I 
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 Com-
mittee 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 con-
cerned 
A BILL 
To establish patient protections with respect to highly 
rebated drugs. 
Be it enacted by the Senate and House of Representa-
tives 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’’. 
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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 recer-
tify, 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 remunera-
tion 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 insur-
ance 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 
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health plan or health insurance issuer (or entity that pro-
vides 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 reduc-
tion 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, un-
less— 
‘‘(1) any such reduction in price is reflected at 
the point of sale to the enrollee; and 
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‘‘(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 man-
agement services. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) ENTITY THAT PROVIDES PHARMACY BENE-
FITS
MANAGEMENT
SERVICES.—The term ‘entity 
that provides pharmacy benefits management serv-
ices’ 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 be-
half of the plan or coverage; or 
‘‘(ii) manages the prescription drug 
benefits provided by the plan or coverage, 
which may include the processing and pay-
ment of claims for prescription drugs, the 
performance of drug utilization review, the 
processing of drug prior authorization re-
quests, the adjudication of appeals or 
grievances related to the prescription drug 
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benefit, contracting with network phar-
macies, controlling the cost of covered pre-
scription 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 remu-
neration under the plan or coverage from drug man-
ufacturers 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 sub-
title 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: 
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‘‘SEC. 725. REQUIREMENTS WITH RESPECT TO COST-SHAR-
ING FOR HIGHLY REBATED DRUGS. 
‘‘(a) IN GENERAL.—No later than April 1, 2024, and 
annually thereafter, the Secretary shall certify (or recer-
tify, 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 mar-
kets 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 serv-
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ices 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 cov-
erage 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 man-
agement services. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) ENTITY THAT PROVIDES PHARMACY BENE-
FITS
MANAGEMENT
SERVICES.—The term ‘entity 
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that provides pharmacy benefits management serv-
ices’ means— 
‘‘(A) any entity that, pursuant to a written 
agreement with a group health plan or a health 
insurance issuer offering group health insur-
ance coverage, directly or through an inter-
mediary— 
‘‘(i) acts as a price negotiator on be-
half of the plan or coverage; or 
‘‘(ii) manages the prescription drug 
benefits provided by the plan or coverage, 
which may include the processing and pay-
ment of claims for prescription drugs, the 
performance of drug utilization review, the 
processing of drug prior authorization re-
quests, the adjudication of appeals or 
grievances related to the prescription drug 
benefit, contracting with network phar-
macies, controlling the cost of covered pre-
scription 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). 
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‘‘(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 ap-
plying any rebates and other remuneration under 
the plan or coverage from drug manufacturers dur-
ing 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 con-
tents in section 1 of the Employee Retirement In-
come 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 amend-
ed by adding at the end the following new section: 
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‘‘SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHAR-
ING FOR HIGHLY REBATED DRUGS. 
‘‘(a) IN GENERAL.—No later than April 1, 2024, and 
annually thereafter, the Secretary shall certify (or recer-
tify, 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 remu-
neration in the previous year aggregated across all com-
mercial 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. 
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