[Congressional Record Volume 167, Number 137 (Monday, August 2, 2021)]
[Senate]
[Pages S5625-S5626]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2225. Mr. BRAUN submitted an amendment intended to be proposed to
amendment SA 2137 proposed by Mr. Schumer (for Ms. Sinema (for herself,
Mr. Portman, Mr. Manchin, Mr. Cassidy, Mrs. Shaheen, Ms. Collins, Mr.
Tester, Ms. Murkowski, Mr. Warner, and Mr. Romney)) to the bill H.R.
3684, to authorize funds for Federal-aid highways, highway safety
programs, and transit programs, and for other purposes; which was
ordered to lie on the table; as follows:
In division I, strike section 90006 and insert the
following:
SEC. 90006. REQUIREMENTS FOR PRESCRIPTION DRUG BENEFITS.
(a) Removal of Safe Harbor Protection for Rebates Involving
Prescription Drugs and Establishment of New Safe Harbor
Protections Involving Prescription Drugs.--
(1) Removal of safe harbor protection for rebates involving
prescription drugs.--Section 1128B(b) of the Social Security
Act (42 U.S.C. 1320a-7b(b)) is amended--
(A) in paragraph (3)(A), by striking ``a discount'' and
inserting ``subject to paragraph (5), a discount''; and
(B) by adding at the end the following:
``(5) Removal of safe harbor protection for rebates
involving prescription drugs.--The safe harbor described in
paragraph (3)(A) shall not apply to a reduction in price or
other remuneration from a manufacturer of prescription drugs
to a sponsor of a prescription drug plan under part D of
title XVIII, an MA organization offering an MA-PD plan under
part C of such title, or a pharmacy benefit manager under
contract with such a sponsor or such an organization and,
except as provided in subparagraphs (L) and (M) of paragraph
(3), paragraphs (1) and (2) shall apply to any such reduction
in price or other remuneration.''.
(2) Establishment of new safe harbor protections involving
prescription drugs .--Section 1128B(b)(3) of the Social
Security Act (42 U.S.C. 1320a-7b(b)(3)) is amended--
(A) in subparagraph (J), by striking ``and'' at the end;
(B) in subparagraph (K), by striking the period at the end
and inserting a semicolon; and
(C) by adding at the end the following:
``(L) a reduction in price offered by a manufacturer of
prescription drugs to a sponsor of a prescription drug plan
under part D of title XVIII, an MA organization offering an
MA-PD plan under part C of such title, or a pharmacy benefit
manager under contract with such a sponsor or such an
organization, that is reflected at the point of sale to the
individual and meets such other conditions as the Secretary
may establish; and
``(M) flat fee service fees a manufacturer of prescription
drugs pays to a pharmacy benefit manager for services
rendered to the manufacturer that relate to arrangements by
the pharmacy benefit manager to provide pharmacy benefit
management services to a health plan, if certain conditions
established by the Secretary are met, including requirements
that the fees are transparent to the health plan.''.
(3) Effective date.--The amendments made by this subsection
shall take effect on January 1, 2023.
(b) Requirements for Private Insurance Plans.--
(1) In general.--Part D of title XXVII of the Public Health
Service Act (42 U.S.C. 300gg-111 et seq.) is amended by
adding at the end the following:
``SEC. 2799A-11. REQUIREMENTS WITH RESPECT TO PRESCRIPTION
DRUG BENEFITS.
``(a) In General.--A group health plan or a health
insurance issuer offering group or individual health
insurance coverage shall not, and shall ensure that any
entity that provides pharmacy benefits management services
under a contract with any such health plan or health
insurance coverage does not, receive from a drug manufacturer
a reduction in price or other remuneration with respect to
any prescription drug received by an enrollee in the plan or
coverage and covered by the plan or coverage, unless--
``(1) any such reduction in price is reflected at the point
of sale to the enrollee and meets such other conditions as
the Secretary may establish; and
``(2) any such other remuneration is a flat fee-based
service fee that a manufacturer of prescription drugs pays to
an entity that provides pharmacy benefits management services
for services rendered to the manufacturer that relate to
arrangements by the pharmacy benefit manager to provide
pharmacy benefit management services to a health plan or
health insurance issuer, if certain conditions established by
the Secretary are met, including requirements that the fees
are transparent to the health plan or health insurance
issuer.
``(b) Entity That Provides Pharmacy Benefits Management
Services.--For purposes of this section, the term `entity
that provides pharmacy benefits management services' means--
``(1) any person, business, or other entity that, pursuant
to a written agreement with a group health plan or a health
insurance issuer offering group or individual health
insurance coverage, directly or through an intermediary--
``(A) acts as a price negotiator on behalf of the plan or
coverage; or
``(B) manages the prescription drug benefits provided by
the plan or coverage, which may include the processing and
payment of claims for prescription drugs, the performance of
drug utilization review, the processing of drug prior
authorization requests, the adjudication of appeals or
grievances related to the prescription drug benefit,
contracting with network pharmacies, controlling the cost of
covered prescription drugs, or the provision of related
services; or
``(2) any entity that is owned, affiliated, or related
under a common ownership structure with a person, business,
or entity described in paragraph (1).''.
