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.
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 The issue is whether Petitioner overpaid Respondent for medical services for 20 patients under the Medicaid Program from February 22, 1997, through February 22, 1999, and, if so, by how much.
Findings Of Fact At all material times, Respondent, who is a licensed physician, was authorized to provide medical services to Medicaid recipients, provided medical services to Medicaid recipients, billed Petitioner for these services, and received payment for these services. The Medicaid program provides for periodic audits of each Medicaid provider, after which Petitioner may seek repayment of amounts revealed by audit to have been overpaid to the provider. After conducting such an audit of Respondent for services rendered from February 22, 1997, through February 22, 1998, and exchanging post-audit information, Petitioner informed Respondent, by letter dated March 1, 2002, that it had overpaid him $238,069.09 for claims that were, in whole or in part, not covered by Medicaid, and demanded repayment of this amount. The letter states that the overpayment was extrapolated from the overpayment amount determined from auditing the records of a random sample of 21 patients for whom Respondent had submitted 423 claims. The actual overpayment amount, before extrapolation is $11,248.14. Petitioner later removed one of the patients from the sample due to a billing error. Among the 21 patients covered by the audit, the deleted patient is identified as Patient 20. The age of each patient set forth below is his or her age at the time of the first office visit during the audit period. Where a series of payments are set forth below, they are listed in the order of the procedures discussed immediately above the payments. Patient 1, who was 17 years old first saw Respondent on March 27, 1998. Petitioner allowed payments for Patient 1's first two visits. On March 27, 1998, Respondent performed an abdominal echogram and other services for abdominal pain of three or four months' duration, and, on April 14, 1998, Respondent performed a doppler echocardiograph and other services for chest pain of three or four days' duration. On April 27, 1998, Patient 1 presented at Respondent's office with fever and chills since the previous day. Patient 1 complained of nausea, frequent and painful urination, and pain in the abdomen and lower back. Without first performing a urinalysis or urine culture, Respondent performed a renal echogram April 27, based on his diagnosis of urosepsis and to rule out a urinary tract infection. Renal echography was not medically necessary to rule out a urinary tract infection, at least until Respondent had first performed a urinalysis and urine culture and considered the results from this laboratory work. Respondent's diagnosis of urosepsis lacks any basis in his records. If Patient 1 had suffered from urosepsis, which is a life-threatening condition that requires urgent treatment--not echography--Respondent should have treated the matter as a medical emergency. Petitioner proved that it overpaid $61.57 for this service. Petitioner allowed a payment for medical services, which did not include any echography, on May 4, 1998. On June 1, 1998, Patient 1 presented at Respondent's office complaining of acute abdominal pain for three or four days. Respondent performed a physical examination and detected an enlarged spleen. He then performed an echogram of the spleen and found a normal spleen without inflammation or cyst. Respondent proceeded with the echography without first performing routine blood work, such as a white blood cell count, to detect infection. The echogram of the spleen was not medically necessary, at least until Respondent had performed routine blood work to confirm or rule out infection. However, as noted in the Preliminary Statement, Dr. Hicks has withdrawn his objection to this payment, so Petitioner did not overpay for this service. Petitioner allowed a payment for a medical service on June 5, 1998. On June 19, 1998, Patient 1 presented at Respondent's office complaining of weakness, fainting, dizziness, fatigue, palpitations, shortness of breath, heartburn, rectal discomfort, and skin rash. After performing a physical examination, Respondent suspected hypothyroidism and performed a thyroid echogram, which revealed a normal thyroid. Again, thyroid echography is not medically necessary without first performing routine laboratory tests of thyroid function. Petitioner proved that it overpaid $45.24 for this service. On August 3, 1998, Patient 1 presented at Respondent's office complaining of weakness in his arms and hands of three to four weeks' duration. A physical examination revealed that Patient 1's grip was weak and his wrists painful upon pressure. Suspecting carpal compression, Respondent conducted three types of nerve conduction velocity tests (NCV), including an H-Reflex test, all of which test nerve function. Patient 1 had a psychiatric diagnosis, as Respondent was aware at the time of this office visit. Before conducting the NCV, Respondent contacted Patient 1's psychiatrist and obtained her approval of the test. Also, before conducting the NCVs, Respondent obtained blood work, so as to determine the blood levels of the psychotropic medications that Patient 1 was taking. Petitioner failed to prove that it overpaid for these services. Patient 1 visited Respondent's office on August 7, August 25, September 16, and October 30, 1998, but Petitioner is not disallowing any of these payments. On November 23, 1998, Patient 1 presented at Respondent's office complaining of pain in his right ankle after tripping and falling the previous day. Respondent conducted a physical examination and found mild swelling, applied an elastic bandage, prescribed Motrin and physical therapy for three weeks, and ordered an X ray. Petitioner claims that Respondent misbilled the procedure. Respondent billed a 73000, which is a procedure under the Current Procedure Terminology manual (CPT), and Petitioner claims that the correct CPT code is 73600, which would generate an overpayment of 59¢. However, as noted in the Preliminary Statement, the evidence fails to support this claim by Petitioner, so Petitioner failed to prove that it overpaid for this service. Patient 2, who was a 57 years old, had seen Respondent for three years. Patient 2 visits the office "constantly," according to Respondent. Petitioner has disallowed payments for services rendered on March 2, March 31, April 28, June 1, August 17, August 28, September 24, October 2, November 3, November 9, December 1, and December 21, 1998, and January 8, 1999. However, as noted in the Preliminary Statement, Dr. Hicks has withdrawn his objection to the aerosol treatment on August 17 and the level of service of the office visit on August 28. On March 2, 1998, Patient 2 presented at Respondent's office with acute onset the previous day of left flank pain, now radiating to the left lumbar and genital areas. Patient 2 denied passing any stones in his urine, although he complained of frequency and pain of urination. Respondent found Patient 2's abdomen distended and liver enlarged. He performed a renal echogram to rule out kidney stones or urinary retention. The results were normal. Respondent's testimony failed to establish the medical necessity of this renal echography. The symptoms are too nonspecific to justify this diagnostic procedure at this time, so Petitioner proved that it overpaid $61.57 for this service. On March 31, 1998, Patient 2 presented at Respondent's office with complaints of leg pain and cramps at night, which arose after walking a block and alleviated with rest. Diagnosing this obese patient with peripheral vascular disease, Respondent performed doppler procedures of the lower extremity veins and arteries. The results revealed mild atheromatous changes in the lower extremities. Petitioner failed to prove that the two procedures billed by Respondent for the March 31 office visit were medically unnecessary, so Petitioner failed to prove that it overpaid for these services. On April 28, 1998, Patient 2 presented at Respondent's office with nausea of three or four days' duration, vomiting associated with indigestion, fatty food intolerance, flatulence, and bitter taste. Patient 2, whom Respondent presumed was alcoholic, had an enlarged liver, as Respondent had noted in previous examinations of Patient 2. Respondent performed a liver echogram, after ordering a laboratory report on January 29, 1998. The results confirmed the presence of liver echogenicity or fatty liver. 