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 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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Patient Ac5 cess to Cancer and Complex Therapies Act’’. 


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1 SEC. 2. REBATE BY MANUFACTURERS FOR SELECTED 

2 DRUGS AND BIOLOGICAL PRODUCTS SUB3 JECT TO MAXIMUM FAIR PRICE NEGOTIA4 TION. 

5 (a) MAINTAINING PAYMENTS UNDER PART B BASED

6 ON ASP+6.—Section 1847A(b)(1)(B) of the Social Secu7 rity Act (42 U.S.C. 1395w–3a(b)(1)(B)) is amended by 

8 striking ‘‘or in the case of such a drug or biological prod9 uct that is a selected drug’’ and all that follows through 

10 the semiocolon and inserting a semicolon. 

11 (b) REBATE BY MANUFACTURERS FOR SELECTED

12 DRUGS AND BIOLOGICAL PRODUCTS SUBJECT TO MAX13 IMUM FAIR PRICE NEGOTIATION.— 

14 (1) IN GENERAL.—Section 1847A of the Social 

15 Security Act (42 U.S.C. 1395w–3a) is amended— 

16 (A) by redesignating subsection (j) as sub17 section (k); and 

18 (B) by inserting after subsection (i) the 

19 following new subsection: 

20 ‘‘(j) REBATE BY MANUFACTURERS FOR SELECTED

21 DRUGS AND BIOLOGICAL PRODUCTS SUBJECT TO MAX22 IMUM FAIR PRICE NEGOTIATION.— 

23 ‘‘(1) REQUIREMENTS.— 

24 ‘‘(A) SECRETARIAL PROVISION OF INFOR25 MATION.—Not later than 6 months after the 

26 end of each calendar quarter beginning on or 


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1 after the first day of the initial price applica2 bility period (as defined in section 1191(b)(2)), 

3 the Secretary shall, for each selected drug (as 

4 defined in section 1192(c)) of each manufac5 turer with an agreement under section 1193 for 

6 which a maximum fair price is in effect and for 

7 which payment may be made under this part, 

8 report to each manufacturer of such selected 

9 drug the following for such calendar quarter 

10 during such price applicability period: 

11 ‘‘(i) Information on the total number 

12 of units of the billing and payment code 

13 for such selected drug furnished under this 

14 part during such calendar quarter. 

15 ‘‘(ii) Information on the sum of— 

16 ‘‘(I) the amount (if any) by 

17 which— 

18 ‘‘(aa) the ASP+6 payment 

19 amount (as defined in paragraph 

20 (5)) for such drug and calendar 

21 quarter, less the ASP+6 coinsur22 ance amount for such drug and 

23 calendar quarter; exceeds 

24 ‘‘(bb) the MFP+6 payment 

25 amount (as so defined) for such 


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1 drug and calendar quarter, less 

2 the MFP+6 coinsurance amount 

3 for such drug and calendar quar4 ter; and 

5 ‘‘(II) the amount (if any) by 

6 which— 

7 ‘‘(aa) the ASP+6 coinsur8 ance amount (as defined in para9 graph (5)) for such drug and cal10 endar quarter; exceeds 

11 ‘‘(bb) the MFP+6 coinsur12 ance amount (as so defined) for 

13 such drug and calendar quarter. 

14 ‘‘(iii) The rebate amount specified 

15 under subparagraph (B) for such drug and 

16 calendar quarter. 

17 ‘‘(B) MANUFACTURER REQUIREMENT.— 

18 For each calendar quarter beginning on or after 

19 the first day of the initial price applicability pe20 riod (as defined in section 1191(b)(2)), the 

21 manufacturer of a selected drug shall, for such 

22 drug, not later than 30 days after the date of 

23 receipt from the Secretary of the information 

24 described in subparagraph (A) for such cal25 endar quarter, provide to the Secretary a rebate 


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1 that is equal to the amount specified in sub2 paragraph (A)(ii) multiplied by the number of 

3 units specified in subparagraph (A)(i) for such 

4 drug for such calendar quarter. The rebate re5 quired under this subparagraph shall be in ad6 dition to any other rebates required under this 

7 title or title XIX, including the payments re8 quired under subsections (h) and (i). 

