STATE OF FLORIDA BOARD OF MEDICINE

Transcription

1 STATE OF FLORIDA BOARD OF MEDICINE Final Order No. DOH MQA - FILED DATE DEC DEPARTMENT OF HEALTH, Petitioner, vs. DOH CASE NO.: LICENSE NO.: ME FRED JOE POWELL, M.D., Respondent. FINAL ORDER THIS CAUSE came before the BOARD OF MEDICINE (Board) pursuant to Sections and (4), Florida Statutes, on December 1, 2017, in Orlando, Florida, for the purpose of considering a Settlement Agreement (attached hereto as Exhibit A) entered into between the parties in this cause. Upon consideration of the Settlement Agreement, the documents submitted in support thereof, the arguments of the parties, and being otherwise fully advised in the premises, IT IS HEREBY ORDERED AND ADJUDGED that the Settlement Agreement as submitted be and is hereby approved and adopted in toto and incorporated herein by reference with the following clarification: The costs set forth in Paragraph 3 of the Stipulated Disposition shall be set at $75,

2 Accordingly, the parties shall adhere to and abide by all the terms and conditions of the Settlement Agreement as clarified above. This Final Order shall take effect upon being filed with the Clerk of the Department of Health. DONE AND ORDERED this day of BOARD OF MEDICINE Claudia Kemp, e.1W J.D., xecutive Director For Magdalena Averhoff, M.D., Chair CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing Final Order has been provided by U.S. Mail to FRED JOE POWELL, M.D., 35 Townsend Place, St. Augustine, Florida 32092; and 4861 Louisa Terrace, Jacksonville, Florida 32205; to Jonathan Rose, Esquire, 337 North Ferncreek Avenue, Orlando, Florida 32803; by to Allison Dudley, Assistant General Counsel, Department of Health, at Allison.Dudley@flhealth.gov; and by to Edward A. Tellechea, Chief Assistant Attorney

3 General, at this \5 day of rtieotpcklqy/--, Deputy Agency Clerk

4 STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, Petitioner, v. DOAH Case Nos.: PL PL FRED 1 POWELL, M.D., DOH Case Nos.: Respondent. SETTLEMENT AGREEMENT FRED J. POWELL, M.D., referred to as the "Respondent," and the Department of Health, referred to as "Department,"-stipulate and agree to the following Agreement and to the entry of a Final Order of the Board of Medicine, referred to as "Board,", incorporating the Stipulated Facts and Stipulated Disposition in this matter. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapter 456, Florida Statutes,- and Chapter 458, Florida Statutes. STIPULATED FACTS At all -times material hereto, Respondent was a licensed physician in the State of Florida having been issued license number ME The Department Charged Respondent with an Administrative Complaint 'that was filed and properly served upon Respondent alleging violations of Chapter 458,

5 Florida Statutes, and the rules adopted pursuant thereto. A true and correct copy of ' the Administrative Complaint is attached hereto as Exhibit A. 3. For purposes of these proceedings, Respondent neither admits nor denies the allegations of fact contained in the Administrative Complaint. STIPULATED CONCLUSIONS OF LAW 1. Respondent admits that, in his/her capacity as a licensed physician, he/she is subject to the provisions of Chapters 456 and 458, Florida Statutes, and the jurisdiction of the Department and the Board. 2. Respondent- admits that the facts alleged in the Administrative Complaint, if proven, would constitute violations of Chapter 458, Florida Statutes. 3. Respondent agrees that the Stipulated Disposition in this case is fair, appropriate and accept4ble to Respondent. STIPULATED DISPOSITION 1. Reprimand - The Board shall issue a Reprimand against Respondent's license. 2. Fine - The Board shall impose an administrative fine of Thirty Thousand Dollars and no Cents ($30,000,00) against Respondent's license which Respondent shall pay to: Payments, Department of Health, Compliance Management Unit, Bin C-76, P.O. Box 6320, Tallahassee, FL , within ninety (90) days from the date of filing of the Final Order accepting this Agreement ("Final Order"). All fines shall be paid by cashier's check or money order. Any change in the terms of payment of DOH v. Fred J. Powell, M.D., Case Number ,

6 any fine imposed by the Board must be approved in advance by the Probation Committee of the Board. RESPONDENT ACKNOWLEDGES THAT THE TIMELY PAYMENT OF THE FINE IS HIS/HER LEGAL OBLIGATION AND RESPONSIBILITY AND RESPONDENT AGREES TO CEASE PRACTICING IF THE FINE IS NOT PAID AS AGREED IN THIS SETTLEMENT AGREEMENT. SPECIFICALLY, IF RESPONDENT HAS NOT RECEIVED WRITTEN CONFIRMATION WITHIN 105 DAYS OF THE DATE OF FILING OF THE FINAL ORDER THAT THE FULL AMOUNT OF THE FINE HAS BEEN RECEIVED BY THE BOARD OFFICE, RESPONDENT AGREES TO CEASE PRACTICE UNTIL RESPONDENT RECEIVES SUCH WRITTEN CONFIRMATION FROM THE BOARD. 3. Reimbursement of Costs - Pursuant to Section , Florida Statutes, Respondent agrees to pay the Department for the Department's costs incurred, in the investigation and prosecution of this case ("Department costs"). Such costs exclude thd costs of obtaining supervision or monitoring of the practice, the cost of quality assurance reviews, any other costs Respondent incurs to comply with the 'Final Order,, and the Board's administrative costs directly associated with Respondent's. probation, if any. Respondent agrees'that the amount of Department costs to be paid in this case is Sixty-seven Thousand Eight-Five Dollars and Two Cents 067, but shall not exceed Seventy-Five Thousand Dollars and No Cents ($75,000.00). -Respondent will pay such Department costs to: Payments, Department of Health, Compliance Management Unit, Bin C-76, P.O. Box 6320, DOH v. Fred J. Powell, M.D., Case Number ,

