The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint dated March 26, 2010, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 456.072, Fla. Stat. The Board of Medicine ("Board") is the entity responsible for regulating the practice of medicine and for imposing penalties on physicians found to have violated the provisions of section 458.331(1). See § 458.331(2), Fla. Stat. At the times material to this proceeding, Dr. Genao was a physician licensed to practice medicine in Florida, having been issued license number ME 58604. Dr. Genao was board-certified in pediatrics, and, until he closed his office in 2008, he practiced pediatric medicine and complementary medicine, which consists primarily of nutrition counseling and infusion therapy. From December 2008 to March 2010, Dr. Genao was employed as a physician at the Full Service Pain Management Clinic ("Clinic"). Prior to his employment with the Clinic, Dr. Genao had not practiced medicine in the field of pain management and had not taken any continuing medical education classes in the field of pain management. His knowledge of pain management medicine prior to his association with the Clinic was limited to the writing of an occasional prescription for Oxycodone or Percoset. When Dr. Genao learned that the Clinic was looking for a physician, he contacted the Clinic and was interviewed by one of the owners. After he was hired by the Clinic, he observed and worked with the medical director of the Clinic, Dr. Friedberg, for approximately three weeks. Then, when he began seeing patients at the Clinic on his own, another physician observed him with his first few patients. This was the only formal training he received in pain management medicine. During the time he was observing the medical director of the Clinic and working with patients at the Clinic, Dr. Genao read about pain management medication in textbooks and on the Internet, and he also attended approximately 35 hours of continuing medical education in the field of pain management medicine. During the time he was working at the Clinic, Dr. Genao had an endorsement on his medical license allowing him to dispense drugs on the premises. Dr. Genao began treating patients V.C. and J.S. at the Clinic in December 2008, soon after he began working at the Clinic. They were among his first patients. Dr. Genao prescribed Roxicodone and Xanax for both V.C. and J.S. during the course of their treatment. He also prescribed Soma for V.C. on one occasion, and he prescribed Percocet for J.S. on one occasion. Roxicodone is a rapid release formula of oxycodone. Oxycodone is an opiate (narcotic) analgesic used for the treatment of acute or chronic pain. Oxycodone is a schedule II controlled substance pursuant to section 893.03(2), Florida Statutes, and has a high potential for abuse. Roxicodone is dispensed in 30-milligram and 15-milligram tablets. This medication begins to relieve pain within 30-to-45 minutes after it is ingested, and it continues to act on pain for up to five hours. Percocet is the brand name for a combination of oxycodone and acetaminophen, and it differs from Roxicodone only in the addition of acetaminophen. Xanax, the brand name of alprazolam, is a benzodiazepine sedative hypnotic that is used to treat anxiety. It is a schedule IV controlled substance pursuant to section 893.03(4), and it has a low potential for abuse relative to schedule I, II, and III controlled substances. Soma is the brand name for carisprodol, which is a muscle relaxant commonly prescribed for muscle pain. It is a schedule IV controlled substance pursuant to section 893.03(4), and it has a low potential for abuse relative to schedule I, II, and III substances. Patient V.C. V.C.'s first visit to the Clinic was on December 20, 2008. At that time, he was screened by the Clinic's staff. The screening included completion of forms recording past substance abuse and psychiatric history. V.C. reported that he had no history of drug abuse and no history of a psychiatric diagnosis. V.C. also reported that he had taken, among other drugs, Roxicodone, Valium, Oxydose, Xanax, Lorcet, Percocet, Vicodin, Oxycontin, and Ambien. On December 20, 2008, V.C. also signed the following documents: A Pain Management Agreement, in which he agreed to follow the guidelines set forth in the agreement regarding the use of controlled pharmaceuticals, including submitting himself for blood or urine testing at the request of his physician; A form entitled "Informed Consent to Take Opiate/Narcotic Pain Medication," in which the benefits and risks of taking this type of medication were set out; A form advising V.C. that, pursuant to section 893.13, Florida Statutes, it was a third degree felony to fail to tell a physician prescribing narcotic pain medication that he had received pain medication from another physician since his last visit to the Clinic and/or to possess narcotic medication by misrepresentation, fraud, subterfuge, forgery, or deception; and A non-overdose contract, in which V.C. agreed to take the medication as prescribed and agreed to accept full responsibility if an overdose of pain medications occurred. V.C. also completed an Initial Pain Assessment form on December 20, 2008, in which V.C. reported the following: He tore his rotator cuff at the gym approximately 20 months prior to his first office visit with Dr. Genao; His pain was burning and sharp, and he was stiff in the morning; His pain interfered substantially with his work and made him depressed and irritable; He had been treated in 2006-2007 by a Dr. Taylor, who had treated him with therapy and cortisone shots, among other modalities, and in 2007-2008 by a Dr. Ward, who did nerve conduction testing; and d. X-rays and an MRI had been taken of his shoulder. V.C. was first seen by Dr. Genao on December 23, 2008. At that time, an Initial Medical Evaluation form was completed, in which the following was noted: a. V.C. sought a medical evaluation in order obtain medication refills; b V.C. had previously been seen in a pain clinic in Davie, Florida, in November 2008; The pain medications currently prescribed for V.C. were Roxicodone and Xanax; V.C.'s neck and shoulder were the areas affected by the pain; The level of pain with medication reported by V.C. was three on a scale of ten, while the level of pain without medication was eight on a scale of ten; The pain was constant, burning, aching, and radiating; There was limited range of motion in V.C.'s left shoulder, and he could not raise his left arm; and An MRI scan of the left shoulder was conducted on February 26, 2007. Dr. Genao obtained a copy of the results of the February 26, 2007, MRI scan, which included the following impression: Rotator cuff tendinosis involving the supraspinatus tendon. There is bursal-sided fraying. There is undersurface fraying and some low-grade partial thickness tear in the central distal aspect of the supraspinatus tendon. Fluid in the overlying subdeltoid bursa reflects moderate bursitis. AC joint degenerative change, as noted above with evidence of a type 2 anterior acromion. Labral blunting and fraying along the anterior, anterosuperior, and posterosuperior aspects of the labrum. Changes that appear to suggest some element of chondral thinning along the bony margin of the glenoid, more evident inferior and posteroinferiorly. Dr. Genao's diagnosis, as stated on the Initial Medical Evaluation form, was tendonitis. The blank space on the Initial Medical Evaluation form reserved for a listing of "Non-pharmaceutical pain modifying therapies" was completed with "N/A." The medication treatment plan that Dr. Genao developed for V.C. consisted of prescriptions for 224 30-milligram tablets of Roxicodone; 56 15-milligram tablets of Roxicodone; and 56 two milligram tablets of Xanax3; this treatment plan was included by Dr. Genao in the Initial Medical Evaluation form. The long-term goals Dr. Genao identified on the Initial Medical Evaluation form were to "decrease pain" and to "improve enjoyment of daily life activities and social interaction and function." Dr. Genao completed a History and Physical Examination Form for V.C. on December 23, 2008. Although a small part of the information on the form was illegible, Dr. Genao noted the following: V.C. suffered from severe pain in his left shoulder due to a weight-lifting injury in November 2006, although he continued to exercise with pain; V.C. was first seen for his shoulder pain by a Dr. Taylor, who prescribed exercise and treated him with cortisone shots and Percocet; V.C. continued to experience pain, however, and he was then seen by a Dr. Ward,4 who treated V.C. with 25-to- 30 milligram tablets of Roxicodone; V.C. worked as a cameraman for a television station, which required him to continually push buttons and pull cables, and it was impossible for him to do his work without pain medication; V.C. had been taking pain medications for about a year before his appointment with Dr. Genao; V.C. had not decided whether to have surgery on his shoulder, although he knew it was an option for treating the pain; V.C.'s previous doctor had prescribed Valium, and then Xanax, to relieve anxiety and stress; V.C. had no other health problems and no side effects from the medications; V.C. was divorced and had a young daughter and a 92- year-old mother, for whom he provided care; V.C. smoked but did not use alcohol; V.C.'s current medications were 30-milligram tablets of Roxicodone and two-milligram tablets of Xanax; V.C. may go on work trips and might need prescriptions filled before scheduled. Under the heading "ROS" on the History and Physical Examination Form, Dr. Genao noted that V.C. reported sleepiness but "none" of the following: Gen: Confusion, appetite, weakness Resp: Cough, wheeze, SOB, hemoptysis CVS: CP, palpitations, PND, Syncope, SOBOE, H/O, HTN, Lipid d/o GI: N/V/D/C, dark tarry stool, BRBPR, Liver problems GU: dysuria, urinary retention, frequency urgency, hesitancy, hematuria, kidney problems Neuro: weakness, numbness, tingling, dizziness, memory, cognition, balance, dexterity, agility MSKT: brittle bones, muscle tone, strength, joint pain/deformities/limitation/swelling, carpal tunnel Psych: depression, anxiety, mood, behavioral changes, h/o psychosis Other than the documents discussed above and copies of the prescriptions Dr. Genao wrote for V.C., the only significant items in Dr. Genao's medical records were "Patient Follow Up Sheets" completed by Dr. Genao for each of V.C.'s appointments subsequent to the initial office visit on December 23, 2008. After his initial office visit, V.C. had six appointments with Dr. Genao, on January 21, 2009; February 18, 2009; April 3, 2009; May 4, 2009; June 1, 2009; and June 29, 2009. Dr. Genao assessed V.C.'s condition during each office visit, and each follow-up sheet included the date of the appointment, V.C.'s vital signs, and the following notations: V.C. did not take vitamins, did exercise, and smoked between one-quarter pack to one pack of cigarettes each day; V.C. experienced pain during normal activities of three on a scale of ten with medications and eight on a scale of ten without medications, except that he reported on May 4, 2009, that he experienced pain during normal activities of two on a scale of ten with medications; V.C. had no side effects from the medications, had no new complaints or injuries, and had experienced improvement in mood and daily activities, Lifestyle changes were discussed and notes from previous office visits were reviewed; V.C. was responding well to the medications; Dr. Genao and V.C. discussed reducing his medication amounts and making changes in the medication prescribed for V.C.; and All questions and concerns were addressed in detail; No referral, labs, or diagnostic tests had been ordered. The medication prescribed at each appointment, together with Dr. Genao's notes, are included on the "Patient Follow Up Sheet" for each appointment as follows: January 21, 2009: 224 Roxicodone 30 mg 56 Roxicodone 15 mg 56 Xanax 2 mg "Pt did fine on his prescriptions. Pain well controlled. No side effects reported." February 18, 2009: 224 Roxicodone 30 mg 56 Roxicodone 15 mg 56 Xanax 2 mg "Pt did fine. No side effects reported." April 3, 2009: 224 Roxicodone 30 mg 84 Roxicodone 15 mg 56 Xanax 2 mg "Tendonitis/bursitis L shoulder [illegible] shoulder acting up. Pt feels better ± same" May 4, 2009: 224 Roxicodone 30 mg 84 Roxicodone 15 mg 56 Xanax 2 mg "Pt doing well. No side effects." June 1, 2009: 224 Roxicodone 30 mg 84 Roxicodone 15 mg 56 Xanax 2 mg "Pt doing fine. Active camera man." June 29, 2009: 196 Roxicodone 30 mg 112 Roxicodone 15 mg 56 Xanax 2 mg 56 Soma 350 mg "Pt doing well. Active at job. Doing some painting job which increase his pain. Lot of muscle spasms." Dr. Genao did not conduct a complete physical examination of V.C. during his initial office visit or during subsequent visits. Rather, because V.C. had voiced no other complaints, Dr. Genao performed a limited physical examination on V.C.'s first office visit that focused on his neck and left shoulder, which were the areas of his body that V.C. identified as the sources of his pain. With respect to this limited physical examination, Dr. Genao noted on the Initial Medical Evaluation form that V.C. had a limited range of motion of his left shoulder and was unable to raise his left arm. According to Dr. Genao, the type of examination he gave V.C. on his initial visit usually takes three-to-five minutes. It was Dr. Genao's practice not to touch the patient or conduct any manual manipulation; rather, Dr. Genao would request that the patient perform movements at his direction, and he would measure the amount of rotation and enter the information on the patient's medical records. There is nothing in V.C.'s medical records to indicate that Dr. Genao did any type of physical examination during any of V.C.'s subsequent office visits, although his height, weight, and vital signs were taken and recorded on the "Patient Follow- Up Sheet" for each appointment. Although V.C. reported that he had been seen previously by a Dr. Taylor and a Dr. Ward, neither Dr. Genao nor anyone at the Clinic contacted the offices of these physicians to obtain copies of V.C.'s medical records. Consequently, Dr. Genao did not have any records of V.C.'s prior medical treatment or of the medications that Dr. Taylor and/or Dr. Ward had prescribed for V.C. Nonetheless, Dr. Genao's treatment plan for V.C. was to continue with the medications that V.C. told Dr. Genao he had been taking prior to December 23, 2008. In prescribing 224 30-milligram tablets of Roxicodone, 56 15- milligram tablets of Roxicodone, and 56 two-milligram tablets of Xanax for V.C. at his first office visit, Dr. Genao relied exclusively on the information V.C. provided about the type, strength, and quantities of the medications that Dr. Ward had prescribed. Dr. Genao continued with the medication treatment plan through V.C.'s February 18, 2009, office visit, and he based the strength and quantity of the pain medications he prescribed for V.C. on his assessment of V.C. at each office visit. The strength and quantity of Roxicodone and Xanax prescribed for V.C. remained the same until April 3, 2009, when Dr. Friedberg, the Clinic's medical director, increased to 84 the quantity of 15-milligram tablets of Roxicodone prescribed for V.C. Dr. Genao followed the lead of Dr. Friedberg at V.C.'s May 4, 2009, office visit and increased the quantity of 15- milligram tablets of Roxicodone prescribed for V.C. to 84, deferring to Dr. Friedberg's knowledge and experience in pain management medicine. At V.C.'s May 4, 2009, office visit, Dr. Genao also continued to prescribe the 30-milligram tablets of Roxicodone and the two-milligram tablets of Xanax in the quantities he had previously prescribed. Dr. Genao did not change V.C.'s medications at his office visit on June 1, 2009. At V.C.'s final office visit on June 29, 2009, Dr. Genao prescribed Soma, a muscle relaxant, for V.C. because V.C. reported that he had fallen and was having muscle spasms; Dr. Genao reduced the number of 30-milligram tablets Roxicodone from 224 to 196, and he increased the number of 15-milligram tablets of Roxicodone from 84 to 112. Dr. Genao did this because he wanted to increase the number of 15-milligram tablets of Roxicodone available to V.C. for dealing with "break-through pain"5 and because he wanted to decrease the total milligrams of Roxicodone V.C. was taking each day. According to Dr. Genao, V.C. had decided, after having received other types of treatments, to use pain medication as the modality of treatment for the pain in his shoulder. Dr. Genao did not discuss different modalities of pain management, such as physical therapy, injection therapy, and surgery, with V.C. because, in Dr. Genao's view, V.C. had the right to chose treatment with pain medication. Because V.C. had made his choice of treatments, Dr. Genao did not refer him to other physicians for any other modality of treatment for his pain or treat him with anti-inflammatory medications. Dr. Genao did not doubt the truthfulness of the information V.C. provided about the type, quantity, and strength of the medications he was taking at the time of his first office visit with Dr. Genao on December 