[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 891 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 891
To extend expiring health provisions and improve health care delivery.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 6, 2025
Mr. Wyden (for himself and Mr. Sanders) introduced the following bill;
which was read twice and referred to the Committee on Finance
_______________________________________________________________________
A BILL
To extend expiring health provisions and improve health care delivery.
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 ``Bipartisan Health
Care Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--MEDICAID
Sec. 101. Streamlined enrollment process for eligible out-of-state
providers under Medicaid and CHIP.
Sec. 102. Making certain adjustments to coverage of home or community-
based services under Medicaid.
Sec. 103. Removing certain age restrictions on Medicaid eligibility for
working adults with disabilities.
Sec. 104. Medicaid State plan requirement for determining residency and
coverage for military families.
Sec. 105. Ensuring the reliability of address information provided
under the Medicaid program.
Sec. 106. Codifying certain Medicaid provider screening requirements
related to deceased providers.
Sec. 107. Modifying certain State requirements for ensuring deceased
individuals do not remain enrolled.
Sec. 108. One-year delay of Medicaid and CHIP requirements for health
screenings, referrals, and case management
services for eligible juveniles in public
institutions; State interim work plans.
Sec. 109. State studies and HHS report on costs of providing maternity,
labor, and delivery services.
Sec. 110. Modifying certain disproportionate share hospital allotments.
Sec. 111. Modifying certain limitations on disproportionate share
hospital payment adjustments under the
Medicaid program.
Sec. 112. Ensuring accurate payments to pharmacies under Medicaid.
Sec. 113. Preventing the use of abusive spread pricing in Medicaid.
TITLE II--MEDICARE
Sec. 201. Extension of increased inpatient hospital payment adjustment
for certain low-volume hospitals.
Sec. 202. Extension of the Medicare-dependent hospital (MDH) program.
Sec. 203. Extension of add-on payments for ambulance services.
Sec. 204. Extending incentive payments for participation in eligible
alternative payment models.
Sec. 205. Temporary payment increase under the Medicare physician fee
schedule to account for exceptional
circumstances.
Sec. 206. Extension of funding for quality measure endorsement, input,
and selection.
Sec. 207. Extension of funding outreach and assistance for low-income
programs.
Sec. 208. Extension of the work geographic index floor.
Sec. 209. Extension of certain telehealth flexibilities.
Sec. 210. Requiring modifier for use of telehealth to conduct face-to-
face encounter prior to recertification of
eligibility for hospice care.
Sec. 211. Extending acute hospital care at home waiver flexibilities.
Sec. 212. Enhancing certain program integrity requirements for DME
under Medicare.
Sec. 213. Guidance on furnishing services via telehealth to individuals
with limited English proficiency.
Sec. 214. In-home cardiopulmonary rehabilitation flexibilities.
Sec. 215. Inclusion of virtual diabetes prevention program suppliers in
MDPP Expanded Model.
Sec. 216. Medication-induced movement disorder outreach and education.
Sec. 217. Report on wearable medical devices.
Sec. 218. Extension of temporary inclusion of authorized oral antiviral
drugs as covered part D drugs.
Sec. 219. Extension of adjustment to calculation of hospice cap amount.
Sec. 220. Multiyear contracting authority for MedPAC and MACPAC.
Sec. 221. Contracting parity for MedPAC and MACPAC.
Sec. 222. Adjustments to Medicare part D cost-sharing reductions for
low-income individuals.
Sec. 223. Requiring Enhanced and Accurate Lists of (REAL) Health
Providers Act.
Sec. 224. Medicare coverage of multi-cancer early detection screening
tests.
Sec. 225. Medicare coverage of external infusion pumps and non-self-
administrable home infusion drugs.
Sec. 226. Assuring pharmacy access and choice for Medicare
beneficiaries.
Sec. 227. Modernizing and Ensuring PBM Accountability.
Sec. 228. Requiring a separate identification number and an attestation
for each off-campus outpatient department
of a provider.
Sec. 229. Medicare sequestration.
Sec. 230. Medicare improvement fund.
TITLE III--HUMAN SERVICES
Sec. 301. Sexual risk avoidance education extension.
Sec. 302. Personal responsibility education extension.
Sec. 303. Extension of funding for family-to-family health information
centers.
TITLE IV--PUBLIC HEALTH EXTENDERS
Subtitle A--Extensions
Sec. 401. Extension for community health centers, National Health
Service Corps, and teaching health centers
that operate GME programs.
Sec. 402. Extension of special diabetes programs.
Subtitle B--World Trade Center Health Program
Sec. 411. 9/11 responder and survivor health funding corrections.
TITLE V--SUPPORT ACT REAUTHORIZATION
Sec. 501. Short title.
Subtitle A--Prevention
Sec. 511. Prenatal and postnatal health.
Sec. 512. Monitoring and education regarding infections associated with
illicit drug use and other risk factors.
Sec. 513. Preventing overdoses of controlled substances.
Sec. 514. Support for individuals and families impacted by fetal
alcohol spectrum disorder.
Sec. 515. Promoting State choice in PDMP systems.
Sec. 516. First responder training program.
Sec. 517. Donald J. Cohen National Child Traumatic Stress Initiative.
Sec. 518. Protecting suicide prevention lifeline from cybersecurity
incidents.
Sec. 519. Bruce's law.
Sec. 520. Guidance on at-home drug disposal systems.
Sec. 521. Assessment of opioid drugs and actions.
Sec. 522. Grant program for State and Tribal response to opioid use
disorders.
Subtitle B--Treatment
Sec. 531. Residential treatment program for pregnant and postpartum
women.
Sec. 532. Improving access to addiction medicine providers.
Sec. 533. Mental and behavioral health education and training grants.
Sec. 534. Loan repayment program for substance use disorder treatment
workforce.
Sec. 535. Development and dissemination of model training programs for
substance use disorder patient records.
Sec. 536. Task force on best practices for trauma-informed
identification, referral, and support.
Sec. 537. Grants to enhance access to substance use disorder treatment.
Sec. 538. State guidance related to individuals with serious mental
illness and children with serious emotional
disturbance.
Sec. 539. Reviewing the scheduling of approved products containing a
combination of buprenorphine and naloxone.
Subtitle C--Recovery
Sec. 541. Building communities of recovery.
Sec. 542. Peer support technical assistance center.
Sec. 543. Comprehensive opioid recovery centers.
Sec. 544. Youth prevention and recovery.
Sec. 545. CAREER Act.
Sec. 546. Addressing economic and workforce impacts of the opioid
crisis.
Subtitle D--Miscellaneous Matters
Sec. 551. Delivery of a controlled substance by a pharmacy to a
prescribing practitioner.
Sec. 552. Technical correction on controlled substances dispensing.
Sec. 553. Required training for prescribers of controlled substances.
Sec. 554. Extension of temporary order for fentanyl-related substances.
TITLE VI--PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND RESPONSE
Sec. 601. Short title.
Subtitle A--State and Local Readiness and Response
Sec. 611. Temporary reassignment of State and local personnel during a
public health emergency.
Sec. 612. Public Health Emergency Preparedness program.
Sec. 613. Hospital Preparedness Program.
Sec. 614. Facilities and capacities of the Centers for Disease Control
and Prevention to combat public health
security threats.
Sec. 615. Pilot program to support State medical stockpiles.
Sec. 616. Enhancing domestic wastewater surveillance for pathogen
detection.
Sec. 617. Reauthorization of Mosquito Abatement for Safety and Health
program.
Subtitle B--Federal Planning and Coordination
Sec. 621. All-Hazards Emergency Preparedness and Response.
Sec. 622. National Health Security Strategy.
Sec. 623. Improving development and distribution of diagnostic tests.
Sec. 624. Combating antimicrobial resistance.
Sec. 625. Strategic National Stockpile and material threats.
Sec. 626. Medical countermeasures for viral threats with pandemic
potential.
Sec. 627. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 628. Fellowship and training programs.
Sec. 629. Regional biocontainment research laboratories.
Sec. 629A. Limitation related to countries of concern conducting
certain research.
Subtitle C--Addressing the Needs of All Individuals
Sec. 631. Improving access to certain programs.
Sec. 632. Supporting at-risk individuals during emergency responses.
Sec. 633. National advisory committees.
Sec. 634. National Academies study on prizes.
Subtitle D--Additional Reauthorizations
Sec. 641. Medical countermeasure priority review voucher.
Sec. 642. Epidemic Intelligence Service.
Sec. 643. Monitoring and distribution of certain medical
countermeasures.
Sec. 644. Regional health care emergency preparedness and response
systems.
Sec. 645. Emergency system for advance registration of volunteer health
professionals.
Sec. 646. Ensuring collaboration and coordination in medical
countermeasure development.
Sec. 647. Military and civilian partnership for trauma readiness.
Sec. 648. National Disaster Medical System.
Sec. 649. Volunteer Medical Reserve Corps.
Sec. 649A. Epidemiology-laboratory capacity.
TITLE VII--PUBLIC HEALTH PROGRAMS
Sec. 701. Action for dental health.
Sec. 702. PREEMIE.
Sec. 703. Preventing maternal deaths.
Sec. 704. Sickle cell disease prevention and treatment.
Sec. 705. Traumatic brain injuries.
Sec. 706. Lifespan respite care.
Sec. 707. Dr. Lorna Breen health care provider protection.
Sec. 708. SCREENS for Cancer.
Sec. 709. DeOndra Dixon INCLUDE Project.
Sec. 710. IMPROVE Initiative.
Sec. 711. Organ Procurement and Transplantation Network.
Sec. 712. Honor Our Living Donors.
Sec. 713. Program for pediatric studies of drugs.
TITLE VIII--FOOD AND DRUG ADMINISTRATION
Subtitle A--Give Kids a Chance
Sec. 801. Research into pediatric uses of drugs; additional authorities
of Food and Drug Administration regarding
molecularly targeted cancer drugs.
Sec. 802. Ensuring completion of pediatric study requirements.
Sec. 803. FDA report on PREA enforcement.
Sec. 804. Extension of authority to issue priority review vouchers to
encourage treatments for rare pediatric
diseases.
Sec. 805. Limitations on exclusive approval or licensure of orphan
drugs.
Subtitle B--United States-Abraham Accords Cooperation and Security
Sec. 811. Establishment of Abraham Accords Office within Food and Drug
Administration.
TITLE IX--LOWERING PRESCRIPTION DRUG COSTS
Sec. 901. Oversight of pharmacy benefit management services.
Sec. 902. Full rebate pass through to plan; exception for innocent plan
fiduciaries.
Sec. 903. Increasing transparency in generic drug applications.
Sec. 904. Title 35 amendments.
TITLE X--MISCELLANEOUS
Sec. 1001. Extension of safe harbor for absence of deductible for
telehealth.
TITLE I--MEDICAID
SEC. 101. STREAMLINED ENROLLMENT PROCESS FOR ELIGIBLE OUT-OF-STATE
PROVIDERS UNDER MEDICAID AND CHIP.
(a) In General.--Section 1902(kk) of the Social Security Act (42
U.S.C. 1396a(kk)) is amended by adding at the end the following new
paragraph:
``(10) Streamlined enrollment process for eligible out-of-
state providers.--
``(A) In general.--The State--
``(i) adopts and implements a process to
allow an eligible out-of-State provider to
enroll under the State plan (or a waiver of
such plan) to furnish items and services to, or
order, prescribe, refer, or certify eligibility
for items and services for, qualifying
individuals without the imposition of screening
or enrollment requirements by such State that
exceed the minimum necessary for such State to
provide payment to an eligible out-of-State
provider under such State plan (or a waiver of
such plan), such as the provider's name and
National Provider Identifier (and such other
information specified by the Secretary); and
``(ii) provides that an eligible out-of-
State provider that enrolls as a participating
provider in the State plan (or a waiver of such
plan) through such process shall be so enrolled
for a 5-year period, unless the provider is
terminated or excluded from participation
during such period.
``(B) Definitions.--In this paragraph:
``(i) Eligible out-of-state provider.--The
term `eligible out-of-State provider' means,
with respect to a State, a provider--
``(I) that is located in any other
State;
``(II) that--
``(aa) was determined by
the Secretary to have a limited
risk of fraud, waste, and abuse
for purposes of determining the
level of screening to be
conducted under section
1866(j)(2), has been so
screened under such section
1866(j)(2), and is enrolled in
the Medicare program under
title XVIII; or
``(bb) was determined by
the State agency administering
or supervising the
administration of the State
plan (or a waiver of such plan)
of such other State to have a
limited risk of fraud, waste,
and abuse for purposes of
determining the level of
screening to be conducted under
paragraph (1) of this
subsection, has been so
screened under such paragraph
(1), and is enrolled under such
State plan (or a waiver of such
plan); and
``(III) that has not been--
``(aa) excluded from
participation in any Federal
health care program pursuant to
section 1128 or 1128A;
``(bb) excluded from
participation in the State plan
(or a waiver of such plan)
pursuant to part 1002 of title
42, Code of Federal Regulations
(or any successor regulation),
or State law; or
``(cc) terminated from
participating in a Federal
health care program or the
State plan (or a waiver of such
plan) for a reason described in
paragraph (8)(A).
``(ii) Qualifying individual.--The term
`qualifying individual' means an individual
under 21 years of age who is enrolled under the
State plan (or waiver of such plan).
``(iii) State.--The term `State' means 1 of
the 50 States or the District of Columbia.''.
(b) Conforming Amendments.--
(1) Section 1902(a)(77) of the Social Security Act (42
U.S.C. 1396a(a)(77)) is amended by inserting ``enrollment,''
after ``screening,''.
(2) The subsection heading for section 1902(kk) of such Act
(42 U.S.C. 1396a(kk)) is amended by inserting ``enrollment,''
after ``screening,''.
(3) Section 2107(e)(1)(G) of such Act (42 U.S.C.
1397gg(e)(1)(G)) is amended by inserting ``enrollment,'' after
``screening,''.
(c) Effective Date.--The amendments made by this section shall take
effect on the date that is 3 years after the date of enactment of this
Act.
SEC. 102. MAKING CERTAIN ADJUSTMENTS TO COVERAGE OF HOME OR COMMUNITY-
BASED SERVICES UNDER MEDICAID.
(a) Increasing Transparency of HCBS Coverage Under Medicaid.--
(1) In general.--Section 1915(c) of the Social Security Act
(42 U.S.C. 1396n(c)) is amended--
(A) in paragraph (2)--
(i) in subparagraph (E)--
(I) by inserting ``, not less
frequently than'' before ``annually'';
and
(II) by inserting ``(including,
with respect to such information
provided on or after July 9, 2027, the
information specified in paragraph
(11))'' before the period at the end;
and
(ii) by adding at the end the following
flush sentence:
``The Secretary shall make all information provided under
subparagraph (E) on or after the date of the enactment of this
sentence publicly available on the website of the Centers for
Medicare & Medicaid Services.''; and
(B) by adding at the end the following new
paragraph:
``(11) For purposes of paragraph (2)(E), the information
specified in this paragraph is the following:
``(A) In the case of a State that limits the number
of individuals who may be provided home or community-
based services under a waiver granted under this
subsection and maintains a list of individuals waiting
to enroll in such waiver, a description of how the
State maintains such list, including--
``(i) information on whether the State
screens individuals on such list to determine
whether such individuals are eligible to
receive such services under such waiver;
``(ii) information on whether (and, if
applicable, how often) the State periodically
re-screens individuals on such list for
eligibility;
``(iii) the number of people on such list
of individuals waiting to enroll in such
waiver; and
``(iv) the average amount of time that
individuals newly enrolled in such waiver
within the past 12 months were on such list of
individuals waiting to enroll in such waiver.
``(B) With respect to homemaker services, home
health aide services, personal care services, and
habilitation services furnished under waivers under
this subsection, by each such service type--
``(i) for individuals newly receiving such
services within the past 12 months, the average
amount of time (which may be determined using
statistically valid random sampling of such
individuals) from when such services are
initially approved for such an individual to
when such individual begins receiving such
services; and
``(ii) the percentage of authorized hours
(which may be determined using statistically
valid random sampling of individuals authorized
to receive such services) that are provided
within the past 12 months.''.
(2) Conforming amendments.--Section 1915 of the Social
Security Act (42 U.S.C. 1396n) is amended--
(A) in subsection (i) by adding at the end the
following new paragraph:
``(8) Reporting requirement.--With respect to homemaker
services, home health aide services, personal care services,
and habilitation services provided under this subsection on or
after July 9, 2027, the State, not less frequently than
annually, shall provide to the Secretary the same information
regarding such services as the State is required to provide
under subsection (c)(11)(B).'';
(B) in subsection (j)(2)(E), by inserting after the
second sentence the following: ``With respect to any
homemaker services, home health aide services, personal
care services, and habilitation services provided under
this subsection on or after July 9, 2027, the State,
not less frequently than annually, shall provide to the
Secretary the same information regarding such services
as the State is required to provide under subsection
(c)(11)(B).''; and
(C) in subsection (k)(3)(E)--
(i) by striking ``and'' after ``the cost of
such services and supports,''; and
(ii) by inserting before the period, the
following: ``, and with respect to homemaker
services, home health aide services, personal
care services, and habilitation services
provided under this subsection on or after July
9, 2027, not less frequently than annually, the
same information regarding such services as the
State is required to provide under subsection
(c)(11)(B)''.
(b) Demonstration Program To Expand HCBS Coverage Under Section
1915(c) Waivers.--Section 1915(c) of the Social Security Act (42 U.S.C.
1396n(c)), as amended by subsection (a), is further amended--
(1) in paragraph (2)(E), by inserting ``, and the
information specified in paragraph (12)(C)(v), when
applicable'' after ``paragraph (11)''; and
(2) by adding at the end the following new paragraph:
``(12) Demonstration program to expand coverage for home or
community-based services.--
``(A) In general.--
``(i) Approval.--Not later than 24 months
after the date on which the planning grants
under subparagraph (B) are awarded,
notwithstanding paragraph (1), the Secretary
may approve a waiver that is standalone from
any other waiver approved under this subsection
for not more than 5 States, selected in
accordance with clause (ii), to include as
medical assistance under the State plan of such
State, for the 3-year period beginning on the
date of such approval, payment for part or all
of the cost of home or community-based services
(other than room and board (as described in
paragraph (1))) approved by the Secretary which
are provided pursuant to a written plan of care
to individuals described in subparagraph
(C)(iii).
``(ii) Selection criteria.--In selecting
States for purposes of clause (i), the
Secretary shall--
``(I) only select States that
received a planning grant under
subparagraph (B);
``(II) only select States that meet
the requirements specified in
subparagraph (C) and such other
requirements as the Secretary may
determine appropriate;
``(III) select States in a manner
that ensures geographic diversity;
``(IV) give preference to States
with a higher percentage (relative to
other States that apply to be selected
for purposes of clause (i)) of the
total State population residing in
rural areas (as determined by the
Secretary);
``(V) give preference to States
that have demonstrated more progress in
rebalancing long-term services and
supports systems under this title, as
determined based on the relative share
of individuals who use home or
community-based services (as defined by
the Secretary) under this title as a
percentage of total individuals who use
long-term services and supports (as
defined by the Secretary) under this
title (in the most recent year for
which such data is available); and
``(VI) give preference to States
that pursue a waiver under this
paragraph that incorporates the
provision of mental health services for
adults with serious mental illness,
children with serious emotional
disturbances, or individuals with
substance use disorder.
``(B) Planning grants.--
``(i) In general.--
``(I) Approval.--Not later than 18
months after the date of the enactment
of this paragraph, the Secretary shall
award planning grants of not more than
$5,000,000 each to not more than 10
States for purposes of preparing to
submit a request for a waiver under
this subsection (including for costs to
implement the waiver or other
activities to expand the provision of
home or community-based services under
this section) to provide home or
community-based services to individuals
described in subparagraph (C)(iii).
``(II) Selection criteria.--In
awarding planning grants under
subclause (I), the Secretary shall use
the selection criteria specified in
subclauses (III) through (VI) of
subparagraph (A)(ii).
``(ii) Consultation.--A State that is
awarded a planning grant under clause (i)
shall, in preparing to submit a request for a
waiver described in such clause, consult with--
``(I) individuals in need of (and
not receiving) home or community-based
services, individuals receiving home or
community-based services, and the
caregivers of such individuals;
``(II) providers furnishing home or
community-based services; and
``(III) such other stakeholders, as
the Secretary may specify.
``(C) State requirements.--In addition to the
requirements specified under this subsection (except
for the requirements described in subparagraphs (C) and
(D) of paragraph (2) and any other requirement the
Secretary determines to be inapplicable in the context
of a waiver relation to individuals who do not require
the level of care described in paragraph (1)), the
requirements specified in this paragraph are, with
respect to a State, the following:
``(i) As of the date that such State
requests a waiver under this subsection to
provide home or community-based services to
individuals described in clause (iii), all
other waivers (if any) granted under this
subsection to such State meet the requirements
of this subsection.
``(ii) The State demonstrates to the
Secretary that approval of a waiver under this
subsection with respect to individuals
described in clause (iii) will not result in a
material increase of the average amount of time
that individuals with respect to whom a
determination described in paragraph (1) has
been made will need to wait to receive home or
community-based services under any waiver
granted under this subsection, as determined by
the Secretary.
``(iii) The State establishes needs-based
criteria, subject to the approval of the
Secretary, to identify individuals for whom a
determination described in paragraph (1) is not
applicable, who will be eligible for home or
community-based services under a waiver
approved under this paragraph, and specifies
the home or community-based services such
individuals so eligible will receive.
``(iv) The State established needs-based
criteria for determining whether an individual
described in clause (iii) requires the level of
care provided in a hospital, nursing facility,
or an intermediate care facility for
individuals with developmental disabilities
under the State plan or under any waiver of
such plan that are more stringent than the
needs-based criteria established under clause
(iii) for determining eligibility for home or
community-based services.
``(v) The State attests that the State's
average per capita expenditure for medical
assistance under the State plan (or waiver of
such plan) provided with respect to such
individuals enrolled in a waiver under this
paragraph will not exceed the State's average
per capita expenditures for medical assistance
for individuals receiving institutional care
under the State plan (or waiver of such plan)
for the duration that the waiver under this
paragraph is in effect.
``(vi) The State provides to the Secretary
data (in such form and manner as the Secretary
may specify) regarding the number of
individuals described in clause (i) with
respect to a State seeking approval of a waiver
under this subsection, to whom the State will
make such services available under such waiver.
``(vii) The State agrees to provide to the
Secretary, not less frequently than annually,
data for purposes of paragraph (2)(E) (in such
form and manner as the Secretary may specify)
regarding, with respect to each preceding year
in which a waiver under this subsection to
provide home and community-based services to
individuals described in clause (iii) was in
effect--
``(I) the cost (as such term is
defined by the Secretary) of such
services furnished to individuals
described in clause (iii), broken down
by type of service;
``(II) with respect to each type of
home and community-based service
provided under the waiver, the length
of time that such individuals have
received such service;
``(III) a comparison between the
data described in subclause (I) and any
comparable data available with respect
to individuals with respect to whom a
determination described in paragraph
(1) has been made and with respect to
individuals receiving institutional
care under this title; and
``(IV) the number of individuals
who have received home and community-
based services under the waiver during
the preceding year.''.
(c) Non-Application of the Paperwork Reduction Act.--Chapter 35 of
title 44, United States Code (commonly referred to as the ``Paperwork
Reduction Act of 1995''), shall not apply to the implementation of the
amendments made by subsections (a) and (b).
(d) CMS Guidance to States on Interim Coverage Under Section 1915
Home and Community-Based Services Authorities.--Not later than January
1, 2027, the Secretary of Health and Human Services shall issue
guidance to the States to clarify how a State may provide, with respect
to an individual who is eligible for home and community-based services
under section 1915 of the Social Security Act (42 U.S.C. 1396n),
coverage of such services pursuant to a provisional written plan of
care, pending finalization, with respect to such individual.
(e) Funding.--
(1) In general.--There are appropriated, out of any funds
in the Treasury not otherwise obligated, $71,000,000 for fiscal
year 2025, to remain available until expended, to the Secretary
of Health and Human Services for purposes of carrying out
subsection (d) and the amendments made by subsection (b).
(2) Reservation for planning grants.--Of the amount
appropriated under paragraph (1), the Secretary of Health and
Human Services shall reserve $50,000,000 of such amount to
award planning grants under the demonstration program
established by the amendments made by subsection (b).
SEC. 103. REMOVING CERTAIN AGE RESTRICTIONS ON MEDICAID ELIGIBILITY FOR
WORKING ADULTS WITH DISABILITIES.
(a) Modification of Optional Buy-In Groups.--
(1) In general.--Section 1902(a)(10)(A)(ii)(XV) of the
Social Security Act (42 U.S.C. 1396a(a)(10)(A)(ii)(XV)) is
amended by striking ``but less than 65,''.
(2) Definition modification.--Section 1905(v)(1)(A) of the
Social Security Act (42 U.S.C. 1396d(v)(1)(A)) is amended by
striking ``, but less than 65,''.
(b) Application to Certain States.--A State that, as of the date of
enactment of this Act, provides for making medical assistance available
to individuals described in subclause (XV) or (XVI) of section
1902(a)(10)(A)(ii) of the Social Security Act (42 U.S.C.
1396a(a)(10)(A)(ii)) shall not be regarded as failing to comply with
the requirements of either such subclause (as amended by subsection
(a)(1)) or with section 1905(v)(1)(A) of the Social Security Act (42
U.S.C. 1396d(v)(1)(A)) (as amended by subsection (a)(2)) before January
1, 2027.
SEC. 104. MEDICAID STATE PLAN REQUIREMENT FOR DETERMINING RESIDENCY AND
COVERAGE FOR MILITARY FAMILIES.
(a) In General.--Section 1902 of the Social Security Act (42 U.S.C.
1396a) is amended--
(1) in subsection (a)--
(A) in paragraph (86), by striking ``and'' at the
end;
(B) in paragraph (87), by striking the period at
the end and inserting ``; and''; and
(C) by inserting after paragraph (87), the
following new paragraph:
``(88) beginning January 1, 2028, provide, with respect to
an active duty relocated individual (as defined in subsection
(uu)(1))--
``(A) that, for purposes of determining eligibility
for medical assistance under the State plan (or waiver
of such plan), such active duty relocated individual is
treated as a resident of the State unless such
individual voluntarily elects not to be so treated for
such purposes;
``(B) that if, at the time of relocation (as
described in subsection (uu)(1)), such active duty
relocated individual is on a home and community-based
services waiting list (as defined in subsection
(uu)(2)), such individual remains on such list until--
``(i) the State completes an assessment and
renders a decision with respect to the
eligibility of such individual to receive the
relevant home and community-based services at
the time a slot for such services becomes
available and, in the case such decision is a
denial of such eligibility, such individual has
exhausted the individual's opportunity for a
fair hearing; or
``(ii) such individual elects to be removed
from such list; and
``(C) payment for medical assistance furnished
under the State plan (or a waiver of the plan) on
behalf of such active duty relocated individual in the
military service relocation State (as referred to in
subsection (uu)(1)(B)(i)), to the extent that such
assistance is available in such military service
relocation State in accordance with such guidance as
the Secretary may issue to ensure access to such
assistance.''; and
(2) by adding at the end the following new subsection:
``(uu) Active Duty Relocated Individual; Home and Community-Based
Services Waiting List.--For purposes of subsection (a)(88) and this
subsection:
``(1) Active duty relocated individual.--The term `active
duty relocated individual' means an individual--
``(A) who--
``(i) is enrolled under the State plan (or
waiver of such plan); or
``(ii) with respect to an individual
described in subparagraph (C)(ii), would be so
enrolled pursuant to subsection
(a)(10)(A)(ii)(VI) if such individual began
receiving home and community-based services;
``(B) who--
``(i) is a member of the Armed Forces
engaged in active duty service and is relocated
to another State (in this subsection referred
to as the `military service relocation State')
by reason of such service;
``(ii) would be described in clause (i)
except that the individual stopped being
engaged in active duty service (including by
reason of retirement from such service) and the
last day on which the individual was engaged in
active duty service occurred not more than 12
months ago; or
``(iii) is a dependent (as defined by the
Secretary) of a member described in clause (i)
or (ii) who relocates to the military service
relocation State with such member; and
``(C) who--
``(i) was receiving home and community-
based services (as defined in section
9817(a)(2)(B) of the American Rescue Plan Act
of 2021) at the time of such relocation; or
``(ii) if the State maintains a home and
community-based services waiting list, was on
such home and community-based services waiting
list at the time of such relocation.
``(2) Home and community-based services waiting list.--The
term `home and community-based services waiting list' means, in
the case of a State that has a limit on the number of
individuals who may receive home and community-based services
under section 1115(a), section 1915(c), or section 1915(j), a
list maintained by such State of individuals who are requesting
to receive such services under 1 or more such sections but for
whom the State has not yet completed an assessment and rendered
a decision with respect to the eligibility of such individuals
to receive the relevant home and community-based services at
the time a slot for such services becomes available due to such
limit.''.
(b) Implementation Funding.--There are appropriated, out of any
funds in the Treasury not otherwise obligated, $1,000,000 for each of
fiscal years 2025 through 2029, to remain available until expended, to
the Secretary of Health and Human Services for purposes of implementing
the amendments made by subsection (a).
SEC. 105. ENSURING THE RELIABILITY OF ADDRESS INFORMATION PROVIDED
UNDER THE MEDICAID PROGRAM.
(a) In General.--Section 1902(a) of the Social Security Act (42
U.S.C. 1396a(a)), as previously amended by this title, is amended--
(1) in paragraph (87), by striking ``and'' at the end;
(2) in paragraph (88), by striking the period at the end
and inserting ``; and''; and
(3) by inserting after paragraph (88) the following new
paragraph:
``(89) beginning January 1, 2026, provide for a process to
regularly obtain address information for individuals enrolled
under such plan (or a waiver of such plan) from reliable data
sources (as described in section 435.919(f)(1)(iii) of title
42, Code of Federal Regulations (or a successor regulation))
and act on any changes to such an address based on such
information in accordance with such section (or successor
regulation), except that this paragraph shall only apply in the
case of the 50 States and the District of Columbia.''.
(b) Application to CHIP.--Section 2107(e)(1) of the Social Security
Act (42 U.S.C. 1397gg(e)(1)) is amended--
(1) by redesignating subparagraphs (H) through (U) as
subparagraphs (I) through (V), respectively; and
(2) by inserting after subparagraph (G) the following new
subparagraph:
``(H) Section 1902(a)(89) (relating to regularly
obtaining address information for enrollees).''.
(c) Ensuring Transmission of Address Information From Managed Care
Organizations.--Section 1932 of the Social Security Act (42 U.S.C.
1396u-2) is amended by adding at the end the following new subsection:
``(j) Transmission of Address Information.--Beginning January 1,
2026, each contract under a State plan with a managed care entity under
section 1903(m) shall provide that the entity transmits to the State
any address information for an individual enrolled with the entity that
is provided to such entity directly from, or verified by such entity
directly with, such individual.''.
SEC. 106. CODIFYING CERTAIN MEDICAID PROVIDER SCREENING REQUIREMENTS
RELATED TO DECEASED PROVIDERS.
Section 1902(kk)(1) of the Social Security Act (42 U.S.C.
1396a(kk)(1)) is amended--
(1) by striking ``The State'' and inserting:
``(A) In general.--The State''; and
(2) by adding at the end the following new subparagraph:
``(B) Additional provider screening.--Beginning
January 1, 2027, as part of the enrollment (or
reenrollment or revalidation of enrollment) of a
provider or supplier under this title, and not less
frequently than quarterly during the period that such
provider or supplier is so enrolled, the State conducts
a check of the Death Master File (as such term is
defined in section 203(d) of the Bipartisan Budget Act
of 2013) to determine whether such provider or supplier
is deceased.''.
SEC. 107. MODIFYING CERTAIN STATE REQUIREMENTS FOR ENSURING DECEASED
INDIVIDUALS DO NOT REMAIN ENROLLED.
Section 1902 of the Social Security Act (42 U.S.C. 1396a), as
previously amended by this title, is amended--
(1) in subsection (a)--
(A) in paragraph (88), by striking ``; and'' and
inserting a semicolon;
(B) in paragraph (89), by striking the period at
the end and inserting ``; and''; and
(C) by inserting after paragraph (89) the following
new paragraph:
``(90) provide that the State shall comply with the
eligibility verification requirements under subsection (vv),
except that this paragraph shall apply only in the case of the
50 States and the District of Columbia.''; and
(2) by adding at the end the following new subsection:
``(vv) Verification of Certain Eligibility Criteria.--
``(1) In general.--For purposes of subsection (a)(90), the
eligibility verification requirements, beginning January 1,
2026, are as follows:
``(A) Quarterly screening to verify enrollee
status.--The State shall, not less frequently than
quarterly, review the Death Master File (as such term
is defined in section 203(d) of the Bipartisan Budget
Act of 2013) to determine whether any individuals
enrolled for medical assistance under the State plan
(or waiver of such plan) are deceased.
``(B) Disenrollment under state plan.--If the State
determines, based on information obtained from the
Death Master File, that an individual enrolled for
medical assistance under the State plan (or waiver of
such plan) is deceased, the State shall--
``(i) treat such information as factual
information confirming the death of a
beneficiary for purposes of section 431.213(a)
of title 42, Code of Federal Regulations (or
any successor regulation);
``(ii) disenroll such individual from the
State plan (or waiver of such plan); and
``(iii) discontinue any payments for
medical assistance under this title made on
behalf of such individual (other than payments
for any items or services furnished to such
individual prior to the death of such
individual).
``(C) Reinstatement of coverage in the event of
error.--If a State determines that an individual was
misidentified as deceased based on information obtained
from the Death Master File, and was erroneously
disenrolled from medical assistance under the State
plan (or waiver of such plan) based on such
misidentification, the State shall immediately reenroll
such individual under the State plan (or waiver of such
plan), retroactive to the date of such disenrollment.
``(2) Rule of construction.--Nothing under this subsection
shall be construed to preclude the ability of a State to use
other electronic data sources to timely identify potentially
deceased beneficiaries, so long as the State is also in
compliance with the requirements of this subsection (and all
other requirements under this title relating to Medicaid
eligibility determination and redetermination).''.
SEC. 108. ONE-YEAR DELAY OF MEDICAID AND CHIP REQUIREMENTS FOR HEALTH
SCREENINGS, REFERRALS, AND CASE MANAGEMENT SERVICES FOR
ELIGIBLE JUVENILES IN PUBLIC INSTITUTIONS; STATE INTERIM
WORK PLANS.
(a) In General.--Section 5121(d) of subtitle C of title V of
division FF of the Consolidated Appropriations Act, 2023 (Public Law
117-328) is amended--
(1) by striking ``The amendments made by this section'' and
inserting the following:
``(1) In general.--Subject to paragraph (2), the amendments
made by this section''; and
(2) by adding at the end the following new paragraph:
``(2) Delay of date by which states must comply with
certain juvenile justice-related requirements.--A State shall
not be regarded as failing to comply with the requirements of
section 1902(a)(84)(D) or 2102(d)(2) of the Social Security Act
(42 U.S.C. 1396a(a)(84)(D), 1397bb(d)(2)) before January 1,
2026.''.
(b) Clarifying Nonapplication of Requirements to Individuals in
Federal Custody.--
(1) Medicaid.--
(A) Subparagraph (D) of section 1902(a)(84) of the
Social Security Act (42 U.S.C. 1396a(a)(84)), as added
by section 5121 of subtitle C of title V of division FF
of the Consolidated Appropriations Act, 2023 (Public
Law 117-328), is amended by striking ``an individual
who is an eligible juvenile'' and inserting ``an
individual (other than an individual who is in Federal
custody, including as an inmate in a Federal prison)
who is an eligible juvenile''.
(B) Section 5122(a) of subtitle C of title V of
division FF of the Consolidated Appropriations Act,
2023 (Public Law 117-328) is amended--
(i) by striking ``paragraph (31)'' each
place it appears and inserting ``the last
numbered paragraph''; and
(ii) in paragraph (1), by striking ``an
individual who is an eligible juvenile'' and
inserting ``an individual (other than an
individual who is in Federal custody, including
as an inmate in a Federal prison) who is an
eligible juvenile''.
(2) CHIP.--
(A) Subsection (d)(2) of section 2102 of the Social
Security Act (42 U.S.C. 1397bb), as added by section
5121 of subtitle C of title V of division FF of the
Consolidated Appropriations Act, 2023 (Public Law 117-
328), is amended by striking ``a targeted low-income
child who'' and inserting ``a targeted low income child
(other than a child who is in Federal custody,
including as an inmate in a Federal prison) who''.
(B) Section 5122(b)(2) of subtitle C of title V of
division FF of the Consolidated Appropriations Act,
2023 (Public Law 117-328) is amended by striking ``a
child who is'' and inserting ``a child (other than a
child who is in Federal custody, including as an inmate
in a Federal prison) who is''.
(3) Effective date.--The amendments made by this subsection
shall take effect as if enacted on December 29, 2022.
(c) Interim Work Plan.--Not later than June 30, 2025, each State
(as such term is defined in section 1101(a)(1) of the Social Security
Act (42 U.S.C. 1301(a)(1)) for purposes of titles XIX and XXI of such
Act) shall submit to the Secretary of Health and Human Services an
interim work plan, in such form and containing such information as the
Secretary may specify, describing the State's progress towards
implementing, and its plans to come into compliance with, the
requirements imposed by the amendments made by section 5121 of subtitle
C of title V of division FF of the Consolidated Appropriations Act,
2023 (Public Law 117-328), consistent with the guidance issued by the
Centers for Medicare & Medicaid Services in State Health Official
Letter #24-004 on July 23, 2024.
SEC. 109. STATE STUDIES AND HHS REPORT ON COSTS OF PROVIDING MATERNITY,
LABOR, AND DELIVERY SERVICES.
(a) State Study.--
(1) In general.--Not later than 24 months after the date of
enactment of this Act, and every 5 years thereafter, each State
(as such term is defined in section 1101(a)(1) of the Social
Security Act (42 U.S.C. 1301(a)(1)) for purposes of titles XIX
and XXI of such Act) shall conduct a study on the costs of
providing maternity, labor, and delivery services in applicable
hospitals (as defined in paragraph (3)) and submit the results
of such study to the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'').
(2) Content of study.--A State study required under
paragraph (1) shall include the following information (to the
extent practicable) with respect to maternity, labor, and
delivery services furnished by applicable hospitals located in
the State:
(A) An estimate of the cost of providing maternity,
labor, and delivery services at applicable hospitals,
based on the expenditures a representative sample of
such hospitals incurred for providing such services
during the 2 most recent years for which data is
available.
(B) An estimate of the cost of providing maternity,
labor, and delivery services at applicable hospitals
that ceased providing labor and delivery services
within the past 5 years, based on the expenditures a
representative sample of such hospitals incurred for
providing such services during the 2 most recent years
for which data is available.
(C) To the extent data allows, an analysis of the
extent to which geographic location, community
demographics, and local economic factors (as defined by
the Secretary) affect the cost of providing maternity,
labor, and delivery services at applicable hospitals,
including the cost of services that support the
provision of maternity, labor, and delivery services.
(D) The amounts applicable hospitals are paid for
maternity, labor, and delivery services, by geographic
location and hospital size, under--
(i) Medicare;
(ii) the State Medicaid program, including
payment amounts for such services under fee-
for-service payment arrangements and under
managed care (as applicable);
(iii) the State CHIP plan, including
payment amounts for such services under fee-
for-service payment arrangements and under
managed care (as applicable); and
(iv) private health insurance.
(E) A comparative payment rate analysis--
(i) comparing payment rates for maternity,
labor, and delivery services (inclusive of all
payments received by applicable hospitals for
furnishing maternity, labor, and delivery
services) under the State Medicaid fee-for-
service program to such payment rates for such
services under Medicare (as described in
section 447.203(b)(3) of title 42, Code of
Federal Regulations), other Federally-funded or
State-funded programs (including, to the extent
data is available, Medicaid managed care
rates), and to the payment rates for such
services, to the extent data is available, of
private health insurers within geographic areas
of the State; and
(ii) analyzing different payment methods
for such services, such as the use of bundled
payments, quality incentives, and low-volume
adjustments.
(F) An evaluation, using such methodology and
parameters established by the Secretary, of whether
each hospital located in the State that furnishes
maternity, labor, and delivery services is expected to
experience in the next 3 years significant changes in
particular expenditures or types of reimbursement for
maternity, labor, and delivery services.
(3) Applicable hospital defined.--For purposes of this
subsection, the term ``applicable hospital'' means any hospital
located in a State that meets either of the following criteria:
(A) The hospital provides labor and delivery
services and more than 50 percent of the hospital's
births (in the most recent year for which such data is
available) are financed by the Medicaid program or
CHIP.
(B) The hospital--
(i) is located in a rural area (as defined
by the Federal Office of Rural Health Policy
for the purpose of rural health grant programs
administered by such Office);
(ii) based on the most recent 2 years of
data available (as determined by the
Secretary), furnished services for less than an
average of 300 births per year; and
(iii) provides labor and delivery services.
(4) Assistance to small hospitals in compiling cost
information.--There are appropriated to the Secretary for
fiscal year 2025, $10,000,000 for the purpose of providing
grants and technical assistance to a hospital described in
paragraph (3)(B) to enable such hospital to compile detailed
information for use in the State studies required under
paragraph (1), to remain available until expended.
(5) HHS report on state studies.--For each year in which a
State is required to conduct a study under paragraph (1), the
Secretary shall issue, not later than 12 months after the date
on which the State submits to the Secretary the data described
in such paragraph, a publicly available report that compiles
and details the results of such study and includes the
information described in paragraph (2).
(b) HHS Report on National Data Collection Findings.--Not later
than 3 years after the date of enactment of this Act, the Secretary
shall submit to Congress, and make publicly available, a report
analyzing the first studies conducted by States under subsection
(a)(1), including recommendations for improving data collection on the
cost of providing maternity, labor, and delivery services.
(c) Implementation Funding.--In addition to the amount appropriated
under subsection (a)(4), there are appropriated, out of any funds in
the Treasury not otherwise obligated, $3,000,000 for fiscal year 2025,
to remain available until expended, to the Secretary of Health and
Human Services for purposes of implementing this section.
SEC. 110. MODIFYING CERTAIN DISPROPORTIONATE SHARE HOSPITAL ALLOTMENTS.
(a) Extending Tennessee DSH Allotments.--Section 1923(f)(6)(A)(vi)
of the Social Security Act (42 U.S.C. 1396r-4(f)(6)(A)(vi)) is
amended--
(1) in the heading, by striking ``2025'' and inserting
``2026 and for the 1st quarter of fiscal year 2027'';
(2) by striking ``fiscal year 2025'' and inserting ``fiscal
year 2026''; and
(3) by inserting ``, and the DSH allotment for Tennessee
for the 1st quarter of fiscal year 2027, shall be $13,275,000''
before the period.
(b) Eliminating and Delaying DSH Allotment Reductions.--Section
1923(f) of the Social Security Act (42 U.S.C. 1396r-4(f)) is amended--
(1) in paragraph (7)(A)--
(A) in clause (i), in the matter preceding
subclause (I), by striking ``April 1, 2025,'' and all
that follows through ``2027'' and inserting ``January
1, 2027, and ending September 30, 2027, and for fiscal
year 2028''; and
(B) in clause (ii), by striking ``April 1, 2025,''
and all that follows through ``2027'' and inserting
``January 1, 2027, and ending September 30, 2027, and
for fiscal year 2028''; and
(2) in paragraph (8), by striking ``2027'' and inserting
``2028''.
SEC. 111. MODIFYING CERTAIN LIMITATIONS ON DISPROPORTIONATE SHARE
HOSPITAL PAYMENT ADJUSTMENTS UNDER THE MEDICAID PROGRAM.
(a) In General.--Section 1923(g) of the Social Security Act (42
U.S.C. 1396r-4(g)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``(other than a hospital described in
paragraph (2)(B))'';
(ii) in clause (i), by inserting ``with
respect to such hospital and year'' after
``described in subparagraph (B)''; and
(iii) in clause (ii)--
(I) in subclause (I), by striking
``and'' at the end;
(II) in subclause (II), by striking
the period and inserting ``; and''; and
(III) by adding at the end the
following new subclause:
``(III) payments made under title
XVIII or by an applicable plan (as
defined in section 1862(b)(8)(F)) for
such services.''; and
(B) in subparagraph (B)--
(i) in the matter preceding clause (i), by
striking ``in this clause are'' and inserting
``in this subparagraph are, with respect to a
hospital and a year,''; and
(ii) by adding at the end the following new
clause:
``(iii) Individuals who are eligible for
medical assistance under the State plan or
under a waiver of such plan and for whom the
State plan or waiver is a payor for such
services after application of benefits under
title XVIII or under an applicable plan (as
defined in section 1862(b)(8)(F)), but only if
the hospital has in the aggregate incurred
costs exceeding payments under such State plan,
waiver, title XVIII, or applicable plan for
such services furnished to such individuals
during such year.'';
(2) by striking paragraph (2);
(3) by redesignating paragraph (3) as paragraph (2); and
(4) in paragraph (2), as so redesignated, by striking
``Notwithstanding paragraph (2) of this subsection (as in
effect on October 1, 2021), paragraph (2)'' and inserting
``Paragraph (2)''.
(b) Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by this section shall apply to payment
adjustments made under section 1923 of the Social Security Act
(42 U.S.C. 1396r-4) for Medicaid State plan rate years
beginning on or after the date of enactment of this Act.
(2) State option to distribute unspent dsh allotments from
prior years up to modified cap.--
(A) In general.--If, for any Medicaid State plan
rate year that begins on or after October 1, 2021, and
before the date of enactment of this Act, a State did
not spend the full amount of its Federal fiscal year
allotment under section 1923 of the Social Security Act
(42 U.S.C. 1396r-4) applicable to that State plan rate
year, the State may use the unspent portion of such
allotment to increase the amount of any payment
adjustment made to a hospital for such rate year,
provided that--
(i) such payment adjustment (as so
increased) is consistent with subsection (g) of
such section (as amended by this section); and
(ii) the total amount of all payment
adjustments for the State plan rate year (as so
increased) does not exceed the disproportionate
share hospital allotment for the State and
applicable Federal fiscal year under subsection
(f) of such section.
(B) No recoupment of payments already made to
hospitals.--A State shall not recoup any payment
adjustment made by the State to a hospital for a
Medicaid State plan rate year described in subparagraph
(A) if such payment adjustment is consistent with
section 1923(g) of such Act (42 U.S.C. 1396r-4(g)) as
in effect on October 1, 2021.
(C) Authority to permit retroactive modification of
state plan amendments to allow for increases.--
(i) In general.--Subject to paragraph (2),
solely for the purpose of allowing a State to
increase the amount of a payment adjustment to
a hospital for a Medicaid State plan rate year
described in subparagraph (A) pursuant to this
paragraph, a State may retroactively modify a
provision of the Medicaid State plan, a waiver
of such plan, or a State plan amendment that
relates to such rate year and the Secretary may
approve such modification.
(ii) Deadline.--A State may not submit a
request for approval of a retroactive
modification to a provision of the Medicaid
State plan, a waiver of such plan, or a State
plan amendment for a Medicaid State plan rate
year after the date by which the State is
required to submit the independent certified
audit for that State plan rate year as required
under section 1923(j)(2) of the Social Security
Act (42 U.S.C. 1396r-4(j)(2)).
(D) Reporting.--If a State increases a payment
adjustment made to a hospital for a Medicaid State plan
rate year pursuant to this paragraph, the State shall
include information on such increased payment
adjustment as part of the next annual report submitted
by the State under section 1923(j)(1) of the Social
Security Act (42 U.S.C. 1396r-4(j)(1)).
SEC. 112. ENSURING ACCURATE PAYMENTS TO PHARMACIES UNDER MEDICAID.
(a) In General.--Section 1927(f) of the Social Security Act (42
U.S.C. 1396r-8(f)) is amended--
(1) in paragraph (1)(A)--
(A) by redesignating clause (ii) as clause (iii);
and
(B) by striking ``and'' after the semicolon at the
end of clause (i) and all that precedes it through
``(1)'' and inserting the following:
``(1) Determining pharmacy actual acquisition costs.--The
Secretary shall conduct a survey of retail community pharmacy
drug prices and applicable non-retail pharmacy drug prices to
determine national average drug acquisition cost benchmarks (as
such term is defined by the Secretary) as follows:
``(A) Use of vendor.--The Secretary may contract
services for--
``(i) with respect to retail community
pharmacies, the determination of retail survey
prices of the national average drug acquisition
cost for covered outpatient drugs that
represent a nationwide average of consumer
purchase prices for such drugs, net of all
discounts, rebates, and other price concessions
(to the extent any information with respect to
such discounts, rebates, and other price
concessions is available) based on a monthly
survey of such pharmacies;
``(ii) with respect to applicable non-
retail pharmacies--
``(I) the determination of survey
prices, separate from the survey prices
described in clause (i), of the non-
retail national average drug
acquisition cost for covered outpatient
drugs that represent a nationwide
average of consumer purchase prices for
such drugs, net of all discounts,
rebates, and other price concessions
(to the extent any information with
respect to such discounts, rebates, and
other price concessions is available)
based on a monthly survey of such
pharmacies; and
``(II) at the discretion of the
Secretary, for each type of applicable
non-retail pharmacy, the determination
of survey prices, separate from the
survey prices described in clause (i)
or subclause (I) of this clause, of the
national average drug acquisition cost
for such type of pharmacy for covered
outpatient drugs that represent a
nationwide average of consumer purchase
prices for such drugs, net of all
discounts, rebates, and other price
concessions (to the extent any
information with respect to such
discounts, rebates, and other price
concessions is available) based on a
monthly survey of such pharmacies;
and'';
(2) in subparagraph (B) of paragraph (1), by striking
``subparagraph (A)(ii)'' and inserting ``subparagraph
(A)(iii)'';
(3) in subparagraph (D) of paragraph (1), by striking
clauses (ii) and (iii) and inserting the following:
``(ii) The vendor must update the Secretary
no less often than monthly on the survey prices
for covered outpatient drugs.
