62Q.83 FORMULARY CHANGES.
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62Q.83 FORMULARY CHANGES.
§
Subdivision 1. Definitions.
(a)For purposes of this section, the following terms have the meanings given.
(b)"Drug" has the meaning given in section 151.01, subdivision 5 .
(c)"Enrollee" has the meaning given in section 62Q.01, subdivision 2b .
(d)"Formulary" means a current list of covered prescription drug products that is subject to periodic review and update.
(e)"Health plan" has the meaning given in section 62Q.01, subdivision 3 .
(f)"Pharmacy benefit manager" has the meaning given in section 62W.02, subdivision 15.
(g)"Prescription" has the meaning given in section 151.01, subdivision 16a .
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Subd. 2. Formulary changes.
(a)Except as provided in paragraphs
(b)and (c), a health plan must not, with respect to an enrollee who was previously prescribed the drug during the plan year, remove a drug from the health plan's formulary or place a drug in a benefit category that increases the enrollee's cost for the duration of the enrollee's plan year.
(b)Paragraph
(a)does not apply if a health plan changes the health plan's formulary:
(1)for a drug that has been deemed unsafe by the United States Food and Drug Administration (FDA);
(2)for a drug that has been withdrawn by the FDA or the drug manufacturer; or
(3)when an independent source of research, clinical guidelines, or evidence-based standards has issued drug-specific warnings or recommended changes with respect to a drug's use for reasons related to previously unknown and imminent patient harm.
(c)Paragraph
(a)does not apply if a health plan removes a brand name drug from the health plan's formulary or places a brand name drug in a benefit category that increases the enrollee's cost if the health plan:
(1)adds to the health plan's formulary a generic or multisource brand name drug rated as therapeutically equivalent according to the FDA Orange Book, a biologic drug rated as interchangeable according to the FDA Purple Book, or a biosimilar at the same or lower cost to the enrollee; and
(2)provides at least a 60-day notice to prescribers, pharmacists, and affected enrollees.