The Issue The issues in this case, as set forth in the Amended Administrative Complaints in each respective case, are as follows: DOH Case No. 2010-01128/DOAH Case No. 11-5692 Count One. Whether Respondent, Jacinta Irene Gillis, M.D. (hereinafter referred to herein as "Dr. Gillis"), violated sections 458.331(1)(nn) and 458.326, Florida Statutes (2008 and 2009), by: Failing to diagnose patient M.G. with intractable pain prior to prescribing a controlled substance under Schedules II-V, as provided in section 893.03, from on or about December 19, 2008 through December 30, 2009; By inappropriately or excessively prescribing potentially lethal, highly abused, controlled substances, to wit: oxycodone, oxycontin, Percocet, and Valium, to M.G. without justification during the same time period; By inappropriately or excessively prescribing controlled substances to M.G. prior to exploring other treatment modalities or rehabilitation; and By failing to order a urine drug screen on M.G. at any time during her course of treatment. Count Two. Whether Dr. Gillis failed to keep legible medical records justifying the course of treatment for M.G. in one or more of the following ways: By failing to document justification for inappropriately or excessively prescribing controlled substances during her course of treatment; and By failing to document justification for not ordering a urine drug screen during the course of treatment. Count Three. Whether Dr. Gillis failed to meet the required standard of care in regards to her treatment of M.G. in one or more of the following ways: By inappropriately or excessively prescribing controlled substances without justification; By failing to confirm whether M.G. presented to a psychiatrist or psychologist after the initial referral by Dr. Gillis; By failing to order a urine drug screening of M.G. during her course of treatment; and By inappropriately or excessively prescribing controlled substances prior to exploring other modalities or rehabilitation. Count Four. Whether Dr. Gillis prescribed controlled substances, other than in the course of her professional practice, by prescribing controlled substances inappropriately or excessively in one or more of the following ways: By inappropriately or excessively prescribing controlled substances prior to exploring other treatment modalities or rehabilitation for M.G.; By inappropriately or excessively prescribing controlled substances without ordering a urine drug screening for M.G.; and By inappropriately or excessively prescribing controlled substances to M.G. without justification. DOH Case No. 2008-20661/DOAH Case No. 11-5961 Count One. Whether Dr. Gillis violated section 458.331(1)(nn), Florida Statutes (2008),1/ and Florida Administrative Code Rule 64B8-9.013(3) in one or more of the following ways: By failing to perform or document performing a complete physical exam of R.S.; By failing to explore or document exploring other treatment modalities or rehabilitation for R.S.; By failing to obtain or document obtaining a complete medical history of R.S.; By failing to document the nature or intensity of R.S.'s pain; By failing to document the current or past treatments of R.S.'s pain; By failing to document information on the effect of pain on R.S.'s physical or psychological function; By failing to develop or document developing a treatment plan for R.S.; and By failing to determine or document determining if there were any underlying or coexisting diseases or conditions for R.S. Count Two. Whether Dr. Gillis violated sections 458.331(1)(nn) and 458.326 in one or more of the following ways: By failing to diagnose R.S. with intractable pain prior to prescribing controlled substances, i.e., Percocet; By prescribing 90 tablets of Percocet 10/325 to R.S. without justification; By prescribing Percocet to R.S. without exploring other treatment modalities or rehabilitation; and By inappropriately prescribing Percocet to R.S. after R.S. reported that he was not currently being treated for pain. Count Three. Whether Dr. Gillis failed to keep legible medical records justifying the course of treatment for R.S. in one or more of the following ways: By failing to document justification for prescribing Percocet to R.S.; By failing to document a complete physical examination of R.S. prior to prescribing Percocet; By failing to document a complete medical history of R.S. prior to prescribing a controlled substance; By failing to document a urine screen on R.S.; and By failing to document a diagnosis of intractable pain for R.S. Count Four. Whether Dr. Gillis violated sections 458.331(1)(nn) and 458.326 in one or more of the following ways: By failing to perform or document performing a complete physical examination of D.H. on either of two visits; By failing to obtain or document obtaining a complete medical history on D.H.; By failing to explore or document exploring other treatment modalities or rehabilitation for D.H.; By failing to document the nature or intensity of D.H.'s pain; By failing to document the current or past treatments of D.H.'s pain; By failing to document information on the effect of pain on D.H.'s physical or psychological function; By failing to develop