[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3285 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 3285
To establish patient protections with respect to highly rebated drugs.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 15, 2023
Mr. Griffith introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
Education and the Workforce, and Ways and Means, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
To establish patient protections with respect to highly rebated drugs.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Fairness for Patient Medications
Act''.
SEC. 2. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR HIGHLY REBATED
DRUGS.
(a) PHSA.--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 COST-SHARING FOR HIGHLY
REBATED DRUGS.
``(a) In General.--No later than April 1, 2024, and annually
thereafter, the Secretary shall certify (or recertify, if applicable)
as a `highly rebated drug' any drug identified in reports submitted
under sections 2799A-10, 725 of the Employee Retirement Income Security
Act, and 9825 of the Internal Revenue Code of 1986 for which total
rebates, reductions in price, and other forms of remuneration in the
previous year aggregated across all commercial markets exceeded 50
percent of total annual spending on such drug in such year.
``(b) Deductible and Cost-Sharing Limitations for Certified
Drugs.--For plan years that begin on or after January 1, 2025, a group
health plan or a health insurance issuer offering group or individual
health insurance coverage (or entity that provides pharmacy benefits
management services on behalf of such a plan or issuer) that provides
coverage of any highly rebated drug shall not impose cost-sharing in
excess of, per 30-day supply, the quotient of the annual net price paid
by such group health plan or health insurance issuer (or entity that
provides pharmacy benefits management services on behalf of such a plan
or issuer), in the most recent calendar year for which a final net
price has been calculated by such plan or coverage (or entity that
provides pharmacy benefit management services on behalf of such plan or
issuer), per 30-day supply of such specific highly rebated drug,
divided by 12.
``(c) Highly Rebated Drug Previously Subject to Formulary
Exclusion.--Beginning on January 1, 2025, in the case of a specific
highly rebated drug covered by a group health plan or health insurance
issuer offering group or individual health insurance coverage (or
entity that provides pharmacy benefits management services on behalf of
such plan or issuer) that provides coverage of a specific highly
rebated drug that was not covered in the previous year, such group
health plan or health insurance issuer shall not receive from a drug
manufacturer a reduction in price or other remuneration with respect to
such specific highly rebated 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
``(2) any such other remuneration is a flat fee-based
service fee not contingent on total volume of sales that a
manufacturer of prescription drugs pays to an entity that
provides pharmacy benefits management services.
``(d) Definitions.--In this section:
``(1) Entity that provides pharmacy benefits management
services.--The term `entity that provides pharmacy benefits
management services' means--
``(A) any 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--
``(i) acts as a price negotiator on behalf
of the plan or coverage; or
``(ii) 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
``(B) any entity that is owned, affiliated, or
related under a common ownership structure with an
entity described in subparagraph (A).
``(2) Net price.--The term `net price', with respect to a
prescription drug, means the final price paid by a group health
plan or health insurance issuer offering group or individual
health insurance coverage (or entity that provides pharmacy
benefits management services on behalf of such a plan or
issuer) after applying any rebates and other remuneration under
the plan or coverage from drug manufacturers during the plan
year.
``(e) Specification.--A health insurance plan will not fail to be
treated as an HDHP for complying with the cost-sharing cap in this
section.''.
(b) ERISA.--
(1) 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. 725. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR HIGHLY
REBATED DRUGS.
``(a) In General.--No later than April 1, 2024, and annually
thereafter, the Secretary shall certify (or recertify, if applicable)
as a `highly rebated drug' any drug identified in reports submitted
under sections 725, 2799A-10 of the Public Health Service Act, and 9825
of the Internal Revenue Code of 1986 for which total rebates,
reductions in price, and other forms of remuneration in the previous
year aggregated across all commercial markets exceeded 50 percent of
total annual spending on such drug in such year.
``(b) Deductible and Cost-Sharing Limitations for Certified
Drugs.--For plan years that begin on or after January 1, 2025, a group
health plan or a health insurance issuer offering group health
insurance coverage (or entity that provides pharmacy benefits
management services on behalf of such a plan or issuer) that provides
coverage of any highly rebated drug shall not impose cost-sharing in
excess of, per 30-day supply, the quotient of the annual net price paid
by such group health plan or health insurance issuer (or entity that
provides pharmacy benefits management services on behalf of such a plan
or issuer), in the most recent calendar year for which a final net
price has been calculated by such plan or coverage (or entity that
provides pharmacy benefit management services on behalf of such plan or
issuer), per 30-day supply of such specific highly rebated drug,
divided by 12.