``(iii) The vendor must differentiate, in
collecting and reporting survey data, for all
cost information collected, whether a pharmacy
is a retail community pharmacy or an applicable
non-retail pharmacy, including whether such
pharmacy is an affiliate (as defined in
subsection (k)(14)), and, in the case of an
applicable non-retail pharmacy, which type of
applicable non-retail pharmacy it is using the
relevant pharmacy type indicators included in
the guidance required by subsection (d)(2) of
section 112 of the Bipartisan Health Care
Act.'';
(4) 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 or
applicable non-retail pharmacy in the State that
receives any payment, reimbursement, administrative
fee, discount, rebate, or other price concession
related to the dispensing of covered outpatient drugs
to individuals receiving benefits under this title,
regardless of whether such payment, reimbursement,
administrative fee, discount, rebate, or other price
concession is received from the State or a managed care
entity or other specified entity (as such terms are
defined in section 1903(m)(9)(D)) directly or from a
pharmacy benefit manager or another entity that has a
contract with the State or a managed care entity or
other specified entity (as so defined), shall respond
to surveys conducted under this paragraph.
``(G) Survey information.--Information on national
drug acquisition prices obtained under this paragraph
shall be made publicly available in a form and manner
to be determined by the Secretary and shall include at
least the following:
``(i) The monthly response rate to the
survey including a list of pharmacies not in
compliance with subparagraph (F).
``(ii) The sampling methodology and number
of pharmacies sampled monthly.
``(iii) Information on price concessions to
pharmacies, including discounts, rebates, and
other price concessions, to the extent that
such information may be publicly released and
has been collected by the Secretary as part of
the survey.
``(H) Penalties.--
``(i) In general.--Subject to clauses (ii),
(iii), and (iv), the Secretary shall enforce
the provisions of this paragraph with respect
to a pharmacy through the establishment of
civil money penalties applicable to a retail
community pharmacy or an applicable non-retail
pharmacy.
``(ii) Basis for penalties.--The Secretary
shall impose a civil money penalty established
under this subparagraph on a retail community
pharmacy or applicable non-retail pharmacy if--
``(I) the retail pharmacy or
applicable non-retail pharmacy refuses
or otherwise fails to respond to a
request for information about prices in
connection with a survey under this
subsection;
``(II) knowingly provides false
information in response to such a
survey; or
``(III) otherwise fails to comply
with the requirements established under
this paragraph.
``(iii) Parameters for penalties.--
``(I) In general.--A civil money
penalty established under this
subparagraph may be assessed with
respect to each violation, and with
respect to each non-compliant retail
community pharmacy (including a
pharmacy that is part of a chain) or
non-compliant applicable non-retail
pharmacy (including a pharmacy that is
part of a chain), in an amount not to
exceed $100,000 for each such
violation.
``(II) Considerations.--In
determining the amount of a civil money
penalty imposed under this
subparagraph, the Secretary may
consider the size, business structure,
and type of pharmacy involved, as well
as the type of violation and other
relevant factors, as determined
appropriate by the Secretary.
``(iv) Rule of application.--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 civil money penalty
or proceeding under section 1128A(a).
``(I) Limitation on use of applicable non-retail
pharmacy pricing information.--No State shall use
pricing information reported by applicable non-retail
pharmacies under subparagraph (A)(ii) to develop or
inform payment methodologies for retail community
pharmacies.'';
(5) in paragraph (2)--
(A) in subparagraph (A), by inserting ``, including
payment rates and methodologies for determining
ingredient cost reimbursement under managed care
entities or other specified entities (as such terms are
defined in section 1903(m)(9)(D)),'' after ``under this
title''; and
(B) in subparagraph (B), by inserting ``and the
basis for such dispensing fees'' before the semicolon;
(6) by redesignating paragraph (4) as paragraph (5);
(7) by inserting after paragraph (3) the following new
paragraph:
``(4) Oversight.--
``(A) In general.--The Inspector General of the
Department of Health and Human Services shall conduct
periodic studies of the survey data reported under this
subsection, as appropriate, including with respect to
substantial variations in acquisition costs or other
applicable costs, as well as with respect to how
internal transfer prices and related party transactions
may influence the costs reported by pharmacies that are
affiliates (as defined in subsection (k)(14)) or are
owned by, controlled by, or related under a common
ownership structure with a wholesaler, distributor, or
other entity that acquires covered outpatient drugs
relative to costs reported by pharmacies not affiliated
with such entities. The Inspector General shall provide
periodic updates to Congress on the results of such
studies, as appropriate, in a manner that does not
disclose trade secrets or other proprietary
information.
``(B) Appropriation.--There is appropriated to the
Inspector General of the Department of Health and Human
Services, out of any money in the Treasury not
otherwise appropriated, $5,000,000 for fiscal year
2025, to remain available until expended, to carry out
this paragraph.''; and
(8) in paragraph (5), as so redesignated--
(A) by inserting ``, and $9,000,000 for fiscal year
2025 and each fiscal year thereafter,'' after ``2010'';
and
(B) by inserting ``Funds appropriated under this
paragraph for fiscal year 2025 and any subsequent
fiscal year shall remain available until expended.''
after the period.
(b) Definitions.--Section 1927(k) of the Social Security Act (42
U.S.C. 1396r-8(k)) is amended--
(1) in the matter preceding paragraph (1), by striking ``In
the section'' and inserting ``In this section''; and
(2) by adding at the end the following new paragraphs:
``(12) Applicable non-retail pharmacy.--The term
`applicable non-retail pharmacy' means a pharmacy that is
licensed as a pharmacy by the State and that is not a retail
community pharmacy, including a pharmacy that dispenses
prescription medications to patients primarily through mail and
specialty pharmacies. Such term does not include nursing home
pharmacies, long-term care facility pharmacies, hospital
pharmacies, clinics, charitable or not-for-profit pharmacies,
government pharmacies, or low dispensing pharmacies (as defined
by the Secretary).
``(13) Affiliate.--The term `affiliate' means any entity
that is owned by, controlled by, or related under a common
ownership structure with a pharmacy benefit manager or a
managed care entity or other specified entity (as such terms
are defined in section 1903(m)(9)(D)).''.
(c) Effective Date.--
(1) In general.--Subject to paragraph (2), the amendments
made by this section shall take effect on the first day of the
first quarter that begins on or after the date that is 6 months
after the date of enactment of this Act.
(2) Delayed application to applicable non-retail
pharmacies.--The pharmacy survey requirements established by
the amendments to section 1927(f) of the Social Security Act
(42 U.S.C. 1396r-8(f)) made by this section shall apply to
retail community pharmacies beginning on the effective date
described in paragraph (1), but shall not apply to applicable
non-retail pharmacies until the first day of the first quarter
that begins on or after the date that is 18 months after the
date of enactment of this Act.
(d) Identification of Applicable Non-Retail Pharmacies.--
(1) In general.--Not later than January 1, 2026, the
Secretary of Health and Human Services shall, in consultation
with stakeholders as appropriate, publish guidance specifying
pharmacies that meet the definition of applicable non-retail
pharmacies (as such term is defined in subsection (k)(12) of
section 1927 of the Social Security Act (42 U.S.C. 1396r-8), as
added by subsection (b)), and that will be subject to the
survey requirements under subsection (f)(1) of such section, as
amended by subsection (a).
(2) Inclusion of pharmacy type indicators.--The guidance
published under paragraph (1) shall include pharmacy type
indicators to distinguish between different types of applicable
non-retail pharmacies, such as pharmacies that dispense
prescriptions primarily through the mail and pharmacies that
dispense prescriptions that require special handling or
distribution. An applicable non-retail pharmacy may be
identified through multiple pharmacy type indicators.
(e) Implementation.--
(1) In general.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services may implement
the amendments made by this section by program instruction or
otherwise.
(2) Nonapplication of administrative procedure act.--
Implementation of the amendments made by this section shall be
exempt from the requirements of section 553 of title 5, United
States Code.
(f) Nonapplication of Paperwork Reduction Act.--Chapter 35 of title
44, United States Code, shall not apply to any data collection
undertaken by the Secretary of Health and Human Services under section
1927(f) of the Social Security Act (42 U.S.C. 1396r-8(f)), as amended
by this section.
SEC. 113. PREVENTING THE USE OF ABUSIVE SPREAD PRICING IN MEDICAID.
(a) In General.--Section 1927 of the Social Security Act (42 U.S.C.
1396r-8) is amended--
(1) in subsection (e), by adding at the end the following
new paragraph:
``(6) Transparent prescription drug pass-through pricing
required.--
``(A) In general.--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) and
collectively referred to in this paragraph as the
`entity') 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 transparent prescription drug
pass-through pricing model under which--
``(i) any payment made by the entity or the
PBM (as applicable) for such a drug--
``(I) is limited to--
``(aa) ingredient cost; and
``(bb) a professional
dispensing fee that is not less
than the professional
dispensing fee that the State
would pay if the State were
making the payment directly in
accordance with the State plan;
``(II) is passed through in its
entirety (except as reduced under
Federal or State laws and regulations
in response to instances of waste,
fraud, or abuse) by the entity or PBM
to the pharmacy or provider that
dispenses the drug; and
``(III) is made in a manner that is
consistent with sections 447.502,
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, except that any
payment by the entity or the PBM for
the ingredient cost of such drug
purchased by a covered entity (as
defined in subsection (a)(5)(B)) may
exceed the actual acquisition cost (as
defined in 447.502 of title 42, Code of
Federal Regulations, or any successor
regulation) for such drug if--
``(aa) such drug was
subject to an agreement under
section 340B of the Public
Health Service Act;
``(bb) such payment for the
ingredient cost of such drug
does not exceed the maximum
payment that would have been
made by the entity or the PBM
for the ingredient cost of such
drug if such drug had not been
purchased by such covered
entity; and
``(cc) such covered entity
reports to the Secretary (in a
form and manner specified by
the Secretary), on an annual
basis and with respect to
payments for the ingredient
costs of such drugs so
purchased by such covered
entity that are in excess of
the actual acquisition costs
for such drugs, the aggregate
amount of such excess;
``(ii) payment to the entity or the PBM (as
applicable) for administrative services
performed by the entity or PBM is limited to an
administrative fee that reflects the fair
market value (as defined by the Secretary) of
such services;
``(iii) the entity or the PBM (as
applicable) makes available to the State, and
the Secretary upon request in a form and manner
specified by the Secretary, all costs and
payments related to covered outpatient drugs
and accompanying administrative services (as
described in clause (ii)) incurred, received,
or made by the entity or the PBM, broken down
(as specified by the Secretary), to the extent
such costs and payments are attributable to an
individual covered outpatient drug, by each
such drug, including any ingredient costs,
professional dispensing fees, administrative
fees (as described in clause (ii)), post-sale
and post-invoice fees, discounts, or related
adjustments such as direct and indirect
remuneration fees, and any and all other
remuneration, as defined by the Secretary; and
``(iv) any form of spread pricing whereby
any amount charged or claimed by the entity or
the PBM (as applicable) that exceeds the amount
paid to the pharmacies or providers on behalf
of the State or entity, including any post-sale
or post-invoice fees, discounts, or related
adjustments such as direct and indirect
remuneration fees or assessments, as defined by
the Secretary, (after allowing for an
administrative fee as described in clause (ii))
is not allowable for purposes of claiming
Federal matching payments under this title.
``(B) Publication of information.--The Secretary
shall publish, not less frequently than on an annual
basis and in a manner that does not disclose the
identity of a particular covered entity or
organization, information received by the Secretary
pursuant to subparagraph (A)(iii)(III) that is broken
out by State and by each of the following categories of
covered entity within each such State:
``(i) Covered entities described in
subparagraph (A) of section 340B(a)(4) of the
Public Health Service Act.
``(ii) Covered entities described in
subparagraphs (B) through (K) of such section.
``(iii) Covered entities described in
subparagraph (L) of such section.
``(iv) Covered entities described in
subparagraph (M) of such section.
``(v) Covered entities described in
subparagraph (N) of such section.
``(vi) Covered entities described in
subparagraph (O) of such section.''; and
(2) in subsection (k), as previously amended by this title,
by adding at the end the following new paragraph:
``(14) Pharmacy benefit manager.--The term `pharmacy
benefit manager' means any person or entity that, either
directly or through an intermediary, acts as a price negotiator
or group purchaser on behalf of a State, managed care entity
(as defined in section 1903(m)(9)(D)), or other specified
entity (as so defined), or manages the prescription drug
benefits provided by a State, managed care entity, or other
specified entity, including the processing and payment of
claims for prescription drugs, the performance of drug
utilization review, the processing of drug prior authorization
requests, the managing of appeals or grievances related to the
prescription drug benefits, contracting with pharmacies,
controlling the cost of covered outpatient drugs, or the
provision of services related thereto. Such term includes any
person or entity that acts as a price negotiator (with regard
to payment amounts to pharmacies and providers for a covered
outpatient drug or the net cost of the drug) or group purchaser
on behalf of a State, managed care entity, or other specified
entity or that carries out 1 or more of the other activities
described in the preceding sentence, irrespective of whether
such person or entity calls itself a pharmacy benefit
manager.''.
(b) Conforming Amendments.--Section 1903(m) of such Act (42 U.S.C.
1396b(m)) is amended--
(1) in paragraph (2)(A)(xiii)--
(A) by striking ``and (III)'' and inserting
``(III)'';
(B) by inserting before the period at the end the
following: ``, and (IV) if the contract includes
provisions making the entity responsible for coverage
of covered outpatient drugs, the entity shall comply
with the requirements of section 1927(e)(6)''; and
(C) by moving the margin 2 ems to the left; and
(2) by adding at the end the following new paragraph:
``(10) No payment shall be made under this title to a State
with respect to expenditures incurred by the State for payment
for services provided by an other specified entity (as defined
in paragraph (9)(D)(iii)) unless such services are provided in
accordance with a contract between the State and such entity
which satisfies the requirements of paragraph (2)(A)(xiii).''.
(c) Effective Date.--The amendments made by this section shall
apply to contracts between States and managed care entities, other
specified entities, or pharmacy benefit managers that have an effective
date beginning on or after the date that is 18 months after the date of
enactment of this Act.
(d) Implementation.--
(1) In general.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services may implement
the amendments made by this section by program instruction or
otherwise.
(2) Nonapplication of administrative procedure act.--
Implementation of the amendments made by this section shall be
exempt from the requirements of section 553 of title 5, United
States Code.
(e) Nonapplication of Paperwork Reduction Act.--Chapter 35 of title
44, United States Code, shall not apply to any data collection
undertaken by the Secretary of Health and Human Services under section
1927(e) of the Social Security Act (42 U.S.C. 1396r-8(e)), as amended
by this section.
TITLE II--MEDICARE
SEC. 201. EXTENSION OF INCREASED INPATIENT HOSPITAL PAYMENT ADJUSTMENT
FOR CERTAIN LOW-VOLUME HOSPITALS.
(a) In General.--Section 1886(d)(12) of the Social Security Act (42
U.S.C. 1395ww(d)(12)) is amended--
(1) in subparagraph (B), in the matter preceding clause
(i), by striking ``fiscal year 2025 beginning on April 1, 2025,
and ending on September 30, 2025, and in fiscal year 2026'' and
inserting ``fiscal year 2026 beginning on January 1, 2026, and
ending on September 30, 2026, and in fiscal year 2027'';
(2) in subparagraph (C)(i)--
(A) in the matter preceding subclause (I), by
striking ``through 2024 and the portion of fiscal year
2025 beginning on October 1, 2024, and ending on March
31, 2025'' and inserting ``through 2025 and the portion
of fiscal year 2026 beginning on October 1, 2025, and
ending on December 31, 2025'';
(B) in subclause (III), by striking ``through 2024
and the portion of fiscal year 2025 beginning on
October 1, 2024, and ending on March 31, 2025'' and
inserting ``through 2025 and the portion of fiscal year
2026 beginning on October 1, 2025, and ending on
December 31, 2025''; and
(C) in subclause (IV), by striking ``fiscal year
2025 beginning on April 1, 2025, and ending on
September 30, 2025, and fiscal year 2026'' and
inserting ``fiscal year 2026 beginning on January 1,
2026, and ending on September 30, 2026, and fiscal year
2027''; and
(3) in subparagraph (D)--
(A) in the matter preceding clause (i), by striking
``through 2024 or during the portion of fiscal year
2025 beginning on October 1, 2024, and ending on March
31, 2025'' and inserting ``through 2025 or during the
portion of fiscal year 2026 beginning on October 1,
2025, and ending on December 31, 2025''; and
(B) in clause (ii), by striking ``through 2024 and
the portion of fiscal year 2025 beginning on October 1,
2024, and ending on March 31, 2025'' and inserting
``through 2025 and the portion of fiscal year 2026
beginning on October 1, 2025, and ending on December
31, 2025''.
(b) Implementation.--Notwithstanding any other provision of law,
the Secretary of Health and Human Services may implement the amendments
made by this section by program instruction or otherwise.
SEC. 202. EXTENSION OF THE MEDICARE-DEPENDENT HOSPITAL (MDH) PROGRAM.
(a) In General.--Section 1886(d)(5)(G) of the Social Security Act
(42 U.S.C. 1395ww(d)(5)(G)) is amended--
(1) in clause (i), by striking ``April 1, 2025'' and
inserting ``January 1, 2026''; and
(2) in clause (ii)(II), by striking ``April 1, 2025'' and
inserting ``January 1, 2026''.
(b) Conforming Amendments.--
(1) In general.--Section 1886(b)(3)(D) of the Social
Security Act (42 U.S.C. 1395ww(b)(3)(D)) is amended--
(A) in the matter preceding clause (i), by striking
``April 1, 2025'' and inserting ``January 1, 2026'';
and
(B) in clause (iv), by striking ``through fiscal
year 2024 and the portion of fiscal year 2025 beginning
on October 1, 2024, and ending on March 31, 2025'' and
inserting ``through fiscal year 2025 and the portion of
fiscal year 2026 beginning on October 1, 2025, and
ending on December 31, 2025''.
(2) Permitting hospitals to decline reclassification.--
Section 13501(e)(2) of the Omnibus Budget Reconciliation Act of
1993 (42 U.S.C. 1395ww note) is amended by striking ``through
fiscal year 2024, or the portion of fiscal year 2025 beginning
on October 1, 2024, and ending on March 31, 2025'' and
inserting ``through fiscal year 2025, or the portion of fiscal
year 2026 beginning on October 1, 2025, and ending on December
31, 2025''.
SEC. 203. EXTENSION OF ADD-ON PAYMENTS FOR AMBULANCE SERVICES.
Section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)) is
amended--
(1) in paragraph (12)(A), by striking ``April 1, 2025'' and
inserting ``January 1, 2027''; and
(2) in paragraph (13), by striking ``April 1, 2025'' each
place it appears and inserting ``January 1, 2027'' in each such
place.
SEC. 204. EXTENDING INCENTIVE PAYMENTS FOR PARTICIPATION IN ELIGIBLE
ALTERNATIVE PAYMENT MODELS.
(a) In General.--Section 1833(z) of the Social Security Act (42
U.S.C. 1395l(z)) is amended--
(1) in paragraph (1)(A)--
(A) by striking ``with 2026'' and inserting ``with
2027''; and
(B) by inserting ``, or, with respect to 2027, 3.53
percent'' after ``1.88 percent'';
(2) in paragraph (2)--
(A) in subparagraph (B)--
(i) in the heading, by striking ``2026''
and inserting ``2027''; and
(ii) in the matter preceding clause (i), by
striking ``2026'' and inserting ``2027'';
(B) in subparagraph (C)--
(i) in the heading, by striking ``2027''
and inserting ``2028''; and
(ii) in the matter preceding clause (i), by
striking ``2027'' and inserting ``2028''; and
(C) in subparagraph (D), by striking ``and 2026''
and inserting ``2026, and 2027''; and
(3) in paragraph (4)(B), by inserting ``or, with respect to
2027, 3.53 percent'' after ``1.88 percent''.
(b) Conforming Amendments.--Section 1848(q)(1)(C)(iii) of the
Social Security Act (42 U.S.C. 1395w-4(q)(1)(C)(iii)) is amended--
(1) in subclause (II), by striking ``2026'' and inserting
``2027''; and
(2) in subclause (III), by striking ``2027'' and inserting
``2028''.
SEC. 205. TEMPORARY PAYMENT INCREASE UNDER THE MEDICARE PHYSICIAN FEE
SCHEDULE TO ACCOUNT FOR EXCEPTIONAL CIRCUMSTANCES.
(a) In General.--Section 1848(t)(1) of the Social Security Act (42
U.S.C. 1395w-4(t)(1)) is amended--
(1) in subparagraph (D), by striking ``and'' at the end;
(2) in subparagraph (E), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following new subparagraph:
``(F) such services furnished on or after March 15,
2025, and before January 1, 2026, by 3.5375 percent.''.
(b) Conforming Amendment.--Section 1848(c)(2)(B)(iv)(V) is amended
by striking ``or 2024'' and inserting ``2024, or 2025''.
SEC. 206. EXTENSION OF FUNDING FOR QUALITY MEASURE ENDORSEMENT, INPUT,
AND SELECTION.
Section 1890(d)(2) of the Social Security Act (42 U.S.C.
1395aaa(d)(2)) is amended--
(1) in the first sentence--
(A) by striking ``$11,030,000'' and inserting
``$14,000,000''; and
(B) by striking ``March 31, 2025'' and inserting
``December 31, 2025''; and
(2) in the third sentence, by striking ``March 31, 2025''
and inserting ``December 31, 2025''.
SEC. 207. EXTENSION OF FUNDING OUTREACH AND ASSISTANCE FOR LOW-INCOME
PROGRAMS.
(a) State Health Insurance Assistance Programs.--Subsection
(a)(1)(B) of section 119 of the Medicare Improvements for Patients and
Providers Act of 2008 (42 U.S.C. 1395b-3 note) is amended--
(1) in clause (xiii), by striking ``and'' at the end;
(2) in clause (xiv), by striking the period and inserting
``; and''; and
(3) by inserting after clause (xiv) the following new
clause:
``(xv) for the period beginning on April 1,
2025, and ending on December 31, 2026,
$26,250,000.''.
(b) Area Agencies on Aging.--Subsection (b)(1)(B) of such section
119 is amended--
(1) in clause (xiii), by striking ``and'' at the end;
(2) in clause (xiv), by striking the period and inserting
``; and''; and
(3) by inserting after clause (xiv) the following new
clause:
``(xv) for the period beginning on April 1,
2025, and ending on December 31, 2026,
$26,250,000.''.
(c) Aging and Disability Resource Centers.--Subsection (c)(1)(B) of
such section 119 is amended--
(1) in clause (xiii), by striking ``and'' at the end;
(2) in clause (xiv), by striking the period and inserting
``; and''; and
(3) by inserting after clause (xiv) the following new
clause:
``(xv) for the period beginning on April 1,
2025, and ending on December 31, 2026,
$7,750,000.''.
(d) Coordination of Efforts To Inform Older Americans About
Benefits Available Under Federal and State Programs.--Subsection (d)(2)
of such section 119 is amended--
(1) in clause (xiii), by striking ``and'' at the end;
(2) in clause (xiv), by striking the period and inserting
``; and''; and
(3) by inserting after clause (xiv) the following new
clause:
``(xv) for the period beginning on April 1,
2025, and ending on December 31, 2026,
$26,250,000.''.
SEC. 208. EXTENSION OF THE WORK GEOGRAPHIC INDEX FLOOR.
Section 1848(e)(1)(E) of the Social Security Act (42 U.S.C. 1395w-
4(e)(1)(E)) is amended by striking ``April 1, 2025'' and inserting
``January 1, 2026''.
SEC. 209. EXTENSION OF CERTAIN TELEHEALTH FLEXIBILITIES.
(a) Removing Geographic Requirements and Expanding Originating
Sites for Telehealth Services.--Section 1834(m) of the Social Security
Act (42 U.S.C. 1395m(m)) is amended--
(1) in paragraph (2)(B)(iii), by striking ``ending March
31, 2025'' and inserting ``ending December 31, 2026''; and
(2) in paragraph (4)(C)(iii), by striking ``ending on March
31, 2025'' and inserting ``ending on December 31, 2026''.
(b) Expanding Practitioners Eligible To Furnish Telehealth
Services.--Section 1834(m)(4)(E) of the Social Security Act (42 U.S.C.
1395m(m)(4)(E)) is amended by striking ``ending on March 31, 2025'' and
inserting ``ending on December 31, 2026''.
(c) Extending Telehealth Services for Federally Qualified Health
Centers and Rural Health Clinics.--Section 1834(m)(8) of the Social
Security Act (42 U.S.C. 1395m(m)(8)) is amended--
(1) in subparagraph (A), by striking ``ending on March 31,
2025'' and inserting ``ending on December 31, 2026'';
(2) in subparagraph (B)--
(A) in the subparagraph heading, by inserting
``before april 1, 2025'' after ``rule'';
(B) in clause (i), by striking ``during the periods
for which subparagraph (A) applies'' and inserting
``before April 1, 2025''; and
(C) in clause (ii), by inserting ``furnished to an
eligible telehealth individual before April 1, 2025''
after ``telehealth services''; and
(3) by adding at the end the following new subparagraph:
``(C) Payment rule for portion of 2025 and 2026.--
``(i) In general.--A telehealth service
furnished to an eligible telehealth individual
by a Federally qualified health center or rural
health clinic on or after April 1, 2025, and
before January 1, 2027, shall be paid as a
Federally qualified health center service or
rural health clinic service (as applicable)
under the prospective payment system
established under section 1834(o) or the
methodology for all-inclusive rates established
under section 1833(a)(3), respectively.
``(ii) Treatment of costs.--Costs
associated with the furnishing of telehealth
services by a Federally qualified health center
or rural health clinic on or after April 1,
2025, and before January 1, 2027, shall be
considered allowable costs for purposes of the
prospective payment system established under
section 1834(o) and the methodology for all-
inclusive rates established under section
1833(a)(3), as applicable.
``(iii) Requiring modifiers.--Not later
than July 1, 2025, the Secretary shall
establish requirements to include 1 or more
codes or modifiers, as determined appropriate
by the Secretary, in the case of claims for
telehealth services furnished to an eligible
telehealth individual by a Federally qualified
health center or rural health clinic.''.
(d) Delaying the In-Person Requirements Under Medicare for Mental
Health Services Furnished Through Telehealth and Telecommunications
Technology.--
(1) Delay in requirements for mental health services
furnished through telehealth.--Section 1834(m)(7)(B)(i) of the
Social Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is amended,
in the matter preceding subclause (I), by striking ``April 1,
2025'' and inserting ``January 1, 2027''.
(2) Mental health visits furnished by rural health
clinics.--Section 1834(y)(2) of the Social Security Act (42
U.S.C. 1395m(y)(2)) is amended by striking ``April 1, 2025''
and inserting ``January 1, 2027''.
(3) Mental health visits furnished by federally qualified
health centers.--Section 1834(o)(4)(B) of the Social Security
Act (42 U.S.C. 1395m(o)(4)(B)) is amended by striking ``April
1, 2025'' and inserting ``January 1, 2027''.
(e) Allowing for the Furnishing of Audio-Only Telehealth
Services.--Section 1834(m)(9) of the Social Security Act (42 U.S.C.
1395m(m)(9)) is amended by striking ``ending on March 31, 2025'' and
inserting ``ending on December 31, 2026''.
(f) Extending Use of Telehealth To Conduct Face-to-Face Encounter
Prior to Recertification of Eligibility for Hospice Care.--Section
1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C.
1395f(a)(7)(D)(i)(II)) is amended--
(1) by striking ``ending on March 31, 2025'' and inserting
``ending on December 31, 2026''; and
(2) by inserting ``, except that this subclause shall not
apply in the case of such an encounter with an individual
occurring on or after April 1, 2025, if such individual is
located in an area that is subject to a moratorium on the
enrollment of hospice programs under this title pursuant to
section 1866(j)(7), if such individual is receiving hospice
care from a provider that is subject to enhanced oversight
under this title pursuant to section 1866(j)(3), or if such
encounter is performed by a hospice physician or nurse
practitioner who is not enrolled under section 1866(j) and is
not an opt-out physician or practitioner (as defined in section
1802(b)(6)(D))'' before the semicolon.
(g) Requiring Modifiers for Telehealth Services in Certain
Instances.--Section 1834(m) of the Social Security Act (42 U.S.C.
1395m(m)) is amended by adding at the end the following new paragraph:
``(10) Required use of modifiers in certain instances.--Not
later than January 1, 2026, the Secretary shall establish
requirements to include 1 or more codes or modifiers, as
determined appropriate by the Secretary, in the case of--
``(A) claims for telehealth services under this
subsection that are furnished through a telehealth
virtual platform--
``(i) by a physician or practitioner that
contracts with an entity that owns such virtual
platform; or
``(ii) for which a physician or
practitioner has a payment arrangement with an
entity for use of such virtual platform; and
``(B) claims for telehealth services under this
subsection that are furnished incident to a physician's
or practitioner's professional service.''.
(h) Program Instruction Authority.--The Secretary of Health and
Human Services may implement the amendments made by this section
through program instruction or otherwise.
SEC. 210. REQUIRING MODIFIER FOR USE OF TELEHEALTH TO CONDUCT FACE-TO-
FACE ENCOUNTER PRIOR TO RECERTIFICATION OF ELIGIBILITY
FOR HOSPICE CARE.
Section 1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C.
1395f(a)(7)(D)(i)(II)), as amended by section 209(f), is further
amended by inserting ``, but only if, in the case of such an encounter
occurring on or after January 1, 2026, any hospice claim includes 1 or
more modifiers or codes (as specified by the Secretary) to indicate
that such encounter was conducted via telehealth'' after ``as
determined appropriate by the Secretary''.
SEC. 211. EXTENDING ACUTE HOSPITAL CARE AT HOME WAIVER FLEXIBILITIES.
Section 1866G of the Social Security Act (42 U.S.C. 1395cc-7) is
amended--
(1) in the section heading, by inserting ``the thomas r.
carper, tim scott, brad r. wenstrup, d.p.m., and earl
blumenauer'' after ``extension of'';
(2) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``March 31, 2025'' and
inserting ``December 31, 2029''; and
(ii) by striking ``in the Acute Hospital
Care at Home initiative of the Secretary'' and
inserting ``in the Thomas R. Carper, Tim Scott,
Brad R. Wenstrup, D.P.M., and Earl Blumenauer
Acute Hospital Care at Home initiative of the
Secretary (in this section referred to as the
`Acute Hospital Care at Home initiative')'';
(B) in paragraph (2), by striking ``of the
Secretary''; and
(C) in paragraph (3)(E), by adding at the end the
following new flush sentence:
``The Secretary may require that such data and
information be submitted through a hospital's cost
report, through such survey instruments as the
Secretary may develop, through medical record
information, or through such other means as the
Secretary determines appropriate.'';
(3) in subsection (b)--
(A) in the subsection heading, by striking
``Study'' and inserting ``Initial Study'';
(B) in paragraph (1)(A), by striking ``of the
Secretary''; and
(C) in paragraph (3), by inserting ``or subsection
(c)'' before the period at the end;
(4) by redesignating subsections (c) and (d) as subsections
(d) and (e), respectively; and
(5) by inserting after subsection (b) the following new
subsection:
``(c) Subsequent Study and Report.--
``(1) In general.--Not later than September 30, 2028, the
Secretary shall conduct a study to--
``(A) analyze, to the extent practicable, the
criteria established by hospitals under the Acute
Hospital Care at Home initiative to determine which
individuals may be furnished services under such
initiative; and
``(B) analyze and compare (both within and between
hospitals participating in the initiative, and relative
to comparable hospitals that do not participate in the
initiative, for relevant parameters such as diagnosis-
related groups)--
``(i) quality of care furnished to
individuals with similar conditions and
characteristics in the inpatient setting and
through the Acute Hospital Care at Home
initiative, including health outcomes, hospital
readmission rates (including readmissions both
within and beyond 30 days post-discharge),
hospital mortality rates, length of stay,
infection rates, composition of care team
(including the types of labor used, such as
contracted labor), the ratio of nursing staff,
transfers from the hospital to the home,
transfers from the home to the hospital
(including the timing, frequency, and causes of
such transfers), transfers and discharges to
post-acute care settings (including the timing,
frequency, and causes of such transfers and
discharges), and patient and caregiver
experience of care;
``(ii) clinical conditions treated and
diagnosis-related groups of discharges from
inpatient settings relative to discharges from
the Acute Hospital Care at Home initiative;
``(iii) costs incurred by the hospital for
furnishing care in inpatient settings relative
to costs incurred by the hospital for
furnishing care through the Acute Hospital Care
at Home initiative, including costs relating to
staffing, equipment, food, prescriptions, and
other services, as determined by the Secretary;
``(iv) the quantity, mix, and intensity of
services (such as in-person visits and virtual
contacts with patients and the intensity of
such services) furnished in inpatient settings
relative to the Acute Hospital Care at Home
initiative, and, to the extent practicable, the
nature and extent of family or caregiver
involvement;
``(v) socioeconomic information on
individuals treated in comparable inpatient
settings relative to the initiative, including
racial and ethnic data, income, housing,
geographic proximity to the brick-and-mortar
facility and whether such individuals are
dually eligible for benefits under this title
and title XIX; and
``(vi) the quality of care, outcomes,
costs, quantity and intensity of services, and
other relevant metrics between individuals who
entered into the Acute Hospital Care at Home
initiative directly from an emergency
department compared with individuals who
entered into the Acute Hospital Care at Home
initiative directly from an existing inpatient
stay in a hospital.
``(2) Selection bias.--In conducting the study under
paragraph (1), the Secretary shall, to the extent practicable,
analyze and compare individuals who participate and do not
participate in the initiative controlling for selection bias or
other factors that may impact the reliability of data.
``(3) Report.--Not later than September 30, 2028, the
Secretary of Health and Human Services shall post on a website
of the Centers for Medicare & Medicaid Services a report on the
study conducted under paragraph (1).
``(4) Funding.--In addition to amounts otherwise available,
there is appropriated to the Centers for Medicare & Medicaid
Services Program Management Account for fiscal year 2026, out
of any amounts in the Treasury not otherwise appropriated,
$6,000,000, respectively, to remain available until expended,
for purposes of carrying out this section.''.
SEC. 212. ENHANCING CERTAIN PROGRAM INTEGRITY REQUIREMENTS FOR DME
UNDER MEDICARE.
(a) Durable Medical Equipment.--
(1) In general.--Section 1834(a) of the Social Security Act
(42 U.S.C. 1395m(a)) is amended by adding at the end the
following new paragraph:
``(23) Master list inclusion and claim review for certain
items.--
``(A) Master list inclusion.--Beginning January 1,
2028, for purposes of the Master List described in
section 414.234(b) of title 42, Code of Federal
Regulations (or any successor regulation), an item for
which payment may be made under this subsection shall
be treated as having aberrant billing patterns (as such
term is used for purposes of such section) if the
Secretary determines that, without explanatory
contributing factors (such as furnishing emergent care
services), a substantial number of claims for such
items under this subsection are for such items ordered
by a physician or practitioner who has not previously
(during a period of not less than 24 months, as
established by the Secretary) furnished to the
individual involved any item or service for which
payment may be made under this title.
``(B) Claim review.--With respect to items
furnished on or after January 1, 2028, that are
included on the Master List pursuant to subparagraph
(A), if such an item is not subject to a determination
of coverage in advance pursuant to paragraph (15)(C),
the Secretary may conduct prepayment review of claims
for payment for such item.''.
(2) Conforming amendment for prosthetic devices, orthotics,
and prosthetics.--Section 1834(h)(3) of the Social Security Act
(42 U.S.C. 1395m(h)(3)) is amended by inserting ``, and
paragraph (23) of subsection (a) shall apply to prosthetic
devices, orthotics, and prosthetics in the same manner as such
provision applies to items for which payment may be made under
such subsection'' before the period at the end.
(b) Report on Identifying Clinical Diagnostic Laboratory Tests at
High Risk for Fraud and Effective Mitigation Measures.--Not later than
January 1, 2026, the Inspector General of the Department of Health and
Human Services shall submit to Congress a report assessing fraud risks
relating to claims for clinical diagnostic laboratory tests for which
payment may be made under section 1834A of the Social Security Act (42
U.S.C. 1395m-1) and effective tools for reducing such fraudulent
claims. The report may include information regarding--
(1) which, if any, clinical diagnostic laboratory tests are
identified as being at high risk of fraudulent claims, and an
analysis of the factors that contribute to such risk;
(2) with respect to a clinical diagnostic laboratory test
identified under paragraph (1) as being at high risk of
fraudulent claims--
(A) the amount payable under such section 1834A
with respect to such test;
(B) the number of such tests furnished to
individuals enrolled under part B of title XVIII of the
Social Security Act (42 U.S.C. 1395j et seq.);
(C) whether an order for such a test was more
likely to come from a provider with whom the individual
involved did not have a prior relationship, as
determined on the basis of prior payment experience;
and
(D) the frequency with which a claim for payment
under such section 1834A included the payment modifier
identified by code 59 or 91; and
(3) suggested strategies for reducing the number of
fraudulent claims made with respect to tests so identified as
being at high risk, including--
(A) an analysis of whether the Centers for Medicare
& Medicaid Services can detect aberrant billing
patterns with respect to such tests in a timely manner;
(B) any strategies for identifying and monitoring
the providers who are outliers with respect to the
number of such tests that such providers order; and
(C) targeted education efforts to mitigate improper
billing for such tests; and
(4) such other information as the Inspector General
determines appropriate.
SEC. 213. GUIDANCE ON FURNISHING SERVICES VIA TELEHEALTH TO INDIVIDUALS
WITH LIMITED ENGLISH PROFICIENCY.
(a) In General.--Not later than 1 year after the date of the
enactment of this section, the Secretary of Health and Human Services,
in consultation with 1 or more entities from each of the categories
described in paragraphs (1) through (7) of subsection (b), shall issue
and disseminate, or update and revise as applicable, guidance for the
entities described in such subsection on the following:
(1) Best practices on facilitating and integrating use of
interpreters during a telemedicine appointment.
(2) Best practices on providing accessible instructions on
how to access telecommunications systems (as such term is used
for purposes of section 1834(m) of the Social Security Act (42
U.S.C. 1395m(m)) for individuals with limited English
proficiency.
(3) Best practices on improving access to digital patient
portals for individuals with limited English proficiency.
(4) Best practices on integrating the use of video
platforms that enable multi-person video calls furnished via a
telecommunications system for purposes of providing
interpretation during a telemedicine appointment for an
individual with limited English proficiency.
(5) Best practices for providing patient materials,
communications, and instructions in multiple languages,
including text message appointment reminders and prescription
information.
(b) Entities Described.--For purposes of subsection (a), an entity
described in this subsection is an entity in 1 or more of the following
categories:
(1) Health information technology service providers,
including--
(A) electronic medical record companies;
(B) remote patient monitoring companies; and
(C) telehealth or mobile health vendors and
companies.
(2) Health care providers, including--
(A) physicians; and
(B) hospitals.
(3) Health insurers.
(4) Language service companies.
(5) Interpreter or translator professional associations.
(6) Health and language services quality certification
organizations.
(7) Patient and consumer advocates, including such
advocates that work with individuals with limited English
proficiency.
SEC. 214. IN-HOME CARDIOPULMONARY REHABILITATION FLEXIBILITIES.
(a) In General.--Section 1861(eee)(2) of the Social Security Act
(42 U.S.C. 1395x(eee)(2)) is amended--
(1) in subparagraph (A)(ii), by inserting ``(including,
with respect to items and services furnished through audio and
video real-time communications technology (excluding audio-
only) on or after April 1, 2025, and before January 1, 2027, in
the home of an individual who is an outpatient of the
hospital)'' after ``outpatient basis''; and
(2) in subparagraph (B), by inserting ``(including, with
respect to items and services furnished through audio and video
real-time communications technology on or after April 1, 2025,
and before January 1, 2027, the virtual presence of such
physician, physician assistant, nurse practitioner, or clinical
nurse specialist)'' after ``under the program''.
(b) Program Instruction Authority.--Notwithstanding any other
provision of law, the Secretary of Health and Human Services may
implement the amendments made by this section by program instruction or
otherwise.
SEC. 215. INCLUSION OF VIRTUAL DIABETES PREVENTION PROGRAM SUPPLIERS IN
MDPP EXPANDED MODEL.
(a) In General.--Not later than January 1, 2026, the Secretary
shall revise the regulations under parts 410 and 424 of title 42, Code
of Federal Regulations, to provide that, for the period beginning
January 1, 2026, and ending December 31, 2030--
(1) an entity may participate in the MDPP by offering only
online MDPP services via synchronous or asynchronous technology
or telecommunications if such entity meets the conditions for
enrollment as an MDPP supplier (as specified in section
424.205(b) of title 42, Code of Federal Regulations (or a
successor regulation));
(2) if an entity participates in the MDPP in the manner
described in paragraph (1)--
(A) the administrative location of such entity
shall be the address of the entity on file under the
Diabetes Prevention Recognition Program; and
(B) in the case of online MDPP services furnished
by such entity to an MDPP beneficiary who was not
located in the same State as the entity at the time
such services were furnished, the entity shall not be
prohibited from submitting a claim for payment for such
services solely by reason of the location of such
beneficiary at such time; and
(3) no limit is applied on the number of times an
individual may enroll in the MDPP.
(b) Definitions.--In this section:
(1) MDPP.--The term ``MDPP'' means the Medicare Diabetes
Prevention Program conducted under section 1115A of the Social
Security Act (42 U.S.C. 1315a), as described in the final rule
published in the Federal Register entitled ``Medicare and
Medicaid Programs; CY 2024 Payment Policies Under the Physician
Fee Schedule and Other Changes to Part B Payment and Coverage
Policies; Medicare Shared Savings Program Requirements;
Medicare Advantage; Medicare and Medicaid Provider and Supplier
Enrollment Policies; and Basic Health Program'' (88 Fed. Reg.
78818 (November 16, 2023)) (or a successor regulation).
(2) Regulatory terms.--The terms ``Diabetes Prevention
Recognition Program'', ``full CDC DPRP recognition'', ``MDPP
beneficiary'', ``MDPP services'', and ``MDPP supplier'' have
the meanings given each such term in section 410.79(b) of title
42, Code of Federal Regulations.
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
SEC. 216. MEDICATION-INDUCED MOVEMENT DISORDER OUTREACH AND EDUCATION.
Not later than January 1, 2026, the Secretary shall use existing
communications mechanisms to provide education and outreach to
physicians and appropriate non-physician practitioners participating
under the Medicare program under title XVIII of the Social Security Act
(42 U.S.C. 1395 et seq.) with respect to periodic screening for
medication-induced movement disorders that are associated with the
treatment of mental health disorders in at-risk patients, as well as
resources related to clinical guidelines and best practices for
furnishing such screening services through telehealth. Such education
and outreach shall include information on how to account for such
screening services in evaluation and management code selection. The
Secretary shall, to the extent practicable, seek input from relevant
stakeholders to inform such education and outreach. Such education and
outreach may also address other relevant screening services furnished
through telehealth, as the Secretary determines appropriate.
SEC. 217. REPORT ON WEARABLE MEDICAL DEVICES.
Not later than 18 months after the date of the enactment of this
Act, the Comptroller General of the United States shall conduct a
technology assessment of, and submit to Congress a report on, the
capabilities and limitations of wearable medical devices used to
support clinical decision-making. Such report shall include a
description of--
(1) the potential for such devices to accurately prescribe
treatments;
(2) an examination of the benefits and challenges of
artificial intelligence to augment such capabilities; and
(3) policy options to enhance the benefits and mitigate
potential challenges of developing or using such devices.
SEC. 218. EXTENSION OF TEMPORARY INCLUSION OF AUTHORIZED ORAL ANTIVIRAL
DRUGS AS COVERED PART D DRUGS.
Section 1860D-2(e)(1)(C) of the Social Security Act (42 U.S.C.
1395w-102(e)(1)(C)) is amended by striking ``March 31, 2025'' and
inserting ``December 31, 2025''.
SEC. 219. EXTENSION OF ADJUSTMENT TO CALCULATION OF HOSPICE CAP AMOUNT.
Section 1814(i)(2)(B) of the Social Security Act (42 U.S.C.
1395f(i)(2)(B)) is amended--
(1) in clause (ii), by striking ``2033'' and inserting
``2034''; and
(2) in clause (iii), by striking ``2033'' and inserting
``2034''.
SEC. 220. MULTIYEAR CONTRACTING AUTHORITY FOR MEDPAC AND MACPAC.
Section 3904 of title 41, United States Code, is amended by adding
at the end the following new subsections:
``(i) The Medicare Payment Advisory Commission.--The Medicare
Payment Advisory Commission may use available funds to enter into
contracts for the procurement of severable services for a period that
begins in one fiscal year and ends in the next fiscal year and may
enter into multiyear contracts for the acquisition of property and
services to the same extent as executive agencies under the authority
of sections 3902 and 3903 of this title.
``(j) The Medicaid and CHIP Payment and Access Commission.--The
Medicaid and CHIP Payment and Access Commission may use available funds
to enter into contracts for the procurement of severable services for a
period that begins in one fiscal year and ends in the next fiscal year
and may enter into multiyear contracts for the acquisition of property
and services to the same extent as executive agencies under the
authority of sections 3902 and 3903 of this title.''.
SEC. 221. CONTRACTING PARITY FOR MEDPAC AND MACPAC.
In fiscal year 2025 and thereafter, for all contracts for goods and
services to which the Medicare and Payment Advisory Commission or the
Medicaid and CHIP Payment and Access Commission is a party, the
following Federal Acquisition Regulation (FAR) clauses will apply: FAR
52.232-39 and FAR 52.233-4 (or a successor clause).
SEC. 222. ADJUSTMENTS TO MEDICARE PART D COST-SHARING REDUCTIONS FOR
LOW-INCOME INDIVIDUALS.
Section 1860D-14(a) of the Social Security Act (42 U.S.C. 1395w-
114(a)) is amended--
(1) in paragraph (1)(D)(ii), by striking ``that does not
exceed $1 for'' and all that follows through the period at the
end and inserting ``that does not exceed--
``(I) for a plan year before 2027--
``(aa) for a generic drug
or a preferred drug that is a
multiple source drug (as
defined in section
1927(k)(7)(A)(i)), $1 or, if
less, the copayment amount
applicable to an individual
under clause (iii); and
``(bb) for any other drug,
$3 or, if less, the copayment
amount applicable to an
individual under clause (iii);
and
``(II) for plan year 2027 and each
subsequent plan year--
``(aa) for a generic drug,
$0;
``(bb) for a preferred drug
that is a multiple source drug
(as defined in section
1927(k)(7)(A)(i)), the dollar
amount applied under this
clause for such a drug for the
preceding plan year, increased
by the annual percentage
increase in the consumer price
index (all items; U.S. city
average) as of September of
such preceding year, or, if
less, the copayment amount
applicable to an individual
under clause (iii); and
``(cc) for a drug not
described in either item (aa)
or (bb), the dollar amount
applied under this clause for
such a drug for the preceding
plan year, increased in the
manner specified in item (bb),
or, if less, the copayment
amount applicable to an
individual under clause (iii).
Any amount established under item (bb) or (cc)
of subclause (II), that is based on an increase
of $1 or $3, that is not a multiple of 5 cents
or 10 cents, respectively, shall be rounded to
the nearest multiple of 5 cents or 10 cents,
respectively.''; and
(2) in paragraph (4)(A)(ii), by inserting ``(before 2027)''
after ``a subsequent year''.
SEC. 223. REQUIRING ENHANCED AND ACCURATE LISTS OF (REAL) HEALTH
PROVIDERS ACT.
(a) In General.--Section 1852(c) of the Social Security Act (42
U.S.C. 1395w-22(c)) is amended--
(1) in paragraph (1)(C)--
(A) by striking ``plan, and any'' and inserting
``plan, any''; and
(B) by inserting the following before the period at
the end: ``, and, in the case of a specified MA plan
(as defined in paragraph (3)(C)), for plan year 2027
and subsequent plan years, the information described in
paragraph (3)(B)''; and
(2) by adding at the end the following new paragraph:
``(3) Provider directory accuracy.--
``(A) In general.--For plan year 2027 and
subsequent plan years, each MA organization offering a
specified MA plan (as defined in subparagraph (C))
shall, for each such plan offered by the organization--
``(i) maintain, on a publicly available
internet website, an accurate provider
directory that includes the information
described in subparagraph (B);
``(ii) not less frequently than once every
90 days (or, in the case of a hospital or any
other facility determined appropriate by the
Secretary, at a lesser frequency specified by
the Secretary but in no case less frequently
than once every 12 months), verify the provider
directory information of each provider listed
in such directory and, if applicable, update
such provider directory information;
``(iii) if the organization is unable to
verify such information with respect to a
provider, include in such directory an
indication that the information of such
provider may not be up-to-date; and
``(iv) remove a provider from such
directory within 5 business days if the
organization determines that the provider is no
longer a provider participating in the network
of such plan.
``(B) Provider directory information.--The
information described in this subparagraph is
information enrollees may need to access covered
benefits from a provider with which such organization
offering such plan has an agreement for furnishing
items and services covered under such plan such as
name, specialty, contact information, primary office or
facility address, whether the provider is accepting new
patients, accommodations for people with disabilities,
cultural and linguistic capabilities, and telehealth
capabilities.
``(C) Specified ma plan.--In this paragraph, the
term `specified MA plan' means--
``(i) a network-based plan (as defined in
subsection (d)(5)(C)); or
``(ii) a Medicare Advantage private fee-
for-service plan (as defined in section
1859(b)(2)) that meets the access standards
under subsection (d)(4), in whole or in part,
through entering into contracts or agreements
as provided for under subparagraph (B) of such
subsection.''.
