The proposed rule amendments to Rules 64B15-19.002 and 19.007 are intended to set forth a penalty range for the recently added violation found in Section 459.015(1)(vv), F.S. The new rule 64B15-19.0065 is intended to set forth violations which are ...

 

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 to Rules 64B15-19.002 and 64B15-19.007, F.A.C. are intended to set forth a penalty range for the recently added violation found in Section 459.015(1)(vv), F.S. The new Rule 64B15-19.0065, F.A.C. is intended to set forth violations which are minor violations and can be addressed through a notice of noncompliance.

SUMMARY: The proposed rule amendments to Rules 64B15-19.002 and 64B15-19.007, F.A.C. set forth a penalty range for the recently added violation found in Section 459.015(1)(vv), F.S. The new rule 64B15-19.0065, F.A.C. sets forth violations which are minor violations and can be addressed through a notice of noncompliance.

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), 456.50, 456.072, 456.073(3), 456.077, 456.079 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.

(1) through (80) No change.
(81) Willfully failing to comply with s. 627.64194 or s. 641.513, F.S. with such frequency as to indicate a general business practice. (Section 459.015(1)(vv), F.S.) FIRST OFFENSE:         SECOND OFFENSE:	letter of concern           reprimand	reprimand and an administrative fine in the amount of $1,000.00 to $5,000.00.   revocation and an administrative fine in the amount of $5,000.00 to $10,000.00.

Rulemaking Authority 456.079, 459.015(5) FS. Law Implemented 381.986(4)(d), 456.072, 456.079, 456.50 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,                      .

 

64B15-19.0065 Notices of Noncompliance; Minor Violations.

(1) For purposes of subsection 456.073(3), F.S., the Board finds the following list to be first time minor offenses.  A minor offense is defined as an offense where there is no danger to public health, safety, and welfare and no indication of a serious inability to practice the profession, appropriate for notices of noncompliance.  A notice of noncompliance in lieu of other action is authorized only if the violation is not a repeat violation and only if there is only one violation. If there are multiple violations, then the Department may not issue a notice of noncompliance, but must prosecute the violations under the other provisions of Section 456.073, F.S. There are only two exceptions to the prohibition against use of a notice of noncompliance when there is more than one violation. The first is that a notice of noncompliance may be issued to a registered dispensing practitioner for a first time violation of one or more of the violations listed in paragraph (2)(b), subparagraphs 2., 3., if there is no evidence of diversion. The second is that a notice of noncompliance may be issued to a licensee for a first time violation of one or both of the violations listed in paragraph (2)(c). Failure of a licensee to take action in correcting the violation within 15 days after notice may result in the institution of regular disciplinary proceedings.

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

(a) Advertising offenses specified herein.

1. Section 459.015(1)(d), F.S., which provides for physician discipline when the physician is found guilty of false, deceptive, or misleading advertising. The only type of false, deceptive, or misleading advertising which would be resolved by a notice of noncompliance would be advertising which is false, deceptive, or misleading because it fails to list the name of the physician conspicuously in the advertisement contrary to subsection 64B15-14.001(2), F.A.C. This would also be a violation of Section 459.015(1)(pp), F.S., which provides for physician discipline when a physician is found guilty of, among other things, violating a rule of the board.

2. Section 459.015(1)(g), F.S., which provides for physician discipline when the physician is found guilty of failing to perform a statutory or legal obligation placed upon a licensed physician. The specific statutory obligation related to advertising, which, if not performed might merit the issuance of a notice of noncompliance, would be a failure to perform the statutory obligation set forth in Section 456.062, F.S., provides that a specific disclosure statement must appear in any advertisement for a free, discounted fee, or reduced fee service, examination or treatment by a health care practitioner licensed pursuant to Chapter 459, F.S.

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

1. Failing to maintain records relating to the receipt and disposition of controlled substances, and the required biennial inventory, as provided for in Section 893.07, F.S. This violation may be resolved by a notice of noncompliance only if the whereabouts of the drugs can be accounted for by other means and there is no evidence of diversion.

2. Failing to, before dispensing any drug, give the patient a written prescription and orally or in writing advise the patient that the prescription may be filled in the practitioner’s office or at any pharmacy, in violation of Section 465.0276(2)(c), F.S. This applies to dispensing practitioners only.

3. Dispensing medication without proper labeling, contrary to the provisions of Section 893.05(2), F.S., and Rule 64B16-28.108, F.A.C. This applies to dispensing practitioners only.

4. Failing to comply with the provisions of Sections 381.026 and 381.0261, F.S., to provide patients with information about their patient rights and how to file a patient complaint.

5. Failing to timely provide medical records upon written request to a patient or a patient’s legal representative within 30 days, contrary to the provisions of Section 456.057, F.S., and Rule 64B15-15.003, F.A.C. This violation may be resolved by a notice of noncompliance only if the medical records were provided to the requestor within 60 days of the request.

6. Failing to update the practitioner’s profile as required by Sections 456.039(3) and 459.008, F.S., except that a notice of noncompliance is not authorized for failing to update the practitioner profile for items in Sections 456.039(1)(a)7., and 456.039(1)(a)8., F.S.

7. Failing to submit notice to the Board when a physician enters into a formal supervisory relationship or standing orders with an emergency medical technician or paramedic licensed pursuant to Section 401.27, F.S., or when the physician enters into an established protocol with an advanced registered nurse practitioner, as set forth in Section 464.012, F.S.

(c) Violating any of the following provisions of Chapter 459, F.S., as prohibited by Section 459.015(1)(pp), F.S.:

1. Section 459.013, F.S., which provides for criminal penalties for the practice of medicine without an active license. A notice of noncompliance would be issued for this violation only if the subject of the investigation met the following criteria: the subject must be the holder of a license to practice medicine at all time material to the matter; that license is otherwise in good standing; and that license must be renewed and placed in an active status within 90 days of becoming delinquent. If the license was delinquent for more than 90 days and the individual continued to practice, then the matter would proceed under the other provisions of Section 456.073, F.S.

2. Failing to notify the Board of a change of practice location, contrary to Sections 459.008(3) and 456.035(1), F.S.

Rulemaking Authority 120.695, 456.073(3), 459.005, F.S.  Law Implemented 120.695, 456.073(3), F.S. History – New

 

64B15-19.007 Citations.

(1) through (2) No change.

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

(a) through (r) No change.

(s) Willfully failing to comply with Section 627.64194 or Section 641.513, F.S., with such frequency as to indicate a general business practice, as required by Section 459.015(1)(vv), F.S.. The fine shall be $250 for a first time violation and the fine shall be $1,000 for a second time violation.

(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,                       .

 

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 26, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 9, 2016