The Issue As stated in the Order of Remand entered March 26, 1999.
Findings Of Fact On or about March 7, 1994, Mark Leibowitz, an attorney representing Patient E.G., sent a Notice of Intent to the Agency for Health Care Administration (AHCA) which advised of his client's intent to file a malpractice action against Respondent. The Notice of Intent was reviewed by Marie Kokol, an employee of AHCA. During the course of his representation of Patient E.G., Mr. Leibowitz obtained a copy of Respondent's medical records for Patient E.G. On or about April 5, 1994, Ms. Kokol requested that Mr. Leibowitz provide her with a copy of those medical records. Those medical records were received by Ms. Kokol at AHCA on or about April 18, 1994. The medical records received from Mr. Leibowitz were incorporated as part of Petitioner's investigative record as pages numbered 234 and 235. These records included Respondent's medical records for Patient E.G. for July 17, 1992, and July 29, 1992. In or about June 1994, the medical records received by Ms. Kokol were sent to AHCA's investigative office in Miami, Florida. On July 14, 1994, Georgina Jorge, an investigator employed by AHCA, issued a subpoena to Respondent for all medical records of Patient E.G. Respondent provided the medical records of Patient E.G. to Ms. Jorge, which were included in the investigative record as pages numbered 293 through 296. Included in the medical records received by Ms. Jorge pursuant to her subpoena issued July 14, 1994, were Respondent's medical records for Patient E.G. dated July 17, 1992, and July 29, 1992. These records were numbered pages 294 and 295. The medical records of Patient E.G. obtained from Mr. Leibowitz (pages 234 and 235) and the medical records received by Ms. Jorge pursuant to her subpoena (pages 294 and 295) should have been identical, but they were not. The subpoenaed medical records (pages 294 and 295) contain handwritten notations not found on the medical records obtained from Mr. Leibowitz (pages 234 and 235). Respondent's medical records for Patient E.G. for July 17, 1992, received pursuant to the subpoena contain the following handwritten notations not found on the medical records obtained from Mr. Leibowitz: unable to dilate today (illegible word) r/o (rule out) retinopathy Respondent's medical records for Patient E.G. for July 29, 1992, received pursuant to the subpoena contain the following handwritten notations not found on the medical record obtained from Mr. Leibowitz: Martha Delgado 326-6421 Pt. Did not keep appt. at BEIP as recommended. The additional notations contained in the medical records obtained pursuant to the subpoena were not dated or signed by Respondent. Dr. William Cobb served as the Petitioner's expert witness at the initial formal hearing. Dr. Cobb reviewed the medical records obtained from Respondent by the agency investigator and based the opinions expressed at the initial formal hearing on those records. A review of his deposition reveals that Dr. Cobb had access to the two sets of medical records and that he observed that there were discrepancies between the two sets of records. Dr. Cobb did not base the opinions he expressed at the initial hearing on the fact that there were two sets of medical records, one with the notations and the other without. Both before and after the Order of Remand, Dr. Cobb expressed the opinion that Respondent practiced within the standard of care on July 17, 1992. His opinions that Respondent committed the violations alleged in the Administrative Complaint were unaffected by the existence of the additional notations on the subpoenaed medical records. A physician may make additional notations to a medical record when the record is reviewed after the initial examination at the end of the day without dating or signing the additional notation. A physician making additional notations to a medical record more than one day after the initial examination must date and sign the additional notation. Dr. Cobb expressed the opinion in his deposition, taken after the remand, that the failure to date and sign additional notations made more than one day after the initial examination would be a violation. 1/ The only plausible explanation for the additional notations on the medical records for July 17 and July 29, 1992, is that Respondent made the notations after Mr. Leibowitz obtained his copy of E.G.'s records. While Dr. Cobb may be correct in his opinion that Respondent's failure to date and sign these notations would be a violation, the Administrative Complaint filed against Respondent did not charge him with that violation.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order consistent with the findings of fact, conclusions of law, and recommendations contained in the Recommended Order entered January 8, 1999. DONE AND ENTERED this 29th day of November, 1999, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of November, 1999.
The Issue The issue in this proceeding was whether Respondent violated Subsections 458.331(1)(g) and (t), Florida Statutes, between June 26, 1980 and September 16, 1983, by prescribing 4,100 Percocet to a single patient, failing to attempt other modalities of pain treatment for that patient and failing to refer the patient to a consulting physician.
Findings Of Fact At all times relevant, Robert G. Gilbert, M.D., Respondent, was licensed as a physician with license number ME0005030 from the Florida Board of Medical Examiners. He has been continually licensed since 1952. (Petitioner's Exhibit #3, T-13, 18) Neither the Department nor any hospitals have ever taken any action against his license. (T-13) Dr. Gilbert admitted at the hearing that he prescribed 4,100 pills of Percodan to his patient, George Watson, for the period of time in question. (T-9) He also stated that he prescribed for Mr. Watson 100 Percocet a month for the last five years that he treated him. (T-20-21) These admissions are consistent with Petitioner's evidence consisting of medical records and original prescription forms retrieved from the pharmacies. (Petitioner's Exhibits #1, 2 and 4) Percodan and Percocet both contain oxycodone; Percodan includes aspirin, and Percocet includes acetaminophen. (T-31) Both Dr. Gilbert and Petitioner's expert, Dr. John Handwerker referred to the PDR (Physicians' Desk Reference) regarding the drugs. The warning in that widely-accepted medical reference is: "May be habit forming"; the indications are "For the relief of moderate to moderately severe pain"; and, * * * Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of narcotics. The usual dosage is one tablet every six hours for pain. PDR, 1984 Edition, p. 928. The Oxycodone content in these drugs places them in the Schedule II, severely restricted medical category. (T-31), See Subsection 893.03(2)(a), Florida Statutes. Dr. Gilbert did not admit that the drugs were the only mode of treatment for this patient. Rather, he and other physicians treating Mr. Watson used ultrasound, heat, cold, massage, transcutaneous neural stimulation ("TNS") and muscle relaxants. (T-9-10) The patient was 6'2" and weighed 210 lbs. He was injured on his job as a City of Miami police officer and for a lengthy period, from 1974 until 1985, Dr. Gilbert was his authorized worker's compensation physician. At no time while Mr. Watson was under Dr. Gilbert's care did he ask for an increase in dosage or exhibit any unusual behavior. The treatment, other than drugs, was utilized from 1974 until about 1977 regularly and then intermittently, as needed, until February 1985. (T-10, 12) The records of George Watson obtained by the D.P.R. from Dr. Gilbert's office, consist primarily of cards reflecting various visits of the patient, correspondence regarding the workers' compensation claim and workers' compensation billing and report forms. The records are replete with references to physiotherapy, often several times a month and, for several months in 1977, on a daily basis. George Watson continually complained of pain. (Petitioner's Exhibit #1) Also included in the records is a three-page report on the patient, dated July 30, 1977, from Ledford Gregory, M.D., an orthopedic surgeon. The report reflects the patient's complaints of severe pain and Dr. Gregory's recommendation to the patient regarding surgery: I am however impressed by the degree of pain he is having and I believe that he is a candidate for surgical therapy. Before a decision would be made in this regard however, he should have an electromyelogram of the lower extremity, a CAT scan of the lumbar spine and a myelogram. We could then decide whether a Gill procedure and decompression would be sufficient or whether there would have to be added a posteriolateral fusion procedure. I have discussed this with the patient. I have explained to him that the odds are fairly good that the operation would give him considerable relief but that there is a chance that his condition would remain unchanged, and there is a slight chance that he might be worse. He will have to make the decision himself as to whether he desires the surgical intervention or not. (Petitioner's Exhibit #1, p. 171). Dr. John Handwerker was qualified as an expert witness for Petitioner. He heard Dr. Gilbert's testimony and reviewed the medical records, including the prescriptions for George Watson. (T-30,31) In his opinion the prescriptions for Percocet/Percodan were inappropriate and excessive as there were other treatment modalities that could have been tried before risking addiction. In his opinion, the TNS unit should have been utilized continually, rather than just in the office, and Dr. Gilbert's records were inadequate to justify the continuing use of the drugs for his patient's pain. (T-32, 33, 38).
Recommendation For the foregoing reasons, it is, therefore, RECOMMENDED: That the Administrative Complaint against Respondent, Robert G. Gilbert, M.D., be dismissed in its entirety. DONE and RECOMMENDED this 23rd day of May, 1986, in Tallahassee, Florida. MARY W. CLARK, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of May, 1986. COPIES FURNISHED: Dorothy Faircloth Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore A. Carpino, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Cecilia Bradley, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Robert G. Gilbert, M.D. 2617 Cardena Street Coral Gables, Florida 33134 APPENDIX 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. Rulings on Proposed Findings of Fact Submitted by the Petitioner Adopted in Paragraph 1. Adopted in Paragraph 2. Rejected as unnecessary. Rejected as unnecessary. 5-7. Rejected as unnecessary. While the veracity of the witness is not in question, the testimony of the Respondent under oath and substantiated by the medical records introduced as Petitioner's exhibit #1 is more competent evidence that other modalities were tried. Without the actual questions asked by the investigator, it is not possible to determine the context or meaning of the seemingly inconsistent prior statements of Respondent during the investigator's interview. Adopted in part in Paragraph 3, the transcript reference does not support the finding proposed in this paragraph. Adopted in Paragraph 6, except as to the characterization of the testimony as "uncontroverted", this is specifically rejected. Adopted in general in Paragraph 6. Rejected as cumulative and unnecessary. Rejected as inconsistent with the evidence. Adopted in general in Paragraph 6. Adopted in general in paragraph 6. But see Conclusions of Law #4 regarding violations which are not included in the complaint. Adopted in paragraph 2. Rejected as cumulative. Rejected as cumulative. Rejected as unnecessary. This conclusion by the expert is rejected as discussed in the Conclusions of Law. 23-25. Rejected as unnecessary. 26. Rejected as irrelevant in this proceeding. Incapacity is not charged in the complaint before me. See Conclusion of Law #4.
The Issue The central issue in this case is whether the Respondent is guilty of the violations alleged in the Amended Administrative Complaint; and, if so, what penalty should be imposed.