7 Tallahassee, FL , within ninety (90) days from the date of filing of the Final Order. All costs shall be paid by cashier's check or money order. Any change in the terms of payment Of costs imposed by the Board must be approved in advance by the Probation Committee of the Board. RESPONDENT ACKNOWLEDGES THAT THE TIMELY PAYMENT OF THE COSTS, IS HIS/HER LEGAL OBLIGATION AND RESPONSIBILITY AND RESPONDENT AGREES TO CEASE PRACTICING IF THE COSTS ARE NOT PAID AS AGREED IN THIS SETTLEMENT AGREEMENT. SPECIFICALLY, IF RESPONDENT HAS NOT RECEIVED WRITTEN CONFIRMATION WITHIN 105 DAYS OF THE DATE OF FILING OF THE FINAL ORDER THAT THE FULL AMOUNT OF THE COSTS NOTED ABOVE HAS BEEN RECEIVED BY THE BOARD OFFICE, RESPONDENT AGREES TO CEASE PRACTICE UNTIL RESPONDENT RECEIVES SUCH WRITTEN CONFIRMATION FROM THE BOARD. 3. Quality Assurance Consultation/Risk Management Assessment - Within sixty (60) days of the date of filing of the Final Order, Respondent shall engage an independent, certified licensed risk manager who will review Respondent's current practice. Specifically, the independent consultant shall review the office procedures employed at Respondent's practice and prepare a report addressing Respondent's, practice which shall include recommended quality assurance improvements of Respondent's practice ("quality assurance report"). Within six (6) months from the filing of the Final Order, Respondent will submit the quality assurance report to the Board's Probation Committee as well as documentation that demonstrates Respondent's DOH v. Fred J. Powell, M.D., Case Number ,

8 compliance with the recommended improvements. Such documentation shall consist of a. follow-up 'report completed by the independent consultant or a licensed risk manager that verifies Respondent's compliance. Respondent shall bear the cost of the Initial consultation and any necessary or appropriate follow-up consultation. 4. Permanent Restriction on Prescribing/Ordering Schedule I through V Controlled Substances- Respondent is permanently restricted from prescribing, ordering, and/or delegating the prescribing or ordering of, any substances listed in Schedules I-V, as defined in Section , Florida Statutes (2016), and may 'from time-to-time be redefined in Florida Statutes and/or the Florida Administrative Code. STANDARD PROVISIONS 1. Appearance - Respondent is required to appear before the Board at the meeting of the Board where this Agreement is considered. 2. No Force or Effect until Final Order - It is expressly understood, that this Agreement is subject to the approval of the Board and the Department. In this regard, the foregoing paragraphs (and only the foregoing paragraphs) shall have no force and effect unless the Board enters a Final Order incorporating the terms of this - Agreement. 3. Continuing Medical Education Unless otherwise provided in this Agreement Respondent shall first submit a written request to the Probation Committee for approval prior to poiformance of said CME course(s). Respondent shall submit DOH v. Fred J. Powell, M.D., Case Number ,

9 documentation to the Board's Probation Committee of having completed a CME course in the form of certified, copies of the receipts, vouchers, certificates, or other papers, such as physician's recognition awards, documenting completion of this medical course within one (1) year of the filing of the Final Order in this matter. All such documentation shall be sent to the Board's Probation Committee, regardless of whether some or any of such documentation was provided previously during the course of any audit or discussion with counsel for the Department. CME hours required by this Agreement shall be in addition to those hours required for renewal of licensure. Unless otherwise approved by,the Board's Probation Committee, such CME course(s) shall consist of a formal, live lecture format. 4. Addresses - Respondent must provide current residence and practice addresses to the Board. Respondent shall notify the Board in writing within ten (10) days of any changes of said addresses 5.. Future Conduct - In the future, Respondent shall not violate Chapter 456, 458 or 893, Florida Statutes, or the rules promulgated pursuant thereto, or- any other state or federal law, rule, or regulation relating to the practice or the ability to practice medicine to include, but not-limited to, all statutory requirements related to practitioner profile and licensure renewal updates. Prior to signing this agreement, the Respondent shall read Chapters 456, 458 and 893 and the Rules of the Board of Medicine, at Chapter 64B8, Florida Administrative-Code. 6. Violation of Terms - It is expressly understood that a violation of the terms of this Agreement shall be considered a violation of a Final Order of the Board, DOH v. Fred 3. Powell, M.D., Case Number , 2'

