct, Dr. Powers opined that the treatment ordered also was below the standard of care. According to Dr. Powers, a reasonably prudent family practitioner would usually prescribe doxycycline for the majority of cases, as opposed to the regimen of medications used by Dr. Lentz. Prescribing antibiotics the way they were prescribed would include adverse side effects, such as nausea and/or diarrhea with resistance to bacteria; development of C. difficile infection, which can be difficult to treat; and potential for allergic reactions, which can be fatal. Dr. Powers testified that when a combination of antibiotics is being used, with each additional antibiotic prescribed, the risk for complications increases exponentially. His testimony is credited. Dr. Powers also opined that the use of heparin in the treatment of Lyme disease, Babesiosis, or Bartonellosis was a departure from the standard of care, and was a dangerous choice for this or any other patient who did not have a need for a blood thinner. Dr. Robbins also believed that Respondent’s care and treatment of D.H. was below the standard of care. He testified that Respondent breached the standard of care by diagnosing D.H. with Babesiosis using the ECP test and the Fry testing for the purpose of diagnosing Bartonellosis. He also testified, consistent with Dr. Powers, that using heparin in the treatment of any of these three diseases was an egregious departure from the standard of care. The testimony of Drs. Robbins and Powers is credited. Dr. Cichon expressed concerns about the amount of medications prescribed by Dr. Lentz to D.H., specifically singling out the prescriptions for Plaquenil and Vermox. While his testimony fell far short of declaring that prescribing these medications represented a departure from the standard of care, his testimony was certainly not a ringing endorsement. It seemed as if he was trying to convince himself that Respondent’s care and treatment of this patient fell within the standard of care. His testimony to that effect is rejected as not credible. D.H. did not have a medical condition that justified the prescription of any of the medications and supplements that Dr. Lentz prescribed, much less for the duration taken. The prescription of any of these medications without a valid diagnosis was a departure from the standard of care attributed to a reasonably prudent similar physician. Patient S.L. Respondent provided care and treatment to patient S.L. from on or about August 17, 2010, to on or about January 7, 2011. On or about August 17, 2010, at her first office visit with Dr. Lentz, S.L. presented with and reported to Respondent a history of heavy rectal bleeding, which occurred every four to five days. At that visit, S.L. informed Respondent that in June, she had been advised to get a colonoscopy. Because of economic constraints, S.L. did not obtain the requested colonoscopy. There is no indication in the patient records for S.L.’s first office visit (or any later visit) that the reason for S.L.’s bleeding prior to his treatment of her had been determined or that it had resolved. S.L. first went to see Dr. Lentz at Hope Medical Clinic8/ because she believed that she had a urinary tract infection. She also had severe back pain, with pins and needles down both legs. Her back pain had started in 2005, following a car accident. S.L. does not recall Respondent ever performing a physical examination, although the patient records indicate that at least a minimal examination was performed. She does recall him talking to her about being from Pennsylvania, but does not recall him asking her about any travel history, whether she had been exposed to ticks, or had ever been bitten by a tick. Dr. Lentz’s medical records for this first visit make no mention of a travel history; no mention of tick exposure; and no mention of any type of rash. Much of the history related to other issues, such as S.L.’s history of bleeding, as opposed to any symptoms that could be said to be indicative of Lyme disease. The symptoms documented are “paresthesis to both legs due to lumbar path. Recent hematochezia. No melena. No upper abd. Pain. No diarrhea. Mostly awake sxs, not hs.” Yet in his assessment/plan notes, he lists diagnoses of lumbago, displacement of lumbar intervertebral disc without myelopathy, and chronic pain syndrome. He prescribed Lyrica, Elavil, Lortab, and ordered a CD57, listing the Lyme disease diagnostic code. There was no medical basis, based on the history presented, to suspect or test for Lyme disease. On September 21, 2010, S.L. presented to Dr. Lentz for a follow-up appointment. At this appointment, Respondent diagnosed S.L. as having Lyme disease. He