Findings Of Fact Based upon the testimony of the witnesses and documentary evidence received at the hearing, I make the following findings of fact: The Department is the state agency charged with the regulation of the practice of medicine in Florida. At all times material to the allegations in the Amended Administrative Complaint, Respondent has been a licensed physician, in the State of Florida, license number ME 0027088. Respondent is board certified in three areas of specialty: gastroenterology, radiology, and internal medicine. Respondent is on the staff of several hospitals in the Palm Beach County region. From March 28, 1986, until April 4, 1986, Respondent treated Goldie Marshak. At the time of such treatment, Mrs. Marshak was a seventy-one year old in good health. Mrs. Marshak had been referred to Respondent by Dr. Neil Katz. Dr. Katz was Mrs. Marshak's regular physician who had unsuccessfully treated her for persistent gas and burping. In accordance with Mrs. Marshak's health plan guidelines, Dr. Katz had referred her to Respondent, a specialist in similar disorders, for additional diagnosis. The referral form indicated Mrs. Marshak suffered from persistent stomach pain and gas. Attached to the referral were the results from a prior upper GI series which established there were no abnormalities of the upper gastrointestinal tract. Respondent first met with Mrs. Marshak on March 28, 1986. At the initial visit Mrs. Marshak completed a form which identified her current problem as "burping and rectal gas as soon as I eat. Some pain upper chest that has diminished." In addition, Mrs. Marshak supplied a social history, a past medical history, drug allergy, operations, injury, hospitalizations, family history, immunizations, and a general review of systems. No other records prepared on that date were retained. There are no records from which it can be determined what physical examination, if any, Respondent gave to Mrs. Marshak on March 28, 1986. Apparently, after reviewing the referral form and discussing her symptoms with Mrs. Marshak, Respondent elected to schedule her for a procedure called a flexible sigmoidoscopy. After conferring With Dr. Katz, whose consent was required for health plan purposes, the procedure was set to be performed April 3, 1986. Mrs. Marshak was given instructions regarding preparations required in order for the examination to be performed. When Mrs. Marshak returned to Respondent's office on April 3, 1986, she had successfully followed the instructions and was ready for the proposed procedure. Mrs. Marshak was given an authorization form which she signed in the presence of Marina Harmon. Mrs. Harmon was an unlicensed employee who assisted Respondent by escorting patients to the procedure room, having them sign the authorization form, and by explaining the procedure to be performed. The authorization form signed by Mrs. Marshak authorized Respondent to perform a flexible sigmoidoscopy. The form did not disclose risks or inherent dangers regarding the procedure but did provide the following: The motive and purpose of the diagnostic procedure, possible alternative methods, the risks and possible consequences involved, and the possibility of complications have been fully explained to me. I acknowledge that no guarantee or assurance has been made as the results that may be obtained. I also specifically authorize the physician, or his designee, to perform such additional procedures or render such treatment as he may, in his professional judgement deem necessary in the event any unforeseen condition arise during the course of the consented-to- diagnostic procedure that would put the patient's (my) well-being in jeopardy. A flexible sigmoidoscopy is a procedure whereby an instrument is inserted into the rectum and is then passed up the colon the desired distance. The length the instrument is extended specifies what the procedure is called. A flexible sigmoidoscopy involves looking into the rectum and the sigmoid colon only. A colonoscopy looks into the digestive tract beyond an anatomical portion of the colon called the splenic flexure. A left-sided colonoscopy involves looking into the lower digestive tract beyond the sigmoid colon but not beyond the splenic flexure. In terms of length, the flexible sigmoidoscopy would be the shortest procedure of the three described. On April 3, 1986, Respondent performed a colonoscopy on Mrs. Marshak which resulted in a perforation of her colon. This perforation would have occurred regardless of the procedure performed since the tear was located approximately twenty centimeters into the colon. During and following the procedure, Mrs. Marshak complained of extreme pain. Respondent presumed the pain to be that typically experienced during the procedure. The pain which continued after the instrument was removed, Respondent attributed to trapped gas within the colon which would be passed naturally in the hours following the procedure. Respondent sent Mrs. Marshak home for rest and advised her that the procedure had not revealed any abnormal condition in the area examined. Once home, Mrs. Marshak continued to have pain and discomfort. Her husband, Kalman Marshak, telephoned Respondent's office to advise of his wife's continued suffering. Respondent did not speak with either of the Marshaks' but did telephone a prescription for Tylenol with Codeine to their pharmacy. Mr. Marshak picked up the drug and administered it to his wife as directed. Codeine is an improper drug to prescribe for a patient who may be retaining gas since it inhibits parastoltic activity of the bowel. Respondent should have discussed the patient's symptoms with her to ascertain whether or not the pain suffered warranted further examination or emergency treatment. Despite the drug, Mrs. Marshak's pain continued through the night. On the morning of April 4, 1986, Mr. Marshak again telephoned Respondent's office to advise them of his wife's discomfort. The Marshaks were given an appointment for three o'clock that afternoon. The delay in setting the appointment or referring the patient for emergency treatment was inappropriate. At the time of her revisit, Mrs. Marshak had a distended abdomen with some tenderness. Respondent took x-rays of the area and reinserted the colonoscope a very short distance in an effort to expel what Respondent believed to be trapped gas in the colon. The procedure did not relieve Mrs. Marshak's pain and she was advised to go to the hospital for further treatment. Subsequent to Mrs. Marshak leaving the office, Respondent read the x-rays and discovered the perforation. Respondent immediately telephoned the emergency room to advise the physician on duty of Mrs. Marshak's condition and her need for attention. The perforation required surgery which resulted in Mrs. Marshak having to wear a colostomy bag for several months. Afterwards, a second surgery restored her colon to allow normal elimination. At the time of the final hearing, Mrs. Marshak had completely recovered from the perforation. On April 8, 1986, Respondent prepared a letter to Dr. Katz which outlined the treatment given to Mrs. Marshak. Any notes or other records used to prepare the letter were destroyed. The x-rays taken at Respondent's office on April 4, 1986, were lost and were, therefore, unavailable. According to Respondent, the missing x-rays were very similar to the ones taken at the hospital when Mrs. Marshak arrived on April 4, 1986. The Respondent did not obtain a consent form or written authorization for the procedure performed on April 4, 1986. The reinsertion of the instrument into the rectum was inappropriate since the x-rays clearly showed the perforation. Other than the letter written to Dr. Katz, Respondent did not maintain any medical records for the treatment he gave to Mrs. Marshak on March 28, April 3, and April 4, 1986.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Department of Professional Regulation, Board of Medicine, enter a Final Order which finds Respondent guilty of the violations alleged in Counts I and IV of the Amended Administrative Complaint, dismisses Counts II and III, imposes an administrative fine in the amount of $1000, places Respondent on probation for a period of two years, and requires Respondent to attend such continuing education courses as may be deemed appropriate by the Board. DONE and RECOMMENDED this 15th day of April, 1988, in Tallahassee, Florida. JOYOUS D. PARRISH 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 15th day of April, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-3397 Rulings on Petitioner's proposed findings of fact: Paragraphs 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 are accepted. To the extent paragraph 11 describes a colonoscopy as "more invasive" the paragraph is accepted. However, as to all of the examinations performed (colonoscopy, flexible sigmoidoscopy or left-sided colonoscopy) the basic description is similar. Consequently "more extensive explanation "is not required. Thus the balance of paragraph" is rejected as contrary to the evidence. Paragraph 12 is rejected as contrary to the weight of the evidence. Paragraph 13 is accepted. Paragraph 14 is accepted however it must be noted that such explanations given by Harmon are in supplement to those given by Rothenberg. Paragraph 15 is accepted but is unnecessary. Paragraphs 16 and 17 are accepted, however, see note above re: paragraph 14. Paragraphs 18 and 19 are accepted. Paragraph 20 is rejected as argument, irrelevant and immaterial. Paragraphs 21, 22, 23, 24 and 25 are accepted. Paragraphs 26, 27 and 28 are accepted with the note that the communications addressed were with Respondent's office. There is no evidence that Respondent personally spoke with Mr. Marshak to determine the patient's condition. Paragraph 29 is rejected as contrary to the evidence. It was inappropriate to delay the revisit until 3 o'clock, but there is no evidence Respondent made that decision. Based upon the testimony, The more appropriate course would have had Respondent discuss the situation directly with the patient (or her husband) and to schedule the revisit as soon as possible or have the patient go to the hospital. Paragraph 30 is accepted. Paragraphs 31, 32, and 33 are accepted. Paragraph 34 is rejected as repetitive and unnecessary. Paragraph 35 is rejected as contrary to the evidence. Paragraph 36 is rejected as irrelevant immaterial and assuming facts not in evidence. Paragraphs 37, 38, 39, 40, 41, 42, and 43 are accepted. Paragraphs 44, 45, 46, and 47, are rejected as argumentative or contrary to the weight of the evidence. Paragraphs 48 and 50 are rejected as argumentative. Paragraph 49 is accepted. Rulings on Respondent's proposed findings of fact: Paragraphs 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 are accepted. With regard to paragraph 12 the area of the perforation was between 15- 25 centimeters according to the weight of the evidence. Paragraphs 13 and 14 are accepted. Paragraph 15 is rejected as contrary to the weight of the evidence as to "reread." That paragraph with the word "read" for "reread" would be accepted. Paragraphs 16, 17, 18, and 19 are accepted. COPIES FURNISHED: Susan Branson, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Charles A. Nugent, Jr., Esquire Cone, Wagner, Nugent, Johnson, Roth & Romano Servico Centre-Suite 300/400 1601 Belvedere Road West Palm Beach, Florida 33406 Dorothy Faircloth, Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact The Respondent is licensed by the Petitioner to practice medicine in the State of Florida. The Respondent is a native of Cuba. He has been licensed as a physician in Florida since 1975, and has been practicing since then in Dade County. The Respondent has not been subject to any prior disciplinary action. Antonio Martos is a resident of Miami Beach. He is a native of Cuba, and does not speak English well. He testified at the hearing through an interpreter. Antonio Martos was a patient of the Respondent during 1976, 1977, 1978 and 1979. Among his complaints were that he had trouble sleeping. Antonio Martos did not see the Respondent at the Respondent's office, but rather saw him at his neighbor's house. Beginning in September, 1976, and once each month thereafter, through May, 1979, the Respondent issued prescriptions for forty- five 300 milligram Quaalude tablets for Antonio Rosario. Three specific prescriptions for these drugs were received into evidence, and the Respondent's medical records reflect the additional prescriptions. Quaalude is a brand name for Methaqualone, a "Schedule II" controlled substance under Section 893.03(2), Florida Statutes. Quaalude tends to induce dependency and tolerance. Long-term use