26. Petitioner failed to prove that this echography was not medically necessary, so Petitioner failed to prove that it overpaid for this service. On June 1, 1998, Patient 2 presented at Respondent's office with complaints of pain on urination, increased frequency of urination, the need to urinate at night, and chills. Respondent performed an echogram of the prostate to rule out cancer; however, Respondent's records did not disclose any laboratory test, which is more appropriate for detecting prostate cancer. Respondent's testimony establishes that this echogram was not medically necessary, so Petitioner proved that it overpaid $51.34 for this service. On September 24, 1998, Patient 2 presented at Respondent's office with a complaint of low back pain after slipping and falling down three days earlier. Respondent performed three NCVs, including an H-Reflex test. Respondent's notes state an intention to do X rays, although the records fail to reveal whether X rays were ever done. Petitioner failed to prove that the three NCV tests were not medically necessary. Petitioner also downcoded the office visit on this date, but, as noted in the Preliminary Statement, due to the failure to produce a CPT manual, Petitioner failed to prove that it overpaid $10.74 for this service. On October 2, 1998, Patient 2 presented at Respondent's office with a complaint of shortness of breath. Respondent administered an aerosol with Ventolin, which is a drug used to combat asthma. This is the same aerosol that Dr. Hicks decided to allow on August 17 upon further review, and the medical necessity for this aerosol is the same as the earlier aerosol, so Petitioner failed to prove that it overpaid $10.62 for this service. On November 3, 1998, Patient 2 presented at Respondent's office with complaints of malaise, fatigue, weakness, and weight gain. Respondent performed a thyroid echogram in connection with a diagnosis of hypothyroidism, and the test results were normal. Patient 2, who suffered from chronic obstructive pulmonary disease (COPD), had not actually gained weight over 1998. Without the results of other tests of thyroid function, a test to measure the size of the thyroid was not medically necessary, so Petitioner proved that it overpaid $45.24 for this service. On November 9, 1998, Patient 2 presented at Respondent's office with complaints of continuing chest pain and palpitations. Respondent had seen Patient 2 three days earlier for the same complaints and performed an electrocardiogram, whose results were abnormal, although not acute. Based on this test, Respondent had referred Patient 2 to a cardiologist. Given the proper referral of Patient 2 to a cardiologist, the ensuing doppler echocardiogram was not medically necessary. The record is devoid of any evidence that Respondent could adequately care for the cardiac condition suffered by Patient 2, so this diagnostic service performed no useful function. Petitioner proved that it overpaid $117.23 and $51.34 for these services. On December 1, 1998, Patient 2 presented at Respondent's office with chest congestion and cough, with some shortness of breath, of three days' duration. Respondent administered an aerosol with medications to treat Patient 2's bronchial asthma and COPD by functioning as a bronchodilator. This treatment was preceded by a spirometry, which tests respiratory function. Petitioner failed to prove that either the diagnostic or therapeutic service provided by Respondent on December 1 was not medically necessary. On December 21, 1998, Patient 2 presented at Respondent's office with the same complaints from his visit nearly three weeks earlier. Respondent performed two duplex scans of the lower extremities to check his circulatory state, These scans were not medically necessary. Although Patient 2 was also complaining of a slow progression of leg pain and cramps, Respondent had performed a diagnostic procedure for these identical symptoms nine months earlier. The absence of any recorded treatment plan in the interim strongly suggests that diagnostic echography is displacing actual treatment. Respondent also performed another spirometry, less than three weeks after the prior spirometry. There was no medical necessity for this second procedure because Patient 2's symptoms and complaints had remained unchanged. Petitioner proved that it overpaid $97.96, $72.39, and $15.70 for these services. On January 8, 1999, Patient 2 presented at Respondent's office, again with respiratory complaints. Respondent claims to have administered a maximum breathing test, but he submitted no documentation of such a test to Petitioner, so Petitioner has proved that it overpaid $9.82 for this service. Patient 3, who was 13 years old, saw Respondent only one time--April 28, 1998. On this date, she presented at Respondent's office with menstrual complaints, abdominal pain, anxiety, and urinary disorders in terms of frequency and urgency. After performing a physical examination (limited as to the pelvic area due to the demands and cultural expectations of the patient and her family) and ordering blood work, Respondent performed pelvic and renal echograms, choosing not to subject the patient to X rays due to her young age. When Respondent later received the blood work, he found evidence supporting a diagnosis of a urinary tract infection. Although the menstrual history should have been developed in the records, the pelvic echogram could have uncovered an ovarian cyst, and legitimate reason existed to avoid an X ray and an extensive pelvic examination. However, the renal echogram was not medically necessary. The proper means of diagnosing a urinary tract infection is the blood work that Respondent ordered. The records mention the possibility of kidney stones, but this condition did not require ruling out based on the complaints of the patient, findings of the physical examination, and unlikelihood of this condition in so young a patient. Petitioner proved that it overpaid $61.57 for the renal echogram, but failed to prove that it overpaid for the pelvic echogram. Patient 4, who was eight years old, first saw Respondent on November 11, 1998. Patient 4 presented with a fever of two days' duration, moderate cough, and runny nose. His grandmother suffered from asthma, but nothing suggests that Patient 4 had been diagnosed with asthma. After conducting a physical examination and taking a history, Respondent diagnosed Patient 4 as suffering from acute tonsillitis, allergic rhinitis, bronchitis, and a cough. Apparently, Respondent misbilled Petitioner for an aerosol treatment because Respondent testified, and his records disclose, that no aerosol was administered, so Petitioner proved that it overpaid $10.62 for this service. Respondent administered a spirometry, which he justified on the basis of the grandmother's asthma. Although the results of the spirometry indicated pulmonary impairment, the test was not medically necessary, given the history and results of the physical examination, so Petitioner proved that it overpaid $32.06 for this service. On February 15, 1999, Patient 4 presented at Respondent's office with a fever of two days' duration, moderate cough, and clear nasal discharge. Again, Respondent administered a spirometry, which again revealed pulmonary impairment, and, again, the test was not medically necessary. Again, Respondent displayed a fondness for diagnostic procedures that yielded no plan of treatment. Petitioner proved that it overpaid $16.94 for this service. Patient 5, who was 61 years old, presented at Respondent's office with a history of weekly visits, as well as osteoarthritis and high blood pressure. On March 26, 1998, Patient 5 presented at Respondent's office with a complaint of left hip pain of three days' duration, but not associated with any trauma. She also reported dizziness and occasional loss of consciousness after faintness. Patient 5 noted that her neck swelled three or four months ago. Respondent billed for two views of the hip, but nothing in his records indicates more than a single view, so Petitioner proved that it overpaid Respondent $6.68 for this aspect of the X-ray service. Respondent also performed a duplex scan of the carotid artery. The scan, which was justified due to Patient 5's dizziness, faintness, and loss of consciousness, revealed atherosclerotic changes of the carotid arteries, so Petitioner failed to prove that it overpaid for this service. On April 9, 1998, Patient 5 presented at Respondent's office with complaints of left flank pain, nasal stuffiness, headaches, and urinary incontinence on exertion. Interestingly, the report from the thyroid echogram, which was performed on the March 26 office visit and allowed by Petitioner, revealed an enlargement and solid mass at the right lobe, but Respondent's records contain no conclusions, diagnosis, or treatment plan for this condition, focusing instead on cold and other minor symptoms described above. Respondent performed kidney and bladder echograms, to rule out stones, cysts, or masses, and a sinus X ray. However, he did not first perform a urinalysis--instead ordering it simultaneously--to gain a better focus on Patient 5's condition, but his records contain no indication of the results of this important test. Petitioner proved that it overpaid $61.57 and $39.73 for the renal and bladder echograms, both of which were normal, although the left kidney revealed some fatty tissue. Although the results were normal, the sinus X ray was medically necessary, so Petitioner failed to prove that it overpaid for this service. On May 13, 1998, Patient 5 presented at Respondent's office with a complaint of chest congestion, "chronic" cough (despite no prior indication of a cough in Respondent's records), and shortness of breath of two or three days' duration. Respondent administered a spirometry. Respondent justified this test, in part, on Patient 5's "acute exacerbation of COPD," but Respondent's records reveal no other symptoms consistent with a diagnosis of COPD. Administering spirometry when confronted with common cold symptoms is not medically necessary, so Petitioner proved that it overpaid $30.06 for this service. On June 29, 1998, Patient 5, who was diabetic, presented at Respondent's office with complaints of gradual onset of leg pain on exertion, alleviated by resting, and cramping at night. A physical examination revealed no right posterior pedal pulse, grade 2 edema and dermatitis, and bilateral varicose veins. Previous blood work had revealed high cholesterol, triglycerides, and low-density lipoprotein cholesterol. Respondent performed a doppler study of the arteries of the lower extremities, which Petitioner allowed. He also performed a doppler study of the veins of the lower extremities and a duplex scan of the veins of the lower extremities, both of which Petitioner disallowed. Petitioner also downcoded the office visit. Given Patient 5's diabetes and the laboratory work, the disallowed study and scan were justified. Petitioner failed to prove that the services were medically unnecessary or, as noted in the Preliminary Statement, due to the absence of the CPT manual, that the office visit should be downcoded, so Petitioner failed to prove that it overpaid for these services. On July 20, 1998, Patient 5 presented at Respondent's office with complaints of diffuse abdominal pain and nausea without vomiting. Respondent