[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 3
To establish a fair price negotiation program, protect the Medicare
program from excessive price increases, and establish an out-of-pocket
maximum for Medicare part D enrollees, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 22, 2021
Mr. Pallone (for himself, Mr. Neal, and Mr. Scott of Virginia)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committees on Ways and
Means, Education and Labor, Oversight and Reform, and Veterans'
Affairs, 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 establish a fair price negotiation program, protect the Medicare
program from excessive price increases, and establish an out-of-pocket
maximum for Medicare part D enrollees, 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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Elijah E. Cummings
Lower Drug Costs Now Act''.
(b) Table of Contents.--The table of contents is as follows:
Sec. 1. Short title; table of contents.
TITLE I--LOWERING PRICES THROUGH FAIR DRUG PRICE NEGOTIATION
Sec. 101. Providing for lower prices for certain high-priced single
source drugs.
Sec. 102. Selected drug manufacturer excise tax imposed during
noncompliance periods.
Sec. 103. Fair Price Negotiation Implementation Fund.
TITLE II--PRESCRIPTION DRUG INFLATION REBATES
Sec. 201. Medicare part B rebate by manufacturers.
Sec. 202. Medicare part D rebate by manufacturers.
Sec. 203. Provision regarding inflation rebates for group health plans
and group health insurance coverage.
Sec. 204. Annual report on drug costs in group health plans and group
health insurance coverage.
Sec. 205. Collection of data.
TITLE III--PART D IMPROVEMENTS AND MAXIMUM OUT-OF-POCKET CAP FOR
MEDICARE BENEFICIARIES
Sec. 301. Medicare part D benefit redesign.
Sec. 302. Allowing certain enrollees of prescription drug plans and MA-
PD plans under Medicare program to spread
out cost-sharing under certain
circumstances.
Sec. 303. Establishment of pharmacy quality measures under Medicare
part D.
TITLE IV--DRUG PRICE TRANSPARENCY
Sec. 401. Drug price transparency.
TITLE V--NIH, FDA, AND OVERDOSE EPIDEMIC FUNDING
Subtitle A--Biomedical Innovation Expansion
Sec. 501. NIH Innovation Initiatives.
Sec. 502. NIH clinical trial.
Sec. 503. Innovation Network.
Subtitle B--Investing in Safety and Innovation
Sec. 511. Food and Drug Administration.
Sec. 512. Study on high-risk, high-reward drugs.
Subtitle C--Overdose Epidemic Response
Sec. 521. Overdose Epidemic Response Fund.
Sec. 522. Substance Abuse and Mental Health Services Administration.
Sec. 523. Centers for Disease Control and Prevention.
Sec. 524. Food and Drug Administration.
Sec. 525. National Institutes of Health.
Sec. 526. Health Resources and Services Administration.
Sec. 527. Administration for Children and Families.
TITLE I--LOWERING PRICES THROUGH FAIR DRUG PRICE NEGOTIATION
SEC. 101. PROVIDING FOR LOWER PRICES FOR CERTAIN HIGH-PRICED SINGLE
SOURCE DRUGS.
(a) Program To Lower Prices for Certain High-Priced Single Source
Drugs.--Title XI of the Social Security Act (42 U.S.C. 1301 et seq.) is
amended by adding at the end the following new part:
``PART E--FAIR PRICE NEGOTIATION PROGRAM TO LOWER PRICES FOR CERTAIN
HIGH-PRICED SINGLE SOURCE DRUGS
``SEC. 1191. ESTABLISHMENT OF PROGRAM.
``(a) In General.--The Secretary shall establish a Fair Price
Negotiation Program (in this part referred to as the `program'). Under
the program, with respect to each price applicability period, the
Secretary shall--
``(1) publish a list of selected drugs in accordance with
section 1192;
``(2) enter into agreements with manufacturers of selected
drugs with respect to such period, in accordance with section
1193;
``(3) negotiate and, if applicable, renegotiate maximum
fair prices for such selected drugs, in accordance with section
1194; and
``(4) carry out the administrative duties described in
section 1196.
``(b) Definitions Relating to Timing.--For purposes of this part:
``(1) Initial price applicability year.--The term `initial
price applicability year' means a plan year (beginning with
plan year 2024) or, if agreed to in an agreement under section
1193 by the Secretary and manufacturer involved, a period of
more than one plan year (beginning on or after January 1,
2024).
``(2) Price applicability period.--The term `price
applicability period' means, with respect to a drug, the period
beginning with the initial price applicability year with
respect to which such drug is a selected drug and ending with
the last plan year during which the drug is a selected drug.
``(3) Selected drug publication date.--The term `selected
drug publication date' means, with respect to each initial
price applicability year, April 15 of the plan year that begins
2 years prior to such year.
``(4) Voluntary negotiation period.--The term `voluntary
negotiation period' means, with respect to an initial price
applicability year with respect to a selected drug, the
period--
``(A) beginning on the sooner of--
``(i) the date on which the manufacturer of
the drug and the Secretary enter into an
agreement under section 1193 with respect to
such drug; or
``(ii) June 15 following the selected drug
publication date with respect to such selected
drug; and
``(B) ending on March 31 of the year that begins
one year prior to the initial price applicability year.
``(c) Other Definitions.--For purposes of this part:
``(1) Fair price eligible individual.--The term `fair price
eligible individual' means, with respect to a selected drug--
``(A) in the case such drug is furnished or
dispensed to the individual at a pharmacy or by a mail
order service--
``(i) an individual who is enrolled under a
prescription drug plan under part D of title
XVIII or an MA-PD plan under part C of such
title if coverage is provided under such plan
for such selected drug; and
``(ii) an individual who is enrolled under
a group health plan or health insurance
coverage offered in the group or individual
market (as such terms are defined in section
2791 of the Public Health Service Act) with
respect to which there is in effect an
agreement with the Secretary under section 1197
with respect to such selected drug as so
furnished or dispensed; and
``(B) in the case such drug is furnished or
administered to the individual by a hospital,
physician, or other provider of services or supplier--
``(i) an individual who is entitled to
benefits under part A of title XVIII or
enrolled under part B of such title if such
selected drug is covered under the respective
part; and
``(ii) an individual who is enrolled under
a group health plan or health insurance
coverage offered in the group or individual
market (as such terms are defined in section
2791 of the Public Health Service Act) with
respect to which there is in effect an
agreement with the Secretary under section 1197
with respect to such selected drug as so
furnished or administered.
``(2) Maximum fair price.--The term `maximum fair price'
means, with respect to a plan year during a price applicability
period and with respect to a selected drug (as defined in
section 1192(c)) with respect to such period, the price
published pursuant to section 1195 in the Federal Register for
such drug and year.
``(3) Average international market price defined.--
``(A) In general.--The terms `average international
market price' and `AIM price' mean, with respect to a
drug, the average price (which shall be the net average
price, if practicable, and volume-weighted, if
practicable) for a unit (as defined in paragraph (4))
of the drug for sales of such drug (calculated across
different dosage forms and strengths of the drug and
not based on the specific formulation or package size
or package type), as computed (as of the date of
publication of such drug as a selected drug under
section 1192(a)) in all countries described in clause
(ii) of subparagraph (B) that are applicable countries
(as described in clause (i) of such subparagraph) with
respect to such drug.
``(B) Applicable countries.--
``(i) In general.--For purposes of
subparagraph (A), a country described in clause
(ii) is an applicable country described in this
clause with respect to a drug if there is
available an average price for any unit for the
drug for sales of such drug in such country.
``(ii) Countries described.--For purposes
of this paragraph, the following are countries
described in this clause:
``(I) Australia.
``(II) Canada.
``(III) France.
``(IV) Germany.
``(V) Japan.
``(VI) The United Kingdom.
``(4) Unit.--The term `unit' means, with respect to a drug,
the lowest identifiable quantity (such as a capsule or tablet,
milligram of molecules, or grams) of the drug that is
dispensed.
``SEC. 1192. SELECTION OF NEGOTIATION-ELIGIBLE DRUGS AS SELECTED DRUGS.
``(a) In General.--Not later than the selected drug publication
date with respect to an initial price applicability year, subject to
subsection (h), the Secretary shall select and publish in the Federal
Register a list of--
``(1)(A) with respect to an initial price applicability
year during 2024, at least 25 negotiation-eligible drugs
described in subparagraphs (A) and (B), but not subparagraph
(C), of subsection (d)(1) (or, with respect to an initial price
applicability year during such period beginning after 2024, the
maximum number (if such number is less than 25) of such
negotiation-eligible drugs for the year) with respect to such
year; and
``(B) with respect to an initial price applicability year
during 2025 or a subsequent year, at least 50 negotiation-
eligible drugs described in subparagraphs (A) and (B), but not
subparagraph (C), of subsection (d)(1) (or, with respect to an
initial price applicability year during such period, the
maximum number (if such number is less than 50) of such
negotiation-eligible drugs for the year) with respect to such
year;
``(2) all negotiation-eligible drugs described in
subparagraph (C) of such subsection with respect to such year;
and
``(3) all new-entrant negotiation-eligible drugs (as
defined in subsection (g)(1)) with respect to such year.
Each drug published on the list pursuant to the previous sentence shall
be subject to the negotiation process under section 1194 for the
voluntary negotiation period with respect to such initial price
applicability year (and the renegotiation process under such section as
applicable for any subsequent year during the applicable price
applicability period). In applying this subsection, any negotiation-
eligible drug that is selected under this subsection for an initial
price applicability year shall not count toward the required minimum
amount of drugs to be selected under paragraph (1) for any subsequent
year, including such a drug so selected that is subject to
renegotiation under section 1194.
``(b) Selection of Drugs.--In carrying out subsection (a)(1) the
Secretary shall select for inclusion on the published list described in
subsection (a) with respect to a price applicability period, the
negotiation-eligible drugs that the Secretary projects will result in
the greatest savings to the Federal Government or fair price eligible
individuals during the price applicability period. In making this
projection of savings for drugs for which there is an AIM price for a
price applicability period, the savings shall be projected across
different dosage forms and strengths of the drugs and not based on the
specific formulation or package size or package type of the drugs,
taking into consideration both the volume of drugs for which payment is
made, to the extent such data is available, and the amount by which the
net price for the drugs exceeds the AIM price for the drugs.
``(c) Selected Drug.--For purposes of this part, each drug included
on the list published under subsection (a) with respect to an initial
price applicability year shall be referred to as a `selected drug' with
respect to such year and each subsequent plan year beginning before the
first plan year beginning after the date on which the Secretary
determines two or more drug products--
``(1) are approved or licensed (as applicable)--
``(A) under section 505(j) of the Federal Food,
Drug, and Cosmetic Act using such drug as the listed
drug; or
``(B) under section 351(k) of the Public Health
Service Act using such drug as the reference product;
and
``(2) continue to be marketed.
``(d) Negotiation-Eligible Drug.--
``(1) In general.--For purposes of this part, the term
`negotiation-eligible drug' means, with respect to the selected
drug publication date with respect to an initial price
applicability year, a qualifying single source drug, as defined
in subsection (e), that meets any of the following criteria:
``(A) Covered part d drugs.--The drug is among the
125 covered part D drugs (as defined in section 1860D-
2(e)) for which there was an estimated greatest net
spending under parts C and D of title XVIII, as
determined by the Secretary, during the most recent
plan year prior to such drug publication date for which
data are available.
``(B) Other drugs.--The drug is among the 125 drugs
for which there was an estimated greatest net spending
in the United States (including the 50 States, the
District of Columbia, and the territories of the United
States), as determined by the Secretary, during the
most recent plan year prior to such drug publication
date for which data are available.
``(C) Insulin.--The drug is a qualifying single
source drug described in subsection (e)(3).
``(2) Clarification.--In determining whether a qualifying
single source drug satisfies any of the criteria described in
paragraph (1), the Secretary shall, to the extent practicable,
use data that is aggregated across dosage forms and strengths
of the drug and not based on the specific formulation or
package size or package type of the drug.
``(3) Publication.--Not later than the selected drug
publication date with respect to an initial price applicability
year, the Secretary shall publish in the Federal Register a
list of negotiation-eligible drugs with respect to such
selected drug publication date.
``(e) Qualifying Single Source Drug.--For purposes of this part,
the term `qualifying single source drug' means any of the following:
``(1) Drug products.--A drug that--
``(A) is approved under section 505(c) of the
Federal Food, Drug, and Cosmetic Act and continues to
be marketed pursuant to such approval; and
``(B) is not the listed drug for any drug that is
approved and continues to be marketed under section
505(j) of such Act.
``(2) Biological products.--A biological product that--
``(A) is licensed under section 351(a) of the
Public Health Service Act, including any product that
has been deemed to be licensed under section 351 of
such Act pursuant to section 7002(e)(4) of the
Biologics Price Competition and Innovation Act of 2009,
and continues to be marketed under section 351 of such
Act; and
``(B) is not the reference product for any
biological product that is licensed and continues to be
marketed under section 351(k) of such Act.
``(3) Insulin product.--Notwithstanding paragraphs (1) and
(2), any insulin product that is approved under subsection (c)
or (j) of section 505 of the Federal Food, Drug, and Cosmetic
Act or licensed under subsection (a) or (k) of section 351 of
the Public Health Service Act and continues to be marketed
under such section 505 or 351, including any insulin product
that has been deemed to be licensed under section 351(a) of the
Public Health Service Act pursuant to section 7002(e)(4) of the
Biologics Price Competition and Innovation Act of 2009 and
continues to be marketed pursuant to such licensure.
For purposes of applying paragraphs (1) and (2), a drug or biological
product that is marketed by the same sponsor or manufacturer (or an
affiliate thereof or a cross-licensed producer or distributor) as the
listed drug or reference product described in such respective paragraph
shall not be taken into consideration.
``(f) Information on International Drug Prices.--For purposes of
determining which negotiation-eligible drugs to select under subsection
(a) and, in the case of such drugs that are selected drugs, to
determine the maximum fair price for such a drug and whether such
maximum fair price should be renegotiated under section 1194, the
Secretary shall use data relating to the AIM price with respect to such
drug as available or provided to the Secretary and shall on an ongoing
basis request from manufacturers of selected drugs information on the
AIM price of such a drug.
``(g) New-Entrant Negotiation-Eligible Drugs.--
``(1) In general.--For purposes of this part, the term
`new-entrant negotiation-eligible drug' means, with respect to
the selected drug publication date with respect to an initial
price applicability year, a qualifying single source drug--
``(A) that is first approved or licensed, as
described in paragraph (1), (2), or (3) of subsection
(e), as applicable, during the year preceding such
selected drug publication date; and
``(B) that the Secretary determines under paragraph
(2) is likely to be included as a negotiation-eligible
drug with respect to the subsequent selected drug
publication date.
``(2) Determination.--In the case of a qualifying single
source drug that meets the criteria described in subparagraph
(A) of paragraph (1), with respect to an initial price
applicability year, if the wholesale acquisition cost at which
such drug is first marketed in the United States is equal to or
greater than the median household income (as determined
according to the most recent data collected by the United
States Census Bureau), the Secretary shall determine before the
selected drug publication date with respect to the initial
price applicability year, if the drug is likely to be included
as a negotiation-eligible drug with respect to the subsequent
selected drug publication date, based on the projected spending
under title XVIII or in the United States on such drug. For
purposes of this paragraph the term `United States' includes
the 50 States, the District of Columbia, and the territories of
the United States.
``(h) Conflict of Interest.--
``(1) In general.--In the case the Inspector General of the
Department of Health and Human Services determines the
Secretary has a conflict, with respect to a matter described in
paragraph (2), the individual described in paragraph (3) shall
carry out the duties of the Secretary under this part, with
respect to a negotiation-eligible drug, that would otherwise be
such a conflict.
``(2) Matter described.--A matter described in this
paragraph is--
``(A) a financial interest (as described in section
2635.402 of title 5, Code of Federal Regulations, as in
effect on the date of the enactment of this section,
(except for an interest described in subsection
(b)(2)(iv) of such section)) on the date of the
selected drug publication date, with respect the price
applicability year (as applicable);
``(B) a personal or business relationship (as
described in section 2635.502 of such title) on the
date of the selected drug publication date, with
respect the price applicability year;
``(C) employment by a manufacturer of a
negotiation-eligible drug during the preceding 10-year
period beginning on the date of the selected drug
publication date, with respect to each price
applicability year; and
``(D) any other matter the General Counsel
determines appropriate.
``(3) Individual described.--An individual described in
this paragraph is--
``(A) the highest-ranking officer or employee of
the Department of Health and Human Services (as
determined by the organizational chart of the
Department) that does not have a conflict under this
subsection; and
``(B) is nominated by the President and confirmed
by the Senate with respect to the position.
``SEC. 1193. MANUFACTURER AGREEMENTS.
``(a) In General.--For purposes of section 1191(a)(2), the
Secretary shall enter into agreements with manufacturers of selected
drugs with respect to a price applicability period, by not later than
June 15 following the selected drug publication date with respect to
such selected drug, under which--
``(1) during the voluntary negotiation period for the
initial price applicability year for the selected drug, the
Secretary and manufacturer, in accordance with section 1194,
negotiate to determine (and, by not later than the last date of
such period and in accordance with subsection (c), agree to) a
maximum fair price for such selected drug of the manufacturer
in order to provide access to such price--
``(A) to fair price eligible individuals who with
respect to such drug are described in subparagraph (A)
of section 1191(c)(1) and are furnished or dispensed
such drug during, subject to subparagraph (2), the
price applicability period; and
``(B) to hospitals, physicians, and other providers
of services and suppliers with respect to fair price
eligible individuals who with respect to such drug are
described in subparagraph (B) of such section and are
furnished or administered such drug during, subject to
subparagraph (2), the price applicability period;
``(2) the Secretary and the manufacturer shall, in
accordance with a process and during a period specified by the
Secretary pursuant to rulemaking, renegotiate (and, by not
later than the last date of such period and in accordance with
subsection (c), agree to) the maximum fair price for such drug
if the Secretary determines that there is a material change in
any of the factors described in section 1194(d) relating to the
drug, including changes in the AIM price for such drug, in
order to provide access to such maximum fair price (as so
renegotiated)--
``(A) to fair price eligible individuals who with
respect to such drug are described in subparagraph (A)
of section 1191(c)(1) and are furnished or dispensed
such drug during any year during the price
applicability period (beginning after such
renegotiation) with respect to such selected drug; and
``(B) to hospitals, physicians, and other providers
of services and suppliers with respect to fair price
eligible individuals who with respect to such drug are
described in subparagraph (B) of such section and are
furnished or administered such drug during any year
described in subparagraph (A);
``(3) the maximum fair price (including as renegotiated
pursuant to paragraph (2)), with respect to such a selected
drug, shall be provided to fair price eligible individuals, who
with respect to such drug are described in subparagraph (A) of
section 1191(c)(1), at the pharmacy or by a mail order service
at the point-of-sale of such drug;
``(4) the manufacturer, subject to subsection (d), submits
to the Secretary, in a form and manner specified by the
Secretary--
``(A) for the voluntary negotiation period for the
price applicability period (and, if applicable, before
any period of renegotiation specified pursuant to
paragraph (2)) with respect to such drug all
information that the Secretary requires to carry out
the negotiation (or renegotiation process) under this
part, including information described in section
1192(f) and section 1194(d)(1); and
``(B) on an ongoing basis, information on changes
in prices for such drug that would affect the AIM price
for such drug or otherwise provide a basis for
renegotiation of the maximum fair price for such drug
pursuant to paragraph (2);
``(5) the manufacturer agrees that in the case the selected
drug of a manufacturer is a drug described in subsection (c),
the manufacturer will, in accordance with such subsection, make
any payment required under such subsection with respect to such
drug; and
``(6) the manufacturer complies with requirements imposed
by the Secretary for purposes of administering the program,
including with respect to the duties described in section 1196.
