STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, Petitioner, v. CASE NO, 2012-08782 THOMAS KARL VELLEFF, M.D., Respondent. a ADMINISTRATIVE COMPLAINT Petitioner, Department of Health, files this Administrative Complaint before the Board of Medicine against Respondent, Thomas Karl Velleff, 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, and Chapters 456 and 458, Florida Statutes (2014). 2. At all times material to this Complaint, Respondent was a licensed medical doctor within the State of Florida, having been issued license number ME 42998. 3. Respondent's address of record is 3150 N. Wickham Road, Suite 9, Melbourne, Florida 32935. 4, Patient M.F., a forty-two (42) year-old female, first presented to Respondent on or about May 24, 2008, with complaints of mid and low back pain. Respondent treated Patient M.F. from on or about May 24, 2008, through on or about November 6, 2013. 5. Patient M.F. was obese and a self-reported smoker. 6. Respondent prescribed to Patient M.F. 150 tablets of Roxicodone 30 m.g., 90 tablets of Dilaudid 8 m.g., and 100 tablets of ibuprofen‘ at appointments on or about November 18, 2009, on or about December 9, 2009, on or about January 6, 2010, on or about February 3, 2010, on or about February 24, 2010, on or about March 24, 2010, and on or about April 16, 2010. 7. On or about April 30, 2010, Patient M.F. presented to Respondent and reported that her medications were stolen, Respondent issued new prescriptions to Patient M.F, and cautioned her to protect her medication. 8. | Respondent prescribed the same medications to Patient M.F. at a follow-up appointment on or about May 26, 2010. ' Ibuprofen is a nonsteroidal anti-inflammatory drug that is used to treat inflammation and pain, [buprafen can be obtained over-the-counter or with a prescription. DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 2 of 35 9. Onor about June 16, 2010, Respondent prescribed to Patient M.F, 150 tablets of Roxicodone 30 m.g., 120 tablets of ibuprofen, and 120 tablets of Dilaudid 8 m.g, 10. Respondent prescribed the same medications to Patient M.F. at follow-up appointments on or about July 14, 2010, on or about August 4, 2010, and on or about September 7, 2010. 11. On or about October 5, 2010, Patient M.F. presented to Respondent and submitted to a drug screen. The drug screen was inconsistent with Patient M.F.’s prescribed medications, returning positive for benzodiazepines? and negative for all other substances. Respondent prescribed to Patient M.F. 180 tablets of Roxicodone 30 m.g. and 120 tablets of ibuprofen 600 m.g. 12. On or about November 2, 2010, Respondent prescribed to Patient M.F. 180 tablets of Roxicodone 30 m.g., 120 tablets of ibuprofen 600 m.g., and 30 tablets of phentermine? 37.5 m.g. 13. Respondent prescribed the same medications to Patient M.F, at follow-up appointments on or about November 30, 2010, on or about ? Benzodiazepines are a class of drugs that cause sedation and can be habit forming. Benzodiazepines are typically prescribed lo treat anxiety or insomnia. * Phentermine is a stimulant commonly prescribed to assist with weight Joss. According to Section 893.03(4). Florida Statutes (2009-2013), phentermine is a Schedule 1V controlled substance, DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 3 of 35 December 28, 2010, on or about January 24, 2011, and on or about February 16, 2011. 14. On or about March 14, 2011, and on or about April 18, 2011, Respondent prescribed to Patient M.F. 180 tablets of Roxicodone 30 m.g., 100 tablets of ibuprofen, and 30 tablets of phentermine 37.5 m.g. 15. On or about May 11, 2011, Patient M.F. presented to Respondent and submitted to a drug screen. The drug screen was inconsistent with Patient M.F.’s prescribed medications, returning positive for both oxycodone and opioids*, and negative for all other substances. Respondent prescribed to Patient M.F. 180 tablets of Roxicodone 30 m.g., 100 tablets of ibuprofen 400 m.g., and 30 tablets of phentermine 37.5 m.g. 16. Respondent prescribed the same medications to Patient M.F. at a follow-up appointment on or about June 7, 2011. 17. On or about July 5, 2011, Respondent prescribed to Patient M.F. 30 tablets of phentermine, 100 tablets of ibuprofen, and 150 tablets of Roxicodone 30 m.g. 18. Respondent prescribed the same medications to Patient M.F. at a follow-up appointment on or about July 21, 2011. “ Opiate, or opioid, drugs have similar actions as the drug opium and are typically prescribed to treat pain, Opioid oe eelrtogiy, Crea teen aahemane Aeon DOH v. Thomas Kari Velleff, M.D, Case No. 2012-08782 Page 4 of 35 19. On or about August 24, 2011, Respondent prescribed to Patient M.F. 30 tablets of phentermine, 120 tablets of ibuprofen 600 m.g., and 120 tablets of Roxicodone 30 m.g. 20. On or about September 16, 2011, Patient M.F, presented to Respondent and reported that she was going out of town on September 30, 2011, to care for an ill family member. Respondent prescribed to Patient M.F. 150 tablets of Roxicodone 30 m.g. and 120 tablets of ibuprofen 600 m.g. 21. Respondent prescribed the same mediation to Patient M.F. at a follow-up appointment on or about October 7, 2011. 