Jul 12 200? 14:29 JUL-12-2887 14:45 STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, v. CASE NO. 2006-15260 MARC S. BARASCH, D.O., RESPONDENT. / ADMINISTRATIVE COMP T COMES NOW Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Osteopathic Medicine against Respondent, Marc S. Barasch, D.O., and in support thereof alleges: 1. Petitioner is the state department charged with regulating the practice of osteopathic medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statues; and Chapter 459, Florida Statutes. 2, At all times material to this Complaint, Respondent was a licensed osteopathic physician within the State of Florida, having been issued license number OS 7132. JAPSU\Medical\Blake\Oateo\ACe\Barasch. M.2006-1 5260(x)1No).doc Pars TOVAN Jul 12 200? 14:29 ee 9@ JUL-12-2087 14:45 3. Respondent’s address of record is 1751 66" Street North, St. Petersburg, Florida 33710. 4. Onor about August 17, 2005, Patient L.B., a then nineteen (19) year-old female, presented to Respondent's office with complaints of migraines, anxiety and depression. 5. On or about August 17, 2005, Respondent prescribed Patient L.B. Klonopin, 0.5 mg, thirty (30) tablets, 1-2 tablets every eight hours. 6. Klonopin, otherwise known as Clonazepam, is a Schedule IV controlled substances as listed under Chapter 893, Florida Statutes. Clonazepam is used to treat seizures and panic attacks. A substance in Schedule IV has a low potential for abuse relative to substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of Clonazepam may lead to limited physical or psychological dependence relative to the substances in Schedule III. 7. On or about August 31, 2005, Respondent prescribed Patient L.B. Klonopin, 0.5 mg, sixty (60) tablets, 1-2 tablet every eight hours. 8. On or about October 12, 2005, Respondent prescribed Patient L.B. Klonopin, 0.5 mg, sixty (60) tablets, 1-2 tablets every eight hours. P8725 Jul 12 200? 14:30 JUL-12-2087 14:45 9, On or about November 30, 2005, Patient L.B. presented to Respondent with complaints of anxiety, depression, and musculosketal pain. Respondent documented in Patient L.B.’s medical records that her musculosketal pain was mild to moderate. 10. On or about November 30, 2005, Respondent prescribed Patient L.B. Klonopin, 0.5 mg, 84 tablets, 1-2 tablets every eight hours and Percocet 5, 325 mg, 56 tablets, up to 4 tablets per day. Prior to prescribing the Klonopin or Percocet, Respondent failed to perform or document performing an adequate physical examination of Patient L.B.; Respondent failed to obtain or document an adequate medical history for Patient L.B.; Respondent failed to justify or document justifications for prescribing controlled substances to Patient L.B.; Respondent failed to refer Patient L.B. for additional consultations or diagnostic testing; Respondent failed to obtain informed consent or an opiate agreement from Patient L.B.; or Respondent prescribed Percocet, which is used to provide relief for moderate to severe pain, to Patient L.B. even though Respondent documented Patient L.B. as having mild to moderate pain. 11. Percocet contains oxycodone, a Schedule Il controlled substance as listed under Chapter 893, Florida Statutes. Percocet is used P9725 Jul 12 200? 14:30 JUL-12-2087 14:46 to relieve moderate to severe pain. A substance in Schedule II has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of this substance may lead to severe psychological or physical dependence. 12. On or about December 14, 2005, Respondent prescribed Patient L.B. Percocet 5, 325 mg, 75 tablets and Klonopin, 0.5 mg, 160 tablets, 1-2 tablets every eight hours. Respondent failed to perform or document performing an adequate physical examination of Patient L.B.; Respondent failed to obtain or document an adequate medical history for Patient L.B.; Respondent failed to justify or document justifications for prescribing controlled substances to Patient L.B.; Respondent failed to refer Patient L.B. for additional consultations or diagnostic testing; Respondent failed to obtain informed consent or an opiate agreement from Patient L.B.; or Respondent prescribed Percocet, which is used to provide relief for moderate to severe pain, to Patient L.B. even though Respondent documented Patient L.B, as having mild to moderate pain. 13. On or about January 16, 2006, Respondent prescribed Patient L.B. Percocet 5, 325 mg, 70 tablets, one tablet every six hours and Klonopin, 0.5 mg, 150 tablets. Respondent failed to perform or document P.1a@/25 Jul 12 200? 14:30 JUL-12-2087 14:46 performing an adequate physical examination of Patient L.B.; Respondent failed to obtain or document an adequate medical history for Patient L.B.; Respondent failed to justify or document justifications for prescribing controlled substances to Patient L.B.; Respondent failed to refer Patient L.B. for additional consultations or diagnostic testing; or Respondent failed to obtain informed consent or an opiate agreement from Patient L.B. 14. On or about March 2, 2006, Respondent prescribed Patient L.B. Percocet 5, 325 mg, 90 tablets, 1 tablet every 6 hours and Klonopin, 0.5 mg, 150 tablets. Respondent failed to perform or document performing an adequate physical examination of Patient L.B.; Respondent failed to obtain or docurnent an adequate medical history for Patient L.B.; Respondent failed to justify or document justifications for prescribing controlled substances to Patient L.B.; Respondent failed to refer Patient L.B. for additional consultations or diagnostic testing; or Respondent failed to obtain informed consent or an opiate agreement from Patient L.B. 15. On or about April 4, 2006, Respondent prescribed Patient L.B. Percocent 5, 325 mg, 120 tablets and Klonopin 0.5 mg, 150 tablets. Respondent failed to perform or document performing an adequate physical examination of Patient L.B.; Respondent failed to obtain or P.1i/725 Jul 12 200? 