``(b) Agreement in Effect Until Drug Is No Longer a Selected
Drug.--An agreement entered into under this section shall be effective,
with respect to a drug, until such drug is no longer considered a
selected drug under section 1192(c).
``(c) Special Rule for Certain Selected Drugs Without AIM Price.--
``(1) In general.--In the case of a selected drug for which
there is no AIM price available with respect to the initial
price applicability year for such drug and for which an AIM
price becomes available beginning with respect to a subsequent
plan year during the price applicability period for such drug,
if the Secretary determines that the amount described in
paragraph (2)(A) for a unit of such drug is greater than the
amount described in paragraph (2)(B) for a unit of such drug,
then by not later than one year after the date of such
determination, the manufacturer of such selected drug shall pay
to the Treasury an amount equal to the product of--
``(A) the difference between such amount described
in paragraph (2)(A) for a unit of such drug and such
amount described in paragraph (2)(B) for a unit of such
drug; and
``(B) the number of units of such drug sold in the
United States, including the 50 States, the District of
Columbia, and the territories of the United States,
during the period described in paragraph (2)(B).
``(2) Amounts described.--
``(A) Weighted average price before aim price
available.--For purposes of paragraph (1), the amount
described in this subparagraph for a selected drug
described in such paragraph, is the amount equal to the
weighted average manufacturer price (as defined in
section 1927(k)(1)) for such dosage strength and form
for the drug during the period beginning with the first
plan year for which the drug is included on the list of
negotiation-eligible drugs published under section
1192(d) and ending with the last plan year during the
price applicability period for such drug with respect
to which there is no AIM price available for such drug.
``(B) Amount multiplier after aim price
available.--For purposes of paragraph (1), the amount
described in this subparagraph for a selected drug
described in such paragraph, is the amount equal to 200
percent of the AIM price for such drug with respect to
the first plan year during the price applicability
period for such drug with respect to which there is an
AIM price available for such drug.
``(d) Confidentiality of Information.--Information submitted to the
Secretary under this part by a manufacturer of a selected drug that is
proprietary information of such manufacturer (as determined by the
Secretary) may be used only by the Secretary or disclosed to and used
by the Comptroller General of the United States or the Medicare Payment
Advisory Commission for purposes of carrying out this part.
``(e) Regulations.--
``(1) In general.--The Secretary shall, pursuant to
rulemaking, specify, in accordance with paragraph (2), the
information that must be submitted under subsection (a)(4).
``(2) Information specified.--Information described in
paragraph (1), with respect to a selected drug, shall include
information on sales of the drug (by the manufacturer of the
drug or by another entity under license or other agreement with
the manufacturer, with respect to the sales of such drug,
regardless of the name under which the drug is sold) in any
foreign country that is part of the AIM price. The Secretary
shall verify, to the extent practicable, such sales from
appropriate officials of the government of the foreign country
involved.
``(f) Compliance With Requirements for Administration of Program.--
Each manufacturer with an agreement in effect under this section shall
comply with requirements imposed by the Secretary or a third party with
a contract under section 1196(c)(1), as applicable, for purposes of
administering the program.
``SEC. 1194. NEGOTIATION AND RENEGOTIATION PROCESS.
``(a) In General.--For purposes of this part, under an agreement
under section 1193 between the Secretary and a manufacturer of a
selected drug, with respect to the period for which such agreement is
in effect and in accordance with subsections (b) and (c), the Secretary
and the manufacturer--
``(1) shall during the voluntary negotiation period with
respect to the initial price applicability year for such drug,
in accordance with this section, negotiate a maximum fair price
for such drug for the purpose described in section 1193(a)(1);
and
``(2) as applicable pursuant to section 1193(a)(2) and in
accordance with the process specified pursuant to such section,
renegotiate such maximum fair price for such drug for the
purpose described in such section.
``(b) Negotiating Methodology and Objective.--
``(1) In general.--The Secretary shall develop and use a
consistent methodology for negotiations under subsection (a)
that, in accordance with paragraph (2) and subject to paragraph
(3), achieves the lowest maximum fair price for each selected
drug while appropriately rewarding innovation.
``(2) Prioritizing factors.--In considering the factors
described in subsection (d) in negotiating (and, as applicable,
renegotiating) the maximum fair price for a selected drug, the
Secretary shall, to the extent practicable, consider all of the
available factors listed but shall prioritize the following
factors:
``(A) Research and development costs.--The factor
described in paragraph (1)(A) of subsection (d).
``(B) Market data.--The factor described in
paragraph (1)(B) of such subsection.
``(C) Unit costs of production and distribution.--
The factor described in paragraph (1)(C) of such
subsection.
``(D) Comparison to existing therapeutic
alternatives.--The factor described in paragraph (2)(A)
of such subsection.
``(3) Requirement.--
``(A) In general.--In negotiating the maximum fair
price of a selected drug, with respect to an initial
price applicability year for the selected drug, and, as
applicable, in renegotiating the maximum fair price for
such drug, with respect to a subsequent year during the
price applicability period for such drug, in the case
that the manufacturer of the selected drug offers under
the negotiation or renegotiation, as applicable, a
price for such drug that is not more than the target
price described in subparagraph (B) for such drug for
the respective year, the Secretary shall agree under
such negotiation or renegotiation, respectively, to
such offered price as the maximum fair price.
``(B) Target price.--
``(i) In general.--Subject to clause (ii),
the target price described in this subparagraph
for a selected drug with respect to a year, is
the average price (which shall be the net
average price, if practicable, and volume-
weighted, if practicable) for a unit of such
drug for sales of such drug, as computed
(across different dosage forms and strengths of
the drug and not based on the specific
formulation or package size or package type of
the drug) in the applicable country described
in section 1191(c)(3)(B) with respect to such
drug that, with respect to such year, has the
lowest average price for such drug as compared
to the average prices (as so computed) of such
drug with respect to such year in the other
applicable countries described in such section
with respect to such drug.
``(ii) Selected drugs without aim price.--
In applying this paragraph in the case of
negotiating the maximum fair price of a
selected drug for which there is no AIM price
available with respect to the initial price
applicability year for such drug, or, as
applicable, renegotiating the maximum fair
price for such drug with respect to a
subsequent year during the price applicability
period for such drug before the first plan year
for which there is an AIM price available for
such drug, the target price described in this
subparagraph for such drug and respective year
is the amount that is 80 percent of the average
manufacturer price (as defined in section
1927(k)(1)) for such drug and year.
``(4) Annual report.--After the completion of each
voluntary negotiation period, the Secretary shall submit to
Congress a report on the maximum fair prices negotiated (or, as
applicable, renegotiated) for such period. Such report shall
include information on how such prices so negotiated (or
renegotiated) meet the requirements of this part, including the
requirements of this subsection.
``(c) Limitation.--
``(1) In general.--Subject to paragraph (2), the maximum
fair price negotiated (including as renegotiated) under this
section for a selected drug, with respect to each plan year
during a price applicability period for such drug, shall not
exceed 120 percent of the AIM price applicable to such drug
with respect to such year.
``(2) Selected drugs without aim price.--In the case of a
selected drug for which there is no AIM price available with
respect to the initial price applicability year for such drug,
for each plan year during the price applicability period before
the first plan year for which there is an AIM price available
for such drug, the maximum fair price negotiated (including as
renegotiated) under this section for the selected drug shall
not exceed the amount equal to 85 percent of the average
manufacturer price for the drug with respect to such year.
``(d) Considerations.--For purposes of negotiating and, as
applicable, renegotiating (including for purposes of determining
whether to renegotiate) the maximum fair price of a selected drug under
this part with the manufacturer of the drug, the Secretary, consistent
with subsection (b)(2), shall take into consideration the factors
described in paragraphs (1), (2), (3), and (5), and may take into
consideration the factor described in paragraph (4):
``(1) Manufacturer-specific information.--The following
information, including as submitted by the manufacturer:
``(A) Research and development costs of the
manufacturer for the drug and the extent to which the
manufacturer has recouped research and development
costs.
``(B) Market data for the drug, including the
distribution of sales across different programs and
purchasers and projected future revenues for the drug.
``(C) Unit costs of production and distribution of
the drug.
``(D) Prior Federal financial support for novel
therapeutic discovery and development with respect to
the drug.
``(E) Data on patents and on existing and pending
exclusivity for the drug.
``(F) National sales data for the drug.
``(G) Information on clinical trials for the drug
in the United States or in applicable countries
described in section 1191(c)(3)(B).
``(2) Information on alternative products.--The following
information:
``(A) The extent to which the drug represents a
therapeutic advance as compared to existing therapeutic
alternatives and, to the extent such information is
available, the costs of such existing therapeutic
alternatives.
``(B) Information on approval by the Food and Drug
Administration of alternative drug products.
``(C) Information on comparative effectiveness
analysis for such products, taking into consideration
the effects of such products on specific populations,
such as individuals with disabilities, the elderly,
terminally ill, children, and other patient
populations.
In considering information described in subparagraph (C), the
Secretary shall not use evidence or findings from comparative
clinical effectiveness research in a manner that treats
extending the life of an elderly, disabled, or terminally ill
individual as of lower value than extending the life of an
individual who is younger, nondisabled, or not terminally ill.
Nothing in the previous sentence shall affect the application
or consideration of an AIM price for a selected drug.
``(3) Foreign sales information.--To the extent available
on a timely basis, including as provided by a manufacturer of
the selected drug or otherwise, information on sales of the
selected drug in each of the countries described in section
1191(c)(3)(B).
``(4) VA drug pricing information.--Information disclosed
to the Secretary pursuant to subsection (f).
``(5) Additional information.--Information submitted to the
Secretary, in accordance with a process specified by the
Secretary, by other parties that are affected by the
establishment of a maximum fair price for the selected drug.
``(e) Request for Information.--For purposes of negotiating and, as
applicable, renegotiating (including for purposes of determining
whether to renegotiate) the maximum fair price of a selected drug under
this part with the manufacturer of the drug, with respect to a price
applicability period, and other relevant data for purposes of this
section--
``(1) the Secretary shall, not later than the selected drug
publication date with respect to the initial price
applicability year of such period, request drug pricing
information from the manufacturer of such selected drug,
including information described in subsection (d)(1); and
``(2) by not later than October 1 following the selected
drug publication date, the manufacturer of such selected drug
shall submit to the Secretary such requested information in
such form and manner as the Secretary may require.
The Secretary shall request, from the manufacturer or others, such
additional information as may be needed to carry out the negotiation
and renegotiation process under this section.
``(f) Disclosure of Information.--For purposes of this part, the
Secretary of Veterans Affairs may disclose to the Secretary of Health
and Human Services the price of any negotiation-eligible drug that is
purchased pursuant to section 8126 of title 38, United States Code.
``SEC. 1195. PUBLICATION OF MAXIMUM FAIR PRICES.
``(a) In General.--With respect to an initial price applicability
year and selected drug with respect to such year, not later than April
1 of the plan year prior to such initial price applicability year, the
Secretary shall publish in the Federal Register the maximum fair price
for such drug negotiated under this part with the manufacturer of such
drug.
``(b) Updates.--
``(1) Subsequent year maximum fair prices.--For a selected
drug, for each plan year subsequent to the initial price
applicability year for such drug with respect to which an
agreement for such drug is in effect under section 1193, the
Secretary shall publish in the Federal Register--
``(A) subject to subparagraph (B), the amount equal
to the maximum fair price published for such drug for
the previous year, increased by the annual percentage
increase in the consumer price index for all urban
consumers (all items; U.S. city average) as of
September of such previous year; or
``(B) in the case the maximum fair price for such
drug was renegotiated, for the first year for which
such price as so renegotiated applies, such
renegotiated maximum fair price.
``(2) Prices negotiated after deadline.--In the case of a
selected drug with respect to an initial price applicability
year for which the maximum fair price is determined under this
part after the date of publication under this section, the
Secretary shall publish such maximum fair price in the Federal
Register by not later than 30 days after the date such maximum
price is so determined.
``SEC. 1196. ADMINISTRATIVE DUTIES; COORDINATION PROVISIONS.
``(a) Administrative Duties.--
``(1) In general.--For purposes of section 1191, the
administrative duties described in this section are the
following:
``(A) The establishment of procedures (including
through agreements with manufacturers under this part,
contracts with prescription drug plans under part D of
title XVIII and MA-PD plans under part C of such title,
and agreements under section 1197 with group health
plans and health insurance issuers of health insurance
coverage offered in the individual or group market)
under which the maximum fair price for a selected drug
is provided to fair price eligible individuals, who
with respect to such drug are described in subparagraph
(A) of section 1191(c)(1), at pharmacies or by mail
order service at the point-of-sale of the drug for the
applicable price period for such drug and providing
that such maximum fair price is used for determining
cost-sharing under such plans or coverage for the
selected drug.
``(B) The establishment of procedures (including
through agreements with manufacturers under this part
and contracts with hospitals, physicians, and other
providers of services and suppliers and agreements
under section 1197 with group health plans and health
insurance issuers of health insurance coverage offered
in the individual or group market) under which, in the
case of a selected drug furnished or administered by
such a hospital, physician, or other provider of
services or supplier to fair price eligible individuals
(who with respect to such drug are described in
subparagraph (B) of section 1191(c)(1)), the maximum
fair price for the selected drug is provided to such
hospitals, physicians, and other providers of services
and suppliers (as applicable) with respect to such
individuals and providing that such maximum fair price
is used for determining cost-sharing under the
respective part, plan, or coverage for the selected
drug.
``(C) The establishment of procedures (including
through agreements and contracts described in
subparagraphs (A) and (B)) to ensure that, not later
than 90 days after the dispensing of a selected drug to
a fair price eligible individual by a pharmacy or mail
order service, the pharmacy or mail order service is
reimbursed for an amount equal to the difference
between--
``(i) the lesser of--
``(I) the wholesale acquisition
cost of the drug;
``(II) the national average drug
acquisition cost of the drug; and
``(III) any other similar
determination of pharmacy acquisition
costs of the drug, as determined by the
Secretary; and
``(ii) the maximum fair price for the drug.
``(D) The establishment of procedures to ensure
that the maximum fair price for a selected drug is
applied before--
``(i) any coverage or financial assistance
under other health benefit plans or programs
that provide coverage or financial assistance
for the purchase or provision of prescription
drug coverage on behalf of fair price eligible
individuals as the Secretary may specify; and
``(ii) any other discounts.
``(E) The establishment of procedures to enter into
appropriate agreements and protocols for the ongoing
computation of AIM prices for selected drugs,
including, to the extent possible, to compute the AIM
price for selected drugs and including by providing
that the manufacturer of such a selected drug should
provide information for such computation not later than
3 months after the first date of the voluntary
negotiation period for such selected drug.
``(F) The establishment of procedures to compute
and apply the maximum fair price across different
strengths and dosage forms of a selected drug and not
based on the specific formulation or package size or
package type of the drug.
``(G) The establishment of procedures to negotiate
and apply the maximum fair price in a manner that does
not include any dispensing or similar fee.
``(H) The establishment of procedures to carry out
the provisions of this part, as applicable, with
respect to--
``(i) fair price eligible individuals who
are enrolled under a prescription drug plan
under part D of title XVIII or an MA-PD plan
under part C of such title;
``(ii) fair price eligible individuals who
are enrolled under a group health plan or
health insurance coverage offered by a health
insurance issuer in the individual or group
market with respect to which there is an
agreement in effect under section 1197; and
``(iii) fair price eligible individuals who
are entitled to benefits under part A of title
XVIII or enrolled under part B of such title.
``(I) The establishment of a negotiation process
and renegotiation process in accordance with section
1194, including a process for acquiring information
described in subsection (d) of such section and
determining amounts described in subsection (b) of such
section.
``(J) The provision of a reasonable dispute
resolution mechanism to resolve disagreements between
manufacturers, fair price eligible individuals, and the
third party with a contract under subsection (c)(1).
``(2) Monitoring compliance.--
``(A) In general.--The Secretary shall monitor
compliance by a manufacturer with the terms of an
agreement under section 1193, including by establishing
a mechanism through which violations of such terms may
be reported.
``(B) Notification.--If a third party with a
contract under subsection (c)(1) determines that the
manufacturer is not in compliance with such agreement,
the third party shall notify the Secretary of such
noncompliance for appropriate enforcement under section
4192 of the Internal Revenue Code of 1986 or section
1198, as applicable.
``(b) Collection of Data.--
``(1) From prescription drug plans and ma-pd plans.--The
Secretary may collect appropriate data from prescription drug
plans under part D of title XVIII and MA-PD plans under part C
of such title in a timeframe that allows for maximum fair
prices to be provided under this part for selected drugs.
``(2) From health plans.--The Secretary may collect
appropriate data from group health plans or health insurance
issuers offering group or individual health insurance coverage
in a timeframe that allows for maximum fair prices to be
provided under this part for selected drugs.
``(3) Coordination of data collection.--To the extent
feasible, as determined by the Secretary, the Secretary shall
ensure that data collected pursuant to this subsection is
coordinated with, and not duplicative of, other Federal data
collection efforts.
``(c) Contract With Third Parties.--
``(1) In general.--The Secretary may enter into a contract
with 1 or more third parties to administer the requirements
established by the Secretary in order to carry out this part.
At a minimum, the contract with a third party under the
preceding sentence shall require that the third party--
``(A) receive and transmit information between the
Secretary, manufacturers, and other individuals or
entities the Secretary determines appropriate;
``(B) receive, distribute, or facilitate the
distribution of funds of manufacturers to appropriate
individuals or entities in order to meet the
obligations of manufacturers under agreements under
this part;
``(C) provide adequate and timely information to
manufacturers, consistent with the agreement with the
manufacturer under this part, as necessary for the
manufacturer to fulfill its obligations under this
part; and
``(D) permit manufacturers to conduct periodic
audits, directly or through contracts, of the data and
information used by the third party to determine
discounts for applicable drugs of the manufacturer
under the program.
``(2) Performance requirements.--The Secretary shall
establish performance requirements for a third party with a
contract under paragraph (1) and safeguards to protect the
independence and integrity of the activities carried out by the
third party under the program under this part.
``SEC. 1197. VOLUNTARY PARTICIPATION BY OTHER HEALTH PLANS.
``(a) Agreement To Participate Under Program.--
``(1) In general.--Subject to paragraph (2), under the
program under this part the Secretary shall be treated as
having in effect an agreement with a group health plan or
health insurance issuer offering group or individual health
insurance coverage (as such terms are defined in section 2791
of the Public Health Service Act), with respect to a price
applicability period and a selected drug with respect to such
period--
``(A) with respect to such selected drug furnished
or dispensed at a pharmacy or by mail order service if
coverage is provided under such plan or coverage during
such period for such selected drug as so furnished or
dispensed; and
``(B) with respect to such selected drug furnished
or administered by a hospital, physician, or other
provider of services or supplier if coverage is
provided under such plan or coverage during such period
for such selected drug as so furnished or administered.
``(2) Opting out of agreement.--The Secretary shall not be
treated as having in effect an agreement under the program
under this part with a group health plan or health insurance
issuer offering group or individual health insurance coverage
with respect to a price applicability period and a selected
drug with respect to such period if such a plan or issuer
affirmatively elects, through a process specified by the
Secretary, not to participate under the program with respect to
such period and drug.
