SF 1806

1st Engrossment - 94th Legislature (2025 - 2026)

Posted on 07/09/2025 08:53 a.m.

A bill for an act
relating to health; prohibiting certain formulary changes during the plan year;
prohibiting the medical assistance program from implementing changes to its
formulary for certain enrollees; amending Minnesota Statutes 2024, section
256B.0625, subdivision 13; proposing coding for new law in Minnesota Statutes,
chapter 62Q.

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

Section 1.

new text begin [62Q.83] FORMULARY CHANGES.
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 terms have
the meanings given.
new text end

new text begin (b) "Drug" has the meaning given in section 151.01, subdivision 5.
new text end

new text begin (c) "Enrollee" has the meaning given in section 62Q.01, subdivision 2b.
new text end

new text begin (d) "Formulary" means a current list of covered prescription drug products that is subject
to periodic review and update.
new text end

new text begin (e) "Health plan" has the meaning given in section 62Q.01, subdivision 3.
new text end

new text begin (f) "Pharmacy benefit manager" has the meaning given in section 62W.02, subdivision
15.
new text end

new text begin (g) "Prescription" has the meaning given in section 151.01, subdivision 16a.
new text end

new text begin Subd. 2. new text end

new text begin Formulary changes. new text end

new text begin (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.
new text end

new text begin (b) Paragraph (a) does not apply if a health plan changes the health plan's formulary:
new text end

new text begin (1) for a drug that has been deemed unsafe by the United States Food and Drug
Administration (FDA);
new text end

new text begin (2) for a drug that has been withdrawn by the FDA or the drug manufacturer; or
new text end

new text begin (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.
new text end

new text begin (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:
new text end

new text begin (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, or a biologic drug rated
as interchangeable according to the FDA Purple Book, at a lower cost to the enrollee; and
new text end

new text begin (2) provides at least a 60-day notice to prescribers, pharmacists, and affected enrollees.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2026, and applies to health
plans offered, sold, issued, or renewed on or after that date.
new text end

Sec. 2.

Minnesota Statutes 2024, section 256B.0625, subdivision 13, is amended to read:

Subd. 13.

Drugs.

(a) Medical assistance covers drugs, except for fertility drugs when
specifically used to enhance fertility, if prescribed by a licensed practitioner and dispensed
by a licensed pharmacist, by a physician enrolled in the medical assistance program as a
dispensing physician, or by a physician, a physician assistant, or an advanced practice
registered nurse employed by or under contract with a community health board as defined
in section 145A.02, subdivision 5, for the purposes of communicable disease control.

(b) The dispensed quantity of a prescription drug must not exceed a 34-day supply unless
authorized by the commissioner or as provided in paragraph (h) or the drug appears on the
90-day supply list published by the commissioner. The 90-day supply list shall be published
by the commissioner on the department's website. The commissioner may add to, delete
from, and otherwise modify the 90-day supply list after providing public notice and the
opportunity for a 15-day public comment period. The 90-day supply list may include
cost-effective generic drugs and shall not include controlled substances.

(c) For the purpose of this subdivision and subdivision 13d, an "active pharmaceutical
ingredient" is defined as a substance that is represented for use in a drug and when used in
the manufacturing, processing, or packaging of a drug becomes an active ingredient of the
drug product. An "excipient" is defined as an inert substance used as a diluent or vehicle
for a drug. The commissioner shall establish a list of active pharmaceutical ingredients and
excipients which are included in the medical assistance formulary. Medical assistance covers
selected active pharmaceutical ingredients and excipients used in compounded prescriptions
when the compounded combination is specifically approved by the commissioner or when
a commercially available product:

(1) is not a therapeutic option for the patient;

(2) does not exist in the same combination of active ingredients in the same strengths
as the compounded prescription; and

(3) cannot be used in place of the active pharmaceutical ingredient in the compounded
prescription.