(b) Accountability for Provider Directory Accuracy.--
(1) Cost sharing for services furnished based on reliance
on incorrect provider directory information.--Section 1852(d)
of the Social Security Act (42 U.S.C. 1395w-22(d)) is amended--
(A) in paragraph (1)(C)--
(i) in clause (ii), by striking ``or'' at
the end;
(ii) in clause (iii), by striking the
semicolon at the end and inserting ``, or'';
and
(iii) by adding at the end the following
new clause:
``(iv) the services are furnished by a
provider that is not participating in the
network of a specified MA plan (as defined in
subsection (c)(3)(C)) but is listed in the
provider directory of such plan on the date on
which the appointment is made, as described in
paragraph (7)(A);''; and
(B) by adding at the end the following new
paragraph:
``(7) Cost sharing for services furnished based on reliance
on incorrect provider directory information.--
``(A) In general.--For plan year 2027 and
subsequent plan years, if an enrollee is furnished an
item or service by a provider that is not participating
in the network of a specified MA plan (as defined in
subsection (c)(3)(C)) but is listed in the provider
directory of such plan (as required to be provided to
an enrollee pursuant to subsection (c)(1)(C)) on the
date on which the appointment is made, and if such item
or service would otherwise be covered under such plan
if furnished by a provider that is participating in the
network of such plan, the MA organization offering such
plan shall ensure that the enrollee is only responsible
for the lesser of--
``(i) the amount of cost sharing that would
apply if such provider had been participating
in the network of such plan; or
``(ii) the amount of cost sharing that
would otherwise apply (without regard to this
subparagraph).
``(B) Notification requirement.--For plan year 2027
and subsequent plan years, each MA organization that
offers a specified MA plan shall--
``(i) notify enrollees of their cost-
sharing protections under this paragraph and
make such notifications, to the extent
practicable, by not later than the first day of
an annual, coordinated election period under
section 1851(e)(3) with respect to a year;
``(ii) include information regarding such
cost-sharing protections in the provider
directory of each specified MA plan offered by
the MA organization.; and
``(iii) notify enrollees of their cost-
sharing protections under this paragraph in an
explanation of benefits.''.
(2) Required provider directory accuracy analysis and
reports.--
(A) In general.--Section 1857(e) of the Social
Security Act (42 U.S.C. 1395w-27(e)) is amended by
adding at the end the following new paragraph:
``(6) Provider directory accuracy analysis and reports.--
``(A) In general.--Beginning with plan years
beginning on or after January 1, 2027, subject to
subparagraph (C), a contract under this section with an
MA organization shall require the organization, for
each specified MA plan (as defined in section
1852(c)(3)(C)) offered by the organization to annually
do the following:
``(i) Conduct an analysis estimating the
accuracy of the provider directory information
of such plan using a random sample of providers
included in such provider directory as follows:
``(I) Such a random sample shall
include a random sample of each
specialty of providers with a high
inaccuracy rate of provider directory
information relative to other
specialties of providers, as determined
by the Secretary.
``(II) For purposes of subclause
(I), one type of specialty may be
providers specializing in mental health
or substance use disorder treatment.
``(ii) Submit to the Secretary a report
containing the results of the analysis
conducted under clause (i), including an
accuracy score for such provider directory
information (as determined using a plan
verification method specified by the Secretary
under subparagraph (B)(i)).
``(B) Determination of accuracy score.--
``(i) In general.--The Secretary shall
specify plan verification methods, such as
using telephonic verification or other
approaches using data sources maintained by an
MA organization or using publicly available
data sets, that MA organizations may use for
estimating accuracy scores of the provider
directory information of specified MA plans
offered by such organizations.
``(ii) Accuracy score methodology.--With
respect to each such method specified by the
Secretary as described in clause (i), the
Secretary shall specify a methodology for MA
organizations to use in estimating such
accuracy scores. Each such methodology shall
take into account the administrative burden on
plans and providers and the relative importance
of certain provider directory information on
enrollee ability to access care.
``(C) Exception.--The Secretary may waive the
requirements of this paragraph in the case of a
specified MA plan with low enrollment (as defined by
the Secretary).
``(D) Transparency.--Beginning with plan years
beginning on or after January 1, 2028, the Secretary
shall post accuracy scores (as reported under
subparagraph (A)(ii)), in a machine readable file, on
the internet website of the Centers for Medicare &
Medicaid Services.''.
(B) Provision of information to beneficiaries.--
Section 1851(d)(4) of the Social Security Act (42
U.S.C. 1395w-21(d)(4)) is amended by adding at the end
the following new subparagraph:
``(F) Provider directory.--Beginning with plan
years beginning on or after January 1, 2028, the
accuracy score of the plan's provider directory (as
reported under section 1857(e)(6)(A)(ii)) listed
prominently on the plan's provider directory.''.
(C) Funding.--In addition to amounts otherwise
available, there is appropriated to the Centers for
Medicare & Medicaid Services Program Management
Account, out of any money in the Treasury not otherwise
appropriated, $4,000,000 for fiscal year 2025, to
remain available until expended, to carry out the
amendments made by this paragraph.
(3) GAO study and report.--
(A) Analysis.--The Comptroller General of the
United States (in this paragraph referred to as the
``Comptroller General'') shall conduct a study of the
implementation of the amendments made by paragraphs (1)
and (2). To the extent data are available and reliable,
such study shall include an analysis of--
(i) the use of cost-sharing protections
required under section 1852(d)(7)(A) of the
Social Security Act, as added by paragraph (1);
(ii) the trends in provider directory
information accuracy scores under section
1857(e)(6)(A)(ii) of the Social Security Act
(as added by paragraph (2)(A)), both overall
and among providers specializing in mental
health or substance use disorder treatment;
(iii) provider response rates by plan
verification methods;
(iv) administrative costs to providers and
Medicare Advantage organizations; and
(v) other items determined appropriate by
the Comptroller General.
(B) Report.--Not later than January 15, 2032, the
Comptroller General shall submit to Congress a report
containing the results of the study conducted under
subparagraph (A), together with recommendations for
such legislation and administrative action as the
Comptroller General determines appropriate.
(c) Guidance on Maintaining Accurate Provider Directories.--
(1) Stakeholder meeting.--
(A) In general.--Not later than 3 months after the
date of enactment of this Act, the Secretary of Health
and Human Services (referred to in this subsection as
the ``Secretary'') shall hold a public meeting to
receive input on approaches for maintaining accurate
provider directories for Medicare Advantage plans under
part C of title XVIII of the Social Security Act (42
U.S.C. 1395w-21 et seq.), including input on approaches
for reducing administrative burden, such as data
standardization, and best practices to maintain
accurate provider directory information.
(B) Participants.--Participants of the meeting
under subparagraph (A) shall include representatives
from the Centers for Medicare & Medicaid Services and
the Assistant Secretary for Technology Policy and
Office of the National Coordinator for Health
Information Technology. Such meeting shall be open to
the public. To the extent practicable, the Secretary
shall include health care providers, companies that
specialize in relevant technologies, health insurers,
and patient advocates.
(2) Guidance to medicare advantage organizations.--Not
later than 12 months after the date of enactment of this Act,
the Secretary shall issue guidance to Medicare Advantage
organizations offering Medicare Advantage plans under part C of
title XVIII of the Social Security Act (42 U.S.C. 1395w-21 et
seq.) on maintaining accurate provider directories for such
plans, taking into consideration input received during the
stakeholder meeting under paragraph (1). Such guidance may
include the following, as determined appropriate by the
Secretary:
(A) Best practices for Medicare Advantage
organizations on how to work with providers to maintain
the accuracy of provider directories and reduce
provider and Medicare Advantage organization burden
with respect to maintaining the accuracy of provider
directories.
(B) Information on data sets and data sources with
information that could be used by Medicare Advantage
organizations to maintain accurate provider
directories.
(C) Approaches for utilizing data sources
maintained by Medicare Advantage organizations and
publicly available data sets to maintain accurate
provider directories.
(D) Information to be included in provider
directories that may be useful for Medicare
beneficiaries to assess plan networks when selecting a
plan and accessing providers participating in plan
networks during the plan year.
(3) Guidance to part b providers.--Not later than 12 months
after the date of enactment of this Act, the Secretary shall
issue guidance to providers of services and suppliers who
furnish items or services for which benefits are available
under part B of title XVIII of the Social Security Act (42
U.S.C. 1395j et seq.) on when to update the National Plan and
Provider Enumeration System for information changes.
SEC. 224. MEDICARE COVERAGE OF MULTI-CANCER EARLY DETECTION SCREENING
TESTS.
(a) Coverage.--Section 1861 of the Social Security Act (42 U.S.C.
1395x) is amended--
(1) in subsection (s)(2)--
(A) by striking the semicolon at the end of
subparagraph (JJ) and inserting ``; and''; and
(B) by adding at the end the following new
subparagraph:
``(KK) multi-cancer early detection screening tests
(as defined in subsection (nnn));''; and
(2) by adding at the end the following new subsection:
``(nnn) Multi-Cancer Early Detection Screening Tests.--
``(1) In general.--The term `multi-cancer early detection
screening test' means a test furnished to an individual for the
concurrent detection of multiple cancer types across multiple
organ sites on or after January 1, 2029, that--
``(A) is cleared under section 510(k), classified
under section 513(f)(2), or approved under section 515
of the Federal Food, Drug, and Cosmetic Act;
``(B) is--
``(i) a genomic sequencing blood or blood
product test that includes the analysis of
cell-free nucleic acids; or
``(ii) a test based on samples of
biological material that provide results
comparable to those obtained with a test
described in clause (i), as determined by the
Secretary; and
``(C) the Secretary determines is--
``(i) reasonable and necessary for the
prevention or early detection of an illness or
disability; and
``(ii) appropriate for individuals entitled
to benefits under part A or enrolled under part
B.
``(2) NCD process.--In making determinations under
paragraph (1)(C) regarding the coverage of a new test, the
Secretary shall use the process for making national coverage
determinations (as defined in section 1869(f)(1)(B)) under this
title.''.
(b) Payment and Standards for Multi-Cancer Early Detection
Screening Tests.--
(1) 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:
``(aa) Payment and Standards for Multi-Cancer Early Detection
Screening Tests.--
``(1) Payment amount.--The payment amount for a multi-
cancer early detection screening test (as defined in section
1861(nnn)) is--
``(A) with respect to such a test furnished before
January 1, 2031, equal to the payment amount in effect
on the date of the enactment of this subsection for a
multi-target stool screening DNA test covered pursuant
to section 1861(pp)(1)(D); and
``(B) with respect to such a test furnished on or
after January 1, 2031, equal to the lesser of--
``(i) the amount described in subparagraph
(A); or
``(ii) the payment amount determined for
such test under section 1834A.
``(2) Limitations.--
``(A) In general.--No payment may be made under
this part for a multi-cancer early detection screening
test furnished during a year to an individual if--
``(i) such individual--
``(I) is under 50 years of age; or
``(II) as of January 1 of such
year, has attained the age specified in
subparagraph (B) for such year; or
``(ii) such a test was furnished to the
individual during the previous 11 months.
``(B) Age specified.--For purposes of subparagraph
(A)(i)(II), the age specified in this subparagraph is--
``(i) for 2029, 65 years of age; and
``(ii) for a succeeding year, the age
specified in this subparagraph for the
preceding year, increased by 1 year.
``(C) Standards following uspstf rating of a or
b.--In the case of a multi-cancer early detection
screening test that is recommended with a grade of A or
B by the United States Preventive Services Task Force,
beginning on the date on which coverage for such test
is provided pursuant to section 1861(ddd)(1), the
preceding provisions of this paragraph shall not
apply.''.
(2) Conforming amendments.--
(A) Section 1833 of the Social Security Act (42
U.S.C. 1395l) is amended--
(i) in subsection (a)--
(I) in paragraph (1)(D)(i)(I), by
striking ``section 1834(d)(1)'' and
inserting ``subsection (d)(1) or (aa)
of section 1834''; and
(II) in paragraph (2)(D)(i)(I), by
striking ``section 1834(d)(1)'' and
inserting ``subsection (d)(1) or (aa)
of section 1834''; and
(ii) in subsection (h)(1)(A), by striking
``section 1834(d)(1)'' and inserting
``subsections (d)(1) and (aa) of section
1834''.
(B) Section 1862(a)(1)(A) of the Social Security
Act (42 U.S.C. 1395y(a)(1)(A)) is amended--
(i) by striking ``or additional preventive
services'' and inserting ``, additional
preventive services''; and
(ii) by inserting ``, or multi-cancer early
detection screening tests (as defined in
section 1861(nnn))'' after ``(as described in
section 1861(ddd)(1))''.
(c) Rule of Construction Relating to Other Cancer Screening
Tests.--Nothing in this section, including the amendments made by this
section, shall be construed--
(1) in the case of an individual who undergoes a multi-
cancer early detection screening test, to affect coverage under
part B of title XVIII of the Social Security Act for other
cancer screening tests covered under such title, such as
screening tests for breast, cervical, colorectal, lung, or
prostate cancer; or
(2) in the case of an individual who undergoes another
cancer screening test, to affect coverage under such part for a
multi-cancer early detection screening test or the use of such
a test as a diagnostic or confirmatory test for a result of the
other cancer screening test.
SEC. 225. MEDICARE COVERAGE OF EXTERNAL INFUSION PUMPS AND NON-SELF-
ADMINISTRABLE HOME INFUSION DRUGS.
(a) In General.--Section 1861(n) of the Social Security Act (42
U.S.C. 1395x(n)) is amended by adding at the end the following new
sentence: ``Beginning with the first calendar quarter beginning on or
after the date that is 1 year after the date of the enactment of this
sentence, an external infusion pump and associated home infusion drug
(as defined in subsection (iii)(3)(C)) or other associated supplies
that do not meet the appropriate for use in the home requirement
applied to the definition of durable medical equipment under section
414.202 of title 42, Code of Federal Regulations (or any successor to
such regulation) shall be treated as meeting such requirement if each
of the following criteria is satisfied:
``(1) The prescribing information approved by the Food and
Drug Administration for the home infusion drug associated with
the pump instructs that the drug should be administered by or
under the supervision of a health care professional.
``(2) A qualified home infusion therapy supplier (as
defined in subsection (iii)(3)(D)) administers or supervises
the administration of the drug or biological in a safe and
effective manner in the patient's home (as defined in
subsection (iii)(3)(B)).
``(3) The prescribing information described in paragraph
(1) instructs that the drug should be infused at least 12 times
per year--
``(A) intravenously or subcutaneously; or
``(B) at infusion rates that the Secretary
determines would require the use of an external
infusion pump.''.
(b) Cost Sharing Notification.--The Secretary of Health and Human
Services shall ensure that patients are notified of the cost sharing
for electing home infusion therapy compared to other applicable
settings of care for the furnishing of infusion drugs under the
Medicare program.
SEC. 226. ASSURING PHARMACY ACCESS AND CHOICE FOR MEDICARE
BENEFICIARIES.
(a) In General.--Section 1860D-4(b)(1) of the Social Security Act
(42 U.S.C. 1395w-104(b)(1)) is amended by striking subparagraph (A) and
inserting the following:
``(A) In general.--
``(i) Participation of any willing
pharmacy.--A PDP sponsor offering a
prescription drug plan shall permit any
pharmacy that meets the standard contract terms
and conditions under such plan to participate
as a network pharmacy of such plan.
``(ii) Contract terms and conditions.--
``(I) In general.--Notwithstanding
any other provision of law, for plan
years beginning on or after January 1,
2028, in accordance with clause (i),
contract terms and conditions offered
by such PDP sponsor shall be reasonable
and relevant according to standards
established by the Secretary under
subclause (II).
``(II) Standards.--Not later than
the first Monday in April of 2027, the
Secretary shall establish standards for
reasonable and relevant contract terms
and conditions for purposes of this
clause.
``(III) Request for information.--
Not later than April 1, 2026, for
purposes of establishing the standards
under subclause (II), the Secretary
shall issue a request for information
to seek input on trends in prescription
drug plan and network pharmacy contract
terms and conditions, current
prescription drug plan and network
pharmacy contracting practices, whether
pharmacy reimbursement and dispensing
fees paid by PDP sponsors to network
pharmacies sufficiently cover the
ingredient and operational costs of
such pharmacies, the use and
application of pharmacy quality
measures by PDP sponsors for network
pharmacies, PDP sponsor restrictions or
limitations on the dispensing of
covered part D drugs by network
pharmacies (or any subsets of such
pharmacies), PDP sponsor auditing
practices for network pharmacies, areas
in current regulations or program
guidance related to contracting between
prescription drug plans and network
pharmacies requiring clarification or
additional specificity, factors for
consideration in determining the
reasonableness and relevance of
contract terms and conditions between
prescription drug plans and network
pharmacies, and other issues as
determined appropriate by the
Secretary.''.
(b) Essential Retail Pharmacies.--Section 1860D-42 of the Social
Security Act (42 U.S.C. 1395w-152) is amended by adding at the end the
following new subsection:
``(e) Essential Retail Pharmacies.--
``(1) In general.--With respect to plan years beginning on
or after January 1, 2028, the Secretary shall publish reports,
at least once every 2 years until 2034, and periodically
thereafter, that provide information, to the extent feasible,
on--
``(A) trends in ingredient cost reimbursement,
dispensing fees, incentive payments and other fees paid
by PDP sponsors offering prescription drug plans and MA
organizations offering MA-PD plans under this part to
essential retail pharmacies (as defined in paragraph
(2)) with respect to the dispensing of covered part D
drugs, including a comparison of such trends between
essential retail pharmacies and pharmacies that are not
essential retail pharmacies;
``(B) trends in amounts paid to PDP sponsors
offering prescription drug plans and MA organizations
offering MA-PD plans under this part by essential
retail pharmacies with respect to the dispensing of
covered part D drugs, including a comparison of such
trends between essential retail pharmacies and
pharmacies that are not essential retail pharmacies;
``(C) trends in essential retail pharmacy
participation in pharmacy networks and preferred
pharmacy networks for prescription drug plans offered
by PDP sponsors and MA-PD plans offered by MA
organizations under this part, including a comparison
of such trends between essential retail pharmacies and
pharmacies that are not essential retail pharmacies;
``(D) trends in the number of essential retail
pharmacies, including variation in such trends by
geographic region or other factors;
``(E) a comparison of cost-sharing for covered part
D drugs dispensed by essential retail pharmacies that
are network pharmacies for prescription drug plans
offered by PDP sponsors and MA-PD plans offered by MA
organizations under this part and cost-sharing for
covered part D drugs dispensed by other network
pharmacies for such plans located in similar geographic
areas that are not essential retail pharmacies;
``(F) a comparison of the volume of covered part D
drugs dispensed by essential retail pharmacies that are
network pharmacies for prescription drug plans offered
by PDP sponsors and MA-PD plans offered by MA
organizations under this part and such volume of
dispensing by network pharmacies for such plans located
in similar geographic areas that are not essential
retail pharmacies, including information on any
patterns or trends in such comparison specific to
certain types of covered part D drugs, such as generic
drugs or drugs specified as specialty drugs by a PDP
sponsor under a prescription drug plan or an MA
organization under an MA-PD plan; and
``(G) a comparison of the information described in
subparagraphs (A) through (F) between essential retail
pharmacies that are network pharmacies for prescription
drug plans offered by PDP sponsors under this part and
essential retail pharmacies that are network pharmacies
for MA-PD plans offered by MA organizations under this
part.
``(2) Definition of essential retail pharmacy.--In this
subsection, the term `essential retail pharmacy' means, with
respect to a plan year, a retail pharmacy that--
``(A) is not a pharmacy that is an affiliate as
defined in paragraph (4); and
``(B) is located in--
``(i) a medically underserved area (as
designated pursuant to section 330(b)(3)(A) of
the Public Health Service Act);
``(ii) a rural area in which there is no
other retail pharmacy within 10 miles, as
determined by the Secretary;
``(iii) a suburban area in which there is
no other retail pharmacy within 2 miles, as
determined by the Secretary; or
``(iv) an urban area in which there is no
other retail pharmacy within 1 mile, as
determined by the Secretary.
``(3) List of essential retail pharmacies.--
``(A) Publication of list of essential retail
pharmacies.--For each plan year (beginning with plan
year 2028), the Secretary shall publish, on a publicly
available internet website of the Centers for Medicare
& Medicaid Services, a list of pharmacies that meet the
criteria described in subparagraphs (A) and (B) of
paragraph (2) to be considered an essential retail
pharmacy.
``(B) Required submissions from pdp sponsors.--For
each plan year (beginning with plan year 2028), each
PDP sponsor offering a prescription drug plan and each
MA organization offering an MA-PD plan shall submit to
the Secretary, for the purposes of determining retail
pharmacies that meet the criterion specified in
subparagraph (A) of paragraph (2), a list of retail
pharmacies that are affiliates of such sponsor or
organization, or are affiliates of a pharmacy benefit
manager acting on behalf of such sponsor or
organization, at a time, and in a form and manner,
specified by the Secretary.
``(C) Reporting by pdp sponsors and ma
organizations.--For each plan year beginning with plan
year 2027, each PDP sponsor offering a prescription
drug plan and each MA organization offering an MA-PD
plan under this part shall submit to the Secretary
information on incentive payments and other fees paid
by such sponsor or organization to pharmacies, insofar
as any such payments or fees are not otherwise
reported, at a time, and in a form and manner,
specified by the Secretary.
``(D) Implementation.--Notwithstanding any other
provision of law, the Secretary may implement this
paragraph by program instruction or otherwise.
``(E) Nonapplication of paperwork reduction act.--
Chapter 35 of title 44, United States Code, shall not
apply to the implementation of this paragraph.
``(4) Definition of affiliate; pharmacy benefit manager.--
In this subsection, the terms `affiliate' and `pharmacy benefit
manager' have the meaning given those terms in section 1860D-
12(h)(7).''.
(c) Enforcement.--
(1) In general.--Section 1860D-4(b)(1) of the Social
Security Act (42 U.S.C. 1395w-104(b)(1)) is amended by adding
at the end the following new subparagraph:
``(F) Enforcement of standards for reasonable and
relevant contract terms and conditions.--
``(i) Allegation submission process.--
``(I) In general.--Not later than
January 1, 2028, the Secretary shall
establish a process through which a
pharmacy may submit to the Secretary an
allegation of a violation by a PDP
sponsor offering a prescription drug
plan of the standards for reasonable
and relevant contract terms and
conditions under subparagraph (A)(ii),
or of subclause (VIII) of this clause.
``(II) Frequency of submission.--
``(aa) In general.--Except
as provided in item (bb), the
allegation submission process
under this clause shall allow
pharmacies to submit any
allegations of violations
described in subclause (I) not
more frequently than once per
plan year per contract between
a pharmacy and a PDP sponsor.
``(bb) Allegations relating
to contract modifications.--In
the case where a contract
between a pharmacy and a PDP
sponsor is modified following
the submission of allegations
by a pharmacy with respect to
such contract and plan year,
the allegation submission
process under this clause shall
allow such pharmacy to submit
an additional allegation
related to those modifications
with respect to such contract
and plan year.
``(III) Access to relevant
documents and materials.--A PDP sponsor
subject to an allegation under this
clause--
``(aa) shall provide
documents or materials, as
specified by the Secretary,
including contract offers made
by such sponsor to such
pharmacy or correspondence
related to such offers, to the
Secretary at a time, and in a
form and manner, specified by
the Secretary; and
``(bb) shall not prohibit
or otherwise limit the ability
of a pharmacy to submit such
documents or materials to the
Secretary for the purpose of
submitting an allegation or
providing evidence for such an
allegation under this clause.
``(IV) Standardized template.--The
Secretary shall establish a
standardized template for pharmacies to
use for the submission of allegations
described in subclause (I). Such
template shall require that the
submission include a certification by
the pharmacy that the information
included is accurate, complete, and
true to the best of the knowledge,
information, and belief of such
pharmacy.
``(V) Preventing frivolous
allegations.--In the case where the
Secretary determines that a pharmacy
has submitted frivolous allegations
under this clause on a routine basis,
the Secretary may temporarily prohibit
such pharmacy from using the allegation
submission process under this clause,
as determined appropriate by the
Secretary.
``(VI) Exemption from freedom of
information act.--Allegations submitted
under this clause shall be exempt from
disclosure under section 552 of title
5, United States Code.
``(VII) Rule of construction.--
Nothing in this clause shall be
construed as limiting the ability of a
pharmacy to pursue other legal actions
or remedies, consistent with applicable
Federal or State law, with respect to a
potential violation of a requirement
described in this subparagraph.
``(VIII) Anti-retaliation and anti-
coercion.--Consistent with applicable
Federal or State law, a PDP sponsor
shall not--
``(aa) retaliate against a
pharmacy for submitting any
allegations under this clause;
or
``(bb) coerce, intimidate,
threaten, or interfere with the
ability of a pharmacy to submit
any such allegations.
``(ii) Investigation.--The Secretary shall
investigate, as determined appropriate by the
Secretary, allegations submitted pursuant to
clause (i).
``(iii) Enforcement.--
``(I) In general.--In the case
where the Secretary determines that a
PDP sponsor offering a prescription
drug plan has violated the standards
for reasonable and relevant contract
terms and conditions under subparagraph
(A)(ii), the Secretary may use
authorities under sections 1857(g) and
1860D-12(b)(3)(E) to impose civil
monetary penalties or other
intermediate sanctions.
``(II) Application of civil
monetary penalties.--The provisions of
section 1128A (other than subsections
(a) and (b)) shall apply to a civil
monetary penalty under this clause in
the same manner as such provisions
apply to a penalty or proceeding under
section 1128A(a).''.
(2) Conforming amendment.--Section 1857(g)(1) of the Social
Security Act (42 U.S.C. 1395w-27(g)(1)) is amended--
(A) in subparagraph (J), by striking ``or'' after
the semicolon;
(B) by redesignating subparagraph (K) as
subparagraph (L);
(C) by inserting after subparagraph (J), the
following new subparagraph:
``(K) fails to comply with the standards for
reasonable and relevant contract terms and conditions
under subparagraph (A)(ii) of section 1860D-4(b)(1);
or'';
(D) in subparagraph (L), as redesignated by
subparagraph (B), by striking ``through (J)'' and
inserting ``through (K)''; and
(E) in the flush matter following subparagraph (L),
as so redesignated, by striking ``subparagraphs (A)
through (K)'' and inserting ``subparagraphs (A) through
(L)''.
(d) Accountability of Pharmacy Benefit Managers for Violations of
Reasonable and Relevant Contract Terms and Conditions.--
(1) In general.--Section 1860D-12(b) of the Social Security
Act (42 U.S.C. 1395w-112) is amended by adding at the end the
following new paragraph:
``(9) Accountability of pharmacy benefit managers for
violations of reasonable and relevant contract terms and
conditions.--For plan years beginning on or after January 1,
2028, each contract entered into with a PDP sponsor under this
part with respect to a prescription drug plan offered by such
sponsor shall provide that any pharmacy benefit manager acting
on behalf of such sponsor has a written agreement with the PDP
sponsor under which the pharmacy benefit manager agrees to
reimburse the PDP sponsor for any amounts paid by such sponsor
under section 1860D-4(b)(1)(F)(iii)(I) to the Secretary as a
result of a violation described in such section if such
violation is related to a responsibility delegated to the
pharmacy benefit manager by such PDP sponsor.''.
(2) 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:
``(F) Accountability of pharmacy benefit managers
for violations of reasonable and relevant contract
terms.--For plan years beginning on or after January 1,
2028, section 1860D-12(b)(9).''.
(e) Biennial Report on Enforcement and Oversight of Pharmacy Access
Requirements.--Section 1860D-42 of the Social Security Act (42 U.S.C.
1395w-152), as amended by subsection (b), is amended by adding at the
end the following new subsection:
``(f) Biennial Report on Enforcement and Oversight of Pharmacy
Access Requirements.--
``(1) In general.--Not later than 2 years after the date of
enactment of this subsection, and at least once every 2 years
thereafter, the Secretary shall publish a report on enforcement
and oversight actions and activities undertaken by the
Secretary with respect to the requirements under section 1860D-
4(b)(1).
``(2) Limitation.--A report under paragraph (1) shall not
disclose--
``(A) identifiable information about individuals or
entities unless such information is otherwise publicly
available; or
``(B) trade secrets with respect to any
entities.''.
(f) Funding.--In addition to amounts otherwise available, there is
appropriated to the Centers for Medicare & Medicaid Services Program
Management Account, out of any money in the Treasury not otherwise
appropriated, $188,000,000 for fiscal year 2025, to remain available
until expended, to carry out this section.
SEC. 227. MODERNIZING AND ENSURING PBM ACCOUNTABILITY.
(a) In General.--
(1) Prescription drug plans.--Section 1860D-12 of the
Social Security Act (42 U.S.C. 1395w-112) is amended by adding
at the end the following new subsection:
``(h) Requirements Relating to Pharmacy Benefit Managers.--For plan
years beginning on or after January 1, 2028:
``(1) Agreements with pharmacy benefit managers.--Each
contract entered into with a PDP sponsor under this part with
respect to a prescription drug plan offered by such sponsor
shall provide that any pharmacy benefit manager acting on
behalf of such sponsor has a written agreement with the PDP
sponsor under which the pharmacy benefit manager, and any
affiliates of such pharmacy benefit manager, as applicable,
agree to meet the following requirements:
``(A) No income other than bona fide service
fees.--
``(i) In general.--The pharmacy benefit
manager and any affiliate of such pharmacy
benefit manager shall not derive any
remuneration with respect to any services
provided on behalf of any entity or individual,
in connection with the utilization of covered
part D drugs, from any such entity or
individual other than bona fide service fees,
subject to clauses (ii) and (iii).
``(ii) Incentive payments.--For the
purposes of this subsection, an incentive
payment (as determined by the Secretary) paid
by a PDP sponsor to a pharmacy benefit manager
that is performing services on behalf of such
sponsor shall be deemed a `bona fide service
fee' (even if such payment does not otherwise
meet the definition of such term under
paragraph (7)(B)) if such payment is a flat
dollar amount, is consistent with fair market
value (as specified by the Secretary), is
related to services actually performed by the
pharmacy benefit manager or affiliate of such
pharmacy benefit manager, on behalf of the PDP
sponsor making such payment, in connection with
the utilization of covered part D drugs, and
meets additional requirements, if any, as
determined appropriate by the Secretary.
``(iii) Clarification on rebates and
discounts used to lower costs for covered part
d drugs.--Rebates, discounts, and other price
concessions received by a pharmacy benefit
manager or an affiliate of a pharmacy benefit
manager from manufacturers, even if such price
concessions are calculated as a percentage of a
drug's price, shall not be considered a
violation of the requirements of clause (i) if
they are fully passed through to a PDP sponsor
and are compliant with all regulatory and
subregulatory requirements related to direct
and indirect remuneration for manufacturer
rebates under this part, including in cases
where a PDP sponsor is acting as a pharmacy
benefit manager on behalf of a prescription
drug plan offered by such PDP sponsor.
``(iv) Evaluation of remuneration
arrangements.--Components of subsets of
remuneration arrangements (such as fees or
other forms of compensation paid to or retained
by the pharmacy benefit manager or affiliate of
such pharmacy benefit manager), as determined
appropriate by the Secretary, between pharmacy
benefit managers or affiliates of such pharmacy
benefit managers, as applicable, and other
entities involved in the dispensing or
utilization of covered part D drugs (including
PDP sponsors, manufacturers, pharmacies, and
other entities as determined appropriate by the
Secretary) shall be subject to review by the
Secretary, in consultation with the Office of
the Inspector General of the Department of
Health and Human Services, as determined
appropriate by the Secretary. The Secretary, in
consultation with the Office of the Inspector
General, shall review whether remuneration
under such arrangements is consistent with fair
market value (as specified by the Secretary)
through reviews and assessments of such
remuneration, as determined appropriate.
``(v) Disgorgement.--The pharmacy benefit
manager shall disgorge any remuneration paid to
such pharmacy benefit manager or an affiliate
of such pharmacy benefit manager in violation
of this subparagraph to the PDP sponsor.
``(vi) Additional requirements.--The
pharmacy benefit manager shall--
``(I) enter into a written
agreement with any affiliate of such
pharmacy benefit manager, under which
the affiliate shall identify and
disgorge any remuneration described in
clause (v) to the pharmacy benefit
manager; and
``(II) attest, subject to any
requirements determined appropriate by
the Secretary, that the pharmacy
benefit manager has entered into a
written agreement described in
subclause (I) with any relevant
affiliate of the pharmacy benefit
manager.
``(B) Transparency regarding guarantees and cost
performance evaluations.--The pharmacy benefit manager
shall--
``(i) define, interpret, and apply, in a
fully transparent and consistent manner for
purposes of calculating or otherwise evaluating
pharmacy benefit manager performance against
pricing guarantees or similar cost performance
measurements related to rebates, discounts,
price concessions, or net costs, terms such
as--
``(I) `generic drug', in a manner
consistent with the definition of the
term under section 423.4 of title 42,
Code of Federal Regulations, or a
successor regulation;
``(II) `brand name drug', in a
manner consistent with the definition
of the term under section 423.4 of
title 42, Code of Federal Regulations,
or a successor regulation;
``(III) `specialty drug';
``(IV) `rebate'; and
``(V) `discount';
``(ii) identify any drugs, claims, or price
concessions excluded from any pricing guarantee
or other cost performance measure in a clear
and consistent manner; and
``(iii) where a pricing guarantee or other
cost performance measure is based on a pricing
benchmark other than the wholesale acquisition
cost (as defined in section 1847A(c)(6)(B)) of
a drug, calculate and provide a wholesale
acquisition cost-based equivalent to the
pricing guarantee or other cost performance
measure.
``(C) Provision of information.--
``(i) In general.--Not later than July 1 of
each year, beginning in 2028, the pharmacy
benefit manager shall submit to the PDP
sponsor, and to the Secretary, a report, in
accordance with this subparagraph, and shall
make such report available to such sponsor at
no cost to such sponsor in a format specified
by the Secretary under paragraph (5). Each such
report shall include, with respect to such PDP
sponsor and each plan offered by such sponsor,
the following information with respect to the
previous plan year:
``(I) A list of all drugs covered
by the plan that were dispensed
including, with respect to each such
drug--
``(aa) the brand name,
generic or non-proprietary
name, and National Drug Code;
``(bb) the number of plan
enrollees for whom the drug was
dispensed, the total number of
prescription claims for the
drug (including original
prescriptions and refills,
counted as separate claims),
and the total number of dosage
units of the drug dispensed;
``(cc) the number of
prescription claims described
in item (bb) by each type of
dispensing channel through
which the drug was dispensed,
including retail, mail order,
specialty pharmacy, long term
care pharmacy, home infusion
pharmacy, or other types of
pharmacies or providers;
``(dd) the average
wholesale acquisition cost,
listed as cost per day's
supply, cost per dosage unit,
and cost per typical course of
treatment (as applicable);
``(ee) the average
wholesale price for the drug,
listed as price per day's
supply, price per dosage unit,
and price per typical course of
treatment (as applicable);
``(ff) the total out-of-
pocket spending by plan
enrollees on such drug after
application of any benefits
under the plan, including plan
enrollee spending through
copayments, coinsurance, and
deductibles;
``(gg) total rebates paid
by the manufacturer on the drug
as reported under the Detailed
DIR Report (or any successor
report) submitted by such
sponsor to the Centers for
Medicare & Medicaid Services;
``(hh) all other direct or
indirect remuneration on the
drug as reported under the
Detailed DIR Report (or any
successor report) submitted by
such sponsor to the Centers for
Medicare & Medicaid Services;
``(ii) the average pharmacy
reimbursement amount paid by
the plan for the drug in the
aggregate and disaggregated by
dispensing channel identified
in item (cc);
``(jj) the average National
Average Drug Acquisition Cost
(NADAC); and
``(kk) total manufacturer-
derived revenue, inclusive of
bona fide service fees,
attributable to the drug and
retained by the pharmacy
benefit manager and any
affiliate of such pharmacy
benefit manager.
``(II) In the case of a pharmacy
benefit manager that has an affiliate
that is a retail, mail order, or
specialty pharmacy, with respect to
drugs covered by such plan that were
dispensed, the following information:
``(aa) The percentage of
total prescriptions that were
dispensed by pharmacies that
are an affiliate of the
pharmacy benefit manager for
each drug.
``(bb) The interquartile
range of the total combined
costs paid by the plan and plan
enrollees, per dosage unit, per
course of treatment, per 30-day
supply, and per 90-day supply
for each drug dispensed by
pharmacies that are not an
affiliate of the pharmacy
benefit manager and that are
included in the pharmacy
network of such plan.
``(cc) The interquartile
range of the total combined
costs paid by the plan and plan
enrollees, per dosage unit, per
course of treatment, per 30-day
supply, and per 90-day supply
for each drug dispensed by
pharmacies that are an
affiliate of the pharmacy
benefit manager and that are
included in the pharmacy
network of such plan.
``(dd) The lowest total
combined cost paid by the plan
and plan enrollees, per dosage
unit, per course of treatment,
per 30-day supply, and per 90-
day supply, for each drug that
is available from any pharmacy
included in the pharmacy
network of such plan.
``(ee) The difference
between the average acquisition
cost of the affiliate, such as
a pharmacy or other entity that
acquires prescription drugs,
that initially acquires the
drug and the amount reported
under subclause (I)(jj) for
each drug.
``(ff) A list inclusive of
the brand name, generic or non-
proprietary name, and National
Drug Code of covered part D
drugs subject to an agreement
with a covered entity under
section 340B of the Public
Health Service Act for which
the pharmacy benefit manager or
an affiliate of the pharmacy
benefit manager had a contract
or other arrangement with such
a covered entity in the service
area of such plan.
``(III) Where a drug approved under
section 505(c) of the Federal Food,
Drug, and Cosmetic Act (referred to in
this subclause as the `listed drug') is
covered by the plan, the following
information:
``(aa) A list of currently
marketed generic drugs approved
under section 505(j) of the
Federal Food, Drug, and
Cosmetic Act pursuant to an
application that references
such listed drug that are not
covered by the plan, are
covered on the same formulary
tier or a formulary tier
typically associated with
higher cost-sharing than the
listed drug, or are subject to
utilization management that the
listed drug is not subject to.
``(bb) The estimated
average beneficiary cost-
sharing under the plan for a
30-day supply of the listed
drug.
``(cc) Where a generic drug
listed under item (aa) is on a
formulary tier typically
associated with higher cost-
sharing than the listed drug,
the estimated average cost-
sharing that a beneficiary
would have paid for a 30-day
supply of each of the generic
drugs described in item (aa),
had the plan provided coverage
for such drugs on the same
formulary tier as the listed
drug.
``(dd) A written
justification for providing
more favorable coverage of the
listed drug than the generic
drugs described in item (aa).
``(ee) The number of
currently marketed generic
drugs approved under section
505(j) of the Federal Food,
Drug, and Cosmetic Act pursuant
to an application that
references such listed drug.
``(IV) Where a reference product
(as defined in section 351(i) of the
Public Health Service Act) is covered
by the plan, the following information:
``(aa) A list of currently
marketed biosimilar biological
products licensed under section
351(k) of the Public Health
Service Act pursuant to an
application that refers to such
reference product that are not
covered by the plan, are
covered on the same formulary
tier or a formulary tier
typically associated with
higher cost-sharing than the
reference product, or are
subject to utilization
management that the reference
product is not subject to.
``(bb) The estimated
average beneficiary cost-
sharing under the plan for a
30-day supply of the reference
product.
``(cc) Where a biosimilar
biological product listed under
item (aa) is on a formulary
tier typically associated with
higher cost-sharing than the
reference product, the
estimated average cost-sharing
that a beneficiary would have
paid for a 30-day supply of
each of the biosimilar
biological products described
in item (aa), had the plan
provided coverage for such
products on the same formulary
tier as the reference product.
``(dd) A written
justification for providing
more favorable coverage of the
reference product than the
biosimilar biological product
described in item (aa).
``(ee) The number of
currently marketed biosimilar
biological products licensed
under section 351(k) of the
Public Health Service Act,
pursuant to an application that
refers to such reference
product.
``(V) Total gross spending on
covered part D drugs by the plan, not
net of rebates, fees, discounts, or
other direct or indirect remuneration.
``(VI) The total amount retained by
the pharmacy benefit manager or an
affiliate of such pharmacy benefit
manager in revenue related to
utilization of covered part D drugs
under that plan, inclusive of bona fide
service fees.
``(VII) The total spending on
covered part D drugs net of rebates,
fees, discounts, or other direct and
indirect remuneration by the plan.
``(VIII) An explanation of any
benefit design parameters under such
plan that encourage plan enrollees to
fill prescriptions at pharmacies that
are an affiliate of such pharmacy
benefit manager, such as mail and
specialty home delivery programs, and
retail and mail auto-refill programs.
``(IX) The following information:
``(aa) A list of all
brokers, consultants, advisors,
and auditors that receive
compensation from the pharmacy
benefit manager or an affiliate
of such pharmacy benefit
manager for referrals,
consulting, auditing, or other
services offered to PDP
sponsors related to pharmacy
benefit management services.
``(bb) The amount of
compensation provided by such
pharmacy benefit manager or
affiliate to each such broker,
consultant, advisor, and
auditor.
``(cc) The methodology for
calculating the amount of
compensation provided by such
pharmacy benefit manager or
affiliate, for each such
broker, consultant, advisor,
and auditor.
``(X) A list of all affiliates of
the pharmacy benefit manager.
``(XI) A summary document submitted
in a standardized template developed by
the Secretary that includes such
information described in subclauses (I)
through (X).
``(ii) Written explanation of contracts or
agreements with drug manufacturers.--
``(I) In general.--The pharmacy
benefit manager shall, not later than
30 days after the finalization of any
contract or agreement between such
pharmacy benefit manager or an
affiliate of such pharmacy benefit
manager and a drug manufacturer (or
subsidiary, agent, or entity affiliated
with such drug manufacturer) that makes
rebates, discounts, payments, or other
financial incentives related to one or
more covered part D drugs or other
prescription drugs, as applicable, of
the manufacturer directly or indirectly
contingent upon coverage, formulary
placement, or utilization management
conditions on any other covered part D
drugs or other prescription drugs, as
applicable, submit to the PDP sponsor a
written explanation of such contract or
agreement.
``(II) Requirements.--A written
explanation under subclause (I) shall--
``(aa) include the
manufacturer subject to the
contract or agreement, all
covered part D drugs and other
prescription drugs, as
applicable, subject to the
contract or agreement and the
manufacturers of such drugs,
and a high-level description of
the terms of such contract or
agreement and how such terms
apply to such drugs; and
``(bb) be certified by the
Chief Executive Officer, Chief
Financial Officer, or General
Counsel of such pharmacy
benefit manager, or affiliate
of such pharmacy benefit
manager, as applicable, or an
individual delegated with the
authority to sign on behalf of
one of these officers, who
reports directly to the
officer.
``(III) Definition of other
prescription drugs.--For purposes of
this clause, the term `other
prescription drugs' means prescription
drugs covered as supplemental benefits
under this part or prescription drugs
paid outside of this part.
``(D) Audit rights.--
``(i) In general.--Not less than once a
year, at the request of the PDP sponsor, the
pharmacy benefit manager shall allow for an
audit of the pharmacy benefit manager to ensure
compliance with all terms and conditions under
the written agreement described in this
paragraph and the accuracy of information
reported under subparagraph (C).
``(ii) Auditor.--The PDP sponsor shall have
the right to select an auditor. The pharmacy
benefit manager shall not impose any
limitations on the selection of such auditor.
``(iii) Provision of information.--The
pharmacy benefit manager shall make available
to such auditor all records, data, contracts,
and other information necessary to confirm the
accuracy of information provided under
subparagraph (C), subject to reasonable
restrictions on how such information must be
reported to prevent redisclosure of such
information.
``(iv) Timing.--The pharmacy benefit
manager must provide information under clause
(iii) and other information, data, and records
relevant to the audit to such auditor within 6
months of the initiation of the audit and
respond to requests for additional information
from such auditor within 30 days after the
request for additional information.
``(v) Information from affiliates.--The
pharmacy benefit manager shall be responsible
for providing to such auditor information
required to be reported under subparagraph (C)
or under clause (iii) of this subparagraph that
is owned or held by an affiliate of such
pharmacy benefit manager.
``(2) Enforcement.--
``(A) In general.--Each PDP sponsor shall--
``(i) disgorge to the Secretary any amounts
disgorged to the PDP sponsor by a pharmacy
benefit manager under paragraph (1)(A)(v);
``(ii) require, in a written agreement with
any pharmacy benefit manager acting on behalf
of such sponsor or affiliate of such pharmacy
benefit manager, that such pharmacy benefit
manager or affiliate reimburse the PDP sponsor
for any civil money penalty imposed on the PDP
sponsor as a result of the failure of the
pharmacy benefit manager or affiliate to meet
the requirements of paragraph (1) that are
applicable to the pharmacy benefit manager or
affiliate under the agreement; and
``(iii) require, in a written agreement
with any such pharmacy benefit manager acting
on behalf of such sponsor or affiliate of such
pharmacy benefit manager, that such pharmacy
benefit manager or affiliate be subject to
punitive remedies for breach of contract for
failure to comply with the requirements
applicable under paragraph (1).
``(B) Reporting of alleged violations.--The
Secretary shall make available and maintain a mechanism
for manufacturers, PDP sponsors, pharmacies, and other
entities that have contractual relationships with
pharmacy benefit managers or affiliates of such
pharmacy benefit managers to report, on a confidential
basis, alleged violations of paragraph (1)(A) or
subparagraph (C).
``(C) Anti-retaliation and anti-coercion.--
Consistent with applicable Federal or State law, a PDP
sponsor shall not--
``(i) retaliate against an individual or
entity for reporting an alleged violation under
subparagraph (B); or
``(ii) coerce, intimidate, threaten, or
interfere with the ability of an individual or
entity to report any such alleged violations.
``(3) Certification of compliance.--
``(A) In general.--Each PDP sponsor shall furnish
to the Secretary (at a time and in a manner specified
by the Secretary) an annual certification of compliance
with this subsection, as well as such information as
the Secretary determines necessary to carry out this
subsection.
``(B) Implementation.--Notwithstanding any other
provision of law, the Secretary may implement this
paragraph by program instruction or otherwise.
``(4) Rule of construction.--Nothing in this subsection
shall be construed as--
``(A) prohibiting flat dispensing fees or
reimbursement or payment for ingredient costs
(including customary, industry-standard discounts
directly related to drug acquisition that are retained
by pharmacies or wholesalers) to entities that acquire
or dispense prescription drugs; or
``(B) modifying regulatory requirements or sub-
regulatory program instruction or guidance related to
pharmacy payment, reimbursement, or dispensing fees.
``(5) Standard formats.--
``(A) In general.--Not later than June 1, 2027, the
Secretary shall specify standard, machine-readable
formats for pharmacy benefit managers to submit annual
reports required under paragraph (1)(C)(i).
``(B) Implementation.--Notwithstanding any other
provision of law, the Secretary may implement this
paragraph by program instruction or otherwise.
``(6) Confidentiality.--
``(A) In general.--Information disclosed by a
pharmacy benefit manager, an affiliate of a pharmacy
benefit manager, a PDP sponsor, or a pharmacy under
this subsection that is not otherwise publicly
available or available for purchase shall not be
disclosed by the Secretary or a PDP sponsor receiving
the information, except that the Secretary may disclose
the information for the following purposes:
``(i) As the Secretary determines necessary
to carry out this part.
``(ii) To permit the Comptroller General to
review the information provided.
``(iii) To permit the Director of the
Congressional Budget Office to review the
information provided.
``(iv) To permit the Executive Director of
the Medicare Payment Advisory Commission to
review the information provided.
``(v) To the Attorney General for the
purposes of conducting oversight and
enforcement under this title.
``(vi) To the Inspector General of the
Department of Health and Human Services in
accordance with its authorities under the
Inspector General Act of 1978 (section 406 of
title 5, United States Code), and other
applicable statutes.
``(B) Restriction on use of information.--The
Secretary, the Comptroller General, the Director of the
Congressional Budget Office, and the Executive Director
of the Medicare Payment Advisory Commission shall not
report on or disclose information disclosed pursuant to
subparagraph (A) to the public in a manner that would
identify--
``(i) a specific pharmacy benefit manager,
affiliate, pharmacy, manufacturer, wholesaler,
PDP sponsor, or plan; or
``(ii) contract prices, rebates, discounts,
or other remuneration for specific drugs in a
manner that may allow the identification of
specific contracting parties or of such
specific drugs.
``(7) Definitions.--For purposes of this subsection:
``(A) Affiliate.--The term `affiliate' means, with
respect to any pharmacy benefit manager or PDP sponsor,
any entity that, directly or indirectly--
``(i) owns or is owned by, controls or is
controlled by, or is otherwise related in any
ownership structure to such pharmacy benefit
manager or PDP sponsor; or
``(ii) acts as a contractor, principal, or
agent to such pharmacy benefit manager or PDP
sponsor, insofar as such contractor, principal,
or agent performs any of the functions
described under subparagraph (C).
``(B) Bona fide service fee.--The term `bona fide
service fee' means a fee that is reflective of the fair
market value (as specified by the Secretary, through
notice and comment rulemaking) for a bona fide,
itemized service actually performed on behalf of an
entity, that the entity would otherwise perform (or
contract for) in the absence of the service arrangement
and that is not passed on in whole or in part to a
client or customer, whether or not the entity takes
title to the drug. Such fee must be a flat dollar
amount and shall not be directly or indirectly based
on, or contingent upon--
``(i) drug price, such as wholesale
acquisition cost or drug benchmark price (such
as average wholesale price);
``(ii) the amount of discounts, rebates,
fees, or other direct or indirect remuneration
with respect to covered part D drugs dispensed
to enrollees in a prescription drug plan,
except as permitted pursuant to paragraph
(1)(A)(ii);
``(iii) coverage or formulary placement
decisions or the volume or value of any
referrals or business generated between the
parties to the arrangement; or
``(iv) any other amounts or methodologies
prohibited by the Secretary.
``(C) Pharmacy benefit manager.--The term `pharmacy
benefit manager' means any person or entity that,
either directly or through an intermediary, acts as a
price negotiator or group purchaser on behalf of a PDP
sponsor or prescription drug plan, or manages the
prescription drug benefits provided by such sponsor or
plan, including the processing and payment of claims
for prescription drugs, the performance of drug
utilization review, the processing of drug prior
authorization requests, the adjudication of appeals or
grievances related to the prescription drug benefit,
contracting with network pharmacies, controlling the
cost of covered part D drugs, or the provision of
related services. Such term includes any person or
entity that carries out one or more of the activities
described in the preceding sentence, irrespective of
whether such person or entity calls itself a `pharmacy
benefit manager'.''.
(2) MA-PD plans.--Section 1857(f)(3) of the Social Security
Act (42 U.S.C. 1395w-27(f)(3)), as amended by section
226(d)(2), is amended by adding at the end the following new
subparagraph:
``(G) Requirements relating to pharmacy benefit
managers.--For plan years beginning on or after January
1, 2028, section 1860D-12(h).''.
