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 The issue in this case is whether Florida Administrative Code Rule 64B-3.004(2) constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact In 1971, Personal Injury Protection (PIP) coverage was required to be included in automobile insurance policies and was required to be obtained by anyone operating a motor vehicle in Florida. In general, PIP coverage provides payment for medically necessary treatment, lost wages and funeral expenses incurred by persons involved in motor vehicle accidents. The reasons PIP insurance coverage was made mandatory were to provide for the speedy payment of medical expenses, lost wages and burial expenses that an individual might incur as a result of being injured in a motor vehicle accident and to reduce the amount of litigation involved in recovering such expenses. Responsibility for such speedy payment rested with the various insurance companies involved in writing motor vehicle insurance. Until 1980, the PIP system operated in a reasonably cost-efficient manner. However, fraud and paying for medically unnecessary medical tests or treatment were problems under the PIP system. In the past, at the option of a given insurance company, such unnecessary testing or treatment resulted in payment, denial of the claim, and perhaps litigation for the denied claim. By the mid-1980s, for a variety of reasons, the PIP system became less cost efficient. The average Florida PIP claim rose by 33 percent and the amount of premium per insured vehicle needed to cover PIP claims rose by 35 percent. Such increases led to higher premiums for the driving public, as well as larger numbers of motorists not carrying PIP coverage, estimated to be around 22 percent of Florida drivers. Indeed since 1999, State Farm Insurance Company, one of the largest insurers of motor vehicles, has experienced an average $100,000,000.00 loss per year. In 2001, the Legislature enacted a fee schedule for certain medical services and tests, including a fee for SEMG. The legislature did not limit the number of times a particular service or test could be used. The 2001 legislation did not solve the problems of continued claims and payment for tests or services that were not medically necessary or overutilized. The 2001 legislation also did not solve the problem of the cost ineffectiveness of companies litigating the issue of whether a particular test was medically necessary or overused. Consequently, during the 2003 legislative session, the Florida Legislature enacted Section 627.736(5)(b)6., Florida Statutes, which provides: The Department of Health, in consultation with the appropriate professional licensing boards, shall adopt, by rule, a list of diagnostic tests deemed not to be medically necessary for use in the treatment of persons sustaining bodily injury covered by personal injury protection benefits under this section. The initial list shall be adopted by January 1, 2004, and shall be revised from time to time as determined by the Department of Health, in consultation with the respective professional licensing boards. Inclusion of a test on the list of invalid diagnostic tests shall be based on lack of demonstrated medical value and a level of general acceptance by the relevant provider community and shall not be dependent for results entirely upon subjective patient response. Notwithstanding its inclusion on a fee schedule in this subsection, an insurer or insured is not required to pay any charges or reimburse claims for any invalid diagnostic test as determined by the Department of Health. The statute was intended to relieve an insurance company of the burden of paying for or litigating the medical necessity of diagnostic tests that the Department listed in a to-be- developed rule. There was no evidence suggesting that the Legislature intended the words used in the statute to have any meaning other than their ordinary meanings. In order to implement the statute, the Department commenced rulemaking pursuant to the legislative directive in Section 727.736(5)(b)6. Florida Statutes. As a starting point, the Department asked the insurance industry to provide a list of diagnostic tests that the insurance industry believed should be in the rule. The list contained four tests--Spinal Ultrasound, Nerve Conduction Velocity (NCV) Studies, Somatosensory Evoked Potential, and Dermatomal Evoked Potential. SEMG was not included on the insurance industry’s list. SEMG is a method of measuring the electrical output of muscles through the placement of electrical sensors on the skin. In general, a muscle at rest has a lower amount of electrical activity than a muscle that is being worked or contracted. Similarly, muscle spasms have more electrical activity associated with them than a muscle at rest. On the other hand, muscle contracture, which is the condition of a muscle at rest that has been permanently shortened and generally hardened through some process, has a different level of electrical activity associated with it than with muscle spasms. There are two types of SEMG, used for different purposes. Neither type of SEMG relies on subjective patient input. Static EMG uses a hand-held device with probes as an assessment (or muscle scanning) procedure to take a quick measure of muscle tension. Although in most cases hand palpation of a muscle gives a practitioner all the necessary information needed to diagnose a patient, SEMG can augment hand palpation when palpation is not determinative and help differentiate contraction from contracture. SEMG, also can assist in determining the need for the more comprehensive application of dynamic SEMG and generates a graphic, recorded reading of muscle tension. Dynamic SEMG is used to document and verify injury, to determine if the patient is injured, and, in concert with other diagnostic procedures, establish the level or the extent of injury. Once a treatment plan is developed and implemented, SEMG testing is used to monitor a patient's response to treatment. Dynamic SEMG provides an objective tool to evaluate the function of paraspinal muscles of injured persons, including those involved in motor vehicle accidents. On July 25, 2003, the Department published a notice for a workshop for proposed Rule 64B-3.004 in volume 29, no. 30 of the Florida Administrative Weekly. On August 29, 2003, the Department re-noticed the workshop in Volume 9, no. 35 of the Florida Administrative Weekly. The workshop was held on September 9, 2003. The draft rule presented at the workshop listed the four tests submitted by the insurance industry. The draft rule did not include SEMG. However, based on comments made during the workshop, some of which came from a chiropractic representative of the Florida Chiropractic Association, SEMG was included in the next iteration of the draft Rule. The next public iteration of the rule appeared in a Notice of Proposed Rule published on Friday, November 14, 2003, in Volume 29, No. 46 of the Florida Administrative Weekly. SEMG appeared for the first time in the November 14, 2003 notice. The proposed rule was, according to the Notice, based “[u]pon review of the testimony provided at the workshop, input received from the Boards, written opinions by members of the health care and insurance communities, and literature in support thereof.” The Notice also announced a public hearing for 9:00 a.m. on Tuesday, November 18, 2003. Additionally, the record for submitting information regarding the proposed rule was held open for 21 days after the November 14, 2003, publication date to give interested persons an opportunity to submit information. During the time the record was held open, the Department received some evidence and studies indicating that SEMG was not useful, or at a minimum, unnecessarily redundant in the diagnosis of the type of injuries often incurred in an automobile accident. However, the Department also received some evidence and studies that SEMG was useful in the treatment of such injuries, particularly when bio- feedback is being employed in treatment. Oddly, on December 2, 2003, prior to the official closure of the record, the final rule was transmitted to the Secretary of the Department for signature and approval for filing with the Secretary of State. In due course, the rule was filed with the Secretary of State and became effective on January 7, 2004. Rule 64B-3.004, as adopted by the Department states, in relevant part, as follows: 64B-3.004 Diagnostic Testing. For the purposes of Section 627.736(5)(b)6., F.S. (2003), the Department of Health, in consultation with the appropriate licensing boards, hereby adopts the following list of diagnostic tests based on their demonstrated medical value and level of general acceptance by the provider community: * * * (2) Surface EMG is deemed not to be medically necessary for use in the diagnosis of persons sustaining bodily injury covered by personal injury protection benefits. * * * Specific Authority 627.736(5) FS. Law Implemented 627.736(5) FS. History - New 1-7- 04. The rule only applies to SEMG when used for diagnostic purposes. The rule does not apply to SEMG when used in the treatment of PIP-covered automobile accident victims. Petitioner, Richard Merritt, is a Doctor of Chiropractic, licensed in Florida, Texas, and Alabama. Prior to the adoption of Rule 64B-3.004, Dr. Merritt billed $130,000 to $160,000 per year for SEMG tests. Dr. Merritt has used SEMG in his practice since the 1980s. Thirty-five percent of Dr. Merritt’s patients have been involved in motor-vehicle accidents. Curiously, Dr. Merritt performs SEMG on all of those patients for which PIP insurance generally pays. Again, curiously, only ten percent of his remaining patients have SEMG that may or may not be covered by other insurance. However, the evidence was not clear as to the differences between patients sustaining injuries in motor-vehicle accidents and other non-accident patients. Dr. Merritt suggested that motor-vehicle accident patients generally have more complicated or layered medical histories than patients who have not been involved in motor-vehicle accidents. No evidence was presented on this alleged difference which seems to be a very dubious distinction between patients. The Florida Insurance Council, Inc.; the Property Casualty Insurers Association of America; The American Insurance Association; The National Association of Mutual Insurance Companies; The Florida Automobile Joint Underwriting Association; State Farm Mutual Automobile Insurance Company; Allstate Insurance Company; Government Employees Insurance Company; The Florida Farm Bureau Insurance Companies; Liberty Mutual Insurance Group; First Floridian Auto and Home Insurance Company; and United Service Automobile Association have standing to intervene in this proceeding. Florida Insurance Council, Property and Casualty Insurance Association of America, and the American Insurance Association, all have a substantial number of members affected by the rule. These associations exist, in part, to protect their member's interests in legislative and regulatory matters involving insurance. The subject matter of this rule is within the associations' scope of interest and activity and they are often involved in these types of rule challenges. Intervenor, Florida Automobile Joint Underwriters Association (JUA), is the automobile residual market in