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Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 [email protected] 112 th Annual FOMA Convention Weston, Florida Friday February 20, 2015

Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 [email protected] 112th Annual FOMA

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Page 1: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Florida Laws & Rules Osteopathic Medicine

Jason D. Winn, PA, Attorney at Law

850/222-7199 [email protected]

112th Annual FOMA Convention

Weston, Florida

Friday February 20, 2015

Page 2: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Disclosure Statement

I have no financial relationship in regard to the content of this presentation - JDW

Page 3: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

LICENSE RENEWAL Current licenses expire midnight, Eastern Time, March 31, 2016.

To ensure you receive your renewal notification from the department, your current mailing address must be on

file. Failure to renew an active or inactive license by the expiration date will result in the license being placed

in delinquent status. Failure by a delinquent licensee to renew before the expiration of the current licensure

cycle renders the license null and void without any further action by the board or the department.

A licensee who remains on inactive status for more than two consecutive biennial licensure cycles and who

wishes to reactivate the license may be required to demonstrate the competency to resume active practice by

sitting for a special purpose examination or by completing other reactivation requirements.

If you are reactivating your license, please refer to the Laws & Rules governing your practice for additional

requirements.

The department will renew your license upon receipt of:

• Completed renewal application

• Required fees

• Updated Practitioner Profile

• Completed Physician Workforce Survey

• Completed Financial Responsibility Form

• NOTE- Osteopathic Physicians licensed after July 1 of the second year of the biennium (odd year), are only required to

complete the HIV/AIDS, Florida Laws and Rules, Professional & Medical Ethics, Federal & State Laws Related to the

Prescribing of Controlled Substances and Prevention of Medical Errors courses

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Page 4: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

2014-2016 Requirements REQUIRED SUBJECT REQUIRED NUMBER IMPORTANT

AREA OF HOURS INFORMATION

General Hours* 20 20 must be AOA 1-A

General Hours* 15 These hours can be AOA or AMA

Medical Errors 2 Must be live

Professional &

Medical Ethics 1 Must be live

Florida Laws and Rules 1 Must be live

Federal & State Laws

Related to the Prescribing

of Controlled Substances 1 Must be live

TOTAL HOURS 40**

* Licensees must obtain 2 hours of domestic violence every third renewal period

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Page 5: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

FOMA AND PCOMS Reports to CE BROKER • THE FOMA AND PCOMS REPORTS THE HOURS YOU

RECEIVE HERE TODAY TO CE BROKER ON YOUR BEHALF! CE BROKER IS THE STATEWIDE CLEARING HOUSE FOR ALL CONTINUING EDUCATION HOURS

FOR HEALTH CARE PROFESSIONALS. FOMA AND THE PCOMS REPORTS FOR YOU!

Page 6: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Section I Laws and Rules for Osteopathic Physicians

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Page 7: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

OSTEOPATHIC PHYSICIANS PRACTICE ACT

Florida Statutes (F.S.):

• Chapter 459: Osteopathic Medicine

• Chapter 456: Health Professions and Occupations: General Provisions

• Chapter 120: Administrative Procedure Act

Florida Administrative Code (F.A.C.):

• Rules: Chapter 64B15: Board of Osteopathic Medicine, F.A.C.

• Rules: Chapter 64B: Division of Medical Quality Assurance, F.A.C.

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Page 8: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Florida Statute 456 GENERAL PROVISIONS

HEALTH PROFESSIONS AND OCCUPATIONS:

• 456.001 Definitions

• THROUGH

• 456.50 Repeated Medical Malpractice

• GENERAL HEALTH CARE PROVISION FOR ALL LICENSED HEALTH CARE PROVIDERS

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Page 9: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Florida Statute 459 Osteopathic Medicine

•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.