(3) Nonapplication of paperwork reduction act.--Chapter 35
of title 44, United States Code, shall not apply to the
implementation of this subsection.
(4) Funding.--
(A) Secretary.--In addition to amounts otherwise
available, there is appropriated to the Centers for
Medicare & Medicaid Services Program Management
Account, out of any money in the Treasury not otherwise
appropriated, $113,000,000 for fiscal year 2025, to
remain available until expended, to carry out this
subsection.
(B) OIG.--In addition to amounts otherwise
available, there is appropriated to the Inspector
General of the Department of Health and Human Services,
out of any money in the Treasury not otherwise
appropriated, $20,000,000 for fiscal year 2025, to
remain available until expended, to carry out this
subsection.
(b) GAO Study and Report on Price-Related Compensation Across the
Supply Chain.--
(1) Study.--The Comptroller General of the United States
(in this subsection referred to as the ``Comptroller General'')
shall conduct a study describing the use of compensation and
payment structures related to a prescription drug's price
within the retail prescription drug supply chain in part D of
title XVIII of the Social Security Act (42 U.S.C. 1395w-101 et
seq.). Such study shall summarize information from Federal
agencies and industry experts, to the extent available, with
respect to the following:
(A) The type, magnitude, other features (such as
the pricing benchmarks used), and prevalence of
compensation and payment structures related to a
prescription drug's price, such as calculating fee
amounts as a percentage of a prescription drug's price,
between intermediaries in the prescription drug supply
chain, including--
(i) pharmacy benefit managers;
(ii) PDP sponsors offering prescription
drug plans and Medicare Advantage organizations
offering MA-PD plans;
(iii) drug wholesalers;
(iv) pharmacies;
(v) manufacturers;
(vi) pharmacy services administrative
organizations;
(vii) brokers, auditors, consultants, and
other entities that--
(I) advise PDP sponsors offering
prescription drug plans and Medicare
Advantage organizations offering MA-PD
plans regarding pharmacy benefits; or
(II) review PDP sponsor and
Medicare Advantage organization
contracts with pharmacy benefit
managers; and
(viii) other service providers that
contract with any of the entities described in
clauses (i) through (vii) that may use price-
related compensation and payment structures,
such as rebate aggregators (or other entities
that negotiate or process price concessions on
behalf of pharmacy benefit managers, plan
sponsors, or pharmacies).
(B) The primary business models and compensation
structures for each category of intermediary described
in subparagraph (A).
(C) Variation in price-related compensation
structures between affiliated entities (such as
entities with common ownership, either full or partial,
and subsidiary relationships) and unaffiliated
entities.
(D) Potential conflicts of interest among
contracting entities related to the use of prescription
drug price-related compensation structures, such as the
potential for fees or other payments set as a
percentage of a prescription drug's price to advantage
formulary selection, distribution, or purchasing of
prescription drugs with higher prices.
(E) Notable differences, if any, in the use and
level of price-based compensation structures over time
and between different market segments, such as under
part D of title XVIII of the Social Security Act (42
U.S.C. 1395w-101 et seq.) and the Medicaid program
under title XIX of such Act (42 U.S.C. 1396 et seq.).
(F) The effects of drug price-related compensation
structures and alternative compensation structures on
Federal health care programs and program beneficiaries,
including with respect to cost-sharing, premiums,
Federal outlays, biosimilar and generic drug adoption
and utilization, drug shortage risks, and the potential
for fees set as a percentage of a drug's price to
advantage the formulary selection, distribution, or
purchasing of drugs with higher prices.
(G) Other issues determined to be relevant and
appropriate by the Comptroller General.
(2) Report.--Not later than 2 years after the date of
enactment of this section, the Comptroller General shall submit
to Congress a report containing the results of the study
conducted under paragraph (1), together with recommendations
for such legislation and administrative action as the
Comptroller General determines appropriate.
(c) MedPAC Reports on Agreements With Pharmacy Benefit Managers
With Respect to Prescription Drug Plans and MA-PD Plans.--
(1) In general.--The Medicare Payment Advisory Commission
shall submit to Congress the following reports:
(A) Initial report.--Not later than the first March
15 occurring after the date that is 2 years after the
date on which the Secretary makes the data available to
the Commission, a report regarding agreements with
pharmacy benefit managers with respect to prescription
drug plans and MA-PD plans. Such report shall include,
to the extent practicable--
(i) a description of trends and patterns,
including relevant averages, totals, and other
figures for the types of information submitted;
(ii) an analysis of any differences in
agreements and their effects on plan enrollee
out-of-pocket spending and average pharmacy
reimbursement, and other impacts; and
(iii) any recommendations the Commission
determines appropriate.
(B) Final report.--Not later than 2 years after the
date on which the Commission submits the initial report
under subparagraph (A), a report describing any changes
with respect to the information described in
subparagraph (A) over time, together with any
recommendations the Commission determines appropriate.
(2) Funding.--In addition to amounts otherwise available,
there is appropriated to the Medicare Payment Advisory
Commission, out of any money in the Treasury not otherwise
appropriated, $1,000,000 for fiscal year 2025, to remain
available until expended, to carry out this subsection.
SEC. 228. REQUIRING A SEPARATE IDENTIFICATION NUMBER AND AN ATTESTATION
FOR EACH OFF-CAMPUS OUTPATIENT DEPARTMENT OF A PROVIDER.
(a) In General.--Section 1833(t) of the Social Security Act (42
U.S.C. 1395l(t)) is amended by adding at the end the following new
paragraph:
``(23) Use of unique health identifiers; attestation.--
``(A) In general.--No payment may be made under
this subsection (or under an applicable payment system
pursuant to paragraph (21)) for items and services
furnished on or after January 1, 2026, by an off-campus
outpatient department of a provider (as defined in
subparagraph (C)) unless--
``(i) such department has obtained, and
such items and services are billed under, a
standard unique health identifier for health
care providers (as described in section
1173(b)) that is separate from such identifier
for such provider;
``(ii) such provider has submitted to the
Secretary, during the 2-year period ending on
the date such items and services are so
furnished, an initial provider-based status
attestation that such department is compliant
with the requirements described in section
413.65 of title 42, Code of Federal Regulations
(or a successor regulation); and
``(iii) after such provider has submitted
an attestation under clause (ii), such provider
has submitted a subsequent attestation within
the timeframe specified by the Secretary.
``(B) Process for submission and review.--Not later
than 1 year after the date of enactment of this
paragraph, the Secretary shall, through notice and
comment rulemaking, establish a process for each
provider with an off-campus outpatient department of a
provider to submit an initial and subsequent
attestation pursuant to clauses (ii) and (iii),
respectively, of subparagraph (A), and for the
Secretary to review each such attestation and
determine, through site visits, remote audits, or other
means (as determined appropriate by the Secretary),
whether such department is compliant with the
requirements described in such subparagraph.
``(C) Off-campus outpatient department of a
provider defined.--For purposes of this paragraph, the
term `off-campus outpatient department of a provider'
means a department of a provider (as defined in section
413.65 of title 42, Code of Federal Regulations, or any
successor regulation) that is not located--
``(i) on the campus (as defined in such
section) of such provider; or
``(ii) within the distance (described in
such definition of campus) from a remote
location of a hospital facility (as defined in
such section).''.
(b) HHS OIG Analysis.--Not later than January 1, 2030, the
Inspector General of the Department of Health and Human Services shall
submit to Congress--
(1) an analysis of the process established by the Secretary
of Health and Human Services to conduct the reviews and
determinations described in section 1833(t)(23)(B) of the
Social Security Act, as added by subsection (a) of this
section; and
(2) recommendations based on such analysis, as the
Inspector General determines appropriate.
SEC. 229. MEDICARE SEQUESTRATION.
Section 251A(6) of the Balanced Budget and Emergency Deficit
Control Act of 1985 (2 U.S.C. 901a(6)) is amended--
(1) in subparagraph (D), by striking ``such that,'' and all
that follows and inserting ``such that the payment reduction
shall be 2.0 percent.''; and
(2) by adding at the end the following:
``(F) On the date on which the President submits the budget
under section 1105 of title 31, United States Code, for fiscal
year 2033, the President shall order a sequestration of
payments for the Medicare programs specified in section 256(d),
effective upon issuance, such that, notwithstanding the 2
percent limit specified in subparagraph (A) for such payments--
``(i) with respect to the first 2 months in which
such order is effective for such fiscal year, the
payment reduction shall be 2.0 percent; and
``(ii) with respect to the last 10 months in which
such order is effective for such fiscal year, the
payment reduction shall be 0 percent.''.
SEC. 230. MEDICARE IMPROVEMENT FUND.
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended by striking ``$1,251,000,000'' and inserting
``$1,938,000,000''.
TITLE III--HUMAN SERVICES
SEC. 301. SEXUAL RISK AVOIDANCE EDUCATION EXTENSION.
Section 510 of the Social Security Act (42 U.S.C. 710) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``and for the period'' and
inserting ``for the period'';
(ii) by inserting ``for the period
beginning on April 1, 2025, and ending on
September 30, 2025, and for the period
beginning on October 1, 2025, and ending on
December 31, 2025,'' before ``allot to each
State''; and
(iii) by striking ``for fiscal year 2024 or
2025'' and inserting ``for fiscal year 2024,
2025, or 2026''; and
(B) in paragraph (2), by striking ``or 2025'' each
place it appears and inserting ``, 2025, or 2026''; and
(2) in subsection (f)(1), by striking ``and for the period
beginning on October 1, 2024, and ending on March 31, 2025, an
amount equal to the pro rata portion of the amount appropriated
for the corresponding period for fiscal year 2024'' and
inserting ``for the period beginning on October 1, 2024, and
ending on March 31, 2025, and for the period beginning on April
1, 2025, and ending on September 30, 2025, an amount equal to
the pro rata portion of the amount appropriated for the
corresponding period for fiscal year 2024, and for the period
beginning on October 1, 2025, and ending on December 31, 2025,
an amount equal to the pro rata portion of the amount
appropriated for the corresponding period for fiscal year
2025''
SEC. 302. PERSONAL RESPONSIBILITY EDUCATION EXTENSION.
Section 513 of the Social Security Act (42 U.S.C. 713) is amended--
(1) in subsection (a)(1)--
(A) in subparagraph (A), in the matter preceding
clause (i)--
(i) by striking ``and for the period'' and
inserting ``for the period''; and
(ii) by inserting ``for the period
beginning on April 1, 2025, and ending on
September 30, 2025, and for the period
beginning on October 1, 2025, and ending on
December 31, 2025,'' before ``the Secretary
shall allot''; and
(B) in subparagraph (B)(i)--
(i) by striking ``and for the period'' and
inserting ``for the period''; and
(ii) by inserting ``, for the period
beginning on April 1, 2025, and ending on
September 30, 2025, and for the period
beginning on October 1, 2025, and ending on
December 31, 2025'' before the period;
(2) in subsection (c)(3), by striking ``fiscal year 2024 or
2025'' and inserting ``fiscal year 2024, 2025, or 2026''; and
(3) in subsection (f), by striking ``and for the period
beginning on October 1, 2024, and ending on March 31, 2025, an
amount equal to the pro rata portion of the amount appropriated
for the corresponding period for fiscal year 2024'' and
inserting ``for the period beginning on October 1, 2024, and
ending on March 31, 2025, and for the period beginning on April
1, 2025, and ending on September 30, 2025, an amount equal to
the pro rata portion of the amount appropriated for the
corresponding period for fiscal year 2024, and for the period
beginning on October 1, 2025, and ending on December 31, 2025,
an amount equal to the pro rata portion of the amount
appropriated for the corresponding period for fiscal year
2025''.
SEC. 303. EXTENSION OF FUNDING FOR FAMILY-TO-FAMILY HEALTH INFORMATION
CENTERS.
Section 501(c)(1)(A)(viii) of the Social Security Act (42 U.S.C.
701(c)(1)(A)(viii)) is amended--
(1) by striking ``$3,000,000'' and inserting
``$7,500,000''; and
(2) by striking ``for the portion of fiscal year 2025
before April 1, 2025'' and inserting ``for the period beginning
on October 1, 2024, and ending on December 31, 2025''.
TITLE IV--PUBLIC HEALTH EXTENDERS
Subtitle A--Extensions
SEC. 401. EXTENSION FOR COMMUNITY HEALTH CENTERS, NATIONAL HEALTH
SERVICE CORPS, AND TEACHING HEALTH CENTERS THAT OPERATE
GME PROGRAMS.
(a) Extension for Community Health Centers.--Section 10503(b)(1) of
the Patient Protection and Affordable Care Act (42 U.S.C. 254b-2(b)(1))
is amended--
(1) in subparagraph (H), by striking ``and'' at the end;
(2) in subparagraph (I), by striking the period and
inserting ``, and $2,315,342,466 for the period beginning on
April 1, 2025, and ending on September 30, 2025; and''; and
(3) by adding at the end the following:
``(J) $4,600,000,000 for fiscal year 2026; and''.
(b) Extension for the National Health Service Corps.--Section
10503(b)(2) of the Patient Protection and Affordable Care Act (42
U.S.C. 254b-2(b)(2)) is amended--
(1) in subparagraph (I), by striking ``and'' at the end;
(2) in subparagraph (J), by striking the period and
inserting ``, and $176,712,329 for the period beginning on
April 1, 2025, and ending on September 30, 2025; and''; and
(3) by adding at the end the following:
``(J) $350,000,000 for fiscal year 2026.''.
(c) Teaching Health Centers That Operate Graduate Medical Education
Programs.--Section 340H(g)(1) of the Public Health Service Act (42
U.S.C. 256h(g)(1)) is amended--
(1) in subparagraph (D), by striking ``; and'' and
inserting a semicolon;
(2) in subparagraph (E), by striking the period and
inserting a semicolon; and
(3) by adding at the end the following: ``
``(F) $112,849,315 for the period beginning on
January 1, 2025, and ending on September 30, 2025;
``(G) $225,000,000 for fiscal year 2026;
``(H) $250,000,000 for fiscal year 2027;
``(I) $275,000,000 for fiscal year 2028; and
``(J) $300,000,000 for fiscal year 2029.''.
(d) Application of Provisions.--Amounts appropriated pursuant to
the amendments made by this section shall be subject to the
requirements contained in Public Law 118-47 for funds for programs
authorized under sections 330 through 340 of the Public Health Service
Act (42 U.S.C. 254b et seq.).
(e) Conforming Amendments.--Section 3014(h)(4) of title 18, United
States Code, is amended by striking ``and section 3101(d) of the Health
Extensions and Other Matters Act, 2025'' and inserting ``section
3101(d) of the Health Extensions and Other Matters Act, 2025, and
section 401(d) of the Bipartisan Health Care Act''.
SEC. 402. EXTENSION OF SPECIAL DIABETES PROGRAMS.
(a) Extension of Special Diabetes Programs for Type I Diabetes.--
Section 330B(b)(2) of the Public Health Service Act (42 U.S.C. 254c-
2(b)(2)) is amended--
(1) in subparagraph (E), by striking ``and'' at the end;
(2) in subparagraph (F), by striking the period at the end
and inserting ``, and $110,327,296 for the period beginning on
April 1, 2025, and ending on September 30, 2025; and''; and
(3) by adding at the end the following:
``(G) $200,000,000 for fiscal year 2026, to remain
available until expended.''.
(b) Extending Funding for Special Diabetes Programs for Indians.--
Section 330C(c)(2) of the Public Health Service Act (42 U.S.C. 254c-
3(c)(2)) is amended--
(1) in subparagraph (E), by striking ``and'' at the end;
(2) in subparagraph (F), by striking the period at the end
and inserting ``, and $110,327,296 for the period beginning on
April 1, 2025, and ending on September 30, 2025; and''; and
(3) by adding at the end the following:
``(G) $200,000,000 for fiscal year 2026, to remain
available until expended.''.
Subtitle B--World Trade Center Health Program
SEC. 411. 9/11 RESPONDER AND SURVIVOR HEALTH FUNDING CORRECTIONS.
(a) In General.--Section 3351(a)(2)(A) of the Public Health Service
Act (42 U.S.C. 300mm-61(a)(2)(A)) is amended--
(1) in clause (x), by striking ``; and'' and inserting a
semicolon;
(2) by redesignating clause (xi) as clause (xii); and
(3) by inserting after clause (x), the following:
``(xi) for each of fiscal years 2026
through 2040--
``(I) the amount determined under
this subparagraph for the previous
fiscal year multiplied by 1.05;
multiplied by
``(II) the ratio of--
``(aa) the total number of
individuals enrolled in the WTC
Program on July 1 of such
previous fiscal year; to
``(bb) the total number of
individuals so enrolled on July
1 of the fiscal year prior to
such previous fiscal year;
and''.
(b) Report to Congress.--
(1) In general.--Not later than 3 years after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this subsection as the ``Secretary'')
shall conduct an assessment of anticipated budget authority and
outlays of the World Trade Center Health Program (referred to
in this subsection as the ``Program'') through the duration of
the Program and submit a report summarizing such assessment
to--
(A) the Speaker and minority leader of the House of
Representatives;
(B) the majority and minority leaders of the
Senate;
(C) the Committee on Health, Education, Labor, and
Pensions and the Committee on the Budget of the Senate;
and
(D) the Committee on Energy and Commerce and the
Committee on the Budget of the House of
Representatives.
(2) Inclusions.--The report required under paragraph (1)
shall include--
(A) a projection of Program budgetary needs on a
per-fiscal year basis through fiscal year 2090;
(B) a review of Program modeling for each of fiscal
years 2017 through the fiscal year prior to the fiscal
year in which the report is issued to assess how
anticipated budgetary needs compared to actual
expenditures;
(C) an assessment of the projected budget authority
and expenditures of the Program through fiscal year
2090 by comparing--
(i) such projected authority and
expenditures resulting from application of
section 3351(a)(2)(A) of the Public Health
Service Act (42 U.S.C. 300mm-61(a)(2)(A)), as
amended by subsection (a); and
(ii) such projected authority and
expenditures that would result if such section
were amended so that the formula under clause
(xi) of such section, as amended by subsection
(a), were to be extended through fiscal year
2090; and
(D) any recommendations of the Secretary to make
changes to the formula under such section
3351(a)(2)(A), as so amended, to fully offset
anticipated Program expenditures through fiscal year
2090.
(c) Technical Amendments.--Title XXXIII of the Public Health
Service Act (42 U.S.C. 300mm et seq.) is amended--
(1) in section 3352(d) (42 U.S.C. 300mm-62(d)), by striking
``Any amounts'' and inserting ``Any unobligated amounts'';
(2) in section 3353(d) (42 U.S.C. 300mm-63(d)), by striking
``Any amounts'' and inserting ``Any unobligated amounts''; and
(3) in section 3354(d) (42 U.S.C. 300mm-64(d)), by striking
``Any amounts'' and inserting ``Any unobligated amounts''.
TITLE V--SUPPORT ACT REAUTHORIZATION
SEC. 501. SHORT TITLE.
This title may be cited as the ``SUPPORT for Patients and
Communities Reauthorization Act of 2025''.
Subtitle A--Prevention
SEC. 511. PRENATAL AND POSTNATAL HEALTH.
Section 317L(d) of the Public Health Service Act (42 U.S.C. 247b-
13(d)) is amended by striking ``such sums as may be necessary for each
of the fiscal years 2019 through 2023'' and inserting ``$4,250,000 for
each of fiscal years 2025 through 2029''.
SEC. 512. MONITORING AND EDUCATION REGARDING INFECTIONS ASSOCIATED WITH
ILLICIT DRUG USE AND OTHER RISK FACTORS.
Section 317N(d) of the Public Health Service Act (42 U.S.C. 247b-
15(d)) is amended by striking ``fiscal years 2019 through 2023'' and
inserting ``fiscal years 2025 through 2029''.
SEC. 513. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
(a) In General.--Section 392A of the Public Health Service Act (42
U.S.C. 280b-1) is amended--
(1) in subsection (a)(2)--
(A) in subparagraph (C), by inserting ``and
associated risks'' before the period at the end; and
(B) in subparagraph (D), by striking ``opioids''
and inserting ``substances causing overdose''; and
(2) in subsection (b)(2)--
(A) in subparagraph (B), by inserting ``, and
associated risk factors,'' after ``such overdoses'';
(B) in subparagraph (C), by striking ``coding'' and
inserting ``monitoring and identifying'';
(C) in subparagraph (E)--
(i) by inserting a comma after ``public
health laboratories''; and
(ii) by inserting ``and other emerging
substances related'' after ``analogues''; and
(D) in subparagraph (F), by inserting ``and
associated risk factors'' after ``overdoses''.
(b) Additional Grants.--Section 392A(a)(3) of the Public Health
Service Act (42 U.S.C. 280b-1(a)(3)) is amended--
(1) in the matter preceding subparagraph (A), by striking
``and Indian Tribes--'' and inserting ``and Indian Tribes for
the following purposes:'';
(2) by amending subparagraph (A) to read as follows:
``(A) To carry out innovative projects for grantees
to detect, identify, and rapidly respond to controlled
substance misuse, abuse, and overdoses, and associated
risk factors, including changes in patterns of such
controlled substance use. Such projects may include the
use of innovative, evidence-based strategies for
detecting such patterns, such as wastewater
surveillance, if proven to support actionable
prevention strategies, in a manner consistent with
applicable Federal and State privacy laws.''; and
(3) in subparagraph (B), by striking ``for any'' and
inserting ``For any''.
(c) Authorization of Appropriations.--Section 392A(e) of the Public
Health Service Act (42 U.S.C. 280b-1(e)) is amended by striking
``$496,000,000 for each of fiscal years 2019 through 2023'' and
inserting ``$505,579,000 for each of fiscal years 2025 through 2029''.
SEC. 514. SUPPORT FOR INDIVIDUALS AND FAMILIES IMPACTED BY FETAL
ALCOHOL SPECTRUM DISORDER.
(a) In General.--Part O of title III of the Public Health Service
Act (42 U.S.C. 280f et seq.) is amended to read as follows:
``PART O--FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM
``SEC. 399H. FETAL ALCOHOL SPECTRUM DISORDERS PREVENTION, INTERVENTION,
AND SERVICES DELIVERY PROGRAM.
``(a) In General.--The Secretary shall establish or continue
activities to support a comprehensive fetal alcohol spectrum disorders
(referred to in this section as `FASD') education, prevention,
identification, intervention, and services delivery program, which may
include--
``(1) an education and public awareness program to support,
conduct, and evaluate the effectiveness of--
``(A) educational programs targeting health
professions schools, social and other supportive
services, educators and counselors and other service
providers in all phases of childhood development, and
other relevant service providers, concerning the
prevention, identification, and provision of services
for infants, children, adolescents and adults with
FASD;
``(B) strategies to educate school-age children,
including pregnant and high-risk youth, concerning
FASD;
``(C) public and community awareness programs
concerning FASD; and
``(D) strategies to coordinate information and
services across affected community agencies, including
agencies providing social services such as foster care,
adoption, and social work, agencies providing health
services, and agencies involved in education,
vocational training and civil and criminal justice;
``(2) supporting and conducting research on FASD, as
appropriate, including to--
``(A) develop appropriate medical diagnostic
methods for identifying FASD; and
``(B) develop effective culturally and
linguistically appropriate evidence-based or evidence-
informed interventions and appropriate supports for
preventing prenatal alcohol exposure, which may co-
occur with exposure to other substances;
``(3) building State and Tribal capacity for the
identification, treatment, and support of individuals with FASD
and their families, which may include--
``(A) utilizing and adapting existing Federal,
State, or Tribal programs to include FASD
identification and FASD-informed support;
``(B) developing and expanding screening and
diagnostic capacity for FASD;
``(C) developing, implementing, and evaluating
targeted FASD-informed intervention programs for FASD;
``(D) providing training with respect to FASD for
professionals across relevant sectors; and
``(E) disseminating information about FASD and
support services to affected individuals and their
families; and
``(4) an applied research program concerning intervention
and prevention to support and conduct service demonstration
projects, clinical studies and other research models providing
advocacy, educational and vocational training, counseling,
medical and mental health, and other supportive services, as
well as models that integrate and coordinate such services,
that are aimed at the unique challenges facing individuals with
Fetal Alcohol Syndrome or Fetal Alcohol Effect and their
families.
``(b) Grants and Technical Assistance.--
``(1) In general.--The Secretary may award grants,
cooperative agreements and contracts and provide technical
assistance to eligible entities to carry out subsection (a).
``(2) Eligible entities.--To be eligible to receive a
grant, or enter into a cooperative agreement or contract, under
this section, an entity shall--
``(A) be a State, Indian Tribe or Tribal
organization, local government, scientific or academic
institution, or nonprofit organization; and
``(B) prepare and submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary may
require, including a description of the activities that
the entity intends to carry out using amounts received
under this section.
``(3) Additional application contents.--The Secretary may
require that an eligible entity include in the application
submitted under paragraph (2)(B)--
``(A) a designation of an individual to serve as a
FASD State or Tribal coordinator of activities such
eligible entity proposes to carry out through a grant,
cooperative agreement, or contract under this section;
and
``(B) a description of an advisory committee the
entity will establish to provide guidance for the
entity on developing and implementing a statewide or
Tribal strategic plan to prevent FASD and provide for
the identification, treatment, and support of
individuals with FASD and their families.
``(c) Definition of FASD-Informed.--For purposes of this section,
the term `FASD-informed', with respect to support or an intervention
program, means that such support or intervention program uses
culturally and linguistically informed evidence-based or practice-based
interventions and appropriate resources to support an improved quality
of life for an individual with FASD and the family of such individual.
``SEC. 399I. STRENGTHENING CAPACITY AND EDUCATION FOR FETAL ALCOHOL
SPECTRUM DISORDERS.
``(a) In General.--The Secretary shall award grants, contracts, or
cooperative agreements, as the Secretary determines appropriate, to
public or nonprofit private entities with demonstrated expertise in the
field of fetal alcohol spectrum disorders (referred to in this section
as `FASD'). Such awards shall be for the purposes of building local,
Tribal, State, and nationwide capacities to prevent the occurrence of
FASD by carrying out the programs described in subsection (b).
``(b) Programs.--An entity receiving an award under subsection (a)
may use such award for the following purposes:
``(1) Developing and supporting public education and
outreach activities to raise public awareness of the risks
associated with alcohol consumption during pregnancy.
``(2) Acting as a clearinghouse for evidence-based
resources on FASD prevention, identification, and culturally
and linguistically appropriate best practices to help inform
systems of care for individuals with FASD across their
lifespan.
``(3) Increasing awareness and understanding of
efficacious, evidence-based screening tools and culturally and
linguistically appropriate evidence-based intervention services
and best practices, which may include improving the capacity
for State, Tribal, and local affiliates.
``(4) Providing technical assistance to recipients of
grants, cooperative agreements, or contracts under section
399H, as appropriate.
``(c) Application.--To be eligible for a grant, contract, or
cooperative agreement under this section, an entity shall submit to the
Secretary an application at such time, in such manner, and containing
such information as the Secretary may require.
``(d) Subcontracting.--A public or private nonprofit entity may
carry out the following activities required under this section through
contracts or cooperative agreements with other public and private
nonprofit entities with demonstrated expertise in FASD:
``(1) Resource development and dissemination.
``(2) Intervention services.
``(3) Training and technical assistance.
``SEC. 399J. AUTHORIZATION OF APPROPRIATIONS.
``There are authorized to be appropriated to carry out this part
$12,500,000 for each of fiscal years 2025 through 2029.''.
(b) Report.--Not later than 4 years after the date of enactment of
this Act, and every year thereafter, the Secretary of Health and Human
Services shall prepare 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
containing--
(1) a review of the activities carried out pursuant to
sections 399H and 399I of the Public Health Service Act, as
amended, to advance public education and awareness of fetal
alcohol spectrum disorders (referred to in this section as
``FASD'');
(2) a description of--
(A) the activities carried out pursuant to such
sections 399H and 399I to identify, prevent, and treat
FASD; and
(B) methods used to evaluate the outcomes of such
activities; and
(3) an assessment of activities carried out pursuant to
such sections 399H and 399I to support individuals with FASD.
SEC. 515. PROMOTING STATE CHOICE IN PDMP SYSTEMS.
Section 399O(h) of the Public Health Service Act (42 U.S.C. 280g-
3(h)) is amended by adding at the end the following:
``(5) Promoting state choice.--Nothing in this section
shall be construed to authorize the Secretary to require States
to use a specific vendor or a specific interoperability
connection other than to align with nationally recognized,
consensus-based open standards, such as in accordance with
sections 3001 and 3004.''.
SEC. 516. FIRST RESPONDER TRAINING PROGRAM.
Section 546 of the Public Health Service Act (42 U.S.C. 290ee-1) is
amended--
(1) in subsection (a), by striking ``tribes and tribal''
and inserting ``Tribes and Tribal'';
(2) in subsections (a), (c), and (d)--
(A) by striking ``approved or cleared'' each place
it appears and inserting ``approved, cleared, or
otherwise legally marketed''; and
(B) by striking ``opioid'' each place it appears;
(3) in subsection (f)--
(A) by striking ``approved or cleared'' each place
it appears and inserting ``approved, cleared, or
otherwise legally marketed'';
(B) in paragraph (1), by striking ``opioid'';
(C) in paragraph (2)--
(i) by striking ``opioid and heroin'' and
inserting ``opioid, heroin, and other drug'';
and
(ii) by striking ``opioid overdose'' and
inserting ``overdose''; and
(D) in paragraph (3), by striking ``opioid and
heroin''; and
(4) in subsection (h), by striking ``$36,000,000 for each
of fiscal years 2019 through 2023'' and inserting ``$56,000,000
for each of fiscal years 2025 through 2029''.
SEC. 517. DONALD J. COHEN NATIONAL CHILD TRAUMATIC STRESS INITIATIVE.
(a) Technical Amendment.--The second part G of title V of the
Public Health Service Act (42 U.S.C. 290kk et seq.), as added by
section 144 of the Community Renewal Tax Relief Act (Public Law 106-
554), is amended--
(1) by redesignating such part as part J; and
(2) by redesignating sections 581 through 584 as sections
596 through 596C, respectively.
(b) In General.--Section 582 of the Public Health Service Act (42
U.S.C. 290hh-1) is amended--
(1) in the section heading, by striking ``violence related
stress'' and inserting ``traumatic events'';
(2) in subsection (a)--
(A) in the matter preceding paragraph (1), by
striking ``tribes and tribal'' and inserting ``Tribes
and Tribal''; and
(B) in paragraph (2), by inserting ``and
dissemination'' after ``the development'';
(3) in subsection (b), by inserting ``and dissemination''
after ``the development'';
(4) in subsection (d)--
(A) by striking ``The NCTSI'' and inserting the
following:
``(1) Coordinating center.--The NCTSI''; and
(B) by adding at the end the following:
``(2) Nctsi grantees.--In carrying out subsection (a)(2),
NCTSI grantees shall develop trainings and other resources, as
applicable and appropriate, to support implementation of the
evidence-based practices developed and disseminated under such
subsection.'';
(5) in subsection (e)--
(A) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively, and adjusting
the margins accordingly;
(B) in subparagraph (A), as so redesignated, by
inserting ``and implementation'' after ``the
dissemination'';
(C) by striking ``The NCTSI'' and inserting the
following:
``(1) Coordinating center.--The NCTSI''; and
(D) by adding at the end the following:
``(2) Nctsi grantees.--NCTSI grantees shall, as
appropriate, collaborate with other such grantees, the NCTSI
coordinating center, and the Secretary in carrying out
subsections (a)(2) and (d)(2).'';
(6) by amending subsection (h) to read as follows:
``(h) Application and Evaluation.--To be eligible to receive a
grant, contract, or cooperative agreement under subsection (a), a
public or nonprofit private entity or an Indian Tribe or Tribal
organization shall submit to the Secretary an application at such time,
in such manner, and containing such information and assurances as the
Secretary may require, including--
``(1) a plan for the evaluation of the activities funded
under the grant, contract, or agreement, including both process
and outcomes evaluation, and the submission of an evaluation at
the end of the project period; and
``(2) a description of how such entity, Indian Tribe, or
Tribal organization will support efforts led by the Secretary
or the NCTSI coordinating center, as applicable, to evaluate
activities carried out under this section.''; and
(7) by amending subsection (j) to read as follows:
``(j) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section--
``(1) $93,887,000 for fiscal year 2025;
``(2) $95,000,000 for fiscal year 2026;
``(3) $97,000,000 for fiscal year 2027;
``(4) $100,000,000 for fiscal year 2028; and
``(5) $100,000,000 for fiscal year 2029.''.
SEC. 518. PROTECTING SUICIDE PREVENTION LIFELINE FROM CYBERSECURITY
INCIDENTS.
(a) National Suicide Prevention Lifeline Program.--Section 520E-
3(b) of the Public Health Service Act (42 U.S.C. 290bb-36c(b)) is
amended--
(1) in paragraph (4), by striking ``and'' at the end;
(2) in paragraph (5), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(6) taking such steps as may be necessary to ensure the
suicide prevention hotline is protected from cybersecurity
incidents and eliminates known cybersecurity
vulnerabilities.''.
(b) Reporting.--Section 520E-3 of the Public Health Service Act (42
U.S.C. 290bb-36c) is amended--
(1) by redesignating subsection (f) as subsection (g); and
(2) by inserting after subsection (e) the following:
``(f) Cybersecurity Reporting.--
``(1) Notification.--
``(A) In general.--The program's network
administrator receiving Federal funding pursuant to
subsection (a) shall report to the Assistant Secretary,
in a manner that protects personal privacy, consistent
with applicable Federal and State privacy laws--
``(i) any identified cybersecurity
vulnerabilities to the program within a
reasonable amount of time after identification
of such a vulnerability; and
``(ii) any identified cybersecurity
incidents to the program within a reasonable
amount of time after identification of such
incident.
``(B) Local and regional crisis centers.--Local and
regional crisis centers participating in the program
shall report to the program's network administrator
identified under subparagraph (A), in a manner that
protects personal privacy, consistent with applicable
Federal and State privacy laws--
``(i) any identified cybersecurity
vulnerabilities to the program within a
reasonable amount of time after identification
of such vulnerability; and
``(ii) any identified cybersecurity
incidents to the program within a reasonable
amount of time after identification of such
incident.
``(2) Notification.--If the program's network administrator
receiving funding pursuant to subsection (a) discovers, or is
informed by a local or regional crisis center pursuant to
paragraph (1)(B) of, a cybersecurity vulnerability or incident,
within a reasonable amount of time after such discovery or
receipt of information, such entity shall report the
vulnerability or incident to the Assistant Secretary.
``(3) Clarification.--
``(A) Oversight.--
``(i) Local and regional crisis centers.--
Except as provided in clause (ii), local and
regional crisis centers participating in the
program shall oversee all technology each
center employs in the provision of services as
a participant in the program.
``(ii) Network administrator.--The
program's network administrator receiving
Federal funding pursuant to subsection (a)
shall oversee the technology each crisis center
employs in the provision of services as a
participant in the program if such oversight
responsibilities are established in the
applicable network participation agreement.
``(B) Supplement, not supplant.--The cybersecurity
incident reporting requirements under this subsection
shall supplement, and not supplant, cybersecurity
incident reporting requirements under other provisions
of applicable Federal law that are in effect on the
date of the enactment of the SUPPORT for Patients and
Communities Reauthorization Act of 2025.''.
(c) Study.--Not later than 180 days after the date of the enactment
of this Act, the Comptroller General of the United States shall--
(1) conduct and complete a study that evaluates
cybersecurity risks and vulnerabilities associated with the 9-
8-8 National Suicide Prevention Lifeline; and
(2) submit a report on the findings of such study to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives.
SEC. 519. BRUCE'S LAW.
(a) Youth Prevention and Recovery.--Section 7102(c) of the SUPPORT
for Patients and Communities Act (42 U.S.C. 290bb-7a(c)) is amended--
(1) in paragraph (3)(A)(i), by inserting ``, which may
include strategies to increase education and awareness of the
potency and dangers of synthetic opioids (including drugs
contaminated with fentanyl) and, as appropriate, other emerging
drug use or misuse issues'' before the semicolon; and
(2) in paragraph (4)(A), by inserting ``and strategies to
increase education and awareness of the potency and dangers of
synthetic opioids (including drugs contaminated with fentanyl)
and, as appropriate, emerging drug use or misuse issues''
before the semicolon.
(b) Interdepartmental Substance Use Disorders Coordinating
Committee.--Section 7022 of the SUPPORT for Patients and Communities
Act (42 U.S.C. 290aa note) is amended--
(1) by striking subsection (g) and inserting the following:
``(g) Working Groups.--
``(1) In general.--The Committee may establish working
groups for purposes of carrying out the duties described in
subsection (e). Any such working group shall be composed of
members of the Committee (or the designees of such members) and
may hold such meetings as are necessary to carry out the duties
delegated to the working group.
``(2) Additional federal interagency work group on fentanyl
contamination of illegal drugs.--
``(A) Establishment.--The Secretary, acting through
the Committee, shall establish a Federal Interagency
Work Group on Fentanyl Contamination of Illegal Drugs
(referred to in this paragraph as the `Work Group')
consisting of representatives from relevant Federal
departments and agencies on the Committee.
``(B) Consultation.--The Work Group shall consult
with relevant stakeholders and subject matter experts,
including--
``(i) State, Tribal, and local subject
matter experts in reducing, preventing, and
responding to drug overdose caused by fentanyl-
contamination of illicit drugs; and
``(ii) family members of both adults and
youth who have overdosed by fentanyl-
contaminated illicit drugs.
``(C) Duties.--The Work Group shall--
``(i) examine Federal efforts to reduce and
prevent drug overdose by fentanyl-contaminated
illicit drugs;
``(ii) identify strategies to improve
State, Tribal, and local responses to overdose
by fentanyl-contaminated illicit drugs;
``(iii) coordinate with the Secretary, as
appropriate, in carrying out activities to
raise public awareness of synthetic opioids and
other emerging drug use and misuse issues;
``(iv) make recommendations to Congress for
improving Federal programs, including with
respect to the coordination of efforts across
such programs; and
``(v) make recommendations for educating
youth on the potency and dangers of drugs
contaminated by fentanyl.
``(D) Annual report to secretary.--The Work Group
shall annually prepare and submit to the Secretary, the
Committee on Health, Education, Labor, and Pensions of
the Senate, and the Committee on Energy and Commerce
and the Committee on Education and the Workforce of the
House of Representatives, a report on the activities
carried out by the Work Group under subparagraph (C),
including recommendations to reduce and prevent drug
overdose by fentanyl contamination of illegal drugs, in
all populations, and specifically among youth at risk
for substance misuse.''; and
(2) by striking subsection (i) and inserting the following:
``(i) Sunset.--The Committee shall
terminate on September 30, 2029.''.
SEC. 520. GUIDANCE ON AT-HOME DRUG DISPOSAL SYSTEMS.
(a) In General.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human Services, in
consultation with the Administrator of the Drug Enforcement
Administration, shall publish guidance to facilitate the use of at-home
safe disposal systems for applicable drugs.
(b) Contents.--The guidance under subsection (a) shall include--
(1) recommended standards for effective at-home drug
disposal systems to meet applicable requirements enforced by
the Food and Drug Administration;
(2) recommended information to include as instructions for
use to disseminate with at-home drug disposal systems;
(3) best practices and educational tools to support the use
of an at-home drug disposal system, as appropriate; and
(4) recommended use of licensed health providers for the
dissemination of education, instruction, and at-home drug
disposal systems, as appropriate.
SEC. 521. ASSESSMENT OF OPIOID DRUGS AND ACTIONS.
(a) In General.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall publish on the
website of the Food and Drug Administration (referred to in this
section as the ``FDA'') a report that outlines a plan for assessing
opioid analgesic drugs that are approved under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) that addresses the
public health effects of such opioid analgesic drugs as part of the
benefit-risk assessment and the activities of the FDA that relate to
facilitating the development of nonaddictive medical products intended
to treat pain or addiction. Such report shall include--
(1) an update on the actions taken by the FDA to consider
the effectiveness, safety, benefit-risk profile, and use of
approved opioid analgesic drugs;
(2) a timeline for an assessment of the potential need, as
appropriate, for labeling changes, revised or additional
postmarketing requirements, enforcement actions, or withdrawals
for opioid analgesic drugs;
(3) an overview of the steps that the FDA has taken to
support the development and approval of nonaddictive medical
products intended to treat pain or addiction, and actions
planned to further support the development and approval of such
products; and
(4) an overview of the consideration by the FDA of clinical
trial methodologies for analgesic drugs, including the enriched
enrollment randomized withdrawal methodology, and the benefits
and drawbacks associated with different trial methodologies for
such drugs, incorporating any public input received under
subsection (b).
(b) Public Input.--In carrying out subsection (a), the Secretary
shall provide an opportunity for public input concerning the regulation
by the FDA of opioid analgesic drugs, including scientific evidence
that relates to conditions of use, safety, or benefit-risk assessment
(including consideration of the public health effects) of such opioid
analgesic drugs.
SEC. 522. GRANT PROGRAM FOR STATE AND TRIBAL RESPONSE TO OPIOID USE
DISORDERS.
The activities carried out pursuant to section 1003(b)(4)(A) of the
21st Century Cures Act (42 U.S.C. 290ee-3a(b)(4)(A)) may include
facilitating access to products used to prevent overdose deaths by
detecting the presence of one or more substances, such as fentanyl and
xylazine test strips, to the extent the purchase and possession of such
products is consistent with Federal and State law.
Subtitle B--Treatment
SEC. 531. RESIDENTIAL TREATMENT PROGRAM FOR PREGNANT AND POSTPARTUM
WOMEN.
Section 508 of the Public Health Service Act (42 U.S.C. 290bb-1) is
amended--
(1) in subsection (d)(11)(C), by striking ``providing
health services'' and inserting ``providing health care
services'';
(2) in subsection (g)--
(A) by inserting ``a plan describing'' after ``will
provide''; and
(B) by adding at the end the following: ``Such plan
may include a description of how such applicant will
target outreach to women disproportionately impacted by
maternal substance use disorder.''; and
(3) in subsection (s), by striking ``$29,931,000 for each
of fiscal years 2019 through 2023'' and inserting ``$38,931,000
for each of fiscal years 2025 through 2029''.
SEC. 532. IMPROVING ACCESS TO ADDICTION MEDICINE PROVIDERS.
Section 597 of the Public Health Service Act (42 U.S.C. 290ll) is
amended--
(1) in subsection (a)(1), by inserting ``diagnosis,'' after
``related to''; and
(2) in subsection (b), by inserting ``addiction medicine,''
after ``psychiatry,''.
SEC. 533. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
Section 756(f) of the Public Health Service Act (42 U.S.C. 294e-
1(f)) is amended by striking ``fiscal years 2023 through 2027'' and
inserting ``fiscal years 2025 through 2029''.
SEC. 534. LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER TREATMENT
WORKFORCE.
Section 781(j) of the Public Health Service Act (42 U.S.C. 295h(j))
is amended by striking ``$25,000,000 for each of fiscal years 2019
through 2023'' and inserting ``$40,000,000 for each of fiscal years
2025 through 2029''.
SEC. 535. DEVELOPMENT AND DISSEMINATION OF MODEL TRAINING PROGRAMS FOR
SUBSTANCE USE DISORDER PATIENT RECORDS.
Section 7053 of the SUPPORT for Patients and Communities Act (42
U.S.C. 290dd-2 note) is amended by striking subsection (e).
SEC. 536. TASK FORCE ON BEST PRACTICES FOR TRAUMA-INFORMED
IDENTIFICATION, REFERRAL, AND SUPPORT.
Section 7132 of the SUPPORT for Patients and Communities Act
(Public Law 115-271; 132 Stat. 4046) is amended--
(1) in subsection (b)(1)--
(A) by redesignating subparagraph (CC) as
subparagraph (DD); and
(B) by inserting after subparagraph (BB) the
following:
``(CC) The Administration for Community Living.'';
(2) in subsection (d)(1), in the matter preceding
subparagraph (A), by inserting ``, developmental disability
service providers'' before ``, individuals who are''; and
(3) in subsection (i), by striking ``2023'' and inserting
``2029''.
SEC. 537. GRANTS TO ENHANCE ACCESS TO SUBSTANCE USE DISORDER TREATMENT.
Section 3203 of the SUPPORT for Patients and Communities Act (21
U.S.C. 823 note) is amended--
(1) by striking subsection (b); and
(2) by striking ``(a) In General.--The Secretary'' and
inserting the following: ``The Secretary''.
SEC. 538. STATE GUIDANCE RELATED TO INDIVIDUALS WITH SERIOUS MENTAL
ILLNESS AND CHILDREN WITH SERIOUS EMOTIONAL DISTURBANCE.
(a) Review of Use of Certain Funding.--Not later than 1 year after
the date of enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary''), acting
through the Assistant Secretary for Mental Health and Substance Use,
shall conduct a review of State use of funds made available under the
Community Mental Health Services Block Grant program under subpart I of
part B of title XIX of the Public Health Service Act (42 U.S.C. 300x et
seq.) (referred to in this section as the ``block grant program'') for
first episode psychosis activities. Such review shall consider the
following:
(1) How States use funds for evidence-based treatments and
services according to the standard of care for individuals with
early serious mental illness and children with a serious
emotional disturbance.
(2) The percentages of the State funding under the block
grant program expended on early serious mental illness and
first episode psychosis, and the number of individuals served
under such funds.
(b) Report and Guidance.--
(1) Report.--Not later than 180 days after the completion
of the review under subsection (a), the Secretary 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 and the Committee on Appropriations of
the House of Representatives a report describing--
(A) the findings of the review under subsection
(a); and
(B) any recommendations for changes to the block
grant program that would facilitate improved outcomes
for individuals with serious mental illness and
children with serious emotional disturbance.
(2) Guidance.--Not later than 1 year after the date on
which the report is submitted under paragraph (1), the
Secretary shall update the guidance provided to States under
the block grant program on coordinated specialty care and other
evidence-based mental health care services for individuals with
serious mental illness and children with a serious emotional
disturbance, based on the findings and recommendations of such
report.
SEC. 539. REVIEWING THE SCHEDULING OF APPROVED PRODUCTS CONTAINING A
COMBINATION OF BUPRENORPHINE AND NALOXONE.
(a) Secretary of HHS.--The Secretary of Health and Human Services
shall, consistent with the requirements and procedures set forth in
sections 201 and 202 of the Controlled Substances Act (21 U.S.C. 811,
812)--
(1) review the relevant data pertaining to the scheduling
of products containing a combination of buprenorphine and
naloxone that have been approved under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
(2) if appropriate, request that the Attorney General
initiate rulemaking proceedings to revise the schedules
accordingly with respect to such products.
(b) Attorney General.--The Attorney General shall review any
request made by the Secretary of Health and Human Services under
subsection (a)(2) and determine whether to initiate proceedings to
revise the schedules in accordance with the criteria set forth in
sections 201 and 202 of the Controlled Substances Act (21 U.S.C. 811,
812).
Subtitle C--Recovery
SEC. 541. BUILDING COMMUNITIES OF RECOVERY.
Section 547(f) of the Public Health Service Act (42 U.S.C. 290ee-
2(f)) is amended by striking ``$5,000,000 for each of fiscal years 2019
through 2023'' and inserting ``$16,000,000 for each of fiscal years
2025 through 2029''.
SEC. 542. PEER SUPPORT TECHNICAL ASSISTANCE CENTER.
Section 547A of the Public Health Service Act (42 U.S.C. 290ee-2a)
is amended--
(1) in subsection (b)(4), by striking ``building; and'' and
inserting the following: ``building, such as--
``(A) professional development of peer support
specialists; and
``(B) making recovery support services available in
nonclinical settings; and'';
(2) by redesignating subsections (d) and (e) as subsections
(e) and (f), respectively;
(3) by inserting after subsection (c) the following:
``(d) Regional Centers.--
``(1) In general.--The Secretary may establish one regional
technical assistance center (referred to in this subsection as
the `Regional Center'), with existing resources, to assist the
Center in carrying out activities described in subsection (b)
within the geographic region of such Regional Center in a
manner that is tailored to the needs of such region.
``(2) Evaluation.--Not later than 4 years after the date of
enactment of the SUPPORT for Patients and Communities
Reauthorization Act of 2025, the Secretary shall evaluate the
activities of the Regional Center 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 findings of such evaluation,
including--
``(A) a description of the distinct roles and
responsibilities of the Regional Center and the Center;
``(B) available information relating to the
outcomes of the Regional Center under this subsection,
such as any impact on the operations and efficiency of
the Center relating to requests for technical
assistance and support within the region of such
Regional Center;
``(C) a description of any gaps or areas of
duplication relating to the activities of the Regional
Center and the Center within such region; and
``(D) recommendations relating to the modification,
expansion, or termination of the Regional Center under
this subsection.
``(3) Termination.--This subsection shall terminate on
September 30, 2029.''; and
(4) in subsection (f), as so redesignated, by striking
``$1,000,000 for each of fiscal years 2019 through 2023'' and
inserting ``$2,000,000 for each of fiscal years 2025 through
2029''.
SEC. 543. COMPREHENSIVE OPIOID RECOVERY CENTERS.
Section 552 of the Public Health Service Act (42 U.S.C. 290ee-7) is
amended--
(1) in subsection (d)(2)--
(A) in the matter preceding subparagraph (A), by
striking ``and in such manner'' and inserting ``, in
such manner, and containing such information and
assurances, including relevant documentation,''; and
(B) in subparagraph (A), by striking ``is capable
of coordinating with other entities to carry out'' and
inserting ``has the demonstrated capability to carry
out, through referral or contractual arrangements'';
(2) in subsection (h)--
(A) by redesignating paragraphs (1) through (4) as
subparagraphs (A) through (D), respectively, and
adjusting the margins accordingly;
(B) by striking ``With respect to'' and inserting
the following:
``(1) In general.--With respect to''; and
(C) by adding at the end the following:
``(2) Additional reporting for certain eligible entities.--
An entity carrying out activities described in subsection (g)
through referral or contractual arrangements shall include in
the submissions required under paragraph (1) information
related to the status of such referrals or contractual
arrangements, including an assessment of whether such referrals
or contractual arrangements are supporting the ability of such
entity to carry out such activities.''; and
(3) in subsection (j), by striking ``2019 through 2023''
and inserting ``2025 through 2029''.
