[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3 Placed on Calendar Senate (PCS)]
<DOC>
Calendar No. 521
116th CONGRESS
2d Session
H. R. 3
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 16, 2019
Received
August 13, 2020
Read the first time
September 8, 2020
Read the second time and placed on the calendar
_______________________________________________________________________
AN ACT
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--MEDICARE PARTS B AND D 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 drugs 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--PROGRAM IMPROVEMENTS FOR MEDICARE LOW-INCOME BENEFICIARIES
Sec. 501. Dissemination to Medicare part D subsidy eligible individuals
of information comparing premiums of
certain prescription drug plans.
Sec. 502. Providing for intelligent assignment of certain subsidy
eligible individuals auto-enrolled under
Medicare prescription drug plans and MA-PD
plans.
Sec. 503. Expanding eligibility for low-income subsidies under part D
of the Medicare program.
Sec. 504. Automatic eligibility of certain low-income territorial
residents for premium and cost-sharing
subsidies under the Medicare program;
Sunset of enhanced allotment program.
Sec. 505. Automatic qualification of certain Medicaid beneficiaries for
premium and cost-sharing subsidies under
part D of the Medicare program.
Sec. 506. Providing for certain rules regarding the treatment of
eligible retirement plans in determining
the eligibility of individuals for premium
and cost-sharing subsidies under part D of
the Medicare program.
Sec. 507. Reducing cost-sharing and other program improvements for low-
income beneficiaries.
TITLE VI--PROVIDING FOR DENTAL, VISION, AND HEARING COVERAGE UNDER THE
MEDICARE PROGRAM
Sec. 601. Dental and oral health care.
Sec. 602. Providing coverage for hearing care under the Medicare
program.
Sec. 603. Providing coverage for vision care under the Medicare
program.
TITLE VII--NIH, FDA, AND OPIOIDS FUNDING
Subtitle A--Biomedical Innovation Expansion
Sec. 701. NIH Innovation Initiatives.
Sec. 702. NIH clinical trial.
Sec. 703. Innovation Network.
Subtitle B--Investing in Safety and Innovation
Sec. 711. Food and Drug Administration.
Sec. 712. Study on high-risk, high-reward drugs.
Subtitle C--Opioid Epidemic Response
Sec. 721. Opioid Epidemic Response Fund.
Sec. 722. Substance Abuse and Mental Health Services Administration.
Sec. 723. Centers for Disease Control and Prevention.
Sec. 724. Food and Drug Administration.
Sec. 725. National Institutes of Health.
Sec. 726. Health Resources and Services Administration.
Sec. 727. Administration for Children and Families.
Subtitle D--Reducing Administrative Costs and Burdens in Health Care
Sec. 731. Reducing administrative costs and burdens in health care.
TITLE VIII--MISCELLANEOUS
Sec. 801. Guaranteed issue of certain Medigap policies.
Sec. 802. Reporting requirements for PDP sponsors regarding point-of-
sale rejections under Medicare part D.
Sec. 803. Providing access to annual Medicare notifications in multiple
languages.
Sec. 804. Temporary increase in Medicare part B payment for certain
biosimilar biological products.
Sec. 805. Waiving medicare coinsurance for colorectal cancer screening
tests.
Sec. 806. Medicare coverage of certain lymphedema compression treatment
items.
Sec. 807. Physician fee update.
Sec. 808. Additional community health center funding.
Sec. 809. Grants to improve trauma support services and mental health
care for children and youth in educational
settings.
Sec. 810. Pathway to Health Careers Act.
Sec. 811. Home Visiting to Reduce Maternal Mortality and Morbidity Act.
Sec. 812. Addition of new measures based on access to biosimilar
biological products to the 5-star rating
system under medicare advantage.
Sec. 813. Sense of Congress regarding the impact of the high cost of
prescription drugs on communities of color
and persons living in rural or sparsely
populated areas of the United States.
Sec. 814. Regulations requiring direct-to-consumer advertisements for
prescription drugs and biological products
to include truthful and not misleading
pricing information.
Sec. 815. Improving transparency and preventing the use of abusive
spread pricing and related practices in
Medicaid.
Sec. 816. Graduate medical education improvements in rural and
underserved communities.
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 2023) 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,
2023).
``(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 2023, 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 2023, 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 2024 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
(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, 2025, 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, 2025, 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, 2025, 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 A of title XXVII of the Public
Health Service Act is amended by inserting after
section 2729 the following new section:
``SEC. 2729A. 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. 716. 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 716''.
(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. 716. 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. 9816. 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 9816,'' 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. 9816. 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, 2020;
(3) $600,000,000 shall become available on October 1, 2021;
(4) $600,000,000 shall become available on October 1, 2022;
and
(5) $600,000,000 shall become available on October 1, 2023.
(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--MEDICARE PARTS B AND D 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:
``(x) 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, 2021, 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, 2021, 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 2022, shall be the dollar amount
specified under such subparagraph for 2021,
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,
2021' 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, 2021.
``(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 (CC)'' and inserting
``(CC)''; and
(iii) by inserting before the semicolon at
the end the following: ``, and (DD) with
respect to a part B rebatable drug (as defined
in paragraph (2) of section 1834(x)) 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'';
(B) by adding at the end of the flush left matter
following paragraph (9), the following:
``For purposes of applying paragraph (1)(DD), subsections (i)(9) and
(t)(8)(F), and section 1834(x)(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(x)) 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, 2021, 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(x)(5),
paragraph (1)(DD) 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(x)(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(x)) for which payment under this part is
not packaged into a payment for a service furnished on
or after July 1, 2021, 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(x)(5),
paragraph (1)(DD) 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(x)(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(x)'' 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(x)'' 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(x)''.
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, 2022, and ending on December
31, 2022, there were extenuating circumstances.
``(3) Applicable year.--For purposes of this section the
term `applicable year' means a year beginning with 2022.
``(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 2023, shall be the dollar amount
specified under such subparagraph for 2022,
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 2022; 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(x)'' and inserting ``section 1927, section
1834(x), 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(x)'' and inserting ``, section 1834(x), 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(x)'' and inserting ``, section 1834(x), 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, 2021, 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(x) 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, 2022, 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, 2021, 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(x) 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 2021, 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, 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,
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 2022
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 2022 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 2022,'' after ``paragraph (4),''; and
(ii) in clause (ii)(III), by striking ``and
each subsequent year'' and inserting ``and
2021''; and
(C) in subparagraph (D)--
(i) in clause (i)--
(I) in the matter preceding
subclause (I), by inserting ``for a
year preceding 2022,'' after
``paragraph (4),''; and
(II) in subclause (I)(bb), by
striking ``a year after 2018'' and
inserting ``each of years 2018 through
2021''; and
(ii) in clause (ii)(V), by striking ``2019
and each subsequent year'' and inserting ``each
of years 2019 through 2021'';
(2) in paragraph (3)(A)--
(A) in the matter preceding clause (i), by
inserting ``for a year preceding 2022,'' after ``and
(4),''; and
(B) in clause (ii), by striking ``for a subsequent
year'' and inserting ``for each of years 2007 through
2021''; 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 2022,
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 2022 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 2021''; 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 2022, 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
2022, for amounts''; and
(D) in subparagraph (E), by striking ``In
applying'' and inserting ``For each of years 2011
through 2021, 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 2021, 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,
2021, 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, 2022.
``(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 2022.--In order for
an agreement with a manufacturer to be in
effect under this section with respect to the
period beginning on January 1, 2022, and ending
on December 31, 2022, 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) 2023 and subsequent years.--In order
for an agreement with a manufacturer to be in
effect under this section with respect to plan
year 2023 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, 2022, 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, 2022, 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 2022 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 2022 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 2022, 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
2022 or the annual out-of-pocket threshold
specified in subsection (b)(4)(B) for the year
for 2022 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
2022, 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 2022, 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 2022, 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 2022, the elimination''; and
(B) in paragraph (2)--
(i) in subparagraph (C), by striking ``The
continuation'' and inserting ``For a year
preceding 2022, 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 2022, 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 2022 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 2022'' 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 2021, the Medicare coverage
gap discount program under section 1860D-14A; and
``(B) for 2022 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 2021, an agreement described
in subsection (b) of section 1860D-14A with the
Secretary; and
``(B) for 2022 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 2021, 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 2022 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, 2022, 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,
2022.''.
(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 2022 and subsequent plan years.
SEC. 302. ALLOWING CERTAIN ENROLLEES OF PRESCRIPTION DRUGS 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 2022 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, 2021, 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. 1150C. 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, 2019;
or
``(ii) 25 percent or more within a 36-month
period beginning on or after January 1, 2019;
``(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, 2021; 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, 2021; or
``(ii) 25 percent or more within a 36-month
period that begins and ends during the 5-year
period preceding January 1, 2021.
``(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, 2019, 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, 2021.
``(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 Pubic 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. 1150D. 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 1150C;
``(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
1150C; 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--PROGRAM IMPROVEMENTS FOR MEDICARE LOW-INCOME BENEFICIARIES
SEC. 501. DISSEMINATION TO MEDICARE PART D SUBSIDY ELIGIBLE INDIVIDUALS
OF INFORMATION COMPARING PREMIUMS OF CERTAIN PRESCRIPTION
DRUG PLANS.
Section 1860D-1(c)(3) of the Social Security Act (42 U.S.C. 1395w-
101(c)(3)) is amended by adding at the end the following new
subparagraph:
``(C) Information on premiums for subsidy eligible
individuals.--
``(i) In general.--For plan year 2022 and
each subsequent plan year, the Secretary shall
disseminate to each subsidy eligible individual
(as defined in section 1860D-14(a)(3))
information under this paragraph comparing
premiums that would apply to such individual
for prescription drug coverage under LIS
benchmark plans, including, in the case of an
individual enrolled in a prescription drug plan
under this part, information that compares the
premium that would apply if such individual
were to remain enrolled in such plan to
premiums that would apply if the individual
were to enroll in other LIS benchmark plans.
``(ii) LIS benchmark plan.--For purposes of
clause (i), the term `LIS benchmark plan'
means, with respect to an individual, a
prescription drug plan under this part that is
offered in the region in which the individual
resides and--
``(I) that provides for a premium
that is not more than the low-income
benchmark premium amount (as defined in
section 1860D-14(b)(2)) for such
region; or
``(II) with respect to which the
premium would be waived as de minimis
pursuant to section 1860D-14(a)(5) for
such individual.''.
SEC. 502. PROVIDING FOR INTELLIGENT ASSIGNMENT OF CERTAIN SUBSIDY
ELIGIBLE INDIVIDUALS AUTO-ENROLLED UNDER MEDICARE
PRESCRIPTION DRUG PLANS AND MA-PD PLANS.
(a) In General.--Section 1860D-1(b)(1) of the Social Security Act
(42 U.S.C. 1395w-101(b)(1)) is amended--
(1) in subparagraph (C)--
(A) by inserting after ``PDP region'' the
following: ``or through use of an intelligent
assignment process that is designed to maximize the
access of such individual to necessary prescription
drugs while minimizing costs to such individual and to
the program under this part to the greatest extent
possible. In the case the Secretary enrolls such
individuals through use of an intelligent assignment
process, such process shall take into account the
extent to which prescription drugs necessary for the
individual are covered in the case of a PDP sponsor of
a prescription drug plan that uses a formulary, the use
of prior authorization or other restrictions on access
to coverage of such prescription drugs by such a
sponsor, and the overall quality of a prescription drug
plan as measured by quality ratings established by the
Secretary''; and
(B) by striking ``Nothing in the previous
sentence'' and inserting ``Nothing in this
subparagraph''; and
(2) in subparagraph (D)--
(A) by inserting after ``PDP region'' the
following: ``or through use of an intelligent
assignment process that is designed to maximize the
access of such individual to necessary prescription
drugs while minimizing costs to such individual and to
the program under this part to the greatest extent
possible. In the case the Secretary enrolls such
individuals through use of an intelligent assignment
process, such process shall take into account the
extent to which prescription drugs necessary for the
individual are covered in the case of a PDP sponsor of
a prescription drug plan that uses a formulary, the use
of prior authorization or other restrictions on access
to coverage of such prescription drugs by such a
sponsor, and the overall quality of a prescription drug
plan as measured by quality ratings established by the
Secretary''; and
(B) by striking ``Nothing in the previous
sentence'' and inserting ``Nothing in this
subparagraph''.
(b) Effective Date.--The amendments made by subsection (a) shall
apply with respect to plan years beginning with plan year 2022.
SEC. 503. EXPANDING ELIGIBILITY FOR LOW-INCOME SUBSIDIES UNDER PART D
OF THE MEDICARE PROGRAM.
Section 1860D-14(a) of the Social Security Act (42 U.S.C. 1395w-
114(a)), as amended by section 301(d), is further amended--
(1) in the subsection heading, by striking ``Individuals''
and all that follows through ``Line'' and inserting ``Certain
Individuals'';
(2) in paragraph (1)--
(A) by striking the paragraph heading and inserting
``Individuals with certain low incomes''; and
(B) in the matter preceding subparagraph (A), by
inserting ``(or, with respect to a plan year beginning
on or after January 1, 2022, 150 percent)'' after ``135
percent''; and
(3) in paragraph (2)--
(A) by striking the paragraph heading and inserting
``Other low-income individuals''; and
(B) in the matter preceding subparagraph (A), by
striking ``In the case of a subsidy'' and inserting
``With respect to a plan year beginning before January
1, 2022, in the case of a subsidy''.
SEC. 504. AUTOMATIC ELIGIBILITY OF CERTAIN LOW-INCOME TERRITORIAL
RESIDENTS FOR PREMIUM AND COST-SHARING SUBSIDIES UNDER
THE MEDICARE PROGRAM; SUNSET OF ENHANCED ALLOTMENT
PROGRAM.
(a) Automatic Eligibility of Certain Low-Income Territorial
Residents for Premium and Cost-Sharing Subsidies Under the Medicare
Program.--
(1) In general.--Section 1860D-14(a)(3) of the Social
Security Act (42 U.S.C. 1395w-114(a)(3)) is amended--
(A) in subparagraph (B)(v)--
(i) in subclause (I), by striking ``and''
at the end;
(ii) in subclause (II), by striking the
period and inserting ``; and''; and
(iii) by inserting after subclause (II) the
following new subclause:
``(III) with respect to plan years
beginning on or after January 1, 2024,
shall provide that any part D eligible
individual who is enrolled for medical
assistance under the State Medicaid
plan of a territory (as defined in
section 1935(f)) under title XIX (or a
waiver of such a plan) shall be treated
as a subsidy eligible individual
described in paragraph (1).''; and
(B) in subparagraph (F), by adding at the end the
following new sentence: ``The previous sentence shall
not apply with respect to eligibility determinations
for premium and cost-sharing subsidies under this
section made on or after January 1, 2024.''.
(2) Conforming amendment.--Section 1860D-31(j)(2)(D) of the
Social Security Act (42 U.S.C. 1395w-141(j)(2)(D)) is amended
by adding at the end the following new sentence: ``The previous
sentence shall not apply with respect to amounts made available
to a State under this paragraph on or after January 1, 2024.''.
(b) Sunset of Enhanced Allotment Program.--
(1) In general.--Section 1935(e) of the Social Security Act
(42 U.S.C. 1396u-5(e)) is amended--
(A) in paragraph (1)(A), by inserting after ``such
State'' the following: ``before January 1, 2021''; and
(B) in paragraph (3)--
(i) in subparagraph (A), in the matter
preceding clause (i), by inserting after ``a
year'' the following: ``(before 2024)''; and
(ii) in subparagraph (B)(iii), by striking
``a subsequent year'' and inserting ``each of
fiscal years 2008 through 2023''.
(2) Territory defined.--Section 1935 of the Social Security
Act (42 U.S.C. 1396u-5) is amended by adding at the end the
following new subsection:
``(f) Territory Defined.--In this section, the term `territory'
means Puerto Rico, the Virgin Islands, Guam, the Northern Mariana
Islands, and American Samoa.''.
SEC. 505. AUTOMATIC QUALIFICATION OF CERTAIN MEDICAID BENEFICIARIES FOR
PREMIUM AND COST-SHARING SUBSIDIES UNDER PART D OF THE
MEDICARE PROGRAM.
Clause (v) of section 1860D-14(a)(3)(B) of the Social Security Act
(42 U.S.C. 1395w-114(a)(3)(B)), as amended by section 504, is further
amended--
(1) in subclause (II), by striking ``and'' at the end;
(2) in subclause (III), by striking the period and
inserting ``; and''; and
(3) by inserting after subclause (III) the following new
subclause:
``(IV) with respect to plan years
beginning on or after January 1, 2024,
shall, notwithstanding the preceding
clauses of this subparagraph, provide
that any part D eligible individual not
described in subclause (I), (II), or
(III) who is enrolled, as of the day
before the date on which such
individual attains the age of 65, for
medical assistance under a State plan
under title XIX (or a waiver of such
plan) pursuant to clause (i)(VIII) or
(ii)(XX) of section 1902(a)(10)(A), and
who has income below 200 percent of the
poverty line applicable to a family of
the size involved, shall be treated as
a subsidy eligible individual described
in paragraph (1) for a limited period
of time, as specified by the
Secretary.''.