found that her liver was enlarged and tender and performed a liver echogram. Petitioner's disallowance of this service suggests an unfamiliarity with the subsequent report dated August 28, 1998, that states that a CT scan of the abdomen revealed possible metastatic disease of the liver and suggested correlation with liver echography. The liver echogram was medically necessary, so Petitioner failed to prove that it overpaid for this service. On August 13, 1998, Patient 5 presented at Respondent's office with complaints of low back pain of months' duration and related symptoms. Respondent performed three NCVs, including an H-Reflex. The NCVs suggested light peripheral neuropathy. Petitioner failed to prove that these tests were not medically necessary. On August 18 and 28, 1998, Patient 5 visited Respondent's office and received injections of vitamin B12 and iron. However, the medical necessity for these injections is absent from Respondent's records. Respondent testified that the iron was needed to combat anemia, but this diagnosis does not appear in the August 18 records. The August 28 records mention anemia, but provide no clinical basis for this diagnosis. Neither set of records documents the injections. Petitioner proved that it overpaid $94.25 and $37.70 for these services. On October 21, 1998, Patient 5 presented at Respondent's office with complaints of chest congestion, cough, and moderate shortness of breath of one day's onset, although she had visited Respondent one week earlier with the same symptoms. Petitioner allowed an aerosol treatment, but disallowed a maximum breathing procedure. Respondent testified that the service was the administration of oxygen, which is documented in the records and medically necessary. Petitioner's worksheets, which are Petitioner Exhibit 19, contain a handwritten note, "no doc[umentation]," but the shortcomings in Petitioner's evidence, as noted in the Preliminary Statement, prevent Petitioner from proving that it overpaid for this service. On November 11, 1998, Patient 5 presented at Respondent's office with complaints of weakness and fatigue of five or six months' duration. Respondent has previously diagnosed Patient 5 with hypothyroidism, and Respondent believed that she was not responding to her medication for this condition. Without ordering blood work to determine thyroid function, Respondent performed a thyroid echogram. However, this echography was not medically necessary, so Petitioner proved that it overpaid $45.24 for this service. On December 4, 1998, Patient 5 presented at Respondent's office with complaints of left chest and ribs pain and recent faintness. Respondent ordered an X ray of the ribs and conducted a physical examination, which revealed a regular heart rhythm. The following day, Respondent performed an echocardiogram and related doppler study. He had performed these tests seven months earlier, but the results were sufficiently different, especially as to new mitral and aortic valve regurgitation, so as to justify re-testing. Given Patient 5's poor health, these tests were medically necessary, so Petitioner failed to prove that it overpaid for these services. On December 17, 1998, Patient 5 presented at Respondent's office with complaints of cervical pain of three or four days' duration and radiating pain into the arms and hands. Noting a decreased grip on both sides and relevant aspects of Patient 5's history, Respondent performed two NCVs, including an H-Reflex, and ordered a cervical X ray. One NCV revealed abnormalities, but the H-Reflex did not. These tests were medically necessary, so Petitioner failed to prove that it overpaid for these services. On January 12, 1999, Patient 5 presented at Respondent's office with complaints of blurred vision, loss of memory, dizziness, and fainting over several months' duration. Respondent performed a carotid echogram, as he had on March 26, 1998. The results of the new carotid echogram were the same as the one performed nine months earlier. The problem is that, again, Respondent betrays his fondness for diagnosis without treatment, as he never addressed the abnormalities detected in the earlier echogram, except to reconfirm their existence nine months later. Petitioner proved that the second carotid echogram was not medically necessary, so it overpaid $99.14 for this service. On February 1, 1999, Patient 5 presented at Respondent's office with continuing complaints of leg pain and cramps. Respondent responded by repeating the doppler study of the veins of the lower extremities and a duplex scan of the veins of the lower extremities that he had performed only seven months earlier and another duplex scan. The main difference in results is that Respondent had suspected from the earlier tests that Patient 5 suffered from "deep venous insufficiency," but he found in the later tests that "mild vein insufficiency is present." Again, though, the tests performed on February 1 lack medical necessity, partly as evidenced by the failure of Respondent to design a treatment plan for Patient 5 after either set of test results. Petitioner proved that it overpaid $99.14, $37.92, and $110.50 for these services. On December 4, 1998, Patient 6 presented at Respondent's office complaining of leg pain, mild shortness of breath, and a cough. Except for the leg pain, the symptoms were of two days' duration. Patient 6 was 35 years old and had a history of schizophrenia and obesity. Respondent performed a physical examination and found decreased breathing with scattered wheezing in both lungs and decreased peripheral pulses, presumably of the lower extremities, although the location is not noted in the medical records. Respondent also found varices on both sides with inflammatory changes and swelling of the ankles. Respondent ordered duplex studies of the vascular system of the lower extremities and a doppler scan of the lower extremities. The results revealed diffuse atheromatous changes in the left lower extremity. Petitioner failed to prove that these services were not medically necessary. On the same date, Respondent performed a spirometry, which was "probably normal." Petitioner proved that this procedure was not medically necessary because of the mildness of the respiratory symptoms and their short duration. Petitioner overpaid $32.06 for this service. Respondent saw Patient 6 on December 9, 12, and 15, 1998, for abdominal pain, but Petitioner has not disallowed any of these services. On December 28, 1998, Patient 6 presented at Respondent's office with complaints of neck pain with gradual onset, now radiating to the upper and middle back, shoulders, and arms, together with tingling and numbness in the hands. Respondent performed three NCVs, including an H-Reflex, even though the physical examination had revealed active deep reflexes and no sensory deficits or focal signs. The results revealed mild abnormalities, which Respondent never discussed in his notes or addressed in a treatment plan. Petitioner proved that these services were not medically necessary, so Petitioner overpaid $195.12, $73.96, and $21.64 for these services. On February 2, 1999, Patient 6 presented at Respondent's office complaining of three days of chills without fever, left flank pain, and urinary frequency. Without first performing a urinalysis, Respondent performed a kidney echogram to rule out kidney stones. The echogram revealed no abnormalities. Petitioner proved that the renal echogram was not medically necessary, so it overpaid $62.37 for this service. On August 25, 1998, Patient 7, who was 58 years old, presented to Respondent's office with complaints of leg pains and cramps of five or six months' duration and some unsteadiness, as well as progressive numbness in her legs and feet. Patient 7 also complained of moderate shortness of breath, anxiety, and depression. The physical examination revealed decreased expansion of the lungs and decreased breath sounds, limited motion of the legs and back, decreased peripheral pulses (presumably of the legs), edema (again, presumably of the lower extremities), varices, and sensorial deficit on the external aspect of the legs. Blood work performed on August 25 was normal for all items, including thyroid function, except that cholesterol was elevated. Respondent ordered a chest X ray and electrocardiogram, which Petitioner allowed, but also ordered doppler studies of the veins and arteries of the lower extremities, an associated duplex scan, a spirometry, three NCVs (including an H-Reflex), and a somatosensory evoked potential test (SSEP), all of which Petitioner denied. Like the NCV, the SSEP is also an electrodiagnostic test that measures nerve function. The NCVs suggested mild peripheral neuropathy, which required clinical correlation, but the SSEP revealed no abnormalities. The doppler studies produced findings that "may represent some early arterial insufficiency" and "may represent some mild venous insufficiency," but were otherwise normal. The spirometry revealed "mild airway obstruction." The results of the tests do not support their medical necessity, nor do the complaints and findings preceding the tests. Petitioner proved that both doppler studies, the duplex scan, all three NCVs, the SSEP, and the spirometry were not medically necessary. Petitioner overpaid $66.48, $38.75, $108.58, $195.12, $73.96, $21.64, $42.68, and $17.70 for these services. Two days later, on August 27, 1998, Patient 7 presented at Respondent's office with swelling of her anterior neck and pain for two weeks. She complained that her eyes were protruding and large and that she had suffered mild shortness of breath for two days. Respondent ordered an echogram of the goiter, which Petitioner denied. Respondent's records contain no acknowledgement of the fact that, two days earlier, blood work revealed normal thyroid function. Even if the laboratory results were not available within two days of the draw, Respondent had to await the results before proceeding to ultrasound. Petitioner proved