of it is inappropriate because of the prospects for abuse. Prescriptions for Quaalude in the quantities and over the period of time for which they were prescribed by the Respondent for Antonio Martos are not in accord with community standards in Dade County, Florida, and are inappropriate and excessive and not in the best interest of the patient. The prescriptions are excessive to such a degree that they could not have been issued in good faith by the Respondent. The Respondent's records respecting Antonio Martos reflect that the Respondent saw him as a patient each month from September, 1976, through May, 1979. With the exception of five of the visits, the records reflect that all of them occurred on the first day of the month. Nearly all of the entries respecting Antonio Martos relate that he complained of insomnia and that his blood pressure was 120/80 and that his pulse rate was 80. It is not medically possible that an individual's pulse rate and blood pressure readings would be identical over such a long period of time on so many occasions. The Respondent fabricated these records to reflect visits that did not occur as indicated in the records. While no evidence was offered to establish with any definitiveness the purpose of the fabrications, it is apparent that the Respondent had a motivation to fabricate his records to reflect proper visits and prescriptions to the patient. Antonio Rosario and his wife testified that he had not been a patient of the Respondent's. This testimony has not been credited. The Martoses' testimony was false with respect to the nature of their relationship with their neighbor, in whose home they visited the Respondent. They were both actually seen to visit the Respondent in a patient relationship at their neighbor's home. It does not appear that the Martoses fabricated their testimony for any malicious reason. They were confronted by police, they clearly did not understand the nature of the confrontation, and it is logical to assume that they were fearful, and that they sought to absolve themselves from any difficulties. Rosario Martos is a resident of Miami Beach, and a native of Cuba. She is married to Antonio Martos. Rosario Martos does not speak English well, and she testified at the hearing through a translator. Rosario Martos was a patient of the Respondent during 1977, 1978, and 1979. She complained primarily of insomnia and high blood pressure. She did not visit the Respondent in his office, but rather saw him at her neighbor's house. Commencing in January, 1977, and each month thereafter through August, 1979, the Respondent issued prescriptions for forty-five 300 milligram Quaalude tablets for Rosario Martos. Eight of these prescriptions were received into evidence at the final hearing, and the remainder are reflected in the Respondent's medical records. Prescriptions for Quaalude in these quantities over this period of time is not in accord with community standards in Dade County, Florida. Such prescriptions are inappropriate and excessive, and not in the best interest of the patient. The prescriptions are so excessive as not to have been issued in good faith. The Respondent's records reflecting Rosario Martos reflect that he visited her once each month from January, 1977, through January, 1979. With a few exceptions, the records reflect that he visited her on the first day of each month. The records reflect that her complaint was always the same, high blood pressure and insomnia. Except for a few occasions, her blood pressure and pulse were 120/80 and 80, respectively. These records were fabricated. It is not medically possible that a patient's pulse and blood pressure could be so consistent on so many occasions over such a long period of time. It is apparent that the records were developed in order to reflect visits which either did not occur, or did not occur in the manner reflected in the records. Rosario Martos testified that she was never a patient of the Respondent, and that she did not receive the prescriptions. Her testimony has not been credited for the reasons set out in paragraph 2 above. Enrique Nebot was a patient of the Respondent's during 1976 through 1979. The Respondent issued prescriptions for forty-five 300 milligram Quaalude tablets to Enrique Nebot once each month beginning in October, 1976, and continuing through June, 1979. Four of these prescriptions were received into evidence at the final hearing, and the rest are reflected in the Respondent's medical records. The Respondent's records reflect only that Enrique Nebot complained of insomnia. Prescriptions of Quaalude in these quantities over this period of time are not in accord with community standards in Dade County, Florida. Such prescriptions are inappropriate and excessive and not in the best interest of the patient. The prescriptions are so excessive that they could not have been issued in good faith. The Respondent's records reflect that Enrique Nebot visited him generally on the fifteenth day of each month beginning in October, 1976, and continuing through June, 1979. The records reflect the same complaints, and a pulse rate of 80 and a blood pressure of 120/80 on each visit. It is not possible that a patient could have the same pulse and blood pressure readings on so many occasions over such a long period of time. The records were fabricated to reflect visits either that did not occur, or that did not occur in the manner described in the records. Gerardo Montes was a patient of the Respondent during 1977 through 1979. The Respondent's records reflect that Gerardo Montes complained of insomnia. Once each month beginning in September, 1977, and continuing through August, 1979, the Respondent issued a prescription to Gerardo Montes for forty- five 300 milligram Quaalude tablets. Seven of these prescriptions were received into evidence at the final hearing. The remainder of them are reflected in the Respondent's medical records. Prescriptions for Quaaludes in these quantities over this period of time are not in accord with community standards in Dade County, Florida. The prescriptions are inappropriate and excessive, and not in the best interest of the patient. The prescriptions are so excessive that they could not have been issued in good faith. The Respondent falsified medical records respecting Gerardo Montes. Records were created to reflect visits once each month commencing in September, 1977, and continuing through August, 1979. The records were written all at one time, rather than in response to individual appointments or visits. Lidia Tabio is a resident of Dade County, Florida, and a native of Cuba. She was a patient of the Respondent during 1976 through 1979. Her complaints were generally hypertension and insomnia. She visited the Respondent either in his office or at home in response to her symptoms. Once each month commencing in September, 1976, and continuing through July, 1979, the Respondent issued prescriptions for forty-five 300 milligram Quaalude tablets to Lidia Tabio. Five of these prescriptions were received into evidence at the final hearing, and the remainder are reflected in the Respondent's records. Prescriptions for Quaaludes in these quantities over this period of time are not in accord with community standards in Dade County, Florida. The prescriptions are inappropriate and excessive and not in the best interest of the patient. The prescriptions are so excessive that they could not have been issued in good faith. The Respondent's records respecting Lidia Tabio reflect that he saw her once each month commencing in September, 1976, and continuing through July, 1979. The visits are reflected to be on the second day of each month. On each occasion the patient's blood pressure reading was related as 120/80, and her pulse reading was reflected, commencing at least in May, 1977, as 77. It is not possible that a patient would reflect such constant blood pressure and pulse readings over such a long period of time. The patient herself testified that she visited the Respondent only in response to symptoms, and not on the second day of each month as reflected in the records. The Respondent fabricated Lidia Tabio's records. Juan Morales Tabio is a resident of Dade County, Florida, and a native of Cuba. Juan Tabio was a patient of the Respondent during 1976 through 1979. His complaints were generally hypertension and insomnia. He visited the Respondent generally in the Respondent's office. The Respondent issued prescriptions for forty-five 300 milligram Quaalude tablets for Juan Tabio once each month commencing in September, 1976, and continuing through August, 1979. One of these prescriptions was received into evidence at the hearing, and the remainder are determined from the Respondent's records. Prescriptions for Quaaludes in these quantities over this period of time are not in accord with community standards in Dade County, Florida. The prescriptions are inappropriate and excessive and not in the best interest of the patient. The prescriptions are so excessive that they could not have been issued in good faith. The Respondent's records respecting Juan Tabio reflect that he visited the Respondent once each month commencing in September, 1976, and continuing through August, 1979. On each occasion the patient's pulse is indicated as having been 80, and blood pressure as 120/80. Such consistent blood pressure and pulse readings over such a long period of time are not possible. These portions of the records are fabricated. Ramon Gonzalez is a resident of Dade County, Florida. He was a patient of the Respondent's during 1976 through 1979. His complaints generally were nervousness and that he could not sleep well. Once each month commencing in March, 1976, and continuing through July, 1979, the Respondent issued prescriptions for forty-five 300 milligram Quaalude tablets for Ramon Gonzalez. One of the prescriptions was received into evidence at the hearing, and the remainder are reflected in the Respondent's medical records. Prescriptions for Quaalude in these quantities over this period of time are not in accord with community standards in Dade County, Florida. The prescriptions are inappropriate and excessive and not in the best interest of the patient. The prescriptions are so excessive that they could not have been issued in good faith. The evidence does not establish that the Respondent's records respecting Ramon Gonzalez were fabricated. Counts XXIX through XXXII of the Administrative Complaint relate to Susan Waxman, an alleged patient of the Respondent. The evidence does not establish that inappropriate prescriptions were issued to Susan Waxman nor that her medical records were in any way fabricated or altered. Counts XXXIII through XXXVI of the Administrative Complaint relate to a person named Lueinea Gonzalez. No evidence was offered with respect to the allegations set out in Counts XXXIII through XXXVI of the Complaint. There was no evidence from which it could be concluded that any of the prescriptions for Quaalude that the Respondent issued were used either by himself, or by persons other than those for whom the prescriptions were issued.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is, hereby, RECOMMENDED: That the Board of Medical Examiners enter a final order finding the Respondent guilty of the charges enumerated in paragraphs 2, 3 and 4 of the Conclusions of Law above; suspending the Respondent's license to practice as a physician in the State of Florida for a period of two years; imposing an administrative fine against the Respondent in the amount of $2,000; and permanently restricting the Respondent's practice so that after the period of his suspension, the Respondent is not permitted to prescribe, dispense, administer, mix, or otherwise prepare any controlled substance. That the Board of Medical Examiners enter a final order dismissing Counts IV, VIII, XII, XVI, XX, XXIV, and XXVII through XXXVI of the Amended Administrative Complaint. RECOMMENDED this day of April, 1981, in Tallahassee, Florida. G. STEVEN PFEIFFER Assistant Director Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this day of April, 1981. COPIES FURNISHED: Deborah J. Miller, Esquire Assistant General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Maurice M. Diliberto, Esquire Suite 800, Ainsley Building 14 Northeast First Avenue Miami, Florida 33132 Ms. Nancy Kelley Wittenberg, Secretary Department of professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, Petitioner, vs. CASE NO. 81-192 RUSQUIN DUANY GONZALEZ, M. D., Respondent. /
The Issue The issues in this case are whether Respondent committed the allegations contained in the Administrative Complaint, and if so, the penalty that should be imposed.
