STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, v. CASE NO. 2010-17708 THOMAS KARL VELLEFF, JR., M.D., RESPONDENT. / ADMINISTRATIVE COMPLAINT Petitioner, Department of Health, by and through its undersigned counsel, files this Administrative Complaint (‘Complaint’) before the Board of Medicine (“Board”) against Respondent, Thomas Karl Velleff, Jr, M.D., and alleges: i. Petitioner is the state department 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 42998. 3. Respondent's address of record is 3915 Hidden Oaks Way, Melbourne, Florida 32934. 4. Respondent is not board certified in any specialty boards recognized by the Florida Board of Medicine. 5. At all times material to this Complaint, Respondent practiced at A Total You, Inc. d/b/a “Nu-Me”, located at 997 E. Oakland Park Boulevard, Oakland Park, Florida 33334 (PMC #437) and 870 SW Martin Downs Boulevard, Palm City, Florida 34990 (PMC #438). 6. At all times material to this Complaint, Respondent practiced medicine in the area of pain management. He engaged in the treatment of pain by prescribing or dispensing controlled substance medications. 7. Clonazepam, a benzodiazepine, is commonly prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes, clonazepam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States, and abuse of clonazepam may lead to limited physical or psychological dependence relative to the substances in Schedule III. Klonopin is a brand name of Clonazepam. 8. Dalmane is the brand name for flurazepam, a benzodiazepine, commonly prescribed to treat insomnia. According to Section 893.03(4), Florida Statutes, flurazepam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 2 a currently accepted medical use in treatment in the United States, and abuse of the substance may lead to limited physical or psychological dependence relative to the substances in Schedule III. 9. Dilaudid is the brand name for hydromorphone and is prescribed to treat pain. According to Section 893.03(2), Florida Statutes, 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, and abuse of hydromorphone may lead to severe psychological or physical dependence. "10. OxyContin is a brand name for a timed - released form of oxycodone. Oxycodone is a semi-synthetic opioid that is prescribed to treat pain. According to Section 893.03(2), Florida Statutes, 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. 11. Restoril is the brand name for temazepam, a benzodiazepine, and is prescribed to treat insomnia. According to Section 893.03(4), Florida Statutes, temazepam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 3 currently accepted medical use in treatment in the United States, and abuse of temazepam may lead to limited physical or psychological dependence relative to the substances in Schedule III. . 12. Roxicodone is a brand name for oxycodone. Oxycodone is a semi-synthetic opioid that is prescribed to treat pain. According to Section 893.03(2), Florida Statutes, oxycodone is a Schedule 1 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. 13. Valium is the brand name for diazepam, a benzodiazepine, and is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes, diazepam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of diazepam may lead to limited physical or psychological dependence relative to the substances in Schedule III. 14. Xanax is the brand name for alprazolam, a benzodiazepine, and is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes, alprazolam is a Schedule IV controlled substance that has a low DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 4 potential for abuse relative to the substances in Schedule UI 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 III. 15. The Department obtained the medical records of Respondent's ‘patients; CM, J.G, C.K., RD., and B.H. Respondent treated these patients for chronic pain and prescribed controlled substances to them inappropriately or in excessive or inappropriate quantities or combinations. 16. The use of immediate release formulations is highly discouraged when managing chronic pain with opioids. Sustained release or long-acting formulations: are preferred in the management of chronic pain. 17. The use of benzodiazepines has not been proven effective in the management of chronic pain. These medications have a high potential for abuse and diversion. / 18. The prevailing professional standard of care required the Respondent to treat all the above mentioned patients in the following manner: a. Obtain a complete medical history and complete physical examination, including a complete and thorough neurological DOH vs, Thomas K. Velleff, Jr, M.D.; Case No, 2010-17708 5 and musculoskeletal examination (including but not limited to reflexes, sensation, and motor function); b. Develop and implement an appropriate treatment plan specific to the needs of each patient and follow-up on that plan; c. Conduct periodic examinations to assess changes in the patient’s condition that