Florida. The JUA makes PIP available to high-risk customers and operates as a standard insurance company under its governing statutes and rules. All the individual companies that sought to intervene in this proceeding pay claims under PIP provisions. Both the JUA and the individual companies are directly affected by the rule. The rule affects rates and premiums which are calculated based in part on loss experience. Loss costs are affected by the rule because the rule regulates what must be paid under PIP coverage. Additionally, the rule affects the profits and losses of individual companies. The issue in this case is limited to a consideration of whether the inclusion of SEMG on the “list of diagnostic tests deemed not to be medically necessary for use in the treatment of persons sustaining bodily injury covered by personal injury protection benefits” is an invalid exercise of delegated legislative authority. Accordingly, the place to start is with the language of the statute being implemented. § 627.736(5)(b)6., Fla. Stat. As indicated earlier, there was no evidence that the Legislature intended the words used in the statute to have any meanings other than their ordinary meanings. Thus, by reading the statute, it is clear that the tests to be included in any proposed rule must be “diagnostic tests.” It is undisputed that “diagnosis” and “treatment” in the medical area are different procedures and refer to different aspects of providing medical care to a patient. When used in a medical context, the term “diagnosis” means the art of distinguishing one disease from another or the determination of the nature of or cause of disease or injury, whereas the term “treatment” means the management and care of a patient for the purpose of combating disease or disorder. See Dortland’s Illustrated Medical Dictionary, 27th Ed. (1988) and Stedman’s Medical Dictionary, 26th Ed. (1995). In short, there is a diagnosis phase of medical care wherein a practitioner uses various tests, procedures and historical information to determine the nature, i.e. what the patient’s condition is and/or how severe the condition is, and the cause, i.e. automobile accident or fall, of a given disease or condition. Distinct from the diagnostic phase there is a treatment phase of medical care wherein a practitioner, through tests, therapies, procedures and medicines manages or cares for a patient’s condition. However, in their ordinary usage, the terms “diagnosis” and “treatment” can overlap. In ordinary usage, the term “diagnosis” does not differ significantly from the medical term and means the art or act of identifying a disease from its signs and symptoms. Webster’s New Collegiate Dictionary (1984). The term “treatment” means “the act or manner or an instance of treating someone or something: HANDLING, USAGE.” Id. The term “treat” means to “deal with.” Id. In its ordinary sense, “treatment” has a broader meaning than it does in its medical sense and can include diagnosis. Thus, in this case, the tests referred to in the statute are diagnostic tests used in handling or dealing with a person who has been physically hurt in a motor vehicle accident. Also, by giving the term “treatment” its ordinary meaning the Department has the authority to differentiate between the appropriateness of a diagnostic test used in the medical diagnostic phase and the same test used in the medical treatment phase. In this case, SEMG, especially static SEMG, is used as a test in both the medical diagnosis and treatment phases in dealing with persons injured in a motor vehicle accident. Therefore, it is a diagnostic test that may be considered under the other criteria of the statute. For a test to be included in the rule it must be medically unnecessary, based on a lack of demonstrated medical value and a lack of general acceptance by the relevant provider community and not be dependant for results entirely from subjective patient response. As can be seen, the statute does not deal with the overuse of a given test, but only defines medical necessity by the three criteria listed above. In reality, some types of test overuse may only be determined on a case-by-case basis, since whether a generally or occasionally, medically beneficial test is useful or redundant at a particular time in treatment or diagnosis depends greatly on the reasons the test is being employed. Thus, if a test has a degree of medical value, it cannot be on the list; if a test has a level of general acceptance by the relevant provider community which includes the Doctors of Chiropractic, it cannot be on the list; and if a test is not dependent for results entirely on subjective patient response, it cannot be on the list. The medical value of any test is not related in any way to the manner in which payment for that procedure is made. In that regard, the medical validity of a procedure does not vary as to whether the patient is covered by Workers' Compensation, Medicare, private insurance, or PIP. PIP patients typically have injuries to the connecting soft tissues of their spine as well as injuries to organs and broken bones. Muscles, ligaments, and tendons can be stretched or injured, which can lead to a breakdown in spinal-joint motion or a spinal-joint misalignment. Spinal-joint misalignment may cause interference in the patient's nervous system. Soft tissue and misalignment injuries are routinely the subject of chiropractic care. SEMG is effective in recording changes in the electrical activity of muscles associated with spinal injuries known as vertebral subluxations. Vertebral subluxations are commonly associated with automobile accidents, and are diagnosed and treated by chiropractic physicians. In spinal injuries, there is a depolarization that occurs at the cellular level. Electrical activity is generated at the cellular level and runs down the muscle fiber. SEMG measures the surface manifestation of the amount of electrical activity generated and the depolarizations in the area. The purpose is to measure muscle tension. SEMG is objective and quantitative. It eliminates subjective impressions or input and provides an objective and unbiased assessment of the electrical activity of the patient's paraspinal muscles. It allows a medical professional to distinguish objectively between observed muscle tension that is electrically active, which is associated with spasm, from observed muscle tension that is not electrically active, which is associated with contracture. It is debatable whether SEMG provides no more useful information to a practitioner than information gleaned by hand palpation of the injured area. The problem is that hand palpation can sometimes be inconclusive, especially in regard to determining if a muscle is hard from spasm or contracture. The question is one of over or redundant use of a test. Again that question is not part of the criteria for inclusion of a test in the rule. The criteria only include whether a test can be used by the practitioner to make a valid diagnosis or conclusion. In regard to SEMG, published documentary evidence demonstrates that spasm and contracture share a similar physical manifestation, i.e. the muscle is hard to the touch, and may not be distinguished through palpation and that, in the occasional instances where had palpation is inconclusive, SEMG can differentiate the conditions, and “provide[] an important element of diagnostic information.” Specific to automobile-related injuries, when hand palpation is inconclusive, SEMG has medical value to chiropractic physicians in that it allows the treating chiropractic physician to determine if a patient has an injury or does not have an injury, to quantify the extent of the injury, to monitor the patient's response to treatment, and to assess the point of maximum clinical improvement or maximum therapeutic benefit. While its diagnostic usefulness may be limited to certain situations when hand palpation is inconclusive, the evidence demonstrated that SEMG had some utility in the diagnostic phase of medical care. Therefore, SEMG should not be included in the proposed rule. Dynamic SEMG is also utilized on motor vehicle accident victims. Its primary use is to provide the level of documentation for services rendered a person involved in a motor- vehicle accident required to demonstrate injury, permanency of injury, the need for treatment, and the response to treatment before payment will be made under a PIP plan. Overall, SEMG has advanced as a clinical tool from its earliest, more experimental uses in which no computer support was available, through the time in which the best technology available was the Commodore 64 (or earlier) computer, to today, when advances in technology and understanding have resulted in the elimination of problems of electrical interference, bandwidth filtering and electrode placement, and have resulted in a higher threshold of sensitivity. The evidence in this case demonstrates that SEMG has medical value for use in the treatment of persons sustaining bodily injury covered by personal injury protection benefits. The Department admitted and the evidence showed that some surface EMG techniques may be useful in the treatment of persons sustaining bodily injury in motor vehicle accidents in appropriate circumstances. Based on the admissions of the Department, it is clear that SEMG has a degree of demonstrated medical value. Therefore, its inclusion on the list of medically unnecessary tests is arbitrary and capricious; has exceeded the Department’s grant of rulemaking authority; and has enlarged, modified, or contravened the specific provisions of law implemented. The Department also admitted and the evidence showed that SEMG is not dependent for results entirely upon subjective patient response. Therefore, under the terms of the statute, the inclusion of SEMG on the list of medically unnecessary tests has exceeded the Department’s grant of rulemaking authority and has enlarged, modified, or contravened the specific provisions of law implemented. The evidence also demonstrated that SEMG is generally accepted in the relevant provider community. In 1996, the two primary organizations that represent chiropractic physicians in Florida, the Florida Chiropractic Association and the Florida Chiropractic Society, were asked to develop a set of guidelines to apply to the chiropractic profession. Their work resulted in a report and the publication of the Chiropractic Practice Guidelines and Parameters for the State of Florida (CPG). The CPG was unanimously accepted and endorsed by the Florida Board of Chiropractic on August 22, 1996. The CPG was copyrighted and published by the Florida Chiropractic Association, Inc. and the Florida Chiropractic Society, Inc. in 1997. The CPG is a set of rules or guidelines that a practicing chiropractic physician can follow regarding the treatment of chiropractic problems. The CPG constitutes the consensus agreement of the chiropractic profession on many of the procedures that a chiropractor might provide. The CPG references SEMG both in comparison with needle EMG and as to its own merits. As a comparative matter, the CPG provides that “needle techniques are appropriate for the evaluation of specific muscles, while surface electrodes are appropriate for kinesiological studies of the “global” function of groups of muscles.” In terms of test-retest reliability and longitudinal