22. On or about January 1, 2012, Patient M.F. presented to Respondent and reported that she ran out of medication early. Patient M.F. submitted to a drug screen which was negative for all tested substances. It was noted that Patient M.F.’s absence the prior three months was due to her being out of town to care for an ill family member. Respondent prescribed to Patient M.F. 120 tablets of ibuprofen 600 m.g. and 150 tablets of Roxicodone 30 m.g. DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 5 of 35 23. On or about February 7, 2012, Respondent prescribed to Patient M.F. 30 tablets of phentermine 37.5 m.g., 150 tablets of Roxicodone 30 m.g., and 120 tablets of ibuprofen 600 m.g. 24. Respondent prescribed the same medications to Patient M.F. at follow-up appointments on or about March 12, 2012, and on or about April 42012, 25. On or about April 24, 2012, Respondent prescribed to Patient M.F. 40 tablets of Dilaudid 8 m.g. 26. On or about April 30, 2012, Respondent prescribed to Patient M.F. 150 tablets of Roxicodone 30 m.g. and 120 tablets of ibuprofen 600 m.g. 27. On or about May 8, 2012, Respondent prescribed to Patient M.F. 150 tablets of Roxicodone 30 m.g., 120 tablets of Dilaudid 8 m.g., 120 tablets of ibuprofen 600 m.g., and 100 tablets of prednisone® 10 m.g. 28. On or about May 25, 2012, Respondent recommended that Patient M.F. use a back brace and prescribed to Patient M.F. 150 tablets of Roxicodone 30 m.g., 150 tablets of Dilaudid 8 m.g., 120 tablets of ibuprofen 600 m.g., and 21 tablets of prednisone 5 m.g. * Prednisone is a corticosteroid thal is used 1o Wveat inflammation. Prednisone is a legend drug which can only be obtained with a prescription. DOH v, Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 6 of 35 29, On or about.June 9, 2012, Respondent prescribed to Patient M.F. 180 tablets of Dilaudid 8 m.g., 100 tablets of prednisone 10 m.g., and 30 tablets of phentermine 37.5 m.g. 30. On or about October 11, 2012, Patient M.F. presented to Respondent and submitted to a drug screen. The drug screen results were inconsistent with Patient M.F.’s prescribed medications, returning positive for benzodiazepines, | morphine®, hydromorphone, — oxycodone, noroxycodone’, and oxymorphone®, and negative for all other substances. Respondent prescribed to Patient M.F. 30 tablets of phentermine, 150 tablets of Dilaudid 8 m.g., 60 tablets of Valium® 10 m.g., and 60 tablets of ibuprofen 600 m.g. 31. Respondent prescribed the same medications to Patient M.F. at a follow-up appointment on or about November 18, 2012. 32. On or about December 6, 2012, Patient MF. presented to Respondent and submitted to a drug screen. The drug screen results were inconsistent with Patient M.F.’s prescribed medications, returning positive © Morphine is prescribed to treat pain, According to Section 893.03(2), Florida Statutes (2009-2013), morphine is a Schedule J controlled substance. 7 Noroxycodone is a metabolite of oxycodone. * Oxymorphone is prescribed to treat pain. According 10 Section 893.03(2), Florida Statutes (2009-2013), oaymorphone is a Schedule 1 controlled substance. * Valium is the brand name for diazepam and is prescribed to treat anxiety. Accarding to Section 893.03(4), Flerida Statutes (2009-2013), diazepam is a Schedule 1V controlled substance. DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 7 of 35 for alprazolam’®, norbuprenorphine!!, oxymorphone, hydromorphone, oxycodone, buprenorphine, noroxycodone, and ‘tetrahydrocannabinols (“THC”)**, Respondent counseled Patient M.F. regarding the THC identified on the drug screen and prescribed to Patient M.F. 180 tablets of Dilaudid 8 m.g., 60 tablets of Valium 10 m.g., 60 tablets of ibuprofen 600 m.g., and 30 tablets of phentermine 37.5 m.g. 33. Respondent prescribed the same medications to Patient M.F. at follow-up appointments on or about January 4, 2013, on or about February 23, 2013, and on or about March 21, 2013. On or about March 21, 2013, Respondent noted that he discussed with Patient M.F. decreasing her medications in the near future. 