Minnesota 2025 2025-2026 Regular Session

Minnesota Senate Bill SF1806 Engrossed / Bill

Filed 03/13/2025

                    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.​
1.7BE 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​
1.10the 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​
1.14to 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​
1.1715.​
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​
1.20plan must not, with respect to an enrollee who was previously prescribed the drug during​
1.21the plan year, remove a drug from the health plan's formulary or place a drug in a benefit​
1.22category that increases the enrollee's cost for the duration of the enrollee's plan year.​
1​Section 1.​
S1806-1 1st Engrossment​SF1806 REVISOR RSI​
SENATE​
STATE OF MINNESOTA​
S.F. No. 1806​NINETY-FOURTH SESSION​
(SENATE AUTHORS: MANN, Wiklund, Lieske, Gruenhagen and Pha)​
OFFICIAL STATUS​D-PG​DATE​
Introduction and first reading​482​02/24/2025​
Referred to Commerce and Consumer Protection​
Comm report: To pass as amended and re-refer to Health and Human Services​03/13/2025​
Author added Pha​ 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​
2.3Administration (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2.4 (2) for a drug that has been withdrawn by the FDA or the drug manufacturer; or​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​
2.6standards has issued drug-specific warnings or recommended changes with respect to a​
2.7drug'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​
2.9health plan's formulary or places a brand name drug in a benefit category that increases the​
2.10enrollee's cost if the health plan:​
2.11 (1) adds to the health plan's formulary a generic or multisource brand name drug rated​
2.12as therapeutically equivalent according to the FDA Orange Book, or a biologic drug rated​
2.13as 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​
2.16plans 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​
2.19specifically used to enhance fertility, if prescribed by a licensed practitioner and dispensed​
2.20by a licensed pharmacist, by a physician enrolled in the medical assistance program as a​
2.21dispensing physician, or by a physician, a physician assistant, or an advanced practice​
2.22registered nurse employed by or under contract with a community health board as defined​
2.23in 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​
2.25authorized by the commissioner or as provided in paragraph (h) or the drug appears on the​
2.2690-day supply list published by the commissioner. The 90-day supply list shall be published​
2.27by the commissioner on the department's website. The commissioner may add to, delete​
2.28from, and otherwise modify the 90-day supply list after providing public notice and the​
2.29opportunity for a 15-day public comment period. The 90-day supply list may include​
2.30cost-effective generic drugs and shall not include controlled substances.​
2.31 (c) For the purpose of this subdivision and subdivision 13d, an "active pharmaceutical​
2.32ingredient" is defined as a substance that is represented for use in a drug and when used in​
2​Sec. 2.​
S1806-1 1st Engrossment​SF1806 REVISOR RSI​ 3.1the manufacturing, processing, or packaging of a drug becomes an active ingredient of the​
3.2drug product. An "excipient" is defined as an inert substance used as a diluent or vehicle​
3.3for a drug. The commissioner shall establish a list of active pharmaceutical ingredients and​
3.4excipients which are included in the medical assistance formulary. Medical assistance covers​
3.5selected active pharmaceutical ingredients and excipients used in compounded prescriptions​
3.6when the compounded combination is specifically approved by the commissioner or when​
3.7a 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​
3.10as the compounded prescription; and​
3.11 (3) cannot be used in place of the active pharmaceutical ingredient in the compounded​
3.12prescription.​
3.13 (d) Medical assistance covers the following over-the-counter drugs when prescribed by​
3.14a licensed practitioner or by a licensed pharmacist who meets standards established by the​
3.15commissioner, in consultation with the board of pharmacy: antacids, acetaminophen, family​
3.16planning products, aspirin, insulin, products for the treatment of lice, vitamins for adults​
3.17with documented vitamin deficiencies, vitamins for children under the age of seven and​
3.18pregnant or nursing women, and any other over-the-counter drug identified by the​