that the goiter echogram was not medically necessary, so it overpaid $43.24 for this service. On September 21, 1998, Patient 7 presented at Respondent's office with complaints of chest pain, palpitations, and shortness of breath. The physical examination revealed no abnormalities. Respondent performed an echocardiogram and related doppler study, largely, as he testified, to rule out thyrotoxicosis. However, as noted above, the blood work one month earlier revealed no thyroid dysfunction, and the medical records fail to account for this blood work in proceeding with a thyroid rule-out diagnosis. Petitioner proved that these services were not medically necessary, so it overpaid $117.23 and $51.34 for these services. On October 6, 1998, Patient 7 presented at Respondent's office with complaints of gradual loss of memory, fainting, and blurred vision. Respondent performed a carotid ultrasound, which revealed mild to moderate atheromatous change, but no occlusion. Petitioner failed to prove that this test was not medically necessary. Petitioner also downcoded the office visit, but, for reasons set forth above, its proof fails to establish that the billed visit should be reduced. On the next day, October 7, Patient 7 presented at Respondent's office in acute distress from pain of three days' duration in the legs, swelling, heaviness, redness, and fever. The physical examination revealed swelling of the legs and decreased peripheral pulses. Concerned with thrombophlebitis, Respondent ordered a chest X ray to rule out an embolism and a duplex scan of the lower extremities, neither of which revealed any significant abnormalities. Petitioner failed to prove that these tests were not medically necessary. On November 12, 1998, Patient 7 presented at Respondent's office with complaints of abdominal pain and vaginal discharge. One note states that the pain is in the left upper quadrant, and another note states that the pain is in the lower abdomen. The physical examination was unremarkable, but Respondent ordered echograms of the pelvis and spleen, which were essentially normal. Petitioner proved that the echograms were not medically necessary, so it overpaid $46.03 and $51.34 for these services. On November 30, 1998, Patient 7 presented at Respondent's office with complaints with worsening neck pain radiating to the shoulders and arms and decreased muscle strength on both sides. The physical examination uncovered decreased grip, normal pulses, and no focal findings. Respondent ordered three upper-extremity NCVs, including an H-Reflex, and an SSEP. The tests did not produce significantly abnormal results, such as to require any treatment beyond the anti-inflammatory medications typically used to treat the osteoarthritis from which Patient 7 suffered. Petitioner proved that the tests were not medically necessary, so it overpaid $193.12, $73.96, $21.64, and $42.68 for these services. One month later, on December 28, Patient 7 presented at Respondent's office with continuing complaints of neck pain and decreased muscle strength. Although the same three NCVs had revealed nothing significant only one month earlier, Respondent performed the same three tests. Petitioner proved that these tests were not medically necessary, so it overpaid $195.12, $73.96, and $21.64 for these services. On January 8, 1999, Patient 7 presented at Respondent's office with complaints of right upper quadrant abdominal pain of three days' duration with vomiting and urinary disorders. The physical examination suggested tenderness in the right upper quadrant of the abdomen. Respondent performed liver and renal echograms, which were normal. Petitioner allowed the liver echogram, but not the renal echogram. Petitioner proved that the renal echograms were not medically necessary, so it overpaid $62.37 for this service. On April 7, 1998, Patient 8, who was 48 years old and suffered from diabetes, presented at Respondent's office with an ulcer on her right foot with tingling, numbness, and muscle weakness in both legs. Relevant history included the amputation of the right toe. The physical examination revealed an ulcer on the right foot, but no tingling or numbness. Respondent ordered an electrocardiogram and a doppler study of the arteries of the lower extremities, both of which Petitioner allowed. However, Petitioner denied a doppler study of the veins of the lower extremities and a duplex scan of the veins of the lower extremities and three NCVs of the lower extremities, including an H-Reflex. The venous doppler study disclosed a mild degree of venous insufficiency and suggested a mild to moderate peripheral vascula disease without occlusion. The NCVs showed abnormal sensory functions compatible with neuropathy. In place of a report on the H-Reflex test, a report on an SSEP indicated some abnormalities. At the end of the visit, Respondent sent Patient 8 to the hospital for treatment of the infected foot ulcer. Petitioner failed to prove that the NCVs, including the H-Reflex or SSEP, and the venous doppler study were not medically necessary. For reasons already discussed, Petitioner also failed to prove that the office visit should be downcoded. On August 18, 1998, Patient 8 presented at Respondent's office with complaints of neck pain of two or three weeks' duration, dizziness, blurred vision, and black outs. Respondent ordered a carotid ultrasound, which revealed no abnormalities. Given the compromised health of the patient, Petitioner failed to prove that this service lacked medical necessity. On August 26, 1998, Patient 8 presented at Respondent's office with gastric complaints of three days' duration radiating to the upper right quadrant and accompanied by vomiting and occasional diarrhea. Patient 8 continued to complain of neck pain. Since yesterday, Patient 8 reported that she had had a frequent cough and shortness of breath. Her history includes fatty food intolerance, nocturnal regurgitations, and heartburn. The physical examination revealed a soft, nontender abdomen and normal bowel sounds. With "diagnoses" of epigastric pain, abdominal pain, and shortness of breath, Respondent performed, among other things, a spirometry. Given the short duration of Patient 8's respiratory complaints, Petitioner proved that the spirometry was not medically necessary, so Petitioner overpaid $17.70 for this service. On September 29, 1998, Patient 8 presented at Respondent's office with complaints of low back pain, malaise, chills, fever, and urinary disorders, all of three days' duration. The physical examination was unremarkable, but for unrelated findings in the lower extremities. Respondent performed an echogram of the kidneys, which revealed no significant problems. Petitioner proved that this ultrasound procedure was not medically necessary, so it overpaid $61.57 for this service. Respondent also billed for a diabetes test, but the test results are omitted from the medical records. Petitioner proved a lack of documentation for the diabetes, so it overpaid $11.50 for this service. On December 11, 1998, Patient 8 presented at Respondent's office with complaints of moderate neck pain, numbness and weakness of the shoulders and arms, and tingling of the hands, all of three or four months' duration. Diagnosing Patient 8 with cervical disc disease, cervical radiculitis, and diabetic peripheral neuropathy, Respondent ordered three NCVs, including an H-Reflex. The NCVs revealed some abnormalities, but evidently not enough on which Respondent could make a diagnosis and form a treatment plan. Although this Recommended Order finds an earlier set of NCVs of the lower extremities medically necessary, even though Respondent did not act on them, these NCVs are different for a couple of reasons. First, at the time of the lower- extremity NCVs, Respondent was preparing to send Patient 8 to the hospital, where follow-up of any abnormalities could be anticipated. Second, the lower-extremity NCVs were of the part of the body that had suffered most from diabetes, as Patient 8 had lost her toe. The NCVs performed on December 11 were basically in response to persistent or recurrent complaints about neck pain with an inception, for the purpose of this case, in mid-August. The record reveals that Respondent exerted some effort to diagnose the cause of the pain, but apparently never found anything on which he could base a treatment plan, because he never treated the pain, except symptomatically. From this point forward, Respondent could no longer justify, as medically necessary, diagnostic services for Patient 8's recurrent neck pain, but instead should have referred her to someone who could diagnose any actual disease or condition and provide appropriate treatment to relieve or eliminate the symptoms. Petitioner proved that the three NCVs were not medically necessary, so it overpaid $195.12, $73.96, and $21.64 for these services. On January 12, 1999, Patient 8 presented at Respondent's office with complaints of leg pain and heaviness of "years'" duration. She "also" complained of lower abdominal pain, more to the left side, of mild intensity, "but persistent and recurrent," as well as a burning sensation in the vagina. The physical examination is notable because Patient 8 reportedly refused a vaginal examination. Failing to order a urinalysis, Respondent proceeded to perform a pelvic echogram, as well as a doppler study of the veins of the lower extremities and two duplex scans of the arteries and veins of the lower extremities. The omission of a urinalysis and a vaginal examination--or at least a compelling reason to forego a vaginal examination--renders the pelvic ultrasound, whose results were normal, premature and not medically necessary. Except for the duplex scan of the arteries, Respondent had performed these lower-extremity procedures nine months earlier, just prior to Patient 8's hospitalization. Absent a discussion in the notes of why it was necessary to repeat these tests when no treatment plan had ensued earlier in 1998, these procedures were