The purpose of the amendment to Rule 59G-1.035 is to clarify the existing procedures for submitting a request for a health service to be considered for coverage and the different types of policies under the Florida Medicaid program.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Medicaid

RULE NO.:RULE TITLE:

59G-1.035Determining Generally Accepted Professional Medical Standards

PURPOSE AND EFFECT: The purpose of the amendment to Rule 59G-1.035 is to clarify the existing procedures for submitting a request for a health service to be considered for coverage and the different types of policies under the Florida Medicaid program.

SUMMARY: This rule specifies Florida Medicaid’s process for determining the circumstances under which a diagnostic test, therapeutic procedure, or medical device or technology is consistent with generally accepted professional medical standards.

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: A checklist was prepared by the Agency to determine the need for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification.

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: 409.919 FS.

LAW IMPLEMENTED: 409.902, 409.905, 409.912, 409.913 FS.

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: July 15, 2015, 1:30 p.m. ‒ 2:30 p.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room C, Tallahassee, Florida 32308-5407

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 48 hours before the workshop/meeting by contacting: Mary McCullough. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Mary McCullough, Bureau of Medicaid Policy, 2727 Mahan Drive, Mail Stop #20, Tallahassee, Florida 32308-5407, telephone: [phone], e-mail: [e-mail], Comments will be received until 5:00 p.m., on July 22, 2015.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59G-1.035 Determining Generally Accepted Professional Medical Standards.

(1) Definitions.

(a) Generally accepted professional medical standards – Standards based on reliable credible scientific evidence published in peer-reviewed scientific literature generally recognized by the relevant medical community or practitioner physician specialty associations’ society recommendations.

(b) Health service(s) – Diagnostic tests, therapeutic procedures, or medical devices or technologies.

(c) Relevant – Having a significant and demonstrable bearing on the matter at hand.

(2) Pursuant to the criteria set forth in Rule 59G-1.010(166)(a)3., Florida Administrative Code (F.A.C.), the Agency for Health Care Administration (hereafter referred to as Agency) will determine when health services are consistent with generally accepted professional medical standards and are not experimental or investigational.

(3) Health services that are covered under the Florida Medicaid program are described in the respective coverage and limitations handbooks, policies, and fee schedules, which are incorporated by reference in the F.A.C. The public may request a health service be considered for coverage under the Florida Medicaid program by submitting a written request via e-mail to [e-mail] to the Deputy Secretary for Medicaid, Agency for Health Care Administration, 2727 Mahan Drive, MS #8, Tallahassee, FL 32308. The request must include the name, a brief description, and any additional information that supports coverage of the health service, including sources of reliable evidence as defined in Rule 59G-1.010(84)(b), F.A.C.

(4) To determine whether the health service is consistent with generally accepted medical standards, the Agency shall may consider the following factors:

(a) Evidence-based clinical practice guidelines.

(b) Published reports and articles in the authoritative medical and scientific literature Credible scientific evidence related to the health service (published in peer-reviewed scientific literature generally recognized by the relevant medical community or practitioner specialty associations).

(c) Effectiveness of the health service in improving the individual’s prognosis or health outcomes.

(d) Utilization trends.

(e) Coverage policies policy by other creditable insurance payor sources.

(f) Recommendations or assessments by clinical or technical experts on the subject or field.

(5) Based upon the information collected, a report with recommendations will be submitted to the Deputy Secretary for Medicaid (or designee) for review. The Deputy Secretary for Medicaid (or designee) will make a final determination as to whether the health service is consistent with generally accepted professional medical standards and not experimental or investigational.

(6) In order for the health service to be covered under the Florida Medicaid program, it must also meet all other medical necessity criteria as defined in Rule 59G-1.010(166), F.A.C., and funded through the General Appropriations Act or Chapter 216, F.S.

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.912, 409.913 FS. History–New 2-26-14, Amended __________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Mary McCullough

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 11, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: March 17, 2015