The Issue The issues to be determined are whether Respondent is unable to practice medicine with reasonable skill and safety by reason of illness, or physical or mental condition, in violation of Section 458.331(1)(s), Florida Statutes (2008, 2009)1/, and if so, what penalty or restriction should be imposed?
Findings Of Fact 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 has been a licensed medical doctor within the State of Florida, having been issued license number ME 33042. She is board certified in internal medicine and has never been the subject of a disciplinary proceeding against her Florida license. Dr. Sharpe's mailing address of record during the time relevant to these proceedings was 6603 San Juan Avenue, #1, Jacksonville, Florida 32210, and she practiced medicine at this address. On November 8, 2008, Detective Elaina Gonzales of the Jacksonville Sheriff's Office Narcotics Division was investigating a complaint that a patient, E.R., might be "doctor shopping." As part of that investigation, Detective Gonzales contacted Dr. Sharpe to see if E.R. was a patient of hers. When Dr. Sharpe confirmed that E.R. had been a patient for a couple of months, Detective Gonzales asked her to locate the chart so that they could verify what medications E.R. had received and the dates they had been prescribed. Dr. Sharpe related that she could not locate the chart at that time, because she was at the office alone, was in a wheelchair, and was very ill with "African fever." Detective Gonzales asked her whether she required her patients to sign pain contracts, and Dr. Sharpe indicated that she did not believe in them. The conversation, which was by telephone, left Detective Gonzales "uneasy," and she found Dr. Sharpe's responses to be strange, in that she appeared to be confused and would answer questions in a tangential manner that was hard to follow. On January 19, 2009, two and a half months later, Detective Gonzales arrested two suspects who attempted to fill fraudulent prescriptions at Panama Pharmacy. During the arrest, there was a search of the suspects' vehicle, and a blank prescription pad bearing Dr. Sharpe's name was seized, along with a prescription for 60 pills of Oxycontin 80 mg dated January 20, 2009, taken from suspect G.L.'s wallet. Four other prescriptions G.L. attempted to fill were recovered from pharmacies. All four were on printed prescription forms bearing Dr. Sharpe's name. The handwriting on the four prescriptions recovered from various pharmacies, while on Dr. Sharpe's prescription pad, is not consistent with the handwriting from prescriptions that Dr. Sharpe identified as ones she wrote. Detective Gonzales attempted to contact Dr. Sharpe to verify whether she wrote the prescriptions on January 19, 2009, but was unable to contact her. The next day, she called Dr. Sharpe and asked whether G.L. was a patient, which Dr. Sharpe confirmed. Detective Gonzales asked Respondent if she post-dated prescriptions, which she denied. Gonzales asked Dr. Sharpe to locate the chart so that she could verify when prescriptions were written for G.L. Dr. Sharpe indicated that she could not find the file, that she did not have an office staff and that she was ill and by herself. Detective Gonzales tried to impress on Dr. Sharpe the importance of verifying the prescriptions, because she had two suspects sitting in jail, and indicated that she would be coming to the office to have Dr. Sharpe look at the prescriptions. Dr. Sharp became upset and at first stated she would not open the door because she was sick. Eventually, she relented and gave instructions for the detective to let the phone ring three times in order for her to gain entrance to the office. Upon Detective Gonzales' arrival at the office at approximately 2:00 p.m. on January 20, 2009, she found Respondent in a wheelchair, wearing a nightgown and socks with no shoes. Dr. Sharpe asked Detective Gonzales to wear gloves so she would not get sick. At the time Detective Gonzales arrived, there was a woman in the reception area who Dr. Sharpe described as helping her. Detective Gonzales observed a patient waiting area and reception area that was cluttered and disorganized. The area appeared to include both household and office furniture, and the reception area contained what appeared to be piles of medical charts. Detective Gonzales showed Dr. Sharpe the prescriptions retrieved from G.L. and from the pharmacies. Dr. Sharpe denied writing the prescriptions presented to the pharmacies and described in paragraph 7. She identified the prescription to G.L. dated January 20, 2009, taken from G.L.'s wallet, as being a prescription she wrote. (See Petitioner's Exhibit 3). When Detective Gonzales asked Dr. Sharpe why she post- dated the prescription, Dr. Sharpe became upset with her, and started telling a story that did not answer the question. Gonzales asked to see the patient's file, and Dr. Sharpe could not find it. Detective called DEA Drug Diversion Investigator Lutz while she was at the office, because she wanted to have someone else observe what she had observed. While she waited for Investigator Lutz to arrive, she sat with Dr. Sharpe and talked, and the woman helping Dr. Sharpe continued to look for G.L.'s file. The file was never located during this visit. During this time, a couple arrived with soup for Dr. Sharpe. Once Investigator Lutz arrived, Detective Gonzales left the reception area to search for a restroom. While in the back part of the building, she observed a room with a bed and a TV on, along with a dresser and clothes. It appeared to Detective Gonzales that Dr. Sharpe was living out of her office. Detective Gonzales asked Dr. Sharpe if she was living in her office, and Respondent said she would stay at the office for a couple of days, because she could not get up and down the stairs at her home. Investigator Lutz has since married, and is now known as Investigator Walters. She and another DEA agent arrived at the office while Detective Gonzales was still present. She also confirmed that Dr. Sharpe was in a wheelchair, wearing a nightgown and robe, and that she did not appear to be feeling well. She also confirmed that the office was disorganized. Dr. Sharpe also asked her and her partner to wear gloves because she was concerned she might be contagious. Investigator Walters was concerned that Dr. Sharpe was not in any condition to be seeing patients. She asked Dr. Sharpe if she was in fact seeing patients, and Dr. Sharpe indicated she was not feeling well, and had been sick for a while, but was seeing patients when she was able. Given her age and the comments regarding her health, Investigator Walters asked Dr. Sharpe if she had thought about retiring. Dr. Sharpe was upset by the question and said she had not thought about doing so. Investigator Walters also indicated that Dr. Sharpe rarely answered a question directly. She would start to, then go off on a tangent about something in her past, and indicated that she thought she had some type of African Fever. Investigator Walters felt the interview was not productive, and Dr. Sharpe kept stressing how poorly she felt, so Investigator Walters asked Dr. Sharpe to contact her in the next couple of weeks. Dr. Sharpe left Investigator Walters one voice message. When Investigator Walters tried to return the call, sometime in February, she reached the answering service and was informed that Dr. Sharpe was still sick. Detective Gonzales also attempted to contact Dr. Sharpe after the January 20 visit. Each time, Dr. Sharpe's answering service indicated that she was ill. A prescription bearing Dr. Sharpe's signature was written for patient D.T. on March 3, 2009. The prescription was for 480 pills of Oxycontin 15mg. (See Petitioner's Exhibit 6). Two other prescriptions written for D.T. on Dr. Sharpe's prescription pad were subsequently recovered from Walgreen's pharmacy and are included in the record as Petitioner's Exhibit One, dated March 5, 2009, was for 360 pills of Oxycontin 40mg. The second, dated April 2, 2009, was also for 360 pills of Oxycontin 40mg. While no testimony was presented indicating that Dr. Sharpe ever confirmed that she had written the two prescriptions described above and contained in Petitioner's Exhibit 9, the handwriting appears to be the same as that on the prescription in Petitioner's Exhibit 6, which Dr. Sharpe confirmed was her handwriting. On March 25, 2009, Investigator Wendy Foy of DOH notified Dr. Sharpe by letter that she was under investigation. Dr. Sharpe was advised that she had 45 days to submit a written response and to contact the office to schedule an interview, if she chose. The letter also requested that she provide a copy of her curriculum vitae. The 45-day period for filing a response would have required that any response be filed by May 9, 2009. Dr. Sharpe called in response to the letter. She appeared to be aggravated that the Department was investigating her, and referred to Detective Gonzales as "a loud mouth detective" who barged in her office, demanding to see information. She told Ms. Foy that she would be providing a written response to the complaint, but said she had been sick for weeks. Ms. Foy called Respondent again because she had not received a response, although the timing of the phone call is not clear. Dr. Sharpe stated that she had been sick and was in the process of writing her response and sending it to her typist. Dr. Sharpe's response was received by the Department on April 28, 2009. The response are as follows:2/ The delay in response is not dismissive. I needed to gather facts and explain myself while considering the facts you need. One thing I find interesting is "confidential" at the top of your letter. The detective -- whose name I don't recall -- I referred to her as "the mouth" acted as a bully here and told me by phone that I pass out medication "like candy" (news to my patients) before I ever met her. She has told pharmacists around the Westside that I am under investigation. They've told my patients. My patients have told me. I have explained to the patients that it is appropriate, if there is a question, to have an investigation. That is the right and the job of the State to protect them. However, she was unprofessional and demonstrated inability or unwillingness; definitely unworthiness to keep a confidence. There is another narcotics detective in the JSO that I work with very well. I have, on occasion, had a questionable prescription. When this happened I reported to her and fired the patient. . . . If indeed the patient IS a patient. You may be interested in the fact that I fly in the dark as I've talked to some of my colleagues. We don't get notified of people that are using narcotics or selling things or anything. If I were a gun salesman or a pawn broker I would have a hot list. I'm supposed to know to spot criminals when what I see are patients that are sick. This whole system is remarkable. It's "gotcha", but that's for another letter. On the day that the questionable detective demanded entry, I had already placed myself in isolation. That is the only thing a good citizen would do with a severe virus to keep it from spreading. Two volunteer friends were sorting out the mail and "shuffling papers". They were friends NOT regular employees or "trained medical assistants." She had them terrified standing over them. She claimed to be waiting for a partner. She was waiting for the DEA. They insisted on entry as well. Before the detective came I had told my helpers I was exhausted and needed a nap. I never got dressed that day. I wore a nightgown and a thermal blanket which is better than a housecoat as I am in a wheelchair. . . . yet they pressed on. Why she lied leaves me mystified, where was I going? I met them all at the door with