[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4204 Introduced in Senate (IS)]
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118th CONGRESS
2d Session
S. 4204
To amend title XIX of the Social Security Act to codify value-based
purchasing arrangements under the Medicaid program and reforms related
to price reporting under such arrangements, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 30, 2024
Mr. Mullin (for himself, Ms. Sinema, Mr. Scott of South Carolina, and
Ms. Hassan) introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend title XIX of the Social Security Act to codify value-based
purchasing arrangements under the Medicaid program and reforms related
to price reporting under such arrangements, and for other purposes.
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 ``Medicaid VBPs for Patients Act'' or
the ``MVP Act''.
SEC. 2. CODIFYING VALUE-BASED PURCHASING ARRANGEMENTS UNDER MEDICAID
AND REFORMS RELATED TO PRICE REPORTING UNDER SUCH
ARRANGEMENTS.
(a) Codifying Multiple Best Price Points.--
(1) In general.--Section 1927(c)(1)(C)(ii) of the Social
Security Act (42 U.S.C. 1396r-8(c)(1)(C)(ii)) is amended--
(A) in subclause (IV), by striking ``and'' at the
end;
(B) in subclause (V), by striking the period and
inserting ``; and''; and
(C) by adding at the end the following new
subclause:
``(VI) may include multiple best
price points for a single dosage form
and strength of a drug of a
manufacturer subject to a value-based
purchasing arrangement (as defined in
subsection (k)(12)), but only if such
manufacturer offers such arrangement to
all States.''.
(2) Rule of construction.--Nothing in the amendments made
by this subsection may be construed to prohibit a manufacturer
from treating a value-based purchasing arrangement as a bundled
sale.
(b) Definition of Average Manufacturer Price.--
(1) In general.--Section 1927(k)(1) of the Social Security
Act (42 U.S.C. 1396r-8(k)(1)) is amended--
(A) in subparagraph (B)(i)--
(i) in subclause (VII), by striking at the
end ``and'';
(ii) in subclause (VIII), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end the following
new subclause:
``(IX) with respect to a covered
outpatient drug that is sold under a
value-based purchasing arrangement (as
defined in paragraph (12)) during the
rebate period, including such a drug
that is an inhalation, infusion,
instilled, implanted, or injectable
drug that is not generally dispensed
through a retail community pharmacy--
``(aa) a refund, rebate,
reimbursement, or free goods
from the manufacturer or third
party on behalf of the
manufacturer; or
``(bb) the withholding or
reduction of a payment to the
manufacturer or third party on
behalf of the manufacturer;
that is triggered by a patient who
fails to achieve outcomes or measures
defined under the terms of such value-
based purchasing arrangement during the
period for which such arrangement is
effective.''; and
(B) by adding at the end the following new
subparagraph:
``(D) Special rule for certain value-based
purchasing arrangements.--For purposes of subparagraph
(A), in determining the average price paid to a
manufacturer for a covered outpatient drug that is sold
under a value-based purchasing arrangement (as defined
in paragraph (12)) that provides that payment for such
drug is made in installments over the course of such
arrangement, such price shall be determined as if the
aggregate price per the terms of the arrangement were
paid in full in the first installment during the rebate
period.''.
(2) Rulemaking.--Not later than 180 days after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall implement the amendments made by this subsection
through rulemaking.
(c) Definition of Value-Based Purchasing Arrangement.--Section
1927(k) of the Social Security Act (42 U.S.C. 1396r-8(k)) is amended by
adding at the end the following paragraph:
``(12) Value-based purchasing arrangement.--The term
`value-based purchasing arrangement' has the meaning given such
term in section 447.502 of title 42, Code of Federal
Regulations (or any successor regulation).''.
SEC. 3. CALCULATION OF AVERAGE SALES PRICE UNDER MEDICARE.
Section 1847A(c)(3) of the Social Security Act (42 U.S.C. 1395w-
3a(c)(3)) is amended--
(1) by striking ``In calculating'' and inserting the
following:
``(A) In general.--Subject to subparagraph (B), in
calculating''; and
(2) by adding at the end the following new subparagraph:
``(B) Certain remuneration under value-based
purchasing arrangements excluded.--In calculating the
manufacturer's average sales price under this
subsection for a drug or biological that is sold under
a value-based purchasing arrangement (as defined in
section 1927(k)(12)) and with respect to which the
manufacturer of such drug or biological has elected to
include multiple best price points (as described in
section 1927(c)(1)(C)(ii)(VI)) in reporting the best
price of such drug under section 1927(b), such
manufacturer's average sales price shall not include
any amount that is excluded from the calculation of the
average manufacturer price of such drug or biological
under section 1927(k)(1)(B)(i)(IX).''.