or document a treatment plan for D.H.; and By failing to determine or document determining if there were any underlying or coexisting diseases or conditions for D.H. Count Five. Whether Dr. Gillis violated sections 458.331(1)(nn) and 458.326 in one or more of the following ways: By failing to diagnose D.H. with intractable pain prior to prescribing a controlled substance, i.e., oxycodone; By prescribing 120 tablets of 30 mg oxycodone without justification; By prescribing 120 tablets of 30 mg oxycodone prior to exploring other treatment modalities or rehabilitation for D.H.; and By prescribing oxycodone to D.H. after D.H. reported that he was not experiencing any pain. Count Six. Whether Dr. Gillis failed to keep legible medical records justifying the course of treatment for D.H. in one or more of the following ways: By failing to document justification for prescribing 120 tablets of 30 mg oxycodone; By failing to document a complete physical examination of D.H. prior to prescribing a controlled substance; By failing to document a complete medical history of D.H.; By failing to document urine drug screening of D.H. prior to prescribing a controlled substance; and By failing to document a diagnosis of intractable pain for D.H. prior to prescribing a controlled substance.
Findings Of Fact The Department is the state agency having responsibility for monitoring health care professionals, including medical doctors. Dr. Gillis is a medical doctor licensed in Florida, North Carolina, and Iowa. She is not board-certified in any area of medicine, but claims to be "eligible" for board-certification in the field of internal medicine. Dr. Gillis received her medical degree from Meharry Medical College in Nashville, Tennessee, in 1997. She completed her internal medicine residency in 2003. Her medical career includes the following places of employment: Medical director/staff physician at Tennessee prison for women: March-August 2003; Hospitalist at Hilton Head Regional Medical Center: August 2003-February 2004; Pain management "specialist" in Atlanta, Georgia: March-September 2004; Staff physician for Illinois Correctional Facilities: September 2004-January 2005; Pain specialist/physician in Rock Island, Illinois: March-September 2005; Hospitalist at Brommen Medical Center in Bloomington, Illinois: May-August 2005; Hospitalist at Horizon Medical Center in Dixon, Tennessee: September 2005-January 2006; Pain specialist for National Health Services Clinic in Nashville, Tennessee: June-August 2006; Hospitalist at Kedlic Medical Center in Richland, Washington: September 2006-January 2007; Hospitalist at Auburn Regional Medical Center in Auburn, Washington: January-June 2007; Hospitalist at Mercy Medical Center in Sioux City, Iowa: July-August 2007; Hospitalist at Albermarle Medical Center in Elizabeth City, North Carolina: September-December 2007; Hospitalist at National Medical Affiliates in Punta Gorda, Florida: January-July 2008; Pain management specialist at UR Medical Clinic in St. Petersburg, Florida: July-November, 2008; and Pain management specialist at Dollar Medical Clinic in St. Petersburg, Florida: January 2009-October 2010. The Department is pursuing sanctions against Dr. Gillis based on her provision of medical care to three patients: D.H., and M.G. Both D.H. and R.S. are pseudonyms used by Deputies Negersmith and Johnson, respectively, as part of an undercover investigation of the clinic where Dr. Gillis was working in 2008. Their initials are used throughout this order for continuity, because all of the patient records and other evidence used those initials, rather than patient names. M.G. was a bona fide patient of Dr. Gillis's while she was operating another clinic in 2009-2010. In 2008, Dr. Gillis worked at a clinic operated by UR Medical Group, Inc., located in Pinellas Park, Florida. The clinic (referred to herein as the "UR Clinic") was owned by Renee Demasso, a non-physician. Dr. Gillis was the only medical doctor on staff at the clinic when she worked there. Another employee at the clinic was Quinton Knight, a large African- American male, who served as the office receptionist. The clinic had a "recruiter" named Jason Norris.2/ A recruiter is a person hired by the clinic to find new patients for the clinic's medical staff, i.e., for Dr. Gillis. On August 4, 2008, Negersmith, posing as D.H., was escorted to the UR Clinic by Norris. Upon arrival, he was given a patient information sheet to fill out. Norris directed him to write "severe lower back pain" on the sheet as the purpose of the visit. D.H. filled out the sheet, providing the following information: His pseudonym, address and contact information; His gender, marital status, height and weight; A fake social security number and date of birth; A fake driver's license number; His supposed occupation, i.e., a lineman for a private employer; A purported ailment, i.e., "severe lower back pain, weakness in knees" as the purpose for his visit; No insurance information; Neck/back pain and headaches as his medical history; A signature and date. All of the information provided was, of course, false. That is, D.H. was a fictitious name for a person pretending to be a patient. After