Connecticut 2022 Regular Session

Connecticut Senate Bill SB00355 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1
2	2
3		-	LCO \\PRDFS1\SCOUSERS\FORZANOF\WS\2022SB-00355-R01-
4		-	SB.docx
5		-	1 of 4
6	3
7		-	General Assembly Substitute Bill No. 355
	4	+	LCO No. 2606 1 of 3
	5	+
	6	+	General Assembly Raised Bill No. 355
8	7		February Session, 2022
	8	+	LCO No. 2606
	9	+
	10	+
	11	+	Referred to Committee on INSURANCE AND REAL ESTATE
	12	+
	13	+
	14	+	Introduced by:
	15	+	(INS)
	16	+
	17	+
9	18
10	19
11	20		AN ACT ESTABLISHING THE 340B DRUG PRICING
12	21		NONDISCRIMINATION ACT.
13	22		Be it enacted by the Senate and House of Representatives in General
14	23		Assembly convened:
15	24
16	25		Section 1. (NEW) (Effective October 1, 2022) (a) For the purposes of this 1
17		-	section and section 2 of this act: 2
18		-	(1) "Covered drug" means a drug purchased by a 340B covered entity 3
19		-	that is subject to the federal pricing requirements set forth in 42 USC 4
20		-	256b, as amended from time to time. 5
21		-	(2) "340B covered entity" means a provider participating in the federal 6
22		-	340B drug pricing program authorized by 42 USC 256b, as amended 7
23		-	from time to time. 8
24		-	(3) "Drug manufacturer" means the following: 9
25		-	(A) An entity described in 42 USC 1396r-8(k)(5) that is subject to the 10
26		-	pricing limitations set forth in 42 USC 256b; and 11
27		-	(B) A wholesaler described in 42 USC 1396r-8(k)(11) engaged in the 12
28		-	distribution of covered drugs for an entity described in 42 USC 1396r-13
29		-	8(k)(5) that is subject to the pricing limitations set forth in 42 USC 256b. 14
30		-	(4) "Payer" means a pharmacy benefits manager. 15
31		-	(5) "Pharmacy benefits manager" has the same meaning as provided 16
32		-	in section 38a-479aaa of the general statutes and includes a wholly or 17 Substitute Bill No. 355
	26	+	section: 2
	27	+	(1) "340B covered entity" means an entity participating in the federal 3
	28	+	340B drug pricing program authorized by 42 USC 256b, as amended 4
	29	+	from time to time, including any pharmacy under contract with the 5
	30	+	entity to dispense drugs through such program on behalf of the entity. 6
	31	+	(2) "Patient" means an individual seeking medical diagnosis and 7
	32	+	treatment. 8
	33	+	(3) "Pharmacy" has the same meaning as provided in section 38a-9
	34	+	479aaa of the general statutes. 10
	35	+	(4) "Pharmacy benefits manager" has the same meaning as provided 11
	36	+	in section 38a-479aaa of the general statutes. 12
	37	+	(b) (1) A pharmacy benefits manager shall not disparately treat any 13 Raised Bill No. 355
33	38
34	39
35		-	LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2022SB-00355-
36		-	R01-SB.docx }
37		-	2 of 4
38	40
39		-	partially owned or controlled subsidiary of a pharmacy benefits 18
40		-	manager. 19
41		-	(6) "Specified pharmacy" means a pharmacy owned by, or under 20
42		-	contract with, a 340B covered entity that is registered with the 340B 21
43		-	discount drug purchasing program set forth in 42 USC 256b to dispense 22
44		-	covered drugs on behalf of the 340B covered entity, whether in person 23
45		-	or by mail. 24
46		-	(b) A payer shall not impose any requirements, conditions or 25
47		-	exclusions that: 26
48		-	(1) Discriminate against a 340B covered entity or a specified 27
49		-	pharmacy in connection with dispensing covered drugs; or 28
50		-	(2) Prevent a 340B covered entity from retaining the benefit of 29
51		-	discounted pricing for the purchase of covered drugs. 30
52		-	(c) Discrimination prohibited pursuant to subsection (b) of this 31
53		-	section includes: 32
54		-	(1) Payment terms, reimbursement methodologies, or other terms 33
55		-	and conditions that distinguish between covered drugs and other drugs, 34
56		-	account for the availability of discounts under the 340B discount drug 35