a box of rubber gloves because, again, I tried to protect anyone else from this terrible virus which kept me out of work for weeks. The DEA asked questions like "what do you give to a new patient?" Well teaching for four years in the United States Peace Corps and before that in Watts before the riots, I believed that there was no such thing as a dumb question but that sure is one. In my diminished state I waited for the rest of the question. An example would be, maybe, presentation of a case. When that did not come I told them all to leave. They were "kicking me when I was down". You've asked about the chart they demanded. My terrified helpers were separated from me and looked everywhere. I didn't know what the problem was as they were in the business office and I was in the waiting room. I NEVER SAW THE PATIENT SHE REQUESTED AS THERE WAS NO CHART. He was due several days later. (Please see the page from my calendar) There were two charts requested, G.L. was going to be seen on February 3, 2009 as a new patient. I never saw him. The other chart they requested was R.G. That chart was taken. I want it back. I have no receipt. I don't know what this woman thinks she knows but she is destructive and inefficient in her gang buster method. We're not used to this. The JSO is better than she is. I recently had the pleasure to write some lovely letters to Sheriff Rutherford regarding some of his staff when I suffered a felony. I never planned to write about this individual or her demeanor. "If you can't say something nice . . .". She is, however, a disgrace and I guess I need to defend myself and let you know the details so that you can come to your own conclusion. The detective demanded two charts. R.G., she took the chart and did not give it back. I've not seen him again, anyway. G.L. They came in on January 15th or 16th -- I'm unsure as I said and he was due to come in for a new patient evaluation (2 hours) on February 3, 2009 at 2:00 pm. If this signifies giving out medicine like candy then I guess it is. As a double check I asked my transcriptionist for a history and physical from her computer memory and there was no such patient as G.L. I've never seen him. I hope this explains your legitimate concerns and her attempt to build a case from thin air. I don't know what she thinks she knows. I do request all of the reports if I can get them as you said is my right. Further, I have such an extensive Curriculum Vitae. I cleaned it up as I don't put everything in it. I don't even know if I have one right now. I have to reconstruct it as nobody asks for them. I will ask my transcriptionist if she has one in memory. As a blind copy I'm going to send you the letters that I've sent the Sheriff because it has a couple of things from my background anyway and my awe of the police force and the JSO here. I don't have an attitude toward them, just her. She is an outlier certainly. Thank you for opportunity to respond to your concerns. Sincerely yours, (signed) Isabella K. Sharpe, M.D. Isabella K. Sharpe, M.S.M.D.,F.A.C.P. Dr. Sharpe's written response differs from Detective Gonzales' and Investigator Walters' accounts of the events in several respects. For example, she identifies the date of their visit to be January 15 or 16, as opposed to January 20. She claims that Detective Gonzales retrieved a chart for a patient R.G. when there has been no testimony about such a patient. She claims that she never saw patient G.L. when Detective Gonzales testified that Respondent confirmed G.L. was her patient and identified the signature on his January 20, 2009, prescription as her signature. She claimed to be "separated" from her volunteers and unable to know what they were looking for, when all testimony indicates that the rooms involved are adjacent, with an opening between them. Detective Gonzalez' and Investigator Walters' testimony is credited. On June 23, 2009, DOH Investigator Foy as well as Investigative Manager Charles Coates went to Respondent's office to serve a subpoena for patient records. The Investigators had arranged previously for an appointment with Respondent for 12 o'clock sharp. When they arrived for the appointment, there were approximately seven or eight people in the waiting area, but appeared to be no one working in the reception area. Within 15 minutes of the investigators' arrival, all but two or three of the people in the waiting room left the office without seeing Respondent. Despite having a noon appointment with Respondent, the investigators waited for approximately an hour to see her. During that entire time, no one appeared to be attending the reception area. It was not only unattended, but it appeared to the investigators that the area was in disarray. There were files stacked that appeared to be medical records in different areas on the counters, in no apparent order. The files were readily accessible to anyone seeking to look at them. Respondent finally appeared after the investigators had waited an hour. Once again, she appeared in a wheelchair with socks and no shoes. She attempted to conduct her interview with the DOH investigators in the patient waiting area in front of the remaining people waiting there. Mr. Coates advised her that the interview should be conducted in private, so the investigators and Respondent moved to the back of the building. During the interview, Dr. Sharpe confirmed that E.R., T.D. and S.D.T. (also referred to as D.T.) were her patients. Mr. Coates presented her with a prescription dated March 3, 2009, for 480 pills of Oxycontin 15mg, referenced in finding of fact Dr. Sharpe confirmed that D.T. was her patient, and that the prescription bore her signature, but that she "must have been out of it" when she wrote the prescription. She volunteered that she had been sick for weeks at a time. Subsequent to the June 23, 2009, interview, Investigator Foy contacted Dr. Sharpe about the records that were the subject of the subpoena. Dr. Sharpe indicated that she did not have time to get them and she wanted to get a volunteer to get the copies to DOH. She also told the investigator that one of her prescription pads was missing prescriptions from the middle of the pad. Dr. Sharpe apparently believed the prescriptions were taken by a volunteer, whom she "fired" by not treating the volunteer any longer. No evidence was presented to indicate that any of the subpoenaed records were ever supplied to the Department. On September 18, 2009, Dr. Sharpe was evaluated by George M. Joseph, M.D., a board certified psychiatrist. Dr. Joseph has been licensed in Florida since 1970, and has performed evaluations for the Professionals Resource Network (PRN) since the mid '80's. In addition to interviewing Dr. Sharpe for 90 minutes, Dr. Joseph administered the MMPI and reviewed investigative materials supplied by the Department and chronicled in the collateral history section of Dr. Joseph's report to the Department (See Petitioner's Exhibit 10). Dr. Sharpe related to Dr. Joseph that her general health was affected when 17 years ago she received vancomycin, a very powerful antibiotic, for an infection. The medicine caused renal failure and neurotoxicity, which in turn caused severe vertigo from which she still suffers. As a result, she is confined to a wheelchair. Dr. Sharpe also indicated to Dr. Joseph that she self-prescribes medicine for a pituitary tumor, and for hypothyroidism. During his interview with Dr. Sharpe, they talked about several topics, including her reaction to Detective Gonzales and the DOH investigation; her prescribing practices; and her office management style. With respect to her prescribing practices, Dr. Sharpe acknowledged treating a number of patients who suffer from severe pain, and indicated that "I have to believe my patient," regarding their reporting of pain. She also stated her belief that other physicians were not giving patients the medication they needed, and that she did, enabling patients to have a better quality of life. She acknowledged that she is not a pain management specialist. Dr. Joseph also noted that in the interview, Dr. Sharpe's thought process was circumstantial and digressive, with reference to previous life experiences as opposed to analyzing a question and discussing it directly. Dr. Joseph opined that Dr. Sharpe has an Axis II, personality disorder not otherwise specified (NOS), with marked characteristics of hyperthymia. A personality disorder, NOS, is recognized in the Diagnostic and Statistical Manual IV (DSM-IV) under diagnostic number 301.9. Hyperthymia is a personality temperament that would be characterized by a prominently upbeat mood, and a person who admits to very few, if any problems. A person who is hyperthymic is overly enthusiastic and upbeat, exuberant, grandiose and talkative. Such a person minimizes the effect of any negative situations and always try to portray herself in a positive light, believing she can "trump" the applicable rules with rules they fashion themselves. A personality temperament becomes indicative of a personality disorder where, as here, it has some affect on a person's functioning occupationally or socially, or both. Dr. Joseph opined that Dr Sharpe is unable to practice with reasonable skill and safety. He reached this ultimate opinion because, in his view, her personality disorder creates a tendency on her part to form judgments about prescribing to pain patients that can be idiosyncratic and excessive, and impairs her clinical judgment. The impairment of her clinical judgment impairs her ability to discern legitimate patients from patients who are manipulating physicians for medications. This represents a danger to patients by the prescription of excessive amounts of medication with possible misuse by those receiving them. Dr. Joseph also opined that Dr. Sharpe's personality disorder impairs her ability to maintain adequate medical records for her patients, and to maintain an orderly practice. He based this opinion on her failure to maintain boundaries with her patients, as illustrated by her using patients as "volunteers" in her office, and her inability to retrieve records when requested. These failures present, in his view, a danger to patients because of the failure to maintain adequate records for providing a history of medications prescribed, any side effects to those medications, and the patient's ongoing treatment. With pain management patients, the need for accurate and available medical records is especially important. In other words, Respondent displayed a cavalier attitude with respect to both prescribing pain medication and recordkeeping, in areas that the medical profession generally regards as very serious, controlled and organized. The Respondent did not present any expert testimony to rebut Dr. Joseph's view. Dr. Joseph's opinion that Respondent cannot practice with reasonable skill and safety at this time is accepted.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED that the Florida Board of Medicine enter a final order finding that Respondent is unable to practice with reasonable skill and safety by virtue of a mental condition, as proscribed in Section 458.331(1)(s), Florida Statutes. It is further recommended that Respondent's license to practice medicine be suspended, until such time as she demonstrates that she can practice with reasonable skill and safety. DONE AND ENTERED this 1st day of December, 2009, 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 1st day of December, 2009.
The Issue Whether, in treating a single patient, who was actually an undercover law enforcement agent, Respondent, a medical doctor, violated sections 458.331(1)(m), (q), and (t), Florida Statutes; if so, whether (and what) disciplinary measures should be taken against Respondent's license to practice medicine.