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Page 10: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Florida Rule 64B15 Osteopathic Medicine

• 64B15-6 PHYSICIAN ASSISTANT(19)

• 64B15-7 ANESTHESIOLOGIST ASSISTANTS (14)

• 64B15-9 PROCEDURE (6)

• 64B15-10 FEES (12)

• 64B15-12 EXAMINATIONS AND LICENSURE (10)

• 64B15-13 CONTINUING EDUCATION (6)

• 64B15-14 PRACTICE REQUIREMENTS (16)

• 64B15-15 MEDICAL RECORDS (5)

• 64B15-16 RESIDENT INTERNSHIP (2)

• 64B15-18 PRESCRIPTIONS OF CERTAIN MEDICINAL DRUGS BY PHARMACISTS (4)

• 64B15-19 DISCIPLINARY GUIDELINES (10)

• 64B15-20 FINANCIAL RESPONSIBILITY (3)

• 64B15-22 REGISTRATION OF HOSPITAL RESIDENTS AND INTERNS (4)

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Page 11: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Section II DEPARTMENT OF HEALTH (DOH) INVESTIGATIONS

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Page 12: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

I. DOH Investigation and Notice

How can an investigation begin?

1) Upon written complaint signed by complaining individual; 2) Anonymous Complaint; 3) Confidential Informant complaint; and 4) DOH.

Does the Department tell me if I am being investigated?

Notice of Investigation – letter of investigation.

Exceptions = Criminal charge or DOH believes notice will be detrimental to investigation

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Page 13: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

II. The Phone Call After the Letter A. You need to fully understand your rights.

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

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Page 14: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

II. The Phone Call After the Letter 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 45 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

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Page 15: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

III. Responding to Letter A. At this point, you SHOULD HAVE an

attorney – sound legal advice

B. DOH – MUST promptly furnish a copy of

complaint or document

C. Within 45 days – you MUST submit a written

response - it 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

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Page 16: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

IV. Your Right to Remain Silent

A. Constitutional right to remain silent 5th Amendment Due Process right to remain silent as applied to the Federal Government

14th Amendment Due Process right to remain silent as applied to the States

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

C. ALL communications - through your attorney

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Page 17: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Why should I invoke my right to remain silent?

• Physician receives letter of investigation into improper advertising because the physician failed to conspicuously identify the osteopathic physician by name in the advertisement or failed to conspicuously identify the osteopathic physician referred to in the advertising as a osteopathic physician.

• Physician decided not to remain silent but to write the DOH on his own behalf….result?

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Page 18: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Why should I invoke my right to remain silent?

RESPONSE?

• Physician writes letter to DOH on letterhead without correctly identifying himself as DO., only – Dr. John Doe

• Physician received initial letter for failing to identify Dr. as DO and in letter to DOH he again failed to identify himself on letterhead as DO. – so, Dr receives a second complaint!!!!!

• If letter written by Attorney – NO SECOND COMPLAINT

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Page 19: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

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

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Page 20: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

VII. When Investigation is Concluded:

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

*If a Minor Violation or Citation, then case does not go to PC panel – licensee receives notice of Minor Violation or Citation and must comply.

B. Presented to probable cause panel -determine whether probable cause exists and an administrative complaint issued; if no probable cause – case dismissed

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Page 21: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Citations Rule 64B15-19.007

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Section III

Page 22: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

I. Citations - 64B15-19.007 (1) As used in this rule, “citation” means an instrument which meets the requirements set forth in Section 456.077, F.S., and which is served upon a licensee or certificateholder for the purpose of assessing a penalty in an amount established by this rule.

(2) In lieu of the disciplinary procedures contained in Section 456.073, F.S., the Department is hereby authorized to dispose of any violation designated herein by issuing a citation to the subject for a complaint that is the basis for the citation.

(3) The following violations with accompanying fines may be disposed of by citation.

(a) Falsely certifying compliance with required continuing medical education hours for the purpose of renewing a license or certificate. The fine shall be $2,000.

(b) Failure to keep current mailing or practice address on file with the Board. The fine shall be $250.