34. On or about April 15, 2013, Patient M.F. presented to Respondent and reported that she ran out of medication early. Patient M.F. submitted to a drug screen. The drug screen results were inconsistent with Patient M.F.’s_ prescribed medications, returning positive for morphine, hydromorphone, oxycodone, oxymorphone, oxazepam’3, alcohol, '? Alprazalam is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes (2009-2013), alprazolam is a Schedule 1V controlled substance.” "' Norbuprenorphine is a metabolite of buprenorphine. Buprenorphine is commonly prescribed to treat pain According to Section 893.03(5), Florida Statutes (2009-2013), buprenorphine is a Schedule V contralled substance. "2 "letrahydrocannabinols are the psychoactive ingredients in marijuana, or cannabis. According to Section 893.03(1), Florida Statutes (2009-2013), THC is a Schedule | controlled substance. “ Qxazepain is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes (2009-2013), oxazepam is a Schedule tV controlled substance. DOH v. Thomas Karl Velleff, M.D. Case No, 2012-08782 Page 8 of 35 benzodiazepines, and opiates, and negative for all other substances. Respondent prescribed to Patient M.F. 180 tablets of Dilaudid 8 m.g., 60 tablets of Valium 10 m.g., 60 tablets of ibuprofen 600 m.g., and 30 tablets of phentermine 37.5 m.g. 35, On or about May 21, 2013, Patient M.F. presented to Respondent and submitted to a drug screen. The drug screen results were inconsistent with Patient M.F.’s prescribed medications, returning positive for hydromorphone and negative for all other substances. Respondent prescribed to Patient M.F. 180 tablets of Dilaudid 8 m.g., 60 tablets of Valium 10 m.g., 60 tablets of ibuprofen 600 m.g., and 30 tablets of phentermine 37.5 m.g. 36. Respondent prescribed the same medications to Patient M.F. at a follow-up appointment on or about June 18, 2013. 37. On or about July 16, 2013, Patient M.F. presented to Respondent and submitted to a drug screen. The drug screen results were inconsistent with Patient M.F.’s prescribed medications, returning positive for hydromorphone, oxycodone, oxymorphone, oxazepam, temazepam**, and nicotine’. Respondent discussed the abnormal drug screen with Patient ' Temazepam is prescribed to treat insomnia. According to Section 893.03(4), Florida Statutes (2009-2013), 1emazepam is a Schedule [V contvolied substance. '> Nicotine is the primary ingredient in tobacco products. DOH v. Thomas Karl Velleff, M.D. Case No, 2012-08782 Page 9 of 35 M.F. and prescribed to Patient M.F. 180 tablets of Dilaudid 8 m.g., 60 tablets of Valium 10 m.g., 90 tablets of ibuprofen 600 m.g., and 30 tablets of phentermine 37.5 m.g. 38. On or about August 13, 2013, Patient M.F. presented to Respondent and submitted to a drug screen. The drug screen results were inconsistent with Patient M.F.'s prescribed medications, returning positive for hydromorphone, and negative for all other substances. Respondent discussed the abnormal drug screen with Patient M.F. and prescribed to Patient M.F. 180 tablets of Dilaudid 8 m.g., 60 tablets of Valium 10 m.g., 90 tablets of ibuprofen 600 m.g., and 30 tablets of phentermine 37.5 m.g. 39, Respondent prescribed the same medications to Patient M.F. at follow-up appointments on or about September 10, 2013, on or about October 10, 2013, and on or about November 6, 2013. 40. From on or about July 05, 2011, through on or about November 06, 2013, Patient M.F. showed signs or symptoms of substance abuse. 41. From on or about July 05, 2011, through on or about November 06, 2013, there was evidence or behavioral indications of diversion by Patient M.F. OOH v. Thomas Karl Velieff, M.D. Case No. 2012-08782 Page 10 of 35 42. From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not obtain, or did not create or maintain adequate documentation of obtaining, a complete and comprehensive patient history for Patient M.F. 43. From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not perform, or did not create or maintain adequate documentation of performing, an adequate and complete physical examination of Patient M.F. 44. From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not develop, or did not create or maintain adequate documentation of developing, a comprehensive treatment plan for Patient M.F. 45. From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not implement, or did not create or maintain adequate documentation of implementing, a comprehensive treatment plan for Patient M.F. 46. From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not develop, or did not create or DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 11 of 35 maintain adequate documentation of developing, a comprehensive, individualized monitoring plan for Patient M.F. 47, From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not implement, or did not create or maintain adequate documentation of implementing, a comprehensive, individualized monitoring plan for Patient M.F. 48, From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not counsel, or did not create or maintain adequate documentation of counseling, Patient M.F. regarding each of her discordant drug screens, 49. From on or about November 18, 2009 through on or about November 06, 2013, Respondent did not wean or did not create or maintain adequate documentation of weaning Patient M.F. off controlled substances. 