A214 C8 STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, v. CASE NO.: 2011-07524 RAMIRO J. ABAUNZA, M.D., RESPONDENT. / ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Medicine against the Respondent, Ramiro J. Abaunza, M.D., and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. 2. At all times material to this Complaint, Respondent was a licensed physician within the State of Florida, having been issued license number ME 38829. 3. Respondent’s address of record is 10348 West Flagler Street, Providence Medical Center, Miami, Florida, 33174. Filed December 30, 2011 1:58 PM Division of Administrative Hearings 4. At all times material to this Complaint, Respondent practiced medicine at Hope for Life Wellness Center, Inc. (Clinic), a pain management clinic located at 6095 Northwest 72"! Avenue, Miami, Florida 33166. 5. While practicing at the Clinic, Respondent prescribed excessive and inappropriate quantities of oxycodone, Lortab 10/500, Dilaudid and Xanax to his patients. 6. Oxycodone is commonly prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010-2011), oxycodone is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence. Oxycodone is an opioid. Opioid, or opiate, drugs have similar actions as the drug opium and are typically prescribed to treat pain. Opioid drugs are synthetically manufactured, while opiate drugs are naturally occurring, but the terms opioid and opiate are often used interchangeably. Opioid drugs are addictive and subject to abuse. te Lortab 10/500 is a brand of drug that contains hydrocodone and acetaminophen and is commonly prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010-201 1), hydrocodone is a Schedule III controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of hydrocodone may lead to severe psychological or physical dependence 8. Xanax is a brand of alprazolam (benzodiazepine) and is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes (2010-2011), alprazolam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule II and has a currently accepted medical use in treatment in the United States. Abuse of alprazolam may lead to limited physical or psychological dependence relative to the substances in Schedule II. 9. Dilaudid is the brand name for hydromorphone and is prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010-201 1), hydromorphone is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of hydromorphone may lead to severe psychological or physical dependence Facts Related to Patient J.K. 10. Patient J.K., a 45-year-old male from Dunnellon, Florida, first presented to the Clinic on September 10, 2010, with complaints of lower back and neck pain resulting from a motor vehicle accident in 2000. 11. Patient J.K. indicated a medical history consisting of chiropractic treatment; non-steroid anti-inflammatories and controlled substances. 12. Patient J.K. presented to Respondent on or about February 21, 2011, April 13, 2011, and May 20, 2011. At each appointment, Respondent diagnosed lumbar facet syndrome, a disc bulge at L4-5 and a herniated disc at L3-L4. 13. Respondent prescribed 210 tablets of oxycodone 30 mg, 60 tablets of Xanax and 120 tablets of Dilaudid to the patient at each visit. 14. Patient J.K. was a high-risk patient for substance abuse or diversion because he resided hundreds of miles away from the Clinic, his initial urine drug screen was negative for benzodiazepines despite his indication that he currently was taking Xanax and he complained that the large amounts of medications he was prescribed were running out early. 15. Respondent failed to employ any pill counts, urine drug screens or other forms of monitoring to ensure Patient J.K. was properly taking the prescribed medications. | 16. Records indicate that Patient J.K. exhibited serial hypertension during his treatment with Respondent; however, Respondent failed to treat or refer the patient regarding this condition. 17. Patient J.K.’s medical records contained a laboratory report dated October 22, 2010, which indicated elevated liver enzymes; however, Respondent neither treated the patient regarding these results nor conducted any follow-up laboratory studies. 18. The controlled substances Respondent prescribed to the patient were not justified. 19. Respondent’s prescriptions of controlled substances to Patient J.K were inappropriate and/or excessive. 20. Respondent’s medical records for Patient J.K. fail to include an adequate patient history; any records from physicians who treated the patient prior to his presentation at the Clinic; a justification for the multiple large prescriptions of controlled substances; or any verification that Patient J.K. was, in fact, properly taking his prescription medications. 21. A reasonably prudent physician would have prescribed justifiable amounts of controlled substances, if any; would have referred the patient to receive consultations with other specialists; would have employed or considered alternative modalities; would have conducted follow-up laboratory tests and would have addressed the patient's hypertension. Facts specific to Patient C.K. 22. Patient C.K., a 44-year-old female from Dunnellon, Florida, first presented to the Clinic on August 29, 2010, with complaints of lower back pain and hip pain and indicated a history of hip replacement procedures. 