Maryland 2025 Regular Session

Maryland Senate Bill SB646 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1
2	2
3	3		EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
4	4		[Brackets] indicate matter deleted from existing law.
5		-	Underlining indicates amendments to bill.
6		-	Strike out indicates matter stricken from the bill by amendment or deleted from the law by
7		-	amendment.
8	5		sb0646
9	6
10	7		SENATE BILL 646
11	8		J5, J4 5lr2852
12		-	CF ~~HB 970~~
	9	+	CF 5lr2851
13	10		By: Senator Muse
14	11		Introduced and read first time: January 25, 2025
15	12		Assigned to: Finance
16		-	Committee Report: Favorable with amendments
17		-	Senate action: Adopted
18		-	Read second time: March 11, 2025
19	13
20		-	~~CHAPTER ______~~
	14	+	A BILL ENTITLED
21	15
22	16		AN ACT concerning 1
23	17
24	18		Health Insurance – Insulin – Prohibition on Step Therapy or Fail–First 2
25	19		Protocols 3
26	20
27	21		FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health 4
28	22		maintenance organizations from imposing a step therapy or fail–first protocol on 5
29		-	insulin or certain other similar medications or an insulin analog used to treat an 6
30		-	insured’s or enrollee’s diabetes; and generally relating to use of step therapy and 7
31		-	fail–first protocols. 8
	23	+	insulin or certain other similar medications used to treat an insured’s or enrollee’s 6
	24	+	diabetes; and generally relating to use of step therapy and fail–first protocols. 7
32	25
33		-	BY repealing and reenacting, without amendments, 9
34		-	Article – Insurance 10
35		-	Section 15–142(a)(1) and (4) and (b) 11
36		-	Annotated Code of Maryland 12
37		-	(2017 Replacement Volume and 2024 Supplement) 13
	26	+	BY repealing and reenacting, without amendments, 8
	27	+	Article – Insurance 9
	28	+	Section 15–142(a)(1) and (4) and (b) 10
	29	+	Annotated Code of Maryland 11
	30	+	(2017 Replacement Volume and 2024 Supplement) 12
38	31
39		-	BY repealing and reenacting, with amendments, 14
40		-	Article – Insurance 15
41		-	Section 15–142(e) 16
42		-	Annotated Code of Maryland 17
43		-	(2017 Replacement Volume and 2024 Supplement) 18
	32	+	BY repealing and reenacting, with amendments, 13
	33	+	Article – Insurance 14
	34	+	Section 15–142(e) 15
	35	+	Annotated Code of Maryland 16
	36	+	(2017 Replacement Volume and 2024 Supplement) 17
44	37
45		-	SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 19
46		-	That the Laws of Maryland read as follows: 20
	38	+	SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 18
	39	+	That the Laws of Maryland read as follows: 19
47	40
48		-	Article – Insurance 21 2 SENATE BILL 646
	41	+	Article – Insurance 20
	42	+
	43	+	15–142. 21
	44	+
	45	+	(a) (1) In this section the following words have the meanings indicated. 22
	46	+
	47	+	(4) (i) “Step therapy or fail–first protocol” means a protocol established 23
	48	+	by an insurer, a nonprofit health service plan, or a health maintenance organization that 24 2 SENATE BILL 646
49	49
50	50
	51	+	requires a prescription drug or sequence of prescription drugs to be used by an insured or 1
	52	+	an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 2
	53	+	is covered. 3
51	54
52		-	15–142. 1
	55	+	(ii) “Step therapy or fail–first protocol” includes a protocol that 4
	56	+	meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 5
	57	+	or terminology used by the insurer, nonprofit health service plan, or health maintenance 6
	58	+	organization to identify the protocol. 7
53	59
54		-	(a) (1) In this section ~~the following words have the meanings indicated. 2~~
	60	+	(b) (1) This section applies to: 8
55	61
56		-	(4) (i) “Step therapy or fail–first protocol” means a protocol established 3
57		-	by an insurer, a nonprofit health service plan, or a health maintenance organization that 4
58		-	requires a prescription drug or sequence of prescription drugs to be used by an insured or 5
59		-	an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee 6
60		-	is covered. 7
	62	+	(i) insurers and nonprofit health service plans that provide hospital, 9
	63	+	medical, or surgical benefits to individuals or groups on an expense–incurred basis under 10
	64	+	health insurance policies or contracts that are issued or delivered in the State; and 11
61	65
62		-	(ii) “Step therapy or fail–first protocol” includes a protocol that 8
63		-	meets the definition under subparagraph (i) of this paragraph regardless of the name, label, 9
64		-	or terminology used by the insurer, nonprofit health service plan, or health maintenance 10
65		-	organization to identify the protocol. 11
	66	+	(ii) health maintenance organizations that provide hospital, 12