23, 2008. He did not order V.C. to submit to urinalysis to determine the amount and type of drugs in V.C.'s system on his first or subsequent visits because Dr. Genao did not consider V.C. to be a patient at high risk of abusing pain medication. Dr. Genao observed that V.C. always kept his appointments, was on time for his appointments, was doing well with his job, and was taking care of his 92-year-old mother and his two-year-old child. In addition, Dr. Genao observed that V.C. behaved in a professional manner during his office visits. Patient J.S. J.S.'s first visit to the Clinic was on December 29, 2008. At that time, he was screened by the Clinic's staff. The screening included completion of forms recording past substance abuse and psychiatric history. J.S. reported that he had no history of drug abuse and no history of a psychiatric diagnosis. J.S. also reported that he had taken, among other drugs, Roxicodone, Percocet, and Lortab. On December 29, 2008, J.S. also signed the following documents: A Pain Management Agreement, in which he agreed to follow the guidelines set forth in the agreement regarding the use of controlled pharmaceuticals, including submitting himself for blood or urine testing at the request of his physician; A form entitled "Informed Consent to Take Opiate/Narcotic Pain Medication," in which the benefits and risks of taking this type of medication were set out; A form advising J.S. that, pursuant to section 893.13, Florida Statutes, it was a third degree felony to fail to tell a physician prescribing narcotic pain medication that he had received pain medication from another physician since his last visit to the Clinic and/or to possess narcotic medication by misrepresentation, fraud, subterfuge, forgery, or deception; and A non-overdose contract, in which J.S. agreed to take the medication as prescribed and agreed to accept full responsibility if an overdose of pain medications occurred. At J.S.'s first office visit with Dr. Genao, on December 29, 2008, an Initial Pain Assessment form was completed, in which J.S. reported the following: His problem started three years prior to his first office visit with Dr. Genao; His pain interfered with his work and his daily routine but did not make him irritable, depressed, or angry; He had been treated in November 2008 by Dr. Beaure, who prescribed 224 30-milligram tablets of Roxicodone, 140 15-milligram tablets of Roxicodone, and 60 two-milligram tablets of Xanax; and He had an MRI in November 2008. An Initial Medical Evaluation form was also completed on December 29, 2007, in which the following was noted: J.S. had been seen in November 2008 by "Dr. Bower" at the AAA pain management clinic; J.S. decided to go to the Clinic because the AAA pain management clinic had closed; J.S. sought a medical evaluation in order to obtain medication refills and medication changes; The pain medications currently prescribed for J.S. were Roxicodone, Xanax, and "Rox 15"; J.S.'s lower back was the area affected by the pain, and it was aggravated by lifting, sitting, standing, walking, and bending; J.S. reported that the level of pain with medication was "N" on a scale of ten and that the level of pain without medication was ten on a scale of ten; J.S. described the pain as constant, sharp, stabbing, throbbing, and radiating; Dr. Genao observed swelling in J.S.'s cervical area, and tenderness, trigger points, and spasms, were observed in his lumbrosacral area; and An MRI scan of the lumbrosacral area was conducted on November 13, 2008. J.S. brought a copy of the November 13, 2008, MRI report to his first office visit with Dr. Genao, and this document was included in Dr. Genao's medical records for J.S. The impression stated in the radiologist's report was that J.S. had a disc protrusion between the L3-4 vertebrae that "touches and mildly effaces the dural sac" and a disc protrusion between the L5-S1 vertebrae that "touches the left exiting S1 exiting nerve root". Dr. Genao's diagnosis, as stated on the Initial Medical Evaluation form, was severe back pain and bulging discs. "No" was filled in the blank space on the Initial Medical Evaluation form reserved for a listing of "Non-pharmaceutical pain modifying therapies." The medication treatment plan that Dr. Genao developed for J.S. consisted of prescriptions for 224 30-milligram tablets of Roxicodone; 56 15-milligram tablets of Roxicodone; and 56 two-milligram tablets of Xanax6; this treatment plan was set forth on the Initial Medical Evaluation form. The long-term goals for J.S. that Dr. Genao identified on the Initial Medical Evaluation form were to "decrease pain" and to "improve enjoyment of daily life activities and social interaction and function." Dr. Genao completed a History and Physical Examination Form for J.S. on December 29, 2008. Although a small part of the information on the form was illegible, Dr. Genao noted the following: J.S. suffered for three years from severe aches and spasms in his lower back, that radiated to his mid-back and neck and went down both legs, especially his right leg, and to his right testicle; J.S. described the pain as ten on a scale of ten; J.S. had been seen by a pain management physician steadily for two years but had to stop this regular pain management treatment because he lacked insurance; J.S. subsequently obtained pain management medications whenever he could afford them, and, when he was last seen in November 2008, he had received prescriptions for both 30- milligram and 15-milligram tablets of Roxicodone; J.S. reported that the pain had become unbearable and interfered with his ability to work and that he had anxiety and problems sleeping; J.S. had no other health problems; J.S. was married with one child; J.S. did not smoke or use alcohol or drugs; J.S.'s current medications were Roxicodone and Xanax; Under the heading "ROS" on the History and Physical Examination Form, Dr. Genao noted that J.S. reported sleepiness; problems with agility, muscle tone, and strength; and anxiety, but he reported "none" of the following: Gen: Confusion, appetite, weakness Resp: Cough, wheeze, SOB, hemoptysis CVS: CP, palpitations, PND, Syncope, SOBOE, H/O, HTN, Lipid d/o GI: N/V/D/C, dark tarry stool, BRBPR, Liver problems GU: dysuria, urinary retention, frequency urgency, hesitancy, hematuria, kidney problems Neuro: weakness, numbness, tingling, dizziness, memory, cognition, balance, dexterity MSKT: brittle bones, muscle tone, strength, joint pain/deformities/limitation/swelling, carpal tunnel Psych: depression, mood, behavioral changes, h/o psychosis Other than the documents discussed above and copies of the prescriptions Dr. Genao wrote for J.S., the only significant items in Dr. Genao's medical records were "Patient Follow Up Sheets" completed for each of J.S.'s appointments with Dr. Genao subsequent to the initial appointment on December 29, 2008. After his initial office visit, J.S. had four appointments with Dr. Genao, on January 26, 2009; February 23, 2009; March 27, 2009, and April 29, 2009.7 Dr. Genao assessed at each office visit, and each follow-up sheet included the date of the appointment, J.S.'s vital signs, and the following notations: J.S. did not take vitamins, did exercise, and smoked between one-quarter pack to one-half pack of cigarettes each day; J.S. experienced pain during normal activities of three on a scale of ten with medications and ten on a scale of ten without medications, except that he reported on April 29, 2009, that he experienced pain during normal activities of nine on a scale of ten with medications; J.S. had no side effects from the medications and had no new complaints or injuries, although he did report at the January 26, 2009, office visit that he had been treated with a "Z-pack" for pneumonia; J.S. experienced improvement in mood and daily activities; Lifestyle changes were discussed and notes from previous office visits were reviewed; J.S. was responding well to the medications; Dr. Genao and J.S. discussed reducing his medication amounts and making medication changes; All questions and concerns were addressed in detail; and No referral, labs, or diagnostic tests were ordered. The medication prescribed at each appointment, together with Dr. Genao's notes, are included on the "Patient Follow Up Sheet" for each appointment as follows: January 26, 2009: 224 Roxicodone 30 mg 112 Roxicodone 15 mg 56 Xanax 2 mg "Pt doing much better. More active at work. Helping [illegible] and performing well at his job. No side effects reported." February 23, 2009: 224 Roxicodone 30 mg 56 Xanax 2 mg 112 Percocet 10/650 mg "Pt did fine. Working almost like a normal person. Pt and wife are happy. Will give Percocet for BTP [breakthrough pain] instead of Roxi 15 mg." March 27, 2009: 224 Roxicodone 30 mg 112 Roxicodone 15 mg 56 Xanax 2 mg Chantix for 2 weeks "Pt doing well. Working some over time and now able to play with daughter. Patient looking to quit smoking asking for Chantix" April 29, 2009: 224 Roxicodone 30 mg 112 Roxicodone 15 mg 56 Xanax 2 mg "Pt very happy with med. Quitting smoking. Did not take Chantix. 2 deaths in the family." Dr. Genao did not conduct a full physical examination of J.S. during his initial office visit or during subsequent office visits. Rather, because J.S. had no other complaints, Dr. Genao performed a limited physical examination on J.S.'s first office visit that focused on his back, which was the area of his body that J.S. identified as the source of his pain. With respect to this limited physical examination, Dr. Genao noted on the Initial Medical Evaluation form that J.S. had muscle spasms and tenderness in trigger points. According to Dr. Genao, the type of examination he gave J.S. on his initial visit usually takes three-to-five minutes. Although it was Dr. Genao's practice not to touch the patient or conduct any manual manipulation, he touched J.S.'s back at several points to determine if it was tender. Otherwise, Dr. Genao requested that J.S. perform movements at his direction, and he noted the results on the Initial Medical Evaluation form. There is nothing in J.S.'s medical records to indicate that Dr. Genao did any type of physical examination during any of J.S.'s subsequent office visits, although his height, weight, and vital signs were taken and recorded on the Patient Follow Up Sheet for each appointment. J.S. reported that he had been seen previously by Dr. Beaure, but neither Dr. Genao nor anyone at the Clinic contacted Dr. Beaure's office to obtain copies of J.S.'s medical records. Consequently, Dr. Genao did not have any records of J.S.'s prior medical treatment or of the medications that Dr. Beaure had prescribed for J.S. Nonetheless, Dr. Genao's treatment plan for J.S. was to continue him on the medications that J.S. told Dr. Genao he had been taking prior to December 29, 2008. In prescribing 224 30-milligram tablets of Roxicodone, 112 15-milligram tablets of Roxicodone, and 56 two- milligram tablets of Xanax, for J.S. at his first office visit, Dr. Genao relied exclusively on the information J.S. provided about the type, strength, and quantities of the medications that Dr. Beaure had prescribed. On February 23, 2009, Dr. Genao substituted 112 10/650-milligram tablets of Percocet for the 112 15-milligram tablets of Roxicodone that he had prescribed on January 26, 2009, at J.S.'s request. J.S. felt that the 15- milligram Roxicodone tablets did not take the edge off of his pain, but the Percocet, which contained ten milligrams of oxycodone and 650 milligrams of acetaminophen, was not as effective as J.S. had expected. Dr. Genao returned to the original prescription of 112 tablets of 15-milligram Roxicodone at J.S.'s March 27, 2009, office visit. Dr. Genao discussed with J.S. different modalities of pain management, such as physical therapy, injection therapy, and surgery, even though he did not note the substance of this discussion in J.S.'s medical records. J.S., however, chose to manage his pain through medication, and Dr. Genao did not refer J.S. to any other physicians for other modalities of treatment for his pain or treat him with anti-inflammatory medications. Dr. Genao did not require J.S. to submit to urinalysis to determine the amount and type of drugs in J.S.'s system on his first or subsequent visits because Dr. Genao did not consider J.S. to be a patient at high risk of abusing pain medications. Dr. Genao did not doubt the truthfulness of the information J.S. provided regarding the type, strength, and quantity of medications J.S. was taking at the time of his first office visit on December 29, 2008. Dr. Genao observed throughout the time that J.S. was his patient that J.S. always kept his appointments, was on time for his appointments, and behaved in a professional and orderly manner. General V.C. and J.S. were among the first patients Dr. Genao treated at the Clinic. He subsequently modified the way in which he approached the treatment of patients seeking help managing pain. He started patients who had not previously taken opioids on small amounts of pain medication and then worked up, or titrated, to the amount that relieved their pain. With V.C. and J.S., however, Dr. Genao prescribed the same type, quantity, and strength of pain medications that they had been taking prior to their first office visits with him because V.C. and J.S. had developed a tolerance for the medications, and Dr. Genao did not want to decrease the amount or change the type of medications and possibly cause them distress or withdrawal symptoms. It was the Clinic's policy to do urine tests to determine what, if any, drugs were in the patient's system at any given time and to obtain copies of patient's medical records. Dr. Genao conceded that he did not order urine tests or ensure that copies of medical records for V.C. and J.S. were obtained by Clinic staff, but, again, he explained that V.C. and J.S. were among his first patients and that he had modified his practices as he became more experienced. Dr. Genao based the type, strength, and quantity of the pain medications he prescribed on his assessment of his patients at each office visit, and he followed the standard procedure of the Clinic in prescribing both 30-milligram and 15- milligram tablets of Roxicodone. Dr. Genao prescribed 224 30- milligram tablets of Roxicodone for both V.C. and J.S.; this amounted to eight tablets a day, and two tablets were to be taken every four-to-six hours.8 Dr. Genao prescribed 15-milligram tablets of Roxicodone to allow V.C. and J.S. to take a 15-milligram Roxicodone tablet for break-through pain rather than having them take a 30-milligram tablet of Roxicodone tablet before the next dose of the greater-strength Roxicodone was due. In this way, Dr. Genao believed that V.C. and J.S. could control their pain with the least amount of medication Dr. Genao used pre-printed prescription forms for Roxicodone and Xanax because those forms were routinely used by the doctors practicing at the Clinic. There were a number of pre-printed forms, and the use of these forms did not mean that Dr. Genao failed to tailor the prescriptions to the specific needs of V.C. and J.S., individually. Summary9 The evidence presented by the Department is not sufficient to establish that Dr. Genao failed to conduct and document appropriate evaluations of V.C. and J.S.10 The Past Substance Abuse and Past Psychiatric History forms, the Initial Pain Assessment forms, the History and Physical Examination Forms, and the Patient's Follow-Up Sheets completed by or for and J.S. included the following: Complete medical histories of these patients relating to their need for pain management; The results of the physical examinations that Dr. Genao performed of the areas related to their complaints of pain to ensure that the symptoms of which they complained correlated with the results of the physical examinations and the information revealed by their MRIs and that there was a medical indication for the use of pain medications; An assessment of the nature and intensity of V.C.'s and J.S.'s pain, with a rating of their pain on a scale of one to ten both with and without medication, together with a description of the nature of their pain; A listing of their current and past treatments for pain, as well as the names of the physicians who had treated them for the pain; A list of underlying or coexistent diseases or conditions that they reported, if any; The effect of the pain on their physical and psychological functioning; A history of their substance abuse, if any; and The diagnoses constituting the medical indications for the prescribing of controlled substances for V.C. and J.S. The evidence presented by the Department is not sufficient to establish that Dr. Genao failed to develop and document appropriate treatment plans for V.C. and J.S. The medication treatment plans were set forth on the Initial Medical Evaluation forms and indicated the type, strength, and quantity of the medications to be prescribed. The short- and long-term goals for V.C. and J.S. were included on the Initial Medication Evaluation form for each of them and included both a decrease in pain and improved enjoyment of daily activities and social interaction as objectives of the treatment plan and the means by which the success of