The proposed rule amendment is intended to clarify subsection (4) with regard to controlled substances for hospitalized patients through telemedicine.

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-9.0141Standards for Telemedicine Practice

PURPOSE AND EFFECT: The proposed rule amendment is intended to clarify subsection (4) with regard to controlled substances for hospitalized patients through telemedicine.

SUMMARY: The proposed rule amendment clarifies subsection (4) by making it clear that ordering controlled substances through telemedicine for hospitalized patients is not prohibited by the rule.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST 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, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. Subsection 64B8-9.0141(4), F.A.C., currently precludes the prescribing of controlled substances through the use of telemedicine. While the current rule does not preclude the ordering of controlled substances to hospitalized patients, the current prescribing prohibition has created doubt amongst licensees and pharmacists because of the ambiguity created by the term “prescribing” as defined in Sections 465.003(14) and 893.02(22), Florida Statutes. The rule amendment in question does not prescribe the behavior or actions of any regulated entity or licensee but rather clarifies that physicians can indeed order controlled substances for hospitalized patients through the use of telemedicine. Furthermore, it will  not increase any fees, business costs, personnel costs, will not decrease profit opportunities, will not require any specialized knowledge to comply, and will also ultimately decrease any direct or indirect regulatory costs. This rule amendment actually reduces perceived regulatory restrictions and allows for hospitals to continue saving money through the use of telemedicine care for hospitalized patients. No person or interested party submitted additional information regarding the economic impact at that time but multiple attorneys representing hospitals and hospital groups raised this issue of concern with the Board and the Board acted in response to those concerns.

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: 458.331(1)(v) FS.

LAW IMPLEMENTED:  458.331(1)(v) 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: Allison M. Dudley, 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:

 

64B8-9.0141 Standards for Telemedicine Practice.

(1) through (3) No change.

(4) Controlled substances shall not be prescribed through the use of telemedicine. This provision does not preclude physicians from ordering controlled substances through the use of telemedicine for patients hospitalized in a facility licensed pursuant to Chapter 395, F.S.

(5) through (7) No change.

Rulemaking Authority 458.331(1)(v) FS. Law Implemented 458.331(1)(v) FS. History‒New 3-12-14, Amended__________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE:  Board of Medicine

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 30, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 15, 2014