23. Patient C.K. presented to Respondent on February 21, 201 1, April 13, 2011, and May 20, 2011. 24. At each visit, Respondent diagnosed facet syndrome at L3-L4, disc bulges at L5-S1 and L4-L5 and a herniated disc at L4-L5 and prescribed 210 tablets of oxycodone 30 mg, 210 tablets of Lortab 10/500 mg and 60 tablets of Xanax to Patient C.K. 25. Patient C.K. was a high-risk patient for substance abuse or diversion, as she resided hundreds of miles away from the Clinic and her husband received similar controlled substances from the Clinic for similar complaints. 26. Respondent failed to employ any pill counts, urine drug screens or other forms of monitoring to ensure Patient C.K. was properly taking the prescribed medications. 27. Medical records indicate that Patient C.K. submitted to only one urine drug screen on October 29, 2010, but the results of that test are not legible. 28. The controlled substances Respondent prescribed to the patient were not justified. 29. Respondent prescribed excessive and/or inappropriate amounts of controlled substances to Patient C.K. 30. Respondent’s medical records for Patient C.K. fail to include an adequate patient history; any records from physicians who treated the patient prior to her presentation at the Clinic; a justification for the multiple large prescriptions of controlled substances; or any verification that Patient C.K. was, in fact, properly taking her prescription medications. 31. A reasonably prudent physician would have prescribed justifiable amounts of controlled substances, if any; would have referred the patient to receive consultations with other specialists; and would have employed or considered alternative modalities. Facts specific to Patient R.W. 32. Patient R.W., a 43-year-old female from Groveland, Florida, first presented to the Clinic on January 31, 2011, with a history of knee surgery and complaints of lower back and leg pain. 33. Ata follow-up appointment on or about March 28, 2011, Respondent diagnosed bulging discs at L5-S1 and L4-L5 and prescribed 150 tablets of oxycodone 30 mg, 120 tablets of Lortab 10/500 mg and 60 tablets of Xanax 2 mg to Patient R.W. 34. Between on or about January 31, 2011, and on or about March 28, 2011, Patient R.W. completed a log of her daily activities and levels of pain, wherein she generally noted pain levels between 8 and 10. 35. Patient R.W.’s log indicated that Respondent’s prescribed treatment of controlled substances was not effective. 36. Nonetheless, Respondent never attempted to reassess the efficacy of the patient’s treatment. 37. At follow-up appointments on or about April 27, 2011, and June 2, 2011, Respondent prescribed 150 tablets of oxycodone 30 mg, 150 tablets of Lortab 10/500 mg and 60 tablets of Xanax 2 mg to Patient R.W. 38. Medical records indicate that the patient continually exhibited hypertension, but Respondent failed to treat or refer the patient for treatment. 39. The controlled substances Respondent prescribed to the patient were not justified. 40. Respondent prescribed excessive or inappropriate quantities of controlled substances to the patient. 41. Respondent’s medical records for Patient R.W. fail to include an adequate patient history; any records from physicians who treated the patient prior to her presentation at the Clinic; a justification for the multiple large prescriptions of controlled substances; or any verification that Patient R.W. was, in fact, properly taking her prescription medications. 42. Patient R.W. was a high-risk patient for substance abuse or diversion, as the patient resided hundreds of miles away from the Clinic, her records indicated she previously received controlled substances without a prescription and her MRI report contained abnormalities suggesting it was not authentic; however, Respondent failed to employ any pill counts, urine drug screens or other forms of monitoring to ensure Patient R.W. was properly taking the prescribed medications. 43. A reasonably prudent physician would have prescribed justifiable amounts of controlled substances, if any; would have referred the patient to receive consultations with other specialists, and would have employed or considered alternative modalities. Facts specific to Patient B.D. 44, Patient B.D., a 27-year-old female from Tennessee, first presented to the Clinic on February 11, 2011, with complaints of anxiety and lower back pain and indicated she previously received medical treatment for her chronic pain. 45. Patient B.D. presented to Respondent on four occasions between on or about April 14, 2011, and on or about July 8, 2011. 46. ' At each appointment, Respondent diagnosed facet syndrome and disc bulges at L5-S1 and L4-L5; and prescribed 150 tablets of oxycodone 30 mg, 150 tablets of Lortab 10/500 mg and 60 tablets of Xanax 2 mg to Patient B.D. 47. Records indicate that Patient B.D. exhibited hypertension at her medical appointments, but Respondent failed to treat or refer the patient for treatment. 48. Records indicate that Respondent failed to perform a physical examination of the patient on July 8, 2011. 