57		-	purchasing program set forth in 42 USC 256b in determining 36
58		-	reimbursement or are less favorable than the payment terms or 37
59		-	reimbursement methodologies for similarly situated entities that are not 38
60		-	furnishing or dispensing covered drugs; 39
61		-	(2) Terms or conditions applied to 340B covered entities or specified 40
62		-	pharmacies based on the furnishing or dispensing of covered drugs or 41
63		-	their status as a 340B covered entity or specified pharmacy, including 42
64		-	restrictions or requirements for participating in standard or preferred 43
65		-	pharmacy networks or requirements related to the frequency or scope 44
66		-	of audits; 45
67		-	(3) Requiring a 340B covered entity or specified pharmacy to identify, 46 Substitute Bill No. 355
	41	+	LCO No. 2606 2 of 3
	42	+
	43	+	340B covered entity by imposing or requiring terms of such 340B 14
	44	+	covered entity that differ from those imposed or required of other 15
	45	+	providers based solely on such 340B covered entity's eligibility or 16
	46	+	designation as a 340B covered entity. 17
	47	+	(2) Disparate terms include: 18
	48	+	(A) The exclusion of 340B eligible or 340B covered entities from 19
	49	+	provider networks; 20
	50	+	(B) Reimbursing 340B eligible or 340B covered entities for a lesser 21
	51	+	amount than the prescription drug coverage reimburses a pharmacy 22
	52	+	benefit manager affiliate for providing the same pharmacist services; 23
	53	+	and 24
	54	+	(C) Assessing any fee, charge-back, participation requirement or 25
	55	+	other adjustment upon a 340B covered entity solely on the basis that the 26
	56	+	340B covered entity participates in the federal 340B drug pricing 27
	57	+	program. 28
	58	+	(c) On and after October 1, 2022, a contract entered into between a 29
	59	+	pharmacy benefit manager and a 340B covered entity shall not contain 30
	60	+	any of the following provisions: 31
	61	+	(1) A reimbursement rate for a prescription drug that would diminish 32
	62	+	the 340B benefit to a 340B covered entity; 33
	63	+	(2) A fee or adjustment that is not imposed on providers or 34
	64	+	pharmacies that are not 340B covered entities; 35
	65	+	(3) A fee or adjustment amount that exceeds the fee or adjustment 36
	66	+	amount imposed on providers or pharmacies that are not 340B covered 37
	67	+	entities; 38
	68	+	(4) Any provision that prevents or interferes with a patient's choice 39
	69	+	to receive a prescription drug from a 340B covered entity, including the 40
	70	+	administration of the drug; 41 Raised Bill No. 355
68	71
69	72
70		-	LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2022SB-00355-
71		-	R01-SB.docx }
72		-	3 of 4
73	73
74		-	either directly or through a third-party, covered drugs or covered drug 47
75		-	costs; 48
76		-	(4) Refusing to contract with or terminating a contract with a 340B 49
77		-	covered entity or specified pharmacy, or otherwise excluding a 340B 50
78		-	covered entity or specified pharmacy from a standard or preferred 51
79		-	network, on the basis that such entity or pharmacy is a 340B covered 52
80		-	entity or a specified pharmacy or for reasons other than those that apply 53
81		-	equally to entities or pharmacies that are not 340B covered entities or 54
82		-	specified pharmacies; 55
83		-	(5) Retaliation against a 340B covered entity or specified pharmacy 56
84		-	based on its exercise of any right or remedy under this section; or 57
85		-	(6) Interfering with an individual's choice to receive a covered drug 58
86		-	from a 340B covered entity or specified pharmacy, whether in person or 59
87		-	via direct delivery, mail or other form of shipment. 60
88		-	(d) The provisions of this section do not apply to the federal Medicare 61
89		-	program and HUSKY Health program, but do apply to entities that 62
90		-	contract with the HUSKY Health program or the federal Medicare 63