ordered a Fry Bartonella test as well as an ECP test, and prescribed doxycycline, Omnicef, and Flagyl. On September 30, 2010, S.L. called Respondent and reported throwing up all of her antibiotics, and asked about medication for her nausea. Dr. Lentz added the diagnosis of Bartonellosis without seeing S.L. or performing any further physical examination. The results of the Fry test in the patient records state: “rare (1-4 organisms per total fields observed) coccobacilli adherent to erythrocytes – indicated by yellow arrow(s). This is suggestive of Hemobartonella(1) or Hemoplasma(2).” The notes also state, “[t]his stain is not FDA approved and is for research only.” At S.L.’s next appointment on October 5, 2010, Dr. Lentz prescribed rifampin and Cleocin, as well as Lovenox injections. Lovenox is a low molecular weight heparin that can be given subcutaneously. At the time Dr. Lentz prescribed it, there was no determination regarding the cause of her heavy rectal bleeding just a few months before. On October 19, 2010, just two weeks after starting the Lovenox injections, S.L. presented to the emergency room at Sacred Heart Hospital with complaints of blood in her urine.9/ Physicians in the emergency room attributed the blood in her urine to the Lovenox injections, and discharged her with a diagnosis of hematuria. That same day, she presented to Dr. Lentz and told him about her emergency room visit. Dr. Lentz lowered the dose for Lovenox, but did not discontinue its use. His notes for this visit indicate that she had left flank pain, slight liver tenderness, no masses, and a “light liver test elevated, <2X normal.”10/ He added a diagnosis for Babesiosis, but did not appear to explore what was causing the liver tenderness and elevated tests. Under his assessment and plan, it states: “1. Cut Lovenox BID to QAM. 2. Add Culturelle/probiotics to GI tract due to antibiotics being used, if urine lightens up and less blood on dipstick, then improvement.” Respondent did not prescribe S.L. a PCR amplification or Bartonella or Babesial DNA, or Western blot immunoassay tests at any time during Respondent’s care and treatment of S.L. Respondent did not refer patient S.L. to a specialist in the diagnosis and treatment of infectious diseases, such as Lyme disease, Bartonellosis, and Babesiosis, at any time during Respondent’s care and treatment of S.L. S.L. testified that the physicians at Sacred Heart Hospital informed her that there was no reason for her to be on the antibiotics or blood thinner prescribed by Dr. Lentz, and based upon their advice, she stopped the medication regimen he prescribed. The medical records from Sacred Heart do not mention this advice, and she saw Dr. Lentz at least twice after her emergency room visit: October 19 and November 2, 2010. After that, the only communications in Dr. Lentz’s medical records for S.L. appear to be requests for medication related to urinary tract infections as opposed to treatment for Lyme disease, Babesiosis, or Bartonellosis. In any event, she quit seeing Dr. Lentz for Lyme disease, Babesiosis, and Bartonellosis at least as of November 2, and testified credibly that she feels fine. Based on the credible testimony of Drs. Powers and Robbins, Dr. Lentz’s diagnosis and treatment of S.L. violated the applicable standard of care in that he failed to obtain an appropriate history to diagnose Lyme disease, Babesiosis or Bartonellosis in the first place. He failed to obtain a travel history, any information regarding possible tick bites, and if there was such a bite, the size of the tick and duration of the bite. He also failed to document symptoms that would suggest the possibility of Lyme disease to justify any objective laboratory testing. S.L.’s symptoms were related to back pain and a history of heavy bleeding. Her symptoms simply did not justify testing for Lyme disease. The evidence was not clear and convincing that Respondent failed to perform an adequate examination. As noted above, while S.L. does not remember one, the medical records reflect notations indicating that one was in fact performed. The problem is that the history and physical examination do not support further investigation for Lyme disease. Respondent also departed from the applicable standard of care by relying on tests that were not appropriate for the diagnosis of Lyme disease, Babesiosis, or Bartonellosis. As stated above, there was no basis to test for these conditions at all, but if testing was going to be performed, then the appropriate tests were not the CD57, ECP, and Fry tests, but rather the ELISA, Western blot, PCR, and serologies discussed above. Respondent’s prescription of multiple antibiotics of