The proposed rule amendments are intended to address disciplinary guidelines for engaging in a pattern of practice when prescribing medicinal drugs or controlled substances that demonstrates a lack of reasonable skill and safety to patients; for ...

 

DEPARTMENT OF HEALTH

Board of Osteopathic Medicine

RULE NOS.:RULE TITLES:

64B15-19.002Violations and Penalties

64B15-19.0065Notices of Noncompliance; Minor Violatons

64B15-19.007Citations

PURPOSE AND EFFECT: The proposed rule amendments are intended to address disciplinary guidelines for engaging in a pattern of practice when prescribing medicinal drugs or controlled substances that demonstrates a lack of reasonable skill and safety to patients; for failure to consult the prescription drug monitoring system and failure to report adverse incidents in planned out-of-hospital births; provisions for a notice of non-compliance to be issued for failure to submit required documentation as required by Section 386.986(4)(b), F.S.; and citation penalties for failure to submit required documentation as required by Section 386.986(4)(b), F.S.; failure to consult the prescription drug monitoring system; and failure to report adverse incidents in planned out-of-hospital births.

SUMMARY: The proposed rule amendments set forth disciplinary guidelines for engaging in a pattern of practice when prescribing medicinal drugs or controlled substances that demonstrates a lack of reasonable skill and safety to patients; for failure to consult the prescription drug monitoring system and failure to report adverse incidents in planned out-of-hospital births; outline the provision for a notice of non-compliance to be issued for failure to submit required documentation as required by Section 386.986(4)(b), F.S.; and set forth citation penalties for failure to submit required documentation as required by Section 386.986(4)(b), F.S.; failure to consult the prescription drug monitoring system; and failure to report adverse incidents in planned out-of-hospital birth.

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 this rule at its Board meeting, the Board concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule 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: 120.695, 456.073(3), 456.077, 456.079, 459.005, 459.015(5) FS.

LAW IMPLEMENTED: 120.695, 381.986(4)(d), 456.072, 456.073(3), 456.077, 456.079, 456.50, 459.015 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: Kama Monroe, J.D., 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:

 

64B15-19.002 Violations and Penalties. In imposing discipline upon applicants and licensees, the board shall act in accordance with the following disciplinary guidelines and shall impose a penalty within the range corresponding to the violations set forth below. The statutory language is intended to provide a description of the violation and is not a complete statement of the violation; the complete statement may be found in the statutory provision cited directly under each violation description.

		MINIMUM	MAXIMUM
(1)  through (58) No change.
(59) Engaging in a pattern of practice when prescribing medicinal drugs or controlled substances which demonstrates a lack of reasonable skill or safety to patients, a violation of any provision of this chapter, or Sections 893.055 and 893.0551, a violation of the applicable practice act, or a violation of any rules adopted under this chapter or the applicable practice act of the prescribing practitioner. (Section 456.072(1)(gg), F.S.)
FIRST OFFENSE:		One year Probation and $1,000.00 $5,000.00 fine.	Revocation Suspension to be followed by probation and $10,000.00 $7, 500.00 fine.
SECOND OFFENSE:		Suspension to be followed by probation and $5,000.00 $7,500.00 fine.	Revocation and $10,000.00 fine.
(60) through (82)  No change.
(83) Failure to consult the prescription drug monitoring system, as required by Section 893.055(8), F.S. (Section 459.015(1)(g), F.S.)
FIRST OFFENSE:	Letter of concern and an administrative fine of $1,000.00.		Reprimand and an administrative fine of $2,500.00.
SECOND OFFENSE:	Reprimand and an administrative fine of $2,500.00.		Suspension and an administrative fine of $5,000.00.
THIRD OFFENSE:	Suspension and an administrative fine of $5,000.00.		Revocation and an administrative fine of $10,000.00.
(84) Failure to report adverse incidents occurring in planned out-of-hospital births as required by Section 456.0495, F.S. (Section 459.015(1)(g), F.S.)
FIRST OFFENSE:	Letter of concern and an administrative fine of $1,000.00.		Reprimand and an administrative fine of $2,500.00.
SECOND OFFENSE:	Reprimand and an administrative fine of $2,500.00.		Suspension and an administrative fine of $5,000.00.
THIRD OFFENSE:	Suspension and an administrative fine of $5,000.00.		Revocation and an administrative fine of $10,000.00.

 

Rulemaking Authority 456.079, 459.015(5) FS. Law Implemented 381.986(4)(d), 456.072, 456.079, 456.50, 459.015 FS. History–New 9-30-87, Amended 10-28-91, 1-12-93, Formerly 21R-19.002, 61F9-19.002, 59W-19.002, Amended 2-2-98, 2-11-01, 6-7-01, 2-26-02, 12-7-05, 11-14-06, 11-27-06, 5-10-10, 7-27-10, 11-10-11, 3-27-12, 7-3-12, 1-1-15, 11-27-16, 4-30-18,                 .

 

64B15-19.0065 Notices of Noncompliance; Minor Violations.

(1) No change.

(2) The following violations are those for which the Board authorizes the Department to issue a notice of noncompliance.

(a) through (c) No change.

(d) Failing to submit documentation to the Department within 14 days of issuing a certification as required under section 381.986(4)(b), F.S.

Rulemaking Authority 120.695, 456.073(3), 459.005 FS. Law Implemented 120.695, 456.073(3) FS. History–New 1-19-17,                  .

 

64B15-19.007 Citations.

(1) through (2) No change.

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

(a) through (s) No change.

(t) Failure to submit documentation to the Department within 14 days of issuing a certification as required under Section 386.986(4)(b), F.S., as required by Section 459.015(1)(ww), F.S.  The first-time violation shall result in a $100.00 fine and requirement for submission of delinquent documentation within 14 days. The second- time violation shall result in a $250.00 fine and requirement for submission of delinquent documentation within 14 days.

(u) Failure to consult the Prescription Drug Monitoring system as required by Section 893.055(8), F.S. The first-time violation shall result in a $100.00 fine.  The second-time violation shall result in a $150.00 fine.  The third-time violation shall result in a $200.00 fine.

(v)  Failure to report adverse incidents occurring in planned out-of-hospital births as required by Section 456.0495, F.S. The fine shall be $1,000.00.

(4) through (5) No change.

Rulemaking Authority 456.077 FS. Law Implemented 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, 8-13-15, 11-27-16,                         .

 

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: May 18, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 31, 2018