HBA-TYH H.B. 2061 76(R) BILL ANALYSIS Office of House Bill AnalysisH.B. 2061 By: Averitt Insurance 3/8/1999 Introduced BACKGROUND AND PURPOSE Currently, Texas is one of the few large states not providing medical access to "off-label" uses of certain drugs. An "off-label" use involves using a federal Food and Drug Administration (FDA)approved drug that is already deemed safe and effective for one medical condition to treat another medical condition. Although such "off-label" uses are often supported by scientific research and detailed in peer-reviewed studies, health plans and health maintenance organization (HMOs) have denied coverage for their use by claiming the use to be "experimental or insignificant." Twenty-six states have enacted legislation to cover at least some medically accepted off-label uses of FDA approved drugs. For example, 12 states guarantee off-label drugs for persons who have cancer or AIDS so long as the uses are supported by standard drug compendia, peer-reviewed research, or government review panels. Additionally, eight states have enacted laws guaranteeing all persons coverage, not just persons with special health care needs, for all off-label uses of the FDA approved drugs prescribed by their physician. H.B. 2061 allows certain prescription drugs to be available for health benefit plan enrollees that suffer from chronic, disabling, or life-threatening illnesses, as long as the drug has been approved by the FDA, is supported by clinical research that appears in peer-reviewed literature for the medical condition, or is supported or accepted in one of the standard reference compendia. RULEMAKING AUTHORITY It is the opinion of the Office of House Bill Analysis that this bill does not expressly delegate any additional rulemaking authority to a state officer, department, agency, or institution. SECTION BY SECTION ANALYSIS SECTION 1. Amends Subchapter E, Chapter 21, Insurance Code, by adding Article 21.53H, as follows: Art. 21.53H. COVERAGE FOR OFF-LABEL USES OF FDA-APPROVED DRUGS Sec. 1. DEFINITIONS. Defines "contraindication," "FDA," "health benefit plan," "indication," "peer-reviewed medical literature," and "standard reference compendia." Sec. 2. SCOPE OF ARTICLE. (a) Provides that this article applies to a health benefit plan that provides coverage for drugs and that: (1) provides benefits for medical or surgical expenses incurred as a result of a health condition, accident, or sickness, including: (A) an individual, group, blanket, or franchise insurance policy or insurance agreement, a group hospital service contract, or an individual or group evidence of coverage that is offered by enumerated entities; or (B) to the extent permitted by Section 1001 et seq., Title 29, U.S.C. (Congressional Findings and Declaration of Policy) (Employee Retirement Income Security Act of 1974), a health benefit plan that is offered by a multiple employer welfare arrangement, an analogous benefit arrangement, or other enumerated entities; or (2) is offered by an approved nonprofit health corporation that is certified under Section 5.01(a), Article 4495b, V.T.C.S. (Certification of Certain Organizations) (Medical Practice Act), and that holds a certificate of authority issued by the commissioner of insurance (commissioner) under Article 21.52F (Certification of Certain Nonprofit Health Corporations) of this code. (b) Provides that this article does not apply to a plan that provides coverage for specified conditions; a small employer health benefit plan written under Chapter 26 (Health Insurance Availability) of this code; a Medicare supplemental policy as defined by Section 1395ss, Title 42, U.S.C. (Certification of Medicare Supplemental Health Insurance Policies) (Social Security Act); workers' compensation insurance coverage; medical payment insurance issued as part of a motor vehicle insurance policy; or a long-term care policy, including a nursing home fixed indemnity policy, unless the commissioner determines that the policy provides benefit coverage so comprehensive that the policy is a health benefit plan as described by Subsection (a) of this section. Sec. 3. MINIMUM STANDARDS OF COVERAGE. (a) Requires a health benefit plan that provides coverage for drugs to provide for any drug prescribed to treat enrollees with chronic, disabling, or life-threatening illnesses so long as the drug has been approved by the FDA for at least one indication, is supported by clinical research that appears in peer-reviewed medical literature for that indication, or is supported or accepted in one of the standard reference compendia. (b) Requires coverage of the drug to include medically necessary services associated with the administration of the drug. (c) Prohibits a drug use to be denied coverage based on a "medical necessity" requirement except for reasons that are unrelated to the legal status of the drug use. (d) Prohibits this section to be construed to require coverage for experimental drugs not otherwise approved for any indication by the FDA. (e) Prohibits this section to be construed to require coverage for a drug when the FDA has determined its use to be contraindicated for treatment of the current indication. SECTION 2.Effective date: September 1, 1999. Makes application of this Act prospective, as of January 1, 2000. SECTION 3.Emergency clause.