Minnesota Session Laws - 1998, Regular Session

                            CHAPTER 301-S.F.No. 1076 
                  An act relating to health; requiring health plan 
                  coverage for off-label use of drugs; proposing coding 
                  for new law in Minnesota Statutes, chapter 62Q.  
        BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
           Section 1.  [62Q.525] [COVERAGE FOR OFF-LABEL DRUG USE.] 
           Subdivision 1.  [SCOPE OF COVERAGE.] This section applies 
        to all health plans, including the coverages described in 
        section 62A.011, subdivision 3, clauses (7) and (10), that are 
        issued or renewed to a Minnesota resident.  
           Subd. 2.  [DEFINITIONS.] (a) For purposes of this section, 
        the terms defined in this subdivision have the meanings given 
        them.  
           (b) "Medical literature" means articles from major peer 
        reviewed medical journals that have recognized the drug or 
        combination of drugs' safety and effectiveness for treatment of 
        the indication for which it has been prescribed.  Each article 
        shall meet the uniform requirements for manuscripts submitted to 
        biomedical journals established by the international committee 
        of medical journal editors or be published in a journal 
        specified by the United States Secretary of Health and Human 
        Services pursuant to United States Code, title 42, section 
        1395x, paragraph (t), clause (2), item (B), as amended, as 
        acceptable peer review medical literature.  Each article must 
        use generally acceptable scientific standards and must not use 
        case reports to satisfy this criterion. 
           (c) "Off-label use of drugs" means when drugs are 
        prescribed for treatments other than those stated in the 
        labeling approved by the federal Food and Drug Administration.  
           (d) "Standard reference compendia" means:  
           (1) the United States Pharmacopeia Drug Information; or 
           (2) the American Hospital Formulary Service Drug 
        Information. 
           Subd. 3.  [REQUIRED COVERAGE.] (a) Every type of coverage 
        included in subdivision 1 that provides coverage for drugs may 
        not exclude coverage of a drug for the treatment of cancer on 
        the ground that the drug has not been approved by the federal 
        Food and Drug Administration for the treatment of cancer if the 
        drug is recognized for treatment of cancer in one of the 
        standard reference compendia or in one article in the medical 
        literature, as defined in subdivision 2.  
           (b) Coverage of a drug required by this subdivision 
        includes coverage of medically necessary services directly 
        related to and required for appropriate administration of the 
        drug.  
           (c) Coverage required by this subdivision does not include 
        coverage of a drug not listed on the formulary of the coverage 
        included in subdivision 1. 
           (d) Coverage of a drug required under this subdivision must 
        not be subject to any copayment, coinsurance, deductible, or 
        other enrollee cost-sharing greater than the coverage included 
        in subdivision 1 applies to other drugs. 
           (e) The commissioner of commerce or health, as appropriate, 
        may direct a person that issues coverage included in subdivision 
        1 to make payments required by this section.  
           Subd. 4.  [CONSTRUCTION.] This section must not be 
        construed to:  
           (1) alter existing law limiting the coverage of drugs that 
        have not been approved by the federal Food and Drug 
        Administration; 
           (2) require coverage for any drug when the federal Food and 
        Drug Administration has determined its use to be 
        contraindicated; 
           (3) require coverage for experimental drugs not otherwise 
        approved for any indication by the federal Food and Drug 
        Administration; or 
           (4) reduce or limit coverage for off-label use of drugs 
        otherwise required by law or contract. 
           Sec. 2.  [EFFECTIVE DATE; APPLICATION.] 
           Section 1 is effective January 1, 1999, and applies to 
        coverage issued or renewed on or after that date. 
           Presented to the governor March 17, 1998 
           Signed by the governor March 18, 1998, 4:25 p.m.