muscle studies, SEMG was found to be superior to needle EMG. The CPG also states that SEMG provides an objective and quantifiable measure of muscular activity in areas of vertebral subluxation. Although the section discussing SEMG concludes with language indicating a degree of qualification, the CMG rates SEMG as “established.” An “established” rating means that SEMG is accepted as appropriate by the practicing chiropractic community for the given indication in the specified patient population. The rating of “established” was made with a Consensus Level of 1, which is the highest level of consensus available. In addition, the rating was supported by various categories of evidence used to analyze a given test, including expert opinion, clinical experience or effectiveness studies (Evidence E), refereed literature or published monographs, legal decisions and/or authority (Evidence L) and available controlled studies (Evidence C). The rating of “established” also requires one or more controlled trials. Therefore, read as a whole, the CMG demonstrates the medical value of SEMG as a clinical and diagnostic tool for evaluating paraspinal muscle activity, quantifying palpation findings, performing longitudinal studies, and detecting muscle spasm. Dr. Jenkins’ testimony regarding the lack of reliability of the CPG and attempt to disown the CPG as an authoritative statement by the Board of Chiropractors cannot be given weight since he was on neither the Florida Committee for Adoption of Guidelines nor the Board of Chiropractic when the CPG was accepted and endorsed. Additionally, during his tenure on the Board stretching back to 1997, the Board has not rescinded or amended the CPG. Finally, the evidence did not demonstrate that the CPG was superceded by the 1999 Universe of Florida Patients with Neck Pain or Injury Medical Practice Guidelines. These Universe Guidelines appear to relate only to medial doctors and not to Chiropractic Physicians. The Guidelines state they are not applicable to Chiropractic Physicians licensed under Chapter 460, Florida Statutes. The fact that the CPG describes SEMG as “[a]ccepted as appropriate by the practicing chiropractic community” provides a strong demonstration of the medical value of the test, and strong evidence of the high level of general acceptance of the test by the relevant provider community. Additionally, the American Medical Association Current Procedural Terminology (CPT) 2004 Manual is a proprietary system of the AMA for reporting medical services and procedures. CPT Codes are the uniform, established system for reporting medical services for reimbursement under government and private insurance programs. CPT coding is mandatory to describe the services a physician renders when submitting that service for payment to an automobile insurance carrier. In order to be assigned a five-digit CPT Code, the procedure must be “consistent with contemporary medical practice and be . . . performed by many practitioners in clinical practice in multiple locations. Code assignment is performed by a CPT Editorial Panel, consisting of 17 physician members, and a larger CPT Advisory Committee of medical and allied health professionals. Among the objectives of the CPT Advisory Committee is to “provide documentation to staff and the CPT Editorial Board regarding the medical appropriateness of various medical and surgical procedures. . . .” (emphasis supplied) Among the considerations for Code assignment are the requirements “that the service/procedure is a distinct service performed by many physicians/practitioners across the United States,” and “that the clinical efficacy of the service/procedure is well established and documented in peer review literature.” Dynamic SEMG has been assigned a five-digit CPT Code 96002. Similarly, The review and interpretation of dynamic SEMG has been assigned a five-digit CPT Code 96004. The fact that SEMG has been found to meet the requirements of the AMA for assignment of five-digit CPT Codes provides evidence of the medical value of the test, and strong evidence of the high level of general acceptance of the test by the relevant provider community. Finally, the rulemaking record for Rule 64B-3.004 contains information regarding SEMG. The literature submitted as part of the rulemaking record reveals, by a preponderance of competent, substantial evidence, that SEMG does not lack demonstrated medical value, and that it has a level of general acceptance by the relevant provider community. The primary documents submitted in the course of rulemaking included the 1993 Guidelines for Chiropractic Quality Assurance and Practice Parameters (Mercy Conference), the National Guideline Clearinghouse summary of the 1998 Council on Chiropractic Practice Guideline entitled Vertebral subluxation in chiropractic practice, a pair of AAEM Literature Reviews, entitled The Use of Surface EMG in the Diagnosis and Treatment of Nerve and Muscle Disorders and Dynamic Electromyography in Gait and Motion Analysis; the American Academy of Neurology study on Clinical utility of surface EMG; a report from Connie Coleman; two submissions from Dr. Jerome True, and a 2003 literature review, Surface EMG in Chronic Paraspinal Pain. Neither the Mercy Conference Guidelines nor the AAEM Surface EMG Literature Reviews contained any information or analysis more recent than 1993. Those documents did not reflect the current state of technology or understanding of SEMG, and could not form the sole bases for a rule based on SEMG’s demonstrated medical value and level of general acceptance in 2003. The National Guideline Clearinghouse summary of the 1998 Council on Chiropractic Practice Guidelines, and the American Academy of Neurology study on Clinical Utility of Surface EMG both provide support of the medical value for SEMG. As indicated, the 1998 Council on Chiropractic Practice Guidelines, which was subject to external peer review, and which even critics of SEMG recognize as being authoritative, determined that SEMG earned a rating of “established” “for recording changes in the electrical activity of muscles associated with vertebral subluxations” based on expert opinion, literature support, and controlled studies. The American Academy of Neurology study drew three conclusions, one of which was that Surface EMG “is an acceptable tool for kinesiologic (movement) analysis of movement disorders because it is a method for recording and quantifying clinically important muscle-related activity with the least interference on the clinical picture,” and confirmed its usefulness for several maladies, some of which result from automobile accidents. A report from Connie Coleman concluded that SEMG should not be in the rule, based on the American Academy of Neurology study, the AAEM Surface EMG Technology Literature Review, and a position paper authored by Aetna Insurance. Ms. Coleman’s report cannot be given any weight since she cited only the negative recommendations of the American Academy of Neurology study regarding SEMG, but omitted the third, positive recommendation from the study referenced above. Furthermore, as support for her recommendation to include spinal ultrasound in the rule, Ms. Coleman relied on the National Guidelines Clearinghouse document referenced above, which she stated was: a comprehensive database of evidence-based clinical practice guidelines and related documents produced by the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services, in partnership with the American Medical Association (AMA) and the American Association of Health Plans (AAHP). However, Ms. Coleman failed to note that the same National Guidelines Clearinghouse document gave SEMG a rating of established “for recording changes in the electrical activity of muscles associated with vertebral subluxations.” Of the two reports submitted by Dr. True, only one recommended that SEMG should have been on the list, with that recommendation based on a single journal article. Dr. True’s other submission mentioned SEMG, but made no specific recommendation regarding the test. However, Dr. True’s second submission did note that allegations of over utilization and abuse have “nothing to do with determining whether a test is medically valid.” Dr. True also relied on the Chiropractic Practice Guidelines and Parameters for the State of Florida, which recognize the medical validity of SEMG. Finally, David Marcarian, the developer and manufacturer of SEMG equipment, submitted several documents, including a literature review of journal articles ranging in dates from 1982 to 2002. The review discussed each of the journal articles, and concluded that “SEMG is a useful diagnostic tool in the evaluation of spine pain patients, and suggests that it be done routinely in cases where there is a need for disability and impairment determination.” The evidence did not demonstrate that Mr. Marcarian’s materials should be given less weight than older material containing dated information. The evidence submitted in this proceeding demonstrates a definite trend in both the understanding of the medical validity of SEMG and its acceptance by the chiropractic and medical community. Each of the 21 journal articles comprising Petitioner’s Exhibit 8, ranging in dates from 1988 to 2004, used SEMG as a tool to provide an objective measurement of muscle activity. Although many of the articles were focused on the muscular conditions leading to such conditions as low back pain, fibromyalgia, and whiplash disorders, rather than the clinical efficacy of SEMG itself, the fact that SEMG was so widely used as a measure of muscle activity is evidence of its medical value. Additionally, several of the articles focused on SEMG as a diagnostic tool in and of itself. Going back as far as 1988, researchers reported that “clear and consistent surface paraspinal EMG patterns can be discerned between differing groups of lower back pain patients and non-pain controls if the methodological limitations inherent in previous studies are corrected,” and concluded that “[t]he findings of the present study clearly point to the utility of differential diagnosis in lower back pain surface EMG studies,” and that “[r]esults strongly indicate that when careful attention is given to both diagnosis and position, surface EMG recordings can differentiate among the various types of lower back pain, as well as between those with and without lower back pain.” Electromyographic recordings of 5 types of low back pain subjects and non-pain controls in different positions, Arena, et al., "Pain", 37 (1989) pp. 63, 64. Through the early 1990s, researchers began noting the effect that technological advances were having on the medical efficacy of Surface EMG. Researchers during that period were recognizing that advances in surface electromyography (EMG) have prompted a renewed interest in examining the fatigue properties of back muscles. See Fatigue, recovery and low back pain in varsity rowers, Roy, et al., Medicine and Science in Sports and Exercise, vol. 22, no. 4, p. 463. As a result of those advances, those researchers concluded that “the EMG technique is able to correctly identify persons with LBP from two very different populations” [Id. at p. 467] and that “the results of this study have verified the usefulness of a surface EMG measurement technique to identify changes in back muscles that are characteristic