Findings Of Fact The Parties Petitioner Department of Health has regulatory jurisdiction over licensed physicians such as Respondent. In particular, Petitioner is authorized to file and prosecute an administrative complaint, as it has done in this instance, when a panel of the Board of Medicine has found probable cause exists to suspect that the physician has committed one or more disciplinable offenses. At all times pertinent to this cause, Respondent was a medical doctor licensed in the State of Florida, having been issued license number ME 92135. Although not the subject of the instant proceeding, Respondent has also been licensed by the State of Florida as a chiropractic physician. Background / Arrangement with Dr. Wagner In or around 1975, Respondent completed his education at the National University of Health Sciences and began to practice chiropractic medicine shortly thereafter. Some fifteen years later, Respondent and an acquaintance——Dr. Joseph Wagner, also a licensed chiropractor in the State of Florida——matriculated at a medical school in the Dominican Republic. Although both Respondent and Dr. Wagner ultimately earned Doctor of Medicine ("MD") degrees in the mid 1990s, Respondent was not licensed in Florida to practice as an MD until early 2006. Significantly, however, Dr. Wagner never obtained licensure as a medical doctor. Consequently, Dr. Wagner is prohibited by statute (with two exceptions, neither of which is applicable in this case6/) from prescribing any medicinal drug. In 2007, Respondent and Dr. Wagner entered into a joint venture designed, in the words of Respondent, to "expand" Dr. Wagner's chiropractic practice. At that time, and for the duration of their business agreement, Respondent's principal place of business was located in Palm Beach County, while Dr. Wagner practiced chiropractic medicine in Daytona Beach. Under the joint venture (which continued until August 2011, when both their offices were raided by the Federal Bureau of Investigation), Respondent traveled to Daytona Beach several times each month and interacted with Dr. Wagner concerning some, but not all, of Dr. Wagner's chiropractic clients (hereinafter "joint-venture clients" or "JVCs"). From what can be gleaned of the credible portions of Respondent's deposition and final hearing testimony, it appears that Respondent's activity with respect to JVCs included a review of client files, and, in some cases, a determination that one or more medications——including narcotics——should be prescribed. Indeed, Respondent's level of participation was so minimal that his face-to-face interaction with JVCs consisted, at most, of an initial introduction, and on no occasion did Respondent personally examine——or perform treatments upon——any JVC. As a consequence of Respondent's phantom-like presence at Dr. Wagner's clinic, it was common for a JVC who presented for routine follow-up appointments, which for some clients occurred as frequently as once time per week, to be seen only by Dr. Wagner or Dr. Wagner's son, John Wagner, who was also a chiropractor. Troublingly, these visits frequently ended (without Respondent having seen or spoken with the JVC on that day) with Dr. Wagner phoning in a prescription refill.7/ At the conclusion of a JVC's office visit, Dr. Wagner—— and possibly Respondent, if the JVC was seen on a day when Respondent was actually present in the Daytona office——dictated medical notes that Dr. Wagner usually transcribed at a later time. Subsequently, and with Respondent's blanket authorization, Dr. Wagner would create a claim form (if the JVC had insurance coverage) to submit to the insurance carrier for reimbursement. Incredibly, Respondent also granted Dr. Wagner complete authority to affix his signature to reimbursement claims and submit them——without Respondent looking at the forms beforehand——to insurance carriers. This was accomplished not by the use of a stamp, which medical professionals often provide to their subordinates to expedite business affairs, but by Dr. Wagner manually signing, in cursive, "John P. Christensen" inside the box of the claim form labeled "signature of the physician or supplier. Another unusual aspect of the joint venture was the manner in which Respondent and Dr. Wagner dealt with reimbursement checks from insurance carriers. By agreement, reimbursement checks for claims that related to JVCs were received by mail at Dr. Wagner's place of business in Daytona Beach. Upon their receipt, Dr. Wagner deposited the checks into a SunTrust checking account for which Respondent had sole signatory authority. At the end of each month, Respondent transferred the entire balance of the SunTrust account into his business account at PNC Bank. Respondent would subsequently draft a check on the PNC account to Dr. Wagner in an amount equal to 50 percent of the monthly proceeds. As Respondent readily admits, his joint venture with Dr. Wagner yielded substantial financial remuneration. Over a four-year period, reimbursement from insurance carriers totaling $800,000——a tidy sum in light of Respondent's nominal participation——was deposited into Respondent's SunTrust account, the proceeds of which were split 50/50 with Dr. Wagner. Against the foregoing backdrop, the undersigned will address, on a client-by-client basis, the specific wrongdoing alleged in the Administrative Complaint. Client K.R. On or about August 25, 2010, K.R. presented to Dr. Wagner's clinic for treatment of a back injury she sustained in an automobile accident approximately eight months earlier. K.R. continued to be seen at Dr. Wagner's clinic, on a weekly basis and as a JVC,8/ until November 11, 2010. During K.R.'s initial office visit, no examination was conducted, nor did Dr. Wagner order that any diagnostic scans (such as x-rays) be taken. Instead, Dr. Wagner simply asked K.R. about her injuries and "cracked" her back for several minutes. While the evidence does not foreclose the possibility that K.R. was introduced briefly to Respondent during the first appointment, it is clear that no further interaction——of any kind——occurred between them. Although Respondent had no contact whatsoever with K.R., the evidence demonstrates that Respondent permitted Dr. Wagner——on the date of K.R.'s first visit and on every follow-up visit, which generally lasted no more than a few minutes——to telephone a local pharmacy on his behalf and direct that certain prescriptions be filled. Specifically, each week from August 25, 2010, through November 10, 2010, K.R. was prescribed seven-day supplies of the following medications: 40 tablets of Lortab9/ (the brand name for the formulation of hydrocodone10/ and acetaminophen); 21 tables of Soma11/ (the brand name for carisoprodol,12/ a muscle relaxant); and 21 tablets of Xanax13/ (a brand name for alprazolam,14/ which is designed to treat anxiety). Petitioner's expert witness in this proceeding, Dr. Orlando Florete, credibly testified that the dosages of Lortab, Xanax, and Soma prescribed to K.R. were excessive, and that the combination of the three medications was inappropriate due to an unacceptably heightened risk of respiratory depression and death. Client M.R. In late July or early August 2009, M.R. presented to Dr. Wagner's clinic for treatment of leg, back, and neck pain. M.R. returned for follow-up appointments at least one time per week for the next several months. At no time did M.R. undergo a medical examination during his visits, which consisted of having his back cracked by either Dr. Wagner or his son (and, on occasion, the use of a bed with heat). Notwithstanding that Respondent and M.R. neither met nor had contact of any kind, Respondent considered M.R. to be a JVC.15/ As a consequence, Respondent allowed Dr. Wagner to phone-in the following medications——with Respondent listed on the prescription bottles as the prescribing physician——for M.R., on a weekly basis, from August 7, 2009, through October 16, 2009: 40 tablets of hydrocodone, with each pill containing 10 milligrams of hydrocodone and 500 milligrams of acetaminophen; and 24 tablets of Xanax, each in two milligram doses Clients L.J., S.J., and J.J. In or around August 2009, S.J., J.J. (S.J's cousin), and L.J. (S.J's mother) were involved in an automobile accident. Thereafter, in late 2009 and early 2010, S.J., J.J., and L.J. presented themselves on multiple occasions for chiropractic treatment at Dr. Wagner's office in Daytona Beach. Although there is insufficient evidence as to what occurred during J.J.'s office visits (no testimony of J.J. has been introduced), S.J. and L.J. were seen initially by Dr. Wagner's son, and later by Dr. Wagner himself during follow-up appointments. As with patient M.R., both S.J. and L.J. neither met nor had any contact whatsoever with Respondent. Nevertheless, as clients that were within the ambit of Respondent and Dr. Wagner's joint venture,16/ Respondent allowed Dr. Wagner to phone-in prescriptions for S.J. and L.J. as follows: Lortab (40 tablets) and Soma (20 tablets) for L.J. on January 30, 2010; and Lortab and Soma (40 and 20 tablets, respectively) for S.J. on November 7, 2009, January 2, 2010, and February 27, 2010. As with the JVCs discussed previously, Respondent was listed in the pharmacy records and on the medication bottles as the prescribing physician. Consistent with the terms of the joint venture, Dr. Wagner submitted reimbursement claims to Direct General Insurance Company ("DGIC," a personal injury protection carrier) for services purportedly rendered to S.J., L.J., and J.J during their office visits. In particular, clear and convincing evidence exists that Dr. Wagner, with Respondent's knowledge and authorization, submitted reimbursement claims to DGIC in connection with S.J., J.J., and L.J. that bear the following dates: January 30, 2010 (S.J.); January 30, 2010, and March 13 and 27, 2010 (L.J.); and April 10 and 24, 2010 (J.J.).17/ While the exact services billed to DGIC varied by patient and date, the content of each of these claim forms represented unambiguously that the examinations and/or treatments were performed by Respondent and no other. This was unquestionably deceptive in light of Respondent's consistent testimony that he never physically conducted medical examinations or treatments in connection with any JVC. Client C.H. In or around December 2008, C.H. was referred to Dr. Wagner's clinic by her personal injury attorney. Over the next four months, C.H. was treated by Dr. Wagner and/or Dr. Wagner's son during multiple office visits. In stark contrast to Respondent's position with respect to patients discussed above (Respondent admitted during his deposition that K.R., M.R., S.J., L.J., and J.J. were JVCs, yet attempted——unsuccessfully——during the final hearing to retract such testimony), Respondent has consistently maintained that C.H. was not a JVC, that he had no knowledge of C.H., and that any prescription phoned in by Dr. Wagner in connection with C.H. was without his knowledge or authorization. As the undersigned credits this portion of Respondent's testimony, any events that occurred at the clinic with respect to C.H. cannot serve as a basis to discipline Respondent. Findings of Ultimate Fact The undersigned finds, as a matter of ultimate fact, that Respondent violated section 458.331(1)(q), Florida Statutes, by prescribing controlled substances to K.R., M.R. S.J., and L.J. outside the course of his professional practice as a medical doctor. It is further determined, as a matter of ultimate fact, that Respondent engaged in deceptive conduct related to the practice of medicine, contrary to section 458.331(1)(k), Florida Statutes. Finally, the undersigned finds, as matters of ultimate fact, that Respondent is not guilty of violating subsections 458.331(1)(m), (1)(t), and (1)(nn), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Board of Medicine: Finding that Respondent violated section 458.331(1)(q), Florida Statutes, as charged in Count II of the Administrative Complaint; Finding that Respondent violated section 458.331(1)(k), as charged in Count V of the Complaint; Dismissing Counts I, III, and IV of the Administrative Complaint; Revoking Respondent's license to practice medicine; and Imposing a total administrative fine of $20,000.00. DONE AND ENTERED this 16th day of March, 2012, in Tallahassee, Leon County, Florida. S EDWARD T. BAUER 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 16th day of March, 2012.
The Issue The issues in this case relate to whether Respondent is guilty of charges that Petitioner has brought against him under Sections 458.331(1)(t), (q), and (m), Florida Statutes, based on allegations that in treating a young patient, Respondent failed to practice medicine with the requisite level of care; inappropriately prescribed excessive quantities of medications; and failed to keep medical records that justified his treatment decisions.