Findings Of Fact The Parties At all times relevant to this case, James Alexander Cocores, M.D., was licensed to practice medicine in the state of Florida, having been issued license number ME 76635. The Department has regulatory jurisdiction over licensed physicians such as Dr. Cocores. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Cocores committed three such offenses. In Count I of the Complaint, the Department charged Dr. Cocores with the offense defined in section 458.331(t), alleging that he committed medical malpractice in the treatment of fictitious patient, L.D. In Count II, Dr. Cocores was charged with prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of his professional practice, an offense under section 458.331(1)(q). In Count III, the Department charged Dr. Cocores with the offense defined in section 458.331(1)(m), alleging that he failed to keep legible medical records that justified L.D.'s course of treatment. Background and Initial Appointment This matter had its genesis in July 2010, following an anonymous complaint that Dr. Cocores was prescribing Roxicodone (oxycodone hydrochloride), Oxycontin (oxycodone hydrochloride controlled release), and other controlled substances, in exchange for a fee, and without conducting an exam. The complainant further alleged that Dr. Cocores would leave prescriptions for controlled substances at the reception desk of his office without seeing the patient. Based on these allegations, the Palm Beach County Sheriff's Office initiated a criminal investigation. Initially, an undercover agent attempted to obtain an appointment with Dr. Cocores for pain management; however, he advised that he was not taking on any new patients for pain management. Thereafter, an undercover officer (hereinafter referred to as L.D.) sought to establish herself as a new patient in need of psychiatric treatment. This strategy was successful, and L.D. obtained an appointment with Dr. Cocores for August 10, 2011. Prior to the first session, an Office-Based Opioid Treatment Order (OBOT Order) was obtained that allowed law enforcement to create undercover audio and video recordings of the sessions by and between L.D. and Dr. Cocores. On August 20, 2011, L.D. presented to Dr. Cocores. As is customary, L.D. completed a lengthy medical questionnaire. In response to the "Presenting Problems" section, L.D. noted "not feeling like me anymore." She further noted, inter alia, that she (1) fatigued easily, (2) was easily distracted, (3) had problems focusing or concentrating, (4) had memory difficulties, believed she was depressed, (6) sometimes had disorganized thinking, social isolation, binged or purged food, anxiety/panic attacks, (7) had trouble sleeping and often wakes during the night, (8) experienced weekly headaches, (9) had mood swings, and (10) was having financial problems. L.D.'s questionnaire further noted that she felt distant from her husband at times and attributed the same to the loss of her brother. Concerning her physical condition, L.D. noted that her last physical exam was approximately two weeks prior and that she had fallen off of a horse in February 2011. Absent from the questionnaire was any indication of pain. L.D. further documented in the questionnaire that she had not had any previous psychiatric or chemical dependence treatment and that there was no family psychiatric history. She also noted daily use of caffeine, alcohol, codeine, pain killers, and sleeping pills (six months prior). L.D. listed Roxicodone, Xanax (alprazolam), and ibuprophen, as her current medications. During the initial consultation, L.D. explained that her issues stemmed from her decision to remove her brother from life support following a motorcycle accident around Christmas of 2010. L.D. advised Dr. Cocores that subsequent to the accident "things just aren't right any more" and that she felt numb and was "just going through the motions." In addition to providing pertinent family history, L.D. discussed her sleeping problems. When Dr. Cocores inquired into the horse accident, L.D. advised she had been under the care of a chiropractor, as well as a pain management physician who was prescribing her oxycodone, Xanax, and ibuprophen. During this initial session, L.D. did not request any medications and none were suggested or prescribed by Dr. Cocores. The initial session included discussions on nutritional counseling, guidelines for bereavement, techniques for mitigating pain in her back, and talk-therapy. At the conclusion of the first session, L.D. and Dr. Cocores agreed to reduce further sessions from one hour to a half-hour, due to her financial hardship. Dr. Cocores's medical notations for the first session are less than one page and reflect that the next discussion will focus upon the decision to remove her brother from life support. September 7, 2011 Session On September 7, 2011, L.D. presented to Dr. Cocores for a follow-up visit. L.D. and Dr. Cocores returned to the topic of removing L.D.'s brother from life-support. L.D. advised Dr. Cocores that she had discussed the same with her pastor, and a discussion followed generally concerning guilt and anger. L.D. initiated a conversation concerning her sleep issues. She advised Dr. Cocores that she had been without Xanax for approximately three weeks, and, therefore, she had been taking her husband's Ambien at night. She explained that her pain management physician had been "shut down by the DEA or something." L.D. advised Dr. Cocores that her pain management physician possessed a former MRI from an automobile injury, as well as X-rays; however, she was not sure she could "get all that." When L.D. inquired as to whether Dr. Cocores could help her, the following dialogue transpired: DR. COCORES: Well, Xanax, I can do. And [the pain management physician] wasn't supposed to be writing this—that oxycodone unless he's a psychiatrist. L.D.: Oh, really? DR. COCORES: Yeah. And then once— L.D.: He didn't say that to me. Maybe (Inaudible) DR. COCORES: (Inaudible.) L.D.: Well, apparently, they were after him. DR. COCORES: They came after me, and I had to change my ways. And—but I am the psychiatrist. So they, so far, are not bothering me. So I can –I –so he wasn't a psychiatrist. He – one of the reasons he might have gotten busted is because he was giving out psychiatric meds with pain medication. You aren't supposed to do that unless you are a psychiatrist. And, basically anyone that writes oxycodone is subject to investigation. And so I stopped writing oxycodone since the DEA was last here in February. And so – and they know I'm not taking any new pain people. But what I can do is I certainly can write the Xanax, and I can certainly write the Motrin. As far as oxycodone, the only thing I could give you to replace it, is either – I would prefer Vicodin 10-milligrams if you can tolerate it and don't get sick on it. That would be best. L.D.: Right. DR. COCORES: I would rather avoid Percocet, which is oxycodone 10. L.D.: Right. Thereafter, L.D. advised Dr. Cocores that she had previously taken Percocet without issue. L.D. again reiterated that she had fallen from a horse; however, she responded affirmatively to Dr. Cocores's question that she did not have surgery for that event. As a result, Dr. Cocores noted that, "[s]o then you also need to get a copy of an MRI for the next time; although, it's not as crucial with the Vicodin." He also noted that, "[w]hat's good about Vicodin is that you can get refills on it." Respondent prescribed 30 dosage units of Xanax 1 mg and 120 dosage unites of Vicodin1/ 10/325 mg to L.D. on September 7, 2011. Dr. Cocores noted that, "[w]ell, if you are going to continue with the pastor, you have enough medicines here for three months. And so that will save you some money. And you can continue with him and then if you need some spot checks for therapy, you can come in." The totality of Dr. Cocores' medical notes for the September 7, 2011, session are as follows: RX Vicodin 10/325 #120 RX Xanax 1mgLS #30 Subsequent Sessions L.D. presented to Dr. Cocores on November 10, 2011, just shy of two months since her last visit. During this "spot check", L.D. and Dr. Cocores very briefly discussed artificial sweeteners and then transitioned to whether the medications were helping L.D. sleep. L.D. advised Dr. Cocores that she had been out of Xanax "for a little bit because I think you – I only got like two months." L.D. advised Dr. Cocores that she didn't like the Vicodin and was hoping to get back on either oxycodone or Percocet.2/ She informed Dr. Cocores that she didn't know who else to go to. Dr. Cocores instructed L.D. that, "we can't do oxycodone. It's just too expensive and too highly scrutinized and too unavailable." Instead, he notified L.D. that "we could do four Percocet, if you want to." Dr. Cocores informed L.D. that the Xanax could be renewed; however, the Percocet could not. As such, it was agreed that L.D. would make a return appointment in one month. On this date, Dr. Cocores prescribed 30 dosage units of Xanax 1 mg and 120 dosage units of Percocet 10/325 mg to L.D. Dr. Cocores' medical notations for the November 10, 2011, visit are as follows: D/C Vicodin Percocet 10/325 Xanax 1mg LS #30 On December 8, 2011, L.D. returned to Dr. Cocores, as scheduled. After discussing various religious traditions, Dr. Cocores segued into whether the medications were working for L.D. She responded affirmatively; however, she noted that she becomes nauseous on occasion. Thereafter, the conversation primarily focused on nutrition. Dr. Cocores also inquired into her pain. L.D. responded by informing Dr. Cocores that her pain was in the thoracic lumbar area and primarily occasioned upon picking up her minor child. Dr. Cocores prescribed 30 dosage units of Xanax 1 mg and 120 dosage units of Percocet 10/325 mg to L.D. Dr. Cocores' medical notes for the December 8, 2011, visit are as follows: Percocet 10/325 #120 Xanax 1mg #30 L.D.'s next spot check with Dr. Cocores occurred on January 4, 2012. On this occasion after L.D. wished Dr. Cocores a Happy New Year and apologized for being 15 minutes late, Dr. Cocores immediately stated, "Well, I'll try to get that—what you need; I guess you just need a refill?" L.D. then advised Dr. Cocores that she was leaving for a ski trip and requested something stronger like "the oxies that I used to take." Dr. Cocores refused this request noting that "they're unobtainable and they're extremely expensive." He further noted that, "there's just too much scrutiny around those medicines." After discussing vacation plans, a follow-up appointment was scheduled. Dr. Cocores again prescribed 30 dosage units of Xanax 1 mg and 120 dosage units of Percocet 10/325 mg to L.D. On this occasion, Dr. Cocores' medical notes simply provide: "Rxs." On February 1, 2012, L.D. returned to Dr. Cocores. Again, Dr. Cocores prescribed 30 dosage units of Xanax 1 mg and 120 dosage units of Percocet 10/325 mg to L.D. Again, his medical notes for this visit provide: "Rxs." L.D. returned to Dr. Cocores on February 29, 2012. After discussing L.D.'s clothing accessories, Dr. Cocores inquired if the two medicines were "working out all right." L.D. responded that things were going really well and she was staying busy with her child. He further asked if she was still attempting to minimize the daily damage to her spine based on correct posture. She noted that she walks big dogs, and picks up her child. Dr. Cocores confirmed that the Percocet and Xanax were not impairing her ability "to drive or be safe." In response, L.D. noted that she gets a foul stomach every once in awhile. Dr. Cocores opined that he thought it was the Tylenol more than the Percocet. L.D. agreed and explained that was why she would rather just have the oxycodone. Dr. Cocores replied to this request by stating, "Is that what you want to do?" Thereafter, Dr. Cocores prescribed 30 dosage units of Xanax 1 mg and 75 dosage units of oxycodone 15 mg to L.D. on February 29, 2012. His medical records for that occasion simply provide: ? (change) Perc?Oxy 15 #75. On March 28, 2012, L.D. returned to Dr. Cocores. After initial greetings, Dr. Cocores confirmed that L.D. had switched to oxycodone from Percocet and inquired as to where she obtained the prescription. He then confirmed that L.D. was "trying to minimize the injury that you inflict upon yourself every day with physical exercise." Dr. Cocores then proceeded to request an updated MRI "or else I can't prescribe it anymore because they're getting very strict with that stuff." L.D. also advised that she needed additional Xanax and Dr. Cocores confirmed through L.D. that the Xanax did not interefere with her functionality. He also asked L.D. whether the oxycodone interfered with her ability to drive or her coordination, to which she said it did not. Dr. Cocores prescribed 30 dosage units of Xanax 1 mg and 75 dosage units of oxycodone 15 mg to L.D. on February 29, 2012. His medical records for that occasion simply provide: Rx Oxy 15 #75 Rx Xanax 1mg #30 L.D.'s last visit to Dr. Cocores occurred on April 25, 2012. Dr. Cocores asked, "So how is the oxycodone and the Xanax working for you, okay? L.D. replied, "I mean, I – I guess I've been doing pretty good, you know." Again, Dr. Cocores asked her whether it interfered with her coordination or driving. L.D. confirmed that she does "okay." Dr. Cocores also confirmed that L.D. had not reinjured her back. L.D. replied that she had not but still lifts her child and walks big dogs and that she gets by. There is no evidence that L.D. provided an updated MRI at any point during this session. Notwithstanding Dr. Cocores's previous demand of an updated MRI as a condition precedent to further prescriptions for oxycodone, he prescribed 30 dosage units of Xanax 1 mg and 75 dosage units of oxycodone 15 mg to L.D. on April 25, 2012. With the exception of writing the date, Dr. Cocores did not author any medical records or notations for this visit. Expert Testimony Medical Malpractice and Recordkeeping Petitioner offered the deposition of Dr. Edward Dieguez, Jr., M.D., as an expert in pain management. Dr. Dieguez is a diplomate of the American Academy of Pain Management, an anesthesiologist, and chronic pain management specialist. Dr. Dieguez opined that Dr. Cocores fell below the standard of care for the use of controlled substances for the treatment of L.D.'s pain, as set forth in Florida Administrative Code Rule 64B8-9.013.3/ Dr. Dieguez opined that Dr. Cocores was deficient in every respect of the rule. Specifically, Dr. Dieguez testified that Dr. Cocores failed to comply with the standard of care in the following respects: 1) failed to perform and document a history and physical examination appropriate for a patient with pain; 2) failed to establish sound clinical grounds to justify the need for the therapy instituted; 3) failed to establish a treatment plan, delineating any objectives that he used to determine treatment success, such as pain relief and improved physical and psychological function; 4) failed to use any other modalities of treatment such as interventional techniques, and failed to request consultations with other specialists such as interventions, orthopaedic surgeons, neurosurgeons, or pain specialists; 5) failed in attempting to prevent drug abuse and diversion; 6) failed to document evidence to support any diagnostic impression for the therapy instituted and; 7) failed to properly document the medications prescribed including the strength, number, frequency, and date of issuance. Dr. Dieguez also opined that the medical records relating to Dr. Cocores's treatment of L.D. were deficient. Dr. Dieguez succinctly opined that, "there was basically no medical records." The undersigned finds that the testimony of Dr. Dieguez is credible. The undersigned concludes, and Dr. Cocores concedes, that the Department presented sufficient evidence to establish that Dr. Cocores breached the prevailing professional standard of care in prescribing pain medication to L.D., as set forth in rule 64B8-9.013, thus violating section 458.331(1)(t)(1)(Count I), and that Dr. Cocores failed to keep appropriate medical records as required by section 458.331(1)(m)(Count III). The Department also presented the testimony of its second expert witness, Scott Teitelbaum, M.D., by deposition transcript. Dr. Teitelbaum, is certified by the American Board of Pediatrics and the American Board of Addiction Medicine. He is an associate professor at the University of Florida, and is the Vice-Chairman of the Department of Psychiatry. Dr. Teitelbaum practices psychiatry on a daily basis. Dr. Teitelbaum confirmed that rule 64B8-9.013 applies to physicians who practice psychiatry in the state of Florida when those physicians prescribe controlled substances for the treatment of their patients' pain. He further opined that Vicodin, Percocet, and oxycodone are not medications used to treat psychiatric disorders or conditions, and, therefore, Dr. Cocores would have breached the standard of care in prescribing the same in the treatment of any psychiatric condition or mental health disorder. Dr. Teitelbaum testified that Dr. Cocores prescribed Xanax to L.D. for sleep issues. In his opinion, Dr. Cocores breached the standard of care in this regard, because he did not obtain a proper history, which would provide the appropriate rationale for the prescription. Additionally, Dr. Teitelbaum opined that Dr. Cocores breached the standard of care in failing to document and monitor the efficacy of the Xanax prescription. Dr. Teitelbaum also opined that the combination of Xanax (benzodiazepine) with an opioid (such as oxycodone) can create a great risk for adverse medical consequences. He explained that a physician prescribing such a combination must complete a thorough assessment of any substance abuse disorder; conduct drug testing and document the use or non-use of other drugs the patient may be taking; and inquire regarding the patient's alcohol usage. Dr. Teitelbaum opined that Dr. Cocores did not take the above-noted precautionary measures, and, therefore breached the standard of care in prescribing Xanax and oxycodone contemporaneously. The undersigned finds Dr. Teitelbaum's testimony to be credible and that it supports an additional and independent basis for finding that Dr. Cocores violated section 458.331(1)(t)(1)(Count I). Course of Physician's Professional Practice Dr. Dieguez further testified that Dr. Cocores was not practicing medicine during the sessions with L.D. Dr. Deiguez's testimony in this regard is rejected. Dr. Dieguez is not a psychiatrist, has never practiced psychiatry, and conceded that he could not testify regarding whether the interactions by and between Dr. Cocores and L.D. met or breached the standard of care from a psychiatric point-of-view. Although Dr. Teitelbaum testified that he was unclear as to "what was being addressed with respect to the medications that were being prescribed," he did not offer an opinion that Dr. Cocores was not practicing medicine. The undersigned finds, as a matter of ultimate fact, that Dr. Cocores's conduct did not occur outside the practice of medicine, and, therefore, he is not guilty of violating section 458.331(1)(q). Mitigation Dr. Cocores presented the testimony of four current or former patients to testify on his behalf. All four indicated that Dr. Cocores is a trustworthy and effective physician that they would recommend to other patients. No evidence was presented that Dr. Cocores has been previously disciplined.