SEC. 544. YOUTH PREVENTION AND RECOVERY.
Section 7102(c) of the SUPPORT for Patients and Communities Act (42
U.S.C. 290bb-7a(c)) (as amended by section 110(a)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (A)--
(i) in clause (i)--
(I) by inserting ``, or a
consortium of local educational
agencies,'' after ``a local educational
agency''; and
(II) by striking ``high schools''
and inserting ``secondary schools'';
and
(ii) in clause (vi), by striking ``tribe,
or tribal'' and inserting ``Tribe, or Tribal'';
(B) by amending subparagraph (E) to read as
follows:
``(E) Indian tribe; tribal organization.--The terms
`Indian Tribe' and `Tribal organization' have the
meanings given such terms in section 4 of the Indian
Self-Determination and Education Assistance Act (25
U.S.C. 5304).'';
(C) by redesignating subparagraph (K) as
subparagraph (L); and
(D) by inserting after subparagraph (J) the
following:
``(K) 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).'';
(2) in paragraph (3)(A), in the matter preceding clause
(i)--
(A) by striking ``and abuse''; and
(B) by inserting ``at increased risk for substance
misuse'' after ``specific populations'';
(3) in paragraph (4)--
(A) in the matter preceding subparagraph (A), by
striking ``Indian tribes'' and inserting ``Indian
Tribes'';
(B) in subparagraph (A), by striking ``and abuse'';
and
(C) in subparagraph (B), by striking ``peer
mentoring'' and inserting ``peer-to-peer support'';
(4) in paragraph (5), by striking ``tribal'' and inserting
``Tribal'';
(5) in paragraph (6)(A)--
(A) in clause (iv), by striking ``; and'' and
inserting a semicolon; and
(B) by adding at the end the following:
``(vi) a plan to sustain the activities
carried out under the grant program, after the
grant program has ended; and'';
(6) in paragraph (8), by striking ``2022'' and inserting
``2027''; and
(7) by amending paragraph (9) to read as follows:
``(9) Authorization of appropriations.--To carry out this
subsection, there are authorized to be appropriated--
``(A) $10,000,000 for fiscal year 2025;
``(B) $12,000,000 for fiscal year 2026;
``(C) $13,000,000 for fiscal year 2027;
``(D) $14,000,000 for fiscal year 2028; and
``(E) $15,000,000 for fiscal year 2029.''.
SEC. 545. CAREER ACT.
(a) In General.--Section 7183 of the SUPPORT for Patients and
Communities Act (42 U.S.C. 290ee-8) is amended--
(1) in the section heading, by inserting ``; treatment,
recovery, and workforce support grants'' after ``career act'';
(2) in subsection (b), by inserting ``each'' before ``for a
period'';
(3) in subsection (c)--
(A) in paragraph (1), by striking ``the rates
described in paragraph (2)'' and inserting ``the
average rates for calendar years 2018 through 2022
described in paragraph (2)''; and
(B) by amending paragraph (2) to read as follows:
``(2) Rates.--The rates described in this paragraph are the
following:
``(A) The highest age-adjusted average rates of
drug overdose deaths for calendar years 2018 through
2022 based on data from the Centers for Disease Control
and Prevention, including, if necessary, provisional
data for calendar year 2022.
``(B) The highest average rates of unemployment for
calendar years 2018 through 2022 based on data provided
by the Bureau of Labor Statistics.
``(C) The lowest average labor force participation
rates for calendar years 2018 through 2022 based on
data provided by the Bureau of Labor Statistics.'';
(4) in subsection (g)--
(A) in each of paragraphs (1) and (3), by
redesignating subparagraphs (A) and (B) as clauses (i)
and (ii), respectively, and adjusting the margins
accordingly;
(B) by redesignating paragraphs (1) through (3) as
subparagraphs (A) through (C), respectively, and
adjusting the margins accordingly;
(C) in the matter preceding subparagraph (A) (as so
redesignated), by striking ``An entity'' and inserting
the following:
``(1) In general.--An entity''; and
(D) by adding at the end the following:
``(2) Transportation services.--An entity receiving a grant
under this section may use not more than 5 percent of the funds
for providing transportation for individuals to participate in
an activity supported by a grant under this section, which
transportation shall be to or from a place of work or a place
where the individual is receiving vocational education or job
training services or receiving services directly linked to
treatment of or recovery from a substance use disorder.
``(3) Limitation.--The Secretary may not require an entity
to, or give priority to an entity that plans to, use the funds
of a grant under this section for activities that are not
specified in this subsection.'';
(5) in subsection (i)(2), by inserting ``, which shall
include employment and earnings outcomes described in
subclauses (I) and (III) of section 116(b)(2)(A)(i) of the
Workforce Innovation and Opportunity Act (29 U.S.C.
3141(b)(2)(A)(i)) with respect to the participation of such
individuals with a substance use disorder in programs and
activities funded by the grant under this section'' after
``subsection (g)'';
(6) in subsection (j)--
(A) in paragraph (1), by inserting ``for grants
awarded prior to the date of enactment of the SUPPORT
for Patients and Communities Reauthorization Act of
2025'' after ``grant period under this section''; and
(B) in paragraph (2)--
(i) in the matter preceding subparagraph
(A), by striking ``2 years after submitting the
preliminary report required under paragraph
(1)'' and inserting ``September 30, 2029''; and
(ii) in subparagraph (A), by striking
``(g)(3)'' and inserting ``(g)(1)(C)''; and
(7) in subsection (k), by striking ``$5,000,000 for each of
fiscal years 2019 through 2023'' and inserting ``$12,000,000
for each of fiscal years 2025 through 2029''.
(b) Reauthorization of the CAREER Act; Recovery Housing Pilot
Program.--
(1) In general.--Section 8071 of the SUPPORT for Patients
and Communities Act (42 U.S.C. 5301 note; Public Law 115-271)
is amended--
(A) by striking the section heading and inserting
``career act; recovery housing pilot program'';
(B) in subsection (a), by striking ``through 2023''
and inserting ``through 2029'';
(C) in subsection (b)--
(i) in paragraph (1), by striking ``not
later than 60 days after the date of enactment
of this Act'' and inserting ``not later than 60
days after the date of enactment of the SUPPORT
for Patients and Communities Reauthorization
Act of 2025''; and
(ii) in paragraph (2)(B)(i)--
(I) in subclause (I)--
(aa) by striking ``for
calendar years 2013 through
2017''; and
(bb) by inserting ``for
calendar years 2018 through
2022'' after ``rates of
unemployment'';
(II) in subclause (II)--
(aa) by striking ``for
calendar years 2013 through
2017''; and
(bb) by inserting ``for
calendar years 2018 through
2022'' after ``participation
rates''; and
(III) by striking subclause (III)
and inserting the following:
``(III) The highest age-adjusted
average rates of drug overdose deaths
for calendar years 2018 through 2022
based on data from the Centers for
Disease Control and Prevention,
including, if necessary, provisional
data for calendar year 2022.''; and
(D) in subsection (f), by striking ``For the 2-year
period following the date of enactment of this Act,
the'' and inserting ``The''.
(2) Conforming amendment.--Subtitle F of title VIII of the
SUPPORT for Patients and Communities Act (Public Law 115-271;
132 Stat. 4095) is amended by striking the subtitle heading and
inserting the following: ``Subtitle F--CAREER Act; Recovery
Housing Pilot Program'' .
(c) Clerical Amendments.--The table of contents in section 1(b) of
the SUPPORT for Patients and Communities Act (Public Law 115-271; 132
Stat. 3894) is amended--
(1) by striking the item relating to section 7183 and
inserting the following:
``Sec. 7183. CAREER Act; treatment, recovery, and workforce support
grants.'';
(2) by striking the item relating to subtitle F of title
VIII and inserting the following:
``Subtitle F--CAREER Act; Recovery Housing Pilot Program''; and
(3) by striking the item relating to section 8071 and
inserting the following:
``Sec. 8071. CAREER Act; Recovery Housing Pilot Program.''.
SEC. 546. ADDRESSING ECONOMIC AND WORKFORCE IMPACTS OF THE OPIOID
CRISIS.
Section 8041(g)(1) of the SUPPORT for Patients and Communities Act
(29 U.S.C. 3225a(g)(1)) is amended by striking ``2023'' and inserting
``2029''.
Subtitle D--Miscellaneous Matters
SEC. 551. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY TO A
PRESCRIBING PRACTITIONER.
Section 309A(a) of the Controlled Substances Act (21 U.S.C.
829a(a)) is amended by striking paragraph (2) and inserting the
following:
``(2) the controlled substance is a drug in schedule III,
IV, or V to be administered--
``(A) by injection or implantation for the purpose
of maintenance or detoxification treatment; or
``(B) subject to a risk evaluation and mitigation
strategy pursuant to section 505-1 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355-1) that includes
elements to assure safe use of the drug described in
subsection (f)(3)(E) of such section, including a
requirement for post-administration monitoring by a
health care provider.''.
SEC. 552. TECHNICAL CORRECTION ON CONTROLLED SUBSTANCES DISPENSING.
Effective as if included in the enactment of Public Law 117-328--
(1) section 1252(a) of division FF of Public Law 117-328
(136 Stat. 5681) is amended, in the matter being inserted into
section 302(e) of the Controlled Substances Act, by striking
``303(g)'' and inserting ``303(h)'';
(2) section 1262 of division FF of Public Law 117-328 (136
Stat. 5681) is amended--
(A) in subsection (a)--
(i) in the matter preceding paragraph (1),
by striking ``303(g)'' and inserting
``303(h)'';
(ii) in the matter being stricken by
subsection (a)(2), by striking ``(g)(1)'' and
inserting ``(h)(1)''; and
(iii) in the matter being inserted by
subsection (a)(2), by striking ``(g)
Practitioners'' and inserting ``(h)
Practitioners''; and
(B) in subsection (b)--
(i) in the matter being stricken by
paragraph (1), by striking ``303(g)(1)'' and
inserting ``303(h)(1)'';
(ii) in the matter being inserted by
paragraph (1), by striking ``303(g)'' and
inserting ``303(h)'';
(iii) in the matter being stricken by
paragraph (2)(A), by striking ``303(g)(2)'' and
inserting ``303(h)(2)'';
(iv) in the matter being stricken by
paragraph (3), by striking ``303(g)(2)(B)'' and
inserting ``303(h)(2)(B)'';
(v) in the matter being stricken by
paragraph (5), by striking ``303(g)'' and
inserting ``303(h)''; and
(vi) in the matter being stricken by
paragraph (6), by striking ``303(g)'' and
inserting ``303(h)''; and
(3) section 1263(b) of division FF of Public Law 117-328
(136 Stat. 5685) is amended--
(A) by striking ``303(g)(2)'' and inserting
``303(h)(2)''; and
(B) by striking ``(21 U.S.C. 823(g)(2))'' and
inserting ``(21 U.S.C. 823(h)(2))''.
SEC. 553. REQUIRED TRAINING FOR PRESCRIBERS OF CONTROLLED SUBSTANCES.
(a) In General.--Section 303 of the Controlled Substances Act (21
U.S.C. 823) is amended--
(1) by redesignating the second subsection designated as
subsection (l) as subsection (m); and
(2) in subsection (m)(1), as so redesignated--
(A) in subparagraph (A)--
(i) in clause (iv)--
(I) in subclause (I)--
(aa) by inserting ``the
American Academy of Family
Physicians, the American
Podiatric Medical Association,
the Academy of General
Dentistry, the American
Optometric Association,''
before ``or any other
organization'';
(bb) by striking ``or the
Commission'' and inserting
``the Commission''; and
(cc) by inserting ``, or
the Council on Podiatric
Medical Education'' before the
semicolon at the end; and
(II) in subclause (III), by
inserting ``or the American Academy of
Family Physicians'' after
``Association''; and
(ii) in clause (v), in the matter preceding
subclause (I)--
(I) by striking ``osteopathic
medicine, dental surgery'' and
inserting ``osteopathic medicine,
podiatric medicine, dental surgery'';
and
(II) by striking ``or dental
medicine curriculum'' and inserting
``or dental or podiatric medicine
curriculum''; and
(B) in subparagraph (B)--
(i) in clause (i)--
(I) by inserting ``the American
Pharmacists Association, the
Accreditation Council on Pharmacy
Education, the American Psychiatric
Nurses Association, the American
Academy of Nursing, the American
Academy of Family Physicians,'' before
``or any other organization''; and
(II) by inserting ``, the American
Academy of Family Physicians,'' before
``or the Accreditation Council''; and
(ii) in clause (ii)--
(I) by striking ``or accredited
school'' and inserting ``, an
accredited school''; and
(II) by inserting ``, or an
accredited school of pharmacy'' before
``in the United States''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect as if enacted on December 29, 2022.
SEC. 554. EXTENSION OF TEMPORARY ORDER FOR FENTANYL-RELATED SUBSTANCES.
Effective as if included in the enactment of the Temporary
Reauthorization and Study of the Emergency Scheduling of Fentanyl
Analogues Act (Public Law 116-114), section 2 of such Act is amended by
striking ``March 31, 2025'' and inserting ``September 30, 2026''.
TITLE VI--PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND RESPONSE
SEC. 601. SHORT TITLE.
This title may be cited as the ``Pandemic and All-Hazards
Preparedness and Response Act''.
Subtitle A--State and Local Readiness and Response
SEC. 611. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A
PUBLIC HEALTH EMERGENCY.
Section 319(e) of the Public Health Service Act (42 U.S.C. 247d(e))
is amended--
(1) in paragraph (1), by striking ``tribal organization or
such Governor or tribal organization's designee'' and inserting
``Tribal organization or the designee of the Governor or Tribal
organization, or the State or Tribal health official'';
(2) in paragraph (2)(B)--
(A) in the matter preceding clause (i), by striking
``tribal organization'' and inserting ``Tribal
organization, or the State or Tribal health official'';
and
(B) in clause (v), by striking ``tribal
organization'' and inserting ``Tribal organization or
State or Tribal health official'';
(3) in paragraph (6)--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``Reauthorization Act of
2013'' and inserting ``and Response Act''; and
(ii) by striking ``appropriate committees
of the Congress'' and inserting ``Committee on
Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce
of the House of Representatives''; and
(B) in subparagraph (A), by inserting ``, including
requests from State or Tribal health officials'' before
the semicolon;
(4) in paragraph (7)(A), by striking ``tribal
organization'' and inserting ``Tribal organization''; and
(5) in paragraph (8), by striking ``March 31, 2025'' and
inserting ``December 31, 2026''.
SEC. 612. PUBLIC HEALTH EMERGENCY PREPAREDNESS PROGRAM.
Section 319C-1 of the Public Health Service Act (42 U.S.C. 247d-3a)
is amended--
(1) in subsection (b)(2)--
(A) in subparagraph (A)(ii), by striking
``influenza'' and inserting ``response planning''; and
(B) in subparagraph (H), by inserting ``, such as
community-based organizations, including faith-based
organizations, and other public and private entities''
after ``stakeholders'';
(2) in subsection (g)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by inserting ``and the ability of
each entity receiving an award under subsection (a) to
respond to all-hazards threats'' before the period at
the end of the first sentence;
(B) in paragraph (2)--
(i) in the paragraph heading, by striking
``influenza'' and inserting ``response''; and
(ii) in subparagraph (A)--
(I) by striking ``to pandemic
influenza'' and inserting ``to a
pathogen causing a pandemic, including
pandemic influenza''; and
(II) by striking ``such pandemic
influenza'' and inserting ``such
pandemic response'';
(C) in paragraph (5)--
(i) in the paragraph heading, by striking
``influenza'' and inserting ``pandemic
response'';
(ii) in the matter preceding subparagraph
(A), by striking ``2019'' and inserting
``2026'';
(iii) in subparagraph (A), by striking
``2018'' and inserting ``2025''; and
(iv) in subparagraph (B), by striking
``pandemic influenza'' and inserting ``a
pathogen causing a pandemic''; and
(D) in paragraph (6)--
(i) in subparagraph (A), in the matter
preceding clause (i), by striking ``The amounts
described in this paragraph are the following
amounts that are payable to an entity for
activities described in this section or section
319C-2'' and inserting ``The Secretary shall
withhold from an entity pursuant to paragraph
(5) for noncompliance with the requirements of
this section or section 319C-2 as follows'';
and
(ii) in subparagraph (B), by inserting
``with respect to the requirements of this
section or section 319C-2'' after ``paragraph
(5)''; and
(3) in subsection (h)(1)(A), by striking ``$685,000,000 for
each of fiscal years 2019 through 2023'' and inserting
``$735,000,000 for each of fiscal years 2025 and 2026, to
remain available through December 31, 2026''.
SEC. 613. HOSPITAL PREPAREDNESS PROGRAM.
(a) Increasing Participation by EMS in the Hospital Preparedness
Program.--
(1) In general.--Section 319C-2 of the Public Health
Service Act (42 U.S.C. 247d-3b) is amended--
(A) in subsection (b)(1)(A)--
(i) in clause (iii)(III), by striking ``;
and'' and inserting a semicolon; and
(ii) by striking clause (iv) and inserting
the following:
``(iv) one or more emergency medical
service organizations; and
``(v) to the extent practicable, one or
more emergency management organizations; and'';
and
(B) in subsection (g)(1)--
(i) by striking ``(1) Local response
capabilities'' and inserting:
``(1) Local response capabilities.--
``(A) Program coordination.--'';
(ii) by striking ``extent practicable,
ensure'' and inserting the following: ``extent
practicable--
``(i) ensure'';
(iii) by striking the period and inserting
``; and''; and
(iv) by adding at the end the following:
``(ii) seek to increase participation of
eligible entities described in subsection
(b)(1)(A) with lower participation rates
relative to other eligible entities, such as
emergency medical services organizations and
health care facilities in underserved areas.''.
(2) Preferences.--Section 319C-2(d)(1)(A)(iii) of the
Public Health Service Act (42 U.S.C. 247d-3b(d)(1)(A)(iii)) is
amended by striking ``subsection (b)(1)(A)(ii)'' and inserting
``clauses (ii) and (iv) of subsection (b)(1)(A)''.
(b) Improving Medical Readiness and Response Capabilities.--Section
319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b) is
amended--
(1) in subsection (b)(2)--
(A) in subparagraph (A), by striking ``and'' at the
end;
(B) in subparagraph (B), by striking the period and
inserting ``; and''; and
(C) by inserting at the end the following:
``(C) designate a lead entity to administer such award and
support coordination between entities described in this
subsection.'';
(2) in subsection (g)(1), as amended by subsection
(a)(1)(B), by adding at the end the following:
``(B) Regional operations.--An eligible entity
shall establish and maintain, or leverage an existing,
capability to enable coordination of regional medical
operations, which may include systems to facilitate
information sharing and coordination, within a
coalition described under subsection (b)(1)(A) and, as
appropriate, among multiple coalitions that are in
close geographic proximity to each other.''; and
(3) in subsection (j)(1)--
(A) in subparagraph (A), by striking ``for each of
fiscal years 2019 through 2023'' and inserting ``for
each of fiscal years 2025 and 2026, to remain available
through December 31, 2026''; and
(B) in subparagraph (B)(iii), by striking
``September 30, 2023'' and inserting ``December 31,
2026''.
SEC. 614. FACILITIES AND CAPACITIES OF THE CENTERS FOR DISEASE CONTROL
AND PREVENTION TO COMBAT PUBLIC HEALTH SECURITY THREATS.
Section 319D(h) of the Public Health Service Act (42 U.S.C. 247d-
4(h)) is amended--
(1) in paragraph (1), by striking ``$25,000,000 for each of
fiscal years 2022 and 2023'' and inserting ``$40,000,000 for
each of fiscal years 2025 and 2026'', to remain available
through December 31, 2026; and
(2) in paragraph (2), by striking ``2022 and 2023'' and
inserting ``2025 and 2026, to remain available through December
31, 2026''.
SEC. 615. PILOT PROGRAM TO SUPPORT STATE MEDICAL STOCKPILES.
(a) In General.--Section 319F-2(i) of the Public Health Service Act
(42 U.S.C. 247d-6b(i)) is amended--
(1) in paragraph (2)(B)(i)--
(A) in subclause (I), by striking ``and 2024'' and
inserting ``through 2025''; and
(B) in subclause (II), by striking ``2025'' and
inserting ``2026'';
(2) in paragraph (4)--
(A) in subparagraph (G), by striking ``; and'' at
the end and inserting a semicolon;
(B) by redesignating subparagraph (H) as
subparagraph (I);
(C) by inserting after subparagraph (G) the
following:
``(H) facilitate the sharing of best practices
among States within a consortia of States in receipt of
funding related to establishing and maintaining a
stockpile of medical products; and''; and
(D) in subparagraph (I), as so redesignated, by
striking ``State efforts'' and inserting ``State or
regional efforts'';
(3) by redesignating paragraphs (5) through (9) as
paragraphs (6) through (10), respectively;
(4) by inserting after paragraph (4) the following:
``(5) Coordination.--An entity in receipt of an award under
paragraph (1), in carrying out the activities under this
subsection, shall coordinate with appropriate health care
entities, health officials, and emergency management officials
within the jurisdiction of such State or States.''; and
(5) in paragraph (10), as so redesignated, by striking
``$3,500,000,000 for each of fiscal years 2023 and 2024'' and
inserting ``$3,365,000,000 for fiscal year 2025, and
$3,265,000,000 for fiscal year 2026''.
(b) GAO Report.--Section 2409(b) of the PREVENT Pandemics Act
(Public Law 117-328) is amended--
(1) in paragraph (2), by striking ``; and'' and inserting a
semicolon;
(2) in paragraph (3), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(4) the impact of any regional stockpiling approaches
carried out under subsection (i)(1) of section 319F-2 of the
Public Health Service Act (42 U.S.C. 247d-6b).''.
SEC. 616. ENHANCING DOMESTIC WASTEWATER SURVEILLANCE FOR PATHOGEN
DETECTION.
(a) In General.--Title III of the Public Health Service Act is
amended by inserting after section 317V (42 U.S.C. 247b-24) the
following:
``SEC. 317W. WASTEWATER SURVEILLANCE FOR PATHOGEN DETECTION.
``(a) Wastewater Surveillance System.--The Secretary, acting
through the Director of the Centers for Disease Control and Prevention
and in coordination with other Federal departments and agencies, shall
award grants, contracts, or cooperative agreements to eligible entities
to establish, maintain, or improve activities related to the detection
and monitoring of infectious diseases through wastewater for public
health emergency preparedness and response purposes.
``(b) Eligible Entities.--To be eligible to receive an award under
this section, an entity shall--
``(1) be a State, Tribal, or local health department, or a
partnership between such a health department and other public
and private entities; and
``(2) submit to the Secretary an application at such time,
in such manner, and containing such information as the
Secretary may reasonably require, which shall include--
``(A) a description of activities proposed to be
carried out pursuant to an award under subsection (a);
``(B) factors such entity proposes to use to select
wastewater sampling sites;
``(C) factors such entity proposes to use to
determine whether a response to findings from such
wastewater sampling may be warranted, and a plan for
responding, as appropriate, consistent with applicable
plans developed by such entity pursuant to section
319C-1;
``(D) a plan to sustain such wastewater
surveillance activities described in such application
following the conclusion of the award period; and
``(E) any additional information the Secretary may
require.
``(c) Consideration.--In making awards under subsection (a), the
Secretary may give priority to eligible entities that have submitted an
application that--
``(1) details plans to provide public access to
deidentified data generated through such wastewater
surveillance activities in a manner that allows for comparison
to such data generated by other recipients of an award under
subsection (a); and
``(2) provides an assessment of community needs related to
ongoing infectious disease monitoring, including estimates of
the incidence and prevalence of infectious diseases that can be
detected in wastewater and availability, at the time of the
application, of other forms of infectious disease detection in
the jurisdiction.
``(d) Use of Funds.--An eligible entity shall, as appropriate, use
amounts awarded under this section to--
``(1) establish or enhance existing capacity and
capabilities to conduct wastewater sampling, testing, and
related analysis;
``(2) conduct wastewater surveillance, as appropriate, in
areas or facilities with increased risk of infectious disease
outbreaks and limited ability to utilize other forms of
infectious disease detection, such as at individual facilities,
institutions, and locations in rural areas or areas in which
wastewater is not treated through the relevant local utility of
the jurisdiction; and
``(3) implement projects that use evidence-based or
innovative practices to conduct wastewater surveillance
activities.
``(e) Partnerships.--In carrying out activities under this section,
eligible entities shall identify opportunities to partner with other
public or private entities to leverage relevant capabilities maintained
by such entities, as appropriate and consistent with this section.
``(f) Technical Assistance.--The Secretary, in consultation with
the heads of other applicable Federal agencies and departments, as
appropriate, shall provide technical assistance to recipients of awards
under this section to facilitate the planning, development, and
implementation of activities described in subsection (d).
``(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $20,000,000 for each of fiscal
years 2025 and 2026, to remain available through December 31, 2026.''.
(b) Wastewater Surveillance Research.--
(1) In general.--The Secretary of Health and Human Services
(in this subsection referred to as the ``Secretary'') shall
continue to conduct or support research on the use of
wastewater surveillance to detect and monitor emerging
infectious diseases, which may include--
(A) research to improve the efficiency and
effectiveness of wastewater sample collection and
analysis and increase the sensitivity and specificity
of wastewater testing methods; and
(B) implementation and development of evidence-
based practices to facilitate the estimation of the
incidence and prevalence of infectious disease within a
community.
(2) Non-duplication of effort.--The Secretary shall ensure
that activities carried out under this subsection do not
unnecessarily duplicate efforts of other agencies and offices
within the Department of Health and Human Services related to
wastewater surveillance.
SEC. 617. REAUTHORIZATION OF MOSQUITO ABATEMENT FOR SAFETY AND HEALTH
PROGRAM.
Section 317S of the Public Health Service Act (42 U.S.C. 247b-21)
is amended--
(1) in subsection (a)(3)(A), by striking ``subsection
(b)(3)'' and inserting ``subsection (b)(4)'';
(2) in subsection (b)--
(A) by redesignating paragraphs (3) through (6) as
paragraphs (4) through (7), respectively; and
(B) by inserting after paragraph (2) the following:
``(3) Considerations.--The Secretary may consider the use
of innovative and novel technology for mosquito prevention and
control in making grants under paragraph (1).'';
(3) by amending subsection (d) to read as follows:
``(d) Uses of Funds.--Amounts appropriated under subsection (f) may
be used by the Secretary to provide training and technical assistance
with respect to the planning, development, and operation of assessments
and plans under subsection (a) and control programs under subsection
(b). The Secretary may provide such training and technical assistance
directly or through awards of grants or contracts to public and private
entities.''; and
(4) in subsection (f)(1), by striking ``2019 through 2023''
and inserting ``2025 and 2026, to remain available through
December 31, 2026''.
Subtitle B--Federal Planning and Coordination
SEC. 621. ALL-HAZARDS EMERGENCY PREPAREDNESS AND RESPONSE.
Section 2811 of the Public Health Service Act (42 U.S.C. 300hh-10)
is amended--
(1) in subsection (b)--
(A) in paragraph (3)--
(i) by striking ``Oversee advanced
research, development, and procurement'' and
inserting the following:
``(A) In general.--Oversee advanced research,
development, procurement, and replenishment''; and
(ii) by adding at the end the following:
``(B) Development of requirements.--Lead the
development and approval, and, on a routine basis, the
review and update, of requirements for such
countermeasures and products, including related
capabilities, to inform the advanced research,
development, procurement, and replenishment decisions
of the Secretary.'';
(B) in paragraph (4)--
(i) in subparagraph (F)--
(I) in the matter preceding clause
(i), by striking ``and in consultation
with the Secretary of Homeland
Security,''; and
(II) in clause (i), by inserting
``enhance'' after ``capabilities and'';
(ii) in subparagraph (G)--
(I) in the matter preceding clause
(i), by inserting ``the Office of
Pandemic Preparedness and Response
Policy,'' after ``Veterans Affairs,'';
(II) in clause (i), by striking
``based on'' and inserting ``based on--
'';
(III) in clause (ii), by striking
``; and'' at the end and inserting a
semicolon;
(IV) in clause (iii), by striking
the period and inserting ``; and''; and
(V) by adding at the end the
following:
``(iv) that include, as appropriate,
participation by relevant industry, academia,
professional societies, and other
stakeholders.'';
(iii) in subparagraph (H)--
(I) by inserting ``and the Director
of the Office of Pandemic Preparedness
and Response Policy'' after ``Security
Affairs''; and
(II) by inserting ``and medical
product and supply capacity planning
pursuant to subparagraph (J), including
discussion of any relevant identified
supply chain vulnerabilities'' before
the period at the end;
(iv) in subparagraph (I), by inserting
``the Director of the Office of Pandemic
Preparedness and Response Policy,'' after
``Security Affairs,''; and
(v) in subparagraph (J)(i), in the matter
preceding subclause (I), by inserting
``(including ancillary medical supplies and
components of medical products, such as active
pharmaceutical ingredients, key starting
materials, medical device components, testing
kits, reagents, and other testing supplies)''
after ``supply needs''; and
(C) in paragraph (7)--
(i) in the matter preceding subparagraph
(A), by inserting ``and the requirements
developed pursuant to paragraph (3)(B)'' after
``subsection (d)'';
(ii) by redesignating subparagraphs (E) and
(F) as subparagraphs (F) and (G), respectively;
and
(iii) by inserting after subparagraph (D)
the following:
``(E) include a professional judgment of
anticipated budget needs for each future fiscal year
accounted for in such plan to account for the full
range of anticipated medical countermeasure needs and
life-cycle costs to address such priorities and
requirements;'';
(2) in subsection (d)--
(A) by amending paragraph (1) to read as follows:
``(1) In general.--Not later than March 15, 2020, and
biennially thereafter, the Assistant Secretary for Preparedness
and Response shall develop 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 coordinated strategy for medical
countermeasures to address chemical, biological, radiological,
and nuclear threats, informed by the requirements developed
pursuant to subsection (b)(3)(B). Not later than 180 days after
the submission of such strategy to such committees, the
Assistant Secretary for Preparedness and Response shall submit
an accompanying implementation plan to such committees. In
developing such a strategy and plan, the Assistant Secretary
for Preparedness and Response shall consult with the Public
Health Emergency Medical Countermeasures Enterprise established
under section 2811-1. Such strategy and plan shall be known as
the Public Health Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan.''; and
(B) in paragraph (2), in the matter preceding
subparagraph (A), by inserting ``strategy and'' before
``plan''; and
(3) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by inserting ``, including such
agents that are an emerging infectious disease'' after
``become a pandemic''; and
(B) in paragraph (2)(A), by striking ``$250,000,000
for each of fiscal years 2019 through 2023'' and
inserting ``$335,000,000 for each of fiscal years 2025
and 2026, to remain available through December 31,
2026''.
SEC. 622. NATIONAL HEALTH SECURITY STRATEGY.
Section 2802 of the Public Health Service Act (42 U.S.C. 300hh-1)
is amended--
(1) in subsection (a)(3)--
(A) by striking ``In 2022, the'' and inserting
``The''; and
(B) by inserting ``, maintaining, and sustaining''
after ``establishing''; and
(2) in subsection (b)--
(A) in paragraph (2)--
(i) in subparagraph (A), by inserting
``that support interagency coordination and
availability of information, as appropriate''
before the period;
(ii) in subparagraph (B), by inserting
``rapid testing,'' after ``and supplies,'';
(B) in paragraph (3)--
(i) in the matter preceding subparagraph
(A), by inserting ``and blood banks'' after
``dental health facilities'';
(ii) in subparagraph (C), by inserting
``and current capacity of facilities within
such systems, as applicable'' before the
period; and
(iii) in subparagraph (D), by inserting
``and other medical products and medical
supplies consistent with the activities carried
out under section 2811(b)(4)(J)'' before the
period;
(C) in paragraph (5), by inserting ``applicable
federally funded activities and'' after ``(including'';
(D) in paragraph (8)--
(i) in subparagraph (A), by inserting
``public health and medical'' before
``activities''; and
(ii) in subparagraph (B), by striking
``familiarity with'' and inserting
``understanding of, and coordination
between,'';
(E) by redesignating paragraphs (9) and (10) as
paragraphs (10) and (12), respectively;
(F) by inserting after paragraph (8) the following:
``(9) Other settings.--Supporting Federal, State, local,
and Tribal coordination and planning with respect to facilities
in which there is an increased risk of infectious disease
outbreaks, including such facilities that address the needs of
at-risk individuals, in the event of a public health emergency
declared under section 319.'';
(G) by inserting after subparagraph (10), as so
redesignated, the following:
``(11) Other hazards.--Assessing current and potential
health security threats from natural disasters with respect to
public health and medical preparedness and response.'';
(H) by inserting after paragraph (12), as so
redesignated, the following:
``(13) Cybersecurity resiliency of health care systems.--
Consistent with the requirements of section 2218 of the
Homeland Security Act of 2002, strengthening the ability of
States, local communities, and Tribal communities to prepare
for, respond to, and be resilient against cybersecurity
vulnerabilities or cybersecurity attacks that affect public
health and health information technology, and encouraging
health care facilities to use recognized security practices
meeting or exceeding the approaches established under section
405(d) of the Cybersecurity Act of 2015.''; and
(I) by striking ``tribal'' each place it appears
and inserting ``Tribal''.
SEC. 623. IMPROVING DEVELOPMENT AND DISTRIBUTION OF DIAGNOSTIC TESTS.
Section 319B of the Public Health Service Act (42 U.S.C. 247d-2) is
amended to read as follows:
``SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBUTION OF DIAGNOSTIC
TESTS.
``(a) Diagnostic Testing Preparedness Plan.--The Secretary shall
develop, make publicly available, not later than 1 year after the date
of enactment of the Pandemic and All-Hazards Preparedness and Response
Act, and update not less frequently than every 3 years thereafter, a
plan for the rapid development, validation, authorization, manufacture,
procurement, and distribution of diagnostic tests, and for rapid
scaling of testing capacity, in response to chemical, biological,
radiological, or nuclear threats, including emerging infectious
diseases, for which a public health emergency is declared under section
319, or that has significant potential to cause such a public health
emergency.
``(b) Purposes.--The purpose of the plan under subsection (a) shall
be to--
``(1) facilitate the development and utilization of
diagnostic tests;
``(2) describe the processes for the rapid development,
validation, authorization, manufacture, procurement, and
distribution of diagnostic tests, and for rapid scaling of
testing capacity; and
``(3) facilitate coordination and collaboration among
public and private entities to improve the rapid development
and utilization of diagnostic testing during a public health
emergency.
``(c) Considerations.--The plan under subsection (a) shall take
into consideration--
``(1) domestic capacity, including any such capacity
established through partnerships with public and private
entities pursuant to subsection (e), to support the
development, validation, manufacture, procurement, and
distribution of tests, and the rapid scaling of testing
capacity;
``(2) novel technologies and platforms that--
``(A) may be used to improve testing capabilities,
including--
``(i) high-throughput laboratory
diagnostics;
``(ii) point-of-care diagnostics; and
``(iii) rapid at-home diagnostics;
``(B) improve the accessibility of diagnostic
tests; and
``(C) facilitate the development and manufacture of
diagnostic tests;
``(3) medical supply needs related to testing, including
diagnostic testing, equipment, supplies, and component parts,
and any potential vulnerabilities related to the availability
of such medical supplies and related planning needs, consistent
with section 2811(b)(4)(J);
``(4) strategies for the rapid and efficient distribution
of tests locally, regionally, or nationwide and appropriate
scaling of laboratory testing capacity; and
``(5) assessment of such strategies through drills and
operational exercises carried out under section 2811(b)(4)(G),
as appropriate.
``(d) Coordination.--To inform the development and update of the
plan under subsection (a), and in carrying out activities to implement
such plan, the Secretary shall coordinate with industry, such as device
manufacturers, clinical and reference laboratories, and medical product
distributors, States, local governmental entities, Indian Tribes and
Tribal organizations, and other relevant public and private entities.
``(e) Capacity Building.--The Secretary may contract with public
and private entities, as appropriate, to increase domestic capacity in
the rapid development, validation, authorization, manufacture,
procurement, and distribution of diagnostic tests, as appropriate, to
State, local, and Tribal health departments and other appropriate
entities for immediate public health response activities to address an
infectious disease with respect to which a public health emergency is
declared under section 319, or that has significant potential to cause
such a public health emergency.''.
SEC. 624. COMBATING ANTIMICROBIAL RESISTANCE.
(a) In General.--Section 319E of the Public Health Service Act (42
U.S.C. 247d-5) is amended--
(1) in subsection (a)--
(A) in paragraph (1), by inserting ``and
activities'' after ``Federal programs'';
(B) in paragraph (2)--
(i) by striking ``public health
constituencies, manufacturers, veterinary and
medical professional societies and others'' and
inserting ``the Advisory Council described in
subsection (b) and relevant public and private
entities''; and
(ii) by inserting ``, pursuant to paragraph
(4),'' after ``comprehensive plan'';
(C) by amending paragraph (3) to read as follows:
``(3) Agenda.--The task force described in paragraph (1)
shall consider factors the Secretary considers appropriate,
including factors to--
``(A) slow the emergence of resistant bacteria and
fungi and prevent the spread of resistant infections;
``(B) strengthen activities to combat resistance
with respect to zoonotic diseases;
``(C) advance development and use of rapid and
innovative capabilities, including diagnostic tests,
for identification and characterization of resistant
bacteria and fungi;
``(D) accelerate basic and applied research and
development for new antibiotics, antifungals, and other
related therapeutics and vaccines; and
``(E) support international collaboration and
capacities for antimicrobial-resistance prevention,
detection, and control.'';
(D) by redesignating paragraph (4) as paragraph
(5);
(E) by inserting after paragraph (3) the following:
``(4) Action plan.--Not later than October 1, 2026, and
every 5 years thereafter, the task force described in paragraph
(1) shall develop and 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 and the Committee on Appropriations of the House of
Representatives a plan regarding Federal programs and
activities to combat antimicrobial resistance, including
measurable outcomes, as appropriate, informed by--
``(A) the agenda described in paragraph (3);
``(B) input provided by the Advisory Council
described in subsection (b); and
``(C) input from other relevant stakeholders
provided pursuant to paragraph (2).'';
(2) by redesignating subsections (b) through (o) as
subsections (c) through (p), respectively;
(3) by inserting after subsection (a) the following:
``(b) Advisory Council.--
``(1) In general.--The Secretary may continue the
Presidential Advisory Council on Combating Antibiotic-Resistant
Bacteria, referred to in this subsection as the `Advisory
Council'.
``(2) Duties.--The Advisory Council shall advise and
provide information and recommendations to the Secretary,
acting through the Task Force established under subsection (a),
regarding Federal programs and activities intended to reduce or
combat antimicrobial-resistant bacteria or fungi that may
present a public health threat and improve capabilities to
prevent, diagnose, mitigate, or treat such resistance. Such
advice, information, and recommendations may be related to
improving Federal efforts related to factors described in
subsection (a)(3) and other topics related to antimicrobial
resistance, as appropriate.
``(3) Meetings and coordination.--
``(A) Meetings.--The Advisory Council shall meet
not less frequently than biannually and, to the extent
practicable, in coordination with meetings of the task
force established under subsection (a).
``(B) Coordination.--The Advisory Council shall, to
the greatest extent practicable, coordinate activities
carried out by the Council with the task force
established under subsection (a).
``(4) FACA.--Chapter 10 of title 5, United States Code,
shall apply to the activities and duties of the Advisory
Council.
``(5) Sunset.--
``(A) In general.--The Advisory Council under this
subsection shall terminate on December 31, 2026.
``(B) Extension of advisory council.--Not later
than October 1, 2026, the Secretary 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 that includes a
recommendation on whether the Advisory Council should
be extended, and identifying whether there are other
committees, councils, or task forces that have
overlapping or similar duties to that of the Advisory
Council, and whether such committees, councils, or task
forces should be combined, restructured, or eliminated,
including with respect to the task force established
under subsection (a).''; and
(4) in subsection (n), as so redesignated, by striking
``(f) through (j)'' and inserting ``(g) through (k)''.
(b) Conforming Amendment.--Section 505 of the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2019 (42 U.S.C.
247d-5 note; Public Law 116-22) is amended by striking subsection (a)
and all that follows through ``Not later'' in subsection (e) and
inserting the following:
``Not later''.
SEC. 625. STRATEGIC NATIONAL STOCKPILE AND MATERIAL THREATS.
Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)
is amended--
(1) in subsection (a)--
(A) in paragraph (2)--
(i) in subparagraph (A), by inserting
``Such review shall include a description of
how the Secretary manages and mitigates risks
associated with gaps between current inventory
levels and stockpiling goals, prioritizes such
risks, and tracks progress toward mitigation of
such risks.'' after the first sentence; and
(ii) in subparagraph (B)(i), by amending
subclause (IV) to read as follows:
``(IV) the emergency health
security threat or threats such
countermeasure procurement is intended
to address, including--
``(aa) whether such
procurement is consistent with
meeting emergency health
security needs associated with
such threat or threats; and
``(bb) in the case of a
countermeasure that addresses a
biological agent, whether such
agent has an increased
likelihood to become resistant
to, more resistant to, or
evade, such countermeasure
relative to other available
medical countermeasures;'';
(B) in paragraph (3)--
(i) in subparagraph (B), by striking ``are
followed, regularly reviewed, and updated with
respect to such stockpile'' and inserting
``with respect to such stockpile are followed,
regularly reviewed, and updated to reflect best
practices'';
(ii) in subparagraph (I), by inserting ``,
through a standard operating procedure,'' after
``ensure'';
(iii) by redesignating subparagraphs (H)
through (K) as subparagraphs (I) through (L),
respectively;
(iv) by inserting after subparagraph (G)
the following:
``(H) utilize tools to enable the timely and
accurate tracking of the contents of the stockpile
throughout the deployment of such contents, including
tracking of the location and geographic distribution
and utilization of such contents;'';
(v) in subparagraph (K), as so
redesignated, by striking ``; and'' at the end
and inserting a semicolon;
(vi) in subparagraph (L), as so
redesignated, by striking the period and
inserting ``; and''; and
(vii) by adding at the end the following:
``(M) communicate to relevant vendors regarding
modifications, renewals, extensions, or terminations of
contracts, or the intent to exercise options for such
contracts, within 30 days, as practicable, of such
determination, including through the development of a
contract notification process.'';
(C) in paragraph (5)(B), in the matter preceding
clause (i), by inserting ``, which may accompany the
review required under paragraph (2),'' after
``Representatives a report''; and
(D) in paragraph (6)(A)--
(i) by redesignating clauses (viii) through
(x) as clauses (ix) through (xi), respectively;
and
(ii) by inserting after clause (vii) the
following:
``(viii) with respect to any change in the
Federal organizational management of the
stockpile, an assessment and comparison of any
differences in the processes and operations
resulting from such change, including--
``(I) planning for potential
countermeasure deployment,
distribution, or dispensing
capabilities;
``(II) organizational structure;
``(III) communication with relevant
stakeholders related to procurement
decisions;
``(IV) processes related to
procurement, deployment, and use of
stockpiled countermeasures;
``(V) communication and
coordination with the Public Health
Emergency Medical Countermeasures
Enterprise and other related Federal
entities;
``(VI) inventory management; and
``(VII) availability and use of
resources for such activities;''; and
(2) in subsection (c)(2)(C), by striking ``promptly'' and
inserting ``, not later than 60 days after each such
determination,'';
(3) in subsection (f)(1), by striking ``$610,000,000 for
each of fiscal years 2019 through 2021, and $750,000,000 for
each of fiscal years 2022 and 2023'' and inserting
``$1,100,000,000 for fiscal year 2025, and $1,210,000,000 for
fiscal year 2026''; and
(4) in subsection (g)(1), by striking ``2019 through 2028''
and inserting ``2025 through 2034''.
SEC. 626. MEDICAL COUNTERMEASURES FOR VIRAL THREATS WITH PANDEMIC
POTENTIAL.
Section 319L of the Public Health Service Act (42 U.S.C. 247d-7e)
is amended--
(1) in subsection (c)--
(A) in paragraph (4)--
(i) in subparagraph (D)--
(I) in clause (ii), by striking ``;
and'' and inserting a semicolon; and
(II) by redesignating clause (iii)
as clause (iv); and
(III) by inserting after clause
(ii) the following:
``(iii) research and development of medical
countermeasures for priority virus families
that have significant potential to cause a
pandemic, including such countermeasures that
take either pathogen-specific or pathogen-
agnostic approaches, and platform technologies
to improve the development and manufacture of
such medical countermeasures; and''; and
(ii) in subparagraph (F)(ii), by inserting
``or priority virus families and other viral
pathogens that pose a threat due to their
significant potential to cause a pandemic,''
after ``pandemic influenza,''; and
(B) in paragraph (5), by adding at the end the
following:
``(I) Notification.--In awarding contracts, grants,
cooperative agreements, or other transactions under
this section, the Secretary shall communicate to
relevant vendors regarding modifications, renewals,
extensions, or terminations of contracts, including
through the development of a contract notification
process, within 30 days of such determination, as
practicable.'';
(2) in subsection (d)(2), by striking ``$611,700,000 for
each of fiscal years 2019 through 2023'' and inserting
``$950,000,000 for each of fiscal years 2025 and 2026''; and
(3) in subsection (e)(1), by amending subparagraph (D) to
read as follows:
``(D) Sunset.--This paragraph shall cease to have
force or effect after December 31, 2026.''.
SEC. 627. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.
Section 2811-1 of the Public Health Service Act (42 U.S.C. 300hh-
10a) is amended--
(1) in subsection (b)--
(A) by redesignating paragraph (11) as paragraph
(13);
(B) by inserting after paragraph (10) the
following:
``(11) The Director of the Biomedical Advanced Research and
Development Authority.
``(12) The Director of the Strategic National Stockpile.'';
and
(C) in paragraph (13), as so redesignated, by
striking ``the Director of the Biomedical Advanced
Research and Development Authority, the Director of the
Strategic National Stockpile, the Director of the
National Institute of Allergy and Infectious
Diseases,'' and inserting ``the Director of the
National Institute of Allergy and Infectious
Diseases''; and
(2) in subsection (c)--
(A) in paragraph (1)--
(i) by redesignating subparagraph (D) as
subparagraph (E); and
(ii) by inserting after subparagraph (C)
the following:
``(D) Assist the Secretary in developing strategies
for appropriate and evidence-based allocation and
distribution of countermeasures to jurisdictions, in a
manner that supports the availability and use of such
countermeasures, for public health and medical
preparedness and response needs.'';
(B) in paragraph (2), by inserting ``relevant
stakeholders, including industry,'' after ``consider
input from''; and
(C) by adding at the end the following:
``(3) Information sharing.--The Secretary shall, as
appropriate and in a manner that does not compromise national
security, communicate and share information related to
recommendations made and strategies developed under paragraph
(1) with relevant stakeholders, including industry and State,
local, and Tribal public health departments.''.
SEC. 628. FELLOWSHIP AND TRAINING PROGRAMS.
Section 317G of the Public Health Service Act (42 U.S.C. 247b-8) is
amended--
(1) by striking ``The Secretary,'' and inserting the
following:
``(a) In General.--The Secretary,''; and
(2) by adding at the end the following:
``(b) Noncompetitive Conversion.--
``(1) In general.--The Secretary may noncompetitively
convert an individual who has completed an epidemiology,
surveillance, or laboratory fellowship or training program
under subsection (a) to a career-conditional appointment
without regard to the provisions of subchapter I of chapter 33
of title 5, United States Code, provided that such individual
meets qualification requirements for the appointment.''.
SEC. 629. REGIONAL BIOCONTAINMENT RESEARCH LABORATORIES.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall make awards to
establish or maintain, as applicable, not fewer than 12 regional
biocontainment laboratories, for purposes of--
(1) conducting biomedical research to support public health
and medical preparedness for, and rapid response to, biological
agents, including emerging infectious diseases;
(2) ensuring the availability of surge capacity for
purposes of responding to such biological agents;
(3) supporting information sharing between, and the
dissemination of findings to, researchers and other relevant
individuals to facilitate collaboration between industry and
academia; and
(4) providing, as appropriate and applicable, technical
assistance and training to researchers and other relevant
individuals to support the biomedical research workforce in
improving the management and mitigation of safety and security
risks in the conduct of research involving such biological
agents.
(b) Requirements.--As a condition of receiving a grant under this
section, a regional biocontainment laboratory shall agree to such
oversight activities as the Secretary determines appropriate, including
periodic meetings with relevant officials of the Department of Health
and Human Services, facility inspections, and other activities as
necessary and appropriate to ensure compliance with the terms and
conditions of such award.
(c) Working Group.--The Secretary shall establish a Working Group,
consisting of a representative from each entity in receipt of an award
under subsection (a). The Working Group shall make recommendations to
the Secretary in administering awards under this section, for purposes
of--
(1) improving the quality and consistency of applicable
procedures and practices within laboratories funded pursuant to
subsection (a); and
(2) ensuring coordination, as appropriate, of federally
funded activities carried out at such laboratories.
(d) Definition.--In this section, the term ``regional
biocontainment laboratory'' means a Biosafety or Animal Biosafety
Level-3 and Level-2 facility located at an institution in the United
States that is designated by the Secretary to carry out the activities
described in subsection (a).
(e) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $52,000,000 for each of fiscal
years 2025 and 2026, to remain available through December 31, 2026.
(f) Administrative Expenses.--Of the amount available to carry out
this section for a fiscal year, the Secretary may use not more than 5
percent for the administrative expenses of carrying out this section,
including expenses related to carrying out subsection (c).
(g) Report to Congress.--Not later than 1 year after the date of
the enactment of this Act, and biannually thereafter, the Secretary, in
consultation with the heads of applicable Federal departments and
agencies shall report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the
House of Representatives on--
(1) the activities and accomplishments of the regional
biocontainment laboratories;
(2) any published or disseminated research findings based
on research conducted in such laboratories in the applicable
year;
(3) oversight activities carried out by the Secretary
pursuant to subsection (b);
(4) activities undertaken by the Secretary to take into
consideration the capacity and capabilities of the network of
regional biocontainment laboratories in activities to prepare
for and respond to biological agents, which may include
leveraging such capacity and capabilities to support the
Laboratory Response Network, as applicable and appropriate;
(5) plans for the maintenance and sustainment of federally
funded activities conducted at the regional biocontainment
laboratories, consistent with the strategy required under
section 2312 of the PREVENT Pandemics Act (Public Law 117-328);
and
(6) activities undertaken by the Secretary to coordinate
with the heads of other relevant Federal departments and
agencies to ensure that work carried out by each such facility
on behalf of the Secretary and such other relevant heads is
prioritized, is complementary to the work carried out by other
such facilities and other relevant federally funded activities,
and avoids unnecessary duplication.
