HF 1306

as introduced - 80th Legislature (1997 - 1998) Posted on 12/15/2009 12:00am

  1.1                          A bill for an act 
  1.2             relating to health; requiring health plan coverage for 
  1.3             off-label use of drugs; establishing an advisory 
  1.4             council; proposing coding for new law in Minnesota 
  1.5             Statutes, chapter 62Q.  
  1.6   BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.7      Section 1.  [62Q.52] [COVERAGE FOR OFF-LABEL DRUG USE.] 
  1.8      Subdivision 1.  [SCOPE OF COVERAGE.] This section applies 
  1.9   to all health plans, including the coverages described in 
  1.10  section 62A.011, subdivision 3, clauses (7) and (10), that are 
  1.11  issued or renewed to a Minnesota resident.  
  1.12     Subd. 2.  [DEFINITIONS.] (a) For purposes of this section, 
  1.13  the terms defined in this subdivision have the meanings given 
  1.14  them.  
  1.15     (b) "Medical literature" means scientific studies published 
  1.16  in a peer-reviewed national professional medical journal.  
  1.17     (c) "Off-label use of drugs" means when drugs are 
  1.18  prescribed for treatments other than those stated in the 
  1.19  labeling approved by the federal Food and Drug Administration.  
  1.20     (d) "Standard reference compendia" means:  
  1.21     (1) the United States Pharmacopeia Drug Information; 
  1.22     (2) the American Medical Association Drug Evaluations; or 
  1.23     (3) the American Hospital Formulary Service Drug 
  1.24  Information. 
  1.25     Subd. 3.  [REQUIRED COVERAGE.] (a) Every type of coverage 
  2.1   included in subdivision 1 that provides coverage for drugs may 
  2.2   not exclude coverage of a drug for a particular indication on 
  2.3   the ground that the drug has not been approved by the federal 
  2.4   Food and Drug Administration for that indication if the drug is 
  2.5   recognized for treatment of the indication in one of the 
  2.6   standard reference compendia or in the medical literature.  
  2.7      (b) Coverage of a drug required by this subdivision 
  2.8   includes coverage of medically necessary services associated 
  2.9   with the administration of the drug.  
  2.10     (c) The commissioner of commerce or health, as appropriate, 
  2.11  may direct a person that issues a health plan subject to the 
  2.12  commissioner's supervision to make payments required by this 
  2.13  section.  
  2.14     Subd. 4.  [ADVISORY COUNCIL.] The commissioner of health 
  2.15  shall appoint an advisory council of medical experts to review 
  2.16  off-label uses of drugs not included in any of the standard 
  2.17  reference compendia or in the medical literature and to advise 
  2.18  the commissioners of commerce and health whether a particular 
  2.19  off-label use is medically appropriate.  The advisory council 
  2.20  shall consist of: 
  2.21     (1) three medical oncologists chosen by the state medical 
  2.22  oncology association; 
  2.23     (2) two specialists in the management of AIDS patients 
  2.24  chosen by the state AIDS medical provider organizations; 
  2.25     (3) one specialist in heart disease appointed by the 
  2.26  University of Minnesota medical system; and 
  2.27     (4) one physician chosen by the state medical association. 
  2.28     The advisory council shall make recommendations from time 
  2.29  to time and whenever a particular dispute about payment for 
  2.30  off-label use is brought to the commissioner of commerce or 
  2.31  health.  
  2.32     Subd. 5.  [CONSTRUCTION.] This section may not be construed 
  2.33  to:  
  2.34     (1) alter existing law limiting the coverage of drugs that 
  2.35  have not been approved by the federal Food and Drug 
  2.36  Administration; 
  3.1      (2) require coverage for any drug when the federal Food and 
  3.2   Drug Administration has determined its use to be 
  3.3   contraindicated; or 
  3.4      (3) require coverage for experimental drugs not otherwise 
  3.5   approved for any indication by the federal Food and Drug 
  3.6   Administration. 
  3.7      Sec. 2.  [EFFECTIVE DATE; APPLICATION.] 
  3.8      Section 1 is effective August 1, 1997, and applies to 
  3.9   health plans issued or renewed on or after that date.