10 for which disciplinary action may be initiated pursuant to Chapters 456 and 458, Florida Statutes. 7. Purpose of Agreement - Respondent, for the purpose of avoiding further administrative action with respect to this cause, executes this Agreement. In this regard, Respondent authorizes the Board to review and examine all investigative - file materials concerning Respondent prior to or in conjunction with consideration of the Agreement. Respondent agrees to support this Agreement at the time it is presented to the Board and shall offer no evidence, testimony or argument that disputes or contravenes any stipulated fact or conclusion of law. Furthermore, should this Agreement not be accepted by the Board, it is agreed that presentation to and consideration of this Agreement and other documents and matters by the Board shall not unfairly or illegally prejudice the Board or any of its members from further participation, consideration or resolution of these proceedings. 8. ' No Preclusion Of Additional Proceedings - Respondent and the Department fully understand that this Agreement and subsequent Final Order will In no way preclude additional proceedings by the Board and/or the Department against Respondent for acts or omissions not specifically set forth in the Administrative Complaint attached-as Exhibit A. 9. Waiver Of Attorney's Fees And Costs - Upon the Board's adoption of this Agreement, the parties hereby agree that with the exception of Department costs -noted above, the parties will bear their own attorney's fees and costs resulting from prosecution or defense of this matter. Respondent waives the right to seek any DOH v. Fred J. Powell, M.D., Case Number ,

11 attorney's fees or costs from the Department and the Board 'in connection with this matter. 10. Waiver of Further Procedural Steps - Upon the Board's adoption of this Agreement, Respondent expressly-waives all further procedural steps and expressly waives all rights to seek judicial review of or to otherwise challenge or contest the validity of the Agreement and the Final Order of the Board incorporating said - Agreement. [Signatures appear on the following page.] DOH v. Fred J. Powell, M.D., Case Number ,

12 SIGNED this 3 day of %, 20I FRED J. PO L, M.D. STATE OF FLORIDA 7) COUNTY OF p tot BEFORE ME perknally appeared F& eoovcdtt, whose -identity is known to me or who produced FL A-chttx-L_ (type of identification) and who, under oath, acknowledges that his/her signature appears above SWORN TO and subscribed before me this 3 day of Ok) JOAN H. VENABLE lei,e le MY COMMISSION # FF : :-Itte EXPIRES: Ma 22, :4 P' Bonded Th Notary Public Underwriters My Commission Expires: NO to RY PUBLIC APPROVED this' day of 601)e k", Celeste Philip, MD, MPH Surgeon General and Secretary By: Michael E. Morris Assistant General Counsel Department of Health DOH v. Fred 3. Powell, M.D., Case Number ,

13 DEPARTMENT OF HEALTH, STATE OF FLORIDA DEPARTMENT OF HEALTH PETITIONER, CLERK: FILED DEPARTMENT OF HEALTH DEPUTY CLERK DATE anew AUG v. CASE NO FRED 3. POWELL, M.D., RESPONDENT. AMENDED ADMINISTRATIVE COMPLAINT Petitioner, Department of Health, by and through its undersigned counsel, files this Administrative Complaint before the Board of Medicine against Respondent, Fred J. Powell, M.D., and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. 2. At all times material to this Complaint, Respondent was a licensed physician within the state of Florida, having been issued license number ME Respondent's address of record is 4861 Louisa Terrace, Jacksonville, Florida

14 4. At all times material to this Complaint, Respondent was board certified in Obstetrics and Gynecology. 5. At all times material this Complaint, Respondent was not board certified in pain management. 6. Patient V.F. was a resident of Kentucky. 7. Between June 3, 2009, and March 8, 2010, Respondent prescribed the following controlled substances to Patient V.F.: a. Oxycodone (opioid) is commonly prescribed to treat pain. According to Section (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. b. Xanax, which contains alprazolam, is a Schedule IV controlled substance under Chapter 893, Florida Statutes. A substance in Schedule IV has a low potential for abuse, and a currently accepted medical use in treatment. Abuse of this substance may lead to limited physical or psychological dependence. 2

15 8. The Board of Medicine has addressed the use of controlled substances, including opioids, for pain relief when it set out the Standards for the Use of Controlled Substances for the Treatment of Pain in Chapter Florida Administrative Code. 9. Chapter 64B , F.A.C., reads in part: (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 should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance. (b) Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and 3

16 psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. (c) Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician should employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to: 1. Urine/serum medication levels screening when requested; 4

17 2. Number and frequency of all prescription refills; and 3. Reasons for which drug therapy may be discontinued (i.e., violation of agreement). (d) Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the physician's evaluation of the patient's progress. If treatment goals are not being achieved, despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance in medication usage and related treatment plans. (e) Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. 5

18 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 medical history and physical examination, including history of drug abuse or dependence, as appropriate; 2. Diagnostic, therapeutic, and laboratory results; 3. Evaluations and consultations; 4. Treatment objectives; 5. Discussion of risks and benefits; 6. Treatments; 7. Medications (including date, type, dosage, and quantity prescribed); 8. Instructions and agreements; and 9. Periodic reviews. Records must remain current and be maintained in an accessible manner and readily available for 6

