STATE OF FLORIDA DEPARTMENT OF HEALTH FLORIDA DEPARTMENT OF HEALTH, Petitioner, V. Case Number: 2012-06500 SANJAY TRIVEDI, M.D., Respondent. ADMINISTRATIVE COMPLAINT Petitioner Department of Health files this Administrative Compiaint before the Board of Medicine against Respondent Sanjay Trivedi, M.D., and states: 1. Petitioner is the state agency charged with regulating the practice of medicine, pursuant to Chapters 20, 456 and 458, Florida Statutes (2010-2011). 2. At all times material to this Complaint, Respondent was licensed to practice as a physician in the State of Florida, pursuant to Chapter 458, Florida Statutes (2010-2011), having been issued license number ME 101999. Respondent's address of record is 624 Fenwick Lane, Jacksonville, Florida 32259. 3. At alt times material to this Complaint, Respondent treated Filed September 26, 2012 3:28 PM Division of Administrative Hearings Florida Department of Health v, Sanjay Trivedi, MD Case Number: 2012-06500 patients at Jacksonville Back and Spine Institute, Inc., located at 1845 University Boulevard North, Jacksonville, Florida 32211. FACTS SPECIFIC TO C.J. 4. On or about October 3, 2011, Law Enforcement officer C.J. (*CJ"), acting in an undercover capacity, presented to the Clinic as a forty- eight-year-old male patient with complaints of stiffness in his lower and middle back. CJ provided copies of his medical record from a prior-treating physician to the Clinic. CJ's prior medical record included the results of a magnetic resonance imaging (“MRI”) study of CJ’s thoracic spine (middle back) dated November September 21, 2011, and CJ's prescription history.’ Cl's medical record included a history of receiving Oxycodone 30 mg, Xanax 2 mg and carisoprodol 350 mg from a prior-treating physician between August 2010 and September 2011. 5. Oxycodone is commonly prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010-2011), oxycodone is a Schedule It 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 ' y's medical record and prescription history were fabricated by Law Enforcement with the assistance of a cooperating physician. CJ’s MRI was authentic. Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 physical dependence. 6. Xanax is the brand name for alprazolam 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 IIT 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 ITI. 7. Carisoprodol, commonly known by the brand name Soma, is a muscle relaxant prescribed to treat muscular pain. According to Section 893.03(4), Florida Statutes (2011), carisoprodol 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 carisoprodol may lead to limited physical or psychological dependence relative to the substances in Schedule III. 8. During the course of this initial visit, C)_ reported a pain level of five on a scale of one-through-ten without pain medication and two on a scale of one-through-ten with pain medication. CJ was asked by a medical assistant at the Clinic to undergo a urine drug screen, which was negative Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 for any substances, including those controlled substances that were previously prescribed to CJ. 9, After paying his visit fee of $250.00, C) was escorted into an examination room, where he was met by Dr. Trivedi. When Dr. Trivedi asked CJ “what bother[ed]” him, CJ replied that his lower and middle back were “stiff.” Dr. Trivedi then performed a_ brief examination of Cl. Following the examination, Dr. Trivedi reviewed CJ’s MRI and prescription history. Dr. Trivedi told C) that his prior-treating physician had over- medicated him and that there was “nothing in the MRI that I can justify giving 30’s (Oxycodone 30 mg) to you.” Dr. Trivedi then told C) that “I can give you 15’s (Oxycodone 15 mg) if you want.” When CJ responded that he “would prefer 30’s,” Dr. Trivedi stated “nothing shows up in your MRI; the best I can give you is 15’s. . . I'll give you Mobic too... if you want something for sleep, I can give you Valium too.” 10. Mobic is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis. 11. Valium is the brand name for diazepam, which is used to treat anxiety. According to Section 893.03(4), Florida Statutes (2011), diazepam is a Schedule IV controlled substance that has a low potential for abuse Florida Department of Health v, Sanjay Trivedi, MD Case Number: 2012-06500 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. 12. At the conclusion of this visit, Dr. Trivedi provided CJ with prescriptions for 28 dosage units of Valium 2 mg, 112 dosage units of Percocet 10-325 mg and 28 dosage units of Mobic 7.5 mg. 13. Percocet 10-325 mg contains oxycodone and acetaminophen, or Tylenol. 14. On or about October 31, 2011, CJ returned to the Clinic for a follow-up visit with Dr. Trivedi. After paying a visit fee of $250.00, C) was escorted to an examination room where a medical assistant took Cl’s weight and blood pressure and inquired about CJ’s pain level. In response, C) reported a pain level of five on a scale of one-through-ten without pain medication and two on a scale of one-through-ten with pain medication. 