(A) No individual or group health insuring corporation policy, contract, or agreement that provides coverage for prescription drugs shall limit or exclude coverage for any drug approved by the United States food and drug administration on the basis that the drug has not been approved by the United States food and drug administration for the treatment of the particular indication for which the drug has been prescribed, provided the drug has been recognized as safe and effective for treatment of that indication in one or more of the standard medical reference compendia adopted by the United States department of health and human services under 42 U.S.C. 1395x(t)(2) , as amended, or in medical literature that meets the criteria specified in division (B) of this section.
Medical literature may be accepted for purposes of division (A) of this section only if all of the following apply:
(1) Two articles from major peer-reviewed professional medical journals have recognized, based on scientific or medical criteria, the drug's safety and effectiveness for treatment of the indication for which it has been prescribed;
(2) No article from a major peer-reviewed professional medical journal has concluded, based on scientific or medical criteria, that the drug is unsafe or ineffective or that the drug's safety and effectiveness cannot be determined for the treatment of the indication for which it has been prescribed;
(3) Each article meets the uniform requirements for manuscripts submitted to biomedical journals established by the international committee of medical journal editors 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. 1395(x)(t)(2)(B) , as amended, as accepted peer-reviewed medical literature.
(C) Coverage of a drug required by division (A) of this section includes medically necessary services associated with the administration of the drug.
(D) Division (A) of this section shall not be construed to do any of the following:
(1) Require coverage for any drug if the United States food and drug administration has determined its use to be contraindicated for the treatment of the particular indication for which the drug has been prescribed;
(2) Require coverage for experimental drugs not approved for any indication by the United States food and drug administration;
(3) Alter any law with regard to provisions limiting the coverage of drugs that have not been approved by the United States food and drug administration;
(4) Require reimbursement or coverage for any drug not included in the drug formulary or list of covered drugs specified in a health insuring corporation contract;
(5) Prohibit a health insuring corporation from limiting or excluding coverage of a drug, provided that the decision to limit or exclude coverage of the drug is not based primarily on the coverage of drugs required by this section.
(E) This section applies only to health insuring corporation policies, contracts, and agreements that are described in division (A) of this section and that are delivered, issued for delivery, or renewed in this state on or after July 1, 1997.
Amended by 129th General AssemblyFile No.48,HB 218, §1, eff. 12/26/2011.
Effective Date: 06-04-1997