Findings Of Fact The evidence presented at final hearing established the facts that follow. Dr. Heller is a Florida-licensed physician who holds license number ME 0036675. A family practitioner in the small, rural community of Okeechobee, Florida, Dr. Heller is board- certified by the American Board of Family Practice. Dr. Heller's Treatment of J.B. On Monday, August 31, 1998, a mother brought her son J.B., then age five, to Dr. Heller's office. This visit was the first of six to Dr. Heller that J.B. and his mother would make over the next six weeks; five of those visits would take place in the 17 days from August 31 to September 16, 1998. This case is about Dr. Heller's treatment of J.B. First Week In taking J.B.'s medical history on August 31, 1998, Dr. Heller learned that from before the age of two the boy had presented behavioral problems and been difficult to control. When he was three years old, J.B. had been treated at a psychiatric hospital. Now J.B. was having difficulty paying attention in school, experiencing mood swings, and becoming easily irritated; he had been violent at home, too. Dr. Heller discussed with J.B.'s mother the medications J.B. was currently taking, as well as the medications that J.B. had tried in the past, to determine whether those medications had been effective in controlling J.B.'s behavior. Dr. Heller learned that J.B. was currently taking ten milligrams of Adderall in the morning.1 He noted that although the Adderall was not particularly effective, J.B.'s behavior worsened when the Adderall wore off. Additionally, J.B.'s mother had stopped giving her son his afternoon dose of Adderall because the medicine apparently suppressed his appetite, and he would not eat when taking it. J.B.'s mother also informed Dr. Heller that J.B. had taken Risperdal in the past, and this drug had helped a great deal.2 She believed he had taken 0.5 milligrams of Risperdal twice a day. J.B. had never taken Prozac.3 During the visit, Dr. Heller talked with J.B. and observed his behavior. Pertinent parts of this discussion and evaluation are included in the doctor's notes. Dr. Heller recorded that J.B. was thin and extremely hyperactive. The child would not sit still for any length of time. J.B. also had difficulty speaking clearly, and his mother confirmed that he had speech and language delays. Dr. Heller wrote that J.B.'s reaction to any criticism was to want to hit someone. After interviewing J.B.'s mother and examining J.B., Dr. Heller diagnosed J.B. preliminarily with several behavioral and mental health problems, namely, attention-deficit hyperactivity disorder ("ADHD"), problems with violence, depression, rejection sensitivity, and possible dysthymia. He believed that J.B. might be bipolar and had concerns about the patient's low weight, which appeared to have been caused by Adderall. He thought that the boy might have some combination of hearing, speech, and language problems as well. To control J.B.'s violent behavior, Dr. Heller started J.B. on 0.5 milligrams of Risperdal, twice a day, the same dose his mother recalled he had taken previously. Although Risperdal is often used as an anti-psychotic agent, it is also helpful in controlling violent behavior. Dr. Heller continued J.B. on the same amount of Adderall that the boy was already taking, to improve his attention in class; prescribed Prozac for J.B., ten milligrams daily for five days to be followed by ten milligrams daily for five more days, to treat the child's depression and mood swings; and instructed J.B.'s mother to bring the boy back after eight days for another examination. On Wednesday, September 2, 1998, J.B. developed a mild dystonic reaction for which he was treated with Benadryl at a local hospital's emergency room and sent home. An unwanted but tolerable side effect of certain drugs, a dystonic reaction is an involuntary, potentially dangerous, sometimes painful contraction of the muscles, usually affecting the upper neck but occasionally striking other parts of the body. Risperdal most likely had caused J.B.'s reaction. Based on the symptoms commonly associated with dystonic reactions——not to mention that J.B. was taken to the emergency room——the event must have frightened the boy and his family. There is no evidence, however, that J.B. was either in pain or in danger from this distressing side effect. When Dr. Heller was informed that day of his patient's condition and emergency treatment therefor, he scheduled an office visit with the child for the next day. On September 3, 1998, J.B.'s mother brought J.B. to Dr. Heller's office as recommended to discuss the dystonic reaction. Despite Risperdal's side effect, the drug was working well, J.B.'s mother reported, and the patient "look[ed] much better" to Dr. Heller. He also noted that the "[c]hild like[d] taking Prozac, [which was] helping him a lot." Dr. Heller decided to continue the boy on these medicines plus the Adderall at the same dosages, and to add Cogentin, 0.5 milligrams twice a day, to control the dystonic reactions.4 Later that afternoon, J.B. returned to Dr. Heller's office complaining of weakness and nosebleeds. In response, Dr. Heller reduced J.B.'s morning dose of Risperdal to 0.25 milligrams and prescribed neosynephrine for the nose bleeds. Second Week Informed by telephone a few days later, on Sunday, September 6, 1998, that J.B.'s nosebleeds had re-occurred, Dr. Heller again advised using neosynephrine and applying pressure——neither of which had yet been tried. Dr. Heller saw J.B. in his office the following Wednesday, September 9, 1998. He observed that the child seemed better behaved and had shown some improvement on Risperdal. During this visit, J.B.'s mother suggested that her son try Ritalin instead of Adderall, telling Dr. Heller that J.B. had done better with Ritalin in the past. Acting on this information, Dr. Heller prescribed slow-release Ritalin, 20 milligrams twice a day, in the place of Adderall. Because J.B. had not suffered another dystonic reaction——evidently the Cogentin was doing its job——Dr. Heller continued J.B. on Cogentin at 0.5 milligrams, twice a day, and instructed the boy to resume taking the originally-prescribed amount of Risperdal: 0.5 milligrams twice a day. He also directed that J.B.'s Prozac be increased to 20 milligrams daily. Dr. Heller asked J.B.'s mother to bring him back to the office in two weeks. Third Week Five days later, on Monday, September 14, 1998, Dr. Heller saw J.B. again. His mother reported that J.B. was doing much better in school——apparently the Ritalin was helping——but he remained angry with and "hateful” to her at home. J.B. himself told Dr. Heller that his mother "irritate[d]” him. Armed with this data, Dr. Heller increased J.B.'s evening dose of Risperdal from 0.5 milligrams to 1.5 milligrams, continuing him on 0.5 milligrams of the drug in the morning. Dr. Heller also increased J.B.'s morning dose of Ritalin from 20 milligrams to 40 milligrams, while keeping the second dose constant at 20 milligrams. He continued J.B. on the same dosages of Prozac and Cogentin. Finally, Dr. Heller recommended family counseling and requested to see the boy again in two days. When Dr. Heller next examined J.B. on Wednesday, September 16, 1998, the patient's mother reported that J.B. was doing better in school on the higher morning dose of Ritalin but was still having problems at home. Dr. Heller observed that the boy was poorly behaved but under control. He decided to stay the course and continue J.B. on the present combination of medicines, at existing dosages, with instructions to return after one month. Fourth and Fifth Weeks J.B. was not brought to Dr. Heller's office during the weeks of September 20 and September 27, 1998. Sixth Week Dr. Heller saw J.B. again on Monday, October 5, 1998. At this time, J.B. was reportedly doing well in school but not at home, where, according to his mother, J.B. expressed "[l]ots of anger towards [his] father"——to the point that she feared the father's visit at Christmas. J.B. had stopped taking his evening dose of Risperdal. The boy was still having some nosebleeds, and he had a rapid heartbeat. His psychological and behavioral problems continued, although his violent behavior was under control. J.B.'s mother gave Dr. Heller a note from Mrs. Glenda McBride, J.B.'s teacher, in which Mrs. McBride had conveyed her concerns about J.B.'s failure to eat at school and his depressive behavior. To stimulate J.B.'s appetite, Dr. Heller prescribed Sinequan——which is an antidepressant that, as a side effect, can increase the user's appetite——at a dose of 25 milligrams, twice a day. He asked to see J.B. in three weeks. As it happened, however, the October 5, 1998, visit was J.B.'s last to Dr. Heller's office. Around that time, the Florida Department of Children and Families ("DCF") became involved, apparently at the instance of J.B.'s older brother, a prison inmate who had accused their mother of overmedicating the boy. The record is empty of substantial competent evidence concerning DCF's investigation, findings, or interventions, if any. What is clear, however, is that J.B.'s physician-patient relationship with Dr. Heller abruptly ended. At hearing, J.B.'s kindergarten teacher recounted an out-of-court statement by the boy's mother informing her that J.B. had been taken off all medications except Ritalin effective October 6, 1998. After that date, according to Mrs. McBride, the child improved visibly in the classroom, where she had the opportunity to observe him until the end of January 1999, when J.B. moved away. The trier accepts Mrs. McBride's testimony as far as it goes——which is not as far as the Department would take it. Specifically, neither Mrs. McBride's testimony nor any other evidence clearly and convincingly establishes that Dr. Heller's treatment of J.B. either failed, was deleterious, or would not have brought about an improvement in J.B.'s condition similar to that witnessed by Mrs. McBride if J.B. had remained in Dr. Heller's care beyond October 5, 1998. For one thing, Mrs. McBride's second-hand testimony regarding the purported change in J.B.'s mix of medicines as of October 6, 1998, is not, by itself, clear and convincing evidence of that fact; and, there was no persuasive direct evidence——e.g. the testimony of J.B.'s next treating physician——to corroborate her account or to explain what subsequent care and treatment, if any, were rendered. For another, there are any number of reasons unrelated to medical care that could have caused or contributed to J.B.'s improvement which are not excluded by or inconsistent with the evidence in the record.5 In sum, the trier expressly does not find, and affirmatively rejects any inference, that DCF "rescued" J.B. from Dr. Heller. The Charges In Count One of its Administrative Complaint, the Department accused Dr. Heller of failing to practice medicine with the requisite degree of care and skill, in violation of Section 458.331(1)(t), Florida Statutes, in four specific respects: (a) inappropriately prescribing excessive doses of medicine to J.B.; (b) failing to take a baseline electrocardiogram ("EKG”) for J.B.; (c) failing to consult a family therapist or counselor for J.B.; and (d) failing to note in J.B.'s medical records information regarding the mental status examination of J.B. or any observations of his behavior in the office. At hearing, however, the Department withdrew the allegation that Dr. Heller had negligently failed to order an EKG. Further, the Department's own expert testified that Dr. Heller's alleged failure to consult with a family therapist was not a breach of the standard of care; needless to say, Dr. Heller's experts agreed. Thus, the alleged negligent acts described in (a) and (d) above are the ones that remain in dispute.6 In Count Two, the Department charged Dr. Heller with prescribing legend drugs other than in the course of his professional practice, in violation of Section 458.331(1)(q), Florida Statutes, based on the following allegations: On or about August 31 and September 9, 1998, [Dr. Heller] ordered an automatic 10 mg. increase in Patient J.B.'s Prosac [sic] prescription without allowing an appropriate amount of time for the medicine to take effect On or about September 14, 1998, [Dr. Heller] increased Patient J.B.'s morning dose of Ritalin from 20 mg. to 40 mg. in one jump; From on or about August 31, 1998 to on or about September 14, 1998, [Dr. Heller] increased Patient J.B.'s dose of Risperdal to a total of 2 mg. a day despite the fact that Patient J.B. suffered an earlier dystonic reaction; On or about October 5, 1998, [Dr. Heller] prescribed Sinnequan [sic] to Patient J.B. in an effort to increase his appetite despite the fact that Patient J.B. was already suffering from the side effects of his other medications; From on or about August 31, 1998 to on or about October 8, 1998, [Dr. Heller] prescribed excessive doses of multiple medications without regard for the interactions and side effects of the high doses on Patient J.B. At hearing, the Department withdrew the allegation, set forth in (a) above, regarding the purportedly excessive increase in J.B.'s Prozac. The Department alleged in Count Three of its Administrative Complaint that Dr. Heller had violated Section 458.331(1)(m), Florida Statutes, by failing to keep medical records that justified the following alleged