``(b) Publication of Election.--With respect to each price
applicability period and each selected drug with respect to such
period, the Secretary and the Secretary of Labor and the Secretary of
the Treasury, as applicable, shall make public a list of each group
health plan and each health insurance issuer offering group or
individual health insurance coverage, with respect to which coverage is
provided under such plan or coverage for such drug, that has elected
under subsection (a) not to participate under the program with respect
to such period and drug.
``SEC. 1198. CIVIL MONETARY PENALTY.
``(a) Violations Relating to Offering of Maximum Fair Price.--Any
manufacturer of a selected drug that has entered into an agreement
under section 1193, with respect to a plan year during the price
applicability period for such drug, that does not provide access to a
price that is not more than the maximum fair price (or a lesser price)
for such drug for such year--
``(1) to a fair price eligible individual who with respect
to such drug is described in subparagraph (A) of section
1191(c)(1) and who is furnished or dispensed such drug during
such year; or
``(2) to a hospital, physician, or other provider of
services or supplier with respect to fair price eligible
individuals who with respect to such drug is described in
subparagraph (B) of such section and is furnished or
administered such drug by such hospital, physician, or provider
or supplier during such year;
shall be subject to a civil monetary penalty equal to ten times the
amount equal to the difference between the price for such drug made
available for such year by such manufacturer with respect to such
individual or hospital, physician, provider, or supplier and the
maximum fair price for such drug for such year.
``(b) Violations of Certain Terms of Agreement.--Any manufacturer
of a selected drug that has entered into an agreement under section
1193, with respect to a plan year during the price applicability period
for such drug, that is in violation of a requirement imposed pursuant
to section 1193(a)(6) shall be subject to a civil monetary penalty of
not more than $1,000,000 for each such violation.
``(c) Application.--The provisions of section 1128A (other than
subsections (a) and (b)) shall apply to a civil monetary penalty under
this section in the same manner as such provisions apply to a penalty
or proceeding under section 1128A(a).
``SEC. 1199. MISCELLANEOUS PROVISIONS.
``(a) Paperwork Reduction Act.--Chapter 35 of title 44, United
States Code, shall not apply to data collected under this part.
``(b) National Academy of Medicine Study.--Not later than December
31, 2027, the National Academy of Medicine shall conduct a study, and
submit to Congress a report, on recommendations for improvements to the
program under this part, including the determination of the limits
applied under section 1194(c).
``(c) MedPAC Study.--Not later than December 31, 2027, the Medicare
Payment Advisory Commission shall conduct a study, and submit to
Congress a report, on the program under this part with respect to the
Medicare program under title XVIII, including with respect to the
effect of the program on individuals entitled to benefits or enrolled
under such title.
``(d) Limitation on Judicial Review.--The following shall not be
subject to judicial review:
``(1) The selection of drugs for publication under section
1192(a).
``(2) The determination of whether a drug is a negotiation-
eligible drug under section 1192(d).
``(3) The determination of the maximum fair price of a
selected drug under section 1194.
``(4) The determination of units of a drug for purposes of
section 1191(c)(3).
``(e) Coordination.--In carrying out this part with respect to
group health plans or health insurance coverage offered in the group
market that are subject to oversight by the Secretary of Labor or the
Secretary of the Treasury, the Secretary of Health and Human Services
shall coordinate with such respective Secretary.
``(f) Data Sharing.--The Secretary shall share with the Secretary
of the Treasury such information as is necessary to determine the tax
imposed by section 4192 of the Internal Revenue Code of 1986.
``(g) GAO Study.--Not later than December 31, 2027, the Comptroller
General of the United States shall conduct a study of, and submit to
Congress a report on, the implementation of the Fair Price Negotiation
Program under this part.''.
(b) Application of Maximum Fair Prices and Conforming Amendments.--
(1) Under medicare.--
(A) Application to payments under part b.--Section
1847A(b)(1)(B) of the Social Security Act (42 U.S.C.
1395w-3a(b)(1)(B)) is amended by inserting ``or in the
case of such a drug or biological that is a selected
drug (as defined in section 1192(c)), with respect to a
price applicability period (as defined in section
1191(b)(2)), 106 percent of the maximum fair price (as
defined in section 1191(c)(2)) applicable for such drug
and a plan year during such period'' after ``paragraph
(4)''.
(B) Exception to part d non-interference.--Section
1860D-11(i) of the Social Security Act (42 U.S.C.
1395w-111(i)) is amended by inserting ``, except as
provided under part E of title XI'' after ``the
Secretary''.
(C) Application as negotiated price under part d.--
Section 1860D-2(d)(1) of the Social Security Act (42
U.S.C. 1395w-102(d)(1)) is amended--
(i) in subparagraph (B), by inserting ``,
subject to subparagraph (D),'' after
``negotiated prices''; and
(ii) by adding at the end the following new
subparagraph:
``(D) Application of maximum fair price for
selected drugs.--In applying this section, in the case
of a covered part D drug that is a selected drug (as
defined in section 1192(c)), with respect to a price
applicability period (as defined in section
1191(b)(2)), the negotiated prices used for payment (as
described in this subsection) shall be the maximum fair
price (as defined in section 1191(c)(2)) for such drug
and for each plan year during such period.''.
(D) Information from prescription drug plans and
ma-pd plans required.--
(i) Prescription drug plans.--Section
1860D-12(b) of the Social Security Act (42
U.S.C. 1395w-112(b)) is amended by adding at
the end the following new paragraph:
``(8) Provision of information related to maximum fair
prices.--Each contract entered into with a PDP sponsor under
this part with respect to a prescription drug plan offered by
such sponsor shall require the sponsor to provide information
to the Secretary as requested by the Secretary in accordance
with section 1196(b).''.
(ii) MA-PD plans.--Section 1857(f)(3) of
the Social Security Act (42 U.S.C. 1395w-
27(f)(3)) is amended by adding at the end the
following new subparagraph:
``(E) Provision of information related to maximum
fair prices.--Section 1860D-12(b)(8).''.
(2) Under group health plans and health insurance
coverage.--
(A) PHSA.--Part D of title XXVII of the Public
Health Service Act (42 U.S.C. 300gg-111 et seq.) is
amended by adding at the end the following new section:
``SEC. 2799A-11. FAIR PRICE NEGOTIATION PROGRAM AND APPLICATION OF
MAXIMUM FAIR PRICES.
``(a) In General.--In the case of a group health plan or health
insurance issuer offering group or individual health insurance coverage
that is treated under section 1197 of the Social Security Act as having
in effect an agreement with the Secretary under the Fair Price
Negotiation Program under part E of title XI of such Act, with respect
to a price applicability period (as defined in section 1191(b) of such
Act) and a selected drug (as defined in section 1192(c) of such Act)
with respect to such period with respect to which coverage is provided
under such plan or coverage--
``(1) the provisions of such part shall apply--
``(A) if coverage of such selected drug is provided
under such plan or coverage if the drug is furnished or
dispensed at a pharmacy or by a mail order service, to
the plans or coverage offered by such plan or issuer,
and to the individuals enrolled under such plans or
coverage, during such period, with respect to such
selected drug, in the same manner as such provisions
apply to prescription drug plans and MA-PD plans, and
to individuals enrolled under such prescription drug
plans and MA-PD plans during such period; and
``(B) if coverage of such selected drug is provided
under such plan or coverage if the drug is furnished or
administered by a hospital, physician, or other
provider of services or supplier, to the plans or
coverage offered by such plan or issuers, to the
individuals enrolled under such plans or coverage, and
to hospitals, physicians, and other providers of
services and suppliers during such period, with respect
to such drug in the same manner as such provisions
apply to the Secretary, to individuals entitled to
benefits under part A of title XVIII or enrolled under
part B of such title, and to hospitals, physicians, and
other providers and suppliers participating under title
XVIII during such period;
``(2) the plan or issuer shall apply any cost-sharing
responsibilities under such plan or coverage, with respect to
such selected drug, by substituting an amount not more than the
maximum fair price negotiated under such part E of title XI for
such drug in lieu of the drug price upon which the cost-sharing
would have otherwise applied, and such cost-sharing
responsibilities with respect to such selected drug may not
exceed such maximum fair price; and
``(3) the Secretary shall apply the provisions of such part
E to such plan, issuer, and coverage, such individuals so
enrolled in such plans and coverage, and such hospitals,
physicians, and other providers and suppliers participating in
such plans and coverage.
``(b) Notification Regarding Nonparticipation in Fair Price
Negotiation Program.--A group health plan or a health insurance issuer
offering group or individual health insurance coverage shall publicly
disclose in a manner and in accordance with a process specified by the
Secretary any election made under section 1197 of the Social Security
Act by the plan or issuer to not participate in the Fair Price
Negotiation Program under part E of title XI of such Act with respect
to a selected drug (as defined in section 1192(c) of such Act) for
which coverage is provided under such plan or coverage before the
beginning of the plan year for which such election was made.''.
(B) ERISA.--
(i) In general.--Subpart B of part 7 of
subtitle B of title I of the Employee
Retirement Income Security Act of 1974 (29
U.S.C. 1181 et seq.) is amended by adding at
the end the following new section:
``SEC. 726. FAIR PRICE NEGOTIATION PROGRAM AND APPLICATION OF MAXIMUM
FAIR PRICES.
``(a) In General.--In the case of a group health plan or health
insurance issuer offering group health insurance coverage that is
treated under section 1197 of the Social Security Act as having in
effect an agreement with the Secretary under the Fair Price Negotiation
Program under part E of title XI of such Act, with respect to a price
applicability period (as defined in section 1191(b) of such Act) and a
selected drug (as defined in section 1192(c) of such Act) with respect
to such period with respect to which coverage is provided under such
plan or coverage--
``(1) the provisions of such part shall apply, as
applicable--
``(A) if coverage of such selected drug is provided
under such plan or coverage if the drug is furnished or
dispensed at a pharmacy or by a mail order service, to
the plans or coverage offered by such plan or issuer,
and to the individuals enrolled under such plans or
coverage, during such period, with respect to such
selected drug, in the same manner as such provisions
apply to prescription drug plans and MA-PD plans, and
to individuals enrolled under such prescription drug
plans and MA-PD plans during such period; and
``(B) if coverage of such selected drug is provided
under such plan or coverage if the drug is furnished or
administered by a hospital, physician, or other
provider of services or supplier, to the plans or
coverage offered by such plan or issuers, to the
individuals enrolled under such plans or coverage, and
to hospitals, physicians, and other providers of
services and suppliers during such period, with respect
to such drug in the same manner as such provisions
apply to the Secretary, to individuals entitled to
benefits under part A of title XVIII or enrolled under
part B of such title, and to hospitals, physicians, and
other providers and suppliers participating under title
XVIII during such period;
``(2) the plan or issuer shall apply any cost-sharing
responsibilities under such plan or coverage, with respect to
such selected drug, by substituting an amount not more than the
maximum fair price negotiated under such part E of title XI for
such drug in lieu of the drug price upon which the cost-sharing
would have otherwise applied, and such cost-sharing
responsibilities with respect to such selected drug may not
exceed such maximum fair price; and
``(3) the Secretary shall apply the provisions of such part
E to such plan, issuer, and coverage, and such individuals so
enrolled in such plans.
``(b) Notification Regarding Nonparticipation in Fair Price
Negotiation Program.--A group health plan or a health insurance issuer
offering group health insurance coverage shall publicly disclose in a
manner and in accordance with a process specified by the Secretary any
election made under section 1197 of the Social Security Act by the plan
or issuer to not participate in the Fair Price Negotiation Program
under part E of title XI of such Act with respect to a selected drug
(as defined in section 1192(c) of such Act) for which coverage is
provided under such plan or coverage before the beginning of the plan
year for which such election was made.''.
(ii) Application to retiree and certain
small group health plans.--Section 732(a) of
the Employee Retirement Income Security Act of
1974 (29 U.S.C. 1191a(a)) is amended by
striking ``section 711'' and inserting
``sections 711 and 726''.
(iii) Clerical amendment.--The table of
sections for subpart B of part 7 of subtitle B
of title I of the Employee Retirement Income
Security Act of 1974 is amended by adding at
the end the following:
``Sec. 726. Fair Price Negotiation Program and application of maximum
fair prices.''.
(C) IRC.--
(i) In general.--Subchapter B of chapter
100 of the Internal Revenue Code of 1986 is
amended by adding at the end the following new
section:
``SEC. 9826. FAIR PRICE NEGOTIATION PROGRAM AND APPLICATION OF MAXIMUM
FAIR PRICES.
``(a) In General.--In the case of a group health plan that is
treated under section 1197 of the Social Security Act as having in
effect an agreement with the Secretary under the Fair Price Negotiation
Program under part E of title XI of such Act, with respect to a price
applicability period (as defined in section 1191(b) of such Act) and a
selected drug (as defined in section 1192(c) of such Act) with respect
to such period with respect to which coverage is provided under such
plan--
``(1) the provisions of such part shall apply, as
applicable--
``(A) if coverage of such selected drug is provided
under such plan if the drug is furnished or dispensed
at a pharmacy or by a mail order service, to the plan,
and to the individuals enrolled under such plan during
such period, with respect to such selected drug, in the
same manner as such provisions apply to prescription
drug plans and MA-PD plans, and to individuals enrolled
under such prescription drug plans and MA-PD plans
during such period; and
``(B) if coverage of such selected drug is provided
under such plan if the drug is furnished or
administered by a hospital, physician, or other
provider of services or supplier, to the plan, to the
individuals enrolled under such plan, and to hospitals,
physicians, and other providers of services and
suppliers during such period, with respect to such drug
in the same manner as such provisions apply to the
Secretary, to individuals entitled to benefits under
part A of title XVIII or enrolled under part B of such
title, and to hospitals, physicians, and other
providers and suppliers participating under title XVIII
during such period;
``(2) the plan shall apply any cost-sharing
responsibilities under such plan, with respect to such selected
drug, by substituting an amount not more than the maximum fair
price negotiated under such part E of title XI for such drug in
lieu of the drug price upon which the cost-sharing would have
otherwise applied, and such cost-sharing responsibilities with
respect to such selected drug may not exceed such maximum fair
price; and
``(3) the Secretary shall apply the provisions of such part
E to such plan and such individuals so enrolled in such plan.
``(b) Notification Regarding Nonparticipation in Fair Price
Negotiation Program.--A group health plan shall publicly disclose in a
manner and in accordance with a process specified by the Secretary any
election made under section 1197 of the Social Security Act by the plan
to not participate in the Fair Price Negotiation Program under part E
of title XI of such Act with respect to a selected drug (as defined in
section 1192(c) of such Act) for which coverage is provided under such
plan before the beginning of the plan year for which such election was
made.''.
(ii) Application to retiree and certain
small group health plans.--Section 9831(a)(2)
of the Internal Revenue Code of 1986 is amended
by inserting ``other than with respect to
section 9826,'' before ``any group health
plan''.
(iii) Clerical amendment.--The table of
sections for subchapter B of chapter 100 of
such Code is amended by adding at the end the
following new item:
``Sec. 9826. Fair Price Negotiation Program and application of maximum
fair prices.''.
(3) Fair price negotiation program prices included in best
price and amp.--Section 1927 of the Social Security Act (42
U.S.C. 1396r-8) is amended--
(A) in subsection (c)(1)(C)(ii)--
(i) in subclause (III), by striking at the
end ``; and'';
(ii) in subclause (IV), by striking at the
end the period and inserting ``; and''; and
(iii) by adding at the end the following
new subclause:
``(V) in the case of a rebate
period and a covered outpatient drug
that is a selected drug (as defined in
section 1192(c)) during such rebate
period, shall be inclusive of the price
for such drug made available from the
manufacturer during the rebate period
by reason of application of part E of
title XI to any wholesaler, retailer,
provider, health maintenance
organization, nonprofit entity, or
governmental entity within the United
States.''; and
(B) in subsection (k)(1)(B), by adding at the end
the following new clause:
``(iii) Clarification.--Notwithstanding
clause (i), in the case of a rebate period and
a covered outpatient drug that is a selected
drug (as defined in section 1192(c)) during
such rebate period, any reduction in price paid
during the rebate period to the manufacturer
for the drug by a wholesaler or retail
community pharmacy described in subparagraph
(A) by reason of application of part E of title
XI shall be included in the average
manufacturer price for the covered outpatient
drug.''.
(4) FEHBP.--Section 8902 of title 5, United States Code, is
amended by adding at the end the following:
``(p) A contract may not be made or a plan approved under this
chapter with any carrier that has affirmatively elected, pursuant to
section 1197 of the Social Security Act, not to participate in the Fair
Price Negotiation Program established under section 1191 of such Act
for any selected drug (as that term is defined in section 1192(c) of
such Act).''.
(5) Option of secretary of veterans affairs to purchase
covered drugs at maximum fair prices.--Section 8126 of title
38, United States Code, is amended--
(A) in subsection (a)(2), by inserting ``, subject
to subsection (j),'' after ``may not exceed'';
(B) in subsection (d), in the matter preceding
paragraph (1), by inserting ``, subject to subsection
(j)'' after ``for the procurement of the drug''; and
(C) by adding at the end the following new
subsection:
``(j)(1) In the case of a covered drug that is a selected drug, for
any year during the price applicability period for such drug, if the
Secretary determines that the maximum fair price of such drug for such
year is less than the price for such drug otherwise in effect pursuant
to this section (including after application of any reduction under
subsection (a)(2) and any discount under subsection (c)), at the option
of the Secretary, in lieu of the maximum price (determined after
application of the reduction under subsection (a)(2) and any discount
under subsection (c), as applicable) that would be permitted to be
charged during such year for such drug pursuant to this section without
application of this subsection, the maximum price permitted to be
charged during such year for such drug pursuant to this section shall
be such maximum fair price for such drug and year.
``(2) For purposes of this subsection:
``(A) The term `maximum fair price' means, with respect to
a selected drug and year during the price applicability period
for such drug, the maximum fair price (as defined in section
1191(c)(2) of the Social Security Act) for such drug and year.
``(B) The term `negotiation eligible drug' has the meaning
given such term in section 1192(d)(1) of the Social Security
Act.
``(C) The term `price applicability period' has, with
respect to a selected drug, the meaning given such term in
section 1191(b)(2) of such Act.
``(D) The term `selected drug' means, with respect to a
year, a drug that is a selected drug under section 1192(c) of
such Act for such year.''.
SEC. 102. SELECTED DRUG MANUFACTURER EXCISE TAX IMPOSED DURING
NONCOMPLIANCE PERIODS.
(a) In General.--Subchapter E of chapter 32 of the Internal Revenue
Code of 1986 is amended by adding at the end the following new section:
``SEC. 4192. SELECTED DRUGS DURING NONCOMPLIANCE PERIODS.
``(a) In General.--There is hereby imposed on the sale by the
manufacturer, producer, or importer of any selected drug during a day
described in subsection (b) a tax in an amount such that the applicable
percentage is equal to the ratio of--
``(1) such tax, divided by
``(2) the sum of such tax and the price for which so sold.
``(b) Noncompliance Periods.--A day is described in this subsection
with respect to a selected drug if it is a day during one of the
following periods:
``(1) The period beginning on the June 16th immediately
following the selected drug publication date and ending on the
first date during which the manufacturer of the drug has in
place an agreement described in subsection (a) of section 1193
of the Social Security Act with respect to such drug.