not medically necessary, so Petitioner overpaid $51.78, $99.14, $37.92, and $110.50 for these services. On January 29, 1998, Patient 9, who was 62 years old, presented at Respondent's office with complaints of weakness and numbness in his legs and fear of falling. A physical examination revealed limited range of motion of both knees. The deep reflexes were normal. Respondent performed three NCVs, including an H-Reflex, and an SSEP, all of the lower extremities. The SSEP was normal, but the NCVs produced results compatible with bilateral neuropathy. Petitioner failed to prove that these services were not medically necessary. On January 31, 1998, Patient 9 presented at Respondent's office with complaints of chest congestion and coughs of three days' duration, accompanied by shortness of breath. This record adds COPD to his history. The physical examination revealed normal full expansion of the lungs, but rhonchis and wheezing on expiration. Respondent ordered a spirometry, which revealed a mild chest restriction. Given the chronic pulmonary disease, Petitioner failed to prove that this service was not medically necessary. On April 14, 1998, Patient 9 presented at Respondent's office with complaints of abdominal pain of three days' duration with vomiting and diarrhea. His history included intolerance to fatty foods. The physical examination found the abdomen to be soft, with some tenderness in the right and left upper quadrants, but no masses, and the bowel sounds were normal. Respondent performed a liver echogram, which was normal. Petitioner proved that the liver echogram was not medically necessary, so it overpaid $44.03 for this service. On May 8, 1998, Patient 9 presented at Respondent's office with complaints of chest pain of moderate intensity behind the sternum, together with palpitations that increased on exertion and eliminated on rest. The physical examination revealed regular heartbeats, a pulse of 84, and blood pressure of 150/90. Respondent performed an electrocardiogram, echocardiogram, and doppler echocardiogram. The electrocardiogram revealed a cardiac abnormality that justified the other procedures, so Petitioner failed to prove that these services were not medically necessary. On June 4, 1998, Patient 9 presented at Respondent's office with complaints of malaise and fatigue, which had worsened over the past couple of weeks. The physical examination showed the lungs to be clear and the heartbeat regular. Patient 9's pulse was 76 and blood pressure was 130/80. Respondent performed a chest X ray and another electrocardiogram, both of which were normal. Petitioner proved that these services were not medically necessary, as the chest X ray was unjustified by the symptoms and physical examination, and an electrocardiogram had just been performed one month earlier, so Petitioner overpaid $18.88 and $15.74 for these services. On July 1, 1998, Patient 9 presented at Respondent's office with complaints of ongoing knee pain. Patient 9 had been re-scheduled for knee surgery and required another clearance. Respondent performed another electrocardiogram, even though he had performed one only three weeks ago, and the results had been normal, as were the results from the July 1 procedure. Petitioner proved that this service was not medically necessary, and it overpaid $15.74 for this service. On August 14, 1998, Patient 9 presented at Respondent's office with complaints of pain in his hands and wrists of three or four months' duration, accompanied by tingling in the fingers and a loss of strength in the hands. Respondent performed two NCVs, which revealed findings compatible with neuropathy, but the records reveal no action by Respondent in forming a treatment plan or referring the patient to a specialist. Petitioner proved that these services were not medically necessary, so it overpaid $195.12 and $73.96 for these services. On March 9, 1998, Patient 10, who was three years old, presented at Respondent's office with a sore throat with fever and malaise. His history included asthma, and he had suffered from mild shortness of breath and a dry cough of three days' duration. The physical examination was unremarkable, except for congested tonsils and scattered rhonchis, but no wheezes. Respondent administered an aerosol, which was appropriate, given the young age of the patient and his asthmatic condition. Petitioner failed to prove that this service was not medically necessary. On the next day, Patient 10 again presented at Respondent's office in "acute distress." Although his temperature was normal, his pulse was 110. The findings of the physical examination were the same as the prior day, except that the lungs were now clear. Respondent billed for another aerosol treatment, but the medical records omit any reference to such a treatment. Petitioner proved that Respondent failed to maintain documentation for this treatment, so Petitioner overpaid $10.03 for this service. On May 21, 1998, Patient 10 presented at Respondent's office with a cough, chest congestion, and mild shortness of breath, but no fever. A physical examination revealed scattered rhonchis, but no wheezes, and the boy's chest expression was full. Diagnosing the patient with acute bronchitis, Respondent administered a spirometry and an aerosol. Again, due to the age of the patient and his asthma, Petitioner failed to prove that the spirometry or aerosol was not medically necessary. On August 18, 1998, Patient 10 presented at Respondent's office with chest congestion, cough, and moderate shortness of breath, all of three days' duration. The physical examination showed that the lungs were free of wheezes. Respondent administered an aerosol and a chest X ray. The aerosol was appropriate given the age of the patient and his asthma. However, the chest X ray was inappropriate given the clear condition of the lungs. Petitioner proved that the chest X ray was not medically necessary, so it overpaid $18.88 for this service. On August 6, 1998, Patient 11, who was three years old, presented at Respondent's office with a fever and sore throat, both since the prior day, as well as abdominal pain of two or three weeks' duration. The physical examination disclosed that the abdomen was normal, as were the bowel sounds. Respondent performed a kidney echogram, which was normal. Given the age of the patient, his overall health, and the lack of confirming findings, Petitioner proved that the echogram was not medically necessary, so it overpaid $61.57 for this service. On October 1, 1998, Patient 12 presented at Respondent's office. Respondent billed an office visit, which Petitioner allowed. This is the only item billed for Patient 12 during the audit period, so there is no dispute as to Patient 12. On March 9, 1998, Patient 13, who was 30 years old, presented at Respondent's office with complaints of back pain, chills, burning urination, and general malaise, all of three days' duration. She also complained of lower abdominal pain, vaginal discharge, and pain during intercourse, but denied abnormal genital bleeding. The physical examination disclosed pain in the cervix on motion, but a normal temperature. Respondent performed echograms of the kidneys and pelvis to address his diagnoses of an infection of the kidneys and pelvic inflammatory disease. However, he ordered no blood work. The ultrasounds of the kidneys and the pelvis were normal. The symptoms and findings justified a pelvic echogram, but not a kidney echogram. Petitioner proved that the kidney echogram was not medically necessary, so that it overpaid $61.57 for this service. Petitioner failed to prove that the pelvic echogram was not medically necessary. On March 17, 1998, Patient 13 presented at Respondent's office with complaints of moderate chest pain behind the sternum with palpitations and anxiety. Diagnosing chest pain, mitral valve prolapse, and anxiety, Respondent ordered an electrocardiogram, which Petitioner allowed, and an echocardiogram and doppler echocardiogram, which Petitioner denied. The results from the latter procedures were normal. Petitioner failed to prove that these two procedures were not medically necessary. On June 12, 1998, Patient 13 presented at Respondent's office with complaints of leg pain of two to three months' duration with heaviness and discomfort, especially at night. Patient 13 also complained of mild shortness of breath and moderate cough. The history included bronchial asthma. The physical examination found normal full expansion of the lungs, but scattered expiratory wheezes in both lungs, as well as a possible enlarged and tender liver. The ankles displayed moderate inflammatory changes. Respondent diagnosed Patient 13 with varicose veins with inflammation and bronchial asthma. Respondent performed a doppler study of the veins of the lower extremities, a duplex scan of these veins, and a spirometry, which Petitioner denied, and an aerosol, which Petitioner allowed. The doppler study suggested a mild degree of venous insufficiency with bilateral varicose veins and edema. The spirometry revealed a moderate chest restriction and mild airway obstruction. Petitioner failed to prove that any of these services were not medically necessary. On March 10, November 16, and December 18, 1998, Patient 14 presented at Respondent's office. On each occasion, Respondent billed an office visit, which Petitioner allowed. These are the only items billed for Patient 14 during the audit period, so there is no dispute as to Patient 14. On March 18, 1998, Patient 15 presented at Respondent's office. Respondent billed an office visit, which Petitioner allowed. This is the only item billed for Patient 15 during the audit period, so there is no dispute as to Patient 15. On March 16 and 19 and April 8,1998, Patient 16 presented at Respondent's office. On each occasion, Respondent billed an office visit, which Petitioner allowed. These are the only items billed for Patient 16 during the audit period, so there is no dispute as to Patient 16. On September 4, 