filling out the form, D.H. discussed with Norris the cost of seeing the doctor. Norris said it would be a $350 charge. After approximately 45 minutes, D.H. was escorted to another waiting area, a vestibule separate from the main waiting area. After a short wait of five to ten minutes, D.H. was shown into an examination room where he met Dr. Gillis. D.H. was told to weigh himself on a floor scale and told Dr. Gillis his weight, 264 pounds. She then took his blood pressure which was 140/80. Dr. Gillis told D.H. that he might want to take some medication to lower his blood pressure. Dr. Gillis inquired as to the history of his present illness. According to the History and Physical Form (referred to herein as the patient chart) filled out by Dr. Gillis as she talked with the patient, D.H. said he had no pain (zero on a one-to-ten scale). Dr. Gillis wrote that D.H. "has difficulty explaining what he is really feeling" and that D.H. said muscle relaxers do not work for him. D.H. then told Dr. Gillis that oxycodone helps him to relax. Dr. Gillis then had D.H. perform three simple tasks: walking a short distance on his toes, walking on his heels, and raising his arms above his head. D.H. walked as directed, but he could not raise his arms higher than shoulder height because he was concealing a firearm in his waistband and raising his arms any higher would have revealed the weapon.3/ So he raised his arms up to shoulder height and then lowered them. D.H. cannot remember whether Dr. Gillis asked him why he could not raise his arms higher. Her notations on the patient chart indicate only that D.H. has less strength in his right foot (leg) and less range of motion in his left arm. At the conclusion of the examination, Dr. Gillis listed "chronic back and neck problems, chronic pain symptoms, non-specific" as the assessment and treatment plan for D.H. The lower left corner of the patient chart has an indication saying "needs records." D.H. purposefully avoided using the word "pain" throughout his examination. The only mention of pain was on the intake sheet he filled out, where he checked a box entitled neck/back pain. D.H. told Dr. Gillis that oxycodone helped him relax. She did not inquire as to whether he was taking any other medications or suggest any other modalities or treatment with D.H. After the examination, D.H. went back to the front office where he received a prescription for 120 tablets of 30 mg oxycodone and for 90 tablets of 600 mg Motrin. He handed Norris $350 in cash, which Norris then gave to Knight. No receipt was provided for the payment. D.H. then went to a local pharmacy and had the prescription filled. Pursuant to prior arrangements, he gave 60 of the oxycodone tablets to Norris for sale on the street.4/ The remaining tablets were placed into locked storage. Norris did not know D.H. was a police officer, of course. On August 27, 2008 (23 days later), D.H. appeared at the UR Clinic again. This time he was accompanied by Deputy Johnson who was posing as patient R.S. The deputies arrived at the clinic and looked for Norris, who was usually hanging around the parking lot. However, Norris was not there, and the deputies could not reach him via telephone, so they decided to go into the clinic anyway and see if they could obtain additional drugs. When D.H. and R.S. came into the clinic without Norris accompanying them, Knight became very upset and agitated. D.H. told Knight that Norris had recently changed his cell phone number, and it was not possible to contact him right then. R.S. started to walk out of the office, but Knight called him back and asked him for $350 and a copy of his identification. Knight then gave R.S. a patient information sheet to fill out. D.H. was not asked to fill out any paperwork at that time. D.H. was then escorted to the examination room where he saw Dr. Gillis again. No tests or physical examination were conducted. The only thing Dr. Gillis asked D.H. was whether he had brought his medical records with him. D.H. told her he had not had time to get them from his prior doctor yet. Dr. Gillis instructed D.H. not to come back to the clinic without his medical records. At the foot of the chart, Dr. Gillis wrote "Dr. Rew, family doctor; 2 weeks records; brought in personally." The note was not explained by Dr. Gillis. The patient chart filled out by Dr. Gillis on the second visit was extremely abbreviated in content. Under chief complaint, Dr. Gillis wrote, "patient states treatment plan is working; no complaints." The chart contains his vital signs: pulse of 142/80 and weight of 268 pounds. The history of present illness section of the form says only that D.H has a zero out of ten level of pain with treatment. She noted that has "no changes from prior testing" and added a note to "refill meds." The assessment and treatment plan section says "chronic back and neck problem." According to D.H., he never mentioned any problem to Dr. Gillis. Dr. Gillis did not inquire as to whether D.H. was currently taking any medications, but wrote, "oxycodone #120" and "Motrin 600 #90" on the current medications section of the chart. There was no physical examination of any kind performed on this visit. D.H. then