Florida Laws Rules Osteopathic Medicine

1. Florida Laws & RulesOsteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com August 1, 2010 Hyatt Regency Grand Cypress Resort, Orlando, FL Florida Society of the American College of Osteopathic Family Physicians

2. 2010 CME Requirements The Biennium if from April 1, 2010 thru March 31, 2012 Effective 4/1/2010 the continuing education (CE) requirements for licensure renewal in Florida has changed. The Board of Osteopathic Medicine has updated its CE requirements to maintain the current educational needs of physicians licensed in this state. These changes include: Change Risk Management to Professional & Medical Ethics Education Change name and content of the Laws Regarding the Use and Abuses of Controlled Substances to the Federal and State Laws Related to the Prescribing of Controlled Substances (defined below). Continuing Education Requirement for FIRST RENEWAL Number of Hours Required General Hours - AOA Category 1A 20 hours General Hours - AOA or AMA12 hours Domestic Violence - AOA or AMA 2 hours every third biennium Professional & Medical Ethics Education - AOA or AMA 1 hour HIV/AIDS - AOA or AMA1 hour Florida Laws & Rules - AOA or AMA1 hour Federal & State Laws Related to the Prescribing of Controlled Substances - AOA or AMA1 hour Prevention of Medical Errors-AOA or AMA2 Total Hours 40Ten continuing medical education credit hours shall be awarded for successful completion of each 6-month training program period.

3. 2010 Requirements (cont.) Continuing education with regard to Ethics, Florida Laws & Rules, Controlled Substances, and the Prevention of Medical Errors must be obtained by completion of live, participatory attendance course. Continuing Education Requirement for all subsequent RENEWAL Number of Hours Required General Hours - AOA Category 1A20 General Hours - AOA or AMA13 to 15 Domestic Violence - AOA or AMA2 every third biennium Professional & Medical Ethics Education - AOA or AMA1 Florida Laws & Rules - AOA or AMA1 Federal & State Laws Related to the Prescribing of Controlled Substances - AOA or AMA1 Prevention of Medical Errors-AOA or AMA2 Total Hours 40

4. 2010 Requirements (cont.) Florida laws and rules means Chapters 456 and 459, F.S., and Rule Chapter 64B15, F.A.C. The federal and state laws related to the prescribing of controlled substances shall include: a review of the applicable federal and state laws and rules; review of the current Florida statistics regarding morbidity and mortality of controlled substance related deaths; pharmacology of opiate drugs; proper prescribing of opiate drugs; and a review of physician liability for overprescribing controlled substances. The Prevention of Medical Errors course shall include a study of root cause analysis, error reduction and prevention, and patient safety. The course shall address medication errors, surgical errors, diagnostic inaccuracies, and system failures, and shall provide recommendations for creating safety systems in health care organizations. The course must include information relating to the five most mis-diagnosed conditions during the previous biennium, as determined by the Board. The following areas have been determined as the five most mis-diagnosed conditions: wrong-site/patient surgery; cancer; cardiac; timely diagnosis of surgical complications and failing to diagnose pre-existing conditions prior to prescribing contraindicated medications. All credit hours must be earned within the biennium for which they are claimed.

5. Fla. Statute 456 HEALTH PROFESSIONS AND OCCUPATIONS: GENERAL PROVISIONS 456.001� Definitions THROUGH 456.50 Repeated Medical Malpractice GENERAL HEALTH CARE PROVISION FOR ALL LICENSED HEALTH CARE PROVIDERS

6. Fla. Stat. 459 OSTEOPATHIC MEDICINE 459.001� Purpose. THROUGH 459.026 Reports of adverse incidents in office practice settings. STATUTE APPLIES TO ALL DO�s and Physician assistants & Anesthesiologist assistants.

7. Fla. Rule 64B15 64B15-6PHYSICIAN ASSISTANT(19) 64B15-7ANESTHESIOLOGIST ASSISTANTS (14) 64B15-9PROCEDURE (6) 64B15-10FEES (1)2 64B15-12EXAMINATIONS AND LICENSURE (9) 64B15-13CONTINUING EDUCATION (6) 64B15-14PRACTICE REQUIREMENTS (14) 64B15-15MEDICAL RECORDS (5) 64B15-16RESIDENT INTERNSHIP (2) 64B15-18PRESCRIPTIONS OF CERTAIN MEDICINAL DRUGS BY PHARMACISTS (4) 64B15-19DISCIPLINARY GUIDELINES (10) 64B15-20FINANCIAL RESPONSIBILITY (3) 64B15-22REGISTRATION OF HOSPITAL RESIDENTS AND INTERNS (4)

9. I. Four ways a DOH investigation on your license can begin Upon written complaint signed by complaining individual B. Upon an anonymous complaint C. Upon complaint by a confidential informant D. Upon the Departments own initiative

10. II. Notice of Investigation A complaint analyst is the first step in the review process There are two statutory exceptions to the notification requirement Sec. Dept. & Chairman of Bd. agree notice would be detrimental Criminal Offense

