The proposed rule amendments are intended to address disciplinary guidelines, notices of noncompliance and citations for various violations.

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NOS.:RULE TITLES:

64B8-8.001Disciplinary Guidelines

64B8-8.011Notice of Noncompliance

64B8-8.017Citation Authority

PURPOSE AND EFFECT: The proposed rule amendments are intended to address disciplinary guidelines, notices of noncompliance and citations for various violations.

SUMMARY: The proposed rule amendments to Rule 64B8-8.00, F.A.C. clarify language with regard to prescription blanks and prescribing software and set forth a range of penalties for liposuction in an unregistered office. The proposed amendment to 64B8-8.011 specifies that failure to comply with the provisions of 456.44(7)(c), F.S., regarding the requirements for informing the patient of nonopioid alternatives is considered a minor violation for which a notice on noncompliance is appropriate. The proposed amendments to Rule 64B8-8.017, F.A.C. set forth citation penalties for repeated failure to comply with the provisions of 456.44(7)(c), F.S., regarding the requirements for informing the patient of nonopioid alternatives.

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: 456.073(3), 456.077, 456.079, 458.309, 458.331(5) FS.

LAW IMPLEMENTED: 381.986(4)(d), 456.50(2), 456.0575, 456.072, 456.072(2)(d), 456.073(3), 456.079, 458.331(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: Claudia Kemp, J.D., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B8-8.001 Disciplinary Guidelines.

(1) No change.

(2) Violations and Range of Penalties. In imposing discipline upon applicants and licensees, in proceedings pursuant to sections 120.57(1) and (2), F.S., 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 verbal identification of offenses are descriptive only; the full language of each statutory provision cited must be consulted in order to determine the conduct included.

RECOMMENDED RANGE OF PENALTY
VIOLATION	FIRST OFFENSE	SECOND OFFENSE	THIRD OFFENSE
(a) through (lll) No change.
(mmm) Failing to timely notify the Department of the theft of prescription blanks from a pain management clinic or a breach of a physician’s electronic prescribing software or other methods for for prescribing within 24 hours as required by section 458.3265(2), F.S. (Section 458.331(1)(qq), F.S.)	(mmm) From a letter of concern to probation, and an administrative fine ranging from $1,000.00 to $5,000.00.	(mmm) From probation  to suspension, followed by a period of probation, and an administrative fine ranging from $5,000.00 to $10,000.00.	(mmm) From suspension, followed by a period of probation to revocation, an administrative fine of $10,000.00.
(nnn) through (vvv) No change.
(www) Performing a liposuction procedure in which more than 1,000 cubic centimeters of supernatant fat is removed, a Level II office surgery, or a Level III office surgery in an office that is not registered with the department pursuant to s. 458.328. (Section 458.331(1)(vv), F.S.)	(www) From twelve (12) months probation to twelve (12) months suspension followed by a term of probation and an administrative fine of $5,000.00 per day.	(www) From twelve (12) months suspension followed by a term of probation and permanent restriction from performing office surgery to revocation and an administrative fine of $5,000.00 per day.	(www) From eighteen (18) months suspension followed by a term of probation and permanent restriction from performing office surgery to revocation and an administrative fine of $5,000.00 per day.

(3) through (8) No change.

Rulemaking Authority 456.079, 458.309, 458.331(5) FS. Law Implemented 381.986(4)(d), 456.50(2), 456.0575, 456.072, 456.079, 458.331(5) FS. History–New 12-5-79, Formerly 21M-20.01, Amended 1-11-87, 6-20-90, Formerly 21M-20.001, Amended 11-4-93, Formerly 61F6-20.001, Amended 6-24-96, 12-22-96, Formerly 59R-8.001, Amended 5-14-98, 12-28-99, 1-31-01, 7-10-01, 6-4-02, 9-10-02, 12-11-02, 8-20-03, 6-7-04, 8-17-04, 1-4-06, 8-13-06, 8-29-06, 11-22-06, 1-30-07, 2-18-09, 12-22-09, 7-27-10, 6-21-11, 12-27-11, 4-22-12, 5-28-12, 1-1-15, 11-9-16, 4-30-18, 8-15-18, 8-28-18,                      .

 

64B8-8.011 Notice of Noncompliance.

(1) through (2) No change.

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

(a) No change.

(b) Failure to perform one of the following statutory or legal obligations:

1. through 18. No change.

19.  Failure to comply with the provisions of Section 456.44(7)(c), F.S., to inform the patient of nonopioid alternatives for the treatment of pain, to discuss the advantages and disadvantages of the use of nonopioid alternatives, to provide the Department’s educational pamphlet, or to document the nonopioid alternatives in the patient’s record.

(c) through (f) No change.

Rulemaking Authority 456.073(3), 458.309 FS. Law Implemented 456.073(3), 456.0575 FS. History–New 11-15-90, Formerly 21M-20.011, 61F6-20.011, 59R-8.011, Amended 1-27-00, 1-8-02, 1-12-03, 6-7-04, 8-26-09, 8-28-18,                           .

 

64B8-8.017 Citation Authority. In lieu of the disciplinary procedures contained in section 456.073, F.S., the offenses enumerated in this rule may be disciplined by the issuance of a citation. The citation shall include a requirement that the licensee correct the offense, if possible, within a specified period of time, impose whatever obligations will correct the offense, and impose the prescribed penalty.

(1) – (2) No change.

(3) The following violations with accompanying penalty may be disposed of by citation with the specified penalty:

VIOLATIONS	PENALTY
(a) through (x) No change.
(y) Failure to comply with the provisions of Section 456.44(7)(c), F.S., to inform the patient of nonopioid alternatives for the treatment of pain, to discuss the advantages and disadvantages of the use of nonopioid alternatives, to provide the Department’s educational pamphlet, or to document the nonopioid alternatives in the patient’s record.	First time Citation ­­-- $50 fine. Second time Citation -- $75 fine. Third time Citation --  $100 fine.

(4) – (5) No change.

Rulemaking Authority 456.077, 458.309 FS. Law Implemented 456.072(2)(d), 456.077 FS. History–New 12-30-91, Formerly 21M-20.017, Amended 11-4-93, Formerly 61F6-20.017, Amended 8-23-95, Formerly 59R-8.017, Amended 4-7-99, 1-27-00, 1-31-02, 1-12-03, 7-27-04, 2-7-05, 1-4-06, 7-3-06, 1-16-08, 12-22-09, 7-9-12, 7-6-15, 11-9-16, 8-28-18, 11-12-18,                        .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Rules/Legislative Committee

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 4, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 64B8-8.001 – July 12, 2019

64B8-8.011 and 8.017 – August 23, 2019.