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MN HF2261
Bill
Status
2/27/2023
Primary Sponsor
Joe Schomacker
Click for details
AI Summary
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Commissioner cannot make coverage determinations or prior authorization requirements for qualified drugs or biologic products more restrictive than FDA-approved label indications and usage sections.
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Coverage and access determinations must be consistent with medically accepted indications for the drug or biologic product.
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"Qualified drugs or biologic products" include drugs and biologics for rare diseases as defined in the federal Orphan Drug Act of 1983.
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Applies to drugs or biologics receiving FDA expedited pathways including breakthrough designation, fast track designation, accelerated approval, priority review, or regenerative medicine advanced therapy designation.
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Amends Minnesota Statutes 2022, section 256B.0625, by adding subdivision 13k.
Legislative Description
Commissioner required to adhere to Food and Drug Administration label requirements when making coverage and access determinations related to qualified drugs or biologic products.
Last Action
Introduction and first reading, referred to Health Finance and Policy
2/27/2023