Rule 59G-1.010(166)(a)3., Florida Administrative Code (F.A.C.), provides in part that in order for a diagnostic test, therapeutic procedure, or medical device or technology to be medically necessary it must be consistent with generally accepted ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Medicaid

RULE NO.:RULE TITLE:

59G-1.035Determining Generally Accepted Professional Medical Standards

PURPOSE AND EFFECT: Subparagraph 59G-1.010(166)(a)3., Florida Administrative Code (F.A.C.), provides in part that in order for a diagnostic test, therapeutic procedure, or medical device or technology to be medically necessary it must be consistent with generally accepted professional medical standards, as determined by the Florida Medicaid program, and not be experimental or investigational as defined in subsection 59G-1.010(84), F.A.C. This new 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: Medicaid coverage determinations are made when all criteria of medical necessity are met. As such, Florida Medicaid must determine if a diagnostic test, therapeutic procedure, or medical device or technology is experimental or investigational. This rule provides the guidelines that Florida Medicaid will use when determining the circumstances under which a diagnostic test, therapeutic procedure, or medical device or technology is consistent with generally accepted professional medical standards. This rule also includes the types of information to be considered in the decision-making process and names the person(s) qualified to make the final determination.

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: Friday, October 25, 2013, 10:00 a.m. − 11:00 a.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room D, 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: Ronique Scorsone at the Bureau of Medicaid Services, [phone]. 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: Ronique Scorsone, Medicaid Services, 2727 Mahan Drive, Mail Stop 20, Tallahassee, Florida 32308-5407, telephone: [phone], e-mail: [e-mail]

 

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 credible scientific evidence published in peer-reviewed scientific literature generally recognized by the relevant medical community or physician specialty society recommendations.

(b) Health technology assessment – A multi-disciplinary policy analysis that examines the medical, economic, social, and ethical implications of the incremental value, diffusion, and use of a medical technology in health care.

(c) Medical Care Advisory Committee (hereafter refered to as Committee) – A committee established in Title 42, Code of Federal Regulations, section 431.12, to advise the Agency for Health Care Administration (Agency) about health and medical care services with respect to policy and planning for the delivery of these services.

(2) In accordance with federal requirements for Title XIX of the Social Security Act and the provisions of state law, the Agency is authorized to make payments for diagnostic tests, therapeutic procedures, or medical devices or technologies (hereafter referred to as health services) furnished by qualified providers to recipients who are determined to be eligible on the dates services were provided. Payment for covered health services is subject to the availability of funding and any limitations or directions provided in the General Appropriations Act or Chapter 216, Florida Statutes (F.S.).

(3) The Division of Medicaid (Medicaid), within the Agency, sets forth coverage, limitation, and exclusion criteria of approved health services in the Florida Medicaid coverage and limitations handbooks and fee schedules, pursuant to the operation of the Administrative Procedure Act (Chapter 120, F.S.).

(4) Health services must meet all required criteria of medical necessity, as defined in Rule 59G-1.010(166), Florida Administrative Code (F.A.C).

(5) Pursuant to the criteria set forth in subparagraph 3. of the medical necessity definition, Medicaid will determine when health services are consistent with generally accepted professional medical standards and are not experimental or investigational.

(6) Individuals, external to the Agency, must submit a written request for review of a noncovered health service to the Deputy Secretary for Medicaid. 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.

(7) When reviewing a health service, Medicaid analyzes evidence-based clinical practice guidelines and credible scientific evidence related to the health service, published in peer-reviewed scientific literature generally recognized by the relevant medical community or practitioner specialty society recommendations. Medicaid may request an external assessment of the evidence to be provided by a clinical or technical expert to supplement the analysis of highly complex health services.

(8) Health services consistent with generally accepted professional medical standards, as determined by Medicaid, and with clinical utility not disputed in medical literature, may be considered for coverage without further evaluation or review by the Committee.

(9) Health services that do not meet the criteria in section (8), or the complexity of the evidence exceeds Medicaid staff expertise or capability, require review by the Committee.

(10) Medicaid determines the health service is consistent with generally accepted professional medical standards using the steps as follows:

(a) Medicaid will develop a preliminary report, which includes:

1. The Medicaid analysis of the credible scientific evidence related to the health service.

2. A health technology assessment evaluation.

3. Findings as to whether equally effective and potentially more cost-effective alternatives exist for the requested health service.

4. Any external assessments provided by a clinical or technical expert.

5. Any questions regarding the impact on the Medicaid program, target recipient population, or practitioner or facility qualifications not adequately addressed by evidence.

6. Recommendations as to whether the health service meets generally accepted professional medical standards, and, if so:

a. Whether there should be imposed individually determined or categorical limitations as to coverage beyond general Medicaid eligibility criteria.

b. The criteria upon which such limitations should be based.

(b) The Committee will be provided a copy of the preliminary report and will have an opportunity to provide comments and feedback for the Agency’s consideration.

(c) The report, along with any recommendations from the Committee, shall be submitted to the Deputy Secretary for Medicaid (or designee) for review. The Deputy Secretary for Medicaid (or designee) shall make a final determination as to whether the health service is consistent with generally accepted professional medical standards and not experimental or investigational.

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.912, 409.913 FS. History–New________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Ronique Scorsone

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 2, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 15, 2012