ALJDEC decisions subject to certification as final

08A-12762-MDX · Arizona Medical Board · 2008-06-29

IN THE OFFICE OF ADMINISTRATIVE HEARINGS

HEARING: June 10, 2008. APPEARANCES: The Arizona Medical Board was represented by its attorney, Philip A. Overcash, Esq. Kenneth M. Fisher, M.D. appeared personally and was represented by his attorney, Calvin L. Raup, Esq. ADMINISTRATIVE LAW JUDGE: Brian Brendan Tully _____________________________________________________________________ Based upon the evidence of record, the Administrative Law Judge makes the following Findings of Fact, Conclusions of Law and Recommended Order:

FINDINGS OF FACT

1. The Arizona Medical Board (“Board”) is the authority for licensing and regulating the practice of allopathic medicine in the State of Arizona. 2. Kenneth M. Fisher, M.D. (“Respondent”) is the holder of License No. 12762 for the practice of allopathic medicine in the State of Arizona. 3. The Board initiated an investigation of Respondent after it received a complaint filed by patient AM, who claimed that Respondent inappropriately touched him in a sexual manner during an initial assessment for the treatment of opioid addiction. 4. During the investigation, Board staff discovered evidence that Respondent had prescribed Suboxone tablets to patient AM. Board staff opined that Respondent’s prescribing the Suboxone to AM was improper. 5. Respondent is a family practice physician. He has specialty training in HIV medicine and he is recognized internationally as a clinician in the treatment of HIV disease. 6. Suboxone is classified as a Schedule III drug by the United States Drug Enforcement Agency (“DEA”). 7. The Drug Addiction Treatment Act of 2000 (“DATA 2000”) is federal legislation permitting the treatment of opioid addiction in an office setting by qualified physician, rather than the traditional opioid treatment program, such as a Methadone Program. 8. DATA 2000 provides, among other things, that Schedule III medications can be used in an approved physician’s office to treat addiction if the United States Food and Drug Administration has approved the medication for such use. 9. In order to prescribe Suboxone, a physician must receive a waiver from the DEA. 10. A physician seeking to obtain a DEA waiver to prescribe Suboxone must successfully complete an approved training course. The course content is based upon the Substance Abuse Mental Health Service Agency 2004 publication Treatment Protocol number 40, Buprenorphine treatment for opioid addiction. 11. The DEA waiver is the same for all approved physicians, regardless of their specialty. The requirements are similar for allopathic and osteopathic physicians.[1] Therefore, the standard of care applies for all approved physicians. 12. A physician who obtains a DEA waiver to prescribe Suboxone receives an “X” number for use in prescribing the medication. 13. On November 10, 2005, AM presented to Respondent to discuss possible treatment for opioid addiction following a previous surgery. 14. On November 10, 2005, Respondent had a DEA waiver to prescribe Suboxone. 15. AM was employed as an emergency medical technician at John C. Lincoln Hospital. 16. Respondent’s practice was to use Suboxone-identified forms when treating patients for opioid addiction involving the use of Suboxone. Respondent used the forms provided by the Suboxone training course he had successfully completed. 17. During his visit with Respondent and his staff, AM was reluctant to have his information documented on the Suboxone forms. 18. There is credible evidence that Respondent documented his examination of AM using a one-page physical form available in the examination room. 19. One of Respondent’s medical assistants wrote on AM’s med list that he was taking 40 milligrams of Oxycontin daily. At the hearing, Respondent credibly testified that the patient was taking that dosage six to eight times daily. 20. Respondent’s physical examination of AM found no evidence of hyperhidrosis or anything warranting the patient’s use of Oxycontin for pain management 21. AM would not disclose the source of his Oxycontin supply to Respondent. 22. Respondent’s treatment plan for AM was the Buprenorphine program. AM was surprised that the program would involve counseling. 23. AM was presented with a contract by Respondent for the Buprenophine program. AM wanted to re-read the contract because he had concerns with the provisions that would permit Respondent to discuss AM with his counselors and family. 24. When treating a patient with Suboxone, the standard practice is to have the patient experiencing opioid withdrawal. The physician then administers the Suboxone incrementally to the patient until an effective optimal dosage is achieved. 25. Suboxone can be delivered to a patient either by the approved physician’s office, if the physician has a dispensing license, or by prescription which is filled by a pharmacy with the patient returning to the physician with the medication for dosage treatment. 26. Respondent did not begin treatment of AM that day for several reasons. First, he did not sign the treatment contract indicating his consent to the treatment program. AM indicated to Respondent that he wanted to think about the terms and conditions of the treatment program. Second, he had used Oxycontin that day and, therefore, could not achieve the state of withdrawal necessary to determine the optimal dosage of Suboxone. 27. Respondent did not have a dispensing license. Therefore, he wrote a prescription of Suboxone to AM with the expectation that AM would return to his office the next day for treatment to establish an optimal dosage. 28. Respondent prescribed Suboxone to AM even though AM had not consented to entering into the treatment program. Respondent should not have prescribed the medication until AM consented to the treatment program’s terms and conditions. 29. AM did not return to Respondent with the prescribed Suboxone to establish the optimal dosage for treatment. It is unknown what AM did with the Suboxone prescribed to him by Respondent. 30. AM was left alone in the Respondent’s examination room with AM’s chart. When the Board reviewed the chart, it did not find documentation of Respondent’s examination of the patient. There is no evidence of the standard of care for leaving a patient alone in an examination room with his or her chart. There is credible evidence that Respondent did document his examination of AM, but such documentation was not in the file examined by Board staff. Respondent failed to safeguard the contents of AM’s chart. Apparently, neither Respondent nor his medical assistant reviewed the file after Respondent’s examination of AM. In light of the reluctance of AM to permit documentation of his examination, Respondent should have made assurances that his examination of AM was preserved in the chart. 31. There is no evidence that Respondent crossed sexual boundaries with AM, which was the allegation that initiated the Board’s investigation in this matter. This finding is made by the Administrative Law Judge even though Respondent was not charged with the violation.