misconduct: (a) his prescribing of excessive doses and multiple medications to J.B.; (b) his failure to take a baseline EKG for J.B.; (c) his failure to consult a family therapist; and (d) his failure to note in J.B.'s medical records information regarding the mental status examination of J.B. or any observations of the patient's behavior in the office. For the reasons set forth in paragraph 23 above, the records dispute has boiled down to the alleged deficiencies described in the foregoing clauses (a) and (d). The Standard of Care At hearing, the Department agreed that the standard of care against which Dr. Heller's conduct must be measured is that level of care, skill, and treatment which is recognized by a reasonably prudent family practitioner as being acceptable under similar conditions and circumstances. The Department disavowed any intent to hold Dr. Heller to the standard of care governing psychiatrists. In its proposed recommended order, however, the Department has asserted that Dr. Heller provided psychiatric treatment to J.B., and that, consequently, a board-certified child psychiatrist should be considered a "similar health care provider.” This contention is somewhat, if not entirely, inconsistent with the stipulation at hearing regarding the applicable standard of care; at the very least, it muddies the water. The greater weight of the evidence shows that mental illnesses and behavioral problems such as J.B.'s are conditions that reasonably fall within the discipline of family practice, and that specialists such as Dr. Heller may appropriately diagnose and treat the mentally ill without thereby engaging in the specialized practice of psychiatry.7 As a matter of fact, therefore, the relevant standard of care in this case is that applicable to small-town family practitioners. The evidence regarding the appropriate standard of care is in conflict. The Department's expert, Dr. Morteza Nadjafi, is a board-certified child psychiatrist who practices in the large city of Orlando, Florida. Based primarily on the medical records that Dr. Heller prepared and without having discussed the case with Dr. Heller himself, Dr. Nadjafi found much to criticize in Dr. Heller's treatment of J.B. Broadly speaking, it is Dr. Nadjafi's opinion that, in caring for——and in documenting his treatment of——J.B., Dr. Heller repeatedly fell short of the minimal standard of care for any physician, irrespective of specialty. On the other hand, Dr. Heller's experts opined that Respondent treated J.B. with the requisite level of care expected of a reasonably prudent family practitioner. They were: Dr. Joseph Talley, author of a textbook entitled Family Practitioner's Guide to the Treatment of Depressive Illnesses that was favorably reviewed in the New England Journal of Medicine, a board-certified family practitioner who regularly treats mentally ill patients in the small North Carolina town where he works; and Dr. David Rooney, a board-certified psychiatrist who presently specializes in treating adults and geriatric patients, whose background includes a one-year, post- graduate internship in family practice that was followed by about a year's employment as a family practitioner in a rural community in Iowa. As the trier of fact and arbiter of credibility, the Administrative Law Judge must resolve the evidential conflict regarding the acceptable degree of care and Dr. Heller's failure or success in practicing with it. Accordingly, the trier has carefully considered the substance and foundations of the several experts' opinions as well as their respective demeanors, testimonial inconsistencies, and possible biases, ultimately determining the appropriate weight to be given each witness's testimony. On balance, all factors considered, the trier believes that Dr. Heller's witnesses painted a more accurate picture of the relevant standard of care.8 Of the three experts, Dr. Talley's testimony was the most persuasive because his specialty, community, and practice are the most similar to Dr. Heller's. Ultimate Factual Determinations In treating J.B., Dr. Heller did not fail to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. To the contrary, Dr. Heller's care and treatment of a difficult patient more likely than not exceeded the relevant standard of care and probably reflected above-average skill for a family practitioner in a small town where there is (according to the Department's expert) no local psychiatrist. The Department failed to adduce clear and convincing evidence that Dr. Heller prescribed drugs to J.B. inappropriately or in excessive or inappropriate quantities, either negligently in violation of the applicable standard of care or (it follows from the foregoing) in amounts that no reasonable physician could justify as medically appropriate. If the Department had proved the latter clearly and convincingly, then the trier would have been allowed to presume that the doctor had prescribed drugs outside the course of his medical practice in violation of Section 458.331(1)(q), Florida Statutes. As it is, however, the greater weight of the evidence shows that Dr. Heller prescribed drugs for J.B. in appropriate quantities, for medically justifiable purposes. Further, the evidence is overwhelming——indeed, is clear and convincing——that Dr. Heller's treatment of J.B. took place in the course of his professional practice. Dr. Heller's medical records pertaining to J.B. were legible; they properly identified the responsible physician (Dr. Heller) by name and professional title; and, as a preponderance of evidence demonstrates, they justified the course of treatment that Dr. Heller rendered to J.B. Dr. Heller not only exercised reasonable care under the circumstances in preparing these records, but also he obeyed the statutory directives regarding record-keeping set forth in Section 458.331(1)(m), Florida Statutes. The Department's evidence to the contrary is not clear and convincing.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the Department having failed to prove the charges brought against Dr. Heller by clear and convincing evidence, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 12th day of June, 2001, in Tallahassee, Leon County, Florida. JOHN G. VAN LANINGHAM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 12th day of June, 2001.
The Issue At issue in this proceeding is whether the proposed amendments set forth in the Notice of Proposed Rule published on May 15, 2013, in the Florida Administrative Register, Vol. 39, No. 95, pages 2609 through 2610 and modified by the Notice of Change, published on March 12, 2015, in the Florida Administrative Register, Vol. 41, No. 49, pages 1236 through 1237, constitute an invalid exercise of delegated legislative authority,1/ and, if so, whether costs and attorney’s fees should be assessed against Respondent and paid to Petitioner.
Findings Of Fact The Petition Petitioners have challenged the Notice of Proposed Rule and Notice of Change as an invalid exercise of delegated legislative authority. The petitions request that a formal hearing be conducted, a final order be entered determining that the proposed rule is an invalid exercise of delegated legislative authority, award petitioners’ costs and attorneys’ fees, and provide such other relief as deemed necessary. The Parties Petitioner Fernandez is a Florida resident and patient with ongoing medical issues that requires him to request and obtain his medical records from his attending or treating physicians from time to time. Petitioner Dax J. Lonetto, Sr., PPLC, is a Florida-based law firm. Dax Lonetto is a Florida-licensed attorney and sole shareholder of the Lonetto PPLC law firm. Eighty-five to 90 percent of Mr. Lonetto’s practice involves social security disability benefits, and the remainder of his practice involves veteran’s benefits and other basic personal injury claims.6/ In order to pursue and obtain social security benefits or veteran’s benefits for clients, Mr. Lonetto must first obtain his clients’ medical records. Petitioner FJA is a statewide, not-for-profit, professional association of approximately 2,500 plaintiff trial attorneys. FJA’s purpose is engaging in advocacy efforts on behalf of its membership, strengthening and upholding Florida’s civil justice system, and protecting the rights of Florida’s citizens and consumers. Paul D. Jess is a Florida-licensed attorney who serves as the general counsel and deputy executive director for FJA. Mr. Jess provided no documentary evidence to support the position that most physician “offices or vendors would charge the maximum [amount] permitted [by the rule].” Mr. Jess admitted that FJA is not “directly injured by this price hike as an association or as a corporation,” because FJA does not order medical records. However, Mr. Jess testified that for the majority of FJA’s members, ordering medical records is a routine practice on behalf of their clients. Further, Mr. Jess believed that a majority of FJA members would be adversely impacted by this proposed rule, based on the increased costs in obtaining their clients’ medical records. Petitioner FCAN is a Florida not-for-profit grassroots organization dedicated to advocating for the rights of Florida consumers. William Newton served as the corporate representative for FCAN. Mr. Newton previously relinquished the full-time executive director’s position and now currently works part-time as FCAN’s deputy director. FCAN currently has about 7,000 individual members. FCAN is a nonpartisan organization which represents Florida consumers in four major issue areas: utilities, insurance, health care, and the environment.7/ With respect to the health care area, FCAN stands for affordable and available health care for everyone, with a focus on trying to improve accessibility, as well as to control the price of health care. Mr. Newton did not know how many of FCAN’s 7,000 members would be affected by the proposed rule change; however, he believed that “almost all of them would be” because they go to the doctor. The Board regulates the practice of medicine in Florida pursuant to chapters 456 and 458, Florida Statutes, and is the agency that is proposing the rule amendments at issue. Intervener BACTES is a release of information (ROI) provider that contracts with physicians in Florida and throughout the country to process and fulfill requests for medical records received by such physicians. William Bailey founded BACTES and served as its CEO from 1991 until July 2013, when he assumed a consultant status with the provider. Mr. Bailey confirmed that BACTES is currently operating in Florida with three offices located in Orlando, Ft. Myers, and Jacksonville. BACTES has no plans to discontinue doing business in Florida.8/ Intervener HealthPort is also an ROI provider that contracts with physicians in Florida and throughout the country to process and fulfill requests for medical records received by such physicians. Kyle Probst, HealthPort’s counsel and director of government relations, confirmed that HealthPort engaged Cynthia Henderson to approach the Board regarding making changes to the rule to “clear up some apparent confusion about how medical records should be billed in the state of Florida.” Intervener FMA is a professional association dedicated to the service and assistance of allopathic and osteopathic physicians in Florida. Approximately 20,000 licensed Florida physicians are members of the FMA. The parties agreed there are approximately 75,000 physicians licensed and regulated by the Board. Not all 75,000 Florida licensed physicians are currently practicing in Florida. The Statute and Current Rule Section 456.057(17), Florida Statutes, provides: A health care practitioner or records owner furnishing copies of reports or records or making the reports or records available for digital scanning pursuant to this section shall charge no more than the actual cost of copying, including reasonable staff time, or the amount specified in administrative rule by the appropriate board, or the department when there is no board. Section 458.309(1) provides in pertinent part: The board has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this chapter conferring duties upon it. Florida Administrative Code Rule 64B8-10.003 is the Board’s rule governing the costs of reproducing medical records. The rule was first adopted on November 11, 1987, as rule 21M-26.003. It was transferred to rule 61F6-26.003, then to rule 59R-10.003, amended on May 12, 1988, amended on March 9, 2009, and then finally transferred to rule 64B8-10.003. The rule currently provides: Costs of Reproducing Medical Records. Recognizing that patient access to medical records is important and necessary to assure continuity of patient care, the Board of Medicine urges physicians to provide their patients a copy of their medical records, upon request, without cost, especially when the patient is economically disadvantaged. The Board, however, also recognizes that the cost of reproducing voluminous medical records may be financially burdensome to some practitioners. Therefore, the following rule sets forth the permitted costs for the reproduction of medical records. Any person licensed pursuant to Chapter 458, F.S., required to release copies of patient medical records may condition such release upon payment by the requesting party of the reasonable costs