15. Upon entering the examination room, Dr. Trivedi asked C) about his pain level. CJ reported that his lower back was stiff and his shoulder was sore. Dr. Trivedi then proceeded to perform a brief examination of CJ. Following the examination, Dr. Trivedi again told CJ Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 that he could not justify prescribing Oxycodone 30 mg to him as CJ’s MRI showed nothing wrong with his back. Nevertheless, Dr. Trivedi agreed to increase CJ's prescription of oxycodone from Percocet 10-325 mg to Oxycodone HCI 15 mg (an increase of 5 mg of oxycodone per dosage unit). 16. Oxycodone HCI is an extended-release form of oxycodone. 17. At the conclusion of this visit, Dr. Trivedi prescribed 28 dosage units of Valium 2 mg, 98 dosage units of Oxycodone HCI 15 mg and 28 dosage units of Mobic 7.5 mg to CJ. 18. An independent medical expert, who is Board-Certified in Pain Management, Anesthesiology and Interventional Pain Management, reviewed the treatment provided by Dr. Trivedi to CJ and opined Dr. Trivedi fell below the minimum standards of care in several respects. In particular, the expert found Dr. Trivedi failed to utilize a multi-disciplinary approach in his treatment of the patient; prescribed controlled substances to the patient without medical justification; prescribed Valium to the patient without medical justification; failed to provide a written treatment plan to the patient; failed to order diagnostic tests; and prescribed controlled substances to the patient after the patient reported running out Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 of medication early, reported no increases in pain, had a normal MRI and tested negative for the substances during drug screens. Facts Specific to G.J. 19. ‘On or about October 3, 2011, Law Enforcement officer G.J. (“GJ”), acting in an undercover capacity, first presented to the Clinic as a forty-two-year-old male patient with complaints of lower and middle back pain. GJ provided copies of his medical record from a prior-treating physician to the Clinic. GJ’s prior medical record included the results of a MRI study of GJ's cervical spine (neck/upper back) dated September 6, 2011, which revealed a small disc herniation in GJ’s upper back, but no other abnormalities. GJ’s prior medical record also contained the patient's prescription history for the period of August 1, 2010, through September 28, 2011, which indicated GJ had received monthly prescriptions for — oxycodone, carisoprodol and alprazolam from a prior-treating physician during that time.’ 20. During the course of this initial visit, G) reported a pain level of four — six on a scale of one-through-ten without pain medication and two on a scale of one-through-ten with pain medication. GJ indicated his pain 2 GI’s medical record and prescription history were fabricated by Law Enforcement with the assistance of a cooperating physician. GJ’s MRI was authentic. Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 was in his lower and middle back despite the fact that his MRI was of his neck and upper back. GJ was asked by a medical assistant at the Clinic to undergo a urine drug screen, which was negative for any substances, including those controlled substances that were previously prescribed to GJ. | 21. After entering the examination room, Dr. Trivedi asked GJ about his neck pain. GJ advised Dr. Trivedi that his pain was in his lower and middle back. Despite this, Dr. Trivedi continued palpating GJ’s neck and questioning GJ about his neck pain. 22. Dr. Trivedi proceeded to conduct an examination of GJ that lasted approximately sixty seconds. At the conclusion of this visit, Dr. Trivedi prescribed 112 dosage units of Roxicodone 30 mg and 28 dosage units of Valium 2 mg to GJ. Dr. Trivedi failed to discuss any other treatment options with G3. | 23. On or about October 31, 2011, GJ returned to the Clinic for a follow-up visit with Dr. Trivedi. After being escorted into an examination room by a medical assistant, GJ again reported a pain level of five on a scale of one-through-ten without pain medication. GJ also reported that he had run out of Roxicodone 30 mg about five days prior to his visit to the Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 Clinic and had resorted to taking his wife’s pain medication. 