went out to the office and got his prescription for 120 tablets of 30 mg oxycodone. Dr. Gillis never asked him whether he had taken all of the prior prescription, nor did she discuss pain with him. As part of his cover, D.H. intentionally avoided the use of the word "pain" when talking to Dr. Gillis. Meanwhile, R.S. completed his patient information sheet, providing the following information: His pseudonym, address and contact information; His gender, marital status, height and weight; A fake social security number and date of birth; A fake driver's license number; His occupation (carpenter work) and employer (unemployed); Purpose of visit, which D.H. listed as "stiffness in both shoulders"; No auto accident involved and no insurance available; Medical history options of high blood pressure and neck/back pain were checked in the list of various diseases and conditions listed on the sheet; An allergy to Keflex; Referred to clinic by a friend. R.S. was then taken back to an examination room where he met Dr. Gillis. He, too, contrived not to mention the word pain in his conversations with Dr. Gillis. He simply said he had a stiff shoulder. Dr. Gillis took his vital signs and had R.S. do the same physical tests that D.H. had performed in his first visit. remembers Dr. Gillis listening to his chest with a stethoscope and then examining his shoulder. The patient chart filled out by Dr. Gillis during R.S.'s visit contained the following information: "Chief complaint--Self employed; carpentry; history of surgery on back, shoulder problems one year ago; surgery and thus pain; no history of pain management." She correctly noted that R.S. was not currently on any medications. Dr. Gillis's assessment and treatment plan for R.S. was listed on the chart as chronic shoulder pain. There is no explanation for that notation. At the bottom corner of the chart, Dr. Gillis wrote "MRI of neck/shoulder; Dr. Wood, Pinellas County Orthopedic." That notation was not explained further by Dr. Gillis. R.S. went back to the front office where he was handed a prescription for Percocet 10/325, even though he never asked for medication. The Percocet was at the maximum strength (10 mg) for oxycodone content for that medication. R.S. then left the office, identified photographs of Dr. Gillis and Knight for his superiors and had no further involvement with the investigation. The testimony of Negersmith and Johnson as to their undercover actions was credible. Each of them had a clear and unambiguous memory of the events and did not appear to have any prejudices or ill intent that might negatively affect their testimony. The truth and veracity of their statements is accepted. At some point in time after the August 27, 2008, visit, the PCSO decided they had enough evidence to prosecute the UR Clinic as a "pill mill." As part of that prosecution, Dr. Gillis was pulled over in a traffic stop one day as she was leaving the clinic. After detaining her and explaining the charges that were being filed, the deputies advised Dr. Gillis to retain all patient records for patients she had been treating at the clinic. Later, Dr. Gillis cooperated with the sheriff's office and provided sets of original patient records to them. Dr. Gillis thereafter left her employment with the UR clinic and opened her own clinic. Patient M.G. presented to Dr. Gillis at her new place of employment, Dollar Medical Clinic, on December 19, 2008. Dr. Gillis was the owner and operator of this new clinic. M.G. filled out a patient information sheet which garnered the following information about him: Name, address and contact information; Marital status (married), and emergency contact information; Height, weight, and date of birth; Purpose of visit, listed as "refill on meds, follow-up on surgery." Auto accident on November 17, 2007; Insurance company information; and Medical history of neck/back pain, headaches, and arthritis. M.G. was then examined by Dr. Gillis. She filled out a patient chart for him that listed a history of surgery and treatments for pain. The patient chart lists Dr. Spuza and Dr. Nucci as physicians from whom M.G. had received care in the past. The patient chart noted that M.G. needed to be referred to a psychiatrist or psychologist as soon as possible. There was also a note indicating that M.G.'s MRI needed to be confirmed. Then there was a note written by Dr. Gillis saying "[p]atient is not going to be patient." There was no explanation as to what that note meant. The assessment and plan of treatment was then listed as "pain dependent" (although the writing on the patient chart is not very clear, and no testimony was elicited from Dr. Gillis to confirm what was written) and that the patient was advised about decreasing his pain medications. M.G. complained of pain at an eight on the one to ten scale with "treatment with oxycodone times four," presumably meaning four times per day. Upon completion of her examination of M.G., Dr. Gillis wrote him a prescription for 240 tablets of 30 mg oxycodone, 120 tablets of 40 mg oxycontin, 30 tablets of 10 mg valium, and 60 tablets of 500 mg naprosyn. According to the prescription, M.G. was supposed to take one of the oxycodone tablets every