Minnesota 2025-2026 Regular Session

Minnesota Senate Bill SF1806 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1		1.1 A bill for an act
2	2		1.2 relating to health; prohibiting certain formulary changes during the plan year;
3		-	1.3 prohibiting the medical assistance program from implementing changes to its
4		-	1.4 formulary for certain enrollees; amending Minnesota Statutes 2024, section
5		-	1.5 256B.0625, subdivision 13; proposing coding for new law in Minnesota Statutes,
6		-	1.6 chapter 62Q.
7		-	1.7BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
8		-	1.8 Section 1. [62Q.83] FORMULARY CHANGES.
9		-	1.9 Subdivision 1.Definitions.(a) For purposes of this section, the following terms have
10		-	1.10the meanings given.
11		-	1.11 (b) "Drug" has the meaning given in section 151.01, subdivision 5.
12		-	1.12 (c) "Enrollee" has the meaning given in section 62Q.01, subdivision 2b.
13		-	1.13 (d) "Formulary" means a current list of covered prescription drug products that is subject
14		-	1.14to periodic review and update.
15		-	1.15 (e) "Health plan" has the meaning given in section 62Q.01, subdivision 3.
16		-	1.16 (f) "Pharmacy benefit manager" has the meaning given in section 62W.02, subdivision
17		-	1.1715.
18		-	1.18 (g) "Prescription" has the meaning given in section 151.01, subdivision 16a.
19		-	1.19 Subd. 2.Formulary changes.(a) Except as provided in paragraphs (b) and (c), a health
20		-	1.20plan must not, with respect to an enrollee who was previously prescribed the drug during
21		-	1.21the plan year, remove a drug from the health plan's formulary or place a drug in a benefit
22		-	1.22category that increases the enrollee's cost for the duration of the enrollee's plan year.
	3	+	1.3 proposing coding for new law in Minnesota Statutes, chapter 62Q.
	4	+	1.4BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
	5	+	1.5 Section 1. [62Q.83] FORMULARY CHANGES.
	6	+	1.6 Subdivision 1.Definitions.(a) For purposes of this section, the following terms have
	7	+	1.7the meanings given.
	8	+	1.8 (b) "Drug" has the meaning given in section 151.01, subdivision 5.
	9	+	1.9 (c) "Enrollee" has the meaning given in section 62Q.01, subdivision 2b.
	10	+	1.10 (d) "Formulary" means a current list of covered prescription drug products that is subject
	11	+	1.11to periodic review and update.
	12	+	1.12 (e) "Health plan" has the meaning given in section 62Q.01, subdivision 3.
	13	+	1.13 (f) "Pharmacy benefit manager" has the meaning given in section 62W.02, subdivision
	14	+	1.1415.
	15	+	1.15 (g) "Prescription" has the meaning given in section 151.01, subdivision 16a.
	16	+	1.16 Subd. 2.Formulary changes.(a) Except as provided in paragraphs (b) and (c), a health
	17	+	1.17plan must not, with respect to an enrollee who was previously prescribed the drug during
	18	+	1.18the plan year, remove a drug from the health plan's formulary or place a drug in a benefit
	19	+	1.19category that increases the enrollee's cost for the duration of the enrollee's plan year.
	20	+	1.20 (b) Paragraph (a) does not apply if a health plan changes the health plan's formulary:
23	21		1Section 1.
24		-	~~S1806-1 1st Engrossment~~~~SF1806~~ REVISOR RSI
	22	+	25-03002 as introduced02/17/25 REVISOR RSI/AC
25	23		SENATE
26	24		STATE OF MINNESOTA
27	25		S.F. No. 1806NINETY-FOURTH SESSION
28		-	(SENATE AUTHORS: MANN, Wiklund, Lieske~~, Gruenhagen~~ and ~~Pha~~)
	26	+	(SENATE AUTHORS: MANN, Wiklund, Lieske and Gruenhagen)
29	27		OFFICIAL STATUSD-PGDATE
30		-	Introduction and first reading48202/24/2025
31		-	Referred to Commerce and Consumer Protection
32		-	Comm report: To pass as amended and re-refer to Health and Human Services03/13/2025
33		-	Author added Pha 2.1 (b) Paragraph (a) does not apply if a health plan changes the health plan's formulary:
34		-	2.2 (1) for a drug that has been deemed unsafe by the United States Food and Drug
35		-	2.3Administration (FDA);
36		-	2.4 (2) for a drug that has been withdrawn by the FDA or the drug manufacturer; or
37		-	2.5 (3) when an independent source of research, clinical guidelines, or evidence-based
38		-	2.6standards has issued drug-specific warnings or recommended changes with respect to a
39		-	2.7drug's use for reasons related to previously unknown and imminent patient harm.
40		-	2.8 (c) Paragraph (a) does not apply if a health plan removes a brand name drug from the
41		-	2.9health plan's formulary or places a brand name drug in a benefit category that increases the
42		-	2.10enrollee's cost if the health plan:
43		-	2.11 (1) adds to the health plan's formulary a generic or multisource brand name drug rated
44		-	2.12as therapeutically equivalent according to the FDA Orange Book, or a biologic drug rated
45		-	2.13as interchangeable according to the FDA Purple Book, at a lower cost to the enrollee; and
46		-	2.14 (2) provides at least a 60-day notice to prescribers, pharmacists, and affected enrollees.