11. The Phone Call After the Letter A. You need to clearly and fully understand B. After you receive written notification about investigation, you will receive a phone call from a Department Investigator C. He/She will try to convince you he/she is your friend D. Try to convince you there is nothing to this matter � �Tallahassee� will close it out

12. E. At this point, you SHOULD HAVE an attorney � sound legal advice F. DOH � MUST promptly furnish a copy of complaint or document which resulted in investigation Within 20 days � you MUST submit written response - MUST be considered by probable cause panel for the Board of Osteopathic Medicine An attorney is able to extend the response timeframe through properly filed motions

13. IV. Your Right to Remain Silent Constitutional right to remain silent You DO NOT have to respond to any questions by DOH investigator If you start to talk � �may be� deemed to have waived your right to remain silent D. ALL communications - through your attorney

14. V. DOH RESOURCES Investigative Subpoena�s Supported by Affidavit Departments initiative or request by probable cause The validity may be challenged a. Was unlawfully issued It is unreasonably broad in scope Requires production of unreasonable materials Investigative Depositions Be aware � using deposition at subsequent formal hearing against you Department may take depositions � own initiative or request probable cause panel; They DO NOT have to notify you

15. When Investigation is Concluded: Entire investigative report with all exhibits is forwarded to Departments legal section in Tallahassee Presented to probable cause panel - to determine whether probable cause should be found and an administrative complaint issued

16. VIII. �Minor Violations� Passed by Florida Legislature in 1989 � could preclude matter from going to probable cause Board of Osteopathic Medicine calls these �Citations�

17. Part II CITATIONS 

18. I. Issuance � alternative to the submission of an investigative report to the probable cause panel. (s. 455.225 (3), FS, 1989) A. Know the list of Citations RULE 64B15-19.007 Not on list then it is NOT a minor violation A violation is a minor violation if it does not demonstrate a serious inability to practice the profession, result in economic or physical harm to a person, or adversely affect the public health, safety, or welfare or create a significant threat of such harm.

19. B. Due Process considerations: Without an opportunity for a hearing May not take corrective action � which licensee does not feel has occurred Choice is yours Be aware � finding of the minor violation remains on the departments records as a violation

20. C. Each licensing board shall establish by rule those minor violations under this provision that do not endanger the public health, safety and welfare and which do not demonstrate a serious inability to practice the profession D. May issue a �notice of noncompliance� to licensees for initial offense of one of the minor violations Get a call � request written notice MUST take action within 15 days Failure � issuance of formal complaint Finding � remains on department record as a violation

21. Part III THE PROBABLE CAUSE PANEL64B15-9.006 Probable Cause Determination

22. I. Your professional license is not officially placed in jeopardy until a determination of probable cause has been made Licensing Board function or department function Board of Osteopathic Medicine makes it a Board Function Florida Statute 456.073

23. II. Consideration of the investigative report by probable cause panel (s. 456.073(4) FS, 2008)  Majority vote � two/three - member panel Exempt from �Sunshine Law� You CANNOT be present Some boards do it without notice to licensee under investigation Notice is not given when it could be detrimental to the investigation Some boards do notice licensee � to appear before panel with counsel Panel may request the department to provide additional investigative information

24. Recording of the probable cause panel proceedings � �Public Records Law� (s. 286.011, FS) Electronically record all proceedings Recorded by a certified court reporter Transcripts may be obtained from the court reported EASIEST WAY TO DETERMINE IF PC PANEL WAS PROPER

25. Request copy of transcript of the probable cause panel proceeding E. Transcript is also important � must meet test of being �meaningful� Must be some evidence to reasonably indicate The Department must justify actions Not just �rubber stamp� recommendation Transcript - the best place to start

26. IV. Submission of a letter of concern or filing of formal charges Letter of concern Violation exists � formal charges not being filed Issued without an opportunity for hearing or to refute or dispute allegations Becomes public record Unclear � considered disciplinary actions Formal charges � The formal charges take the form of an administrative complaint.

27. Part IV THE ADMINISTRATIVE COMPLAINT AND YOUR ELECTION OF RIGHTS

28. Administrative Complaint States clearly that it is an administrative complaint Should never be ignored Always served Election of your rights

29. II. Election of Your Rights Timetable Filed within 20 days of service Failure to file � licensee in default Extension of time from department Three ways to proceed: Formal hearing Informal hearing Settlement agreement

30. III. The Formal Hearing Formal hearing before a hearing officer Division of Administrative Hearings Full evidentiary hearing � department must meet its burden of proving up the material Quite similar to a criminal or civil case Absolute fool - try and go this route WITHOUT legal assistance

31. IV. The Informal Hearing DO NOT dispute the material factual allegations. If you dispute then YOU ARE NOT GOING INFORMAL. Informal hearing � held before full board of Osteopathic Medicine Mitigate Go informal � take a calculated risk NEVER � without conferring with a lawyer