may warrant a change in the established plan of care; d. Prescribe controlled substances, specifically opioids, for the management of pain in a medically necessary and prudent manner, based on accepted scientific knowledge of the treatment of chronic pain and on sound clinical grounds; e. Provide clear justification for the prescription of controlled substances; f. Opioids are to be used as part of a multi-modality plan of care and not as a sole treatment modality; : g. Put in place a compliance monitoring program regarding medication and controlled substance usage, the program includes a variety of strategies including but not limited to, random/unannounced urine. or serum drug screening, monitoring of aberrant behaviors, pill counts, and evaluation of DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 6 risk factors for substance abuse (e.g. prior history of substance abuse or incidents with law enforcement regarding controlled substances); h. Communicate with providers that previously treated the patient and other providers concurrently treating the patient to confirm the medications and doses prescribed by those providers and the circumstances that made the patient change providers; i. Recommend, implement, and follow-up on _ alternative treatment modalities, other than the prescription of controlled substances, for the treatment of chronic pain; j. Confirm al! work-ups (i.e. MRI's and other imaging studies), failed therapies, and other procedures performed and their outcomes. k. Consult with or refer the patient to a pain management specialist or to other specialists and follow-up with those consultations and referrals. Facts Specific to Patient C.M. 19. On or about April 15, 2009, patient C.M., a forty-one (41) year old female, initially presented to Respondent with chronic spinal pain of over 10 years. DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 7 20. During the initial evaluation of C.M., Respondent did not perform or document a complete physical examination, including a complete peripheral neurological examination. . 21. From onor about April 15, 2009, to on or about September 14, 2011, the treatment period, C.M. presented to Respondent for treatment. 22. During the treatment period, approximately once a month, Respondent prescribed to C.M., OxyContin 60 mg, and between 120 and 240 tablets of Roxicodone 30 mg. 23. During the treatment period, Respondent also prescribed to C.M. the benzodiazepines Valium and Restoril. 24. Respondent did not provide or document in C.M/s medical records the functional parameters or functional improvements to justify the pain medications prescribed. 25. Respondent did not provide a diagnosis or document a diagnosis that would justify the long term use of the benzodiazepines Valium and Restoril. 26. Respondent failed to implement or document a compliance monitoring program for C.M.’s controlled substance usage. 27. Respondent did not monitor or document the management of the patient's constipation, an expected side effect of opioid medication. DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 8 . 28. Respondent did not provide, implement and follow-up on other treatment modalities for patient C.M. | COUNT I —Patient C.M. 29. Petitioner re-alleges and incorporates by reference Paragraphs one (1) through twenty-eight (28), as if fully set forth herein. 30. Section 458.331(1)(t), Florida Statutes (2008-2011), subjects a doctor to discipline for committing medical malpractice as defined in Section 456.50. Section 456.50, Florida Statutes (2008-2011), defines medical malpractice 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. 31. Level of care, skill, and treatment recognized in general law related to health care licensure means the standard of care specified in Section 766.102. Section 766.102(1), Florida Statutes (2008-2011), defines the standard of care to mean “[t]he 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.” DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 9 32. Respondent failed to meet the prevailing professional standard of care regarding the treatment of patient C.M. in one or more of the following ways: a. b. _ 33. By failing to perform a complete physical examination; By failing to justify the pain medications prescribed; . By failing to provide a diagnosis that would justify the prescription and usage of benzodiazepines; . By failing to implement a compliance monitoring program for the patient's medication usage; . By failing to monitor or manage the patient's side effects of Opioid usage; . By failing to implement and follow-up on other treatment modalities. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2008-2011), by committing medical malpractice. COUNT II—Patient C.M. 34. Petitioner re-alleges and incorporates by reference Paragraphs one (1) through twenty-eight (28), as if fully set forth herein. DOH vs, Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 10 35. Section 458.331(1)(m), Florida Statutes (2008-2011), provides that 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 procédure 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 administers; and reports of consultations and hospitalizations constitutes grounds for disciplinary action by the Board of Medicine. 