[Congressional Record Volume 168, Number 133 (Saturday, August 6, 2022)]
[Senate]
[Pages S4360-S4361]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 5481. Mr. BARRASSO (for himself and Mr. Marshall) submitted an 
amendment intended to be proposed to amendment SA 5194 proposed by Mr. 
Schumer to the bill H.R. 5376, to provide for reconciliation pursuant 
to title II of S. Con. Res. 14; which was ordered to lie on the table; 
as follows:

        At the end of part 1 of subtitle B of title I, add the 
     following:

     SEC. 11005. REBATE BY MANUFACTURERS FOR SELECTED DRUGS AND 
                   BIOLOGICAL SUBJECT TO MAXIMUM FAIR PRICE 
                   NEGOTIATION.

       (a) Maintaining Payments Under Part B Based on ASP+6.--
     Section 11001(b)(1) of this Act is amended by striking 
     subparagraph (A).
       (b) Rebate by Manufacturers for Selected Drugs and 
     Biologicals Subject to Maximum Fair Price Negotiation.--
       (1) In general.--Section 1847A of the Social Security Act 
     (42 U.S.C. 1395w-3a), as amended by section 11101, is 
     amended--
       (A) by redesignating subsection (j) as subsection (k); and
       (B) by inserting after subsection (i) the following new 
     subsection:
       ``(j) Rebate by Manufacturers for Selected Drugs and 
     Biologicals Subject to Maximum Fair Price Negotiation.--
       ``(1) Requirements.--
       ``(A) Secretarial provision of information.--Not later than 
     6 months after the end of each calendar quarter beginning on 
     or after the first day of the initial price applicability 
     period (as defined in section 1191(b)(2)), the Secretary 
     shall, for each selected drug (as defined in section 1192(c)) 
     of each manufacturer with an agreement under section 1193 for 
     which a maximum fair price is in effect and for which payment 
     may be made under this part, report to each manufacturer of 
     such selected drug the following for such calendar quarter 
     during such price applicability period:
       ``(i) Information on the total number of units of the 
     billing and payment code for such selected drug furnished 
     under this part during such calendar quarter.
       ``(ii) Information on the sum of--

       ``(I) the amount (if any) by which--

       ``(aa) the ASP+6 payment amount (as defined in paragraph 
     (5)) for such drug and calendar quarter, less the ASP+6 
     coinsurance amount for such drug and calendar quarter; 
     exceeds
       ``(bb) the MFP+6 payment amount (as so defined) for such 
     drug and calendar quarter, less the MFP+6 coinsurance amount 
     for such drug and calendar quarter; and

       ``(II) the amount (if any) by which--

       ``(aa) the ASP+6 coinsurance amount (as defined in 
     paragraph (5)) for such drug and calendar quarter; exceeds
       ``(bb) the MFP+6 coinsurance amount (as so defined) for 
     such drug and calendar quarter.
       ``(iii) The rebate amount specified under subparagraph (B) 
     for such drug and calendar quarter.
       ``(B) Manufacturer requirement.--For each calendar quarter 
     beginning on or after the first day of the price 
     applicability period, the manufacturer of a selected drug 
     shall, for such drug, not later than 30 days after the date 
     of receipt from the Secretary of the information described in 
     subparagraph (A) for such calendar quarter, provide to the 
     Secretary a rebate that is equal to the amount specified in 
     subparagraph (A)(ii) multiplied by the number of units 
     specified in subparagraph (A)(i) for such drug for such 
     calendar quarter. The rebate required under this subparagraph 
     shall be in addition to any other rebates required under this 
     title or title XIX, including the payments required under 
     subsections (h) and (i).
       ``(2) Calculation of beneficiary coinsurance based on 
     mfp+6.--
       ``(A) In general.--Subject to subparagraph (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 
     Secretary, to the payment amount that would otherwise apply 
     under subsection (b)(1)(B).
       ``(B) Clarification regarding application of inflation 
     rebate.--If a rebate is required under subsection (i) with 
     respect to a selected drug for a calendar quarter, the lesser 
     of the amount of coinsurance computed under subparagraph (A) 
     or the coinsurance computed under subsection (i)(5) shall 
     apply for such drug and calendar quarter.
       ``(3) Rebate deposits.--Amounts paid as rebates 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 subsection (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 respect to a 
     selected drug for a calendar quarter during 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.
       ``(B) ASP+6 payment amount.--The `ASP+6 payment amount' is 
     equal to 106 percent of the amount determined under paragraph 
     (4) of subsection (b) for such drug during 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 percent 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 require a manufacturer to 
     provide selected drugs at maximum fair prices other than 
     through the rebate required under this subsection.''.
       (2) Amounts payable; cost-sharing.--Section 1833(a)(1) of 
     the Social Security Act (42 U.S.C. 1395l(a)(1)), as amended 
     by section 11101(b), is amended--