(2) ERISA.--
(A) In general.--Subpart B of part 7 of subtitle B of title
I of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1185 et seq.) is amended by adding at the end the
following:
``SEC. 726. REQUIREMENTS WITH RESPECT TO PRESCRIPTION DRUG
BENEFITS.
``(a) In General.--A group health plan or a health
insurance issuer offering group health insurance coverage
shall not, and shall ensure that any entity that provides
pharmacy benefits management services under a contract with
any such health plan or health insurance coverage does not,
receive from a drug manufacturer a reduction in price or
other remuneration with respect to any prescription drug
received by an enrollee in the plan or coverage and covered
by the plan or coverage, unless--
``(1) any such reduction in price is reflected at the point
of sale to the enrollee and meets such other conditions as
the Secretary may establish; and
``(2) any such other remuneration is a flat fee-based
service fee that a manufacturer of prescription drugs pays to
an entity that provides pharmacy benefits management services
for services rendered to the manufacturer that relate to
arrangements by the pharmacy benefit manager to provide
pharmacy benefit management services to a health plan or
health insurance issuer, if certain conditions established by
the Secretary are met, including requirements that the fees
are transparent to the health plan or health insurance
issuer.
``(b) Entity That Provides Pharmacy Benefits Management
Services.--For purposes of this section, the term `entity
that provides pharmacy benefits management services' means--
[[Page S5626]]
``(1) any person, business, or other entity that, pursuant
to a written agreement with a group health plan or a health
insurance issuer offering group health insurance coverage,
directly or through an intermediary--
``(A) acts as a price negotiator on behalf of the plan or
coverage; or
``(B) manages the prescription drug benefits provided by
the plan or coverage, which may include the processing and
payment of claims for prescription drugs, the performance of
drug utilization review, the processing of drug prior
authorization requests, the adjudication of appeals or
grievances related to the prescription drug benefit,
contracting with network pharmacies, controlling the cost of
covered prescription drugs, or the provision of related
services; or
``(2) any entity that is owned, affiliated, or related
under a common ownership structure with a person, business,
or entity described in paragraph (1).''.
(B) Clerical amendment.--The table of contents of the
Employee Retirement Income Security Act of 1974 is amended by
inserting after the item relating to section 725 the
following:
``Sec. 725. Requirements with respect to prescription drug benefits.''.
(3) IRC.--
(A) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986 is amended by adding at the end
the following:
``SEC. 9826. REQUIREMENTS WITH RESPECT TO PRESCRIPTION DRUG
BENEFITS.
``(a) In General.--A group health plan shall not, and shall
ensure that any entity that provides pharmacy benefits
management services under a contract with any such health
plan does not, receive from a drug manufacturer a reduction
in price or other remuneration with respect to any
prescription drug received by an enrollee in the plan and
covered by the plan, unless--
``(1) any such reduction in price is reflected at the point
of sale to the enrollee and meets such other conditions as
the Secretary may establish; and
``(2) any such other remuneration is a flat fee-based
service fee that a manufacturer of prescription drugs pays to
an entity that provides pharmacy benefits management services
for services rendered to the manufacturer that relate to
arrangements by the pharmacy benefit manager to provide
pharmacy benefit management services to a health plan, if
certain conditions established by the Secretary are met,
including requirements that the fees are transparent to the
health plan.
``(b) Entity That Provides Pharmacy Benefits Management
Services.--For purposes of this section, the term `entity
that provides pharmacy benefits management services' means--
``(1) any person, business, or other entity that, pursuant
to a written agreement with a group health plan, directly or
through an intermediary--
``(A) acts as a price negotiator on behalf of the plan; or
``(B) manages the prescription drug benefits provided by
the plan, which may include the processing and payment of
claims for prescription drugs, the performance of drug
utilization review, the processing of drug prior
authorization requests, the adjudication of appeals or
grievances related to the prescription drug benefit,
contracting with network pharmacies, controlling the cost of
covered prescription drugs, or the provision of related
services; or
``(2) any entity that is owned, affiliated, or related
under a common ownership structure with a person, business,
or entity described in paragraph (1).''.
(B) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of the Internal Revenue Code of
1986 is amended by adding at the end the following:
``Sec. 9816. Requirements with respect to prescription drug
benefits.''.
(4) Effective date.--The amendments made by paragraphs (1),
(2), and (3) shall take effect on January 1, 2023.
______