9 ‘‘(2) CALCULATION OF BENEFICIARY COINSUR10 ANCE BASED ON MFP+6.— 

11 ‘‘(A) IN GENERAL.—Subject to subpara12 graph (B), in the case of a selected drug with 

13 respect to which a rebate is paid under this 

14 subsection— 

15 ‘‘(i) the amount of any coinsurance 

16 applicable under this part to an individual 

17 to whom such drug is furnished during a 

18 calendar quarter shall be equal to the 

19 MFP+6 coinsurance amount; and 

20 ‘‘(ii) the amount of such coinsurance 

21 for such calendar quarter shall be applied 

22 as a percent, as determined by the Sec23 retary, to the payment amount that would 

24 otherwise apply under subsection 

25 (b)(1)(B). 


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1 ‘‘(B) CLARIFICATION REGARDING APPLICA2 TION OF INFLATION REBATE.—If a rebate is re3 quired under subsection (i) with respect to a se4 lected drug for a calendar quarter, the lesser of 

5 the amount of coinsurance computed under sub6 paragraph (A) or the coinsurance computed 

7 under subsection (i)(5) shall apply for such 

8 drug and calendar quarter. 

9 ‘‘(3) REBATE DEPOSITS.—Amounts paid as re10 bates under paragraph (1)(B) shall be deposited into 

11 the Federal Supplementary Medical Insurance Trust 

12 Fund established under section 1841. 

13 ‘‘(4) CIVIL MONEY PENALTY.—The civil money 

14 penalty established under paragraph (7) of sub15 section (i) shall apply to the failure to comply with 

16 this subsection in the same manner as such penalty 

17 applies to failures to comply with the requirements 

18 under paragraph (1)(B) of subsection (i). 

19 ‘‘(5) DEFINITIONS.—In this subsection, with re20 spect to a selected drug for a calendar quarter dur21 ing a price applicability period: 

22 ‘‘(A) ASP+6 COINSURANCE AMOUNT.— 

23 The ‘ASP+6 coinsurance amount’ is equal to 

24 20 percent of the ASP+6 payment amount. 


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1 ‘‘(B) ASP+6 PAYMENT AMOUNT.—The 

2 ‘ASP+6 payment amount’ is equal to 106 per3 cent of the amount determined under para4 graph (4) of subsection (b) for such drug dur5 ing such calendar quarter. 

6 ‘‘(C) MFP+6 COINSURANCE AMOUNT.— 

7 The ‘MFP+6 coinsurance amount’ is equal to 

8 20 percent of the MFP+6 payment amount. 

9 ‘‘(D) MFP+6 PAYMENT AMOUNT.—The 

10 ‘MFP+6 payment amount’ is equal to 106 per11 cent of the maximum fair price (as defined in 

12 section 1191(c)(2)) applicable for such drug 

13 during such calendar quarter. 

14 ‘‘(6) CLARIFICATION.—Nothing in part E of 

15 title XI or this subsection shall be construed to re16 quire a manufacturer to provide selected drugs at 

17 maximum fair prices other than through the rebate 

18 required under this subsection.’’. 

19 (2) AMOUNTS PAYABLE; COST-SHARING.—Sec20 tion 1833(a)(1) of the Social Security Act (42 

21 U.S.C. 1395l(a)(1)) is amended— 

22 (A) in subparagraph (G), by striking ‘‘sub23 section (i)(9)’’ and inserting ‘‘paragraphs (9) 

24 and (10) of subsection (i)’’; 


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1 (B) in subparagraph (S), by striking ‘‘sub2 paragraph (EE)’’ and inserting ‘‘subparagraphs 

3 (EE) and (II)’’; 

4 (C) by striking ‘‘and (HH)’’ and inserting 

5 ‘‘(HH)’’; and 

6 (D) by inserting before the semicolon at 

7 the end the following: ‘‘, and (II) with respect 

8 to a selected drug (as defined in section 

9 1192(c)) that is subject to a rebate under sec10 tion 1847A(j), the amounts paid shall be equal 

11 to the percent of the payment amount otherwise 

12 determined under section 1847A(b)(1)(B) that 

13 equals the difference between (i) 100 percent, 

14 and (ii) the percent applied under section 

15 1847A(j)(2)(A)(ii)’’. 

16 (3) ASC CONFORMING AMENDMENTS.—Section 

17 1833(i) of the Social Security Act (42 U.S.C. 

