I 
118TH CONGRESS 
1ST SESSION H. R. 5391 
To amend title XVIII of the Social Security Act to provide for a rebate 
by manufacturers for selected drugs and biological products subject to 
maximum fair price negotiation. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 12, 2023 
Mr. BURGESS (for himself and Mr. MURPHY) 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 subse-
quently 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 XVIII of the Social Security Act to provide 
for a rebate by manufacturers for selected drugs and 
biological products subject to maximum fair price nego-
tiation. 
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 ‘‘Protecting Patient Ac-
cess to Cancer and Complex Therapies Act’’. 
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SEC. 2. REBATE BY MANUFACTURERS FOR SELECTED 
DRUGS AND BIOLOGICAL PRODUCTS SUB-
JECT TO MAXIMUM FAIR PRICE NEGOTIA-
TION. 
(a) MAINTAINING PAYMENTS UNDER PART B BASED 
ON ASP+6.—Section 1847A(b)(1)(B) of the Social Secu-
rity Act (42 U.S.C. 1395w–3a(b)(1)(B)) is amended by 
striking ‘‘or in the case of such a drug or biological prod-
uct that is a selected drug’’ and all that follows through 
the semiocolon and inserting a semicolon. 
(b) REBATE BY MANUFACTURERS FOR SELECTED 
DRUGS AND BIOLOGICAL PRODUCTS SUBJECT TO MAX-
IMUM FAIR PRICE NEGOTIATION.— 
(1) IN GENERAL.—Section 1847A of the Social 
Security Act (42 U.S.C. 1395w–3a) is amended— 
(A) by redesignating subsection (j) as sub-
section (k); and 
(B) by inserting after subsection (i) the 
following new subsection: 
‘‘(j) REBATE BY MANUFACTURERS FOR SELECTED 
DRUGS AND BIOLOGICAL PRODUCTS SUBJECT TO MAX-
IMUM FAIR PRICE NEGOTIATION.— 
‘‘(1) REQUIREMENTS.— 
‘‘(A) SECRETARIAL PROVISION OF INFOR-
MATION.—Not later than 6 months after the 
end of each calendar quarter beginning on or 
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that is equal to the amount specified in sub-
paragraph (A)(ii) multiplied by the number of 
units specified in subparagraph (A)(i) for such 
drug for such calendar quarter. The rebate re-
quired under this subparagraph shall be in ad-
dition to any other rebates required under this 
title or title XIX, including the payments re-
quired under subsections (h) and (i). 
‘‘(2) CALCULATION OF BENEFICIARY COINSUR-
ANCE BASED ON MFP+6.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), in the case of a selected drug with 
respect to which a rebate is paid under this 
subsection— 
‘‘(i) the amount of any coinsurance 
applicable under this part to an individual 
to whom such drug is furnished during a 
calendar quarter shall be equal to the 
MFP+6 coinsurance amount; and 
‘‘(ii) the amount of such coinsurance 
for such calendar quarter shall be applied 
as a percent, as determined by the Sec-
retary, to the payment amount that would 
otherwise 
apply 
under 
subsection 
(b)(1)(B). 
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‘‘(B) CLARIFICATION REGARDING APPLICA-
TION OF INFLATION REBATE.—If a rebate is re-
quired under subsection (i) with respect to a se-
lected drug for a calendar quarter, the lesser of 
the amount of coinsurance computed under sub-
paragraph (A) or the coinsurance computed 
under subsection (i)(5) shall apply for such 
drug and calendar quarter. 
‘‘(3) REBATE DEPOSITS.—Amounts paid as re-
bates under paragraph (1)(B) shall be deposited into 
the Federal Supplementary Medical Insurance Trust 
Fund established under section 1841. 
‘‘(4) CIVIL MONEY PENALTY.—The civil money 
penalty established under paragraph (7) of sub-
section (i) shall apply to the failure to comply with 
this subsection in the same manner as such penalty 
applies to failures to comply with the requirements 
under paragraph (1)(B) of subsection (i). 
‘‘(5) DEFINITIONS.—In this subsection, with re-
spect to a selected drug for a calendar quarter dur-
ing a price applicability period: 
‘‘(A) ASP+6 COINSURANCE
AMOUNT.— 
The ‘ASP+6 coinsurance amount’ is equal to 
20 percent of the ASP+6 payment amount. 
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‘‘(B) ASP+6 PAYMENT
AMOUNT.—The 
‘ASP+6 payment amount’ is equal to 106 per-
cent of the amount determined under para-
graph (4) of subsection (b) for such drug dur-
ing such calendar quarter. 
‘‘(C) MFP+6 COINSURANCE
AMOUNT.— 
The ‘MFP+6 coinsurance amount’ is equal to 
20 percent of the MFP+6 payment amount. 
‘‘(D) MFP+6 PAYMENT
AMOUNT.—The 
‘MFP+6 payment amount’ is equal to 106 per-
cent of the maximum fair price (as defined in 
section 1191(c)(2)) applicable for such drug 
during such calendar quarter. 
‘‘(6) CLARIFICATION.—Nothing in part E of 
title XI or this subsection shall be construed to re-
quire a manufacturer to provide selected drugs at 
maximum fair prices other than through the rebate 
required under this subsection.’’. 