``(2) The period beginning on the April 1st immediately
following the June 16th described in paragraph (1) and ending
on the first date during which the manufacturer of the drug has
agreed to a maximum fair price under such agreement.
``(3) In the case of a selected drug with respect to which
the Secretary of Health and Human Services has specified a
renegotiation period under such agreement, the period beginning
on the first date after the last date of such renegotiation
period and ending on the first date during which the
manufacturer of the drug has agreed to a renegotiated maximum
fair price under such agreement.
``(4) With respect to information that is required to be
submitted to the Secretary of Health and Human Services under
such agreement, the period beginning on the date on which such
Secretary certifies that such information is overdue and ending
on the date that such information is so submitted.
``(5) In the case of a selected drug with respect to which
a payment is due under subsection (c) of such section 1193, the
period beginning on the date on which the Secretary of Health
and Human Services certifies that such payment is overdue and
ending on the date that such payment is made in full.
``(c) Applicable Percentage.--For purposes of this section, the
term `applicable percentage' means--
``(1) in the case of sales of a selected drug during the
first 90 days described in subsection (b) with respect to such
drug, 65 percent,
``(2) in the case of sales of such drug during the 91st day
through the 180th day described in subsection (b) with respect
to such drug, 75 percent,
``(3) in the case of sales of such drug during the 181st
day through the 270th day described in subsection (b) with
respect to such drug, 85 percent, and
``(4) in the case of sales of such drug during any
subsequent day, 95 percent.
``(d) Selected Drug.--For purposes of this section--
``(1) In general.--The term `selected drug' means any
selected drug (within the meaning of section 1192 of the Social
Security Act) which is manufactured or produced in the United
States or entered into the United States for consumption, use,
or warehousing.
``(2) United states.--The term `United States' has the
meaning given such term by section 4612(a)(4).
``(3) Coordination with rules for possessions of the united
states.--Rules similar to the rules of paragraphs (2) and (4)
of section 4132(c) shall apply for purposes of this section.
``(e) Other Definitions.--For purposes of this section, the terms
`selected drug publication date' and `maximum fair price' have the
meaning given such terms in section 1191 of the Social Security Act.
``(f) Anti-Abuse Rule.--In the case of a sale which was timed for
the purpose of avoiding the tax imposed by this section, the Secretary
may treat such sale as occurring during a day described in subsection
(b).''.
(b) No Deduction for Excise Tax Payments.--Section 275 of the
Internal Revenue Code of 1986 is amended by adding ``or by section
4192'' before the period at the end of subsection (a)(6).
(c) Conforming Amendments.--
(1) Section 4221(a) of the Internal Revenue Code of 1986 is
amended by inserting ``or 4192'' after ``section 4191''.
(2) Section 6416(b)(2) of such Code is amended by inserting
``or 4192'' after ``section 4191''.
(d) Clerical Amendments.--
(1) The heading of subchapter E of chapter 32 of the
Internal Revenue Code of 1986 is amended by striking ``Medical
Devices'' and inserting ``Other Medical Products''.
(2) The table of subchapters for chapter 32 of such Code is
amended by striking the item relating to subchapter E and
inserting the following new item:
``subchapter e. other medical products''.
(3) The table of sections for subchapter E of chapter 32 of
such Code is amended by adding at the end the following new
item:
``Sec. 4192. Selected drugs during noncompliance periods.''.
(e) Effective Date.--The amendments made by this section shall
apply to sales after the date of the enactment of this Act.
SEC. 103. FAIR PRICE NEGOTIATION IMPLEMENTATION FUND.
(a) In General.--There is hereby established a Fair Price
Negotiation Implementation Fund (referred to in this section as the
``Fund''). The Secretary of Health and Human Services may obligate and
expend amounts in the Fund to carry out this title and titles II and
III (and the amendments made by such titles).
(b) Funding.--There is authorized to be appropriated, and there is
hereby appropriated, out of any monies in the Treasury not otherwise
appropriated, to the Fund $3,000,000,000, to remain available until
expended, of which--
(1) $600,000,000 shall become available on the date of the
enactment of this Act;
(2) $600,000,000 shall become available on October 1, 2022;
(3) $600,000,000 shall become available on October 1, 2023;
(4) $600,000,000 shall become available on October 1, 2024;
and
(5) $600,000,000 shall become available on October 1, 2025.
(c) Supplement Not Supplant.--Any amounts appropriated pursuant to
this section shall be in addition to any other amounts otherwise
appropriated pursuant to any other provision of law.
TITLE II--PRESCRIPTION DRUG INFLATION REBATES
SEC. 201. MEDICARE PART B REBATE BY MANUFACTURERS.
(a) In General.--Section 1834 of the Social Security Act (42 U.S.C.
1395m) is amended by adding at the end the following new subsection:
``(z) Rebate by Manufacturers for Single Source Drugs With Prices
Increasing Faster Than Inflation.--
``(1) Requirements.--
``(A) Secretarial provision of information.--Not
later than 6 months after the end of each calendar
quarter beginning on or after July 1, 2023, the
Secretary shall, for each part B rebatable drug, report
to each manufacturer of such part B rebatable drug the
following for such calendar quarter:
``(i) Information on the total number of
units of the billing and payment code described
in subparagraph (A)(i) of paragraph (3) with
respect to such drug and calendar quarter.
``(ii) Information on the amount (if any)
of the excess average sales price increase
described in subparagraph (A)(ii) of such
paragraph for such drug and calendar quarter.
``(iii) The rebate amount specified under
such paragraph for such part B rebatable drug
and calendar quarter.
``(B) Manufacturer requirement.--For each calendar
quarter beginning on or after July 1, 2023, the
manufacturer of a part B rebatable 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 paragraph (3) for such drug for such
calendar quarter.
``(2) Part b rebatable drug defined.--
``(A) In general.--In this subsection, the term
`part B rebatable drug' means a single source drug or
biological (as defined in subparagraph (D) of section
1847A(c)(6)), including a biosimilar biological product
(as defined in subparagraph (H) of such section), paid
for under this part, except such term shall not include
such a drug or biological--
``(i) if the average total allowed charges
for a year per individual that uses such a drug
or biological, as determined by the Secretary,
are less than, subject to subparagraph (B),
$100; or
``(ii) that is a vaccine described in
subparagraph (A) or (B) of section 1861(s)(10).
``(B) Increase.--The dollar amount applied under
subparagraph (A)(i)--
``(i) for 2024, shall be the dollar amount
specified under such subparagraph for 2023,
increased by the percentage increase in the
consumer price index for all urban consumers
(United States city average) for the 12-month
period ending with June of the previous year;
and
``(ii) for a subsequent year, shall be the
dollar amount specified in this clause (or
clause (i)) for the previous year, increased by
the percentage increase in the consumer price
index for all urban consumers (United States
city average) for the 12-month period ending
with June of the previous year.
Any dollar amount specified under this subparagraph
that is not a multiple of $10 shall be rounded to the
nearest multiple of $10.
``(3) Rebate amount.--
``(A) In general.--For purposes of paragraph (1),
the amount specified in this paragraph for a part B
rebatable drug assigned to a billing and payment code
for a calendar quarter is, subject to paragraph (4),
the amount equal to the product of--
``(i) subject to subparagraphs (B) and (G),
the total number of units of the billing and
payment code for such part B rebatable drug
furnished under this part during the calendar
quarter; and
``(ii) the amount (if any) by which--
``(I) the payment amount under
subparagraph (B) or (C) of section
1847A(b)(1), as applicable, for such
part B rebatable drug during the
calendar quarter; exceeds
``(II) the inflation-adjusted
payment amount determined under
subparagraph (C) for such part B
rebatable drug during the calendar
quarter.
``(B) Excluded units.--For purposes of subparagraph
(A)(i), the total number of units of the billing and
payment code for each part B rebatable drug furnished
during a calendar quarter shall not include--
``(i) units packaged into the payment for a
procedure or service under section 1833(t) or
under section 1833(i) (instead of separately
payable under such respective section);
``(ii) units included under the single
payment system for renal dialysis services
under section 1881(b)(14); or
``(iii) units of a part B rebatable drug of
a manufacturer furnished to an individual, if
such manufacturer, with respect to the
furnishing of such units of such drug, provides
for discounts under section 340B of the Public
Health Service Act or for rebates under section
1927.
``(C) Determination of inflation-adjusted payment
amount.--The inflation-adjusted payment amount
determined under this subparagraph for a part B
rebatable drug for a calendar quarter is--
``(i) the payment amount for the billing
and payment code for such drug in the payment
amount benchmark quarter (as defined in
subparagraph (D)); increased by
``(ii) the percentage by which the rebate
period CPI-U (as defined in subparagraph (F))
for the calendar quarter exceeds the benchmark
period CPI-U (as defined in subparagraph (E)).
``(D) Payment amount benchmark quarter.--The term
`payment amount benchmark quarter' means the calendar
quarter beginning January 1, 2016.
``(E) Benchmark period cpi-u.--The term `benchmark
period CPI-U' means the consumer price index for all
urban consumers (United States city average) for July
2015.
``(F) Rebate period cpi-u.--The term `rebate period
CPI-U' means, with respect to a calendar quarter
described in subparagraph (C), the greater of the
benchmark period CPI-U and the consumer price index for
all urban consumers (United States city average) for
the first month of the calendar quarter that is two
calendar quarters prior to such described calendar
quarter.
``(G) Counting units.--
``(i) Cut-off period to count units.--For
purposes of subparagraph (A)(i), subject to
clause (ii), to count the total number of
billing units for a part B rebatable drug for a
quarter, the Secretary may use a cut-off period
in order to exclude from such total number of
billing units for such quarter claims for
services furnished during such quarter that
were not processed at an appropriate time prior
to the end of the cut-off period.
``(ii) Counting units for claims processed
after cut-off period.--If the Secretary uses a
cut-off period pursuant to clause (i), in the
case of units of a part B rebatable drug
furnished during a quarter but pursuant to
application of such cut-off period excluded for
purposes of subparagraph (A)(i) from the total
number of billing units for the drug for such
quarter, the Secretary shall count such units
of such drug so furnished in the total number
of billing units for such drug for a subsequent
quarter, as the Secretary determines
appropriate.
``(4) Special treatment of certain drugs and exemption.--
``(A) Subsequently approved drugs.--Subject to
subparagraph (B), in the case of a part B rebatable
drug first approved or licensed by the Food and Drug
Administration after July 1, 2015, clause (i) of
paragraph (3)(C) shall be applied as if the term
`payment amount benchmark quarter' were defined under
paragraph (3)(D) as the third full calendar quarter
after the day on which the drug was first marketed and
clause (ii) of paragraph (3)(C) shall be applied as if
the term `benchmark period CPI-U' were defined under
paragraph (3)(E) as if the reference to `July 2015'
under such paragraph were a reference to `the first
month of the first full calendar quarter after the day
on which the drug was first marketed'.
``(B) Timeline for provision of rebates for
subsequently approved drugs.--In the case of a part B
rebatable drug first approved or licensed by the Food
and Drug Administration after July 1, 2015, paragraph
(1)(B) shall be applied as if the reference to `July 1,
2023' under such paragraph were a reference to the
later of the 6th full calendar quarter after the day on
which the drug was first marketed or July 1, 2023.
``(C) Exemption for shortages.--The Secretary may
reduce or waive the rebate amount under paragraph
(1)(B) with respect to a part B rebatable drug that is
described as currently in shortage on the shortage list
in effect under section 506E of the Federal Food, Drug,
and Cosmetic Act or in the case of other exigent
circumstances, as determined by the Secretary.
``(D) Selected drugs.--In the case of a part B
rebatable drug that is a selected drug (as defined in
section 1192(c)) for a price applicability period (as
defined in section 1191(b)(2))--
``(i) for calendar quarters during such
period for which a maximum fair price (as
defined in section 1191(c)(2)) for such drug
has been determined and is applied under part E
of title XI, the rebate amount under paragraph
(1)(B) shall be waived; and
``(ii) in the case such drug is determined
(pursuant to such section 1192(c)) to no longer
be a selected drug, for each applicable year
beginning after the price applicability period
with respect to such drug, clause (i) of
paragraph (3)(C) shall be applied as if the
term `payment amount benchmark quarter' were
defined under paragraph (3)(D) as the calendar
quarter beginning January 1 of the last year
beginning during such price applicability
period with respect to such selected drug and
clause (ii) of paragraph (3)(C) shall be
applied as if the term `benchmark period CPI-U'
were defined under paragraph (3)(E) as if the
reference to `July 2015' under such paragraph
were a reference to the July of the year
preceding such last year.
``(5) Application to beneficiary coinsurance.--In the case
of a part B rebatable drug, if the payment amount for a quarter
exceeds the inflation adjusted payment for such quarter--
``(A) in computing the amount of any coinsurance
applicable under this title to an individual with
respect to such drug, the computation of such
coinsurance shall be based on the inflation-adjusted
payment amount determined under paragraph (3)(C) for
such part B rebatable drug; and
``(B) the amount of such coinsurance is equal to 20
percent of such inflation-adjusted payment amount so
determined.
``(6) 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.
``(7) Civil money penalty.--If a manufacturer of a part B
rebatable drug has failed to comply with the requirements under
paragraph (1)(B) for such drug for a calendar quarter, the
manufacturer shall be subject to, in accordance with a process
established by the Secretary pursuant to regulations, a civil
money penalty in an amount equal to at least 125 percent of the
amount specified in paragraph (3) for such drug for such
calendar quarter. The provisions of section 1128A (other than
subsections (a) (with respect to amounts of penalties or
additional assessments) and (b)) shall apply to a civil money
penalty under this paragraph in the same manner as such
provisions apply to a penalty or proceeding under section
1128A(a).
``(8) Study and report.--
``(A) Study.--The Secretary shall conduct a study
of the feasibility of and operational issues involved
with the following:
``(i) Including multiple source drugs (as
defined in section 1847A(c)(6)(C)) in the
rebate system under this subsection.
``(ii) Including drugs and biologicals paid
for under MA plans under part C in the rebate
system under this subsection.
``(iii) Including drugs excluded under
paragraph (2)(A) and units of the billing and
payment code of the drugs excluded under
paragraph (3)(B) in the rebate system under
this subsection.
``(B) Report.--Not later than 3 years after the
date of the enactment of this subsection, the Secretary
shall submit to Congress a report on the study
conducted under subparagraph (A).
``(9) Application to multiple source drugs.--The Secretary
may, based on the report submitted under paragraph (8) and
pursuant to rulemaking, apply the provisions of this subsection
to multiple source drugs (as defined in section
1847A(c)(6)(C)), including, for purposes of determining the
rebate amount under paragraph (3), by calculating manufacturer-
specific average sales prices for the benchmark period and the
rebate period.''.
(b) Amounts Payable; Cost-Sharing.--Section 1833 of the Social
Security Act (42 U.S.C. 1395l) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in subparagraph (S), by striking ``with
respect to'' and inserting ``subject to
subparagraph (DD), with respect to'';
(ii) by striking ``and (DD)'' and inserting
``(EE)''; and
(iii) by inserting before the semicolon at
the end the following: ``, and (EE) with
respect to a part B rebatable drug (as defined
in paragraph (2) of section 1834(z)) for which
the payment amount for a calendar quarter under
paragraph (3)(A)(ii)(I) of such section for
such quarter exceeds the inflation-adjusted
payment under paragraph (3)(A)(ii)(II) of such
section for such quarter, the amounts paid
shall be the difference between (i) the payment
amount under paragraph (3)(A)(ii)(I) of such
section for such drug, and (ii) 20 percent of
the inflation-adjusted payment amount under
paragraph (3)(A)(ii)(II) of such section for
such drug''; and
(B) by adding at the end of the flush left matter
following paragraph (9), the following:
``For purposes of applying paragraph (1)(EE), subsections (i)(9) and
(t)(8)(F), and section 1834(z)(5), the Secretary shall make such
estimates and use such data as the Secretary determines appropriate,
and notwithstanding any other provision of law, may do so by program
instruction or otherwise.'';
(2) in subsection (i), by adding at the end the following
new paragraph:
``(9) In the case of a part B rebatable drug (as defined in
paragraph (2) of section 1834(z)) for which payment under this
subsection is not packaged into a payment for a covered OPD service (as
defined in subsection (t)(1)(B)) (or group of services) furnished on or
after July 1, 2023, under the system under this subsection, in lieu of
calculation of coinsurance and the amount of payment otherwise
applicable under this subsection, the provisions of section 1834(z)(5),
paragraph (1)(EE) of subsection (a), and the flush left matter
following paragraph (9) of subsection (a), shall, as determined
appropriate by the Secretary, apply under this subsection in the same
manner as such provisions of section 1834(z)(5) and subsection (a)
apply under such section and subsection.''; and
(3) in subsection (t)(8), by adding at the end the
following new subparagraph:
``(F) Part b rebatable drugs.--In the case of a
part B rebatable drug (as defined in paragraph (2) of
section 1834(z)) for which payment under this part is
not packaged into a payment for a service furnished on
or after July 1, 2023, under the system under this
subsection, in lieu of calculation of coinsurance and
the amount of payment otherwise applicable under this
subsection, the provisions of section 1834(z)(5),
paragraph (1)(EE) of subsection (a), and the flush left
matter following paragraph (9) of subsection (a),
shall, as determined appropriate by the Secretary,
apply under this subsection in the same manner as such
provisions of section 1834(z)(5) and subsection (a)
apply under such section and subsection.''.
(c) Conforming Amendments.--
(1) To part b asp calculation.--Section 1847A(c)(3) of the
Social Security Act (42 U.S.C. 1395w-3a(c)(3)) is amended by
inserting ``or section 1834(z)'' after ``section 1927''.
(2) Excluding parts b drug inflation rebate from best
price.--Section 1927(c)(1)(C)(ii)(I) of the Social Security Act
(42 U.S.C. 1396r-8(c)(1)(C)(ii)(I)) is amended by inserting
``or section 1834(z)'' after ``this section''.
(3) Coordination with medicaid rebate information
disclosure.--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 ``or
to carry out section 1847B'' and inserting ``to carry out
section 1847B or section 1834(z)''.
SEC. 202. MEDICARE PART D REBATE BY MANUFACTURERS.
(a) In General.--Part D of title XVIII of the Social Security Act
is amended by inserting after section 1860D-14A (42 U.S.C. 1395w-114a)
the following new section:
``SEC. 1860D-14B. MANUFACTURER REBATE FOR CERTAIN DRUGS WITH PRICES
INCREASING FASTER THAN INFLATION.
``(a) In General.--
``(1) In general.--Subject to the provisions of this
section, in order for coverage to be available under this part
for a part D rebatable drug (as defined in subsection (h)(1))
of a manufacturer (as defined in section 1927(k)(5)) dispensed
during an applicable year, the manufacturer must have entered
into and have in effect an agreement described in subsection
(b).
``(2) Authorizing coverage for drugs not covered under
agreements.--Paragraph (1) shall not apply to the dispensing of
a covered part D drug if--
``(A) the Secretary has made a determination that
the availability of the drug is essential to the health
of beneficiaries under this part; or
``(B) the Secretary determines that in the period
beginning on January 1, 2023, and ending on December
31, 2023, there were extenuating circumstances.
``(3) Applicable year.--For purposes of this section the
term `applicable year' means a year beginning with 2023.