(c) Failure to register as a dispensing practitioner. The fine shall be $500.

(d) Failure of the licensee to satisfy continuing education hours. The fine shall be $75 for each hour not completed or completed late. In addition, the licensee shall make up all hours not completed, and such hours shall not be counted toward the current renewal cycle.

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Page 23: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

I. Citations - (cont) (e) Failure to report to the Board within 30 days after the licensee has been convicted or found guilty of, or entered a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction. The fine shall be $800.

(f) Failure to conspicuously list the name of the osteopathic physician in an advertisement as required in paragraph 64B15-14.001(2)(k), F.A.C. The fine shall be $500.

(g) Advertising or holding oneself out as a board-certified specialist, if not qualified under Section 459.0152, F.S. The fine shall be $1,500.

(h) Failure to include the disclosure statement in an advertisement as required in Section 456.062, F.S. The fine shall be $750.

(i) Failure to timely provide medical records, upon request to a patient or a patient’s legal representative. The fine shall be $500.

(j) Charging copying fees for patient records in violation of Rule 64B15-15.003, F.A.C. The fine shall be $750.

(k) Failure to update physician profile as required in Sections 456.039(3) and 459.008, F.S. The fine shall be $50 per day not in compliance not to exceed $5,000.

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Page 24: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

I. Citations - (cont) (l) Failure to comply with Section 381.0261, F.S., by failing to inform patients of the address and telephone number of the agency responsible for responding to patient complaints or failure to make available a summary of rights to patients as required in Sections 459.015(1)(g) and 456.072(1)(k), F.S.; Section 381.0261(4)(b), F.S. The fine shall be $100 non-willful and $500 willful.

(m) Failure to report another licensee in violation; Sections 456.072(1)(i) and 459.015(1)(e), F.S. The fine shall be $500.

(n) Allowing a physician in training who has failed to register as required in Section 459.021, F.S., to practice medicine. The director of medical education in the training program shall be fined $500 for violating Section 456.072(1)(j), F.S.

(o) Failure to comply with the guidelines for the use of obesity drugs in instances which do not result in patient harm. The fine shall be $500.

(p) Failure to pay fine or costs imposed by Board Order within 30 days of the due date of the fine or costs. The fine shall be $1,000.

(q) Negligently failing to file a report or record required by state or federal law. The fine shall be $500.

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Page 25: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

I. Citations - (cont) (4) If the subject does not dispute the matter in the citation in writing within 30 days after the citation is served by personal service or within 30 days after receipt by certified mail, the citation shall become a final order of the Board of Osteopathic Medical Examiners. For violations of paragraphs (3)(a) through (c) and (3)(e) through (o) above, the subject has 30 days from the date the citation becomes a final order to pay the fine and costs. For violations of paragraph (3)(d) above, the subject has one year from the date the citation becomes a final order to pay the fine and costs and to submit certified documentation of completion of all CEU requirements for the period for which the citation was issued.

Failure to pay the fine and costs within the prescribed time period constitutes a violation of Section 459.015(1)(bb), F.S., which will result in further disciplinary action. All fines and costs are to be made payable to “Department of Health – Citation.”

(5) Once the citation becomes a final order, the citation and complaint become a public record pursuant to Chapter 119, F.S., unless otherwise exempt from the provisions of Chapter 119, F.S. The citation and complaint may be considered as aggravating circumstances in future disciplinary actions pursuant to Rule 64B15-19.003, F.A.C.

Rulemaking Authority 456.073, 456.077 FS. Law Implemented 456.073, 456.077 FS. History–New 10-28-91, Amended 8-24-92, 11-17-92, Formerly 21R-19.007, 61F9-19.007, 59W-19.007, Amended 11-27-97, 11-12-00, 1-29-03, 7-13-03, 5-12-05, 4-15-10, 10-8-12.

