[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,''.
______