[[Page S4361]]

       (A) in subparagraph (G), by striking ``subsection (i)(9)'' 
     and inserting ``paragraphs (9) and (10) of subsection (i)'';
       (B) in subparagraph (S), by striking ``subparagraph (EE)'' 
     and inserting ``subparagraphs (EE) and (FF)'';
       (C) by striking ``and (EE)'' and inserting ``(EE)''; and
       (D) by inserting before the semicolon at the end the 
     following: ``, and (FF) with respect to a selected drug (as 
     defined in section 1192(c)) that is subject to a rebate under 
     section 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 following new paragraph:
       ``(10) 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 under this subsection, in lieu of 
     calculation of coinsurance and the amount of payment 
     otherwise applicable under this subsection, the provisions of 
     section 1847(j)(2) and paragraph (1)(FF) 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 subsection (a) apply under such 
     section and subsection.''.
       (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 rebate.--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 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 section 1847A(b)(1)(B), under the 
     system under this subsection, in lieu of the calculation of 
     the copayment amount and the amount otherwise applicable 
     under this subsection (other than the application of the 
     limitation described in subparagraph (C)), the provisions of 
     section 1847A(j)(2) and paragraph (1)(FF) of subsection (a), 
     shall, as determined by the Secretary 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 rebates from asp 
     calculation.--Section 1847A(c)(3) of the Social Security Act 
     (42 U.S.C. 1395w-3a(c)(3)), as amended by section 11101(c)(1) 
     and 11102(b)(1), is amended by striking ``subsection (i)'' 
     and inserting ``subsection (i), subsection (j)''.
       (6) Coordination with medicaid rebate information 
     disclosures.--Section 1927(b)(3)(D)(i) of the Social Security 
     Act (42 U.S.C. 1396r-8(b)(3)(D)(i)), as amended by section 
     11101(c)(3) and 11102(b)(3), is amended by striking ``and the 
     rebate'' and inserting ``and the rebates''.
       (7) Provision of rebates.--Section 1193(a) of the Social 
     Security Act, as added by section 11001, is amended--
       (A) in paragraph (1), by striking subparagraph (B) and 
     inserting the following:
       ``(B) by paying rebates in accordance with section 
     1847A(j);''.
       (B) in paragraph (2), by striking subparagraph (B) and 
     inserting the following:
       ``(B) by paying rebates in accordance with section 
     1847A(j);''.
       (C) in paragraph (3), by striking subparagraph (B) and 
     inserting the following:
       ``(B) by paying rebates in accordance with section 
     1847A(j);''.
       (c) Conforming Amendments.--
       (1) Section 1847(i)(5) of the Social Security Act, as added 
     by section 11101, 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 defined 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 Security Act, as 
     added by section 11101, is amended--
       (A) by striking ``(or, in the case of a part B rebatable 
     drug that is a selected drug (as defined in section 1192(c) 
     for which, the payment amount described in section 
     1847A(b)(1)(B))''; and
       (B) by striking ``or section 1847A(b)(1)(B), as 
     applicable,''.
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