HF 2261

as introduced - 93rd Legislature (2023 - 2024) Posted on 02/27/2023 03:06pm

A bill for an act
relating to human services; requiring the commissioner to adhere to Food and Drug
Administration label requirements when making coverage and access determinations
related to qualified drugs or biologic products; amending Minnesota Statutes 2022,
section 256B.0625, by adding a subdivision.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2022, section 256B.0625, is amended by adding a subdivision
to read:

new text begin Subd. 13k. new text end

new text begin Coverage and access determinations. new text end

new text begin (a) The commissioner, when adopting
and implementing a preferred drug list and prior authorization requirements and making
other decisions related to drug coverage and enrollee access to drugs, shall not make
determinations or recommendations related to qualified drugs or biologic products that are
more restrictive than the indications and usage section of the label approved by the Food
and Drug Administration. The determinations and recommendations must also be consistent
with the medically accepted indication of the drug or biologic product.
new text end

new text begin (b) For purposes of this subdivision, "qualified drugs or biologic products" means:
new text end

new text begin (1) drugs and biologic products for rare diseases, as defined in the federal Orphan Drug
Act of 1983, Public Law 97-414; and
new text end

new text begin (2) drugs or biologic products designated or approved through any of the following
expedited pathways established by the Food and Drug Administration for treatment of a
serious or life-threatening illness: (i) breakthrough designation, (ii) fast track designation,
(iii) accelerated approval pathway, (iv) priority review, or (v) regenerative medicine advanced
therapy designation.
new text end