47		-	2.15 EFFECTIVE DATE.This section is effective January 1, 2026, and applies to health
48		-	2.16plans offered, sold, issued, or renewed on or after that date.
49		-	2.17 Sec. 2. Minnesota Statutes 2024, section 256B.0625, subdivision 13, is amended to read:
50		-	2.18 Subd. 13.Drugs.(a) Medical assistance covers drugs, except for fertility drugs when
51		-	2.19specifically used to enhance fertility, if prescribed by a licensed practitioner and dispensed
52		-	2.20by a licensed pharmacist, by a physician enrolled in the medical assistance program as a
53		-	2.21dispensing physician, or by a physician, a physician assistant, or an advanced practice
54		-	2.22registered nurse employed by or under contract with a community health board as defined
55		-	2.23in section 145A.02, subdivision 5, for the purposes of communicable disease control.
56		-	2.24 (b) The dispensed quantity of a prescription drug must not exceed a 34-day supply unless
57		-	2.25authorized by the commissioner or as provided in paragraph (h) or the drug appears on the
58		-	2.2690-day supply list published by the commissioner. The 90-day supply list shall be published
59		-	2.27by the commissioner on the department's website. The commissioner may add to, delete
60		-	2.28from, and otherwise modify the 90-day supply list after providing public notice and the
61		-	2.29opportunity for a 15-day public comment period. The 90-day supply list may include
62		-	2.30cost-effective generic drugs and shall not include controlled substances.
63		-	2.31 (c) For the purpose of this subdivision and subdivision 13d, an "active pharmaceutical
64		-	2.32ingredient" is defined as a substance that is represented for use in a drug and when used in
65		-	2Sec. 2.
66		-	S1806-1 1st EngrossmentSF1806 REVISOR RSI 3.1the manufacturing, processing, or packaging of a drug becomes an active ingredient of the
67		-	3.2drug product. An "excipient" is defined as an inert substance used as a diluent or vehicle
68		-	3.3for a drug. The commissioner shall establish a list of active pharmaceutical ingredients and
69		-	3.4excipients which are included in the medical assistance formulary. Medical assistance covers
70		-	3.5selected active pharmaceutical ingredients and excipients used in compounded prescriptions
71		-	3.6when the compounded combination is specifically approved by the commissioner or when
72		-	3.7a commercially available product:
73		-	3.8 (1) is not a therapeutic option for the patient;
74		-	3.9 (2) does not exist in the same combination of active ingredients in the same strengths
75		-	3.10as the compounded prescription; and
76		-	3.11 (3) cannot be used in place of the active pharmaceutical ingredient in the compounded
77		-	3.12prescription.
78		-	3.13 (d) Medical assistance covers the following over-the-counter drugs when prescribed by
79		-	3.14a licensed practitioner or by a licensed pharmacist who meets standards established by the
80		-	3.15commissioner, in consultation with the board of pharmacy: antacids, acetaminophen, family
81		-	3.16planning products, aspirin, insulin, products for the treatment of lice, vitamins for adults
82		-	3.17with documented vitamin deficiencies, vitamins for children under the age of seven and
83		-	3.18pregnant or nursing women, and any other over-the-counter drug identified by the
84		-	3.19commissioner, in consultation with the Formulary Committee, as necessary, appropriate,
85		-	3.20and cost-effective for the treatment of certain specified chronic diseases, conditions, or
86		-	3.21disorders, and this determination shall not be subject to the requirements of chapter 14. A
87		-	3.22pharmacist may prescribe over-the-counter medications as provided under this paragraph
88		-	3.23for purposes of receiving reimbursement under Medicaid. When prescribing over-the-counter
89		-	3.24drugs under this paragraph, licensed pharmacists must consult with the recipient to determine
90		-	3.25necessity, provide drug counseling, review drug therapy for potential adverse interactions,
91		-	3.26and make referrals as needed to other health care professionals.
92		-	3.27 (e) Effective January 1, 2006, medical assistance shall not cover drugs that are coverable
93		-	3.28under Medicare Part D as defined in the Medicare Prescription Drug, Improvement, and
94		-	3.29Modernization Act of 2003, Public Law 108-173, section 1860D-2(e), for individuals eligible
95		-	3.30for drug coverage as defined in the Medicare Prescription Drug, Improvement, and
96		-	3.31Modernization Act of 2003, Public Law 108-173, section 1860D-1(a)(3)(A). For these
97		-	3.32individuals, medical assistance may cover drugs from the drug classes listed in United States
98		-	3.33Code, title 42, section 1396r-8(d)(2), subject to this subdivision and subdivisions 13a to
99		-	3Sec. 2.
100		-	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
101		-	4.2not be covered.