36. Respondent failed to maintain legible medical records justifying the course of treatment of patient C.M. in one or more of the following ways: a. By failing to document a complete physical examination (in the alternative to Count I, paragraph 32. a.); / b, By failing to document the justification for the medications prescribed to the patient (in the alternative to Count I, paragraph 32. b.); DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 It 37. . By failing to document a diagnoses that would justify the prescription and usage of benzodiazepines (in the alternative to Count I, paragraph 32. c.); . By failing to document a compliance monitoring program for the patient’s controlled substance usage (in the alternative to Count I, paragraph 32. d.); . By failing to document the management of the patient's expected side effects of opioid usage (in the alternative to Count I, paragraph 32, e.) . By failing to document the implementation and follow-up of alternative treatment modalities (in the alternative to Count I, paragraph 32. f.). Based on the foregoing Respondent has violated Section 458.331(1)(m), Florida Statutes (2008-2011), by failing to maintain legible medical records justifying the course of treatment of patient C.M. 38. COUNT III — Patient C.M. Petitioner re-alleges and incorporates by reference Paragraphs one (1) through twenty-eight (28), as if fully set forth herein. 39. Section 458.331(1)(q), Florida Statutes (2008-2011), subjects a licensee to discipline, including suspension, for prescribing, dispensing, DOH vs. Thomas K. Veileff, Jr, M.D.; Case No. 2010-17708 12 administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. For purposes of Section 458.331(1)(q), it shall be legally presumed that prescribing, dispensing, administering, 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. 40. During the treatment period, Respondent prescribed controlled substances to patient C.M. inappropriately, in excessive or inappropriate quantities or combinations. 41. Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes (2008-2011), by inappropriately prescribing controlled substances to patient C.M. Facts Specific to Patient J.G. _ 42. On or about March 24, 2010, patient J.G., a fifty-four (54) year old male, initially presented to Respondent with chronic neck and low back pain. Patient J.G. also reported a history of a gunshot wound to the head and a craniotomy 35 years prior to the initial evaluation. In addition, the DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 13 patient reported a history of lumbar compression fractures due to a motor vehicle accident in January of 2009. 43. During the initial evaluation of J.G., Respondent performed and documented an inadequate non-focal neurological examination. 44. From on or about March 24, 2010 to on or about September 26, 2011, the treatment period, J.G.. presented to Respondent for treatment. 45. During the treatment period, approximately once a month, Respondent prescribed to J.G. between 60 and 180 tablets of Roxicodone in 15 mg and 30 mg doses. 46. During the treatment period, Respondent also prescribed to J.G. the benzodiazepines Dalmane, Restoril, and Valium. 47. Respondent did not provide or document functional parameters or functional gains to justify the pain medications prescribed. 48. Respondent did not provide a diagnosis or document a diagnosis that would justify the prescription and long term use of the benzodiazepines Dalmane, Restoril, and Valium. 49. On or about October 12, 2010, J.G. had a discordant urine drug screen that was negative for opioids and positive for cannabis (THC). However, Respondent did not document this result in his notes. DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 14 50. Respondent failed to implement or document a compliance monitoring program for J.G.’s controlled substance usage. 51. Respondent did not monitor or document the management of the patient’s expected side effects of opioid medication, particularly constipation. 52. While Respondent did refer J.G. to physical therapy and “water therapy” in August of 2011, Respondent did not follow-up on these alternative treatment modalities. COUNT IV-Patient J.G. 53. Petitioner re-alleges and incorporates by reference paragraphs one. (1) through eighteen (18) and forty-two (42) through fifty-two (52), as if fully set forth herein. 54. Section 458.331(1)(t), Florida Statutes (2009-2011), subjects a doctor to discipline for committing medical malpractice as defined in ' Section 456.50. Section 456.50, Florida Statutes (2009-2011), defines medical malpractice 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. 