14:31 JUL-12-2087 14:46 P.12/25 document an adequate medical history for Patient L.B.; Respondent failed to justify or document justifications for prescribing controlled substances to ‘Patient L.B.; Respondent failed to refer Patient L.B. for additional consultations or diagnostic testing; or Respondent failed to obtain informed consent or an opiate agreement from Patient L.B. 16. On or about May 4, 2006, Respondent prescribed Patient L.B. Percocent 5, 325 mg, 110 tablets and Klonopin 0.5 mg, 120 tablets. Patient L.B. was taking 3-4 tablets of Klonopin per day and up to 7 Perocet tablets per day. Respondent failed to perform or document performing an adequate physical examination of Patient L.B.; Respondent failed to obtain or document an adequate medical history for Patient L.B.; Respondent failed to justify or document justifications for prescribing controlled substances to Patient L.B.; Respondent failed to refer Patient L.B. for additional consultations or diagnostic testing; or Respondent failed to obtain informed consent or an opiate agreement from Patient L.B. 17. On or about May 5, 2006, it was documented in Patient L.B.'s medical records that Patient L.B.‘s mother contacted Respondent's office and reported that Patient L.B. was abusing the Klonopin and Percocet that were being prescribed by the Respondent. Jul 12 200? 14:31 ee ee 18. In or about May 2006, Respondent dismissed Patient L.B. from JUL-12-2087 14:47 his care and practice. Respondent failed to document his last interaction with Patient L.B. dismissing her from his care and practice; Respondent failed to ask or document asking Patient L.B. or have Patient L.B. inform Respondent’s staff where she wanted her medical records sent; Respondent failed to inform Patient L.B. or document informing Patient L.B. that there was a certain allotment of medication that would be available so that Patient L.B. could have some time to find another physician; or Respondent failed to document an opiate agreement in his file to support his decision to terminate Patient L.B. from his care and practice. COUNT ONE 19. Petitioner realleges and incorporates paragraphs one (1) through eighteen (18) as fully set forth herein. 30. Section 459.015(1)(0), Florida Statutes (2005), provides that failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed osteopathic physician or the osteopathic physician extender or supervising osteopathic physician by name and professional title who is or are responsible for rendering, ordering, supervising, of billing for each diagnostic or treatment procedure P.13/25 Jul 12 200? 14:31 JUL-12-2087 14:47 P.14/25 and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations, constitutes grounds for discipline by the Board of Osteopathic Medicine. 21. Respondent failed to keep legible medical records that justify the course of treatment of Patient L.B. in one or more of the following ways: a) by failing to record or inadequately recording a physical examination(s) of Patient L.B.; b) by failing to document a complete and proper history of Patient L.B.; c) by failing to document justification for prescribing and/or continuing to prescribe Klonopin or Percocet to Patient L.B., including but not limited to dosage and frequency; d) _ by failing to document justifications for prescribing Percocet, a Schedule II controlled substance used to relieve moderate to severe pain, Jul 12 2007 14:32 JUL-12-2087 14:47 even though Respondent documented in the medical record that Patient LB. was suffering from mild to moderate pain; e) by failing to document informed consent or an opiate agreement with Patient L.B.; f) by failing to document Respondent’s last interaction with Patient L.B. which terminated the physician/patient relationship; g) _ by failing to document that he told Patient L.B. or had Patient L.B. inform his staff where her medical records should be sent; h) by failing to document informing Patient L.B. that a certain allotment of medication would be available so that she could find a physician in an appropriate amount of time; or i) by failing to document referring Patient L.B. for additional consultations or diagnostic testing. 22. Based on the foregoing, Respondent violated Section 459.015(1)(0), Florida Statutes (2005), by failing to keep legible medical records that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results, records of P.15/25 Jul 12 2007 14:32 JUL-12-2087 14:47 P.16/25 drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations. COUNT TWO 23. Petitioner realleges and incorporates paragraphs one (1) through eighteen (18) as fully set forth herein. 24. Section 459.015(1)(t), Florida Statutes (2005), provides that . prescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing a legend drug, including all controlled substance, other than in the course of the osteopathic physician’s professional practice is grounds for disciplinary action by the Board of Osteopathic Medicine. For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and not in the course of the osteopathic physician’s professional practice, without regard to his or her intent. 