32. V. The Stipulated Settlement Avoid both formal and informal � �stipulated settlement agreement� Agreement between the licensee and the Department and Board Must fully and completely agree upon all terms CANNOT unilaterally bring proposal before regulatory board Must be a joint settlement proposal

33. D. Usually enclosed with administrative complaint Department�s offer of settlement Negotiate and modify proposal The Department must agree � or there is NO settlement agreement E. Board has various options: Accept the agreement Reject the agreement Counteroffer

34. F. Certain advantages in seeking a stipulated settlement before filing an �election of rights form� Immediate reaction from Department Resolve matter � without sizeable legal bill

36. Your constitutional rights... a brief review. 5th & 14th Amendments to the US Constitution Your license�is a property right Due process of law

37. Due process means such things as: Proper and adequate notice Adequate time See agency�s investigative file Discovery Subpoena Counsel Examine and cross examine witnesses Etc. E. You MUST understand what your due process rights are�

38. II. Burden of Proof in Professional License Disciplinary Cases 1987 � Supreme Court of FL clarified standard of proof required Rejected the so called �preponderance of the evidence� C. Considered penal in nature D. Standard of Proof is �Clear and convincing evidence� � highly probable E. Falls just short of � �beyond a reasonable doubt� F. Very stringent standard of proof

39. III. Orders A. Failure to respond to complaint: entry of a DEFAULT order; suspending or revoking license. Failure to file responsive pleading - institution of a default judgment Default is NOT an automatic procedure Must be based upon clear and convincing evidence Burden of proof placed upon the government

40. B. Discovery in formal hearings Public records demand � file and transcript Investigative file Failure of agency to provide timely witness Agency has duty to timely furnish names & addresses, upon request Eliminate surprise and facilitate determination of true relevant facts Florida case law � opportunity to depose those witnesses

41. C. Right to PROTECTIVE order from discovery deposition in license disciplinary prosecution Licensee has the protection of the �right to remain silent �� 5th Amendment Protect licensee from a notice of taking the licensee�s deposition issued by the prosecuting agency

42. IV. Imposition of Penalties The Board of Osteopathic Medicine adopted such a rule: Rule 64B15-19.002 Know the range of penalties

43. Part VI JUDICIAL REVIEW AND STAYS OF FINAL AGENCY ORDERS

44. I. Generally , one of the parties is unhappy with final action. You will be the unhappy party Rarity � Department feels need to appeal the decision A. Seek judicial review � District Court of Appeal. Five District Court of Appeals Each has jurisdiction to hear appeals from licensing boards

45. Agency orders proper for judicial review Material error in procedure or a failure to follow prescribed procedure Without proper notice or without affording you a hearing Due process of law If the agency has erroneously interpreted a provision of the law Findings are not supported by competent and substantial (clear and convincing) evidence

46. C. Stays Filing � does not itself stay enforcement of agency decision Seek a stay order - Not unusual to take over a year D. If agency suspends or revokes license � petition for a stay granted as a matter of right Reasonable conditions might include posting of bond Probable danger to the health, safety or welfare of the citizens might be evidence you are impaired The burden of proof is on the agency to prove probable danger

47. Recent Changes in the Law 456.072 (t) (t)��Failing to identify through written notice, which may include the wearing of a name tag, or orally to a patient the type of license under which the practitioner is practicing. Any advertisement for health care services naming the practitioner must identify the type of license the practitioner holds. This paragraph does not apply to a practitioner while the practitioner is providing services in a facility licensed under chapter 394, chapter 395, chapter 400, or chapter 429. Each board, or the department where there is no board, is authorized by rule to determine how its practitioners may comply with this disclosure requirement.

48. RECENT ACTIONS BY BOARD Allegations of Complaint: 459.015(1)(bb)- violate an order of the Board � unrepresented by counsel Maximum/Minimum penalties: FIRST OFFENSE: min: denial or reprimand and Fine of $5000; max: denial or suspension to be followed by probation and $5,000 fine SECOND OFFENSE: min: denial or suspension to be followed by probation and$7,500 fine; max: denial or revocation and$10,000 fine

49. 459.015(1)(bb)- First Offense Reprimand $5000.00 fine to be paid within 30 days of the Final Order Suspension for 2 years Probation for 4 years to include indirect supervision; 100% review of all charts where controlled substances were prescribed or 10% overall chart review, which ever is greater Restrictions during probation- cannot own, operate or practice in a pain management clinic and cannot prescribe schedule II controlled substances while on probation

50. Board Actions Continued Allegations of Complaint: 456.015(1)(bb)- wrong site surgery; represented by counsel Maximum/Minimum Penalties First Offense: Min: denial or probation and$5,000 fine. Max: denial or revocation and $10,000 fine Second Offense: Min: denial or suspension and$10,000 fine Max: denial or revocation and $10,000 fine

51. Searching the Web!!! www.myflorida.com www.doh.state.fl.us http://www.doh.state.fl.us/mqa/osteopath/os_boardinfo.html www.foma.org www.jwinnlaw.com