24. After Dr. Trivedi entered the examination room, he asked GJ about his neck pain. GJ, once again, told Dr. Trivedi that his pain was located in his lower back, not his neck. Dr. Trivedi recommended GJ undergo an MRI of his lower back and then performed an examination of GJ lasting approximately forty-five seconds. When GJ told Dr. Trivedi that the amount of Roxicodone Dr. Trivedi had prescribed to him during his previous visit (four dosage units per day) was not enough, Dr. Trivedi agreed to increase the dosage to five units per day. When GJ asked Dr. Trivedi whether he could provide him with any additional pain medication, Dr. Trivedi indicated he would also prescribe Mobic to GJ. 25. At the conclusion of this visit, Dr. Trivedi prescribed 140 dosage units of Roxicodone 30 mg, 28 dosage units of Valium 2 mg and 28 dosage units of Mobic 7.5 mg to G3. Dr. Trivedi failed to discuss any other treatment options with GJ. 26. An independent medical expert, who is Board-Certified in Pain Management, Anesthesiology and Interventional Pain Management, reviewed the treatment provided by Dr. Trivedi to GJ and opined Dr. Trivedi fell below the standard of care in several ways. In particular, the Florida Department of Health v, Sanjay Trivedi, MD Case Number; 2012-06500 expert found Dr. Trivedi performed an inadequate physical examination of the patient; failed to utilize a multi-disciplinary approach in his treatment of the patient; prescribed controlled substances to the patient without medical justification; failed to provide a written treatment plan to the patient; and prescribed controlled substances to the patient after the patient reported running out of medication early, reported no increases in pain and tested negative for the substances during a drug screen. Facts Specific to T.R. 27. On or about October 17, 2011, Law Enforcement officer T.R. (TR”), acting in an undercover capacity, first presented to the Clinic as a twenty-seven-year-old male patient with complaints of lower, middle and upper back pain. TR provided copies of his medical record from a prior- treating physician to the Clinic. TR’s prior medical record included the results of a MRI study of TR’s lumbar spine (lower back) dated August 12, 2011, which revealed a disc bulge and minor/moderate stenosis in TR's lower back, but no other abnormalities. TR's prior medical record also contained the patient's prescription history for the period of September 1, 2010, through September 16, 2011, which indicated TR had received monthly prescriptions for oxycodone, carisoprodol and alprazolam from a 10 Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 prior-treating physician during that time.’ 28. During the course of this initial visit, TR reported a pain level of four — five on a scale of one-through-ten without pain medication and two on a scale of one-through-ten with pain medication. TR was asked by a medica! assistant at the Clinic to undergo a urine drug screen, which was negative for any substances, including those controlled substances that were previously prescribed to TR. 29. After entering the examination room, Dr. Trivedi asked TR about his back pain. TR advised Dr. Trivedi that his upper back was “stiff” and did not report having any pain in his lower or middle back. Dr. Trivedi proceeded to conduct an examination of TR that lasted less than two minutes. During the exam, TR did not complain of pain. Dr. Trivedi did not perform any range of motion examination of TR's spine. 30. Dr. Trivedi asked TR whether he had taken oxycodone and Xanax in the past. When TR responded in the affirmative, Dr. Trivedi indicated he would prescribe oxycodone ‘and Valium to TR as he did not like to prescribe oxycodone and Xanax in combination. 31. At the conclusion of this visit, Dr. Trivedi prescribed 112 dosage 3 TR's medical record and prescription history were fabricated by Law Enforcement with the assistance of a cooperating physician, TR's MRI was authentic. 11 Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 units of Roxicodone 30 mg, 28 dosage units of Valium 2 mg and 28 dosage units of Mobic 7.5 mg to TR. 32. On or about November 14, 2011, TR returned to the Clinic for a follow-up visit with Dr. Trivedi. After paying a $250.00 visit fee and being escorted into an examination room by a medical assistant, GJ reported a pain level of four on a scale of one-through-ten without pain medication. GJ also reported that he had run out of pain medication prior to his visit to the Clinic. 33. After Dr. Trivedi entered the examination room, he ake TR about his lower back pain. TR told Dr. Trivedi that his pain was located in his upper back and that his lower back was fine. Nevertheless, Dr. Trivedi insisted that TR’s pain was located in his lower back and that TR would need to undergo an MRI of his lower back. Dr. Trivedi then performed an examination of TR lasting approximately fifty seconds. When TR told Dr. Trivedi that the amount of Roxicodone Dr. Trivedi had prescribed to him during his previous visit (four dosage units per day) was inadequate because he had run out of the medication early, Dr. Trivedi agreed to increase the dosage. 34. At the conclusion of this visit, Dr. Trivedi prescribed 126 dosage 12 Florida Department of Health v, Sanjay Trivedi, MD Case Number: 2012-06500 units of Roxicodone 30 mg (an increase of 14 dosage units), 28 dosage units of Valium 2 mg and 56 dosage units of ibuprofen 600 mg to TR. Dr. Trivedi failed to inquire as to whether TR had seen a neurologist pursuant to the neurological prescription he had provided to TR during his prior visit. 