The proposed new rule 64B15-19.0041 is intended to set forth standard terms utilized by the board in its disciplinary orders and orders requiring probation. The proposed amendment to Rule 64B15-19.005 is intended to provide clarification with ...

 

DEPARTMENT OF HEALTH

Board of Osteopathic Medicine

RULE NOS.:RULE TITLES:

64B15-19.0041Standard Terms Applicable to Orders

64B15-19.005Probationary Conditions and Definitions

PURPOSE AND EFFECT: The proposed new Rule 64B15-19.0041, F.A.C., is intended to set forth standard terms utilized by the board in its disciplinary orders and orders requiring probation. The proposed amendment to Rule 64B15-19.005, F.A.C., is intended to provide clarification with regard to supervising/monitoring physicians.

SUMMARY: The proposed new Rule 64B15-19.0041, F.A.C., is sets forth standard terms utilized by the board in its disciplinary orders and orders requiring probation. The proposed amendment to Rule 64B15-19.005, F.A.C., provides clarification with regard to supervising/monitoring physicians.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of these rules at its Board meeting, the Board determined that these rules will not have any adverse impact on licensees and their businesses or the businesses that employ them. The rules will not increase any business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rules will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 459.005 459.015(5) FS.

LAW IMPLEMENTED: 459.015(2) (5) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Christy Robinson, Executive Director, Board of Osteopathic Medicine/MQA, 4052 Bald Cypress Way, Bin #C06, Tallahassee, Florida 32399-3256

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B15-19.0041 Standard Terms Applicable to Orders.

Unless otherwise approved by the Board or its designee, or addressed by the Final Order, the following are the terms applicable to all Final Orders rendered by the Board in disciplinary proceedings.

(1) PAYMENT OF FINES AND COSTS. All fines and costs shall be paid by check or money order made payable to the Board and sent to DOH/Compliance Management Unit, Bin #C76, P. O. Box 6320, Tallahassee, Florida 32314-6320, within 30 days of the filing of the Order.

(2) ADDRESSES. Respondent must keep current residence and practice addresses on file with the Board. Respondent shall notify the Compliance Office, in writing, within 10 days of any changes of those addresses. Furthermore, if the Respondent’s license is on probation, the Respondent shall notify the Compliance Office within 10 days in the event that Respondent leaves the active practice of medicine in Florida.

(3) COMPLIANCE ADDRESS. All reports, correspondence and inquiries shall be sent to: DOH, Compliance Management Unit, Bin #C76, 4052 Bald Cypress Way, Tallahassee, Florida 32399-3251, Attn: Osteopathic Medicine Compliance Officer.

(4) CONTINUING EDUCATION. Continuing education imposed by Board Order shall be in addition to those hours required for biennial renewal of licensure. The Board confers authority on the Chair to approve or disapprove said continuing education courses. The Respondent is required to submit a course syllabus for all continuing education courses that the Respondent needs to have the Chair approve. The courses shall consist of a formal live lecture format. The time frame for completing such continuing education follows:

(a) Florida Medical Association sponsored medical records course or Board approved equivalent is to be completed within twelve (12) months from the date the Order is filed;

(b) University of Florida sponsored prescribing course or Board-approved equivalent is to be completed within twelve (12) months from the date the Order is filed; and

(c) Continuing medical education is to be completed within twelve (12) months from the date the order is filed.

(5) LECTURES. In the event the Respondent is required by Board Order to present an original one (1) hour lecture on a specific topic, one component of the lecture must address the specific events arising from the Respondent’s disciplinary matter.  The Respondent shall present the lecture to the medical staff of a hospital or ambulatory surgical center at which the Respondent maintains staff privileges or to an osteopathic medical society meeting.

(a) Respondent is required to submit a written plan to the Board for approval prior to the performance of said lecture. The written plan shall include an outline of the content to be presented, a list of references, and proposed venue, date, and time. The Board confers authority to the Chair to approve proposed lecture.

(b) Lectures imposed by Order of the Board shall be completed within six (6) months from the date the Order is filed. Within seven (7) months of the Order, documentation from the physician shall set forth the date, time, place, topic, and duration of the lecture, and be submitted to the Compliance Officer. In addition, the Respondent shall submit to the Compliance Officer a letter from the facility’s certified licensed risk manager or Director of Medical Education or if presented to an osteopathic medical society a letter signed by the society’s executive director or president which indicates the date, time, location, and length of the lecture and the number of physicians (osteopathic and allopathic) in attendance.