CONCLUSIONS OF LAW

1. The Board has jurisdiction over Respondent and the subject matter in this case. 2. Pursuant to A.A.C. R2-19-119(B), the Board has the burden of proof in this matter. The standard of proof is preponderance to the evidence. A.A.C. R2-19-119(A). 3. Respondent did not violate the provisions of A.R.S. § 1401(27) (a), specifically 21 U.S.C. 823(g), Control Substances Act, as alleged in the Board’s Complaint. 4. Respondent did violate the provisions of A.R.S. § 32-1401(27) (e). The factual basis for this conclusion is Respondent’s failure to protect his notes contained in AM’s chart. The Administrative Law Judge concludes that Respondent’s explanation for the missing documentation of his examination of AM to be credible, but not excusable. It is unclear why AM was left alone in the examining room with his chart, especially since the patient was extremely reluctant to allow Respondent to document his examination. 5. Respondent violated the provisions of A.R.S. § 32-1401(27) (q). While the standard of care permits an authorized physician to initially prescribe Suboxone with the intent that the patient later return to the physician in a state of withdrawal so that incremental dosages of Suboxone could then be administered to achieve the optimal dosage, Respondent violated that standard of care by prescribing Suboxone to AM before he agreed to the terms and conditions of the treatment program. AM was illegally taking Oxycontin for pleasure not pain relief. He did not have a prescription for Oxycontin, a controlled medication. AM expressed reluctance to the terms and conditions of the treatment program. Nevertheless, Respondent prescribed Suboxone to AM with the expectation that he would consent to the treatment program and return to his practice with the prescribed medication to determine optimal dosage. AM did not return to Respondent’s practice after receiving the prescription for Suboxone. AM had access to the prescribed Suboxone, which he could obtain and take without medical supervision.

RECOMMENDED ORDER

Respondent shall be issued a Letter of Reprimand on the effective date of the Order entered in Case No. MD-06-0323A.

Done this day, June 29, 2008

______________________________________ Brian Brendan Tully Administrative Law Judge

Original transmitted by mail this ____ day of ____________, 2008, to:

Lisa Wynn, Executive Director Arizona Medical Board 9545 East Doubletree Ranch Road Scottsdale, AZ 85258

By ___________________________ ----------------------- [1] The Board’s expert at the hearing was Dr. Carol Peairs, M.D., an allopathic physician who is board certified in anesthesiology with a subspecialty board certification in pain medicine. Respondent’s expert was Dr. Steven Charles Boles, D.O., an osteopathic physician who is board certified in family medicine and addiction medicine. Drs. Peairs and Boles possess DEA waivers for Suboxone. Dr. Boles has taught approved training courses for obtaining Suboxone waivers.

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Office of Administrative Hearings 1400 West Washington, Suite 101 Phoenix, Arizona 85007 (602) 542-9826