the treatment was to be measured. Dr. Genao indicated on the Initial Medication Evaluation forms for V.C. and J.S. that there would be no non-pharmaceutical pain modifying therapies for either patient. After treatment began, Dr. Genao completed a Patient's Follow-Up Form for each of V.C.'s and J.S.'s office visits, in which he indicated that no new referrals, labs, or diagnostic tests had been ordered; he made notes relating the progress of these patients toward the goals of the treatment plan; and he indicated that he had discussed with V.C. and J.S. reducing the amount of medication or changing medications. The evidence presented by the Department is also insufficient to establish, with the requisite degree of certainty, that Dr. Genao fell below the level of care, skill, and treatment recognized as appropriate by a reasonably prudent physician, in light of all relevant circumstances, with respect to those aspects of the treatment of V.C. and J.S. identified in the Administrative Complaint. The testimony of the Department's expert witness is found to be generally unpersuasive, with the following but a few examples of the basis for this finding: The Department's expert offered a sometimes meandering commentary on what he considered deficiencies in Dr. Genao's treatment of V.C. and J.S., but he neither limited his commentary to the allegations in the Administrative Complaint, nor articulated the standards of care by which he evaluated Dr. Genao's treatment of V.C. and J.S. In several instances, the Department's expert was led by the Department's counsel with questions regarding standards of care to which he was required only to respond with a "yes" or a "no." The testimony of the Department's expert was contradictory in important respects, such as when he testified that treatment of V.C.'s shoulder pain with controlled substances may be needed and then testified that "this kind of medications [sic]" is not what "we use to treat shoulder pain."11 The Department's expert testified in terms of his opinions and his "feelings" about particular matters; used words and phrases such as "seems" and "appears" and "I would state"; and stated conclusions without explanation. Two of the most problematic aspects of the testimony of the Department's expert were his statements that the quantity and dosage of Roxicodone prescribed by Dr. Genao for V.C. and J.S. were excessive and that there was no indication for prescribing both 30-milligram and 15-milligram tablets of Roxicodone.12 These statements are specifically rejected as unpersuasive because the Department's expert did not offer any cogent explanation to support these opinions or articulate any standards of care from which he derived the opinions. Indeed, with respect to the testimony that the quantity of Roxicodone prescribed for V.C. and J.S. was excessive, the Department's expert began discussing the manner in which one would titrate the dosage of opioids for a person who was "opioid naïve" when the medical histories provided by V.C. and J.S. established that they had recently been prescribed Roxicodone by other physicians.13 Furthermore, the only explanation the Department's expert provided to support his opinion that Dr. Genao's prescribing both 30-milligram and 15-milligram tablets of Roxicodone was excessive, "kind of like double dosing almost,"14 was that both 30-milligram and 15-milligram tablets of Roxicodone are immediate release opioids used to treat acute pain. While an accurate statement of fact, this testimony begs the question and did not address Dr. Genao's explanation that he prescribed the 15-milligram tablets of Roxicodone to allow V.C. and J.S. to take a minimal dosage of the drug to combat breakthrough pain, a subject which the Department's expert also failed to address.15 The opinion of the Department's expert that Dr. Genao should have ordered urine drug screens for V.C. and J.S. in order to meet what he would "consider" the standard of care is unpersuasive, first, because the Department's expert never articulated a standard of care related to the routine administration of urine drug screens and, second, because he based his opinion that these patients should have been administered urine drug-screening tests on his assumptions that V.C. and J.S. were at high risk of drug abuse and/or diversion.16 These assumptions, however, were based on nothing more than the amount and type of medications prescribed for V.C. and J.S. With respect to V.C., the Department's expert testified that "[t]he nature of these prescriptions alone place this patient into a high risk category because of the combination that are [sic] very abusable, have a high street value, and are [sic] highly diverted."17 With respect to J.S., the Department's expert testified that "[a] twenty[-]eight year[-]old male on this much medication, that would be a high risk patient"18 and that [t]his is a patient requiring or requesting a very, very high combination of multiple controlled substances. So that alone would be cause for concern. I mean, signs are patients losing their scripts, selling them, knowing that they have other recreational or illicit substances in the urine. So I would say he [J.S.] has the symptoms of potential substance abuse or diversion.[19] The Department's expert did not base his assumptions that V.C. and J.S. were high-risk patients on any evidence in the record that either of them claimed to have lost prescriptions or gave any indication whatsoever that they were diverting and/or abusing the medications Dr. Genao prescribed for them. In addition, by basing his assumption that V.C. and J.S. were at high risk of medication abuse exclusively on the type and amount of medications Dr. Genao was prescribing for them, the Department's expert failed to consider the individual characteristics, circumstances, or conditions of V.C. and J.S. The notes that Dr. Genao included on the Patient Follow Up Sheets for V.C. and J.S. indicated that V.C. and J.S. were both doing well on their medications; that they had no side effects; that their activities of daily were improving; that they were able to perform their jobs better than they could without medication; and, with respect to J.S., that he was able to play with his daughter and that he and his wife were very happy. The testimony of the Department's expert witness is not sufficient to establish that Dr. Genao violated any standard of care by failing to refer V.C. or J.S. for modalities of treatment other than medication to control their pain. First, the Department's expert did not articulate a standard of care with respect to the circumstances in which it would be appropriate for a physician to refer a patient for treatment modalities such as physical therapy, surgery, neuropathic medications, or pain blocks or the circumstances in which it would be appropriate to treat a patient with muscle relaxers or anti-inflammatory medications. In fact, the testimony of the Department's expert was inconsistent with respect to his opinion regarding the appropriate treatment for V.C.'s shoulder pain: He testified that treatment with pain medications would be appropriate for V.C.; he testified that he "could support" Dr. Genao's treatment of V.C. for at least the short term; he testified that pain medications were "not something that we use to treat shoulder pain"; and, finally, he testified, without any supporting explanation, that Dr. Genao should have referred V.C. to an orthopedic surgeon for surgery.20 With respect to J.S., the Department's expert witness merely acknowledged, in response to a question posed by the Department's counsel, that he did not see any recommendations in the medical records for J.S. for treatment modalities other than pain medication; he continued his testimony with a statement regarding his practice of putting patients on opioids only as "a last resort," after having obtained the opinions of surgeons and other clinicians,"21 but this opinion was not given in the context of the standard of care which would be followed by a reasonably prudent similar physician under similar conditions and circumstances. Finally, with respect to a physician's utilizing treatment modalities other than pain medications, the Department's counsel posed the following question: "Is it within the standard of care for a physician to merely recommend that the patient undergo these modalities or should they [a physician] require that they [a patient] undergo them?"22 The Department's expert witness responded: Well, I mean, I think that depends on a physician's judgment. When we talk about prescribing medications like this I think a prudent physician should mandate that a patient at least see some other colleagues to help co-manage a difficult case. It's not mandatory but I think it would be highly recommended.[23] Not only does this testimony fail to address a standard of care relating to utilization of other treatment modalities, the opinion of the Department's expert regarding a practice that he considers "highly recommended" is limited to "a difficult case." The Department's expert witness did not, however, testify that the cases of V.C. and J.S. were difficult cases, so that this opinion is irrelevant to the issues in this case. Finally, and importantly, the Department's expert concedes that a physician should use his or her own judgment with respect to referrals for treatment modalities for pain other than pain medications.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the all counts of the Administrative Complaint against Esteban A. Genao, M.D. DONE AND ENTERED this 28th day of January, 2011, in Tallahassee, Leon County, Florida. S Patricia M. Hart 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 28th day of January, 2011.
The Issue In addition to the issue of whether the Respondent committed the acts alleged, the administrative complaint alleges on its face that the Respondent was not licensed to practice medicine in the State of Florida until July 13, 1982. Most of the administrative complaint relates to alleged violations by the Respondent prior to the date of his licensure. A primary issue is the Petitioner's jurisdiction over the Respondent to prosecute for acts committed prior to his licensure. A major factual issue in this case are the dates upon which the doctor's conduct allegedly took place.
Findings Of Fact The Respondent was licensed as a medical doctor on July 13, 1982, in the State of Florida. Prior to that date the Respondent was not licensed to practice medicine in this or any other state. Prior to his licensure he was participating in a medical internship program in Pensacola, Florida. He was permitted to practice and prescribe medicine as an intern in and within the limits of this program. (Re: Count I through Count IV) The Respondent presented prescriptions for Eskatrol and Dexedrine on two different occasions to two different pharmacies. These prescriptions listed the Respondent as the person for whom the prescriptions were filled and signed by the Respondent. Neither prescription was accepted by the pharmacists and neither prescription was introduced into evidence. Eskatrol and Dexedrine are amphetamine compounds and are Schedule II controlled substances. The Respondent's ex-wife placed the Respondent's use of amphetamines in February of 1981. See Transcript page 95 line 19 through page 96 line 1. One of the pharmacists to whom the prescription was presented by the Respondent was Ann Cole Wilson, the Respondent's former sister-in-law and sister of his ex-wife. Wilson's testimony concerning the date of the alleged occurrence testifies as follows: Q. Can you tell me what occurred on that occasion, and tell me approximately when this occurred? A. Like I say, it's hard to remember. It was sometime during the summer months. Q. The summer of what year? A. Oh, gosh. Right now it's been, let's see, `82 or `83. Q. The summer of `82? A. I would say `82 yeah. The other pharmacist who testified regarding the Respondent's presentation of prescriptions for amphetamines was Elizabeth S. Grimsley. Grimsley testified regarding the alleged events as follows: Q. How did you come to meet him? A. He brought in a prescription one night for, two prescriptions, rather, written for him by himself for Eskatrol and Dexedrine, amphetamine prescriptions. Q. These prescriptions were written for the use of Dr. Taylor and they were written by Dr. Taylor? A. Yes, sir. Q. Do you remember approximately when this occurred? A. No, sir; roughly a year and a half or two years ago, I suppose. The latter witness is very vague about the date, and the former witness has an interest in these proceedings by virtue of her relationship with the Respondent's former wife. The relationship by Respondent and his former wife is characterized by hostility and continuing litigation arising out of their divorce and concerning child custody. It is concluded that the Petitioner failed to prove the acts occurred after the date of the Respondent's licensure. (Counts V, VI) The Respondent ordered legend and other drugs from pharmaceutical companies using the name of Michael Archer, M.D. and Archer's DEA registration number. Archer did not approve the order or give the Respondent permission to use his DEA registration in order to obtain these drugs. Respondent's actions took place in 1981 and 1982 prior to the date of the Respondent's licensure by the Florida Board. See the depositions of Farrell, Schied & Perez. (Count VII) Between the dates of March 3, 1982, and June 30, 1982, the Respondent submitted drug orders for and received thirty Crescormon No. 4 iu- vials from Pharmacia Corporated, 800 Centennial Avenue, Piscataway, New Jersey 08854. These events occurred prior to the Respondent's licensure by the Petitioner. See deposition of Schied, Exhibit 3. Respondent ordered amino acids from Varitex Corporation, a Michigan company. These materials which are not legend drugs were ordered and received by the Respondent prior to the date of his licensure by the Petitioner. See deposition of Myers, Exhibit 4. Respondent ordered various drugs from Generix Drug Corp., 1900 W. Commercial Blvd., Ft. Lauderdale, Florida, in the same manner. All these transactions occurred before the Respondent was licensed. See the deposition of Perez, Exhibit 5. (Count VIII) The Respondent sold or provided Darrell R. Black substances represented by the Respondent and thought to be by Black a drug with the trade name Dianabol. Dianabol is a steroid and a legend drug. This transaction was not a part of Dr. Taylor's practice under the Pensacola Education Program, the internship in which Dr. Taylor was participating. This transaction occurred in 1981, prior to Dr. Taylor's licensure by the Board. See Transcript page 38. The Respondent sold or provided to Shaun Francis Farrell drugs represented by the Respondent and thought to be by Farrell testosterone and Deca-Durabolin. This transaction was not part of the Respondent's internship in the Pensacola Educational Program. These transactions occurred in 1981, prior to Respondent's licensure by the Board. See Transcript page 46. (Count IX) The Respondent presented prescriptions for and received various metabolic steroids during 1981. However, all of these were presented prior to the date of the Respondent's licensure by the Board. See Transcript, pages 15, 16, 20, 21, 22, 31, 32, 33. One prescription for Trisorlan was presented by the Respondent for himself on October 20, 1982. Trisorlan is a legend drug, however it is not a controlled substance. Trisorlan is a drug affecting the pigmentation of skin. Transcript page 24. No evidence was received concerning the propriety of Dr. Taylor prescribing this medication for himself. (Count XI) No evidence was received that the Respondent held himself out as being licensed to practice medicine. Black and Ferrell did not see Respondent as a doctor. Respondent saw Cayton at the hospital and was authorized to treat patients within the scope of his internship. Most of the witnesses stated that they knew that the Respondent was a doctor, that he was "practicing" at Sacred Heart Hospital. The Respondent holds a degree as an M.D. and was practicing at Sacred Heart as an intern. Further to the extent that the Respondent may have held himself out as a physician contrary to Section 458.327, he did so prior to the date of his licensure and acquisition of jurisdiction by the Board.
Recommendation Having found no evidence to support the jurisdiction of the Board over the Respondent on the allegations of Count X, the Hearing Officer recommends that the Board take no action against the Respondent and the administrative complaint against the Respondent be dismissed. DONE and ORDERED this 4th day of February, 1985, in Tallahassee, Florida. STEPHEN F. DEAN 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 4th day of February, 1985. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Dorothy Faircloth, Executive Department of Professional Director Regulation Department of Professional 130 North Monroe Street Regulation Tallahassee, Florida 32301 Board of Medical Examiners 130 North Monroe Street William Taylor, M.D. Tallahassee, Florida 32301 5271 Myrtlewood Sarasota, Florida 33580 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaint?