SEC. 506. PROVIDING FOR CERTAIN RULES REGARDING THE TREATMENT OF
ELIGIBLE RETIREMENT PLANS IN DETERMINING THE ELIGIBILITY
OF INDIVIDUALS FOR PREMIUM AND COST-SHARING SUBSIDIES
UNDER PART D OF THE MEDICARE PROGRAM.
Section 1860D-14(a)(3)(C)(i) of the Social Security Act (42 U.S.C.
1395w-114(a)(3)(C)(i)) is amended, by striking ``except that support
and maintenance furnished in kind shall not be counted as income; and''
and inserting ``except that--
``(I) support and maintenance
furnished in kind shall not be counted
as income; and
``(II) for plan years beginning on
or after January 1, 2024, any
distribution or withdrawal from an
eligible retirement plan (as defined in
subparagraph (B) of section 402(c)(8)
of the Internal Revenue Code of 1986,
but excluding any defined benefit plan
described in clause (iv) or (v) of such
subparagraph and any qualified trust
(as defined in subparagraph (A) of such
section) which is part of such a
defined benefit plan) shall be counted
as income; and''.
SEC. 507. REDUCING COST-SHARING AND OTHER PROGRAM IMPROVEMENTS FOR LOW-
INCOME BENEFICIARIES.
(a) Increase in Income Eligibility to 150 Percent of FPL for
Qualified Medicare Beneficiaries.--
(1) In general.--Section 1905(p)(2)(A) of the Social
Security Act (42 U.S.C. 1396d(p)(2)(A)) is amended by striking
``shall be at least the percent provided under subparagraph (B)
(but not more than 100 percent) of the official poverty line''
and all that follows through the period at the end and
inserting the following: ``shall be--
``(i) before January 1, 2022, at least the
percent provided under subparagraph (B) (but
not more than 100 percent) of the official
poverty line (as defined by the Office of
Management and Budget, and revised annually in
accordance with section 673(2) of the Omnibus
Budget Reconciliation Act of 1981) applicable
to a family of the size involved; and
``(ii) on or after January 1, 2022, equal
to 150 percent of the official poverty line (as
so defined and revised) applicable to a family
of the size involved.''.
(2) Not counting in-kind support and maintenance as
income.--Section 1905(p)(2)(D) of the Social Security Act (42
U.S.C. 1396d(p)(2)(D)) is amended by adding at the end the
following new clause:
``(iii) In determining income under this
subsection, support and maintenance furnished
in kind, as described in section 1612(a)(2)(A),
shall not be counted as income.''.
(3) Conforming amendments.--
(A) Section 1902(a)(10)(E) of the Social Security
Act (42 U.S.C. 1396a(a)(10)(E)) is amended--
(i) in clause (iii), by striking ``for
making medical'' and inserting ``before January
1, 2022, for making medical''; and
(ii) in clause (iv), by striking ``subject
to sections'' and inserting ``before January 1,
2022, subject to sections''.
(B) Section 1933 of the Social Security Act (42
U.S.C. 1396u-3) is amended--
(i) in subsection (a), by striking ``A
State plan'' and inserting ``Subject to
subsection (h), a State plan''; and
(ii) by adding at the end the following new
subsection:
``(h) Sunset.--The provisions of this section shall have no force
or effect after December 31, 2021.''.
(b) 100 Percent FMAP.--Section 1905 of the Social Security Act (42
U.S.C. 1396d) is amended by adding at the end the following new
subsection:
``(gg) Increased FMAP for Expanded Medicare Cost-Sharing
Populations.--
``(1) In general.--Notwithstanding subsection (b), with
respect to expenditures described in paragraph (2) the Federal
medical assistance percentage shall be equal to 100 percent.
``(2) Expenditures described.--The expenditures described
in this paragraph are expenditures made on or after January 1,
2022, for medical assistance for medicare cost-sharing provided
to any individual under clause (i) or (ii) of section
1902(a)(10)(E) who would not have been eligible for medicare
cost-sharing under any such clause under the income or resource
eligibility standards in effect on October 1, 2018.''.
TITLE VI--PROVIDING FOR DENTAL, VISION, AND HEARING COVERAGE UNDER THE
MEDICARE PROGRAM
SEC. 601. DENTAL AND ORAL HEALTH CARE.
(a) Coverage.--Section 1861(s)(2) of the Social Security Act (42
U.S.C. 1395x(s)(2)) is amended--
(1) in subparagraph (GG), by striking ``and'' after the
semicolon at the end;
(2) in subparagraph (HH), by striking the period at the end
and adding ``; and''; and
(3) by adding at the end the following new subparagraph:
``(II) dental and oral health services (as defined in
subsection (kkk));''.
(b) Dental and Oral Health Services Defined.--Section 1861 of the
Social Security Act (42 U.S.C. 1395x) is amended by adding at the end
the following new subsection:
``(kkk) Dental and Oral Health Services.--
``(1) In general.--The term `dental and oral health
services' means items and services (other than such items and
services for which payment may be made under part A as
inpatient hospital services) that are furnished during 2025 or
a subsequent year, for which coverage was not provided under
part B as of the date of the enactment of this subsection, and
that are--
``(A) the preventive and screening services
described in paragraph (2) furnished by a doctor of
dental surgery or of dental medicine (as described in
subsection (r)(2)) or an oral health professional (as
defined in paragraph (4)); or
``(B) the basic treatments specified for such year
by the Secretary pursuant to paragraph (3)(A) and the
major treatments specified for such year by the
Secretary pursuant to paragraph (3)(B) furnished by
such a doctor or such a professional.
``(2) Preventive and screening services.--The preventive
and screening services described in this paragraph are the
following:
``(A) Oral exams.
``(B) Dental cleanings.
``(C) Dental x-rays performed in the office of a
doctor or professional described in paragraph (1)(A).
``(D) Fluoride treatments.
``(3) Basic and major treatments.--For 2025 and each
subsequent year, the Secretary shall specify--
``(A) basic treatments (which may include basic
tooth restorations, basic periodontic services, tooth
extractions, and oral disease management services); and
``(B) major treatments (which may include major
tooth restorations, major periodontic services,
bridges, crowns, and root canals);
that shall be included as dental and oral health services for
such year.
``(4) Oral health professional.--The term `oral health
professional' means, with respect to dental and oral health
services, a health professional who is licensed to furnish such
services, acting within the scope of such license, by the State
in which such services are furnished.''.
(c) Payment; Coinsurance; and Limitations.--
(1) In general.--Section 1833(a)(1) of the Social Security
Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) in subparagraph (N), by inserting ``and dental
and oral health services (as defined in section
1861(kkk))'' after ``section 1861(hhh)(1))'';
(B) by striking ``and'' before ``(CC)''; and
(C) by inserting before the semicolon at the end
the following: ``, and (DD) with respect to dental and
oral health services (as defined in section 1861(kkk)),
the amount paid shall be the payment amount specified
under section 1834(x)''.
(2) Payment and limits specified.--Section 1834 of the
Social Security Act (42 U.S.C. 1395m) is amended by adding at
the end the following new subsection:
``(x) Payment and Limits for Dental and Oral Health Services.--
``(1) In general.--The payment amount under this part for
dental and oral health services (as defined in section
1861(kkk)) shall be, subject to paragraph (3), the applicable
percent (specified in paragraph (2)) of the lesser of the
actual charge for the services or the amount determined under
the payment basis determined under section 1848. In determining
such amounts determined under such payment basis, the Secretary
shall consider payment rates paid to dentists for comparable
services under State plans under title XIX, under the TRICARE
program under chapter 55 of title 10 of the United States Code,
and by other health care payers, such as Medicare Advantage
plans under part C.
``(2) Applicable percent.--For purposes of paragraph (1),
the applicable percent specified in this paragraph is, with
respect to dental and oral health services (as defined in
section 1861(kkk)) furnished in a year--
``(A) that are preventive and screening services
described in paragraph (2) or basic treatments
specified for such year pursuant to paragraph (3)(A) of
such section, 80 percent; and
``(B) that are major treatments specified for such
year pursuant to paragraph (3)(B) of such section--
``(i) in the case such services are
furnished during 2025, 10 percent;
``(ii) in the case such services are
furnished during 2026 or a subsequent year
before 2029, the applicable percent specified
under this subparagraph for the previous year,
increased by 10 percentage points; and
``(iii) in the case such services are
furnished during 2029 or a subsequent year, 50
percent.
``(3) Limitations.--With respect to dental and oral health
services that are--
``(A) preventive and screening oral exams, payment
may be made under this part for not more than two such
exams during a 12-month period;
``(B) dental cleanings, payment may be made under
this part for not more than two such cleanings during a
12-month period; and
``(C) not described in subparagraph (A) or (B),
payment may be made under this part only at such
frequencies and under such circumstances determined
appropriate by the Secretary.''.
(d) Payment Under Physician Fee Schedule.--
(1) In general.--Section 1848(j)(3) of the Social Security
Act (42 U.S.C. 1395w-4(j)(3)) is amended by inserting
``(2)(II),'' before ``(3)''.
(2) Exclusion from mips.--Section 1848(q)(1)(C)(ii) of the
Social Security Act (42 U.S.C. 1395w-4(q)(1)(C)(ii)) is
amended--
(A) in subclause (II), by striking ``or'' at the
end;
(B) in subclause (III), by striking the period at
the end and inserting ``; or''; and
(C) by adding at the end the following new
subclause:
``(IV) with respect to 2025 and
each subsequent year, is a doctor of
dental surgery or of dental medicine
(as described in section 1861(r)(2)) or
is an oral health professional (as
defined in section 1861(kkk)(4)).''.
(3) Inclusion of oral health professionals as certain
practitioners.--Section 1842(b)(18)(C) of the Social Security
Act (42 U.S.C. 1395u(b)(18)(C)) is amended by adding at the end
the following new clause:
``(vii) With respect to 2025 and each subsequent year, an
oral health professional (as defined in section
1861(kkk)(4)).''.
(e) Dentures.--
(1) In general.--Section 1861(s)(8) of the Social Security
Act (42 U.S.C. 1395x(s)(8)) is amended--
(A) by striking ``(other than dental)''; and
(B) by inserting ``and excluding dental, except for
a full or partial set of dentures furnished on or after
January 1, 2025'' after ``colostomy care''.
(2) Special payment rules.--
(A) Limitations.--Section 1834(h) of the Social
Security Act (42 U.S.C. 1395m(h)) is amended by adding
at the end the following new paragraph:
``(6) Special payment rule for dentures.--Payment may be
made under this part with respect to an individual for
dentures--
``(A) not more than once during any 5-year period
(except in the case that a doctor or professional
described in section 1861(kkk)(1)(A) determines such
dentures do not fit the individual); and
``(B) only to the extent that such dentures are
furnished pursuant to a written order of such a doctor
or professional.''.
(B) Application of competitive acquisition.--
(i) In general.--Section 1834(h)(1)(H) of
the Social Security Act (42 U.S.C.
1395m(h)(1)(H)) is amended--
(I) in the subparagraph heading, by
inserting ``, dentures'' after
``orthotics'';
(II) by inserting ``, of dentures
described in paragraph (2)(D) of such
section,'' after ``2011,''; and
(III) in clause (i), by inserting
``, such dentures'' after
``orthotics''.
(ii) Conforming amendment.--Section
1847(a)(2) of the Social Security Act (42
U.S.C. 1395w-3(a)(2)) is amended by adding at
the end the following new subparagraph:
``(D) Dentures.--Dentures described in section
1861(s)(8) for which payment would otherwise be made
under section 1834(h).''.
(iii) Exemption of certain items from
competitive acquisition.--Section 1847(a)(7) of
the Social Security Act (42 U.S.C. 1395w-
3(a)(7)) is amended by adding at the end the
following new subparagraph:
``(C) Certain dentures.--Those items and services
described in paragraph (2)(D) if furnished by a
physician or other practitioner (as defined by the
Secretary) to the physician's or practitioner's own
patients as part of the physician's or practitioner's
professional service.''.
(f) Exclusion Modifications.--Section 1862(a) of the Social
Security Act (42 U.S.C. 1395y(a)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (O), by striking ``and'' at the
end;
(B) in subparagraph (P), by striking the semicolon
at the end and inserting ``, and''; and
(C) by adding at the end the following new
subparagraph:
``(Q) in the case of dental and oral health services (as
defined in section 1861(kkk)) that are preventive and screening
services described in paragraph (2) of such section, which are
furnished more frequently than provided under section
1834(x)(3) and under circumstances other than circumstances
determined appropriate under such section;''; and
(2) in paragraph (12), by inserting before the semicolon at
the end the following: ``and except that payment may be made
under part B for dental and oral health services that are
covered under section 1861(s)(2)(II)''.
(g) Certain Non-application.--
(1) In general.--Paragraphs (1) and (4) of section 1839(a)
of the Social Security Act (42 U.S.C. 1395r(a)) are amended by
adding at the end of each such paragraphs the following: ``In
applying this paragraph there shall not be taken into account
benefits and administrative costs attributable to the
amendments made by section 601 (other than subsection (g)) of
the Elijah E. Cummings Lower Drug Costs Now Act and the
Government contribution under section 1844(a)(4)''.
(2) Payment.--Section 1844(a) of such Act (42 U.S.C.
1395w(a)) is amended--
(A) in paragraph (3), by striking the period at the
end and inserting ``; plus''; and
(B) by adding at the end the following new
paragraph:
``(4) a Government contribution equal to the amount that is
estimated to be payable for benefits and related administrative
costs incurred that are attributable to the amendments made by
section 601 (other than subsection (g)) of the Elijah E.
Cummings Lower Drug Costs Now Act.''.
(h) Implementation Funding.--
(1) In general.--The Secretary of Health and Human Services
(in this subsection referred to as the ``Secretary'') shall
provide for the transfer from the Federal Supplementary Medical
Insurance Trust Fund under section 1841 of the Social Security
Act (42 U.S.C. 1395t) to the Centers for Medicare & Medicaid
Services Program Management Account of--
(A) $20,000,000 for each of fiscal years 2020
through 2025 for purposes of implementing the
amendments made by this section; and
(B) such sums as determined appropriate by the
Secretary for each subsequent fiscal year for purposes
of administering the provisions of such amendments.
(2) Availability and additional use of funds.--Funds
transferred pursuant to paragraph (1) shall remain available
until expended and may be used, in addition to the purpose
specified in paragraph (1)(A), to implement the amendments made
by sections 602 and 603.
SEC. 602. PROVIDING COVERAGE FOR HEARING CARE UNDER THE MEDICARE
PROGRAM.
(a) Provision of Aural Rehabilitation and Treatment Services by
Qualified Audiologists.--Section 1861(ll)(3) of the Social Security Act
(42 U.S.C. 1395x(ll)(3)) is amended by inserting ``(and, beginning
January 1, 2023, such aural rehabilitation and treatment services)''
after ``assessment services''.
(b) Coverage of Hearing Aids.--
(1) Inclusion of hearing aids as prosthetic devices.--
Section 1861(s)(8) of the Social Security Act (42 U.S.C.
1395x(s)(8)) is amended by inserting ``, and including hearing
aids furnished on or after January 1, 2023, to individuals
diagnosed with profound or severe hearing loss'' before the
semicolon at the end.
(2) Payment limitations for hearing aids.--Section 1834(h)
of the Social Security Act (42 U.S.C. 1395m(h)), as amended by
section 601(e)(2)(A), is further amended by adding at the end
the following new paragraph:
``(7) Limitations for hearing aids.--Payment may be made
under this part with respect to an individual, with respect to
hearing aids furnished on or after January 1, 2023--
``(A) not more than once during a 5-year period;
``(B) only for types of such hearing aids that are
not over-the-counter hearing aids (as defined in
section 520(q)(1) of the Federal Food, Drug, and
Cosmetic Act) and that are determined appropriate by
the Secretary; and
``(C) only if furnished pursuant to a written order
of a physician or qualified audiologist (as defined in
section 1861(ll)(4)(B)).''.
(3) Application of competitive acquisition.--
(A) In general.--Section 1834(h)(1)(H) of the
Social Security Act (42 U.S.C. 1395m(h)(1)(H)), as
amended by section 601(e)(2)(B)(i), is further
amended--
(i) in the header, by inserting ``, hearing
aids'' after ``dentures'';
(ii) by inserting ``, of hearing aids
described in paragraph (2)(E) of such
section,'' after ``paragraph (2)(D) of such
section''; and
(iii) in clause (i), by inserting ``, such
hearing aids'' after ``such dentures''.