SEC. 629A. LIMITATION RELATED TO COUNTRIES OF CONCERN CONDUCTING
CERTAIN RESEARCH.
Section 2315(c) of the PREVENT Pandemics Act (42 U.S.C. 6627) is
amended to read as follows:
``(c) Limitations on Countries of Concern Conducting Certain
Research.--
``(1) In general.--The Secretary of Health and Human
Services (referred to in this subsection as the `Secretary')
shall not fund research that may reasonably be anticipated to
involve the creation, transfer, and use of enhanced pathogens
of pandemic potential or biological agents or toxins listed
pursuant to section 351A(a)(1) of the Public Health Service Act
if such research is conducted by a foreign entity at a facility
located in a country that is determined to be a country of
concern as defined in paragraph (2).
``(2) Countries of concern.--
``(A) Definition.--For purposes of this subsection,
a `country of concern' means the People's Republic of
China, the Democratic People's Republic of Korea, the
Russian Federation, the Islamic Republic of Iran, and
any other country as determined pursuant to
subparagraph (B).
``(B) Additional countries.--The Director of
National Intelligence (referred to in this subsection
as the `Director') shall, in consultation with the
Secretary, add additional countries of concern for
purposes of paragraph (1), only if--
``(i) the Director determines that evidence
exists that a country has malicious intent
related to the creation, enhancement, transfer,
or use of pathogens of pandemic potential or
biological agents or toxins listed pursuant to
such section 351A(a)(1); and
``(ii) in a manner that does not compromise
national security, the Director provides such
evidence in a report submitted to the Committee
on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and
Commerce of the House of Representatives.
``(C) Limitation.--Paragraph (1) shall not take
effect with respect to a country of concern identified
under subparagraph (B) until the date that is 15 days
after the date on which the Director submits the report
described in subparagraph (B)(ii).
``(3) Clarification.--
``(A) In general.--The requirement of paragraph (1)
may be waived by the President for the duration of the
initial response to an outbreak of a novel emerging
infectious disease if the President determines that
such requirement impedes the ability of the Federal
Government to immediately respond to such outbreak.
``(B) Notification.--The President shall notify
such committees of Congress not later than 48 hours
after exercising the waiver under subparagraph (A), and
shall provide updates to such committees related to the
use of such waiver every 15 days thereafter.
``(4) Sunset.--The limitation under this subsection shall
expire on December 31, 2026.''.
Subtitle C--Addressing the Needs of All Individuals
SEC. 631. IMPROVING ACCESS TO CERTAIN PROGRAMS.
(a) Procedures Related to the Transition of Certain Claims.--
(1) Procedures for correcting submissions.--
(A) Requests initially submitted under section
319f-4.--
(i) In general.--In the case of a request
for compensation submitted under section 319F-4
of the Public Health Service Act (42 U.S.C.
247d-6e) for an injury or death related to a
medical product for active immunization to
prevent coronavirus disease 2019 that the
Secretary determines to be ineligible pursuant
to subsection (b)(4)(B) of such section 319F-4,
the Secretary shall, not later than 30 days
after such determination, notify the individual
submitting the request of such determination.
(ii) Submission of petition.--An individual
who receives a notification described in clause
(i) shall be eligible to submit a petition to
the United States Court of Federal Claims under
section 2111 of the Public Health Service Act
(42 U.S.C. 300aa-11) with respect to the same
medical product administration claimed in the
request submitted under section 319F-4 of such
Act (42 U.S.C. 247d-6e), provided such petition
is submitted not later than the later of--
(I) 1 year after receiving such
notification under clause (i); or
(II) the last date on which the
individual otherwise would be eligible
to submit a petition relating to such
injury, as specified in section 2116 of
such Act (42 U.S.C. 300aa-16).
(iii) Eligibility.--To be eligible to
submit a petition in accordance with clause
(ii), the petitioner shall have submitted the
request that was determined to be ineligible as
described in clause (i) not later than the
applicable deadline for filing a petition under
such section 2116.
(B) Requests initially submitted under section
2111.--
(i) In general.--If a special master
determines that--
(I) a petition submitted under
section 2111 of the Public Health
Service Act (42 U.S.C. 300aa-11)
related to a medical product for active
immunization to prevent coronavirus
disease 2019 that is ineligible for the
program under subtitle 2 of title XXI
of the Public Health Service Act (42
U.S.C. 300aa-10 et seq.) because it
relates to a medical product
administered at a time when the medical
product was not included in the table
under section 2114 of such Act (42
U.S.C. 300aa-14); and
(II) the medical product was
administered when it was a covered
countermeasure subject to a declaration
under section 319F-3(b) of such Act (42
U.S.C. 247d-6d(b)),
the special master shall, not later than 30
days after such determination, notify the
petitioner of such determination.
(ii) Submission of request.--An individual
who receives a notification described in clause
(i) shall be eligible to submit a request for
compensation under section 319F-4(b) of the
Public Health Service Act (42 U.S.C. 247d-
6e(b)) with respect to the same medical product
administration claimed in the petition
submitted under section 2111 of such Act (42
U.S.C. 300aa-11)--
(I) not later than 1 year after
receiving such notification; or
(II) in the case that the
notification is issued after judicial
review of the petition under subsection
(e) or (f) of section 2112 of such Act
(42 U.S.C. 300aa-12), not later than 1
year after the judgment of the United
States Court of Federal Claims or the
mandate is issued by the United States
Court of Appeals for the Federal
Circuit pursuant to such subsection (e)
or (f).
(iii) Eligibility.--To be eligible to
submit a request for compensation in accordance
with clause (ii), the individual submitting the
request shall have submitted the petition under
section 2111 of the Public Health Service Act
(42 U.S.C. 300aa-11) that was determined to be
ineligible not later than 1 year after the date
of administration of the medical product.
(2) Changes to certain programs.--
(A) Section 319f-4.--Section 319F-4 of the Public
Health Service Act (42 U.S.C. 247d-6e) is amended--
(i) in subsection (b)(4)--
(I) by striking ``Except as
provided'' and inserting the following:
``(A) In general.--Except as provided''; and
(II) by adding at the end the
following:
``(B) Exclusion of injuries eligible for petition
under title xxi.--Notwithstanding any other provision
of this section, no individual may be eligible for
compensation under this section with respect to a
vaccine that, at the time it was administered, was
included in the Vaccine Injury Table under section
2114.''; and
(ii) in subsection (d)(3)--
(I) by striking ``This section''
and inserting the following:
``(A) In general.--This section''; and
(II) by adding at the end the
following:
``(B) Exhaustion of remedies.--A covered individual
shall not be considered to have exhausted remedies as
described in paragraph (1), nor be eligible to seek
remedy under section 319F-3(d), unless such individual
has provided to the Secretary all supporting
documentation necessary to facilitate the
determinations required under subsection (b)(4).''.
(B) Title xxi.--Title XXI of the Public Health
Service Act (42 U.S.C. 300aa-1 et seq.) is amended--
(i) in section 2111(a)(2)(A) (42 U.S.C.
300aa-11(a)(2)(A)), in the matter preceding
clause (i), by inserting ``containing the
information required under subsection (c)''
after ``unless a petition'';
(ii) in section 2112(d) (42 U.S.C. 300aa-
12(d))--
(I) by adding at the end of
paragraph (1) the following: ``Such
designation shall not occur until the
petitioner has filed all materials
required under section 2111(c).''; and
(II) in paragraph (3)(A)(ii), by
striking ``the petition was filed'' and
inserting ``on which the chief special
master makes the designation pursuant
to paragraph (1)'';
(iii) in section 2114(e) (42 U.S.C. 300aa-
14(e)), by adding at the end the following:
``(4) Licensure requirement.--Notwithstanding paragraphs
(2) and (3), the Secretary may not revise the Vaccine Injury
Table to include a vaccine for which the Centers for Disease
Control and Prevention has issued a recommendation for routine
use in children or pregnant women until at least one
application for such vaccine has been approved under section
351. Upon such revision of the Vaccine Injury Table, all
vaccines in a vaccine category on the Vaccine Injury Table,
including vaccines authorized under emergency use pursuant to
section 564 of the Federal Food, Drug, and Cosmetic Act, shall
be considered included in the Vaccine Injury Table.''; and
(iv) in section 2116 (42 U.S.C. 300aa-16),
by adding at the end the following:
``(d) Clarification.--Notwithstanding subsections (a) and (b), an
injury or death related to a vaccine administered at a time when the
vaccine was a covered countermeasure subject to a declaration under
section 319F-3(b) shall not be eligible for compensation under the
Program.''.
(b) Accelerating Injury Compensation Program Administration and
Ensuring Program Integrity.--
(1) Petitions for compensation.--Section 2111(a)(2)(A)(i)
of the Public Health Service Act (42 U.S.C. 300aa-
11(a)(2)(A)(i)) is amended--
(A) in subclause (I), by striking ``, and'' and
inserting a semicolon;
(B) in subclause (II)--
(i) by moving the margin 2 ems to the
right; and
(ii) by striking ``, or'' and inserting ``;
and''; and
(C) by adding at the end the following:
``(III) the judgment described in subclause (I)
does not result from a petitioner's motion to dismiss
the case; or''.
(2) Determination of good faith.--Section 2115(e)(1) of the
Public Health Service Act (42 U.S.C. 300aa-15(e)(1)) is amended
by adding at the end the following: ``When making a
determination of good faith under this paragraph, the special
master or court may consider whether the petitioner
demonstrated an intention to obtain compensation on such
petition and was not merely seeking to satisfy the exhaustion
requirement under section 2121(b).''.
(c) Extension of Deadlines To Submit Requests for Compensation for
Certain Injuries.--
(1) In general.--With respect to claims filed under section
319F-4 of the Public Health Service Act (42 U.S.C. 247d-6e)
alleging a covered injury caused by the administration or use
of a covered countermeasure pursuant to a declaration under
section 319F-3(b) of such Act (42 U.S.C. 247d-6d(b)) relating
to coronavirus disease 2019, the following shall apply:
(A) Notwithstanding the filing deadline applicable
under such section 319F-4, the claim shall be filed
within 3 years of the administration or use of the
covered countermeasure, or 1 year after the date of
enactment of this Act, whichever is later, and, if a
claim filed under such section 319F-4 with respect to
such administration or use was filed before the date of
enactment of this Act and denied on the basis of having
not been filed within the time period required under
subsection (b)(4) of such section 319F-4, such claim
may be refiled pursuant to this subparagraph.
(B) With respect to a claim relating to the
administration of a medical product for active
immunization to prevent coronavirus disease 2019 such a
claim may be filed under the such section 319F-4 only
if the administration of such vaccine occurred prior to
the addition of the vaccine to the Vaccine Injury Table
under section 2114 of the Public Health Service Act (42
U.S.C. 300aa-14).
SEC. 632. SUPPORTING AT-RISK INDIVIDUALS DURING EMERGENCY RESPONSES.
(a) Technical Assistance for At-Risk Individuals and Disasters.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') may provide
appropriate technical assistance to States, localities, Tribes,
and other applicable entities related to addressing the unique
needs and considerations of at-risk individuals, as defined in
section 2802(b)(4) of the Public Health Service Act (42 U.S.C.
300hh-1(b)(4)), in the event of a public health emergency
declared by the Secretary pursuant to section 319 of the Public
Health Service Act (42 U.S.C. 247d).
(2) Technical assistance.--The technical assistance
described in paragraph (1) shall include--
(A) developing, identifying, evaluating, and
disseminating evidence-based or evidence-informed
strategies to improve health and address other near-
term or long-term outcomes for at-risk individuals
related to public health emergencies, including by
addressing such unique needs and considerations in
carrying out public health and medical activities to
prepare for, respond to, and recover from, such public
health emergencies; and
(B) assisting applicable entities, through
contracts or cooperative agreements, as appropriate, in
the implementation of such evidence-based strategies.
(3) Consultation.--In carrying out activities under
paragraph (2), the Secretary shall take into consideration
relevant findings and recommendations of, and, as appropriate,
consult with, the National Advisory Committee on Individuals
with Disabilities and Disasters established under section 2811C
of the Public Health Service Act (42 U.S.C. 300hh-10d), the
National Advisory Committee on Children and Disasters under
section 2811A of such Act (42 U.S.C. 300hh-10b), and the
National Advisory Committee on Seniors and Disasters under
section 2811B of such Act (42 U.S.C. 300hh-10c).
(b) Crisis Standards of Care.--Not later than 2 years after the
date of enactment of this Act, the Secretary, acting through the
Director of the Office for Civil Rights of the Department of Health and
Human Services, shall issue guidance to States and localities on the
development or modification of State and local crisis standards of care
for use during the response to a public health emergency declared by
the Governor of a State or by the Secretary under section 319 of the
Public Health Service Act (42 U.S.C. 247d), or a major disaster or
emergency declared by the President under section 401 or 501,
respectively, of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act (42 U.S.C. 5170, 5191) to ensure that such standards of
care are consistent with the nondiscrimination requirements of section
504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), title II of the
Americans with Disabilities Act of 1990 (42 U.S.C. 12131 et seq.), and
the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.).
SEC. 633. NATIONAL ADVISORY COMMITTEES.
(a) National Advisory Committee on Children and Disasters.--
Subsection (g) of section 2811A of the Public Health Service Act (42
U.S.C. 300hh-10b) is amended to read as follows:
``(g) Sunset.--
``(1) In general.--The Advisory Committee shall terminate
on December 31, 2026.
``(2) Extension of advisory committee.--Not later than
October 1, 2025, the Secretary shall submit to Congress a
recommendation on whether the Advisory Committee should be
extended beyond the date described in paragraph (1).''.
(b) National Advisory Committee on Seniors and Disasters.--Section
2811B of the Public Health Service Act (42 U.S.C. 300hh-10c) is
amended--
(1) in subsection (d)--
(A) in paragraph (1)--
(i) by inserting ``and departments'' after
``agencies''; and
(ii) by striking ``17 members'' and
inserting ``25 members''; and
(B) in paragraph (2)--
(i) by striking subparagraphs (J) and (K);
(ii) by redesignating subparagraphs (A)
through (I) and (L) as clauses (i) through (x),
respectively, and adjusting the margins
accordingly;
(iii) by inserting before clause (i), as so
redesignated, the following:
``(B) Federal members.--The Federal members shall
include the following:''; and
(iv) by inserting before subparagraph (B),
as so designated, the following:
``(A) Non-federal members.--The Secretary in
consultation with such other heads of agencies and
departments as may be appropriate, shall appoint to the
Advisory Committee under paragraph (1) at least 13
individuals, including the following:
``(i) At least 3 non-Federal health care
providers with expertise in geriatric medical
disaster planning, preparedness, response, or
recovery.
``(ii) At least 3 representatives of State,
local, territorial, or Tribal agencies with
expertise in geriatric disaster planning,
preparedness, response, or recovery.
``(iii) At least 2 non-Federal
professionals with training in gerontology,
such as social workers, scientists, human
services specialists, or other non-medical
professionals, with experience in disaster
planning, preparedness, response, or recovery
among other adults.''; and
(2) by amending subsection (g) to read as follows:
``(g) Sunset.--The Advisory Committee shall terminate on December
31, 2026.''.
(c) National Advisory Committee on Individuals With Disabilities
and Disasters.--Section 2811C of the Public Health Service Act (42
U.S.C. 300hh-10d) is amended--
(1) by redesignating subsections (c) through (g) as
subsections (d) through (h), respectively;
(2) by inserting after subsection (b) the following:
``(c) Additional Duties.--The Advisory Committee may provide advice
and recommendations to the Secretary with respect to individuals with
disabilities and the medical and public health grants and cooperative
agreements as applicable to preparedness and response activities under
this title and title III.'';
(3) in subsection (d), as so redesignated--
(A) in paragraph (1), by striking ``17 members''
and inserting ``25 members'';
(B) in paragraph (2)--
(i) by striking subparagraphs (K) through
(M);
(ii) by redesignating subparagraphs (A)
through (J) as clauses (i) through (x),
respectively, and adjusting the margins
accordingly;
(iii) by inserting before clause (i), as so
redesignated, the following:
``(B) Federal members.--The Federal members shall
include the following:'';
(iv) by adding at the end of subparagraph
(B), as so designated, the following:
``(xi) Representatives of such other
Federal agencies as the Secretary determines
necessary to fulfill the duties of the Advisory
Committee.''; and
(v) by inserting before subparagraph (B),
as so designated, the following:
``(A) Non-federal members.--The Secretary in
consultation with such other heads of agencies and
departments as may be appropriate, shall appoint to the
Advisory Committee under paragraph (1) at least 13
individuals, including the following:
``(i) At least 4 non-Federal health care
professionals with expertise in disability
accessibility before, during, and after
disasters, medical and mass care disaster
planning, preparedness, response, or recovery.
``(ii) At least 3 representatives of State,
local, Tribal, or territorial agencies with
expertise in disaster planning, preparedness,
response, or recovery for individuals with
disabilities.
``(iii) At least 4 individuals with a
disability with expertise in disaster planning,
preparedness, response, or recovery for
individuals with disabilities.
``(iv) Other members as the Secretary
determines appropriate, of whom--
``(I) at least one such member
shall represent a local, State, or
national organization with expertise in
individuals with disabilities;
``(II) at least one such member
shall be an individual with a
disability; and
``(III) at least one such member
shall be an individual with expertise
in the needs of housing services,
including during the response to, and
recovery from, disasters.''; and
(C) by adding at the end the following:
``(3) Consideration.--In appointing members, including the
Chair, to the Committee under this subsection, the Secretary
may give consideration to disability status.''; and
(4) by amending subsection (h), as so redesignated, to read
as follows:
``(h) Sunset.--The Advisory Committee shall terminate on December
31, 2026.''.
SEC. 634. NATIONAL ACADEMIES STUDY ON PRIZES.
(a) In General.--Not later than 90 days after the date of enactment
of this Act, the Secretary of Health and Human Services shall seek to
enter into an agreement with the National Academies of Sciences,
Engineering, and Medicine (referred to in this section as the
``National Academies'') to conduct a study to examine--
(1) alternative models for directly funding, or stimulating
investment in, biomedical research and development that delink
research and development costs from the prices of drugs,
including the progressive replacement of patents and regulatory
exclusivities on new drugs with a combination of expanded
support for research and innovation prizes to reward the
successful development of drugs or achievement of related
milestones;
(2) the dollar amount of innovation prizes for different
stages of research and development of different classes or
types of drugs, and total annual funding, that would be
necessary to stimulate investment sufficient to achieve such
successful drug development and related milestones;
(3) the relative effectiveness and efficiency of such
alternative models in stimulating innovation, compared to the
status quo that includes patents and regulatory exclusivities;
(4) strategies to implement such alternative models
described in paragraph (1), including a phased transition; and
(5) the anticipated economic and societal impacts of such
alternative models, including an assessment of impact on--
(A) the number and variety of new drugs that would
be developed, approved, and marketed in the United
States, including such new drugs intended to prevent,
diagnose, or treat a rare disease or condition;
(B) the rate at which new drugs would be developed,
approved, and marketed in the United States;
(C) access to medication;
(D) health outcomes;
(E) average lifespan and disease burden in the
United States;
(F) the number of manufacturers that would be
seeking approval for a drug or bringing a drug to
market for the first time;
(G) Federal discretionary and mandatory spending;
and
(H) public and private insurance markets.
(b) Requirements.--In conducting the study pursuant to subsection
(a), the National Academies shall hold not fewer than 2 public
listening sessions to solicit feedback from interested parties,
including representatives of academia, professional societies, patient
advocates, public health organizations, relevant Federal departments
and agencies, drug developers, representatives of other relevant
industries, and subject matter experts.
(c) Report.--Not later than 2 years after the agreement under
subsection (a), the National Academies 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
and the Committee on Appropriations of the House of Representatives a
report on the study conducted pursuant to subsection (a).
Subtitle D--Additional Reauthorizations
SEC. 641. MEDICAL COUNTERMEASURE PRIORITY REVIEW VOUCHER.
Section 565A(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4a) is amended by striking ``October 1, 2023'' and
inserting ``December 31, 2026''.
SEC. 642. EPIDEMIC INTELLIGENCE SERVICE.
Section 317F(c)(2) of the Public Health Service Act (42 U.S.C.
247b-7(c)(2)) is amended by striking ``2019 through 2023'' and
inserting ``2025 and 2026, to remain available through December 31,
2026''.
SEC. 643. MONITORING AND DISTRIBUTION OF CERTAIN MEDICAL
COUNTERMEASURES.
Section 319A(e) of the Public Health Service Act (42 U.S.C. 247d-
1(e)) is amended by striking ``2019 through 2023'' and inserting ``2025
and 2026, to remain available through December 31, 2026''.
SEC. 644. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND RESPONSE
SYSTEMS.
Section 319C-3 of the Public Health Service Act (42 U.S.C. 247d-3c)
is amended--
(1) in subsection (b)(3), by striking ``under the'' and all
that follows through ``such Act)'' and inserting ``under law'';
and
(2) in subsection (e)(2), by striking ``September 30,
2023'' and inserting ``December 31, 2026''.
SEC. 645. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF VOLUNTEER HEALTH
PROFESSIONALS.
(1) In general.--Section 319I of the Public Health Service
Act (42 U.S.C. 247d-7b) is amended--
(A) in subsection (a), by striking ``Not later than
12 months after the date of enactment of the Pandemic
and All-Hazards Preparedness Act, the Secretary shall
link existing State verification systems to maintain a
single national interoperable network of systems,'' and
inserting ``The Secretary shall continue to maintain a
single national interoperable network of verification
systems,'' and
(B) in subsection (k), by striking ``2019 through
2023'' and inserting ``2025 and 2026, to remain
available through December 31, 2026''.
SEC. 646. ENSURING COLLABORATION AND COORDINATION IN MEDICAL
COUNTERMEASURE DEVELOPMENT.
Section 319L-1(b) of the Public Health Service Act (42 U.S.C. 247d-
7f(b)) is amended by striking ``March 31, 2025'' and inserting
``December 31, 2026''.
SEC. 647. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS.
Section 1291(g) of the Public Health Service Act (42 U.S.C. 300d-
91(g)) is amended by striking ``2019 through 2023'' and inserting
``2025 and 2026, to remain available through December 31, 2026''.
SEC. 648. NATIONAL DISASTER MEDICAL SYSTEM.
Section 2812 of the Public Health Service Act (42 U.S.C. 300hh-11)
is amended--
(1) in subsection (c)(4)(B), by striking ``March 31, 2025''
and inserting ``December 31, 2026''; and
(2) in subsection (g), by striking ``$57,400,000 for each
of fiscal years 2019 through 2023'' and inserting ``$65,900,000
for each of fiscal years 2025 and 2026, to remain available
through December 31, 2026''.
SEC. 649. VOLUNTEER MEDICAL RESERVE CORPS.
Section 2813(i) of the Public Health Service Act (42 U.S.C. 300hh-
15(i)) is amended by striking ``2019 through 2023'' and inserting
``2025 through 2026, to remain available through December 31, 2026''.
SEC. 649A. EPIDEMIOLOGY-LABORATORY CAPACITY.
Section 2821(b) of the Public Health Service Act (42 U.S.C. 300hh-
31(b)) is amended, in the matter preceding paragraph (1), by striking
``2019 through 2023'' and inserting ``2025 and 2026, to remain
available through December 31, 2026''.
TITLE VII--PUBLIC HEALTH PROGRAMS
SEC. 701. ACTION FOR DENTAL HEALTH.
Section 340G(f) of the Public Health Service Act (42 U.S.C.
256g(f)) is amended by striking ``$13,903,000 for each of fiscal years
2019 through 2023'' and inserting ``$15,000,000 for each of fiscal
years 2025 through 2029, to remain available until expended''.
SEC. 702. PREEMIE.
(a) Research Relating to Preterm Labor and Delivery and the Care,
Treatment, and Outcomes of Preterm and Low Birthweight Infants.--
(1) In general.--Section 3(e) of the Prematurity Research
Expansion and Education for Mothers who deliver Infants Early
Act (42 U.S.C. 247b-4f(e)) is amended by striking ``fiscal
years 2019 through 2023'' and inserting ``fiscal years 2025
through 2029''.
(2) Technical correction.--Effective as if included in the
enactment of the PREEMIE Reauthorization Act of 2018 (Public
Law 115-328), section 2 of such Act is amended, in the matter
preceding paragraph (1), by striking ``Section 2'' and
inserting ``Section 3''.
(b) Interagency Working Group.--Section 5(a) of the PREEMIE
Reauthorization Act of 2018 (Public Law 115-328) is amended by striking
``The Secretary of Health and Human Services, in collaboration with
other departments, as appropriate, may establish'' and inserting ``Not
later than 18 months after the date of the enactment of the Bipartisan
Health Care Act, the Secretary of Health and Human Services, in
collaboration with other departments, as appropriate, shall
establish''.
(c) Study on Preterm Births.--
(1) In general.--The Secretary of Health and Human Services
shall enter into appropriate arrangements with the National
Academies of Sciences, Engineering, and Medicine under which
the National Academies shall--
(A) not later than 30 days after the date of
enactment of this Act, convene a committee of experts
in maternal health to study premature births in the
United States; and
(B) upon completion of the study under subparagraph
(A)--
(i) approve by consensus a report on the
results of such study;
(ii) include in such report--
(I) an assessment of each of the
topics listed in paragraph (2);
(II) the analysis required by
paragraph (3); and
(III) the raw data used to develop
such report; and
(iii) not later than 24 months after the
date of enactment of this Act, transmit such
report to--
(I) the Secretary of Health and
Human Services;
(II) the Committee on Energy and
Commerce of the House of
Representatives; and
(III) the Committee on Finance and
the Committee on Health, Education,
Labor, and Pensions of the Senate.
(2) Assessment topics.--The topics listed in this
subsection are each of the following:
(A) The financial costs of premature birth to
society, including--
(i) an analysis of stays in neonatal
intensive care units and the cost of such
stays;
(ii) long-term costs of stays in such units
to society and the family involved post-
discharge; and
(iii) health care costs for families post-
discharge from such units (such as medications,
therapeutic services, co-payments for visits,
and specialty equipment).
(B) The factors that impact preterm birth rates.
(C) Opportunities for earlier detection of
premature birth risk factors, including--
(i) opportunities to improve maternal and
infant health; and
(ii) opportunities for public health
programs to provide support and resources for
parents in-hospital, in non-hospital settings,
and post-discharge.
(3) Analysis.--The analysis required by this subsection is
an analysis of--
(A) targeted research strategies to develop
effective drugs, treatments, or interventions to bring
at-risk pregnancies to term;
(B) State and other programs' best practices with
respect to reducing premature birth rates; and
(C) precision medicine and preventative care
approaches starting early in the life course (including
during pregnancy) with a focus on behavioral and
biological influences on premature birth, child health,
and the trajectory of such approaches into adulthood.
SEC. 703. PREVENTING MATERNAL DEATHS.
(a) Maternal Mortality Review Committee.--Section 317K(d) of the
Public Health Service Act (42 U.S.C. 247b-12(d)) is amended--
(1) in paragraph (1)(A), by inserting ``(including
obstetricians and gynecologists)'' after ``clinical
specialties''; and
(2) in paragraph (3)(A)(i)--
(A) in subclause (I), by striking ``as applicable''
and inserting ``if available''; and
(B) in subclause (III), by striking ``, as
appropriate'' and inserting ``and coordinating with
death certifiers to improve the collection of death
record reports and the quality of death records,
including by amending cause of death information on a
death certificate, as appropriate''.
(b) Best Practices Relating to the Prevention of Maternal
Mortality.--Section 317K of the Public Health Service Act (42 U.S.C.
247b-12) is amended--
(1) by redesignating subsections (e) and (f) as subsections
(f) and (g), respectively; and
(2) by inserting after subsection (d) the following:
``(e) Best Practices Relating to the Prevention of Maternal
Mortality.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall, in consultation with the Administrator of the Health
Resources and Services Administration, disseminate to
hospitals, State professional society groups, and perinatal
quality collaboratives, best practices on how to prevent
maternal mortality and morbidity that consider and reflect best
practices identified through other relevant Federal maternal
health programs.
``(2) Frequency.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall disseminate the best practices referred to in paragraph
(1) not less than once per fiscal year.''.
(c) Extension.--Subsection (g) of section 317K of the Public Health
Service Act (42 U.S.C. 247b-12), as redesignated by subsection (b), is
amended by striking ``$58,000,000 for each of fiscal years 2019 through
2023'' and inserting ``$100,000,000 for each of fiscal years 2025
through 2029''.
SEC. 704. SICKLE CELL DISEASE PREVENTION AND TREATMENT.
(a) In General.--Section 1106(b) of the Public Health Service Act
(42 U.S.C. 300b-5(b)) is amended--
(1) in paragraph (1)(A)(iii), by striking ``prevention and
treatment of sickle cell disease'' and inserting ``treatment of
sickle cell disease and the prevention and treatment of
complications of sickle cell disease'';
(2) in paragraph (2)(D), by striking ``prevention and
treatment of sickle cell disease'' and inserting ``treatment of
sickle cell disease and the prevention and treatment of
complications of sickle cell disease'';
(3) in paragraph (3)--
(A) in subparagraph (A), by striking ``enter into a
contract with'' and inserting ``make a grant to, or
enter into a contract or cooperative agreement with,'';
and
(B) in subparagraph (B), in each of clauses (ii)
and (iii), by striking ``prevention and treatment of
sickle cell disease'' and inserting ``treatment of
sickle cell disease and the prevention and treatment of
complications of sickle cell disease''; and
(4) in paragraph (6), by striking ``$4,455,000 for each of
fiscal years 2019 through 2023'' and inserting ``$8,205,000 for
each of fiscal years 2025 through 2029''.
(b) Sense of Congress.--It is the sense of Congress that further
research should be undertaken to expand the understanding of the causes
of, and to find cures for, heritable blood disorders, including sickle
cell disease.
SEC. 705. TRAUMATIC BRAIN INJURIES.
(a) The Bill Pascrell, Jr., National Program for Traumatic Brain
Injury Surveillance and Registries.--
(1) Prevention of traumatic brain injury.--Section 393B of
the Public Health Service Act (42 U.S.C. 280b-1c) is amended--
(A) in subsection (a), by inserting ``and
prevalence'' after ``incidence'';
(B) in subsection (b)--
(i) in paragraph (1), by inserting ``and
reduction of associated injuries and
fatalities'' before the semicolon;
(ii) in paragraph (2), by inserting ``and
related risk factors'' before the semicolon;
and
(iii) in paragraph (3)--
(I) in the matter preceding
subparagraph (A), by striking ``2020''
each place it appears and inserting
``2030''; and
(II) in subparagraph (A)--
(aa) in clause (i), by
striking ``; and'' and
inserting a semicolon;
(bb) by redesignating
clause (ii) as clause (iv);
(cc) by inserting after
clause (i) the following:
``(ii) populations at higher risk of
traumatic brain injury, including populations
whose increased risk is due to occupational or
circumstantial factors;
``(iii) causes of, and risk factors for,
traumatic brain injury; and''; and
(dd) in clause (iv), as so
redesignated, by striking
``arising from traumatic brain
injury'' and inserting ``,
which may include related
mental health and other
conditions, arising from
traumatic brain injury,
including''; and
(C) in subsection (c), by inserting ``, and other
relevant Federal departments and agencies'' before the
period at the end.
(2) National program for traumatic brain injury
surveillance and registries.--Section 393C of the Public Health
Service Act (42 U.S.C. 280b-1d) is amended--
(A) by amending the section heading to read as
follows: ``the bill pascrell, jr., national program for
traumatic brain injury surveillance and registries'';
(B) in subsection (a)--
(i) in the matter preceding paragraph (1),
by inserting ``to identify populations that may
be at higher risk for traumatic brain injuries,
to collect data on the causes of, and risk
factors for, traumatic brain injuries,'' after
``related disability,'';
(ii) in paragraph (1), by inserting ``,
including the occupation of the individual,
when relevant to the circumstances surrounding
the injury'' before the semicolon; and
(iii) in paragraph (4), by inserting
``short- and long-term'' before ``outcomes'';
(C) by striking subsection (b);
(D) by redesignating subsection (c) as subsection
(b);
(E) in subsection (b), as so redesignated, by
inserting ``and evidence-based practices to identify
and address concussion'' before the period at the end;
and
(F) by adding at the end the following:
``(c) Availability of Information.--The Secretary, acting through
the Director of the Centers for Disease Control and Prevention, shall
make publicly available aggregated information on traumatic brain
injury and concussion described in this section, including on the
website of the Centers for Disease Control and Prevention. Such
website, to the extent feasible, shall include aggregated information
on populations that may be at higher risk for traumatic brain injuries
and strategies for preventing or reducing risk of traumatic brain
injury that are tailored to such populations.''.
(3) Authorization of appropriations.--Section 394A of the
Public Health Service Act (42 U.S.C. 280b-3) is amended--
(A) in subsection (a), by striking ``1994, and''
and inserting ``1994,''; and
(B) in subsection (b), by striking ``2020 through
2024'' and inserting ``2025 through 2029''.
(b) State Grant Programs.--
(1) State grants for projects regarding traumatic brain
injury.--Section 1252 of the Public Health Service Act (42
U.S.C. 300d-52) is amended--
(A) in subsection (b)(2)--
(i) by inserting ``, taking into
consideration populations that may be at higher
risk for traumatic brain injuries'' after
``outreach programs''; and
(ii) by inserting ``Tribal,'' after
``State,'';
(B) in subsection (c), by adding at the end the
following:
``(3) Maintenance of effort.--With respect to activities
for which a grant awarded under subsection (a) is to be
expended, a State or American Indian consortium shall agree to
maintain expenditures of non-Federal amounts for such
activities at a level that is not less than the level of such
expenditures maintained by the State or American Indian
consortium for the fiscal year preceding the fiscal year for
which the State or American Indian consortium receives such a
grant.
``(4) Waiver.--The Secretary may, upon the request of a
State or American Indian consortium, waive not more than 50
percent of the matching fund amount under paragraph (1), if the
Secretary determines that such matching fund amount would
result in an inability of the State or American Indian
consortium to carry out the purposes under subsection (a). A
waiver provided by the Secretary under this paragraph shall
apply only to the fiscal year involved.'';
(C) in subsection (e)(3)(B)--
(i) by striking ``(such as third party
payers, State agencies, community-based
providers, schools, and educators)''; and
(ii) by inserting ``(such as third party
payers, State agencies, community-based
providers, schools, and educators)'' after
``professionals'';
(D) in subsection (h), by striking paragraphs (1)
and (2) and inserting the following:
``(1) American indian consortium; state.--The terms
`American Indian consortium' and `State' have the meanings
given such terms in section 1253.
``(2) Traumatic brain injury.--
``(A) In general.--Subject to subparagraph (B), the
term `traumatic brain injury'--
``(i) means an acquired injury to the
brain;
``(ii) may include--
``(I) brain injuries caused by
anoxia due to trauma; and
``(II) damage to the brain from an
internal or external source that
results in infection, toxicity,
surgery, or vascular disorders not
associated with aging; and
``(iii) does not include brain dysfunction
caused by congenital or degenerative disorders,
or birth trauma.
``(B) Revisions to definition.--The Secretary may
revise the definition of the term `traumatic brain
injury' under this paragraph, as the Secretary
determines necessary, after consultation with States
and other appropriate public or nonprofit private
entities.''; and
(E) in subsection (i), by striking ``2020 through
2024'' and inserting ``2025 through 2029''.
(2) State grants for protection and advocacy services.--
Section 1253(l) of the Public Health Service Act (42 U.S.C.
300d-53(l)) is amended by striking ``2020 through 2024'' and
inserting ``2025 through 2029''.
(c) Report to Congress.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human Services
(referred to in this Act as the ``Secretary'') 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 that contains--
(1) an overview of populations who may be at higher risk
for traumatic brain injury, such as individuals affected by
domestic violence or sexual assault and public safety officers
as defined in section 1204 of the Omnibus Crime Control and
Safe Streets Act of 1968 (34 U.S.C. 10284);
(2) an outline of existing surveys and activities of the
Centers for Disease Control and Prevention on traumatic brain
injuries and any steps the agency has taken to address gaps in
data collection related to such higher risk populations, which
may include leveraging surveys such as the National Intimate
Partner and Sexual Violence Survey to collect data on traumatic
brain injuries;
(3) an overview of any outreach or education efforts to
reach such higher risk populations; and
(4) any challenges associated with reaching such higher
risk populations.
(d) Study on Long-Term Symptoms or Conditions Related to Traumatic
Brain Injury.--
(1) In general.--The Secretary, in consultation with
stakeholders and the heads of other relevant Federal
departments and agencies, as appropriate, shall conduct, either
directly or through a contract with a nonprofit private entity,
a study to--
(A) examine the incidence and prevalence of long-
term or chronic symptoms or conditions in individuals
who have experienced a traumatic brain injury;
(B) examine the evidence base of research related
to the chronic effects of traumatic brain injury across
the lifespan;
(C) examine any correlations between traumatic
brain injury and increased risk of other conditions,
such as dementia and mental health conditions;
(D) assess existing services available for
individuals with such long-term or chronic symptoms or
conditions; and
(E) identify any gaps in research related to such
long-term or chronic symptoms or conditions of
individuals who have experienced a traumatic brain
injury.
(2) Public report.--Not later than 2 years after the date
of enactment of this Act, the Secretary shall--
(A) 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 detailing the findings, conclusions, and
recommendations of the study described in paragraph
(1); and
(B) in the case that such study is conducted
directly by the Secretary, make the report described in
subparagraph (A) publicly available on the website of
the Department of Health and Human Services.
SEC. 706. LIFESPAN RESPITE CARE.
(a) Definition of Family Caregiver.--Section 2901(5) of the Public
Health Service Act (42 U.S.C. 300ii(5)) is amended by striking ``unpaid
adult'' and inserting ``unpaid individual''.
(b) Funding.--Section 2905 of the Public Health Service Act (42
U.S.C. 300ii-4) is amended by striking ``fiscal years 2020 through
fiscal year 2024'' and inserting ``fiscal years 2025 through 2029''.
SEC. 707. DR. LORNA BREEN HEALTH CARE PROVIDER PROTECTION.
(a) Dissemination of Best Practices.-- Section 2 of the Dr. Lorna
Breen Health Care Provider Protection Act (Public Law 117-105) is
amended by striking ``2 years'' and inserting ``5 years''.
(b) Education and Awareness Initiative Encouraging Use of Mental
Health and Substance Use Disorder Services by Health Care
Professionals.--Section 3 of the Dr. Lorna Breen Health Care Provider
Protection Act (Public Law 117-105) is amended--
(1) in subsection (b), by inserting ``and annually
thereafter,'' after ``of this Act,''; and
(2) in subsection (c), by striking ``2022 through 2024''
and inserting ``2025 through 2029''.
(c) Programs To Promote Mental Health Among the Health Professional
Workforce.--The second section 764 of the Public Health Service Act (42
U.S.C. 294t), as added by section 4 of the Dr. Lorna Breen Health Care
Provider Protection Act (Public Law 117-105), is amended--
(1) by redesignating such section 764 as section 764A;
(2) in subsection (a)(3)--
(A) by striking ``to eligible entities in'' and
inserting ``to eligible entities that--
``(A) are in'';
(B) by striking the period and inserting ``; or'';
and
(C) by adding at the end the following:
``(B) have a focus on the reduction of
administrative burden on health care workers.'';
(3) in subsection (c), by inserting ``not less than'' after
``period of''; and
(4) in subsection (f), by striking ``2022 through 2024''
and inserting ``2025 through 2029''.
SEC. 708. SCREENS FOR CANCER.
(a) National Breast and Cervical Cancer Early Detection Program.--
Title XV of the Public Health Service Act (42 U.S.C. 300k et seq.) is
amended--
(1) in section 1501 (42 U.S.C. 300k)--
(A) in subsection (a)--
(i) in paragraph (2), by striking ``the
provision of appropriate follow-up services and
support services such as case management'' and
inserting ``that appropriate follow-up services
are provided'';
(ii) in paragraph (3), by striking
``programs for the detection and control'' and
inserting ``for the prevention, detection, and
control'';
(iii) in paragraph (4), by striking ``the
detection and control'' and inserting ``the
prevention, detection, and control'';
(iv) in paragraph (5)--
(I) by striking ``monitor'' and
inserting ``ensure''; and
(II) by striking ``; and'' and
inserting a semicolon;
(v) by redesignating paragraph (6) as
paragraph (9);
(vi) by inserting after paragraph (5) the
following:
``(6) to enhance appropriate support activities to increase
breast and cervical cancer screenings, such as navigation of
health care services, implementation of evidence-based or
evidence-informed strategies to increase breast and cervical
cancer screening in health care settings, and facilitation of
access to health care settings;
``(7) to reduce disparities in breast and cervical cancer
incidence, morbidity, and mortality, including in populations
with higher than average rates;
``(8) to improve access to breast and cervical cancer
screening and diagnostic services and reduce related barriers,
including factors that relate to negative health outcomes;
and''; and
(vii) in paragraph (9), as so redesignated,
by striking ``through (5)'' and inserting
``through (8)''; and
(B) by striking subsection (d);
(2) in section 1503 (42 U.S.C. 300m)--
(A) in subsection (a)--
(i) in paragraph (1), by striking ``that,
initially'' and all that follows through the
semicolon and inserting ``that appropriate
breast and cervical cancer screening and
diagnostic services are provided consistent
with relevant evidence-based recommendations;
and'';
(ii) by striking paragraphs (2) and (4);
(iii) by redesignating paragraph (3) as
paragraph (2); and
(iv) in paragraph (2), as so redesignated,
by striking ``; and'' and inserting a period;
and
(B) by striking subsection (d);
(3) in section 1508(b) (42 U.S.C. 300n-4(b))--
(A) by striking ``1 year after the date of the
enactment of the National Breast and Cervical Cancer
Early Detection Program Reauthorization of 2007, and
annually thereafter,'' and inserting ``2 years after
the date of enactment of the Bipartisan Health Care
Act, and every 5 years thereafter,'';
(B) by striking ``Labor and Human Resources'' and
inserting ``Health, Education, Labor, and Pensions'';
and
(C) by striking ``preceding fiscal year'' and
inserting ``preceding 2 fiscal years in the case of the
first report after the date of enactment of the
Bipartisan Health Care Act and preceding 5 fiscal years
for each report thereafter''; and
(4) in section 1510(a) (42 U.S.C. 300n-5(a))--
(A) by striking ``2011, and'' and inserting
``2011,''; and
(B) by inserting ``, and $235,500,000 for each of
fiscal years 2025 through 2029'' before the period at
the end before the period at the end.
(b) GAO Study.--Not later than September 30, 2027, the Comptroller
General of the United States shall report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives on the work of the
National Breast and Cervical Cancer Early Detection Program,
including--
(1) an estimate of the number of individuals eligible for
services provided under such program;
(2) a summary of trends in the number of individuals served
through such program; and
(3) an assessment of any factors that may be driving the
trends identified under paragraph (2), including any barriers
to accessing breast and cervical cancer screenings provided by
such program.
SEC. 709. DEONDRA DIXON INCLUDE PROJECT.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.) is amended by adding at the end the following:
``SEC. 409K. DOWN SYNDROME RESEARCH.
``(a) In General.--The Director of NIH shall carry out a program of
research, training, and investigation related to Down syndrome to be
known as the `INvestigation of Co-occurring conditions across the
Lifespan to Understand Down syndromE Project' or the `INCLUDE Project'.
``(b) Program Elements.--The program under subsection (a) shall
include--
``(1) high-risk, high reward research on the effects of
trisomy 21 on human development and health;
``(2) promoting research for participants with Down
syndrome across the lifespan, including cohort studies to
facilitate improved understanding of Down syndrome and co-
occurring conditions and development of new interventions;
``(3) expanding the number of clinical trials that are
inclusive of, or expressly for, participants with Down
syndrome, including novel biomedical and pharmacological
interventions and other therapies designed to promote or
enhance activities of daily living;
``(4) research on the biological mechanisms in individuals
with Down syndrome pertaining to structural, functional, and
behavioral anomalies and dysfunction as well as stunted growth;
``(5) supporting research to improve diagnosis and
treatment of conditions co-occurring with Down syndrome,
including the identification of biomarkers related to risk
factors, diagnosis, and clinical research and therapeutics;
``(6) research on the causes of increased prevalence, and
concurrent treatment, of co-occurring conditions, such as
Alzheimer's disease and related dementias and autoimmunity, in
individuals with Down syndrome; and
``(7) research, training, and investigation on improving
the quality of life of individuals with Down syndrome and their
families.
``(c) Coordination; Prioritizing Nonduplicative Research.--The
Director of NIH shall ensure that--
``(1) the programs and activities of the institutes and
centers of the National Institutes of Health relating to Down
syndrome and co-occurring conditions are coordinated, including
through the Office of the Director of NIH and priority-setting
reviews conducted pursuant to section 402(b)(3); and
``(2) such institutes and centers, prioritize, as
appropriate, Down syndrome research that does not duplicate
existing research activities of the National Institutes of
Health.
``(d) Consultation With Stakeholders.--In carrying out activities
under this section, the Director of NIH shall, as appropriate and to
the maximum extent feasible, consult with relevant stakeholders,
including patient advocates, to ensure that such activities take into
consideration the needs of individuals with Down syndrome.
``(e) Biennial Reports to Congress.--
``(1) In general.--The Director of NIH shall submit, on a
biennial basis, to the Committee on Energy and Commerce and the
Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies of the Committee on Appropriations of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions and the Subcommittee on Labor,
Health and Human Services, Education, and Related Agencies of
the Committee on Appropriations of the Senate, a report that
catalogs the research conducted or supported under this
section.
``(2) Contents.--Each report under paragraph (1) shall
include--
``(A) identification of the institute or center
involved;
``(B) a statement of whether the research is or was
being carried out directly by such institute or center
or by multiple institutes and centers; and
``(C) identification of any resulting real-world
evidence that is or may be used for clinical research
and medical care for patients with Down syndrome.''.
SEC. 710. IMPROVE INITIATIVE.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.), as amended by section 710, is further amended by adding at
the end the following:
``SEC. 409L. IMPROVE INITIATIVE.
``(a) In General.--The Director of the National Institutes of
Health shall carry out a program of research to improve health outcomes
to be known as the Implementing a Maternal health and PRegnancy
Outcomes Vision for Everyone Initiative (referred to in this section as
the `Initiative').
``(b) Objectives.--The Initiative shall--
``(1) advance research to--
``(A) reduce preventable causes of maternal
mortality and severe maternal morbidity;
``(B) reduce health disparities related to maternal
health outcomes, including such disparities associated
with medically underserved populations; and
``(C) improve health for pregnant and postpartum
women before, during, and after pregnancy;
``(2) use an integrated approach to understand the factors,
including biological, behavioral, and other factors, that
affect maternal mortality and severe maternal morbidity by
building an evidence base for improved outcomes in specific
regions of the United States; and
``(3) target health disparities associated with maternal
mortality and severe maternal morbidity by--
``(A) implementing and evaluating community-based
interventions for disproportionately affected women;
and
``(B) identifying risk factors and the underlying
biological mechanisms associated with leading causes of
maternal mortality and severe maternal morbidity in the
United States.
``(c) Sunset.--The authority under this section shall expire on
September 30, 2029.''.
SEC. 711. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.
Section 372 of the Public Health Service Act (42 U.S.C. 274) is
amended--
(1) in subsection (b)(2)--
(A) by moving the margins of subparagraphs (M)
through (O) 2 ems to the left;
(B) in subparagraph (A)--
(i) in clause (i), by striking ``, and''
and inserting ``; and''; and
(ii) in clause (ii), by striking the comma
at the end and inserting a semicolon;
(C) in subparagraph (C), by striking ``twenty-four-
hour telephone service'' and inserting ``24-hour
telephone or information technology service'';
(D) in each of subparagraphs (B) through (M), by
striking the comma at the end and inserting a
semicolon;
(E) in subparagraph (N), by striking
``transportation, and'' and inserting
``transportation;'';
(F) in subparagraph (O), by striking the period and
inserting a semicolon; and
(G) by adding at the end the following:
``(P) encourage the integration of electronic health
records systems through application programming interfaces (or
successor technologies) among hospitals, organ procurement
organizations, and transplant centers, including the use of
automated electronic hospital referrals and the grant of
remote, electronic access to hospital electronic health records
of potential donors by organ procurement organizations, in a
manner that complies with the privacy regulations promulgated
under the Health Insurance Portability and Accountability Act
of 1996, at part 160 of title 45, Code of Federal Regulations,
and subparts A, C, and E of part 164 of such title (or any
successor regulations); and
``(Q) consider establishing a dashboard to display the
number of transplants performed, the types of transplants
performed, the number and types of organs that entered the
Organ Procurement and Transplantation Network system and failed
to be transplanted, and other appropriate statistics, which
should be updated more frequently than annually.''; and
(2) by adding at the end the following:
``(d) Registration Fees.--
``(1) In general.--The Secretary may collect registration
fees from any member of the Organ Procurement and
Transplantation Network for each transplant candidate such
member places on the list described in subsection (b)(2)(A)(i).
Such registration fees shall be collected and distributed only
to support the operation of the Organ Procurement and
Transplantation Network. Such registration fees are authorized
to remain available until expended.
``(2) Collection.--The Secretary may collect the
registration fees under paragraph (1) directly or through
awards made under subsection (b)(1)(A).
``(3) Distribution.--Any amounts collected under this
subsection shall--
``(A) be credited to the currently applicable
appropriation, account, or fund of the Department of
Health and Human Services as discretionary offsetting
collections; and
``(B) be available, only to the extent and in the
amounts provided in advance in appropriations Acts, to
distribute such fees among awardees described in
subsection (b)(1)(A).
