The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint dated December 8, 2009, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. (2009). The Board of Medicine ("Board") is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Sections 458.331(1) and 456.072(1), Florida Statutes. See §§ 458.331(2) and 456.072(2), Fla. Stat. At the times pertinent to this proceeding, Dr. Rodriguez was a physician licensed by the State of Florida, having been issued license number ME71465. At the times pertinent to this proceeding, Dr. Rodriguez owned and practiced at Children Plus Health Center, which was located at 7599 South Dixie Highway, West Palm Beach, Florida. Dr. Rodriguez was identified on the front window of his offices as a licensed pediatrician. On January 31, 2008, Agent Murray, while working in an undercover capacity for the Palm Beach County Sheriff's Office, entered Dr. Rodriguez's offices and asked the receptionist if she could see Dr. Rodriguez. Using the name "Lisa Caterra," Agent Murray completed a patient information sheet that asked for the patient's name, date of birth, sex, social security number, address, telephone number; the name and telephone number of the patient's employer, the name and telephone number of an emergency contact, and the type of insurance. Agent Murray indicated on the patient information form that she was insured under Medicaid, but she was advised at the front desk that Dr. Rodriguez accepted Medicaid only for pediatric patients. Agent Murray then paid $125.00 in cash to the person at the front desk before she saw Dr. Rodriguez on January 31, 2008. While she was waiting to see Dr. Rodriguez, Agent Murray observed a number of adults waiting in the waiting room, in addition to children with their parent or parents. Agent Murray waited approximately three and one-half hours before she was taken to an examination room. Dr. Rodriguez entered and asked how he could help her. Agent Murray told Dr. Rodriguez that she had been under the care of a physician in Bradenton, that she was taking "roxys" and "liquid roxys," that it was too far for her to visit her doctor in Bradenton, and that a friend who was a patient of Dr. Rodriguez told her that she should see Dr. Rodriguez and could get "roxys" from him. In the examination room, Dr. Rodriguez asked Agent Murray to describe her problem. Agent Murray told him that she had been in a car accident in 2006. When questioned by Dr. Rodriguez, Agent Murray denied having pain in her neck, shoulders, or middle back. She stated that she did not know where her pain was, that it was "[s]ometimes, maybe, in my "lower area, I guess."4 Dr. Rodriguez asked Agent Murray if she had had an MRI, and she told him that one had been taken in December 2006. Dr. Rodriguez told her that this MRI was too old and that she needed to get another. Dr. Rodriguez also asked Agent Murray if she had anxiety or headaches. She stated that she "had headaches from all the screaming children in the waiting room."5 The medical records of Agent Murray's January 31, 2008, visit to Dr. Rodriguez consisted of an Adult-Chart Initiation History form and an Adult Initial Physical form. The Adult-Chart Initiation History form, which was not dated or signed, contained a past medical history that showed no childhood illnesses, no major operations, no major illnesses, and an accident in November 2006. The social history noted on the chart reflected that "Lisa Caterra" did not smoke and drank occasionally. Dr. Rodriguez also wrote something illegible on the blank for allergies and listed several medicines, the only one of which that could be deciphered was Xanax. The Adult Initial Physical form dated January 31, 2008, contained a notation of Agent Murray's temperature, blood pressure, pulse, height and weight; and a notation in the section for the primary working diagnosis of lower back pain, no neck or shoulder pain, and anxiety. What purported to be a "provider signature" appeared at the bottom of the form. After she left Dr. Rodriguez's examination room on January 31, 2008, Agent Murray went to the front desk to make another appointment with Dr. Rodriguez. After she made the appointment, Agent Murray was handed two hand-written prescriptions, in the name of "Lisa Caterra," for 120 tablets of 30-milligram Roxicodone and 60 tablets of 2-milligram Xanax. She also was given two preprinted prescriptions, in the name of "Lisa Caterra," for 160 tablets of 500 milligram Naproxen and 12 tablets of four-milligram Decadron. During her appointment with Dr. Rodriguez on January 31, 2008, Dr. Rodriguez did not perform a physical examination; did not do a blood or urine toxicology; did not ask Agent Murray for a complete medical history; did not formulate a treatment plan; did not require Agent Murray to sign a contract regarding the prescription of controlled substances; and did not give Agent Murray any instructions or information on the drugs he had prescribed for her. Agent Murray also had appointments with Dr. Rodriguez on March 4, 2008, April 4, 2008, and May 7, 2008. When she arrived at Dr. Rodriguez's office for her March 4, 2008, appointment, Agent Murray paid $125.00 in cash to a person at the front desk. She was then taken to an examination room where she waited for Dr. Rodriguez. When Dr. Rodriguez entered the examination room where Agent Murray was waiting, he was carrying a stack of folders and what appeared to be three stacks of prescription pads. Dr. Rodriguez asked how he could help her, and Agent Murray stated that she was there for her refills. Agent Murray observed Dr. Rodriguez write the name "Lisa Caterra" on the top prescription of each of the three stacks, and, after asking her if she wanted Roxicodone, Xanax, and Methadone, he handed her prescriptions for 120 tablets of 30-milligram Roxicodone, 120 tablets of 10-milligram Methadone, and 120 tablets of two-milligram Xanax. The hand-written prescription forms had already been completed except for the patient's name. The prescription form for Methadone included a notation: "DX: wean OFF Roxicodone." Dr. Rodriguez did not discuss the prescription for methadone with Agent Murray, nor was there any discussion about his reasons for not prescribing Naproxen or Decadron at the March 4, 2008, appointment. Dr. Rodriguez spent approximately one minute with Agent Murray during the March 4, 2008, appointment. He did not discuss a plan of treatment with Agent Murray, and he did not conduct a physical examination, ask any questions regarding her alleged pain, or conduct a urine or blood toxicology. There are only two items in Dr. Rodriguez's medical records related to Agent Murray's March 4, 2008, appointment. One item was a form that included the name "Lisa Caterra," and notations for blood pressure, temperature, pulse rate, height, and weight. The form included a checklist headed "Physical Exam," but the checklist was blank. The only other notations on the form were what appear to be abbreviations for the prescriptions that Dr. Rodriguez wrote for Agent Murray on March 4, 2008. The other item in Dr. Rodriguez's medical records related to Agent Murray's March 4, 2008, appointment was a form headed "Children Plus Health Group, P.A. The name "Lisa Caterra" was written at the top of the form, which included three identical tables with checklists under columns headed "Patient's Condition," Affected Region," and "Treatment." Blanks for the patient's signature and the date were below each of the three tables on the form. The table dated March 4, 2008, contained Agent Murray's signature for "Lisa Caterra," but none of the blanks on the checklists were marked. Agent Murray's appointments with Dr. Rodriguez on April 4, 2008, and on May 7, 2008, lasted approximately one minute, and Agent Murray paid cash at the front desk prior to being taken to the examination room. Dr. Rodriguez entered the examination room on each occasion, confirmed that Agent Murray's name was "Lisa"; confirmed that she wanted Roxicodone, Methadone, and Xanax; wrote "Lisa Caterra" at the top of each of three prescriptions that had been filled out prior to Dr. Rodriguez's coming into the examination room, and handed the prescriptions to Agent Murray. The drugs, dosage, and quantities on the three prescriptions were identical to the drugs, dosage and quantities on the prescriptions Dr. Rodriguez wrote for "Lisa Caterra" on March 4, 2008: 120 tablets of 30- milligram Roxicodone, 120 tablets of 10-milligram Methadone, and 120 tablets of two-milligram Xanax. The only items included in Dr. Rodriguez's medical records related to Agent Murray's April 4, 2008, and May 7, 2008, appointments consisted of the form that contained the checklist for a physical examination and the form that included the tables to record the patient's condition, the affected region, and the treatment. The form that included a checklist headed "Physical Exam" dated April 4, 2008, included the name "Lisa Caterra," and notations for blood pressure, temperature, pulse rate, height, and weight. The "Physical Exam" checklist was blank, and the only other notations on the form were what appear to be abbreviations for the prescriptions that Dr. Rodriguez wrote for Agent Murray on April 4, 2008. The form dated May 7, 2008, was completely blank. The form headed "Children Plus Health Group, P.A., which included the three tables to record the patient's condition, the affected region, and the treatment, contained check marks in the blanks in the column for "Patient's Condition" beside "Difficulty Sleeping" and "Patient cont. c/o pain" on the table dated April 4, 2008. The signature of "Lisa Caterra" was below the table, next to the date. The table dated May 7, 2008, was blank, except for the signature of "Lisa Caterra" and the date. The only other item in the medical records maintained by Dr. Rodriguez for "Lisa Caterra" was a sheet of paper that was blank except for the name "Lisa Caterra" and the date of birth Agent Murray wrote on the patient information form. This document was apparently intended to include notes of Dr. Rodriguez's diagnostic descriptions. After her first appointment on January 31, 2008, Dr. Rodriguez did not ask Agent Murray if she was in pain, and he did not, at any of the four appointments, conduct a physical examination, obtain a medical history, order any tests, or formulate a treatment plan. Roxicodone, which is a the name of a brand of the generic drug oxycodone; Xanax, which is also known as alprazolam; and Methadone are controlled substances listed in Section 893.03, Florida Statutes. This combination of drugs is potentially lethal, and there is no legitimate medical basis for prescribing this combination of drugs in the quantities and the dosages prescribed by Dr. Rodriguez for "Lisa Caterra." Roxicodone is an opioid analgesic and Xanax is a sedative hypnotic benzodiazepine drug; the combination of these drugs could cause respiratory depression and possibly death, and the addition of Methadone makes the combination of drugs extremely dangerous. Dr. Rodriguez's relationship with Agent Murray, in her undercover role as "Lisa Caterra," consisted solely of his writing prescriptions for controlled substances. The combination of drugs and the dosages and quantities of the drugs were potentially lethal. Under these circumstances, Dr. Rodriguez was not prescribing these medications in the course of his professional practice.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order revoking the license of Sergio Rodriguez, M.D., to practice medicine in the State of Florida, and imposing an administrative fine in the amount of $40,000.00. DONE AND ENTERED this 29th day of September, 2010, in Tallahassee, Leon County, Florida. S PATRICIA M. HART Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of September, 2010.
The Issue Should Respondent's license to practice podiatric medicine be disciplined for failure to keep required written medical records, for prescribing or dispensing legend drugs other than in the course of his professional podiatric practice, for failing to practice as a reasonably prudent podiatric physician, and for practicing beyond the scope of his license?
Findings Of Fact Petitioner is the state agency charged with regulating the practice of podiatric medicine pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 461, Florida Statutes. Dr. McNally has been licensed without interruption to practice podiatry in the State of Florida since October 22, 1996. He has not been the subject of disciplinary action by the Board of Podiatry. Dr. McNally was licensed as a podiatrist in the State of Florida by the Agency for Health Care Administration (AHCA) in October 1996. He was born on June 19, 1969. Ms. Sara Helen Lowe, a pharmacist, is an inspector for AHCA. She conducted a survey of pharmacies in the vicinity of Destin and Ft. Walton area and discovered that Respondent had written multiple prescriptions for legend drugs which were in the name of Patient B.R. She also determined from her survey that Respondent had prescribed the legend drug Phentermine for six of his patients. A legend drug is a drug for which a prescription is required and includes Schedule II controlled substances under Chapter 893, Florida Statutes. A Schedule II controlled substance is a pharmaceutical which has medical uses and also has a potential for being abused. Mrs. B.R. is the wife of Patient B.R. She was aware that her husband received numerous prescriptions from Dr. McNally for multiple drugs including oxycodone and methadone in 1998 and 1999. Mrs. B.R. was aware that her husband had an open wound on his foot for several years. She was also aware that he suffered chronic and severe pain from this condition. Mrs. B.R. was concerned about the amount of drugs being consumed by Patient B.R. and discussed this matter with Dr. McNally. During this conversation, Dr. McNally told her that, "B.R. was in chronic pain, and that the amount of medication that B.R. took was basically B.R.'s problem." Mrs. B.R. was angry with regard to the amount and type of drugs which were prescribed by Dr. McNally. However, she thought that during this time his foot wound was improving. Mrs. B.R. was aware that Dr. McNally brought drugs to patient B.R.'s hospital room when patient B.R. was hospitalized in November of 1998. Mrs. B.R. was aware that her husband was hospitalized on an emergency basis for an overdose of Tegrital, a drug designed to combat seizures. This drug was not prescribed by Dr. McNally. It was prescribed by another doctor. The pain that patient B.R. suffered caused a hardship in Mrs. B.R.'s home but she preferred that he take the pain medication rather than see him suffer. Patient B.R. lives in Destin with his wife. He is receiving disability payments due to a hip replacement, a knee replacement, and an ulcer on his right foot. In an effort to relieve the pain in B.R.'s foot Respondent prescribed Oxycodone, Endodan, Endocet, Methadone, Roxicet, Roxiprin, Percocet, Oxycontin, Morphine Sulfate Er, MS Contin, Oramorph SR, and Roxicodone. All of these are forms of oxycodone, methadone, or morphine, alone, or in combinations with acetaminophen. Dr. McNally prescribed approximately 8,705 units of oxycodone, 250 units of methadone, and 510 units of morphine for patient B.R. during the eighteen-month period he treated him. These drugs were prescribed to him subsequent to his first visit to Dr. McNally in 1997. All of the foregoing drugs are Schedule II controlled substances pursuant to Chapter 893, Florida Statutes. Patient B.R. obtained prescriptions during office visits and by telephoning Dr. McNally. When B.R. called Dr. McNally the doctor would ask him what drugs he wished to have and B.R. would tell him. Dr. McNally would then provide the prescription to a pharmacy telephonically. On at least one occasion the prescription was left inside the screen door of Dr. McNally's dwelling for Patient B.R. to pick up. Office visits were on some occasions made at the offices of Dr. Haire from which Dr. McNally occasionally practiced. During office visits Dr. McNally would sometimes take B.R.'s temperature. He checked B.R.'s vital signs approximately every six months. Patient B.R. got prescriptions from Dr. McNally when Dr. McNally was on an extended trip to Europe in early 1998 or 1999. While Patient B.R. was a patient in the local hospital, Dr. McNally brought him drugs because the pain medication provided by the hospital was inadequate. Dr. McNally brought the drugs to his hospital room four or five times. He bought these drugs with patient B.R.'s credit cards. Patient B.R. was in the hospital November 9 through 17, 1998. Dr. McNally submitted insurance claims for patient B.R. for a portion of the time he was treating patient B.R. but eventually stopped. Patient B.R. stopped seeing Dr. McNally. Subsequently, a therapist, Sherry Levitis, recommended that patient B.R. attend a pain management center in New Orleans. As a result of his attendence there he experienced a decrease in needle-like pains. The pain management succeeded in getting B.R. to gradually reduce the amount of pain-killing drugs that he was ingesting. Patient B.R. never received any drug rehabilitation. The pain management clinic taught him that he could get by without the aid of drugs. Patient B.R. went to different pharmacies to have his prescriptions filled because he thought they would question the amount if he received too many drugs from the same business. He was advised by Dr. McNally to avoid making frequent visits to the same pharmacy. Patient B.R. never shared the drugs he obtained with others. The use of these drugs changed patient B.R.'s personality and caused domestic difficulties. He became dependent on the drugs. Buying the drugs was a financial strain. At the time of the hearing patient B.R. still was suffering from the ulcer on his right foot. Though he has had surgery on the ulcer three times, it has not healed. Patient B.R. believes his emergency trip to the hospital was the result of his taking Tegrital which is an anti- seizure medicine. He believes he should have coordinated the taking of this medicine with Dr. McNally and that his failure to do so was the cause of the medical event which resulted in emergency hospitalization. The medical doctor who prescribed the Tegrital never asked him if he was taking other medications. Numerous efforts were made by Dr. McNally to address patient B.R.'s foot condition and the resultant pain, including surgery, orthotics, and pain management efforts. The drugs prescribed by Dr. McNally enabled patient B.R. to get off of his couch and live a more normal life. Patient B.R. had better results in addressing his pain and treating his ulcer with Dr. McNally than with any other doctor. At the insistence of Petitioner, Dr. McNally supplied to Petitioner what he claimed to be patient records in the case of B.R. Petitioner believed these records to be phony. Dr. McNally prescribed Phentermine to patients and asserted that he believed it would enhance circulation in the lower extremities. Dr. McNally has been out of the country often and has prescribed drugs for patients in the United States while he was physically located in Italy. Dr. McNally prescribed drugs for patient B.R. while in Europe. He provided patient B.R. with numerous prescriptions for limited amounts because he did not want him to have too many drugs in his possession at once. Dr. McNally, at the time of the hearing, was not accepting new patients but was continuing to treat some old ones. He no longer carries malpractice insurance. Dr. McNally claimed that the medical records in the case of patient B.R., records which he supplied to ACHA at ACHA's request, were prepared by him either at the time of patient B.R.'s visits, a few days after a visit, or several days after a visit. Dr. McNally used the word "analgesic" when preparing records on patient B.R. He did not enter the actual names of the drugs. "Analgesic" could encompass all drugs which relieve pain. Dr. McNally turned to pharmaceuticals in B.R.'s case because he had tried all available alternative treatments without success. Dr. McNally prescribed drugs for the benefit of patient B.R. in the belief that he was doing what was best for his patient. Barry C. Blass, D.P.M., testified. He is an expert in the field of podiatry. Dr. Blass reviewed the evidence with regard to Dr. McNally and his treatment of patient B.R. and with regard to Dr. McNally's prescriptions of Phentermine for six patients. The pain-relieving drugs prescribed by Dr. McNally for B.R. were far in excess of an amount which would be appropriate. The amounts of legend drugs prescribed were about double that permitted by the instructions contained on the container. Dr. Blass reviewed 229 pages of office notes addressing the treatment of patient B.R. which purported to encompass the period January 2, 1998 through September 29, 1999. Almost all of the notes were identical with the exception of the dates. For the notes to be legitimate, patient B.R. would have had to visit Dr. McNally every day during October 1998 and almost everyday on several other months. It is a deficiency for a physician to fail to note on office notes that a patient has been prescribed legend drugs. The standard of care requires a physician to sign office notes. Respondent did not sign his notes. Additionally, the office notes were inconsistent with the hospital records of B.R., in that they indicated treatment in Dr. McNally's office when in fact B.R. was on those dates resident in a hospital. The office notes provided by the Respondent were manufactured, are not authentic, were not prepared at or near a time of an actual office visit, if there was an office visit, and are not, therefore, actual medical records addressing the treatment of patient B.R. It is inappropriate for a physician to bring drugs into a hospital for the use of a hospitalized patient. Phentermine is a diet drug which has no podiatric uses and therefore should not be prescribed by a podiatrist. Phentermine is usually prescribed as a remedy for exogenous obesity. Thomas L. Hicks, M.D., is an expert in the field of medicine. His testimony was provided by deposition. Dr. Hicks reviewed the medical records supplied by Dr. McNally, and provided expert opinions based on that review. It is inappropriate for a podiatrist to prescribe Phentermine. Respondent's prescriptions for Phentermine were unsafe and in excess of the customary dosages recommended by the manufacturer. By writing these prescriptions, Dr. McNally practiced outside of the scope of his license. The amount of Schedule II drugs prescribed for patient B.R. was inappropriate, dangerous, and not justified by the medical records. Dr. McNally wrote the prescriptions for patient B.R. at very frequent intervals which, while peculiar, did not violate the Practice Act. Usually when writing prescriptions for chronic pain a physician prescribes for a longer period of time. Richard D.Roth, D.P.M., testified. He is an expert in the field of podiatric medicine. Dr. Roth reviewed the medical records supplied by Dr. McNally. The prescribing of Phentermine by Dr. McNally was outside of the scope of his license and was potentially dangerous. Dr. McNally's treatment notes were inadequate in that, for example, they do not describe the exact location, size, or depth of an ulcer, among other things. Neither do they describe the types of analgesics prescribed even though massive doses of narcotic analgesics were prescribed. Dr. McNally's records in the case of patient B.R. are grotesquely incomplete. Most of the notes provided by Dr. McNally were canned notes generated by a computer.
Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That the Board of Podiatric Medicine enter a final order finding that the Respondent, George C. P. McNally, failed to keep required medical records during the period January 2, 1998 through September 29, 1999, in violation of Section 461.013(1)(l), Florida Statutes; that the Respondent prescribed legend drugs other than in the course of his professional podiatric practice during the period January 1988 through August 1999, in violation of Section 461.013(1)(o), Florida Statutes; that Respondent failed to practice as a reasonably prudent podiatric physician during the period January 2, 1998 through September 29, 1999, in violation of Section 461.013(1)(s), Florida Statutes; and that Respondent practiced beyond the scope of his license during the period January 1988 through August 1999, in violation of Section 461.013(1)(u), Florida Statutes. It is recommended that Respondent's license to practice podiatric medicine be suspended for a period of six months, that he pay a $2,000 fine, and that he pay for the cost of the investigation and prosecution. The cost of investigation and prosecution shall be assessed at the time the matter is presented to the Board of Podiatric medicine. DONE AND ENTERED this 9th day of November, 2000, in Tallahassee, Leon County, Florida HARRY L. HOOPER 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 9th day of November, 2000. COPIES FURNISHED: Wings S. Benton, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 George C. P. McNally Post Office Box 5585 Destin, Florida 32540 Joe Baker, Jr., Executive Director Board of Podiatric Medicine Department of Health 4052 Bald Cypress Way, Bin C07 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
The Issue The issues in this case are whether Respondent, a physician, failed to adhere to the applicable level of care in prescribing controlled substances; failed to follow standards for the use of controlled substances for the treatment of pain; and failed to keep legible medical records justifying the course of a patient's treatment; if so, whether Petitioner should impose discipline on Respondent's medical license within the applicable penalty guidelines or take some other action.
Findings Of Fact At all times relevant to this case, Respondent Lowell Anthony Adkins, M.D., was licensed to practice medicine in the state of Florida. Dr. Adkins is a family practitioner who has a clinical interest in pain management. Petitioner Department of Health (the "Department") has regulatory jurisdiction over licensed physicians such as Dr. Adkins. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Adkins committed three such offenses——namely, failure to adhere to the applicable level of care in prescribing controlled substances; failure to follow standards for the use of controlled substances for the treatment of pain; and failure to keep legible medical records justifying the course of treatment——in connection with the care he provided to J.D., a young adult (early twenties) whom Dr. Adkins saw on about a half-dozen occasions between September 2007 and March 2008. The events giving rise to this dispute began on September 19, 2007, when J.D. was first seen by Dr. Adkins. J.D. presented with complaints of chronic pain in both knees, which were swollen, and a history of juvenile arthritis. Until recently before this visit, J.D. had been treated for several months by a Dr. Gelinas, who had prescribed Vicodin to alleviate the pain. J.D. told Dr. Adkins that the Vicodin had made him nauseous and failed to control his pain. He also reported that nonsteroidal anti-inflammatory drugs ("NSAIDs") caused him to have nosebleeds. Dr. Adkins took J.D.'s medical history and performed a physical examination. J.D. characterized the degree of pain he was experiencing as severe (grading it as 8 on a scale of 1 to 10 with 10 being the worst), which was an exaggeration intended to deceive the doctor (although he did in fact have some pain). As part of his ruse, which fooled Dr. Adkins, J.D. purposely faked the range of motion tests to give the impression that the condition of his knees was worse than it actually was. J.D. was not candid with Dr. Adkins in providing information about his symptoms because——unknown to Dr. Adkins at the time, who reasonably assumed that his patient's statements for purposes of medical diagnosis or treatment were reliable1——J.D. was addicted to narcotic pain medication and wanted a prescription to feed this addiction. Dr. Adkins wrote a prescription authorizing J.D. to obtain 60 tablets of Oxycodone having a dosage of 15 milligrams ("mg") apiece. Because Oxycodone is a narcotic pain reliever, Dr. Adkins required J.D. to sign a Medication Contract, which enumerated J.D.'s responsibilities regarding the proper use of the controlled substances he was being prescribed. The terms and conditions of the contract included the following: The physicians and staff of Lowell Adkins M.D.P.A. will be the ONLY physicians that will be writing for these medications and I will not seek these medications from other physicians, INCLUDING EMERGENCY ROOM PHYSICIANS. . . . I will take the medications as prescribed and not take more on a daily basis unless approved by my physician. At the initial visit on September 19, 2007, J.D. also signed a release authorizing Dr. Gelinas to provide copies of J.D.'s medical records to Dr. Adkins, which was done. Dr. Gelinas's handwritten chart is largely illegible, but it shows that J.D. carried a diagnosis of arthralgia (joint pain) based on the problems he was having with his knees. In addition, the records included the radiologist's report regarding an MRI of J.D.'s right knee, which had been examined on July 31, 2007. The MRI report gives as J.D.'s diagnosis: "History of juvenile rheumatoid arthritis since age 12. Complaints of pain, crepitus, locking, and instability." The study did not discover any significant damage or disease, except for a "tiny incipient Baker's cyst." For the next half-year, J.D. saw Dr. Adkins on a monthly basis. J.D. continued to complain of chronic pain and repeatedly reported that the pain medication Dr. Adkins was prescribing was not adequately controlling his pain. For much of this time, J.D. held two jobs, working full-time as a small- engine mechanic until being laid off in December 2007, and moonlighting in a sporting goods store, which became his only source of income after the loss of his regular job. These jobs required J.D. to be physically active, and Dr. Adkins periodically increased the dosage of the pain medication he was prescribing, so that J.D. could function at work. Dr. Adkins ordered X-rays of J.D.'s knees as well, but J.D. declined to get them. While under Dr. Adkins's care, J.D. suffered at least two traumatic injuries requiring treatment for acute pain. In October 2007, J.D. injured his shoulder at work and went to an urgent care center for treatment. The doctor prescribed Oxycodone to control the pain associated with this injury. J.D. told Dr. Adkins that he had hurt his shoulder but did not let Dr. Adkins know that he had obtained a prescription for Oxycodone from another physician, in violation of the Medication Contract he had entered into. On or about December 29, 2007, J.D. suffered a serious and painful injury to his finger at work. For this he went to the emergency room, accompanied by his mother who told the ER doctor that J.D. was addicted to, and abusing, narcotic pain medication. Despite the objection of J.D.'s mother, the ER doctor prescribed Oxycodone for pain. Thereafter, J.D. visited a workers' compensation physician for treatment of this same injury, and he was again prescribed Oxycodone. J.D. informed Dr. Adkins of the injury to his finger but not these prescriptions, which represented additional breaches of the Medication Contract.2 A couple of months before the trip to the ER described above, J.D.'s mother ("T.R.") had attempted to stop Dr. Adkins from prescribing Oxycodone to J.D., raising similar concerns about J.D.'s alleged drug abuse. On November 26, 2007, she had dropped by Dr. Adkins's office to report to him that J.D. was crushing and snorting his pain medication. Dr. Adkins was not immediately available, so T.R. left her business card and requested that Dr. Adkins call her, which he did later that evening. Upon hearing T.R.'s concerns, Dr. Adkins requested that she arrange to accompany J.D. on his next office visit, so that the three of them could discuss the situation together. T.R. did show up for J.D.'s next doctor's appointment, on December 14, 2007. J.D., however, had not invited her, and he became very angry when, upon arriving at Dr. Adkins's office, he found his mother already waiting there. The two argued loudly in the reception area, causing a scene. J.D. refused to allow his mother to come into the examination room with him and Dr. Adkins. Consequently, Dr. Adkins met separately with J.D. and T.R. T.R. told Dr. Adkins that J.D. was on probation as a result of drug-related charges and that he was participating in a Drug Court program, but she apparently provided no paperwork to substantiate these assertions. Dr. Adkins had not been aware that J.D. might be in trouble with the law, and he was somewhat surprised by the news because ordinarily the authorities contact him when a patient of his has been arrested for unlawful possession or use of prescription medication. T.R. further claimed that J.D. had been snorting his medication, although she had not actually seen him do so. T.R.'s concerns upset Dr. Adkins, and when he met with J.D. alone, he lectured him on the need for strict compliance with the Medication Contract. Dr. Adkins told J.D. that he would be discharged from Dr. Adkins's practice if J.D. ever snorted the medication again. Dr. Adkins ordered a urine toxicology screen and required J.D. to be tested. J.D. complied, and the drug screen was negative for illegal substances. Dr. Adkins agreed to continue treating J.D. with narcotic analgesics. When J.D. lost his full-time job in December 2007, he lost his health insurance. After that, J.D. paid out-of-pocket for his doctor's appointments. Following a visit on March 19, 2008, however, J.D. stopped seeing Dr. Adkins. In summary, Dr. Adkins prescribed Oxycodone to J.D. in the following dosages and amounts, on the dates shown below: Date Dosage Amount 09/19/07 15 mg 60 tablets 10/19/07 30 mg 90 tablets 11/16/07 30 mg 120 tablets 12/14/07 30 mg 120 tablets 01/14/08 30 mg 150 tablets 02/22/08 30 mg 150 tablets 03/19/08 30 mg 180 tablets The Department's expert witness, Marc R. Gerber, M.D., testified at hearing that the foregoing amounts and dosages of opioids, which Dr. Adkins prescribed to J.D., did not violate the standard of care. T. 165. The undersigned finds this to be true, based on Dr. Gerber's testimony. In its Amended Administrative Complaint, the Department alleged that Dr. Adkins had practiced below the requisite level of care in prescribing narcotic pain medication to J.D.——and thus violated section 458.326(3), Florida Statutes3——in one or more of the following ways: By failing to diagnose Patient J.D. with intractable pain; and/or By failing to refer Patient J.D. to a Psychiatric-addiction specialist, especially after he was informed by Patient's mother that he was, allegedly, an addict; and/or By failing to refer Patient J.D. to an orthopedic specialist to have the pain in his knee evaluated; and/or By prescribing excessive narcotics for Patient J.D.'s alleged pain condition prior to exploring the effectiveness of other NSAIDs; and/or By failing to refer Patient J.D. to a rheumatoid arthritis specialist and/or by failing to verify the complaints of pain from juvenile rheumatoid arthritis with blood tests. Although Dr. Gerber clearly expressed concerns about Dr. Adkins's treatment of J.D., his testimony ultimately failed to establish, unequivocally, that any of the acts or omissions enumerated above constituted an unambiguous violation of the applicable standard of care. As mentioned, Dr. Gerber specifically refuted the allegation that Dr. Adkins had prescribed "excessive narcotics," as charged in subparagraph d). He further testified that, in his opinion, Dr. Adkins had not violated section 458.326, see T. 164——a blanket statement that casts doubt on all of the standard-of-care violations that the Department has alleged. Dr. Gerber testified that he "had no problem with respect to how J.D. presented to Dr. Adkins and the treatment Dr. Adkins had rendered to J.D. through December." T. 161. This testimony, given by the Department's expert, precludes the undersigned from finding without hesitation that the acts and omissions described in subparagraphs a), c), and e) above violated the standard of care. As for subparagraph b), Dr. Gerber stopped well short of stating that the standard of care required Dr. Adkins to refer J.D. to an addiction specialist. To the contrary, he expressed the opinion that, at the time (i.e., 2007-2008), the decision whether to make such a referral was left to the physician's discretion. T. 124, 153. The most Dr. Gerber could say on this point was that, in his view, one "hundred percent of pain specialist [sic] would . . . possibly refer out to an addiction specialist." T. 155 (emphasis added). This testimony is insufficiently convincing to establish clearly that Dr. Adkins's "failure" to refer J.D. to an addiction specialist violated the standard of care. The essence of Dr. Gerber's opinion on the standard of care was captured in the following remarks, which he made on cross-examination in the course of explaining his opinion that Dr. Adkins had not violated section 458.326: We wouldn't even be here if there wasn't the issue [that is, J.D.'s addiction] brought to his [Dr. Adkins's] attention [by T.R.] and the negative urine screen. [T]here are not major issues early on and I never said that there were. I had concerns but this whole case and the whole issue, standard of care, revolves around what was not done when significant issues [relating to J.D.'s addiction] were made available. That's really what I feel comfortable giving my opinion on is what happened after November." T. 163. Dr. Gerber then identified three steps that, in his opinion, Dr. Adkins should have taken "after November" to satisfy the standard of care: (1) order a urine toxicology test; (2) talk with the patient and his mother; and (3) "possibly change the medication regimen." T. 167-68. Although the Department did not allege that Dr. Adkins had violated the standard of care by failing to take any of these measures, the evidence shows that Dr. Adkins did, in fact, perform the first two. The third is plainly too indefinite on its face to qualify as a standard of care. The Department's other expert, James F. Schaus, M.D., who testified via videotaped deposition, was, like Dr. Gerber, unable to unambiguously declare that Dr. Adkins's treatment of J.D. had fallen below the applicable standard of care. On this subject he hedged: I found some problems in the case that could or could not be deviations from the standard of care, but it certainly raised some concerns on my part. . . . * * * Standard of care is to me a black and white, you know, question, and there's many shades of gray, like any case. And in this case, there are shades of gray when it comes to standard of care. As I said earlier, I found a few things that could be potential deficiencies in his care that may or may not come to the level of a deviation of the standard of care. And I'm not prepared to say definitively that he did deviate from the standard of care. But I do identify those concerns, those various concerns. J.F.S. 11, 13 (emphasis added). Dr. Schaus's testimony is insufficient to support a finding, based on clear and convincing evidence, that Dr. Adkins's treatment of J.D. fell below the applicable level of care, skill, and treatment. The remaining charges against Dr. Adkins are based on alleged deficiencies in the medical record of J.D.'s treatment. In Count Two of the Amended Administrative Complaint, the Department has charged Dr. Adkins with violating, in one or more of the following ways, the administrative rule which sets forth standards for prescribing narcotic pain medications: By prescribing controlled substances for pain control, to wit: oxycodone and carisprodol, to Patient J.D. without documenting the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and any history of substance abuse; and/or By prescribing controlled substances for pain control, to wit: oxycodone and carisprodol, to Patient J.D. without documenting one or more recognized medical indications for the use of a controlled substance. As will be discussed below, the provisions of the rule that articulated standards for documenting a pain-management patient's evaluation, which are the provisions that Dr. Adkins is alleged to have violated, were aspirational rather than prescriptive at the time of the alleged violations, enumerating matters that a physician should include in the medical record as opposed to mandating what must be done. Nevertheless, even though the chart that Dr. Adkins prepared contemporaneously was written in his own hand and is difficult to decipher, the undersigned finds upon review of the medical record that Dr. Adkins substantially followed the rule's guidelines. To be sure, Dr. Adkins's handwriting is hard to read. This, coupled with Dr. Adkins's use of abbreviations and other types of informal shorthand when making his notes, prevents the undersigned from forming a full understanding of everything in the medical record. The undersigned can make out enough words, however, to appreciate that Dr. Adkins documented the nature of J.D.'s pain, current and past treatment for pain, and various diseases or conditions that had caused, or were causing, pain, e.g., swollen knees, a rotator cuff injury, and the avulsion of J.D.'s finger. The Department has failed to prove, with clear and convincing evidence, that Dr. Adkins's documentation of his evaluation of J.D. fell short of the guidelines. In Count Three of the Amended Administrative Complaint, the Department has alleged that Dr. Adkins violated the statute governing medical recordkeeping in one or more of the following ways: By failing to keep legible medical records documenting the reasons for prescribing oxycodone and carisprodal for Patient J.D.; and/or By failing to keep medical records which legibly recorded the patient history, examination results, test results, and drugs prescribed for Patient J.D.; and/or By failing to keep medical records which justify the course of treatment for Patient J.D. Having reviewed the medical record, the undersigned finds the evidence insufficient to prove, clearly and convincingly, that Dr. Adkins failed to justify the course of treatment for Patient J.D. The chart is barely legible, however, and in this regard Dr. Adkins has committed a disciplinable offense; the chart itself is clear and convincing proof of guilt.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Dr. Adkins not guilty of the charges set forth in the Counts One and Two of the Amended Administrative Complaint; finding Dr. Adkins guilty of the charge set forth in Count Three, namely failing to keep legible medical records, an offense defined in section 458.331(1)(m); and imposing the following penalties: reprimand, administrative fine in the amount of $1,000, and obligation to complete the Medical Records course. DONE AND ENTERED this 26th day of October, 2011, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of October, 2011.