lengthy duration also violated the standard of care, for reasons discussed above at paragraphs 60 and 79. Likewise, Respondent’s prescription of Lovenox fell below the standard of care. The use of Lovenox for Lyme disease, Babesiosis, and Bartonellosis is not warranted at all, but is especially egregious here, where S.L. had excessive bleeding problems of which Respondent was aware just months before Lovenox was prescribed, with no documentation that the cause of the bleeding had been identified and addressed, and no indication that Respondent did anything to investigate the cause of the bleeding. That he continued to prescribe the Lovenox, albeit at a lower dose, after her visit to the emergency room with hematuria, just compounds the problem. Dr. Cichon testified that Respondent met the standard of care in diagnosing and treating S.L., saying that she had unexplained pain that could be due to Lyme disease. He struggled to identify any symptoms that are commonly associated with Lyme disease. His testimony seemed to indicate anytime there is unexplained pain, Lyme disease is a possibility. His testimony on this issue is not credible. The same can be said for his support of the diagnosis of Babesiosis. Dr. Cichon identified the primary symptoms of Babesiosis as headaches, sweating, and air hunger. S.L. did not have these symptoms, leaving only the ECP test as a basis for diagnosis. Relying on the ECP (which is only slightly elevated) is contrary to Dr. Cichon’s own testimony regarding the primary importance of a thorough history to support such a diagnosis. Similarly, Dr. Cichon acknowledged in his testimony that he could not tell from Respondent’s medical records whether S.L. had any symptoms to support a diagnosis for Bartonellosis, and stated that her symptoms could be due to her lumbar pathology. Given these inconsistencies, his opinion that Dr. Lentz did not depart from the applicable standard of care in the diagnosis of each of these diseases is not credible and is rejected. Medical records must justify the course of treatment for a patient. Dr. Lentz’s medical records for S.L. do not justify the diagnosis or treatment of Lyme disease, Babesiosis, or Bartonellosis. The medical records do not document symptoms that are consistent with the diagnoses of any of these diseases, and fail to provide a complete medical history. Patients J.L., W.L., and D.D. J.L. is the mother of S.L. W.L. is J.L.’s husband and S.L.’s father, and D.D. is S.L.’s son and J.L. and W.L.’s grandson. On September 22, 2010, approximately one month after S.L. began treatment with Dr. Lentz, J.L. wrote him the following e-mail: Dr. Lentz: Thank you for talking with me on the phone today. We are really concerned about S.L. and we can not [sic] express to you how much you are appreciated for all you have done for her. You are a true blessing to our family. My husband was bitten by a tick over the July 4th weekend in MO. He developed the bulleye [sic] rash and went to our family doctor. Dr. Calvin Blount. He was give [sic] 10 days of antibiotics, but no follow up or blood test were ever ordered. We would like to be tested for Lyme. We believe that S.L. might have contracted Lyme before she became pregnant with D.D. and would like him tested also. Here is our information. Please let me know if you need any additional information. Thank you again for all you have done. As noted above, there was an insufficient basis to justify the ordering of any tests related to Lyme disease for S.L. The only basis for ordering tests for D.D. is the suspicion that S.L. may have been infected prior to giving birth to D.D. If there is no basis for suspecting S.L. has Lyme disease, there is no basis for suspecting D.D. has Lyme disease. Respondent did not make an appointment for, take a history from, or perform a physical examination of J.L., W.L., or D.D. Based upon this e-mail alone, he ordered CD57 and ECP tests for all three of them, as well as C4a and C3a tests for J.L. and W.L. To justify ordering the tests, he listed “Lyme Disease (088.81)” under his assessment/plan for each patient. Although he never saw any of these patients, he coded each encounter as “high complexity.” On October 14, 2010, Dr. Lentz sent an e-mail to J.L. stating that “D.D. is positive for Lyme and negative for Babesia.” On October 24, 2010, Dr. Lentz sent an e-mail to J.L. stating, “W.L. C4A is back=20,000+ indicative of active Lyme.” On October 25, 2010, Dr. Lentz sent an e-mail to J.L. which stated, “[t]he CD57 is 50=positive, and the ECP is 11.5=positive for Babesia. My initial charge is $400 and $200 for return visits. Since I will be seeing both you and [W.L.], I will drop that to $300 initial