49. Patient B.D. was a high-risk patient for substance abuse or diversion, as the patient resided in Tennessee and her MRI report contained abnormalities suggesting it was not authentic; however, Respondent failed to employ any pill counts, urine drug screens or other forms of monitoring to ensure Patient B.D. was properly taking the prescribed medications. 50. The controlled substances Respondent prescribed to the patient were not justified. - : 51. Respondent prescribed excessive or inappropriate quantities of controlled substances to the patient. 52. A reasonably prudent physician would have prescribed justifiable amounts of controlled substances, if any; would have referred the patient to receive consultations with other specialists; would have employed or considered alternative modalities; and would have treated the patient’s hypertension. 53. Respondent’s medical records for Patient B.D. fail to include an adequate patient history; any records from physicians who treated the patient prior to her presentation at the Clinic; a justification for the multiple large prescriptions of controlled substances; or any verification that Patient B.D. was, in fact, properly taking her prescription medications. 54. The medical record contains only one urine drug screen, which was illegible. COUNT ONE 55. Petitioner realleges and incorporates Paragraphs 1 through 54, as if fully set forth herein. 56. Section 458.331(1)(t)l., Florida Statutes (2010-2011), subjects a physician to discipline for committing medical malpractice as defined in Section 456.50, Florida Statutes (2010-2011). 57. “Medical malpractice” is defined by Section 456.50(1)(g), Florida Statutes (2010-2011), as “the failure to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure.” Section 456.50(1)(e), Florida Statutes (2010-2011), provides that the “level of care, skill, and treatment recognized in general law related to health care licensure" means the standard of care that is specified in Section 766.102(1), Florida Statutes (2010), which is set forth as follows: The prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers. _ Section 458.331(1)(t)l., Florida Statutes (2010-2011), directs the Board of Medicine (Board) to give “great weight” to this provision of Section 766.102, Florida Statutes (2010-2011). 58. Respondent failed to meet the prevailing standard of care in one or more of the following manners: a. By prescribing inappropriate or excessive quantities of controlled substances to Patients J.K., C.K., R.W. and/or B.D.; b. By prescribing two immediate-release opioids medications to Patients J.K., C.K., R.W. and/or B.D.; c. By failing to refer Patients J.K., C.K., R.W. and/or B.D. to receive consultations with other medical specialists; d. By failing to employ alternative modalities for treatment regarding Patients J.K., C.K., R.W. and/or B.D.; e. By failing to properly monitor Patients J.K., C.K., R.W. and/or B.D.; f By failing to adequately treat Patient J.K. regarding elevated his liver enzymes; and/or g. By failing to adequately treat the hypertensive conditions of Patients J.K., R.W. and/or B.D. 59. Based on the foregoing, Respondent has violated Section 458.331(1)(t)1., Florida Statutes (2010-2011), by committing medical malpractice. 12 COUNT TWO 60. Petitioner realleges and incorporates Paragraphs | through 54, as if fully set forth herein. 61. Section 458.331(1)(m), Florida Statutes (2010-2011), subjects a physician to discipline for failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure 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. 62. Rule 64B8-9.003(3), Florida Administrative Code, provides the standards for the adequacy of medical records as: The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; ‘records of drugs prescribed, dispensed, or administered, reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient. 13 63. Respondent failed to keep legible medical records in one or more of the following ways: a. Failing to document and/or justify the course of treatment of Patients J.K., C.K., R.W. and/or B.D.; b. Failing to adequately document support for the diagnosis of Patients J.K., C.K., R.W. and/or B.D.; c. Failing to record legible urine drug screen results; and/or d. Failing to adequately document patient histories for Patients J.K., C.K., R.W. and/or B.D. 64. Based on the foregoing, Respondent has violated Section 458.331(1)(m), Florida Statutes (2010-2011), by failing to keep legible medical records. COUNT THREE 65. Petitioner realleges and incorporates Paragraphs 1 through 54, as if fully set forth herein. 66. Section 458.331(1)(q), Florida Statutes (2010-2011), subjects a physician to discipline for 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, 14 mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician’s professional practice, without regard to his or her intent. 