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Capital IconMinnesota Legislature

SF 3400

as introduced - 91st Legislature (2019 - 2020) Posted on 03/17/2020 11:40am

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to health; allowing pharmacy and provider choice related to the prescribing
and dispensing of biological products; amending Minnesota Statutes 2018, sections
151.01, by adding subdivisions; 256B.0625, by adding a subdivision; 256L.03,
by adding a subdivision; 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 42.
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 43.
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

Sec. 2.

Minnesota Statutes 2018, section 151.01, is amended by adding a subdivision to
read:


new text begin Subd. 42. 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

Sec. 3.

Minnesota Statutes 2018, section 151.01, is amended by adding a subdivision to
read:


new text begin Subd. 43. 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

Sec. 4.

Minnesota Statutes 2018, section 256B.0625, is amended by adding a subdivision
to read:


new text begin Subd. 13k. new text end

new text begin Biological products. new text end

new text begin Drug coverage and reimbursement under medical
assistance must comply with section 62W.0751.
new text end

Sec. 5.

Minnesota Statutes 2018, section 256L.03, is amended by adding a subdivision to
read:


new text begin Subd. 3c. new text end

new text begin Biological products. new text end

new text begin Drug coverage and reimbursement under MinnesotaCare
must comply with section 62W.0751.
new text end