(2) AMOUNTS PAYABLE; COST-SHARING.—Sec-
tion 1833(a)(1) of the Social Security Act (42 
U.S.C. 1395l(a)(1)) is amended— 
(A) in subparagraph (G), by striking ‘‘sub-
section (i)(9)’’ and inserting ‘‘paragraphs (9) 
and (10) of subsection (i)’’; 
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(B) in subparagraph (S), by striking ‘‘sub-
paragraph (EE)’’ and inserting ‘‘subparagraphs 
(EE) and (II)’’; 
(C) by striking ‘‘and (HH)’’ and inserting 
‘‘(HH)’’; and 
(D) by inserting before the semicolon at 
the end the following: ‘‘, and (II) with respect 
to a selected drug (as defined in section 
1192(c)) that is subject to a rebate under sec-
tion 1847A(j), the amounts paid shall be equal 
to the percent of the payment amount otherwise 
determined under section 1847A(b)(1)(B) that 
equals the difference between (i) 100 percent, 
and (ii) the percent applied under section 
1847A(j)(2)(A)(ii)’’. 
(3) ASC CONFORMING AMENDMENTS.—Section 
1833(i) of the Social Security Act (42 U.S.C. 
1395l(i)) is amended by adding at the end the fol-
lowing new paragraph: 
‘‘(11) In the case of a selected drug (as defined 
in section 1192(c)), subject to a rebate under section 
1847A(j) for which payment under this subsection is 
not packaged into a payment for a service furnished 
on or after the initial price applicability year for the 
selected drug under the revised payment system 
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under this subsection, in lieu of calculation of coin-
surance and the amount of payment otherwise appli-
cable under this subsection, the provisions of section 
1847(j)(2) and paragraph (1)(II) of subsection (a), 
shall, as determined appropriate by the Secretary, 
apply under this subsection in the same manner as 
such provisions of section 1847A(j)(2) and sub-
section (a) apply under such section and sub-
section.’’. 
(4) OPPS CONFORMING AMENDMENT.—Section 
1833(t)(8) of the Social Security Act (42 U.S.C. 
1395l(t)(8)) is amended by adding at the end the 
following new subparagraph: 
‘‘(G) SELECTED DRUGS SUBJECT TO RE-
BATE.—In the case of a selected drug (as de-
fined in section 1192(c)), subject to a rebate 
under section 1847A(j) for which payment 
under this subsection is not packaged into a 
payment for a covered OPD service (or group 
of services) furnished on or after the initial 
price applicability year for the selected drug, 
and the payment for such drug is the same as 
the amount for a calendar quarter under sec-
tion 1847A(b)(1)(B), under the system under 
this subsection, in lieu of the calculation of the 
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copayment amount and the amount otherwise 
applicable under this subsection (other than the 
application of the limitation described in sub-
paragraph (C)), the provisions of section 
1847A(j)(2) and paragraph (1)(II) of sub-
section (a), shall, as determined by the Sec-
retary apply under this section in the same 
manner 
as 
such 
provisions 
of 
section 
1847A(j)(2) and subsection (a) apply under 
such section and subsection.’’. 
(5) EXCLUSION OF SELECTED DRUG MFP RE-
BATES
FROM
ASP
CALCULATION.—Section 
1847A(c)(3) of the Social Security Act (42 U.S.C. 
1395w–3a(c)(3)) is amended by striking ‘‘subsection 
(i)’’ and inserting ‘‘subsection (i), subsection (j)’’. 
(6) COORDINATION WITH MEDICAID REBATE IN-
FORMATION
DISCLOSURES.—Section 
1927(b)(3)(D)(i) of the Social Security Act (42 
U.S.C. 1396r–8(b)(3)(D)(i)) is amended by striking 
‘‘and the rebate’’ and inserting ‘‘and the rebates’’. 
(7) PROVISION OF REBATES.—Section 1193(a) 
of the Social Security Act (42 U.S.C. 1320f–2(a)) is 
amended— 
(A) in paragraph (1), by striking subpara-
graph (B) and inserting the following: 
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‘‘(B) by paying rebates in accordance with 
section 1847A(j);’’; 
(B) in paragraph (2), by striking subpara-
graph (B) and inserting the following: 
‘‘(B) by paying rebates in accordance with 
section 1847A(j);’’; and 
(C) in paragraph (3), by striking subpara-
graph (B) and inserting the following: 
‘‘(B) by paying rebates in accordance with 
section 1847A(j);’’. 
(c) CONFORMING AMENDMENTS.— 
(1) Section 1847A(i)(5) of the Social Security 
Act (42 U.S.C. 1395w–3a(i)(5)) is amended, in the 
matter preceding subparagraph (A)— 
(A) by striking ‘‘In the case’’ and inserting 
‘‘Subsection to subsection (j)(2)(B), in the 
case’’; and 
(B) by striking ‘‘(or, in the case of a part 
B rebatable drug that is a selected drug (as de-
fined in section 1192(c)), the payment amount 
described in subsection (b)(1)(B) for such 
drug)’’; and 
(2) Section 1833(a)(1)(EE) of the Social Secu-
rity Act (42 U.S.C. 1395l(a)(1)(EE)) is amended— 
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(A) by striking ‘‘(or, in the case of a part 
B rebatable drug that is a selected drug (as de-
fined in section 1192(c) for which, the payment 
amount described in section 1847A(b)(1)(B)) 
for such drug for such quarter’’; and 
(B) 
by 
striking 
‘‘or 
section 
1847A(b)(1)(B), as applicable,’’. 
Æ 
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