three hours, 24 hours per day, i.e., eight times per day. That was in addition to the oxycontin, which was to be taken every six hours. According to Dr. Gerber, "no pain doctor in the country would write a prescription like that." It would also be almost impossible for a patient to take all of those medications as prescribed. Approximately one month later, on January 16, 2009, M.G. returned to Dr. Gillis for the first of several follow-up visits. The patient chart filled out by Dr. Gillis that day indicates the chief complaint by M.G. to be "pain, top of buttocks radiating down leg to foot on left side." M.G. said his pain level was an eight out of ten with his medications. Dr. Gillis wrote a note to refill the medications and that there were "no acute changes" to M.G.'s condition. This time, the assessment and treatment plan was abbreviated as "A/P." This was the beginning of very cursory notes in the patient charts for M.G. The notes on the chart became shorter and less detailed as time went on. The "A/P" was listed as chronic neck pain and dental issues. Dr. Gillis then wrote prescriptions for 240 more oxycodone tablets, 120 more oxycontin tablets, 30 valium and 30 amoxicillin tablets. There is no record in the chart as to why the amoxicillin was added to M.G.'s medication regimen. There is no justification for providing essentially the same regimen of treatment when the patient was complaining of pain at a level of eight out of ten. M.G. came back for another follow-up on February 13, 2009. At that visit, Dr. Gillis charted the chief complaint as "thorac lumbar surgery [indecipherable] months ago." Again M.G. complained of a level of pain at eight out of ten when using his medications. Dr. Gillis noted her intent to refill the medications and that there were no acute changes in M.G.'s condition. His "A/P" was listed as chronic back pain. A prescription for the same medications, same doses, and same amounts as the previous visit was issued. M.G. returned on March 12, 2009, for a follow-up visit. The chief complaint at that time was "patient has difficulty [indecipherable]." Under history of present illness, Dr. Gillis wrote that M.G. has no history of pain prior to surgery and that he gets no relief from valium or Soma. There is no prescription for Soma in the records, so M.G. must have been getting that drug from some other source. There is no indication Dr. Gillis inquired as to where he got the medication, whether he was on any other medications, or how often he was taking the medication. Dr. Gillis again wrote that there were no acute changes in M.G.'s condition although he did not present with the same chief complaint. The "A/P" appears to be chronic back pain, although the writing is not clear. Prescriptions for oxycodone and oxycontin were renewed as before, and a prescription for Ambien was added. The valium prescription was not refilled. No explanation for the change in the drug regimen was provided by Dr. Gillis. On April 4, 2009, M.G. returned for another visit. This time his chief complaint was that he ran out of medications and had a seizure. There is no indication that Dr. Gillis inquired as to the type of seizure or whether M.G. had received any treatment for it. There is no evidence as to when M.G. ran out of his medications or how many pills he had taken since the prior visit. M.G. still complained of pain at a level of eight out of ten with his treatment. There is no indication of his pain level after he ran out of his medications. The "A/P" was listed as chronic back pain. The prescriptions written by Dr. Gillis for this visit were the same as the previous visit. For his next visit, May 12, 2009, there is no chief complaint listed on the patient chart. Dr. Gillis again wrote that there was no acute change in the patient's condition, that M.G.'s pain level was 6.5 out of ten with his treatment, and that the prescriptions should be refilled. The same oxycodone and oxycontin prescriptions (240 and 120 tablets, respectively) were written, along with the Ambien prescription. M.G. visited Dr. Gillis again on June 12, 2009. The chief complaint for that visit was low back pain caused by tripping over a toy car at his home. M.G.'s pulse and weight were measured, and there was a note on the chart that M.G. had "CBP" (which is presumably chronic back pain) and a toothache. A notation at the bottom of the chart said "25$," but is not explained. Dr. Gillis prescribed the same regimen of 240 pills of oxycodone and 120 pills of oxycontin. In the current medications section of the chart, Dr. Gillis wrote "Meds." That notation was not explained. As in each of the previous visits, Dr. Gillis did not perform a urine screen to determine whether M.G. had been taking the medications or not. M.G. came back to see Dr. Gillis on July 6, 2009. The chart for that visit says the chief complaint by M.G. was a surgical procedure called percantaneous distectomy and that M.G. "had care since the procedure." There is also a note that indicates "5 procedures," but the note is not explained. M.G. reported his pain level as five out of ten, with medications, and ten out of ten, without. Dr. Gillis prescribed the same, oxycodone and