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. 1Section 1. S1806-1 1st EngrossmentSF1806 REVISOR RSI SENATE STATE OF MINNESOTA S.F. No. 1806NINETY-FOURTH SESSION (SENATE AUTHORS: MANN, Wiklund, Lieske, Gruenhagen and Pha) OFFICIAL STATUSD-PGDATE Introduction and first reading48202/24/2025 Referred to Commerce and Consumer Protection Comm report: To pass as amended and re-refer to Health and Human Services03/13/2025 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has been deemed unsafe by the United States Food and Drug 2.3Administration (FDA); 2.4 (2) for a drug that has been withdrawn by the FDA or the drug manufacturer; or 2.5 (3) when an independent source of research, clinical guidelines, or evidence-based 2.6standards has issued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 2Sec. 2. S1806-1 1st EngrossmentSF1806 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 3Sec. 2. S1806-1 1st EngrossmentSF1806 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. 4Sec. 2. S1806-1 1st EngrossmentSF1806 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. 5Sec. 2. S1806-1 1st EngrossmentSF1806 REVISOR RSI