19 review. Records must remain current and be maintained in an accessible manner and readily available for review. 10. On or about June 3, 2009, Patient presented to Respondent for an initial visit with complaints of lumbar pain and left knee pain. 11. On or about July 1, 2009, Patient V.F. presented to Respondent with cervical, thoracic and lumbar pain. Patient V.F. did not report complaints of anxiety. Respondent reported that he used all of his medication two weeks prior to the visit. 12. On or about July 1, 2009, Respondent prescribed Roxycodone 15 mg, 90 tablets and Xanax 2 mg, 10 tablets to Patient V.F. 13. On or about July 29, 2009, Patient V.F. presented to Respondent with cervical, thoracic and lumbar pain. Patient V.F. did not report complaints of anxiety. Respondent reported that he used all of his medication prior to the visit 14. On or about July 29, 2009, Respondent prescribed Oxycodone 15 mg, 120 tablets and Xanax 2 mg, 15 tablets to Patient V.F. 15. On or about August 26, 2009, Patient V.F. presented to Respondent with cervical, thoracic, lumbar and knee pain. Patient V.F. did 7

20 not report complaints of anxiety. Respondent reported that he used all of his medication prior to the visit. 16. On or about August 26, 2009, Respondent prescribed Oxycodone 30 mg, 90 tablets, Oxycodone 15 mg, 30 tablets and Xanax 2 mg, 15 tablets to Patient V.F. 17. On or about September 23, 2009, Patient V.F. presented to Respondent with cervical, thoracic, lumbar and knee pain. Patient V.F. did not report complaints of anxiety. 18. On or about September 23, 2009, Respondent prescribed Oxycodone 30 mg, 100 tablets, Oxycodone 15 mg, 60 tablets and Xanax 2 mg, 15 tablets to Patient V.F. 19. On or about October 21, 2009, Patient V.F. presented to Respondent with cervical, thoracic, lumbar and knee pain. Patient V.F. did not report complaints of anxiety. 20. On or about October 21, 2009, Respondent prescribed Oxycodone 30 mg, 100 tablets, Oxycodone 15 mg, 60 tablets and Xanax 2 mg, 15 tablets to Patient V.F. 8

21 21. On or about November 18, 2009, Patient V.F. presented to Respondent with cervical, thoracic and lumbar pain. Patient V.F. did not report complaints of anxiety. 22. On or about November 18, 2009, Respondent recorded urine drug screen which returned positive for opiates. However, there is no record that the urine drug screen was performed. 23. On or about November 18, 2009, Respondent prescribed Oxycodone 30 mg, 120 tablets, Oxycodone 15 mg, 60 tablets and Xanax 2 mg, 15 tablets to Patient V.F. 24. On or about December 16, 2009, Patient V.F. presented to Respondent with lumbar pain with radiculopathy. Patient V.F. did not report complaints of anxiety. 25. On or about December 16, 2009, Respondent prescribed Oxycodone 30 mg, 140 tablets, Oxycodone 15 mg, 60 tablets and Xanax 2 mg, 15 tablets to Patient V.F. 26. On or about January 13, 2010, Patient V.F. presented to Respondent with lumbar pain with radiculopathy. Respondent reported that he used all of the prescribed medication prior to the visit. 9

22 27. On or about January 13, 2010, Respondent prescribed Oxycodone 30 mg, 150 tablets, Oxycodone 15 mg, 60 tablets and Xanax 2 mg, 25 tablets to Patient V.F. 28. On or about February 10, 2010, Patient V.F. presented to Respondent with lumbar pain with radiculopathy. Patient reported that his symptoms were worse. 29. On or about February 10, 2010, Respondent prescribed Oxycodone 30 mg, 150 tablets, Oxycodone 15 mg, 90 tablets and Xanax 2 mg, 25 tablets to Patient V.F. 30. On or about March 8, 2010, Patient V.F. presented to Respondent with complaints of lumbar pain with radiculopathy. Patient V.F. did not report complaints of anxiety. Respondent documented that he would refer Patient V.F. to an orthopedist. However, there is no documentation in the record that Respondent made the referral. 31. On or about March 8, 2010, Respondent prescribed Oxycodone 30 mg, 150 tablets, Oxycodone 15 mg, 90 tablets and Xanax 2 mg, 25 tablets to Patient V.F. 32. Respondent failed to document efficacy of the controlled substances or Patient V.F.'s compliance with the controlled substances. 10

23 33. Respondent failed to maintain sufficient medical records to justify prescribing the controlled substances as set forth herein. 34. Respondent failed to maintain sufficient records to justify prescription of large doses and quantities of controlled substances as set forth herein. 35. Respondent failed to order diagnostic tests, refer Patient V.F. for alternative conservative treatment or refer Patient V.F. for evaluation by other healthcare specialists. COUNT ONE 36. Petitioner incorporates and realleges paragraph one (1) through thirty-five (35), as if fully set forth herein. 37. Section (1)(t), Florida Statutes ( ), provides that committing medical malpractice constitutes grounds for disciplinary action by the Board of Medicine. Medical Malpractice is defined in Section , Florida Statutes ( ), 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. 38. For purposes of Section (1)(t), Florida Statutes ( ), The level of care, skill, and treatment recognized in general law 11