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 Dr. Cocores violated sections 458.331(1)(t) and (m), Florida Statutes, as Charged in Counts I and III of the Complaint; Dismissing Count II of the Complaint; Imposing $10,000 in administrative fines, suspending Dr. Cocores from the practice of medicine for two years, requiring 200 hours of community service, five years of probation after completion of the suspension, and such restrictions on his license thereafter as the Board of Medicine deems prudent and for as long as the Board of Medicine deems prudent, and such educational courses in the prescription of controlled substances, as the Board of Medicine may require. DONE AND ENTERED this 24th day of June, 2013, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 24th day of June, 2013.
The Issue Whether Respondent violated sections 458.331(1)(m), (q), and (t), Florida Statutes (2007-2011), and, if so, what discipline should be imposed.
Findings Of Fact The Parties DOH is the state agency charged with regulating the practice of licensed physicians pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. DOH is pursuing sanctions against Respondent based on her provision of medical care to patients A.M., C.B., and P.A. At all times relevant to this case, Respondent was licensed as a medical doctor within the State of Florida, having been issued license number ME 59800. Respondent is board certified by the American Board of Internal Medicine with a specialty in Infectious Disease. Respondent received her medical degree from Christian Medical College in India in 1984. Her medical career, according to her curriculum vitae, includes the following places of employment: 1996 Bay Area Primary Care 1997 American Family and Geriatrics 1998 Faculty appointment at University of South Florida – voluntary 2/99-11/99 Veteran’s Administration (Medical Officer on Duty) 1993-present Private Practice Respondent’s June 30, 2014, deposition testimony was that she is currently working as a medical provider at Fort Tryon Rehab and Nursing Home in New York, and prior to that she was working at a walk-in clinic in Queens, New York. Respondent testified that she currently resides in Pinellas Park, Florida. In 2008, Respondent’s Florida practice, Bay Area Infectious Disease (BAID), was located at 5840 Park Boulevard, Pinellas Park, Florida, and most recently at 1527 South Missouri Avenue, Clearwater, Florida. Each practice location is now closed. Respondent later testified that she had a practice located at 6251 Park Boulevard, Pinellas Park, Florida, which is also closed. Jamie Carrizosa, M.D. (Dr. Carrizosa) is a board- certified internal medicine and infectious disease physician who testified as an expert for DOH. Prior to his retirement in July 2011, Dr. Carrizosa had an active medical practice including hospital privileges. He is currently an Associate Professor of Medicine at the University of Central Florida, teaching first and second year students in the areas of microbiology and immunology. While in private practice, he treated patients with suspected skin infections, MRSA skin infections, candidiasis and other types of skin diseases. Issa Ephtimios, M.D. (Dr. Ephtimios) is a board- certified physician in internal medicine, infectious diseases and infection control who testified as an expert for Respondent. He is an attending physician at Sacred Heart Hospital, West Florida Hospital, Baptist Hospital, and Select Specialty Hospital in Pensacola, Florida. DOH Case No. 2009-13497 (DOAH Case No. 13-0595PL) On October 8, 2008, A.M. presented to Respondent with complaints of fatigue, headaches, and moodiness, according to a History and Physical Medi-Forms document. A BAID contract for services and an authorization for BAID to disclose protected health information (PHI) were executed on October 8. Within the records there was a diagram that contained pictures of a front and back body diagram and the handwritten words: “fatigue cold sweats fevers headaches.” Neither A.M.’s name nor the date appeared on the diagram, yet Respondent identified the diagram as belonging to A.M. and showing A.M.’s small lesions. On October 9, A.M. executed a Bay Area Infectious Disease and Infusion, PLC, “CONSENT FOR TREATMENT” form. Respondent’s progress notes are generally listed in the S.O.A.P. format.16/ The following appeared on one of A.M.’s October 9th Progress Notes: S: Complaint: MRSA,17/ headecha [sic], she like [sic] to talk W Dr. Pimple on but [sic] 3 rounds Zyvox, [illegible] c/o lethargic, gain wt, fatigue, headaches Pale, feets [sic] not Percocet –[illegible].” O: Exam: Ht 5.6” Wt 172 Age 16 M/F BMI T BP 118/64 P 65 R PO2 99_ Gluc A: General Appearance: WNL/18 HEENT: WNL Neck: WNL Chest: WNL Breast: WNL Heart: WNL Lungs: WNL Abdomen: WNL Genitalia: WNL Skin: WNL + multiple abcees [sic] Spine: WNL Extremities: WNL [All the “WNL” were typed capital letters.] DIAGNOSIS: Skin Abcess- Buttock, leg MRSA – Community Acquired P: PLAN: Vancomycin 1 gr daily [illegible] A second Progress Note for A.M., also dated October 9, contains the same information in the “S” and “O” portions, but at the “A” portion, it has no notations other than the pre-printed “WNL” at the “Skin” section, and it does not contain a “Diagnosis.” Respondent admitted that there were times when she would “complete records later on.” Respondent’s progress notes for A.M. from October 10 through October 16 were in a slightly different SOAP format. A.M.’s October 10 Progress Note reflects the following: S: Complaint: Vanco reaction O: Examination: BP P T R HT WT PO2 Glucose General Appearance; Awake alert,orientedx3 Head: Normocephalic atraurmatic EENT: PERLA, EOMI,Sclera-non-icteric, conjunctiva-pink Neck: Supple, no JVD. No Lymph nodes Heart: S1 S2 normal, murmurs Lungs: clear Abdomen: Soft, no masses, no tenderness, BS+, no hepatomegaly, no splenomegaly Left Lymph-inguinal: WNL Right Lymph-inguinal: WNL Extremities: No clubbing, cyanosis, edema Neurological: Motor-5/5, sensory-5/5, Deep tendon reflexes 2+ Cranial nerves Intact Skin: no rashes + circled Abscess Muskuloskeletal: WNL CLINICAL ASSESSMENT: MRSA, Skin Abcess CVIO PLAN: Zyvox A.M.’s progress notes between October 11 and 31, 2008, reflect various subjective complaints regarding her skin conditions. The physical examinations for each day do not contain consistent information regarding A.M.’s blood pressure, her height, weight, respirations, PO2, and glucose. On two days the “skin” section reflected “no rashes,” yet the clinical assessment reported “Skin Abces – improvely” [sic] or just “skin abcess.” On three progress notes (October 17, 18 and 20, 2008), there is a hand-written notation at the “Heart” section which indicates that A.M. might have a heart murmur, yet in the diagnosis section there is no mention of a heart issue or endocarditis.19/ All other progress notes regarding the “heart” contain the pre-printed “WNL.” A.M.’s IV/IM procedure notes beginning on October 10 and continuing through October 31, each reflect “heart murmur” in the diagnosis section along with “MRSA Skin abcess.” Respondent testified that she felt justified in using IV Vancomycin because A.M. was “doing the heart murmur.” However, Respondent’s initial plan included Vancomycin before any heart murmur was detected or assessed. Vancomycin is a prescription medication used to treat staphylococcal infections, and is usually utilized for more serious infections such as endocarditis. Zyvox is a prescription medication that comes in either an IV or oral form used to treat infections. Respondent claimed that there were missing medical records for A.M. However, with respect to patient A.M., Respondent claimed a progress note (part of the history and physical exam) from October 8 was the only medical record that was missing. Respondent then asserted that A.M. brought in her primary doctor’s referral which reflected A.M.’s treatment, including the medication prescribed; yet those medical records are not present. Respondent further testified that she “usually” puts prior treatment provider records in her patient’s file. Respondent maintained that she kept a lot of A.M.’s medical records on a computer that was bought in January 2001. However, that computer crashed in October 2011. A computer crash is plausible; however, the DOH subpoena was properly issued and served on Respondent on January 28, 2010, more than nine months before the alleged computer crash. Respondent then claimed that she “did not have access to that computer, which later crashed,” followed by her claim that “that practice was closed and when they came here, we only had the old, whatever, paper records.” Respondent’s position on these records was disingenuous at best. Respondent claimed that A.M. was seen and her medical records were at a different location (6251 Park Boulevard) than where the subpoena was served (5840 Park Boulevard).20/ Respondent then claimed the records that were moved from one facility to another facility could not be located. Respondent alluded to a potential police report regarding an alleged theft of medical records and other office items; however, nothing substantiated that, and Respondent’s testimony about possible criminal activity is not credible. Respondent admitted that some of A.M.’s medical records, specifically progress notes, were pre-printed, and that she wrote on some of the progress notes. In the progress notes dated October 10, 11, 13 through 18, 20 through 25, and 27 through 30, the handwriting appears to be the same, except for the change in each date. Further, Respondent confirmed A.M.’s 18 pages of progress notes of Vancomycin administration, yet distanced herself from them by saying “sometimes the charts were completed later on, so it’s possibility that it -- that it -- you know, it’s progress notes for the IV administration, but – um . . . the dates are written by nurses, so I don’t -- I don’t know.” Respondent’s inability or unwillingness to identify who may have written on A.M.’s progress notes and her avoidance in answering direct questions or claiming she did not recall the patient (and then discussing the patient) greatly diminished her credibility. Respondent claimed that there were “some verbal changes” she gave that were in a “set of nursing records,” which were not present. Any “changes” or directions given by Respondent should have been contained within her medical records for the care of A.M. Respondent maintained that her diagnosis of A.M. was based on Respondent’s total clinical picture of A.M., including A.M.’s “symptoms, her presentation, her lesions, her course -- she’d had repeated courses of oral antibiotics, and was getting recurrence.” Yet, Respondent also claimed A.M. “came in with these culture results from the primary, and that’s how the staff . . . it states MRSA, because it was already documented MRSA.” Standard of Care Respondent was required to practice medicine in her care of A.M. with “that level of care, skill, and treatment which is recognized in general law related to health care licensure.” Based on the credited opinions of Dr. Carrizosa, Respondent’s treatment and care of A.M. violated the standard of care for the following reasons. A reasonably prudent health care provider suspecting a patient has MRSA would observe the abrasion(s), culture the abrasion (MRSA), send the culture out for laboratory confirmation, prescribe oral antibiotics, and if the MRSA does not respond to the oral antibiotics, prescribe and administer IV antibiotics. Dr. Carrizosa noted that Respondent did not provide a description of A.M.’s abscesses, did not indicate that A.M.’s abscesses were drained, incised, cleaned or bandaged, or that Respondent