18 1395l(i)) is amended by adding at the end the fol19 lowing new paragraph: 

20 ‘‘(11) In the case of a selected drug (as defined 

21 in section 1192(c)), subject to a rebate under section 

22 1847A(j) for which payment under this subsection is 

23 not packaged into a payment for a service furnished 

24 on or after the initial price applicability year for the 

25 selected drug under the revised payment system 


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1 under this subsection, in lieu of calculation of coin2 surance and the amount of payment otherwise appli3 cable under this subsection, the provisions of section 

4 1847(j)(2) and paragraph (1)(II) of subsection (a), 

5 shall, as determined appropriate by the Secretary, 

6 apply under this subsection in the same manner as 

7 such provisions of section 1847A(j)(2) and sub8 section (a) apply under such section and sub9 section.’’. 

10 (4) OPPS CONFORMING AMENDMENT.—Section 

11 1833(t)(8) of the Social Security Act (42 U.S.C. 

12 1395l(t)(8)) is amended by adding at the end the 

13 following new subparagraph: 

14 ‘‘(G) SELECTED DRUGS SUBJECT TO RE15 BATE.—In the case of a selected drug (as de16 fined in section 1192(c)), subject to a rebate 

17 under section 1847A(j) for which payment 

18 under this subsection is not packaged into a 

19 payment for a covered OPD service (or group 

20 of services) furnished on or after the initial 

21 price applicability year for the selected drug, 

22 and the payment for such drug is the same as 

23 the amount for a calendar quarter under sec24 tion 1847A(b)(1)(B), under the system under 

25 this subsection, in lieu of the calculation of the 


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1 copayment amount and the amount otherwise 

2 applicable under this subsection (other than the 

3 application of the limitation described in sub4 paragraph (C)), the provisions of section 

5 1847A(j)(2) and paragraph (1)(II) of sub6 section (a), shall, as determined by the Sec7 retary apply under this section in the same 

8 manner as such provisions of section 

9 1847A(j)(2) and subsection (a) apply under 

10 such section and subsection.’’. 

11 (5) EXCLUSION OF SELECTED DRUG MFP RE12 BATES FROM ASP CALCULATION.—Section 

13 1847A(c)(3) of the Social Security Act (42 U.S.C. 

14 1395w–3a(c)(3)) is amended by striking ‘‘subsection 

15 (i)’’ and inserting ‘‘subsection (i), subsection (j)’’. 

16 (6) COORDINATION WITH MEDICAID REBATE IN17 FORMATION DISCLOSURES.—Section 

18 1927(b)(3)(D)(i) of the Social Security Act (42 

19 U.S.C. 1396r–8(b)(3)(D)(i)) is amended by striking 

20 ‘‘and the rebate’’ and inserting ‘‘and the rebates’’. 

21 (7) PROVISION OF REBATES.—Section 1193(a) 

22 of the Social Security Act (42 U.S.C. 1320f–2(a)) is 

23 amended— 

24 (A) in paragraph (1), by striking subpara25 graph (B) and inserting the following: 


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1 ‘‘(B) by paying rebates in accordance with 

2 section 1847A(j);’’; 

3 (B) in paragraph (2), by striking subpara4 graph (B) and inserting the following: 

5 ‘‘(B) by paying rebates in accordance with 

6 section 1847A(j);’’; and 

7 (C) in paragraph (3), by striking subpara8 graph (B) and inserting the following: 

9 ‘‘(B) by paying rebates in accordance with 

10 section 1847A(j);’’. 

11 (c) CONFORMING AMENDMENTS.— 

12 (1) Section 1847A(i)(5) of the Social Security 

13 Act (42 U.S.C. 1395w–3a(i)(5)) is amended, in the 

14 matter preceding subparagraph (A)— 

15 (A) by striking ‘‘In the case’’ and inserting 

16 ‘‘Subsection to subsection (j)(2)(B), in the 

17 case’’; and 

18 (B) by striking ‘‘(or, in the case of a part 

19 B rebatable drug that is a selected drug (as de20 fined in section 1192(c)), the payment amount 

21 described in subsection (b)(1)(B) for such 

22 drug)’’; and 

23 (2) Section 1833(a)(1)(EE) of the Social Secu24 rity Act (42 U.S.C. 1395l(a)(1)(EE)) is amended— 


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1 (A) by striking ‘‘(or, in the case of a part 

2 B rebatable drug that is a selected drug (as de3 fined in section 1192(c) for which, the payment 

4 amount described in section 1847A(b)(1)(B)) 

5 for such drug for such quarter’’; and 

6 (B) by striking ‘‘or section 

7 1847A(b)(1)(B), as applicable,’’. 

Æ 


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