The Issue The issues in this case are whether Respondent violated section 458.331(1)(m), Florida Statutes, by failing to keep legible medical records that justify the course of treatment of a patient, as set forth in the Second Amended Administrative Complaint, and, if so, what is the appropriate sanction.
Findings Of Fact The Department is the state agency charged with regulating the practice of medicine pursuant to section 20.43, chapter 456, and chapter 458, Florida Statutes (2015). The Board of Medicine is charged with final agency action with respect to physicians licensed pursuant to chapter 458. Dr. Velilla is a licensed physician in the state of Florida, having been issued license number ME 98818. Dr. Velilla's address of record is 12709 Miramar Parkway Miramar, Florida 33027. Dr. Velilla has been a medical director at Evolution MD since the summer of 2010. Dr. Velilla was licensed to practice medicine in the state of Florida during all times relevant to Petitioner's Second Amended Administrative Complaint. Dr. Velilla is Board-certified in internal medicine by the American Board of Internal Medicine. On or about December 29, 2010, Patient C.A. consulted with Dr. Velilla regarding possible abdominal liposuction and fat transfer to the gluteal area. These are cosmetic surgery procedures, undertaken with the object of enhancing the patient's appearance, and are purely elective. On or about February 10, 2011, Dr. Velilla performed an evaluation of Patient C.A. and ordered routine pre-operative laboratory studies. The laboratory report prepared by First Quality Laboratory indicated readings within normal limits for blood urea nitrogen (BUN) at 19.8 and creatinine serum at .7, but an abnormally high BUN/creatinine ratio reading of 30.43. It showed an abnormally high globulin reading at 3.40, an abnormally low INR reading of .79, an abnormally low MCH reading of 25.2, and an abnormally low MCHC reading of 30.7. On or about February 15, 2011, Dr. Velilla reviewed Patient C.A.'s pre-operative laboratory report results. He placed a checkmark next to the high BUN/creatinine reading and the low INR reading. He wrote "Rev." with the date and signed his name on each page. Dr. Velilla testified that he performed a glomerular filtration rate test, a calculation used to check on the functioning of the kidneys, and the result indicated normal renal function. He testified that a BUN/creatinine ratio outside of the normal range could be caused by several factors, and that after his assessment, the reading was not of concern to him in proceeding to surgery. Dr. Velilla did not make any notation on Patient C.A.'s medical records to indicate how or why he concluded that the abnormal BUN/creatinine ratio reading was not of concern. On February 24, 2011, Patient C.A. filled out a "General Consent" form. Patient C.A. agreed to disclose her medical history, authorized the release of medical records for certain purposes, agreed to use skin care products as directed, and acknowledged possible side effects from the use of skin care products. The form also stated, "I understand that Cesar Velilla, M.D. P.A. services generally consist of a series of treatment [sic] to achieve maximum benefit, and this consent shall apply to all services rendered to me by Cesar Velilla, M.D., P.A., including ongoing or intermittent treatments." On February 24, 2011, Patient C.A. filled out a "Medical History" form. Patient C.A. indicated she was not under the care of a dermatologist, did not have a history of erythema ab igne, was not on any mood-altering or anti-depression medication, had never used Accutane, had never had laser hair removal, had no recent tanning or sun exposure, had no thick or raised scars from cuts or burns, and had never had local anesthesia with lidocaine. The form did not ask for information about any prior abdominal procedures, previous liposuction treatments, multiple pregnancies, or abdominal hernias. On February 24, 2011, Patient C.A. signed a "Consent for Laser-Assisted Lipolysis Procedure SLIM LIPOSCULPT." The form did not include consent for fat transfer to the gluteal area or describe risks or possible complications of that procedure. Patient C.A. also signed a "Consent for Local Aneshesia [sic]" form. As Dr. Obi testified, the risks from a fat transfer procedure are generally the same as those of the liposuction procedure; although with a fat transfer, you have additional potential for fat embolism. On or about February 24, 2011, Dr. Velilla performed liposuction of the abdomen and thighs with fat transfer to the gluteal area on Patient C.A. at Evolution MD. Patient C.A.'s liposuction was not the "Slim Liposculpt" laser-assisted procedure. The testimony was clear that the "Slim Liposculpt" procedure would use a laser to melt the fat before liposuction, which could not be done on Patient C.A. because the fat was to be transferred. There was testimony that a laser could be used to improve skin retraction, however. As Dr. Velilla testified, Patient C.A. had requested the fat transfer in addition to the liposuction prior to the procedure. Dr. Velilla discussed the risks of both the liposuction and the fat transfer with Patient C.A., and she consented to have the procedure done. As Dr. Velilla testified, this consent was later documented on the operative report prepared sometime after the surgery and dated February 24, 2011, the date of the surgery. Dr. Velilla's testimony was supplemented by the operative report, which stated in pertinent part: The patient requested liposuction with fat transfer and understood and accepted risks including but not exclusive to bleeding, infection, anesthesia, scarring, pain, waves, bumps, ripples, contour deformities, numbness, skin staining, fluid collections, non- retraction of the skin, deep venous thrombosis, fat embolism, pulmonary embolism, death, necrotizing fasciitis, damage to surrounding structures, need for revision surgery, poor aesthetic result and other unexpected occurrences. No guarantees were given or implied and the patient had no further questions prior to the procedure. Other options including not having surgery were discussed and dismissed by the patient. The operative report adequately documented Patient C.A.'s earlier oral informed consent for liposuction with fat transfer. Patient C.A. did not execute a written informed consent for the fat transfer prior to the procedure. Dr. Velilla also noted in the operative report that the "patient physical examination and pre-operative blood work were within normal limits." Neither the operative report nor any other documentation indicated whether a complete physical examination or a focused physical examination was given, or what that examination consisted of. Patient C.A. was scheduled for a second liposuction procedure on her arms on February 26, 2011. It was decided to defer the procedure on her arms to this later date in order to keep the amount of lidocaine at a safe level during the initial procedure. On or about February 26, 2011, Patient C.A. presented to Evolution MD with complaints of nausea and mild pain. Dr. Velilla was not at the Evolution MD office. Mild pain is to be expected on the second day after a fat transfer procedure, and nausea can be anticipated in some patients who are taking opiods, as had been prescribed for Patient C.A. There was insufficient competent evidence in the record to support a finding that Patient C.A.'s symptoms were unusual or that Dr. Velilla was ever informed of more serious symptoms in Patient C.A. that day. Dr. Velilla spoke by telephone with an Evolution MD staff member about Patient C.A.'s symptoms and instructed the staff member to ask Patient C.A. to wait for his arrival at the office. A "Progress Note" signed on February 26, 2011, by Ms. Amanda Santiago, of Dr. Velilla's office, indicated that Patient C.A. said the pain and nausea were "due to the Vicodin." The note indicates that Dr. Velilla was called, that he stated he might stop the Vicodin and start Patient C.A. on Advil or Tylenol for pain, and that he asked that Patient C.A. be prepared for surgery. The note does not indicate that Dr. Velilla directed that Patient C.A.'s vital signs be taken, or that they were taken. The note states that Patient C.A. decided not to have the procedure on her arms done and that Dr. Velilla was again called. The note indicates that he asked the staff to take pictures of Patient C.A. and ask her to wait for him to arrive. Dr. Velilla did not order Evolution MD staff to take Patient C.A.'s vital signs. Her vital signs were not recorded by Evolution MD staff on February 26, 2011. Contrary to Dr. Velilla's request, Patient C.A. left Evolution MD on February 26, 2011, prior to Dr. Velilla's arrival at the office, and Evolution MD staff were unable to contact her. On or about February 27, 2011, Patient C.A. presented to Coral Springs Medical Center where she was admitted with a diagnosis of severe dehydration, intravascular volume depletion, diarrhea, nausea, and vomiting. Subsequently, Patient C.A. was admitted to the intensive care unit. Patient C.A. remained hospitalized until March 31, 2011. Standards and Ultimate Facts Dr. Obi is a surgeon specializing in plastic surgery. He does not conduct laser-assisted liposuction, but performs what is known as "wet" or "super wet" liposuction, as was performed by Dr. Velilla in this case. He has been a Diplomate of the American Board of Plastic Surgery since 1982. Dr. Obi reviewed Patient C.A.'s medical records from Evolution MD, other related records, and the Second Amended Administrative Complaint. Taken as a whole, Dr. Obi's testimony with respect to the medical history documented for Patient C.A. was not clear and convincing. He testified that Patient C.A. was undergoing a significant operative procedure and that it involved multiple anatomic areas. He also noted that the history did not include information as to whether Patient C.A. had prior abdominal surgical procedures, earlier liposuction, multiple pregnancies, or abdominal hernias. He testified that this information could indicate increased risks of injury and that this relevant history must be documented. Dr. Obi stated that in his opinion the patient history did not meet the minimum standards of the medical records rule. On the other hand, Dr. Obi seemed to have only a partial understanding of what the medical records rule required, and he had no opinion on whether the patient history justified the course of treatment of Patient C.A.--the actual statutory standard that Dr. Velilla was charged with violating in the Second Amended Administrative Complaint: Q. What does the rule say? A: What does the rule say? The medical record rule I believe requires – I can't tell you verbatim what it says. It requires adequate documentation so that in the event that the care of a patient has to be transferred to another healthcare professional the documentation is adequate that the patient, that the professional could immediately step in and take over. Q: Okay. You believe that's part of either the statute or the rule enacted by the Board of Medicine? A: If the Board of Medicine is the group responsible for the medical record rule, then I would say yes. Q: Okay. Have you reviewed what has been alleged in the amended administrative complaint, or second amended administrative complaint, as to the statutory provision for medical record adequacy? A: The statutory, I'm not sure that I have. * * * Q: And do you believe that the records fail to justify the course of treatment of the patient with those history findings? A: That's not what I said. I didn't say it failed to justify. What I said is it wasn't complete. Q: Okay, do you have an opinion as to whether the records fail to justify the course of treatment of the patient? A: No. Q: You don't have an opinion. Okay, thank you. In contrast, Dr. Soler testified that in his opinion the patient history that was documented as part of Patient C.A.'s medical records did justify her course of treatment. With respect to the physical examination, Dr. Obi noted that there was only a single line in the operative record stating that the physical examination was within normal limits. He noted that the documentation did not indicate what had been examined and did not record any specific findings or results of any examination that was conducted. However, he never offered an opinion that the record of the physical examination failed to justify the course of treatment of Patient C.A. Dr. Soler testified that in his opinion, the record of the physical examination did justify the course of treatment of the patient. Petitioner did not show by clear and convincing evidence that the documentation of Patient C.A.'s medical history and physical examination failed to justify her course of treatment. Dr. Obi testified that the medical records should have contained more evaluation or explanation of the abnormal laboratory report results: Q: And so was the check mark, when coupled with that note in the pre op, or in the operative report, sufficient documentation of Dr. Velilla's evaluation of the of the patient's pre-operative lab results? A: In my opinion, no. Q: And what do you base that on? A: If you have an abnormal result, I think it is incumbent on you – it – depending on what the abnormality is, and depending on what your interpretation of that abnormality is, it's incumbent to explain it. Sometimes you need to repeat the tests. Sometimes it may be perfectly within normal limits, but on the laboratory sheet, if it says that it's high, or out of the range of normal, I think other than just check mark, I think you just acknowledge what your thoughts are. Q: And do you remember if there was anything abnormal in Patient C.A.'s pre-operative laboratory results? A: There was one area that I commented on. That was the BUN-creatinine ratio. Q: And what is the BUN-creatinine ratio? A: It's just a ratio of some parameters dealing with kidney function. Q: Okay, and what does that lab result tell you about a patient, if anything? A: Well, you know, it can call your attention to the area, I mean, it can tell you, you know, that the patient has some renal issues. It can tell you that the patient is, you know, potentially dehydrated, it can tell you that the patient, you know, is within normal. But if the values are – if one value is high and the other one is low, it may give you a, a high reading. And that's understandable, but all you need to do is document that. It was Dr. Obi's opinion that the medical records failed to contain a sufficient evaluation or explanation of the abnormal BUN/creatinine ratio laboratory result. He acknowledged that the abnormal result was not necessarily indicative of a renal problem. However, Dr. Obi also testified: Q: Okay. Do you have an opinion as to whether those records are adequate to justify the course of treatment of the patient? A: The failure to document the thought process on this ratio would, in and of itself, not prevent or preclude the operative procedure from being done, if that's your question. At best, Dr. Obi's testimony was thus ambiguous as to whether or not failure to include an explanation of the abnormal laboratory result failed to justify the course of treatment of Patient C.A. Dr. Soler testified that no other documentation or chart entry was required to address the lab report value in order to justify proceeding with the surgery. Dr. Sandler testified that the BUN/creatinine ratio was a renal-related test, but does not itself indicate kidney malfunction. Dr. Sandler also testified that in his opinion, no other documentation was needed prior to proceeding with the surgical procedure. The Department did not clearly and convincingly show that the documentation in the medical records relating to abnormal laboratory results failed to justify the course of treatment of Patient C.A. Dr. Obi testified that Dr. Velilla had a duty to order the taking of Patient C.A.'s vital signs since he was not yet in the office when she returned on February 26, 2011, the date the second liposuction had been scheduled. He testified that if the medical records rule "requires doing what's appropriate at each visit," then Patient C.A.'s records did not meet the requirements of that rule. He testified that if Patient C.A. was an "outlier" in that her symptoms were uncommon, the standard of care required that Patient C.A.'s vital signs be taken. Dr. Obi admitted that there was no documentation in the medical records to suggest that Dr. Velilla had ordered the staff at Evolution MD to take Patient C.A.'s vital signs, but he testified that the order should have been given and that it should have been documented. Dr. Obi testified that there was no written documentation of an informed consent for the fat transfer and that the consent for the "Slim Liposculpt" procedure was consent for a procedure that was not done. Again, Dr. Obi seemed unfamiliar with the specific requirements of the medical records rule: Q: And is, is the –is a written documentation of the fat transfer required by the medical record rule in this case? A: In terms of the actual requirement, it would be my opinion that it should be required. Now, I can't say if it says that for every procedure, every surgical procedure, every invasive procedure, that a written consent must be documented; because obviously, you now, the patient consented. It's implied that the patient consented because she showed up for the procedure. Dr. Obi testified that he was aware that the operative report contained statements that Patient C.A. had been informed of the risks of the fat transfer procedure and that she had specifically consented. He admitted he was unsure as to "which board, or organization, or outfit" requires a written informed consent. Aggravating and Mitigating Factors No evidence was introduced to show that Dr. Velilla has had any prior discipline imposed. There was no evidence that Dr. Velilla was under any legal restraints in February 2011. It was not shown that Dr. Velilla received any special pecuniary benefit or self-gain from his actions in February 2011. It was not shown that the actions of Dr. Velilla in this case involved any trade or sale of controlled substances. On May 17, 2014, Dr. Velilla received a certificate showing completion of an FMA educational activity conducted in Jacksonville, Florida, entitled "Quality Medical Record Keeping for Health Care Professionals."
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order dismissing the Second Amended Administrative Complaint against the professional license of Dr. Cesar Augusto Velilla. DONE AND ENTERED this 8th day of June, 2016, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD 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 8th day of June, 2016.
The Issue Whether disciplinary action should be taken against Respondent’s license to practice as a medical doctor based on allegations that he violated sections 458.331(1)(t), (m), and (q), Florida Statutes (2008-2010), as alleged in Petitioner’s Amended Administrative Complaint.