(d) Medical assistance covers the following over-the-counter drugs when prescribed by
a licensed practitioner or by a licensed pharmacist who meets standards established by the
commissioner, in consultation with the board of pharmacy: antacids, acetaminophen, family
planning products, aspirin, insulin, products for the treatment of lice, vitamins for adults
with documented vitamin deficiencies, vitamins for children under the age of seven and
pregnant or nursing women, and any other over-the-counter drug identified by the
commissioner, in consultation with the Formulary Committee, as necessary, appropriate,
and cost-effective for the treatment of certain specified chronic diseases, conditions, or
disorders, and this determination shall not be subject to the requirements of chapter 14. A
pharmacist may prescribe over-the-counter medications as provided under this paragraph
for purposes of receiving reimbursement under Medicaid. When prescribing over-the-counter
drugs under this paragraph, licensed pharmacists must consult with the recipient to determine
necessity, provide drug counseling, review drug therapy for potential adverse interactions,
and make referrals as needed to other health care professionals.

(e) Effective January 1, 2006, medical assistance shall not cover drugs that are coverable
under Medicare Part D as defined in the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Public Law 108-173, section 1860D-2(e), for individuals eligible
for drug coverage as defined in the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Public Law 108-173, section 1860D-1(a)(3)(A). For these
individuals, medical assistance may cover drugs from the drug classes listed in United States
Code, title 42, section 1396r-8(d)(2), subject to this subdivision and subdivisions 13a to
13g, except that drugs listed in United States Code, title 42, section 1396r-8(d)(2)(E), shall
not be covered.

(f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing
Program and dispensed by 340B covered entities and ambulatory pharmacies under common
ownership of the 340B covered entity. Medical assistance does not cover drugs acquired
through the federal 340B Drug Pricing Program and dispensed by 340B contract pharmacies.

(g) Notwithstanding paragraph (a), medical assistance covers self-administered hormonal
contraceptives prescribed and dispensed by a licensed pharmacist in accordance with section
151.37, subdivision 14; nicotine replacement medications prescribed and dispensed by a
licensed pharmacist in accordance with section 151.37, subdivision 15; and opiate antagonists
used for the treatment of an acute opiate overdose prescribed and dispensed by a licensed
pharmacist in accordance with section 151.37, subdivision 16.

(h) Medical assistance coverage for a prescription contraceptive must provide a 12-month
supply for any prescription contraceptive if a 12-month supply is prescribed by the
prescribing health care provider. The prescribing health care provider must determine the
appropriate duration for which to prescribe the prescription contraceptives, up to 12 months.
For purposes of this paragraph, "prescription contraceptive" means any drug or device that
requires a prescription and is approved by the Food and Drug Administration to prevent
pregnancy. Prescription contraceptive does not include an emergency contraceptive drug
approved to prevent pregnancy when administered after sexual contact. For purposes of this
paragraph, "health plan" has the meaning provided in section 62Q.01, subdivision 3.

new text begin (i) Notwithstanding a removal of a drug from the drug formulary under subdivision 13d,
except as provided in paragraphs (j) and (k), medical assistance covers a drug, with respect
to an enrollee who was previously prescribed the drug during the calendar year and while
the drug was on the formulary, at the same level until January 1 of the calendar year following
the year in which the commissioner removed the drug from the formulary.
new text end

new text begin (j) Paragraph (i) does not apply if the commissioner changes the drug formulary:
new text end

new text begin (1) for a drug that has been deemed unsafe by the United States Food and Drug
Administration (FDA);
new text end

new text begin (2) for a drug that has been withdrawn by the FDA or the drug manufacturer; or
new text end

new text begin (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.
new text end

new text begin (k) Paragraph (i) does not apply if the commissioner removes a brand name drug from
the formulary if the commissioner:
new text end

new text begin (1) adds to the formulary a generic or multisource brand name drug rated as
therapeutically equivalent according to the FDA Orange Book, or a biologic drug rated as
interchangeable according to the FDA Purple Book, at the same or lower cost to the enrollee;
and
new text end

new text begin (2) provides at least a 60-day notice to prescribers, pharmacists, and affected enrollees.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2026, or upon federal approval,
whichever is later. The commissioner of human services shall notify the revisor of statutes
when federal approval is obtained.
new text end