``(b) Agreements.--
``(1) Terms of agreement.--An agreement described in this
subsection, with respect to a manufacturer of a part D
rebatable drug, is an agreement under which the following shall
apply:
``(A) Secretarial provision of information.--Not
later than 9 months after the end of each applicable
year with respect to which the agreement is in effect,
the Secretary, for each part D rebatable drug of the
manufacturer, shall report to the manufacturer the
following for such year:
``(i) Information on the total number of
units (as defined in subsection (h)(2)) for
each dosage form and strength with respect to
such part D rebatable drug and year.
``(ii) Information on the amount (if any)
of the excess average manufacturer price
increase described in subsection (c)(1)(B) for
each dosage form and strength with respect to
such drug and year.
``(iii) The rebate amount specified under
subsection (c) for each dosage form and
strength with respect to such drug and year.
``(B) Manufacturer requirements.--For each
applicable year with respect to which the agreement is
in effect, the manufacturer of the part D rebatable
drug, for each dosage form and strength with respect to
such drug, not later than 30 days after the date of
receipt from the Secretary of the information described
in subparagraph (A) for such year, shall provide to the
Secretary a rebate that is equal to the amount
specified in subsection (c) for such dosage form and
strength with respect to such drug for such year.
``(2) Length of agreement.--
``(A) In general.--An agreement under this section,
with respect to a part D rebatable drug, shall be
effective for an initial period of not less than one
year and shall be automatically renewed for a period of
not less than one year unless terminated under
subparagraph (B).
``(B) Termination.--
``(i) By secretary.--The Secretary may
provide for termination of an agreement under
this section for violation of the requirements
of the agreement or other good cause shown.
Such termination shall not be effective earlier
than 30 days after the date of notice of such
termination. The Secretary shall provide, upon
request, a manufacturer with a hearing
concerning such a termination, but such hearing
shall not delay the effective date of the
termination.
``(ii) By a manufacturer.--A manufacturer
may terminate an agreement under this section
for any reason. Any such termination shall be
effective, with respect to a plan year--
``(I) if the termination occurs
before January 30 of the plan year, as
of the day after the end of the plan
year; and
``(II) if the termination occurs on
or after January 30 of the plan year,
as of the day after the end of the
succeeding plan year.
``(C) Effectiveness of termination.--Any
termination under this paragraph shall not affect
rebates due under the agreement under this section
before the effective date of its termination.
``(D) Delay before reentry.--In the case of any
agreement under this section with a manufacturer that
is terminated in a plan year, the Secretary may not
enter into another such agreement with the manufacturer
(or a successor manufacturer) before the subsequent
plan year, unless the Secretary finds good cause for an
earlier reinstatement of such an agreement.
``(c) Rebate Amount.--
``(1) In general.--For purposes of this section, the amount
specified in this subsection for a dosage form and strength
with respect to a part D rebatable drug and applicable year is,
subject to subparagraphs (B) and (C) of paragraph (5), the
amount equal to the product of--
``(A) the total number of units of such dosage form
and strength with respect to such part D rebatable drug
and year; and
``(B) the amount (if any) by which--
``(i) the annual manufacturer price (as
determined in paragraph (2)) paid for such
dosage form and strength with respect to such
part D rebatable drug for the year; exceeds
``(ii) the inflation-adjusted payment
amount determined under paragraph (3) for such
dosage form and strength with respect to such
part D rebatable drug for the year.
``(2) Determination of annual manufacturer price.--The
annual manufacturer price determined under this paragraph for a
dosage form and strength, with respect to a part D rebatable
drug and an applicable year, is the sum of the products of--
``(A) the average manufacturer price (as defined in
subsection (h)(6)) of such dosage form and strength, as
calculated for a unit of such drug, with respect to
each of the calendar quarters of such year; and
``(B) the ratio of--
``(i) the total number of units of such
dosage form and strength dispensed during each
such calendar quarter of such year; to
``(ii) the total number of units of such
dosage form and strength dispensed during such
year.
``(3) Determination of inflation-adjusted payment amount.--
The inflation-adjusted payment amount determined under this
paragraph for a dosage form and strength with respect to a part
D rebatable drug for an applicable year, subject to
subparagraphs (A) and (D) of paragraph (5), is--
``(A) the benchmark year manufacturer price
determined under paragraph (4) for such dosage form and
strength with respect to such drug and an applicable
year; increased by
``(B) the percentage by which the applicable year
CPI-U (as defined in subsection (h)(5)) for the
applicable year exceeds the benchmark period CPI-U (as
defined in subsection (h)(4)).
``(4) Determination of benchmark year manufacturer price.--
The benchmark year manufacturer price determined under this
paragraph for a dosage form and strength, with respect to a
part D rebatable drug and an applicable year, is the sum of the
products of--
``(A) the average manufacturer price (as defined in
subsection (h)(6)) of such dosage form and strength, as
calculated for a unit of such drug, with respect to
each of the calendar quarters of the payment amount
benchmark year (as defined in subsection (h)(3)); and
``(B) the ratio of--
``(i) the total number of units of such
dosage form and strength dispensed during each
such calendar quarter of such payment amount
benchmark year; to
``(ii) the total number of units of such
dosage form and strength dispensed during such
payment amount benchmark year.
``(5) Special treatment of certain drugs and exemption.--
``(A) Subsequently approved drugs.--In the case of
a part D rebatable drug first approved or licensed by
the Food and Drug Administration after January 1, 2016,
subparagraphs (A) and (B) of paragraph (4) shall be
applied as if the term `payment amount benchmark year'
were defined under subsection (h)(3) as the first
calendar year beginning after the day on which the drug
was first marketed by any manufacturer and subparagraph
(B) of paragraph (3) shall be applied as if the term
`benchmark period CPI-U' were defined under subsection
(h)(4) as if the reference to `January 2016' under such
subsection were a reference to `January of the first
year beginning after the date on which the drug was
first marketed by any manufacturer'.
``(B) Exemption for shortages.--The Secretary may
reduce or waive the rebate under paragraph (1) with
respect to a part D rebatable drug that is described as
currently in shortage on the shortage list in effect
under section 506E of the Federal Food, Drug, and
Cosmetic Act or in the case of other exigent
circumstances, as determined by the Secretary.
``(C) Treatment of new formulations.--
``(i) In general.--In the case of a part D
rebatable drug that is a line extension of a
part D rebatable drug that is an oral solid
dosage form, the Secretary shall establish a
formula for determining the amount specified in
this subsection with respect to such part D
rebatable drug and an applicable year with
consideration of the original part D rebatable
drug.
``(ii) Line extension defined.--In this
subparagraph, the term `line extension' means,
with respect to a part D rebatable drug, a new
formulation of the drug (as determined by the
Secretary), such as an extended release
formulation, but does not include an abuse-
deterrent formulation of the drug (as
determined by the Secretary), regardless of
whether such abuse-deterrent formulation is an
extended release formulation.
``(D) Selected drugs.--In the case of a part D
rebatable drug that is a selected drug (as defined in
section 1192(c)) for a price applicability period (as
defined in section 1191(b)(2))--
``(i) for plan years during such period for
which a maximum fair price (as defined in
section 1191(c)(2)) for such drug has been
determined and is applied under part E of title
XI, the rebate under subsection (b)(1)(B) shall
be waived; and
``(ii) in the case such drug is determined
(pursuant to such section 1192(c)) to no longer
be a selected drug, for each applicable year
beginning after the price applicability period
with respect to such drug, subparagraphs (A)
and (B) of paragraph (4) shall be applied as if
the term `payment amount benchmark year' were
defined under subsection (h)(3) as the last
year beginning during such price applicability
period with respect to such selected drug and
subparagraph (B) of paragraph (3) shall be
applied as if the term `benchmark period CPI-U'
were defined under subsection (h)(4) as if the
reference to `January 2016' under such
subsection were a reference to January of the
last year beginning during such price
applicability period with respect to such drug.
``(d) Rebate Deposits.--Amounts paid as rebates under subsection
(c) shall be deposited into the Medicare Prescription Drug Account in
the Federal Supplementary Medical Insurance Trust Fund established
under section 1841.
``(e) Information.--For purposes of carrying out this section, the
Secretary shall use information submitted by manufacturers under
section 1927(b)(3).
``(f) Civil Money Penalty.--In the case of a manufacturer of a part
D rebatable drug with an agreement in effect under this section who has
failed to comply with the terms of the agreement under subsection
(b)(1)(B) with respect to such drug for an applicable year, the
Secretary may impose a civil money penalty on such manufacturer in an
amount equal to 125 percent of the amount specified in subsection (c)
for such drug for such year. The provisions of section 1128A (other
than subsections (a) (with respect to amounts of penalties or
additional assessments) and (b)) shall apply to a civil money penalty
under this subsection in the same manner as such provisions apply to a
penalty or proceeding under section 1128A(a).
``(g) Judicial Review.--There shall be no judicial review of the
following:
``(1) The determination of units under this section.
``(2) The determination of whether a drug is a part D
rebatable drug under this section.
``(3) The calculation of the rebate amount under this
section.
``(h) Definitions.--In this section:
``(1) Part d rebatable drug defined.--
``(A) In general.--The term `part D rebatable drug'
means a drug or biological that would (without
application of this section) be a covered part D drug,
except such term shall, with respect to an applicable
year, not include such a drug or biological if the
average annual total cost under this part for such year
per individual who uses such a drug or biological, as
determined by the Secretary, is less than, subject to
subparagraph (B), $100, as determined by the Secretary
using the most recent data available or, if data is not
available, as estimated by the Secretary.
``(B) Increase.--The dollar amount applied under
subparagraph (A)--
``(i) for 2024, shall be the dollar amount
specified under such subparagraph for 2023,
increased by the percentage increase in the
consumer price index for all urban consumers
(United States city average) for the 12-month
period beginning with January of 2023; and
``(ii) for a subsequent year, shall be the
dollar amount specified in this subparagraph
for the previous year, increased by the
percentage increase in the consumer price index
for all urban consumers (United States city
average) for the 12-month period beginning with
January of the previous year.
Any dollar amount specified under this subparagraph
that is not a multiple of $10 shall be rounded to the
nearest multiple of $10.
``(2) Unit defined.--The term `unit' means, with respect to
a part D rebatable drug, the lowest identifiable quantity (such
as a capsule or tablet, milligram of molecules, or grams) of
the part D rebatable drug that is dispensed to individuals
under this part.
``(3) Payment amount benchmark year.--The term `payment
amount benchmark year' means the year beginning January 1,
2016.
``(4) Benchmark period cpi-u.--The term `benchmark period
CPI-U' means the consumer price index for all urban consumers
(United States city average) for January 2016.
``(5) Applicable year cpi-u.--The term `applicable year
CPI-U' means, with respect to an applicable year, the consumer
price index for all urban consumers (United States city
average) for January of such year.
``(6) Average manufacturer price.--The term `average
manufacturer price' has the meaning, with respect to a part D
rebatable drug of a manufacturer, given such term in section
1927(k)(1), with respect to a covered outpatient drug of a
manufacturer for a rebate period under section 1927.''.
(b) Conforming Amendments.--
(1) To part b asp calculation.--Section 1847A(c)(3) of the
Social Security Act (42 U.S.C. 1395w-3a(c)(3)), as amended by
section 201(c)(1), is further amended by striking ``section
1927 or section 1834(z)'' and inserting ``section 1927, section
1834(z), or section 1860D-14B''.
(2) Excluding part d drug inflation rebate from best
price.--Section 1927(c)(1)(C)(ii)(I) of the Social Security Act
(42 U.S.C. 1396r-8(c)(1)(C)(ii)(I)), as amended by section
201(c)(2), is further amended by striking ``or section
1834(z)'' and inserting ``, section 1834(z), or section 1860D-
14B''.
(3) Coordination with medicaid rebate information
disclosure.--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
201(c)(3), is further amended by striking ``or section
1834(z)'' and inserting ``, section 1834(z), or section 1860D-
14B''.
SEC. 203. PROVISION REGARDING INFLATION REBATES FOR GROUP HEALTH PLANS
AND GROUP HEALTH INSURANCE COVERAGE.
(a) In General.--Not later than December 31, 2023, the Secretary of
Labor, in consultation with the Secretary of Health and Human Services
and the Secretary of the Treasury, shall submit to Congress a report
on--
(1) potential models for an agreement process with
manufacturers of prescription drugs under which such
manufacturers provide for inflation rebates with respect to
such drugs that are furnished or dispensed to participants and
beneficiaries of group health plans and health insurance
coverage offered in the group market in a manner similar to how
manufacturers provide for rebates under section 1834(z) of the
Social Security Act, as added by section 201, and section
1860D-14B of such Act, as added by section 202, with respect to
prescription drugs that are furnished or dispensed under part B
of title XVIII of such Act and part D of such title,
respectively; and
(2) potential models for enforcement mechanisms with
respect to such an agreement process that ensure that such
inflation rebates are proportionally distributed, with respect
to costs, to group health plans and health insurance issuers
offering health insurance coverage in the group market, to
participants and beneficiaries of such plans and coverage, or
to both.
(b) Regulations.--Not later than December 31, 2024, the Secretary
of Labor shall, in consultation with the Secretary of Health and Human
Services and the Secretary of the Treasury, promulgate regulations to
implement a model described in subsection (a)(1) and a model described
in subsection (a)(2), if the Secretary determines that--
(1) the prices of a sufficient number (as determined by the
Secretary) of drugs described in subsection (a)(1) have
increased over a period of time (as determined by the
Secretary) at a percentage that exceeds the percentage by which
the consumer price index for all urban consumers (United States
city average) has increased over such period; and
(2) such model described in subsection (a)(1) and such
model described in subsection (a)(2) are feasible.
SEC. 204. ANNUAL REPORT ON DRUG COSTS IN GROUP HEALTH PLANS AND GROUP
HEALTH INSURANCE COVERAGE.
(a) Initial Report.--Not later than December 31, 2023, the
Secretary of Labor shall, in consultation with the Secretary of Health
and Human Services and the Secretary of the Treasury, submit to
Congress a report, with respect to a period (as determined by the
Secretary of Labor), on--
(1) whether the prices of prescription drugs that are
furnished or dispensed to participants and beneficiaries of
group health plans and health insurance coverage offered in the
group market during such period have increased at a percentage
that exceeds the percentage by which the consumer price index
for all urban consumers (United States city average) increased
for such period; and
(2) whether there are mechanisms by which manufacturers of
prescription drugs have attempted to recover rebate payments
required of such manufacturers under section 1834(z) of the
Social Security Act, as added by section 201, and section
1860D-14B of such Act, as added by section 202, with respect to
prescription drugs that are furnished or dispensed under part B
of title XVIII of such Act and part D of such title,
respectively, through increased prices charged with respect to
drugs that are furnished or dispensed to participants and
beneficiaries of group health plans and health insurance
coverage offered in the group market during such period.
(b) Annual Report.--Not later than December 31 of each year
following 2023, the Secretary of Labor shall, in consultation with the
Secretary of Health and Human Services and the Secretary of the
Treasury, submit to Congress a report updating the information and
analysis included in the report required under subsection (a),
reflecting, in part, new price and cost information and data for the
12-month period after the period on which the prior year's report was
based.
SEC. 205. COLLECTION OF DATA.
(a) Manufacturers of Prescription Drugs.--Manufacturers of
prescription drugs shall submit to the Secretary of Health and Human
Services, the Secretary of Labor, and the Secretary of the Treasury
appropriate data as necessary for the Secretaries to obtain information
needed to provide the reports under sections 203 and 204.
(b) Group Health Plans and Health Insurance Issuers Offering Health
Insurance Coverage in the Group Market.--Group health plans and health
insurance issuers offering health insurance coverage in the group
market shall submit to the Secretary of Health and Human Services, the
Secretary of Labor, and the Secretary of the Treasury appropriate data
as necessary for the Secretaries to obtain information needed to
provide the reports under sections 203 and 204.
TITLE III--PART D IMPROVEMENTS AND MAXIMUM OUT-OF-POCKET CAP FOR
MEDICARE BENEFICIARIES
SEC. 301. MEDICARE PART D BENEFIT REDESIGN.
(a) Benefit Structure Redesign.--Section 1860D-2(b) of the Social
Security Act (42 U.S.C. 1395w-102(b)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (A), in the matter preceding
clause (i), by inserting ``for a year preceding 2024
and for costs above the annual deductible specified in
paragraph (1) and up to the annual out-of-pocket
threshold specified in paragraph (4)(B) for 2024 and
each subsequent year'' after ``paragraph (3)'';
(B) in subparagraph (C)--
(i) in clause (i), in the matter preceding
subclause (I), by inserting ``for a year
preceding 2024,'' after ``paragraph (4),''; and
(ii) in clause (ii)(III), by striking ``and
each subsequent year'' and inserting ``through
2023''; and
(C) in subparagraph (D)--
(i) in clause (i)--
(I) in the matter preceding
subclause (I), by inserting ``for a
year preceding 2024,'' after
``paragraph (4),''; and
(II) in subclause (I)(bb), by
striking ``a year after 2018'' and
inserting ``each of years 2018 through
2023''; and
(ii) in clause (ii)(V), by striking ``2019
and each subsequent year'' and inserting ``each
of years 2019 through 2023'';
(2) in paragraph (3)(A)--
(A) in the matter preceding clause (i), by
inserting ``for a year preceding 2024,'' after ``and
(4),''; and
(B) in clause (ii), by striking ``for a subsequent
year'' and inserting ``for each of years 2007 through
2023''; and
(3) in paragraph (4)--
(A) in subparagraph (A)--
(i) in clause (i)--
(I) by redesignating subclauses (I)
and (II) as items (aa) and (bb),
respectively, and moving the margin of
each such redesignated item 2 ems to
the right;
(II) in the matter preceding item
(aa), as redesignated by subclause (I),
by striking ``is equal to the greater
of--'' and inserting ``is equal to--
``(I) for a year preceding 2024,
the greater of--'';
(III) by striking the period at the
end of item (bb), as redesignated by
subclause (I), and inserting ``; and'';
and
(IV) by adding at the end the
following:
``(II) for 2024 and each succeeding
year, $0.''; and
(ii) in clause (ii), by striking ``clause
(i)(I)'' and inserting ``clause (i)(I)(aa)'';
(B) in subparagraph (B)--
(i) in clause (i)--
(I) in subclause (V), by striking
``or'' at the end;
(II) in subclause (VI)--
(aa) by striking ``for a
subsequent year'' and inserting
``for each of years 2021
through 2023''; and
(bb) by striking the period
at the end and inserting a
semicolon; and
(III) by adding at the end the
following new subclauses:
``(VII) for 2024, is equal to
$2,000; or
``(VIII) for a subsequent year, is
equal to the amount specified in this
subparagraph for the previous year,
increased by the annual percentage
increase described in paragraph (6) for
the year involved.''; and
(ii) in clause (ii), by striking ``clause
(i)(II)'' and inserting ``clause (i)'';
(C) in subparagraph (C)(i), by striking ``and for
amounts'' and inserting ``and, for a year preceding
2024, for amounts''; and
(D) in subparagraph (E), by striking ``In
applying'' and inserting ``For each of years 2011
through 2023, in applying''.
(b) Decreasing Reinsurance Payment Amount.--Section 1860D-15(b)(1)
of the Social Security Act (42 U.S.C. 1395w-115(b)(1)) is amended by
inserting after ``80 percent'' the following: ``(or, with respect to a
coverage year after 2023, 20 percent)''.
(c) Manufacturer Discount Program.--
(1) In general.--Part D of title XVIII of the Social
Security Act (42 U.S.C. 1395w-101 et seq.), as amended by
section 202, is further amended by inserting after section
1860D-14B the following new section:
``SEC. 1860D-14C. MANUFACTURER DISCOUNT PROGRAM.