91		-	program if such entities are a payer and have discretion to negotiate or 64
92		-	establish rates of payment for drugs. 65
93		-	Sec. 2. (NEW) (Effective October 1, 2022) (a) A drug manufacturer shall 66
94		-	comply with federal pricing requirements set forth in 42 USC 256b when 67
95		-	selling covered drugs to 340B covered entities located in this state and 68
96		-	shall not impose any preconditions, limitations, delays or other barriers 69
97		-	to the purchase of covered drugs that are not required under 42 USC 70
98		-	256b. 71
99		-	(b) Preconditions, limitations, delays or other barriers prohibited by 72
100		-	subsection (a) of this section include: 73
101		-	(1) Implementation of policies or limitations that restrict the ability of 74
102		-	340B covered entities or specified pharmacies to dispense covered 75
103		-	drugs, including restrictions on the number or type of locations through 76 Substitute Bill No. 355
	74	+	LCO No. 2606 3 of 3
104	75
105		-
106		-	LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2022SB-00355-
107		-	R01-SB.docx }
108		-	4 of 4
109		-
110		-	which covered drugs may be dispensed by or on behalf of a 340B 77
111		-	covered entity; 78
112		-	(2) Conditioning the sale of covered drugs for 340B covered entities 79
113		-	on enrollment with third-party vendors or on the sharing of claims 80
114		-	information or other data; 81
115		-	(3) Charging 340B covered entities for covered drugs at amounts 82
116		-	above the federal ceiling price, including policies that condition 83
117		-	discounts on rebate requests; 84
118		-	(4) Interfering with an individual's choice to receive a covered drug 85
119		-	from a 340B covered entity or specified pharmacy, whether in person or 86
120		-	via direct delivery, mail or other form of shipment; 87
121		-	(5) Delays in shipping covered drugs compared to drugs that are not 88
122		-	discounted; and 89
123		-	(6) Retaliation against a 340B covered entity or specified pharmacy 90
124		-	based on such entity's or pharmacy's exercise of any right or remedy 91
125		-	under this section. 92
126		-	(c) The Insurance Commissioner shall adopt regulations, in 93
127		-	accordance with the provisions of chapter 54 of the general statutes, to 94
128		-	implement the provisions of this section and section 1 of this act. 95
	76	+	(5) Any provision that excludes a 340B covered entity from pharmacy 42
	77	+	benefit manager networks based on the 340B cover ed entity's 43
	78	+	participation in the federal 340B Drug Pricing Program; and 44
	79	+	(6) Any provision that discriminates against a 340B covered entity. 45
	80	+	(d) For contracts between a pharmacy benefit manager and a 340B 46
	81	+	covered entity entered into, amended or renewed after October 1, 2022, 47
	82	+	to the extent any such provision violates subsection (c) of this section, 48
	83	+	such contract shall be deemed void and unenforceable. 49
	84	+	(e) The Insurance Commissioner shall adopt regulations, in 50
	85	+	accordance with the provisions of chapter 54 of the general statutes, to 51
	86	+	implement the provisions of this section. 52
129	87		This act shall take effect as follows and shall amend the following
130	88		sections:
131	89
132	90		Section 1 October 1, 2022 New section
133		-	Sec. 2 October 1, 2022 New section
134	91
135		-	Statement of ~~Legislative Commissioners~~:
136		-	~~In Section 1, Subsecs. (b)(1) and (c)(5),~~ the ~~word "and" was changed to~~
137		-	~~"or" for accuracy~~.
138		-
139		-	~~INS Joint Favorable Subst.~~
	92	+	Statement of Purpose:
	93	+	To implement the 340B Drug Pricing Nondiscrimination Act.
	94	+	[Proposed deletions are enclosed in brackets. Proposed additions are indicated by underline, except
	95	+	that when the entire text of a bill or resolution or a section of a bill or resolution is new, it is not
	96	+	underlined.]
140	97