(B) Conforming amendment.--
(i) In general.--Section 1847(a)(2) of the
Social Security Act (42 U.S.C. 1395w-3(a)(2)),
as amended by section 601(e)(2)(B)(ii), is
further amended by adding at the end the
following new subparagraph:
``(E) Hearing aids.--Hearing aids described in
section 1861(s)(8) for which payment would otherwise be
made under section 1834(h).''.
(ii) Exemption of certain items from
competitive acquisition.--Section 1847(a)(7) of
the Social Security Act (42 U.S.C. 1395w-
3(a)(7)), as amended by section
601(e)(2)(B)(iii), is further amended by adding
at the end the following new subparagraph:
``(D) Certain hearing aids.--Those items and
services described in paragraph (2)(E) if furnished by
a physician or other practitioner (as defined by the
Secretary) to the physician's or practitioner's own
patients as part of the physician's or practitioner's
professional service.''.
(4) Inclusion of audiologists as certain practitioners to
receive payment on an assignment-related basis.--Section
1842(b)(18)(C) of the Social Security Act (42 U.S.C.
1395u(b)(18)(C)), as amended by section 601(d)(4), is further
amended by adding at the end the following new clause:
``(viii) With respect to 2023 and each
subsequent year, a qualified audiologist (as
defined in section 1861(ll)(4)(B)).''.
(c) Exclusion Modification.--Section 1862(a)(7) of the Social
Security Act (42 U.S.C. 1395y(a)(7)) is amended by inserting ``(except
such hearing aids or examinations therefor as described in and
otherwise allowed under section 1861(s)(8))'' after ``hearing aids or
examinations therefor''.
(d) Certain Non-application.--
(1) In general.--The last sentence of section 1839(a)(1) of
the Social Security Act (42 U.S.C. 1395r(a)(1)), as added by
section 601(g)(1), is amended by striking ``section 601 (other
than subsection (g))'' and inserting ``sections 601 (other than
subsection (g)), 602 (other than subsection (d))''.
(2) Payment.--Paragraph (4) of section 1844(a) of such Act
(42 U.S.C. 1395w(a)), as added by section 601(g)(2), is amended
by striking ``section 601 (other than subsection (g))'' and
inserting ``sections 601 (other than subsection (g)), 602
(other than subsection (d))''.
(e) Report; Regulations.--
(1) Report.--Not later than the date that is 3 years after
the date of the enactment of this Act, the Inspector General of
the Department of Health and Human Services shall conduct a
study to assess (and submit to the Secretary of Health and
Human Services a report on) any program integrity or
overutilization risks with respect to allowing qualified
audiologists (as defined in paragraph (4)(B) of 1861(ll) of the
Social Security Act (42 U.S.C. 1395x(ll))) to furnish audiology
services (as defined in paragraph (3) of such section) to
individuals entitled to benefits under part A of title XVIII of
such Act (42 U.S.C. 1395c et seq.) and enrolled for benefits
under part B of such title (42 U.S.C.1395j et seq.) without
such individuals being referred by a physician (as defined in
section 1861(r) of such Act (42 U.S.C. 1395x(r))) or
practitioner (as described in section 602.32 of title 42, Code
of Federal Regulations) to such qualified audiologists. In
conducting such study, the Inspector General may take into
account experiences with audiologists furnishing audiology
services to enrollees in other Federal programs, including in a
health benefit plan under chapter 89 of title 5, United States
Code or in health care benefits under the TRICARE program under
chapter 55 of title 10 of the United States Code or under
chapter 17 of title 38 of such Code.
(2) Regulations.--The Secretary of Health and Human
Services may promulgate regulations to allow qualified
audiologists (as so defined) to furnish audiology services (as
so defined) without a referral from a physician or
practitioner, consistent with the findings submitted to the
Secretary pursuant to paragraph (1)(B).
(f) Implementation Funding.--
(1) In general.--The Secretary of Health and Human Services
(in this subsection referred to as the ``Secretary'') shall
provide for the transfer from the Federal Supplementary Medical
Insurance Trust Fund under section 1841 of the Social Security
Act (42 U.S.C. 1395t) to the Centers for Medicare & Medicaid
Services Program Management Account of--
(A) $20,000,000 for each of fiscal years 2020
through 2024 for purposes of implementing the
amendments made by this section; and
(B) such sums as determined appropriate by the
Secretary for each subsequent fiscal year for purposes
of administering the provisions of such amendments.
(2) Availability and additional use of funds.--Funds
transferred pursuant to paragraph (1) shall remain available
until expended and may be used, in addition to the purpose
specified in paragraph (1)(A), to implement the amendments made
by sections 601 and 603.
SEC. 603. PROVIDING COVERAGE FOR VISION CARE UNDER THE MEDICARE
PROGRAM.
(a) Coverage.--Section 1861(s)(2) of the Social Security Act (42
U.S.C. 1395x(s)(2)), as amended by section 601(a), is further amended--
(1) in subparagraph (HH), by striking ``and'' after the
semicolon at the end;
(2) in subparagraph (II), by striking the period at the end
and adding ``; and''; and
(3) by adding at the end the following new subparagraph:
``(JJ) vision services (as defined in subsection (lll));''.
(b) Vision Services Defined.--Section 1861 of the Social Security
Act (42 U.S.C. 1395x), as amended by section 601(b), is further amended
by adding at the end the following new subsection:
``(lll) Vision Services.--The term `vision services' means--
``(1) routine eye examinations to determine the refractive
state of the eyes, including procedures performed during the
course of such examination; and
``(2) contact lens fitting services;
furnished on or after January 1, 2023, by or under the direct
supervision of an optometrist or ophthalmologist who is legally
authorized to furnish such examinations, procedures, or fitting
services (as applicable) under State law (or the State regulatory
mechanism provided by State law) of the State in which the
examinations, procedures, or fitting services are furnished.''.
(c) Payment Limitations.--Section 1834 of the Social Security Act
(42 U.S.C. 1395m), as amended by section 601(c)(2), is further amended
by adding at the end the following new subsection:
``(y) Limitation for Vision Services.--With respect to vision
services (as defined in section 1861(lll)) and an individual, payment
may be made under this part for only 1 routine eye examination
described in paragraph (1) of such section and 1 contact lens fitting
service described in paragraph (2) of such section during a 2-year
period.''.
(d) Payment Under Physician Fee Schedule.--Section 1848(j)(3) of
the Social Security Act (42 U.S.C. 1395w-4(j)(3)), as amended by
section 601(d)(1), is further amended by inserting ``(2)(JJ),'' before
``(3)''.
(e) Coverage of Conventional Eyeglasses and Contact Lenses.--
Section 1861(s)(8) of the Social Security Act (42 U.S.C. 1395x(s)(8)),
as amended by section 602(b)(1), is further amended by striking ``, and
including one pair of conventional eyeglasses or contact lenses
furnished subsequent to each cataract surgery with insertion of an
intraocular lens'' and inserting ``, including one pair of conventional
eyeglasses or contact lenses furnished subsequent to each cataract
surgery with insertion of an intraocular lens, if furnished before
January 1, 2023, including conventional eyeglasses or contact lenses,
whether or not furnished subsequent to such a surgery, if furnished on
or after January 1, 2024''.
(f) Special Payment Rules for Eyeglasses and Contact Lenses.--
(1) Limitations.--Section 1834(h) of the Social Security
Act (42 U.S.C. 1395m(h)), as amended by section 601(e)(2)(A)
and section 602(b)(2), is further amended by adding at the end
the following new paragraph:
``(8) Payment limitations for eyeglasses and contact
lenses.--
``(A) In general.--With respect to eyeglasses and
contact lenses furnished to an individual on or after
January 1, 2023, subject to subparagraph (B), payment
may be made under this part only--
``(i) during a 2-year period, for either 1
pair of eyeglasses (including lenses and
frames) or not more than a 2-year supply of
contact lenses that is provided in not more
than 180-day increments;
``(ii) with respect to amounts attributable
to the lenses and frames of such a pair of
eyeglasses or amounts attributable to such a 2-
year supply of contact lenses, in an amount not
greater than--
``(I) for a pair of eyeglasses
furnished in, or a 2-year supply of
contact lenses beginning in, 2023--
``(aa) $85 for the lenses
of such pair of eyeglasses and
$85 for the frames of such pair
of eyeglasses; or
``(bb) $85 for such 2-year
supply of contact lenses; and
``(II) for the lenses and frames of
a pair of eyeglasses furnished in, or a
2-year supply of contact lenses
beginning in, a subsequent year, the
dollar amounts specified under this
subparagraph for the previous year,
increased by the percentage change 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;
``(iii) for types of eyeglass lenses, and
for types of contact lenses, as determined
appropriate by the Secretary;
``(iv) if furnished pursuant to a written
order of a physician described in section
1861(lll); and
``(v) if during the 2-year period described
in clause (i), the individual did not already
receive (as described in subparagraph (B)) one
pair of conventional eyeglasses or contact
lenses subsequent to a cataract surgery with
insertion of an intraocular lens furnished
during such period.
``(B) Exception.--With respect to a 2-year period
described in subparagraph (A)(i), in the case of an
individual who receives cataract surgery with insertion
of an intraocular lens, notwithstanding subparagraph
(A), payment may be made under this part for one pair
of conventional eyeglasses or contact lenses furnished
subsequent to such cataract surgery during such
period.''.
(2) Application of competitive acquisition.--
(A) In general.--Section 1834(h)(1)(H) of the
Social Security Act (42 U.S.C. 1395m(h)(1)(H)), as
amended by section 601(e)(2)(B)(i) and section
602(b)(3)(A), is further amended--
(i) in the header by inserting ``,
eyeglasses, and contact lenses'' after
``hearing aids'';
(ii) by inserting ``and of eyeglasses and
contact lenses described in paragraph (2)(F) of
such section,'' after ``paragraph (2)(E) of
such section,''; and
(iii) in clause (i), by inserting ``, or
such eyeglasses and contact lenses'' after
``such hearing aids''.
(B) Conforming amendment.--
(i) In general.--Section 1847(a)(2) of the
Social Security Act (42 U.S.C. 1395w-3(a)(2)),
as amended by section 601(e)(2)(B)(ii) and
section 602(b)(3)(B)(i), is further amended by
adding at the end the following new
subparagraph:
``(F) Eyeglasses and contact lenses.--Eyeglasses
and contact lenses described in section 1861(s)(8) for
which payment would otherwise be made under section
1834(h).''.
(ii) Exemption of certain items from
competitive acquisition.--Section 1847(a)(7) of
the Social Security Act (42 U.S.C. 1395w-
3(a)(7)), as amended by section
601(e)(2)(B)(iii) and section 602(b)(3)(B)(ii),
is further amended by adding at the end the
following new subparagraph:
``(E) Certain eyeglasses and contact lenses.--Those
items and services described in paragraph (2)(F) if
furnished by a physician or other practitioner (as
defined by the Secretary) to the physician's or
practitioner's own patients as part of the physician's
or practitioner's professional service.''.
(g) Exclusion Modifications.--Section 1862(a) of the Social
Security Act (42 U.S.C. 1395y(a)), as amended by section 601(f), is
further amended--
(1) in paragraph (1)--
(A) in subparagraph (P), by striking ``and'' at the
end;
(B) in subparagraph (Q), by striking the semicolon
at the end and inserting ``, and''; and
(C) by adding at the end the following new
subparagraph:
``(R) in the case of vision services (as defined in section
1861(lll)) that are routine eye examinations and contact lens
fitting services (as described in paragraph (1) or (2),
respectively, of such section), which are furnished more
frequently than once during a 2-year period;''; and
(2) in paragraph (7)--
(A) by inserting ``(other than such an examination
that is a vision service that is covered under section
1861(s)(2)(JJ))'' after ``eye examinations''; and
(B) by inserting ``(other than such a procedure
that is a vision service that is covered under section
1861(s)(2)(JJ))'' after ``refractive state of the
eyes''.
(h) Certain Non-application.--
(1) In general.--The last sentence of section 1839(a)(1) of
the Social Security Act (42 U.S.C. 1395r(a)(1)), as added by
section 601(g)(1) and amended by section 602(d)(1), is further
amended by inserting ``, and 603 (other than subsection (h))''
after ``602 (other than subsection (d))''.
(2) Payment.--Paragraph (4) of section 1844(a) of such Act
(42 U.S.C. 1395w(a)), as added by section 601(g)(2) and amended
by section 602(d)(2), is further amended by inserting ``, and
603 (other than subsection (h))'' after ``602 (other than
subsection (d))''.
(i) Implementation Funding.--
(1) In general.--The Secretary of Health and Human Services
(in this subsection referred to as the ``Secretary'') shall
provide for the transfer from the Federal Supplementary Medical
Insurance Trust Fund under section 1841 of the Social Security
Act (42 U.S.C. 1395t) to the Centers for Medicare & Medicaid
Services Program Management Account of--
(A) $20,000,000 for each of fiscal years 2020
through 2024 for purposes of implementing the
amendments made by this section; and
(B) such sums as determined appropriate by the
Secretary for each subsequent fiscal year for purposes
of administering the provisions of such amendments.
(2) Availability and additional use of funds.--Funds
transferred pursuant to paragraph (1) shall remain available
until expended and may be used, in addition to the purpose
specified in paragraph (1)(A), to implement the amendments made
by sections 601 and 602.
TITLE VII--NIH, FDA, AND OPIOIDS FUNDING
Subtitle A--Biomedical Innovation Expansion
SEC. 701. 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 2021, $255,400,000.
``(ii) For fiscal year 2022, $260,400,000.
``(iii) For fiscal year 2023, $163,400,000.
``(iv) For fiscal year 2024, $547,000,000.
``(v) For fiscal year 2025, $848,000,000.
``(vi) For fiscal year 2026, $842,400,000.
``(vii) For fiscal year 2027,
$1,089,600,000.
``(viii) For fiscal year 2028,
$1,115,600,000.
``(ix) For fiscal year 2029,
$1,170,600,000.
``(x) For fiscal year 2030, $1,207,600,000.
``(B) Supplemental funding for certain projects.--
Of the total amounts made available under subparagraph
(A) for each of fiscal years 2021 through 2030, 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 2021
and 2022, $50,000,000.
``(II) For fiscal year 2024,
$100,000,000.
``(III) For each of fiscal years
2025 and 2026, $300,000,000.
``(IV) For each of fiscal years
2027 through 2029, $317,000,000.
``(V) For fiscal year 2030,
$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 2021
and 2022, $50,000,000.
``(II) For fiscal year 2024,
$128,000,000.
``(III) For fiscal year 2025,
$209,000,000.
``(IV) For fiscal year 2026,
$100,000,000.
``(V) For fiscal year 2027,
$325,000,000.
``(VI) For fiscal year 2028,
$350,000,000.
``(VII) For fiscal year 2029,
$400,000,000.
``(VIII) For fiscal year 2030,
$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 2021 through 2030.
``(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 2021
through 2024, $100,000,000.
``(II) For each of fiscal years
2025 and 2026, $120,000,000.
``(III) For each of fiscal years
2027 through 2029, $125,000,000.
``(IV) For fiscal year 2030,
$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 2021,
$40,000,000.
``(II) For fiscal year 2022,
$45,000,000.
``(III) For fiscal year 2023,
$48,000,000.
``(IV) For each of fiscal years
2024 and 2025, $52,400,000.
``(V) For fiscal year 2026,
$55,800,000.
``(VI) For fiscal year 2027,
$56,000,000.
``(VII) For fiscal year 2028,
$57,000,000.
``(VIII) For each of fiscal years
2029 and 2030, $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)''; and
(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 2021 through 2030 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 ``2030''.
(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, 2030''.
SEC. 702. 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 or section 351 of this Act 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, $680,000,000 for each of fiscal years 2021 through
2025, 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. 703. INNOVATION NETWORK.
Part A of title IV of the Public Health Service Act (42 U.S.C. 281
et seq.), as amended by section 702, 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 2021 through 2025, to be available until expended.''.
Subtitle B--Investing in Safety and Innovation
SEC. 711. 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 2020, $417,500,000.
``(ii) For each of fiscal years 2021 and
2022, $157,500,000.
``(iii) For each of fiscal years 2023
through 2025, $152,500,000.
``(iv) For each of fiscal years 2026
through 2029, $202,500,000.
``(B) Supplemental funding for certain
activities.--Of the total amounts made available under
subparagraph (A) for each of fiscal years 2026 through
2029, 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 of the Federal Food, Drug, and
Cosmetic Act, as added by section 3073 of this 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 2020,
$180,000,000.
``(II) For each of fiscal years
2021 through 2029, $60,000.
``(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 2020
through 2029, $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 2020,
$50,000,000.
``(II) For each of fiscal years
2021 through 2029, $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 2020 through 2029, $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 2020 through 2029, $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 2020,
$112,500,000.
``(II) For each of fiscal years
2021 through 2029, $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 2020
through 2022, $10,000,000.
``(II) For each of fiscal years
2023 through 2029, $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 2020
through 2029, $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 2020 through 2029, $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 ``2030''.