Findings Of Fact At all pertinent times, respondent Manuel P. Villaflor, M.D., held a Florida license as a physician, No. ME 0020072. He practices in Daytona Beach, where he has an office on Ridgewood Avenue. UNTIMELY DEATH K.D., a white male, was pronounced dead at 3:59 P.M. on October 19, 1985, a few days shy of his 34th birthday. The autopsy disclosed superficial abrasions, acute blunt trauma to K.D.'s face, scalp and right hand, and acute, diffuse subdural hemorrhage. A paper bag full of prescriptidn medicine containers accompanied the body to the autopsy. Apparently because the labels indicated that Dr. Villaflor had written pain killing prescriptions for K.D., the medical examiner's office notified DPR. Some four months later, analysis of samples of K.D.'s blood and urine revealed that codeine, oxycodone, amitriptyline, also known as Elavil, nortriptyline, also known as Pamelor, and chlordiazepoxide, also known as Librium, had been present in the corpse in quantities "beyond the reference range for therapeutic use." Botting deposition, p. 6. The pathologist amended his initial conclusion that head injuries resulting from "multi-focal blunt trauma," id., p. 7, had caused R.D.'s death, by adding "multiple drug intoxication," id., as another cause of death. As far as the record shows, Dr. Villaflor never prescribed Elavil, Pamelor, Librium or their chemical equivalents for K.D. An osteopath whom K.D. saw toward the end of his life prescribed at least two of these medications, as well as medicine containing oxycodone. CONTROLLED SUBSTANCES UNCONTROLLED On November 15, 1985, Diane Rabideau, an investigator for DPR, called on Dr. Villaflor at his office. He was polite and cooperative. Ms. Rabideau had some difficulty understanding him; he is not a native English speaker, and he had recently suffered a stroke. But she understood well enough Dr. Villaflor's assertions that he did not believe K.D. to have been addicted to any drugs, and that he had not over-prescribed any medicine. Ms. Rabideau inspected the controlled substances kept in Dr. Villaflor's office. She found Tenuate Dospan, Restoril, Darvocet, Valium, Tylenol No. 4, Fiorinal No. 3, Xanax, Vicodin, Tylenol with codeine elixir, Dalmane, Anexsia, Centrax, "Tussend Ex. 1/2 oz.," Limbitrol, Equagesic, Phrenilin with codeine, Novahistine, Naldecon, Ativan, Nucofed, and "P.V. Tussin." When she saw them, they were not under lock and key. No inventory records reflected what was on hand and what had been dispensed. The parties stipulated that Dr. Villaflor "failed to maintain records of the[se] schedule controlled substances . . . as required by Section 893.07, Florida Statutes"; and that he "failed to keep the[se] drugs . . . under lock and key as required by 21 C.F.R. Section 1301.72." When Ms. Rabideau pointed out these omissions, Dr. Villaflor and his wife, who works with him in the office, said they would comply in the future. Mrs. Villaflor said she had not known of these requirements. A subsequent inspection by a DPR investigation found Dr. Villaflor in full compliance with reporting requirements governing controlled substances. K.D.'s PAIN On July 8, 1981, Dr. Villaflor saw K.D., apparently for the first time, at the Halifax Hospital Medical Center emergency room, and admitted him to the hospital. K.D. had sustained an electrical shock when he struck a high voltage power line with an aluminum ladder, as he was hurrying for shelter from a sudden rain. He lost consciousness "surrounded by a bluish flame." Petitioner's Exhibit No. 12. The elecricity burned his feet and made his lower legs tender, as well. Discharged from the hospital, he visited Dr. Villaflor's office on July 15, 1981. In these proceedings, DPR does not question Dr. Villaflor's prescription of Percocet, a combination of Tylenol and oxycodone, for pain on that visit. As a teenager, K.D. had broken his collar bone in falls from motorcycles on two separate occasions. One accident involved a ride over a waterfall. When he was 2l years old, he "was smashed between a construction vehicle and a bulldozer," Petitioner's Exhibit No. 12, suffering "a severe crushing injury to his chest." Some ten years later he "still ha[d] very mobile ribs secondary to this injury," and persistent pain in his back and legs. In November of 1981, Dr. Kolin, a psychiatrist in Orlando, admitted K.D. to Orlando Regional Medical Center. A myelogram "revealed a mild L5 radicular lesion on the left, consistent with chronic myofascial pain and left L5 radiculitis." Petitioner's Exhibit No. 11. During this hospital stay, K.D.'s "narcotic medications were tapered and discontinued." Id. Dr. Villaflor sent copies of his records to Dr. Kolin, to whom Dr. Gillespie in Nashua, New Hampshire, had referred K.D. Apparently Dr. Villaflor never asked and Dr. Kolin never volunteered to forward Dr. Kolin's records to Dr. Villaflor. Gary G. Parsons, a vocation rehabilitation counselor, met K.D. on February 8, 1982. After K.D. made a perfect score on an aptitude test, a state agency subsidized his vocational training at the American Computer Institute. When K.D.'s training there concluded on January 4, 1983, Mr. Parsons tried to assist him in obtaining employment, but eventually concluded that K.D. could not hold a job because "his pain, and his limitation was greater than" (T. 283) Mr. Parsons had originally realized. K.D.'s pain or his physical condition "was primary in his conversation almost every time" (T. 283-4) he and Mr. Parsons spoke. Even after the vocational rehabilitation file was closed on June 26, 1984, he came by Mr. Parsons' office twice. Both times K.D. seemed depressed to Mr. Parsons, who had recommended he go for counseling to the Human Resources Center, a community mental health center. Mr. Parsons saw K.D. for the last time on March 22, 1985. At least as early as August of 1984, K.D. mentioned suicide to Mr. Parsons as a possibility. In March of 1985, K.D. began weekly counselling sessions with Dr. Rafael Parlade, a clinical psychologist at the Human Resources Center. In these sessions "the two issues . . . were his suicidal ideation combination with the depression, and the departure of his live-in girlfriend." (T. 273) He "still had a lot of pain." (T. 274) Dr. Parlade hoped K.D. would "increase his activities," (T. 276) so that with . . . activity in his life more, he would focus away from his pain. Because for a period of time that was all he was living with. (T. 276) Dr. Parlade viewed decreasing the amount of pain medication as a secondary goal (T. 275), a result he hoped would flow from K.D.'s being less preoccupied with the pain he experienced continually. PAIN REMEDIES On January 31, 1983, K.D. visited Dr. Villaflor's office. Dr. Villaflor's notes for that day mentioned K.D.'s "Electrocution High Voltage in 7/81" and reflect a prescription for 50 tablets of Talwin. K.D.'s blood pressure, 120 over 70, is noted, and reference is made to a TENS unit, or transcutaneous nerve stimulator. Somebody at the Orlando Pain Clinic K.D. had visited had recommended one of these electrical devices to K.D., but it had proved ineffective against his pain. At one time or other, K.D. resorted to acupuncture and resumed wearing a corset of the kind originally prescribed for the back pain he experienced in the wake of the cascading motorcycle accident. Dr. Villaflor's office notes of April 15, 1983, record "Back Pain," a second prescription for 50 tablets of Talwin and another prescription for Xanax. On May 11, 1983, Dr. Villaflor's records again note K.D.'s "Back Pain" and indicate prescriptions for Xanax and Percocet. Nothing suggests Dr. Villaflor knew that Talwin had been dispensed to K.D. five days earlier, when K.D. appeared at his office on May 26, 1983. Essentially illegible, Dr. Villaflor's office notes for May 26, 1983, reflect prescriptions for Percocet and Xanax tablets, with which K.D. obtained 30 quarter milligram Xanax tablets on June 6, 1983, and 35 Percocet tablets on June 8, 1983. Xanax, a tranquilizer, is taken three or four times daily. Since Percocet may be taken every four to six hours, it was "very much within reason" (T. 239) for Dr. Villaflor to prescribe more on June 9, 1983. When this prescription was filled on June 22, 1983, K.D. received 45 tablets. On July 7, 1983, Dr. Villaflor saw K.D. at his office for the first time in almost a month, and prescribed 35 more tablets of Percocet, also known as oxycodone with acetaminophen. The same day K.D. had the prescription filled, obtaining 35 tablets. Some three weeks later, on July 29, 1983, Dr. Villaflor again prescribed and K.D. again obtained 35 Percocet tablets. On the same day two other prescriptions Dr. Villaflor wrote for K.D. were filled, one for Atarax, an antihistamine sometimes prescribed in lieu of a tranquilizer, and one for Tylenol with codeine. This 35-tablet Tylenol prescription was refilled on September 7, 1983. With more and less potent pain medications, K.D. could take one or the other, as appropriate, depending upon the intensity of the pain. Since no other prescription for pain killing medication was written or filled until October 4, 1983, these prescriptions were, according to one of the Department's witnesses, "[w]ithin reason." (T. 243) On the October 4 visit, Dr. Villaflor noted "Back Pain from Electrocution" and recorded K.D.'s blood pressure as 138 over 70 or 80, before prescribing 45 Percocet tablets. That day, K.D. obtained the Percocet. He returned to Dr. Villaflor's office on October 13, 1983, complaining not only of back pain, but also of nausea and vomiting. Dr. Villaflor prescribed an additional 30 Percocet tablets. On October 15, 1983, K.D. acquired 50 tablets of the antihistamine Dr. Villaflor had been prescribing for him, "hydroxizine pam." On November 3, 1983, he obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets. On November 12, 1983, the antihistamine prescripton was refilled as was, on November 16, the Tylenol No. 3 prescription. Perhaps Dr. Villaflor wrote the antihistamine prescription two days before it was first filled. The office notes are difficult to decipher. He wrote the Percocet and Tylenol prescriptions when he saw K.D. on November 3, 1983, at which time he recorded his blood pressure (132 over 70) and noted "back injury." On December 2, 1983, Dr. Villaflor's office notes reflect a visit and prescriptions for Tylenol No. 3, Percocet and the antihistamine. With respect to prescriptions filled on and after November 3, 1983, but before December 2, 1983, DPR's witness testified that the amount of medication was "a little high, but it's still, you know, again, acceptable for a person in pain." (T. 246) On December 2, 1983, K.D. obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets, the latter by virtue of a prescription that was refilled on December 14, 1983. On January 3, 1984, K.D. returned to Dr. Villaflor's office where he obtained prescriptions for Percocet and Tylenol No. 3. In March, Dr. Villaflor began prescribing a tranquilizer, Dalmane, instead of the antihistamine, but the new year progressed much as the old year had, in terms of Dr. Villaflor's prescriptions and documentation, and, apparently, of K.D.'s pain, as well, until early August. On August 3, 1984, Dr. Villaflor prescribed for K.D., 200 "Sk- Oxycodone w/Apap" tablets, 200 Tylenol No. 4 tablets and 180 Dalmane capsules. K.D. had asked for them to take along to New England, where he travelled for an extended visit with his parents and others. This represented more than a two months' supply, and the prescriptions inspired a pharmacist, Paul Douglas, to telephone Dr. Villaflor's office before filling them. Mr. Douglas had called once before in the spring of the year, when he noticed that a total of 100 Tylenol (acetaminophen with codeine) No. 3 tablets and 60 tablets of Percocet (or the generic equivalent) had been dispensed to K.D. for use over a 24-day (April 2 to April 26, 1984) period. The pharmacist was concerned on that occasion because K.D. would have needed only 144, not 160, tablets during that period, if he had been taking no more than one every four hours. Back in Daytona Beach, K.D. presented himself at Dr. Villaflor's office on November 5, 1984, and received prescriptions for 45 tablets of Percocet, 55 tablets of Tylenol No. 3 and a quantity of Dalmane. All three prescriptions were filled the same day, and the prescription for Tylenol No. 3 was refilled on November 19, 1984. After his last telephone call to Dr. Villaflor's office, the pharmacist talked to K.D., telling him he would "not fill these medications again . . . until the prescribed number of days." (T. 222). On December 5, 1984, K.D. appeared a second time after his return from up north, and Dr. Villaflor again prescribed all three drugs, this time specifying 50 tablets of Percocet and 50 tablets of Tylenol No. 3. K.D. caused these prescriptions to be filled the day he got them. The office notes for both these visits mention only electrical shock by way of explanation for the prescriptions. On December 19, 1984, Dr. Villaflor suffered a stroke and was hospitalized. Two days later prescriptions he had purportedly written for K.D. were filled, but their authenticity, like that of the prescriptions filled on November 21, 1984, is not certain. While Dr. Villaflor was indisposed on account of the stroke, Dr. Wagid F. Guirgis filled in for him. The day he began, K.D. came in complaining of severe pain in his lower back and legs. Dr. Guirgis prescribed Dalmane, 50 Percocet tablets and 50 Tylenol No. 3 tablets, the latter prescription being twice refillable. Dr. Guirgis suggested to R.D. that he see an orthopedist or a neurologist, and, on January 21, 1985, refused K.D.'s request to prescribe more Percocet. At no time did Dr. Guirgis and Dr. Villaflor discuss K.D. or his treatment. Later the same day K.D. went to Dr. M.H. Ledbetter's office. This osteopath prescribed 30 Percocet tablets to be taken twice daily, as well as Elavil and Tranxene. On February 4, 1985, Dr. Ledbetter prescribed the same medicines. On February 28, 1985, Dr. Ledbetter prescribed Elavil, Librium and 50 tablets of Percocet. On March 22, 1985, he prescribed the same things. On April 19, 1985, K.D. again visited Dr. Ledbetter. The same day he purchased Librium and 60 Percocet tablets at Walgreen's. Dr. Ledbetter prescribed Librium, Elavil and 60 tablets of Percocet, to be taken twice daily, when he saw K.D. on May 16, 1985. In May Dr. Villaflor returned to his office, and K.D. appeared on May 21, 1985, five days after he had seen Dr. Ledbetter. Dr. Villaflor prescribed 60 Percocet and 50 Tylenol No. 3 tablets for K.D., along with Dalmane and a vitamin (Bl2) injection. K.D. weighed 142 pounds that day and his blood pressure was also noted. The office notes report "same complaints." On June 18, 1985, Dr. Villaflor prescribed 60 Percocet tablets, ten fewer than he prescribed on K.D.'s next visit, on July 17, 1985 , when K.D. limped "on left foot." In July, Dr. Villaflor also prescribed Dalmane and 50 Tylenol No. 3 tablets. On both visits K.D.'s weight (142 then 138) and blood pressure (122 then 120 over 80) were noted. On August 19, 1985, K.D.'s weight had fallen to 132 pounds but his blood pressure remained 120 over 80. Sixty Percocet tablets - one every four hours - were prescribed, as were 50 Tylenol No. 3 tablets. The diagnosis indicated in Dr. Villaflor's office notes was "electrocution." On September 16, 1985, Dr. Villaflor again prescribed Dalmane, Tylenol and 60 Percocet tablets. On October 17, 1985, K.D. limped to his last visit to Dr. Villaflor's office. His face bruised, K.D. complained that both feet were swollen, and reported that he had lost his balance and fallen down four stairs and over a concrete wall. For the last time, Dr. Villaflor prescribed Tylenol No. 3 and Percocet for K.D., 30 and 60 tablets respectively. Unbeknownst to Dr. Villaflor, K.D. had continued to visit Dr. Ledbetter, himself unaware of Dr. Villaflor's renewed involvement with K.D. On June 7, July 5, July 26, August 27, September 16 and October 10, 1985, Dr. Ledbetter prescribed Librium, Elavil and Percocet. Dr. Ledbetter's office notes also reflect K.D.'s fall. REQUIRED PRACTICE Keeping complete medical records is important not only as a mnemonic aid for the treating physician, but also to make the patient's history available to other physicians who may succeed or assist the recordkeeper. Although each is "a moderate type of analgesic," (T. 324), both codeine and oxycodone are "narcotic derivatives . . . [and] addictive in nature." Id. Dalmane "can be" (T. 221) "potentially addictive." Id. Because of his depression, K.D. "was not a good candidate" to entrust with several hundred pills at once. A physician who suspects addiction should limit prescriptions to "around ten to fifteen" (T.326) tablets and "start checking with other pharmacies to make sure if a patient is getting drugs from any other source . . . ." Id. He should perform "very close and repeated physical exams" (T. 327) and be alert for "overdose side effects," id., such as dizziness, slurred speech, or staggering. The evidence here fell short of a clear and convincing showing that Dr. Villaflor was remiss in failing to suspect addiction, however, Dr. Ledbetter, who had similar, albeit similarly incomplete, information apparently did not suspect. The evidence did not prove the existence of side effects from the drugs Dr. Villaflor prescribed. Although, on his last visit to Dr. Villaflor's office, K.D. reported dizziness, the cause is unknown. On the other hand, his office records do not suggest that Dr. Villaflor took any steps to determine the cause of K.D.'s dizziness or of his swollen feet. Dr. Villaflor's treatment of K.D. fell below acceptable levels, if he failed to refer K.D. for periodic reevaluations of the underlying orthopedic or neurological problem, which his records suggest he did not do. His treatment was also inadequate for failure periodically to "get the medicine . . . out of the system . . . for a limited time" (T. 337) in an effort to learn what side effects, if any, the drugs he prescribed caused, either singly or in combination. This is so, even though the effort might have been frustrated, if K.D. had acquired the same medicines from other sources.