oxycontin medications as in the previous visits. There is no explanation as to why the medication levels were the same, even though M.G. was reporting less pain than in prior visits and had undergone surgery during the interim. M.G.'s next visit to Dr. Gillis was on August 5, 2009. His chief complaint on that day is essentially unreadable, and Dr. Gerber could not decipher it at all. There is a mention of Xanax in the chart, but its purpose is not explained. M.G.'s pain level is listed as six out of ten, with medications, ten out of ten, without. That is close to the pain levels described in the prior visit. However, without some sort of physical or functional exam or a psychological assessment, it was impossible to determine whether M.G. was functioning, no matter what his pain level. Dr. Gillis refilled the oxycodone and oxycontin prescriptions and added a prescription for ten tablets of Percocet 1/650, a minimal and almost useless dose. The "A/P" listed chronic lower back pain and seizure activities, but there was no discussion as to what seizures occurred or when. On September 9, 2009, M.G. presented with a complaint of a stiff neck. The chart mentioned an MRI, but did not explain or elaborate on it. The assessment of the patient was listed as "Ch LBP" (presumably chronic lower back pain), but there was no explanation of the relationship between the assessment and the presenting problem. There was no documentation of care in treatment on the patient chart. Dr. Gillis refilled the oxycodone and oxycontin and also added a prescription for Mobic, an anti-inflammatory medication. M.G. came back to visit Dr. Gillis on October 7, 2009. The chief complaint said M.G. had good and bad days and that the last surgery did not have good results. His pain level was down to six out of ten, with medications, and ten out of ten, without. Chronic lower back pain continues to be the assessment and treatment plan notation. Nonetheless, he was prescribed the exact same levels of oxycodone and oxycontin as all of the other visits. On November 4, 2009, M.G. returned to see Dr. Gillis. A different patient chart form was utilized by Dr. Gillis at that visit. The form includes a question, "Hello, how are you doing?" to which M.G. responded, "Terrible." M.G. said the ongoing treatment was working, but that he was not sleeping better. His pain level on that day was back up to seven out of ten, with medications. In her notes, Dr. Gillis said to "refill with adjustment with valium." There is no explanation as to why valium would be added to M.G.'s medication regimen. M.G. then visited Dr. Gillis on December 2, 2009. In response to the question about how he was feeling, M.G. said he was "planning for surgery; not doing good." He said the treatment was working and he was sleeping better. The assessment update on the chart said chronic lower back pain with exacerbations. The exacerbations were not explained. M.G. was prescribed the same medications as the previous visit. M.G.'s thirteenth and last monthly visit to Dr. Gillis occurred on December 20, 2009. When asked how he felt, M.G. answered "Alright." He said the treatment was working, but that some of his medications had been stolen. He reported not having oxycodone for nine days and oxycontin for seven days (or, possibly, not having nine oxycodone tablets or seven oxycontin tablets, the record is not clear.) He also said he had taken his medications that very day, but there was no indication in the record as to which medications he was talking about. He said his lower back pain was at a level of seven to eight on that day. Dr. Gillis did not inquire about the inconsistent statements and refilled his prescriptions anyway. The patient records for M.G. do not discuss whether he was paying for the cost of the prescriptions out-of-pocket or whether insurance was covering some of the cost. The cost of the medications would have been approximately $600.00 per month. It is clear that M.G. presented as a complex patient and was obviously receiving medical care elsewhere at the same time he was being treated by Dr. Gillis. He was apparently receiving medications from other sources at the same time Dr. Gillis was treating him. Dr. Gillis was at least somewhat aware of M.G.'s other medical care, but she never did monitoring or screening of M.G. that would have given her insight into how her treatment plan was interacting with M.G.'s other treatment. And, once Dr. Gillis saw that her treatment was not alleviating M.G.'s pain, she should have referred him to a board-certified pain management specialist. Dr. Marc Gerber was accepted at final hearing as an expert witness for the Department. Dr. Gerber is a board- certified pain management specialist who currently treats patients with pain management issues. Dr. Gerber's testimony was clear, concise, and credible. He did not appear to have any prejudice against Dr. Gillis as a person, but was very concerned about how she was practicing medicine. His testimony forms the basis for the following findings of fact. Relying upon the patient charts and patient information sheets provided by Dr. Gillis, there does not appear to have been a diagnosis of intractable pain for