50. From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not refer, or did not create or maintain adequate documentation of referring, Patient M.F. to an addiction medicine specialist, or a mental health addiction facility. DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 12 of 35 51. From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not refer, or did not create or maintain adequate documentation of referring, Patient M.F. to a physical therapist. 52. From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not refer, or did not create or maintain adequate documentation of referring, Patient M.F. to an interventional pain specialist for consideration of trigger point injections. 53. From on or about November 18, 2009, through on or about November 06, 2013, Respondent did not refer, or did not create or maintain adequate documentation of referring, Patient M.F. to a neurologist or physiatrist for consideration of electro-diagnostic testing. 54. From on or about July 05, 2011, through on or about November 06, 2013, Respondent did not develop, or did not create or maintain adequate documentation of developing, a written plan for assessing Patient M.F.’s risk of aberrant drug-related behavior. 55. From on or about July 05, 2011, through on or about November 06, 2013, Respondent did not assess, or did not create or maintain DOH v. Thomas Karl Velleff, M.D. Case No, 2012-08782 Page 13 of 35 adequate documentation of assessing, Patient M.F.’s risk of aberrant drug- related behavior, in accordance with a written plan. 56. From on or about July 05, 2011, through on or about November 06, 2013, Respondent did not monitor, or did not create or maintain adequate documentation of monitoring, Patient M.F.’s risk of aberrant drug-related behavior, on an ongoing basis, in accordance with a written plan. 57. From on or about July 05, 2011, through on or about November 06, 2013, Respondent did not perform, or did not create or maintain adequate documentation of performing, a physical examination of Patient M.F. proportionate to her diagnosis. 58. From on or about July 05, 2011, through on or about November 06, 2013, Respondent did not refer, or did not create or maintain adequate documentation of referring, Patient M.F. to a board-certified pain management physician, an addiction medicine specialist, or a mental health addiction facility, as it pertains to drug abuse or addiction, immediately after Patient M.F. showed signs or symptoms of substance abuse. 59. From on or about July 05, 2011, through on or about November 06, 2013, Respondent did not discontinue, or did not create or maintain DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 14 of 35 adequate documentation of discontinuing, controlled substance therapy for Patient M.F. upon evidence or behavior indications of diversion by Patient MF. 60. From on or about July 05, 2011, through on or about November 06, 2013, Respondent did not discharge, or did not create or maintain adequate documentation of discharging, Patient M.F. upon evidence or behavior indications of diversion by Patient M.F. 61. Respondent prescribed controlled substances to Patient M.F., from on or about November 18, 2009, through on or about November 06, 2013, without having adequate justification, or Respondent did not create or maintain adequate documentation of having adequate justification for prescribing controlled substances to Patient M.F. 62. Respondent prescribed combinations of controlled substances to Patient M.F., from on or about November 18, 2009, through on or about November 06, 2013, without having adequate justification, or Respondent did not create or maintain adequate documentation of having adequate justification for the combinations of controlled substances prescribed to Patient M.F. DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 15 of 35 63. Respondent prescribed quantities of controlled substances to Patient M.F., from on or about November 18, 2009, through on or about November 06, 2013, without having adequate justification for those quantities, or Respondent did not create or maintain adequate documentation of having adequate justification for the quantities of controlled substances prescribed to Patient M.F. 64. Prescribing controlled substances or combinations of controlled substances without having adequate justification is prescribing controlled substances inappropriately. 