Findings Of Fact The following Findings of Fact are based on the testimony presented at the final hearing, exhibits accepted into evidence, admitted facts set forth in the pre-hearing stipulation, and matters officially recognized. The Parties and the Origin of This Litigation The Department is the state agency charged with regulating the practice of medicine pursuant to chapter 456, Florida Statutes (2006-2017). At all times relevant to the instant case, Dr. McKenzie was a Florida-licensed physician having been issued license ME 93485. Dr. McKenzie is also licensed to practice medicine in Alabama. Dr. McKenzie is board-certified in internal medicine with sub-specialties in pulmonary disease and sleep medicine. Dr. McKenzie earned his medical degree at the University of South Alabama (“USA”) in May of 2000. Over the next three years, Dr. McKenzie completed an internship and a residency in Internal Medicine at USA. By June of 2005, Dr. McKenzie had left USA after completing a fellowship in “Pulmonary & Sleep Medicine, Critical Care.” Dr. Victor Ortega has a medical practice in Panama City, Florida, known as Pulmonary Associates, and Dr. McKenzie began working for Dr. Ortega on approximately July 1, 2005. Dr. McKenzie had no ownership interest in Pulmonary Associates. He was an employee of Dr. Ortega. Therefore, Dr. Ortega owned the medical records for the patients Dr. McKenzie treated at Pulmonary Associates. Dr. McKenzie worked at Pulmonary Associates until July of 2006, and the separation was acrimonious. Dr. McKenzie elected to leave Pulmonary Associates after learning that the compensation system instituted by Dr. Ortega unfairly enriched him at the expense of his associates.1/ Dr. McKenzie began practicing at Bay Clinic, Inc. (“Bay Clinic”), in Panama City in July 2006, and continued there through May 2009. At Bay Clinic, Dr. McKenzie shared office space and administrative expenses with Dr. Jesus Ramirez. Dr. McKenzie had no ownership interest in Bay Clinic. The record is unclear as to whether Dr. McKenzie had an employment contract with Bay Clinic. In May of 2009, Dr. McKenzie opened his own practice at The Lung and Sleep Center in Panama City. Dr. McKenzie owns The Lung and Sleep Center, and he owns the medical records for the patients he treats there. In addition to his practice at The Lung and Sleep Center, Dr. McKenzie is a staff physician at Bay Medical Center, Select Specialty Hospital, and Health South in Panama City. Since August of 2015, Dr. McKenzie has been a clinical instructor for the nurse practitioner program at USA. Because Dr. McKenzie has been practicing in close proximity to Pulmonary Associates, Dr. Ortega sued Dr. McKenzie in 2011 in order to enforce a non-compete agreement.2/ During the course of that litigation, Dr. Ortega’s attorney asked Dr. McKenzie during a deposition whether he had ever treated a current or former employee with narcotic medications at Pulmonary Associates. Because Dr. McKenzie had rendered such treatment to K.D., he responded affirmatively. On January 28, 2011, Dr. Ortega wrote the following letter to the Board of Medicine: A deposition with Dr. McKenzie took place and is enclosed. Dr. McKenzie acknowledged under sworn statement that he had prescribed controlled substances for employees at Pulmonary Associates of Bay County. That person, of course, was [K.D.]. Dr. McKenzie’s attorney opposed any further questioning alleging privacy violations, etc. Since [K.D.] was our employee and he was under contract and under the privacy and umbrella of our corporation, that record keeping was by contract to be kept under our protection. As I understand it, this is a criminal occurrence and violation of the prescription of controlled substances. I am forwarding all this to the law enforcement agency and to the state with the hope that you will proceed accordingly with prosecution and stop this practice as soon as possible. I recognize that the problem of illegal use, abuse, and prescription of controlled substances is a significant issue throughout the United States. This represents one more way in which drugs are being diverted from their legal and appropriate use. To this day I am certain that this illegal prescription practice continues with different individuals. The rapid check of prescriptions at the local pharmacies for controlled substances, particularly Lortab, Dilaudid, etc., by this physician will reveal a number of individuals which I am sure will not have corresponding medical record entries to justify the use of pain control medication by appropriate evaluation, diagnosis, and treatments as required by law. (emphasis added). Dr. Ortega ultimately identified A.W., R.W., and K.D. to the Department as patients who received inappropriate prescriptions from Dr. McKenzie. However, the Department and the Florida Department of Law Enforcement’s (“FDLE”) investigation began due to a confidential informant observing Dr. McKenzie disposing of pill bottles at a car wash. FDLE investigated the matter, but limited resources led to FDLE referring the case to the Department for administrative action. The Department’s allegations pertaining to A.W., R.W., and K.D. will be separately addressed below. Was Dr. McKenzie’s Treatment of A.W. Below the Standard of Care? A.W. has been a Florida-licensed nurse since April of 2007 and has worked at Bay Medical Center since 2005. She was in nursing school when her employment at Bay Medical Center began. A.W. and Dr. McKenzie were co-workers at Bay Medical Center. While Dr. McKenzie was married and A.W. was engaged, they began a romantic relationship in 2005 that continued until 2006 or 2007. When A.W. learned that Dr. McKenzie’s wife was pregnant, their relationship ended, and A.W. did not have any meaningful communication with Dr. McKenzie for the next year. Even though she was already treating with a general medicine practitioner who she considered to be her primary care physician, A.W. began treating with Dr. McKenzie in approximately April of 2009 because she was experiencing “really severe headaches,” anxiety, and abdominal pain. Dr. McKenzie prescribed Lortab, the brand name for an opioid pain medication consisting of acetaminophen and hydrocodone. Under section 893.03(3), Florida Statutes (2008-2017), hydrocodone, in the dosages found in Lortab, is a Schedule III controlled substance. From April of 2009 through October of 2010, Dr. McKenzie prescribed 90 Lortab pills a month to A.W. A.W. was to take one pill every six hours as needed for pain. When A.W. began treating with Dr. McKenzie, they resumed having a personal relationship. While A.W. describes their relationship at that time as being friendly rather than romantic, A.W. and Dr. McKenzie were having sex while Dr. McKenzie was writing prescriptions for her. A.W.’s first documented treatment with Dr. McKenzie at The Lung and Sleep Center occurred on July 22, 2009, and she presented with several issues. For instance, A.W. was experiencing anxiety, and Dr. McKenzie noted on the medical record that A.W. needed to see a psychiatrist. A.W. was also experiencing pain from multiple sources. Migraines were one source of pain, and Dr. McKenzie recommended continuing with Lortab and discussed obtaining a neurology consult. A.W. also had abdominal pain, and Dr. McKenzie discussed obtaining a colonoscopy and consulting with a gastroenterologist. In addition to migraines and abdominal pain, A.W. was experiencing pain from pleurisy. Pleurisy is inflammation of the lining of the lungs, and its symptoms include chest and back pain. It is characterized by a sharp pain that worsens with deep breaths. Pleurisy is treated with nonsteroidal anti-inflammatory drugs (“NSAIDs”) such as Motrin, Aleve, and ibuprofen. If NSAIDs have no effect, then, narcotics can be used. A.W.’s next documented treatment at The Lung and Sleep Center occurred on December 9, 2009. Dr. McKenzie noted in the medical record associated with that office visit that A.W. had gastroesophageal reflux disease, i.e., GERD. In order to treat that condition, Dr. McKenzie prescribed over-the-counter Prilosec and advised A.W. to avoid NSAIDs because they can aggravate heartburn. If a patient cannot take NSAIDs, then Lortab is a reasonable alternative. By the time of her next documented office visit at The Lung and Sleep Center on July 22, 2009, A.W. was still suffering from anxiety, abdominal pain, and pleurisy. A.W. had neglected to obtain any of the consultations recommended by Dr. McKenzie. Dr. McKenzie testified that it can be difficult to get patients to obtain consultations: So a lot of times, it’s hard to get people to be compliant. Nobody wants to go and have scopes in both ends, but especially when something flares up and goes away, because every time you see – it’s like taking your car to the mechanic, when you take it to the mechanic, it quits knocking. So a lot of these people come in, well, it’s not that bad. And they they go home and it will be bad. So a lot of times it’s hard to get them to be compliant with these. Because the [esophagogastroduodenoscopy] and the colonoscopy, I don’t know if anybody has had one, but they can be unpleasant, at best. Because A.W. is a nurse, Dr. McKenzie assumed that she would eventually obtain the consultations: [O]ne thing about A.W. is she’s a nurse. And so you kind of put more weight, because a normal patient, when they say, well, I’m going to call psychiatry, or I’m going to get this down or this done, you know, then you may push them a little harder. But if you have a medical professional, when they tell you that, well, I’ll call this and I’ll do that, you kind of put more weight to that. And so, you know, she did – you know, and she was told, and she said, well, I’ll call psychiatry. And then she would call – was going to call GI and she was going to call neurology. And she eventually did, of course. When asked about prescribing narcotics for a year to a patient who was not obtaining the recommended consultations, Dr. McKenzie testified as follows: So you give people the benefit of the doubt. And her symptoms would come and go. And then she said – like I said, she kept saying, well, I’m going to go see this person, see this person. She worked nights. She had a lot of compounding issues that would make it harder for her to follow up and be compliant. Dr. McKenzie did not have an office visit with A.W. every time that he wrote a prescription for her. The next documented visit by A.W. to The Lung and Sleep Center occurred on December 9, 2009. The medical record notes that A.W. continued to have stomach pain. As a result, she was to continue avoiding NSAIDs, and she was supposed to consult with a gastroenterologist. A.W. was still suffering from pleurisy, anxiety, and migraines. A.W.’s next documented treatment at The Lung and Sleep Center occurred on May 5, 2010. A.W. still had not obtained the consultations mentioned above, and Dr. McKenzie recognized that doing so would be difficult because A.W. was working nights. A.W.’s last documented treatment at The Lung and Sleep Center occurred on October 11, 2010. She still had not obtained the consultations previously recommended by Dr. McKenzie. Dr. McKenzie notified A.W. during this office visit that he would not prescribe any more pain medication until she obtained the psychiatry, neurology, and gastroenterology consultations they had discussed. A.W. then treated with Dr. Mariusz J. Klin, a gastroenterologist, on November 24, 2010. Dr. Klin performed an endoscopy on A.W. and discovered that she was suffering from “severe gastritis from NSAIDs and a 2 centimeter hernia.” Dr. McKenzie testified that severe gastritis is painful. A lot of people call the ambulance, you know, they get all kinds of heart workup and all kinds of pulmonary workup and they did a lot of workup because of the severe pain. And it’s episodic. You can have episodes where you won’t have any issues and then you’ll have flare-ups and have issues. Dr. McKenzie testified that a hiatal hernia can be painful: It can be. A lot of times your – what causes a hiatal hernia is your stomach and your esophagus are above the diaphragm. And your esophagus fits into your diaphragm like a lock and key. And so if your esophagus is in the right place, it helps close off the stomach so the acid can’t come out. Well, when you have a hernia, it pulls the lock and key in the wrong direction to be optimal, so now the stomach acid can leak out and cause more of a problem. Dr. Francisco Calimano, the Department’s expert witness, reviewed A.W.’s medical records and provided expert testimony on the Department’s behalf. Dr. Calimano is licensed to practice medicine in Florida and is board-certified in internal medicine, pulmonary medicine, and critical care medicine. Dr. Calimano testified that the amount of Lortab prescribed to A.W. by Dr. McKenzie was “excessive.” However, Dr. Calimano’s objection was directed more toward the length of time that Dr. McKenzie prescribed 90 Lortab pills a month, rather than the monthly amount of Lortab prescribed. Specifically, Dr. Calimano testified that he would do no more than a two to three month Lortab prescription for a patient with migraines, anxiety, and abdominal pain: In my opinion, you know, in my professional opinion, you know, at least in the scope of practice that I have, which I am not a pain specialist, I wouldn’t go for this length of time prescribing this amount of narcotics. I will feel uncomfortable doing that. So I think that I would refer to the pain management specialist. I would have been, you know, up to the point I said, you know, usually what I tell my patients is I give you a prescription, because you are having acute pain. I might give a second prescription if the pain is not resolved or so with the understanding that he needs to get that addressed. Before I give him that second prescription, I tell him I no longer will prescribe you these medications. And so before she runs out of that prescription, she knows in advance that it’s a no, the answer is no. That she needs to get some help, professional help. Because I think if not I would be doing a disfavor. Dr. David Hart Goldstein provided expert testimony on Dr. McKenzie’s behalf. Dr. Goldstein is licensed to practice medicine in Florida, and he practices internal, pulmonary, and hospital medicine at Sarasota Memorial Hospital. In addition, Dr. Goldstein currently works as an Assistant Clinical Professor of Internal, Pulmonary, and Hospitalist Medicine at Florida State University’s School of Medicine. Dr. Goldstein rendered a different opinion regarding Dr. McKenzie’s treatment of A.W. and the Lortab prescriptions: Q: Does anything appear remarkable to you in terms of the dosage? A: The dosages are on the high side. But when a patient has severe pain sometimes you need a higher dose. It seems that Dr. McKenzie was managing this patient for a long period of time. There was no pain specialist involved at that time. Q: From your review of the record, did it appear that patient A.W. had significant gastric distress? A: Yes. In fact, it appears from the record and the note by Dr. Klin that she tried other methods to relieve the pain. The reasons I say that is his diagnosis was severe gastritis related to the use of NSAIDs. Meaning that she tried using things like Advil. So that caused the issue. So NSAIDs would be prohibited. And this would be consistent with a person who has, according to the record, significant headaches, abdominal pain, which was [caused] by gastritis and pleurisy. Q: So from your review of the records, particularly Dr. Klin’s clinical records, would it be appropriate if NSAIDs were not effective to step up to a Lortab prescription? A: If that was the only way the patient’s pain could be managed, yes. * * * Q: So taking all of these records together, did you see anything clinically inappropriate as to either the medical care or the prescribing that Dr. McKenzie offered to patient A.W. during this timeframe? A: The only thing is as I mentioned – I think I mentioned it in my deposition also. There are a lot of prescriptions for Lortab. The medical record documents that she has a lot of pain. I think there might have been better documentation of the fact that this was failing or this was working. So I am not that impressed with the documentation, but the record is consistent with symptoms that can be treated and are often treated with narcotics such as Percocet or Lortab. Q: Dr. Goldstein, did you see anything that appeared to you to be a practice beneath the standard of care? A: Just as I mentioned, I don’t think the records were great, but I don’t believe that’s a deviation of the standard of care. I just think that’s poor recordkeeping. As for the length of time that Dr. McKenzie prescribed Lortab to A.W., Dr. Goldstein testified that, “I would not prescribe it for a year unless I was comfortable that this patient had made attempts to see a neurologist and had migraines and was not abusing this medication.” Because A.W.’s gastric issues prevented her from taking NSAIDs, Dr. Goldstein opined that it was appropriate to treat A.W.’s headache pain, abdominal pain, and pleurisy with Lortab. With regard to the fact that Dr. McKenzie wrote prescriptions for A.W. without a corresponding office visit, Dr. Calimano acknowledged that “you don’t absolutely need a face-to-face contact with the patient if you have established a diagnosis and you are sure of what you are treating and so on.” Nevertheless, Dr. Calimano objected to Dr. McKenzie not doing more to treat the sources of A.W.’s pain, and the Department takes Dr. McKenzie to task because A.W.’s medical records do not set forth a treatment plan, objectives, etc. However, A.W. was a difficult patient because she did not obtain the consultations requested by Dr. McKenzie until he threatened to discharge her as a patient. Such consultations would be an essential prerequisite to formulating an effective treatment plan for A.W. If A.W. had obtained those consultations when she had been directed to do so, then her illnesses might have resolved much sooner. While Dr. McKenzie probably should have threatened to discharge A.W. sooner, he believed that A.W., as a medical professional, would eventually obtain the consultations, and he recognized that A.W.’s night shift work made it difficult for her to obtain those consultations. In sum, even Dr. Goldstein acknowledged that Dr. McKenzie’s recordkeeping for A.W. could have been better. However, the evidence does not clearly and convincingly demonstrate that Dr. McKenzie’s treatment of A.W., under these particular circumstances, fell below the standard of care.3/ Did Dr. McKenzie Falsify A.W.’s Medical Records and Use Her to Illegally Obtain Lortab? Contrary to the medical records described above, A.W. asserts that she has never sought treatment at The Lung and Sleep Center. While she acknowledges visiting The Lung and Sleep Center, she asserts that she was only there as a friend of Dr. McKenzie and to assist her father with obtaining treatment.4/ A.W. testified that Dr. McKenzie never determined the cause of her headaches, her anxiety, or her abdominal pain. A.W. testified that