24 related to health care licensure means the standard of care specified in Section , Florida Statutes ( ), which 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...." 39. Respondent failed to meet the prevailing standard of care by inappropriately and/or excessively prescribing controlled substances, Oxycodone and Xanax, to Patient V.F., without justification as alleged herein. 40. Respondent violated Section (1)(t), Florida Statutes ( ), by failing to practice medicine with the level of care of a reasonably prudent similar physidan as being acceptable under similar conditions and circumstances in the treatment of patient V.F. by inappropriately and/or excessively prescribing controlled substances, Oxycodone 15 mg, Oxycodone 30 mg or Xanax to Patient V.F., without justification as alleged herein. 12

25 COUNT TWO 41. Petitioner incorporates and realleges paragraphs one (1) through thirty-five (35), as if set forth herein. 42. Section (1)(q), Florida Statutes ( ), 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 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 intent. 43. Respondent prescribed, dispensed, or otherwise prepared a legend drug, other than in the course of his professional practice, by inappropriately and excessively prescribing the controlled substances Oxycodone 15 mg, Oxycodone 30 mg, and Xanax to Patient V.F. without justification as alleged herein. 13

26 44. Based on the forgoing, Respondent violated Section (1)(q), Florida Statutes ( ) when he prescribed, any controlled substance, other than in the course of his professional practice by inappropriately and excessively prescribing the controlled substances Oxycodone 15 mg, Oxycodone 30 mg, and Xanax to Patient V.F. without justification as set forth herein. COUNT THREE 45. Petitioner incorporates and realleges paragraphs one (1) through thirty-five (35), as if fully set forth herein. 46. Section (1)(m), Florida Statutes ( ), subjects a licensee to discipline for failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations. 14

27 47. Respondent failed to maintain medical records that justified the course of treatment for Patient V.F. by failing to record justification for prescribing controlled substances, Oxycodone 15 mg, Oxycodone 30 mg, and Xanax, for Patient V.F. as alleged herein. 48. On or about the dates set forth above, Respondent violated Section (1)(m), Florida Statutes ( ), by failing to keep medical records that justified the course of treatment for Patient V.F. 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 Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. [Signatures on Next Page] 15

28 SIGNED this S day of Atluct, Celeste Philip, MD, MPH Surgeon General & Secretary MEM/sw PCP: June 23, 2011 PCP Members: Leon, Orr & Goersch Michael E. Morris, Esq. Assistant General Counsel DOH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL Florida Bar # (850) , Ext (850) FAX 16

29 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section and , 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 (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 (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 (5), Florida Administrative Code. Mediation under Section , 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 (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. 17

30 STATE OF FLORIDA DEPARTMENT OF HEALTH FILED Department Of Health Deputy Clerk CLERK,:4.affe/ DATE AUG DEPARTMENT OF HEALTH, PETITIONER, v. CASE NO FRED J. POWELL, M.D., RESPONDENT. AMENDED ADMINISTRATIVE COMPLAINT Petitioner, Department of Health, by and through its undersigned counsel, files this Administrative Complaint before the Board of Medicine against Respondent, Fred J. Powell, M.D., and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter ' 456, Florida Statutes; and Chapter 458, Florida Statutes. 2. At all times material to this Complaint, Respondent was a licensed physician within the state of Florida, having been issued license number ME DOH v. Fred J. PowII, M.D.,

31 3. Respondent's address of record is 35 Townsend Place, St. Augustine, Florida At all times material to this Complaint, Respondent was board certified in Obstetrics and Gynecology. 5. At all times material to this complaint, Respondent was not board certified in pain management. 6. At all times material to this complaint, Respondent prescribed one or more controlled substance to Patients AH, CS, BG, ARH, BH, BS, AB, and BC. 7. The Board of Medicine has addressed the use of controlled substances, including opioids, for pain relief when it set out the Standards for the Use of Controlled Substances for the Treatment of Pain in Chapter 64B , Florida Administrative Code. 8. Chapter 64B , F.A.C., reads in part: (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 should document the 3:\PSU\Medical\Morris, Mike \Powell, Fred \Amended AC-Fred Powell doc 2

32 nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance. (b) Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. (c) Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of \PSU\Medical\Morris, Mike\Powell, Fred J \Amended AC-Fred Powell doc 3

33 controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician should employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to: 1. Urine/serum medication levels screening when requested; 2. Number and frequency of all prescription refills; and 3. Reasons for which drug therapy may be discontinued (i.e., violation of agreement). (d) Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the physician's evaluation of the patient's 3: \PSU \Medical\Morris, Mike\Powell, Fred \Amended AC-Fred Powell doc 4

34 progress. If treatment goals are not being achieved, despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance in medication usage and related treatment plans. (e) Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder 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: 3: \PSU\Medical\Morris, Mike \Powell, Fred J \Amended AC-Fred Powell doc 5