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Page 26: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

II. Accepting a Citation

If you accept, you do so without an opportunity for a hearing; However, a Minor Violation or Citation is better than a formal administrative complaint! Choice is yours – always seek the advice of legal counsel. Be aware – finding of the minor violation remains on the departments records as a violation; Because you are only eligible if FIRST TIME OFFENSE

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Page 27: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

III. Example Failure to conspicuously list the name of the osteopathic physician in an advertisement as required in paragraph 64B15-14.001(2)(k), F.A.C. The fine shall be $500. Failure to timely provide medical records, upon request to a patient or a patient’s legal representative. The fine shall be $500.

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Page 28: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

III. Example 459.008(4) – 40 hours of CME every biennium

Statute gives authority to Board to write rule: 64B15-19.007(3)(d) Failure of the licensee to satisfy continuing education hours. The fine shall be $75 for each hour not completed or completed late. In addition, the licensee shall make up all hours not completed, and such hours shall not be counted toward the current renewal cycle.(CONTINUED)

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Page 29: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

III. Example 40 hours every biennium Only completed 20 hours total. First time violation receive citation. Citation results: 20 hours x $75.00 = $1,500.00 20 hours to do TOTAL do 20 hrs & pay $1,500.00

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Page 30: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Section IV

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THE PROBABLE CAUSE PANEL 64B15-9.006 Probable Cause

Determination

Page 31: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

A. Your professional license is not officially placed in jeopardy until a determination of probable cause has been made by no fewer than two and no more than three members of the Board of Osteopathic Medicine, in lieu of current member of Board, chair may appoint former member to serve on PC Panel

B. Licensing Board function or department function

Board of Osteopathic Medicine makes it a Board Function

C. Florida Statute 456.073

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I. Probable Cause Panel

Page 32: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

A. Majority vote – two/three - member panel; if two members, and tie, Chair appoints 3rd member

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

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II. Consideration by PC Panel

Page 33: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

A. Electronically record all proceedings

B. Recorded by a certified court reporter

C. Transcripts may be obtained from the court reporter

D. Request copy of transcript of the probable cause panel proceeding

E. Transcript is also important – must meet test of being “meaningful” – Discussion of evidence by PC members

• Must be some evidence to reasonably indicate

• The Department must justify actions • Not just “rubber stamp” recommendation • Transcript - the best place to start

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III. Recordings of PC Panel

Page 34: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

IV. PC or NO PC 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.

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Page 35: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

THE ADMINISTRATIVE COMPLAINT AND YOUR ELECTION OF RIGHTS

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Section V

Page 36: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

States clearly that it is an administrative complaint, shouldn’t be ignored, is always served and includes an election of rights.

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I. Service

Page 37: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

A. Once received, you must file within 20 days

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

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II. Election of Rights

Page 38: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

A. Once received, you must file within 20 days

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

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II. Election of Rights

Page 39: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

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

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III. Formal Hearing

Page 40: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

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

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III. Formal Hearing

Page 41: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

A. DO NOT dispute the material factual allegations.

B. If you dispute then YOU MUST GO FORMAL.

C. Informal hearing – held before full board of Osteopathic Medicine

D. Mitigate

E. Go informal – take a calculated risk

F. NEVER – without conferring with a lawyer

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IV. Informal Hearing

Page 42: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Usually enclosed with administrative complaint. It is the Department’s offer to settle the case, upon acceptance by the Board of Osteopathic Medicine.

You may Negotiate and modify proposal

The Department must agree – or there is NO settlement agreement

Board has various options:

A. Accept the agreement

B. Reject the agreement

C. Counteroffer

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V. Stipulated Settlement

Page 43: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

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

D. CANNOT unilaterally bring proposal before regulatory board

E. Must be a joint settlement proposal

F. Certain advantages in seeking a stipulated settlement before filing an “election of rights form”

G. Immediate reaction from Department

H. Resolve matter – without sizeable legal bill

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VI. Stipulated Settlement

Page 44: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Prosecutions of Administrative Complaints

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Section VI

Page 45: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

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

B. Your license…is a property right

C. Due process of law

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I. Licensee Rights

Page 46: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Due process includes:

A. Proper and adequate notice

B. Adequate time

C. See agency’s investigative file

D. Discovery

E. Subpoena

F. Counsel

G. Examine and cross examine witnesses

You MUST understand what your due process rights are…

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II. Due Process Means?