provided any patient education to A.M. Although labs were ordered, there was no request for a bacterial culture or for an antimicrobial susceptibility test to be completed. Dr. Carrizosa expressed concern that young people can eliminate antibiotics within six to eight hours and there is a need for monitoring their medications to ensure they maintain a therapeutic level. Dr. Carrizosa opined that Respondent did not meet the standard of care in her treatment of A.M. The evidence clearly and convincingly establishes that Respondent violated the standard of care applicable to an infectious disease practitioner. Respondent presented the deposition testimony of Dr. Ephtimios. Dr. Ephtimios reviewed the same records as Dr. Carrizosa. Dr. Ephtimios admitted he had several lengthy conversations with Respondent during which time she provided additional information to Dr. Ephtimios that was not in A.M.’s written records regarding “the rationale for using the Vancomycin.” Respondent shared additional information with Dr. Ephtimios yet failed to recall or remember the patient during her own deposition testimony. Dr. Ephtimios’ opinion is not credible. Respondent’s deposition behavior lessens her credibility. Medical Records Medical records are maintained for a number of reasons. Primarily, medical records are necessary for the planning of patient care; for continuity of treatment; and to document the course of the patient’s medical evaluation, treatment, and progression through treatment. Further, medical records should document any communications between health care providers, and they serve as a basis for health care providers to be paid by either the patient or another party. See, rule 64B8-9.003. The medical records of A.M.’s contact with Respondent’s office between October 8, 2008, and October 31, 2008, do not meet Florida’s standards for medical records. A.M.’s records do not describe the abscesses, do not indicate if any of the abscesses were drained, incised, or cultured. Respondent failed to provide any assessment of a staph infection or provide any laboratory support for the use of the medication administered. Respondent did not document A.M.’s possible heart murmur, and failed to provide a diagnostic basis for endocarditis. Further portions of the medical record are illegible. There is no clear indication that Respondent provided A.M. with any education on her condition. Inappropriate Drug Therapy Respondent authorized the administration of Vancomycin and/or Zyvox to a 16-year-old female without adequately monitoring A.M.’s condition, or documenting the need for such use. Respondent’s failure to document the need for Vancomycin through appropriate or adequate testing was not in the best interest of A.M. DOH Case No. 2011-06111 (DOAH Case No. 14-0514PL) On February 28, 2011, patient C.B., a 42-year-old female, presented to Respondent with complaints of food allergy issues, and gastrointestinal problems, gas, bloating, and other stomach issues.21/ When she presented to Respondent in February 2011, C.B. did not have any concerns about candida or thrush.22/ Respondent prescribed a Medrol Pak (a steroid) and directed C.B. to have lab tests for the candida antibody and an immune system panel. One week later, C.B. again presented to Respondent. C.B. did not have any of the symptoms for a chronic yeast infection such as vaginal itching or thrush. Respondent advised C.B. that she had a chronic yeast infection and her immune system required treatment. However, Respondent did not prescribe any medication to C.B. at that time. On March 14, 2011, C.B. returned to Respondent’s office and received Immunoglobulin23/ via an intravenous (IV) line. On March 22, 24 and 25, 2011, C.B. received IV Ambisome.24/ Thereafter, C.B. developed a rash on her arm where the IV had been placed and a papule on her stomach. C.B. declined further IV treatments because she did not think the medication was working. On March 29, Respondent prescribed VFEND25/ to C.B. On March 30 and 31 and April 1, 2011, C.B. was a “no show” at Respondent’s office. Yet each of C.B.’s progress notes contained information regarding C.B.’s general appearance. Respondent testified that those progress notes are preprinted forms and would be adjusted upon a patient’s examination. On April 4, 2011, Respondent’s progress note for C.B. reflects “Discuss with patient in detail, patient complains of one papule, advised patient about candidiasis, GI tract not responding to azoles. Complains of diarrhea, abdominal symptoms, wants IV meds.” C.B.’s progress note dated April 5, 2011, reflects under the “S: COMPLAINT: No show - Refused to get PICC line out. Patient walked out yesterday. Patient was told to wait for dressing change. Patient states to receptionist she will come today.” Respondent elected to document on April 5, something that happened on April 4, despite the fact that the progress note for April 4 reflected a discussion with C.B. On April 11, 2011, C.B. presented a request for her medical records to Respondent’s staff. C.B. received copies of her medical records and provided them to DOH. Respondent testified as to C.B.’s 2011 presentation and Respondent’s course of treatment, including what medications were prescribed. Respondent confirmed that an undated “History and Physical” (H&P) for C.B. was C.B.’s “initial history and physical” created from a template. This H&P purports to reflect that C.B. was “discharged [from Respondent’s practice] for misbehavior . . . was in jail. . . [and] begging [for Respondent] to help her.” This H&P also contained Respondent’s physical examination of C.B., which was recorded on a “Progress Note” of the same date. Differences in the two records of the same date exist. C.B. testified that she has never been in jail and that she had not been discharged from Respondent’s practice. C.B. is found to be a credible witness. Respondent’s testimony is not credible. Respondent averred that she discussed C.B.’s vaginal itching with C.B. during the March 7, 2011, office visit, yet Respondent did not prescribe any medications for C.B. C.B.’s first IV immunoglobulin was administered on March 14, a week later. Respondent claims she discussed her care and treatment with C.B. on Wednesday, March 23, 2011. C.B. did not see Respondent on March 23, as C.B. went to Respondent’s office located on Park Boulevard in Pinellas Park and that location was closed. C.B. found out that Respondent was working at an address in Clearwater. C.B. did not have adequate time to get to that Clearwater location before it closed for the day. Thus, C.B. missed the appointment on that day. C.B.’s candid and succinct testimony is credible. Respondent testfied that certain medical records for C.B. were missing: anything that was documented electronic or anything -- any reports or any old records, old reports, it doesn’t contain anything. And she came in for the treatment of a disease that’s been existing since 2006, so a lot of workup that’s done in the prior years for -- which is the relevant basis of the treatment at this point is not there. Respondent was not clear which medical records were missing. C.B. had not been a patient of Respondent for approximately two years. Respondent’s reliance or purported reliance on C.B.’s “old records, old reports” without adequate confirmation of C.B.’s current health issues via appropriate work-ups, laboratory studies and tests falls below the reasonably prudent similar health care provider standard. Standard of Care Respondent was required to meet the same standard of care as outlined in paragraph 25 above. Dr. Carrizosa’s testimony was clear, concise, and credible. He did not appear to have any prejudice against Respondent as a person, but was concerned about how she was practicing medicine. Based on the credited opinions of Dr. Carrizosa, Respondent’s treatment and care of C.B. violated the standard of care for the following reasons. Respondent failed to practice in such a manner as to determine within a reasonable degree of medical certainty that C.B. had systemic candida as was diagnosed by Respondent. Further, the laboratory results were not positive for an antimicrobial sensitivity culture taken from C.B. Additionally, C.B.’s complete blood count (CBC) and the differential count, which included neutrophils and lymphocytes, were normal. The administration of Ambisome, the most expensive of all the drugs available, was not warranted as C.B. did not have systemic candidiasis. Further, the immunoglobulin treatment was inappropriate as there was no evidence that C.B. had an immune dysfunction. Medical Records Dr. Ephtimios also provided an opinion on behalf of Respondent. Dr. Ephtimios had a discussion with Respondent regarding the care and treatment provided to C.B. outside the medical records provided. Dr. Ephtimios admitted that he does not use a Medrol Pak in his practice; he does not feel comfortable practicing immunology (and would have referred C.B. out to an immunologist.) Dr. Ephtimios would not have ordered the laboratory tests that Respondent ordered; his understanding of what candidiasis means may differ from Respondent’s, and he speculated on what he thought Respondent “meant” in several instances. Dr. Ephtimios provided a somewhat exhaustive approach to the various forms of candidiasis; however, he qualified each approach. Each physician practices medicine using their own skill set and different methods of providing clinical assessments and treatment. However, Dr. Ephtimios provided various qualifiers to his opinion which rendered it less credible. The basis for creating, maintaining and retaining medical records is expressed in paragraph 25 above. The medical record of C.B.’s contact with Respondent’s office during this time does not meet Florida’s standards for medical records. C.B.’s records do not reflect an appropriate evaluation, as they fail to analyze C.B.’s main complaints, they fail to analyze the previous evaluations of C.B., and her physical exams were incomplete. DOH Case No. 2011-17799 (DOAH Case No. 14-0515PL) According to Respondent, patient P.A., a 38-year-old female, was “an ongoing patient [of hers] for over ten years.” Respondent saw P.A. between February 2008 and December 2011. Respondent provided medical records to DOH regarding P.A. However, Respondent admitted she did not provide all P.A.’s medical records because “a lot of records were missing,” and Respondent knew “at one point when they were very old records in the 6251 office some of them were also shredded.” Respondent further claimed in response to additional questioning about her shredding statement, [B]ecause the statute says, you know, after three years, so I’m not sure if the -- because I know some of the records were shredded by one of the secretaries. * * * The one [statute] which says once a practice is closed retain records for three years. Respondent identified one of P.A.’s progress notes (dated January 26, 2011) as “our procedure note,” but when asked “What was going on here according to these notes,” Respondent answered: “It’s hard to say. It’s not my handwriting.” Respondent could read the handwriting, but had “no clue” who wrote the progress note. Further, Respondent was unable to state if P.A. was administered either the gentamicin 40 milligrams or the clindamycin 600 milligrams as listed on the progress note. Medical Records The basis for creating, maintaining and retaining medical records is expressed in paragraph 25 above. In this instance, the testimony of Respondent clearly and convincingly proves Respondent violated section 458.331(1)(m) and rule 64B8-9.003. No evidence was presented that Respondent has been previously disciplined.