visits. Call Amy for the schedule.” Dr. Lentz testified that he did not diagnose J.L., W.L., or D.D. with any condition, and did not really consider them to be patients. In his view, he was simply doing a favor for the family members of a patient. However, he created records that referred to each patient as being new patients needing tests for Lyme disease, and included diagnostic codes for the lab tests. With respect to each of them, he made an interpretation of the tests that he ordered. At least with respect to D.D., he admitted in his deposition that he diagnosed D.D. with Lyme disease based on the laboratory tests. Both S.L. and W.L. testified credibly that, based on the communications received from Dr. Lentz, they each believed that he had diagnosed them with Lyme disease, and that he had diagnosed J.L. with Babesia. It is found that he did, in fact, provide diagnoses to J.L., W.L., and D.D., without the benefit of a personal history, or a physical examination. Respondent did not refer J.L., W.L., or D.D. to a specialist in the diagnosis and treatment of infectious diseases such as Lyme disease, Bartonellosis, or Babesiosis. Respondent did not order for J.L., W.L., or D.D. an ELISA or Western blot test, PCR amplification of Bartonella or Babesial DNA, or blood smear tests. J.L. and W.L. decided to get a second opinion regarding the Lyme disease and Babesiosis diagnoses, and went to see Dr. Anastasio. Dr. Anastasio testified that J.L. did not have the required exposure to or symptoms for Lyme disease. Because she came to him with a Lyme disease diagnosis, he ordered a Lyme Western blot, a PCR for Babesiosis, and a PCR for Bartonellosis. J.L.’s Western blot IgM was negative, with two of the three antibody bands tested returning as absent. The Western blot IgG was negative, with all ten antibody bands returning as absent. J.L.’s PCRs for both Babesiosis and Bartonellosis were negative. Dr. Anastasio testified that he did not believe that J.L. had either Lyme disease or Babesia. His testimony was persuasive, and is credited. Dr. Anastasio testified that, given W.L.’s history of a tick bite followed by a rash, there was at least a basis to believe his symptoms could be an indication of Lyme disease. The tick bite and rash were approximately six months prior to W.L. presenting to Dr. Anastasio, and almost three months prior to Dr. Lentz ordering tests for him. Given these time frames, there was plenty of time for W.L. to develop antibodies to Lyme disease if he was in fact infected with the disease. Dr. Anastasio testified that at the time he saw W.L., W.L.’s symptoms were not consistent with late Lyme disease. Dr. Anastasio ordered several tests for W.L., including a Lyme Western blot, a PCR for Babesiosis, a blood smear for Babesiosis, and a PCR for Bartonellosis. The Western blot test was negative, with zero out of ten antibodies present. Both PCR tests and the blood smear were also negative. Dr. Anastasio concluded that W.L. did not have Lyme disease, Babesiosis, or Bartonellosis, and his testimony to that effect is credited.11/ Respondent failed to meet the applicable standard of care with respect to the care and treatment of patients W.L., J.L., and D.D. Based on the credible testimony of Drs. Powers and Robbins, Dr. Lentz departed from the standard of care in ordering tests for all three patients when he did so without seeing them, taking a history with respect to any of them, or conducting a physical examination of any of them to determine whether any of the requested tests were warranted or even justified. Respondent also departed from the applicable standard of care when he ordered tests that would not even assist in diagnosing Lyme disease, Babesiosis, or Bartonellosis had testing for those conditions been appropriate. Moreover, Dr. Powers testified credibly that the appropriate way to order tests for a suspected condition is to use the symptoms that are being investigated by the physician ordering the test, as opposed to the suspected disease being considered. For example, one ordering a mammogram would list “screening” or “diagnostic,” not “breast cancer,” because at that point, breast cancer has not been, and might never be, diagnosed. Documenting the symptom as opposed to the disease is important in terms of continuing care, so that there is no confusion by a subsequent health care provider reading the records about a premature diagnosis. Dr. Powers’ testimony is credited. Dr. Lentz also claimed that because J.L., W.L., and D.D. were not his patients, he did not need to have medical records for them that complied with section 458.331(1)(n). However, Dr. Lentz created patient records for all three in