Page 47: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Due process includes:

A. Proper and adequate notice

B. Adequate time

C. See agency’s investigative file

D. Discovery

E. Subpoena

F. Counsel

G. Examine and cross examine witnesses

You MUST understand what your due process rights are…

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II. Due Process Means?

Page 48: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

After completion of the case, and a finding of guilt by either the Board or ALJ, an Order is entered with penalties:

Penalties can include a reprimand, probation, practice restrictions, or revocation of licensure.

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III. Decision

Page 49: Florida Laws & Rules - Florida Osteopathic Medical ...Florida Laws & Rules Osteopathic Medicine Jason D. Winn, PA, Attorney at Law 850/222-7199 jwinn@jwinnlaw.com 112th Annual FOMA

Rule 64B18-14.002 which include:

(d)Advertising in a manner which is false, deceptive or misleading. The Board shall impose a penalty ranging from reprimand to probation and a fine of $10,000.

(f) Failing to report to the Department any person the licensee knows to be in violation of Chapter 461, F.S., or the rules of the Board or Department. The Board shall impose a penalty of a reprimand and a fine of $500 to $2,000.

(hh) Failure to report a criminal conviction or plea to the Board in writing within 30 days. The Board shall impose a penalty ranging from reprimand to probation and a $500 to $1,000 administrative fine.

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IV. Penalties

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JUDICIAL REVIEW AND STAYS OF FINAL ORDERS

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Section VII

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Upon Order, one party wins – one party looses. If you loose, you can file a Motion to Stay the Order while you Appeal! •You will be the unhappy party •Rarity – Department feels need to appeal

the decision! The burden of proof is on the agency to prove probable danger

Seek judicial review – District Court of Appeal. •Five District Court of Appeals •Each has jurisdiction to hear appeals from

licensing boards

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I. Administrative Proceedings

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CHANGES IN LAWS AND RULES & RECENT RULINGS BOARD OF OSTEOPATHIC MEDICINE

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Section VIII

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Determination To Transfer Hydrocodone Combination

Products (HCPs) to Schedule II

a. DEA rescheduled hydrocodone Based on

consideration of all comments, the scientific and

medical evaluation and accompanying

recommendation of the HHS, and based on the

DEA's consideration of its own eight-factor analysis,

the DEA finds that these facts and all other relevant

data constitute substantial evidence of potential for

abuse of HCPs. As such, the DEA has rescheduled

HCPs as a schedule II controlled substance under the

CSA.

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I. DEA Actions

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Placement of Tramadol Into Schedule IV

a. Based on consideration of all comments, the scientific and

medical evaluation and accompanying recommendation of the

HHS, and based on the DEA's consideration of its own eight-

factor analysis, the DEA finds that these facts and all other

relevant data constitute substantial evidence of potential for

abuse of tramadol. As such, the DEA is scheduling tramadol as

a controlled substance under the CSA.

b. Based on these findings, the Deputy Administrator of the

DEA concludes that tramadol, including its salts, isomers, and

salts of isomers, warrants control in schedule IV of the

CSA. 21 U.S.C. 812(b)(4).

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I. DEA Actions (cont.)

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Prescription Drug Monitoring Program

a. Any physician prescribing controlled substances level II-IV

should be registered through the PDMP. While not mandatory

at this time, if you prescribe a controlled substance II-IV and

not view the PDMP, you may be falling below the standard of

care.

456.44, F.S.