1998, Patient 17, who was 52 years old, presented at Respondent's office with complaints of leg pain after exertion and cold feet, as well as low back pain of several years' duration that had worsened over the past two to three weeks. Patient 17 also complained of low back pain that had persisted for several years, but had worsened over the past two to three weeks. The history included an heart bypass. The only abnormalities on the physical examination were decreased expansion of the chest, edema of the ankles, decreased peripheral pulses, and cold feet. Respondent performed a duplex scan of the arteries of the lower extremities, a spine X ray, and an injection to relieve back pain, all of which Petitioner allowed. Respondent also performed an electrocardiogram, which Petitioner denied. Even though the electrocardiogram revealed several abnormalities, nothing in the symptoms, history, or examination suggests any medical necessity for this procedure. Petitioner proved that the electrocardiogram was not medically necessary, so Petitioner overpaid $15.74 for this service. Four days later, on September 8, Patient 17 presented at Respondent's office with complaints of continuing low back pain, now radiating to the legs. The history and findings from the physical examination were identical to those of the office visit four days earlier. Respondent performed three NCVs, including an H-Reflex, which revealed a mild neuropathy. However, the symptoms and history did not justify these diagnostic procedures focused on the legs when the back was the longstanding problem area, nor did Respondent have any treatment plan for the back problem. Eventually, according to Respondent's testimony, a month or two later, he sent this patient to the hospital, where he could receive treatment for this painful condition. Petitioner proved that the three NCVs were not medically necessary, so it overpaid $195.12, $73.96, and $21.64 for these services. On October 2, 1998, Patient 17 presented at Respondent's office with complaints of chest pain on exertion of three days' duration. The physical examination disclosed decreased breath sounds in the lungs, but a regular rhythm of the heart. Respondent performed an echocardiogram, doppler echocardiogram, and duplex scan of the extracranial arteries. Given the patient's history of coronary artery disease and heart bypass, Petitioner failed to prove that these services were not medically necessary. On December 10, 1998, Patient 17 presented at Respondent's office with complaints of left flank pain and bilateral back pain of three days' acute duration, as well as urinary disorder and nausea. The physical examination was unremarkable. Respondent performed a kidney echogram, which was negative, to address his working diagnoses of urinary tract infection and kidney stones. However, Respondent performed no urinalysis, and the complaints did not justify elaborate diagnostics to rule out the improbable condition of stones. Petitioner proved that the kidney echogram was not medically necessary, so it overpaid $59.57 for this service. On October 9, 1998, Patient 18, who was 35 years old, presented at Respondent's office with complaints of chest pain and palpitations of gradual onset over nearly one year, unrelated to exertion and accompanied occasionally by moderate shortness of breath. Patient 18 reported that she had smoked heavily for several years and suffered from intermittent smoker's cough and phlegms. Relevant history included asthma and bronchitis. The physical examination revealed that the lungs were clear and the chest expanded fully. Petitioner allowed several cardiac diagnostic procedures, but denied a spirometry and aerosol, the former as medically unnecessary and the latter as lacking documentation. The spirometry revealed severe chest restriction. Given the results of the spirometry and the history of Patient 18 as a heavy smoker, Petitioner failed to prove that the spirometry was not medically necessary, but, given the mild symptoms at the time of the treatment, without regard to whether Respondent provided documentation, Petitioner proved that the aerosol was not medically necessary, so it overpaid $10.62 for this service. On October 16, 1998, Patient 18 presented at Respondent's office with complaints of persistent neck pain, radiating to the arms and hands. The physical examination disclosed a substantial limitation in range of motion of the neck, but no focal signs. Respondent performed three NCVs, including an H-Reflex, and an SSEP of the upper extremities, which revealed some abnormalities. Notwithstanding the positive findings, the absence of any treatment plan undermines the medical necessity of these diagnostic procedures. In response to these findings, Respondent merely changed Patient 18's anti- inflammatory medication, which he obviously could have done with negative NCVs and an SSEP. Petitioner has proved that the three NCVs and SSEP were not medically necessary, so it overpaid $195.12, $73.96, $21.64, and $42.68 for these services. On October 17, 1998, Patient 18 presented at Respondent's office with complaints of pelvic pain and vaginal discharge with left flank pain and urinary disorders. She also complained of leg pain and fatigue after standing. A previously performed urinalysis had revealed blood in the urine. The physical examination found vaginal discharge and pain in cervix motion to the right and left sides. It also found normal peripheral pulses and normal movement in all limbs, although some varicosities and inflammatory changes were present. Respondent performed echograms of the kidneys and pelvis and a doppler study and duplex scan of the veins of the lower extremities. Although both echograms were normal, these procedures were justified due to the symptoms and findings. The procedures performed on the lower extremities, which revealed a mild degree of venous insufficiency, were not justified by the complaints or findings. Petitioner failed to prove that the echograms were not medically necessary, but proved that the doppler and duplex procedures were not medically necessary, so it overpaid $38.75 and $108.58 for these services. On November 18, 1998, Patient 18 presented at Respondent's office with complaints of weakness of two to three months' duration and eating disorders. The physical examination uncovered a palpable, enlarged thyroid, even though, one month earlier, the physical examination found the thyroid to be non- palpable. Although the medical records indicate that Respondent ordered laboratory tests of thyroid function, no such reports are in his medical records, and, more importantly, he performed a thyroid echogram, which was normal, prior to obtaining the results of any laboratory work concerning thyroid function. Petitioner proved that the echogram was not medically necessary, so it overpaid $45.24 for this service. On January 21, 1999, Patient 19, who was four months old, presented at Respondent's office with a cough. Eight days earlier, Patient 19 had presented at Respondent's office with the same condition, and Respondent had recommended that the patient's mother hospitalize him if the symptoms worsened. A physical examination revealed that the lungs were clear and the chest fully expanded. Respondent administered an aerosol. Petitioner proved that the aerosol was not medically necessary, so it overpaid $10.97 for this service. On February 2, 1998, Patient 21, who was 46 years old, presented at Respondent's office with complaints of generalized headache and chest discomfort. For the past two weeks, Patient 21 had also suffered from painful urination. The relevant history included non-insulin-dependent diabetes and paranoid schizophrenia. The physical examination indicated that Patient 21's heart beat in regular rhythm. Patient 21's blood pressure was 190/105, and his cholesterol and triglyceride were high. His femoral and popliteal pulses were decreased. Respondent performed an electrocardiogram, which Petitioner allowed, and, after learning that the results were borderline abnormal, an echocardiogram and doppler echocardiogram, which Petitioner denied. Given the symptoms, Respondent was justified in proceeding with additional diagnostic tests, especially given the difficulty of treating a schizophrenic patient. Petitioner failed to prove that the echocardiogram and doppler echocardiogram were not medically necessary. On March 2, 1998, Patient 21 presented at Respondent's office with complaints, of four months' duration, of leg pain when standing or walking a few blocks. The physical examination revealed decreased peripheral pulses. Respondent performed a doppler study and duplex scan of the veins of the lower extremities, which were both normal. Given the diabetes and schizophrenia, these diagnostic procedures were justified. Petitioner failed to prove that these services were not medically necessary. On April 2, 1998, Patient 21 presented at Respondent's office with complaints of worsening leg pain, now accompanied by numbness and tingling in the feet and sensorial deficit on the soles of the feet. The physical examination was substantially the same as the one conducted one month earlier, except that the deep reflexes were hypoactive. Respondent performed three NCVs, including an H-Reflex, on the lower extremities, and they revealed abnormal motor functions. However, the failure of Respondent to prepare a treatment plan or refer Patient 21 to a specialist precludes a finding of medical necessity. Petitioner has proved that these NCVs were not medically necessary, so it overpaid $195.12, $73.96, and $21.64 for these services. On April 30, 1998, Patient 21 presented at Respondent's office with complaints of difficulty urinating for the past three or four days. A physical examination revealed an enlarged, tender prostate. Forming a working diagnosis of prostatitis and chronic renal failure, Respondent performed prostate and kidney echograms, which were both normal, but no laboratory work on the urinary problems. Petitioner