The Issue The issues are whether Respondent obtained Oxycontin by using a forged prescription, in violation of Section 464.018(1)(h), Florida Statutes, and Rule 64B9-8.005, Florida Administrative Code, which prohibit unprofessional conduct, and in violation of Section 464.018(1)(i), Florida Statutes, which prohibit the unauthorized possession, sale, or distribution of controlled substances; and whether Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety, in violation of Section 464.018(1)(j), Florida Statutes, which prohibits the inability to practice nursing with reasonable skill and safety by reason of illness or use of alcohol, drugs, narcotics, or chemicals or as a result of any mental or physical condition. If so, an additional issue is what penalty should be imposed.
Findings Of Fact Respondent is a licensed registered nurse, holding license number RN 521142. She has been so licensed for 31 years. Respondent's long career in nursing has featured dedication, hard work, commitment, and competence. The record does not reveal any past discipline. For most of Respondent's professional career, starting in 1971, she has worked at Indian River Memorial Hospital in Vero Beach. Respondent has worked in various capacities at the hospital, including the emergency room and operating room. Respondent later helped develop a neurological unit at the hospital. Starting in 1980, she worked for a couple of years at Vero Orthopedics. Since 1997, Respondent has worked on a contract basis at the Indian River Memorial Hospital, although her present physical infirmities, partly described below, prevent her from working at present. In May 2000, Respondent injured her back while moving a heavy patient in the hospital. A couple of months later, Respondent underwent a laminectomy to relieve the pain from two herniated disks. Six weeks after the surgery, Respondent reinjured her back and had to undergo additional surgery. Six weeks after the second surgery, Respondent, who was not doing well, left her job at the orthopedic clinic and took a less strenuous job. One month after doing so, Respondent was still experiencing pain when she got into and out of cars. In June 2001, Respondent underwent a third operation, in which the surgeon fused two injured vertebrae. The surgery obtained access to the vertebrae by a posterior incision running from the breast to the pubis. The surgery also required a hip bone graft, thus necessitating an incision to the hip. The recovery from this excruciatingly painful surgery was difficult, and Respondent has not yet returned to work, although she is nearing the point at which she can perform some nursing-related work, such as teaching. At present, she still has difficulty walking or standing. When discharging Respondent from the hospital in late June 2001, Dr. Gomez prescribed her Oxycontin for pain. Dr. Gomez was covering for Respondent's neurosurgeon, Dr. Magana. Later, Dr. Cunningham, a pain management specialist and Respondent's family physician, resumed the care of Respondent. Dr. Cunningham continues to monitor Respondent and treat her pain. On direct examination, Respondent testified that she has not taken Oxycontin since December 2001. (However, on August 9, 2002, Respondent told her certified addictions professional that she had not taken any Oxycontin since March 2001.) Respondent testified that, after Oxycontin, she took no pain medication besides nonsteroidal anti-inflammatory medications and steroids. However, on cross-examination, Respondent admitted that she takes Methadose as needed, pursuant to a prescription from Dr. Cunningham. Respondent testified that he switched her from Oxycontin in July 2002. Respondent filled the Methadose prescription at a different drug store than the one that she has used for her other prescriptions. On October 5, 2001, Respondent presented a forged prescription to a different drug store than the one she has used for her other prescriptions. The prescription was for fifty 20- mg. Oxycontin tablets, which Respondent picked up two days later. Respondent fraudulently obtained the Oxycontin for her own use. Oxycontin is an analgesic opioid and a schedule II controlled substance. It is highly addictive and presently among the most commonly abused controlled substances. Oxycontin can produce a feeling of short-lived euphoria, as well as impaired cognitive functioning and impaired judgment. Methadose, a form of methadone, is a synthetic analgesic. It is also used in the detoxification process undergone by heroin addicts. Petitioner has proved by clear and convincing evidence that Respondent engaged in unprofessional conduct in her acquisition of the Oxycontin by using a forged prescription and that Respondent unlawfully possessed a controlled substance. Petitioner has not proved by clear and convincing evidence that Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety. First, Petitioner did not prove by clear and convincing evidence that Respondent still uses Oxycontin. It appears likely that she may have substituted Methadose for Oxycontin to manage her pain. It is unclear from the present record whether Respondent's use of Methadose is also to assist her in overcoming an addiction to Oxycontin. But even if Petitioner had pleaded Methadose rather than Oxycontin, the record does not reveal the extent to which Respondent presently uses Methadose. For the reasons stated in the preceding paragraph, the relevance of the Methadose is not to prove the third count of the Administrative Complaint, but to underscore the risk that Respondent may pose if she practices nursing at present. Respondent was not candid at the hearing. She was not candid about the October 2001 incident. She was not candid about the recent use of Methadose and was evasive about the drug's properties. The two-hour evaluation that Respondent underwent by a certified addictions professional was cursory and curiously deferential to Respondent. This remarkable evaluation is entitled to absolutely no weight whatsoever. The opinion of the certified addictions professional that Respondent does not suffer from a drug abuse or dependency may or may not be true, but, if true, the result is a chance occurrence, rather than a professional conclusion following the comprehensive collection of relevant, reliable data and the careful, informed analysis of such data. The safeguards provided by the pretrial intervention program, into which Respondent entered after her arrest for the fraudulent acquisition of the Oxycontin, are inadequate. The random drug tests always occur on Tuesdays, just not every Tuesday. The assurances that ensue from Respondent's apparent compliance with the conditions of her probation, which include negative urinalyses, are meaningful, but not sufficiently rigorous to provide the necessary protection to a nurse's patients. On December 26, 2001, Petitioner entered an emergency suspension order in this case. The record amply demonstrates that Respondent will suffer considerable financial distress if denied the opportunity to practice her profession. However, Respondent's lack of candor precludes a detailed analysis of the safeguards in her current monitoring program and a detailed prescription of what, if any, additional safeguards would be required to permit any discipline short of a suspension. In its proposed recommended order, Petitioner seeks a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the Intervention Project for Nurses (IPN); treatment as recommended by the IPN; probation for three years if no treatment is recommended by the IPN; an administrative fine of $750; a reprimand; and the assessment of costs of the investigation and prosecution.
Recommendation It is RECOMMENDED that the Board of Nursing enter a final order finding Respondent guilty of violating Section 464.018(1)(i), Florida Statutes, and imposing a penalty of a $250 administrative fine, a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the IPN; treatment as recommended by the Intervention Project for Nurses; probation for three years if no treatment is recommended by the Intervention Project for Nurses; and the assessment of costs of the investigation and prosecution, upon remand, if necessary. DONE AND ENTERED this 20th day of December, 2002, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2002. COPIES FURNISHED: Dan Coble, RN PhD CNAA C, BC Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399-3252 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Amy M. Pietrodangelo Assistant General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Suzanne H. Suarez Suzanne Hope Suarez, P.A. The Legal Building 447 3rd Avenue North, Suite 404 St. Petersburg, Florida 33701-3255
The Issue The issue in this case is whether Florida Administrative Code Emergency Rule 65DER17-2 (the “Emergency Rule”) constitutes an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes. (Unless specifically stated otherwise herein, all references to Florida Statutes will be to the 2017 version.) More specifically, on September 19, 2017, the Florida Department of Children and Families (the “Department”), published the Emergency Rule, which dealt with the need for and licensing of new methadone medication-assisted treatment centers for persons dealing with opioid addiction. Pursuant to the Emergency Rule, the Department decided which providers would receive approval notices to submit licensure applications in certain counties based on the order in which complete and responsive applications were received by the Department. A number of parties are challenging the validity of the Emergency Rule.
Findings Of Fact Parties and Standing Respondent, the Department, is the state agency responsible for licensing providers of care in methadone medication-assisted treatment facilities. It is the agency, which promulgated the Emergency Rule. Petitioner, Dacco Behavioral Health, Inc. (“Dacco”), is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Dacco submitted three applications for licensure under the Emergency Rule. Its applications were not approved by the Department. Dacco timely filed an administrative challenge to its denied applications. Dacco has standing in this proceeding. Petitioner, OPI, is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. OPI submitted six applications for licensure under the Emergency Rule. None of its applications were approved by the Department. OPI timely filed an administrative challenge to its denied applications. OPI has standing in this proceeding. Petitioner, Aspire Health Partners, Inc. (“Aspire”), is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Aspire submitted two applications for licensure under the Emergency Rule. Neither of its applications was approved by the Department. Aspire timely filed an administrative challenge to its denied applications. Aspire has standing in this proceeding. Intervenor, CRC, is a Delaware limited liability company registered to do business in Florida. CRC is currently licensed to operate a methadone medication-assisted treatment clinic in Florida. CRC submitted 16 applications for licensure under the Emergency Rule. Its applications were not approved by the Department. CRC timely filed an administrative challenge to its denied applications. CRC has standing to intervene in this proceeding. Intervenor, Riverwood Group, LLC (“Riverwood”), is a Delaware limited liability company authorized to do business in Florida. Riverwood is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Riverwood submitted six applications for licensure under the Emergency Rule. Its applications were not approved by the Department. Riverwood timely filed an administrative challenge to its denied applications. Riverwood has standing to intervene in this proceeding. Intervenor, Symetria, is a Florida limited liability company whose parent company is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Symetria submitted 11 applications for licensure under the Emergency Rule. One of its applications was approved; the other 10 were not approved by the Department. Symetria did not file an administrative challenge to the denial of its applications. Opposition to Symetria’s standing was raised by Intervenors appearing in support of Respondent. Symetria was allowed to participate at final hearing pending adequate proof of standing. Symetria did not prove its standing at final hearing. Symetria does not have standing in this proceeding on behalf of Petitioners as it does not satisfy the two-prong test announced in Agrico Chemical Company v. Department of Environmental Regulation, 406 So. 2d 478 (Fla. 1st DCA 1978). (After entry of this Final Order, Symetria will be stricken from the style of the case.) It should be noted that Symetria apparently never received notice as to its denied applications and may have challenged those denials, if notices had been issued, but that possibility is too speculative to award standing in this matter. It should also be noted that none of the parties hereto objected to Symetria’s involvement in the final hearing, including its introduction of evidence and examination of witnesses. Intervenor, CFSATC, d/b/a Central Florida Substance Abuse (“CFSATC”), is a Florida corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. CFSATC submitted seven applications for licensure under the Emergency Rule. None of its applications were approved by the Department. CFSATC timely filed an administrative challenge to its denied applications. CFSATC has standing to intervene in this proceeding. Intervenor, Bay County Healthcare Services, LLC (“Bay County Healthcare”), is a Georgia limited liability company and is currently licensed to operate a methadone medication- assisted treatment clinic in Florida. Bay County Healthcare submitted eight applications for licensure under the Emergency Rule. None of its applications were approved by the Department. Bay County Healthcare timely filed an administrative challenge to its denied applications. Bay County Healthcare has standing to intervene in this proceeding. Intervenor, Palm Beach Drug Testing, LLC, d/b/a Relax Mental Health Care (“Relax”), submitted 14 applications for licensure under the Emergency Rule; eight of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of Relax. Relax has standing to intervene in this proceeding. Intervenor, Colonial Management Group, L.P. (“Colonial”), operates methadone medication-assisted treatment centers nationwide, including Florida. Colonial submitted 19 applications for licensure under the Emergency Rule; all 19 of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of Colonial. Colonial has standing to intervene in this proceeding. Intervenor, PAS, submitted 48 applications for licensure under the Emergency Rule; twenty of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of PAS. PAS has standing to intervene in this proceeding. Procedural History On May 3, 2017, Governor Scott signed Executive Order No. 17-146, alluding to the nearly 4,000 deaths in Florida caused by opioids during calendar year 2015. Florida had nearly 10 percent of all opioid-related deaths in the entire country that year. The Governor declared that an opioid epidemic threatens the State and has created an emergency situation. He directed the State Health Officer and Surgeon General to announce a statewide public health emergency. The Governor’s executive order noted that the United States Department of Health and Human Services had awarded a grant of $27,150,403 per year for two years to the Department to provide prevention, treatment, and recovery support services to address the opioid epidemic. The Governor said it was necessary to immediately draw down those federal grant funds in order to provide services to Florida communities, and that the State could not wait until the next fiscal year (which would start two months hence, on July 1, 2017) to begin that distribution. On June 29, 2017, the Governor signed Executive Order No. 17-177, extending for an additional 60 days the state of emergency declaration set forth in Executive Order 17-146. This action was precipitated by hurricanes threatening the State. The executive orders issued by the Governor appear to direct State agencies to utilize the federal grant monies to bolster existing providers of treatment. Nothing in the executive orders issued by the Governor directs the approval of additional opioid treatment centers. There is, however, an omnibus provision in the executive order directing the State Health Officer to “take any action necessary to protect the public health.” The Department’s response to the executive orders was to publish emergency rule 65DER17-1 in the FAR on August 25, 2017. That rule was superseded by the Emergency Rule, which revised the dates during which applications for licensure could be submitted. This change was deemed necessary in response to the devastation wrought by Hurricane Irma, making travel to Tallahassee (for delivery of applications) somewhat difficult during the timeframes set forth in emergency rule 65DER17-1. The Notice of Emergency Rule, as published in the Florida Administrative Register, states in full (with strikethrough/underline in original): Notice of Emergency Rule DEPARTMENT OF CHILDREN AND FAMILIESSubstance Abuse Program RULE NO.: RULE TITLE: 65DER17-2 Standards for Medication-Assisted Treatment for Opioid Addiction SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE: On May 3, 2017, the Governor of the State of Florida signed Executive Order Number 17-146 declaring that the opioid epidemic threatens the State with an emergency and that, as a consequence of this danger, a state of emergency exists. Also, in the executive order, the Governor directed the State Health Officer and Surgeon General to declare a statewide public health emergency, pursuant to its authority in section 381.00315, F.S. On June 29, 2017, the Governor signed Executive Order Number 17-177 to extend the state of emergency declaration. The department was recently awarded a two-year grant to address this opioid epidemic. The department will use these funds in part to expand methadone medication-assisted treatment services in needed areas of the state as part of a comprehensive plan to address the opioid crisis. Revising the licensure requirements through an emergency rule is necessary to accommodate the critical need for more methadone medication-assisted treatment providers. Due to the impact of Hurricane Irma on providers and individuals in treatment, the department has determined that extending the submission dates for applicants is necessary. REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair under the circumstances because it ensures equitable treatment of methadone medication-assisted treatment providers. SUMMARY: This rule makes changes to permanent Rule 65D-30.014 F.A.C., relating to licensure requirements for methadone medication-assisted treatment programs. THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Bill Hardin. He can be reached at William.Hardin@myflfamilies.com or Office of Substance Abuse and Mental Health, 1317 Winewood Boulevard, Building 6, Tallahassee, Florida 32399-0700. THE FULL TEXT OF THE EMERGENCY RULE IS: 65DER17-2 (65D-30.014): Standards for Medication-Assisted Treatment for Opioid Addiction. 