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, Neelam Uppal, M.D., violated section 458.331(1)(m), (q) and (t), Florida Statutes; suspending her license for six months followed by two years probation with terms and conditions to be set by the Board of Medicine; imposing an administrative fine of $10,000.00; requiring the successful completion of a course or courses to make, keep and maintain medical records; requiring a course in professional responsibility and ethics, and such other educational courses as the Board of Medicine may require; and assessing costs as provided by law. DONE AND ENTERED this 17th day of September, 2014, in Tallahassee, Leon County, Florida. S LYNNE A. QUIMBY-PENNOCK 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 17th day of September,2014.
Findings Of Fact At all times pertinent to the issues herein, the Board of Medicine was the state agency responsible for the licensing of physicians and the regulation of the practice of medicine in this state. Respondent was licensed as a physician in Florida and holds license number ME 0017915. He practices medicine, specializing in psychiatry, in Clearwater, Florida. He is board certified in that specialty. On September 7, 1987, Patient #1, a 55 year old married female, whose husband had recently separated from many years in the armed service of the United States, came to see Respondent at his office, complaining of severe headaches, loneliness, depression, and a lowering of self esteem. She had been referred to him by physicians at the U.S. Coast Guard Station Dispensary. Respondent examined Patient #1 and found her to be of limited intelligence, considerably overweight, anxious, depressed and confused. She was ashamed of her new status in life as a result of her husband's inability to find work and was experiencing difficulties with him and her children. She was suffering from severe insomnia. Respondent's examination of Patient #1 was limited. He was satisfied with the medical work-up which had been conducted by his colleagues at the Dispensary. Because he was consulting psychiatrist for that facility, he knew all the physicians there and was familiar with the caliber of their work. Based on the medical information furnished him from the Dispensary and his own examination, he diagnosed Patient #1 as suffering a major depression and a psychogenic pain disorder manifested by headaches and insomnia. He developed a treatment plan for the patient which included a wide variety of psychotherapy interventions, the first of which was to effect relief of the symptoms. This included clarification of relationships, interpretation of dreams and fantasies, and allowed for catharsis. When Respondent found out that empathy and intervention alone would not work on this patient, and he had established a relationship with her, he started psychotropic medications including Elavil, the drug of choice for this type of condition in 1988. Elavil is a "superb" antidepressant. While the antidepressant factor is "cranking in", the medication also works as a sedative. For this reason, it is normally prescribed for administration at bedtime. Patient #1 responded to this course of treatment and she and the Respondent established a good and friendly working relationship, which he noted in his April 4, 1988 letter and treatment report to the Coast Guard and to CHAMPUS. In that treatment report, however, Respondent noted Patient #1 had a suicidal ideation. The term "suicidal ideation" does not import that the patient was, at that time, seriously considering suicide. Her mentioning suicide was but an overcompensation - more an alerting statement of depression and sadness with emptiness and angst. She never indicated to Respondent any thought of or plan to commit suicide. Patient #1 thrived for many months in Respondent's therapy. She complained often of her impoverished condition, however, and as a result, he wrote prescriptions for her in such a way that they could be filled at the Coast Guard dispensary without charge. This required writing prescriptions for more tablets of a drug at a lower strength which was stocked by the Dispensary. It was a surprise to him to learn, later on, that she was filling her prescriptions at Eckerds. Throughout the period he treated her, Dr. Fireman prescribed psychotropic drugs for Patient #1, which consisted primarily of amitriptyline, (Elavil), and butalbital, (Fiorinal), in varying strengths, and, at times, in compounds with other substances. As was noted previously, Elavil is an antidepressant with sedative effects. The recommended daily dose for a patient in an outpatient setting is indicated as 150 mg by the Physicians' Desk Reference, (PDR), which also recommends suicidal patients not be allowed unrestricted access to it because of the danger of intentional overdose. Other qualified psychiatrists who testified, including Dr. Spreyhe and Dr. El Yousef, indicate up to 300 or even 350 mg/day may be appropriate. As Dr. Spreyhe noted, it is not so much the daily dose on any given day which is pertinent but the aliquot over an extended period. In that regard, he notes, Dr. Fireman's prescriptions for both Elavil and Fiorinal were within recommended maximums and, therefore, within the appropriate standard of care. Fiorinal is a barbiturate anti-anxiety agent and muscle relaxant with habit forming potential. Fiorinal #3 contains codeine, a legend drug and narcotic. Generally, according to Dr. El Yousef, it should be dispensed for use at a rate of between 8 to 12 tablets per day over the short term, but over a 9 month period he would prescribe between 4 and 9 tablets per day. Pharmacy records indicate that over the period he treated patient #1, Respondent gave her numerous prescriptions for both Elavil and Fiorinal which, at first glance, appear to be excessive. For example, the records reflect that on December 29, 1987, Respondent wrote prescription number 390073 for 100 Elavil 25 mg tablets. Though the prescription clearly indicates no refills were authorized, and the back of the prescription form, where refills are noted by the pharmacist, fails to reflect any refills were authorized by the physician, the pharmacy records indicate two additional dispensings by the pharmacy for 100 tablets each on January 11 and April 20, 1988. There is no evidence to indicate how these additional fillings came about; who arranged for them, or who received them. On February 22, 1988, Respondent wrote prescription number 394289 to the patient for 12 Fiorinal #3 tablets. Again the prescription form authorizes no refills and the back of the prescription form indicates but one coordinated refill but the pharmacy records show the prescription was filled twice - once on April 6, 1988 and once on April 23, 1998. Only the latter is annotated. On March 3, 1988, Respondent wrote prescription number 397144 to the patient for 60 Fiorinal tablets. While the doctor's refill note reflects none were allowed, the computer printout sticker for the bottle reflects 2 refills were authorized. The back of the prescription form shows no refills annotated thereon as required, but the pharmacy's computer listing of all prescriptions indicates the prescription was refilled on May 28 and again on June 3, 1988. No further explanation is given. Prescription number 396378, written to the patient by Respondent on March 14, 1988 for 50 Fiorinal tablets, reflects no refills authorized by the physician nor does the reverse of the form bear any refill annotations. Nonetheless, the pharmacy records as shown on the computer printout indicates a refill on March 27 and April 6, 1988 with no explanation therefore. Before the last refill, however, Respondent wrote prescription number 397091 to the patient on March 29, 1988, for 21 Fiorinal #2, later approved for #3's. He also, on April 4, 1988, wrote prescription number 398853 for 35 Fiorinal tablets. Respondent claims he would not authorize a refill of a prior prescription for the same medication for which he is writing a new prescription, and, since neither of the refills of the earlier prescription properly reflect any physician authorization, it is so found. On May 2, 1988, Respondent wrote prescription 399717 for 50 Fiorinal tablets, and prescription 399718 for 100 Elavil 25 mg tablets. Both reflect Respondent's instruction that no refill be given, and neither form bears an annotation for authorized phone refills. Yet, the pharmacy's computer printout indicates that the prescription for Elavil was written on May 31, 1988 even though the bottle sticker shows it was filled on May 3, 1988. On August 1, 1988, Respondent wrote prescription 405572 for 100 Fiorinal and 475573 for 100 Elavil 100 mg tablets. Both were filled the next day but neither form bears any annotation of authorized refill, consistent with the physician's instructions. On August 16, 1988, Respondent prescribed another 100 Fiorinal by Prescription 406536. It was not refilled. On August 29, 1988, Respondent wrote prescription 407201 for 150 Elavil 50 mg tablets to patient #1, and number 407202 for 100 Fiorinal tablets. Both prescription forms clearly reflected no refills, but the back of the forms reflect refills were authorized. The Elavil prescription was refilled on September 10, 1988 by pharmacist Ivan Funkhouser who contends he refilled on the basis either of a call to or from the doctor's office. He cannot recall which. He also, at the same time, refilled the Fiorinal prescription under the same conditions. The Elavil prescription was filled again, this time for 225 tablets, on September 30, 1988, by pharmacist Robert Wivagg who also indicated phone refills made only on the basis of a call to or from the physician's office. In this case, however, he believes that because of the amounts involved, he would have spoken to the physician himself before filling the prescription. He cannot be sure of this, however, and Respondent denies having ever prescribed 225 Elavil tablets, regardless of strength, at one time. Mr. Lewis, the pharmacy expert, indicates that proper pharmacy practice would have allowed the pharmacist to issue fewer tablets than on the prescription but not more without express approval of the physician. The Fiorinal prescription, refilled on September 30, 1988, this time for 150 tablets, is not reflected on the prescription form though it is on the computer printout. Respondent denies that he ever called in prescriptions for Patient #1 because he never had to. She came to his office frequently enough that he was able to provide her with a new prescription for whatever medication she needed. Indeed, his medical office billing records reflect that in June, 1988 he saw her on June 6, 13, 20, and 27; in July, 1988 on July 5, 12, 19, and 26; and in August, 1988, on August 2, 9, 16, and 30. It would appear, therefore, that the refills of prescriptions reflected on the pharmacy computer printout either are in error or were arranged for under some unexplained process not involving Respondent. There appears to be no reason for him having had to authorize refills since he saw the patient so frequently, notwithstanding his comments to Ms. Sutton, during the investigation, that 90 percent of the refill calls are authorized by him personally, and only 10 percent through his secretary. There was no showing that the authorization comment Ms. Sutton recalls was related to this particular patient. Further, according to Ms. Maguire, Respondent's secretary, Respondent frequently refuses to grant refills, and, to her knowledge, he never gives refills to psychiatric patients. Since most, if not all Respondent's patients are psychiatric patients, this does not make sense. Respondent does not deny writing the two prescriptions on August 29, 1988. At that particular time patient #1 was planning a trip to New York to make peace with her dying mother. As a result, and since her headaches had gotten worse, as had her depression, he decided to increase her dosage of Elavil. This was a medical decision which is not in issue here. He admits that Elavil is a drug which is often used to commit suicide and that prescribed at even its lowest strength, a full prescription can be lethal. This became, therefore, an assessment problem wherein Respondent, the physician, had to evaluate the risk of the patient's depression against the benefits to be gained by the use of the drug. Respondent gave patient #1 enough Elavil to hold her through her visit up north. He had previously given her sixty 50 mg tablets to be taken 6 per day for a 300 mg dose at bedtime. He now told her not to use the 50 mg tablets any more and to destroy them. He believed she did. He then gave her a new prescription for one hundred and twenty 25 mg tablets for her trip. He unequivocally states that he never prescribes more than 300 mg/day of Elavil. He admits, however, that while she was on that dosage, he neither hospitalized her nor had blood work done on her. Respondent feels his original treatment plan and diagnosis were sufficient and his records pertaining to those factors were adequate. He uses checkoff forms because he believes they are the most open way of showing how he sees his patient and what he is doing for her. This same conclusion was reached by Dr. Spreyhe, another Board certified psychiatrist who is Clinical Professor of psychiatry at the University of South Florida Medical School, who has served as an expert witness for the Department in the past, and who continues to serve as a contract consultant for it and as a member of the Medical Advisory Committee of the Department. Examination of Respondent's medical records pertaining to Patient #1 indicates that the medical history and treatment plan are in the form of check sheets on which the physician makes no more than minimally worded entries. The Department's witness, Dr. Greener, an expert in the completeness of medical records, is of the opinion that Respondent's records should have reflected an initial detailed assessment of the patient's condition, including