(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. 712. 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--Opioid Epidemic Response
SEC. 721. OPIOID 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 opioid 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 $1,980,000,000 for each of
fiscal years 2021 through 2025.
(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 2021 through 2025, 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 722, $1,500,000,000 for each of fiscal
years 2021 through 2025.
(2) CDC.--For the Centers for Disease Control and
Prevention to carry out programs and activities pursuant to
section 723, $120,000,000 for each of fiscal years 2021 through
2025.
(3) FDA.--For the Food and Drug Administration to carry out
programs and activities pursuant to section 724, $10,000,000
for each of fiscal years 2021 through 2025.
(4) NIH.--For the National Institutes of Health to carry
out programs and activities pursuant to section 725,
$240,000,000 for each of fiscal years 2021 through 2025.
(5) HRSA.--For the Health Resources and Services
Administration to carry out programs and activities pursuant to
section 726, $90,000,000 for each of fiscal years 2021 through
2025.
(6) ACF.--For the Administration for Children and Families
to carry out programs and activities pursuant to section 727,
$20,000,000 for each of fiscal years 2021 through 2025.
(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 2021 through 2025 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 2022 through 2026, 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. 722. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.
(a) In General.--The entirety of the funds made available pursuant
to section 721(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
731(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. 723. CENTERS FOR DISEASE CONTROL AND PREVENTION.
(a) Addressing Opioid Use Disorder.--The entirety of the funds made
available pursuant to section 721(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
721(c)(2) for carrying out this section, not more than 20 percent may
be used for intramural purposes.
SEC. 724. FOOD AND DRUG ADMINISTRATION.
The entirety of the funds made available pursuant to section
721(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. 725. NATIONAL INSTITUTES OF HEALTH.
The entirety of the funds made available pursuant to section
721(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. 726. HEALTH RESOURCES AND SERVICES ADMINISTRATION.
The entirety of the funds made available pursuant to section
721(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. 727. ADMINISTRATION FOR CHILDREN AND FAMILIES.
Of the funds made available pursuant to section 721(c)(6) for each
of fiscal years 2021 through 2025, $20,000,000 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.).
Subtitle D--Reducing Administrative Costs and Burdens in Health Care
SEC. 731. REDUCING ADMINISTRATIVE COSTS AND BURDENS IN HEALTH CARE.
Title II of the Public Health Service Act (42 U.S.C. 202 et seq.)
is amended by adding at the end the following:
``PART E--REDUCING ADMINISTRATIVE COSTS AND BURDENS IN HEALTH CARE
``SEC. 281. ELIMINATING UNNECESSARY ADMINISTRATIVE BURDENS AND COSTS.
``(a) Reducing Administrative Burdens and Costs.--The Secretary, in
consultation with providers of health services, health care suppliers
of services, health care payers, health professional societies, health
vendors and developers, health care standard development organizations
and operating rule entities, health care quality organizations, health
care accreditation organizations, public health entities, States,
patients, and other appropriate entities, shall, in accordance with
subsection (b)--
``(1) establish a goal of reducing unnecessary costs and
administrative burdens across the health care system, including
the Medicare program under title XVIII of the Social Security
Act, the Medicaid program under title XIX of such Act, and the
private health insurance market, by at least half over a period
of 10 years from the date of enactment of this section;
``(2) develop strategies and benchmarks for meeting the
goal established under paragraph (1);
``(3) develop recommendations for meeting the goal
established under paragraph (1); and
``(4) take action to reduce unnecessary costs and
administrative burdens based on recommendations identified in
this subsection.
``(b) Strategies, Recommendations, and Actions.--
``(1) In general.--To achieve the goal established under
subsection (a)(1), the Secretary, in consultation with the
entities described in such subsection, shall not later than 1
year after the date of enactment of this section, develop
strategies and recommendations and take actions to meet such
goal in accordance with this subsection. No strategies,
recommendation, or action shall undermine the quality of
patient care or patient health outcomes.
``(2) Strategies.--The strategies developed under paragraph
(1) shall address unnecessary costs and administrative burdens.
Such strategies shall include broad public comment and shall
prioritize--
``(A) recommendations identified as a result of
efforts undertaken to implement section 3001;
``(B) recommendations and best practices identified
as a result of efforts undertaken under this part;
``(C) a review of regulations, rules, and
requirements of the Department of Health and Human
Services that could be modified or eliminated to reduce
unnecessary costs and administrative burden imposed on
patients, providers, payers, and other stakeholders
across the health care system; and
``(D) feedback from stakeholders in rural or
frontier areas on how to reduce unnecessary costs and
administrative burdens on the health care system in
those areas.
``(3) Recommendations.--The recommendations developed under
paragraph (1) shall include--
``(A) actions that improve the standardization and
automation of administrative transactions;
``(B) actions that integrate clinical and
administrative functions;
``(C) actions that improve patient care and reduce
unnecessary costs and administrative burdens borne by
patients, their families, and other caretakers;
``(D) actions that advance the development and
adoption of open application programming interfaces and
other emerging technologies to increase transparency
and interoperability, empower patients, and facilitate
better integration of clinical and administrative
functions;
``(E) actions to be taken by the Secretary and
actions that need to be taken by other entities; and
``(F) other areas, as the Secretary determines
appropriate, to reduce unnecessary costs and
administrative burdens required of health care
providers.
``(4) Consistency.--Any improvements in electronic
processes proposed by the Secretary under this section should
leverage existing information technology definitions under
Federal Law. Specifically, any electronic processes should not
be construed to include a facsimile, a proprietary payer portal
that does not meet standards specified by the Secretary, or an
electronic form image.
``(5) Actions.--The Secretary shall take action to achieve
the goal established under subsection (a)(1), and, not later
than 1 year after the date of enactment of this section, and
biennially thereafter, submit to Congress and make publically
available, a report describing the actions taken by the
Secretary pursuant to goals, strategies, and recommendations
described in this subsection.
``(6) FACA.--The Federal Advisory Committee Act (5 U.S.C.
App.) shall not apply to the development of the goal,
strategies, recommendations, or actions described in this
section.
``(7) Rule of construction.--Nothing in this subsection
shall be construed to authorize, or be used by, the Federal
Government to inhibit or otherwise restrain efforts made to
reduce waste, fraud, and abuse across the health care system.
``SEC. 282. GRANTS TO STATES TO DEVELOP AND IMPLEMENT RECOMMENDATIONS
TO ACCELERATE STATE INNOVATION TO REDUCE HEALTH CARE
ADMINISTRATIVE COSTS.
``(a) Grants.--
``(1) In general.--Not later than 6 months after the date
of enactment of this section, the Secretary shall award grants
to at least 15 States, and one coordinating entity designated
as provided for under subsection (e), to enable such States to
establish and administer private-public multi-stakeholder
commissions for the purpose of reducing health care
administrative costs and burden within and across States. Not
less than 3 of such grants shall be awarded to States that are
primarily rural, frontier, or a combination thereof, in nature.
``(2) Entities.--For purposes of this section, the term
`State' means a State, a State designated entity, or a multi-
State collaborative (as defined by the Secretary).
``(3) Priority.--In awarding grants under this section, the
Secretary shall give priority to applications submitted by
States that propose to carry out a pilot program or support the
adoption of electronic health care transactions and operating
rules.
``(b) Application.--
``(1) In general.--To be eligible to receive a grant under
subsection (a) a State shall submit to the Secretary an
application in such a manner and containing such information as
the Secretary may reasonably require, including the information
described in paragraph (2).
``(2) Required information.--In addition to any additional
information required by the Secretary under this subsection, an
application shall include a description of--
``(A) the size and composition of the commission to
be established under the grant, including the
stakeholders represented and the degree to which the
commission reflects important geographic and population
characteristics of the State;
``(B) the relationship of the commission to the
State official responsible for coordinating and
implementing the recommendations resulting from the
commission, and the role and responsibilities of the
State with respect to the commission, including any
participation, review, oversight, implementation or
other related functions;
``(C) the history and experience of the State in
addressing health care administrative costs, and any
experience similar to the purpose of the commission to
improve health care administrative processes and the
exchange of health care administrative data;
``(D) the resources and expertise that will be made
available to the commission by commission members or
other possible sources, and how Federal funds will be
used to leverage and complement these resources;
``(E) the governance structure and procedures that
the commission will follow to make, implement, and
pilot recommendations;
``(F) the proposed objectives relating to the
simplification of administrative transactions and
operating rules, increased standardization, and the
efficiency and effectiveness of the transmission of
health information;
``(G) potential cost savings and other improvements
in meeting the objectives described in subparagraph
(F); and
``(H) the method or methods by which the
recommendations described in subsection (c) will be
reviewed, tested, adopted, implemented, and updated as
needed.
``(c) Multi-Stakeholder Commission.--
``(1) In general.--Not later than 90 days after the date on
which a grant is awarded to a State under this section, the
State official described in subsection (b)(2)(B), the State
insurance commissioner, or other appropriate State official
shall convene a multi-stakeholder commission, in accordance
with this subsection.
``(2) Membership.--The commission convened under paragraph
(1) shall include representatives from health plans, health
care providers, health vendors, relevant State agencies, health
care standard development organizations, and operating rule
entities, relevant professional and trade associations,
patients, and other entities determined appropriate by the
State.
``(3) Recommendations.--Not later than one year after the
date on which a grant is awarded to a State under this section,
the commission shall make recommendations and plans, consistent
with the application submitted by the State under subsection
(b), and intended to meet the objectives defined in the
application. Such recommendations shall comply with, and build
upon, all relevant Federal requirements and regulations, and
may include--
``(A) common, uniform specifications, best
practices, and conventions, for the efficient,
effective exchange of administrative transactions
adopted pursuant to the Health Insurance Portability
and Accountability Act of 1996 (Public Law 104-191);
``(B) the development of streamlined business
processes for the exchange and use of health care
administrative data; and
``(C) specifications, incentives, requirements,
tools, mechanisms, and resources to improve--
``(i) the access, exchange, and use of
health care administrative information through
electronic means;
``(ii) the implementation of utilization
management protocols; and
``(iii) compliance with Federal and State
laws.
``(d) Use of Funds for Implementation.--A State may use amounts
received under a grant under this section for one or more of the
following:
``(1) The development, implementation, and best use of
shared data infrastructure that supports the electronic
transmission of administrative data.
``(2) The development and provision of training and
educational materials, forums, and activities as well as
technical assistance to effectively implement, use, and benefit
from electronic health care transactions and operating rules.
``(3) To accelerate the early adoption and implementation
of administrative transactions and operating rules designated
by the Secretary and that have been adopted pursuant to the
Health Insurance Portability and Accountability Act of 1996
(Public Law 104-191), including transactions and operating
rules described in section 1173(a)(2) of the Social Security
Act.
``(4) To accelerate the early adoption and implementation
of additional or updated administrative transactions, operating
rules, and related data exchange standards that are being
considered for adoption under the Health Insurance Portability
and Accountability Act of 1996 or are adopted pursuant to such
Act, or as designated by the Secretary, including the
electronic claim attachment.
``(5) To conduct pilot projects to test approaches to
implement and use the electronic health care transactions and
operating rules in practice under a variety of different
settings. With respect to the electronic attachment
transaction, priority shall be given to pilot projects that
test and evaluate methods and mechanisms to most effectively
incorporate patient health data from electronic health records
and other electronic sources with the electronic attachment
transaction.
``(6) To assess barriers to the adoption, implementation,
and effective use of electronic health care transactions and
operating rules, as well as to explore, identify, and plan
options, approaches, and resources to address barriers and make
improvements.
``(7) The facilitation of public and private initiatives to
reduce administrative costs and accelerate the adoption,
implementation, and effective use of electronic health care
transactions and operating rules for State programs.
``(8) Developing, testing, implementing, and assessing
additional data exchange specifications, operating rules,
incentives, requirements, tools, mechanisms, and resources to
accelerate the adoption and effective use of the transactions
and operating rules.
``(9) Ongoing needs assessments and planning related to the
development and implementation of administrative simplification
initiatives.
``(e) Coordinating Entity.--
``(1) Functions.--Not later than 6 months after the date of
enactment of this section, the Secretary shall designate a
coordinating entity under this subsection for the purpose of--
``(A) providing technical assistance to States
relating to the simplification of administrative
transactions and operating rules, increased
standardization, and the efficiency and effectiveness
of the transmission of health care information;
``(B) evaluating pilot projects and other efforts
conducted under this section for impact and best
practices to inform broader national use;
``(C) using consistent evaluation methodologies to
compare return on investment across efforts conducted
under this section;
``(D) compiling, synthesizing, disseminating, and
adopting lessons learned to promote the adoption of
electronic health care transactions and operating rules
across the health care system; and
``(E) making recommendations to the Secretary and
the National Committee on Vital and Health Statistics
regarding the national adoption of efforts conducted
under this section.
``(2) Eligibility.--The entity designated under paragraph
(1) shall be a qualified nonprofit entity that--
``(A) focuses its mission on administrative
simplification;
``(B) has demonstrated experience using a multi-
stakeholder and consensus-based process for the
development of common, uniform specifications,
operating rules, best practices, and conventions, for
the efficient, effective exchange of administrative
transactions that includes representation by or
participation from health plans, health care providers,
vendors, States, relevant Federal agencies, and other
health care standard development organizations;
``(C) has demonstrated experience providing
technical assistance to health plans, health care
providers, vendors, and States relating to the
simplification of administrative transactions and
operating rules, increased standardization, and the
efficiency and effectiveness of the transmission of
health care information;
``(D) has demonstrated experience evaluating and
measuring the adoption and return on investment of
administrative transactions and operating rules;
``(E) has demonstrated experience gathering,
synthesizing, and adopting common, uniform
specifications, operating rules, best practices, and
conventions for national use based on lessons learned
to promote the adoption of electronic health care
transactions and operating rules across the health care
system;
``(F) has a public set of guiding principles that
ensure processes are open and transparent, and supports
nondiscrimination and conflict of interest policies
that demonstrate a commitment to open, fair, and
nondiscriminatory practices;
``(G) builds on the transaction standards issued
under Health Insurance Portability and Accountability
Act of 1996; and
``(H) allows for public review and updates of
common, uniform specifications, operating rules, best
practices, and conventions to support administrative
simplification.
``(f) Period and Amount.--A grant awarded to a State under this
section shall be for a period of 5 years and shall not exceed
$50,000,000 for such 5-year period. A grant awarded to the coordinating
entity designated by the Secretary under subsection (e) shall be for a
period of 5 years and shall not exceed $15,000,000 for such 5-year
period.
``(g) Reports.--
``(1) States.--Not later than 1 year after receiving a
grant under this section, and biennially thereafter, a State
shall submit to the Secretary a report on the outcomes
experienced by the State under the grant.
``(2) Coordinating entity.--Not later than 1 year after
receiving a grant under this section, and at least biennially
thereafter, the coordinating entity shall submit to the
Secretary and the National Committee on Vital and Health
Statistics a report of evaluations conducted under the grant
under this section and recommendations regarding the national
adoption of efforts conducted under this section.
``(3) Secretary.--Not later than 6 months after the date on
which the States and coordinating entity submit the report
required under paragraphs (1) and (2), the Secretary, in
consultation with National Committee on Vital and Health
Statistics, shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report on the
outcomes achieved under the grants under this section.
``(4) GAO.--Not later than 6 months after the date on which
the Secretary submits the final report under paragraph (3), the
Comptroller General of the United States shall conduct a study,
and submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives, a report on the outcomes of
the activities carried out under this section which shall
contain a list of best practices and recommendations to States
concerning administrative simplification.
``(h) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $250,000,000 for the 5-fiscal-
year period beginning with fiscal year 2020.''.
TITLE VIII--MISCELLANEOUS
SEC. 801. GUARANTEED ISSUE OF CERTAIN MEDIGAP POLICIES.
(a) Guaranteed Issue of Medigap Policies to All Medigap-Eligible
Medicare Beneficiaries.--
(1) In general.--Section 1882(s) of the Social Security Act
(42 U.S.C. 1395ss(s)) is amended--
(A) in paragraph (2)(A), by striking ``65 years of
age or older and is enrolled for benefits under part
B'' and inserting ``entitled to, or enrolled for,
benefits under part A and enrolled for benefits under
part B'';
(B) in paragraph (2)(D), by striking ``who is 65
years of age or older as of the date of issuance and'';
(C) in paragraph (3)(B)(ii), by striking ``is 65
years of age or older and''; and
(D) in paragraph (3)(B)(vi), by striking ``at age
65''.
(2) Additional enrollment period for certain individuals.--
(A) One-time enrollment period.--
(i) In general.--In the case of a specified
individual, the Secretary shall establish a
one-time enrollment period described in clause
(iii) during which such an individual may
enroll in any medicare supplemental policy of
the individual's choosing.