order to order the laboratory tests for them. He coded the action taken as having high complexity. The definition of medicine includes “diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition.” § 458.305(3), Fla. Stat. Respondent clearly engaged in the practice of medicine when he wrote prescriptions for tests for the purpose of diagnosing disease. By ordering these tests, creating medical charts for them (however limited they may be), interpreting the test results and communicating those results, he established a physician-patient relationship with J.L., W.L., and D.D. Accordingly, he was required to have patient records that justified the course of treatment (here, the diagnosis of Lyme disease, Babesiosis, and Bartonella). The records presented do not meet that requirement. DOAH Case No. 15-2890PL; DOH Case No. 2012-01987 (Patient C.H.) At the time of the events giving rise to this case, C.H. was a 23-year-old woman. She was married and attending her final year of chiropractic school in Kennesaw, Georgia. C.H. testified that in December 2010, she had experienced a bout with the flu, including an episode where she passed out in the shower, for which she was prescribed a Z-pack, and recovered. She then had gum surgery during the Christmas break, requiring anesthesia, after which she visited her husband’s family in Missouri over the Christmas holiday. After C.H. returned to Georgia, she returned to class for the spring semester. In early February of 2011, she had an episode in class where her heart started beating very rapidly, and upon a physician’s advice, went to the emergency room. Tests given there were normal. Follow-up tests also did not reveal the basis for her symptoms, and in March 2011, her mother contacted Dr. Lentz based upon the suggestion of a family friend who had treated with him. On or about March 20, S.H. contacted Respondent by e-mail regarding her 23-year-old daughter, C.H. S.H. had been referred to Respondent by a family friend. S.H. reported that she had found a checklist for Lyme disease symptoms online, which included some of the symptoms her daughter was experiencing, such as fatigue, rapid heartbeat, chest pain, headaches, blurry vision, and difficulty concentrating. She also related that C.H. was in her final year of chiropractic school and had recently completed her national boards, and thought that some of the symptoms might be related to stress and anxiety from her studies. In that e-mail, S.H. reported to Respondent that C.H. had tested negative for Lyme disease the previous week. Respondent received a copy of C.H.’s negative Lyme disease test report from blood collected on or about March 16, 2011. On or about March 22, 2011, Respondent documented his assessment of C.H. as Lyme disease and chronic fatigue syndrome. He ordered CD57, C3a, C4a, and ECP laboratory tests of C.H.’s blood. At the time these tests were ordered, Respondent had not seen or talked to C.H., taken her history, or performed a physical examination. Respondent did not at any time prescribe an ELISA test or Western blot test for C.H. On April 14, 2011, S.H. e-mailed Dr. Lentz to see if any test results had been received for C.H. Dr. Lentz replied, “CD57 51+ positive for Lyme. Babesia is negative at this time.” When asked how to proceed, he told her she needed to start treatment until the CD57 is over 120.12/ S.H. asked via e-mail whether C.H. should get treatment from Dr. Lentz or her family doctor, saying they would prefer to work through him, as this is his specialty. Dr. Lentz responded, “This is more than a good family physician can handle. I have 35 years of family practice and know first hand. Lyme is a multi-faceted problem and requires extra time and effort to educate and direct this complex problem.” On or about April 18, 2011, Respondent prescribed the antibiotics Omnicef (cefdinir) and azithromycin to C.H. At the time he prescribed these medications, Respondent had not seen C.H., and there is no documentation in the patient records that Respondent made any inquiry regarding potential allergies before prescribing these antibiotics. On or about April 25, 2011, C.H. presented to Respondent for the first, and only, office visit. The medical records for that date contain symptoms that C.H. credibly denies having reported to him, such as double vision, twitching, tremors and shakes, explosive (behavior), and shortness of breath. C.H. does not recall being weighed at that visit, although the record contains a weight for her. It does not however, indicate her temperature, pulse, or respiration rate. She recalls a minimum examination for which she remained clothed in shorts and a t- shirt. During the