1.1 	A bill for an act
1.2 	relating to health; prohibiting certain formulary changes during the plan year; 
1.3 	prohibiting the medical assistance program from implementing changes to its 
1.4 	formulary for certain enrollees;amending Minnesota Statutes 2024, section 
1.5 	256B.0625, subdivision 13; proposing coding for new law in Minnesota Statutes, 
1.6 	chapter 62Q.
1.7 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.8 	Section 1. [62Q.83] FORMULARY CHANGES.
1.9 		Subdivision 1.Definitions. (a) For purposes of this section, the following terms have 
1.10 	the meanings given.
1.11 	(b) "Drug" has the meaning given in section 151.01, subdivision 5.
1.12 	(c) "Enrollee" has the meaning given in section 62Q.01, subdivision 2b.
1.13 	(d) "Formulary" means a current list of covered prescription drug products that is subject 
1.14 	to periodic review and update.
1.15 	(e) "Health plan" has the meaning given in section 62Q.01, subdivision 3.
1.16 	(f) "Pharmacy benefit manager" has the meaning given in section 62W.02, subdivision 
1.17 	15.
1.18 	(g) "Prescription" has the meaning given in section 151.01, subdivision 16a.
1.19 		Subd. 2.Formulary changes. (a) Except as provided in paragraphs (b) and (c), a health 
1.20 	plan must not, with respect to an enrollee who was previously prescribed the drug during 
1.21 	the plan year, remove a drug from the health plan's formulary or place a drug in a benefit 
1.22 	category that increases the enrollee's cost for the duration of the enrollee's plan year.
2.1 	(b) Paragraph (a) does not apply if a health plan changes the health plan's formulary:
2.2 	(1) for a drug that has been deemed unsafe by the United States Food and Drug 
2.3 	Administration (FDA);
2.4 	(2) for a drug that has been withdrawn by the FDA or the drug manufacturer; or
2.5 	(3) when an independent source of research, clinical guidelines, or evidence-based 
2.6 	standards has issued drug-specific warnings or recommended changes with respect to a 
2.7 	drug's use for reasons related to previously unknown and imminent patient harm.
2.8 	(c) Paragraph (a) does not apply if a health plan removes a brand name drug from the 
2.9 	health plan's formulary or places a brand name drug in a benefit category that increases the 
2.10 	enrollee's cost if the health plan:
2.11 	(1) adds to the health plan's formulary a generic or multisource brand name drug rated 
2.12 	as therapeutically equivalent according to the FDA Orange Book, or a biologic drug rated 
2.13 	as interchangeable according to the FDA Purple Book, at a lower cost to the enrollee; and
2.14 	(2) provides at least a 60-day notice to prescribers, pharmacists, and affected enrollees.

2.15 	EFFECTIVE DATE. This section is effective January 1, 2026, and applies to health 
2.16 	plans offered, sold, issued, or renewed on or after that date.