35 1. The medical history and physical examination, including history of drug abuse or dependence, as appropriate; 2. Diagnostic, therapeutic, and laboratory results; 3. Evaluations and consultations; 4. Treatment objectives; 5. Discussion of risks and benefits; 6. Treatments; 7. Medications (including date, type, dosage, and quantity prescribed); 8. Instructions and agreements; and 9. Periodic reviews. Records must remain current and be maintained in an accessible manner and readily available for review. Records must remain current and be maintained in an accessible manner and readily available for review. DEFINITIONS OF CONTROLLED SUBSTANCES 9. Oycodone is commonly prescribed to treat pain. According to Section (2), Florida Statutes, oxycodone is a Schedule II controlled J: \PSU\Medical \Morris, Mike\Powell, Fred \Amended AC-Fred Powell doc 6

36 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. 10. Percocet contains oxycodone hydrochloride, a semi-synthetic narcotic analgesic, which is a Schedule II controlled substance under Chapter 893, Florida Statutes. Percocet is indicated for relief of moderate to moderately severe pain. It has a high potential for abuse and has a currently accepted, but limited, medical use in treatment in the United States, and abuse of the substance may lead to severe physical and psychological dependence. 11. Xanax, which contains alprazolam, is a Schedule IV controlled substance under Chapter 893, Florida Statutes. A substance in Schedule IV has a low potential for abuse, and a currently accepted medical use in treatment. Abuse of this substance may lead to limited physical or psychological dependence. 12. Valium, which contains diazepam, is a schedule IV controlled substance under Chapter 893, Florida Statutes. A substance in schedule IV has a low potential for abuse, and a currently accepted medical use in ):\PSU\Medical\Morris, Mike\Powell, Fred \Amended AC-Fred Powell doc 7

37 treatment. Abuse of this substance may lead to limited physical or psychological dependence. FACTS PERTAINING TO PATIENT AH 13. Between April 22, 2009, and January 4, 2010, Respondent treated Patient AH, a 40 year old male, for pain management. 14. Patient AH presented to Respondent with a medical history of cervical, thoracic, and lumbar back pain for 10 years. Patient AH also had a history of a motor vehicle accident in The Patient provided an MRI of the lumbar and cervical spine dated February 10, 2009, reflecting a small disc herniation at level L4-5 and L5-S1 and a disc herniation at C5- C Between April 22, 2009, and January 4, 2010, Patient AH presented to Respondent with complaints of cervical, thoracic, and lumbar pain. During the time of treatment, Patient AH reported no improvement. 16. Respondent prescribed controlled substances to Patient AH as set forth in the table below: Date Name of drug Quantity Type of Drug 4/23/09 Lortab 10/500 mg 120 Opioid 4/23/09 Xanax 2 mg 15 Benzodiazepine 3: \PSL1 \Medical \Morris, Mike\Powell, Fred J \Amended AC-Fred Powell doc 8

38 5/21/09 5/21/09 Lorcet 10/325 mg Xanax 2 mg 150 Opioid 15 Benzodiazepine 6/18/09 Percocet 10/325 mg 150 Opioid 6/18/09 Xanax 2 mg 15 Benzodiazepine 7/13/09 Lortab 10/500 mg 150 Opioid 7/13/09 Xanax 2 mg 15 Benzodiazepine 9/2/09 Lortab 10/500 mg 100 Opioid 9/2/09 Oxycodone 15 mg 30 Opioid 9/2/09 Xanax 2 mg. 20 Benzodiazepine 9/30/09 Oxycodone 15 mg 120 Opioid 9/30/09 Xanax 2 mg 20 Benzodiazepine 10/28/09 Oxycodone 30 mg 90 Opioid 10/28/09 Xanax 2 mg 20 Benzodiazepine 11/25/09 Oxycodone 30 mg 100 Opioid 11/25/09 Xanax 2 mg 20 Benzodiazepine 12/15/09 Oxycodone 30 mg 90 Opioid 12/15/09 Xanax 2 mg 20 Benzodiazepine 1/4/09 Oxycodone 30 mg 120 Opioid 3: \PSU\Medical\Morris, Mike\Powell, Fred \Amended AC-Fred Powell doc 9

39 17. There is no record other than Respondent's notation in the record that urine drug screens were performed for Patient AH. 18. Respondent failed to document efficacy of the controlled substances or Patient AH's compliance with the controlled substances. 19. Respondent failed to maintain sufficient medical records to justify prescribing the controlled substances as set forth herein. Respondent failed to document the name and date of the Range of Motion and Orthopedic tests. 20. Respondent failed to maintain sufficient records to justify prescription of large doses and quantities of controlled substances as set forth herein. 21. Respondent failed to order diagnostic tests, refer Patient All for alternative conservative treatment or refer Patient AH for evaluation by other healthcare specialists. FACTS PERTAINING TO PATIENT CS 22. Between March 17, 2009, and December 23, 2009, Respondent treated Patient CS, a 47 year old male, for pain management. At all times material to this Complaint, Patient CS was a Kentucky resident. 3: \PSU\Medical\Morris, Mike\Powell, Fred \Amended AC-Fred Powell doc 10

