AGENCY FOR HEALTH CARE ADMINISTRATION
RULE NO.: RULE TITLE:
59G-1.035Determining Generally Accepted Professional Medical Standards
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 39, No. 193, October 3, 2013 issue of the Florida Administrative Register.
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 service(s) – Diagnostic tests, therapeutic procedures, or medical devices or technologies. 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) Relevant – Having a significant and demonstrable bearing on the matter at hand. Medical Care Advisory Committee (hereafter referred 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).
(2)(5) Pursuant to the criteria set forth in subparagraph 59G-1.010(166)(a)3., Florida Administrative Code (F.A.C.), the Agency for Health Care Administration (hereafter referred to as Agency) 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.
(3)(6) Health services that are covered under the Florida Medicaid program are described in the respective coverage and limitations handbooks 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 to the Deputy Secretary for Medicaid, Agency for Health Care Administration, 2727 Mahan Drive, MS #8, Tallahassee, FL 32308 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 paragraph 59G-1.010(84)(b), F.A.C.
(4) To determine whether the health service is consistent with generally accepted professional medical standards, the Agency may consider the following factors:
(a) Evidence-based clinical practice guidelines.
(b) 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 policy by other creditable insurance payor sources.
(f) Recommendations or assessments by clinical or technical experts on the subject or field.
(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.
(5)(c) Based upon the information collected, a report with The report, along with any recommendations from the Committee, shall will be submitted to the Deputy Secretary for Medicaid (or designee) for review. The Deputy Secretary for Medicaid (or designee) will shall 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, 409.905, 409.912, 409.913 FS. History–New________.