Dr. McKenzie never performed a physical exam on her or discussed a treatment plan with her. A.W. also denies that she received any treatment from Dr. McKenzie at Bay Clinic, but she acknowledges visiting him there as a friend. As noted above, A.W.’s Lortab prescriptions enabled her to obtain 90 Lortab pills a month. As a result, she could take one pill every six hours. A.W. testified that she could not tolerate taking that amount of Lortab. The medicine made her drowsy and upset her stomach. A.W. also testified that she never had to take four Lortab pills in a single day in order to control her pain. After the first month of her treatment with Dr. McKenzie, A.W. testified that she continued to fill the Lortab prescriptions but gave a large majority of the pills to Dr. McKenzie. A.W. testified that she kept a few pills for those times when she would experience severe headaches or abdominal pain, and one pill a day was enough to keep her pain under control. As for why she gave large portions of her Lortab prescriptions to Dr. McKenzie, A.W. testified that she did so “[b]ecause he was my friend, and he had told me he was going through a lot, and he was embarrassed to go see a physician in town. He asked me if he wrote me a script could I give him some back or give it back to him.” During the time in question, Dr. McKenzie was experiencing marital difficulties and opening his own practice. A.W. testified that she would fill the Lortab prescriptions at a CVS Pharmacy in Panama City and then meet Dr. McKenzie in a parking lot so that she could give him the medication. A.W. and Dr. McKenzie’s personal relationship ended again in 2011 when A.W. became pregnant. At some point in 2011, A.W. was contacted by investigators from the Department and the Drug Enforcement Agency. A.W. then alerted Dr. McKenzie to the aforementioned agencies’ investigation. A.W. testified that she assisted Dr. McKenzie with fabricating medical records demonstrating that she had treated at The Lung and Sleep Center and that the Lortab prescriptions were medically necessary. She testified that she did so because Dr. McKenzie was her friend and she wanted the investigation to “go away.” Moreover, A.W. testified that she was worried that she could be charged with impaired nursing. When asked why she fabricated medical records, A.W. testified as follows: Because he was my friend and I didn’t want him to get in trouble for all of this, and I wanted it to be done with. I was worried about being a nurse and being a part of this. And I had been – the whole impaired nursing thing had been brought up, and I figured if I did this everything would just go away. A.W. learned of the Administrative Complaint when Dr. McKenzie showed it to her during a 2014 visit to his apartment. A.W. visited Dr. McKenzie’s apartment “quite a few times” and their last sexual encounter probably occurred in 2015. Despite testifying that she and Dr. McKenzie had been friends, A.W. testified against Dr. McKenzie at the final hearing and claimed that she was doing so because she felt it was the right thing to do and did not “want this over [her] head anymore.” Medical records from Dr. Klin and a Dr. Elzawahry memorialize treatment rendered to A.W. in October and November of 2010. However, those records, which were in the possession of The Lung and Sleep Center, bear a facsimile timestamp of March 1, 2011, and March 2, 2011. Those dates are four months after A.W.’s treatment dates. Also, the facsimile timestamps are seven days after the Department served Dr. McKenzie with a subpoena for A.W.’s medical records. While concerning, the facsimile timestamps do not conclusively demonstrate that Dr. McKenzie fabricated the records pertaining to A.W.’s treatment at The Lung and Sleep Center. While the undersigned has doubts about Dr. McKenzie’s credibility, there are reasons to question A.W.’s credibility. A.W. and Dr. McKenzie had a complicated relationship, and Dr. McKenzie is currently seeing another nurse employed at Bay Medical Center. The undersigned cannot ignore the possibility that A.W. and Dr. McKenzie’s prior relationship did not end on good terms. As noted above, Dr. Ortega brought A.W., R.W., and K.D. to the Department’s attention. The January 28, 2011, letter from Dr. Ortega to the Board of Medicine is suspicious because Dr. Ortega confidently states (without stating the basis for his assertions) that there are other patients who have received illegal prescriptions from Dr. McKenzie. Given the January 28, 2011, letter and the acrimony between them, one of Dr. McKenzie’s defenses to the Amended Administrative Complaint is that Dr. Ortega persuaded or coerced A.W., R.W., and K.D. to provide false testimony against him. It is possible that Dr. Ortega could be in a position to exercise some sort of leverage over A.W. due to the fact that Dr. Ortega works as a pulmonary doctor at Bay Medical Center and A.W. is a pulmonary nurse. During the hearing, A.W. acknowledged that she is taking 14 medications such as Latuda for psychosis; Ativan for anxiety; Prozac for depression; Nuvigil for Attention Deficit Disorder (“ADD”) and narcolepsy; Adderall for ADD; Fioricet for migraines; Metoprobol for hypertension; Lamictal for bipolar disorder; Carafate to coat her stomach; Prilosec for indigestion, gastric reflux, and gastritis; and Rispedal, a mood stabilizer associated with bipolar disorder. The fact that A.W. is currently receiving treatment for psychosis and bipolar disorder does not cause the undersigned to discredit her testimony. However, the undersigned cannot ignore the fact that there was no testimony as to what extent (if any) the aforementioned conditions affected her during the time period relevant to the instant case. In sum, there is evidence indicating that Dr. McKenzie used A.W. to obtain Lortab. Nevertheless, the evidence taken as a whole does not clearly and convincingly demonstrate that Dr. McKenzie prescribed Lortab to A.W. outside the course of his professional practice. Was Dr. McKenzie’s Treatment of R.W. Below the Standard of Care? R.W. was a Florida-licensed respiratory therapist from approximately 2000 to 2012. R.W. met Dr. McKenzie sometime between 2005 and 2006 when both of them were employed at Gulf Coast Medical Center. Dr. McKenzie and R.W. often worked together. While R.W. considered Dr. McKenzie to be a friend, they did not spend time together outside the hospital. Since his first marriage ended in 1993, R.W. had been taking Ativan in order to alleviate anxiety resulting from his divorce. Ativan is the brand name for Lorazepam and is prescribed for anxiety. According to section 893.03(4), Lorazepam is a Schedule IV controlled substance. Approximately one year after meeting Dr. McKenzie, R.W. inquired about becoming Dr. McKenzie’s patient. R.W. had become heavily dependent on Ativan and admits that he was engaging in “doctor shopping” in order to obtain more Ativan prescriptions. Other doctors had declined to treat R.W. because they believed he was taking too much Ativan: Q: So my question was about Dr. McKenzie and how did you begin treating as a patient with Dr. McKenzie. A: I was taking large amounts of Ativan. After that many years, you build up a tolerance to it. I [did] what was called doctor shopping. I had asked a couple of other physicians if they would follow me for my Ativan. Because generally I am healthy. And I had become dependent on it and was taking pretty large amounts of it and approached him about that, if he would prescribe it for me. Q: Did the other physicians you had asked to follow you begin following you and providing you with Ativan? A: No. Q: Why not? A: They said I was taking an incredibly large dose of it. They didn’t think I should be on that much. Q: Did they offer to take you as a patient and prescribe you alternatives? A: No. Q: They wouldn’t follow you altogether? A: They wouldn’t follow me altogether. They wanted to know who had been prescribing me that much. I guess it was because I wasn’t getting the answer I was wanting, I just didn’t pursue it any further. Q: So what did you do to get it after that? A: I approached Dr. McKenzie. Q: Was Dr. McKenzie aware that any other practitioners wouldn’t give it to you? A: I don’t know. I don’t believe I made that – I don’t know. Q: Do you recall how you approached Dr. McKenzie about the Ativan? A: Yeah. We were at the hospital. I approached him. I said, look, I am on Ativan. Explained the reason I was on it. I am on large doses of it. I need someone to follow me for this, is that something you could do. The first documented treatment occurred on November 2, 2007, when R.W. presented at Bay Clinic. A patient intake form indicates that R.W. placed notations on the form indicating that he was suffering from “anxiety/stress” and “problems with sleep.” A follow-up note dated November 20, 2007, lists Ativan as R.W.’s current medication and states that he will continue with Ativan. The note records the following: The patient follows up today. He is complaining of chest pain. He states that he has had chest pain in the center of his chest which radiated into both arms for about 15 minutes. He has had no further episodes of this. The patient had a normal stress test last year. We will try to obtain the results. The patient does have a smoking history. Today we did an EKG which showed no significant abnormalities. The patient states that he has been under a lot of stress. He continues to take his Ativan. The patient is an avid kick boxer[5/] and exercises often. Lab work was obtained. The patient knows to seek immediate medical attention for any worsening of his condition. The next documented treatment occurred on August 29, 2008, at Bay Clinic. The medical record reports the following: The patient follows up today. States that he has had no further chest pain. The patient does have significant anxiety. The patient has been on Ativan for several years. Risks, benefits, and alternatives [to] Ativan were explained to patient and patient voiced understanding. The patient does not want to decrease the Ativan. Does not want to change the Ativan. The patient denies suicidal or homicidal ideation. The patient jogs several miles each day. The patient exercises. The patient is a respiratory therapist, and I have contact with [the] patient every day. The patient is compliant with his medications. Does use it at the same pharmacy. The patient is under a narcotic contract here. If the patient violates his contract[6/], the patient knows that he will be discharged immediately. The patient knows to seek immediate medical attention for any worsening condition. The medical record notes that Dr. McKenzie will continue R.W. on Ativan. On January 24, 2009, R.W. was injured in an automobile accident. Another vehicle traveling 40 mph rammed into the back of R.W.’s Corvette. According to R.W., the other vehicle was traveling [f]ast enough to knock me from a red light. I was at a red light. I was in a Corvette. Fast enough to fold the tail end of my Corvette under and knock me across the intersection to the railroad tracks. Pretty hard. When asked if the accident was “significant,” R.W. responded by testifying that his car had been “totaled.” On February 9, 2009, R.W. received a prescription from Bay Clinic for Lortab, but no refills were authorized. On April 3, 2009, R.W. received a second prescription from Bay Clinic for Lortab. Again, no refills were authorized. The next documented treatment occurred at Bay Clinic on May 1, 2009. R.W. presented with anxiety and some depression. Dr. McKenzie discussed R.W. treating with a psychiatrist and prescribing Luvox, an antidepressant. This record notes that R.W. was still experiencing pain from the motor vehicle accident and that Dr. McKenzie “will try NSAIDs.” The next documented treatment occurred on July 23, 2009. With regard to R.W.’s anxiety, Dr. McKenzie wanted R.W. to see a psychiatrist, but R.W. refused. Dr. McKenzie noted in the medical record that he was going to begin decreasing R.W.’s Ativan dosage and replacing it with a short-acting benzodiazepine. Dr. McKenzie explained that he wanted to wean R.W. off of Ativan because: He had been on Ativan, as he testified, for 25 years before I met him. And the goal was to try to get him off the Ativan. And so, we were going to change him from a long- acting benzodiazepine Ativan to a short- acting one, Xanax. And so what you try to do is wean his Ativan down and then wean him to the short-acting, and it’s easier for people to get off the short-acting. But, somebody that’s been on benzodiazepines or like Ativan for 25 years, it does the same thing to your brain that alcohol does. And so abruptly withdrawing benzodiazepines can put people in DT’s, delirium tremens and with a 25 percent mortality, being that one in four people could die if you just took somebody off those medications. Given R.W.’s 25-year use of Ativan, slowly weaning R.W. from Ativan and to a less harmful anxiety drug was certainly a reasonable goal. The medical record indicates that R.W. was still experiencing back pain from the motor vehicle accident and had “failed NSAIDs.” The record notes that Dr. McKenzie and R.W. discussed obtaining x-rays. At that time, Dr. McKenzie began prescribing at least 90 Lortab pills per month to R.W. The next documented treatment occurred on November 20, 2009. R.W. was continuing to take Lortab for chronic back pain, and Dr. McKenzie was still in the process of weaning R.W. from Ativan. This record notes that R.W. refused a psychiatric consult. In February of 2010, Dr. McKenzie increased the Lortab prescription from 90 to 120 pills a month. The next documented treatment occurred on March 10, 2010. R.W. was still experiencing chronic back pain and anxiety. Dr. McKenzie noted that R.W. needed an MRI and consultations with an orthopedist and a pain management specialist. There is a notation in the record indicating that R.W. needed x-rays. However, R.W. reported that he needed to “check his funds” before obtaining the x-rays. In addition, there is a notation that Dr. McKenzie “will stop Lortab soon.” The next documented treatment occurred on August 12, 2010. R.W. was still experiencing chronic back pain, and Dr. McKenzie wanted R.W. to consult with an orthopedist and a pain management specialist. R.W. was aware that Dr. McKenzie wanted MRIs taken. R.W. was still experiencing anxiety, but the medical record notes that Dr. McKenzie was only going to prescribe one more refill of his medication. Dr. McKenzie noted on the record that R.W. stated, “I will get you. This is bullshit.” R.W. testified that his faith has enabled him to stop taking any medication other than BC headache powder. There is no dispute that Dr. McKenzie did not require an office visit from R.W. each time he wrote a prescription. With regard to whether that practice was appropriate, Dr. McKenzie testified as follows: Ideally we did but, like I said, sometimes patients would come in and pick up a prescription. And it’s kind of the rule that they have one each time but, like I said, that’s sometimes rules can’t be ideal. I mean, if you know the patient, and you know what the issues are, I don’t think there was any law or statute that said they need to be seen every single time. With regard to whether Dr. McKenzie’s treatment of R.W. fell below the standard of care, Dr. Calimano explained that a physician should begin treating a patient complaining of back pain by taking the patient’s history and performing a physical exam. The physical exam would be followed by imaging studies such as an MRI. If there is nothing pressuring the patient’s spine, then treatment options include physical therapy and NSAIDs. If the patient’s pain is very severe, then the physician could prescribe narcotics for a short period of time. If the patient’s condition does not improve, then the physician would refer the patient to the appropriate specialists, such as ones dealing with the spine and pain management. With regard to R.W.’s anxiety, Dr. Calimano stated that he would have attempted to refer R.W. to a psychiatrist. Dr. Calimano was of the opinion that Dr. McKenzie’s medical records do not justify the amount of Lortab and Ativan prescribed to R.W. However, his testimony did not sufficiently address the notations regarding R.W.’s pain from the violent motor vehicle accident. His opinion appeared to focus on the notations regarding chest pain. With regard to the Xanax and Lortab Dr. McKenzie prescribed to R.W. between November 20, 2009, and August 12, 2010, Dr. Goldstein testified as follows: Q: Anything about the dosing or the frequency for the Xanax prescriptions that looks remarkable to you? A: Xanax, one milligram. You know, it can be given up to four milligrams a day. So one milligram [four times a day] is on the higher end, but it’s not above the prescribing recommendations. Lortab is being given continuously. Patient has continuous pain. And it’s documented that the doctor wanted to send this patient to a pain specialist, to an ortho doctor and to rehab. So there is a lot of documented pain medicine there. Again, the only thing I mention is there might have been better documentation as to why he needed to continue it. But there is nothing remarkable about the dosages. Q: So, Dr. Goldstein, based upon all the medical records that we’ve been through regarding R.W. and the medication administration record on page 39, could you offer an opinion to the Court as to whether or not you perceive that Dr. McKenzie’s treatment or prescribing of R.W. during the time period at issue to be beneath the acceptable standard of care? A: The fact that the patient was referred to a psychiatrist. The fact that Xanax was given and it was documented on that last note we mentioned, that the patient was not suicidal, which is important if you are prescribing that. The fact that the patient was referred to an orthopedic doctor, a rehab doctor and a pain specialist, I believe it was within the standard of care. I don’t think the documentation is great, but I can’t see anything that says this is beneath the standard of care. The Department takes Dr. McKenzie to task for not doing more to address R.W.’s anxiety, such as recommending behavior modifications and/or psychotherapy. The Department also takes issue with Dr. McKenzie’s not doing more to treat R.W.’s chronic back pain. However, the medical records indicate that Dr. McKenzie attempted several times to have R.W. treat with a psychiatrist, but R.W. refused. It appears from the medical records that R.W. was not compliant with Dr. McKenzie’s request for x-rays. Dr. McKenzie did not offer a reason why he maintained R.W. as a patient when R.W. would not obtain the recommended consultations and tests. But, Dr. McKenzie noted during his testimony regarding A.W. that he gives more leeway to medical professionals when it comes to obtaining recommended consultations. Given R.W.’s refusal to pursue the recommended consultations and tests, it probably would have been appropriate for Dr. McKenzie to have ended the prescriptions much sooner. Nevertheless, the greater weight of the evidence demonstrates that R.W. was a difficult patient who was resistant to