examination, Respondent asked if she had ever been bitten by a tick or had a rash, and checked some areas of her body for a tick bite/rash, which she denied ever having. Dr. Lentz did not inquire about her travel history. Despite the fact that one of her symptoms was the inability to take a deep breath and had suffered from heart palpitations, his patients do not reflect a temperature, pulse, or respiration rate. At that visit, Respondent added the antibiotic Flagyl (metronidazole) and Interfase Plus Prothera, an enzyme formulation, to C.H.’s medications. C.H. testified that at that visit, Dr. Lentz told her that he was a specialist with numerous years of experience, and that he was the only one certified to be able to treat this, and she would have to be under his constant care. C.H. also testified that he told her she would need to be medicated for the rest of her life, because Lyme disease lives forever in your body, and that she would probably never be able to get pregnant or have children. C.H. was devastated by this information. The entire visit with Dr. Lentz, including both the taking of her history and the physical examination, lasted approximately ten minutes. C.H.’s testimony is credited. On or about June 10, 2011, Respondent prescribed CD57, C3a, C4a, and ECP tests for C.H. On or about July 2, 2011, Respondent prescribed C.H. with Babesiosis. He made this diagnosis completely on the basis of test results, as C.H. had not returned to his office after her first and only visit. On or about July 9, 2011, Respondent added artemisinin (an antimalarial), Hepapro (a nutritional supplement); Mepron (atovaquone, an antiparasitic), heparin injections (an anticoagulant), magnesium oxide (antacid, laxative, dietary supplement), and omega-3 fatty acids to C.H.’s treatment. Respondent did not prescribe a blood smear examination for Babesial parasites or PCR amplification for Babesial DNA for C.H. At no time during her treatment did Dr. Lentz refer C.H. to a specialist. Indeed, he represented to her and to her mother that he was a specialist in Lyme disease and that he was better equipped to treat these conditions than a normal family practitioner would be. C.H.’s condition worsened rather than improved under the medication regimen Dr. Lentz prescribed. She suffered diarrhea and blurred vision and her other symptoms did not improve. Dr. Joel Rosenstock is a medical doctor licensed to practice medicine in the State of Georgia. He is board certified in internal medicine with a subspecialty in infectious disease, and has practiced infectious disease medicine for over 30 years. During the time related to this proceeding, Dr. Rosenstock was practicing in Atlanta, Georgia, at the AbsoluteCARE Medical Center and Pharmacy. C.H. first presented to Dr. Rosenstock on July 12, 2011, at which time she reported Dr. Lentz’s diagnoses of Lyme disease and Babesiosis. In contrast to her brief visit with Dr. Lentz, her consultation with Dr. Rosenstock lasted two to three hours. Dr. Rosenstock immediately ordered a Western blot test for C.H., which was negative. He conducted a thorough history and physical for her, and asked C.H. questions about her travel history, her dogs and where they slept, her hobbies, etc. He advised her that he did not believe that she had Lyme disease or Babesiosis, and recommended that she stop all of the antibiotics and other medications that Dr. Lentz had prescribed. He warned her that it could take several months before the drugs were out of her system, so relief from the side effects would not be immediate. Within a few weeks of stopping the medications, C.H. was feeling much better and was on her way to feeling back to her old self. Dr. Rosenstock did not believe that any of the tests that Dr. Lentz ordered for C.H. were useful in diagnosing Lyme disease or Babesiosis, and did not believe that heparin served any purpose in treating C.H. Based on the credible opinions of Drs. Powers and Robbins, and the testimony of Dr. Rosenstock as a subsequent treating provider, it is found that Dr. Lentz departed from the applicable standard of care in the care and treatment of C.H. in several respects. First, Respondent departed from the applicable standard of care by ordering blood tests and prescribing antibiotic treatment for C.H. (as well as other medications) when he had never actually seen her. At the time he ordered the blood tests, and at the time he first ordered medications for C.H., he had not obtained a history for her, much less a history that was suggestive of Lyme disease, and had not conducted a physical examination of any kind. All he had as a basis for ordering tests was the e-mail from her mother. This e-mail was an