65. Prescribing quantities of controlled substances without having adequate justification for those quantities is prescribing controlled substances excessive or inappropriate quantities. Standard of Care 66. The prevailing professional standard of care required Respondent to: a. Obtain a complete and comprehensive patient history for Patient M.F.; and/or DOH v. Thomas Karl Velleff, M.D. Case No, 2012-08782 Page 16 of 35 . Perform an adequate and complete physical examination of Patient M.F.; and/or Develop a comprehensive treatment plan for Patient M.F.; and/or . Implement a comprehensive treatment plan for Patient M.F.; and/or . Develop a comprehensive, individualized monitoring plan for Patient M.F.; and/or Implement a comprehensive, individualized monitoring plan for Patient M.F.; and/or . Adequately counsel Patient M.F. regarding each of her discordant drug screens; and/or . Wean Patient M.F. off controlled substances; and/or Refer Patient M.F. to an addiction medicine specialist, or a mental health addiction facility; and/or Refer Patient M.F. to a physical therapist; and/or . Refer Patient M.F, to an interventional pain specialist for consideration of trigger point injections; and/or Refer Patient M.F. to a neurologist or physiatrist for consideration of electro-diagnostic testing; and/or DOH y. Thomas Karl Velleff, M.0. Case No. 2012-08782 Page 17 of 35 m.Not prescribe controlled substances to Patient M.F. without having adequate justification; and/or . Not prescribe combinations of controlled substances to Patient M.F, without having adequate justification; and/or . Not prescribe quantities of controlled substances to Patient M.F. without having adequate justification for those quantities; and/or . Adequately justify the controlled substances prescribed to Patient M.F.; and/or . Adequately justify the combinations of controlled substances prescribed to Patient M.F.; and/or Adequately justify the quantities of controlled substances prescribed to Patient M.F. DOH vy. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 18 of 35 COUNT ONE Violation of Section 458.331(1)(t), Florida Statutes 67. Petitioner realleges and incorporates paragraphs one (1) through sixty-six (66) as if fully set forth herein. 68. Section 458.331(1)(t), Florida Statutes (2009-2013), subjects a physician to discipline for committing medical malpractice as defined in Section 456.50, Florida Statutes. Medical malpractice is defined by Section 456.50(1)(g), Florida Statutes (2009-2013), 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 (2009-2013), 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. Section 766.102(1), Florida Statutes (2009- 2013), provides that 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. DOH v. Thomas Karl Velleff, M.D. Case No, 2012-08782 Page 19 of 35 69. Respondent fell below the minimum standard of care in his treatment of Patient M.F, between on or about November 18, 2009, and on or about November 6, 2013, in one or more of the following ways: a. By failing to obtain a complete and comprehensive patient history for Patient M.F.; and/or . By failing to perform an adequate and complete physical examination of Patient M.F.; and/or . By failing to develop a comprehensive treatment plan for Patient M.F.; and/or . By failing to implement a comprehensive treatment plan for Patient M.F.; and/or . By failing to develop a comprehensive, individualized monitoring plan for Patient M.F.; and/or By failing to implement a comprehensive, individualized monitoring plan for Patient M.F.; and/or . By failing to adequately counsel Patient M.F. regarding each of her discordant drug screens; and/or . By failing to wean Patient M.F. off controlled substances; and/or DOH v. Thomas Kar! Velleff, M.D. Case No, 2012-08782 Page 20 of 35 . By failing to refer Patient M.F. to an addiction medicine specialist, or a mental health addiction facility; and/or By failing to refer Patient M.F, to a physical therapist; and/or . By failing to refer Patient M.F. to an interventional pain specialist for consideration of trigger point injections; and/or By failing to refer Patient M.F. to a neurologist or physiatrist for consideration of electro-diagnostic testing; and/or .By prescribing controlled substances to Patient M.F, without having adequate justification; and/or . By prescribing combinations of controlled substances to Patient M.F. without having adequate justification; and/or . By prescribing quantities of controlled substances to Patient M.F. without having adequate justification for those quantities; and/or . By failing to adequately justify the controlled substances prescribed to Patient M.F.; and/or . By failing to adequately justify the combinations of controlled substances prescribed to Patient M.F.; and/or By failing to adequately justify the quantities of controlled substances prescribed to Patient M.F. DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 21 of 35 70. Based on the foregoing, Respondent violated Section 458.331(1)(t), Florida Statutes (2009-2013). COUNT TWO Violation of Section 458.331(1)(m), Florida Statutes 71. Petitioner realleges and incorporates paragraphs one (1) through sixty-five (65) as if fully set forth herein. 