3.19commissioner, in consultation with the Formulary Committee, as necessary, appropriate,​
3.20and cost-effective for the treatment of certain specified chronic diseases, conditions, or​
3.21disorders, and this determination shall not be subject to the requirements of chapter 14. A​
3.22pharmacist may prescribe over-the-counter medications as provided under this paragraph​
3.23for purposes of receiving reimbursement under Medicaid. When prescribing over-the-counter​
3.24drugs under this paragraph, licensed pharmacists must consult with the recipient to determine​
3.25necessity, provide drug counseling, review drug therapy for potential adverse interactions,​
3.26and 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​
3.28under Medicare Part D as defined in the Medicare Prescription Drug, Improvement, and​
3.29Modernization Act of 2003, Public Law 108-173, section 1860D-2(e), for individuals eligible​
3.30for drug coverage as defined in the Medicare Prescription Drug, Improvement, and​
3.31Modernization Act of 2003, Public Law 108-173, section 1860D-1(a)(3)(A). For these​
3.32individuals, medical assistance may cover drugs from the drug classes listed in United States​
3.33Code, title 42, section 1396r-8(d)(2), subject to this subdivision and subdivisions 13a to​
3​Sec. 2.​
S1806-1 1st Engrossment​SF1806 REVISOR RSI​ 4.113g, except that drugs listed in United States Code, title 42, section 1396r-8(d)(2)(E), shall​
4.2not be covered.​
4.3 (f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing​
4.4Program and dispensed by 340B covered entities and ambulatory pharmacies under common​
4.5ownership of the 340B covered entity. Medical assistance does not cover drugs acquired​
4.6through the federal 340B Drug Pricing Program and dispensed by 340B contract pharmacies.​
4.7 (g) Notwithstanding paragraph (a), medical assistance covers self-administered hormonal​
4.8contraceptives prescribed and dispensed by a licensed pharmacist in accordance with section​
4.9151.37, subdivision 14; nicotine replacement medications prescribed and dispensed by a​
4.10licensed pharmacist in accordance with section 151.37, subdivision 15; and opiate antagonists​
4.11used for the treatment of an acute opiate overdose prescribed and dispensed by a licensed​
4.12pharmacist in accordance with section 151.37, subdivision 16.​
4.13 (h) Medical assistance coverage for a prescription contraceptive must provide a 12-month​
4.14supply for any prescription contraceptive if a 12-month supply is prescribed by the​
4.15prescribing health care provider. The prescribing health care provider must determine the​
4.16appropriate duration for which to prescribe the prescription contraceptives, up to 12 months.​
4.17For purposes of this paragraph, "prescription contraceptive" means any drug or device that​
4.18requires a prescription and is approved by the Food and Drug Administration to prevent​
4.19pregnancy. Prescription contraceptive does not include an emergency contraceptive drug​
4.20approved to prevent pregnancy when administered after sexual contact. For purposes of this​
4.21paragraph, "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,​
4.23except as provided in paragraphs (j) and (k), medical assistance covers a drug, with respect​
4.24to an enrollee who was previously prescribed the drug during the calendar year and while​
4.25the drug was on the formulary, at the same level until January 1 of the calendar year following​
4.26the 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​
4.29Administration (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​
4.32standards has issued drug-specific warnings or recommended changes with respect to a​
4.33drug's use for reasons related to previously unknown and imminent patient harm.​
4​Sec. 2.​
S1806-1 1st Engrossment​SF1806 REVISOR RSI​ 5.1 (k) Paragraph (i) does not apply if the commissioner removes a brand name drug from​
5.2the formulary if the commissioner:​
5.3 (1) adds to the formulary a generic or multisource brand name drug rated as​
5.4therapeutically equivalent according to the FDA Orange Book, or a biologic drug rated as​
5.5interchangeable according to the FDA Purple Book, at the same or lower cost to the enrollee;​
5.6and​
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,​
5.9whichever is later. The commissioner of human services shall notify the revisor of statutes​
5.10when federal approval is obtained.​
5​Sec. 2.​
S1806-1 1st Engrossment​SF1806 REVISOR RSI​