To amend chapter 376, RSMo, by adding three new sections relating to payment for drugs for off-label use.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF MISSOURI, AS FOLLOWS:

     Section A. Chapter 376, RSMo, is amended by adding thereto three new sections to be known as sections 376.1226, 376.1228 and 376.1230, to read as follows:

     376.1226. Sections 376.1226 to 376.1230 shall apply to all health benefit plans that are issued, amended, delivered or renewed on or after the effective date of this act and provide coverage for drugs, and to all persons making determinations regarding payment or reimbursement for prescription drugs under these health benefit plans.

     376.1228. As used in sections 376.1226 to 376.1230, the following terms mean:

     (1) "Director", the director of the department of insurance;

     (2) "Drug", any substance prescribed by a licensed health care provider acting within the scope of the provider's license and that is intended for use in the diagnosis, mitigation, treatment or prevention of disease. The term includes only those substances that are approved by the FDA for at least one indication;

     (3) "FDA", the federal Food and Drug Administration;

     (4) "Health benefit plan", a risk transferring contract entered into to provide, deliver, arrange for, pay for or reimburse the cost of health care services;

     (5) "Health carrier", a person that contracts or offers to contract on a risk assuming basis to provide, deliver, arrange for, pay for, or reimburse any of the cost of health care services unless the person assuming the risk is accepting the risk from a duly licensed health carrier;

     (6) "Peer-reviewed medical literature", a published scientific study in a journal or other publication in which original manuscripts have been published only after having been critically reviewed for scientific accuracy, validity and reliability by unbiased independent experts, and that has been determined by the International Committee of Medical Journal Editors to have met the uniform requirements for manuscripts submitted to biomedical journals or is published in a journal specified by the United States Department of Health and Human Services pursuant to section 1861(t)(2)(B) of the Social Security Act, 107 Stat. 591 (1993), 42 U.S.C. 1395x(t)(2)(B), as amended, as acceptable peer-reviewed medical literature. Peer-reviewed medical literature does not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manu- facturing company or health carrier;

     (7) "Standard reference compendia":

     (a) The American Hospital Formulary Service-Drug Information; or

     (b) The United States Pharmacopoeia-Drug Information.

     376.1230. 1. A health benefit plan that provides coverage for drugs shall provide coverage for any drug prescribed to treat an indication so long as the drug has been approved by the FDA for at least one indication, if the drug is recognized for treatment of the covered indication in one of the standard reference compendia or in substantially accepted peer-reviewed medical literature.

     2. Coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.

     3. This section shall not be construed to require coverage for a drug when the FDA has determined its use to be contra-indicated for treatment of the current indication.

     4. A drug use that is covered by reason of subsection 1 of this section shall not be denied coverage based on a "medical necessity" requirement except for reasons that are unrelated to the legal status of the drug use.

     5. Drugs or services furnished in a research trial, if the sponsor of the research trial furnishes the drugs or services without charge to any participant in the research trial shall not be subject to coverage under subsection 1 of this section.