obtaining the consultations desired by Dr. McKenzie. If he had been more compliant in obtaining those consultations, then Dr. McKenzie may have been more successful in treating R.W.’s anxiety and chronic pain. In sum, the evidence does not clearly and convincingly demonstrate that Dr. McKenzie’s treatment of R.W. fell below the standard of care given the circumstances associated with R.W. Did Dr. McKenzie Falsify R.W.’s Medical Records and Use Him to Illegally Obtain Lortab? R.W. testified that any pain from his motor vehicle accident only lasted two days, and he denies experiencing any chronic/long-term pain following the accident. R.W. testified that Dr. McKenzie prescribed Lortab and asked him to transfer the medicine to him. R.W. testified that he returned pain medication to Dr. McKenzie on a monthly basis over the course of approximately one year. The transactions would occur at the hospital or in parking lots at a Wal-Mart or a service station. R.W. testified that he would typically give 90 to 100 pills to Dr. McKenzie and retain 10 to 20 for his own use. R.W. denies being addicted to Lortab but acknowledges that he was a recreational user and that he “abused” Lortab and Percocet. As for why Dr. McKenzie engaged in this practice, R.W. testified that: As in my deposition, Dr. McKenzie had a corneal abrasion. And I understand, maybe I don’t understand, that physicians, I guess, it’s looked down upon if they are taking medications. So he had a corneal abrasion and asked if I would get him a prescription filled for the pain for his corneal abrasion. When asked why he agreed to divert drugs to Dr. McKenzie, R.W. stated that, “I don’t have a good answer for that. Stupidity I would assume.” As for why he stopped diverting drugs to Dr. McKenzie, R.W. stated that, “Again, when it stopped, my life, it was falling apart. It was a mess.” When asked why he stopped treating with Dr. McKenzie, R.W. testified as follows. A: I don’t even recall. My life was blowing up there. It was a total mess there near the end of my tenure with Gulf Coast. I mean, it was a train wreck. Q: What does that mean? A: I was taking a lot of Ativan. I was taking Lortab. I was drinking heavily. It was a wreck. Q: So the question is why did you stop treating with Dr. McKenzie? A: I left employ – you know, I don’t recall other than we just parted ways and I went my way and that is that. I don’t recall. Q: Did Dr. McKenzie ever have any discussion with you about terminating you as a patient of his? A: He may have. I don’t recall. I am not going to say he didn’t. The Department argues that Dr. McKenzie fabricated the medical records discussed in the previous section because R.W. claims that he only received treatment from Dr. McKenzie at The Lung and Sleep Center on two occasions. Moreover, R.W. claims that he never received treatment from Dr. McKenzie at Bay Clinic.7/ As for why he testified against Dr. McKenzie, R.W. stated the following: A: Well, first of all, I was subpoenaed here. You answer a subpoena. This has been going on for many, many years. Too many for me. I don’t want to be here today. And that is just a fact. Several years ago, I think it was during a – I don’t think, I know. During a fit of anger, withdrawals, all the above, I contacted your department and asked that this be investigated. And I believe the lady’s name was [] Ms. McBride, [and she] came to my residence in Mexico Beach and said that she was going to follow- up and I never heard back. When I heard from you, I was floored that it had taken that long. I figured, well, maybe my – it was a – maybe my suspicions were unfounded when I didn’t hear anything back from her. Q: What do you mean maybe your suspicions were unfounded? A: Maybe I was [the] one off. He was – maybe he was helping me out. Maybe we were helping each other out. I don’t really know. All I know is that I had brought it to your office’s attention a long time ago and nothing was ever done about it. Q: Did anyone ever offer you anything for your testimony today? A: No. Other than the $8.42 check I got from the State for gas I believe. It was delivered to me with my subpoena. Q: Are you referring to [the] witness fee? A: Yes. That I tore up. As was the case with A.W., Dr. McKenzie argues that Dr. Ortega somehow influenced or coerced R.W. into falsely testifying that Dr. McKenzie received Lortab from R.W. Dr. McKenzie testified that Dr. Ortega supervised R.W. at Bay Clinic when R.W. was employed as a respiratory therapist. Therefore, if R.W. held a grudge against Dr. McKenzie for cutting off his Ativan supply as indicated in the August 12, 2010, medical record, it is certainly possible that Dr. Ortega could have learned of that circumstance and sought to take advantage of it. As noted above, the undersigned has doubts about Dr. McKenzie’s credibility. However, R.W.’s statements about engaging in “doctor shopping” for years in order to obtain Ativan, abusing Lortab, and being a “train wreck” when he stopped treating with Dr. McKenzie cast substantial doubt on R.W.’s credibility. Indeed, it appears that R.W.’s difficulties may be the reason why he is no longer a respiratory therapist. Moreover, given R.W.’s own description of the severity of his car accident, it is surprising that he would testify that he experienced little or no pain afterwards. That is especially true given the fact that his car was struck from behind and totaled. Finally, given R.W.’s longstanding dependency on Ativan, R.W. certainly had a motive for filing a false report with the Department after Dr. McKenzie cut off his Ativan supply. In sum, the evidence taken as a whole does not clearly and convincingly demonstrate that Dr. McKenzie prescribed Lortab to R.W. outside the course of his professional practice. Was Dr. McKenzie’s Treatment of K.D. Below the Standard of Care? K.D. began working at Pulmonary Associates in 2007 and was employed there at the same time that Dr. McKenzie worked there. K.D. considered Dr. McKenzie to be her primary care physician, and she treated with him from some point in 2006 at least until August of 2009. K.D. treated with Dr. McKenzie at Gulf Coast Medical Center, Bay Medical Center, Pulmonary Associates, and Bay Clinic. However, K.D. usually treated with Dr. McKenzie at Gulf Coast Medical Center. As her primary care physician, Dr. McKenzie was typically K.D.’s attending physician when she was admitted to either Bay Medical Center or Gulf Coast Medical Center. K.D. primary health problem was intractable pain originating from her hips and one of her knees. K.D.’s knee pain resulted from two knee surgeries and appears to have been aggravated by a car accident. During the course of her treatment with Dr. McKenzie, K.D. was often admitted into hospitals for treatment of her pain. A medical record from Bay Medical Center dated January 22, 2008, describes K.D.’s general condition during the treatment with Dr. McKenzie: This patient is a 37-year-old female who has had long standing problems with chronic pain, particularly involving the right lower extremity. Her history is extensive in that she has been previously diagnosed with torn meniscus in the right knee. She has undergone 2 previous orthoscopic procedures. Also, she has been treated for chronic pes anserinus bursitis. She has had a plethora of complaints over recent years including chronic pain syndrome, migraine headaches, asthma, fibromyalgia, anxiety, depression, and recurrent pain in the right knee and occasionally in the right hip. She was in a motor vehicle accident about a year or so ago, which resulted in no significant abnormalities on workup, but aggravated her chronic pain. She also had a fall and an MRI of the right hip was carried out at the end of 2006, and a partial tear of the gluteus medius was noted. All of her MRIs of the knee demonstrate minimal degenerative change, and previous meniscal pathology. * * * She has been diagnosed previously with chronic pain syndrome and has been utilizing up to 12 mg a day of oral Dilaudid for quite a few months. This is on the basis of chronic migraine headaches and fibromyalgia. From January 2007 through July 22, 2009, Dr. McKenzie prescribed Lortab and Dilaudid on a monthly basis for K.D.’s pain. Dilaudid is a brand name for hydromorphone. Dilaudid is an opioid pain medication that is four times stronger than Lortab. Under section 893.03(2), hydromorphone is a Schedule II controlled substance. For several months in 2008, K.D. was receiving a 120-pill supply of Lortab intended to last 15 days and a 120-pill supply of Dilaudid intended to last 10 days. He also prescribed Xanax for anxiety and Ambien for sleep. The Department takes issue with Dr. McKenzie prescribing two short-acting narcotics, Lortab and Dilaudid, to K.D. between January 2007 and July 22, 2009, without medical records supporting those prescriptions. According to the Department, there is no justified medical purpose for prescribing Lortab and Dilaudid together. Dr. Calimano testified as follows: I’m a pulmonologist, so anything that depress[es] or repress[es] your respiratory drive is always a concern with me. Plus they are all habit forming, so I will be concerned. Going back to the use of narcotics, sometimes you can use a combination of narcotics. But when you are using narcotics on a chronic basis for, like, terminally ill patients and so on, the combination will be you do a long-term or long acting narcotic. You know, there are some preparations, Morphine, and so on and so forth that will last 12 hours. And then you use preparations for breakthrough pain, like short acting ones and so on. But if you have two narcotics that are both, like, will give you the hit quickly, but will disappear three or four hours later, I am not sure, you know, what the advantage would be. In contrast, Dr. Goldstein testified that prescribing two short-acting narcotics is appropriate in order to treat “breakthrough pain:” Q: Is Dilaudid a short acting narcotic? A: Yes. It’s considered an immediate release with a half life of two to three hours. Q: Is Lortab a short acting narcotic? A: Yes. Two to three hours. The answer is yes. Q: In your practice, have you ever prescribed a combination of both Lortab and Dilaudid? A: Yes. But never to be used, as I said in my deposition, at the exact same time. You could use one and another for breakthrough. In other words, you wouldn’t say to the patient take a Dilaudid and a Lortab at the same time for pain. You would say take a Dilaudid on the scheduled basis. And then you may use Lortab for breakthrough. Lortab is not as strong as Dilaudid. And it would be better to use Lortab for breakthrough than Dilaudid for breakthrough. Q: Why would you prescribe a patient two short acting narcotics as opposed to one long acting narcotic such as Fentanyl or Morphine with a short acting narcotic for breakthrough pain? A: Yes. As a matter of fact, the recommendations for pain control, and you can check it [is] up-to-date, are to reserve the long acting pain medications like Oxycontin and Fentanyl for people who have severe chronic pain like cancer. And that should not be the first thing. That should be the last thing you should do. In other words, we try to get away with short acting and try to stay away from the long acting ones. In other words, the long acting one is progression. That’s something you go to next, not before. If the long acting pain medications, for patients, for example, who have cancer and are on hospice, those are the ones we give Fentanyl patches to or Oxycontin. And that’s currently what a lot of the pain management doctors are doing with severe pain. The short acting ones are not as effective. Dr. McKenzie explained why he prescribed two short- acting narcotics as follows: Well, I mean, that your – the goal for the patient is to get them off narcotics. And just like Dr. Goldstein testified that, you know, once you put people on long-acting narcotics, they’re kind of stuck there. And so, you know, what you – cancer patients and terminally ill patients, you put them on long-acting, you know, morphine, long-acting Oxycontin and then for the breakthrough pain, you add a short-acting [narcotic]. Well, that’s not the goal with [K.D.]. The goal is to get her off these medications. And so the medications that I had her on were two short-acting and, yes, you have to use caution with two short acting medications but, again, the goal was to get her off the medication, not advance her to a higher level where she’s – it’s a lot harder to get her off. Once you get somebody on a long-acting narcotic, pain medications to wean them off and that’s the perpetual state that she was in, trying to get her off the narcotics, not keep going up. The Department also takes issue with the lack of medical records supporting the prescriptions written between February 26, 2008, and July 22, 2009. According to the Department, Dr. McKenzie should have had a treatment plan with objectives to assess the success of K.D.’s treatment. In addition, the Department asserts that Dr. McKenzie should have documented recommendations for referrals to other physicians. For the vast majority of the time between February 26, 2008, and July 22, 2009, Dr. McKenzie’s non- hospital practice was based at Bay Clinic, and Dr. McKenzie testified that K.D. had office visits with him in 2008 at Bay Clinic. Therefore, it is possible that Dr. McKenzie treated K.D. at Bay Clinic between February 26, 2008, and July 22, 2009, and that the lack of medical records is attributable to him retaining no ownership over the corresponding records. The Department has presented no persuasive evidence conclusively establishing that Dr. McKenzie owned or should have owned the medical records associated with the patients he treated at Bay Clinic. While K.D. testified that she only visited Bay Clinic on two occasions, Christen Tubbs, a former medical assistant at Bay Clinic, testified that K.D. visited Bay Clinic frequently and that there were many medical records pertaining to K.D. at Bay Clinic.8/ For reasons discussed in detail below, Ms. Tubbs’ testimony on this point was more credible than K.D.’s. As a result, medical records pertaining to K.D.’s treatment at Bay Clinic were created but unavailable for the final hearing. Without those medical records, it is impossible to evaluate whether Dr. McKenzie practiced below the standard of care with regard to not having a treatment plan with objectives to assess the success of K.D.’s treatment. The lack of medical records makes it extremely difficult to evaluate whether Dr. McKenzie practiced below the standard of care by prescribing Lortab and Dilaudid to K.D. in the quantities at issue. The Department presented no sufficiently persuasive evidence demonstrating that the quantities of Lortab and Dilaudid prescribed to K.D. were per se below the standard of care given the circumstances associated with K.D.’s treatment.9/ In sum, the Department has not presented clear and convincing evidence that Dr. McKenzie’s treatment of K.D. fell below the standard of care. Did Dr. McKenzie Use K.D. to Illegally Obtain Lortab? Rather than ingesting the Lortab prescribed for her, K.D. testified that she would fill the Lortab prescriptions and give the pills to Dr. McKenzie in a mall parking lot or her home. According to K.D., Dr. McKenzie would usually give her $40 to $100 for the Lortab. K.D. testified that she would not have taken Lortab because she is allergic to it. K.D. explained that she had her tonsils removed at 16 and was given hydrocodone, an ingredient in Lortab. The hydrocodone caused her to have an itchy, swollen throat. Medical records from Bay Medical Center and Gulf Coast Medical Center note that K.D. was allergic to Lortab. Dr. McKenzie pointed out that he authored a July 16, 2007, medical record, which stated K.D. was allergic to Lortab. However, that same record notes that K.D. “states it makes her nose itch, but has no significant abnormal affect.” Dr. McKenzie testified as follows: And so that, as far as I’m concerned, that she was not, you know, she was not allergic to Lortab. Plus, she had over 80 different independent medical exams because she had been in the hospital 20, 30 different times where she didn’t tell physicians, at that time, or nurses, that she was allergic to Lortab. So that’s not on there. So she would pick and choose who she would tell she was allergic to Lortab and who she wasn’t. And you would say, well, is that a red flag, well, I didn’t know that. And so I don’t go back and look. She was my patient. She told me she wasn’t allergic to Lortab. That’s what I document. And so I would prescribe Lortab for her. Even in the hospital, they did a – and it’s in the records, we can find the Bates number, they got tired of her saying Lortab or not, and there’s a whole section where they went through and viewed every single allergy she had, and they deemed her not to be allergic to Lortab. So, I don’t see how her telling one physician that she’s allergic to Lortab and one physician that she’s not, that that’s – that’s a red flag or that’s anything that I would even notice if I was to go back and look at these medical records. There are aspects of K.D.’s testimony that cause the undersigned to consider Dr. McKenzie’s testimony to be more credible. Rather than testifying during the final hearing, K.D. was deposed on August 9, 2017, at the Gadsden Correctional Facility where she was serving a 36-month sentence for recruiting patients to obtain prescriptions by fraud. K.D. agreed that the aforementioned offense was a “felony conviction.” K.D.’s own testimony suggested that she had a motive to provide false testimony against Dr. McKenzie. Specifically, K.D. testified that she became addicted to pain medication and asserts Dr. McKenzie knew of her addiction. K.D. stated that pain medication “destroyed” her life and was the reason why she was in prison. While K.D. did not directly state that she blamed Dr. McKenzie for her difficulties, one could easily infer from her testimony that she holds a grudge against him. As is the case with A.W. and R.W., there is a connection between K.D. and Dr. Ortega. K.D. testified that she was forced to resign from Pulmonary Associates because she was suspected of embezzlement. Dr. Ortega brought charges against her, but those charges were dismissed after K.D.’s father paid restitution. While K.D. denies that Dr. Ortega offered to drop the charges against her if she gave testimony against Dr. McKenzie, this circumstance must be taken into account when evaluating K.D.’s credibility. The Department has failed to present clear and convincing evidence that Dr. McKenzie prescribed Lortab to K.D. outside the course of his professional practice.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Amended Administrative Complaint. DONE AND ENTERED this 1st day of May, 2018, in Tallahassee, Leon County, Florida. S G. W. CHISENHALL 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 1st day of May, 2018.
The Issue The issue for consideration in this case is whether Respondent's license as a physician in Florida should be disciplined because of the matters alleged in the Administrative Complaint filed herein.