72. Section 458.331(1)(m), Florida Statutes (2009-2013), 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 the 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. . 73. Rule 64B8-9.003(2), Florida Administrative Code, provides that a licensed physician shall maintain patient medical records in English, in a legible manner, and with sufficient detail to clearly demonstrate why the course of treatment was undertaken. DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 22 of 35 74, Rule 64B8-9.003(3), Florida Administrative Code, provides that 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 the by the physician in determining the appropriate treatment of the patient. 75. Respondent failed to keep legible medical records that justify the course of treatment of Patient M.F. in one or more of the following ways: a, By failing to create or maintain adequate documentation of obtaining a complete and comprehensive patient history for Patient M.F.; and/or b. By failing to create or maintain adequate documentation of performing an adequate and complete physical examination of Patient M.F.; and/or OOH v. Thomas Karl Velleff, M.D. Case No, 2012-08782 Page 23 of 35 . By failing to create or maintain adequate documentation developing a comprehensive treatment plan for Patient M.F.; and/or . By failing to create or maintain adequate documentation implementing a comprehensive treatment plan for Patient M.F.; and/or . By failing to create or maintain adequate documentation developing a comprehensive, individualized monitoring plan for Patient M.F.; and/or By failing to create or maintain adequate documentation implementing a comprehensive, individualized monitoring plan for Patient M.F.; and/or . By failing to create or maintain adequate documentation of adequately counseling Patient M.F. regarding each of her discordant drug screens; and/or . By failing to create or maintain adequate documentation of referring Patient M.F. to an addiction medicine specialist, or a mental health addiction facility; and/or By failing to create or maintain adequate documentation of referring Patient M.F. to a physical therapist; and/or DOH v. Thomas Karl Velteff, M.D. Case No, 2012-08782 Page 24 of 35 By failing to create or maintain adequate documentation of referring Patient M.F. to an interventional pain specialist for consideration of trigger point injections; and/or . By failing to create or maintain adequate documentation of referring Patient M.F. to a neurologist or physiatrist for consideration of electro-diagnostic testing; and/or By failing to create or maintain adequate documentation of developing a written plan for assessing Patient M.F.’s risk of aberrant drug-related behavior; and/or .By failing to create or maintain adequate documentation of assessing Patient M.F.’s risk for aberrant drug-related behavior, in accordance with a written plan; and/or . By failing to create or maintain adequate documentation of monitoring Patient M.F.’s risk for aberrant drug-related behavior, on an ongoing basis, in accordance with a written plan; and/or . By failing to create or maintain adequate documentation of performing a physical examination of Patient M.F. proportionate to her diagnosis; and/or DOH v, Thomas Karl Velleff, M.D. Case No, 2012-08782 Page 25 of 35 . By failing to create or maintain adequate documentation of referring Patient M.F. to a board-certified pain management physician, an addiction medicine specialist, or a mental health addiction facility, as it pertains to drug abuse or addiction, immediately after Patient M.F. showed signs or symptoms of substance abuse ; and/or . By failing to create or maintain adequate documentation of discontinuing controlled substance therapy for Patient M.F. upon evidence or behavior indications of diversion by Patient M.F ; and/or By failing to create or maintain adequate documentation of discharging Patient M.F. upon evidence or behavior indications of diversion by Patient M.F ; and/or . By failing to create or maintain adequate documentation of having adequate justification for prescribing controlled substances to Patient M.F.; and/or By failing to create or maintain adequate documentation of having adequate justification for prescribing combinations of controlled substances to Patient M.F.; and/or DOH v. Thomas Kari Velleff, M.D. Case No, 2012-08782 Page 26 of 35 u. By failing to create or maintain adequate documentation of having adequate justification for the quantities of controlled substances prescribed to Patient M.F. 76. Based on the foregoing, Respondent violated Section 458.331(1)(m), Florida Statutes (2009-2013). COUNT THREE Violation of Section 458.331(1)(q), Florida Statutes 77. Petitioner realleges and incorporates paragraphs one (1) through sixty-five (65) as if fully set forth herein. 