65DER17-2 supersedes 65DER17-1. In addition to Rule 65D-30.004, F.A.C., the following standards apply to Standards for Medication-Assisted Treatment for Opioid Addiction. State Authority. The state authority is the department’s Office of Substance Abuse and Mental Health. Federal Authority. The federal authority is the Center for Substance Abuse Treatment. Determination of Need. Criteria. In accordance with s. 397.427, F.S., the department shall not license any new medication-assisted treatment programs for opioid addiction until the department conducts a needs assessment to determine whether additional providers are needed in Florida. The determination of need shall only apply to methadone medication-assisted treatment programs for opioid addiction. Department of Correction facilities are excluded from this process. The department shall use a methodology based on a formula that identifies the number of people who meet the criteria for dependence or abuse of heroin or pain relievers who did not receive any treatment, and the number of opioid-caused deaths. This formula will be weighted, with 70 percent driven by the number of people with an unmet need for treatment and 30 percent driven by the number of deaths. In its effort to determine need, the department shall examine the following data: Population estimates by age and by county; Number of opioid-caused deaths; Estimated number of past-year nonmedical pain reliever users; and Estimated number of life-time heroin users; Procedure. By August 28, 2017, the department will conduct a needs assessment to determine whether additional methadone medication-assisted treatment providers are needed in Florida. The department will publish a determination of need in the Florida Administrative Register and on the department’s website at http://www.myfl families.com/service-programs/substance- abuse on August 30, 2017. If the department determines that additional providers are needed, the department will also publish instructions for submitting an appropriate application. Applicants interested in providing methadone medication-assisted treatment must complete and submit CF-MH 4036 titled, “Methadone Medication-Assisted Treatment Provider Application in Response to Emergency Rule”, June 2017, incorporated herein by reference. Form CF-MH 4036 is available from the department’s website at https://eds.myflfamilies.com/DCFForms Internet/Search/DCFFormSearch.aspx and at http://www.myflfamilies.com/service- programs/substance-abuse. Applications must be complete and responsive to all of the questions on this form. Applications will be accepted at department headquarters from October 2, 2017 September 22, 2017 at 8 a.m. Eastern Time until October 23, 2017 October 13, 2017, at 5 p.m. Eastern Time. Applications must be delivered to the following address: Florida Department of Children and Families, Office of Substance Abuse and Mental Health, 1317 Winewood Boulevard, Building 6, Tallahassee, Florida 32399-0700. For the application review period in response to this emergency rule, the department will use CF-MH 4037 titled, “Review Form for Methadone Medication- Assisted Treatment Provider Application in Response to Emergency Rule”, June 2017, incorporated herein by reference. Form CF- MH 4037 is available from the department’s website at https://eds.myflfamilies.com/ DCFFormsInternet/Search/DCFFormSearch.aspx and at http://www.myflfamilies.com/service- programs/substance-abuse. Should the number of applications for a new provider in a Florida county exceed the determined need, the selection of a provider shall be based on the order in which complete and responsive applications are received by the Office of Substance Abuse and Mental Health headquarters. Applicants who are approved to apply for licensure will receive notices from the department by November 17, 2017 November 10, 2017. Applicants who receive approval notices shall submit applications for licensure to the department’s regional Substance Abuse and Mental Health office(s) where the service will be provided. The regional Substance Abuse and Mental Health office will process applications for licensure in accordance with the standards and requirements in 65D-30, F.A.C. through (6) No change. Rulemaking Authority 397.321(5) F.S. Law Implemented 397.311(25)(a)7., 397.321(1), 397.419, FS. History–New 5-25-00, Amended 4-3-03, Amended 8-25-17, Amended 9-19-17. THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE. EFFECTIVE DATE: 9/19/2017 Petitioners filed challenges to the Emergency Rule at DOAH on December 11, 2017, 83 days after the effective date set forth in the FAR. Respondent asserts that the Emergency Rule is merely an amendment to Rule 65DER 17-1, which had an effective date of August 25, 2017. Thus, reasons Respondent, challenges to the Emergency Rule were due on or before November 23, 2017, i.e., 90 days after August 25, 2017. However, emergency rules are not renewable so as to expand their validity beyond 90 days. § 120.54(4), Fla. Stat. As set forth above, the clear language appearing in the FAR establishes September 19, 2017, as the effective date of the Emergency Rule. Had the Department wished to retain the effective date from the prior rule, it certainly could have done so. It did not. Petitioners’ challenge to the Emergency Rule was timely. Background Florida has had rules in effect for 18 years regarding the need for opioid treatment centers around the State. Florida Administrative Code Rule 65D-30.014 is entitled, “Standards for Medication and Methadone Maintenance Treatment.” This rule sets forth the process for providers to request licenses to establish new opioid treatment facilities, based on the Department’s annual determination of need. According to the rule, the Department is to conduct an annual assessment of need, publishing the results of that assessment by June 30 of each year, although, inexplicably, no assessment was done for calendar years 2016 or 2017. After the need assessment is published, the Department directs interested parties to submit applications for licensure to the Department’s district office in the area where the need exists. All such applications would have to be submitted no later than on a “closing date” to be provided by the Department. The Department’s district office would receive the application(s) and conduct a formal rating of the applicant(s). There were minimum requirements each applicant must meet in order to be considered for licensure. If the number of applicants exceeded the determined need, the selection of a provider would be done based on certain substantive criteria, e.g., number of years the applicant has been licensed; the organizational capability of the applicant; and the applicant’s history of noncompliance with Department rules. Pursuant to rule 65D-30.014, the Department had conducted assessments in calendar years 2012, 2013, 2014, and 2015. The award of licenses based on the 2012 and 2013 need assessment was delayed by litigation. A need for 31 additional treatment centers was found in 2014, but no applications were accepted by the Department due to the ongoing litigation relating to the previous years. The following year, 2015, the Department found a need for only five additional treatment centers, even though none of the 31 treatment centers identified as needed in 2014 had been awarded to anyone. The 2015 assessment was lower than the prior year due to some changes in the methodology used by the Department. The Department did not accept any applications to meet the established need in 2015. One rationale for not accepting applications, even though there was a need, was that the Department was drafting new rules. That process would give stakeholders an opportunity for input. The notices that the rules were being developed, however, were not filed until some 11 months after the 2015 need projections were published. The Department explained that it was busy with other rulemaking duties during that time, causing some delay. Developing the Emergency Rule After entry of the Governor’s executive orders, the Department began the process of distributing the federal grant money to existing treatment centers. The Department, though it never met with the Governor to discuss use of the grant funds, handed out the funds to various existing clinics in order to help them deal with the clinics’ backlogs and waiting lists. There was no discussion between the Governor and the Department concerning the necessity for new clinics. A needs assessment was apparently conducted by the Department. The Department based its assessment in part on data it had gathered when applying for the federal grant. Existing treatment centers had provided the Department waiting lists, indicative of a greater need than could be met by the existing clinics. That data, however, was only from public providers; private providers were not included. The public providers were essentially those contracting with the Department’s “managing entities,” who act as intermediaries between the provider and the Department. An emergency rule was proposed as the vehicle for addressing the need and acquiring applications for licensure. Though the Department’s Director of Substance Abuse and Mental Health thought it best to simply proceed with the rule currently under development, the Emergency Rule was pursued. The thinking at the Department was that the existing rule had created considerable litigation that the Emergency Rule might avoid. That did not happen. The emergent situation warranting an emergency rule was, according to the Department, the scenario described by the Governor in his executive orders. The Department of Health had declared a public health emergency, which was also used as a basis for creating the Emergency Rule. The federal grant funds, however, were not an impetus for creating the Emergency Rule. The Emergency Rule relied upon data from calendar year 2015, as it was the latest data available to the Department at that time. The Governor’s executive orders had also relied upon 2015 data. Some interim data had been available, but the only full year of information available at the time the rule was promulgated was for 2015. The interim data, however, indicated a sharp (approximately 30 percent) increase in need. The Department published a determination of need on its website on August 30, 2017. Apparently the need determination was not published in the FAR despite the directive to do so in subsection (3)(b) of the Emergency Rule. The Department found a need for one clinic each in 47 of Florida’s 67 counties, as well as for two in Hillsborough County, for a total of 49 new clinics. Pursuant to the Emergency Rule, interested applicants were to file an application on the Department’s approved form (CF-MH 4036, attached hereto as an Addendum) expressing an interest in becoming licensed in one or more of those counties. Such applications were to be “accepted at department headquarters from October 2, 2017, at 8 a.m., Eastern Time, until October 27, 2017 at 5 p.m., Eastern Time. Applications must be delivered to [the department].” In contrast to rule 65D- 30.014, applications under the Emergency Rule were to be filed at the Department’s headquarters in Tallahassee rather than in the various district offices around the State. The application form utilized by the Department is a one-page document. The form requests minimal identification information concerning the applicant and its business (questions 1 through 10). Question 11 asks if the applicant plans to accept Medicaid-eligible, indigent, and/or pregnant women as patients. The 12th question directs the applicant to submit documentation concerning its target population, proof of a physician on staff, the anticipated date of initiation of services, and proof of registration with the Department of Revenue or Division of Corporations. The Department also created a “review form,” used to check the completeness of applications. The review form mirrors the application, providing a space for the Department reviewer to state whether the applicant had completed each section of the application form. The Department maintains that the applicants’ responses to Question 11 were not considered in its review of the applications submitted under the Emergency Rule. This was because, according to the Department, a response to that question might favor one applicant over another. The Department did not elaborate as to how this “favoritism” might negatively affect the process. The question had been used under the prior rules and had been deemed important, presumably because--as reported by some of the parties herein--a large majority of their patients were either Medicaid-eligible, indigent persons, or pregnant women. It certainly was reasonable that the Department would ensure that those groups of citizens, who were undoubtedly accounted for in the need assessment, had access to approved treatment centers under the Emergency Rule. Nonetheless, the Department did not utilize the Question 11 responses in its review. This is contrary to the plain language of the Emergency Rule, which states: “Applications must be complete and responsive to all questions on this form.” (emphasis added). See 65DER17- 2(3)(b)1. The Emergency Rule as published contained the following language: “REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair under the circumstances because it ensures equitable treatment of methadone medication-assisted treatment providers.” Neither the Emergency Rule language nor the Department at final hearing provided a persuasive rationale for that statement and conclusion. In fact, the Department acknowledged that if the first person in line had filed applications for all 49 new clinics, all the other applicants would have been denied the right to seek licensure. How is that fair? What the Emergency Rule did was to set a window within which interested applicants could either mail, overnight-deliver, or hand-deliver a copy of the one-page application and attachments to the Department’s headquarters in Tallahassee. The Department felt that allowing applications to be submitted via email would potentially crash its email system, so email submission was not allowed. The applications received first by the Department were to be approved, notwithstanding any substantive shortcomings or comparative failings of those applications as compared to applications received later. No other criteria were considered; first was deemed best. What is fair about approving competing applications based on who filed first rather than on substantive differences in the services being proposed? What actually transpired vis-à-vis submission of the applications was not foreseen by the Department or by most of the applicants. That is, some applicants either lined up at Department headquarters days prior to the 8:00 a.m. acceptance time on October 2, 2017, or had someone wait in line for them. Then, when the doors opened at 8:00 a.m., the first person in line presented applications for 19 of the 49 sites identified by the Department as having a need. The second applicant in line submitted 17 applications, etc. By the time each of the Petitioners reached the front of the line, only minutes after the doors had opened, applications for their prospective counties of interest had already been filed. Under the Emergency Rule, the earlier filed applications were accepted without comparison to competing applications. As a result, Colonial was approved for 19 licenses; PAS was approved for 20; and Relax obtained eight; i.e., 47 of the 49 licenses were obtained by just three individual applicants. Again, the Department acknowledged that “[a]fter it, you know, happened the way it did, there were many considerations that we should have made.” Ute Gazioch, Jt. Exh. 6, page 81. Interestingly, the first application accepted by the Department was by an applicant who did not even appear at Department headquarters. That applicant, Lakeview Center, Inc., submitted its application via FedEx. The FedEx box containing Lakeview Center’s application was received and clocked in by an office at Department headquarters, other than the Substance Abuse and Mental Health office, at 7:40 a.m., i.e., prior to the window for filing. When the application made its way to the appropriate office, it was deemed received at 8:00 a.m. As a result, it was “first in line.” The incongruity of that situation was not persuasively justified by the Department. In fact, the Department testified that if all of the applications had been filed at the wrong office, it would likely have simply defaulted to an 8:00 a.m. arrival time for each one. Upon being approved, an applicant would then be allowed to submit an application for licensure. Under the licensure process, the applicant would be vetted in order to assure it met at least minimal requirements for obtaining a license. No comparison of the approved applicant to other applicants was made by the Department to ascertain whether another applicant might be superior as to services provided. Rather, if the approved applicant could satisfy, even minimally, the licensure requirements, it would be granted the right to seek a license. Once licensed, it could take considerable time and financial resources to effectuate the opening of a new opioid treatment clinic. There are many factors to be addressed and resolved, including but not limited to: acquisition of an appropriate site, whether by way of purchase of undeveloped property and new construction or lease/purchase of an existing building; construction or renovation, as needed; zoning concerns; permitting by state, county, and/or municipal bodies; staffing; coordination of state and federal licenses or certifications; etc. It is not uncommon for the process to take up to two years, sometimes more. In addition, the financial expenditures could be in the hundreds of thousands of dollars (and even as much as a million dollars) for each project. For this reason, the Department did not foresee that any entity might apply for so many applications as actually transpired. The likelihood that a single entity would have the time, money, or other resources to move forward on multiple products at one time is small. It is more likely that a single entity receiving approval for multiple new clinics might “bank” the approvals, expending time and money for only a few at a time, at best. If so, that could result in far fewer new clinics coming on line than the 49 projected by the Department under the Emergency Rule. As the applications contained no requirement to provide financial information, it is impossible for the Department to determine whether the approved entities, which received multiple approvals, could successfully–-and timely–-complete their projects. There is no specific time frame for which a granted applicant must commence operations once approved. However, as the approvals were done pursuant to an “emergency,” it follows that clinics should be opened as soon as practicable. Petitioners assert that the “first in line” scheme enunciated in the Emergency Rule is arbitrary, capricious, and patently contrary to a determination of the applicants’ ability to provide care to persons suffering opioid addiction. The facts bear that assertion out.