102		-	4.3 (f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing
103		-	4.4Program and dispensed by 340B covered entities and ambulatory pharmacies under common
104		-	4.5ownership of the 340B covered entity. Medical assistance does not cover drugs acquired
105		-	4.6through the federal 340B Drug Pricing Program and dispensed by 340B contract pharmacies.
106		-	4.7 (g) Notwithstanding paragraph (a), medical assistance covers self-administered hormonal
107		-	4.8contraceptives prescribed and dispensed by a licensed pharmacist in accordance with section
108		-	4.9151.37, subdivision 14; nicotine replacement medications prescribed and dispensed by a
109		-	4.10licensed pharmacist in accordance with section 151.37, subdivision 15; and opiate antagonists
110		-	4.11used for the treatment of an acute opiate overdose prescribed and dispensed by a licensed
111		-	4.12pharmacist in accordance with section 151.37, subdivision 16.
112		-	4.13 (h) Medical assistance coverage for a prescription contraceptive must provide a 12-month
113		-	4.14supply for any prescription contraceptive if a 12-month supply is prescribed by the
114		-	4.15prescribing health care provider. The prescribing health care provider must determine the
115		-	4.16appropriate duration for which to prescribe the prescription contraceptives, up to 12 months.
116		-	4.17For purposes of this paragraph, "prescription contraceptive" means any drug or device that
117		-	4.18requires a prescription and is approved by the Food and Drug Administration to prevent
118		-	4.19pregnancy. Prescription contraceptive does not include an emergency contraceptive drug
119		-	4.20approved to prevent pregnancy when administered after sexual contact. For purposes of this
120		-	4.21paragraph, "health plan" has the meaning provided in section 62Q.01, subdivision 3.
121		-	4.22 (i) Notwithstanding a removal of a drug from the drug formulary under subdivision 13d,
122		-	4.23except as provided in paragraphs (j) and (k), medical assistance covers a drug, with respect
123		-	4.24to an enrollee who was previously prescribed the drug during the calendar year and while
124		-	4.25the drug was on the formulary, at the same level until January 1 of the calendar year following
125		-	4.26the year in which the commissioner removed the drug from the formulary.
126		-	4.27 (j) Paragraph (i) does not apply if the commissioner changes the drug formulary:
127		-	4.28 (1) for a drug that has been deemed unsafe by the United States Food and Drug
128		-	4.29Administration (FDA);
129		-	4.30 (2) for a drug that has been withdrawn by the FDA or the drug manufacturer; or
130		-	4.31 (3) when an independent source of research, clinical guidelines, or evidence-based
131		-	4.32standards has issued drug-specific warnings or recommended changes with respect to a
132		-	4.33drug's use for reasons related to previously unknown and imminent patient harm.
133		-	4Sec. 2.
134		-	S1806-1 1st EngrossmentSF1806 REVISOR RSI 5.1 (k) Paragraph (i) does not apply if the commissioner removes a brand name drug from
135		-	5.2the formulary if the commissioner:
136		-	5.3 (1) adds to the formulary a generic or multisource brand name drug rated as
137		-	5.4therapeutically equivalent according to the FDA Orange Book, or a biologic drug rated as
138		-	5.5interchangeable according to the FDA Purple Book, at the same or lower cost to the enrollee;
139		-	5.6and
140		-	5.7 (2) provides at least a 60-day notice to prescribers, pharmacists, and affected enrollees.
141		-	5.8 EFFECTIVE DATE.This section is effective January 1, 2026, or upon federal approval,
142		-	5.9whichever is later. The commissioner of human services shall notify the revisor of statutes
143		-	5.10when federal approval is obtained.
144		-	5Sec. 2.
145		-	S1806-1 1st EngrossmentSF1806 REVISOR RSI
	28	+	Introduction and first reading02/24/2025
	29	+	Referred to Commerce and Consumer Protection 2.1 (1) for a drug that has been deemed unsafe by the United States Food and Drug
	30	+	2.2Administration (FDA);
	31	+	2.3 (2) for a drug that has been withdrawn by the FDA or the drug manufacturer; or
	32	+	2.4 (3) when an independent source of research, clinical guidelines, or evidence-based
	33	+	2.5standards has issued drug-specific warnings or recommended changes with respect to a
	34	+	2.6drug's use for reasons related to previously unknown and imminent patient harm.
	35	+	2.7 (c) Paragraph (a) does not apply if a health plan removes a brand name drug from the
	36	+	2.8health plan's formulary or places a brand name drug in a benefit category that increases the
	37	+	2.9enrollee's cost if the health plan:
	38	+	2.10 (1) adds to the health plan's formulary a generic or multisource brand name drug rated
	39	+	2.11as therapeutically equivalent according to the FDA Orange Book, or a biologic drug rated
	40	+	2.12as interchangeable according to the FDA Purple Book, at a lower cost to the enrollee; and
	41	+	2.13 (2) provides at least a 60-day notice to prescribers, pharmacists, and affected enrollees.
	42	+	2.14 EFFECTIVE DATE.This section is effective January 1, 2026, and applies to health
	43	+	2.15plans offered, sold, issued, or renewed on or after that date.
	44	+	2Section 1.
	45	+	25-03002 as introduced02/17/25 REVISOR RSI/AC