78. Section 458.331(1)(q), Florida Statutes (2009-2013), 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, 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 v. Thomas Karl Velleff, M.D. Case No, 2012-08782 Page 27 of 35 79. Respondent prescribed a legend drug which was a controlled substance other than in the course of his professional practice between on or about November 18, 2009, and on or about November 6, 2013, in one or more of the following ways: a. By prescribing controlled substances to Patient M.F. inappropriately; and/or b. By prescribing combinations of controlled substances to Patient M.F. inappropriately; and/or c. By prescribing controlled substances to Patient M.F. in excessive or inappropriate quantities. 80. Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes (2009-2013). COUNT FOUR Violation of Section 456.072(1)(mm), Florida Statutes 81. Petitioner realleges and incorporates paragraphs one (1) through sixty-five (65) as if fully set forth herein. 82. Section 456.072(1)(mm), Florida Statutes (2011-2013), subjects a physician to discipline for failure to comply with controlled substance prescribing requirements of s. 456.44. DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 28 of 35 83. Section 456.44(2)(b), Florida Statutes (2011-2013), provides that a physician licensed under Chapter 458 who prescribes any controlled substance listed in Schedule II, III, or IV as defined in Section 893.03, Florida Statutes for the treatment of chronic nonmalignant pain, must comply with the requirements of this section. 84. Section 456.44(3), Florida Statutes (2011-2013), sets forth standards of practice for controlled substance prescribing which do not supersede the level of care, skill, and treatment recognized in general law related to health care licensure and provides in pertinent part: (a) A complete medical history and a physical examination must be conducted before beginning any treatment and must be documented in the medical record. The exact components of the physical examination shall be left to the judgment of the clinician who is expected to perform a physical examination proportionate to the diagnosis that justifies a treatment. The medical record must, at a minimum, 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, a ‘review of previous medical records, previous diagnostic studies, and history of alcohol and substance abuse, The medical record shall also document the presence of one or more recognized medical indications for the use of a controlled substance. Each registrant must develop a written plan for assessing each patient’s risk of aberrant drug-related behavior, which may include patient drug testing. Registrants must assess each patient's risk for aberrant drug-related behavior and monitor that risk on an ongoing basis in accordance with the plan. OOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 29 of 35 (b) Each registrant must develop a written individualized treatment plan for each patient. The treatment plan shall state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and shall indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician shall adjust drug therapy to the individual medical needs of each patient. Other treatment modalities, including a rehabilitation program, shall be considered depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. The interdisciplinary nature of the treatment plan shail be documented. (g) Patients with signs or symptoms of substance abuse shail be immediately referred to a board-certified pain management physician, an addiction medicine specialist, or a mental health addiction facility as it pertains to drug abuse or addiction unless the physician is board-certified or board-eligible in pain management. Throughout the period of time before receiving the consultant's report, a prescribing physician shall clearly and completely document medical justification for continued treatment with controlled substances and those steps taken to ensure medically appropriate use of controlled substances by the patient. Upon receipt of the consultant's written report, the prescribing physician shall incorporate the consultant’s recommendations for continuing, modifying, or discontinuing controlled substance therapy. The resulting changes in treatment shall be specifically documented in the patient's medical record. Evidence or behavioral indications of diversion shali be followed by discontinuation of controlled substance therapy, and the patient shall be discharged, and all results of testing and actions taken by the physician shall be documented in the patient’s