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General Assembly Substitute Bill No. 355
February Session, 2022
AN ACT ESTABLISHING THE 340B DRUG PRICING
NONDISCRIMINATION ACT.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. (NEW) (Effective October 1, 2022) (a) For the purposes of this 1
section and section 2 of this act: 2
(1) "Covered drug" means a drug purchased by a 340B covered entity 3
that is subject to the federal pricing requirements set forth in 42 USC 4
256b, as amended from time to time. 5
(2) "340B covered entity" means a provider participating in the federal 6
340B drug pricing program authorized by 42 USC 256b, as amended 7
from time to time. 8
(3) "Drug manufacturer" means the following: 9
(A) An entity described in 42 USC 1396r-8(k)(5) that is subject to the 10
pricing limitations set forth in 42 USC 256b; and 11
(B) A wholesaler described in 42 USC 1396r-8(k)(11) engaged in the 12
distribution of covered drugs for an entity described in 42 USC 1396r-13
8(k)(5) that is subject to the pricing limitations set forth in 42 USC 256b. 14
(4) "Payer" means a pharmacy benefits manager. 15
(5) "Pharmacy benefits manager" has the same meaning as provided 16
in section 38a-479aaa of the general statutes and includes a wholly or 17 Substitute Bill No. 355
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partially owned or controlled subsidiary of a pharmacy benefits 18
manager. 19
(6) "Specified pharmacy" means a pharmacy owned by, or under 20
contract with, a 340B covered entity that is registered with the 340B 21
discount drug purchasing program set forth in 42 USC 256b to dispense 22
covered drugs on behalf of the 340B covered entity, whether in person 23
or by mail. 24
(b) A payer shall not impose any requirements, conditions or 25
exclusions that: 26
(1) Discriminate against a 340B covered entity or a specified 27
pharmacy in connection with dispensing covered drugs; or 28
(2) Prevent a 340B covered entity from retaining the benefit of 29
discounted pricing for the purchase of covered drugs. 30
(c) Discrimination prohibited pursuant to subsection (b) of this 31
section includes: 32
(1) Payment terms, reimbursement methodologies, or other terms 33
and conditions that distinguish between covered drugs and other drugs, 34
account for the availability of discounts under the 340B discount drug 35
purchasing program set forth in 42 USC 256b in determining 36
reimbursement or are less favorable than the payment terms or 37
reimbursement methodologies for similarly situated entities that are not 38
furnishing or dispensing covered drugs; 39
(2) Terms or conditions applied to 340B covered entities or specified 40
pharmacies based on the furnishing or dispensing of covered drugs or 41
their status as a 340B covered entity or specified pharmacy, including 42
restrictions or requirements for participating in standard or preferred 43
pharmacy networks or requirements related to the frequency or scope 44
of audits; 45
(3) Requiring a 340B covered entity or specified pharmacy to identify, 46 Substitute Bill No. 355
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either directly or through a third-party, covered drugs or covered drug 47
costs; 48
(4) Refusing to contract with or terminating a contract with a 340B 49
covered entity or specified pharmacy, or otherwise excluding a 340B 50
covered entity or specified pharmacy from a standard or preferred 51
network, on the basis that such entity or pharmacy is a 340B covered 52
entity or a specified pharmacy or for reasons other than those that apply 53
equally to entities or pharmacies that are not 340B covered entities or 54
specified pharmacies; 55
(5) Retaliation against a 340B covered entity or specified pharmacy 56
based on its exercise of any right or remedy under this section; or 57
(6) Interfering with an individual's choice to receive a covered drug 58
from a 340B covered entity or specified pharmacy, whether in person or 59
via direct delivery, mail or other form of shipment. 60
(d) The provisions of this section do not apply to the federal Medicare 61
program and HUSKY Health program, but do apply to entities that 62
contract with the HUSKY Health program or the federal Medicare 63
program if such entities are a payer and have discretion to negotiate or 64
establish rates of payment for drugs. 65
Sec. 2. (NEW) (Effective October 1, 2022) (a) A drug manufacturer shall 66
comply with federal pricing requirements set forth in 42 USC 256b when 67
selling covered drugs to 340B covered entities located in this state and 68
shall not impose any preconditions, limitations, delays or other barriers 69
to the purchase of covered drugs that are not required under 42 USC 70
256b. 71
(b) Preconditions, limitations, delays or other barriers prohibited by 72
subsection (a) of this section include: 73
(1) Implementation of policies or limitations that restrict the ability of 74
340B covered entities or specified pharmacies to dispense covered 75
drugs, including restrictions on the number or type of locations through 76 Substitute Bill No. 355
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which covered drugs may be dispensed by or on behalf of a 340B 77
covered entity; 78
(2) Conditioning the sale of covered drugs for 340B covered entities 79
on enrollment with third-party vendors or on the sharing of claims 80
information or other data; 81
(3) Charging 340B covered entities for covered drugs at amounts 82
above the federal ceiling price, including policies that condition 83
discounts on rebate requests; 84
(4) Interfering with an individual's choice to receive a covered drug 85
from a 340B covered entity or specified pharmacy, whether in person or 86
via direct delivery, mail or other form of shipment; 87
(5) Delays in shipping covered drugs compared to drugs that are not 88
discounted; and 89
(6) Retaliation against a 340B covered entity or specified pharmacy 90
based on such entity's or pharmacy's exercise of any right or remedy 91
under this section. 92
(c) The Insurance Commissioner shall adopt regulations, in 93
accordance with the provisions of chapter 54 of the general statutes, to 94
implement the provisions of this section and section 1 of this act. 95
This act shall take effect as follows and shall amend the following
sections:
Section 1 October 1, 2022 New section
Sec. 2 October 1, 2022 New section
Statement of Legislative Commissioners:
In Section 1, Subsecs. (b)(1) and (c)(5), the word "and" was changed to
"or" for accuracy.
INS Joint Favorable Subst.