M.G. Intractable pain is pain for which, in the generally accepted course of medical practice, the cause cannot be removed and otherwise treated. There does not appear to have been an appropriate and complete physical examination of M.G. performed by Dr. Gillis. The oxycodone and oxycontin prescriptions for M.G. over a 13-month period are excessive. Despite her initial note wherein she advised M.G. that his medication levels must be decreased, Dr. Gillis continued the same regimen of oxycodone and oxycontin throughout M.G.'s treatment. There is no indication the medications were working, as M.G. continued to complain about pain for the entire 13 months he was under Dr. Gillis' care. Other than adding other medications, Valium, Mobic, Percocet, and Ambien for very brief periods, there was no change to M.G.'s prescription regimen. The patient charts for the visits to Dr. Gillis do not contain any justification for why the medications were prescribed in those quantities. The amount of oxycodone and oxycontin prescribed was, in itself, excessive. According to the prescriptions, M.G. was supposed to take one oxycontin every six hours. Oxycontin is a time-release medication that should only be taken once every 12 hours at most. M.G. was prescribed eight tablets of 30 mg oxycodone per day, i.e., one every four hours or two every eight hours--in addition to the oxycontin. The totality of those medications could be lethal. There are no indications in the patient charts that Dr. Gillis was taking vital signs and doing a physical evaluation of M.G. at every visit. Nonetheless, she continued to prescribe the high dosages of potentially lethal medications. Most importantly, Dr. Gillis never had a urine drug screen done on M.G. Such a test would have revealed whether M.G. was actually taking the drugs he was prescribed. It would have provided a determination of the level of drugs or other substances in M.G.'s body and then how the drugs were affecting him. A urine drug screen done at the time of M.G.'s earliest visit would have established a baseline for measuring the effectiveness and utility of future prescriptions. For a patient such as M.G., with a history of surgeries, a need for psychiatric evaluation, and a propensity to take large amounts of drugs, a urine drug screen would have been an essential element of the periodic review required for all such patients. Dr. Gillis erroneously stated that she had rejected and R.S. as patients after their first and second visits, respectively. The evidence shows that both "patients" voluntarily stopped visiting the clinic after completing their undercover work. Neither of the patients was told by Dr. Gillis not to return (although D.H. was told not to come back without bringing his medical records). Dr. Gillis did not testify at final hearing and did not provide any credible rebuttal to the facts asserted by the Department's witnesses. Dr. Gillis did demonstrate an understanding of the practice of medicine through her questioning of the Department's medical expert, but her treatment of patients R.S., D.H. and M.G. was deficient. The Department did not specifically allege, nor was there any evidence to support that Dr. Gillis intentionally practiced medicine in an inappropriate manner. However, her treatment of the patients in question indicates serious shortcomings in her ability to effectively and appropriately manage pain for her patients. Furthermore, Dr. Gillis represented herself at final hearing and, without assistance of counsel, was not able to effectively present a strong defense to the Department's allegations. Although she was given ample opportunity to testify concerning her care and treatment of the patients at issue, she declined to do so. Although the Department's perception of Dr. Gillis' treatment of D.H., R.S. and M.G. was based on its expert's review of medical records only, Dr. Gillis's refusal to testify left Dr. Gerber's perception as the only reliable source of information.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Department of Health suspending the license of Respondent, Jacinta Irene Gillis, M.D., until such time as Dr. Gillis can demonstrate competency in the practice of medicine, especially as it relates to pain management, to the satisfaction of the Board of Medicine. It is further RECOMMENDED that the final order assess the cost of investigating and prosecuting this case and that payment of such costs be a condition precedent to ending the suspension of Dr. Gillis's license to practice. DONE AND ENTERED this 3rd day of February, 2012, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of February, 2012.
