HF 1516

as introduced - 92nd Legislature (2021 - 2022) Posted on 02/01/2022 11:40am

A bill for an act
relating to health; allowing pharmacy and provider choice related to the prescribing
and dispensing of biological products; requiring a report; amending Minnesota
Statutes 2020, section 151.01, by adding subdivisions; proposing coding for new
law in Minnesota Statutes, chapter 62W.

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

Section 1.

new text begin [62W.0751] ALTERNATIVE BIOLOGICAL PRODUCTS.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the following definitions
have the meanings given them.
new text end

new text begin (b) "Biological product" has the meaning provided in section 151.01, subdivision 40.
new text end

new text begin (c) "Biosimilar" or "biosimilar product" has the meaning provided in section 151.01,
subdivision 43.
new text end

new text begin (d) "Interchangeable biological product" has the meaning provided in section 151.01,
subdivision 41.
new text end

new text begin (e) "Reference biological product" has the meaning provided in section 151.01,
subdivision 44.
new text end

new text begin Subd. 2. new text end

new text begin Pharmacy and provider choice related to dispensing reference biological
products, interchangeable biological products, or biosimilar products. new text end

new text begin (a) A pharmacy
benefit manager or health carrier must not require or demonstrate a preference for a pharmacy
or health care provider to prescribe or dispense any of the following:
new text end

new text begin (1) a reference biological product;
new text end

new text begin (2) any product that is biosimilar to the reference biological product; or
new text end

new text begin (3) any product that is an interchangeable biological product, relative to the reference
biological product.
new text end

new text begin (b) If a pharmacy benefit manager or health carrier elects coverage of a product listed
in paragraph (a), clauses (1) to (3), it must also elect equivalent coverage for all of the
products listed in paragraph (a), clauses (1) to (3).
new text end

new text begin (c) Nothing in this section must require switching from a prescribed product listed in
paragraph (a), clauses (1) to (3), to another product listed in paragraph (a), clauses (1) to
(3), that has a higher retail price.
new text end

new text begin (d) This section does not apply to coverage provided through a public health care program
under chapter 256B or 256L, or health plan coverage through the State Employee Group
Insurance Plan (SEGIP) under chapter 43A.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2022.
new text end

Sec. 2.

Minnesota Statutes 2020, section 151.01, is amended by adding a subdivision to
read:

new text begin Subd. 43. new text end

new text begin Biosimilar product. new text end

new text begin "Biosimilar" or "biosimilar product" means a biological
product that the United States Food and Drug Administration has:
new text end

new text begin (1) licensed, and determined to be "biosimilar" under United States Code, title 42, section
262(i)(2);
new text end

new text begin (2) determined to be "biosimilar," as set forth in the most recent edition or supplement
of the United States Food and Drug Administration publication titled "Lists of Licensed
Biological Products with Reference Product Exclusivity and Biosimilarity or
Interchangeability Evaluations"; or
new text end

new text begin (3) determined to be therapeutically equivalent, as set forth in the most recent edition
or supplement of the United States Food and Drug Administration publication titled
"Approved Drug Products with Therapeutic Equivalence Evaluations."
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2022.
new text end

Sec. 3.

Minnesota Statutes 2020, section 151.01, is amended by adding a subdivision to
read:

new text begin Subd. 44. new text end

new text begin Reference biological product. new text end

new text begin "Reference biological product" means the
single biological product for which the United States Food and Drug Administration has
approved an initial biological product license application, against which other biological
products are evaluated for licensure as biosimilar products or interchangeable biological
products.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2022.
new text end

Sec. 4. new text begin STUDY OF PHARMACY AND PROVIDER CHOICE OF BIOLOGICAL
PRODUCTS.
new text end

new text begin The commissioner of health, within the limits of existing resources, shall analyze the
effect of Minnesota Statutes, section 62W.0751, on the net price for different payors of
biological products, interchangeable biological products, and biosimilar products. The
commissioner of health shall report findings to the chairs and ranking minority members
of the legislative committees with jurisdiction over health and human services policy and
finance, and insurance, by December 15, 2023.
new text end