55. Level of care, skill, and treatment recognized in general law related to health care licensure means the standard of care specified in DOH vs. Thomas K. Velleff, Jr., M.D.; Case No, 2010-17708 15 Section 766.102. Section 766.102(1), Florida Statutes (2009-2011), defines the standard of care to mean “[t]he 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.” 56. Respondent failed to meet the prevailing professional standard of care regarding the treatment of patient J.G. in one or more of the following ways: a. By performing an inadequate neurological examination; b. By failing to justify the pain medications prescribed; c. By failing to provide a diagnosis that would justify the prescription and usage of benzodiazepines; d. By failing to implement a compliance monitoring program for the patient’s controlled substance usage; : e. By failing to monitor or manage the patient's side effects of opioid medication; f. By failing to follow-up on the alternative treatment modalities. DOH vs. Thomas K. Velleff, 3r., M.D.; Case No. 2010-17708 16 57. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2009-2011), by committing medical malpractice. COUNT V-Patient J.G. 58. Petitioner re-alleges and incorporates by reference Petitioner re-alleges and incorporates by reference paragraphs one (1) through eighteen (18) and forty-two (42) through fifty-two (52), as if fully set forth herein. 59. Section 458.331(1)(m), Florida Statutes (2009-2011), provides that 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 administers; and reports of consultations and hospitalizations constitutes grounds for disciplinary action by the Board of Medicine. DOH vs. Thomas K, Velleff, Jr, M.D.; Case No. 2010-17708 17 60. Respondent failed to maintain legible medical records justifying the course of treatment of patient J.G. in one or more of the following ways: . By failing to adequately document a neurological examination (in the alternative to Count IV, paragraph 56. a.); . By failing to document the justification for the pain medications prescribed (in the alternative to Count IV, paragraph 56. b.); . By failing to document a diagnosis that would justify the prescription and usage of benzodiazepines (in the alternative to Count IV, paragraph 56. c.); . By failing to document a compliance monitoring program for the patient's controlled substance usage (in the alternative to Count IV, paragraph 56. d.); . By failing to document the monitoring or management of the patient’s constipation (in the alternative to Count 1, paragraph 56. e.); | By failing to document following up on the recommended alternative treatment modalities (in the alternative to Count IV, paragraph 56. f.). DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 18 - 61. Based on the foregoing Respondent has violated Section 458.331(1)(m), Florida Statutes (2009-2011), by failing to maintain legible medical records justifying the course of treatment of patient J.G. COUNT VI-Patient J.G. 62. Petitioner re-alleges and incorporates by reference Petitioner re-alleges and incorporates by reference paragraphs one (1) through eighteen (18) and forty-two (42) through fifty-two (52), as if fully set forth herein. 63. Section 458.331(1)(q), Florida Statutes (2009-2011), subjects a licensee to discipline, including suspension, 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 purposes of Section 458.331(1)(q), it shall be legally presumed that prescribing, dispensing, administering, 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. DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 19 64. During the treatment period, Respondent prescribed controlled substances to patient J.G. inappropriately, in excessive or inappropriate quantities or combinations. 65. Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes (2009-2011), by inappropriately prescribing controlled substances to patient J.G. Facts Specific to Patient C.K. 66. On or about January 26, 2010, patient C.K., a forty-one (41) year old female, initially presented to Respondent with diffuse body pain. 67. During the initial evaluation of C.K., Respondent performed and documented a neurological examination in superficial terms with no significant abnormalities. 68. From on or about January 26, 2010 to on or about July 13, 2010, the treatment period, C.K. presented to Respondent for treatment. 69. During the treatment period, approximately once a month, Respondent prescribed between 150 and 180 tablets of Roxicodene 30 mg. 70. During the treatment period, Respondent also prescribed to C.K. the benzodiazepine Valium. DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 20 71. The patient’s medical records did not contain any Magnetic Resonance Imaging (MRI) or any other imaging studies or results. 72. Respondent did not provide or document in C.K.'s medical records medical indications or functional parameters to justify the prescription of opioids. 73. Respondent did not provide a diagnosis or document a diagnosis that would warrant the long term use of benzodiazepines. . 