(ii) Application.--The provisions of--
(I) paragraph (2) of section
1882(s) of the Social Security Act (42
U.S.C. 1395ss(s)) shall apply with
respect to a specified individual who
is described in subclause (I) of
subparagraph (B)(iii) as if references
in such paragraph (2) to the 6 month
period described in subparagraph (A) of
such paragraph were references to the
one-time enrollment period established
under clause (i); and
(II) paragraph (3) of such section
shall apply with respect to a specified
individual who is described in
subclause (II) of subparagraph (B)(iii)
as if references in such paragraph (3)
to the period specified in subparagraph
(E) of such paragraph were references
to the one-time enrollment period
established under clause (i).
(iii) Period.--The enrollment period
established under clause (i) shall be the 6-
month period beginning on January 1, 2024.
(B) Specified individual.--For purposes of this
paragraph, the term ``specified individual'' means an
individual who--
(i) is entitled to hospital insurance
benefits under part A of title XVIII of the
Social Security Act (42 U.S.C. 1395c et seq.)
pursuant to section 226(b) or section 226A of
such Act (42 U.S.C. 426(b); 426-1);
(ii) is enrolled for benefits under part B
of such Act (42 U.S.C. 1395j et seq.); and
(iii)(I) would not, but for the amendments
made by subparagraphs (A) and (B) of paragraph
(1) and the provisions of this paragraph (if
such provisions applied to such individual), be
eligible for the guaranteed issue of a medicare
supplemental policy under paragraph (2) of
section 1882(s) of such Act (42 U.S.C.
1395ss(s)); or
(II) would not, but for the amendments made
by subparagraphs (C) and (D) of paragraph (1)
and the provisions of this paragraph (if such
provisions applied to such individual), be
eligible for the guaranteed issue of a medicare
supplemental policy under paragraph (3) of such
section.
(C) Outreach plan.--
(i) In general.--The Secretary shall
develop an outreach plan to notify specified
individuals of the one-time enrollment period
established under subparagraph (A).
(ii) Consultation.--In implementing the
outreach plan developed under clause (i), the
Secretary shall consult with consumer
advocates, brokers, insurers, the National
Association of Insurance Commissioners, and
State Health Insurance Assistance Programs.
(3) Effective date.--The amendments made by paragraph (1)
shall apply to medicare supplemental policies effective on or
after January 1, 2024.
(b) Guaranteed Issue of Medigap Policies for Medicare Advantage
Enrollees.--
(1) In general.--Section 1882(s)(3) of the Social Security
Act (42 U.S.C. 1395ss(s)(3)), as amended by subsection (a), is
further amended--
(A) in subparagraph (B), by adding at the end the
following new clause:
``(vii) The individual--
``(I) was enrolled in a Medicare Advantage plan
under part C for not less than 12 months;
``(II) subsequently disenrolled from such plan;
``(III) elects to receive benefits under this title
through the original Medicare fee-for-service program
under parts A and B; and
``(IV) has not previously elected to receive
benefits under this title through the original Medicare
fee-for-service program pursuant to disenrollment from
a Medicare Advantage plan under part C.'';
(B) by striking subparagraph (C)(iii) and inserting
the following:
``(iii) Subject to subsection (v)(1), for purposes of an individual
described in clause (vi) or (vii) of subparagraph (B), a medicare
supplemental policy described in this subparagraph shall include any
medicare supplemental policy.''; and
(C) in subparagraph (E)--
(i) in clause (iv), by striking ``and'' at
the end;
(ii) in clause (v), by striking the period
at the end and inserting ``; and''; and
(iii) by adding at the end the following
new clause--
``(vi) in the case of an individual described in
subparagraph (B)(vii), the annual, coordinated election period
(as defined in section 1851(e)(3)(B)) or a continuous open
enrollment period (as defined in section 1851(e)(2)) during
which the individual disenrolls from a Medicare Advantage plan
under part C.''.
(2) Effective date.--The amendments made by paragraph (1)
shall apply to medicare supplemental policies effective on or
after January 1, 2024.
SEC. 802. REPORTING REQUIREMENTS FOR PDP SPONSORS REGARDING POINT-OF-
SALE REJECTIONS UNDER MEDICARE PART D.
Section 1860D-4(g) of the Social Security Act (42 U.S.C. 1395w-
104(g)) is amended by adding at the end the following new paragraph:
``(3) Reporting requirements regarding point-of-sale
rejections.--
``(A) In general.--With respect to a plan year
beginning on or after January 1, 2020, a PDP sponsor
offering a prescription drug plan shall submit to the
Secretary, in a form and manner specified by the
Secretary, information on point-of-sale rejections made
during a period of time occurring in such plan year (as
specified by the Secretary), including each of the
following:
``(i) The reason for each point-of-sale
rejection.
``(ii) Identifying information for each
drug with respect to which a point-of-sale
rejection was made.
``(iii) With respect to applicable types of
point-of-sale rejections (as specified by the
Secretary), each of the following:
``(I) Whether such a rejection was
consistent with the formulary of the
plan (as approved by the Secretary).
``(II) Whether a coverage
determination or appeal of a coverage
determination was requested for the
drug with respect to which such a
rejection was made.
``(III) The outcome of any such
coverage determination or appeal of a
coverage determination.
``(IV) The length of time between
when such a rejection was made and when
the drug with respect to which such
rejection was made is dispensed, as
applicable.
``(B) Public availability of information.--The
Secretary shall make publicly available on the public
website of the Centers for Medicare & Medicaid Services
information submitted under subparagraph (A).
``(C) Use of information.--The Secretary may use
information submitted under subparagraph (A), as
determined appropriate, in developing measures for the
5-star rating system under section 1853(o)(4).
``(D) Implementation.--Notwithstanding any other
provision of law, the Secretary may implement this
paragraph through program instruction or otherwise.
``(E) Funding.--The are authorized to be
appropriated to the Secretary from the Federal
Supplementary Medical Insurance Trust Fund under
section 1841 such sums as may be necessary to implement
this paragraph.''.
SEC. 803. PROVIDING ACCESS TO ANNUAL MEDICARE NOTIFICATIONS IN MULTIPLE
LANGUAGES.
(a) In General.--Section 1804 of the Social Security Act (42 U.S.C.
1395b-2) is amended by adding at the end the following new subsection:
``(e) The notice provided under subsection (a) shall be translated
into languages in addition to English and Spanish. In carrying out the
previous sentence, the Secretary shall prioritize translation of the
notice into languages in which documents provided by the Commissioner
of Social Security are translated and language that are the most
frequently requested for translation for purposes of applying for old-
age insurance benefits under title II.''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to notices distributed prior to each Medicare open enrollment
period beginning after January 1, 2020.
SEC. 804. TEMPORARY INCREASE IN MEDICARE PART B PAYMENT FOR CERTAIN
BIOSIMILAR BIOLOGICAL PRODUCTS.
Section 1847A(b)(8) of the Social Security Act (42 U.S.C. 1395w-
3a(b)(8)) is amended--
(1) by redesignating subparagraphs (A) and (B) as clauses
(i) and (ii), respectively, and moving the margin of each such
redesignated clause 2 ems to the right;
(2) by striking ``product.--The amount'' and inserting the
following: ``product.--
``(A) In general.--Subject to subparagraph (B), the
amount''; and
(3) by adding at the end the following new subparagraph:
``(B) Temporary payment increase.--
``(i) In general.--In the case of a
qualifying biosimilar biological product that
is furnished during the applicable 5-year
period for such product, the amount specified
in this paragraph for such product with respect
to such period is the sum determined under
subparagraph (A), except that clause (ii) of
such subparagraph shall be applied by
substituting `8 percent' for `6 percent'.
``(ii) Applicable 5-year period.--For
purposes of clause (i), the applicable 5-year
period for a biosimilar biological product is--
``(I) in the case of such a product
for which payment was made under this
paragraph as of December 31, 2019, the
5-year period beginning on January 1,
2020; and
``(II) in the case of such a
product for which payment is first made
under this paragraph during a calendar
quarter during the period beginning
January 1, 2020, and ending December
31, 2024, the 5-year period beginning
on the first day of such calendar
quarter during which such payment is
first made.
``(iii) Qualifying biosimilar biological
product defined.--For purposes of this
subparagraph, the term `qualifying biosimilar
biological product' means a biosimilar
biological product described in paragraph
(1)(C) with respect to which--
``(I) in the case of a product
described in clause (ii)(I), the
average sales price is not more than
the average sales price for the
reference biological product; and
``(II) in the case of a product
described in clause (ii)(II), the
wholesale acquisition cost is not more
than the wholesale acquisition cost for
the reference biological product.''.
SEC. 805. WAIVING MEDICARE COINSURANCE FOR COLORECTAL CANCER SCREENING
TESTS.
Section 1833(a) of the Social Security Act (42 U.S.C. 1395l(a)) is
amended--
(1) in the second sentence, by striking ``section 1834(0)''
and inserting ``section 1834(o)'';
(2) by moving such second sentence 2 ems to the left; and
(3) by inserting the following third sentence following
such second sentence: ``For services furnished on or after
January 1, 2021, paragraph (1)(Y) shall apply with respect to a
colorectal cancer screening test regardless of the code that is
billed for the establishment of a diagnosis as a result of the
test, or for the removal of tissue or other matter or other
procedure that is furnished in connection with, as a result of,
and in the same clinical encounter as the screening test.''.
SEC. 806. MEDICARE COVERAGE OF CERTAIN LYMPHEDEMA COMPRESSION TREATMENT
ITEMS.
(a) Coverage.--
(1) In general.--Section 1861 of the Social Security Act
(42 U.S.C. 1395x), as amended by section 601 and section 603,
is further amended--
(A) in subsection (s)(2)--
(i) in subparagraph (II), by striking
``and'' after the semicolon at the end;
(ii) in subparagraph (JJ), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end the following
new subparagraph:
``(KK) lymphedema compression treatment items (as defined
in subsection (mmm));''; and
(B) by adding at the end the following new
subsection:
``(mmm) Lymphedema Compression Treatment Items.--The term
`lymphedema compression treatment items' means compression garments,
devices, bandaging systems, components, and supplies, including
multilayer compression bandaging systems, standard fit gradient
compression garments, and other compression garments, devices,
bandaging systems, components, or supplies (as determined by the
Secretary), that are--
``(1) furnished on or after January 1, 2022, to an
individual with a diagnosis of lymphedema for the treatment of
such condition;
``(2) primarily and customarily used in the medical
treatment of lymphedema, as determined by the Secretary; and
``(3) prescribed by a physician (or a physician assistant,
nurse practitioner, or a clinical nurse specialist (as those
terms are defined in section 1861(aa)(5)) to the extent
authorized under State law).''.
(2) Payment.--
(A) In general.--Section 1833(a)(1) of the Social
Security Act (42 U.S.C. 1395l(a)(1)), as amended by
section 601(c)(1), is further amended--
(i) by striking ``and'' before ``(DD)'';
and
(ii) by inserting before the semicolon at
the end the following: ``, and (EE) with
respect to lymphedema compression treatment
items (as defined in section 1861(mmm)), the
amount paid shall be equal to 80 percent of the
lesser of the actual charge or the amount
determined under the payment basis determined
under section 1834(z)''.
(B) Payment basis and limitations.--Section 1834 of
the Social Security Act (42 U.S.C. 1395m), as amended
by sections 601(c)(2) and 603(c), is further amended by
adding at the end the following new subsection:
``(z) Payment for Lymphedema Compression Treatment Items.--
``(1) In general.--The Secretary shall determine an
appropriate payment basis for lymphedema compression treatment
items (as defined in section 1861(mmm)). In making such a
determination, the Secretary may take into account payment
rates for such items under State plans (or waivers of such
plans) under title XIX, the Veterans Health Administration, and
group health plans and health insurance coverage (as such terms
are defined in section 2791 of the Public Health Service Act),
and such other information as the Secretary determines
appropriate.
``(2) Frequency limitation.--No payment may be made under
this part for lymphedema compression treatment items furnished
other than at such frequency as the Secretary may establish.
``(3) Application of competitive acquisition.--In the case
of lymphedema compression treatment items that are included in
a competitive acquisition program in a competitive acquisition
area under section 1847(a)--
``(A) the payment basis under this subsection for
such items furnished in such area shall be the payment
basis determined under such competitive acquisition
program; and
``(B) the Secretary may use information on the
payment determined under such competitive acquisition
programs to adjust the payment amount otherwise
determined under this subsection for an area that is
not a competitive acquisition area under section 1847,
and in the case of such adjustment, paragraphs (8) and
(9) of section 1842(b) shall not be applied.''.
(3) Conforming amendments.--
(A) Exclusions.--Section 1862(a)(1) of the Social
Security Act (42 U.S.C. 1395y(a)(1)), as amended by
section 601(f) and section 603(g), is further amended--
(i) in subparagraph (Q), by striking
``and'' at the end;
(ii) in subparagraph (R), by striking the
semicolon and inserting ``, and''; and
(iii) by adding at the end the following
new subparagraph:
``(S) in the case of lymphedema compression treatment items
(as defined in section 1861(mmm)), which are furnished more
frequently than is established pursuant to section
1834(z)(2);''.
(B) Application of competitive acquisition.--
(i) In general.--Section 1847(a)(2) of the
Social Security Act (42 U.S.C. 1395w-3(a)(2)),
as amended by sections 601(e)(2)(B)(ii),
602(b)(3)(B)(i), and 603(f)(2)(B), is further
amended by adding at the end the following new
subparagraph:
``(G) Lymphedema compression treatment items.--
Lymphedema compression treatment items (as defined in
section 1861(mmm)) for which payment would otherwise be
made under section 1834(z).''.
(b) Inclusion in Requirements for Suppliers of Medical Equipment
and Supplies.--Section 1834(j)(5) of the Social Security Act (42 U.S.C.
1395m(j)(5)) is amended--
(1) by redesignating subparagraphs (E) and (F) as
subparagraphs (F) and (G), respectively; and
(2) by inserting after subparagraph (D) the following new
subparagraph:
``(E) lymphedema compression treatment items (as
defined in section 1861(mmm));''.
(c) Study and Report on Implementation.--
(1) Study.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall conduct a
study on the implementation of Medicare coverage of certain
lymphedema compression treatment items under the amendments
made by this Act. Such study shall include an evaluation of the
following:
(A) Medicare beneficiary utilization of items and
services under parts A and B of title XVIII of the
Social Security Act as a result of the implementation
of such amendments.
(B) Whether the Secretary has determined, pursuant
to section 1861(mmm) of the Social Security Act, as
added by subsection (a)(1), that lymphedema compression
treatment items other than compression bandaging
systems and standard fit gradient compression garments
are covered under such section.
(2) Report.--Not later than January 1, 2024, the Secretary
shall submit to Congress and make available to the public a
report on the study conducted under paragraph (1).
SEC. 807. PHYSICIAN FEE UPDATE.
Section 1848(d)(19) of the Social Security Act (42 U.S.C. 1395w-
4(d)(19)) is amended to read as follows:
``(19) Update for 2020 through 2025.--The update to the
single conversion factor established in paragraph (1)(C)--
``(A) for each of 2020 through 2022 shall be 0.5
percent; and
``(B) for each of 2023 through 2025 shall be 0.0
percent.''.
SEC. 808. ADDITIONAL COMMUNITY HEALTH CENTER FUNDING.
Section 10503 of the Patient Protection and Affordable Care Act (42
U.S.C. 254b-2) is amended by striking subsection (c) and inserting the
following:
``(c) Additional Enhanced Funding; Capital Projects.--There is
authorized to be appropriated, and there is appropriated, out of any
monies in the Treasury not otherwise appropriated, to the CHC Fund--
``(1) to be transferred to the Secretary of Health and
Human Services to provide additional enhanced funding for the
community health center program under section 330 of the Public
Health Service Act, $1,000,000,000 for each of fiscal years
2021 through 2025; and
``(2) to be transferred to the Secretary of Health and
Human Services for capital projects of the community health
center program under section 330 of the Public Health Service
Act, $5,000,000,000 for the period of fiscal years 2021 through
2025.''.
SEC. 809. GRANTS TO IMPROVE TRAUMA SUPPORT SERVICES AND MENTAL HEALTH
CARE FOR CHILDREN AND YOUTH IN EDUCATIONAL SETTINGS.
(a) Grants, Contracts, and Cooperative Agreements Authorized.--The
Secretary, in coordination with the Assistant Secretary for Mental
Health and Substance Use, is authorized to award grants to, or enter
into contracts or cooperative agreements with, State educational
agencies, local educational agencies, Indian Tribes (as defined in
section 4 of the Indian Self-Determination and Education Assistance
Act) or their tribal educational agencies, a school operated by the
Bureau of Indian Education, a Regional Corporation, or a Native
Hawaiian educational organization, for the purpose of increasing
student access to evidence-based trauma support services and mental
health care by developing innovative initiatives, activities, or
programs to link local school systems with local trauma-informed
support and mental health systems, including those under the Indian
Health Service.
(b) Duration.--With respect to a grant, contract, or cooperative
agreement awarded or entered into under this section, the period during
which payments under such grant, contract, or agreement are made to the
recipient may not exceed 4 years.