40 23. Between March 17, 2009, and December 23, 2009, Patient CS presented to Respondent with complaints of cervical, thoracic, and lumbar pain. During the time of treatment, Patient CS reported no improvement. 24. He reported a history of neck and back pain for 8 years following an accident involving a "4 wheeler." 25. Between March 17, 2009, and December 23, 2009, Respondent prescribed controlled substances to Patient CS as set forth in the table below: Date Name of drug Quantity Type of drug 3/17/09 Percocet 10/325 mg 120 Opioid 3/17/09 Roxicodone 30 mg 180 Opioid 3/17/09 Xanax 2 mg 60 Benzodiazepine 4/14/09 Percocet 10/325 mg 120 Opioid 4/14/09 Roxicodone 30 mg 150 Opioid 4/14/09 Xanax 2 mg 60 Benzodiazepine 5/12/09 Percocet 10/325 mg 60 Opioid 5/12/09 Roxicodone 30 mg 180 Opioid 5/12/09 Xanax 2 mg 60 Benzodiazepine JAPSU\Medical\Morris, Mike\Powell, Fred \Amended AC-Fred Powell doc 11

41 6/9/09 Oxycodone 30 mg 180 Opioid 6/9/09 Oxycodone 15 mg 60 Opioid 6/9/09 Xanax 2 mg 60 Benzodiazepine 7/7/09 Oxycodone 30 mg 180 Opioid 7/7/09 Percocet 10/325 mg 90 Opioid 17/7/09 8/4/09 8/4/09 8/4/09 Xanax 2 mg 60 Percocet 10/325 mg 90 Oxycodone 15 mg 360 Valium 10 mg 30 Benzodiazepine Opioid Opoid Benzodiazepine 9/3/09 Percocet 10/325 mg 90 Opioid 9/3/09 Oxycodone 30 mg 180 Opioid 9/3/09 Xanax 2 mg 30 Benzodiazepine 10/1/09 10/1/09 Oxycodone 30 mg 180 Xanax 2 mg 30 Opioid Benzodiazepine 10/1/09 Percocet 10/325 mg 90 Opoid 10/29/09 Oxycodone 30 mg 180 Opioid 10/29/09 10/29/09 Xanax 2 mg 30 Percocet 10/325 mg 90 Benzodiazepine Opoid ):\PSU\Medical\Morris, Mike\Powell, Fred \Amended AC-Fred Powell doc 12

42 11/25/09 Oxycodone 30 mg 180 Opioid 11/25/09 Xanax 2 mg 30 Benzodiazepine 11/25/09 Percocet 10/325 mg 90 Opoid 12/23/09 Oxycodone 30 mg 180 Opioid (NO COPIES) 12/23/09 Xanax 2 mg (NO COPIES) 30 Benzodiazepine 12/23/09 Percocet 10/325 mg 90 Opoid (NO COPIES) 26. There is no record other than Respondent's notation in the record that urine drug screens were performed for Patient CS. 27. Respondent failed to document efficacy of the controlled substances or Patient CS's compliance with the controlled substances. 28. Respondent failed to maintain sufficient medical records to justify prescribing the controlled substances as set forth herein. Respondent failed to document the name and date of the patient on the Orthopedic and Range of Motion tests. 3: \PSU\MedicalWorris, Mike\Powell, Fred \Amended AC-Fred Powell doc 13

43 29. Respondent failed to maintain sufficient records to justify prescription of large doses and quantities of controlled substances as set forth herein. 30. Respondent failed to order diagnostic tests, refer Patient CS for alternative conservative treatment or refer Patient CS for evaluation by other healthcare specialists. FACTS PERTAINING TO PATIENT BG 31. Between March 17, 2009, and December 22, 2009, Respondent treated Patient BG, a 47 year old male, for pain management. Patient BG was a resident of Tennessee. 32. On March 17, 2009, Patient BG presented to Respondent with a history of back pain, prior work related injury to the low back, prior neck injury, and left knee replacement. 33. Between March 17, 2009, and December 22, 2009, Patient BG presented to Respondent with complaints of cervical, thoracic, and lumbar pain. During the time of treatment, Patient BG reported no improvement. 34. Respondent prescribed controlled substances to Patient BG as indicated in the following table: 3: \PSU\Medical \Morris, Mike \Powell, Fred \Amended AC-Fred Powell doc 14

44 Date Name of Drug Quantity Type of Drug 3/17/09 Roxicodone 15 mg (signed 120 Opioid by another doctor) 3/17/09 Roxicodone 30 mg (signed 120 Opoid by another doctor) 3/17/09 Xanax 2 mg (signed by 30 Benzodiazepine another doctor) 4/15/09 Roxicodone 30 mg 120 Opioid _ 4/15/09 Roxicodone 30 mg 30 Opioid 4/15/09 Xanax 2 mg 30 Benzodiazepine 5/13/09 Roxicodone 30 mg 120 Opioid 5/13/09 Roxicodone 15 mg 60 Opioid 5/13/09 Xanax 2 mg 30 Benzodiazepine 6/11/09 Oxycodone 15 mg 60 Opioid 6/11/09 Oxycodone 30 mg 150 Opioid 6/11/09 Xanax 2 mg 30 Benzodiazepine 7/9/09 Oxycodone 15 mg 60 Opioid 7/9/09 Oxycodone 30 mg 150 Opioid 3: \PSU\Medical\Morris, Mike\Powell, Fred \Amended AC-Fred Powell doc 15