74. Respondent did not implement or document a compliance monitoring program for C.K.’s controlled substance usage. No urine drug screens were documented in the patient’s medical record. 75. Respondent did not monitor or document the management of the patient's side effects of opioid medication, particularly constipation. 76. Respondent did not provide, implement and follow-up on other treatment modalities for patient C.K. | ‘COUNT VII- Patient C.K. 77. Petitioner re-alleges and incorporates by reference Paragraphs one (1) through eighteen (18) and sixty-six (66) through seventy-six (76), as if fully set forth herein. 78. Section 458.331(1)(t), Florida Statutes (2009-2010), subjects a doctor to discipline for committing medical malpractice as defined in DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 21 Section 456.50. Section 456.50, Florida Statutes (2009-2010), defines medical malpractice 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. — 79. Level of care, skill, and treatment recognized in general law related to health care licensure means the standard of care specified in Section 766.102. Section 766.102(1), Florida Statutes (2009-2010), defines the standard of care to mean “[t]he 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.” 80. Respondent failed to meet the prevailing professional standard of care regarding the treatment of patient C.K. in one or more of the following ways: - : | a. By failing to justify the opioids prescribed; b. By failing to provide a diagnosis that would justify the prescription and usage of benzodiazepines; c. By failing to implement a compliance monitoring program for the patient's controlled substance usage; DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 22 d. By failing to monitor or manage of the patient's side effects of opioid medication; e. By failing to recommend, implement or follow-up on alternative treatment modalities. 81. Based on the foregoing, Respondent violated Section 458.331(1)(t), Florida Statutes (2009-2010), by committing medical malpractice. COUNT VITI-Patient C.K. 82. Petitioner re-alleges and incorporates by reference Paragraphs one (1) through eighteen (18) and sixty-six (66) through seventy-six (76), as if fully set forth herein. 83. Section 458.331(1)(m), Florida Statutes (2009-2010), provides that 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, DOH vs. Thomas K. Velleff, Jr., M.D.; Case No. 2010-17708 23 dispensed, or administers; and reports of consultations and hospitalizations constitutes grounds for disciplinary action by the Board of Medicine. 84. Respondent failed to maintain legible medical records justifying the course of treatment of patient C.K. in one or more of the following ways: . By failing to document the justification for the opioids prescribed (in the alternative to Count VII, paragraph 80. a.); . By failing to document a diagnosis that would justify the prescription and usage of benzodiazepines (in the alternative to Count VII, paragraph 80. b.); . By failing to document a compliance monitoring program for the patient's controlled substance usage (in the alternative to Count VIL, paragraph 80. c.); . By failing to document the monitoring or management of the patient's side effects of opioid medication (in the alternative to Count VII, paragraph 80. d.); . By failing to document recommending alternative treatment modalities (in the alternative to Count VII, paragraph 80. e.). DOH vs. Thomas K, Velleff, Jr, M.D.; Case No. 2010-17708 24 85. Based on the foregoing, Respondent has violated Section 458.331(1)(m), Florida Statutes (2009-2010), by failing to maintain legible medical records justifying the course of treatment of patient C.K. Cou NT_IX-Patient C.K. 86. Petitioner re-alleges and incorporates by reference Paragraphs one (1) through eighteen (18) and sixty-six (66) through seventy-six (76), as if fully set forth herein. ’ 87. Section 458.331(1)(q), Florida Statutes (2009-2010), subjects a licensee to discipline, including suspension, 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 purposes of Section 458.331(1)(q), it shall be legally presumed that prescribing, dispensing, administering, 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. 88. During the treatment period, Respondent prescribed controlled substances to patient C.K. inappropriately, in excessive or inappropriate quantities or combinations, DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 25 89. Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes (2009-2010), by inappropriately prescribing controlled substances to patient C.K. Facts Specific to Patient P.D. 90. On or about August 27, 2009, patient P.D., a fifty (50) year old male, initially presented to Respondent with complaints of chronic spinal pain, teft hip pain, and bilateral leg pain. P.D. reported a history of cervical and lumbar spine surgeries and spinal injections. . 