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									Florida Laws & Rules
Osteopathic 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
          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.
      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
       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.
         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
               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.
            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)
Section II
DEPARTMENT OF
HEALTH (DOH)
INVESTIGATIONS

   Part I
      INVESTIGATIONS
I. Four ways a DOH investigation
on your license can begin
A. 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
II. Notice of Investigation
A. A complaint analyst is the first step in the
   review process
B. There are two statutory exceptions to the
   notification requirement
   Sec. Dept. & Chairman of Bd. agree notice
    would be detrimental
   Criminal Offense
III. 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
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

G. 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
IV. Your Right to Remain Silent
A. Constitutional right to remain silent

B. You DO NOT have to respond to any
   questions by DOH investigator

C. If you start to talk – “may be” deemed
   to have waived your right to remain silent

D. ALL communications - through your
   attorney
        V. DOH RESOURCES
A. Investigative Subpoena’s
   1. Supported by Affidavit
   2. Departments initiative or request by probable cause
   3. The validity may be challenged
      a. Was unlawfully issued
      b. It is unreasonably broad in scope
      c. Requires production of unreasonable materials
B. Investigative Depositions
   1. Be aware – using deposition at subsequent formal hearing
      against you
   2. Department may take depositions – own initiative or
      request probable cause panel; They DO NOT have to
      notify you
VII. When Investigation is Concluded:

 A. Entire investigative report with all
    exhibits is forwarded to Departments
    legal section in Tallahassee

 B. Presented to probable cause panel - to
    determine whether probable cause should
    be found and an administrative complaint
    issued
VIII. “Minor Violations”
A. Passed by Florida Legislature in 1989 –
   could preclude matter from going to
   probable cause
B. Board of Osteopathic Medicine calls these

   “Citations”
Part II

CITATIONS
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

        1. Not on list then it is NOT a minor violation
        2. 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.
B. Due Process considerations:
  1. Without an opportunity for a hearing
  2. May not take corrective action – which
     licensee does not feel has occurred
  3. Choice is yours
  4. Be aware – finding of the minor
     violation remains on the departments
     records as a violation
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
     1.   Get a call – request written notice
     2.   MUST take action within 15 days
     3.   Failure – issuance of formal complaint
     4.   Finding – remains on department record as a
          violation
Part III

THE PROBABLE
CAUSE PANEL
64B15-9.006 Probable
Cause Determination
I. Your professional license is not
   officially placed in jeopardy until a
   determination of probable cause has
   been made

A. Licensing Board function or department
   function
   Board of Osteopathic Medicine makes it a
      Board Function

B. Florida Statute 456.073
II. Consideration of the investigative
report by probable cause panel
(s. 456.073(4) FS, 2008)

A. Majority vote – two/three - member panel
B. Exempt from “Sunshine Law”
  1.   You CANNOT be present
  2.   Some boards do it without notice to licensee under
       investigation
  3.   Notice is not given when it could be detrimental to
       the investigation
  4.   Some boards do notice licensee – to appear before
       panel with counsel
  5.   Panel may request the department to provide
       additional investigative information
III. Recording of the probable cause
     panel proceedings –
   “Public Records Law”
   (s. 286.011, FS)
A. Electronically record all proceedings

B.   Recorded by a certified court reporter

C. Transcripts may be obtained from
    the court reported
EASIEST WAY TO DETERMINE IF PC
   PANEL WAS PROPER
D. Request copy of transcript of the
   probable cause panel proceeding

E. Transcript is also important – must meet
   test of being “meaningful”
     1. Must be some evidence to reasonably
        indicate
     2. The Department must justify actions
     3. Not just “rubber stamp” recommendation
     4. Transcript - the best place to start
IV. Submission of a letter of
concern or filing of formal charges
 A. Letter of concern
   1.   Violation exists – formal charges not being filed
   2.   Issued without an opportunity for hearing or to
        refute or dispute allegations
   3.   Becomes public record
   4.   Unclear – considered disciplinary actions
 B. Formal charges – The formal
    charges take the form of an
    administrative complaint.
Part IV

THE ADMINISTRATIVE
COMPLAINT AND
YOUR ELECTION OF
RIGHTS
I. Administrative Complaint

A. States clearly that it is an
   administrative complaint
B. Should never be ignored
C. Always served
D. Election of your rights
II. Election of Your Rights Timetable

A.   Filed within 20 days of service
B.   Failure to file – licensee in default
C.   Extension of time from department
D.   Three ways to proceed:
     1. Formal hearing
     2. Informal hearing
     3. Settlement agreement
III. The Formal Hearing

A. Formal hearing before a hearing officer
   Division of Administrative Hearings

B. 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
IV. The Informal Hearing
A. DO NOT dispute the material factual
   allegations.
   If you dispute then YOU ARE NOT GOING
     INFORMAL.
B. Informal hearing – held before full board
   of Osteopathic Medicine
C. Mitigate
D. Go informal – take a calculated risk
E. NEVER – without conferring with a
   lawyer
V. The Stipulated Settlement
A.   Avoid both formal and informal –
     “stipulated settlement agreement”
B.   Agreement between the licensee and
     the Department and Board
C.   Must fully and completely agree upon
     all terms
        CANNOT unilaterally bring proposal before
         regulatory board
        Must be a joint settlement proposal
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
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
Part V

PROSECUTIONS OF
ADMINISTRATIVE
COMPLAINTS
I. Your constitutional rights...
   a brief review.

  A. 5th & 14th Amendments to the US
     Constitution

  B. Your license…is a property right

  C. Due process of law
D. 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…
 II. Burden of Proof in Professional
 License Disciplinary Cases
A.   1987 – Supreme Court of FL clarified standard of proof
     required
B. 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
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
B.    Discovery in formal hearings
     1.   Public records demand – file and transcript

     2.   Investigative file

     3.   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
C. Right to PROTECTIVE order from
   discovery deposition in license
   disciplinary prosecution
  1. Licensee has the protection of the “right to
     remain silent “– 5th Amendment
  2. Protect licensee from a notice of taking the
     licensee’s deposition issued by the
     prosecuting agency
IV. Imposition of Penalties
A. The Board of Osteopathic Medicine
   adopted such a rule: Rule 64B15-19.002

B. Know the range of penalties
Part VI
JUDICIAL REVIEW
AND STAYS OF FINAL
AGENCY ORDERS
Administrative Proceedings
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
B. Agency orders proper for judicial
   review
1.   Material error in procedure or a failure to
     follow prescribed procedure
        Without proper notice or without affording you a
         hearing
        Due process of law
2. If the agency has erroneously interpreted a
   provision of the law
3. Findings are not supported by competent and
   substantial (clear and convincing) evidence
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
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.
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
  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
     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
       Searching the Web!!!
• www.myflorida.com
• www.doh.state.fl.us
• http://www.doh.state.fl.us/mqa/osteopath/o
  s_boardinfo.html
• www.foma.org
• www.jwinnlaw.com

								
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