67. Respondent prescribed controlled substances inappropriately or in excessive or inappropriate quantities in one or more of the following manners: a. In his prescription of controlled substances to Patients J.K., C.K., R.W. and/or B.D. without justification; b. By prescribing two immediate-release opioids medications to Patients J.K., C.K., R.W. and/or B.D. without justification; and/or Cc: By failing to properly monitor the use of controlled substances by Patients J.K., C.K., R.W. and/or B.D. 68. Based on the foregoing, Respondent has violated Section 458.331(1)(q), Florida Statutes (2010-2011), 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. COUNT FOUR 69. Petitioner realleges and incorporates Paragraphs 1 through 54, as if fully set forth herein. 70. Section 458.331(1)(nn), Florida Statutes (2010-2011), allows the Board to discipline a physician for violating any provision of Chapters 456 or 458, Florida Statutes, or any rules adopted pursuant thereto. 71. Rule 64B8-9.013, Florida Administrative Code, sets forth the standards for the use of controlled substances for the treatment of pain, in part, as follows: (3) Standards. The Board has adopted the following standards for the use of controlled substances for pain control: (a) Evaluation of the Patient. A complete medical history and physical examination must be conducted and documented in the medical record. The medical record shall 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 shall document the presence of one or more recognized medical indications for the use of a controlled substance. * * * (d) Periodic Review. Based on the individual circumstances of the patient, the physician shall review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy shall depend on the physician’s evaluation of the patient’s progress. If treatment goals are not being achieved, despite medication adjustments, the physician shall reevaluate the appropriateness of continued treatment. The physician shall monitor 16 patient compliance in medication usage and related treatment plans. (e) Consultation. The physician shall be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention must 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 requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients. (£) Medical Records. The physician is required to keep accurate and complete records to include, but not be limited to: 1. The complete medical history and a physical examination, including history of drug abuse or dependence, as appropriate; 2. Diagnostic, therapeutic, and laboratory results; 3. Evaluations and consultations; 4. Treatment objectives; 5. Discussion of risks and benefits; 6. Treatments; 7. Medications (including date, type, dosage, and quantity prescribed); 8. Instructions and agreements; 9. Drug testing results; and 10. Periodic reviews. Records must remain current, maintained in an accessible manner, readily available for review, and must be in full compliance with Rule 64B8-9.003, F.A.C, and Section 458.331(1)(m), ES. Records must remain current and be maintained in an accessible manner and readily available for review. 72. Respondent violated the standards for the use of controlled substances for the treatment of pain one or more of the following manners: a. By failing to obtain adequate patient histories for Patients J.K.., C.K., R.W. and/or B.D.; b. By failing to justify the prescriptions of controlled substances to Patients J.K., C.K., R.W. and/or B.D.; c. By failing to appropriately monitor Patients J.K., C.K., R.W. and/or B.D., who were high-risk patients, for drug diversion or drug abuse; and/or d. ‘By failing to conduct periodic reviews of the treatment of Patient R.W. 73. Based on the foregoing, Respondent has violated Section 458.331(1)(nn), Florida Statutes (2010-2011), by violating any provision of Chapters 456 or 458, Florida Statutes, or any rules adopted pursuant thereto. COUNT FIVE 74, Petitioner realleges and incorporates Paragraphs 1 through 54, as if fully set forth herein. 75. Section 458.331(1)(nn), Florida Statutes (2011), allows the Board to discipline a physician for violating any provision of Chapters 456 or 458, Florida Statutes, or any rules adopted pursuant thereto. 76. Section 458.3265(2)(c), Florida Statutes (2011), provides, in part: A physician must perform a physical examination of a patient on the same day that he or she dispenses or prescribes a controlled substance to a patient at a pain-management clinic. ... 77. Respondent prescribed controlled substances to Patient B.D. on July 8, 2011, without performing a physical examination. 78. Based on the foregoing, Respondent has violated Section 458.331(1)(nn), Florida Statutes (2011), by violating any provision of Chapters 456 or 458, Florida Statutes, or any rules adopted pursuant thereto. WHEREFORE, the Petitioner respectfully requests that the Board of 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. DOH vs. Ramiro J. Abaunza, M.D. Case No. 2011-07524 SIGNED this |S day of November - , 2011. TH DEPARTMENT OF HEAL DEPUTY CLERK CLERK Angel Sanders DATE NOV 21 201 gdb PCP: November 18, 2011 PCP Members: El-Bahri; Levine DOH vs. Ramiro J. Abaunza, M.D. H. Frank Farmer, Jr., M.D., Ph.D., F.A.C.P. State Surgeon General Assistant General Counsel DOH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Florida Bar # 013311 (850) 245-4640 (850) 245-4681 FAX Case No. 2011-07524 20 DOH vs. Ramiro J. Abaunza, M.D. Case No. 2011-07524 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 any other discipline imposed. 21

Docket for Case No: 11-006501PL