insufficient basis upon which to determine that testing for Lyme disease was warranted. When he did actually see C.H., he failed to perform an adequate physical examination and failed to take an adequate history that included travel history, possible exposure to ticks, how long any tick bite may have lasted, and the size and appearance of the tick. Respondent failed to use the generally accepted tests for the diagnosis of Lyme disease and Babesiosis, instead relying on tests that are meant for investigational purposes and indicate on their face that they are not meant for diagnostic purposes. Moreover, as noted above, at the time he ordered the tests, he had no basis upon which to believe C.H. had Lyme disease. Although even his own expert witness consistently stated that a diagnosis of Lyme disease is based in large part upon a thorough history, here, Dr. Lentz had no history. Dr. Cichon’s testimony that it was appropriate to rely on the information in S.H.’s e-mail about her daughter’s symptoms (keeping in mind that her daughter is an adult, not a child) is rejected as not credible. Respondent also departed from the applicable standard of care by prescribing Omnicef, azithromycin, artemisinin, Hepapro, Mepron, heparin injections, magnesium oxide, and omega-3 fatty acids for a condition that she did not have. Given that C.H. had no condition justifying the prescription of these drugs, the prescriptions were both inappropriate and excessive. They also were prescribed for a duration that was not justified, and exposed C.H. to complications that were unnecessary. Respondent was required to keep medical records that justified the course of treatment. His medical records for C.H. fell well short of this requirement. He failed to document a complete history, an adequate physical examination, or why he did not refer her case to a specialist. He also departed from the applicable standards when he used a diagnosis of Lyme disease as the basis for blood tests at a time when he had never seen the patient. Failure to Timely Report Diagnoses or Suspicion of Lyme Disease to the Department of Health (DOAH Case Nos. 15-2889 and 15-2890) Finally, in DOAH Case Nos. 15-2889 and 15-2890, the Department alleged that Respondent failed to report his diagnoses of Lyme disease or suspicions of Lyme disease for patients D.H., J.L., W.L., S.L., D.D., and C.H. to the Department of Health. Section 381.0031, Florida Statutes (2010-2011), requires certain licensed health care practitioners and facilities in Florida to report the diagnosis or suspicion of the existence of diseases of public health significance to the Department of Health. Lyme disease is one of the diseases identified by rule that meets the definition of a disease that is “a threat of public health and therefore of significance to public health.” § 381.0031(2), Fla. Stat.; Fla. Admin. Code R. 64D-3.029. There are forms that are identified by rule for use in reporting these cases. Fla. Admin. Code R. 64D-3.030(3). Ashley Rendon is a biological scientist for the Department of Health in Okaloosa County. Ms. Rendon is an epidemiologist whose duties include investigating reportable disease conditions and outbreaks of public health significance in Okaloosa County. According to Ms. Rendon, whose testimony is consistent with the Department’s rules on this subject, all diagnosed or suspected cases of Lyme disease must be reported to the Department. Once reported, the county health office will conduct an analysis of the reported diagnosis or suspicion, based on a “guidance to surveillance” document, to determine whether the reported case meets the definition for Lyme disease such that the case needs to be reported to the statewide system and to the CDC. Ms. Rendon testified that whether a suspected case or a diagnosis meets the case definition is not for the practitioner to decide. Ms. Rendon’s testimony is credited. According to Ms. Rendon, the Department maintains records both for those reported cases that met the case definition and those reported cases that did not. For 2010, there was one case of Lyme disease that was confirmed, probable, or suspect. None were reported for 2011. There were seven to eight additional cases that were reviewed, but not reported as probable, confirmed, or suspect. Not all reported results are confirmed by ELISA or Western blot. Ms. Rendon reviewed the records of the Department to determine whether Dr. Lentz had reported any cases of Lyme disease, whether suspected or diagnosed, to the Department. There was one instance where a patient of Dr. Lentz’s apparently called in and asked questions, but there was no record of Dr. Lentz or anyone in his office reporting