of LBP in rowers . . . The technique may be useful to athletic trainers and other health professionals for evaluating the muscular component of LBP in their patients.” (Id. at 468). During that same period, researchers were beginning to conclude that, though not without limitations, "[e]lectromyo- graphic spectral analysis was shown again to be a highly sensitive and highly specific diagnostic test.” Comparison of Spinal Mobility and Isometric Trunk Extensor Forces with Electromyographic Spectral Analysis in Identifying Low Back Pain, Klein, et al., Physical Therapy, vol. 71, no. 6, p. 41 (1991). Other groups noted that contemporaneous research studies “have also shown the reliability of dynamic EMG measurements of paraspinal low back muscles,” and concluded that “[w]e believe that [EMG] is an invaluable aid in detecting and objectifying disturbed function in paraspinal muscles in back pain patients and in general disability. This agrees with recent research which indicates that kinetic EMG patterns (in contrast to static levels) may best show the complex biomechanical events in the lumbar region.” Electric Behavior of Low Back Muscles During Lumbar Pelvic Rhythm in Low Back Pain Patients and Healthy Controls, Sihvonen, et al., Arch. Phys. Med. Rehabil., vol. 72, pp. 1080, 1086 (1991). By the mid to late 1990s, the continuing research, though still recognizing that there were things left to learn, was becoming more conclusive as to the value of SEMG. In 1997, researchers funded by the Department of Veterans’ Affairs stated that “[w]e predict that in the future the concept of surface EMG- based imbalance or load sharing parameters may provide the clinician with important person-specific information already in the acute stage of the injury, to help prevent the development of a chronic disability. Surface EMG provides us with a powerful, noninvasive tool to investigate the status and function of muscles.” Development of new protocols and analysis procedures for the assessment of LBP by surface EMG techniques, Oddsson, et al., Journal of Rehabilitation Research and Development, vol. 34, no. 4, p. 425 (1997). During that same year, researchers in California studying muscular electrical signals, noted the technological advances that were serving to make SEMG more effective. In their study, they found that “[s]uccessful myoelectric recording with surface electrodes during dynamic exercise of the low back is relatively recent. This is largely due to the recent development of small high-competence preamplifiers located close to the muscle which reduces the electronic artifact during dynamic activity to allow analysis of the myoelectric signal.” Relationships Between Myoelectric Activity, Strength, and MRI of Lumbar Extensor Muscles in Back Pain Patients and Normal Subjects, Mooney, et al., Journal of Spinal Disorders, vol. 10, no. 4, p. 354 (1997). By the early 2000s, SEMG was becoming established as a reliable and valuable tool in the assessment and diagnosis of automobile related injury. In a peer-reviewed study regarding whiplash-associated disorders (WAD), the authors concluded that: Patients with whiplash associated disorder Grade II can be distinguished from healthy control subjects according to the presence of cervical muscle dysfunction, as assessed by surface electromyography of the upper trapezius muscles. Particulary the decreased ability to relax the trapezius muscles seems to be a promising feature to identify patients with whiplash associated disorder Grade II. Assessment of the muscle (dys)function by surface electromyography offers a refinement of the whiplash associated disorder classification and provides an indication to a suitable therapeutic approach. Cervical Muscle Dysfunction in the chronic Whiplash Associated Disorder Grade II (WAD II), Nederhand, et al., Spine, vol. 25 (15), p. 8 of 10 (2000). The authors noted that “the use of palpation to assess either muscle point tenderness or muscle spasm is questionable because manually tested musculoskeletal signs have shown poor interexaminer reliability, and very little is known about its diagnostic validity.” Id. The authors found that “SEMG as a measure of the inability to relax the upper trapezius muscles may be useful in diagnostic testing. In the literature this feature was shown to be related to cervical pain and muscle fatigue and therefore supports the clinical importance of this study’s findings.” Id. at p. 8 of 10. Also in 2000, researchers, while still recognizing the lack of absolute precision with all manner of electro-diagnostic testing (including X-rays, MRIs, CT scans, myelograms), stated that “surface electromyography (SEMG) is a non-invasive method of analysis of the degree of muscular activity and function.” Chronic Low Back Pain Assessment Using Surface Electromyography, Ambroz et al., JOEM, vol. 42, no. 6, p. 661 (2000). In recognition of the advances in technology, the authors noted that “[r]ecent technological advancement has overcome the previous limitations of data acquisition and processing.” Id. at 661. That study, while noting the need for accounting for physical conditions including body fat, and recognizing the advantages of further testing and study, made the following findings: More recent investigations have found a significant relationship between pain and SEMG-measured muscle activity in the upper and lower back and have suggested that SEMG can be a valid tool for objectively assessing LBP. Also, although Biederman questioned the reliability of SEMG reading in biofeedback research, two subsequent studies addressing the validity of this technique reported good reliability for the static and dynamic SEMG activities in the assessment of CLBP. By using a rigorous matching protocol that included BMI [body mass index], our study demonstrated a statistically significant difference between CLBP patients and pain free controls. Thus, the results of this study support the previous investigations suggesting that SEMG is a useful diagnostic tool in the assessment of CLBP. Furthermore, in this study the use of one of the latest and more technologically advanced semi devices available has contributed to a more reliable collection and processing of this data, giving more strength to this analysis. Finally, in 2004, the evidence regarding the medical value of SEMG demonstrates that it has achieved a full level of general acceptance. In a study released in June 2004, the authors concluded that “[s]urface electromyography has been shown to be useful in the evaluation of spine pain in much the same way that EKGs have become indispensable for chest pain evaluation. SEMG testing is easy to do, inexpensive, has no morbidity, and provides important information for the pain practitioner.” Objective Documentation of Spine Pain, Ambroz, et al., Practical Pain Management, May/June 2004, p. 36 Thus, it is clear that the evidence in this case demonstrates that there was no “lack” of demonstrated medical value to SEMG, but, that SEMG has a level of general acceptance for use in the treatment of patients by the relevant provider community. The real dispute in this case is how often SEMG is used in the relevant provider community. Therefore, the inclusion of SEMG in Florida Administrative Code Rule 64B-3.004 exceeds the Department’s grant of rulemaking authority, enlarges, modifies, or contravenes the specific provisions of Section 627.736(5)(b)6., Florida Statutes, and is arbitrary and capricious.
The Issue At issue in this proceeding is whether Emmanuel Theodore, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Fundamental findings Christian Theodore is the father and natural guardian of Emmanuel Theodore (Emmanuel), a minor. Emmanuel was born a live infant on September 15, 1991, at St. Mary's Hospital, a hospital located in West Palm Beach, Florida, and his birth weight was in excess of 2500 grams. The physician providing obstetrical services during the birth of Emmanuel was Annie Dawn-Marie Graham, M.D., who was, at all times material hereto, a participating physician in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. Coverage under the Plan Pertinent to this case, coverage is afforded under the Plan when the claimant demonstrates, more likely than not, that the infant suffered an "injury to the brain or spinal cord . . . cause by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." Sections 766.302(2) and 766.309(1)(a), Florida Statutes. Here, the parties argued, at hearing, that Emmanuel's neurologic motor status was most likely dispositive of the subject claim. Consequently, no proof was offered regarding his mental status and, given the conclusions which follow, it was unnecessary to address whether any untoward events occurred during the course of Emmanuel's birth. Emmanuel's neurologic motor status On November 7, 1996, following the filing of the claim for compensation, Emmanuel was examined by Michael Duchowny, M.D., a board certified pediatric neurologist. Dr. Duchowny's examination of Emmanuel's neurological motor status revealed normal muscle strength, bulk, and tone; no unusual movements or weakness of the lymphs or trunk; and, no muscle atrophy. Hands were held in a very steady fashion without posturing, and Emmanuel completed finger-to-nose and other tasks of coordination without difficulty. Fine motor coordination was similarly intact, without asymmetries. Finally, muscle strength with respect to gait was noted as normal and, despite prominent pes planus (flat feet), there were no difficulties in Emmanuel's ability to stand and walk. In Dr. Duchowny's opinion, which is credited, Emmanuel's motor status was normal, or, stated otherwise, he evidenced no physical impairment.