(c) Use of Funds.--An entity that receives a grant, contract, or
cooperative agreement under this section shall use amounts made
available through such grant, contract, or cooperative agreement for
evidence-based activities, which shall include any of the following:
(1) Collaborative efforts between school-based service
systems and trauma-informed support and mental health service
systems to provide, develop, or improve prevention, screening,
referral, and treatment and support services to students, such
as providing trauma screenings to identify students in need of
specialized support.
(2) To implement schoolwide positive behavioral
interventions and supports, or other trauma-informed models of
support.
(3) To provide professional development to teachers,
teacher assistants, school leaders, specialized instructional
support personnel, and mental health professionals that--
(A) fosters safe and stable learning environments
that prevent and mitigate the effects of trauma,
including through social and emotional learning;
(B) improves school capacity to identify, refer,
and provide services to students in need of trauma
support or behavioral health services; or
(C) reflects the best practices for trauma-informed
identification, referral, and support developed by the
Interagency Task Force on Trauma-Informed Care.
(4) Services at a full-service community school that
focuses on trauma-informed supports, which may include a full-
time site coordinator, or other activities consistent with
section 4625 of the Elementary and Secondary Education Act of
1965 (20 U.S.C. 7275).
(5) Engaging families and communities in efforts to
increase awareness of child and youth trauma, which may include
sharing best practices with law enforcement regarding trauma-
informed care and working with mental health professionals to
provide interventions, as well as longer term coordinated care
within the community for children and youth who have
experienced trauma and their families.
(6) To provide technical assistance to school systems and
mental health agencies.
(7) To evaluate the effectiveness of the program carried
out under this section in increasing student access to
evidence-based trauma support services and mental health care.
(8) To establish partnerships with or provide subgrants to
Head Start agencies (including Early Head Start agencies),
public and private preschool programs, child care programs
(including home-based providers), or other entities described
in subsection (a), to include such entities described in this
paragraph in the evidence-based trauma initiatives, activities,
support services, and mental health systems established under
this section in order to provide, develop, or improve
prevention, screening, referral, and treatment and support
services to young children and their families.
(d) Applications.--To be eligible to receive a grant, contract, or
cooperative agreement under this section, an entity described in
subsection (a) shall submit an application to the Secretary at such
time, in such manner, and containing such information as the Secretary
may reasonably require, which shall include the following:
(1) A description of the innovative initiatives,
activities, or programs to be funded under the grant, contract,
or cooperative agreement, including how such program will
increase access to evidence-based trauma support services and
mental health care for students, and, as applicable, the
families of such students.
(2) A description of how the program will provide
linguistically appropriate and culturally competent services.
(3) A description of how the program will support students
and the school in improving the school climate in order to
support an environment conducive to learning.
(4) An assurance that--
(A) persons providing services under the grant,
contract, or cooperative agreement are adequately
trained to provide such services; and
(B) teachers, school leaders, administrators,
specialized instructional support personnel,
representatives of local Indian Tribes or tribal
organizations as appropriate, other school personnel,
and parents or guardians of students participating in
services under this section will be engaged and
involved in the design and implementation of the
services.
(5) A description of how the applicant will support and
integrate existing school-based services with the program in
order to provide mental health services for students, as
appropriate.
(6) A description of the entities in the community with
which the applicant will partner or to which the applicant will
provide subgrants in accordance with subsection (c)(8).
(e) Interagency Agreements.--
(1) Local interagency agreements.--To ensure the provision
of the services described in subsection (c), a recipient of a
grant, contract, or cooperative agreement under this section,
or their designee, shall establish a local interagency
agreement among local educational agencies, agencies
responsible for early childhood education programs, Head Start
agencies (including Early Head Start agencies), juvenile
justice authorities, mental health agencies, child welfare
agencies, and other relevant agencies, authorities, or entities
in the community that will be involved in the provision of such
services.
(2) Contents.--In ensuring the provision of the services
described in subsection (c), the local interagency agreement
shall specify with respect to each agency, authority, or entity
that is a party to such agreement--
(A) the financial responsibility for the services;
(B) the conditions and terms of responsibility for
the services, including quality, accountability, and
coordination of the services; and
(C) the conditions and terms of reimbursement among
such agencies, authorities, or entities, including
procedures for dispute resolution.
(f) Evaluation.--The Secretary shall reserve not more than 3
percent of the funds made available under subsection (l) for each
fiscal year to--
(1) conduct a rigorous, independent evaluation of the
activities funded under this section; and
(2) disseminate and promote the utilization of evidence-
based practices regarding trauma support services and mental
health care.
(g) Distribution of Awards.--The Secretary shall ensure that
grants, contracts, and cooperative agreements awarded or entered into
under this section are equitably distributed among the geographical
regions of the United States and among tribal, urban, suburban, and
rural populations.
(h) Rule of Construction.--Nothing in this section shall be
construed--
(1) to prohibit an entity involved with a program carried
out under this section from reporting a crime that is committed
by a student to appropriate authorities; or
(2) to prevent Federal, State, and tribal law enforcement
and judicial authorities from exercising their responsibilities
with regard to the application of Federal, tribal, and State
law to crimes committed by a student.
(i) Supplement, Not Supplant.--Any services provided through
programs carried out under this section shall supplement, and not
supplant, existing mental health services, including any special
education and related services provided under the Individuals with
Disabilities Education Act (20 U.S.C. 1400 et seq.).
(j) Consultation With Indian Tribes.--In carrying out subsection
(a), the Secretary shall, in a timely manner, meaningfully consult with
Indian Tribes and their representatives to ensure notice of
eligibility.
(k) Definitions.--In this section:
(1) Elementary school.--The term ``elementary school'' has
the meaning given such term in section 8101 of the Elementary
and Secondary Education Act of 1965 (20 U.S.C. 7801).
(2) Evidence-based.--The term ``evidence-based'' has the
meaning given such term in section 8101(21)(A)(i) of the
Elementary and Secondary Education Act of 1965 (20 U.S.C.
7801(21)(A)(i)).
(3) Native hawaiian educational organization.--The term
``Native Hawaiian educational organization'' has the meaning
given such term in section 6207 of the Elementary and Secondary
Education Act of 1965 (20 U.S.C. 7517).
(4) Local educational agency.--The term ``local educational
agency'' has the meaning given such term in section 8101 of the
Elementary and Secondary Education Act of 1965 (20 U.S.C.
7801).
(5) Regional corporation.--The term ``Regional
Corporation'' has the meaning given the term in section 3 of
the Alaska Native Claims Settlement Act (43 U.S.C. 1602).
(6) School.--The term ``school'' means a public elementary
school or public secondary school.
(7) School leader.--The term ``school leader'' has the
meaning given such term in section 8101 of the Elementary and
Secondary Education Act of 1965 (20 U.S.C. 7801).
(8) Secondary school.--The term ``secondary school'' has
the meaning given such term in section 8101 of the Elementary
and Secondary Education Act of 1965 (20 U.S.C. 7801).
(9) Secretary.--The term ``Secretary'' means the Secretary
of Education.
(10) Specialized instructional support personnel.--The term
``specialized instructional support personnel'' has the meaning
given such term in section 8101 of the Elementary and Secondary
Education Act of 1965 (20 U.S.C. 7801).
(11) State educational agency.--The term ``State
educational agency'' has the meaning given such term in section
8101 of the Elementary and Secondary Education Act of 1965 (20
U.S.C. 7801).
(l) Authorization of Appropriations.--There is authorized to be
appropriated, and there is appropriated, out of any money in the
Treasury not otherwise appropriated, to carry out this section,
$20,000,000 for each of fiscal years 2021 through 2025.
SEC. 810. PATHWAY TO HEALTH CAREERS ACT.
(a) Short Title.--This section may be cited as the ``Pathways to
Health Careers Act''.
(b) Extension Through Fiscal Year 2020 of Funding for Demonstration
Projects to Address Health Professions Workforce Needs.--
(1) In general.--Section 2008(c)(1) of the Social Security
Act (42 U.S.C. 1397g(c)(1)) is amended by striking ``2019.''
and inserting ``2020, and to provide technical assistance and
cover administrative costs associated with implementing the
successor to this section $15,000,000 for fiscal year 2020.''.
(2) Availability of other funds.--Upon the date of the
enactment of this section--
(A) amounts expended pursuant to section 1501 of
division B of Public Law 116-59, or any other prior law
making amounts available for fiscal year 2020 for
activities authorized by section 2008 of the Social
Security Act, shall be charged to the appropriation
made by subsection (c)(1) of such section 2008 for
fiscal year 2020 (not including the amount for
technical assistance and administrative costs); and
(B) if such enactment occurs on or before November
21, 2019, the availability of funds appropriated in,
and the authority provided under, such section 1501
shall terminate.
(c) Career Pathways Through Health Profession Opportunity Grants.--
Effective October 1, 2020, section 2008 of the Social Security Act (42
U.S.C. 1397g) is amended to read as follows:
``SEC. 2008. CAREER PATHWAYS THROUGH HEALTH PROFESSION OPPORTUNITY
GRANTS.
``(a) Application Requirements.--An eligible entity desiring a
grant under this section for a project shall submit to the Secretary an
application for the grant, that includes the following:
``(1) A description of how the applicant will use a career
pathways approach to train eligible individuals for health
professions that pay well or will put eligible individuals on a
career path to an occupation that pays well, under the project.
``(2) A description of the adult basic education and
literacy activities, work readiness activities, training
activities, and case management and career coaching services
that the applicant will use to assist eligible individuals to
gain work experience, connection to employers, and job
placement, and a description of the plan for recruiting,
hiring, and training staff to provide the case management,
mentoring, and career coaching services, under the project
directly or through local governmental, apprenticeship,
educational, or charitable institutions.
``(3) In the case of an application for a grant under this
section for a demonstration project described in subsection
(c)(2)(B)(i)(I)--
``(A) a demonstration that the State in which the
demonstration project is to be conducted has in effect
policies or laws that permit certain allied health and
behavioral health care credentials to be awarded to
people with certain arrest or conviction records (which
policies or laws shall include appeals processes,
waivers, certificates, and other opportunities to
demonstrate rehabilitation to obtain credentials,
licensure, and approval to work in the proposed health
careers), and a plan described in the application that
will use a career pathway to assist participants with
such a record in acquiring credentials, licensing, and
employment in the specified careers;
``(B) a discussion of how the project or future
strategic hiring decisions will demonstrate the
experience and expertise of the project in working with
job seekers who have arrest or conviction records or
employers with experience working with people with
arrest or conviction records;
``(C) an identification of promising innovations or
best practices that can be used to provide the
training;
``(D) a proof of concept or demonstration that the
applicant has done sufficient research on workforce
shortage or in-demand jobs for which people with
certain types of arrest or conviction records can be
hired;
``(E) a plan for recruiting students who are
eligible individuals into the project; and
``(F) a plan for providing post-employment support
and ongoing training as part of a career pathway under
the project.
``(4) In the case of an application for a grant under this
section for a demonstration project described in subsection
(c)(2)(B)(i)(II)--
``(A) a description of the partnerships, strategic
staff hiring decisions, tailored program activities, or
other programmatic elements of the project, such as
training plans for doulas and other community health
workers and training plans for midwives and other
allied health professions, that are designed to support
a career pathway in pregnancy, birth, or post-partum
services; and
``(B) a demonstration that the State in which the
demonstration project is to be conducted recognizes
doulas or midwives, as the case may be.
``(5) A demonstration that the applicant has experience
working with low-income populations, or a description of the
plan of the applicant to work with a partner organization that
has the experience.
``(6) A plan for providing post-employment support and
ongoing training as part of a career pathway under the project.
``(7) A description of the support services that the
applicant will provide under the project, including a plan for
how child care and transportation support services will be
guaranteed and, if the applicant will provide a cash stipend or
wage supplement, how the stipend or supplement would be
calculated and distributed.
``(8) A certification by the applicant that the project
development included--
``(A) consultation with a local workforce
development board established under section 107 of the
Workforce Innovation and Opportunity Act;
``(B) consideration of apprenticeship and pre-
apprenticeship models registered under the Act of
August 16, 1937 (also known as the `National
Apprenticeship Act');
``(C) consideration of career pathway programs in
the State in which the project is to be conducted; and
``(D) a review of the State plan under section 102
or 103 of the Workforce Innovation and Opportunity Act.
``(9) A description of the availability and relevance of
recent labor market information and other pertinent evidence of
in-demand jobs or worker shortages.
``(10) A certification that the applicant will directly
provide or contract for the training services described in the
application.
``(11) A commitment by the applicant that, if the grant is
made to the applicant, the applicant will--
``(A) during the planning period for the project,
provide the Secretary with any information needed by
the Secretary to establish adequate data reporting and
administrative structure for the project;
``(B) hire a person to direct the project not later
than the end of the planning period applicable to the
project;
``(C) accept all technical assistance offered by
the Secretary with respect to the grant;
``(D) participate in such in-person grantee
conferences as are regularly scheduled by the
Secretary;
``(E) provide all data required by the Secretary
under subsection (g); and
``(F) notify the local disabled veterans' outreach
program specialists under section 4103A of title 38,
United States Code, and the local veterans' employment
representatives under section 4104 of such title, of
the grantee's outreach plan for advertising training
opportunities to potential participants in the project.
``(b) Preferences in Considering Applications.--In considering
applications for a grant under this section, the Secretary shall give
preference to--
``(1) applications submitted by applicants to whom a grant
was made under this section or any predecessor to this section;
``(2) applications submitted by applicants who have
business and community partners in each of the following
categories:
``(A) State and local government agencies and
social service providers, including a State or local
entity that administers a State program funded under
part A of this title;
``(B) institutions of higher education,
apprenticeship programs, and local workforce
development boards established under section 107 of the
Workforce Innovation and Opportunity Act; and
``(C) health care employers, health care industry
or sector partnerships, labor unions, and labor-
management partnerships;
``(3) applications that include opportunities for mentoring
or peer support, and make career coaching available, as part of
the case management plan;
``(4) applications which describe a project that will serve
a rural area in which--
``(A) the community in which the individuals to be
enrolled in the project reside is located;
``(B) the project will be conducted; or
``(C) an employer partnership that has committed to
hiring individuals who successfully complete all
activities under the project is located;
``(5) applications that include a commitment to providing
project participants with a cash stipend or wage supplement;
and
``(6) applications which have an emergency cash fund to
assist project participants financially in emergency
situations.
``(c) Grants.--
``(1) Competitive grants.--
``(A) Grant authority.--
``(i) In general.--The Secretary, in
consultation with the Secretary of Labor and
the Secretary of Education, may make a grant in
accordance with this paragraph to an eligible
entity whose application for the grant is
approved by the Secretary, to conduct a project
designed to train low-income individuals for
allied health professions, health information
technology, physicians assistants, nursing
assistants, registered nurse, advanced practice
nurse, and other professions considered part of
a health care career pathway model.
``(ii) Guarantee of grantees in each state
and the district of columbia.--For each grant
cycle, the Secretary shall award a grant under
this paragraph to at least 2 eligible entities
in each State that is not a territory, to the
extent there are a sufficient number of
applications submitted by the entities that
meet the requirements applicable with respect
to such a grant. If, for a grant cycle, there
are fewer than 2 such eligible entities in a
State, the Secretary shall include that
information in the report required by
subsection (g)(2) that covers the fiscal year.
``(B) Guarantee of grants for indian populations.--
From the amount reserved under subsection (i)(2)(B) for
each fiscal year, the Secretary shall award a grant
under this paragraph to at least 10 eligible entities
that are an Indian tribe, a tribal organization, or a
tribal college or university, to the extent there are a
sufficient number of applications submitted by the
entities that meet the requirements applicable with
respect to such a grant.
``(C) Guarantee of grantees in the territories.--
From the amount reserved under subsection (i)(2)(C) for
each fiscal year, the Secretary shall award a grant
under this paragraph to at least 2 eligible entities
that are located in a territory, to the extent there
are a sufficient number of applications submitted by
the entities that meet the requirements applicable with
respect to such a grant.
``(2) Grants for demonstration projects.--
``(A) Grant authority.--The Secretary, in
consultation with the Secretary of Labor and the
Secretary of Education (and, with respect to
demonstration projects of the type described in
subparagraph (B)(i)(I), the Attorney General) shall
make a grant in accordance with this subsection to an
eligible entity whose application for the grant is
approved by the Secretary, to conduct a demonstration
project that meets the requirements of subparagraph
(B).
``(B) Requirements.--The requirements of this
subparagraph are the following:
``(i) Type of project.--The demonstration
project shall be of 1 of the following types:
``(I) Individuals with arrest or
conviction records demonstration.--The
demonstration project shall be of a
type designed to provide education and
training for eligible individuals with
arrest or conviction records to enter
and follow a career pathway in the
health professions through occupations
that pay well and are expected to
experience a labor shortage or be in
high demand.