35. An independent medical expert, who is Board-Certified in Pain Management, Anesthesiology and Interventional Pain Management, reviewed the treatment provided by Dr. Trivedi to TR and opined Dr. Trivedi fell below the standard of care in several respects. In particular, the expert found Dr. Trivedi performed an inadequate physical examination of the patient; failed to utilize a multi-disciplinary approach in his treatment of the patient; prescribed controlled substances to the patient without medical justification; failed to provide a written treatment plan to the patient; and prescribed controlled substances to the patient after the patient reported running out of medication early, reported no increases in pain and tested negative for the substances during a drug screen. COUNT I — SECTION 458.331(1)(t), FLORIDA STATUTES 36. Petitioner realleges and incorporates paragraphs 1 through 35 above, as if set forth herein. 13 Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 37. Section 458.331(1)(t)1., Florida Statutes (2010-2011), subjects a physician to discipline for committing medical malpractice as defined in Section 456.50, Florida Statutes (2010-2011). “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 (2010-2011), 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. 38. Section 458.331(1)(t)1., Florida Statutes (2010-2011), directs the Board of Medicine to give “great weight” to this provision of Section 766.102, Florida Statutes (2010-2011). 39. Dr. Trivedi failed to meet the prevailing standard of care in one or more of the following manners: 14 Florida Department of Health v, Sanjay Trivedi, MD Case Number: 2012-06500 a. By prescribing inappropriate quantities of controlled substances to Patients CJ, GJ and TR without justification; b. By failing to employ other modalities for the treatment of pain in connection with Patients CJ, GJ and TR; and c. By failing to order appropriate diagnostic or objective tests for Patients CJ, GJ and TR. COUNT II — SECTION 458.331(1 FL STATUTES 40. Petitioner realleges and incorporates paragraphs 1 through 35 above, as if set forth herein. 41. Section 458.331(1)(q), Florida Statutes (2010-2011), subjects a licensee 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. It is legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, including alt 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. 15 Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 42. Respondent violated Section 458.331(1)(q), Florida Statutes (2010-2011), by prescribing controlled substances inappropriately or in excessive or inappropriate quantities to Patients CJ, GJ and TR. COUNT III —S TON 458.331(1)(nn), FLORIDA TUTE 43. Petitioner realleges and incorporates paragraphs 1 through 35 above, as if set forth herein. 44. Section 458.331(1)(nn), Florida Statutes (2010-2011), subjects a physician to discipline for violating any provision of Chapters 456 or 458, Florida Statutes, or any rules adopted pursuant thereto. 45. Rule 64B8-9.013, Florida Administrative Code, sets forth 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. (b) Treatment Plan. The written treatment plan shall state 16 Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 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, if necessary, to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. ‘ * * * (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. (f) 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; 46. Dr. Trivedi violated Rule 64B8-9.013, Florida Administrative Code, in one or more of the following manners: 17 Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 a. By failing to document an adequate treatment plan for Patients CJ, GJ and TR. b. By failing to conduct or document an adequate physical examination of Patients CJ, GJ and TR; c. By failing to document adequate justification for the prescription of controlled substances to Patients CJ, GJ and TR; and d. __By failing to appropriately monitor Patients CJ, GJ and TR for drug diversion or drug abuse. WHEREFORE, Petitioner respectfully requests 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 the Board deems appropriate. 18 Florida Department of Health v. Sanjay Trivedi, MD Case Number: 2012-06500 SIGNED this _24* __ day of ree 2012. John H. Armstrong, MD State Surgeon General and Secretary of Health #13 7A = ad Daniel a Chief Legal Counsel FILED DOH Prosecution Services Unit DEPARTMENT OF HEALTH 4052 Bald Cypress Way, Bin C-65 DEPUTY CLERK Tallahassee, FL 32399-3265 ae SB Florida Bar No.: 176834 (850) 245-4640 (850) 245-4681 FAX - PCP: Mem : Dr. Nuss & Ms. Goersch PCP: 77 Da 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 C 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. 19

Docket for Case No: 12-003216PL