(6) WRITTEN ARTICLES. In the event the Respondent is required by Board Order to write an article addressing the subject based upon the specific events arising from the Respondent’s disciplinary matter, Respondent is required to submit the article to the Board for approval within six (6) months from the date the Order is filed.  The article shall be a minimum of ten (10) pages and shall contain a title page, abstract, introduction, review of results, discussion, conclusion, acknowledgements, and references. The article must review at least five (5) articles on the required subject published in medical peer-reviewed journals within the past three (3) years. The Respondent shall describe how the information reviewed will be used in his or her practice.  The Board confers authority to the Chair for approval of the article.

(7) PRN REQUIRED. Should the Board determine that a contract by the Professionals Resource Network (PRN) is appropriate, Respondent shall participate and comply with the PRN contract.

(a) Respondent shall enter into an after care contract with PRN, shall comply with all its terms, and shall be responsible for assuring that the medical director of PRN send the Board a copy of said contract.

(b) Respondent shall execute a release that authorizes PRN to release information and medical records (including psychiatric records and records relating to treatment for drug dependence and alcoholism) to the Board of Osteopathic Medicine as needed to monitor the progress of Respondent in the PRN program.

(c) Respondent shall authorize the director of PRN to report to the Board of Osteopathic Medicine any problems that may occur with Respondent and any violations of Chapter 456 or 459, F.S. Such a report shall be made within 30 days of the occurrence of any problems, or violations of Chapter 456 or 459, F.S.

(8) RESTRICTIONS ON TREATING FEMALE PATIENTS.  Should the Board determine there should be a restriction on treating female patients, Respondent shall not examine or treat female patients without a female chaperone who is a health care practitioner licensed by the Florida Department of Health present in the room in any examination or treatment setting.  The Respondent is required to maintain a log of each such patient contact, and the name of the chaperone present.  The log shall be immediately available to a Department of Health inspector, monitor, and Board Compliance Officer upon request.

(9) CONTINUITY OF PRACTICE.

(a) TOLLING PROVISIONS. In the event the Respondent leaves the State of Florida for a period of 30 days or more or otherwise does not or may not engage in the active practice of osteopathic medicine in the State of Florida, then certain provisions of the requirements in the Board’s Order shall be tolled and shall remain in a tolled status until Respondent returns to the active practice of osteopathic medicine in the State of Florida. Respondent shall notify the Compliance Officer 10 days prior to his or her return to practice in the State of Florida. The following requirements shall be tolled until the Respondent returns to active practice:

1. The time period of probation shall be tolled.

2. The provisions regarding supervision whether direct or indirect by the monitor/supervisor, and required reports from the monitor/supervisor shall be tolled.

3. The requirement for quality assurance review of Respondent’s practice shall be tolled.

4. Any requirements regarding lectures.

(b) ACTIVE PRACTICE. In the event that Respondent leaves the active practice of osteopathic medicine for a period of one year or more, the Respondent may be required to appear before the Board and demonstrate the ability to practice osteopathic medicine with reasonable skill and safety to patients prior to resuming the practice of osteopathic medicine in the State of Florida.

(10) PROBATION TERMS. If probation was imposed by Board Order, the following provisions are applicable:

(a) DEFINITIONS.

1. INDIRECT SUPERVISION is supervision by a monitoring physician (monitor), as set forth in the Board’s Order. Indirect supervision does not require that the monitor practice on the same premises as the Respondent. However, the monitor shall practice within a reasonable geographic proximity to Respondent, which shall be within 20 miles and shall be readily available for consultation. The monitor shall be board-certified in the Respondent’s specialty area.

2. DIRECT SUPERVISION is supervision by a supervising physician (supervisor), as set forth in the Order. Direct supervision requires that the supervisor and Respondent work in the same office. The supervisor shall be board-certified in the Respondent’s specialty area.

(b) REQUIRED SUPERVISION.