of reproducing the records. For patients and governmental entities, the reasonable costs of reproducing copies of written or typed documents or reports shall not be more than the following: For the first 25 pages, the cost shall be $1.00 per page. For each page in excess of 25 pages, the cost shall be 25 cents. For other entities, the reasonable costs of reproducing copies of written or typed documents or reports shall not be more than $1.00 per page. Reasonable costs of reproducing x- rays, and such other special kinds of records shall be the actual costs. The phrase “actual costs” means the cost of the material and supplies used to duplicate the record, as well as the labor costs and overhead costs associated with such duplication. Specific Authority 456.057(18),9/ 458.309 FS. Law Implemented 456.057(18) FS. History-New 11-17-87, Amended 5-12- 88, Formerly 21M-26.003, 61F6-26.003, 59R-10.003, Amended 3-9-09. This rule was first created in 1987 and was effective in May 1988. In pertinent part, that first rule provided that chapter 458 licensees could condition the release of copies of patient medical records “upon payment . . . of reasonable costs of reproducing the records.” The rule then defined “reasonable costs of reproducing copies . . . [should] not be more than” a $1.00 for the first 25 pages and 25 cents per page in excess of 25 pages. In 2009, the rule was revised to allow patients and governmental entities to get copies of medical records at that same rate. For all other entities the “reasonable costs of reproducing copies . . . [should] not be more than $1.00 per page.” Over the course of 26 months, the Board had access to as much information as the Board staff and interested parties could provide it. The Board heard testimony in no fewer than nine public hearings.10/ The proposed rule language was dissected and discussed on multiple levels, and the Board devoted countless hours to listening to and evaluating those comments. Rule Development In June 2012, the Department of Health (Department) and the Board received an email correspondence on behalf of HealthPort requesting clarification on the costs for reproducing electronic medical records. That correspondence, the current rule 64B8-10.003, and the applicable statutes were placed on the agenda for the Board’s August 2012 Rules/Legislative Committee (RLC or Committee) meeting. At the August RLC meeting, the Committee discussed the requested action and heard from an attorney representing HealthPort. The Committee voted to table the item and seek additional information. The Board commenced rulemaking to amend rule 64B8-10.003 in early October 2012. At the RLC meeting on October 11, 2012, the Committee voted unanimously to recommend noticing this proposed change for rule development. The Board’s counsel was to draft language for a proposed rule change to be presented at the next RLC meeting. On October 30, 2012, a Notice of Development of Rulemaking (Notice) was published in the Florida Administrative Register. The Notice listed the “PURPOSE AND EFFECT: [as] The Board proposed the development of rule amendments to address the cost of reproduction of medical records which are stored in an electronic format.” At the November 2012 RLC meeting, the Committee received a draft rule proposal, excerpts of the October RLC meeting report, and materials from the October meeting. The Committee heard from various speakers on the proposed rule language. One Committee member suggested that the RLC would benefit from knowing what other state medical boards allowed physicians to charge. Another suggested the Board staff look at a different charge for paper versus electronic production. Following the discussion, the Committee approved two motions: one to move to one rate (but undecided on what that rate would be); and the second to have then Executive Director, Alison Dudley, “come back to [the RLC] with the aspects of what costs are elsewhere so that [the RLC could] make that decision about what that rate and particular medium” is, in order to move forward. The Board’s staff prepared a survey that was sent to administrators in medicine via a web portal, asking the following specific questions: Does your board have a rule or law that outlines what a physician can charge for medical records? Flat rate or per page? Does that law or rule delineate different charges for paper medical records versus electronic medical records? What are the charges? Does the law or rule delineate different charges for producing the medical records on paper versus on a CD? What are the charges? Does the law or rule contemplate charges for other services such as diagnostic tests or X-rays? What are the charges? Does your law or rule define “electronic medical record?” If so, what is that definition? Can you share your law and/or rule with us? Thank you for your responses. Of the 50 or so administrators contacted, the Board staff received 13 responses. Those responses were provided to the RLC for review. At the January 31, 2013, RLC meeting, the agenda included multiple items for the Committee’s consideration: the transcript from the November 29, 2013, RLC meeting; excerpts of the RLC report dated December 2012; an email from Ms. Henderson; a 2003 White paper; the costs charged by Florida Clerk of Courts, Florida hospitals, and other Florida health care boards; costs charged by other state medical boards; and all the materials presented at the prior meetings. The Committee received testimony from individuals regarding their understanding of how the proposed changes to the rule would or could affect their patient/clients. As a result of those comments and the RLC’s discussion, the Committee voted to have draft language prepared that included one fee for any records release with the following specific language: “stored and delivered in any format or medium.” The draft language was to be presented at the next RLC meeting. At the April 4, 2013, RLC meeting, the Committee agenda included excerpts from its January meeting, draft language, and an article regarding the federal Health Portability and Accountability Act (HIPAA) requirements. The Committee heard from individuals again and considered the various recommendations regarding the appropriate language for the proposed rule. The draft language presented at this RLC meeting, in the underline/strike-through method, provided the following: Costs of Reproducing Medical Records. Recognizing that patient access to medical records is important and necessary to assure continuity of patient care, the Board of Medicine urges physicians to provide their patients a copy of their medical records, upon request, without cost, especially when the patient is economically disadvantaged. The Board, however, also recognizes that the cost of reproducing voluminous medical records may be financially burdensome to some practitioners. Therefore, the following rule sets forth the permitted costs for the reproduction of medical records stored and delivered in any format or medium. Any person licensed pursuant to Chapter 458, F.S., required to release copies of patient medical records may condition such release upon payment by the requesting party of the reasonable costs of reproducing the records. For patients and governmental entities, the reasonable costs of reproducing copies of written or typed documents or reports shall not be more than the following: For the first 25 pages, the cost shall be $1.00 per page. For each page in excess of 25 pages, the cost shall be 25 cents. (2)(3) The For other entities, the reasonable costs of reproducing copies of written or typed documents or reports shall not be more than $1.00 per page. (3)(4) Reasonable costs of reproducing x-rays, and such other special kinds of records shall be the actual costs. The phrase “actual costs” means the cost of the material and supplies used to duplicate the record, as well as the labor costs and overhead costs associated with such duplication. Additionally, the Committee discussed the anticipated financial impact that the proposed changes would have on small businesses, including whether or not a statement of estimated regulatory costs (SERC)11/ was necessary. The Department staff could not say whether the proposed change would increase the Department’s cost in excess of $200,000 a year. Following the discussion, the Committee voted to table the SERC decision until additional information could be brought before the Board and the proposed draft rule language was approved. The full Board met on April 5 and approved the RLC report which included the approval of the draft rule language. Additionally, the Department staff reported that, after conferring with other staff in Tallahassee, the Department did not feel that the cost associated with the draft rule language would exceed $200,000 a year in the aggregate. The Board voted that a SERC was not required. Between the October 2012 Notice and the May 2013 publication of the proposed rule changes, the RLC met in noticed public meetings discussing the potential rule revision. The rule record is clear that the proposed changes were discussed extensively by Committee members with input from attorneys, residents, association representatives and corporate representatives. On May 15, 2013, a Notice of Proposed Rule (using the proposed language found in paragraph 26 above) was published in the Florida Administrative Register, Vol. 39, No. 95. The purpose for the proposed rule was to provide a single fee for reproducing medical records. The Board received a request for a hearing and numerous comments from the public on the proposed changes. The rule hearing was scheduled for the next available Board meeting. On August 2, 2013, the Board held a public hearing on the proposed rule in Deerfield Beach. The Board agenda included: the proposed rule 64B8-10.003; the rule hearing request; the rule hearing notice; a summary of the issue for Board consideration submitted by Ms. Henderson; copies of the notices sent regarding the hearing; meeting reports from the RLC meetings held on August 2, 2012, October 11, 2012, November 29, 2012, January 31, 2013, and April 4, 2013; and over 60 written comments. At the Board meeting over 15 people addressed the Board, expressing either opposition to or support of the proposed changes. As a result of the testimony received, the Board chair directed that the public rule hearing be transcribed and the transcript be sent to the RLC for its consideration and determination. At the Orlando RLC meeting on October 3, 2013, the Committee conducted a rule hearing on the proposed rule language. The RLC’s agenda included: draft proposed language for the rule; a draft RLC meeting report; a transcript from the August 2, 2013, rule hearing; an article regarding Florida doctors and medical records; and additional comments from seven different sources. The Committee was charged to consider the testimony from the August 2013 public rule hearing, as well as the testimony from this rule hearing to make recommendations to the full Board. The Committee heard testimony from individuals who either opposed or supported the proposed rule. The Committee members asked questions of the various presenters, and provided education to those presenters and attendees as to the multiplicity of medical practices, attendant issues, and personal experiences in dealing with medical records requests. The Committee agreed that the rule should be as set forth in the draft rule language. The Committee also agreed that there might be an “adverse impact” on small businesses, and that a SERC should be prepared. In November 2013, Board staff distributed a survey to 1,41912/ Florida-licensed physicians seeking responses to the following questions: Do you handle the copying of your medical records with your own staff? If yes continue to 1a. If no, go to Question 2. Yes. No. 1a. Do you have a designated staff person who only handles the review and copying of medical records? If yes, continue to 1b. If no, continue to 1c. Yes. No. 1b. How much do you pay this person on a monthly basis, including any benefits that are provided? 