Findings Of Fact The Respondent, Solomon D. Klotz, M.D., at all times pertinent hereto, has held a current, valid medical license number ME 0002269, issued by the Board of Medical Examiners, Department of Professional Regulation, which is the agency charged with enforcing Chapter 458, the "Medical Practice Act," as it relates to qualification for licensure and standards for regulating medical practice of physicians licensed in the State of Florida. The Respondent is also board- certified by the American Board of Internal Medicine in internal medicine and is board- certified in the field of allergy and immunology by the American Board of Allergy and Immunology. The Respondent obtained his M.D. Degree from New York Medical College in 1937, obtaining a Masters from that institution in 1942. He was licensed in New York in 1938 and was made a diplomate of the National Board of Medical Examiners in 1938. He was issued his Florida license in 1941. He served in the Medical Corps of the United States Army in World War II and during the years 1945 and 1946 was a clinical instructor at New York Medical College, and a research fellow at Metropolitan Hospital Research Unit in New York. The Respondent has practiced in his specialty field of internal medicine as well as allergy and immunology in Florida for many years. He is presently a clinical professor at the College of Health of the University of Central Florida, and an adjunct professor at the Department of Biological Sciences at the University of Central Florida. Respondent is presently on the medical staffs at Winter Park Memorial Hospital, Florida Hospital, Orlando Regional Medical Center and Humana Hospital/Lucerne, with a senior consultant rating at each of the above hospitals. The Respondent is a member of 21 professional societies and was a founding member of the Salk Institute for Biological Studies and, the board of the Joint Council of Allergy and Immunology. He has served as president of the American College of Allergists, the Florida Allergy Society, Southeastern Allergy Society, and is president of the medical staff of Florida Hospital in Orlando. The Respondent has published or presented more than 50 research papers, seven of which have been published within the past three years in such journals as the Annals of Allergy, the Journal of the Florida Medical Association, the Journal of the American Academy of Allergy and Immunology and the American Heart Journal. Concerning the disease or condition most pertinent to the charges in the administrative complaint, the Respondent published a paper jointly with Dr. Von Hilsheimer in 1970 concerning minimal brain dysfunction, attention disorders and the diagnosis of functional narcolepsy. Dr. George Von Hilsheimer was accepted as Respondent's expert witness concerning the diagnosis of narcolepsy and the various forms or manifestations of narcolepsy and the treatment thereof. He is a licensed psychologist in the State of Florida, having been educated at the University of Miami with postgraduate work at the University of Chicago. He interned in psychology at the Corsack Clinic and the Seabrook Institute in San Francisco. He completed his Ph.D. in psychology with a multiple major in neuropsychology, psychoimmunology and psychotherapy. He is an associate fellow in the Society for Clinical Ecology, a consultant to the Science Advisory Committee of the Environmental Protection Agency as a neuropsychologist and behavioral toxochologist. He is eligible for board certification by the Academy for Psychosomatic Medicine and the American Academy of Behavioral Medicine. He has published numerous reference papers and a number of books, one of which books focused on the diagnosis of minimal brain dysfunction and the issue of psychosomatic versus somatic causes for behavior. He has presented two papers in conjunction with the Respondent on the issue of minimal brain dysfunction, tension disorders and the diagnosis of functional narcolepsy. Since 1980, Dr. Von Hilsheimer's practice has been split between psychotherapy and psychoimmunology. In the past ten years he has presented numerous continuing education workshops for physicians, which courses were certified by the American Medical Association. Dr. Dale K. Lindberg, M.D., was accepted as an expert witness for the Petitioner regarding the pharmacological effects, uses and indications of the drugs related to the charges in the administrative complaint. Dr. Lindberg has been a licensed physician in the State of Florida since 1959. He is board certified in nuclear medicine. He took a residency in nuclear medicine at Mt. Sinai Hospital in Miami Beach between the years 1974 and 1977. Since 1973, his practice has been limited to primarily that of supervising methadone maintenance programs and clinics. Prior to 1973 his practice was in the area of family practice, as well as nuclear medicine. He is a member of the Broward County Medical Association, Florida Medical Association, American Medical Association, Broward County Family Practice Association, as well as the Society of Nuclear Medicine. Dr. Lindberg has never treated a patient with narcolepsy nor has he seen patients exhibiting the various kinds of narcoleptic behavior. METHAQUALONE PRESCRIPTIONS; COUNTS I, II AND III The first three counts in the administrative complaint concern prescriptions written June 24, 1982, for allegedly excessive and unjustified amounts of a controlled substance, methaqualone, prescribed to patients Harri Klotz (Count I) , Sam Meiner (Count II) and Charles Meiner (Count III). Those prescriptions consisted of 121 sopor (150 mgs) for Harri Klotz; 189 parest for Sam Meiner; and 34 quaaludes for Charles Meiner, all of which are methaqualone medications. The Respondent received a telephone call on or shortly before June 24, 1982, the date the prescriptions were written, from a pharmacist whom he regularly dealt with, who informed him that, inasmuch as, effective July 1, 1982, he would be unable to fill methaqualone prescriptions due to a change in the law by which it became a Schedule I drug, that he would make available the small quantity of methaqualone remaining in stock to the Respondent for his patients who required the drug. The Respondent acknowledged having a few such patients and accordingly wrote prescriptions for the above odd numbers of capsules to patients whom had been regularly receiving methaqualone medication for a period of time previously. Patient Harri Klotz is the Respondent's wife. She has been a patient of Respondent since approximately 1940. She suffers from generalized osteo- arthritis involving mainly the hips, which was first diagnosed in 1967. Due to progressive severity of the disease she received surgery in October, 1970, in Germany, for replacement of both hip joints with artificial prosthesis. Since that time the right hip prosthesis joint cracked, causing her severe, chronic pain which caused her great difficulty in sleeping. After taking numerous combinations of medicine, Mrs. Klotz was found to respond most effectively to methaqualone, which induced sleep in spite of the pain, without undesirable side effects the next morning. She ultimately had the right hip prosthesis repaired. Her medical records indicate that this medication had also been prescribed for her by her treating physicians when the prosthetic devices were implanted. In 1981 she again began experiencing the same type of agonizing, chronic pain in her left hip and consulted an orthopedic surgeon at regular intervals concerning it. It was not until November, 1952, however, that the diagnosis was made that her left prosthesis had also broken. During the various attempts to diagnose the cause of this problem with her left hip, she was experiencing severe, chronic pain. Finally, after a third stint of surgery the left hip prosthesis was replaced and her symptoms ultimately improved. In the meantime however, on October 14, 1981, Respondent purchased 1,000 quaaludes for his wife. He did not dispense the entire lot to her, rather she was given 30 capsules at a time for use in inducing sleep during the period when she suffered from her painful condition at intervals of one and one-half to two months. The Respondent carefully monitored her dosage and kept the balance under lock and key at his office, duly recording on a dispensing record the capsules actually given to his wife on each occasion. On June 24, 1982, before methaqualone became a Schedule I Controlled Substance, he last prescribed that substance for his wife when he wrote the prescription for 121 sopor. He has not since prescribed a methaqualone substance to his wife. On June 24, 1982, the Respondent prescribed methaqualone to Sam Meiner. Mr. Meiner (Respondent's counsel) has been a patient of the Respondent since approximately 1968. Be suffers from a severe, chronic painful condition called regional enteritis, a condition characterized by severe, chronic pain and acute bowel spasms associated with acute exacerbations of the enteritis condition. As a result of this condition he has had two bowel resection surgeries, during the course of which surgeons removed approximately six feet of his small intestine. He has suffered from this disease chronically for approximately 18 years, having his first surgery in 1967 and the second in 1977. "hen the enteritis condition became acutely inflamed after his second surgery, he once again sought Respondent's medical advice. He has been a continuous patient of the Respondent ever since that time, seeing him almost on a weekly basis. Included in the total medical care Respondent has given this patient is a prescription of methaqualone for its beneficial soporific and antispasmodic effects designed to curtail the severity and duration of the bowel spasm incidents. Other physicians, as well as Respondent, in treating this patient have attempted many other combinations of medications before the Respondent and patient determined that methaqualone was the most effective modality. Since being under the Respondent's care with attendant methaqualone medication, the patient has required no hospitalization and has been able to lead a substantially normal existence, even though this disease or condition if unsuccessfully treated can ultimately prove fatal, especially if additional such surgical procedures are resorted to. Witness Meiner was shown to have no abnormal adverse effects nor physical or psychological dependence on the drug. It is now no longer legally obtainable, the patient being afforded his last prescription therefor on June 24, 1982, some six days before the prescription of the drug became illegal. On June 24, 1982, the Respondent prescribed 34 methaqualone capsules to Charles Meiner. Charles Meiner (also counsel for Respondent) suffers from a chronic, severe back injury involving a ruptured or degenerative disc. He periodically suffers excruciating, chronic back pain, resulting in his inability to sleep. He has been a patient of the Respondent since 1969. In 1973 he required hospitalization due to the severity of the back pain. lie has seen the Respondent for this problem at regular intervals ever since. He had been prescribed methaqualone on a number of occasions prior to June, 1982, as the medication helps his insomnia resulting from the chronic back pain, without imposing any adverse effect the following morning or inhibiting his ability to function in the legal profession. Be has never taken more than one tablet per day and some days only a half tablet during the course of his back pain flare- ups. In May of 1982, his back condition became particularly severe, with persistent pain. Because of this exacerbation of his back condition, he was given a prescription for 34 quaalude tablets on June 24, 1982, to relieve his pain and enable him to sleep. During the time Respondent prescribed methaqualone to these three above-named patients, methaqualone was an acceptable medication for relief of the symptoms these patients exhibited. Petitioner's witness Dr. Lindberg acknowledged that the prescribing of methaqualone by the Respondent to these patients on or before July 1, 1982, was for a medically justifiable purpose, and that the dosages involved were within recommended daily dosages for the treatment of the symptoms exhibited by these patients, as depicted in the Physician's Desk Reference (PDR) a work relied on by both parties throughout this proceeding. AMPHETAMINE PRESCIPTIONS: COUNTS IV, V, VII, XI, XII, XIII, XIV, XVI, XVII, XVIII and XIX. The prescription of amphetamines became restricted as to use by the enactment of Section 458.331(1)(cc) , Florida Statutes, effective August 30, 1980. This restricted the prescription of any drug which is an amphetamine or a sympathomimetic amine drug (a Schedule II drug) except, as pertinent here, for the condition of narcolepsy. Prior to the restriction of the drug, the Respondent had prescribed such drugs for short-term use for patients who were attempting to embark on a successful weight-control program. The Petitioner's expert witness, Dr. Lindberg, acknowledged that this was a medically appropriate use of this type of medication at the time and that he himself had made similar prescriptions for similar purposes. The Respondent conceded that as of July 3, 1980, that he was not aware of the change in the legal status of amphetamine type drugs by the enactment of the above statute, and did not become aware of such restrictions until the pharmacist with whom he regularly dealt informed him that he could not prescribe Biphetamine, Dexedrine or other sympathomimetics unless the patient had a narcoleptic condition. Upon becoming aware of this restriction after August 30,1980, the Respondent discontinued use of those drugs except for the treatment of narcoleptic symptoms in patients. Dr. Lindberg opined that the only type of narcolepsy he would recognize was "ideopathic narcolepsy." By this he meant that he would only diagnose narcolepsy when all four recognized symptoms are present: excessive daytime sleepiness, cataplexy (a condition when muscles become limp) , hypnogogic hallucinations (dreams shortly before going to sleep or upon awakening) and sleep paralysis whereby the patient is unable to move, although the limbs are not rigid. Dr. Lindberg has never treated a patient with narcolepsy nor has he ever observed a patient exhibit narcoleptic behavior in his practice. Both the Respondent and Dr. Von Hilsheimer, the Respondent's expert witness on the subject, have studied and treated this condition and published recognized research papers on the subject of narcolepsy. Further, the Respondent in connection with his speciality in the field of allergies, has performed testing regarding patients with certain food sensitivities and has observed that some of them will exhibit narcoleptic symptoms as a reaction to certain foods. Dr. Von Hilsheimer, as delineated above, has extensive experience in the diagnosis and treatment of narcolepsy in its various forms and in teaching recognition of the condition to doctors through continuing education courses. Idiopathic narcolepsy, the extreme or classic view of the disease, may involve exhibition of all four of the above symptoms in a patient, however, only 10 percent of patients legitimately diagnosed as narcoleptic present all four symptoms, and therefore most of the scientific and medical community uses the term "narcolepsy" In a broader, more general sense to mean essentially excessive, inappropriate daytime sleepiness, especially at inappropriate times. In addition to narcolepsy being a primary affliction, it can also be a subsyndrome, or secondary disorder related to a different medical problem. It can be permanent or can be a transient condition and can be a by-product of unusual psychological or physical stress. The Respondent prescribed a small dosage of an amphetamine for Nina Balabon between January 11, 1980, and September 17, 1982, at various times. (Count IV) Ms. Balabon is a 92 year old woman who has been taking a very small dosage of Dexedrine for many years. The dosage is substantially below that allowable for such a patient as conceded by the Petitioner and delineated in the Physician's Desk Reference. Ms. Balabon lives alone in Woodstock, New York, and is the foster mother of the Respondent's wife. She had been under the care of another physician who prescribed this course of treatment and drug for her so that she could remain alert enough to independently function and take care of herself in her own home. She is home-bound and after her doctor's death, she was unable to secure another doctor who would make house calls. She called upon the Respondent who is, in effect, a family member, and financially supports her, and asked him to prescribe the medication for her, in conjunction with which she retained the services of a visiting nurse. In her old age she has become afflicted with lassitude, inappropriate and excessive daytime sleepiness, depression and a diminished "will to live." The Respondent visits her in Woodstock, New York, periodically and he or his wife, telephone her at least once a week. A visiting nurse checks on her condition weekly and reports to the Respondent on her physical condition. The Petitioner's expert witness, Dr. Lindberg, has never seen this patient, but surmised upon her recorded weight that she is slightly malnourished. Accordingly, he opines that it is inappropriate to give a person with such a condition (slight malnourishment) amphetamines to curb her appetite and provide her "pep." The Respondent, however, did not prescribe amphetamine for this purpose. Be found, in the exercise of his medical judgment that she exhibits definite symptoms of narcolepsy. The dosage is extremely small and the patient is not shown to suffer any adverse effects therefrom. It was not shown that the dosage curbed her appetite, and indeed, Respondent established that the patient is not malnourished. She is a very small, slightly built woman and her mere recorded weight is not an indication in itself of malnourishment such that the prescription involved would be contraindicated. Petitioner's expert witness, further was unaware that the patient exhibited symptoms of narcoleptic behavior, and admitted that otherwise the dosages were quite small and not excessive for such a patient. Dr. Lindberg merely opposed the prescription of the medication because he believed that the law changed regarding the use of this drug, such that after August 30, 1980, it is only permissible for narcoleptic symptoms. In any event, the Respondent's diagnosis of the patient was uncontradicted and the 92 year old patient was shown to benefit from this treatment of her condition because it permitted her, with the assistance of the visiting nurse, to continue living independently rather than suffering commission to a nursing home or other institutional facility. Count VII concerns alleged prescriptions of amphetamines to one Doris