The Issue The issue is whether Respondent practiced medicine within the applicable standard of care, as required by Section 458.331(1)(t), Florida Statutes, and, if not, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 30404. He earned his medical degree in 1974. Respondent has been Board-certified in the specialty of internal medicine since 1977 and in the subspecialty of cardiovascular disease since 1981. At the time of the incident in question, Respondent was a staff cardiologist with the Cleveland Clinic Florida, which is located in Fort Lauderdale. At present, he is an attending cardiologist with the Broward General Medical Center, which is located in Fort Lauderdale. H. T., a 58 year-old male, was scheduled for a spinal fusion on January 5, 1993, at the Cleveland Clinic Florida. This back surgery was expected to take 8-10 hours. Although the surgery was not an emergency, H. T. was suffering from complex pain that was worsened by standing, walking, and bending forward and was intensifying with time. Dissatisfied with his current level of functioning, H. T. was a suitable candidate for back surgery, based on his symptoms and diagnosis. On December 30, 1992, H. T., now suffering "severe" lower back pain, reported to the Cleveland Clinic Florida for a preoperative evaluation. He took a resting electrocardiogram (EKG). The computer program that interpreted the results identified a possible inferior myocardial infarction of an undetermined age and a possible left atrial enlargement. Another cardiologist with the Cleveland Clinic Florida, Dr. Vincent Font, examined the computer-generated interpretation and did not reject it. The radiology report from the December 30, 1992, examination was completed by Dr. Robert J. Hyman of the Cleveland Clinic Florida. The report notes that H. T.'s heart was enlarged. Due to the results of the preoperative evaluation done on December 30, 1992, H. T. had to obtain a cardiac clearance before his back surgery on January 5, 1993. Thus, on January 4, 1993, H. T. presented to Respondent at the Cleveland Clinic Florida to obtain a cardiac clearance. On January 4, 1993, H. T. provided Respondent with a history of 60 pack-years of cigarette smoking, which had been discontinued two months earlier. Respondent's blood pressure was 196/98. He stood five feet, eleven inches, and weighed 192 pounds. Based on the values considered normal at the time, H. T.'s blood pressure was somewhat elevated and his weight was somewhat excessive. However, H. T.'s only significant cardiac risk factors were his history of cigarette smoking and, to a lesser extent, his age. Respondent administered a stress EKG on January 4, 1993. The report states: This patient had uneventful pre-exercise maneuvers and then had a sub-maximal level exercise performance limited by left leg pain. He exercised for 6 min. according to the modified Bruce protocol. Patient attained a maximum heart rate of 124 bpm which was 76% of the maximum predicted heart rate of 162 bpm. There was exaggerated blood pressure reaching a maximum of 242/104 during peak exercise. Test was terminated because of leg and back pain. There was no ventricular hypertrophy with upsloping ST segment depression of about 2 mm. in the inferior and lateral leads, consistent with secondary changes due to LVH. Post-exercise recovery phase was uneventful. Respondent added the following clinical impressions to the report: No chest pain during exercise. Adequate functional capacity limited by left leg pain. Abnormal EKG due to left ventricular hypertrophy with secondary ST T-wave abnormalities. The most important part of Respondent's physical examination of H. T. was his observation of the exercise stress test. At no time during or after the test did H. T. exhibit any sign of cardiac insufficiency, such as shortness of breath or pallor. Nor did H. T. experience any pain in the front of his chest. Respondent also examined H. T.'s medical records, in which H. T. reported a cerebrovascular accident, seizures, and a transient ischemic attack. However, this history was contradicted by other history provided by H. T. ten weeks earlier, at which time H. T. had denied any history of convulsions or strokes. Discussing the history with H. T., Respondent learned that H. T. had erroneously indicated that he had suffered these three conditions. After examining the relevant information, Respondent concluded that, within a reasonable degree of medical probability, H. T. was appropriate, from a cardiac perspective, for serious orthopedic surgery. In his consultation report, Respondent noted that H. T. denied any history of hypertension, and Respondent suggested that H. T.'s blood pressure was high due to anxiety over surgery. The report also notes that H. T. denied chest pain at rest or under exertion and also denied shortness of breath or other symptoms of heart failure. Regarding the electrocardiogram, the consultation report states that H. T. displayed a normal sinus rhythm and his septal Q-saves were consistent with early left ventricular hypertrophy, which was consistent with possible mild hypertensive heart disease. Regarding the stress EKG, the consultation report states that H. T. achieved exaggerated blood pressure response with frequent premature atrial contractions, although these were of minor significance. The report notes that the EKG pattern was characteristic of left ventricular hypertrophy with secondary ST T-wave abnormality. The report suggests that H. T. have his blood pressure rechecked. Central to Respondent's cardiac clearance of H. T. for extensive back surgery was the fact that the stress EKG subjected H. T. to more stress than he would experience during and after surgery, the test adequately raised H. T.'s blood pressure, and the EKG returned to normal once H. T.'s blood pressure returned to normal. Respondent placed considerable emphasis on H. T.'s cardiac response to six minutes' stress, under the modified Bruce protocol, without experiencing pain. Respondent terminated the test due to leg pain that was consistent with the symptoms to be alleviated by the back surgery. After Respondent cleared H. T. for back surgery, the surgery took place on January 5, 1993. H. T. emerged from 11 hours of surgery in stable condition. When he awakened postoperatively, H. T. followed commands and spoke with his wife. However, early the next morning, H. T. suffered respiratory depression. His treating physician withdrew the morphine that H. T. had been receiving; after responding well, H. T. again exhibited respiratory depression, rapidly followed by respiratory arrest. H. T. fell into a coma, secondary to a deprivation of oxygen to the brain. However, he did not exhibit signs of an acute myocardial infarction and never displayed any signs suggesting that he had not tolerated the surgery well from a cardiac perspective. After the withdrawal of certain life- support interventions, H. T. died on January 22, 1993. An autopsy took place about seven hours after H. T. died. The autopsy found that all three major vessels constituting the coronary arteries were more than 90 percent occluded. However, a serial section of the myocardium did not reveal definite recent or remote infarcts. The medical examiner concluded that there was "no clear cut finding to explain the course of [H. T.]" and that further examination of abnormalities in the heart and brain would be necessary. Subsequent examination of the heart resulted in findings of, among other things, "severe" coronary atherosclerosis with 90 to 95 percent narrowing and concentric left ventricular hypertrophy. A cardiologist performing a cardiac clearance must take the patient's history, perform a physical examination, examine relevant medical records, and finally evaluate the patient and stratify the cardiac risk posed by the subject surgery. Respondent performed all of the necessary steps of a cardiac clearance in evaluating the likelihood that H. T. could undergo extensive back surgery without serious cardiac complications. The abnormalities in H. T.'s EKG during the stress test most likely suggested the presence of left ventricular hypertrophy, not a myocardial infarction. Left ventricular hypertrophy is consistent with several other factors suggestive of longstanding hypertension. Moreover, a cardiac clearance for noncardiac surgery is generally appropriate if the patient, as did H. T., completes six minutes of the stress test, elevates his blood pressure and pulse, experiences no chest pain, and displays no pallor. The cardiac clearance of such a patient is appropriate even though he suffers from an underlying cardiac disease. The postmortem findings of atherosclerotic disease do not establish functional cardiac disease. The postmortem findings cannot assess the extent of occlusion of vessels under pressure, as opposed to vessels no longer under pressure. Also, the postmortem findings do not assess the vulnerability of the plaque. Petitioner has failed to prove that Respondent's cardiac clearance of H. T. deviated from the applicable standard of care. H. T. required intensive back surgery to obtain relief from severe pain. The abnormalities reported in the resting EKG did not suggest a recent myocardial infarction. The abnormalities in the stress EKG likely revealed a thickening of the left ventricle, probably resulting from hypertension. These findings did not necessitate additional cardiac testing before clearing H. T. for extensive back surgery. Most significantly, H. T. underwent the rigors of the stress EKG without significant cardiac symptoms. An experienced cardiologist, Respondent assessed H. T.'s cardiac function under conditions that approximated the stress of the spinal fusion. Later, undergoing the surgery, Respondent suffered no cardiac problems. Even if Petitioner had proved an underlying cardiac condition, such as severe occlusion or a myocardial infarct, Petitioner did not prove that these conditions precluded H. T. from obtaining much-needed back surgery prior to resolving any and all underlying cardiac conditions.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint against Respondent. DONE AND ENTERED this 5th day of November, 2001, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 5th day of November, 2001. COPIES FURNISHED: Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701 John E. Terrel, Senior Attorney Agency for Health Care Administration Post Office Box 14229 Mail Stop 39-A Tallahassee, Florida 32317-4229 Paul R. Regensdorf Akerman, Senterfitt & Eidson, P.A. Las Olas Centre II, 16th Floor 350 East Las Olas Boulevard Fort Lauderdale, Florida 33301
The Issue At issue in this proceeding is whether Thalya Greene, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Fundamental findings Daniel Greene and Lizbeth Greene, are the parents and natural guardians of Thalya Greene (Thalya), a minor. Thalya was born a live infant on August 27, 1998, at Baptist Medical Center, a hospital located in Jacksonville, Florida, and her birth weight was in excess of 2,500 grams. The physician providing obstetrical services during Thalya's birth was R. William Quinlan, M.D., who was, at all times material hereto, a participating physician in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. Thalya's birth At or about 4:35 a.m., August 27, 1998, Mrs. Greene (with an estimated date of confinement of September 19, 1998, and the fetus at 36+ weeks) presented to Baptist Medical Center in early labor. Vaginal examination revealed the membranes to be intact, and the cervix at 3 centimeters dilatation, effacement at 50 percent, and the fetus at station -2. External fetal monitoring applied at 4:37 a.m., reflected a reassuring fetal heart tone, and Mrs. Greene was admitted to labor and delivery at or about 4:40 a.m. Mrs. Greene's labor progressed steadily, and external fetal monitoring reflected a reassuring fetal heart tone throughout the course of labor and delivery. At or about 7:30 a.m., dilatation was noted as complete; at 7:49 a.m., the membranes were artificially ruptured, with clear fluid noted; and at 7:55 a.m. Thalya was delivered spontaneously (cephalic presentation) without incident. On delivery, Thalya was noted as "pale blue" in color, and was bulb suctioned and accorded free flow oxygen; however, she breathed spontaneously, and did not require resuscitation. Initial newborn assessment noted no apparent abnormalities. Apgar scores were recorded as 7 at one minute and 8 at five minutes. The Apgar scores assigned to Thalya are a numerical expression of the condition of a newborn infant, and reflect the sum points gained on assessment of heart rate, respiratory effort, muscle tone, reflex irritability, and color, with each category being assigned a score ranging from the lowest score of 0 through a maximum score of 2. As noted, at one minute, Thalya's Apgar score totaled 7, with heart rate, muscle tone, and reflect irritability being graded at 2 each; respiratory effort being graded at 1; and color being graded at 0. At five minutes, Thalya's Apgar score totaled 8, with