``(c) Highly Rebated Drug Previously Subject to Formulary
Exclusion.--Beginning on January 1, 2025, in the case of a specific
highly rebated drug covered by a group health plan or health insurance
issuer offering group health insurance coverage (or entity that
provides pharmacy benefits management services on behalf of such plan
or issuer) that provides coverage of a specific highly rebated drug
that was not covered in the previous year, such group health plan or
health insurance issuer shall not receive from a drug manufacturer a
reduction in price or other remuneration with respect to such specific
highly rebated 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
``(2) any such other remuneration is a flat fee-based
service fee not contingent on total volume of sales that a
manufacturer of prescription drugs pays to an entity that
provides pharmacy benefits management services.
``(d) Definitions.--In this section:
``(1) Entity that provides pharmacy benefits management
services.--The term `entity that provides pharmacy benefits
management services' means--
``(A) any 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--
``(i) acts as a price negotiator on behalf
of the plan or coverage; or
``(ii) 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
``(B) any entity that is owned, affiliated, or
related under a common ownership structure with an
entity described in subparagraph (A).
``(2) Net price.--The term `net price', with respect to a
prescription drug, means the final price paid by a group health
plan or health insurance issuer offering group health insurance
coverage (or entity that provides pharmacy benefits management
services on behalf of such a plan or issuer) after applying any
rebates and other remuneration under the plan or coverage from
drug manufacturers during the plan year.
``(e) Specification.--A health insurance plan will not fail to be
treated as an HDHP for complying with the cost-sharing cap in this
section.''.
(2) Clerical amenmdnet.--The table of contents in section 1
of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1001 et seq.) is amended by inserting after the item
related to section 725 the following:
``Sec. 725. Requirements with respect to cost-sharing for highly
rebated drugs.''.
(c) IRC.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986 is amended by adding at the end
the following new section:
``SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR HIGHLY
REBATED DRUGS.
``(a) In General.--No later than April 1, 2024, and annually
thereafter, the Secretary shall certify (or recertify, if applicable)
as a `highly rebated drug' any drug identified in reports submitted
under sections 9825, 2799A-10 of the Public Health Service Act, and 725
of the Employee Retirement Income Security Act for which total rebates,
reductions in price, and other forms of remuneration in the previous
year aggregated across all commercial markets exceeded 50 percent of
total annual spending on such drug in such year.
``(b) Deductible and Cost-Sharing Limitations for Certified
Drugs.--For plan years that begin on or after January 1, 2025, a group
health plan (or entity that provides pharmacy benefits management
services on behalf of such a plan) that provides coverage of any highly
rebated drug shall not impose cost-sharing in excess of, per 30-day
supply, the quotient of the annual net price paid by such group health
plan (or entity that provides pharmacy benefits management services on
behalf of such a plan), in the most recent calendar year for which a
final net price has been calculated by such plan (or entity that
provides pharmacy benefit management services on behalf of such plan),
per 30-day supply of such specific highly rebated drug, divided by 12.
``(c) Highly Rebated Drug Previously Subject to Formulary
Exclusion.--Beginning on January 1, 2025, in the case of a specific
highly rebated drug covered by a group health plan (or entity that
provides pharmacy benefits management services on behalf of such plan)
that provides coverage of a specific highly rebated drug that was not
covered in the previous year, such group health plan shall not receive
from a drug manufacturer a reduction in price or other remuneration
with respect to such specific highly rebated 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
``(2) any such other remuneration is a flat fee-based
service fee not contingent on total volume of sales that a
manufacturer of prescription drugs pays to an entity that
provides pharmacy benefits management services.
``(d) Definitions.--In this section:
``(1) Entity that provides pharmacy benefits management
services.--The term `entity that provides pharmacy benefits
management services' means--
``(A) any entity that, pursuant to a written
agreement with a group health plan, directly or through
an intermediary--
``(i) acts as a price negotiator on behalf
of the plan; or
``(ii) 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
``(B) any entity that is owned, affiliated, or
related under a common ownership structure with an
entity described in subparagraph (A).
``(2) Net price.--The term `net price', with respect to a
prescription drug, means the final price paid by a group health
plan (or entity that provides pharmacy benefits management
services on behalf of such a plan) after applying any rebates
and other remuneration under the plan from drug manufacturers
during the plan year.
``(e) Specification.--A health insurance plan will not fail to be
treated as an HDHP for complying with the cost-sharing cap in this
section.''.
(2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of such Code is amended by adding
at the end the following new item:
``Sec. 9826. Requirements with respect to cost-sharing for highly
rebated drugs.''.
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