``(a) Establishment.--The Secretary shall establish a manufacturer
discount program (in this section referred to as the `program'). Under
the program, the Secretary shall enter into agreements described in
subsection (b) with manufacturers and provide for the performance of
the duties described in subsection (c). The Secretary shall establish a
model agreement for use under the program by not later than January 1,
2023, in consultation with manufacturers, and allow for comment on such
model agreement.
``(b) Terms of Agreement.--
``(1) In general.--
``(A) Agreement.--An agreement under this section
shall require the manufacturer to provide applicable
beneficiaries access to discounted prices for
applicable drugs of the manufacturer that are dispensed
on or after January 1, 2024.
``(B) Provision of discounted prices at the point-
of-sale.--The discounted prices described in
subparagraph (A) shall be provided to the applicable
beneficiary at the pharmacy or by the mail order
service at the point-of-sale of an applicable drug.
``(C) Timing of agreement.--
``(i) Special rule for 2024.--In order for
an agreement with a manufacturer to be in
effect under this section with respect to the
period beginning on January 1, 2024, and ending
on December 31, 2024, the manufacturer shall
enter into such agreement not later than 30
days after the date of the establishment of a
model agreement under subsection (a).
``(ii) 2025 and subsequent years.--In order
for an agreement with a manufacturer to be in
effect under this section with respect to plan
year 2025 or a subsequent plan year, the
manufacturer shall enter into such agreement
(or such agreement shall be renewed under
paragraph (4)(A)) not later than January 30 of
the preceding year.
``(2) Provision of appropriate data.--Each manufacturer
with an agreement in effect under this section shall collect
and have available appropriate data, as determined by the
Secretary, to ensure that it can demonstrate to the Secretary
compliance with the requirements under the program.
``(3) Compliance with requirements for administration of
program.--Each manufacturer with an agreement in effect under
this section shall comply with requirements imposed by the
Secretary or a third party with a contract under subsection
(d)(3), as applicable, for purposes of administering the
program, including any determination under subparagraph (A) of
subsection (c)(1) or procedures established under such
subsection (c)(1).
``(4) Length of agreement.--
``(A) In general.--An agreement under this section
shall be effective for an initial period of not less
than 12 months and shall be automatically renewed for a
period of not less than 1 year unless terminated under
subparagraph (B).
``(B) Termination.--
``(i) By the secretary.--The Secretary may
provide for termination of an agreement under
this section for a knowing and willful
violation of the requirements of the agreement
or other good cause shown. Such termination
shall not be effective earlier than 30 days
after the date of notice to the manufacturer of
such termination. The Secretary shall provide,
upon request, a manufacturer with a hearing
concerning such a termination, and such hearing
shall take place prior to the effective date of
the termination with sufficient time for such
effective date to be repealed if the Secretary
determines appropriate.
``(ii) By a manufacturer.--A manufacturer
may terminate an agreement under this section
for any reason. Any such termination shall be
effective, with respect to a plan year--
``(I) if the termination occurs
before January 30 of a plan year, as of
the day after the end of the plan year;
and
``(II) if the termination occurs on
or after January 30 of a plan year, as
of the day after the end of the
succeeding plan year.
``(iii) Effectiveness of termination.--Any
termination under this subparagraph shall not
affect discounts for applicable drugs of the
manufacturer that are due under the agreement
before the effective date of its termination.
``(iv) Notice to third party.--The
Secretary shall provide notice of such
termination to a third party with a contract
under subsection (d)(3) within not less than 30
days before the effective date of such
termination.
``(c) Duties Described.--The duties described in this subsection
are the following:
``(1) Administration of program.--Administering the
program, including--
``(A) the determination of the amount of the
discounted price of an applicable drug of a
manufacturer;
``(B) the establishment of procedures under which
discounted prices are provided to applicable
beneficiaries at pharmacies or by mail order service at
the point-of-sale of an applicable drug;
``(C) the establishment of procedures to ensure
that, not later than the applicable number of calendar
days after the dispensing of an applicable drug by a
pharmacy or mail order service, the pharmacy or mail
order service is reimbursed for an amount equal to the
difference between--
``(i) the negotiated price of the
applicable drug; and
``(ii) the discounted price of the
applicable drug;
``(D) the establishment of procedures to ensure
that the discounted price for an applicable drug under
this section is applied before any coverage or
financial assistance under other health benefit plans
or programs that provide coverage or financial
assistance for the purchase or provision of
prescription drug coverage on behalf of applicable
beneficiaries as the Secretary may specify; and
``(E) providing a reasonable dispute resolution
mechanism to resolve disagreements between
manufacturers, applicable beneficiaries, and the third
party with a contract under subsection (d)(3).
``(2) Monitoring compliance.--
``(A) In general.--The Secretary shall monitor
compliance by a manufacturer with the terms of an
agreement under this section.
``(B) Notification.--If a third party with a
contract under subsection (d)(3) determines that the
manufacturer is not in compliance with such agreement,
the third party shall notify the Secretary of such
noncompliance for appropriate enforcement under
subsection (e).
``(3) Collection of data from prescription drug plans and
ma-pd plans.--The Secretary may collect appropriate data from
prescription drug plans and MA-PD plans in a timeframe that
allows for discounted prices to be provided for applicable
drugs under this section.
``(d) Administration.--
``(1) In general.--Subject to paragraph (2), the Secretary
shall provide for the implementation of this section, including
the performance of the duties described in subsection (c).
``(2) Limitation.--In providing for the implementation of
this section, the Secretary shall not receive or distribute any
funds of a manufacturer under the program.
``(3) Contract with third parties.--The Secretary shall
enter into a contract with 1 or more third parties to
administer the requirements established by the Secretary in
order to carry out this section. At a minimum, the contract
with a third party under the preceding sentence shall require
that the third party--
``(A) receive and transmit information between the
Secretary, manufacturers, and other individuals or
entities the Secretary determines appropriate;
``(B) receive, distribute, or facilitate the
distribution of funds of manufacturers to appropriate
individuals or entities in order to meet the
obligations of manufacturers under agreements under
this section;
``(C) provide adequate and timely information to
manufacturers, consistent with the agreement with the
manufacturer under this section, as necessary for the
manufacturer to fulfill its obligations under this
section; and
``(D) permit manufacturers to conduct periodic
audits, directly or through contracts, of the data and
information used by the third party to determine
discounts for applicable drugs of the manufacturer
under the program.
``(4) Performance requirements.--The Secretary shall
establish performance requirements for a third party with a
contract under paragraph (3) and safeguards to protect the
independence and integrity of the activities carried out by the
third party under the program under this section.
``(5) Implementation.--Notwithstanding any other provision
of law, the Secretary may implement the program under this
section by program instruction or otherwise.
``(6) Administration.--Chapter 35 of title 44, United
States Code, shall not apply to the program under this section.
``(e) Enforcement.--
``(1) Audits.--Each manufacturer with an agreement in
effect under this section shall be subject to periodic audit by
the Secretary.
``(2) Civil money penalty.--
``(A) In general.--The Secretary may impose a civil
money penalty on a manufacturer that fails to provide
applicable beneficiaries discounts for applicable drugs
of the manufacturer in accordance with such agreement
for each such failure in an amount the Secretary
determines is equal to the sum of--
``(i) the amount that the manufacturer
would have paid with respect to such discounts
under the agreement, which will then be used to
pay the discounts which the manufacturer had
failed to provide; and
``(ii) 25 percent of such amount.
``(B) Application.--The provisions of section 1128A
(other than subsections (a) and (b)) shall apply to a
civil money penalty under this paragraph in the same
manner as such provisions apply to a penalty or
proceeding under section 1128A(a).
``(f) Clarification Regarding Availability of Other Covered Part D
Drugs.--Nothing in this section shall prevent an applicable beneficiary
from purchasing a covered part D drug that is not an applicable drug
(including a generic drug or a drug that is not on the formulary of the
prescription drug plan or MA-PD plan that the applicable beneficiary is
enrolled in).
``(g) Definitions.--In this section:
``(1) Applicable beneficiary.--The term `applicable
beneficiary' means an individual who, on the date of dispensing
a covered part D drug--
``(A) is enrolled in a prescription drug plan or an
MA-PD plan;
``(B) is not enrolled in a qualified retiree
prescription drug plan; and
``(C) has incurred costs, as determined in
accordance with section 1860D-2(b)(4)(C), for covered
part D drugs in the year that exceed the annual
deductible with respect to such individual for such
year, as specified in section 1860D-2(b)(1), section
1860D-14(a)(1)(B), or section 1860D-14(a)(2)(B), as
applicable.
``(2) Applicable drug.--The term `applicable drug', with
respect to an applicable beneficiary--
``(A) means a covered part D drug--
``(i) approved under a new drug application
under section 505(c) of the Federal Food, Drug,
and Cosmetic Act or, in the case of a biologic
product, licensed under section 351 of the
Public Health Service Act; and
``(ii)(I) if the PDP sponsor of the
prescription drug plan or the MA organization
offering the MA-PD plan uses a formulary, which
is on the formulary of the prescription drug
plan or MA-PD plan that the applicable
beneficiary is enrolled in;
``(II) if the PDP sponsor of the
prescription drug plan or the MA organization
offering the MA-PD plan does not use a
formulary, for which benefits are available
under the prescription drug plan or MA-PD plan
that the applicable beneficiary is enrolled in;
or
``(III) is provided through an exception or
appeal; and
``(B) does not include a selected drug (as defined
in section 1192(c)) during a price applicability period
(as defined in section 1191(b)(2)) with respect to such
drug.
``(3) Applicable number of calendar days.--The term
`applicable number of calendar days' means--
``(A) with respect to claims for reimbursement
submitted electronically, 14 days; and
``(B) with respect to claims for reimbursement
submitted otherwise, 30 days.
``(4) Discounted price.--
``(A) In general.--The term `discounted price'
means, with respect to an applicable drug of a
manufacturer dispensed during a year to an applicable
beneficiary--
``(i) who has not incurred costs, as
determined in accordance with section 1860D-
2(b)(4)(C), for covered part D drugs in the
year that are equal to or exceed the annual
out-of-pocket threshold specified in section
1860D-2(b)(4)(B)(i) for the year, 90 percent of
the negotiated price of such drug; and
``(ii) who has incurred such costs, as so
determined, in the year that are equal to or
exceed such threshold for the year, 70 percent
of the negotiated price of such drug.
``(B) Clarification.--Nothing in this section shall
be construed as affecting the responsibility of an
applicable beneficiary for payment of a dispensing fee
for an applicable drug.
``(C) Special case for certain claims.--
``(i) Claims spanning deductible.--In the
case where the entire amount of the negotiated
price of an individual claim for an applicable
drug with respect to an applicable beneficiary
does not fall above the annual deductible
specified in section 1860D-2(b)(1) for the
year, the manufacturer of the applicable drug
shall provide the discounted price under this
section on only the portion of the negotiated
price of the applicable drug that falls above
such annual deductible.
``(ii) Claims spanning out-of-pocket
threshold.--In the case where the entire amount
of the negotiated price of an individual claim
for an applicable drug with respect to an
applicable beneficiary does not fall entirely
below or entirely above the annual out-of-
pocket threshold specified in section 1860D-
2(b)(4)(B)(i) for the year, the manufacturer of
the applicable drug shall provide the
discounted price--
``(I) in accordance with
subparagraph (A)(i) on the portion of
the negotiated price of the applicable
drug that falls below such threshold;
and
``(II) in accordance with
subparagraph (A)(ii) on the portion of
such price of such drug that falls at
or above such threshold.
``(5) Manufacturer.--The term `manufacturer' means any
entity which is engaged in the production, preparation,
propagation, compounding, conversion, or processing of
prescription drug products, either directly or indirectly by
extraction from substances of natural origin, or independently
by means of chemical synthesis, or by a combination of
extraction and chemical synthesis. Such term does not include a
wholesale distributor of drugs or a retail pharmacy licensed
under State law.
``(6) Negotiated price.--The term `negotiated price' has
the meaning given such term in section 423.100 of title 42,
Code of Federal Regulations (or any successor regulation),
except that, with respect to an applicable drug, such
negotiated price shall not include any dispensing fee for the
applicable drug.
``(7) Qualified retiree prescription drug plan.--The term
`qualified retiree prescription drug plan' has the meaning
given such term in section 1860D-22(a)(2).''.
(2) Sunset of medicare coverage gap discount program.--
Section 1860D-14A of the Social Security Act (42 U.S.C. 1395-
114a) is amended--
(A) in subsection (a), in the first sentence, by
striking ``The Secretary'' and inserting ``Subject to
subsection (h), the Secretary''; and
(B) by adding at the end the following new
subsection:
``(h) Sunset of Program.--
``(1) In general.--The program shall not apply with respect
to applicable drugs dispensed on or after January 1, 2024, and,
subject to paragraph (2), agreements under this section shall
be terminated as of such date.
``(2) Continued application for applicable drugs dispensed
prior to sunset.--The provisions of this section (including all
responsibilities and duties) shall continue to apply after
January 1, 2024, with respect to applicable drugs dispensed
prior to such date.''.
(3) Inclusion of actuarial value of manufacturer discounts
in bids.--Section 1860D-11 of the Social Security Act (42
U.S.C. 1395w-111) is amended--
(A) in subsection (b)(2)(C)(iii)--
(i) by striking ``assumptions regarding the
reinsurance'' and inserting ``assumptions
regarding--
``(I) the reinsurance''; and
(ii) by adding at the end the following:
``(II) for 2024 and each subsequent
year, the manufacturer discounts
provided under section 1860D-14C
subtracted from the actuarial value to
produce such bid; and''; and
(B) in subsection (c)(1)(C)--
(i) by striking ``an actuarial valuation of
the reinsurance'' and inserting ``an actuarial
valuation of--
``(i) the reinsurance'';
(ii) in clause (i), as inserted by clause
(i) of this subparagraph, by adding ``and'' at
the end; and
(iii) by adding at the end the following:
``(ii) for 2024 and each subsequent year,
the manufacturer discounts provided under
section 1860D-14C;''.
(d) Conforming Amendments.--
(1) Section 1860D-2 of the Social Security Act (42 U.S.C.
1395w-102) is amended--
(A) in subsection (a)(2)(A)(i)(I), by striking ``,
or an increase in the initial'' and inserting ``or, for
a year preceding 2024, an increase in the initial'';
(B) in subsection (c)(1)(C)--
(i) in the subparagraph heading, by
striking ``at initial coverage limit''; and
(ii) by inserting ``for a year preceding
2024 or the annual out-of-pocket threshold
specified in subsection (b)(4)(B) for the year
for 2024 and each subsequent year'' after
``subsection (b)(3) for the year'' each place
it appears; and
(C) in subsection (d)(1)(A), by striking ``or an
initial'' and inserting ``or, for a year preceding
2024, an initial''.
(2) Section 1860D-4(a)(4)(B)(i) of the Social Security Act
(42 U.S.C. 1395w-104(a)(4)(B)(i)) is amended by striking ``the
initial'' and inserting ``for a year preceding 2024, the
initial''.
(3) Section 1860D-14(a) of the Social Security Act (42
U.S.C. 1395w-114(a)) is amended--
(A) in paragraph (1)--
(i) in subparagraph (C), by striking ``The
continuation'' and inserting ``For a year
preceding 2024, the continuation'';
(ii) in subparagraph (D)(iii), by striking
``1860D-2(b)(4)(A)(i)(I)'' and inserting
``1860D-2(b)(4)(A)(i)(I)(aa)''; and
(iii) in subparagraph (E), by striking
``The elimination'' and inserting ``For a year
preceding 2024, the elimination''; and
(B) in paragraph (2)--
(i) in subparagraph (C), by striking ``The
continuation'' and inserting ``For a year
preceding 2024, the continuation''; and
(ii) in subparagraph (E), by striking
``1860D-2(b)(4)(A)(i)(I)'' and inserting
``1860D-2(b)(4)(A)(i)(I)(aa)''.
(4) Section 1860D-21(d)(7) of the Social Security Act (42
U.S.C. 1395w-131(d)(7)) is amended by striking ``section 1860D-
2(b)(4)(B)(i)'' and inserting ``section 1860D-2(b)(4)(C)(i)''.
(5) Section 1860D-22(a)(2)(A) of the Social Security Act
(42 U.S.C. 1395w-132(a)(2)(A)) is amended--
(A) by striking ``the value of any discount'' and
inserting the following: ``the value of--
``(i) for years prior to 2024, any
discount'';
(B) in clause (i), as inserted by subparagraph (A)
of this paragraph, by striking the period at the end
and inserting ``; and''; and
(C) by adding at the end the following new clause:
``(ii) for 2024 and each subsequent year,
any discount provided pursuant to section
1860D-14C.''.
(6) Section 1860D-41(a)(6) of the Social Security Act (42
U.S.C. 1395w-151(a)(6)) is amended--
(A) by inserting ``for a year before 2024'' after
``1860D-2(b)(3)''; and
(B) by inserting ``for such year'' before the
period.
(7) Section 1860D-43 of the Social Security Act (42 U.S.C.
1395w-153) is amended--
(A) in subsection (a)--
(i) by striking paragraph (1) and inserting
the following:
``(1) participate in--
``(A) for 2011 through 2023, the Medicare coverage
gap discount program under section 1860D-14A; and
``(B) for 2024 and each subsequent year, the
manufacturer discount program under section 1860D-
14C;'';
(ii) by striking paragraph (2) and
inserting the following:
``(2) have entered into and have in effect--
``(A) for 2011 through 2023, an agreement described
in subsection (b) of section 1860D-14A with the
Secretary; and
``(B) for 2024 and each subsequent year, an
agreement described in subsection (b) of section 1860D-
14C with the Secretary; and''; and
(iii) by striking paragraph (3) and
inserting the following:
``(3) have entered into and have in effect, under terms and
conditions specified by the Secretary--
``(A) for 2011 through 2023, a contract with a
third party that the Secretary has entered into a
contract with under subsection (d)(3) of section 1860D-
14A; and
``(B) for 2024 and each subsequent year, a contract
with a third party that the Secretary has entered into
a contract with under subsection (d)(3) of section
1860D-14C.''; and
(B) by striking subsection (b) and inserting the
following:
``(b) Effective Date.--Paragraphs (1)(A), (2)(A), and (3)(A) of
subsection (a) shall apply to covered part D drugs dispensed under this
part on or after January 1, 2011, and before January 1, 2024, and
paragraphs (1)(B), (2)(B), and (3)(B) of such subsection shall apply to
covered part D drugs dispensed under this part on or after January 1,
2024.''.
(8) Section 1927 of the Social Security Act (42 U.S.C.
1396r-8) is amended--
(A) in subsection (c)(1)(C)(i)(VI), by inserting
before the period at the end the following: ``or under
the manufacturer discount program under section 1860D-
14C''; and
(B) in subsection (k)(1)(B)(i)(V), by inserting
before the period at the end the following: ``or under
section 1860D-14C''.
(e) Effective Date.--The amendments made by this section shall
apply with respect to plan year 2024 and subsequent plan years.
SEC. 302. ALLOWING CERTAIN ENROLLEES OF PRESCRIPTION DRUG PLANS AND MA-
PD PLANS UNDER MEDICARE PROGRAM TO SPREAD OUT COST-
SHARING UNDER CERTAIN CIRCUMSTANCES.