the reasons for her referral to him, a complete medical history, and a subsequent detailed mental status examination. This should be followed by a formulation of her problems and a treatment program. After the initial evaluation, according to Dr. Greener, the physician should make regular progress notes as to treatments, communications with others, phone calls received, prescriptions issued, and matters of that nature. This is done to memorialize the particulars for the patient and to keep a tally of which and how much of any drug is given to the patient. This would show over or under use as a possible flag as to how well the patient follows instructions or if the patient develops a use addiction problem. Based on Dr. Greener's review of Respondent's records for patient #1 and the prescription records relevant to her, he concluded those records were "totally inadequate." This conclusion is based on his opinion that the initial evaluation is cursory and without detail and there are few progress notes in the records. Those which are there are inadequate in detail and full of conclusions without the required supporting information such as drug side-effects, the patient's ability to follow instructions, follow-up, changes in dosages, and the like. He complains that Respondent's records do not really outline a plan of treatment designed specifically for that patient. For example, the forms used by Respondent are merely check-off forms even though, during the period, the patient was receiving continuing analgesic medications. From Respondent's records, it was impossible to determine how the patient was doing on the medications prescribed or whether additional medical evaluation was required. It is important to put this information in patient records to memorialize what is done and not just to keep the information in the treating physician's memory. Respondent denies that his initial evaluation and treatment plan, prepared by the use of form check sheets, is below standard. Dr. Spreyhe concluded the use of such check sheets is not inappropriate for the initial work-up of a patient and he opined that Respondent's forms, and the information thereon provide sufficient information for an independent understanding of the patient's situation and are within an appropriate standard of care. It is so found. However, the medical progress notes which make up the bulk of the remaining medical records are not so complete and, in Dr. Spreyhe's opinion are insufficient. Respondent concurs and admits this. It is so found. As to Respondent's prescribing practices, Dr. Greener is far more conservative than Respondent in prescribing Elavil. He starts with a low dose and gradually works up to a therapeutic level dosage depending upon the patient. He would start an average patient out at 25 mg/day and work up to a maintenance dose of 150 mg/day. Elavil is a dangerous drug and the doctor must closely monitor the patient for possible side effects and the direct effect it is having on the patient. It should never be ordered "prn", (as needed) when that designation relates to the amount to be taken. Based on Respondent's records for this patient, it would appear to Dr. Greener that the medication was being used improperly. There appears to have been no monitoring of the amount of the drug the patient was getting and it would appear that the patient was given the prerogative as to dose, which is not a good thing to do. In his opinion, a dose at 300 mg/day of Elavil is very and unnaturally high and he would not use so high a dose. He would do other tests first to see why the medication was not working at the lower dosage. As was seen before, however, other physicians of equal expertise disagree. Fiorinal is habit forming and, according to Dr. Greener, should be used only over the short term. If needed for a longer period, the patient should be reviewed to see why. The doctor must keep in mind the addictive properties of the drug. Here, Dr. Greener is of the opinion that Respondent prescribed excessive amounts of Fiorinal for patient #1. From January 27, 1988 through March 2, 1988, a period of 34 or 35 days, Respondent prescribed 302 tablets and Dr. Greener would be concerned that the patient was addicted. On March 21, 1988 Respondent prescribed another 50 tablets, and on March 27,1988, he prescribed 50 more followed by another 60 somewhat later and more after that. All of these were being prescribed for a patient whose records reflect she was doing "OK", and was "nicely stabilized". To Dr. Greener, this is just too much, especially for a patient who is obviously addicted and who appears to be taking the medication only to prevent withdrawal symptoms. By his prescription regimen, a patient would get no more than 10 tablets a day for no more than 4 to 5 days, and he would prescribe this drug for 9 months, as here, only with support for it in the patient records, including the opinions of other specialists to whom the patient would have been referred. While it is obvious Dr. Greener is more conservative in his approach to medication than is Respondent, the evidence does not clearly show Respondent's approach fell below standards. Dr. Spreyhe is of the opinion that the levels of Elavil and Fiorinal prescribed by Respondent for this patient were appropriate in both dosage and amounts. He has patients of his own who take such doses and he is not swayed by the PDR recommendations for dosage which, he believes, is too conservative. As for the Fiorinal, he would prescribe no more than 8 per day because there is some information that a patient may develop a tolerance for the substance. In any case, the drug is appropriate for the treatment of psychogenic headaches as were suffered by Respondent's patient here. Both W.L.P. and M.J.S. have been patients of Respondent. Both found him to be concerned and available. When patient #1 died, Ms. Sherman was in a therapy group with her. She did not appear to be suicidal and was looking forward to her proposed trip to New York. Patient #1 died on October 8, 1988. The report of the Hillsborough County Medical Examiner reflected her death as suicide from the combined effects of amitriptyline, (Elavil), butalbital, (Fiorinal), and salicylate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be issued herein, finding Respondent not guilty of all allegations except those relating to his failure to keep adequate medical records regarding Patient #1 as alleged in Count One, of which he is shown to be guilty, and imposing an administrative reprimand and a requirement for continuing medical education in the area of proper record keeping. RECOMMENDED this 31st day of August, 1994, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 31st day of August, 1994. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 93-5048 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. - 6. Accepted and incorporated herein. 7. Accepted as a restatement of witness testimony but not as a Finding of Fact. 8. Accepted as a restatement of witness testimony but not as a Finding of Fact. 9. & 10. Accepted that the medications were dispensed based on prescriptions written under the patient's name. 11. & 12. Accepted and incorporated herein. 13. & 14. Accepted as a restatement of witness testimony. - 18. Accepted and incorporated herein. Rejected as not a necessary conclusion to be drawn. Accepted. - 23. Accepted as restatements of witness testimony. Accepted and incorporated herein. - 26. Accepted and incorporated herein as pertaining to the dosage level of Elavil used and the balance accepted as a restatement of witness testimony. Accepted and incorporated herein. Accepted as a restatement of witness testimony. Accepted and incorporated herein. Accepted. & 32. Rejected as Findings of Fact, and found to be Conclusions of Law. FOR THE RESPONDENT: Accepted and incorporated herein. - 4. Accepted and incorporated herein. - 7. Accepted and incorporated herein. Accepted and incorporated herein. - 12. Accepted and incorporated herein. 13. & 14. Accepted. 15. & 16. Accepted and incorporated herein. 17. & 18. Accepted. 19. & 20. Accepted and incorporated herein. 21. Accepted. 22. This Proposed Finding of Fact is, in reality, a restatement of the evidence presented, in several subparagraphs, some of which are identified by letter and some of which are not. It is, however, accepted as an accurate restatement of the evidence admitted at hearing on this point, except where it becomes argument. 23. & 24. Accepted and incorporated herein. 25. First four sentences accepted and incorporated herein. Balance considered only as argument in support of the position taken. 26. Accepted and incorporated herein. 27. Accepted. 28. Rejected as a Conclusion of Law and not a Finding of Fact. 29. - 31. Accepted as basic findings. This does not go to their adequacy, however. 32. & 33. Rejected as contra to the weight of the evidence. & 35. Accepted as the substance of the witness' testimony. Accepted and incorporated herein. Accepted. Accepted. Rejected as a Conclusion of Law. COPIES FURNISHED: Steven Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard Suite 210 Tampa, Florida 33619 Bruce D. Lamb, Esquire Christopher J. Schulte, Esquire Shear, Newman, Hahn & Rosenkranz, P.A. Post Office Box 2378 Tampa, Florida 33601 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Dr. Marm Harris Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I make the following relevant factual findings: During times material hereto, and particularly from January 1, 1983 through December 31, 1985, Respondent, Eusebio Subias, M.D., was a licensed medical doctor in Florida, board certified in Psychiatry and an eligible Medicaid provider of psychiatric services pursuant to the Medicaid contract he is party to with DHRS dated October, 1982. (Petitioner's Exhibit 1). Medicaid regulations and guidelines require physicians to meet board certification in psychiatry before they may provide reimbursable psychiatric services to Medicaid eligible recipients. As part of his agreement to participate in the Medicaid Program, Respondent agreed to keep such records as are necessary to fully disclose the extent of services provided to individuals receiving assistance in the state plan. Respondent also agreed to abide by the provisions of pertinent Florida administrative rules, statutes, policies, procedures and directives in the manual of the Florida Medicaid Program. (Petitioner's Exhibit 2). During 1986, the Surveillance & Utilization Review System unit of the Medicaid Office indicated that the amount of Respondent's medicaid billing greatly exceeded that of his peers. Based on that indication, the Office of Program Integrity asked Respondent to provide them with copies of certain medical records for the year 1982. Respondent provided the Department with those records as requested. (Petitioner's Composite Exhibit 3). Those records were forwarded to the peer review committee for evaluation. The records were reviewed by both the local and state peer review committees. The 1982 records contained inadequate information for the peer review committee to document or otherwise justify the number of office visits per patient. The records did not contain reasons for treatment, reasons for frequency of visits or what specific services were rendered to patients. (Petitioner's Exhibits 16 and 17, Pages 3 and 4 and Composite Exhibit 3). On April 21, 1986, Petitioner notified Respondent that it determined that he overbilled Medicaid in the amount of $17,820.09 for the calendar year 1982. Respondent was then notified that a similar review would be conducted for the period January 1, 1983 through December 31, 1985. That review and the results thereof are the subject of this proceeding. The Department subsequently requested, and Respondent provided medical records for 85 specific recipients which were selected by means of the "Disproportionate Stratified Random Sampling" (DSRS). (Petitioner's Exhibit 7). Respondent's 1983-85 records contain substantially more details than the records he provided Petitioner during the 1982 review period. Petitioner had its medical consultant, Dr. Forsthoefel, review the 1983-85 records. He was a member of the peer committee which made the peer review determination in 1982 which was used as a guide for the degree of overutilization. Forsthoefel denied those office visits that he determined were not supported by documentation in the medical records and concluded that the visits were not medically necessary. As a result, Petitioner sent Respondent a letter advising that he had overbilled medicaid in the amount of $79,093.05 for the years 1983-1985. (Petitioner's Exhibits 9 and 13). By letter dated September 5, 1986, Respondent requested a meeting to discuss the Department's proposed action and such a meeting was granted on October 31, 1986 at 1:30 p.m. Dr. Forsthoefel, Dr. Conn, Petitioner's Chief Medical Consultant in 1982, Millie Martin, and Respondent attended the October 31 meeting. During the meeting, Respondent attempted to individually review each of the approximately 3200 medical records for patients he treated during the years 1983-85 such that he could explain and document the medical necessity of each of the patient's office visits. He also requested that Petitioner have the records reviewed by a psychiatrist. Neither Dr. Conn nor Dr. Forsthoefel are psychiatrists. Dr. Conn left soon after the meeting began. Dr. Forsthoefel, unable and unwilling to comply with Respondent's request that each medical record be individually reviewed, concluded that continuing the meeting would not be productive and left after approximately 2 hours. The Department again denied those visits which it had early concluded were not medically necessary based on the review by its medical consultants. By letter dated November 10, 1986, Petitioner again advised Respondent that the Department would seek a $79,093.05 overpayment for the years 1983-85 and advised him of his rights to a formal hearing. Drs. Mutter