Calloway between February 16, 1982 and October 13, 1982. Petitioner failed to introduce any evidence or testimony concerning this count. With regard to Count XI, Respondent prescribed on only one occasion, 50 Biphetamine capsules for Lori Carroccia on September 29, 1980. At the time this prescription was written and issued, the Respondent was unaware of the recent restrictions imposed by the legislature on the purposes for which amphetamine-type drugs could be prescribed by the passage of Section 458.331(1)(cc), Florida Statutes, effective July 1, 1980. The Respondent had known this patient for approximately six years and she was his nurse, employed at his clinic at the time the prescription was written. The single prescription was written when she complained to him of difficulty in starting a weight loss program and asked for his assistance. Prior to writing the prescription, he checked Ms. Carroccia's physical health, checked her weight and blood pressure, and indeed was already aware of her medical history because of his close association with her. During the entire two months she received this medication Respondent saw her on a daily basis and monitored her progress. The medication proved to be an effective means for her to develop a successful weight loss program. She suffered no adverse effects from receiving this drug. The Respondent only prescribed this medication once, in a small dosage to Initiate her weight loss program and not for the purposes of maintaining weight loss or a particular weight level through long-term prescriptions. Petitioner's sole expert witness conceded that the dosages were not excessive and were medically indicated in the PDR for the initiation of such a weight loss program. Petitioner's expert witness admitted that his opinion regarding inappropriateness of the prescription was solely predicated on the change in the legal status of the drug. The Respondent prescribed an amphetamine medication to patient Evelyn Lilly between April 14, 1981 and December 19, 1981 (Count XII). Ms. Lilly had been his patient since 1979 for allergy evaluation and treatment to alleviate chronic symptoms of runny nose, throat infections and irritations and sinus headaches. Respondent gave her an allergic evaluation in response to these symptoms. In completing her patient history he noted that Ms. Lilly suffers from rheumatism and arthritis. During the course of her allergy treatments Ms. Lilly's weight began increasing dramatically, with a worsening of her arthritic condition. Respondent noted she was markedly fatigued and became concerned about her general physical condition. In response to her fatigue or lassitude complaints, he initially performed a thyroid test in an effort to determine the cause of her lassitude and rapid weight gain. That test was inconclusive. lie then decided that between the complications of arthritis and her allergies he must reduce her weight before he could successfully treat either of those conditions. He initially prescribed Tenuate Dosepan which proved ineffective and then Ritalin, which also proved ineffective. She was then prescribed a course of Biphetamine. She responded dramatically to this medication with relief of her lassitude and the loss of 30 to 40 pounds. After noting that the initial sympathomimetic type drugs prescribed were ineffective and that the change to the Biphetamine produced markedly successful results, Respondent came to the conclusion that the patient was narcoleptic. Narcolepsy sometimes is not alleviated with the prescribing of one type of sympathomimetic drug when the switch to treatment with another type will suddenly prove to be successful in alleviating the narcoleptic symptoms. The doctor's chart for this patient did not definitely indicate the purpose of the prescription of the amphetamine medication, although Dr. Klotz candidly responded in his testimony that it may have been in part for weight control because a reduction in weight would help alleviate her arthritic joint problems. However, inasmuch as narcolepsy can be indicated when one type of sympathomimetic drug will not relieve its symptoms and another type will and since is. Lilly in her reaction to the medications displayed this phenomenon, Respondent, in the reasonable exercise of his medical judgment concluded that she displayed symptoms of narcolepsy. This view is corroborated by Dr. Von Hilsheimer. He has had more than 1,000 patients referred to him over the years by the Respondent. Approximately one-third of these patients were obese and yet he was only aware of four such patients who were treated with biphetamines by the Respondent. Be thus concludes that the Respondent used some differential reason other than mere weight control for prescribing biphetamine which led to the diagnosis of symptomatic narcolepsy with Ms. Lilly. The Petitioner's expert witness once again felt that the Biphetamine and Ritalin prescriptions for Ms. Lilly were inappropriate and excessive, but acknowledged that his criticism of these prescriptions was predicated solely on the fact that the medication had become illegal for prescription for weight control purposes before Ms. Lilly's prescriptions were made. Dr. Lindberg ultimately agreed however, after consulting the PDR that the amounts and types of medication were within appropriate indications, dosage limits and amounts and thus the amounts prescribed were within the reasonable exercise of the Respondent's judgment as a physician for the symptoms displayed, and alleviated them. Concerning this patient, as with all the others involved herein, Petitioner's expert witness bases his testimony merely on the doctor's patient chart which does not specifically refer to narcoleptic symptoms. Respondent admits his records are not detailed in all cases, since the patients were not referrals, but were his patients for many years such that he was intimately familiar with their histories and conditions. Based on the lack of reference to narcoleptic symptoms in the records themselves, Dr. Lindberg opined that the prescription was medically inappropriate, however, the mere absence of reference to that condition in the medical records alone does not establish the medical inappropriateness of the prescription, especially in view of the Respondent's showing (corroborated by Dr. Von Hilsheimer) that indeed Ms. Lilly was narcoleptic. Mr. Emmett Peter was prescribed biphetamines between October 16, 1979 and September 14, 1982 by the Respondent (Count XVI). Mr. peter has been Respondent's patient since 1969 and `gas definitely diagnosed as a narcoleptic individual by a physician who treated him prior to that time and related that fact in his initial medical history provided Respondent. At the time he and his wife became patients of the Respondent, Mr. Peter was receiving a medication called Obedrin, which is a dexedrine-type drug. During the entire time he received medication from the Respondent, he periodically visited the Respondent on his own behalf, as well as accompanying his wife to the Respondent's clinic for treatment, at which times the Respondent also observed Mr. Peter. Although the Respondent was unaware of the change in the law regarding restriction of the use of amphetamines to the treatment of narcolepsy at the time he prescribed Mr. Peter's medications at issue in this case, he continued to prescribe the medication for Mr. Peter after he became aware of the law, because he definitely diagnosed Mr. Peter to be a narcoleptic. The Respondent's expert witness, Dr. Von Hilsheimer, has seen both Mr. and Mrs. Peter on a professional basis as a researcher. He had numerous occasions to observe Mr. Peter, approximately twice a week from March, 1980 through May, 1982. Be became quickly aware of the fact that Mr. Peter was narcoleptic due to the fact that Mr. Peter, when waiting for his wife at Dr. Von Hilsheimer's office, often fell asleep in a very dramatic way, sometimes even when Dr. Von Hilsheimer was engaged in conversation with him. It was thus established that Mr. Peter, based upon his medical history and the personal observation of both Dr. Klotz and Dr. Von Hilsheimer, suffers from a minimal brain dysfunction manifested as excessive, inappropriate sleepiness. Dr. Von Hilsheimer further noted that Mr. Peter's condition is also characterized by moderate cataplexy, another symptom of narcolepsy. There is no question that Mr. Peter suffers from narcolepsy, therefore the prescription of amphetamine medications to Mr. Peter was clearly medically appropriate and the Petitioner admitted that the amounts of the medication were not excessive. On February 24, 1981, Charne D. Porter, the Respondent's daughter was given a prescription for 30 10-mg Ritalin tablets (Count XVII). The Respondent has been her treating physician most of her life. At the time the prescription was written she was editing and producing a motion picture. She was working very long hours and complained to Respondent that she was having difficulty staying awake during all times of the day and in completing her film-editing work. Prior to this period of time however, her typical work schedule involved such long hours with no apparent ill effects. This was not an unusual work schedule for her. Dr. Von Hilsheimer has known Ms. Porter since 1979 and she has consulted him professionally in the past. He was quite familiar with the patient history and had occasion to see her during the time the medication involved was prescribed. During this period of time he found that when she was attempting to do film-editing work which is normally a stimulating, arousing type of endeavor, she did not have her normal responsiveness and while talking to him would doze off in the middle of a conversation in his office. The work she was trying to do at the time was quite arousing under unusual conditions of lighting and interest and yet she would still doze off at inappropriate times during the day while working. The doctor did not find that her long work schedule or hours were responsible for such a condition. Ms. Porter had a debilitating illness consisting of the lingering aftereffects of a form of hepatitis and this, coupled with the stress related to her film-editing job (for which she was obtaining treatment through self-hypnosis training by Dr. Von Hilsheimer) caused her to lose her normal "arousal ability." Because of this she did have an attack or episode of transient narcolepsy as diagnosed by Respondent and Dr. Von Hilsheimer. During visits in his office he observed her display three of the four commonly recognized symptoms of narcolepsy during approximately the same period of time in which she received the Ritalin prescription. These inappropriate sleep episodes were a transient condition and Ms. Porter recovered from that condition and is functioning well personally and professionally. The small original Ritalin prescription needed no renewal. The use of the Ritalin prescription was a reasonable exercise of Respondent's medical judgment and approach to alleviating the transitory narcolepsy symptoms exhibited by Ms. Porter and caused her no harm whatever. Patient Sandy Lee Bradford was prescribed Biphetamine between December 14, 1980 and December 15, 1981. She is the daughter of the Respondent's secretary and has been the Respondent's patient for many years. On December 15, 1980, due to her complaint of fatigue, daytime sleepiness episodes, along with inability to lose weight and excessive weight gain, the Respondent first prescribed biphetamines to her. Over a one year period she subsequently received four other prescriptions of biphetamines. Each time she received a new prescription, she personally saw and consulted with Dr. Klotz. At the time the prescriptions were administered she had recently been divorced and was suffering unusual stress and emotional anxiety related to that divorce, which Respondent believed had a direct effect on her sudden weight gain and inability to lose weight. At the time the Respondent made these prescriptions, he was as yet unaware of the change in the legal status of amphetamine-type drugs such that it was no longer legally permissible to prescribe them for weight loss purposes. The Respondent candidly admitted that he primarily prescribed the drugs for assisting her in embarking on a successful weight loss program, not for chronic use. Other anorectic medications had been tried on this patient and had proved ineffective, however, with the judicious prescription and use of the biphetamine medication the patient made substantial progress in losing weight and in alleviating symptoms of fatigue. When Respondent became aware of the change in the legal status of biphetamines, he discontinued that medication promptly and substituted Tenuate Dosepan, which proved ineffective. He then substituted Ionamine which also proved ineffective, in an attempt to avoid prescribing biphetamines for the patient. The biphetamines prescribed were in appropriate, non-excessive quantities for the condition and symptoms exhibited by the patient and successfully alleviated her complaints with no harm to the patient. He discontinued biphetamines because he felt he could not with reasonable medical certainty, diagnose her as a narcoleptic patient. Dr. Lindberg conceded that the prescriptions were medically appropriate, but for the change in the law regarding their permissible use, and that change was the sole basis for his opinion that the prescription was inappropriate. Patient Trudy Heintz was prescribed Dexedrine between January 3, 1980 and October 29, 1982. She has been a patient of the Respondent since the early 1950's. She has displayed, over many years, symptoms of excessive, inappropriate daytime sleepiness and a simple inability to perform her employment duties as a result. The Respondent was treating her for phlebitis and arthritis, and thus she is an internal medicine patient. As such the Respondent monitored her physical condition quite closely, making physical examinations including monitoring of blood pressure when necessary. He observed no adverse effects caused by the administration of Dexedrine to this patient, which alleviated her narcoleptic symptoms and enabled her to remain productive and fully functional in her employment and daily pursuits. The Respondent thus diagnosed her as suffering from narcolepsy and established that as an appropriate basis for the prescription of Dexedrine. He continued to prescribe Dexedrine for the patient, even after he became aware of the restriction of its use because he genuinely believes that she is a true narcoleptic. Dr. Lindberg opined that the Dexedrine was inappropriate medication and was prescribed in excessive amounts. He did not believe that Ms. Heintz exhibited narcoleptic behavior, but he had never observed the patient and based his opinion merely upon less than detailed references to narcoleptic behavior in the patient's records. The Respondent, however, established that this patient had been a patient for many years and he was intimately familiar with the physical condition, complaints and medical history, and makes notes only for his own use. Because of his familiarity with her medical history and problems, it was unnecessary for him to make his own notes in sufficient detail so that Dr. Lindberg would be able to thoroughly review the patient's status and treatment indications by looking at her chart alone. Dr. Lindberg, in opining that the dosage was excessive at 30 mg. per day failed to take into account that the PDR provides that the accepted prescription of Dexedrine for narcolepsy is from 5 mg to 60 mg per day with no time limitation as to its use. His opinion as to excessiveness was based on the medical indications in the PDR for obesity only, not for narcolepsy. Such a dosage for this patient was not excessive in view of her proven diagnosis of narcolepsy. Count XXI concerns the purchase on October 14, 1981, of 1,000 quaalude tablets with regard to which it is alleged that the Respondent failed to maintain proper records justifying purchase and disposal of them as allegedly required by Section 21 USC 1306.04(b). Section 21 USC 1306.04(b) has not been placed in evidence in this proceeding, nor has it been made the subject of judicial notice, pursuant to Section 120.61, Florida Statutes. In any event, the 1,000 quaalude tablets were purchased by the Respondent for use by his wife, Harri Klotz. The Drug Enforcement Administration (DEA) Form 222, required to be maintained by the purchaser of such drugs was maintained by the Respondent and his office manager, and a dispensing record also maintained by them shows that the medication was dispensed upon receipt to Respondent's wife. In fact the drugs were established to be retained in the Respondent's office under lock and key and not physically dispensed to the Respondent's wife at one time, rather they were dedicated to her use, but maintained securely on the Respondent's office premises. Mrs. Klotz was then dispensed 30 tablets at a time in approximately one and one-half to two month intervals, and an additional journal card was established by Ms. Lindblom, the office manager, showing the dates when Mrs. Klotz drew down upon that medication in 30 tablet increments which withdrawals were recorded ads "pills dispensed." Additionally, the 130 methaqualone tablets prescribed for Mrs. Klotz on June 24, 1982, were for the purpose of providing her an additional supply to be used in a light, periodic, controlled manner because the drugs were about to become illegal. Later in August or September, 1982, Ms. Lindblom, when she became aware that the additional prescribing of methaqualone might be illegal, upon advice of Mr. Meiner, the Respondent's counsel, elected to dispose of the remaining quaalude tablets at which time 790 of the original 1,130 tablets dedicated to the use of Mrs. Klotz remained at the Respondent's office and were disposed of. Thus the receipt of 1,000 quaalude tablets was duly recorded in Respondent's record and the 30 tablet dispensations of the medication periodically from October 14, 1981 through June 28, 1982, were recorded in a dispensing record in evidence, which record also reflects the disposal of the 790 unused tablets.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses and the pleadings and arguments of counsel, it is, therefore RECOMMENDED: That the Administrative Complaint against the Respondent, Solomon D. Klotz, be DISMISSED except as to the minor violations of Section 458.331(1)(h) and (cc) Florida Statutes, proven with regards to Counts XI and XVIII for which, under the circumstances of this case, no disciplinary action should be taken. DONE and ENTERED this 4th day of May, 1984, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Chief Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Sam C. Meiner, Esquire 26 Wall Street Orlando, Florida 32801 Helen C. Ellis, Esquire 1804 Old Fort Drive Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