2.17 	Sec. 2. Minnesota Statutes 2024, section 256B.0625, subdivision 13, is amended to read:
2.18 		Subd. 13.Drugs. (a) Medical assistance covers drugs, except for fertility drugs when 
2.19 	specifically used to enhance fertility, if prescribed by a licensed practitioner and dispensed 
2.20 	by a licensed pharmacist, by a physician enrolled in the medical assistance program as a 
2.21 	dispensing physician, or by a physician, a physician assistant, or an advanced practice 
2.22 	registered nurse employed by or under contract with a community health board as defined 
2.23 	in section 145A.02, subdivision 5, for the purposes of communicable disease control.
2.24 	(b) The dispensed quantity of a prescription drug must not exceed a 34-day supply unless 
2.25 	authorized by the commissioner or as provided in paragraph (h) or the drug appears on the 
2.26 	90-day supply list published by the commissioner. The 90-day supply list shall be published 
2.27 	by the commissioner on the department's website. The commissioner may add to, delete 
2.28 	from, and otherwise modify the 90-day supply list after providing public notice and the 
2.29 	opportunity for a 15-day public comment period. The 90-day supply list may include 
2.30 	cost-effective generic drugs and shall not include controlled substances.
2.31 	(c) For the purpose of this subdivision and subdivision 13d, an "active pharmaceutical 
2.32 	ingredient" is defined as a substance that is represented for use in a drug and when used in 
3.1 	the manufacturing, processing, or packaging of a drug becomes an active ingredient of the 
3.2 	drug product. An "excipient" is defined as an inert substance used as a diluent or vehicle 
3.3 	for a drug. The commissioner shall establish a list of active pharmaceutical ingredients and 
3.4 	excipients which are included in the medical assistance formulary. Medical assistance covers 
3.5 	selected active pharmaceutical ingredients and excipients used in compounded prescriptions 
3.6 	when the compounded combination is specifically approved by the commissioner or when 
3.7 	a commercially available product:
3.8 	(1) is not a therapeutic option for the patient;
3.9 	(2) does not exist in the same combination of active ingredients in the same strengths 
3.10 	as the compounded prescription; and
3.11 	(3) cannot be used in place of the active pharmaceutical ingredient in the compounded 
3.12 	prescription.
3.13 	(d) Medical assistance covers the following over-the-counter drugs when prescribed by 
3.14 	a licensed practitioner or by a licensed pharmacist who meets standards established by the 
3.15 	commissioner, in consultation with the board of pharmacy: antacids, acetaminophen, family 
3.16 	planning products, aspirin, insulin, products for the treatment of lice, vitamins for adults 
3.17 	with documented vitamin deficiencies, vitamins for children under the age of seven and 
3.18 	pregnant or nursing women, and any other over-the-counter drug identified by the 
3.19 	commissioner, in consultation with the Formulary Committee, as necessary, appropriate, 
3.20 	and cost-effective for the treatment of certain specified chronic diseases, conditions, or 
3.21 	disorders, and this determination shall not be subject to the requirements of chapter 14. A 
3.22 	pharmacist may prescribe over-the-counter medications as provided under this paragraph 
3.23 	for purposes of receiving reimbursement under Medicaid. When prescribing over-the-counter 
3.24 	drugs under this paragraph, licensed pharmacists must consult with the recipient to determine 
3.25 	necessity, provide drug counseling, review drug therapy for potential adverse interactions, 
3.26 	and make referrals as needed to other health care professionals.
3.27 	(e) Effective January 1, 2006, medical assistance shall not cover drugs that are coverable 
3.28 	under Medicare Part D as defined in the Medicare Prescription Drug, Improvement, and 
3.29 	Modernization Act of 2003, Public Law 108-173, section 1860D-2(e), for individuals eligible 
3.30 	for drug coverage as defined in the Medicare Prescription Drug, Improvement, and 
3.31 	Modernization Act of 2003, Public Law 108-173, section 1860D-1(a)(3)(A). For these 
3.32 	individuals, medical assistance may cover drugs from the drug classes listed in United States 
3.33 	Code, title 42, section 1396r-8(d)(2), subject to this subdivision and subdivisions 13a to 
4.1 	13g, except that drugs listed in United States Code, title 42, section 1396r-8(d)(2)(E), shall 
4.2 	not be covered.
4.3 	(f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing 
4.4 	Program and dispensed by 340B covered entities and ambulatory pharmacies under common 
4.5 	ownership of the 340B covered entity. Medical assistance does not cover drugs acquired 
4.6 	through the federal 340B Drug Pricing Program and dispensed by 340B contract pharmacies.
4.7 	(g) Notwithstanding paragraph (a), medical assistance covers self-administered hormonal 
4.8 	contraceptives prescribed and dispensed by a licensed pharmacist in accordance with section 
4.9 	151.37, subdivision 14; nicotine replacement medications prescribed and dispensed by a 
4.10 	licensed pharmacist in accordance with section 151.37, subdivision 15; and opiate antagonists 
4.11 	used for the treatment of an acute opiate overdose prescribed and dispensed by a licensed 
4.12 	pharmacist in accordance with section 151.37, subdivision 16.
4.13 	(h) Medical assistance coverage for a prescription contraceptive must provide a 12-month 
4.14 	supply for any prescription contraceptive if a 12-month supply is prescribed by the 
4.15 	prescribing health care provider. The prescribing health care provider must determine the 
4.16 	appropriate duration for which to prescribe the prescription contraceptives, up to 12 months. 
4.17 	For purposes of this paragraph, "prescription contraceptive" means any drug or device that 
4.18 	requires a prescription and is approved by the Food and Drug Administration to prevent 
4.19 	pregnancy. Prescription contraceptive does not include an emergency contraceptive drug 
4.20 	approved to prevent pregnancy when administered after sexual contact. For purposes of this 
4.21 	paragraph, "health plan" has the meaning provided in section 62Q.01, subdivision 3.
4.22 	(i) Notwithstanding a removal of a drug from the drug formulary under subdivision 13d, 
4.23 	except as provided in paragraphs (j) and (k), medical assistance covers a drug, with respect 
4.24 	to an enrollee who was previously prescribed the drug during the calendar year and while 
4.25 	the drug was on the formulary, at the same level until January 1 of the calendar year following 
4.26 	the year in which the commissioner removed the drug from the formulary.
4.27 	(j) Paragraph (i) does not apply if the commissioner changes the drug formulary:
4.28 	(1) for a drug that has been deemed unsafe by the United States Food and Drug 
4.29 	Administration (FDA);
4.30 	(2) for a drug that has been withdrawn by the FDA or the drug manufacturer; or
4.31 	(3) when an independent source of research, clinical guidelines, or evidence-based 
4.32 	standards has issued drug-specific warnings or recommended changes with respect to a 
4.33 	drug's use for reasons related to previously unknown and imminent patient harm.
5.1 	(k) Paragraph (i) does not apply if the commissioner removes a brand name drug from 
5.2 	the formulary if the commissioner:
5.3 	(1) adds to the formulary a generic or multisource brand name drug rated as 
5.4 	therapeutically equivalent according to the FDA Orange Book, or a biologic drug rated as 
5.5 	interchangeable according to the FDA Purple Book, at the same or lower cost to the enrollee; 
5.6 	and
5.7 	(2) provides at least a 60-day notice to prescribers, pharmacists, and affected enrollees.

5.8 	EFFECTIVE DATE. This section is effective January 1, 2026, or upon federal approval, 
5.9 	whichever is later. The commissioner of human services shall notify the revisor of statutes 
5.10 	when federal approval is obtained.