REGISTRATION.—Effective January 1, 2012, a physician licensed under chapter 458, chapter 459, chapter 461, or chapter 466 who prescribes any controlled substance listed in schedule II, schedule III, or schedule IV, as defined in s. 893.03, for the treatment of chronic nonmalignant pain, must:

(a) Designate himself or herself as a controlled substance prescribing practitioner on the physician’s practitioner profile.

(b) Comply with the requirements of this section and applicable board rules.

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II. Controlled Substances

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This subsection does not apply to a board-eligible or board-certified

anesthesiologist, physiatrist, rheumatologist, or neurologist, or to a board-

certified physician who has surgical privileges at a hospital or ambulatory

surgery center and primarily provides surgical services. This subsection does

not apply to a board-eligible or board-certified medical specialist who has

also completed a fellowship in pain medicine approved by the Accreditation

Council for Graduate Medical Education or the American Osteopathic

Association, or who is board eligible or board certified in pain medicine by

the American Board of Pain Medicine or a board approved by the American

Board of Medical Specialties or the American Osteopathic Association and

performs interventional pain procedures of the type routinely billed using

surgical codes. This subsection does not apply to a physician who prescribes

medically necessary controlled substances for a patient during an inpatient

stay in a hospital licensed under chapter 395.

History.—s. 3, ch. 2011-141; s. 31, ch. 2012-160.

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II. Controlled Substances Exempt

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Allegations of Complaint: 459.015(1)(x)- malpractice (2 counts); 459.015(1)(t)- inappropriate prescribing (2 counts); 459.015(1)(pp)- violating a law or rule of the board (2 counts); 459.015(1)(o)- medical Records violation (2 counts) Dr. was present and represented Action Taken: Board moved to accept the settlement agreement: Reprimand $15,000.00 fine to be paid within 2 years of the Final Order - Costs of $12,170.00 to be paid within 2 years Completion of the Prescribing Controlled Drugs: Critical Issues and Common Pitfalls of Prescribing course sponsored by the University of Florida in 12 months Completion of the Quality Medical Record Keeping for Health Care Professionals course sponsored by the FMA within 12 months Completion of 5 hours of Risk Management continuing education within 12 months Permanent Practice Restriction: may not own, operate, or work in a Pain Management Clinic

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III. Rulings by Board

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Allegations of Complaint: 459.0137(2)(a)1- practicing in an unregistered pain management clinic Dr. was not present or represented by counsel. Action Taken: Dr moved to accept the settlement agreement as presented: • Letter of Concern • $5000.00 Fine to be paid within 1 year of the Final Order • Costs of $1660.09 to be paid within 1 year of the Final Order • Completion of the Legal and Ethical Implications in Medicine: A Physician’s Survival Guide- Laws and Rules course within 1 year of the Final Order • Completion of the Prescribing Controlled Drugs: Critical Issues and Common Pitfalls of Prescribing course sponsored by the University of Florida in 12 months Dr. seconded the motion, which passed unanimously. Additional Action Taken: Dr. Burns moved to find that the FMA laws and rules course was deemed equivalent as the course mentioned in the settlement agreement. Member seconded the motion, which passed unanimously.

Prepared exclusively for the FOMA

III. Rulings by Board

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Allegations of Compliant: 459.015(10(g)- fail to perform a legal obligation; 459.015(1)(t)- inappropriate prescribing; 459.015(1)(x)- malpractice Action Taken: Dr. moved to reject the proposed settlement agreement. Dr. seconded the motion, which passed unanimously. Dr. then moved to offer the following counter settlement agreement: Reprimand $10,000.00 fine $10,292.55 in costs CME- must complete 4 hours in the prevention of medical errors and 10 hours in medical ethics Probation for 2 years to include: appearances at the first and last meeting once probation commences; indirect supervision, reports, etc. Practice restriction- shall not use any non-FDA drugs or devices Lecture or article- must do a one hour lecture pedigree papers and internet ordering- the lecture must be approved by the Chair prior to the presentation and a list of attendees must be submitted; or, draft an article on the same topic suitable for publication in a medical journal- article must also be approved by the Chair Prepared exclusively for the FOMA

III. Rulings by Board

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Allegations of Complaint: 459.015(1)(x)- malpractice; 459.015(1)(t)-

inappropriate prescribing; 459.015(1)(o)- medical records violation;

459.015(1)(pp)- violating a aw or rule of the board

Dr. was present and represented by counsel. Dr. was recused due to

participation on the probable cause panel. Mr. Lawrence represented the

Department and presented the case to the Board.