Section 1860D-2(b)(2) of the Social Security Act (42 U.S.C. 1395w-
102(b)(2)), as amended by section 301, is further amended--
(1) in subparagraph (A), by striking ``Subject to
subparagraphs (C) and (D)'' and inserting ``Subject to
subparagraphs (C), (D), and (E)''; and
(2) by adding at the end the following new subparagraph:
``(E) Enrollee option regarding spreading cost-
sharing.--The Secretary shall establish by regulation a
process under which, with respect to plan year 2024 and
subsequent plan years, a prescription drug plan or an
MA-PD plan shall, in the case of a part D eligible
individual enrolled with such plan for such plan year
who is not a subsidy eligible individual (as defined in
section 1860D-14(a)(3)) and with respect to whom the
plan projects that the dispensing of the first fill of
a covered part D drug to such individual will result in
the individual incurring costs that are equal to or
above the annual out-of-pocket threshold specified in
paragraph (4)(B) for such plan year, provide such
individual with the option to make the coinsurance
payment required under subparagraph (A) (for the
portion of such costs that are not above such annual
out-of-pocket threshold) in the form of periodic
installments over the remainder of such plan year.''.
SEC. 303. ESTABLISHMENT OF PHARMACY QUALITY MEASURES UNDER MEDICARE
PART D.
Section 1860D-4(c) of the Social Security Act (42 U.S.C. 1395w-
104(c)) is amended--
(1) by redesignating the paragraph (6), as added by section
50354 of division E of the Bipartisan Budget Act of 2018
(Public Law 115-123), as paragraph (7); and
(2) by adding at the end the following new paragraph:
``(8) Application of pharmacy quality measures.--
``(A) In general.--A PDP sponsor that implements
incentive payments to a pharmacy or price concessions
paid by a pharmacy based on quality measures shall use
measures established or approved by the Secretary under
subparagraph (B) with respect to payment for covered
part D drugs dispensed by such pharmacy.
``(B) Standard pharmacy quality measures.--The
Secretary shall establish or approve standard quality
measures from a consensus and evidence-based
organization for payments described in subparagraph
(A). Such measures shall focus on patient health
outcomes and be based on proven criteria measuring
pharmacy performance.
``(C) Effective date.--The requirement under
subparagraph (A) shall take effect for plan years
beginning on or after January 1, 2024, or such earlier
date specified by the Secretary if the Secretary
determines there are sufficient measures established or
approved under subparagraph (B) to meet the requirement
under subparagraph (A).''.
TITLE IV--DRUG PRICE TRANSPARENCY
SEC. 401. DRUG PRICE TRANSPARENCY.
Part A of title XI of the Social Security Act is amended by adding
at the end the following new sections:
``SEC. 1150D. REPORTING ON DRUG PRICES.
``(a) Definitions.--In this section:
``(1) Manufacturer.--The term `manufacturer' means the
person--
``(A) that holds the application for a drug
approved under section 505 of the Federal Food, Drug,
and Cosmetic Act or licensed under section 351 of the
Public Health Service Act; or
``(B) who is responsible for setting the wholesale
acquisition cost for the drug.
``(2) Qualifying drug.--The term `qualifying drug' means
any drug that is approved under subsection (c) or (j) of
section 505 of the Federal Food, Drug, and Cosmetic Act or
licensed under subsection (a) or (k) of section 351 of the
Public Health Service Act--
``(A) that has a wholesale acquisition cost of $100
or more, adjusted for inflation occurring after the
date of enactment of this section, for a month's supply
or a typical course of treatment that lasts less than a
month, and is--
``(i) subject to section 503(b)(1) of the
Federal Food, Drug, and Cosmetic Act; and
``(ii) not a preventative vaccine; and
``(B) for which, during the previous calendar year,
at least 1 dollar of the total amount of sales were for
individuals enrolled under the Medicare program under
title XVIII or under a State Medicaid plan under title
XIX or under a waiver of such plan.
``(3) Wholesale acquisition cost.--The term `wholesale
acquisition cost' has the meaning given that term in section
1847A(c)(6)(B).
``(b) Report.--
``(1) Report required.--The manufacturer of a qualifying
drug shall submit a report to the Secretary if, with respect to
the qualifying drug--
``(A) there is an increase in the price of the
qualifying drug that results in an increase in the
wholesale acquisition cost of that drug that is equal
to--
``(i) 10 percent or more within a 12-month
period beginning on or after January 1, 2021;
or
``(ii) 25 percent or more within a 36-month
period beginning on or after January 1, 2021;
``(B) the estimated price of the qualifying drug or
spending per individual or per user of such drug (as
estimated by the Secretary) for the applicable year (or
per course of treatment in such applicable year as
determined by the Secretary) is at least $26,000
beginning on or after January 1, 2023; or
``(C) there was an increase in the price of the
qualifying drug that resulted in an increase in the
wholesale acquisition cost of that drug that is equal
to--
``(i) 10 percent or more within a 12-month
period that begins and ends during the 5-year
period preceding January 1, 2023; or
``(ii) 25 percent or more within a 36-month
period that begins and ends during the 5-year
period preceding January 1, 2023.
``(2) Report deadline.--Each report described in paragraph
(1) shall be submitted to the Secretary--
``(A) in the case of a report with respect to an
increase in the price of a qualifying drug that occurs
during the period beginning on January 1, 2021, and
ending on the day that is 60 days after the date of the
enactment of this section, not later than 90 days after
such date of enactment;
``(B) in the case of a report with respect to an
increase in the price of a qualifying drug that occurs
after the period described in subparagraph (A), not
later than 30 days prior to the planned effective date
of such price increase for such qualifying drug;
``(C) in the case of a report with respect to a
qualifying drug that meets the criteria under paragraph
(1)(B), not later than 30 days after such drug meets
such criteria; and
``(D) in the case of a report with respect to an
increase in the price of a qualifying drug that occurs
during a 12-month or 36-month period described in
paragraph (1)(C), not later than April 1, 2023.
``(c) Contents.--A report under subsection (b), consistent with the
standard for disclosures described in section 213.3(d) of title 12,
Code of Federal Regulations (as in effect on the date of enactment of
this section), shall, at a minimum, include--
``(1) with respect to the qualifying drug--
``(A) the percentage by which the manufacturer will
raise the wholesale acquisition cost of the drug within
the 12-month period or 36-month period as described in
subsection (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i),
or (b)(1)(C)(ii), as applicable, and the effective date
of such price increase or the cost associated with a
qualifying drug if such drug meets the criteria under
subsection (b)(1)(B) and the effective date at which
such drug meets such criteria;
``(B) an explanation for, and description of, each
price increase for such drug that will occur during the
12-month period or the 36-month period described in
subsection (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i),
or (b)(1)(C)(ii), as applicable;
``(C) an explanation for, and description of, the
cost associated with a qualifying drug if such drug
meets the criteria under subsection (b)(1)(B), as
applicable;
``(D) if known and different from the manufacturer
of the qualifying drug, the identity of--
``(i) the sponsor or sponsors of any
investigational new drug applications under
section 505(i) of the Federal Food, Drug, and
Cosmetic Act for clinical investigations with
respect to such drug, for which the full
reports are submitted as part of the
application--
``(I) for approval of the drug
under section 505 of such Act; or
``(II) for licensure of the drug
under section 351 of the Public Health
Service Act; and
``(ii) the sponsor of an application for
the drug approved under such section 505 of the
Federal Food, Drug, and Cosmetic Act or
licensed under section 351 of the Public Health
Service Act;
``(E) a description of the history of the
manufacturer's price increases for the drug since the
approval of the application for the drug under section
505 of the Federal Food, Drug, and Cosmetic Act or the
issuance of the license for the drug under section 351
of the Public Health Service Act, or since the
manufacturer acquired such approved application or
license, if applicable;
``(F) the current wholesale acquisition cost of the
drug;
``(G) the total expenditures of the manufacturer
on--
``(i) materials and manufacturing for such
drug;
``(ii) acquiring patents and licensing for
such drug; and
``(iii) purchasing or acquiring such drug
from another manufacturer, if applicable;
``(H) the percentage of total expenditures of the
manufacturer on research and development for such drug
that was derived from Federal funds;
``(I) the total expenditures of the manufacturer on
research and development for such drug that is
necessary to demonstrate that it meets applicable
statutory standards for approval under section 505 of
the Federal Food, Drug, and Cosmetic Act or licensure
under section 351 of the Public Health Service Act, as
applicable;
``(J) the total expenditures of the manufacturer on
pursuing new or expanded indications or dosage changes
for such drug under section 505 of the Federal Food,
Drug, and Cosmetic Act or section 351 of the Public
Health Service Act;
``(K) the total expenditures of the manufacturer on
carrying out postmarket requirements related to such
drug, including under section 505(o)(3) of the Federal
Food, Drug, and Cosmetic Act;
``(L) the total revenue and the net profit
generated from the qualifying drug for each calendar
year since the approval of the application for the drug
under section 505 of the Federal Food, Drug, and
Cosmetic Act or the issuance of the license for the
drug under section 351 of the Public Health Service
Act, or since the manufacturer acquired such approved
application or license; and
``(M) the total costs associated with marketing and
advertising for the qualifying drug;
``(2) with respect to the manufacturer--
``(A) the total revenue and the net profit of the
manufacturer for each of the 12-month period described
in subsection (b)(1)(A)(i) or (b)(1)(C)(i) or the 36-
month period described in subsection (b)(1)(A)(ii) or
(b)(1)(C)(ii), as applicable;
``(B) all stock-based performance metrics used by
the manufacturer to determine executive compensation
for each of the 12-month periods described in
subsection (b)(1)(A)(i) or (b)(1)(C)(i) or the 36-month
periods described in subsection (b)(1)(A)(ii) or
(b)(1)(C)(ii), as applicable; and
``(C) any additional information the manufacturer
chooses to provide related to drug pricing decisions,
such as total expenditures on--
``(i) drug research and development; or
``(ii) clinical trials, including on drugs
that failed to receive approval by the Food and
Drug Administration; and
``(3) such other related information as the Secretary
considers appropriate and as specified by the Secretary.
``(d) Information Provided.--The manufacturer of a qualifying drug
that is required to submit a report under subsection (b), shall ensure
that such report and any explanation for, and description of, each
price increase described in subsection (c)(1) shall be truthful, not
misleading, and accurate.
``(e) Civil Monetary Penalty.--Any manufacturer of a qualifying
drug that fails to submit a report for the drug as required by this
section, following notification by the Secretary to the manufacturer
that the manufacturer is not in compliance with this section, shall be
subject to a civil monetary penalty of $75,000 for each day on which
the violation continues.
``(f) False Information.--Any manufacturer that submits a report
for a drug as required by this section that knowingly provides false
information in such report is subject to a civil monetary penalty in an
amount not to exceed $100,000 for each item of false information.
``(g) Public Posting.--
``(1) In general.--Subject to paragraph (4), the Secretary
shall post each report submitted under subsection (b) on the
public website of the Department of Health and Human Services
the day the price increase of a qualifying drug is scheduled to
go into effect.
``(2) Format.--In developing the format in which reports
will be publicly posted under paragraph (1), the Secretary
shall consult with stakeholders, including beneficiary groups,
and shall seek feedback from consumer advocates and readability
experts on the format and presentation of the content of such
reports to ensure that such reports are--
``(A) user-friendly to the public; and
``(B) written in plain language that consumers can
readily understand.
``(3) List.--In addition to the reports submitted under
subsection (b), the Secretary shall also post a list of each
qualifying drug with respect to which the manufacturer was
required to submit such a report in the preceding year and
whether such manufacturer was required to submit such report
based on a qualifying price increase or whether such drug meets
the criteria under subsection (b)(1)(B).
``(4) Protected information.--In carrying out this section,
the Secretary shall enforce applicable law concerning the
protection of confidential commercial information and trade
secrets.
``SEC. 1150E. ANNUAL REPORT TO CONGRESS.
``(a) In General.--Subject to subsection (b), the Secretary shall
submit to the Committees on Energy and Commerce and Ways and Means of
the House of Representatives and the Committees on Health, Education,
Labor, and Pensions and Finance of the Senate, and post on the public
website of the Department of Health and Human Services in a way that is
user-friendly to the public and written in plain language that
consumers can readily understand, an annual report--
``(1) summarizing the information reported pursuant to
section 1150D;
``(2) including copies of the reports and supporting
detailed economic analyses submitted pursuant to such section;
``(3) detailing the costs and expenditures incurred by the
Department of Health and Human Services in carrying out section
1150D; and
``(4) explaining how the Department of Health and Human
Services is improving consumer and provider information about
drug value and drug price transparency.
``(b) Protected Information.--In carrying out this section, the
Secretary shall enforce applicable law concerning the protection of
confidential commercial information and trade secrets.''.
TITLE V--NIH, FDA, AND OVERDOSE EPIDEMIC FUNDING
Subtitle A--Biomedical Innovation Expansion
SEC. 501. NIH INNOVATION INITIATIVES.
(a) NIH Innovation Account.--
(1) In general.--Section 1001(b) of the 21st Century Cures
Act (Public Law 114-255) is amended by adding at the end the
following:
``(5) Supplemental funding and additional activities.--
``(A) In general.--In addition to the funds made
available under paragraph (2), there are authorized to
be appropriated, and are hereby appropriated, to the
Account, out of any monies in the Treasury not
otherwise appropriated, to be available until expended
without further appropriation, the following:
``(i) For fiscal year 2022, $255,400,000.
``(ii) For fiscal year 2023, $160,400,000.
``(iii) For fiscal year 2024, $414,600,000.
``(iv) For fiscal year 2025, $547,000,000.
``(v) For fiscal year 2026, $948,000,000.
``(vi) For fiscal year 2027, $842,400,000.
``(vii) For fiscal year 2028,
$1,089,600,000.
``(viii) For fiscal year 2029,
$1,115,600,000.
``(ix) For fiscal year 2030,
$1,170,600,000.
``(x) For fiscal year 2031, $956,400,000.
``(B) Supplemental funding for certain projects.--
Of the total amounts made available under subparagraph
(A) for each of fiscal years 2022 through 2031, a total
amount not to exceed the following shall be made
available for the following categories of NIH
Innovation Projects:
``(i) For projects described in paragraph
(4)(A), an amount not to exceed a total of
$2,070,600,000 as follows:
``(I) For each of fiscal years 2022
and 2024, $50,000,000.
``(II) For fiscal year 2025,
$100,000,000.
``(III) For each of fiscal years
2026 and 2027, $300,000,000.
``(IV) For each of fiscal years
2028 through 2030, $317,000,000.
``(V) For fiscal year 2031,
$319,600,000.
``(ii) For projects described in paragraph
(4)(B), an amount not to exceed a total of
$2,041,900,000 as follows:
``(I) For each of fiscal years 2022
and 2024, $50,000,000.
``(II) For fiscal year 2025,
$128,000,000.
``(III) For fiscal year 2026,
$209,000,000.
``(IV) For fiscal year 2027,
$100,000,000.
``(V) For fiscal year 2028,
$325,000,000.
``(VI) For fiscal year 2029,
$350,000,000.
``(VII) For fiscal year 2030,
$400,000,000.
``(VIII) For fiscal year 2031,
$429,900,000.
``(iii) For projects described in paragraph
(4)(C), an amount not to exceed a total of
$1,558,400,000 as follows:
``(I) For each of fiscal years 2024
and 2025, $151,200,000.
``(II) For each of fiscal years
2026 through 2030, $251,200,000.
``(iv) For projects described in paragraph
(4)(D), an amount not to exceed $15,400,000 for
each of fiscal years 2022 through 2031.
``(C) Additional nih innovation projects.--In
addition to funding NIH Innovation Projects pursuant to
subparagraph (B), of the total amounts made available
under subparagraph (A), a total amount not to exceed
the following shall be made available for the following
categories of NIH Innovation Projects:
``(i) To support research related to
combating antimicrobial resistance and
antibiotic resistant bacteria, including
research into new treatments, diagnostics, and
vaccines, research, in consultation with the
Centers for Disease Control and Prevention,
into stewardship, and the development of
strategies, in coordination with the Biomedical
Advanced Research and Development Authority
under section 319L of the Public Health Service
Act, to support commercialization of new
antibiotics, not to exceed a total of
$1,144,500,000, as follows:
``(I) For each of fiscal years 2022
through 2025, $100,000,000.
``(II) For each of fiscal years
2026 and 2027, $120,000,000.
``(III) For each of fiscal years
2028 through 2030, $125,000,000.
``(IV) For fiscal year 2031,
$129,500,000.
``(ii) To support research and research
activities related to rare diseases or
conditions, including studies or analyses that
help to better understand the natural history
of a rare disease or condition and
translational studies related to rare diseases
or conditions, not to exceed a total of
$530,600,000, as follows:
``(I) For fiscal year 2022,
$40,000,000.
``(II) For fiscal year 2023,
$45,000,000.
``(III) For fiscal year 2024,
$48,000,000.
``(IV) For each of fiscal years
2025 and 2026, $52,400,000.
``(V) For fiscal year 2027,
$55,800,000.
``(VI) For fiscal year 2028,
$56,000,000.
``(VII) For fiscal year 2029,
$57,000,000.
``(VIII) For each of fiscal years
2030 and 2031, $62,000,000.''.
(2) Conforming amendments.--Section 1001 of the 21st
Century Cures Act (Public Law 114-255) is amended--
(A) in subsection (a), by striking ``subsection
(b)(4)'' and inserting ``subsections (b)(4) and
(b)(5)'';
(B) in subsection (b)(1), by striking ``paragraph
(4)'' and inserting ``paragraphs (4) and (5)'';
(C) in subsection (c)(2)(A)(ii), by inserting ``or
pursuant to subsection (b)(5)'' after ``subsection
(b)(3)''; and
(D) in subsection (d), by inserting ``or pursuant
to subsection (b)(5)'' after ``subsection (b)(3)''.
(b) Workplan.--Section 1001(c)(1) of the 21st Century Cures Act
(Public Law 114-255) is amended by adding at the end the following:
``(D) Updates.--The Director of NIH shall, after
seeking recommendations in accordance with the process
described in subparagraph (C), update the work plan
submitted under this subsection for each of fiscal
years 2022 through 2031 to reflect the amendments made
to this section by the Elijah E. Cummings Lower Drug
Costs Now Act.''.
(c) Annual Reports.--Section 1001(c)(2)(A) of the 21st Century
Cures Act (Public Law 114-255) is amended by striking ``2027'' and
inserting ``2031''.
(d) Sunset.--Section 1001(e) of the 21st Century Cures Act (Public
Law 114-255) is amended by striking ``September 30, 2026'' and
inserting ``September 30, 2031''.
SEC. 502. NIH CLINICAL TRIAL.
Part A of title IV of the Public Health Service Act (42 U.S.C. 281
et seq.) is amended by adding at the end the following:
``SEC. 404O. CLINICAL TRIAL ACCELERATION PILOT INITIATIVE.
``(a) Establishment of Pilot Program.--The Secretary, acting
through the Director of the National Institutes of Health, shall, not
later than 2 years after the date of enactment of this Act, establish
and implement a pilot program to award multi-year contracts to eligible
entities to support phase II clinical trials and phase III clinical
trials--
``(1) to promote innovation in treatments and technologies
supporting the advanced research and development and production
of high need cures; and
``(2) to provide support for the development of medical
products and therapies.
``(b) Eligible Entities.--To be eligible to receive assistance
under the pilot program established under subsection (a), an entity
shall--
``(1) be seeking to market a medical product or therapy
that is the subject of clinical trial or trials to be supported
using such assistance;
``(2) be a public or private entity, which may include a
private or public research institution, a contract research
organization, an institution of higher education (as defined in
section 101 of the Higher Education Act of 1965 (20 U.S.C.