25. Respondent prescribed Klonopin or Percocet, both controlled substances, to Patient L.B. inappropriately or in excessive or inappropriate quantities, in that Respondent prescribed controlled substances without 10 Jul 12 2007 14:32 JUL-12-2087 14:48 medical justification, in quantities which endangered the patient’s health, were not in the best interest of the patient or in a manner not in the course of the physician's professional practice. 26. Based on the foregoing, Respondent violated Section 459.015(1)(t) Florida Statutes (2005), by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician’s professional practice. For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and not in the course of the osteopathic physician's professional practice, without regard to his or her intent. COUNT THREE 27. Petitioner realleges and incorporates paragraphs one (1) through eighteen (18) as fully set forth herein. 28. Section 459.015(1)(x), Florida Statutes (2005), provides that gross or repeated malpractice or the failure to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by i P.1?/23 Jul 12 2007 14:32 JUL-12-2087 14:48 P.18/25 a reasonable prudent similar osteopathic physician as being acceptable under similar conditions and circumstances constitutes grounds for discipline by the Board of Osteopathic Medicine. 29. Respondent failed to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician, in one or more of the following ways: a) by failing to perform an adequate physical examination(s) of Patient L.B.; b) by failing to justify the continued prescribing of Percocet or Klonopin, including but not limited to dosage and frequency; c) by failing to use specialized consultations for diagnosis and/or treatment; d) by failing to use diagnostic testing for diagnosis and/or treatment; e) by failing to justify why Respondent prescribed Percocet to Patient L.B., which is used to provide relief for moderate to severe pain, 12 Jul 12 2007 14:33 JUL-12-2087 14:48 P.19/25 even though Respondent documented that Patient L.B. was complaining of mild to moderate pain; or f) by failing to obtain informed consent or an opiate agreement from Patient L.B. 30. Rule 64B15-14.005, Florida Administrative Code (“FA.C.”), which is part of the chapter of the Florida Administrative Code where the Board of Osteopathic Medicine establishes standards of care for osteopathic physicians, provides in relevant part: 64B15-14.005 Standards for the Use of Controlled Substances for Treatment of Pain. (1) Pain management principles. (a) The Board of Osteopathic Medicine recognizes that principles of quality medical practice dictate that the people of the State of Florida have access to appropriate and effective pain relief. The appropriate application of up- to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. The Board encourages osteopathic physicians to review effective pain management as a part of quality medical practice for all patients with pain, acute or chronic, and it is especially important for patients who experience pain as a result of terminal illness. All osteopathic physicians should become knowledgeable about effective methods of pain treatment as well as statutory requirements for prescribing controlled substances. (b) Inadequate pain control may result from an osteopathic physician's lack of knowledge about pain management or an inadequate understanding of addiction. Fears of investigation or sanction by federal, state, or local regulatory agencies may also result in inappropriate or inadequate Jul 12 2007 14:33 hd ee JUL-12-2087 14:49 P. 28/25 treatment of chronic pain patients. Osteopathic physicians should not fear - disciplinary action from the Board or other state regulatory or enforcement agencies for prescribing, dispensing, or administering controlled substances including opioid analgesics, for a legitimate medical purpose and that is supported by appropriate documentation establishing a valid medical need and treatment plan. Accordingly, these guidelines have been developed to clarify the Board's position on pain control, specifically as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management. (c) The Board recognizes that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. Osteopathic physicians are referred to the U.S. Agency for Health Care Policy and Research Clinical Practice Guidelines for a sound approach to the management of acute and cancer-related pain. The medical management of pain including intractable pain should be based on current knowledge and research and includes the use of both pharmacologic and non- pharmacologic modalities. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Osteopathic physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction. (d) The Board of Osteopathic Medicine is obligated under the laws of the State of Florida to protect the public health and safety. The Board recognizes that inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Osteopathic physicians should be diligent in preventing the diversion of drugs for illegitimate purposes. (2) The Board will consider prescribing, ordering, administering, or dispensing controlled substances for pain to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds. All such prescribing must be based on clear documentation of unrelieved pain and in compliance with applicable state or federal law. (f) Each case of prescribing for pain will be evaluated on an individual basis. The Board will not take disciplinary action against an osteopathic Jul 12 2007 14:33 P.21/25 ee ee JUL-12-2087 14:49 physician for failing to adhere strictly to the provisions of these guidelines, if good cause is shown for such deviation. The osteopathic physician's conduct will be evaluated to a great extent by the treatment outcome, taking into account whether the drug used is medically and/or pharmacologically recognized to be appropriate for the diagnosis, the patient's individual need including any improvement in functioning, and recognizing that some types of pain cannot be completely relieved. (g) The Board will judge the validity of prescribing based on the osteopathic physician's treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing. The goal is to control the patient's pain for its duration while effectively addressing other aspects of the patient's functioning, including physical, psychological, social, and work-related factors. The following guidelines are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of professional practice. * * * (3) Guidelines. The Board has adopted the following guidelines when evaluating the use of controlled substances for pain control: (a) Evaluation of the Patient. A complete medical history and physical exarnination must be conducted and documented in the medical record. The medical record should document 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 history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance. (b) Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the osteopathic physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with the physical and psychosocial impairment. (c) Informed Consent and Agreement for Treatment. The osteopathic Jul 12 2007 14:34 JUL-12-2087 14:58 P.22/25 physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one osteopathic physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the osteopathic physician may employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to: 1. urine/serum medication levels screening when requested; 2. number and frequency of all prescription refills; and 3. reasons for which drug therapy may be discontinued (i.e., violation of agreement). (d) Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the osteopathic physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the osteopathic physician's evaluation of progress toward stated treatment objectives such as improvement in patient's pain intensity and improved physical and/or psychosocial function, i.e., ability to work, need of health care resources, activities of daily living, and quality of social life. If treatment goals are not being achieved, despite medication adjustments, the osteopathic physician should reevaluate the appropriateness of ‘continued treatment. The osteopathic physician should monitor patient compliance in medication usage and related treatment plans. (e) Consultation. The osteopathic physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients. (f) Medical Records. The osteopathic physician is required to keep accurate and complete records to include, but not be limited to: 1. the medical history and physical examination; 2. diagnostic, therapeutic, and laboratory results; 3. evaluations and consultations; Jul 12 2007 14:34 JUL-12-2087 14:58 P.2a/25 2257 4, treatment objectives; 5. discussion of risks and benefits; 6. treatments; 7. medications (including date, type, dosage, and quantity prescribed); 8. instructions and agreements; and 9. periodic reviews. Records must remain current and be maintained in an accessible manner and readily available for review. (g) Compliance with Controlled Substances Laws and Regulations. To prescribe, dispense, or administer controlled substances, the osteopathic physician must be licensed in the state and comply with applicable federal and state regulations. Osteopathic physicians are referred to the Physicians Manual: An Informational Outline of the Controlled Substances Act of 1970, published by the U.S. Drug Enforcement Agency, for specific rules governing controlled substances as well as applicable state regulations. 31. By failing to meet the standards of practice established in Rule 64B15-14.005, FA.C., Respondent has failed to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. 32. Based on the foregoing, Respondent has violated Section 459.015(1)(x), Florida Statutes (2005), by failing to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. Additionally, Respondent has violated the standards of practice established by the Board of Osteopathic Jul 12 2007 14:35 Medicine in Rule 64B15-14.005, FA.C., thereby violating Section JUL-12-2087 14:58 P.24/25 459.015(1)(x), Florida Statutes (2005), in Respondent's treatment of Patient L.B. WHEREFORE, Petitioner respectfully requests that the Board of Osteopathic Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. . ae Nouranl SIGNED this day of 2006. M. Rony, Francois; 7M.S.P.H., Ph.D ei e E oL cre’ of Health a3 lake Hunter D F HEALTH istant General Counsel EP, L ARTMENT ouenk tint Beal OH Prosecution Services Unit DATE 4052 Bald Cypress Way, Bin C-65 Waco" Tallahassee, FL 32399-3265 Florida Bar No. 0570788 (850) 245-4640, ext. 8114 ae (850) 245-4682 FAX pcp: fou. Ft A008 | >A PCP Members: [aa.fimon, D.o-04 fade, DO. 18 jUL-12-2007 14151 Jul 12 2007 14:35 P.25/25 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed. 19 TOTAL P.25

Docket for Case No: 07-003158PL