``(II) Pregnancy and childbirth
career pathway demonstration.--The
demonstration project shall be of a
type designed to provide education and
training for eligible individuals to
enter and follow a career pathway in
the field of pregnancy, childbirth, or
post-partum, in a State that recognizes
doulas or midwives and that provides
payment for services provided by doulas
or midwives, as the case may be, under
private or public health insurance
plans.
``(ii) Duration.--The demonstration project
shall be conducted for not less than 5 years.
``(C) Minimum allocation of funds for each type of
demonstration project.--
``(i) Individuals with arrest or conviction
records demonstrations.--Not less than 25
percent of the amounts made available for
grants under this paragraph shall be used to
make grants for demonstration projects of the
type described in subparagraph (B)(i)(I).
``(ii) Pregnancy and childbirth career
pathway demonstrations.--Not less than 25
percent of the amounts made available for
grants under this paragraph shall be used to
make grants for demonstration projects of the
type described in subparagraph (B)(i)(II).
``(3) Grant cycle.--The grant cycle under this section
shall be not less than 5 years, with a planning period of not
more than the 1st 12 months of the grant cycle. During the
planning period, the amount of the grant shall be in such
lesser amount as the Secretary determines appropriate.
``(d) Use of Grant.--
``(1) In general.--An entity to which a grant is made under
this section shall use the grant in accordance with the
approved application for the grant.
``(2) Support to be provided.--
``(A) Required support.--A project for which a
grant is made under this section shall include the
following:
``(i) An assessment for adult basic skill
competency, and provision of adult basic skills
education if necessary for lower-skilled
eligible individuals to enroll in the project
and go on to enter and complete post-secondary
training, through means including the
following:
``(I) Establishing a network of
partners that offer pre-training
activities for project participants who
need to improve basic academic skills
or English language proficiency before
entering a health occupational training
career pathway program.
``(II) Offering resources to enable
project participants to continue
advancing adult basic skill proficiency
while enrolled in a career pathway
program.
``(III) Embedding adult basic skill
maintenance as part of ongoing post-
graduation career coaching and
mentoring.
``(ii) A guarantee that child care is an
available and affordable support service for
project participants through means such as the
following:
``(I) Referral to, and assistance
with, enrollment in a subsidized child
care program.
``(II) Direct payment to a child
care provider if a slot in a subsidized
child care program is not available or
reasonably accessible.
``(III) Payment of co-payments or
associated fees for child care.
``(iii) Case management plans that include
career coaching (with the option to offer
appropriate peer support and mentoring
opportunities to help develop soft skills and
social capital), which may be offered on an
ongoing basis before, during, and after initial
training as part of a career pathway model.
``(iv) A plan to provide project
participants with transportation through means
such as the following:
``(I) Referral to, and assistance
with enrollment in, a subsidized
transportation program.
``(II) If a subsidized
transportation program is not
reasonably available, direct payments
to subsidize transportation costs.
For purposes of this clause, the term
`transportation' includes public transit, or
gasoline for a personal vehicle if public
transit is not reasonably accessible or
available.
``(v) In the case of a demonstration
project of the type described in subsection
(c)(2)(B)(i)(I), access to legal assistance for
project participants for the purpose of
addressing arrest or conviction records and
associated workforce barriers.
``(B) Allowed support.--The goods and services
provided under a project for which a grant is made
under this section may include the following:
``(i) A cash stipend that is at least
monthly.
``(ii) A reserve fund for financial
assistance to project participants in emergency
situations.
``(iii) Tuition, and training materials
such as books, software, uniforms, shoes, and
hair nets.
``(iv) In-kind resource donations such as
interview clothing and conference attendance
fees.
``(v) Assistance with accessing and
completing high school equivalency or adult
basic education courses as necessary to achieve
success in the project and make progress toward
career goals.
``(vi) Assistance with programs and
activities, including legal assistance, deemed
necessary to address arrest or conviction
records as an employment barrier.
``(vii) Other support services as deemed
necessary for family well-being, success in the
project, and progress toward career goals.
``(C) Treatment of support for purposes of means-
tested programs.--Any goods or services provided to an
eligible individual participating in a project for
which a grant is made under this section shall not be
considered income, and shall not be taken into account
for purposes of determining the eligibility of the
individual for, or amount of benefits to be provided to
the individual, under any means-tested program.
``(3) Training.--The number of hours of training provided
to an eligible individual under a project for which a grant is
made under this section, for a recognized postsecondary
credential, including an industry-recognized credential, which
is awarded in recognition of attainment of measurable technical
or occupational skills necessary to gain employment or advance
within an occupation (including a certificate awarded by a
local workforce development board established under section 107
of the Workforce Innovation and Opportunity Act), shall be--
``(A) not less than the number of hours of training
required for certification in that level of skill by
the State in which the project is conducted; or
``(B) if there is no such requirement, such number
of hours of training as the Secretary finds is
necessary to achieve that skill level.
``(4) Income limitation.--An entity to which a grant is
made under this section shall not use the grant to provide
support to a person who is not an eligible individual.
``(5) Inclusion of tanf recipients.--In the case of a
project for which a grant is made under this section that is
conducted in a State that has a program funded under part A of
title IV, at least 10 percent of the eligible individuals to
whom support is provided under the project shall meet the
income eligibility requirements under that State program,
without regard to whether the individuals receive benefits or
services directly under that State program.
``(6) Prohibition.--An entity to which a grant is made
under this section shall not use the grant for purposes of
entertainment, except that case management and career coaching
services may include celebrations of specific career-based
milestones such as completing a semester, graduation, or job
placement.
``(e) Technical Assistance.--
``(1) In general.--The Secretary shall provide technical
assistance--
``(A) to assist eligible entities in applying for
grants under this section;
``(B) that is tailored to meet the needs of
grantees at each stage of the administration of
projects for which grants are made under this section;
``(C) that is tailored to meet the specific needs
of Indian tribes, tribal organizations, and tribal
colleges and universities;
``(D) that is tailored to meet the specific needs
of the territories;
``(E) that is tailored to meet the specific needs
of eligible entities in carrying out demonstration
projects for which a grant is made under this section;
and
``(F) to facilitate the exchange of information
among eligible entities regarding best practices and
promising practices used in the projects.
``(2) Continuation of peer technical assistance
conferences.--The Secretary shall continue to hold peer
technical assistance conferences for entities to which a grant
is made under this section or was made under the immediate
predecessor of this section.
``(f) Evaluation of Demonstration Projects.--
``(1) In general.--The Secretary shall, by grant, contract,
or interagency agreement, conduct rigorous and well-designed
evaluations of the demonstration projects for which a grant is
made under this section.
``(2) Requirement applicable to individuals with arrest or
conviction records demonstration.--In the case of a project of
the type described in subsection (c)(2)(B)(i)(I), the
evaluation shall include identification of successful
activities for creating opportunities for developing and
sustaining, particularly with respect to low-income individuals
with arrest or conviction records, a health professions
workforce that has accessible entry points, that meets high
standards for education, training, certification, and
professional development, and that provides increased wages and
affordable benefits, including health care coverage, that are
responsive to the needs of the workforce.
``(3) Requirement applicable to pregnancy and childbirth
career pathway demonstration.--In the case of a project of the
type described in subsection (c)(2)(B)(i)(II), the evaluation
shall include identification of successful activities for
creating opportunities for developing and sustaining,
particularly with respect to low-income individuals and other
entry-level workers, a career pathway that has accessible entry
points, that meets high standards for education, training,
certification, and professional development, and that provides
increased wages and affordable benefits, including health care
coverage, that are responsive to the needs of the birth,
pregnancy, and post-partum workforce.
``(4) Rule of interpretation.--Evaluations conducted
pursuant to this subsection may include a randomized controlled
trial, but this subsection shall not be interpreted to require
an evaluation to include such a trial.
``(g) Reports.--
``(1) To the secretary.--An eligible entity awarded a grant
to conduct a project under this section shall submit interim
reports to the Secretary on the activities carried out under
the project, and, on the conclusion of the project, a final
report on the activities. Each such report shall include data
on participant outcomes related to earnings, employment in
health professions, graduation rate, graduation timeliness,
credential attainment, participant demographics, and other data
specified by the Secretary.
``(2) To the congress.--During each Congress, the Secretary
shall submit to the Committee on Ways and Means of the House of
Representatives and the Committee on Finance of the Senate a
report--
``(A) on the demographics of the participants in
the projects for which a grant is made under this
section;
``(B) on the rate of which project participants
completed all activities under the projects;
``(C) on the employment credentials acquired by
project participants;
``(D) on the employment of project participants on
completion of activities under the projects, and the
earnings of project participants at entry into
employment;
``(E) on best practices and promising practices
used in the projects;
``(F) on the nature of any technical assistance
provided to grantees under this section;
``(G) on, with respect to the period since the
period covered in the most recent prior report
submitted under this paragraph--
``(i) the number of applications submitted
under this section, with a separate statement
of the number of applications referred to in
subsection (b)(5);
``(ii) the number of applications that were
approved, with a separate statement of the
number of such applications referred to in
subsection (b)(5); and
``(iii) a description of how grants were
made in any case described in the last sentence
of subsection (c)(1)(A)(ii); and
``(H) that includes an assessment of the
effectiveness of the projects with respect to
addressing health professions workforce shortages or
in-demand jobs.
``(h) Definitions.--In this section:
``(1) Allied health profession.--The term `allied health
profession' has the meaning given in section 799B(5) of the
Public Health Service Act.
``(2) Career pathway.--The term `career pathway' has the
meaning given that term in section 3(7) of the Workforce
Innovation and Opportunity Act.
``(3) Doula.--The term `doula' means an individual who--
``(A) is certified by an organization that has been
established for not less than 5 years and that requires
the completion of continuing education to maintain the
certification, to provide non-medical advice,
information, emotional support, and physical comfort to
an individual during the individual's pregnancy,
childbirth, and post-partum period; and
``(B) maintains the certification by completing the
required continuing education.
``(4) Eligible entity.--The term `eligible entity' means
any of the following entities that demonstrates in an
application submitted under this section that the entity has
the capacity to fully develop and administer the project
described in the application:
``(A) A local workforce development board
established under section 107 of the Workforce
Innovation and Opportunity Act.
``(B) A State or territory, a political subdivision
of a State or territory, or an agency of a State,
territory, or such a political subdivision, including a
State or local entity that administers a State program
funded under part A of this title.
``(C) An Indian tribe, a tribal organization, or a
tribal college or university.
``(D) An institution of higher education (as
defined in the Higher Education Act of 1965).
``(E) A hospital (as defined in section 1861(e)).
``(F) A high-quality skilled nursing facility.
``(G) A Federally qualified health center (as
defined in section 1861(aa)(4)).
``(H) A nonprofit organization described in section
501(c)(3) of the Internal Revenue Code of 1986, a labor
organization, or an entity with shared labor-management
oversight, that has a demonstrated history of providing
health profession training to eligible individuals.
``(I) In the case of a demonstration project of the
type provided for in subsection (c)(2)(B)(i)(II) of
this section, an entity recognized by a State, Indian
tribe, or tribal organization as qualified to train
doulas or midwives, if midwives or doulas, as the case
may be, are permitted to practice in the State
involved.
``(J) An opioid treatment program (as defined in
section 1861(jjj)(2)), and other high quality
comprehensive addiction care providers.
``(5) Eligible individual.--The term `eligible individual'
means an individual whose family income does not exceed 200
percent of the Federal poverty level.
``(6) Federal poverty level.--The term `Federal poverty
level' means the poverty line (as defined in section 673(2) of
the Omnibus Budget Reconciliation Act of 1981, including any
revision required by such section applicable to a family of the
size involved).
``(7) Indian tribe; tribal organization.--The terms `Indian
tribe' and `tribal organization' have the meaning given the
terms in section 4 of the Indian Self-Determination and
Education Assistance Act (25 U.S.C. 450b).
``(8) Institution of higher education.--The term
`institution of higher education' has the meaning given the
term in section 101 or 102(a)(1)(B) of the Higher Education Act
of 1965.
``(9) Territory.--The term `territory' means the
Commonwealth of Puerto Rico, the United States Virgin Islands,
Guam, the Northern Mariana Islands, and American Samoa.
``(10) Tribal college or university.--The term `tribal
college or university' has the meaning given the term in
section 316(b) of the Higher Education Act of 1965.
``(i) Funding.--
``(1) In general.--Out of any funds in the Treasury of the
United States not otherwise appropriated, there are
appropriated to the Secretary to carry out this section
$425,000,000 for each of fiscal years 2021 through 2025.
``(2) Allocation of funds.--Of the amount appropriated for
a fiscal year under paragraph (1) of this subsection--
``(A) 75 percent shall be available for grants
under subsection (c)(1)(A);
``(B) 4 percent shall be reserved for grants under
subsection (c)(1)(B);
``(C) 5 percent shall be reserved for grants under
subsection (c)(1)(C);
``(D) 6 percent shall be available for
demonstration project grants under subsection (c)(2);
``(E) 6 percent, plus all amounts referred to in
subparagraphs (A) through (D) of this paragraph that
remain unused after all grant awards are made for the
fiscal year, shall be available for the provision of
technical assistance and associated staffing; and
``(F) 4 percent shall be available for studying the
effects of the demonstration and non-demonstration
projects for which a grant is made under this section,
and for associated staffing, for the purpose of
supporting the rigorous evaluation of the demonstration
projects, and supporting the continued study of the
short-, medium-, and long-term effects of all such
projects, including the effectiveness of new or added
elements of the non-demonstration projects.
``(j) Nonapplicability of Preceding Sections of This Subtitle.--
``(1) In general.--Except as provided in paragraph (2), the
preceding sections of this subtitle shall not apply to a grant
awarded under this section.
``(2) Exception for certain limitations on use of grants.--
Section 2005(a) (other than paragraphs (2), (3), (5), (6), and
(8)) shall apply to a grant awarded under this section to the
same extent and in the same manner as such section applies to
payments to States under this subtitle.''.
SEC. 811. HOME VISITING TO REDUCE MATERNAL MORTALITY AND MORBIDITY ACT.
(a) Short Title.--This section may be cited as the ``Home Visiting
to Reduce Maternal Mortality and Morbidity Act''.
(b) Increase in Tribal Set-aside Percentage.--
(1) In general.--Section 511(j)(2)(A) of the Social
Security Act (42 U.S.C. 711(j)(2)(A)) is amended by striking
``3'' and inserting ``6''.
(2) Effective date.--The amendment made by paragraph (1)
shall take effect on October 1, 2020.
(c) Increase in Funding.--Section 511(j)(1) of such Act (42 U.S.C.
711(j)(1)) is amended--
(1) by striking ``and'' at the end of subparagraph (G); and
(2) by striking subparagraph (H) and inserting the
following:
``(H) $400,000,000 for each of fiscal years 2017
through 2020;
``(I) $600,000,000 for fiscal year 2021; and
``(J) $800,000,000 for fiscal year 2022.''.
(d) Use of Additional Funds.--Section 511(c) of such Act (42 U.S.C.
711(c)) is amended by adding at the end the following:
``(6) Use of certain funds to provide additional resources
to address high rates of maternal mortality and morbidity,
support unmet needs identified by the needs assessment, or
increase allocations to states and territories based on
relative population or poverty.--The Secretary shall ensure
that any amounts exceeding $400,000,000 that are used for
grants under this subsection for a fiscal year are used to--
``(A) provide additional funding priority to
States, tribes, and territories to address high rates
of maternal mortality and morbidity;
``(B) address unmet needs identified by a needs
assessment conducted under subsection (b); or
``(C) increase the amounts allocated under this
section to States and to Puerto Rico, Guam, the Virgin
Islands, the Northern Mariana Islands, and American
Samoa, based on the proportion of children who have not
attained 5 years of age and are living in poverty.''.
SEC. 812. ADDITION OF NEW MEASURES BASED ON ACCESS TO BIOSIMILAR
BIOLOGICAL PRODUCTS TO THE 5-STAR RATING SYSTEM UNDER
MEDICARE ADVANTAGE.
(a) In General.--Section 1853(o)(4) of the Social Security Act (42
U.S.C. 1395w-23(o)(4)) is amended by adding at the end the following
new subparagraph:
``(E) Addition of new measures based on access to
biosimilar biological products.--
``(i) In general.--For 2021 and subsequent
years, the Secretary shall add a new set of
measures to the 5-star rating system based on
access to biosimilar biological products
covered under part B and, in the case of MA-PD
plans, such products that are covered part D
drugs. Such measures shall assess the impact a
plan's benefit structure may have on enrollees'
utilization of or ability to access biosimilar
biological products, including in comparison to
the reference biological product, and shall
include measures, as applicable, with respect
to the following:
``(I) Coverage.--Assessing whether
a biosimilar biological product is on
the plan formulary in lieu of or in
addition to the reference biological
product.
``(II) Preferencing.--Assessing
tier placement or cost-sharing for a
biosimilar biological product relative
to the reference biological product.