	67	+	medical, or surgical benefits to individuals or groups under contracts that are issued or 13
	68	+	delivered in the State. 14
66	69
67		-	(b) (1) This section applies to: 12
	70	+	(2) An insurer, a nonprofit health service plan, or a health maintenance 15
	71	+	organization that provides coverage for prescription drugs through a pharmacy benefits 16
	72	+	manager is subject to the requirements of this section. 17
68	73
69		-	(i) ~~insurers and nonprofit health service plans that provide hospital,~~ 13
70		-	~~medical, or surgical benefits to individuals or groups~~ on an ~~expense–incurred basis under 14~~
71		-	~~health insurance policies or contracts that are issued or delivered in the State; and 15~~
	74	+	(e) An entity subject to this section may not impose a step therapy or fail–first 18
	75	+	protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 19
	76	+	Drug Administration if: 20
72	77
73		-	(ii) health maintenance organizations that provide hospital, 16
74		-	medical, or surgical benefits to individuals or groups under contracts that are issued or 17
75		-	delivered in the State. 18
	78	+	(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 21
	79	+	stage four advanced metastatic cancer; and 22
76	80
77		-	(2) An insurer, a nonprofit health service plan, or a health maintenance 19
78		-	organization that provides coverage for prescription drugs through a pharmacy benefits 20
79		-	manager is subject to the requirements of this section. 21
	81	+	[(2)] (II) use of the prescription drug is: 23
80	82
81		-	(e) An entity subject to this section may not impose a step therapy or fail–first 22
82		-	protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 23
83		-	Drug Administration if: 24
	83	+	[(i)] 1. consistent with the U.S. Food and Drug 24
	84	+	Administration–approved indication or the National Comprehensive Cancer Network 25
	85	+	Drugs & Biologics Compendium indication for the treatment of stage four advanced 26
	86	+	metastatic cancer; and 27
84	87
85		-	(1) (I) the prescription drug is used to treat the insured’s or enrollee’s 25
86		-	stage four advanced metastatic cancer; and 26
	88	+	[(ii)] 2. supported by peer–reviewed medical literature; OR 28
87	89
88		-	[(2)~~] (II) use of~~ the prescription ~~drug~~ is: 27
	90	+	(2) THE PRESCRIPTION DRU G IS: 29
89	91
90		-	[(i)] 1. consistent with the U.S. Food and Drug 28
91		-	Administration–approved indication or the National Comprehensive Cancer Network 29
92		-	Drugs & Biologics Compendium indication for the treatment of stage four advanced 30
93		-	metastatic cancer; and 31
	92	+	(I) USED TO TREAT THE INSURED ’S OR ENROLLEE ’S TYPE 1, 30
	93	+	TYPE 2, OR GESTATIONAL DIABE TES; AND 31
94	94
95		-	[(ii)] 2. supported by peer–reviewed medical literature; OR 32
96		-
97		-	(2) THE PRESCRIPTION DRU G IS: 33 SENATE BILL 646 3
	95	+	(II) 1. INSULIN; OR 32
	96	+	SENATE BILL 646 3
98	97
99	98
	99	+	2. AN INSULIN ANALOG OR OTHER PRESCRIPTION D RUG 1
	100	+	THAT PERFORMS A SIMI LAR FUNCTION TO INSU LIN, REGARDLESS OF THE 2
	101	+	ACTIVATION PERIOD , WHETHER THE SOLUTION IS MIXED BEFORE OR AFTE R 3
	102	+	DISPENSING, OR WHETHER THE DRUG IS ADMINISTERED BY I NJECTION OR 4
	103	+	INHALATION. 5
100	104
101		-	(I) INSULIN OR AN INSULI N ANALOG USED TO TREAT THE 1
102		-	INSURED’S OR ENROLLEE ’S TYPE 1, TYPE 2, OR GESTATIONAL DIABETES ; AND 2
	105	+	SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 6
	106	+	policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 7
	107	+	after January 1, 2026. 8
103	108
104		-	(II) 1. INSULIN; OR 3
	109	+	SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 9
	110	+	January 1, 2026. 10
105	111
106		-	2. AN INSULIN ANALOG OR OTHER PRESCRIPTION D RUG 4
107		-	THAT PERFORMS A SIMI LAR FUNCTION TO INSU LIN, REGARDLESS OF THE 5
108		-	ACTIVATION PERIOD , WHETHER THE SOLUTION IS MIXED BEFORE OR A FTER 6
109		-	DISPENSING, OR WHETHER TH E DRUG IS ADMINISTER ED BY INJECTION OR 7
110		-	INHALATION. 8
111		-
112		-	SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 9
113		-	policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 10
114		-	after January 1, 2026. 11
115		-
116		-	SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 12
117		-	January 1, 2026. 13
118		-
119		-
120		-
121		-
122		-	Approved:
123		-	________________________________________________________________________________
124		-	Governor.
125		-	________________________________________________________________________________
126		-	President of the Senate.
127		-	________________________________________________________________________________
128		-	Speaker of the House of Delegates.