heart rate, respiratory effort, muscle tone, and reflex irritability being graded at 2 each, and color again being graded at 0. Thalya was admitted to the newborn nursery at or about 8:50 a.m. Assessment on admission was grossly normal. Thalya's status post-delivery was uneventful until 11:30 a.m. (approximately 3 1/2 hours after delivery) when she experienced a choking episode (secondary to spitting up) and turned dusky over the face and chest. In response, Thalya was placed under a radiant warmer, suctioned, and given blow by oxygen (for approximately 3 minutes) until she pinked up. Thereafter, Thalya's course was again uneventful until 1:00 a.m., August 28, 1998, when she again appeared dusky, and was accorded blow by oxygen. At the time, it was noted that the CBC drawn during the first dusky spell was within normal limits and that the blood culture that had been obtained was preliminarily negative. Thereafter, Thalya's course was again without apparent complication until approximately 10:23 p.m., when she "became dusky not associated with feed," and was again suctioned and accorded blow by oxygen. At that time, Thalya was noted as "pink and intermittently tachypneic with rare grunting." Following neurologic consult, Thalya was transferred to the neonatal intensive care unit (NICU) for further observation and management. Thalya was received in the NICU at 10:34 p.m. At the time, she was observed as "warm and pink with grunting noted." EKG leads were applied and revealed a heart rate of 180, respiratory rate of 50, blood pressure of 76/49, and a rectal temperature of 100.3. Examination revealed nystagmus (an involuntary rapid movement of the eyeball) and some jerky movements of her extremities. CBC showed a white blood count of 5,000, and blood culture was ordered. Working diagnosis was "suspected septis" and Thalya was started on ampicillin and gentamicin. At 12:35 a.m., August 29, 1998, Thalya evidenced symptoms of seizure activity, and was loaded with phenobarbital. Spinal tap of August 29, 1998, as well as the results of the blood culture drawn of August 28, 1998, was positive for Group B Streptococcus. An infectious disease consult was obtained and Thalya was managed on antibiotics for three weeks, and maintained on phenobarbital for her seizure activity. CT and MRI of the head on August 29, 1998, were normal; however, a head ultrasound of September 3, 1998, showed minimal intra-axial fluid. Chromosomal studies were normal. Thalya was discharged to her parents' care on September 15, 1998, on phenobarbital and ampicillin. Final diagnosis on discharge included bacterial infection due to Streptococcus, Group B; streptococcal meningitis; and seizures. Thalya's subsequent development Following her discharge from Baptist Medical Center, Thalya was initially followed by Carlos H. Gama, M.D., a pediatric neurologist. Dr. Gama's first neurological examination occurred on November 3, 1998, when Thalya was 2 months of age, and was reported as follows: I had the opportunity of seeing Thalya for a neurological evaluation. The following are my diagnosis and recommendations. Diagnosis: Status post neonatal Group B Streptococcal meningitis. Seizures. Hypotnia. Recommendations: Obtain EEG. Obtain trough Phenobarbital level. Obtain records. Return to this office in one month for reevaluation and further recommendations. Comments: * * * . . . Since discharged from NICU mother reports that Thalya had done well. She is feeding well and thriving. No seizures have been noted. She continues on Phenobarbital, taking 4mls po bid. A blood level was obtained prior to this visit but this result is not available. Mother reports that Thalya has normal awake and sleep cycles. She seems to be moving all extremities spontaneously and symmetrically. There has not been any apneic spells or unusual behaviors suggestive of seizure like activity . . . . The examination today reveals a head circumference is 40.5cm (in the 90th percentile). Her weight is in the 90th percentile and height is in the 50th percentile. The baby is alert. She is able to turn her eyes to light, but does not track the examiner in a 90 degree range. The pupils were equal and reactive. Red reflex was present bilaterally. Facial grimace was symmetric. Suck was appropriate. Strength seems to be grossly unremarkable. Deep tendon reflexes were +2 in the upper extremities, +3 in the lower extremities at the knees and +2 at the ankles. No clonus was seen. Babinski's were present bilaterally. There was evidence of hypotonia of her axial musculature, being approximately moderate in severity. There was also decrease in head control. The patient's moro reflex reveals appropriate abduction of her upper extremities symmetrically. Traction response was decreased. Tone and neck reflex was absent. Palmar and Plantar reflexes were present. Muscle tone was low. The sensory examination to touch seemed to be unremarkable. Spine examination was noncontributory. The patient has no obvious dysmorphic features, organomegalies or skin abnormalities. Anterior fontanel was open and normal tense with no musculatures. Therefore, it is my opinion that Thalya has a history of neonatal Group B Streptococcal meningitis and sepsis associated with seizures. She is now seizure free. Her examination is remarkable for hypotonia, which most likely is on central basis. Therefore, the above recommendations were made. She will be reassessed in one month in this office. The EEG (Electroencephalogram) recommended by Dr. Gama was obtained on November 9, 1998, and read as abnormal. Specifically, the EEG report noted: This EEG is abnormal because of mild background disorganization which was seen bilaterally but more prominently over the right hemisphere, especially in the frontal region. This finding suggest[s] a diffused cerebral dysfunction such as seen in mild encephalopathy. In addition, a structural lesion in the right hemisphere cannot be excluded. Thalya was next seen by Dr. Gama on December 7, 1998. The results of that examination were reported as follows: Diagnosis: Seizure disorder. Stable on Phenobarbital. S/P [status post] Bacterial Group B Streptococcal Meningitis. Hypotonia. Developmental delay. Abnormal EEG. * * * Comments: . . . Thalya continues to be active. She is feeding well and gaining weight properly. She is making more cooing sounds and attempting to roll over, but she has not been successful in this area. Her examination demonstrates that her head circumference is 42cm. She is alert. She follows the examiner. Her pupils are equal and reactive. Face is unremarkable. She does seem to stick her tongue out intermittently. The motor examination demonstrates that she has decrease traction and head control for her age. She also has a tendency to keep her hands fisted, but this is only intermittently. She does not reach for objects yet. She is unable to hold weight in her lower extremities. Muscle tone seems to be slightly decreased in the axial musculature in particular. Therefore, it is my recommendation that we proceed with an MRI of the brain to rule out structural abnormalities of the right hemisphere.1 In addition, we have discussed the treatment with Phenobarbital. This should be continued for at least six months before making any further recommendations . . . She will be reassessed in this office in 1-2 months. Dr. Gama's next neurological examination of Thalya occurred on January 12, 1999, and was reported as follows: Diagnosis: Seizure disorder. Stable on Phenobarbital. S/P bacterial group B streptococcal meningitis. Hypotonia. Improving. Borderline developmental delay. Abnormal EEG * * * Comments: Thalya is doing extremely well. She is getting physical therapy twice a week and making progress. She is more attentive. She follows the examiner in a 180 degree range. She has good social skills. Anterior fontanel is soft. Head circumference is 44cm which is slightly above the 90th percentile, but she has been growing parallel to this with no problems. Cranial nerve examination is unremarkable. Motor examination demonstrates that she is unable to put weight in lower extremities, otherwise, she moves all extremities spontaneously. Deep tendon reflexes were unremarkable. No obvious pathological reflexes were elicited during today's visit. Muscle tone was normal to low. Denver Developmental Screen test reveals that she seems to be appropriate for her age in most of the areas. However, she is unable to roll over but she is showing some attempts to do this. The rest of the examination was noncontributory. Thalya was last seen by Dr. Gama on April 29, 1999, and he reported the results of that follow-up neurological examination as follows: Diagnosis: Seizure disorder. Stable on Phenobarbital. S/P Bacterial Group B Streptococcal Meningitis. Hypotonia. Improved. Comments: Thalya continues to do extremely well, with no recurrent seizures. She is tolerating the medication properly . . . . The patient continues to make progress in her development. The examination today demonstrates that her head circumference is 46.7cm. She is maintaining this in the 90th percentile. She has no obvious focal or lateralizing deficits. Her muscle tone has improved considerably and she is gaining milestones appropriately. She was felt to be at her age level in most of the areas tested . . . . Thalya's subsequent neurologic development was followed by Joseph A. Cimino, M.D., a board-certified pediatric neurologist. Dr. Cimino reported the results of his first neurological examination by October 15, 1999, as follows: DIAGNOSES: 1) GBS meningitis/sepsis. Neonatal seizures. Static encephalopathy with motor and language delay. * * * DEVELOPMENTAL HISTORY: The history is obtained from the parents. The child rolled from front to back at 7 months, back to front at 8 months, sat at 7 to 8 months, crawled at 11 months. She was getting in to sitting at 10 to 11 months, pulled to stand at 12 months, began to cruise at 13 months, is not yet walking independently, says mama but not specifically, does not say dada nor does she wave hi or bye. She began physical therapy at 3 months of age and this was initially twice a week and 1 month ago was decreased to once a week. She is not in speech therapy, although the family states the EIP evaluation at 10 months showed she had a receptive language at 4 months. The concern is that audiological evaluation have shown some missed frequency hearing deficit. * * * PHYSICAL EXAMINATION: The head circumference is 48 1/4 cms which is between the 75th and 98th percentile for chronologic age of 14 months. GENERAL EXAM: On inspection this is a well- nourished, healthy youngster who is alert and attentive. The abdomen was soft and nontender without organomegaly. The cardiovascular exam revealed regular rate and rhythm and no murmurs were appreciated. No cranial bruits are noted. The extremities were normal. The lungs were clear to auscultation. The skin exam was without café au lait spots or hypopigmented macules. The spine was without hair tufts or dimpling. In observing this child crawl and again reaching for objects I did not see any focality, nothing to suggest an old infarction which may be a complication of neonatal bacterial meningitis. In addition a CT scan was reported as negative. NEUROLOGICAL EXAM: The child is very social and attentive with good reciprocal play with a puppet. She smiled quite easily. Although