91. During the initial evaluation of patient P.D., Respondent performed and documented a brief and superficial peripheral neurological examination. ' 92, From on or about August 27, 2009 to on or about October 7, 2011, the treatment period, P.D. presented to Respondent for treatment. 93. During the treatment period, approximately once a month, Respondent prescribed to P.D. 90 tablets of Roxicodone 15 mg, and 240 tablets of Roxicodone 30 mg. 94. During the treatment period, Respondent also prescribed to P.D..the benzodiazepines Xanax, Valium, and clonazepam. 95. There were medical indications in the patient’s medical records to justify the long term prescription of opioids, however Respondent did DOH vs, Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 26 not provide or document functional improvements or parameters to justify the high amount of strong opioids prescribed. ' 96. Respondent did not provide a diagnosis or document a diagnosis that would justify the long term prescription and use of benzodiazepines. 97. Respondent did not implement or document a compliance monitoring program for P.D.s controlled substance usage. In over two years of treatment, no urine drug tests or other measures of compliance monitoring were documented in the patient’s medical record. 98. Respondent did not monitor or document the management of the patient's side effects of opioid medication, particularly constipation. 99. Except for a referral to physical therapy in October of 2011 and referrals for neurosurgery re-evaluation, Respondent did not provide, implement, and follow-up on other treatment modalities for patient P.D. Respondent did not follow-up with these referrals or document the follow- up of the referrals. COUNT X-Patient P.D. 100. Petitioner re-alleges and incorporates by reference Paragraphs one (1) through eighteen (18) and ninety (90) through ninety-nine (99), as if fully set forth herein. DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 27 101. Section 458.331(1)(t), Florida Statutes (2009-2011), subjects a doctor to discipline for committing medical malpractice as defined in Section 456.50. Section 456.50, Florida Statutes (2009-2011), defines medical malpractice 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. | 102. Level of care, skill, and treatment recognized in general law related to health care licensure means the standard of care specified in Section 766.102. Section 766.102(1), Florida Statutes (2009-2011), defines the standard of care to mean “(t]he 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.” 103. Respondent failed to meet the prevailing professional standard of care regarding the treatment of patient P.D. in one or more of the following ways: a. By failing to justify the high amount of opioids prescribed; b. By failing to provide a diagnosis that would justify the prescription and usage of benzodiazepines; DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 28 c. By failing to implement a compliance monitoring program for the patient's controlled substance usage; d. By failing to monitor or manage the patient's expected side effects of opioid medication; e. By failing to implement and follow-up on alternative treatment modalities. . 104. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2009-2011), by committing medical | maipractice. COUNT XI-Patient P.D. 105. Petitioner re-alleges and incorporates by reference Paragraphs one (1) through eighteen (18) and ninety (90) through ninety-nine (99), as if fully set forth herein. 106. Section 458.331(1)(m), Florida Statutes (2009-2011), provides that 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 DOH vs. Thomas K. Velleff, Jr, M.D,; Case No. 2010-17708 29 histories; examination results; test results; records of drugs prescribed, dispensed, or administers; and reports of consultations and hospitalizations constitutes grounds for disciplinary action by the Board of Medicine. — 107. Respondent failed to maintain legible medical records justifying the course of treatment of patient P.D. in one or more of the following ways: a. By failing to document functional improvements or parameters to justify the high amount of opioids prescribed (in the alternative to Count X, paragraph 103. a.); b. By failing to document a diagnosis that would justify the prescription and usage of benzodiazepines (in the alternative to Count X, paragraph 103. b.); c. By failing to document compliance monitoring program for the patient’s controlled substance usage (in the alternative to Count X, paragraph 103. c.); : d. By failing to document the monitoring or management of the patient’s side effects of opioid medication (in the alternative to Count X, paragraph 103. d.); DOH vs, Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 30 e. By failing to document the implementation and follow-up of alternative treatment modalities (in the alternative to Count X, paragraph 103. e.). | 108. Based on the foregoing, Respondent has violated Section 458.331(1)(m), Florida Statutes (2009-2011), by failing to maintain legible medical records justifying the course of treatment of patient P.D. COUNT XIT-Patient P.D. 109. Petitioner re-alleges and incorporates by reference Paragraphs one (1) through eighteen (18) and ninety (90) through ninety-nine (99), as if fully set forth herein. 