medical record. DOH v, Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 30 of 35 This subsection does not apply to a_ board-certified anesthesiologist, physiatrist, or neurologist, or to a board- certified physician who has surgical privileges at a hospital or ambulatory surgery center and primarily provides surgical services. This subsection does not apply to a board-certified medical specialist who has also completed a fellowship in pain medicine approved by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association, or who is board certified in pain medicine by a board approved by the American Board of Medical Specialties or the American Osteopathic Association and performs interventional pain procedures of the type routinely billed using surgical codes. 85. Respondent violated Section 456.072(1)(mm), Florida Statutes by violating Section 456.44(2)(b), Florida Statutes (2011-2013.) 86. Respondent violated Section 456.44(2)(b), Florida Statutes by violating Section 456.44(3)(a)(b) and (e), Florida Statutes (2011-2013.) 87. Respondent violated Section 456.44(3)(a), Florida Statutes in one or more of the following ways: a. By failing to obtain a complete medical history of Patient M.F.; and/or b. By failing to perform a physical examination of Patient M.F. proportionate to her diagnosis; and/or c. By failing to develop a written plan for assessing Patient M.F.’s risk of aberrant drug-related behavior; and/or DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 31 of 35 d, By failing to assess Patient M.F.’s risk of aberrant drug-related behavior in accordance with a written plan; and/or e, By failing to monitor Patient M.F.’s risk of aberrant drug-related behavior on an ongoing basis in accordance with a written plan. 88. Respondent violated Section 456.44(3)(b), Florida Statutes by failing to develop a written individualized treatment plan for Patient M.F. stating the objectives for treatment. 89. Respondent violated Section 456.44(3)(g), Florida Statutes in one or more of the following ways: a. By failing to refer Patient M.F. to a board-certified pain management physician, an addiction medicine specialist, or a mental health addiction facility as it pertains to drug abuse or addiction immediately after Patient M.F. showed signs or symptoms of substance abuse; and/or b. By failing to discontinue controlled substance therapy for Patient M.F. upon evidence or behavior indications of diversion by Patient M.F.; and/or c. By failing to discharge patient M.F. upon evidence or behavior indications of diversion by Patient M.F. DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 32 of 35 90. Based on the foregoing, Respondent violated Section 456.072(1)(mm), Florida Statutes (2011-2013). WHEREFORE, Petitioner respectfully requests that the Board of Medicine enter an order imposing one or more of the following penalties: revocation or suspension of Respondent's license, imposition of an administrative fine, placement of Respondent on probation, corrective action, remedial education, and/or any other relief that the Board deems appropriate. [Signature appears on the following page.] yor sf SIGNED this ol day of Nive?I282 , 2015. John H. Armstrong, MD, FACS State Surgeon General and Secretary of Health unr Jo fpf 2 Fie- Arielle E. Davis yy? Assistant General Counsel poss Florida Bar No. 0088605 DOH-Prosecution Services Unit 4052 Bald Cypress Way-Bin C-65 (850) 245-4444, Ext. 8201 (850) 245-4684 Fax E-Mail: Arielle. Davis@flhealth.gov DOH v. Thomas Karl Velleff, M.D. Case No, 2012-08782 Page 33 of 35 PCPVL-20- (5 PCP Members: cy EkRahrl iN. } STeronda M.D * B. Goeth , Be ed DEPARTMENT OF HEALTH DEPUTY CLERK cLeRK NDEI Goede DATE: 11-23-45 DOH v. Thomas Karl velleff, M.D. Case No. 2012-08782 Page 34 of 35 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. A request or petition for an administrative hearing must be in writing and must be received by the Department within 21 days from the day Respondent received the Administrative Complaint, pursuant to Rule 28-106.111(2), Florida Administrative Code. If Respondent fails to request a hearing within 21 days of receipt of this Administrative Complaint, Respondent waives the right to request a hearing on the facts alleged in this Administrative Complaint pursuant to Rule 28- 106.111(4), Florida Administrative Code. Any request for an administrative proceeding to challenge or contest the material facts or charges contained in the Administrative Complaint must conform to Rule 28-106,2015(5), Florida Administrative Code. Mediation under Section 120.573, Florida Statutes, is not available to resolve this Administrative Complaint. 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. DOH v. Thomas Karl Velleff, M.D. Case No. 2012-08782 Page 35 of 35

Docket for Case No: 20-002999PL