OUTCOME –

Reprimand

• $10,000.00 fine to be paid within 30 days of the Final Order

• Costs of $12,777.55 to be paid within 30 days of the Final Order

• Permanent Practice Restriction: may not own, operate, or work in a Pain

Management Clinic

• Permanent Practice Restriction: may not prescribe or dispense any

controlled substance

The motion passed unanimously.

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III. Rulings by Board

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(1) For the purpose of implementing the provisions of Section 459.015(1)(o), F.S., osteopathic physicians shall maintain written legible records on each patient. Such written records shall contain, at a minimum, the following information about the patient: (a) Patient histories; (b) Examination results; (c) Test results; (d) Records of drugs prescribed, dispensed or administered; (e) Reports of consultations; and (f) Reports of hospitalizations.

(2) Medical records in which compounded medications are administered to a patient in an office setting must contain, at a minimum, the following information: (a) The name and concentration of medication administered; (b) The lot number of the medication administered; (c) The expiration date of the medication administered; (d) The name of the compounding pharmacy or manufacturer; (e) The site of administration on the patient; (f) The amount of medication administered; and (g) The date medication administered. (3) Whenever patient records are released or transferred, the osteopathic physician releasing or transferring the records shall maintain either the original records or copies thereof and a notation shall be made in the retained records indicating to whom the records were released or transferred. However, whenever patient records are released or transferred directly to another Florida licensed physician, or licensed health care provider it is sufficient for the releasing or transferring osteopathic physician to maintain a listing of each patient whose records have been so released or transferred which listing also includes the physician or licensed health care provider to whom such records were released or transferred. Such listing shall be maintained for a period of five (5) years. (4) In order that the patients may have meaningful access to their records pursuant to Section 456.058, F.S., an osteopathic physician shall maintain the written record of a patient for a period of at least five (5) years from the date the patient was last examined or treated by the osteopathic physician. However, upon the death of the osteopathic physician, the provisions of Rule 64B15-15.001, F.A.C., are controlling. Rulemaking Authority 459.005 FS. Law Implemented 456.058, 459.015(1)(o) FS. History–New 11-30-94, Amended 10-25-95, Formerly 59W-15.004, Amended 12-22-97, 9-9-13.

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IV. Rule Changes64B15-15.004

Written Records;

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House bill 323 passed modifying Florida Statutes 456.42 and 893.04, F.S., and

requires the written prescriptions for specified controlled substances to be

legibly dated in a specified format.

456.42(2) A written prescription for a controlled substance listed in chapter

893 must have the quantity of the drug prescribed in both textual and

numerical formats, must be dated in numerical, month/day/year format, or

with the abbreviated month written out, or the month written out in whole on

the face of the prescription, and must be either written on a standardized

counterfeit-proof prescription pad produced by a vendor approved by the

department or electronically prescribed as that term is used in s. 408.0611. As a

condition of being an approved vendor, a prescription pad vendor must submit

a monthly report to the department that which, at a minimum, documents the

number of prescription pads sold and identifies the purchasers. The department

may, by rule, require the reporting of additional information.

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IV. New Law

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Searching the Web!!!

• www.myflorida.com

• www.floridahealth.gov

• www.floridasosteopathicmedicine.gov

• www.leg.state.fl.us/Statutes/index.cfm

• www.foma.org

• www.jwinnlaw.com

• www.osteopathic.org

• www.acofp.org