failed to prove that the prostate echogram was not medically necessary, but proved that the kidney echogram was not medically necessary, so it overpaid $61.57 for this service. On July 3, 1998, Patient 21 presented at Respondent's office with complaints of visual disorders, dizziness, blacking out, and fainting, all of several months' duration. Respondent performed a carotid echogram, which was normal. Petitioner failed to prove that this service was not medically necessary. On August 4, 1998, Patient 21 presented at Respondent's office with complaints of moderate neck pain of five or six months' duration, radiating to the shoulders and arms and accompanied by tingling and numbness of the hands. The physical examination disclosed decreased femoral and popliteal pulses, limited motion in the neck and shoulders, pain in the shoulders upon manual palpation, pain in the wrists upon passive movements, and decreased grip on both sides. Respondent performed two NCVs, including an H-Reflex, and an SSEP, all of the upper extremities. The NCVs suggested bilateral carpal tunnel syndrome, and the SSEP showed some abnormalities of nerve root function. Respondent responded to these data with a prescription for physical therapy three times weekly. Petitioner failed to proved that the two NCVs and SSEP were not medically necessary. On September 1, 1998, Patient 21 presented at Respondent's office with complaints of "chest oppression" and hypertension since the previous day. Patient 21 also complained of moderate neck pain and urinary discomfort of three days' duration. His blood pressure was 160/100, and his heart was in regular rhythm. Respondent performed an electrocardiogram, which Petitioner allowed, and a 24-hour electrocardiogram with a halter monitor, after learning that the results of the initial electrocardiogram were abnormal. Petitioner disallowed the latter procedure, but failed to prove that it was not medically necessary. On October 6, 1998, Patient 21 presented at Respondent's office with complaints of chest pain, dizziness, fainting, excessive hunger and weight gain, and weakness. His blood pressure was 170/100, and his pulse was 88. His heart beat in a regular rhythm, and his thyroid was enlarged, but smooth. Respondent performed an echogram of the thyroid, even though he had not ordered laboratory work of thyroid function. He performed an echocardiogram and a doppler echocardiogram. All echograms were normal, although Patient 21 suffered from some mild to moderate sclerosis of the aorta. Petitioner proved that these echograms were not medically necessary because the thyroid echogram was not preceded or even accompanied by laboratory work of thyroid function, and the other procedures of repeated diagnostic tests that Respondent had performed eight months earlier and were normal at that time. Petitioner thus overpaid $43.24, $61.96, and $29.31 for these services. On November 6, 1998, Patient 21 presented at Respondent's office. Petitioner downcoded the office visit, but, as discussed above, the failure of Petitioner to produce the CPT manual prevents a determination that Respondent overbilled the visit. On January 4, 1999, Patient 21 presented at Respondent's office with complaints of flank pain of four months' duration accompanied by several urinary disorders, chills, and occasional fever. The physical examination revealed a distended and soft abdomen and tenderness in the flanks and right upper quadrant. Respondent performed a kidney ultrasound, despite having performed one eight months earlier and obtained normal results, but learned this time that the left kidney had a cyst consistent with chronic renal failure. Petitioner failed to prove that this service was not medically necessary. On January 29, 1999, Patient 21 presented at Respondent's office with complaints of moderate back pain of two weeks' duration, radiating to the legs, and weakness in the legs. The physical examination revealed pain on bending backward or forward and muscle spasm. Respondent performed a lumbar X ray, which Petitioner allowed, and three lumbosacral NCVs, including an H-Reflex, which Petitioner denied. The NCVs revealed mild neuropathy, although an SSEP, evidently billed as an H-Reflex, was normal. Petitioner failed to prove that these services were not medically necessary. The total overpayments, before extrapolation, from Petitioner to Respondent are thus $5952.99.
Recommendation It is RECOMMENDED that the Agency of Health Care Administration enter a final order determining that, prior to extrapolation, Respondent owes $5952.99 for overpayments under the Medicaid program. DONE AND RECOMMENDED this 26th day of May, 2006, in Tallahassee, Leon County, Florida. S 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 26th day of May, 2006. COPIES FURNISHED: Alan Levine, Secretary Agency for Health Care Administration Fort Knox Building, Suite 3116 2727 Mahan Drive Tallahassee, Florida 32308 Christa Calamas, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Jeffries H. Duvall Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Craig A. Brand Law Offices of Craig A. Brand, P.A. 5201 Blue Lagoon Drive, Suite 720 Miami, Florida 33126 Oscar Mendez-Turino 2298 Southwest 8th Street Miami, Florida 33135
Findings Of Fact The Respondent, Glenn R. Johnston, is a medical doctor, holding license number ME0018091. His address is 201 North Lakemont Avenue, Winter Park, Florida 32759. The Respondent obtained his Bachelor of Science degree from the University of Florida in 1966, and his medical degree from Bowman Gray School of Medicine in 1970. He served his internship and a two-year general family practice residency at Jacksonville Naval Hospital while serving in the Navy, and became board certified in family practice in 1973. Subsequently, the Respondent served for four years as Chief of the Family Practice Department at the Naval Regional Medical Center in Orlando. In approximately 1976 the Respondent entered private practice in Orlando with a group of doctors, and began his own medical practice in 1977. The Respondent has been married for sixteen years, and has two children, ages 11 and 13. The Respondent performs his family practice in a responsible manner, utilizing the prescription of narcotics and narcotic pain medications at an overall very low rate. The Respondent has never before been the subject of an investigation by the Department of Professional Regulation, and this is the first proceeding against him and his medical license. Between the dates of approximately July 1, 1980, and June 30, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrdchloride for his patient, Robert Hicks in the quantity of 4499. Between the dates of July 3, 1980, and July 3, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrochloride for his patient, James Everett, in the quantity of 4320. Between the dates of approximately July 3, 1980, and June 10, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrochloride for his patient, Harold Stacy, in the quantity of 2550. Between the dates of approximately October 2, 1980, and November 20, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrochloride, Percodan, and Tylox to his patient, Billy Carr, in the quantities of 1620, 30 and 30, respectively. Dilaudid, Percodan, and Tylox are Schedule II controlled substances pursuant to Chapter 593, Florida Statutes. The Physicians Desk Reference (PDR) states the following relative to Dilaudid: Description: DILAUDID (hydromorphone hydrochloride) (WARNING: May be habit forming), a hydrogenated keton of morphine, is a narcotic analgesic . . . * * * DRUG ABUSE AND DEPENDENCE: DILAUDID is a Schedule II narcotic. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, DILAUDID should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when DILAUDID is used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependency may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. * * * Oral: The usual oral dose is 2mg. every 4 to 6 hours as necessary. The dose must be individually adjusted according to severity of pain, patient response and patient size. More severe pain may require 4mg. or more every 4 to 6 hours. If the pain increases in severity, analgesia is not adequate or tolerance occurs, a gradual increase in dosage may be required. If pain is exceedingly severe, or if prompt response is desired, parenteral DILAUDID should be used initially in adequate amounts to control the pain. The Respondent prescribed Dilaudid to patient Robert Hicks for severe chronic pain associated with multiple medical problems, primarily related to his severe degenerative rheumatoid arthritis. Mr. Hicks, 49 years of age, had a long history of multiple joint pains, degeneration of his normal joints, chronic pain in his joints, swelling and abnormal laboratory tests. He had been diagnosed as having rheumatoid arthritis since 1976 by a neurosurgeon, confirmed by blood tests and x-rays. He was classified as 100 percent disabled in 1977 by the Veterans Administration because of the chronic joint pains of rheumatoid arthritis. He had been seen by numerous doctors and treated with various pain medications including Dilaudid, which was the only drug that allowed him to function. The pains, discomfort and disability that Mr. Hicks suffered were located in most of the joints of his body, especially in his lumbosacral spine, with involvement in the left hip, shoulder areas, both knees and elbows, with swelling and deformity in the hands. Practically every joint in his body was involved. Mr. Hicks frequently used a cane for walking, and occasionally used crutches. He had difficulty in standing from a sitting position and on occasion he used a wheelchair. The Respondent tried several different medications to treat his rheumatoid arthritis, in addition to physical therapy, and used various pain medications, but Dilaudid proved to be the best when used in conjunction with treatment medications that would allow Mr. Hicks sufficient relief to work and function in a