[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2764 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 2764
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 SENATE OF THE UNITED STATES
September 12, 2023
Mr. Barrasso introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Protecting Patient Access to Cancer
and Complex Therapies Act of 2023''.
SEC. 2. REBATE BY MANUFACTURERS FOR SELECTED DRUGS AND BIOLOGICAL
PRODUCTS SUBJECT TO MAXIMUM FAIR PRICE NEGOTIATION.
(a) Maintaining Payments Under Part B Based on ASP+6.--Section
1847A(b)(1)(B) of the Social Security Act (42 U.S.C. 1395w-3a(b)(1)(B))
is amended by striking ``or in the case of such a drug or biological
product that is a selected drug'' and all that follows through the
semicolon and inserting a semicolon.
(b) Rebate by Manufacturers for Selected Drugs and Biological
Products Subject to Maximum 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 subsection
(k); and
(B) by inserting after subsection (i) the following
new subsection:
``(j) Rebate by Manufacturers for Selected Drugs and Biological
Products 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
initial price applicability period (as defined in
section 1191(b)(2)), 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)) is amended--
(A) in subparagraph (G), by striking ``subsection
(i)(9)'' and inserting ``paragraphs (9) and (11) of
subsection (i)'';
(B) in subparagraph (S), by striking ``subparagraph
(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 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:
``(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 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)(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
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)(II) 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)) 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)) 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 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);''; and
(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 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 defined in
section 1192(c)), the payment amount described in
subsection (b)(1)(B) for such drug)''.
(2) Section 1833(a)(1)(EE) of the Social Security Act (42
U.S.C. 1395l(a)(1)(EE)) 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)) for such drug for such
quarter''; and
(B) by striking ``or section 1847A(b)(1)(B), as
applicable,''.
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