Findings Of Fact At all times pertinent to the issues herein, the Petitioner, Board of Medicine, has been the state agency responsible for the licensing of physicians and the regulation of the medical profession in Florida. Respondent was a licensed physician in Florida under license number ME 0039846. On September 23, 1988, Respondent saw Patient #1, a 55 year old female, who presented with a primary complaint of chronic pain in the neck and low back resulting from an automobile accident. The patient history taken by the Respondent revealed a head injury, a back injury and a whiplash injury, all within the previous five years. The patient also had a history of unstable blood pressure, especially in times of stress, and a history of alcohol abuse which had been in remission for the past two years. Respondent examined the patient and found she was suffering from depression but evidenced no suicidal ideations or indications of psychosis. Respondent diagnosed a major depressive reaction and myofacial syndrome of the neck and low back. Dr. Morales treated this patient from September 23, 1988 to February 1, 1990, prescribing various antidepressants and anti-anxiety medications including Limbitrol, Prozac, Valium, Halcion and Tranxene for her. He also prescribed various opiates including Percodan and Percocet. Respondent claims he made a copy of each prescription he wrote for the patient medical records of each patient so that he could keep track of the number of pills he prescribed for that patient. He claims that the quantity of a prescribed medication was kept in a separate area of the patient's chart and not with the clinical notes. Though Respondent claims this procedure was a common office practice and done consistently in every patient's chart, the evidence indicates otherwise. His method of recording medication in the clinical record was inconsistent. At some places in the record he would indicate the exact number of a specific pill prescribed. At other places in the record, he would not. Examples of this practice, as seen from the medical records of Patient #1 available, shows the following entries: October 20, 1988, Rx for Valium for patient #1 but no indication of the amount prescribed is found in the records. March 2, 1989, Rx for Percodan QID (4 times a day), but no indication in records of the amount prescribed. July 8, 1989 Rx for Percodan - 60 tabs. August 2, 1989 Respondent notes to continue with Percoset, but no notation in records as to amount. September 7, 1989 Rx for Percocet but records do not reflect amount prescribed. November 15, 1989 Rx for 60 Percocet. December 6, 1989 Rx for 30 Percocet pills. While Patient #1 was under Respondent's care, she was admitted to the hospital twice. On September 18, 1989 she was admitted to Largo Medical Center for narcotics addiction and was discharged on September 28, 1989. On September 18, 1989, while the patient was in the hospital, Dr. Farullah, a staff physician, called Respondent to discuss the patient with him. This conversation, including the Respondent's name, is itemized in the hospital records for this patient. It is appropriate practice protocol upon the admission of a patient to the hospital for the admitting physician to notify the patient's attending physician about the patient's diagnoses and condition. It would appear this was done here by Dr. Farullah. Nonetheless, Respondent claims he did not know the patient was hospitalized, contending he did not recall the conversation, and noting that the information regarding hospitalization might not have been included in it. Respondent claims he never heard of Dr. Farulla until a subsequent visit from the patient in his office on October 24, 1989. After the patient's discharge from the hospital, she came to Respondent's office for a 30 minute visit on October 4, 1989. Though this visit occurred only 6 days after her discharge from the hospital, Respondent claims the subject of her hospitalization was not discussed. Two days later, on October 6, 1989, the patient returned to Respondent's office for another 30 minute visit and again, the subject of her hospitalization did not come up. This patient was readmitted to the hospital on October 10, 1989 with a diagnosis of, among other things, drug dependency. She was discharged on October 20, 1989, but, again, Respondent claims he did not know of her hospitalization. He saw her on October 24, 1989 for another 30 minute visit during which, he claims, the subject of her hospitalization did not come up. This appears to be a conflict with his previous testimony , noted in Paragraph 8, supra, wherein he stated he never heard of Dr. Farullah until he met with the patient in his office on October 24, 1989. On April 10, 1990, in the course of filing a disability claim with the Department of Health and Rehabilitative Services, (DHRS), the patient signed a medical release form. Thereafter, HRS requested the patient's records from the Respondent, but they were not forthcoming. A second request was transmitted to the Respondent who replied that the records requested had been copied but not dispatched because no release form accompanied the request. Respondent indicated that upon receipt of the release form, the records would be forwarded, and on June 4, 1990, they were, in fact, sent by the Respondent. This was approximately 17 months before the burglary of Respondent's office to be discussed, infra. Respondent claims it was his policy, however, in responding to requests for information to the Social Security Administration, (disability claims are paid by Social Security), to provide only clinical notes, initial evaluation, and a medical summary update. Other records, including prescription records, are not sent. Respondent's office was burglarized on November 30, 1991 by one of his former employees. According to Respondent, all the medical records he had were taken during the break-in. Though they were ultimately returned, he claims they were incomplete when returned. However, comparison done by the Department's investigator, of the medical records of Patient #1 which were sent to HRS before the burglary with those taken from Respondent's office after the burglary, indicated they were the same, except for some duplicates. Nonetheless, Respondent claims that some of the records pertaining to Patient #1, including prescription records, were not recovered. This could explain the absence of prescription records in both sets of records, but that is not found to be the case here, however. According to the Board's expert, Dr. Boorstin, a Board Certified Psychiatrist who specializes in addiction psychiatry and opiastic medicine, the benzodiazepins prescribed for Patient #1 by the Respondent, were inappropriate because of her known alcoholism, and he failed to adequately monitor her for possible addiction or dependence. Even though her condition had been in remission for two years, Dr. Boorstin concluded it was below standard practice to prescribe those drugs to this patient. Dr. Boorstin also concluded that Respondent failed to keep adequate written medical records for this patient and did not justify the less than conservative prescription of anti-anxiety and pain medications to a known alcoholic. A physician must keep track of the drugs being used by a patient to be sure no abuse trends exist. The Respondent should have detailed with exactitude in his records the number of each specific medication. From September 30, 1988 to February 1, 1990, a period of 16 months, he prescribed various opiate-based pain killers to Patient #1, including Tylenol #3, Codeine, Percodan and Percocet. His prescription of the latter two, in Dr. Boorstin's opinion, fell below the appropriate standard of care. The patient's hospital records indicate she was suffering from drug addiction, and if, as the Department claims, Respondent knew of her hospitalizations and the reason therefor, his prescription of liberal amounts of opiate based drugs was inappropriate. The evidence shows the patient was admitted to the hospital on two occasions, both times for, among other problems, drug addiction. Less than one month after her second discharge, Respondent prescribed Percocet for this patient for pain relief at a rate of two tables every six hours. According to Dr. Boorstin, the usual adult dosage is one tablet every six hours. This is outlined in the Physician's Desk Reference, (PDR), a compendium of drugs and medications with manufacturer's recommendations for dosage. Though authoritative in nature, the PDR is not mandatory in application, and physicians often use it as a guide only, modifying strength and dosage as is felt appropriate for the circumstance. On at least one occasion, Respondent's medical records for this patient show he prescribed Percocet but not the amount prescribed. This is below standard. The same is true for the noted prescription for Percodan. Both Percodan and Percocet are Schedule II drugs. A notation in the records for a prescription for Valium also reveals no indication was given as to the amount prescribed. Again, this is below standard. Dr. Boorstin's opinion is contradicted by that of Dr. Wen-Hsien Wu, the Director of the Pain Management Center at the Schools of Dentistry and Medicine of New Jersey, the New Jersey Medical School, who testified by deposition for the Respondent. Dr. Wu claims he has prescribed medications in amounts and dosages far in excess of those prescribed by Respondent and for a much longer period of time. Wu is Board certified in anesthesiology and has published numerous articles on pain management. Dr. Wu contends there is no contraindication for the use of narcotic therapy in Patient #1's alcoholism. The use of narcotics is appropriate if the patient can return to function with careful monitoring. Here, it would appear that Patient #1 was monitored through her frequent visits to the Respondent's office. It is impossible to tell from the Respondent's patient records just how much medication he prescribed for his patient. Because of the failure to indicate the number of pills of each type Respondent was prescribing, it is impossible to form a conclusion as to whether the amount prescribed was appropriate or excessive. Notwithstanding Respondent's claim in his Proposed Findings of Fact that "...there is no indication of drug abuse in the prescribed drug area", the medical records show that on each admission of Patient #1, a diagnosis of drug addiction was made. To be sure, these records do not reflect the drug to which the addiction relates.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered herein finding Respondent guilty of all allegations except prescribing in inappropriate amounts. It is also recommended that Respondent be ordered to pay an administrative fine of $3,500 within 90 days of the date of the Final Order herein, be reprimanded, and within one year of the date of the Final Order herein, attend continuing medical education courses at the University of South Florida Medical School in appropriate medical record keeping and in the prescribing of abusable drugs. RECOMMENDED this 12th day of June, 1995, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of June, 1995. APPENDIX TO RECOMMENDED ORDER The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: Accepted and incorporated herein. - 5. Accepted and incorporated herein. 6. - 15. Accepted and incorporated herein. 16. - 19. Accepted and incorporated herein. & 21. Accepted as a representation by Respondent. Accepted as Respondent's position but not accepted as fact. Accepted and incorporated herein. Accepted. - 27. Accepted and incorporated herein. Rejected as unproven. & 30. Accepted but repetitive of other evidence previously admitted. 31. & 32. Accepted and incorporated herein. - 38. Not appropriate Findings of Fact but merely recitations of the contents of records. Accepted and incorporated herein. - 42. Restatement of witness testimony. FOR THE RESPONDENT: Accepted and incorporated herein. - 5. Accepted and incorporated herein. 6. & 7. Accepted as testimony of Respondent, but not as probative of any issue. 8. - 11. Accepted and incorporated herein 12. & 13. Accepted. 14. - 16. Accepted and incorporated herein. 17. Accepted. 18. & 19. Accepted. 20. Accepted. 21. Accepted. 22. - 24. Accepted. 25. - 29. Accepted and incorporated herein. 30. & 31. Accepted. 32. Accepted. & 34. Accepted as opinions of the witness, but not as the ultimate fact. Accepted as to admissions but rejected as to Respondent not being advised. Accepted and incorporated herein. COPIES FURNISHED: Steven A, Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33617 Grover C. Freeman, Esquire Freeman, Hunter & Malloy 201 E. Kennedy Boulevard Suite 1950 Tampa, Florida 33602 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0770 Assistant Director Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue The issue for determination is whether Petitioner is liable for overpayment of Medicaid claims for the period from 9/1/94 through 9/30/96, as stated in Respondent's Final Agency Audit Report dated May 5, 1998.
Findings Of Fact At all times material hereto, the Agency for Health Care Administration (Respondent) was the state agency charged with administration of the Medicaid program in the State of Florida pursuant to Section 409.907, Florida Statutes. At all times material hereto, Henry M. Rubinstein, D.C., (Petitioner) was a licensed chiropractor in the State of Florida and was providing chiropractic services to Medicaid recipients. Petitioner provided the services pursuant to a contract with Respondent under the Medicaid provider number 0503517-00. His Medicaid patients for years have included children and multi-handicapped children. Petitioner has published in peer review journals and is a board certified chiropractor. Dennis L. Jones, D.C., is a licensed chiropractor in the State of Florida. 1/ He was involved in the creation of Florida's Medicaid program and monitors the Florida Chiropractic Medicaid Program. Dr. Jones also serves as a Medicaid chiropractic consultant, including the issuance of prior authorizations for treatment. Prior authorizations are required for a chiropractor to provide and bill for visits by Medicaid recipients in excess of the set limited number. The maximum number of visits allowed per year prior to July 1, 1994, was 12, and after July 1, 1994, was 24. After July 1, 1994, prior authorization was required for visits beyond 24 for Medicaid recipients under the age of Prior authorization was granted for requests that demonstrated medical necessity. Dr. Jones denied many of Petitioner's requests for prior authorization. He denied the requests on the basis that the treatments were extending for periods of up to two years without detailed explanation of medical necessity to substantiate such extended periods of care. Dr. Jones observed that Petitioner's requests for such extended care routinely lacked substantiation and documentation for such extended care, such as x-rays, orthopedic and neurological findings, and subjective/objective descriptions. However, Dr. Jones granted some of Petitioner's requests for prior authorization to exceed the maximum number of visits. Dr. Jones had concerns as to the sufficiency of the documentation of Petitioner's requests for prior authorizations. As a result, when such requests were granted, Dr. Jones noted on the request forms that supplemental medical necessity needed to be documented more completely in the future. In 1996, Dr. Jones related his concerns about Petitioner in a letter to Respondent and included with the letter prior authorizations for primarily special needs children covering the years 1994 through 1996. Twenty-nine prior authorizations were included, with 25 of them for special needs children. His concerns related primarily to Petitioner's Medicaid patients who were special needs children and for whom Dr. Jones had reviewed only prior authorizations submitted by Petitioner. Further, in his letter, Dr. Jones requested an investigation into possible patient brokering, a criminal act. However, a request from a complainant for an investigation into a particular area of alleged violation does not prevent Respondent from identifying and investigating other areas of possible violation revealed by the documents provided. Dr. Jones' letter was referred to one of Respondent's employees, Judith M. Jensen. At that time, Ms. Jensen was also in the process of reviewing another complaint lodged against Petitioner by Dr. Jones, regarding prior authorizations for children, but covering a different time period--from 1993 through 1995. Ms. Jensen was, and is, employed by Respondent as a Human Services Program Specialist. Her duties include monitoring Medicaid claims and investigating Medicaid complaints and aberrant billings for Respondent's Medicaid Program Integrity Office. In investigating all billing irregularities or specific complaints, a review is typically made of the Medicaid provider's medical records. Substantiation of Medicaid claims that are submitted and paid is by adequate and proper medical record documentation. An audit, based upon a billing irregularity or complaint, is usually begun with the selection of a provider or a group of providers. Next, a sample of the chosen provider's Medicaid claims is chosen for a particular time period, which is the audit period. An analyst for Respondent then requests from the provider the medical records for the Medicaid recipients sampled for the audit period. The medical records are provided to and analyzed by a medical peer reviewer. If the medical peer reviewer recommends denial of payment for any of the claims, resulting in overpayment, Respondent forwards a preliminary audit letter to the Medicaid provider, describing the audit findings and requesting any supplemental medical records. A review of any submitted supplemental medical records is conducted, and the audit findings are adjusted in accordance with the results of the review. If an overpayment continues to be indicated after the review, Respondent forwards a final audit letter to the Medicaid provider. Respondent has a limited number of analysts and medical peer reviewers. Due to such constraints on Respondent, sampling is utilized due to its reliability, cost-effectiveness, and commonly accepted method for review of high volumes of Medicaid claims. Ms. Jensen initiated Respondent's review of Petitioner's Medicaid claims. She began the audit by requesting an ad hoc computer report on Petitioner's billing history for all Medicaid recipients under the age of 21 for the time period from 9/1/94 through 9/30/96. Ms. Jensen's request concentrated only on Medicaid recipients under the age of 21 because Dr. Jones alerted Respondent primarily to prior authorizations for children. Ms. Jensen received the ad hoc computer report, which was a detail of all of Petitioner's Medicaid billings for Medicaid recipients under the age of 21 for the period from 9/1/94 through 9/30/96. The report provided that for the time period indicated, Petitioner billed and was paid for 4,499 claims for 85 recipients, for a total amount of $71,731.30. Having received this information, Ms. Jensen requested a computer-generated selection of a random sample of 20 recipients from the total population of the 85 recipients. Twenty recipients were randomly selected from the total population of the 85 recipients, which showed, among other things, claims totaling 1,307 and payment for the claims totaling $20,710.69. Afterwards, Ms. Jensen requested Petitioner to provide all the medical records for the 20 sampled recipients for the time period from 9/1/94 through 9/30/96. Petitioner complied with Ms. Jensen's request. Having received the medical records, Ms. Jensen engaged a peer review consultant, Dr. Ronald J. Hoffman, D.C., to evaluate the records submitted by Petitioner. She provided the medical records to Dr. Hoffman.. 2/ He was provided with the medical records of only 10 Medicaid recipients on two separate occasions, instead of all 20 at the same time. The Medicaid recipients' medical records were not "sanitized" when they were submitted to Dr. Hoffman, meaning that the names of the Medicaid recipients and provider, Petitioner, were not redacted. Dr. Hoffman, as a peer reviewer, rarely reviews files which have been sanitized. The failure to sanitize the medical records found to be of no consequence to Dr. Hoffman's determinations. Dr. Hoffman is a licensed chiropractor in the State of Florida and has been practicing for over 30 years. His practice includes patients who are pediatric and multi-handicapped, but these patients comprise a very small number of his patients. He performs chiropractic Medicaid utilization review for Respondent and is a Medicaid provider. He has performed chiropractic utilization review for more than 15 years. For the Medicaid program, Dr. Hoffman has been a consultant since 1997, but Petitioner's review was the first peer review performed by Dr. Hoffman for the Medicaid program. When Dr. Hoffman performs peer reviews for Respondent, he relies upon State statutes and Respondent's guidelines, specifically, The Chiropractic Coverage and Limitation Handbook, and his years of experience Dr. Hoffman is knowledgeable about what a medical record should contain in order for the medical record to demonstrate medical necessity for Medicaid reimbursement purposes. The medical record should contain the complete medical history; an examination showing the condition of the patient and why the patient is being treated; symptoms; standardized testing, including orthopedic and neurological tests; treatment notes; a treatment program; objective findings; special procedures; and an evaluation of the patient's progress. 3/ Petitioner agrees that, according to the Medicaid provider reimbursement handbook, the following are requirements for medical records: patient history; chief complaint for each visit; diagnostic tests and results; diagnosis; treatment plan, including prescriptions; medications, supplies, scheduling frequency for follow-up or other services; progress reports, treatment rendered; original signatures and dates; dates of service; and referrals to others. Dr. Hoffman was aware from review of the medical records provided by Petitioner that the Medicaid recipients were special needs children. However, he was unaware of Florida's special needs statutes (Subsections 409.803(1)(c) and 409.9126(1)(b), and Section 409.9121, Florida Statutes), which address, among other things, health care needs for special needs children, and he did not use the statutes in his determination. The failure to use the special needs statutes had little or no effect on Dr. Hoffman's review. The undersigned is persuaded and a finding of fact is made that Dr. Hoffman's failure to use the special needs statutes in his review did not invalidate his determinations. Dr. Hoffman was tendered and is accepted as an expert in chiropractic medicine. He is also found to be an appropriate peer reviewer for Petitioner's situation. Dr. Hoffman's testimony is found to be credible. After having reviewed the medical records, regarding the 20 randomly sampled Medicaid recipients, pursuant to Respondent's Medicaid peer review, Dr. Hoffman produced two reports of his findings. 4/ During his review, Dr. Hoffman considered all of the Medicaid recipients' visits, including those that had been granted prior authorization. Patient 1 was recipient K.K., with a date of birth of 5/18/86. 