45 7/9/09 Xanax 2 mg ' 30 Benzodiazepine 8/6/09 Oxycodone 30 mg 30 Opioid 8/6/09 8/6/09 Oxycodone 30 mg 150 Opioid Xanax 2 mg 30 Benzodiazepine 9/3/09 Oxycodone 15 mg 60 Opioid 9/3/09 Oxycodone 30 mg 150 Opioid 9/3/09 Xanax 2 mg 30 Benzodiazepine 10/1/09 Oxycodone 15 mg (NO 70 Opioid COPIES) 10/1/09 Oxycodone 30 mg (NO 150 Opioid COPIES) 10/1/09 Xanax 2 mg (NO COPIES) 30 Benzodiazepine 10/29/09 Oxycodone 30 mg (NO 35 Opioid COPIES). 10/29/09 Oxycodone 30 mg (NO 150 Opioid COPIES) 10/29/09 Xanax 2 mg (NO COPIES) 30 Benzodiazepine JAPSLAMedical\Morris, Mike\Powell, Fred \Amended AC-Fred Powell doc 16

46 11/24/09 Oxycodone 15 mg (NO 60 Opioid COPIES) 11/24/09 Oxycodone 30 mg (NO 150 Opioid COPIES) 11/24/09 Xanax 2 mg (NO COPIES) 30 Benzodiazepine 12/22/09 Oxycodone 15 mg (NO 60 Opioid COPIES) 12/22/09 Oxycodone 30 mg (NO 150 Opioid COPIES) 12/22/09 Xanax 2 mg (NO COPIES) 30 Benzodiazepine 35. Respondent failed to document efficacy of the controlled substances or Patient BG's compliance with the controlled substances. 36. Respondent failed to maintain sufficient medical records to justify prescribing the controlled substances as set forth herein. 37. Respondent failed to maintain sufficient records to justify prescription of large doses and quantities of controlled substances as set forth herein. 3: \PSU\Medical \Morris, Mike\Powell, Fred \Amended AC-Fred Powell doc 17

47 38. Respondent failed, to order diagnostic tests, refer Patient GB for alternative conservative treatment or refer Patient BG for evaluation by other healthcare specialists. FACTS PERTAINING TO PATIENT ARH 39. Between March 25, 2009, and July 30, 2009, Respondent treated Patient ARH, a 37 year old female, for pain management. Although the records reflect that ARH resides in Tarpon Springs, Florida, her driver's license reflects that she was resident of Kentucky. 40. On or about March 25, 2009, Patient ARH presented to Respondent with a history of back pain dating back to She had a history of two prior motor vehicle accidents. She also reported that she was disabled. 41. Patient ARH provided an MRI of the lumbar spine dated March 25, 2008, reflecting multilevel degenerative changes. Patient ARH provided a prior MRI of the cervical spine dated April 21, 2008, reflecting a bulging disks and degenerative changes at C4-5 and C5-6 as well as a posterior disk herniation at C6-7. Respondent did not order any recent MRI of the cervical or lumbar spine. 3: \PSU \Medical \Morns, Mike\Powell, Fred \Amended AC-Fred Powell doc 18

48 42. Between March 25, 2009, and July 30, 2009, Patient ARH presented to Respondent with complaints of cervical, thoracic, and lumbar pain. During the time of treatment, Patient ARH reported no improvement. 43. Respondent prescribed controlled substances to Patient ARH as indicated in the following table: Date Name of Drug Quantity Type of Drug 3/25/09 Roxicodone 30 mg 30 Opioid 3/25/09 Roxicodone 30 mg 150 Opioid 3/25/09 Xanax 2 mg 60 Benzodiazepine 4/22/09 Roxicodone 30 mg 100 Opioid 4/22/09 Roxicodone 30 mg 150 Opioid 4/22/09 Xanax 2 mg 60 Benzodiazepine 4/22/09 Percocet 10/325 mg 120 Opioid 5/20/09 Oxycodone 30 mg 150 Opioid 5/20/09 Oxycodone 15 mg 60 Opioid 5/20/09 Oxycodone 30 mg 30 Opioid 5/20/09 Xanax 2 mg 60 Benzodiazepine 7/2/09 Oxycodone 15 mg 60 Opioid 3: \PSU\Medical\Morns, Mike\Powell, Fred \Amended AC-Fred Powell doc 19

49 7/2/09 Oxycodone 30 mg 150. Opioid 7/2/09 Xanax 2 mg 60 Benzodiazepine 7/30/09 7/30/09 7/30/09 Oxycodone 15 mg 60 Opioid Oxycodone 30 mg 150 Opioid Xanax 2 mg 60 Benzodiazepine 44. On March 25, 2009, and July 2, 2009, Respondent noted that patient "ran out of medication on 1/22/09." However, Respondent did not document any discussion with the patient concerning the cause for running out of the medication early. 45. Respondent failed to document consideration to use of long acting opiates versus short acting opiates. 46. Respondent's documentation of ARH's physical examinations were not sufficient. Respondent failed to include the name and date on the Range of Motion and orthopedic tests. 47. Respondent failed to document efficacy of the controlled substances or Patient ARH's compliance with the controlled substances. 48. Respondent failed to maintain sufficient medical records to justify prescribing the controlled substances as set forth herein. \PSUWedicalWorris, Mike \Powell, Fred ) \Amended AC-Fred Powell doc 20