with hands-on evaluation she did become irritable and cried. Assessment of tone was quite difficult. She tracked very nicely with full extraocular movements no ophthalmoparesis or nystagmus. The pupils were equal and reactive to light and facial movements were symmetric. I was not able to get an adequate look at the fundi. Corneal reflexes were intact. With regards to the motor exam, she reached quite nicely for objects without preference. She in fact did crawl well, transitioned into a sitting position but did W sit, usually associated with low muscle tone. With hands-on exam it was very difficult as she was crying and had a lot of active resistance to know exactly the status of her tone. She pulls to stand with a mature pattern with hip flexion. She sat quite nicely with her back straight, able manipulate objects. She did not slip through my grip on vertical suspension. Her deep tendon reflexes were 2/4 and symmetric in both the upper and lower extremities. The sensory exam was grossly intact to pain. IMPRESSION: GBS meningitis/sepsis . . . early onset. Neonatal seizure without recurrence, successfully tapered off of Phenobarbital. Prematurity 36 weeks gestation. Language delay. I think at 13 months adjusted age she should be saying mama and dada specifically, have more jargoning, waving hi and bye, and say several other words in addition to mama and dada which are used specifically. There is clearly risk of hearing deficit given meningitis and the use of Gentamicin and this child needs to be followed closely. History of motor delay. Clearly rolling at 6 months adjusted age is delayed. Sitting at 6 to 7 months adjusted age is normal, the family gave a chronologic age of 7 to 8 months but at 36 weeks gestation it is fair to make a 1 month adjustment which I am assuming they would do at EIP. She began to cruise at 13 months chronologic age which is 1 year. Her adjusted age is now 13 months and clearly walking independently can be normal up to 18 months at the outside limits. She appears to be making nice improvement in this area . . . . Thalya was next seen by Dr. Cimino on May 1, 2000, and most recently on November 10, 2000. Dr. Cimino reported the results of his most recent follow-up examination as follows: DIAGNOSES: 1) GBS meningitis. Neonatal seizures. Prematurity 36 weeks gestation Language delay. CLINICAL HISTORY: This is a 2 year old female seen in follow up on 5/1/2000. At that time she was having episodes of spacing out. We obtained an EEG that was normal for the awake and sleep state. Because of the GBS meningitis and developmental delay we obtained an MRI also done in September that was normal. She underwent a speech evaluation on 6/23/2000 that showed auditory comprehension at 9-12 months, verbal expression at 6-9 months. Impression was overall global delay and she has been in speech therapy twice a week at Brook's Rehab. Her chronologic age at the time of the evaluation was 22 months. At this time she began to walk at 15 months. She says mama and specifically, dada non- specifically. She will repeat words but does not have a lot of spontaneous words. She does wave hi and bye. PHYSICAL EXAMINATION: The head circumference is 50 1/4 cms which is between the 75th and 98th percentile. This continues to grow at the same rate. She is crying and extremely uncooperative. She is very frightened by many of her past appointments. She did track, had full extraocular movements without nystagmus or ophthalmoparesis. Her facial movements do appear sysmetric. Tone is low even with her resisting. She ran to her mother, I did not see any abnormalities. Her gait certainly was not wide based. She seemed to get off the floor well. Her sensory exam was grossly intact to pain. The deep tendon reflexes were difficult due to her withdrawal. IMPRESSION: Status-post Group B strep neonatal meningitis with neonatal seizure without recurrence. Language delay. Most likely reflecting sequela of the meningitis. There is a good percentage of these children who do have severe deficits. However, the EEG and MRI did not show any abnormalities. There is no slowing of the background activity and no decrease or delay in myelination reported on the MRI. PLAN: . . . Continue speech therapy . . . Reassess in 6 months. The cause of Thalya's neurologic dysfunction Regarding the cause of Thalya's neurological dysfunction, the proof is compelling that during labor and delivery Mrs. Greene was vaginally infected with Group B Streptococcal (GBS), that during delivery the infection was transmitted to Thalya, and that over the next 24 to 48 hours the infection process rapidly progressed causing meningitis and the resultant brain injury. Consequently, it may be said that Thalya's neurologic dysfunction is associated with a brain injury caused by meningitis (an inflammation of the membranes that envelop the brain and spinal cord), secondary to a GBS infection acquired during the birthing process (most likely subsequent to rupture of the membranes and during the course of delivery). The dispute regarding compensability As a touchstone to resolving the dispute regarding compensability, it is worthy of note that the Plan establishes a no-fault administrative system that provides compensation for an infant who suffers a narrowly defined "birth-related neurological injury." Under the Plan, a "birth-related neurological injury" is defined as: [I]njury to the brain or spinal cord of a live infant weighing at least 2,500 grams at birth caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired. Section 766.302(2), Florida Statutes. Here, there is no serious dispute that Thalya is neurologically impaired or that such impairment is attributable to a brain injury caused by the infection process discussed infra. Rather, what is at issue is whether the cause of Thalya's brain injury and the nature of her impairment fit the narrowly defined term "birth-related neurological injury." In this regard, it is Intervenor's view that Thalya's brain injury (occasioned by an infectious process) may reasonably be described as having been "caused by mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period," and that such injury rendered her "permanently and substantially mentally and physically impaired." Conversely, Petitioners and Respondent are of the view that that the cause of Thalya's brain injury was not a "mechanical injury," and that she was not rendered "permanently and substantially mentally and physically impaired." Of the two, Petitioners' and Respondent's view is by far the more compelling. The nature and timing of Thalya's injury To address the nature and timing of Thalya's injury, the parties offered the opinions of three physicians: Charles Kalstone, M.D., a physician board-certified in obstetrics and gynecology; Joseph Cimino, M.D., a physician board-certified in pediatric neurology; and James Perry, M.D., a Fellow of the American Academy of Neurology. (Joint Exhibits 2-4). Notably, these physicians shared strikingly similar views, and were of the opinion that Thalya's brain injury was caused by infection induced meningitis, a process distinguishable from an injury caused by oxygen deprivation or mechanical injury. Stated otherwise, the physicians were of the opinion that Thalya's injury could not reasonably be described as having been caused by oxygen deprivation or mechanical injury.2 Given the plain and ordinary meaning of the words used in the term "mechanical injury" (as physical harm or damage caused by machinery, tools, or physical forces), their conclusion was most reasonable.3 Consequently, it is resolved that Thalya's brain injury was not caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period. Thalya's current mental and physical presentation At hearing, the only authoritative proof offered with regard to Thalya's current mental and physical presentation was the testimony of Dr. Cimino, Thalya's pediatric neurologist. It was Dr. Cimino's opinion that while Thalya may evidence substantial cognitive impairment, she does not evidence substantial physical impairment. Such opinions are grossly consistent with the record and are credited.
The Issue At issue in this proceeding is whether Travis Chestnut, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Fundamental findings Treena Chestnut and Terrance Chestnut are the parents and natural guardians of Travis Chestnut (Travis), a minor. Travis was born a live infant on July 26, 1994, at University Medical Center, a hospital located in Jacksonville, Florida, and his birth weight was in excess of 2,500 grams. The physician providing obstetrical services during the birth of Travis was James Lewis Jones, M.D., who was, at all time material hereto, a participating physician in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. Mrs. Chestnut's antepartum course and Travis' delivery Prior to Mrs. Chestnut's admission to University Medical Center, her prenatal course had been essentially uncomplicated. Notwithstanding, she was noted at risk because of a prior cesarean section delivery for fetal distress, and when admitted Travis was slightly post-term at 41.5 weeks. At or about 2:00 a.m., July 25, 1994, Mrs. Chestnut was admitted to University Medical Center. At the time, Mrs. Chestnut was noted to be in labor, and vaginal examination revealed the cervix to be at 2 centimeters, effacement at 100 percent, and the fetus at station 0 with vertex presentation. The membranes were noted to be intact, and fetal heart tone was noted at 135 to 145 beats per minute, with good fetal movement. At 8:45 a.m., an epidural was inserted for analgesia, and at 9:05 a.m. Mrs. Chestnut's membranes spontaneously ruptured, with clear fluid noted. Vaginal examination revealed the cervix to be at 2 to 3 centimeters, effacement at 100 percent, and the fetus at station 0. A scalp electrode was placed, and fetal heart tone was noted to continue in the 135 to 145 beat per minute range. Mrs. Chestnut's labor progressed slowly through July 25, 1994. During that period, fetal heart tones evidenced good beat to beat variability (short-term and long-term) with accelerations and occasional variable decelerations. Commencing at or about 2:00 a.m. July 26, 1994, late decelerations were noted, and fetal heart tones began to demonstrate, with increasing intensity and duration, early variable and late decelerations, with rates as low as the 70's, as well as fetal tachycardia. At approximately 2:25 a.m., dilation was noted as complete, and Mrs. Chestnut was instructed to push. At 2:28 a.m. a supplemental dose of epidural analgesia was administered, and at 2:34 a.m. deep variable decelerations were noted and Mrs. Chestnut was taken, via bed, to the delivery room. Mrs. Chestnut was noted in the delivery room at 2:39 a.m., at which time fetal heart rate was recorded in the 90's, and she was prepared for delivery. Mrs. Chestnut continued to push, and fetal heart tone remained in the 90's. Three attempts to deliver the infant by vacuum were attempted and failed. Fetal heart tone dropped to the 80's and a scalp pH performed at 2:54 a.m. was 6.95 (reflective of fetal acidosis). Given the circumstances, an emergency cesarean section was ordered, the incision started at 3:00 a.m., and Travis was delivered at 3:05 a.m. During delivery, difficulty was experienced elevating the infant's head, as he was deep in the pelvis, and a cord prolapse was noted. On