1001)), a medical center, a biotechnology company, or an
academic research institution; and
``(3) comply with requirements of the Federal Food, Drug,
and Cosmetic Act and section 351 of this Act, as applicable, at
all stages of development, manufacturing, review, approval, and
safety surveillance of a medical product.
``(c) Duties.--The Secretary, acting through the Director of
National Institutes of Health, shall--
``(1) in establishing the pilot program under subsection
(a), consult with--
``(A) the Director of the National Center for
Advancing Translational Sciences and the other national
research institutes in considering their requests for
new or expanded clinical trial support efforts; and
``(B) the Commissioner of Food and Drugs and any
other head of a Federal agency as the Secretary
determines to be appropriate to ensure coordination and
efficiently advance clinical trial activities;
``(2) in implementing the pilot program under subsection
(a), consider consulting with patients and patient advocates;
and
``(3) in awarding contracts under the pilot program under
subsection (a), consider--
``(A) the expected health impacts of the clinical
trial or trials to be supported under the contract; and
``(B) the degree to which the medical product or
therapy that is the subject of such clinical trial or
trials is a high need cure.
``(d) Exclusion.--A contract may not be awarded under the pilot
program under subsection (a) if the drug that is the subject of the
clinical trial or trials to be supported under the contract is a drug
designated under section 526 of the Federal Food, Drug, and Cosmetic
Act as a drug for a rare disease or condition.
``(e) NIH Clinical Trial Accelerator Account.--
``(1) Establishment.--There is established in the Treasury
an account, to be known as the `NIH Clinical Trial Accelerator
Account' (referred to in this section as the `Account'), for
purposes of carrying out this section.
``(2) Transfer of direct spending savings.--There shall be
transferred to the Account from the general fund of the
Treasury, $400,000,000 for each of fiscal years 2022 through
2026, to be available until expended without further
appropriation.
``(3) Work plan.--Not later than 180 days after the date of
enactment of this Act, the Secretary shall submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a work plan that includes the
proposed implementation of this section and the proposed
allocation of funds in the Account.
``(f) Reports to Congress.--Not later than October 1 of each fiscal
year, the Secretary shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on--
``(1) the implementation of this section;
``(2) any available results on phase II clinical trials and
phase III clinical trials supported under this section during
such fiscal year; and
``(3) the extent to which Federal funds are obligated to
support such clinical trials, including the specific amount of
such support and awards pursuant to an allocation from the
Account under subsection (e).
``(g) Definitions.--In this section:
``(1) Phase ii clinical trial.--The term `phase II clinical
trial' means a phase II clinical investigation, as described in
section 312.21 of title 21, Code of Federal Regulations (or any
successor regulations).
``(2) Phase iii clinical trials.--The term `phase III
clinical trial' means a phase III clinical investigation, as
described in section 312.21 of title 21, Code of Federal
Regulations (or any successor regulations).
``(3) High need cure.--The term `high need cure' has the
meaning given such term in section 480(a)(3).''.
SEC. 503. INNOVATION NETWORK.
Part A of title IV of the Public Health Service Act (42 U.S.C. 281
et seq.), as amended by section 502, is further amended by adding at
the end the following:
``SEC. 404P. INNOVATION NETWORK.
``(a) Funds.--The Director of NIH shall award grants or contracts
to eligible entities to develop, expand, and enhance the
commercialization of biomedical products.
``(b) Eligible Entity.--In this section, the term `eligible entity'
means an entity receiving funding under--
``(1) the Small Business Innovation Research program of the
National Institutes of Health; or
``(2) the Small Business Technology Transfer program of the
National Institutes of Health.
``(c) Use of Funds.--An eligible entity shall use the funds
received through such grant or contract to support--
``(1) the Commercialization Readiness Pilot program of the
National Institutes of Health;
``(2) the Innovation Corps program of the National
Institutes of Health;
``(3) the Commercialization Accelerator program of the
National Institutes of Health;
``(4) the Commercialization Assistance program of the
National Institutes of Health; and
``(5) such other programs and activities as the Director of
NIH determines to be appropriate, to support the
commercialization stage of research, later stage research and
development, technology transfer, and commercialization
technical assistance.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $100,000,000 for each of fiscal
years 2022 through 2026, to be available until expended.''.
Subtitle B--Investing in Safety and Innovation
SEC. 511. FOOD AND DRUG ADMINISTRATION.
(a) FDA Innovation Account.--
(1) In general.--Section 1002(b) of the 21st Century Cures
Act (Public Law 114-255) is amended--
(A) in paragraph (1), by striking ``paragraph (4)''
and inserting ``paragraphs (4) and (5)''; and
(B) by adding at the end the following new
paragraph:
``(5) Supplemental funding and additional activities.--
``(A) In general.--In addition to the funds made
available under paragraph (2), there are authorized to
be appropriated, and are hereby appropriated, to the
Account, out of any monies in the Treasury not
otherwise appropriated, to be available until expended
without further appropriation, the following:
``(i) For fiscal year 2022, $417,500,000.
``(ii) For each of fiscal years 2023 and
2024, $157,500,000.
``(iii) For each of fiscal years 2025
through 2027, $152,500,000.
``(iv) For each of fiscal years 2028
through 2031, $202,500,000.
``(B) Supplemental funding for certain
activities.--Of the total amounts made available under
subparagraph (A) for each of fiscal years 2028 through
2031, a total amount not to exceed $50,000,000 for each
such fiscal year, shall be made available for the
activities under subtitles A through F (including the
amendments made by such subtitles) of title III of this
Act and section 1014 (relating to Intercenter
Institutes) of the Federal Food, Drug, and Cosmetic
Act.
``(C) Additional fda activities.--In addition to
funding activities pursuant to subparagraph (B), of the
total amounts made available under subparagraph (A), a
total amount not to exceed the following shall be made
available for the following categories of activities:
``(i) For modernization of the technical
infrastructure of the Food and Drug
Administration, including enhancements such as
interoperability across the agency, and
additional capabilities to develop an advanced
information technology infrastructure to
support the agency's regulatory mission:
``(I) For fiscal year 2022,
$180,000,000.
``(II) For each of fiscal years
2023 through 2031, $60,000,000.
``(ii) For support for continuous
manufacturing of drugs and biological products,
including complex biological products such as
regenerative medicine therapies, through grants
to institutions of higher education and
nonprofit organizations and other appropriate
mechanisms, for each of fiscal years 2022
through 2031, $20,000,000.
``(iii) For support for the Commissioner of
Food and Drugs to engage experts, such as
through the formation and operation of public-
private partnerships or other appropriate
collaborative efforts, to advance the
development and delivery of individualized
human gene therapy products:
``(I) For fiscal year 2022,
$50,000,000.
``(II) For each of fiscal years
2023 through 2031, $10,000,000.
``(iv) For support for inspections,
enforcement, and quality surveillance
activities across the Food and Drug
Administration, including foreign and domestic
inspections across products, for each of fiscal
years 2022 through 2031, $20,000,000.
``(v) For support for activities of the
Food and Drug Administration related to customs
and border protection to provide improvements
to technologies, inspection capacity, and sites
of import (including international mail
facilities) in which the Food and Drug
Administration operates, for each of fiscal
years 2022 through 2031, $10,000,000.
``(vi) To further advance the development
of a coordinated postmarket surveillance system
for all medical products, including drugs,
biological products, and devices, linked to
electronic health records in furtherance of the
Food and Drug Administration's postmarket
surveillance capabilities:
``(I) For fiscal year 2022,
$112,500,000.
``(II) For each of fiscal years
2023 through 2031, $12,500,000.
``(vii) For support for Food and Drug
Administration activities to keep pace with the
projected product development of regenerative
therapies, including cellular and somatic cell
gene therapy products:
``(I) For each of fiscal years 2022
through 2024, $10,000,000.
``(II) For each of fiscal years
2025 through 2031, $5,000,000.
``(viii) For carrying out section 714A of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379d-3a; relating to hiring authority
for scientific, technical, and professional
personnel), for each of fiscal years 2022
through 2031, $2,500,000.
``(ix) For the Food and Drug Administration
to support improvements to the technological
infrastructure for reporting and analysis of
adverse events associated with the use of drugs
and biological products, for each of fiscal
years 2022 through 2031, $12,500,000.''.
(2) Conforming amendments.--Section 1002 of the 21st
Century Cures Act (Public Law 114-255) is amended--
(A) in subsection (a), by inserting before the
period at the end the following: ``or pursuant to
subparagraph (A) of subsection (b)(5) to carry out the
activities described in subparagraphs (B) and (C) of
such subsection''; and
(B) in subsection (d)--
(i) by inserting ``or pursuant to
subparagraph (A) of subsection (b)(5)'' after
``subsection (b)(3)''; and
(ii) by striking ``subsection (b)(4)'' and
inserting ``subsections (b)(4) and (b)(5)''.
(b) Annual Report.--Section 1002(c)(2)(A) of the 21st Century Cures
Act (Public Law 114-255) is amended, in the matter preceding clause
(i), by striking ``2026'' and inserting ``2032''.
(c) Sunset.--Section 1002(e) of the 21st Century Cures Act (Public
Law 114-255) is amended by striking ``September 30, 2025'' and
inserting ``September 30, 2030''.
SEC. 512. STUDY ON HIGH-RISK, HIGH-REWARD DRUGS.
(a) In General.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human Services shall
conduct a study to identify--
(1) diseases or conditions that lack a treatment approved
by the Food and Drug Administration and instances in which
development of a treatment for such diseases or conditions
could fill an unmet medical need for the treatment of a serious
or life-threatening disease or condition or a rare disease or
condition; and
(2) appropriate incentives that would lead to the
development, approval, and marketing of such treatments.
(b) Report to Congress; Recommendations.--Not later than one year
after the date of enactment of this Act, the Secretary shall submit to
the Congress a report that includes--
(1) findings from the study under subsection (a); and
(2) recommendations regarding legislation necessary to
create appropriate incentives identified pursuant to subsection
(a)(2).
Subtitle C--Overdose Epidemic Response
SEC. 521. OVERDOSE EPIDEMIC RESPONSE FUND.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall use any funds
made available pursuant to subsection (b) to carry out the programs and
activities described in subsection (c) to address the overdose and
substance use disorder epidemic. Such funds shall be in addition to any
funds which are otherwise available to carry out such programs and
activities.
(b) Opioid Epidemic Response Fund.--
(1) Establishment of account.--There is established in the
Treasury an account, to be known as the Opioid Epidemic
Response Fund (referred to in this section as the ``Fund''),
for purposes of funding the programs and activities described
in subsection (c).
(2) Funding.--There is authorized to be appropriated, and
there is appropriated, to the Fund, out of any monies in the
Treasury not otherwise appropriated $2,000,000,000 for each of
fiscal years 2022 through 2026.
(3) Availability.--Amounts made available by paragraph (2)
shall be made available to the agencies specified in subsection
(c) in accordance with such subsection. Amounts made available
to an agency pursuant to the preceding sentence for a fiscal
year shall remain available until expended.
(c) Programs and Activities.--Of the total amount in the Fund for
each of fiscal years 2022 through 2026, such amount shall be allocated
as follows:
(1) SAMHSA.--For the Substance Abuse and Mental Health
Services Administration to carry out programs and activities
pursuant to section 522, $1,500,000,000 for each of fiscal
years 2022 through 2026.
(2) CDC.--For the Centers for Disease Control and
Prevention to carry out programs and activities pursuant to
section 523, $120,000,000 for each of fiscal years 2022 through
2026.
(3) FDA.--For the Food and Drug Administration to carry out
programs and activities pursuant to section 524, $10,000,000
for each of fiscal years 2022 through 2026.
(4) NIH.--For the National Institutes of Health to carry
out programs and activities pursuant to section 525,
$240,000,000 for each of fiscal years 2022 through 2026.
(5) HRSA.--For the Health Resources and Services
Administration to carry out programs and activities pursuant to
section 526, $90,000,000 for each of fiscal years 2022 through
2026.
(6) ACF.--For the Administration for Children and Families
to carry out programs and activities pursuant to section 527,
$40,000,000 for each of fiscal years 2022 through 2026.
(d) Accountability and Oversight.--
(1) Work plan.--
(A) In general.--Not later than 180 days after the
date of enactment of this Act, the Secretary of Health
and Human Services shall submit to the Committee on
Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the
Committee on Energy and Commerce, the Committee on
Appropriations, and the Committee on Education and
Labor of the House of Representatives, a work plan
including the proposed allocation of funds made
available pursuant to subsection (b) for each of fiscal
years 2022 through 2026 and the contents described in
subparagraph (B).
(B) Contents.--The work plan submitted under
subparagraph (A) shall include--
(i) the amount of money to be obligated or
expended out of the Fund in each fiscal year
for each program and activity described in
subsection (c); and
(ii) a description and justification of
each such program and activity.
(2) Annual reports.--Not later than October 1 of each of
fiscal years 2023 through 2027, the Secretary of Health and
Human Services shall submit to the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Energy and
Commerce, the Committee on Appropriations, and the Committee on
Education and Labor of the House of Representatives, a report
including--
(A) the amount of money obligated or expended out
of the Fund in the prior fiscal year for each program
and activity described in subsection (c);
(B) a description of all programs and activities
using funds made available pursuant to subsection (b);
and
(C) how the programs and activities are responding
to the opioid and substance use disorder epidemic.
(e) Limitations.--Notwithstanding any authority in this subtitle or
any appropriations Act, any funds made available pursuant to subsection
(b) may not be used for any purpose other than the programs and
activities described in subsection (c).
SEC. 522. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.
(a) In General.--The entirety of the funds made available pursuant
to section 521(c)(1) shall be for the Assistant Secretary for Mental
Health and Substance Use to continue to award the State Opioid Response
Grants funded by the heading ``Substance Abuse And Mental Health
Services Administration--Substance Abuse Treatment'' in title II of the
Departments of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act, 2018 (Public Law 115-141). Subject
to subsections (b) and (c), such grants shall be awarded in the same
manner and subject to the same conditions as were applicable to such
grants for fiscal year 2018.
(b) Requirement That Treatment Be Evidence-Based.--As a condition
on receipt of a grant pursuant to subsection (a), a grantee shall agree
that--
(1) treatments, practices, or interventions funded through
the grant will be evidence-based; and
(2) such treatments, practices, and interventions will
include medication-assisted treatment for individuals diagnosed
with opioid use disorder, using drugs only if the drugs have
been approved or licensed by the Food and Drug Administration
under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or section 351 of the Public Health Service Act
(42 U.S.C. 262).
(c) Reservations.--Of the amount made available pursuant to section
521(c)(1) for a fiscal year--
(1) not less than $75,000,000 shall be reserved to make
grants under subsection (a) to Indian Tribes or Tribal
organizations; and
(2) not less than $50,000,000 shall be reserved to make
grants under subsection (a) to political subdivisions of
States, such as counties, cities, or towns.
SEC. 523. CENTERS FOR DISEASE CONTROL AND PREVENTION.
(a) Addressing Opioid Use Disorder.--The entirety of the funds made
available pursuant to section 521(c)(2) shall be for the Director of
the Centers for Disease Control and Prevention, pursuant to applicable
authorities in the Public Health Service Act (42 U.S.C. 201 et seq.),
to continue and expand programs of the Centers for Disease Control and
Prevention to address opioid and substance use disorder, including by--
(1) improving the timeliness and quality of data on the
opioid use disorder epidemic, including improvement of--
(A) data on fatal and nonfatal overdoses;
(B) syndromic surveillance;
(C) data on long-term sequelae (including neonatal
abstinence syndrome); and
(D) cause of death reporting related to substance
abuse or opioid overdose;
(2) expanding and strengthening evidence-based prevention
and education strategies;
(3) supporting responsible prescribing practices, including
through development and dissemination of prescriber guidelines;
(4) improving access to and use of effective prevention,
treatment, and recovery support, including through grants and
the provision of technical assistance to States and localities;
(5) strengthening partnerships with first responders,
including to protect their safety;
(6) considering the needs of vulnerable populations;
(7) addressing infectious diseases linked to the opioid
crisis;
(8) strengthening prescription drug monitoring programs;
and
(9) providing financial and technical assistance to State
and local health department efforts to treat and prevent
substance use disorder.
(b) Limitation.--Of the funds made available pursuant to section
521(c)(2) for carrying out this section, not more than 20 percent may
be used for intramural purposes.
SEC. 524. FOOD AND DRUG ADMINISTRATION.
The entirety of the funds made available pursuant to section
521(c)(3) shall be for the Commissioner of Food and Drugs, pursuant to
applicable authorities in the Public Health Service Act (42 U.S.C. 201
et seq.) or the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) and other applicable law, to support widespread innovation in
non-opioid and non-addictive medical products for pain treatment,
access to opioid addiction treatments, appropriate use of approved
opioids, and efforts to reduce illicit importation of opioids. Such
support may include the following:
(1) Facilitating the development of non-opioid and non-
addictive pain treatments.
(2) Advancing guidance documents for sponsors of non-opioid
pain products.
(3) Developing evidence to inform the potential for
nonprescription overdose therapies.
(4) Examining expanded labeling indications for medication-
assisted treatment.
(5) Conducting public education and outreach, including
public workshops or public meetings, regarding the benefits of
medication-assisted treatment, including all drugs approved by
the Food and Drug Administration, and device treatment options
approved or cleared by the Food and Drug Administration.
(6) Exploring the expansion and possible mandatory nature
of prescriber education regarding pain management and
appropriate opioid prescribing through authorities under
section 505-1 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355-1).
(7) Examining options to limit the duration of opioid
prescriptions for acute pain, including through packaging
options.
(8) Increasing staff and infrastructure capacity to inspect
and analyze packages at international mail facilities and
pursue criminal investigations.
SEC. 525. NATIONAL INSTITUTES OF HEALTH.
The entirety of the funds made available pursuant to section
521(c)(4) shall be for the Director of the National Institutes of
Health, pursuant to applicable authorities in the Public Health Service
Act (42 U.S.C. 201 et seq.), to carry out activities related to--
(1) accelerating research for addressing the opioid use
disorder epidemic, including developing non-opioid medications
and interventions, including non-addictive medications, to
manage pain, as well as developing medications and
interventions to treat and to prevent substance use disorders;
(2) conducting and supporting research on which treatments
(in terms of pain management as well as treating and preventing
substance use disorders) are optimal for which patients; and
(3) conducting and supporting research on creating longer-
lasting or faster-acting antidotes for opioid overdose,
particularly in response to the prevalence of fentanyl and
carfentanyl overdoses.
SEC. 526. HEALTH RESOURCES AND SERVICES ADMINISTRATION.
The entirety of the funds made available pursuant to section
521(c)(5) shall be for the Administrator of the Health Resources and
Services Administration, pursuant to applicable authorities in titles
III, VII, and VIII of the Public Health Service Act (42 U.S.C. 241 et
seq.), to carry out activities that increase the availability and
capacity of the behavioral health workforce. Such activities shall
include providing loan repayment assistance for substance use disorder
treatment providers.
SEC. 527. ADMINISTRATION FOR CHILDREN AND FAMILIES.
Of the funds made available pursuant to section 521(c)(6) for each
of fiscal years 2022 through 2026, $40,000,000 for each such fiscal
year shall be for the Secretary of Health and Human Services to carry
out title I of the Child Abuse Prevention and Treatment Act (42 U.S.C.
5101 et seq.).
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