1c. How much do you spend on special equipment and supplies (copier, paper etc.) for the copying of medical records annually? If you send your medical records for copying by a service, how much do you pay each month for this service? On average, how many requests for copies of medical records do you receive each month? The Board staff received 28 responses from the 1,419 surveys sent out. Of those 28 responses, 27 handled the copying of medical records in-house. Twelve practitioners had a designated staff person to review and copy medical records, while 15 did not. Fifteen declined to provide how much their personnel were paid. There was a wide range of pay for the others. The costs associated for special equipment and supplies to provide copies of medical records ranged from $120 to $20,000 per month. Only one practitioner responded that medical records were sent out to a copying service. The number of medical record requests varied from one to more than 600 per month. The next public hearing was held in Orlando on December 6, 2013. The Board materials included: the hearing notice for December 6, 2013; proposed rule language; the transcript of the October 3, 2013, meeting; section 164.524, Access of Individuals to Protected Health Information; new comments received; the survey results; and material from the previous public hearings and meetings. The Board considered the testimony from the public hearings that had been held on August 2 and October 3. Each speaker was afforded the opportunity to express their position and comments received were either “opposed” or “supported” the proposed rule changes. Following the testimony, the Board voted to change proposed subsection (2) by adding the following language, which is underscored: [t]he reasonable costs of reproducing copies of written or typed documents or reports shall not be more than $1.00 per page, but shall not exceed actual costs. Thereafter, the Board again revisited the question of whether a SERC was necessary. The Board considered whether the newly revised language would adversely affect, or was likely to directly or indirectly increase regulatory costs to any entity in excess of $200,000 in the aggregate in Florida within one year of the implementation of the rule. The Board determined that a SERC was necessary. On February 6, 2014, the RLC met in Kissimmee for another public hearing on the proposed rule amendments. The Committee was to consider changes authorized by the Board during its December meeting. The agenda materials included: draft language of the rule; additional correspondence; and the materials from the prior meetings/hearings. If the draft rule language was approved, two questions had to be addressed: would the proposed rule have an adverse impact on small businesses; and would the proposed rule be likely to directly or indirectly increase regulatory costs to any entity in excess of $200,000 in the aggregate in Florida within one year after its implementation? Testimony was received from several individuals. Following the testimony, the Committee members had a discussion about the terms “actual costs” versus “reasonable costs.” The Committee voted to revise the draft rule language to “reasonable costs” and approved a “Notice of Change” to be published. The Committee also determined that the amendment would not have an adverse impact on small businesses, nor was it likely to directly or indirectly increase regulatory costs in excess of $200,000. On April 3, 2014, the RLC held another public hearing in Deerfield Beach on the proposed rule. There remained some inconsistencies in the changes that were approved and the Committee reconsidered the proposed rule language. The material in the RLC’s agenda included: materials presented at previous meetings including correspondence; draft changes to the rule; the hearing notice; an article regarding electronic records; an excerpt of the February 2014 meeting; and the transcript of the February 2014 meeting. The Committee received testimony from several speakers who pointed out concerns about the proposed rule, and provided alternatives to it. After the testimony, the Committee voted to have new language prepared addressing those concerns and, in some instances, incorporated alternative suggestions. Additionally, the Committee understood that an additional public hearing would be necessary, and that the SERC might need to be revised. On June 5, 2014, the RLC met in Tampa for another public hearing to consider the revised draft rule language. The agenda included: the hearing notice; the proposed draft language; a proposed SERC; multiple written comments; transcripts from prior RLC and Board meetings where the proposed rule was discussed; and RLC meeting reports. The Committee voted to table the discussion of the proposed rule until another hearing could be held in South Florida. On October 9, 2014, the RLC met in Deerfield Beach and held a rule hearing regarding the revised rule language. The Committee received additional testimony from concerned individuals. The Committee voted to accumulate all the comments and present everything to the full Board at the December 2014 meeting. In October 2014, Ms. Dudley was asked to speak at the Capital Medical Society in Tallahassee. Ms. Dudley took the opportunity to hand out the survey (found in paragraph 34) to the participants. Although she received four additional responses to the survey, the audience was not physicians, but staff who primarily handled the medical records for medical offices. On December 4, 2014, the RLC met in St. Petersburg for an additional rule hearing on the proposed rule language. The Committee was to review all the comments submitted. The RLC’s agenda material included: the hearing notice; the suggested changes to the draft proposed rule from March and May 2014; the excerpt of the RLC meeting report in October 2014; multiple correspondence from concerned individuals; survey responses from physician offices (including the four additional surveys); materials from the prior hearings and RLC meetings; and the proposed SERC. At the beginning of this rule hearing, the Board’s executive director provided a suggested revision to the proposed rule by adding a new paragraph: “(4) Accessing medical records through patient portals does not constitute the reproduction of medical records.” Testimony was received from various individuals regarding the proposed rule language. The Committee reviewed all the comments submitted. The Committee determined that a SERC should be prepared. The Board held another rule hearing on the proposed rule language on February 6, 2015, in Stuart. The agenda material included: the hearing notice; the draft changes; the excerpt of the RLC meeting; survey responses from physician offices; newly received written comments; a proposed SERC; and materials presented at the previous hearings and meetings. The Board heard testimony from several individuals who either opposed or supported the proposed rule language. The Board reviewed the changes to the proposed rule and the proposed SERC, and heard testimony from presenters. Based on that testimony, the Board members further discussed the proposed rule language and voted to modify it again. After the proposed rule language discussion, the Board then addressed whether it believed, with the latest revision to the draft rule, that a SERC was necessary. The Board voted to accept the SERC as presented. On February 17, 2015, the Joint Administrative Procedures Committee (JAPC) wrote the Board regarding the SERC and inquired as to whether the draft rule would require legislative ratification. As a result of the JAPC inquiry on March 4, 2015, the Board held a telephonic conference meeting. The Board heard from three individuals regarding whether the proposed rule required legislative ratification and the status of the SERC. The Board determined that the rule would require legislative ratification and the SERC needed to be revised. The Board approved the following changes to the proposed rule (the initial paragraph and sections (1) and (2) are found in paragraph 26 above): (4) Reasonable costs of reproducing x- rays, and such other special kinds of records shall be the actual costs. The phrase “actual costs” means the cost of the material and supplies used to duplicate the record, as well as the labor costs and overhead costs associated with duplication, plus postage. Accessing medical records through patient portals does not constitute the reproduction of medical records. On March 12, 2015, the Notice of Change was published in the Florida Administrative Register, and the four petitions were filed. Following the filing of the petitions at DOAH, the parties requested a continuance to allow the Petitioners the opportunity to present their lower-cost alternatives to the Board. At the April 10, 2015, Board meeting, the Board addressed an allegation that the Board had failed to consider five lower-cost regulatory alternatives (Alternatives). The Board had not considered the Alternatives because they had not been filed for the Board’s consideration. Once the Alternatives were filed, they were placed on the next available Board agenda. The first Alternative was to leave the rule in its current state. After hearing from interested parties, the Board determined that it had evaluated the issues around the rule and the costs during the prior hearings and meetings. The Board agreed that the status quo was not viable for a variety of reasons. The Board voted to reject this Alternative. The second Alternative asked that the medical record holder only be allowed to charge the actual cost of copying, including reasonable staff time consistent with section 457.057(17). The Board discussed that through the multiple public hearings it had determined that it would be impossible to determine the actual charge for copying. The actual cost for an urban multi-partner physician would be different than a solo practitioner’s office in a rural location. The Board voted unanimously to reject this Alternative. The third Alternative asked the Board to conduct an evaluation or study regarding what the actual costs of copying are for medical record holders based on the type of request, type of medical record, the format of the record, and the format of the record to be delivered. The Board discussed what it had heard about in the prior meetings: other states allowed higher levels of reimbursing; and hospitals charged $1.00 per page as authorized by statute. The Board attempted to obtain the data sought but was unsuccessful in obtaining any significant response. Further, the Board does not have the statutory authority to require physicians to respond to any data or survey requests. The Board voted unanimously to reject this Alternative. The fourth Alternative asked the Board to eliminate the per-page price and impose a restriction that the prices could not exceed the maximum price authorized by HIPAA. The Board did not concur that HIPAA set an exact amount, and trying to determine the costs for each practitioner in each type of practice would be frustrating to all involved. The Board voted unanimously to reject this Alternative. The fifth Alternative asked the Board to keep the current rule, but separate the costs for electronic versus digital copies. The Board discussed the movement towards all electronic medical records, but paper records and other records will still exist. The Board determined that there is a need for the proposed rule to address the current circumstance. The Board voted unanimously to reject this Alternative. Those opposed to the alleged increase testified there was no basis for the change, that the proposed change quadrupled the price for patients and governmental entities, and that it was arbitrary and capricious, especially with respect to electronic records. These opponents fail to recognize changes in medicine. HIPAA brought patient confidentiality and the need to maintain that confidentiality into sharp focus. Medical practitioners are required to ensure that confidential patient information is not disseminated to unauthorized persons. Physicians must pay to have medical records copied, whether it is done “in-house” or by an ROI provider. Labor costs have increased and the tedious review to ensure that confidential information remains confidential is time-consuming and costly. Medical practices can be quite varied in type, size, sophistication, location, and much more. Petitioners’ claim that the proposed rule should be the “actual cost” to the practitioner is impracticable. A general practitioner in a rural solo practice, who receives one request for medical records, might be able to ascertain the “actual cost” to produce that one medical record. A specialist in an urban multi-partner practice group, who receives multiple requests for medical records, would find it nearly impossible to ascertain the “actual cost” to produce each requested medical record without extensive business record-keeping. This proposed rule retains the suggestion that physicians “provide their patients with a copy of their medical records, upon request, without cost, especially when the patient is economically disadvantaged.” Physicians provide medical records, free of charge, to subsequent or specialty physicians to ensure care. However, physicians are not in the business of repeatedly producing medical records. Those in favor of the proposed rule testified that the cost to physicians for reproducing medical records has not increased in years. The stringent HIPAA requirements placed an additional requirement on health care providers to ensure that private individual health data is kept confidential. The process to release medical records is not simply to pull a paper, digital or electronic medical record, copy it, and send it out the door. The process, as explained, takes valuable time from practitioners and their staff. In a simplified fashion once the request is made: staff must verify the requester’s identity and right to obtain the copy; the request must be logged into a HIPAA log; staff must locate and retrieve the medical record in whatever format it is in; staff must redact confidential information; staff must review for specific health treatment records (mental health, alcohol or drug treatment, HIV status) that cannot be provided pursuant to statute; a copy may need to be made or a paper copy may need to be scanned to an electronic disc; and the practitioner must review it to make sure it can be provided as requested. It is a time-consuming process.
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.