Lyme disease. Dr. Lentz claimed that he had at least on one occasion attempted to report in the past, but that he could not say if he had reported any of the patients named in the Administrative Complaints. He claimed that the Department would not accept reports that are not supported by two-tier testing results, so he stopped trying to report. His claim is rejected as not credible. There is clear and convincing evidence to establish that Respondent failed to report his diagnoses of Lyme disease for patients D.H., J.L., W.L., D.D., S.L., and C.H. General Observations Of the seven patients presented in this proceeding, Dr. Lentz saw only two before ordering tests for Lyme disease and in some cases, Babesiosis or Bartonellosis. With respect to C.H., not only did he fail to see her before ordering testing, but he ordered medications for her without ever obtaining a medical history or performing a physical examination. Some of the patients specifically requested testing for Lyme disease. However, it is the physician’s responsibility to determine whether there is any realistic reason to believe that a patient has a need for such tests. Moreover, in several instances, the general, non-specific symptoms related by the patients suggest several other alternative conditions that could cause the patients’ problems. Even Respondent’s expert opined that Lyme disease, Bartonellosis and Babesiosis share a lot of general, non-specific symptoms with other illnesses, including serious diagnoses such as ALS, MS, and rheumatoid diseases. These are all, according to Dr. Cichon, differential diagnoses that a physician should sometimes consider when trying to find a diagnosis. Yet with all of these patients, Dr. Lentz went straight to Lyme disease every time. He did not consider much of anything else when even to a lay person, the records cry out for a more thoughtful and measured approach. In short, it seems that Dr. Lentz wanted to find Lyme disease regardless of the symptoms presented, and so he did. By doing so, he cost these patients not only the money used for testing and, with respect to C.C., W.L., S.L., and C.H., subjecting them to treatments they did not need and, in at least with respect to S.L., could not afford, but he subjected them to a treatment regimen that made them miserable, was of questionable benefit, and exposed them to unnecessary risks. Petitioner presented the expert testimony of Dr. Charles Powers, a general family practitioner, and Dr. William Robbins, an infectious disease specialist. It also presented the testimony of subsequent treating physicians: Dr. Janelle Robertson, Dr. Patrick Anastasio, and Dr. Joel Rosenstock. Each subsequent treating physician testified credibly that the symptoms presented simply did not justify a diagnosis of Lyme disease, and the testing they either conducted or reviewed did not indicate a basis for such a diagnosis. Their testimony was consistent with that of both expert witnesses presented by the Department, and the testimony of these subsequent treating physicians and expert witnesses have been accorded great weight. Respondent presented the testimony of Dr. Michael Cichon, a retired infectious disease specialist. Dr. Cichon’s testimony was in many respects inconsistent, and at times he seemed to be struggling to actually support the care and treatment that Respondent performed in these cases. While he championed Respondent’s use of the CD57, the ECP, and the Fry test, he also admitted that he seldom, if ever, used some of these tests, and that there were problems with standardization of the tests. Moreover, the tests themselves indicated on their face that they were for investigational, as opposed to diagnostic, use, and should not be used as the sole basis for diagnosis of patients. Because of the significant inconsistencies with his testimony and the contrasts between what he advocated and what Dr. Lentz sometimes did, his testimony is given little weight.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent has violated section 458.331(1)(g), (m), and (t), as alleged in the three Administrative Complaints at issue in this proceeding; and by the findings that Respondent violated section 458.331(1)(t) with respect to all seven patients, Respondent is guilty of repeated malpractice. It is further recommended that the Board of Medicine revoke his license to practice medicine in the State of Florida, impose an administrative fine in the amount of $30,000, and impose costs pursuant to section 456.072. DONE AND ENTERED this 8th day of July, 2016, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON 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 8th day of July, 2016.