``(4) Transparency.--The Secretary shall--
``(A) promptly post on the website of the Organ
Procurement and Transplantation Network--
``(i) the amount of registration fees
collected under this subsection from each
member of the Organ Procurement and
Transplantation Network; and
``(ii) a list of activities such fees are
used to support; and
``(B) update the information posted pursuant to
subparagraph (A), as applicable for each calendar
quarter for which fees are collected under paragraph
(1).
``(5) GAO review.--Not later than 2 years after the date of
enactment of this subsection, the Comptroller General of the
United States shall, to the extent data are available--
``(A) conduct a review concerning the activities
under this subsection; and
``(B) submit to the Committee on Health, Education,
Labor, and Pensions and the Committee on Finance of the
Senate and the Committee on Energy and Commerce of the
House of Representatives, a report on such review,
including related recommendations, as applicable.
``(6) Sunset.--The authority to collect registration fees
under paragraph (1) shall expire on the date that is 3 years
after the date of enactment of the Bipartisan Health Care
Act.''.
SEC. 712. HONOR OUR LIVING DONORS.
(a) No Consideration of Income of Organ Recipient.--Section 377 of
the Public Health Service Act (42 U.S.C. 274f) is amended--
(1) by redesignating subsections (c) through (f) as
subsections (d) through (g), respectively;
(2) by inserting after subsection (b) the following:
``(c) No Consideration of Income of Organ Recipient.--The recipient
of a grant under this section, in providing reimbursement to a donating
individual through such grant, shall not give any consideration to the
income of the organ recipient.''; and
(3) in subsection (f), as so redesignated--
(A) in paragraph (1), by striking ``subsection
(c)(1)'' and inserting ``subsection (d)(1)''; and
(B) in paragraph (2), by striking ``subsection
(c)(2)'' and inserting ``subsection (d)(2)''.
(b) Removal of Expectation of Payments by Organ Recipients.--
Section 377(e) of the Public Health Service Act (42 U.S.C. 274f(e)), as
redesignated by subsection (a)(1), is amended--
(1) in paragraph (1), by adding ``or'' at the end;
(2) in paragraph (2), by striking ``; or'' and inserting a
period; and
(3) by striking paragraph (3).
(c) Annual Report.--Section 377 of the Public Health Service Act
(42 U.S.C. 274f), as amended by subsections (a) and (b), is amended by
adding at the end the following:
``(h) Annual Report.--Not later than December 31 of each year,
beginning in fiscal year 2026, the Secretary shall--
``(1) prepare, submit to the Congress, and make public a
report on whether grants under this section provided adequate
funding during the preceding fiscal year to reimburse all
donating individuals participating in the grant program under
this section for all qualifying expenses; and
``(2) include in each such report--
``(A) the estimated number of all donating
individuals participating in the grant program under
this section who did not receive reimbursement for all
qualifying expenses during the preceding fiscal year;
and
``(B) the total amount of funding that is estimated
to be necessary to fully reimburse all donating
individuals participating in the grant program under
this section for all qualifying expenses.''.
SEC. 713. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.
284m(d)(1)) is amended by striking ``section,'' and all that follows
through the period at the end and inserting ``section, $25,000,000 for
each of fiscal years 2025 through 2027.''.
TITLE VIII--FOOD AND DRUG ADMINISTRATION
Subtitle A--Give Kids a Chance
SEC. 801. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES
OF FOOD AND DRUG ADMINISTRATION REGARDING MOLECULARLY
TARGETED CANCER DRUGS.
(a) In General.--
(1) Additional active ingredient for application drug;
limitation regarding novel-combination application drug.--
Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c(a)(3)) is amended--
(A) by redesignating subparagraphs (B) and (C) as
subparagraphs (C) and (D), respectively; and
(B) by striking subparagraph (A) and inserting the
following:
``(A) In general.--For purposes of paragraph
(1)(B), the investigation described in this paragraph
is a molecularly targeted pediatric cancer
investigation of--
``(i) the drug or biological product for
which the application referred to in such
paragraph is submitted; or
``(ii) such drug or biological product used
in combination with--
``(I) an active ingredient of a
drug or biological product--
``(aa) for which an
approved application under
section 505(j) under this Act
or under section 351(k) of the
Public Health Service Act is in
effect; and
``(bb) that is determined
by the Secretary, after
consultation with the
applicant, to be part of the
standard of care for treating a
pediatric cancer; or
``(II) an active ingredient of a
drug or biological product--
``(aa) for which an
approved application under
section 505(b) of this Act or
section 351(a) of the Public
Health Service Act to treat an
adult cancer is in effect and
is held by the same person
submitting the application
under paragraph (1)(B); and
``(bb) that is directed at
a molecular target that the
Secretary determines to be
substantially relevant to the
growth or progression of a
pediatric cancer.
``(B) Additional requirements.--
``(i) Design of investigation.--A
molecularly targeted pediatric cancer
investigation referred to in subparagraph (A)
shall be designed to yield clinically
meaningful pediatric study data that is
gathered using appropriate formulations for
each age group for which the study is required,
regarding dosing, safety, and preliminary
efficacy to inform potential pediatric
labeling.
``(ii) Limitation.--An investigation
described in subparagraph (A)(ii) may be
required only if the drug or biological product
for which the application referred to in
paragraph (1)(B) contains either--
``(I) a single new active
ingredient; or
``(II) more than one active
ingredient, if an application for the
combination of active ingredients has
not previously been approved but each
active ingredient is in a drug product
that has been previously approved to
treat an adult cancer.
``(iii) Results of already-completed
preclinical studies of application drug.--With
respect to an investigation required pursuant
to paragraph (1)(B), the Secretary may require
the results of any completed preclinical
studies relevant to the initial pediatric study
plan be submitted to the Secretary at the same
time that the initial pediatric study plan
required under subsection (e)(1) is submitted.
``(iv) Rule of construction regarding
inactive ingredients.--With respect to a
combination of active ingredients referred to
in subparagraph (A)(ii), such subparagraph
shall not be construed as addressing the use of
inactive ingredients with such combination.''.
(2) Determination of applicable requirements.--Section
505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c(e)(1)) is amended by adding at the end the
following: ``The Secretary shall determine whether subparagraph
(A) or (B) of subsection (a)(1) applies with respect to an
application before the date on which the applicant is required
to submit the initial pediatric study plan under paragraph
(2)(A).''.
(3) Clarifying applicability.--Section 505B(a)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is
amended by adding at the end the following:
``(C) Rule of construction.--No application that is
subject to the requirements of subparagraph (B) shall
be subject to the requirements of subparagraph (A), and
no application (or supplement to an application) that
is subject to the requirements of subparagraph (A)
shall be subject to the requirements of subparagraph
(B).''.
(4) Conforming amendments.--Section 505B(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
(A) in paragraph (3)(C), as redesignated by
paragraph (1)(A) of this subsection, by striking
``investigations described in this paragraph'' and
inserting ``investigations referred to in subparagraph
(A)''; and
(B) in paragraph (3)(D), as redesignated by
paragraph (1)(A) of this subsection, by striking ``the
assessments under paragraph (2)(B)'' and inserting
``the assessments required under paragraph (1)(A)''.
(b) Guidance.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall--
(1) not later than 12 months after the date of enactment of
this Act, issue draft guidance on the implementation of the
amendments made by subsection (a); and
(2) not later than 12 months after closing the comment
period on such draft guidance, finalize such guidance.
(c) Applicability.--The amendments made by this section apply with
respect to any application under section 505(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)) and any application under
section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)),
that is submitted on or after the date that is 3 years after the date
of enactment of this Act.
(d) Reports to Congress.--
(1) Secretary of health and human services.--Not later than
6 years after the date of 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 the Secretary's efforts, in coordination
with industry, to ensure implementation of the amendments made
by subsection (a).
(2) GAO study and report.--
(A) Study.--Not later than 8 years after the date
of enactment of this Act, the Comptroller General of
the United States shall conduct a study of the
effectiveness of requiring assessments and
investigations described in section 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.355c), as
amended by subsection (a), in the development of drugs
and biological products for pediatric cancer
indications, including consideration of any benefits
to, or burdens on, pediatric cancer drug development.
(B) Findings.--Not later than 10 years after the
date of enactment of this Act, the Comptroller General
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 containing the findings of the study conducted
under subparagraph (A).
SEC. 802. ENSURING COMPLETION OF PEDIATRIC STUDY REQUIREMENTS.
(a) Equal Accountability for Pediatric Study Requirements.--Section
505B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d))
is amended--
(1) in paragraph (1), by striking ``Beginning 270'' and
inserting ``Noncompliance letter.--Beginning 270'';
(2) in paragraph (2)--
(A) by striking ``The drug or'' and inserting
``Effect of noncompliance.--The drug or''; and
(B) by striking ``(except that the drug or
biological product shall not be subject to action under
section 303)'' and inserting ``(except that the drug or
biological product shall be subject to action under
section 303 only if such person demonstrated a lack of
due diligence in satisfying the applicable
requirement)''; and
(3) by adding at the end the following:
``(3) Limitation.--The Secretary shall not issue
enforcement actions under section 303 for failures under this
subsection in the case of a drug or biological product that is
no longer marketed.''.
(b) Due Diligence.--Section 505B(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c(d)), as amended by subsection (a), is
further amended by adding at the end the following:
``(4) Due diligence.--Before the Secretary may conclude
that a person failed to submit or otherwise meet a requirement
as described in the matter preceding paragraph (1), the
Secretary shall--
``(A) issue a noncompliance letter pursuant to
paragraph (1);
``(B) provide such person with a 45-day period
beginning on the date of receipt of such noncompliance
letter to respond in writing as set forth in such
paragraph; and
``(C) after reviewing such written response,
determine whether the person demonstrated a lack of due
diligence in satisfying such requirement.''.
(c) Conforming Amendments.--Section 303(f)(4)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(4)(A)) is amended by
striking ``or 505-1'' and inserting ``505-1, or 505B''.
(d) Transition Rule.--The Secretary of Health and Human Services
may take enforcement action under section 303 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333) only for failures described in
section 505B(d) of such Act (21 U.S.C. 355c(d)) that occur on or after
the date that is 180 days after the date of enactment of this Act.
SEC. 803. FDA REPORT ON PREA ENFORCEMENT.
Section 508(b) of the Food and Drug Administration Safety and
Innovation Act (21 U.S.C. 355c-1(b)) is amended--
(1) in paragraph (11), by striking the semicolon at the end
and inserting ``, including an evaluation of compliance with
deadlines provided for in deferrals and deferral extensions;'';
(2) in paragraph (15), by striking ``and'' at the end;
(3) in paragraph (16), by striking the period at the end
and inserting ``; and''; and
(4) by adding at the end the following:
``(17) a listing of penalties, settlements, or payments
under section 303 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353) for failure to comply with requirements under
such section 505B, including, for each penalty, settlement, or
payment, the name of the drug, the sponsor thereof, and the
amount of the penalty, settlement, or payment imposed; and''.
SEC. 804. EXTENSION OF AUTHORITY TO ISSUE PRIORITY REVIEW VOUCHERS TO
ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES.
(a) Extension.--Paragraph (5) of section 529(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by
striking ``December 20, 2024, unless'' and all that follows through the
period at the end and inserting ``September 30, 2029.''.
(b) User Fee Payment.--Section 529(c)(4) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360ff(c)(4)) is amended by striking
subparagraph (A) and inserting the following:
``(A) In general.--The priority review user fee
required by this subsection shall be due upon the
submission of a human drug application under section
505(b)(1) or section 351(a) of the Public Health
Service Act for which the priority review voucher is
used. All other user fees associated with the human
drug application shall be due as required by the
Secretary or under applicable law.''.
(c) GAO Report on Effectiveness of Rare Pediatric Disease Priority
Voucher Awards in Incentivizing Rare Pediatric Disease Drug
Development.--
(1) GAO study.--
(A) Study.--The Comptroller General of the United
States shall conduct a study of the effectiveness of
awarding rare pediatric disease priority vouchers under
section 529 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360ff), as amended by subsection (a), in the
development of human drug products that treat or
prevent rare pediatric diseases (as defined in such
section 529).
(B) Contents of study.--In conducting the study
under subparagraph (A), the Comptroller General shall
examine the following:
(i) The indications for each drug or
biological product that--
(I) is the subject of a rare
pediatric disease product application
(as defined in section 529 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360ff)) for which a priority
review voucher was awarded; and
(II) was approved under section 505
of the Federal Food, Drug, and Cosmetic
Act (42 U.S.C. 355) or licensed under
section 351 of the Public Health
Service Act (42 U.S.C. 262).
(ii) Whether, and to what extent, an unmet
need related to the treatment or prevention of
a rare pediatric disease was met through the
approval or licensure of such a drug or
biological product.
(iii) The size of the company to which a
priority review voucher was awarded under
section 529 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360ff) for such a drug
or biological product.
(iv) The value of such priority review
voucher if transferred.
(v) Identification of each drug for which a
priority review voucher awarded under such
section 529 was used.
(vi) The size of the company using each
priority review voucher awarded under such
section 529.
(vii) The length of the period of time
between the date on which a priority review
voucher was awarded under such section 529 and
the date on which it was used.
(viii) Whether, and to what extent, an
unmet need related to the treatment or
prevention of a rare pediatric disease was met
through the approval under section 505 of the
Federal Food, Drug, and Cosmetic Act (42 U.S.C.
355) or licensure under section 351 of the
Public Health Service Act (42 U.S.C. 262) of a
drug for which a priority review voucher was
used.
(ix) Whether, and to what extent, companies
were motivated by the availability of priority
review vouchers under section 529 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360ff) to attempt to develop a drug for a rare
pediatric disease.
(x) Whether, and to what extent, pediatric
review vouchers awarded under such section were
successful in stimulating development and
expedited patient access to drug products for
treatment or prevention of a rare pediatric
disease that wouldn't otherwise take place
without the incentive provided by such
vouchers.
(xi) The impact of such priority review
vouchers on the workload, review process, and
public health prioritization efforts of the
Food and Drug Administration.
(xii) Any other incentives in Federal law
that exist for companies developing drugs or
biological products described in clause (i).
(2) Report on findings.--Not later than 5 years after the
date of the enactment of this Act, the Comptroller General of
the United States 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
containing the findings of the study conducted under paragraph
(1).
SEC. 805. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICENSURE OF ORPHAN
DRUGS.
(a) In General.--Section 527 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360cc) is amended--
(1) in subsection (a), in the matter following paragraph
(2), by striking ``same disease or condition'' and inserting
``same approved use or indication within such rare disease or
condition'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``same rare disease or condition'' and
inserting ``same approved use or indication for which
such 7-year period applies to such already approved or
licensed drug''; and
(B) in paragraph (1), by inserting ``, relating to
the approved use or indication,'' after ``the needs'';
(3) in subsection (c)(1), by striking ``same rare disease
or condition as the already approved drug'' and inserting
``same use or indication for which the already approved or
licensed drug was approved or licensed''; and
(4) by adding at the end the following:
``(f) Approved Use or Indication Defined.--In this section, the
term `approved use or indication' means the use or indication approved
under section 505 of this Act or licensed under section 351 of the
Public Health Service Act for a drug designated under section 526 for a
rare disease or condition.''.
(b) Application of Amendments.--The amendments made by subsection
(a) shall apply with respect to any drug designated under section 526
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb),
regardless of the date on which the drug was so designated, and
regardless of the date on which the drug was approved under section 505
of such Act (21 U.S.C. 355) or licensed under section 351 of the Public
Health Service Act (42 U.S.C. 262).
Subtitle B--United States-Abraham Accords Cooperation and Security
SEC. 811. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE WITHIN FOOD AND DRUG
ADMINISTRATION.
(a) In General.--Chapter X of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 391 et seq.) is amended by adding at the end the
following:
``SEC. 1015. ABRAHAM ACCORDS OFFICE.
``(a) In General.--The Secretary, acting through the Commissioner
of Food and Drugs, shall establish within the Food and Drug
Administration an office, to be known as the Abraham Accords Office, to
be headed by a director.
``(b) Office.--Not later than 2 years after the date of enactment
of this section, the Secretary shall--
``(1) in consultation with the governments of Abraham
Accords countries, as well as appropriate United States
Government diplomatic and security personnel--
``(A) select the location of the Abraham Accords
Office in an Abraham Accords country; and
``(B) establish such office; and
``(2) assign to such office such personnel of the Food and
Drug Administration as the Secretary determines necessary to
carry out the functions of such office.
``(c) Duties.--The Secretary, acting through the Director of the
Abraham Accords Office, shall--
``(1) after the Abraham Accords Office is established--
``(A) as part of the Food and Drug Administration's
work to strengthen the international oversight of
regulated commodities, provide technical assistance to
regulatory partners in Abraham Accords countries on
strengthening regulatory oversight and converging
regulatory requirements for the oversight of regulated
products, including good manufacturing practices and
other issues relevant to manufacturing medical products
that are regulated by the Food and Drug Administration;
and
``(B) facilitate interactions between the Food and
Drug Administration and interested parties in Abraham
Accords countries, including by sharing relevant
information regarding United States regulatory pathways
with such parties, and facilitate feedback on the
research, development, and manufacturing of products
regulated in accordance with this Act; and
``(2) carry out other functions and activities as the
Secretary determines to be necessary to carry out this section.
``(d) Abraham Accords Country Defined.--In this section, the term
`Abraham Accords country' means a country identified by the Department
of State as having signed the Abraham Accords Declaration.
``(e) National Security.--Nothing in this section shall be
construed to require any action inconsistent with a national security
recommendation provided by the Federal Government.''.
(b) Report to Congress.--
(1) In general.--Not later than 3 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit to the Congress a report on the Abraham
Accords Office, including--
(A) an evaluation of how the Office has advanced
progress toward conformance with Food and Drug
Administration regulatory requirements by manufacturers
in the Abraham Accords countries;
(B) a numerical count of parties that the Office
has helped facilitate interactions or feedback pursuant
to section 1015(c)(1)(B) of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a));
(C) a summary of technical assistance provided to
regulatory partners in Abraham Accords countries
pursuant to subparagraph (A) of such section
1015(c)(1); and
(D) recommendations for increasing and improving
coordination between the Food and Drug Administration
and entities in Abraham Accords countries.
(2) Abraham accords country defined.--In this subsection,
the term ``Abraham Accords country'' has the meaning given such
term in section 1015(d) of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)).
TITLE IX--LOWERING PRESCRIPTION DRUG COSTS
SEC. 901. OVERSIGHT OF PHARMACY BENEFIT MANAGEMENT SERVICES.
(a) Public Health Service Act.--Title XXVII of the Public Health
Service Act (42 U.S.C. 300gg et seq.) is amended--
(1) in part D (42 U.S.C. 300gg-111 et seq.), by adding at
the end the following new section:
``SEC. 2799A-11. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT
MANAGEMENT SERVICES.
``(a) In General.--For plan years beginning on or after the date
that is 30 months after the date of enactment of this section (referred
to in this subsection and subsection (b) as the `effective date'), a
group health plan or a health insurance issuer offering group health
insurance coverage, or an entity providing pharmacy benefit management
services on behalf of such a plan or issuer, shall not enter into a
contract, including an extension or renewal of a contract, entered into
on or after the effective date, with an applicable entity unless such
applicable entity agrees to--
``(1) not limit or delay the disclosure of information to
the group health plan (including such a plan offered through a
health insurance issuer) in such a manner that prevents an
entity providing pharmacy benefit management services on behalf
of a group health plan or health insurance issuer offering
group health insurance coverage from making the reports
described in subsection (b); and
``(2) provide the entity providing pharmacy benefit
management services on behalf of a group health plan or health
insurance issuer relevant information necessary to make the
reports described in subsection (b).
``(b) Reports.--
``(1) In general.--For plan years beginning on or after the
effective date, in the case of any contract between a group
health plan or a health insurance issuer offering group health
insurance coverage offered in connection with such a plan and
an entity providing pharmacy benefit management services on
behalf of such plan or issuer, including an extension or
renewal of such a contract, entered into on or after the
effective date, the entity providing pharmacy benefit
management services on behalf of such a group health plan or
health insurance issuer, not less frequently than every 6
months (or, at the request of a group health plan, not less
frequently than quarterly, and under the same conditions,
terms, and cost of the semiannual report under this
subsection), shall submit to the group health plan a report in
accordance with this section. Each such report shall be made
available to such group health plan in plain language, in a
machine-readable format, and as the Secretary may determine,
other formats. Each such report shall include the information
described in paragraph (2).
``(2) Information described.--For purposes of paragraph
(1), the information described in this paragraph is, with
respect to drugs covered by a group health plan or group health
insurance coverage offered by a health insurance issuer in
connection with a group health plan during each reporting
period--
``(A) in the case of a group health plan that is
offered by a specified large employer or that is a
specified large plan, and is not offered as health
insurance coverage, or in the case of health insurance
coverage for which the election under paragraph (3) is
made for the applicable reporting period--
``(i) a list of drugs for which a claim was
filed and, with respect to each such drug on
such list--
``(I) the contracted compensation
paid by the group health plan or health
insurance issuer for each covered drug
(identified by the National Drug Code)
to the entity providing pharmacy
benefit management services or other
applicable entity on behalf of the
group health plan or health insurance
issuer;
``(II) the contracted compensation
paid to the pharmacy, by any entity
providing pharmacy benefit management
services or other applicable entity on
behalf of the group health plan or
health insurance issuer, for each
covered drug (identified by the
National Drug Code);
``(III) for each such claim, the
difference between the amount paid
under subclause (I) and the amount paid
under subclause (II);
``(IV) the proprietary name,
established name or proper name, and
the National Drug Code;
``(V) for each claim for the drug
(including original prescriptions and
refills) and for each dosage unit of
the drug for which a claim was filed,
the type of dispensing channel used to
furnish the drug, including retail,
mail order, or specialty pharmacy;
``(VI) with respect to each drug
dispensed, for each type of dispensing
channel (including retail, mail order,
or specialty pharmacy)--
``(aa) whether such drug is
a brand name drug or a generic
drug, and--
``(AA) in the case
of a brand name drug,
the wholesale
acquisition cost,
listed as cost per days
supply and cost per
dosage unit, on the
date such drug was
dispensed; and
``(BB) in the case
of a generic drug, the
average wholesale
price, listed as cost
per days supply and
cost per dosage unit,
on the date such drug
was dispensed; and
``(bb) the total number
of--
``(AA) prescription
claims (including
original prescriptions
and refills);
``(BB) participants
and beneficiaries for
whom a claim for such
drug was filed through
the applicable
dispensing channel;
``(CC) dosage units
and dosage units per
fill of such drug; and
``(DD) days supply
of such drug per fill;
``(VII) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply to the plan
or coverage after rebates, fees,
alternative discounts, or other
remuneration received from applicable
entities;
``(VIII) the total amount of out-
of-pocket spending by participants and
beneficiaries on such drug, including
spending through copayments,
coinsurance, and deductibles, but not
including any amounts spent by
participants and beneficiaries on drugs
not covered under the plan or coverage,
or for which no claim is submitted
under the plan or coverage;
``(IX) the total net spending on
the drug;
``(X) the total amount received, or
expected to be received, by the plan or
issuer from any applicable entity in
rebates, fees, alternative discounts,
or other remuneration;
``(XI) the total amount received,
or expected to be received, by the
entity providing pharmacy benefit
management services, from applicable
entities, in rebates, fees, alternative
discounts, or other remuneration from
such entities--
``(aa) for claims incurred
during the reporting period;
and
``(bb) that is related to
utilization of such drug or
spending on such drug; and
``(XII) to the extent feasible,
information on the total amount of
remuneration for such drug, including
copayment assistance dollars paid,
copayment cards applied, or other
discounts provided by each drug
manufacturer (or entity administering
copayment assistance on behalf of such
drug manufacturer), to the participants
and beneficiaries enrolled in such plan
or coverage;
``(ii) a list of each therapeutic class (as
defined by the Secretary) for which a claim was
filed under the group health plan or health
insurance coverage during the reporting period,
and, with respect to each such therapeutic
class--
``(I) the total gross spending on
drugs in such class before rebates,
price concessions, alternative
discounts, or other remuneration from
applicable entities;
``(II) the net spending in such
class after such rebates, price
concessions, alternative discounts, or
other remuneration from applicable
entities;
``(III) the total amount received,
or expected to be received, by the
entity providing pharmacy benefit
management services, from applicable
entities, in rebates, fees, alternative
discounts, or other remuneration from
such entities--
``(aa) for claims incurred
during the reporting period;
and
``(bb) that is related to
utilization of drugs or drug
spending;
``(IV) the average net spending per
30-day supply and per 90-day supply by
the plan or by the issuer with respect
to such coverage and its participants
and beneficiaries, among all drugs
within the therapeutic class for which
a claim was filed during the reporting
period;
``(V) the number of participants
and beneficiaries who filled a
prescription for a drug in such class,
including the National Drug Code for
each such drug;
``(VI) if applicable, a description
of the formulary tiers and utilization
mechanisms (such as prior authorization
or step therapy) employed for drugs in
that class; and
``(VII) the total out-of-pocket
spending under the plan or coverage by
participants and beneficiaries,
including spending through copayments,
coinsurance, and deductibles, but not
including any amounts spent by
participants and beneficiaries on drugs
not covered under the plan or coverage
or for which no claim is submitted
under the plan or coverage;
``(iii) with respect to any drug for which
gross spending under the group health plan or
health insurance coverage exceeded $10,000
during the reporting period or, in the case
that gross spending under the group health plan
or coverage exceeded $10,000 during the
reporting period with respect to fewer than 50
drugs, with respect to the 50 prescription
drugs with the highest spending during the
reporting period--
``(I) a list of all other drugs in
the same therapeutic class as such
drug;
``(II) if applicable, the rationale
for the formulary placement of such
drug in that therapeutic category or
class, selected from a list of standard
rationales established by the
Secretary, in consultation with
stakeholders; and
``(III) any change in formulary
placement compared to the prior plan
year; and
``(iv) in the case that such plan or issuer
(or an entity providing pharmacy benefit
management services on behalf of such plan or
issuer) has an affiliated pharmacy or pharmacy
under common ownership, including mandatory
mail and specialty home delivery programs,
retail and mail auto-refill programs, and cost
sharing assistance incentives funded by an
entity providing pharmacy benefit services--
``(I) an explanation of any benefit
design parameters that encourage or
require participants and beneficiaries
in the plan or coverage to fill
prescriptions at mail order, specialty,
or retail pharmacies;
``(II) the percentage of total
prescriptions dispensed by such
pharmacies to participants or
beneficiaries in such plan or coverage;
and
``(III) a list of all drugs
dispensed by such pharmacies to
participants or beneficiaries enrolled
in such plan or coverage, and, with
respect to each drug dispensed--
``(aa) the amount charged,
per dosage unit, per 30-day
supply, or per 90-day supply
(as applicable) to the plan or
issuer, and to participants and
beneficiaries;
``(bb) the median amount
charged to such plan or issuer,
and the interquartile range of
the costs, per dosage unit, per
30-day supply, and per 90-day
supply, including amounts paid
by the participants and
beneficiaries, when the same
drug is dispensed by other
pharmacies that are not
affiliated with or under common
ownership with the entity and
that are included in the
pharmacy network of such plan
or coverage;
``(cc) the lowest cost per
dosage unit, per 30-day supply
and per 90-day supply, for each
such drug, including amounts
charged to the plan or coverage
and to participants and
beneficiaries, that is
available from any pharmacy
included in the network of such
plan or coverage; and
``(dd) the net acquisition
cost per dosage unit, per 30-
day supply, and per 90-day
supply, if such drug is subject
to a maximum price discount;
and
``(B) with respect to any group health plan,
including group health insurance coverage offered in
connection with such a plan, regardless of whether the
plan or coverage is offered by a specified large
employer or whether it is a specified large plan--
``(i) a summary document for the group
health plan that includes such information
described in clauses (i) through (iv) of
subparagraph (A), as specified by the Secretary
through guidance, program instruction, or
otherwise (with no requirement of notice and
comment rulemaking), that the Secretary
determines useful to group health plans for
purposes of selecting pharmacy benefit
management services, such as an estimated net
price to group health plan and participant or
beneficiary, a cost per claim, the fee
structure or reimbursement model, and estimated
cost per participant or beneficiary;
``(ii) a summary document for plans and
issuers to provide to participants and
beneficiaries, which shall be made available to
participants or beneficiaries upon request to
their group health plan (including in the case
of group health insurance coverage offered in
connection with such a plan), that--
``(I) contains such information
described in clauses (iii), (iv), (v),
and (vi), as applicable, as specified
by the Secretary through guidance,
program instruction, or otherwise (with
no requirement of notice and comment
rulemaking) that the Secretary
determines useful to participants or
beneficiaries in better understanding
the plan or coverage or benefits under
such plan or coverage;
``(II) contains only aggregate
information; and
``(III) states that participants
and beneficiaries may request specific,
claims-level information required to be
furnished under subsection (c) from the
group health plan or health insurance
issuer; and
``(iii) with respect to drugs covered by
such plan or coverage during such reporting
period--
``(I) the total net spending by the
plan or coverage for all such drugs;
``(II) the total amount received,
or expected to be received, by the plan
or issuer from any applicable entity in
rebates, fees, alternative discounts,
or other remuneration; and
``(III) to the extent feasible,
information on the total amount of
remuneration for such drugs, including
copayment assistance dollars paid,
copayment cards applied, or other
discounts provided by each drug
manufacturer (or entity administering
copayment assistance on behalf of such
drug manufacturer) to participants and
beneficiaries;
``(iv) amounts paid directly or indirectly
in rebates, fees, or any other type of
compensation (as defined in section
408(b)(2)(B)(ii)(dd)(AA) of the Employee
Retirement Income Security Act) to brokerage
firms, brokers, consultants, advisors, or any
other individual or firm, for--
``(I) the referral of the group
health plan's or health insurance
issuer's business to an entity
providing pharmacy benefit management
services, including the identity of the
recipient of such amounts;
``(II) consideration of the entity
providing pharmacy benefit management
services by the group health plan or
health insurance issuer; or
``(III) the retention of the entity
by the group health plan or health
insurance issuer;
``(v) an explanation of any benefit design
parameters that encourage or require
participants and beneficiaries in such plan or
coverage to fill prescriptions at mail order,
specialty, or retail pharmacies that are
affiliated with or under common ownership with
the entity providing pharmacy benefit
management services under such plan or
coverage, including mandatory mail and
specialty home delivery programs, retail and
mail auto-refill programs, and cost-sharing
assistance incentives directly or indirectly
funded by such entity; and
``(vi) total gross spending on all drugs
under the plan or coverage during the reporting
period.
``(3) Opt-in for group health insurance coverage offered by
a specified large employer or that is a specified large plan.--
In the case of group health insurance coverage offered in
connection with a group health plan that is offered by a
specified large employer or is a specified large plan, such
group health plan may, on an annual basis, for plan years
beginning on or after the date that is 30 months after the date
of enactment of this section, elect to require an entity
providing pharmacy benefit management services on behalf of the
health insurance issuer to submit to such group health plan a
report that includes all of the information described in
paragraph (2)(A), in addition to the information described in
paragraph (2)(B).
``(4) Privacy requirements.--
``(A) In general.--An entity providing pharmacy
benefit management services on behalf of a group health
plan or a health insurance issuer offering group health
insurance coverage shall report information under
paragraph (1) in a manner consistent with the privacy
regulations promulgated under section 13402(a) of the
Health Information Technology for Economic and Clinical
Health Act and consistent with the privacy regulations
promulgated under the Health Insurance Portability and
Accountability Act of 1996 in part 160 and subparts A
and E of part 164 of title 45, Code of Federal
Regulations (or successor regulations) (referred to in
this paragraph as the `HIPAA privacy regulations') and
shall restrict the use and disclosure of such
information according to such privacy regulations and
such HIPAA privacy regulations.
``(B) Additional requirements.--
``(i) In general.--An entity providing
pharmacy benefit management services on behalf
of a group health plan or health insurance
issuer offering group health insurance coverage
that submits a report under paragraph (1) shall
ensure that such report contains only summary
health information, as defined in section
164.504(a) of title 45, Code of Federal
Regulations (or successor regulations).
``(ii) Restrictions.--In carrying out this
subsection, a group health plan shall comply
with section 164.504(f) of title 45, Code of
Federal Regulations (or a successor
regulation), and a plan sponsor shall act in
accordance with the terms of the agreement
described in such section.
``(C) Rule of construction.--
``(i) Nothing in this section shall be
construed to modify the requirements for the
creation, receipt, maintenance, or transmission
of protected health information under the HIPAA
privacy regulations.
``(ii) Nothing in this section shall be
construed to affect the application of any
Federal or State privacy or civil rights law,
including the HIPAA privacy regulations, the
Genetic Information Nondiscrimination Act of
2008 (Public Law 110-233) (including the
amendments made by such Act), the Americans
with Disabilities Act of 1990 (42 U.S.C. 12101
et seq.), section 504 of the Rehabilitation Act
of 1973 (29 U.S.C. 794), section 1557 of the
Patient Protection and Affordable Care Act (42
U.S.C. 18116), title VI of the Civil Rights Act
of 1964 (42 U.S.C. 2000d), and title VII of the
Civil Rights Act of 1964 (42 U.S.C. 2000e).
``(D) Written notice.--Each plan year, group health
plans, including with respect to group health insurance
coverage offered in connection with a group health
plan, shall provide to each participant or beneficiary
written notice informing the participant or beneficiary
of the requirement for entities providing pharmacy
benefit management services on behalf of the group
health plan or health insurance issuer offering group
health insurance coverage to submit reports to group
health plans under paragraph (1), as applicable, which
may include incorporating such notification in plan
documents provided to the participant or beneficiary,
or providing individual notification.
``(E) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to the entity from which
the report was received or to that entity's business
associates as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations)
or as permitted by the HIPAA privacy regulations.
``(F) Clarification regarding public disclosure of
information.--Nothing in this section shall prevent an
entity providing pharmacy benefit management services
on behalf of a group health plan or health insurance
issuer offering group health insurance coverage, from
placing reasonable restrictions on the public
disclosure of the information contained in a report
described in paragraph (1), except that such plan,
issuer, or entity may not--
``(i) restrict disclosure of such report to
the Department of Health and Human Services,
the Department of Labor, or the Department of
the Treasury; or
``(ii) prevent disclosure for the purposes
of subsection (c), or any other public
disclosure requirement under this section.
``(G) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required with respect to any group
health plan established by a plan sponsor that is, or
is affiliated with, a drug manufacturer, drug
wholesaler, or other direct participant in the drug
supply chain, in order to prevent anti-competitive
behavior.
``(5) Standard format and regulations.--
``(A) In general.--Not later than 18 months after
the date of enactment of this section, the Secretary
shall specify through rulemaking a standard format for
entities providing pharmacy benefit management services
on behalf of group health plans and health insurance
issuers offering group health insurance coverage, to
submit reports required under paragraph (1).
``(B) Additional regulations.--Not later than 18
months after the date of enactment of this section, the
Secretary shall, through rulemaking, promulgate any
other final regulations necessary to implement the
requirements of this section. In promulgating such
regulations, the Secretary shall, to the extent
practicable, align the reporting requirements under
this section with the reporting requirements under
section 2799A-10.
``(c) Requirement To Provide Information to Participants or
Beneficiaries.--A group health plan, including with respect to group
health insurance coverage offered in connection with a group health
plan, upon request of a participant or beneficiary, shall provide to
such participant or beneficiary--
``(1) the summary document described in subsection
(b)(2)(B)(ii); and
``(2) the information described in subsection
(b)(2)(A)(i)(III) with respect to a claim made by or on behalf
of such participant or beneficiary.
``(d) Enforcement.--
``(1) In general.--The Secretary shall enforce this
section. The enforcement authority under this subsection shall
apply only with respect to group health plans (including group
health insurance coverage offered in connection with such a
plan) to which the requirements of subparts I and II of part A
and part D apply in accordance with section 2722, and with
respect to entities providing pharmacy benefit management
services on behalf of such plans and applicable entities
providing services on behalf of such plans.
``(2) Failure to provide information.--A group health plan,
a health insurance issuer offering group health insurance
coverage, an entity providing pharmacy benefit management
services on behalf of such a plan or issuer, or an applicable
entity providing services on behalf of such a plan or issuer
that violates subsection (a); an entity providing pharmacy
benefit management services on behalf of such a plan or issuer
that fails to provide the information required under subsection
(b); or a group health plan that fails to provide the
information required under subsection (c), shall be subject to
a civil monetary penalty in the amount of $10,000 for each day
during which such violation continues or such information is
not disclosed or reported.
``(3) False information.--A health insurance issuer, an
entity providing pharmacy benefit management services, or a
third party administrator providing services on behalf of such
issuer offered by a health insurance issuer that knowingly
provides false information under this section shall be subject
to a civil monetary penalty in an amount not to exceed $100,000
for each item of false information. Such civil monetary penalty
shall be in addition to other penalties as may be prescribed by
law.
``(4) Procedure.--The provisions of section 1128A of the
Social Security Act, other than subsections (a) and (b) and the
first sentence of subsection (c)(1) of such section shall apply
to civil monetary penalties under this subsection in the same
manner as such provisions apply to a penalty or proceeding
under such section.
``(5) Waivers.--The Secretary may waive penalties under
paragraph (2), or extend the period of time for compliance with
a requirement of this section, for an entity in violation of
this section that has made a good-faith effort to comply with
the requirements in this section.
``(e) Rule of Construction.--Nothing in this section shall be
construed to permit a health insurance issuer, group health plan,
entity providing pharmacy benefit management services on behalf of a
group health plan or health insurance issuer, or other entity to
restrict disclosure to, or otherwise limit the access of, the Secretary
to a report described in subsection (b)(1) or information related to
compliance with subsections (a), (b), (c), or (d) by such issuer, plan,
or entity.
``(f) Definitions.--In this section:
``(1) Applicable entity.--The term `applicable entity'
means--
``(A) an applicable group purchasing organization,
drug manufacturer, distributor, wholesaler, rebate
aggregator (or other purchasing entity designed to
aggregate rebates), or associated third party;
``(B) any subsidiary, parent, affiliate, or
subcontractor of a group health plan, health insurance
issuer, entity that provides pharmacy benefit
management services on behalf of such a plan or issuer,
or any entity described in subparagraph (A); or
``(C) such other entity as the Secretary may
specify through rulemaking.
``(2) Applicable group purchasing organization.--The term
`applicable group purchasing organization' means a group
purchasing organization that is affiliated with or under common
ownership with an entity providing pharmacy benefit management
services.
``(3) Contracted compensation.--The term `contracted
compensation' means the sum of any ingredient cost and
dispensing fee for a drug (inclusive of the out-of-pocket costs
to the participant or beneficiary), or another analogous
compensation structure that the Secretary may specify through
regulations.
``(4) Gross spending.--The term `gross spending', with
respect to prescription drug benefits under a group health plan
or health insurance coverage, means the amount spent by a group
health plan or health insurance issuer on prescription drug
benefits, calculated before the application of rebates, fees,
alternative discounts, or other remuneration.
``(5) Net spending.--The term `net spending', with respect
to prescription drug benefits under a group health plan or
health insurance coverage, means the amount spent by a group
health plan or health insurance issuer on prescription drug
benefits, calculated after the application of rebates, fees,
alternative discounts, or other remuneration.
``(6) Plan sponsor.--The term `plan sponsor' has the
meaning given such term in section 3(16)(B) of the Employee
Retirement Income Security Act of 1974.
``(7) Remuneration.--The term `remuneration' has the
meaning given such term by the Secretary through rulemaking,
which shall be reevaluated by the Secretary every 5 years.
``(8) Specified large employer.--The term `specified large
employer' means, in connection with a group health plan
(including group health insurance coverage offered in
connection with such a plan) established or maintained by a
single employer, with respect to a calendar year or a plan
year, as applicable, an employer who employed an average of at
least 100 employees on business days during the preceding
calendar year or plan year and who employs at least 1 employee
on the first day of the calendar year or plan year.
``(9) Specified large plan.--The term `specified large
plan' means a group health plan (including group health
insurance coverage offered in connection with such a plan)
established or maintained by a plan sponsor described in clause
(ii) or (iii) of section 3(16)(B) of the Employee Retirement
Income Security Act of 1974 that had an average of at least 100
participants on business days during the preceding calendar
year or plan year, as applicable.
``(10) Wholesale acquisition cost.--The term `wholesale
acquisition cost' has the meaning given such term in section
1847A(c)(6)(B) of the Social Security Act.''; and
(2) in section 2723 (42 U.S.C. 300gg-22)--
(A) in subsection (a)--
(i) in paragraph (1), by inserting ``(other
than section 2799A-11)'' after ``part D''; and
(ii) in paragraph (2), by inserting
``(other than section 2799A-11)'' after ``part
D''; and
(B) in subsection (b)--
(i) in paragraph (1), by inserting ``(other
than section 2799A-11)'' after ``part D'';
(ii) in paragraph (2)(A), by inserting
``(other than section 2799A-11)'' after ``part
D''; and
(iii) in paragraph (2)(C)(ii), by inserting
``(other than section 2799A-11)'' after ``part
D''.
(b) Employee Retirement Income Security Act of 1974.--
(1) In general.--Subtitle B of title I of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1021 et seq.)
is amended--
(A) in subpart B of part 7 (29 U.S.C. 1185 et
seq.), by adding at the end the following:
``SEC. 726. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT
MANAGEMENT SERVICES.
``(a) In General.--For plan years beginning on or after the date
that is 30 months after the date of enactment of this section (referred
to in this subsection and subsection (b) as the `effective date'), a
group health plan or a health insurance issuer offering group health
insurance coverage, or an entity providing pharmacy benefit management
services on behalf of such a plan or issuer, shall not enter into a
contract, including an extension or renewal of a contract, entered into
on or after the effective date, with an applicable entity unless such
applicable entity agrees to--
``(1) not limit or delay the disclosure of information to
the group health plan (including such a plan offered through a
health insurance issuer) in such a manner that prevents an
entity providing pharmacy benefit management services on behalf
of a group health plan or health insurance issuer offering
group health insurance coverage from making the reports
described in subsection (b); and
``(2) provide the entity providing pharmacy benefit
management services on behalf of a group health plan or health
insurance issuer relevant information necessary to make the
reports described in subsection (b).
``(b) Reports.--
``(1) In general.--For plan years beginning on or after the
effective date, in the case of any contract between a group
health plan or a health insurance issuer offering group health
insurance coverage offered in connection with such a plan and
an entity providing pharmacy benefit management services on
behalf of such plan or issuer, including an extension or
renewal of such a contract, entered into on or after the
effective date, the entity providing pharmacy benefit
management services on behalf of such a group health plan or
health insurance issuer, not less frequently than every 6
months (or, at the request of a group health plan, not less
frequently than quarterly, and under the same conditions,
terms, and cost of the semiannual report under this
subsection), shall submit to the group health plan a report in
accordance with this section. Each such report shall be made
available to such group health plan in plain language, in a
machine-readable format, and as the Secretary may determine,
other formats. Each such report shall include the information
described in paragraph (2).
``(2) Information described.--For purposes of paragraph
(1), the information described in this paragraph is, with
respect to drugs covered by a group health plan or group health
insurance coverage offered by a health insurance issuer in
connection with a group health plan during each reporting
period--
``(A) in the case of a group health plan that is
offered by a specified large employer or that is a
specified large plan, and is not offered as health
insurance coverage, or in the case of health insurance
coverage for which the election under paragraph (3) is
made for the applicable reporting period--
``(i) a list of drugs for which a claim was
filed and, with respect to each such drug on
such list--
``(I) the contracted compensation
paid by the group health plan or health
insurance issuer for each covered drug
(identified by the National Drug Code)
to the entity providing pharmacy
benefit management services or other
applicable entity on behalf of the
group health plan or health insurance
issuer;
``(II) the contracted compensation
paid to the pharmacy, by any entity
providing pharmacy benefit management
services or other applicable entity on
behalf of the group health plan or
health insurance issuer, for each
covered drug (identified by the
National Drug Code);
``(III) for each such claim, the
difference between the amount paid
under subclause (I) and the amount paid
under subclause (II);
``(IV) the proprietary name,
established name or proper name, and
the National Drug Code;
``(V) for each claim for the drug
(including original prescriptions and
refills) and for each dosage unit of
the drug for which a claim was filed,
the type of dispensing channel used to
furnish the drug, including retail,
mail order, or specialty pharmacy;
``(VI) with respect to each drug
dispensed, for each type of dispensing
channel (including retail, mail order,
or specialty pharmacy)--
``(aa) whether such drug is
a brand name drug or a generic
drug, and--
``(AA) in the case
of a brand name drug,
the wholesale
acquisition cost,
listed as cost per days
supply and cost per
dosage unit, on the
date such drug was
dispensed; and
``(BB) in the case
of a generic drug, the
average wholesale
price, listed as cost
per days supply and
cost per dosage unit,
on the date such drug
was dispensed; and
``(bb) the total number
of--
``(AA) prescription
claims (including
original prescriptions
and refills);
``(BB) participants
and beneficiaries for
whom a claim for such
drug was filed through
the applicable
dispensing channel;
``(CC) dosage units
and dosage units per
fill of such drug; and
``(DD) days supply
of such drug per fill;
``(VII) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply to the plan
or coverage after rebates, fees,
alternative discounts, or other
remuneration received from applicable
entities;
``(VIII) the total amount of out-
of-pocket spending by participants and
beneficiaries on such drug, including
spending through copayments,
coinsurance, and deductibles, but not
including any amounts spent by
participants and beneficiaries on drugs
not covered under the plan or coverage,
or for which no claim is submitted
under the plan or coverage;
``(IX) the total net spending on
the drug;
``(X) the total amount received, or
expected to be received, by the plan or
issuer from any applicable entity in
rebates, fees, alternative discounts,
or other remuneration;
``(XI) the total amount received,
or expected to be received, by the
entity providing pharmacy benefit
management services, from applicable
entities, in rebates, fees, alternative
discounts, or other remuneration from
such entities--
``(aa) for claims incurred
during the reporting period;
and
``(bb) that is related to
utilization of such drug or
spending on such drug; and
``(XII) to the extent feasible,
information on the total amount of
remuneration for such drug, including
copayment assistance dollars paid,
copayment cards applied, or other
discounts provided by each drug
manufacturer (or entity administering
copayment assistance on behalf of such
drug manufacturer), to the participants
and beneficiaries enrolled in such plan
or coverage;
``(ii) a list of each therapeutic class (as
defined by the Secretary) for which a claim was
filed under the group health plan or health
insurance coverage during the reporting period,
and, with respect to each such therapeutic
class--
``(I) the total gross spending on
drugs in such class before rebates,
price concessions, alternative
discounts, or other remuneration from
applicable entities;
``(II) the net spending in such
class after such rebates, price
concessions, alternative discounts, or
other remuneration from applicable
entities;
``(III) the total amount received,
or expected to be received, by the
entity providing pharmacy benefit
management services, from applicable
entities, in rebates, fees, alternative
discounts, or other remuneration from
such entities--
``(aa) for claims incurred
during the reporting period;
and
``(bb) that is related to
utilization of drugs or drug
spending;
``(IV) the average net spending per
30-day supply and per 90-day supply by
the plan or by the issuer with respect
to such coverage and its participants
and beneficiaries, among all drugs
within the therapeutic class for which
a claim was filed during the reporting
period;
``(V) the number of participants
and beneficiaries who filled a
prescription for a drug in such class,
including the National Drug Code for
each such drug;
``(VI) if applicable, a description
of the formulary tiers and utilization
mechanisms (such as prior authorization
or step therapy) employed for drugs in
that class; and
``(VII) the total out-of-pocket
spending under the plan or coverage by
participants and beneficiaries,
including spending through copayments,
coinsurance, and deductibles, but not
including any amounts spent by
participants and beneficiaries on drugs
not covered under the plan or coverage
or for which no claim is submitted
under the plan or coverage;
``(iii) with respect to any drug for which
gross spending under the group health plan or
health insurance coverage exceeded $10,000
during the reporting period or, in the case
that gross spending under the group health plan
or coverage exceeded $10,000 during the
reporting period with respect to fewer than 50
drugs, with respect to the 50 prescription
drugs with the highest spending during the
reporting period--
``(I) a list of all other drugs in
the same therapeutic class as such
drug;
``(II) if applicable, the rationale
for the formulary placement of such
drug in that therapeutic category or
class, selected from a list of standard
rationales established by the
Secretary, in consultation with
stakeholders; and
``(III) any change in formulary
placement compared to the prior plan
year; and
``(iv) in the case that such plan or issuer
(or an entity providing pharmacy benefit
management services on behalf of such plan or
issuer) has an affiliated pharmacy or pharmacy
under common ownership, including mandatory
mail and specialty home delivery programs,
retail and mail auto-refill programs, and cost
sharing assistance incentives funded by an
entity providing pharmacy benefit services--
``(I) an explanation of any benefit
design parameters that encourage or
require participants and beneficiaries
in the plan or coverage to fill
prescriptions at mail order, specialty,
or retail pharmacies;
``(II) the percentage of total
prescriptions dispensed by such
pharmacies to participants or
beneficiaries in such plan or coverage;
and
``(III) a list of all drugs
dispensed by such pharmacies to
participants or beneficiaries enrolled
in such plan or coverage, and, with
respect to each drug dispensed--
``(aa) the amount charged,
per dosage unit, per 30-day
supply, or per 90-day supply
(as applicable) to the plan or
issuer, and to participants and
beneficiaries;
``(bb) the median amount
charged to such plan or issuer,
and the interquartile range of
the costs, per dosage unit, per
30-day supply, and per 90-day
supply, including amounts paid
by the participants and
beneficiaries, when the same
drug is dispensed by other
pharmacies that are not
affiliated with or under common
ownership with the entity and
that are included in the
pharmacy network of such plan
or coverage;
``(cc) the lowest cost per
dosage unit, per 30-day supply
and per 90-day supply, for each
such drug, including amounts
charged to the plan or coverage
and to participants and
beneficiaries, that is
available from any pharmacy
included in the network of such
plan or coverage; and
``(dd) the net acquisition
cost per dosage unit, per 30-
day supply, and per 90-day
supply, if such drug is subject
to a maximum price discount;
and
``(B) with respect to any group health plan,
including group health insurance coverage offered in
connection with such a plan, regardless of whether the
plan or coverage is offered by a specified large
employer or whether it is a specified large plan--
``(i) a summary document for the group
health plan that includes such information
described in clauses (i) through (iv) of
subparagraph (A), as specified by the Secretary
through guidance, program instruction, or
otherwise (with no requirement of notice and
comment rulemaking), that the Secretary
determines useful to group health plans for
purposes of selecting pharmacy benefit
management services, such as an estimated net
price to group health plan and participant or
beneficiary, a cost per claim, the fee
structure or reimbursement model, and estimated
cost per participant or beneficiary;
``(ii) a summary document for plans and
issuers to provide to participants and
beneficiaries, which shall be made available to
participants or beneficiaries upon request to
their group health plan (including in the case
of group health insurance coverage offered in
connection with such a plan), that--
``(I) contains such information
described in clauses (iii), (iv), (v),
and (vi), as applicable, as specified
by the Secretary through guidance,
program instruction, or otherwise (with
no requirement of notice and comment
rulemaking) that the Secretary
determines useful to participants or
beneficiaries in better understanding
the plan or coverage or benefits under
such plan or coverage;
``(II) contains only aggregate
information; and
``(III) states that participants
and beneficiaries may request specific,
claims-level information required to be
furnished under subsection (c) from the
group health plan or health insurance
issuer; and
``(iii) with respect to drugs covered by
such plan or coverage during such reporting
period--
``(I) the total net spending by the
plan or coverage for all such drugs;
``(II) the total amount received,
or expected to be received, by the plan
or issuer from any applicable entity in
rebates, fees, alternative discounts,
or other remuneration; and
``(III) to the extent feasible,
information on the total amount of
remuneration for such drugs, including
copayment assistance dollars paid,
copayment cards applied, or other
discounts provided by each drug
manufacturer (or entity administering
copayment assistance on behalf of such
drug manufacturer) to participants and
beneficiaries;
``(iv) amounts paid directly or indirectly
in rebates, fees, or any other type of
compensation (as defined in section
408(b)(2)(B)(ii)(dd)(AA)) to brokerage firms,
brokers, consultants, advisors, or any other
individual or firm, for--
``(I) the referral of the group
health plan's or health insurance
issuer's business to an entity
providing pharmacy benefit management
services, including the identity of the
recipient of such amounts;
``(II) consideration of the entity
providing pharmacy benefit management
services by the group health plan or
health insurance issuer; or
``(III) the retention of the entity
by the group health plan or health
insurance issuer;
``(v) an explanation of any benefit design
parameters that encourage or require
participants and beneficiaries in such plan or
coverage to fill prescriptions at mail order,
specialty, or retail pharmacies that are
affiliated with or under common ownership with
the entity providing pharmacy benefit
management services under such plan or
coverage, including mandatory mail and
specialty home delivery programs, retail and
mail auto-refill programs, and cost-sharing
assistance incentives directly or indirectly
funded by such entity; and
``(vi) total gross spending on all drugs
under the plan or coverage during the reporting
period.