``(III) Utilization management
tools.--Assessing whether and how
utilization management tools are used
with respect to a biosimilar biological
product relative to the reference
biological product.
``(IV) Utilization.--Assessing the
percentage of enrollees prescribed the
biosimilar biological product when the
reference biological product is also
available.
``(ii) Definitions.--In this subparagraph,
the terms `biosimilar biological product' and
`reference biological product' have the meaning
given those terms in section 1847A(c)(6).
``(iii) Protecting patient interests.--In
developing such measures, the Secretary shall
ensure that each measure developed to address
coverage, preferencing, or utilization
management is constructed such that patients
retain equal access to appropriate therapeutic
options without undue administrative burden.''.
(b) Clarification Regarding Application to Prescription Drug
Plans.--To the extent the Secretary of Health and Human Services
applies the 5-star rating system under section 1853(o)(4) of the Social
Security Act (42 U.S.C. 1395w-23(o)(4)), or a similar system, to
prescription drug plans under part D of title XVIII of such Act, the
provisions of subparagraph (E) of such section, as added by subsection
(a) of this section, shall apply under the system with respect to such
plans in the same manner as such provisions apply to the 5-star rating
system under such section 1853(o)(4).
SEC. 813. SENSE OF CONGRESS REGARDING THE IMPACT OF THE HIGH COST OF
PRESCRIPTION DRUGS ON COMMUNITIES OF COLOR AND PERSONS
LIVING IN RURAL OR SPARSELY POPULATED AREAS OF THE UNITED
STATES.
It is the sense of the Congress that--
(1) the United States has the highest drug prices in the
world and for millions of Americans the cost of prescription
drugs is increasing as a barrier to proper disease treatment,
especially for communities of color and for persons living in
rural or sparsely populated areas of the nation;
(2) the Patient Protection and Affordable Care Act (Public
Law 111-148) substantially reduced the number of uninsured
Americans, but over 28 million Americans remain without
insurance and approximately 55 percent of uninsured Americans
under the age of 65 are persons of color;
(3) without health insurance, paying retail prices for
medications is invariably burdensome or financially impossible;
(4) the median net worth of Caucasian households in 2016
was 9.7 times higher than African-American households and 8.3
times higher than Hispanic households, which contributes to
disparities in negative health consequences, including for
example the underuse of insulin among insured adults with
diabetes; and
(5) due to the high cost of prescription drugs to
communities of color and for persons living in rural or
sparsely populated areas of the nation, this Act should
positively impact such communities and persons (and the
Secretaries of Health and Human Services, Labor, and Treasury
should monitor such impact).
SEC. 814. REGULATIONS REQUIRING DIRECT-TO-CONSUMER ADVERTISEMENTS FOR
PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS TO INCLUDE
TRUTHFUL AND NOT MISLEADING PRICING INFORMATION.
(a) In General.--Not later than the date that is one year after the
date of the enactment of the Elijah E. Cummings Lower Drug Costs Now
Act, the Secretary of Health and Human Services, acting through the
Administrator of the Centers for Medicare & Medicaid Services (referred
to in this section as the ``Administrator''), shall promulgate final
regulations requiring each direct-to-consumer advertisement on
television (including broadcast, cable, streaming, and satellite
television) for a prescription drug or biological product for which
payment is available under title XVIII or XIX of the Social Security
Act to include a textual statement, which shall be truthful and not
misleading, indicating the list price, as determined on the first day
of the quarter during which the advertisement is being aired or
otherwise broadcast, for a typical 30-day regimen or typical course of
treatment (whichever is most appropriate).
(b) Determinations.--In promulgating final regulations under
subsection (a), the Administrator shall determine--
(1) whether such regulations should apply with respect to
additional forms of advertising;
(2) the manner and format of textual statements described
in such subsection;
(3) appropriate enforcement mechanisms; and
(4) whether such textual statements should include any
other price information, as appropriate.
SEC. 815. IMPROVING TRANSPARENCY AND PREVENTING THE USE OF ABUSIVE
SPREAD PRICING AND RELATED PRACTICES IN MEDICAID.
(a) Pass-through Pricing Required.--
(1) In general.--Section 1927(e) of the Social Security Act
(42 U.S.C. 1396r-8(e)) is amended by adding at the end the
following:
``(6) Pass-through pricing required.--A contract between
the State and a pharmacy benefit manager (referred to in this
paragraph as a `PBM'), or a contract between the State and a
managed care entity or other specified entity (as such terms
are defined in section 1903(m)(9)(D)) that includes provisions
making the entity responsible for coverage of covered
outpatient drugs dispensed to individuals enrolled with the
entity, shall require that payment for such drugs and related
administrative services (as applicable), including payments
made by a PBM on behalf of the State or entity, is based on a
pass-through pricing model under which--
``(A) any payment made by the entity or the PBM (as
applicable) for such a drug--
``(i) is limited to--
``(I) ingredient cost; and
``(II) a professional dispensing
fee that is not less than the
professional dispensing fee that the
State plan or waiver would pay if the
plan or waiver was making the payment
directly;
``(ii) is passed through in its entirety by
the entity or PBM to the pharmacy that
dispenses the drug; and
``(iii) is made in a manner that is
consistent with section 1902(a)(30)(A) and
sections 447.512, 447.514, and 447.518 of title
42, Code of Federal Regulations (or any
successor regulation) as if such requirements
applied directly to the entity or the PBM;
``(B) payment to the entity or the PBM (as
applicable) for administrative services performed by
the entity or PBM is limited to a reasonable
administrative fee that covers the reasonable cost of
providing such services;
``(C) the entity or the PBM (as applicable) shall
make available to the State, and the Secretary upon
request, all costs and payments related to covered
outpatient drugs and accompanying administrative
services incurred, received, or made by the entity or
the PBM, including ingredient costs, professional
dispensing fees, administrative fees, post-sale and
post-in-voice fees. Discounts, or related adjustments
such as direct and indirect remuneration fees, and any
and all remuneration; and
``(D) any form of spread pricing whereby any amount
charged or claimed by the entity or the PBM (as
applicable) that is in excess of the amount paid to the
pharmacies on behalf of the entity, including any post-
sale or post-invoice fees, discounts, or related
adjustments such as direct and indirect remuneration
fees or assessments (after allowing for a reasonable
administrative fee as described in subparagraph (B)),
is not allowable for purposes of claiming Federal
matching payments under this title.''.
(2) Conforming amendment.--Clause (xiii) of section
1903(m)(2)(A) of such Act (42 U.S.C. 1396b(m)(2)(A)) is
amended--
(A) by striking ``and (III)'' and inserting
``(III)''; and
(B) by inserting before the period at the end the
following: ``, and (IV) pharmacy benefit management
services provided by the entity, or provided by a
pharmacy benefit manager on behalf of the entity under
a contract or other arrangement between the entity and
the pharmacy benefit manager, shall comply with the
requirements of section 1927(e)(6)''.
(3) Effective date.--The amendments made by this subsection
apply to contracts between States and managed care entities,
other specified entities, or pharmacy benefits managers that
are entered into or renewed on or after the date that is 18
months after the date of enactment of this Act.
(b) Survey of Retail Prices.--
(1) In general.--Section 1927(f) of the Social Security Act
(42 U.S.C. 1396r-8(f)) is amended--
(A) by striking ``and'' after the semicolon at the
end of paragraph (1)(A)(i) and all that precedes it
through ``(1)'' and inserting the following:
``(1) Survey of retail prices.--The Secretary shall conduct
a survey of retail community drug prices, to include at least
the national average drug acquisition cost, as follows:
``(A) Use of vendor.--The Secretary may contract
services for--
``(i) with respect to retail community
pharmacies, the determination on a monthly
basis of retail survey prices of the national
average drug acquisition cost for covered
outpatient drugs for such pharmacies, net of
all discounts and rebates (to the extent any
information with respect to such discounts and
rebates is available), the average
reimbursement received for such drugs by such
pharmacies from all sources of payment,
including third parties, and, to the extent
available, the usual and customary charges to
consumers for such drugs; and'';
(B) by adding at the end of paragraph (1) the
following:
``(F) Survey reporting.--In order to meet the
requirement of section 1902(a)(54), a State shall
require that any retail community pharmacy in the State
that receives any payment, administrative fee,
discount, or rebate related to the dispensing of
covered outpatient drugs to individuals receiving
benefits under this title, regardless of whether such
payment, fee, discount, or rebate is received from the
State or a managed care entity directly or from a
pharmacy benefit manager or another entity that has a
contract with the State or a managed care entity, shall
respond to surveys of retail prices conducted under
this subsection.
``(G) Survey information.--Information on retail
community prices obtained under this paragraph shall be
made publicly available and shall include at least the
following:
``(i) The monthly response rate of the
survey including a list of pharmacies not in
compliance with subparagraph (F).
``(ii) The sampling frame and number of
pharmacies sampled monthly.
``(iii) Characteristics of reporting
pharmacies, including type (such as independent
or chain), geographic or regional location, and
dispensing volume.
``(iv) Reporting of a separate national
average drug acquisition cost for each drug for
independent retail pharmacies and chain
operated pharmacies.
``(v) Information on price concessions
including on and off invoice discounts,
rebates, and other price concessions.
``(vi) Information on average professional
dispensing fees paid.
``(H) Penalties.--
``(i) Failure to provide timely
information.--A retail community pharmacy that
fails to respond to a survey conducted under
this subsection on a timely basis may be
subject to a civil monetary penalty in the
amount of $10,000 for each day in which such
information has not been provided.
``(ii) False information.--A retail
community pharmacy that knowingly provides
false information in response to a survey
conducted under this subsection may be subject
to a civil money penalty in an amount not to
exceed $100,000 for each item of false
information.
``(iii) Other penalties.--Any civil money
penalties imposed under this subparagraph shall
be in addition to other penalties as may be
prescribed by law. The provisions of section
1128A (other than subsections (a) and (b))
shall apply to a civil money penalty under this
subparagraph in the same manner as such
provisions apply to a penalty or proceedings
under section 1128A(a).
``(I) Report on specialty pharmacies.--
``(i) In general.--Not later than 1 year
after the effective date of this subparagraph,
the Secretary shall submit a report to Congress
examining specialty drug coverage and
reimbursement under this title.
``(ii) Content of report.--Such report
shall include a description of how State
Medicaid programs define specialty drugs, how
much State Medicaid programs pay for specialty
drugs, how States and managed care plans
determine payment for specialty drugs, the
settings in which specialty drugs are dispensed
(such as retail community pharmacies or
specialty pharmacies), whether acquisition
costs for specialty drugs are captured in the
national average drug acquisition cost survey,
and recommendations as to whether specialty
pharmacies should be included in the survey of
retail prices to ensure national average drug
acquisition costs capture drugs sold at
specialty pharmacies and how such specialty
pharmacies should be defined.'';
(C) in paragraph (2)--
(i) in subparagraph (A), by inserting ``,
including payments rates under Medicaid managed
care plans,'' after ``under this title''; and
(ii) in subparagraph (B), by inserting
``and the basis for such dispensing fees''
before the semicolon; and
(D) in paragraph (4), by inserting ``, and
$5,000,000 for fiscal year 2020 and each fiscal year
thereafter,'' after ``2010''.
(2) Effective date.--The amendments made by this subsection
take effect on the 1st day of the 1st quarter that begins on or
after the date that is 18 months after the date of enactment of
this Act.
(c) Manufacturer Reporting of Wholesale Acquisition Cost.--Section
1927(b)(3) of such Act (42 U.S.C. 1396r-8(b)(3)) is amended--
(1) in subparagraph (A)(i)--
(A) in subclause (I), by striking ``and'' after the
semicolon;
(B) in subclause (II), by adding ``and'' after the
semicolon;
(C) by moving the left margins of subclause (I) and
(II) 2 ems to the right; and
(D) by adding at the end the following:
``(III) in the case of rebate
periods that begin on or after the date
of enactment of this subclause, on the
wholesale acquisition cost (as defined
in section 1847A(c)(6)(B)) for covered
outpatient drugs for the rebate period
under the agreement (including for all
such drugs that are sold under a new
drug application approved under section
505(c) of the Federal Food, Drug, and
Cosmetic Act);''; and
(2) in subparagraph (D)--
(A) in the matter preceding clause (i), by
inserting ``and clause (vii) of this subparagraph''
after ``1847A'';
(B) in clause (v), by striking ``and'' after the
comma;
(C) in clause (vi), by striking the period and
inserting ``, and''; and
(D) by inserting after clause (vi) the following:
``(vii) to the Secretary to disclose
(through a website accessible to the public)
the most recently reported wholesale
acquisition cost (as defined in section
1847A(c)(6)(B)) for each covered outpatient
drug (including for all such drugs that are
sold under a new drug application approved
under section 505(c) of the Federal Food, Drug,
and Cosmetic Act), as reported under
subparagraph (A)(i)(III).''.
SEC. 816. GRADUATE MEDICAL EDUCATION IMPROVEMENTS IN RURAL AND
UNDERSERVED COMMUNITIES.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following new
section:
``SEC. 399V-7. GRADUATE MEDICAL EDUCATION IMPROVEMENTS IN RURAL AND
UNDERSERVED COMMUNITIES.
``(a) Rural and Underserved Community GME Grant Program.--Not later
than 1 year after the date of the enactment of this Act, the Secretary
of Health and Human Services (in this section referred to as the
`Secretary'), acting through the Administrator of the Health Resources
and Services Administration, shall establish a rural and underserved
community graduate medical education grant program under which the
Secretary shall award grants to specified hospitals (as defined in
subsection (b)) that have not established an approved medical residency
training program (as defined for purposes of section 1886(h) of the
Social Security Act (42 U.S.C. 1395ww(h))) in order to encourage such
hospitals to establish such a program, or to establish an affiliation
with a hospital that has established such a program in order to host
residents under such program.
``(b) Use of Funds.--Grants awarded under subsection (a) may be
used by a specified hospital for any initial costs associated with
establishing such a program or such an affiliation, including costs
associated with faculty development, administration, infrastructure,
supplies, and legal and consultant services.
``(c) Specified Hospital Defined.--For purposes of subsection (a),
the term `specified hospital' means a hospital or critical access
hospital (as such terms are defined in section 1861 of the Social
Security Act (42 U.S.C. 1395x)) that--
``(1) is--
``(A) located in a rural area (as defined in
section 1886(d)(2)(D) of such Act (42 U.S.C.
1395ww(d)(2)(D))); or
``(B) treated as being located in a rural area
pursuant to section 1886(d)(8)(E) of such Act (42
U.S.C. 1395ww(d)(8)(E)); and
``(2) is located in a medically underserved area (as
defined in section 330I(a) of the Public Health Service Act (42
U.S.C. 254c-14(a))).
``(d) Critical Access Hospital Grant Program.--Not later than 1
year after the date of the enactment of this Act, the Secretary, acting
through the Administrator of the Health Resources and Services
Administration, shall establish a grant program under which the
Secretary awards grants to critical access hospitals (as defined in
section 1861 of the Social Security Act (42 U.S.C. 1395x)) that do not
have in effect an affiliation with a hospital with an approved medical
residency training program to host residents of such program in order
to assist such critical access hospitals in setting up such
affiliations in order to host such residents.
``(e) Limitation on Grant Amounts.--No hospital may receive an
aggregate amount of grants under this section in excess of $250,000.
``(f) Reports.--
``(1) HHS.--Not later than 5 years after the date of the
enactment of this Act, the Secretary of Health and Human
Services 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
graduate medical residency training programs of hospitals that
received a grant under subsection (a) or (d). Such report shall
include the following:
``(A) The number of hospitals that applied for a
grant under this section.
``(B) The number of hospitals that were awarded
such a grant.
``(C) The number of residency positions created by
hospitals receiving such a grant.
``(D) An estimate of the number of such positions
such hospitals will create after the date of the
submission of such report.
``(E) A description of any challenges faced by
hospitals in applying for such a grant or using funds
awarded under such a grant.
``(2) GAO.--Not later than 10 years after the date of the
enactment of this Act, the Comptroller General of the United
States shall submit to Congress a report containing an analysis
of--
``(A) the number of residents who trained at a
hospital or critical access hospital that received a
grant under subsection (a) or (d); and
``(B) whether such residents continued to practice
medicine in a rural area (as defined in section
1886(d)(2)(D) of the Social Security Act (42 U.S.C.
1395ww(d)(2)(D))) or in a medically underserved area
(as defined in section 330I(a) of the Public Health
Service Act (42 U.S.C. 254c-14(a))) after completing
such training.
``(g) Funding.--There are authorized to be appropriated such sums
as are necessary for purposes of making grants under this section for
each of fiscal years 2020 through 2029.''.
Passed the House of Representatives December 12, 2019.
Attest:
CHERYL L. JOHNSON,
Clerk.
Calendar No. 521
116th CONGRESS
2d Session
H. R. 3
_______________________________________________________________________
AN ACT
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.
_______________________________________________________________________
September 8, 2020
Read the second time and placed on the calendar