110. Section 458.331(1)(q), Florida Statutes (2009-2011), subjects a licensee to discipline, including suspension, 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 purposes of Section 458.331(1)(q), it shall be legally presumed that prescribing, dispensing, administering, 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. DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 31 111. During the treatment period, Respondent prescribed controlled substances to patient P.D. inappropriately, in excessive or inappropriate quantities or combinations. 112. Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes (2009-2011), by inappropriately prescribing - controlled substances to patient P.D. Facts Specific to Patient B.H. 113. On or about July 12, 2008, patient B.H. a thirty-nine (39) year old male, initially presented to Respondent with neck pain of approximately six months evolution. 114. During the initial evaluation of B.H., Respondent did not perform or document a complete physical examination, including a complete peripheral neurological examination. | 115. From on or about July 12, 2008, to on or about October 17, 2011, the treatment period, B.H. presented to Respondent for treatment. ~ 116. During the treatment period, approximately once a month, Respondent prescribed between 150 and 240 tablets of Roxicodone 30 mg. 117. From on or about February 24, 2009, to on or about April 21, 2009, Respondent prescribed between 120 and 240 tablets of Roxicodone 15 mg. DOH vs. Thomas K. Velleff, Jr, M.D.; Case No, 2010-17708 32 118. From on or about April 21, 2009, to on or about October 17, 2011, approximately once a month, Respondent prescribed between 90 and 120 tablets of Dilaudid 8 mg. | 119. During the treatment period, Respondent also prescribed to B.H. the benzodiazepines Xanax and Restoril. 120. On or about September 13, 2011, Respondent prescribed to BH. Viagra without appropriate justification. 121. Respondent did not provide or document in B.H.’s medical records the functional parameters to justify the high amount of opioids prescribed. 122. Respondent did not provide a diagnosis or document a diagnosis that would justify the jong term prescription and use of benzodiazepines. 123. Respondent did not implement or document a compliance monitoring program for B.H’s controlled substance usage. In over three years of treatment, Respondent only documented one urine drug screening, dated on or about October 4, 2010, in the patient's medical record. DOH vs. Thomas K, Velleff, Jr, M.D.; Case No. 2010-17708 33 ’ 124, Respondent did not monitor or document the management of the patient’s expected side effects of opicid medication, particularly constipation. - 125. Except for a referral to physical therapy and a referral for neurosurgery consultation, Respondent did not provide, implement, and follow-up on other treatment modalities for patient B.H. COUNT XITI-Patient B.H. 126. Petitioner re-alleges and incorporates by reference paragraphs one (1) through eighteen (18) and one hundred thirteen (113) through one hundred twenty-five (125), as if fully set forth herein. 127. Section 458.331(1)(t), Florida Statutes (2008-2011), subjects a doctor to discipline for committing medical malpractice as defined in Section 456.50. Section 456.50, Florida Statutes (2008-2011), defines medical malpractice 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. ~ 128. Level of care, skill, and treatment recognized in general law related to health care licensure means the standard of care specified in Section 766.102. Section 766.102(1), Florida Statutes (2008-2011), defines the standard of care to mean “{t]he prevailing professional DOH vs. Thomas K. Velleff, Jr, M.D.; Case No, 2010-17708 34 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.” 129. Respondent failed to meet the prevailing professional standard of care regarding the treatment of patient B.H. in one or more of the following ways: a. b. By failing to perform a complete physical examination; By failing to justify the prescription for Viagra; . By failing to justify the high amounts of opioids prescribed; . By failing to provide a diagnosis that would justify the prescription and usage of benzodiazepines; . By failing to implement a compliance monitoring program for the patient's controlled substance usage; . By failing to monitor or manage the patient’s expected side effects of opioid medication; g. By failing to implement and follow-up on alternative treatment modalities. DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 35 130. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2008-2011), by committing medical malpractice. COUNT XIV-Patient B.H. 131. Petitioner re-alleges and incorporates by reference paragraphs one (i) through eighteen (18) and one hundred thirteen (113) through one hundred twenty-five (125), as if fully set forth herein. 132. Section 458.331(1)(m), Florida Statutes (2008-2011), provides that 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 physiclan 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 administers; and reports of consultations and hospitalizations constitutes grounds for disciplinary action by the Board of Medicine. - 133. Respondent failed to maintain legible medical records justifying the course of treatment of patient B.H. in one or more of the following ways: DOH vs. Thomas K. Velleff, Jr, M.D.; Case No, 2010-17708 36 a. By failing to document a complete physical examination (in the alternative to Count XIII, paragraph 129. a.); b. By failing to document the justification for the prescription of Viagra (in the alternative to Count XIII, paragraph 129. b.); c. By falling to document the justification for the high amounts of opioids prescribed (in the alternative to Count XIII, paragraph 129. c.); d. By failing to document a diagnoses that would justify the prescription and usage of benzodiazepines (in the alternative to Count XIII, paragraph 129. d.); e. By failing to document a compliance monitoring program for the patient's controlled substance usage (in the alternative to Count XIII, paragraph 129. e.); f. By failing to document the management of the patient's expected side effects of opioid usage (in the alternative to Count XIII, paragraph 129. f.) g. By failing to document the implementation and follow-up of alternative treatment modalities (in the alternative to Count XIII, paragraph 129. g.). DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 37 134. Based on the foregoing Respondent has violated Section 458,331(1)(m), Florida Statutes (2008-2011), by failing to maintain legible medical records justifying the course of treatment of patient B.H. , COUNT XV-Patient B.H. 135. Petitioner re-alleges and incorporates by reference paragraphs one (1) through eighteen (18) and one hundred thirteen (113) through one hundred twenty-five (125), as if fully set forth herein. 136. Section 458.331(1)(q), Florida Statutes (2008-2011), subjects a licensee to discipline, including suspension, 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 purposes of Section 458.331(1)(q), it shall be legally presumed that prescribing, dispensing, administering, 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. 137. During the treatment period, Respondent prescribed controlled substances to patient B.H. inappropriately, in excessive or inappropriate quantities or combinations. DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 38 - 138. Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes (2008-2011), by inappropriately prescribing controlled substances to patient B.H. COUNT XVI 139. Petitioner re-alleges and incorporates by reference paragraphs one (1) through one hundred thirty-eight (138) as if fully set forth herein. _ 140. Section 456.072(1)(gg), Florida Statutes (2009-2011), provides in pertinent part that engaging in a pattern of practice when prescribing medicinal drugs or controlled substances which demonstrates a lack of reasonable skill or safety to patients, a violation of any provision of this chapter, a violation of the applicable practice act, or a violation of any rules adopted under this chapter or the applicable practice act of the prescribing practitioner constitutes grounds for disciplinary action by the Board of Medicine. 141. On or about the dates set forth above, Respondent inappropriately prescribed high amounts of controlled substances to patients C.M., J.G., C.K., P.D., and B.H. without medical justification. 142. Based on the foregoing, Respondent violated Section 456.072(1)(qg), Florida Statutes (2009-2011), by engaging in a pattern of DOH vs. Thomas K. Velleff, Jr, M.D.; Case No. 2010-17708 39 practice when prescribing medicinal drugs or controlled substances which demonstrates a lack of reasonable skill or safety to patients. WHEREFORE, 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. [Signature appears on the following page] DOH vs. Thomas K. Velieff, Jr, M.D.; Case No. 2010-17708 40 nd N43 : SIGNED. this 22 day of NM ave m ber , 2013 John H. Armstrong, MD, FACS, FCCP State Surgeon General & Secretary of Health, State of Florida André Ourso Assistant General Counsel Fla. Bar No. 91570 Florida Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Telephone: 850-245-4444 Facsimile: 850-245-4684 Email: Andre.Ourso@flhealth.gov FILED DEPARTMENT OF 1 DEPUTY CLERK TH CLERKENG OD . AO/ pare M2213 PCP: 11/22/13 PCP Members: Dr. El-Bahri, Dr. Bearison, Ms. Tootle DOH vs. Thomas K, Velleff, Jr, M.D.; Case No. 2010-17708 41 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. DOH vs. Thomas K. Velleff, Jr., M.D.; Case No. 2010-17708 42

Docket for Case No: 20-002998PL