SEC. 4. GUIDANCE ON VALUE-BASED PURCHASING ARRANGEMENTS FOR INPATIENT
DRUGS UNDER MEDICAID.
Not later than 180 days after the date of the enactment of this
Act, the Secretary of Health and Human Services shall issue guidance to
State Medicaid agencies on the option of entering into a value-based
purchasing arrangement (as defined in section 1927(k)(12) of the Social
Security Act (42 U.S.C. 1396r-8(k)(12))) with manufacturers for drugs
or biological products provided as part of, or as incident to and in
the same setting as, inpatient hospital services furnished under a
State plan under title XIX of the Social Security Act (42 U.S.C. 1396
et seq.), or under a waiver of such plan, where such drugs or
biological products are reimbursed directly and not paid for as part of
payment for such inpatient hospital services, including guidance on how
multiple States may enter into agreements with one another and with
manufacturers which permit the transfer of funds between the
participating States so that individuals who reside in a State
different from the State in which they receive a drug subject to a
value-based purchasing arrangement as an inpatient may be treated as if
they received such drug in the State in which they reside.
SEC. 5. EXCEPTION UNDER THE ANTIKICKBACK STATUTE.
(a) In General.--Section 1128B(b)(3) of the Social Security Act (42
U.S.C. 1320a-7b(b)(3)) is amended--
(1) in subparagraph (J), by moving the left margin of such
subparagraph 2 ems to the left;
(2) in subparagraph (K)--
(A) by moving the left margin of such subparagraph
2 ems to the left; and
(B) by striking ``and'' at the end;
(3) in subparagraph (L)(iii), by striking the period and
inserting ``; and''; and
(4) by adding at the end the following new subparagraph:
``(M) any remuneration provided by a manufacturer
or third party on behalf of a manufacturer to a State
under a value-based purchasing arrangement (as defined
in section 1927(k)(12)) under a State plan under title
XIX (or waiver of such plan) in the case a patient
fails to achieve outcomes or measures defined in such
arrangement following the administration of a covered
outpatient drug (as defined in section 1927(k)(2)).''.
(b) Rulemaking.--Not later than 180 days after the date of the
enactment of this Act, the Inspector General of the Department of
Health and Human Services shall through rulemaking implement the
amendments made by this section.
SEC. 6. GAO STUDY AND REPORT ON USE OF VALUE-BASED PURCHASING
ARRANGEMENTS.
(a) Study.--The Comptroller General of the United States shall
conduct a study on the extent to which value-based purchasing
arrangements (as defined in section 1927(k)(12)) of the Social Security
Act (42 U.S.C. 1396r-8(k)(12)) facilitate patient access to covered
outpatient drugs, improve patient outcomes, lower overall health system
costs, and lower costs for patients in Federal health care programs. In
conducting such study, the Comptroller General shall--
(1) study the impact of this Act on--
(A) access to transformative therapies, including
rare disease gene therapies, generally;
(B) mitigating socioeconomic disparities in
accessing covered outpatient drugs sold under value-
based purchasing arrangements through its requirement
that State Medicaid programs have access to the same
value-based purchasing arrangement pricing structure
that are available in the commercial market for such
drugs;
(C) the Medicaid drug rebate program under section
1927 of the Social Security Act (42 U.S.C. 1396r-8),
the 340B drug pricing program under section 340B of the
Public Health Service Act (42 U.S.C. 256b), and part B
of title XVIII of the Social Security Act (42 U.S.C.
1395j et seq.), including compliance with such
programs;
(D) expenditures under State Medicaid programs; and
(E) prices for such drugs under the Medicaid
program in States that do not enter into such
arrangements;
(2) analyze all the types of value-based purchasing
arrangement pricing structures, which structures are working
well (as measured by price and ease of implementing), and which
need improvement; and
(3) study the potential long-term savings for States that
enter into such arrangements under State Medicaid programs.
(b) Report.--Not later than June 30, 2028, the Comptroller General
of the United States shall submit to Congress a report containing the
results of the study conducted under subsection (a).
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