Findings Of Fact Respondent is a licensed medical doctor having been issued license number 0028827. At all times material hereto, Respondent worked at or operated Health Centers, Inc., a clinic which ostensibly treated persons suffering from stress. At the behest of the Legislature, Petitioner performed a survey of prescriptions for Schedule II controlled substances filled by all pharmacies in the State of Florida. That drug survey revealed that nine different pharmacies in Dade County filled 3,139 prescriptions issued by Respondent between June 1980 and August 1981 for a total of 137,314 tablets of Methaqualone, a Schedule II controlled substance commonly known as quaaludes. Michael Bransfield visited Respondent at Health Centers, Inc. on July 28, 1980, August 26, 1980, December 2, 1980 and December 31, 1980. On the first visit he received a prescription for 45 quaaludes, and he received a prescription for an additional 40 quaaludes on each subsequent visit. On September 17, 1980 Bransfield was admitted to Mount Sinai Hospital after an overdose of quaaludes caused him to fall two stories. The hospital records indicate that Methaqualone was in his blood at the time of the injury. "Drug abuse" was listed on the hospital records as both an admission and discharge diagnosis. In addition to the other injuries Bransfield received in his fall, he fractured his skull and was required to undergo brain surgery for the removal of an epidural hematoma. Bransfield had a set of his medical records from Mount Sinai Hospital forwarded to Respondent. Prior to issuing to Bransfield the 40 quaaludes on December 2, 1980 and the 40 quaaludes on December 31, 1980, Respondent knew that Bransfield had undergone brain surgery as a result of a quaalude overdose. Under the circumstances, issuing prescriptions to Bransfield for quaaludes was life threatening in that it would have been impossible to distinguish a loss of consciousness from drug-induced sleep. Thus, unconsciousness as a result of the head injury would go unnoticed and untreated. Michele Heller visited Respondent on the following dates and received the following prescriptions from him: August 1, 1980 40 quaaludes December 12, 1980 40 quaaludes January 9, 1981 40 quaaludes February 10, 1981 40 quaaludes March 23, 1981 40 quaaludes April 22, 1981 45 quaaludes May 22, 1981 45 quaaludes July 25, 1981 45 quaaludes August 29, 1981 45 quaaludes September 26, 1981 -0- September 29, 1981 45 quaaludes Ana L. Fernandez visited Respondent at Health Centers, Inc. on August 22, 1981 and received a prescription for 45 quaaludes. Methaqualone is a hypnotic drug, used for the production of sleep. It was used initially for the treatment of insomnia but only on a short-term basis- -approximately two weeks--for the reason that it is strongly addictive. By approximately 1980 the use of Methaqualone was largely abandoned by the medical profession since it was well known by that time that Methaqualone was being highly abused, both by drug abusers and by people who wanted to "get high." Since Methaqualone is a depressant, it is an inappropriate medication for a person who is depressed. The medical records of Bransfield, Fernandez and Heller all indicate that they often suffered from depression. The medical records of Bransfield, Fernandez and Heller all indicate that Respondent started them on a monthly prescription of either 40 or 45 quaaludes on their very first visit to him although no tests were administered and no laboratory results obtained in order too ascertain if any of those three patients suffered from some physical problem. The only diagnosis appearing in the medical records of Bransfield, Fernandez or Heller is the word "stress" without any modifiers in explanation of that alleged condition. Additionally, the only "treatment" reflected in Respondent's records of those patients is the monthly prescription of 40 or 45 quaaludes. No other medication was tried, and the only time Respondent failed to prescribe 40 or 45 quaaludes occurred when Heller returned to Respondent's office for her monthly prescription without waiting the required 30 days. Although Heller's medical records indicated on her first visit to Respondent that she awakened rested, Respondent prescribed for her Methaqualone, a sleep producing drug. Respondent's records for Bransfield's December 2, 1980 visit indicate that Bransfield reported be was feeling much improved, that he was dealing with his stress, and that he was feeling that he had control over his present life. Yet, Respondent continued to prescribe 80 additional quaaludes after the patient said that he was better. Respondent's medical records for Bransfield, Fernandez and Heller do not reflect that any of them suffered from any condition for which Methaqualone could be statutori1y prescribed. The mere prescription of Methaqualone is not an appropriate treatment for stress since it does nothing to identify a patient's stressors so that the patient can effectuate necessary life style changes and/or learn how to deal with those stressors.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent guilty of the allegations contained in the Administrative Complaint filed against him and revoking his license to practice medicine under the laws of the State of Florida. DONE and ORDERED this 8th day of March, 1985 at Tallahassee, Florida. LINDA M. RIGOT, 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 8th day of March, 1985. COPIES FURNISHED: 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 Michael J. Cohen, Esquire 517 Southwest First Avenue Fort Lauderdale, Florida 32301 William A. Cain, Esquire May L. Cain, Esquire 11755 Biscayne Boulevard Suite 401 North Miami, Florida 33181
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.
