United States HR 4390: PROTECT 340B Act of 2021

Bill Text

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117TH CONGRESS
1ST SESSION H. R. 4390
To amend title XXVII of the Public Health Service Act to ensure the
equitable treatment of covered entities and pharmacies participating in
the 340B drug discount program, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JULY 9, 2021
Mr. MCKINLEY (for himself and Ms. SPANBERGER) introduced the following
bill; which was referred to the Committee on Energy and Commerce, and
in addition to the Committee on Ways and Means, for a period to be sub-
sequently determined by the Speaker, in each case for consideration of
such provisions as fall within the jurisdiction of the committee concerned
A BILL
To amend title XXVII of the Public Health Service Act
to ensure the equitable treatment of covered entities and
pharmacies participating in the 340B drug discount pro-
gram, and for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Preserving Rules Or-4
dered for The Entities Covered Through 340B Act of 5
2021’’ or the ‘‘PROTECT 340B Act of 2021’’. 6
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SEC. 2. FINDINGS AND PURPOSE. 1
(a) FINDINGS.—Congress finds the following: 2
(1) The 340B drug pricing program is an es-3
sential part of the Nation’s health care safety net. 4
(2) 340B enables safety-net providers to stretch 5
scarce resources further to offer services and treat 6
patients through the savings these providers receive 7
under the program. 8
(3) 340B savings support hospitals, clinics, and 9
health centers’ care for patients who have low in-10
comes, including those with low incomes enrolled in 11
Medicare and Medicaid. 12
(4) 340B savings are critically important to 13
rural hospitals that operate on very slim margins 14
and serve patients in isolated areas with limited ac-15
cess to health care. 16
(5) 340B supports care for those in need with-17
out using taxpayer dollars. 18
(6) Some commercial payers and pharmacy ben-19
efit managers are paying less to 340B covered enti-20
ties and their contract pharmacies for 340B drugs, 21
requiring identification of 340B drug claims or oth-22
erwise discriminating against 340B covered entities 23
and their contract pharmacies on the basis of their 24
status as providers or pharmacies that dispense 25
340B drugs. 26
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(7) These types of discriminatory actions un-1
dermine the purpose of the 340B program and harm 2
the patients served by 340B covered entities. Com-3
mercial payers and pharmacy benefit managers’ im-4
position of requirements on a 340B pharmacy be-5
cause it is a pharmacy that dispenses 340B drugs, 6
or requirements with respect to the use of and bill-7
ing for drugs purchased under 340B because they 8
are 340B drugs is inconsistent with public policy be-9
cause of the deleterious effects on the nation’s 10
health care safety net. 11
(b) PURPOSES.—The purposes of this Act are the fol-12
lowing: 13
(1) To prohibit discriminatory actions, includ-14
ing several specified actions, by a pharmacy benefit 15
manager, a group health plan, a health insurance 16
issuer offering group or individual health insurance, 17
or a sponsor of a Medicare part D prescription drug 18
plan against 340B covered entities and their phar-19
macies and requiring them to be treated as any 20
other provider or pharmacy. 21
(2) To provide for the imposition of civil mone-22
tary penalties on pharmacy benefit managers that 23
violate the new protections and require the Health 24
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Services and Resources Administration to promul-1
gate implementing regulations. 2
(3) To authorize the Secretary to contract with 3
a third-party entity to collect and review data from 4
State Medicaid agencies and covered entities to pre-5
vent Medicaid duplicate discounts. 6
SEC. 3. ENSURING THE EQUITABLE TREATMENT OF COV-7
ERED ENTITIES AND PHARMACIES PARTICI-8
PATING IN THE 340B DRUG DISCOUNT PRO-9
GRAM. 10
(a) GROUP HEALTH PLAN AND HEALTH INSURANCE 11
ISSUER REQUIREMENTS.—Subpart II of part A of title 12
XXVII of the Public Health Service Act (42 U.S.C. 13
300gg–11 et seq.) is amended by adding at the end the 14
following new section: 15
‘‘SEC. 2730. REQUIREMENTS RELATING TO THE 340B DRUG 16
DISCOUNT PROGRAM. 17
‘‘(a) IN GENERAL.—A group health plan, a health 18
insurance issuer offering group or individual health insur-19
ance coverage, or a pharmacy benefit manager may not 20
discriminate against a covered entity (as defined in sub-21
section (d)(1)) or a specified pharmacy (as defined i