1. If the terms of the Order include indirect monitoring of the licensee’s practice (monitoring) or direct monitoring of the licensee’s practice (supervision), the Respondent shall not practice osteopathic medicine without an approved monitor/supervisor, as specified by the Final Order.

2. The monitor/supervisor must be licensed under Chapter 459, F.S., or Chapter 458, F.S., in good standing, in active status, without restriction or limitation on his or her license, must be qualified by training and experience, and must not have any conflicts of interest that would prohibit him or her from impartially performing his or her duties as a monitor. Specific grounds for rejecting a proposed monitor/ supervisor by the Board or its designee shall include but are not limited to the following:

a. The proposed monitor/supervisor has previously been subject to disciplinary action against his/her medical license in this or any other jurisdiction;

b. The proposed monitor/supervisor is currently under investigation, or is the subject of a pending disciplinary action;

c. The proposed monitor/supervisor is not actively engaged in the same or similar specialty area;

d. The proposed monitor/supervisor is not practicing within a distance of no more than 20 miles from the Respondent’s practice location;

e. The proposed monitor/supervisor is a relative or employee of the Respondent.

(c) TEMPORARY APPROVAL. The Board confers authority on the Chair to temporarily approve Respondent’s monitor/supervisor. To obtain this temporary approval, Respondent shall submit to the Compliance Officer the name and curriculum vitae of the proposed monitor/supervisor, and letter from the proposed monitor/supervisor stating that he or she is willing to serve as a monitor/supervisor, that he or she has received a copy of the Administrative Complaint and Final Order, that he or she is aware of his or her duties and responsibilities as a monitor/supervisor, that he or she discloses any conflicts of interests, and specifies distance to the Respondent’s practice location, and that he or she agrees to appear before the Board for formal approval at the next meeting of the Board. This information shall be furnished to the Chair by way of the Compliance Officer. Should Respondent’s monitoring/supervising physician be temporarily approved, said approval shall only remain in effect until the next meeting of the Board. Absent said approval, Respondent shall not practice osteopathic medicine until a monitoring/supervising physician is approved.

(d) FORMAL APPROVAL. Respondent shall have the monitor/supervisor with him or her at the first probation appearance before the Board.  Prior to consideration of the monitor/supervisor by the Board, the Respondent shall provide the monitor/supervisor a copy of the Administrative Complaint and the Board’s Order in this case.  Respondent shall submit a current curriculum vitae, a description of current practice, and a letter agreeing to serve from the proposed monitor/supervisor to the Compliance Officer no later than 21 days before the Respondent’s first scheduled probation appearance. Respondent’s monitor/ supervisor shall also appear before the Board at such times as directed by the Board. It shall be the Respondent’s responsibility to ensure the appearance of his or her monitor/supervisor as directed. Failure of the monitor/supervisor to appear as directed shall constitute a violation of the terms of the Board’s Order and shall render the Respondent subject to additional disciplinary action.

(e) CHANGE IN MONITOR/SUPERVISOR. In the event that Respondent’s monitor/supervisor is unable or unwilling to fulfill his/her responsibilities as a monitor/supervisor as described above, the Respondent shall advise the Compliance Office of this fact within 24 hours of becoming aware of the situation. Respondent shall submit to the Compliance Office the name of a temporary monitor/supervisor for consideration. Respondent shall not practice pending approval of this temporary monitor/ supervisor by the Chair.  Furthermore, Respondent shall make arrangements with his or her temporary monitor/supervisor to appear before the Board at its next regularly scheduled meeting for consideration of the monitor/supervisor.  Respondent shall only practice under the supervision of the temporary monitor/supervisor (approved by the Chair) until the next regularly scheduled meeting of the Board whereat the issue of the Respondent’s new monitor/supervisor shall be addressed.

(f) APPEARANCES.  The Respondent shall appear before the Board at the first Board meeting after probation commences, at the last meeting of the Board preceding scheduled termination of probation, and at such other times as requested by the Board or Board Chair.

(g) REPORTS. If directed by Board Order, probation reports, in affidavit form, shall be submitted by the Respondent and shall contain the following:

1. Brief statement of why physician is on probation.

2. Practice location.

3. Describe current practice (type and composition).

4. Brief statement of compliance with probationary terms.

5. Describe relationship with monitoring/supervising physician.

6. Advise Compliance Officer of any problems including office incident reports filed; loss or restriction of hospital staff privileges; loss or restriction of DEA registration; or any Medicare/Medicaid program exclusions, restrictions or limitations.