and Tumarkin were commissioned by Petitioner to review the medical records under scrutiny with each doctor reviewing one half of the records. Based on their review, Respondent was denied reimbursement for even more office visits based on their opinion that the records did not contain sufficient documentation or notations that would indicate continued office visits were medically necessary. (Petitioner's Exhibits 17a and 18). Dr. Tumarkin made his comments on Respondent's medical records in green ink. Those records which did not contain green marking were records numbered 3 and 27 resulting in the Department's overstating the overpayment claim by $125.01. Respondent introduced information regarding Medicaid's denial of claims which should have been billed to Medicare. During the period from May 1985 through December 31, 1985, certain denials fall within the 1983-85 review period and since the Department never paid such claims, the Department agreed at hearing to reduce its overpayment amount by $6,421.44. Also at hearing, Petitioner determined that it made an error in its computation of the figures stated in the November 10, 1986 letter and was now seeking $78,661.93 minus $6,421.44 for the amount claimed to be overbilled by Respondent as $72,240.49. Respondent, who is of hispanic origin, treats a substantial number of Spanish speaking patients. Respondent graduated from medical school in Cuba at the age of 22 and participated in a rotating internship at Mercy Hospital in Hampton, Ohio. He came to Florida in 1963 and was licensed in 1964. In April, 1963, Respondent was employed at Hollywood Memorial Hospital. Respondent was the third Spanish speaking doctor to practice in South Florida and was the first to be promoted to a chairmanship at Hollywood Memorial Hospital. Respondent was the first clinical director at Coral Reef's Hospital. He is a member of several medical societies and was involved in the development of several psychotic drugs, including Elavil. Respondent is board certified in psychiatry. Respondent has staff privileges at Hollywood Memorial Hospital and three other area hospital. He has practiced psychiatry for more than 25 years in the United State and is accomplished in the treatment of severe psychotic patients. Respondent was tendered and received as an expert in psychiatry. Southeastern Florida was inundated during the early 1980's with mentally ill refugees during the Mariel Boat Lift. That area has a uniquely high need for psychiatric services due to its characteristic as a metropolitan area with a large homeless population. The Marlowe Study which was commissioned by Petitioner to review the need for psychiatric services in Dade County during the period which coincided with the Respondent's 1983-1985 office practice here under review, concluded that insufficient resources were earmarked for the treatment of mentally ill residents of Dade County, Florida. Respondent prefers to treat severely psychotic patients on an outpatient basis. He has been very successful in utilizing this method of treatment and it has resulted in substantial public benefit in the form of substantial financial savings that would have otherwise been required to hospitalize such patients for treatment. Respondent is paid $35.01 for a 45 minute session for each Medicaid patient whereas the average cost for inpatient treatment at an area hospital is approximately $400.00 per day. Respondent modified his record keeping practice in 1982 so that his medical records for 1983-85 contained the minimum requirements for medical records necessary to support Medicaid billings as specified in Rule 10C- 7.030(1)(m) and 10C-7.062(1(n) Florida Administrative Code. All of the medical experts testified that Respondent's records for the period at issue here met the minimum requirements specified in the required regulations and DHRS's procedure manuals. Those requirements are: dates of services; patients name and date of birth; name and title of person performing the service, when it is someone other than the billing practitioner; chief complaint on each visit; pertinent medical history; pertinent findings on examinations; medications administered or prescribed; description of treatment when applicable; recommendations for additional treatments or consultations; and tests and results. Petitioner presented testimony through Ms. Martin to the effect that Respondent had admitted during his October 1986 meeting with the medicaid consultants that he had, from memory, gone back and recreated his medical records for 1983-85. Respondent denied this at hearing and credibly testified that based on the deficiencies found in the latter part of 1982 concerning his medical records, he commenced to prepare a complete medical record for each patient visit. Respondent's testimony in this regard is credited and none of the medical professionals, save Ms. Martin, presented any evidence which would call into question the accuracy of Respondent's records during the period 1983- Ms. Martin's testimony to the contrary is rejected. Dr. Forsthoefel candidly admitted that he is not qualified to render an opinion with respect to medical necessity and appropriateness of specialized psychiatric services. Respondent is the first psychiatrist reviewed by the Medicaid officials of Petitioner for over-utilization as Petitioner's officials were unaware of any other psychiatrist who had been reviewed prior to Respondent. The peer review process for determination of over-utilization and mis- utilization of Medicaid services is designed so that the physician being reviewed may discuss individual patient records and cases with the Committee, as well as the Medicaid consultants who later apply peer review findings, and such discussion will be considered in arriving at a final determination. (Peer Review SOP, April, 1987, Respondent's Exhibit 12). An integral part of peer review for the physician being reviewed is to be able to discuss individual cases with the reviewer prior to a final determination being made concerning medical necessity and appropriateness. Such interplay and explanations regarding certain aspects of a case can lead to a more detailed determination concerning an overpayment issue. Respondent's October 1986 review should have been a complete new review of individual records affording him an opportunity to discuss specific cases with the physician consultants, provide him an opportunity to substantiate certain treatments based upon his recollection and justify the treatment modality he utilized for the 85 patients which comprised the random sampling. 2/ Respondent was not permitted to meaningfully discuss those individual cases even though he requested an opportunity to do so. This is so despite Petitioner's consultant's admission that such a consultation would have aided them and perhaps changed their opinion with respect to medical necessity and appropriateness of specific treatments rendered by Respondent. (Testimony of Conn, Forsthoefel, Tumarkin and Whiddon). While some experts would treat severely psychotic patients on a less frequent basis than Respondent and hospitalize them sooner, Respondent's method of treatment is well accepted among qualified board certified psychiatrists. Dr. Tumarkin's different treatment philosophy wherein he favored inpatient treatment for severely psychotic patients while Respondent showed a preference for outpatient treatment, is in no way indicative of inappropriateness by Respondent's method of treatment since his method was proven to be successful. Additionally, one expert, Dr. Tumarkin would have allowed more visits as being medically necessary and appropriate had he been advised by Petitioner's representatives that he should apply the community standard for medical necessity and appropriateness of psychiatric services. A Medicaid provider of psychiatric services is required to provide services equivalent to that of their peers. Had Dr. Tumarkin consulted with Respondent, his opinion concerning medical necessity and appropriateness would have been affected and he would have requested such had he known that he was allowed to. This is especially so based on the fact that his treatment preference is more hospital oriented. It is thus concluded that Respondent was not given a fair opportunity to present circumstances relevant to the overpayment amount in question here, despite his request to do so. (Petitioner's Exhibit 14). A review of a Peer Comparison Analysis with Respondent's practice respecting the number of office procedures per patient performed by him in contrast to other medicaid psychiatrists, indicates that Respondent saw his patients, on average, less than the average for other psychiatrists in Dade, Monroe and Broward Counties between the years 1983-85. (Petitioner's Exhibit 22). Dr. Stillman is board certified in psychiatry and has been practicing for more than 30 years. He reviewed, as Respondent's expert witness, all of the 85 patient charts in question. Dr. Mutter rendered a specific report about the even numbered charts that he reviewed. His reports indicates, with respect to many charts, that he was unable to find specific documentation supporting the reasons and medical necessity for treatment. This testimony was sharply contradicted by that of both Dr. Stillman and Respondent who easily located specific record documentation which indicated the medical necessity and reasons for services provided to patients by Respondent. Examples of over-utilization from Dr. Mutter's report were inquired about and on each occasion, Respondent and Dr. Stillman were able to identify documents not referred to by Dr. Mutter that substantiated the medical need and reasons for treatment. Drs. Subias and Stillman's testimony was not contradicted by Petitioner. Without going through each patient's records, a review of the findings concerning several patients is illustrative and will be herein discussed. Patient number 85, S. T., Jr. 3/ was a schizophrenic, suffering from epilepsy with borderline intellectual functioning. He was a very psychotic patient who was, during his early years, treated in an institution. (Petitioner's Composite Exhibit 5). He was obese, apprehensive, disoriented, suffered from impaired insight and judgment, a depressed mood, flat affect and a constant feeling of rejection. Respondent commenced treating patient number 85 twice weekly as an outpatient and as his condition improved, he was seen once a week and office visits were reduced further as his condition continued to improve. Without this intense continuity of treatment, patient number 85 would have decompensated and would have required an extensive institutionalization. Respondent provided substantial documentation as to the need for each of S. T.'s visits. Patient number 83, C. C., was a schizophrenic who suffered from depression, was delusional with a flat affect, poor reality contact and went through extended periods of depression on a monthly basis. Respondent prescribed benadryl to counteract patient C. C.'s delusional symptoms and otherwise justified his method of treatments, frequency and reason for each visit. Respondent substantiated that it was medically necessary to treat patient C. C. on each occasion where treatment was provided. Respondent's medical records provided the documentation for treatment in each instance. Patient number 81, F. D., was a schizophrenic who suffered severe mental depression. His condition had deteriorated to the point whereby family therapy sessions had to be scheduled by Respondent. Respondent was able to keep F. D. out of the hospital, he remained with his family and his condition improved to the point where the frequency of visits were reduced. Respondent's records justified the medical necessity and reasons for the treatment he provided patient F. D. Respondent testified as to his method of treatment as to patients 88, 78, 77, 52, 56, 48, 46, 38, 40, 60, 68 and as to each of those patients, Respondent's records document that the patients treatment and visits were medically necessary and appropriate. Dr. Stillman demonstrated that on each occasion, there was substantial record documentation which supported the necessity for the treatment as provided by Respondent. Based upon the inconsistent evidence presented by Petitioner respecting its claim that Respondent failed to document the medical necessity for the treatment he provided to the patients during the years 1983-85 and the direct evidence presented by Respondent which established that all of the services rendered by him to Medicaid recipients were medically necessary and appropriate under the circumstances, it is concluded that Petitioner failed to establish by a preponderance of the evidence that any of the treatments here in dispute were unnecessary, inappropriate or were not otherwise documented by the medical records under review. Moreover, all of the experts agree that the treating psychiatrist is best able to determine the medical necessity and appropriateness of specific treatments to render to a patient as that psychiatrist has direct contact with, and is best able to fully apply his or her training and experience. Respondent amply demonstrated that the services here at issue were medically necessary, appropriate and was of clear benefit to the patient. Petitioner has failed to meet its burden of establishing any basis for an overpayment as claimed. 4/
Recommendation Based on the foregoing Findings of- Fact and Conclusions of Law, it is RECOMMENDED that: The Department of Health and Rehabilitative Services enter a Final Order finding that there was no overpayment to Respondent during the years 1983- 85. Respondent is entitled to a refund of all monies held pursuant to the overpayment calculation by the Department in this cause together with 10% for annual interest pursuant to Rule 10C-7.060(12), Florida Administrative Code. DONE and ORDERED this 18th day of November, 1988, in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of November, 1988.