reasonably normal life-style. The Respondent prescribed 4 mg. Dilaudid tablets to Mr. Hicks, to be taken in doses within the limits recommended by the Physician's Desk Reference (PDR) in that the overall quantity prescribed for him did not exceed the maximum limit recommended by the PDR. Mr. Hicks also had other medical problems appropriately treated by the Respondent, such as subdeltoid bursitis, lateral ankylosing spondylitis, spondylolisthesis, Reiter's Syndrome, cervical spondylosis and diabetes. The Respondent prescribed Dilaudid in quantities of two pills of 4 mgs. every four hours as needed for pain, to patient James Everett for chronic severe pain stemming primarily from the lower chest wall and left upper abdominal chest wall which followed a transthoracic hiatal hernia repair performed in 1965. Mr. Everett also had angina with a history of one or two myocardial infarctions in 1970; he was on medication for the angina. The hiatal hernia repair left a surgical scar across his entire left chest, extending from the midportion of the back all the way across his chest and ending right above the stomach, at the lower part of the anterior chest wall, with another scar extending from his epigastric region down the mid-rib and into the lower midline area. During the surgical repair, Mr. Everett suffered a collapsed lung and suffered a great deal of scar tissue visible in his chest x-rays in the area where most of the pain is reported. Most of his pain resulted from the surgical scar tissue rather than the angina, as confirmed by a cardiologist. Mr. Everett was a very debilitated, elderly person, older looking than his 60 years, obese, very pale, with a slow gait; he perspired quite a bit and appeared to be a patient with chronic medical problems. Mr. Everett had been taking Dilaudid on prescription from his previous physician when he became the Respondent's patient. The quantity of Dilaudid prescribed for Mr. Everett did not exceed the maximum recommended dosage. The Respondent tried other medications and therapies to relieve the patient's chronic severe pain, with limited success, and used other methods of treatment for the patient's problems, which included diabetes and high blood pressure. Mr. Everett had been classified 100 percent disabled by the Veterans Administration because of his chronic severe pain. The Respondent concluded that Dilaudid was the only pain medication that would give the patient sufficient relief from pain to enable him to continue his employment and to function in his daily life. The Respondent prescribed Dilaudid in quantities of 2 tablets of 4 mgs. every 4 hours as needed for pain, to patient Harold Stacy for chronic severe pain relating to acute possibly pinched, nerve, lumbosacral low back pain with radiation into the left leg and degenerative arthritis, possible spinal cord tumor, early hypertrophic osteoarthritis, and possible hernitated disc. At age 49, Mr. Stacy was semi-crippled, always requiring a cane while walking and always in a great deal of pain. The hypertrophic arthritis was confirmed by calcium deposits visible on x-ray films. Mr. Stacy was never able to function normally, and could not maintain employment without the pain relief the Dilaudid provided. The Respondent used other medications in an attempt to relieve the pain, but found that Dilaudid was the only medication which would allow Mr. Stacy to work and function in as reasonable a fashion as possible. The Respondent treated Mr. Stacy's physical and health problems with an appropriate variety of treatment methods and medications. The quantity of Dilaudid prescribed for Mr. Stacy did not exceed the PDR recommended dosage. The Respondent prescribed Dilaudid, in dosages of 1-2 tablets of 4 mgs. every 4 hours, to patient Billy Carr for relief of chronic severe low back pain, related to chronic lumbosacral spine strain, chronic prostatitis and spondylolisthesis. Mr. Carr, at age 49, walked with a severe limp, had pain in his perineal area, had difficulty in sitting, and had a deformity in one of his legs due to a pseudoarthritis resulting from a malunion of a fracture of his femur. The Respondent tried several different pain medications and treatment methods, but found that Dilaudid was the only medication which would relieve the pain to allow Mr. Carr to work and enjoy as reasonable a life-style as possible. The quantity of Dilaudid prescribed for Mr. Carr did not exceed the maximum PDR recommended dosage. The Respondent is a board certified family practitioner. The Petitioner's expert witness, Dr. Robert Johnson, is a general practitioner who is not board certified. The Respondent's expert witnesses, Drs. Charles Grant, James Louttit and Clarence Bailey, are board certified in family practice and testified as such. All four expert witnesses testified, and it is so found, that a medically justifiable purpose in treating a patient is determined by the treating physician, and means a treatment which enhances the well-being of a patient and enhances the quality of a patient's life, in a manner the physician feels qualified to render. Reasonable physicians differ in the manner of treating the same condition. Reasonable physicians differ in the manner of treating pain. A person's pain is not measurable. A person's pain threshold is not measurable. One method of determining the level of medication needed to relieve a person's pain is by titration, that is, adjusting the quantity and type of medication to the patient's symptoms. Dilaudid is approved by the Federal Drug Administration for the treatment of pain. The Physician Desk Reference (PDR) does not place a cap on the quantity of Dilaudid to be prescribed for a patient in chronic moderate to severe pain. The analgesic effect of Dilaudid shortens with continued use. Some patients require a greater amount of Dilaudid to relieve pain than other patients. It is a medically justifiable purpose to prescribe Dilaudid to a patient for the relief of moderate to severe pain. It is a medically justifiable purpose to continue to prescribe Dilaudid to a patient for chronic moderate to severe pain. It is ethical, and medically justifiable, for a physician to treat a patient who is already habituated or tolerant to Dilaudid, and who has chronic moderate to severe pain, for the purpose of relieving this pain, since the patient should be given relief from the pain. There is no evidence that any of the four patients treated by the Respondent were drug abusers. It was medically justifiable for the Respondent to prescribe Dilaudid to each of his four patients during the time periods alleged in the Administrative Complaint. The quantities of Dilaudid prescribed by the Respondent to each of the four patients during the time period alleged in the Administrative Complaint were neither excessive nor inappropriate. The evidence is not sufficient to support a finding of fact that the Respondent failed to practice medicine with that level of care, skill and treatment which is recognized by a reasonable and prudent physician as being acceptable, under the circumstances alleged in the Administrative Complaint. There is insufficient evidence to support a finding that the Respondent engaged in repeated malpractice in the treatment of the four subject patients. Dr. Robert B. Johnson, testifying on behalf of the Petitioner as an expert general practitioner, did not feel that it was medically justifiable for the Respondent to prescribe Dilaudid in the quantities alleged, to each of the four patients, and he testified that such quantities were excessive. However, Dr. Johnson neither saw nor examined the patients, and he was not able to tell from reviewing the patient records how much pain any of the four patients were experiencing. Dr. Johnson also testified that, in his opinion, it is a gross departure from acceptable medical practice to prescribe the quantities of Dilaudid in question to a patient with any history other than terminal cancer, and that it would even be a questionable practice for this purpose; that three months would be the maximum length of time Dilaudid should be prescribed to a patient; and that it is not proper for a physician to continue to treat a patient for chronic moderate to severe pain by prescription of Dilaudid in the quantities and over the time periods alleged in the complaint; yet Dr. Johnson could find no physical harm to any of the four patients resulting from the Respondent's treatment. On the basis of the records reviewed, Dr. Johnson could not testify that the Respondent prescribed the Dilaudid in question other than in the course of his medical practice. The opinions of Dr. Johnson, however, were contradicted by the expert opinions of the Respondent's medical witnesses, Drs. Hailey, Grant and Louttit, except for their agreement that the Respondent's patients suffered no physical harm from their treatment by the Respondent, and that the Respondent prescribed Dilaudid to the four subject patients in the course of his medical practice. Where the expert medical opinions are in conflict, the testimony of Dr. Johnson is rejected as less credible than the opinions of Drs. Bailey, Grant and Louttit.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medical Examiners enter a Final Order finding the Respondent, Glenn R. Johnston, M.D., not guilty of Counts I, IV, VII, X and XIII in the Administrative Complaint, and that the Board dismiss the Administrative Complaint with prejudice. THIS RECOMMENDED ORDER entered this 30th day of September, 1983. WILLIAM B. THOMAS, 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 30th day of September, 1983. COPIES FURNISHED: Spiro T. Kypreos, Esquire 130 North Monroe Street Tallahassee, Florida 32301 Paul Watson Lambert, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Department of Professional Regulation, Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, Petitioner, vs. CASE NO. 83-356 GLENN R. JOHNSTON, M.D., License No. 12142 Respondent. /
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