(h) MONITOR/SUPERVISOR REPORTS. If directed by Board Order, monitor/supervisor reports, in affidavit form, shall include the following:

1. Brief statement of why physician is on probation.

2. Description of probationer’s practice.

3. Brief statement of probationer’s compliance with terms of probation.

4. Brief description of probationer’s relationship with monitoring physician.

5. Detail any problems which may have arisen with probationer.

(i) MONITOR/SUPERVISOR MEDICAL RECORDS REVIEW. Should the Board determine that the Respondent’s medical records need to be reviewed, the Board shall set forth the percentage of the records and type of records to be reviewed by the monitoring/supervising physician. The patient records shall be selected by the supervising physician on a random basis at least once every month.

(j) INVESTIGATIVE REPORTS. Respondent understands that during the period of probation, at a minimum, semi-annual investigative reports will be compiled with the Department of Health concerning compliance with the terms and conditions of probation and the rules and statutes regulating the practice of medicine.

(11) COSTS OF COMPLIANCE. Respondent shall pay all costs necessary to comply with the terms of the Board’s Order. Such costs include, but are not limited to, the costs of preparation of the investigative reports detailing compliance with the terms of the Order, the cost of analysis of any blood or urine specimens submitted pursuant to the Order, and administrative costs directly associated with Respondent’s probation. See Section 459.015(2), F.S.

(12) SUPERVISION OF PHYSICIAN ASSISTANTS AND/OR ANESTHESIOLOGIST ASSISTANTS. Respondent is required to notify, in writing, any physician assistant and/or anesthesiologist assistant which the Probationer supervises, of his or her probationary status. A copy of said written notification(s) shall be submitted to the Board’s Compliance Officer within 10 days of entry of the Board’s Order. Supervision of physician assistants and/or anesthesia assistants is prohibited when a physician is on probation.

(13) SUSPENSION. In the event that a Respondent’s license expires during the period that the license is suspended, this action shall not relieve the Respondent of the responsibility to renew the license at the end of each licensure period. If the Respondent fails to renew the license at the end of any licensure period, all normal conditions and consequences imposed by statute or rule of the Board for failure to timely and properly renew a license shall apply. Renewal of a suspended license during the period of suspension shall not affect the suspension of the license and the suspension shall continue until all requirements for reinstatement have been met.

(14) RETURN OF LICENSE. Any Order which suspends a license, revokes a license, or accepts a Respondent’s offer to voluntarily relinquish his or her license shall require the Respondent to return the license to the Department within 30 days from the date the Final Order is filed. This shall not apply to instances where the Board or a court has granted the Respondent a stay of the suspension.

Rulemaking Authority 459.005(1),  459.015(5) FS. Law Implemented 459.015(5) FS. History–New__________.

 

64B15-19.005 Probationary Conditions and Definitions.

(1) through (2) No change.

(3) Provisions governing all supervised or monitored physicians.

(a) through (c) No change.

(d) The supervisor/monitor must be a licensee under Chapter 459, F.S.,or Chapter 458, F.S., in good standing and without restriction or limitation on his license. However, when no physician licensed under Chapter 459, F.S., is available to supervise/monitor a licensee, the Board shall approve a physician licensed under Chapter 458, F.S., provided that said licensee is willing to serve as a supervisor/ monitor. In addition, the Board may reject any proposed supervisor/monitor on the basis that he or she has previously been subject to any disciplinary action against his or her license to practice osteopathic medicine in this or any other jurisdiction. The supervisor/ monitor must be actively engaged in the same or similar specialty area unless otherwise provided by the Board. The Board may also reject any proposed supervisor/monitor for good cause shown.

(4) No change.

Rulemaking Authority 459.005 FS. Law Implemented 459.015(2) FS. History–New 4-18-89, Formerly 21R-19.005, 61F9-19.005, Amended 9-5-94, Formerly 59W-19.005, Amended 11-27-97, 10-20-98, 11-2-05,___________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Osteopathic Medicine

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Osteopathic Medicine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 22, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 24, 2014