delivery, Travis was atonic, with a heart rate of less than 60 and no respiratory effort. He was dried for 10 seconds, then begun on positive pressure ventilation with bag and mask. Heart rate increased to greater than 100 within 10 seconds, and color became pink within 20 seconds. Travis required support until 10 minutes of age, when regular sustained respiratory effort was noted. First gasp occurred between 1 and 2 minutes of age, and was progressively more frequent through 15 minutes of age. Shallow regular respirations began at about 5 minutes of age, and were adequate and sustained by 10 minutes of age. Slight tone was developed in the extremities by 10 minutes, and spontaneous movement of the extremities developed by 12 minutes. Apgars were 4, 5, 7, 7, and 8 at one, two, five, ten, and fifteen minutes, respectively.1 Cord gas at delivery reflected a pH of 6.76. Arterial blood gas at 20 minutes of age on blow by oxygen included a pH of 7.04. Neurologic impression at birth was severe neonatal depression/fetal distress and severe metabolic acidosis. At 20 minutes of life, Travis was transferred to the neonatal intensive care unit (NICU) for further management. At about three-and-one-half hours of age seizures were noted, and phenobarbital was started. Also noted, were lip smacking, eye deviation, spasticity, and hypertonic extremities. CT scan showed left parietal infarct and left post-occipital subdural hematoma. The EEG was markedly abnormal. MRI on August 3, 1994, reflected high signal gyral areas in both parietal and occipital lobes, consistent with cortical injury or hemorrhage. Travis remained in the intensive care unit until August 19, 1994, when he was discharged to the care of his parents. On discharge, he was noted to be doing well clinically, with no reported seizures while on maintenance phenobarbital. Physical examination revealed positive blink and suck, and symmetric motor patterns, although with increased tone. Neurologic impression on discharge was "perinatal encephalopathy - improved[,] neonatal seizures well controlled [and] developmentally at risk." The genesis and timing of Travis' neurologic insult Here, the proof that is pertinent to the nature and timing of Travis' neurologic insult is consistent with a brain- related injury caused by oxygen deprivation occurring in the course of labor, delivery, and the immediate post-delivery period. In this regard, it is observed, inter alia, that Mrs. Chestnut's prenatal course was uneventful; on admission to the hospital, the fetus evidenced reassuring fetal heart tones and fetal movement; only after protracted labor did the fetus begin to evidence multiple variable decelerations; prior to delivery, Travis suffered a period of prolonged bradycardia; prior to and following delivery, Travis was severely acidotic; upon delivery, Travis evidenced profound neurologic depression; and, following delivery, Travis developed seizure activity. Consequently, the proof supports the conclusion, more likely than not, that Travis suffered an "injury to the brain . . . caused by oxygen deprivation . . . occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital." Section 766.302(2), Florida Statutes. Having resolved the genesis and timing of Travis' neurologic insult, it remains to resolve its significance or, stated differently, whether the proof supports the conclusion that Travis' injury rendered him "permanently and substantially mentally and physically impaired," as required by Sections 766.302(2) and 766.309(1), Florida Statutes. The significance of Travis' neurologic impairment The proof offered by Petitioners to quantify the significance of Travis' impairment was less than compelling. In this regard, it is observed that Petitioners offered the affidavit of Stuart C. Edelberg, M.D., (Petitioners' Exhibit 2), an apparent expert in obstetrics and gynecology, who opined, based on his record review, that Travis' "impairment is permanent and substantial, both mentally and physically." Notably, Dr. Edelberg was not shown to have examined Travis, and his affidavit is hearsay, subject to the limitations imposed by Section 120.57(1)(c), Florida Statutes (1996 Supp.). Compared to the proof offered by Petitioners, Respondent offered the testimony, through deposition, of Michael Duchowny, M.D., an expert in pediatric neurology. (Respondent's Exhibit 1.) Dr. Duchowny examined Travis on July 16, 1996, and on January 24, 1997. Dr. Duchowny's examinations revealed that Travis did suffer some impairment of motor function, as evidenced by increased muscle tone, increased deep tendon reflexes, and diminished fine motor coordination; however, he walked independently and without support in a stable fashion. As for his cognitive abilities, Dr. Duchowny did observe expressive disfluency, but Travis' receptive skills were good, he could communicate non-verbally, and mental functioning was in the normal or near normal range. It was Dr. Duchowny's opinion that, although Travis does suffer some permanent mental and physical impairment, it is not substantial and, based on improvements observed between the examinations of July 16, 1996, and January 24, 1997, further improvement is most likely. Dr. Duchowny's observations and opinions are most consistent with the records offered into evidence (Petitioners' Exhibit 1), and are credited.2 Based on the proof, it cannot be concluded that Travis' injury has rendered him permanently and substantially mentally and physically impaired. Rather, the competent and persuasive proof is to the contrary.
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
The Issue At issue in this proceeding is whether Cassidy Taylor Shiver, a minor, suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Fundamental findings Kellie Dawn Shiver and Robert L. Shiver are the parents and natural guardians of Cassidy Taylor Shiver (Cassidy), a minor. Cassidy was born a live infant on November 5, 1996, at DeSoto Memorial Hospital, a hospital located in Arcadia, Florida, and her birth weight was in excess of 2500 grams. The physician providing obstetrical services during Cassidy's birth was Dumitru-Dan Teodoreseu, M.D., who was, at all times material hereto, a participating physician in the Florida Birth-Related Neurological Injury Compensation Plan (the Plan), as defined by Section 766.302(7), Florida Statutes. Coverage under the Plan Pertinent to this case, coverage is afforded under the Plan when the claimant demonstrates, more likely than not, that the infant suffered an "injury to the brain or spinal cord . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." Sections 766.302(2) and 766.309(1)(a), Florida Statutes. Here, Cassidy's neurologic condition is dispositive of the claim and it is unnecessary to address the timing or cause of her condition. Cassidy's neurologic status On January 7, 1999, following the filing of the claim for compensation, Cassidy was evaluated by Michael Duchowny, M.D., a board-certified pediatric neurologist. Dr. Duchowny chronicled Cassidy's history and the results of his examination as follows: I evaluated Cassidy Shiver on January 7, 1999. Cassidy is a 2 year old girl who comes for an evaluation of developmental problems. Cassidy was accompanied by her mother and maternal grandmother. HISTORY ACCORDING TO THE FAMILY: The family began by explaining that Cassidy's seizures are her main ongoing problem. She had her last seizure several weeks ago and is now taking phenobarbital 20 mg b.i.d. Her seizure onset was at 2 months of age. She has essentially had persistent seizures, except for a 6 month seizure free interval. Each episode lasts approximately 1 to 2 minutes and typically occurs 15 to 20 minutes after falling asleep. Cassidy experiences the rapid onset of tonic and subsequently clonic movements primarily involving the upper extremities. They are associated with loss of consciousness and foaming at the mouth. She has a period of postictal depression before regaining normal baseline status during daytime attacks. Cassidy was allegedly the product of a 32 weeks gestation, born with the birth weight of 5-pounds, 9-ounces. The delivery was by a vacuum extraction and left Cassidy with a large right cephalohematoma. There was a significant collection of blood which ultimately "ruptured". Mrs. Shiver indicated that Cassidy experienced damage to both frontal lobes which was documented on both CT and MRI studies. Despite Cassidy's stormy neonatal course, her growth and development have proceeded reasonably well. She walked at 16 months and said single words at 22 months. She is not yet potty trained. Cassidy is fully immunized, has no known allergies and has never undergone surgery. She sporadically sees physical and occupational therapist, but Mrs. Shiver's [sic] performs the therapies at home. Cassidy has made a remarkable recovery, in that her motor function is essentially within the normal range with the exception of a minor arm asymmetry and with decreased left swing. Cassidy is quite curious and socially engaging. Her vision and hearing are said to be adequate and there has been no deterioration in her overall developmental level. PHYSICAL EXAMINATION today reveals Cassidy to be alert and cooperative. The skin is warm and moist. Her hair is blonde and of normal texture. Cassidy's head circumference measures 50.2 cm which is within standard percentiles. The anterior and posterior fontanelles are closed. There are no significant cranial or facial asymmetries. The neck is supple without masses, thyromegaly or adenopathy. The cardiovascular, respiratory and abdominal examinations are normal. NEUROLOGICAL EXMINATION reveals Cassidy to be alert, curious and slightly overactive. She does participate in the examination fully and is socially engaging. Cassidy maintains central gaze fixation and demonstrates conjugate following movements. The pupils are 4 mm and react briskly to direct and consentually presented light. There are no fundoscopic abnormalities. The tongue and palate move well. Motor examination reveals symmetric strength, bulk and tone. There are no adventitious movements or evidence of focal weakness. The gait is stable with an arm swing that indeed shows some posturing of the left arm. This is minimal however and does not affect Cassidy's stance or balance. She demonstrates good dexterity with both hands and has a well developed fine motor coordination for age. She uses both hands in a coordinated fashion. The deep tendon reflexes are 2+ and symmetric with flexor plantar responses. There is no evidence of gait, truncal or extremity ataxia. The neurovascular examination reveals no cervical, cranial or ocular bruits and no temperature or pulse asymmetries. The sensory examination is deferred. Cassidy did not speak in words or sentences at any time during the evaluation, but tends to verbalize consonants only. In SUMMARY, Cassidy's neurologic examination reveals evidence of an expressive language delay and a minor non-functional asymmetry of upper arm swing on her gait. Otherwise, Cassidy appears to be developing well and is being managed appropriately for her seizure diathesis. In Dr. Duchowny's opinion, which is credited, Cassidy is not currently substantially physically impaired and, notwithstanding any events which may have occurred at birth, is not likely to be so impaired in the future. 1/ (Respondent's Exhibit 1, pages 8, 9, and 11.)