``(3) Opt-in for group health insurance coverage offered by
a specified large employer or that is a specified large plan.--
In the case of group health insurance coverage offered in
connection with a group health plan that is offered by a
specified large employer or is a specified large plan, such
group health plan may, on an annual basis, for plan years
beginning on or after the date that is 30 months after the date
of enactment of this section, elect to require an entity
providing pharmacy benefit management services on behalf of the
health insurance issuer to submit to such group health plan a
report that includes all of the information described in
paragraph (2)(A), in addition to the information described in
paragraph (2)(B).
``(4) Privacy requirements.--
``(A) In general.--An entity providing pharmacy
benefit management services on behalf of a group health
plan or a health insurance issuer offering group health
insurance coverage shall report information under
paragraph (1) in a manner consistent with the privacy
regulations promulgated under section 13402(a) of the
Health Information Technology for Economic and Clinical
Health Act (42 U.S.C. 17932(a)) and consistent with the
privacy regulations promulgated under the Health
Insurance Portability and Accountability Act of 1996 in
part 160 and subparts A and E of part 164 of title 45,
Code of Federal Regulations (or successor regulations)
(referred to in this paragraph as the `HIPAA privacy
regulations') and shall restrict the use and disclosure
of such information according to such privacy
regulations and such HIPAA privacy regulations.
``(B) Additional requirements.--
``(i) In general.--An entity providing
pharmacy benefit management services on behalf
of a group health plan or health insurance
issuer offering group health insurance coverage
that submits a report under paragraph (1) shall
ensure that such report contains only summary
health information, as defined in section
164.504(a) of title 45, Code of Federal
Regulations (or successor regulations).
``(ii) Restrictions.--In carrying out this
subsection, a group health plan shall comply
with section 164.504(f) of title 45, Code of
Federal Regulations (or a successor
regulation), and a plan sponsor shall act in
accordance with the terms of the agreement
described in such section.
``(C) Rule of construction.--
``(i) Nothing in this section shall be
construed to modify the requirements for the
creation, receipt, maintenance, or transmission
of protected health information under the HIPAA
privacy regulations.
``(ii) Nothing in this section shall be
construed to affect the application of any
Federal or State privacy or civil rights law,
including the HIPAA privacy regulations, the
Genetic Information Nondiscrimination Act of
2008 (Public Law 110-233) (including the
amendments made by such Act), the Americans
with Disabilities Act of 1990 (42 U.S.C. 12101
et seq.), section 504 of the Rehabilitation Act
of 1973 (29 U.S.C. 794), section 1557 of the
Patient Protection and Affordable Care Act (42
U.S.C. 18116), title VI of the Civil Rights Act
of 1964 (42 U.S.C. 2000d), and title VII of the
Civil Rights Act of 1964 (42 U.S.C. 2000e).
``(D) Written notice.--Each plan year, group health
plans, including with respect to group health insurance
coverage offered in connection with a group health
plan, shall provide to each participant or beneficiary
written notice informing the participant or beneficiary
of the requirement for entities providing pharmacy
benefit management services on behalf of the group
health plan or health insurance issuer offering group
health insurance coverage to submit reports to group
health plans under paragraph (1), as applicable, which
may include incorporating such notification in plan
documents provided to the participant or beneficiary,
or providing individual notification.
``(E) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to the entity from which
the report was received or to that entity's business
associates as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations)
or as permitted by the HIPAA privacy regulations.
``(F) Clarification regarding public disclosure of
information.--Nothing in this section shall prevent an
entity providing pharmacy benefit management services
on behalf of a group health plan or health insurance
issuer offering group health insurance coverage, from
placing reasonable restrictions on the public
disclosure of the information contained in a report
described in paragraph (1), except that such plan,
issuer, or entity may not--
``(i) restrict disclosure of such report to
the Department of Health and Human Services,
the Department of Labor, or the Department of
the Treasury; or
``(ii) prevent disclosure for the purposes
of subsection (c), or any other public
disclosure requirement under this section.
``(G) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required with respect to any group
health plan established by a plan sponsor that is, or
is affiliated with, a drug manufacturer, drug
wholesaler, or other direct participant in the drug
supply chain, in order to prevent anti-competitive
behavior.
``(5) Standard format and regulations.--
``(A) In general.--Not later than 18 months after
the date of enactment of this section, the Secretary
shall specify through rulemaking a standard format for
entities providing pharmacy benefit management services
on behalf of group health plans and health insurance
issuers offering group health insurance coverage, to
submit reports required under paragraph (1).
``(B) Additional regulations.--Not later than 18
months after the date of enactment of this section, the
Secretary shall, through rulemaking, promulgate any
other final regulations necessary to implement the
requirements of this section. In promulgating such
regulations, the Secretary shall, to the extent
practicable, align the reporting requirements under
this section with the reporting requirements under
section 725.
``(c) Requirement To Provide Information to Participants or
Beneficiaries.--A group health plan, including with respect to group
health insurance coverage offered in connection with a group health
plan, upon request of a participant or beneficiary, shall provide to
such participant or beneficiary--
``(1) the summary document described in subsection
(b)(2)(B)(ii); and
``(2) the information described in subsection
(b)(2)(A)(i)(III) with respect to a claim made by or on behalf
of such participant or beneficiary.
``(d) Rule of Construction.--Nothing in this section shall be
construed to permit a health insurance issuer, group health plan,
entity providing pharmacy benefit management services on behalf of a
group health plan or health insurance issuer, or other entity to
restrict disclosure to, or otherwise limit the access of, the Secretary
to a report described in subsection (b)(1) or information related to
compliance with subsections (a), (b), or (c) of this section or section
502(c)(13) by such issuer, plan, or entity.
``(e) Definitions.--In this section:
``(1) Applicable entity.--The term `applicable entity'
means--
``(A) an applicable group purchasing organization,
drug manufacturer, distributor, wholesaler, rebate
aggregator (or other purchasing entity designed to
aggregate rebates), or associated third party;
``(B) any subsidiary, parent, affiliate, or
subcontractor of a group health plan, health insurance
issuer, entity that provides pharmacy benefit
management services on behalf of such a plan or issuer,
or any entity described in subparagraph (A); or
``(C) such other entity as the Secretary may
specify through rulemaking.
``(2) Applicable group purchasing organization.--The term
`applicable group purchasing organization' means a group
purchasing organization that is affiliated with or under common
ownership with an entity providing pharmacy benefit management
services.
``(3) Contracted compensation.--The term `contracted
compensation' means the sum of any ingredient cost and
dispensing fee for a drug (inclusive of the out-of-pocket costs
to the participant or beneficiary), or another analogous
compensation structure that the Secretary may specify through
regulations.
``(4) Gross spending.--The term `gross spending', with
respect to prescription drug benefits under a group health plan
or health insurance coverage, means the amount spent by a group
health plan or health insurance issuer on prescription drug
benefits, calculated before the application of rebates, fees,
alternative discounts, or other remuneration.
``(5) Net spending.--The term `net spending', with respect
to prescription drug benefits under a group health plan or
health insurance coverage, means the amount spent by a group
health plan or health insurance issuer on prescription drug
benefits, calculated after the application of rebates, fees,
alternative discounts, or other remuneration.
``(6) Plan sponsor.--The term `plan sponsor' has the
meaning given such term in section 3(16)(B).
``(7) Remuneration.--The term `remuneration' has the
meaning given such term by the Secretary through rulemaking,
which shall be reevaluated by the Secretary every 5 years.
``(8) Specified large employer.--The term `specified large
employer' means, in connection with a group health plan
(including group health insurance coverage offered in
connection with such a plan) established or maintained by a
single employer, with respect to a calendar year or a plan
year, as applicable, an employer who employed an average of at
least 100 employees on business days during the preceding
calendar year or plan year and who employs at least 1 employee
on the first day of the calendar year or plan year.
``(9) Specified large plan.--The term `specified large
plan' means a group health plan (including group health
insurance coverage offered in connection with such a plan)
established or maintained by a plan sponsor described in clause
(ii) or (iii) of section 3(16)(B) that had an average of at
least 100 participants on business days during the preceding
calendar year or plan year, as applicable.
``(10) Wholesale acquisition cost.--The term `wholesale
acquisition cost' has the meaning given such term in section
1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-
3a(c)(6)(B)).'';
(B) in section 502 (29 U.S.C. 1132)--
(i) in subsection (a)(6), by striking ``or
(9)'' and inserting ``(9), or (13)'';
(ii) in subsection (b)(3), by striking
``under subsection (c)(9)'' and inserting
``under paragraphs (9) and (13) of subsection
(c)''; and
(iii) in subsection (c), by adding at the
end the following:
``(13) Secretarial enforcement authority relating to
oversight of pharmacy benefit management services.--
``(A) Failure to provide information.--The
Secretary may impose a penalty against a plan
administrator of a group health plan, a health
insurance issuer offering group health insurance
coverage, or an entity providing pharmacy benefit
management services on behalf of such a plan or issuer,
or an applicable entity (as defined in section 726(f))
that violates section 726(a); an entity providing
pharmacy benefit management services on behalf of such
a plan or issuer that fails to provide the information
required under section 726(b); or any person who causes
a group health plan to fail to provide the information
required under section 726(c), in the amount of $10,000
for each day during which such violation continues or
such information is not disclosed or reported.
``(B) False information.--The Secretary may impose
a penalty against a plan administrator of a group
health plan, a health insurance issuer offering group
health insurance coverage, an entity providing pharmacy
benefit management services, or an applicable entity
(as defined in section 726(f)) that knowingly provides
false information under section 726, in an amount not
to exceed $100,000 for each item of false information.
Such penalty shall be in addition to other penalties as
may be prescribed by law.
``(C) Waivers.--The Secretary may waive penalties
under subparagraph (A), or extend the period of time
for compliance with a requirement of this section, for
an entity in violation of section 726 that has made a
good-faith effort to comply with the requirements of
section 726.''; and
(C) in section 732(a) (29 U.S.C. 1191a(a)), by
striking ``section 711'' and inserting ``sections 711
and 726''.
(2) Clerical amendment.--The table of contents in section 1
of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1001 et seq.) is amended by inserting after the item
relating to section 725 the following new item:
``Sec. 726. Oversight of entities that provide pharmacy benefit
management services.''.
(c) Internal Revenue Code of 1986.--
(1) In general.--Chapter 100 of the Internal Revenue Code
of 1986 is amended--
(A) by adding at the end of subchapter B the
following:
``SEC. 9826. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT
MANAGEMENT SERVICES.
``(a) In General.--For plan years beginning on or after the date
that is 30 months after the date of enactment of this section (referred
to in this subsection and subsection (b) as the `effective date'), a
group health plan, or an entity providing pharmacy benefit management
services on behalf of such a plan, shall not enter into a contract,
including an extension or renewal of a contract, entered into on or
after the effective date, with an applicable entity unless such
applicable entity agrees to--
``(1) not limit or delay the disclosure of information to
the group health plan in such a manner that prevents an entity
providing pharmacy benefit management services on behalf of a
group health plan from making the reports described in
subsection (b); and
``(2) provide the entity providing pharmacy benefit
management services on behalf of a group health plan relevant
information necessary to make the reports described in
subsection (b).
``(b) Reports.--
``(1) In general.--For plan years beginning on or after the
effective date, in the case of any contract between a group
health plan and an entity providing pharmacy benefit management
services on behalf of such plan, including an extension or
renewal of such a contract, entered into on or after the
effective date, the entity providing pharmacy benefit
management services on behalf of such a group health plan, not
less frequently than every 6 months (or, at the request of a
group health plan, not less frequently than quarterly, and
under the same conditions, terms, and cost of the semiannual
report under this subsection), shall submit to the group health
plan a report in accordance with this section. Each such report
shall be made available to such group health plan in plain
language, in a machine-readable format, and as the Secretary
may determine, other formats. Each such report shall include
the information described in paragraph (2).
``(2) Information described.--For purposes of paragraph
(1), the information described in this paragraph is, with
respect to drugs covered by a group health plan during each
reporting period--
``(A) in the case of a group health plan that is
offered by a specified large employer or that is a
specified large plan, and is not offered as health
insurance coverage, or in the case of health insurance
coverage for which the election under paragraph (3) is
made for the applicable reporting period--
``(i) a list of drugs for which a claim was
filed and, with respect to each such drug on
such list--
``(I) the contracted compensation
paid by the group health plan for each
covered drug (identified by the
National Drug Code) to the entity
providing pharmacy benefit management
services or other applicable entity on
behalf of the group health plan;
``(II) the contracted compensation
paid to the pharmacy, by any entity
providing pharmacy benefit management
services or other applicable entity on
behalf of the group health plan, for
each covered drug (identified by the
National Drug Code);
``(III) for each such claim, the
difference between the amount paid
under subclause (I) and the amount paid
under subclause (II);
``(IV) the proprietary name,
established name or proper name, and
the National Drug Code;
``(V) for each claim for the drug
(including original prescriptions and
refills) and for each dosage unit of
the drug for which a claim was filed,
the type of dispensing channel used to
furnish the drug, including retail,
mail order, or specialty pharmacy;
``(VI) with respect to each drug
dispensed, for each type of dispensing
channel (including retail, mail order,
or specialty pharmacy)--
``(aa) whether such drug is
a brand name drug or a generic
drug, and--
``(AA) in the case
of a brand name drug,
the wholesale
acquisition cost,
listed as cost per days
supply and cost per
dosage unit, on the
date such drug was
dispensed; and
``(BB) in the case
of a generic drug, the
average wholesale
price, listed as cost
per days supply and
cost per dosage unit,
on the date such drug
was dispensed; and
``(bb) the total number
of--
``(AA) prescription
claims (including
original prescriptions
and refills);
``(BB) participants
and beneficiaries for
whom a claim for such
drug was filed through
the applicable
dispensing channel;
``(CC) dosage units
and dosage units per
fill of such drug; and
``(DD) days supply
of such drug per fill;
``(VII) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply to the plan
after rebates, fees, alternative
discounts, or other remuneration
received from applicable entities;
``(VIII) the total amount of out-
of-pocket spending by participants and
beneficiaries on such drug, including
spending through copayments,
coinsurance, and deductibles, but not
including any amounts spent by
participants and beneficiaries on drugs
not covered under the plan, or for
which no claim is submitted under the
plan;
``(IX) the total net spending on
the drug;
``(X) the total amount received, or
expected to be received, by the plan
from any applicable entity in rebates,
fees, alternative discounts, or other
remuneration;
``(XI) the total amount received,
or expected to be received, by the
entity providing pharmacy benefit
management services, from applicable
entities, in rebates, fees, alternative
discounts, or other remuneration from
such entities--
``(aa) for claims incurred
during the reporting period;
and
``(bb) that is related to
utilization of such drug or
spending on such drug; and
``(XII) to the extent feasible,
information on the total amount of
remuneration for such drug, including
copayment assistance dollars paid,
copayment cards applied, or other
discounts provided by each drug
manufacturer (or entity administering
copayment assistance on behalf of such
drug manufacturer), to the participants
and beneficiaries enrolled in such
plan;
``(ii) a list of each therapeutic class (as
defined by the Secretary) for which a claim was
filed under the group health plan during the
reporting period, and, with respect to each
such therapeutic class--
``(I) the total gross spending on
drugs in such class before rebates,
price concessions, alternative
discounts, or other remuneration from
applicable entities;
``(II) the net spending in such
class after such rebates, price
concessions, alternative discounts, or
other remuneration from applicable
entities;
``(III) the total amount received,
or expected to be received, by the
entity providing pharmacy benefit
management services, from applicable
entities, in rebates, fees, alternative
discounts, or other remuneration from
such entities--
``(aa) for claims incurred
during the reporting period;
and
``(bb) that is related to
utilization of drugs or drug
spending;
``(IV) the average net spending per
30-day supply and per 90-day supply by
the plan and its participants and
beneficiaries, among all drugs within
the therapeutic class for which a claim
was filed during the reporting period;
``(V) the number of participants
and beneficiaries who filled a
prescription for a drug in such class,
including the National Drug Code for
each such drug;
``(VI) if applicable, a description
of the formulary tiers and utilization
mechanisms (such as prior authorization
or step therapy) employed for drugs in
that class; and
``(VII) the total out-of-pocket
spending under the plan by participants
and beneficiaries, including spending
through copayments, coinsurance, and
deductibles, but not including any
amounts spent by participants and
beneficiaries on drugs not covered
under the plan or for which no claim is
submitted under the plan;
``(iii) with respect to any drug for which
gross spending under the group health plan
exceeded $10,000 during the reporting period
or, in the case that gross spending under the
group health plan exceeded $10,000 during the
reporting period with respect to fewer than 50
drugs, with respect to the 50 prescription
drugs with the highest spending during the
reporting period--
``(I) a list of all other drugs in
the same therapeutic class as such
drug;
``(II) if applicable, the rationale
for the formulary placement of such
drug in that therapeutic category or
class, selected from a list of standard
rationales established by the
Secretary, in consultation with
stakeholders; and
``(III) any change in formulary
placement compared to the prior plan
year; and
``(iv) in the case that such plan (or an
entity providing pharmacy benefit management
services on behalf of such plan) has an
affiliated pharmacy or pharmacy under common
ownership, including mandatory mail and
specialty home delivery programs, retail and
mail auto-refill programs, and cost sharing
assistance incentives funded by an entity
providing pharmacy benefit services--
``(I) an explanation of any benefit
design parameters that encourage or
require participants and beneficiaries
in the plan to fill prescriptions at
mail order, specialty, or retail
pharmacies;
``(II) the percentage of total
prescriptions dispensed by such
pharmacies to participants or
beneficiaries in such plan; and
``(III) a list of all drugs
dispensed by such pharmacies to
participants or beneficiaries enrolled
in such plan, and, with respect to each
drug dispensed--
``(aa) the amount charged,
per dosage unit, per 30-day
supply, or per 90-day supply
(as applicable) to the plan,
and to participants and
beneficiaries;
``(bb) the median amount
charged to such plan, and the
interquartile range of the
costs, per dosage unit, per 30-
day supply, and per 90-day
supply, including amounts paid
by the participants and
beneficiaries, when the same
drug is dispensed by other
pharmacies that are not
affiliated with or under common
ownership with the entity and
that are included in the
pharmacy network of such plan;
``(cc) the lowest cost per
dosage unit, per 30-day supply
and per 90-day supply, for each
such drug, including amounts
charged to the plan and to
participants and beneficiaries,
that is available from any
pharmacy included in the
network of such plan; and
``(dd) the net acquisition
cost per dosage unit, per 30-
day supply, and per 90-day
supply, if such drug is subject
to a maximum price discount;
and
``(B) with respect to any group health plan,
regardless of whether the plan is offered by a
specified large employer or whether it is a specified
large plan--
``(i) a summary document for the group
health plan that includes such information
described in clauses (i) through (iv) of
subparagraph (A), as specified by the Secretary
through guidance, program instruction, or
otherwise (with no requirement of notice and
comment rulemaking), that the Secretary
determines useful to group health plans for
purposes of selecting pharmacy benefit
management services, such as an estimated net
price to group health plan and participant or
beneficiary, a cost per claim, the fee
structure or reimbursement model, and estimated
cost per participant or beneficiary;
``(ii) a summary document for plans to
provide to participants and beneficiaries,
which shall be made available to participants
or beneficiaries upon request to their group
health plan, that--
``(I) contains such information
described in clauses (iii), (iv), (v),
and (vi), as applicable, as specified
by the Secretary through guidance,
program instruction, or otherwise (with
no requirement of notice and comment
rulemaking) that the Secretary
determines useful to participants or
beneficiaries in better understanding
the plan or benefits under such plan;
``(II) contains only aggregate
information; and
``(III) states that participants
and beneficiaries may request specific,
claims-level information required to be
furnished under subsection (c) from the
group health plan; and
``(iii) with respect to drugs covered by
such plan during such reporting period--
``(I) the total net spending by the
plan for all such drugs;
``(II) the total amount received,
or expected to be received, by the plan
from any applicable entity in rebates,
fees, alternative discounts, or other
remuneration; and
``(III) to the extent feasible,
information on the total amount of
remuneration for such drugs, including
copayment assistance dollars paid,
copayment cards applied, or other
discounts provided by each drug
manufacturer (or entity administering
copayment assistance on behalf of such
drug manufacturer) to participants and
beneficiaries;
``(iv) amounts paid directly or indirectly
in rebates, fees, or any other type of
compensation (as defined in section
408(b)(2)(B)(ii)(dd)(AA) of the Employee
Retirement Income Security Act (29 U.S.C.
1108(b)(2)(B)(ii)(dd)(AA))) to brokerage firms,
brokers, consultants, advisors, or any other
individual or firm, for--
``(I) the referral of the group
health plan's business to an entity
providing pharmacy benefit management
services, including the identity of the
recipient of such amounts;
``(II) consideration of the entity
providing pharmacy benefit management
services by the group health plan; or
``(III) the retention of the entity
by the group health plan;
``(v) an explanation of any benefit design
parameters that encourage or require
participants and beneficiaries in such plan to
fill prescriptions at mail order, specialty, or
retail pharmacies that are affiliated with or
under common ownership with the entity
providing pharmacy benefit management services
under such plan, including mandatory mail and
specialty home delivery programs, retail and
mail auto-refill programs, and cost-sharing
assistance incentives directly or indirectly
funded by such entity; and
``(vi) total gross spending on all drugs
under the plan during the reporting period.
``(3) Opt-in for group health insurance coverage offered by
a specified large employer or that is a specified large plan.--
In the case of group health insurance coverage offered in
connection with a group health plan that is offered by a
specified large employer or is a specified large plan, such
group health plan may, on an annual basis, for plan years
beginning on or after the date that is 30 months after the date
of enactment of this section, elect to require an entity
providing pharmacy benefit management services on behalf of the
health insurance issuer to submit to such group health plan a
report that includes all of the information described in
paragraph (2)(A), in addition to the information described in
paragraph (2)(B).
``(4) Privacy requirements.--
``(A) In general.--An entity providing pharmacy
benefit management services on behalf of a group health
plan shall report information under paragraph (1) in a
manner consistent with the privacy regulations
promulgated under section 13402(a) of the Health
Information Technology for Economic and Clinical Health
Act (42 U.S.C. 17932(a)) and consistent with the
privacy regulations promulgated under the Health
Insurance Portability and Accountability Act of 1996 in
part 160 and subparts A and E of part 164 of title 45,
Code of Federal Regulations (or successor regulations)
(referred to in this paragraph as the `HIPAA privacy
regulations') and shall restrict the use and disclosure
of such information according to such privacy
regulations and such HIPAA privacy regulations.
``(B) Additional requirements.--
``(i) In general.--An entity providing
pharmacy benefit management services on behalf
of a group health plan that submits a report
under paragraph (1) shall ensure that such
report contains only summary health
information, as defined in section 164.504(a)
of title 45, Code of Federal Regulations (or
successor regulations).
``(ii) Restrictions.--In carrying out this
subsection, a group health plan shall comply
with section 164.504(f) of title 45, Code of
Federal Regulations (or a successor
regulation), and a plan sponsor shall act in
accordance with the terms of the agreement
described in such section.
``(C) Rule of construction.--
``(i) Nothing in this section shall be
construed to modify the requirements for the
creation, receipt, maintenance, or transmission
of protected health information under the HIPAA
privacy regulations.
``(ii) Nothing in this section shall be
construed to affect the application of any
Federal or State privacy or civil rights law,
including the HIPAA privacy regulations, the
Genetic Information Nondiscrimination Act of
2008 (Public Law 110-233) (including the
amendments made by such Act), the Americans
with Disabilities Act of 1990 (42 U.S.C. 12101
et seq.), section 504 of the Rehabilitation Act
of 1973 (29 U.S.C. 794), section 1557 of the
Patient Protection and Affordable Care Act (42
U.S.C. 18116), title VI of the Civil Rights Act
of 1964 (42 U.S.C. 2000d), and title VII of the
Civil Rights Act of 1964 (42 U.S.C. 2000e).
``(D) Written notice.--Each plan year, group health
plans shall provide to each participant or beneficiary
written notice informing the participant or beneficiary
of the requirement for entities providing pharmacy
benefit management services on behalf of the group
health plan to submit reports to group health plans
under paragraph (1), as applicable, which may include
incorporating such notification in plan documents
provided to the participant or beneficiary, or
providing individual notification.
``(E) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to the entity from which
the report was received or to that entity's business
associates as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations)
or as permitted by the HIPAA privacy regulations.
``(F) Clarification regarding public disclosure of
information.--Nothing in this section shall prevent an
entity providing pharmacy benefit management services
on behalf of a group health plan, from placing
reasonable restrictions on the public disclosure of the
information contained in a report described in
paragraph (1), except that such plan or entity may
not--
``(i) restrict disclosure of such report to
the Department of Health and Human Services,
the Department of Labor, or the Department of
the Treasury; or
``(ii) prevent disclosure for the purposes
of subsection (c), or any other public
disclosure requirement under this section.
``(G) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required with respect to any group
health plan established by a plan sponsor that is, or
is affiliated with, a drug manufacturer, drug
wholesaler, or other direct participant in the drug
supply chain, in order to prevent anti-competitive
behavior.
``(5) Standard format and regulations.--
``(A) In general.--Not later than 18 months after
the date of enactment of this section, the Secretary
shall specify through rulemaking a standard format for
entities providing pharmacy benefit management services
on behalf of group health plans, to submit reports
required under paragraph (1).
``(B) Additional regulations.--Not later than 18
months after the date of enactment of this section, the
Secretary shall, through rulemaking, promulgate any
other final regulations necessary to implement the
requirements of this section. In promulgating such
regulations, the Secretary shall, to the extent
practicable, align the reporting requirements under
this section with the reporting requirements under
section 9825.
``(c) Requirement To Provide Information to Participants or
Beneficiaries.--A group health plan, upon request of a participant or
beneficiary, shall provide to such participant or beneficiary--
``(1) the summary document described in subsection
(b)(2)(B)(ii); and
``(2) the information described in subsection
(b)(2)(A)(i)(III) with respect to a claim made by or on behalf
of such participant or beneficiary.
``(d) Rule of Construction.--Nothing in this section shall be
construed to permit a health insurance issuer, group health plan,
entity providing pharmacy benefit management services on behalf of a
group health plan or health insurance issuer, or other entity to
restrict disclosure to, or otherwise limit the access of, the Secretary
to a report described in subsection (b)(1) or information related to
compliance with subsections (a), (b), or (c) of this section or section
4980D(g) by such issuer, plan, or entity.
``(e) Definitions.--In this section:
``(1) Applicable entity.--The term `applicable entity'
means--
``(A) an applicable group purchasing organization,
drug manufacturer, distributor, wholesaler, rebate
aggregator (or other purchasing entity designed to
aggregate rebates), or associated third party;
``(B) any subsidiary, parent, affiliate, or
subcontractor of a group health plan, health insurance
issuer, entity that provides pharmacy benefit
management services on behalf of such a plan or issuer,
or any entity described in subparagraph (A); or
``(C) such other entity as the Secretary may
specify through rulemaking.
``(2) Applicable group purchasing organization.--The term
`applicable group purchasing organization' means a group
purchasing organization that is affiliated with or under common
ownership with an entity providing pharmacy benefit management
services.
``(3) Contracted compensation.--The term `contracted
compensation' means the sum of any ingredient cost and
dispensing fee for a drug (inclusive of the out-of-pocket costs
to the participant or beneficiary), or another analogous
compensation structure that the Secretary may specify through
regulations.
``(4) Gross spending.--The term `gross spending', with
respect to prescription drug benefits under a group health
plan, means the amount spent by a group health plan on
prescription drug benefits, calculated before the application
of rebates, fees, alternative discounts, or other remuneration.
``(5) Net spending.--The term `net spending', with respect
to prescription drug benefits under a group health plan, means
the amount spent by a group health plan on prescription drug
benefits, calculated after the application of rebates, fees,
alternative discounts, or other remuneration.
``(6) Plan sponsor.--The term `plan sponsor' has the
meaning given such term in section 3(16)(B) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1002(16)(B)).
``(7) Remuneration.--The term `remuneration' has the
meaning given such term by the Secretary, through rulemaking,
which shall be reevaluated by the Secretary every 5 years.
``(8) Specified large employer.--The term `specified large
employer' means, in connection with a group health plan
established or maintained by a single employer, with respect to
a calendar year or a plan year, as applicable, an employer who
employed an average of at least 100 employees on business days
during the preceding calendar year or plan year and who employs
at least 1 employee on the first day of the calendar year or
plan year.
``(9) Specified large plan.--The term `specified large
plan' means a group health plan established or maintained by a
plan sponsor described in clause (ii) or (iii) of section
3(16)(B) of the Employee Retirement Income Security Act of 1974
(29 U.S.C. 1002(16)(B)) that had an average of at least 100
participants on business days during the preceding calendar
year or plan year, as applicable.
``(10) Wholesale acquisition cost.--The term `wholesale
acquisition cost' has the meaning given such term in section
1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-
3a(c)(6)(B)).'';
(2) Exception for certain group health plans.--Section
9831(a)(2) of the Internal Revenue Code of 1986 is amended by
inserting ``other than with respect to section 9826,'' before
``any group health plan''.
(3) Enforcement.--Section 4980D of the Internal Revenue
Code of 1986 is amended by adding at the end the following new
subsection:
``(g) Application to Requirements Imposed on Certain Entities
Providing Pharmacy Benefit Management Services.--In the case of any
requirement under section 9826 that applies with respect to an entity
providing pharmacy benefit management services on behalf of a group
health plan, any reference in this section to such group health plan
(and the reference in subsection (e)(1) to the employer) shall be
treated as including a reference to such entity.''.
(4) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of the Internal Revenue Code of
1986 is amended by adding at the end the following new item:
``Sec. 9826. Oversight of entities that provide pharmacy benefit
management services.''.
SEC. 902. FULL REBATE PASS THROUGH TO PLAN; EXCEPTION FOR INNOCENT PLAN
FIDUCIARIES.
(a) In General.--Section 408(b)(2) of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1108(b)(2)) is amended--
(1) in subparagraph (B)(viii)--
(A) by redesignating subclauses (II) through (IV)
as subclauses (III) through (V), respectively;
(B) in subclause (I)--
(i) by striking ``subclause (II)'' and
inserting ``subclause (III)''; and
(ii) by striking ``subclauses (II) and
(III)'' and inserting ``subclauses (III) and
(IV)''; and
(C) by inserting after subclause (I) the following:
``(II) Pursuant to subsection (a), subparagraphs (C) and
(D) of section 406(a)(1) shall not apply to a responsible plan
fiduciary, notwithstanding any failure to remit required
amounts under subparagraph (C)(i), if the following conditions
are met:
``(aa) The responsible plan fiduciary did not know
that the covered service provider failed or would fail
to make required remittances and reasonably believed
that the covered service provider remitted such
required amounts.
``(bb) The responsible plan fiduciary, upon
discovering that the covered service provider failed to
remit the required amounts, requests in writing that
the covered service provider remit such amounts.
``(cc) If the covered service provider fails to
comply with a written request described in subclause
(III) within 90 days of the request, the responsible
plan fiduciary notifies the Secretary of the covered
service provider's failure, in accordance with
subclauses (III) and (IV).''; and
(2) by adding at the end the following:
``(C)(i)(I) For plan years beginning on or after the date
that is 30 months after the date of enactment of this
subparagraph (referred to in this clause as the `effective
date'), no contract or arrangement or renewal or extension of a
contract or arrangement, entered into on or after the effective
date, for services between a covered plan and a covered service
provider, through a health insurance issuer offering group
health insurance coverage, a third-party administrator, an
entity providing pharmacy benefit management services, or other
entity, for pharmacy benefit management services, is reasonable
within the meaning of this paragraph unless such entity
providing pharmacy benefit management services--
``(aa) remits 100 percent of rebates, fees,
alternative discounts, and other remuneration received
from any applicable entity that are related to
utilization of drugs or drug spending under such health
plan or health insurance coverage, to the group health
plan or health insurance issuer offering group health
insurance coverage; and
``(bb) does not enter into any contract for
pharmacy benefit management services on behalf of such
a plan or coverage, with an applicable entity unless
100 percent of rebates, fees, alternative discounts,
and other remuneration received under such contract
that are related to the utilization of drugs or drug
spending under such group health plan or health
insurance coverage are remitted to the group health
plan or health insurance issuer by the entity providing
pharmacy benefit management services.
``(II) Nothing in subclause (I) shall be construed to
affect the term of a contract or arrangement, as in effect on
the effective date (as described in such subclause), except
that such subclause shall apply to any renewal or extension of
such a contract or arrangement entered into on or after such
effective date, as so described.
``(ii) With respect to such rebates, fees, alternative
discounts, and other remuneration--
``(I) the rebates, fees, alternative discounts, and
other remuneration under clause (i)(I) shall be--
``(aa) remitted--
``(AA) on a quarterly basis, to the
group health plan or the group health
insurance issuer, not later than 90
days after the end of each quarter; or
``(BB) in the case of an
underpayment in a remittance for a
prior quarter, as soon as practicable,
but not later than 90 days after notice
of the underpayment is first given;
``(bb) fully disclosed and enumerated to
the group health plan or health insurance
issuer; and
``(cc) returned to the covered service
provider for pharmacy benefit management
services on behalf of the group health plan if
any audit by a plan sponsor, issuer or a third
party designated by a plan sponsor, indicates
that the amounts received are incorrect after
such amounts have been paid to the group health
plan or health insurance issuer;
``(II) the Secretary may establish procedures for
the remittance of rebates fees, alternative discounts,
and other remuneration under subclause (I)(aa) and the
disclosure of rebates, fees, alternative discounts, and
other remuneration under subclause (I)(bb); and
``(III) the records of such rebates, fees,
alternative discounts, and other remuneration shall be
available for audit by the plan sponsor, issuer, or a
third party designated by a plan sponsor, not less than
once per plan year.
``(iii) To ensure that an entity providing pharmacy benefit
management services is able to meet the requirements of clause
(ii)(I), a rebate aggregator (or other purchasing entity
designed to aggregate rebates) and an applicable group
purchasing organization shall remit such rebates to the entity
providing pharmacy benefit management services not later than
45 days after the end of each quarter.
``(iv) A third-party administrator of a group health plan,
a health insurance issuer offering group health insurance
coverage, or a covered service provider for pharmacy benefit
management services under such health plan or health insurance
coverage shall make rebate contracts with rebate aggregators or
drug manufacturers available for audit by such plan sponsor or
designated third party, subject to reasonable restrictions (as
determined by the Secretary) on confidentiality to prevent re-
disclosure of such contracts or use of such information in
audits for purposes unrelated to this section.
``(v) Audits carried out under clauses (ii)(III) and (iv)
shall be performed by an auditor selected by the responsible
plan fiduciary. Payment for such audits shall not be made,
whether directly or indirectly, by the entity providing
pharmacy benefit management services.
``(vi) Nothing in this subparagraph shall be construed to--
``(I) prohibit reasonable payments to entities
offering pharmacy benefit management services for bona
fide services using a fee structure not described in
this subparagraph, provided that such fees are
transparent and quantifiable to group health plans and
health insurance issuers;
``(II) require a third-party administrator of a
group health plan or covered service provider for
pharmacy benefit management services under such health
plan or health insurance coverage to remit bona fide
service fees to the group health plan;
``(III) limit the ability of a group health plan or
health insurance issuer to pass through rebates, fees,
alternative discounts, and other remuneration to the
participant or beneficiary; or
``(IV) modify the requirements for the creation,
receipt, maintenance, or transmission of protected
health information under the privacy regulations
promulgated under the Health Insurance Portability and
Accountability Act of 1996 in part 160 and subparts A
and E of part 164 of title 45, Code of Federal
Regulations (or successor regulations).
``(vii) For purposes of this subparagraph--
``(I) the terms `applicable entity' and `applicable
group purchasing organization' have the meanings given
such terms in section 726(e);
``(II) the terms `covered plan', `covered service
provider', and `responsible plan fiduciary' have the
meanings given such terms in subparagraph (B); and
``(III) the terms `group health insurance
coverage', `health insurance coverage', and `health
insurance issuer' have the meanings given such terms in
section 733.''.
(b) Rule of Construction.--Subclause (II)(aa) of section
408(b)(2)(B)(viii) of the Employee Retirement Income Security Act of
1974 (29 U.S.C. 1108(b)(2)(B)(viii)), as amended by subsection (a),
shall not be construed to relieve or limit a responsible plan fiduciary
from the duty to monitor the practices of any covered service provider
that contracts with the applicable covered plan, including for the
purposes of ensuring the reasonableness of compensation. For purposes
of this subsection, the terms ``covered plan'', ``covered service
provider'', and ``responsible plan fiduciary'' have the meanings given
such terms in section 408(b)(2)(B)(ii) of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1108(b)(2)(B)(ii)).
(c) Clarification of Covered Service Provider.--
(1) Services.--
(A) In general.--Section 408(b)(2)(B)(ii)(I)(bb) of
the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1108(b)(2)(B)(ii)(I)(bb)) is amended--
(i) in subitem (AA) by striking ``Brokerage
services,'' and inserting ``Services (including
brokerage services),''; and
(ii) in subitem (BB)--
(I) by striking ``Consulting,'' and
inserting ``Other services,''; and
(II) by striking ``related to the
development or implementation of plan
design'' and all that follows through
the period at the end and inserting
``including any of the following: plan
design, insurance or insurance product
selection (including vision and
dental), recordkeeping, medical
management, benefits administration
selection (including vision and
dental), stop-loss insurance, pharmacy
benefit management services, wellness
design and management services,
transparency tools, group purchasing
organization agreements and services,
participation in and services from
preferred vendor panels, disease
management, compliance services,
employee assistance programs, or third-
party administration services, or
consulting services related to any such
services.''.
(B) Sense of congress.--It is the sense of Congress
that the amendment made by subparagraph (A) clarifies
the existing requirement of covered service providers
with respect to services described in section
408(b)(2)(B)(ii)(I)(bb)(BB) of the Employee Retirement
Income Security Act of 1974 (29 U.S.C.
1108(b)(2)(B)(ii)(I)(bb)(BB)) that were in effect since
the application date described in section 202(e) of the
No Surprises Act (Public Law 116-260; 29 U.S.C. 1108
note), and does not impose any additional requirement
under section 408(b)(2)(B) of such Act.
(2) Certain arrangements for pharmacy benefit management
services considered as indirect.--
(A) In general.--Section 408(b)(2)(B)(i) of the
Employee Retirement Income Security Act of 1974 (29
U.S.C. 1108(b)(2)(B)(i)) is amended--
(i) by striking ``requirements of this
clause'' and inserting ``requirements of this
subparagraph''; and
(ii) by adding at the end the following:
``For purposes of applying section 406(a)(1)(C)
with respect to a transaction described under
this subparagraph or subparagraph (C), a
contract or arrangement for services between a
covered plan and an entity providing services
to the plan, including a health insurance
issuer providing health insurance coverage in
connection with the covered plan, in which such
entity contracts, in connection with such plan,
with a service provider for pharmacy benefit
management services, shall be considered an
indirect furnishing of goods, services, or
facilities between the covered plan and the
service provider for pharmacy benefit
management services acting as the party in
interest.''.
(B) Health insurance issuer and health insurance
coverage defined.--Section 408(b)(2)(B)(ii)(I)(aa) of
such Act (29 U.S.C. 1108(b)(2)(B)(ii)(I)(aa)) is
amended by inserting before the period at the end ``and
the terms `health insurance coverage' and `health
insurance issuer' have the meanings given such terms in
section 733(b)''.
(C) Technical amendment.--Section
408(b)(2)(B)(ii)(I)(aa) of the Employee Retirement
Income Security Act of 1974 (29 U.S.C.
1108(b)(2)(B)(ii)(I)(aa)) is amended by inserting
``in'' after ``defined''.
SEC. 903. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.
(a) In General.--Section 505(j)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the
following:
``(H)(i) Upon request (in controlled correspondence or an analogous
process) by a person that has submitted or intends to submit an
abbreviated application under this subsection for a drug that is
required by regulation to contain one or more of the same inactive
ingredients in the same concentrations as the listed drug referred to,
or for which the Secretary determines there is a scientific
justification for an approach that is in vitro, in whole or in part, to
be used to demonstrate bioequivalence for a drug if such a drug
contains one or more of the same inactive ingredients in the same
concentrations as the listed drug referred to, the Secretary shall
inform the person whether such drug is qualitatively and quantitatively
the same as the listed drug. The Secretary may also provide such
information to such a person on the Secretary's own initiative during
the review of an abbreviated application under this subsection for such
drug.
``(ii) Notwithstanding section 301(j), if the Secretary determines
that such drug is not qualitatively or quantitatively the same as the
listed drug, the Secretary shall identify and disclose to the person--
``(I) the ingredient or ingredients that cause such drug
not to be qualitatively or quantitatively the same as the
listed drug; and
``(II) for any ingredient for which there is an identified
quantitative deviation, the amount of such deviation.
``(iii) If the Secretary determines that such drug is qualitatively
and quantitatively the same as the listed drug, the Secretary shall not
change or rescind such determination after the submission of an
abbreviated application for such drug under this subsection unless--
``(I) the formulation of the listed drug has been changed
and the Secretary has determined that the prior listed drug
formulation was withdrawn for reasons of safety or
effectiveness; or
``(II) the Secretary makes a written determination that the
prior determination must be changed because an error has been
identified.
``(iv) If the Secretary makes a written determination described in
clause (iii)(II), the Secretary shall provide notice and a copy of the
written determination to the person making the request under clause
(i).
``(v) The disclosures authorized under clauses (i) and (ii) are
disclosures authorized by law, including for purposes of section 1905
of title 18, United States Code. This subparagraph shall not otherwise
be construed to authorize the disclosure of nonpublic qualitative or
quantitative information about the ingredients in a listed drug, or to
affect the status, if any, of such information as trade secret or
confidential commercial information for purposes of section 301(j) of
this Act, section 552 of title 5, United States Code, or section 1905
of title 18, United States Code.''.
(b) Guidance.--
(1) In general.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue draft guidance, or update guidance,
describing how the Secretary will determine whether a drug is
qualitatively and quantitatively the same as the listed drug
(as such terms are used in section 505(j)(3)(H) of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a)),
including with respect to assessing pH adjusters.
(2) Process.--In issuing guidance under this subsection,
the Secretary of Health and Human Services shall--
(A) publish draft guidance;
(B) provide a period of at least 60 days for
comment on the draft guidance; and
(C) after considering any comments received and not
later than one year after the close of the comment
period on the draft guidance, publish final guidance.
(c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies beginning on the
date of enactment of this Act, irrespective of the date on which the
guidance required by subsection (b) is finalized.
SEC. 904. TITLE 35 AMENDMENTS.
(a) In General.--Section 271(e) of title 35, United States Code, is
amended--
(1) in paragraph (2)(C), in the flush text following clause
(ii), by adding at the end the following: ``With respect to a
submission described in clause (ii), the act of infringement
shall extend to any patent that claims the biological product,
a method of using the biological product, or a method or
product used to manufacture the biological product.''; and
(2) by adding at the end the following:
``(7)(A) Subject to subparagraphs (C), (D), and (E), if the sponsor
of an approved application for a reference product, as defined in
section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))
(referred to in this paragraph as the `reference product sponsor'),
brings an action for infringement under this section against an
applicant for approval of a biological product under section 351(k) of
such Act that references that reference product (referred to in this
paragraph as the `subsection (k) applicant'), the reference product
sponsor may assert in the action a total of not more than 20 patents of
the type described in subparagraph (B), not more than 10 of which shall
have issued after the date specified in section 351(l)(7)(A) of such
Act.
``(B) The patents described in this subparagraph are patents that
satisfy each of the following requirements:
``(i) Patents that claim the biological product that is the
subject of an application under section 351(k) of the Public
Health Service Act (42 U.S.C. 262(k)) (or a use of that
product) or a method or product used in the manufacture of such
biological product.
``(ii) Patents that are included on the list of patents
described in paragraph (3)(A) of section 351(l) of the Public
Health Service Act (42 U.S.C. 262(l)), including as provided
under paragraph (7) of such section 351(l).
``(iii) Patents that--
``(I) have an actual filing date of more than 4
years after the date on which the reference product is
approved; or
``(II) include a claim to a method in a
manufacturing process that is not used by the reference
product sponsor.
``(C) The court in which an action described in subparagraph (A) is
brought may increase the number of patents limited under that
subparagraph--
``(i) if the request to increase that number is made
without undue delay; and
``(ii)(I) if the interest of justice so requires; or
``(II) for good cause shown, which--
``(aa) shall be established if the subsection (k)
applicant fails to provide information required section
351(k)(2)(A) of the Public Health Service Act (42
U.S.C. 262(k)(2)(A)) that would enable the reference
product sponsor to form a reasonable belief with
respect to whether a claim of infringement under this
section could reasonably be asserted; and
``(bb) may be established--
``(AA) if there is a material change to the
biological product (or process with respect to
the biological product) of the subsection (k)
applicant that is the subject of the
application;
``(BB) if, with respect to a patent on the
supplemental list described in section
351(l)(7)(A) of Public Health Service Act (42
U.S.C. 262(l)(7)(A)), the patent would have
issued before the date specified in such
section 351(l)(7)(A) but for the failure of the
Office to issue the patent or a delay in the
issuance of the patent, as described in
paragraph (1) of section 154(b) and subject to
the limitations under paragraph (2) of such
section 154(b); or
``(CC) for another reason that shows good
cause, as determined appropriate by the court.
``(D) In determining whether good cause has been shown for the
purposes of subparagraph (C)(ii)(II), a court may consider whether the
reference product sponsor has provided a reasonable description of the
identity and relevance of any information beyond the subsection (k)
application that the court believes is necessary to enable the court to
form a belief with respect to whether a claim of infringement under
this section could reasonably be asserted.
``(E) The limitation imposed under subparagraph (A)--
``(i) shall apply only if the subsection (k) applicant
completes all actions required under paragraphs (2)(A),
(3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of section 351(l)
of the Public Health Service Act (42 U.S.C. 262(l)); and
``(ii) shall not apply with respect to any patent that
claims, with respect to a biological product, a method for
using that product in therapy, diagnosis, or prophylaxis, such
as an indication or method of treatment or other condition of
use.''.
(b) Applicability.--The amendments made by subsection (a) shall
apply with respect to an application submitted under section 351(k) of
the Public Health Service Act (42 U.S.C. 262(k)) on or after the date
of enactment of this Act.
TITLE X--MISCELLANEOUS
SEC. 1001. EXTENSION OF SAFE HARBOR FOR ABSENCE OF DEDUCTIBLE FOR
TELEHEALTH.
Section 223(c)(2)(E)(ii) of the Internal Revenue Code of 1986 is
amended to read as follows:
``(ii) Safe harbor for absence of
deductible for telehealth.--
``(I) In general.--In the case of
an eligible month or an eligible plan
year, a plan shall not fail to be
treated as a high deductible health
plan by reason of failing to have a
deductible for telehealth and other
remote care services.
``(II) Eligible month.--For
purposes of this clause, the term
`eligible month' means months beginning
after March 31, 2022, and before
January 1, 2023, and months beginning
after March 31, 2025, and before
January 1, 2026.
``(III) Eligible plan year.--For
purposes of this clause, the term
`eligible plan year' means plan years
beginning--
``(aa) on or before
December 31, 2021,
``(bb) after December 31,
2022, and before January 1,
2025, or
``(cc) after December 31,
2024, and before January 1,
2027.''.
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