5/ Dr. Hoffman's opinion was that Patient 1's medical records did not support a finding of medical necessity. The medical records failed to support justification for Patient 1's 198 visits from 11/10/94 through 9/10/96. X-rays contained in the medical records were of such poor quality that they were of no diagnostic value; however, the x-rays were not a factor in the determination of medical necessity. Petitioner's medical notes were practically the same for each visit, with Petitioner noting practically the same comment(s); and there was no recorded orthopedic or neurological testing and no standard chiropractic evaluation forms justifying the number of treatments billed. Patient 1's medical records failed to demonstrate medical necessity for the visits. For Patient 1, 198 claims were paid in the amount of $3,081.30. Prior authorizations granted totaled $2,964. 6/ Patient 2 was recipient N.M., with a date of birth of 8/11/83. Dr. Hoffman's opinion was that Patient 2's medical records lacked documentation demonstrating that the treatments were a medical necessity for Medicaid reimbursement purposes for the 175 visits from 7/12/94 through 6/27/96. The medical records contained no standard medical notes or examination forms and no orthopedic, neurological or chiropractic examination forms to justify treatments; and were redundant and repetitive. X-rays contained in the medical records were of such poor quality that they were of no diagnostic value; but, the x-rays have no impact on the determination of medical necessity. Patient 2's medical records failed to demonstrate medical necessity for the visits. For Patient 2, 175 claims were paid in the amount of $2,726.50. Prior authorizations granted totaled $2,964. Patient 3 was recipient D.A., with a date of birth of 4/6/89. Dr. Hoffman's opinion was that Patient 3's medical records lacked justification for the 173 visits from 8/23/94 through 7/30/96. The medical records contained no standard procedures performed by an acceptable chiropractic physician licensed in the State of Florida. The medical records also indicated that a medical radiologist, Dr. Robert S. Elias, M.D., read the recipient's x-rays for the purpose of a medical diagnosis of treatment and that Dr. Elias' diagnosis directly conflicted with Petitioner's diagnosis; however, the x-rays were not a factor in the determination of medical necessity. Patient 3's medical records failed to demonstrate medical necessity for the visits. For Patient 3, 173 claims were paid in the amount of $2,693.70. Prior authorizations granted totaled $2,604. Patient 6 was recipient T.W., with a date of birth of 2/5/90. Dr. Hoffman's opinion was that Patient 6's medical records lacked justification for the 160 visits from 1/3/95 through 9/3/96. The medical records contained no standardized chiropractic notes, no specified diagnosis, and no routine re- examinations. Furthermore, the medical records failed to show why Petitioner was treating Patient 6. X-rays contained in the medical records were not of diagnostic quality and were, therefore, of no diagnostic value; however, the x-rays had no impact on the determination of medical necessity. Patient 6's medical records failed to demonstrate medical necessity for the visits. For Patient 6, 160 claims were paid in the amount of $2,502.20. Prior authorizations granted totaled $1,882.90. Patient 24 was recipient G.H., with a date of birth of 7/20/95. Dr. Hoffman's opinion was that Patient 24's medical records failed to justify the approximately 73 visits. The medical records contained no standardized chiropractic notes, no objective findings, and no standardized testing, including range of motion, muscle spasms, and orthopedic or neurological tests. For many of the visits, the only documentation contained in the medical records consisted of the same notation or statement: "Patient doing well." Patient 24's medical records failed to demonstrate medical necessity for the visits. For Patient 24, 72 claims were paid in the amount of $1,158.09. The medical records do reflect that any prior authorizations were granted. Patient 25 was recipient O.M., with a date of birth of 4/25/83. Dr. Hoffman's opinion was that Patient 25's medical records failed to justify the 87 visits. The medical records contained no standardized chiropractic notes, no justification of diagnosis, and no standard medical tests. The notes that were recorded were quite sparse and repetitive and typically recorded as "Doing well." Patient 25's medical records failed to demonstrate medical necessity for the visits. For Patient 25, 71 claims were paid in the amount of $1,131.69. Prior authorizations granted totaled $753.60. Patient 27 was recipient C.F., with a date of birth of 2/12/84. Dr. Hoffman's opinion was that Patient 27's medical records failed to justify the 67 visits from 10/11/95 through 3/25/96. The medical records contained no standardized chiropractic notes, no standardized examination forms, and no documentation of Patient 27's progress. Patient 27's medical records failed to demonstrate medical necessity for the visits. For Patient 27, 67 claims were paid in the amount of $1,079.59. The medical records do reflect that any prior authorizations were granted. Patient 28 was recipient K.H., with a date of birth of 8/22/94. Dr. Hoffman's opinion was that Patient 28's medical records failed to justify the 69 visits. The medical records contained no standardized chiropractic notes and no standardized testing, and showed no specific treatment provided based upon the requirements of the Medicaid laws. Patient 28's medical records failed to demonstrate medical necessity for the visits. For Patient 28, 66 claims were paid in the amount of $1,031.79. The medical records do reflect that any prior authorizations were granted. Patient 33 was recipient K.D., with a date of birth of 2/15/84. Dr. Hoffman's opinion was that Patient 33's medical records failed to justify the 73 visits. The medical records contained no standardized chiropractic notes and no standardized testing. Patient 33's medical records failed to demonstrate medical necessity for the visits. For Patient 33, 51 claims were paid in the amount of $800.70. Prior authorizations granted totaled $376.80. Patient 35 was recipient T.M., with a date of birth of 10/15/91. Dr. Hoffman's opinion was that Patient 35's medical records failed to justify the 51 visits from 2/15/95 through 6/10/96. The medical records contained no standardized chiropractic notes justifying the treatment provided. The medical records also stated that Dr. Elias read Patient 35's x- rays for the purposes of medical diagnosis of treatment and that Dr. Elias' diagnosis directly conflicted with Petitioner's diagnosis; however, the x-rays were not a factor in determining medical necessity. Patient 35's medical records failed to demonstrate medical necessity for the visits. For Patient 35, 51 claims were paid in the amount of $828.39. Prior authorizations granted totaled $753.60. Patient 39 was recipient B.T., with a date of birth of 8/8/95. Dr. Hoffman's opinion was that Patient 39's medical records failed to justify the 47 visits from 2/9/95 through 10/19/95. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 39's medical records failed to demonstrate medical necessity for the visits. For Patient 39, 47 claims were paid in the amount of $765.59. Prior authorizations granted totaled $753.60. Patient 40 was recipient T.H., with a date of birth of 7/11/84. Dr. Hoffman's opinion was that Patient 40's medical records failed to justify the 46 visits from 11/15/94 through 2/28/95. The medical records contained no standardized chiropractic notes justifying the treatment provided. The medical records also indicated that Dr. Elias read the recipient's x-rays for the purposes of medical diagnosis of treatment and that Dr. Elias' diagnosis directly conflicted with Petitioner's diagnosis; however, the x-rays were not a factor in determining medical necessity. Patient 40's medical records failed to demonstrate medical necessity for the visits. For Patient 40, 46 claims were paid in the amount of $731.70. Prior authorizations granted totaled $753.60. Patient 45 was recipient T.W., with a date of birth of 9/26/90. Dr. Hoffman's opinion was that Patient 45's medical records failed to justify the 22 visits from 4/24/95 through 11/15/95. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 45's medical records failed to demonstrate medical necessity for the visits. For Patient 45, 26 claims were paid in the amount of $408.20. Prior authorizations granted totaled $376.80. Patient 48 was recipient S.L., with a date of birth of 1/31/91. Dr. Hoffman's opinion was that Patient 48's medical records failed to justify the 23 visits from 3/25/96 through 9/11/96. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 48's medical records failed to demonstrate medical necessity for the visits. For Patient 48, 23 claims were paid in the amount of $388.79. The medical records do reflect that any prior authorizations were granted. Patient 54 was recipient H.A., with a date of birth of 1/31/88. Dr. Hoffman's opinion was that Patient 54's medical records failed to justify the 7 visits from 9/6/95 through 10/2/95. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 54's medical records failed to demonstrate medical necessity for the visits. For Patient 54, 19 claims were paid in the amount of $298.30. The medical records do reflect that any prior authorizations were granted. Patient 58 was recipient T.W., with a date of birth of 11/19/81. Dr. Hoffman's opinion was that Patient 58's medical records failed to justify the 23 visits from 3/25/96 through 9/30/96. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 58's medical records failed to demonstrate medical necessity for the visits. For Patient 58, 17 claims were paid in the amount of $294.59. The medical records do reflect that any prior authorizations were granted. Patient 59 was recipient C.P., with a date of birth of 4/11/93. Dr. Hoffman's opinion was that Patient 59's medical records failed to justify the 22 visits from 4/10/96 through 10/9/96. The medical records contained no standardized chiropractic notes, no documentation of standardized testing of the spine, no documentation of standard tests, including orthopedic and neurological tests, and no medical justification for ongoing care and treatment. Patient 59's medical records failed to demonstrate medical necessity for the visits. For Patient 59, 16 claims were paid in the amount of $278.89. Prior authorizations granted totaled $376.80. Patient 64 was recipient M.L., with a date of birth of 8/20/89. Dr. Hoffman's opinion was that Patient 64's medical records failed to justify the 8 visits from 8/30/95 through 10/2/95. The medical records contained no standardized chiropractic notes, no documentation of standardized testing, and no description of Patient 64's pain or physical condition. Patient 64's medical records failed to demonstrate medical necessity for the visits. For Patient 64, 13 claims were paid in the amount of $204.10. The medical records do reflect that any prior authorizations were granted. Patient 69 was recipient A.L., with a date of birth of 1/14/92. Dr. Hoffman's opinion was that Patient 69's medical records failed to justify the 9 visits from 2/27/95 through 3/20/95. The medical records contained no standardized chiropractic notes, and the documentation contained in the records was minimal and repetitious. Patient 69's medical records failed to demonstrate medical necessity for the visits. For Patient 64, 13 claims were paid in the amount of $204.10. The medical records do reflect that any prior authorizations were granted. Patient 77 was recipient N.J., with a date of birth of 4/16/80. Dr. Hoffman's opinion was that Patient 77's medical records failed to justify the 7 visits from 3/6/95 through 3/29/95. The medical records contained no standardized chiropractic notes justifying the treatment provided. Patient 77's medical records failed to demonstrate medical necessity for the visits. For Patient 77, 7 claims were paid in the amount of $137.59. The medical records do reflect that any prior authorizations were granted. Dr. Hoffman recommended denial of all claims for the 20 sampled Medicaid recipients for the period from 9/1/94 through 9/30/96 due to Petitioner's failure to adequately document medical necessity in the recipients' medical records. For the 20 sampled Medicaid recipients for the period from 9/1/94 through 9/30/96, the total of the Medicaid payments was $20,710.69. As a result, the denial amount, the overpayment, for the 20 sampled recipients was the same, $20,710.69. The overpayment for the 20 sampled Medicaid recipients was extrapolated to the entire universe or total population of the 85 Medicaid recipients under the age of 21 for the period from 9/1/94 through 9/30/96, which resulted in a total projected overpayment of $70,518.26. The actual total amount of Medicaid payments for the 85 Medicaid recipients for the covered time period was $71,731.30. Considering the actual total payment of $71,731.30, the projected overpayment of $70,518.26 is very close to the actual total payment and is inherently reasonable. There is an expectation that, because all the claims of the 20 sampled Medicaid recipients were denied, the projected denial for all the claims in the universe of 85 recipients would be very close to the actual total payment. The difference between the projected overpayment of $70,518.26 and the actual amount paid of $71,731.30 is $1,213.04. This difference is negligible and such negligible difference reflects the inherent accuracy and reliability of the statistical methodology utilized. The maximum error range is 5 percent. The difference between the projected overpayment total and the actual payment total is also well within the maximum error range of 5 percent, or $3,587, for a 95 percent statistical confidence interval. To illustrate Respondent's statistical methodology, first, begin with sampled Medicaid recipient Patient 1. As indicated previously, the total number of actual claims for the total population of 85 Medicaid recipients, who were under the age of 21, was 4,499, and the total amount paid for the claims was $71,731.30; the data being taken from Respondent's Medicaid claims database. For Patient 1, 198 claims were audited and $3,081.30 was the total amount paid for the claims. All of the $3,081.30 was denied and determined to be an overpayment. Second, the same process was used with all 20 Medicaid recipients sampled, which produced a total of 1,307 claims, which were all denied, and produced a total of $20,710.69 in overpayment. The total sampled overpayment of $20,710.69 was divided by the total number of sampled claims (1,307) to obtain a mean overpayment per sampled claim of $15.85. The overpayment per sampled claim of $15.85 was multiplied by the number of claims in the total population (4,499) to obtain a point estimate of the total population overpayment, which was $71,291.04. Third, adjusting the point estimate of $71,291.04 for any potential statistical error, Respondent's model reduces the point estimate by 1.73 standard deviations, yielding an error- adjusted total overpayment of $70,518.26. Respondent has a level of confidence that there is 95 percent chance that actual overpayment is a minimum of $70,518.26. The point estimate of $71,291.04 is very close to the actual payment of $70,731.30 for the claims of the total population of the 85 Medicaid recipients; therefore, the overpayment of $70,518.26 is relatively conservative. Respondent's audit was conducted in conformity with Respondent's standards and conformed to Respondent's manner in conducting audits. The audit also had no known deviations or irregularities or deficiencies in the technical processes utilized, except the failure to take into account the prior authorizations granted. As to the statistical aspect of Respondent's audit, Respondent presented the testimony of a statistical expert, Dr. James T. McClave, Ph.D. 7/ Dr. McClave's testimony is considered credible. Using statistical methods in Medicaid overpayment determinations is a common and well-accepted standard of practice. Statistical modeling in Medicaid auditing scientifically and accurately determines the extent of overpayments in a population of payments from a small sample of overpayments drawn from the population of payments. Statistical modeling is capable of providing reliable estimates of the integrity, or lack thereof, of a Medicaid provider's billings, within reasonable time and resource constraints. In the statistical formula, a sample of claims is used to obtain a valid statistical estimate of the overpayment, if any, associated with the entire population of claims from which the sample of claims was drawn. A point estimate, being the best estimate the sample has to offer of the overpayment, is taken; and then a factor, allowing for the uncertainty associated with the sample, is subtracted such that there is a specified level of confidence that what is obtained is the conservative estimate of what the total population overpayment would be. The point estimate is referred to as "the lower 95 percent confidence bound," 8/ and the number obtained is a number which one "can be 95 percent confident that it is an underestimate of what the total overpayment would be" 9/ if the entire population was sampled. Respondent complied with the statistical methodology. The random selection process and the ad hoc computer report were valid and reliable. The results of the sampling and extrapolation were valid and reliable on the basis of the total population of Petitioner's Medicaid patients was pediatric patients and the results were limited to Petitioner's Medicaid patients under the age of 21. Further, the sample size of 20 Medicaid recipients from the total population of 85 was adequate. However, the results of the sampling and extrapolation are not reliable as they pertain to the failure of Respondent to take into consideration the granted prior authorizations. Respondent is compelled and should be provided an opportunity to re-apply its statistical methodology in light of granted prior authorizations not being considered. Uncertainty now exists as to what effect the granted prior authorizations would have on the outcome of the total overpayments. The denial of all of Petitioner's claims was a situation of first impression for Respondent. Prior to the instant case, Respondent had had no chiropractor's Medicaid claims go through peer review and denial recommended. By letter dated February 4, 1998, Respondent forwarded to Petitioner a Preliminary Agency Audit Report (Preliminary Audit Report). The Preliminary Audit Report informed Petitioner, among other things, that Respondent's preliminary determination was that Petitioner had received an overpayment of $70,518.26 due to the claims being determined not medically necessary, and requested, among other things, that Petitioner submit any additional information or documentation which may reduce the overpayment. The Preliminary Audit Report also informed Petitioner of the overpayment calculation and statistical formula used by Respondent. In response to the request for additional information or documentation, Petitioner forwarded to Ms. Jensen a videotape and testimonials. Ms. Jensen did not send the testimonials and videotape to Dr. Hoffman, the peer reviewer, for his review because these items (1) were determined by her to have been created prior to recording of the medical records at issue, and, therefore, did not constitute a medical record for review; and (2) were, consequently, not relevant. The undersigned is persuaded and a finding of fact is made that the testimonials and videotape were not relevant and need not have been submitted to Dr. Hoffman for his review. By letter dated May 5, 1998, Respondent forwarded to Petitioner its Final Agency Audit Report (Final Audit Report). The Final Audit Report, based upon the recommendations of Dr. Hoffman, notified Petitioner, among other things, that the final determination was that he had received an overpayment of $70,518.26, due to the Medicaid claims not being medically necessary. The Final Audit Report also notified Petitioner, among other things, of the overpayment calculation and statistical formula used by Respondent. Moreover, Petitioner was notified that his type of violation warranted termination from the Medicaid program and a $2,000 fine, but that, in lieu of termination from the Medicaid program, he could continue as a provider by paying a $5,000 fine. In a subsequent letter to Petitioner, regarding clarification of continued participation in the Medicaid program, Ms. Jensen explained that, as a requirement for continued participation in the Medicaid program, in addition to the $5,000 fine, Petitioner must comply with Medicaid policy and Florida Statutes and rules. Petitioner was placed on notice that to continue as a Medicaid provider he must abide by Medicaid billing requirements. Respondent's Final Audit Report did not contain any notice of mediation being available. Section 120.573, Florida Statutes, requires notice of whether mediation (settlement) is available in agency action that affects substantial interests. There is no dispute that Respondent's Final Audit Report affects Petitioner's substantial interests. No evidence was presented that either Petitioner inquired about mediation or that Petitioner or Respondent sought or desired mediation. Moreover, no evidence was presented that Petitioner was harmed or suffered as a result of not receiving the notice. No evidence was presented to support a finding that the basis of the audit findings involved a conspiracy. A finding of fact is made that the basis of the audit findings does not involve a conspiracy between Respondent and its employees and Dr. Jones and Dr. Hoffman and Dr. McClave or anyone else. Respondent did not initiate any disciplinary action against Petitioner's license as a chiropractor and, therefore, Subsections 455.225(1) and 455.621(1), Florida Statutes, are not applicable. No evidence was presented that any criminal action was referred or taken against Petitioner as a result of Respondent's audit. No evidence was presented that Respondent suspected Petitioner of having committed a criminal violation, that a criminal act had been committed by Petitioner, or that Respondent had determined that Petitioner had committed a criminal act.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order against Henry M. Rubinstein, D.C. and therein: Sustaining the failure of Dr. Rubinstein's medical records, except as to granted prior authorizations, for Medicaid recipients under the age of 21 for the period from 9/1/94 through 9/30/96, to demonstrate medical necessity. Sustaining the Final Agency Audit Report, except as indicated and consistent with this Recommended Order. Requiring Dr. Rubinstein to repay overpayments, without interest, in an amount subsequently determined in a proceeding by the Agency for Health Care Administration and within a time period under terms and conditions deemed appropriate. Imposing a fine of $5,000. DONE AND ENTERED this 11th day of April, 2000, in Tallahassee, Leon County, Florida. ERROL H. POWELL 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 11th day of April, 2000.
