S 891
Bipartisan Health Care Act
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Bill overview
The Bipartisan Health Care Act aims to extend expiring health provisions and improve healthcare delivery. It focuses on streamlining Medicaid enrollment for out-of-state providers, adjusting coverage for home and community-based services, and removing age restrictions for working adults with disabilities. The bill also includes provisions to enhance Medicare payments, address issues related to pharmacy payments, and support pandemic preparedness and response efforts. Finally, it extends funding for various public health programs and initiatives.
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119th CONGRESS — 1st Session
S. 891
IN THE SENATE OF THE UNITED STATES
A BILL
To extend expiring health provisions and improve health care delivery.
.Bipartisan Health Care Act
The table of contents for this Act is as follows:
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:
The State—
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
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.
In this paragraph:
The term eligible out-of-State provider means, with respect to a State, a provider—
that is located in any other State;
that—
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
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
that has not been—
excluded from participation in any Federal health care program pursuant to section 1128 or 1128A;
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
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).
The term qualifying individual means an individual under 21 years of age who is enrolled under the State plan (or waiver of such plan).
The term State means 1 of the 50 States or the District of Columbia.
Section 1902(a)(77) of the Social Security Act (42 U.S.C. 1396a(a)(77)) is amended by inserting enrollment,
after screening,
.
The subsection heading for section 1902(kk) of such Act (42 U.S.C. 1396a(kk)) is amended by inserting enrollment,
after screening,
.
Section 2107(e)(1)(G) of such Act (42 U.S.C. 1397gg(e)(1)(G)) is amended by inserting enrollment,
after screening,
.
The amendments made by this section shall take effect on the date that is 3 years after the date of enactment of this Act.
in paragraph (2)—
in subparagraph (E)—
by inserting , not less frequently than
before annually
; and
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
by adding at the end the following flush sentence:
by adding at the end the following new paragraph:
For purposes of paragraph (2)(E), the information specified in this paragraph is the following:
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—
information on whether the State screens individuals on such list to determine whether such individuals are eligible to receive such services under such waiver;
information on whether (and, if applicable, how often) the State periodically re-screens individuals on such list for eligibility;
the number of people on such list of individuals waiting to enroll in such waiver; and
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.
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—
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
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.
Section 1915 of the Social Security Act (42 U.S.C. 1396n) is amended—
in subsection (i) by adding at the end the following new paragraph:
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).
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
in subsection (k)(3)(E)—
andafter
the cost of such services and supports,; and
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)
.
Section 1915(c) of the Social Security Act (42 U.S.C. 1396n(c)), as amended by subsection (a), is further amended—
in paragraph (2)(E), by inserting , and the information specified in paragraph (12)(C)(v), when applicable
after paragraph (11)
; and
by adding at the end the following new paragraph:
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).
In selecting States for purposes of clause (i), the Secretary shall—
only select States that received a planning grant under subparagraph (B);
only select States that meet the requirements specified in subparagraph (C) and such other requirements as the Secretary may determine appropriate;
select States in a manner that ensures geographic diversity;
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);
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
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.
In awarding planning grants under subclause (I), the Secretary shall use the selection criteria specified in subclauses (III) through (VI) of subparagraph (A)(ii).
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—
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;
providers furnishing home or community-based services; and
such other stakeholders, as the Secretary may specify.
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:
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.
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.
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.
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.
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.
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.
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—
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;
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;
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
the number of individuals who have received home and community-based services under the waiver during the preceding year.
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).
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.
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).
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,
.
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,
.
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.
andat the end;
in paragraph (87), by striking the period at the end and inserting ; and
; and
by inserting after paragraph (87), the following new paragraph:
beginning January 1, 2028, provide, with respect to an active duty relocated individual (as defined in subsection (uu)(1))—
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—
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
such individual elects to be removed from such list; and
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.
by adding at the end the following new subsection:
For purposes of subsection (a)(88) and this subsection:
The term active duty relocated individual means an individual—
who—
is enrolled under the State plan (or waiver of such plan); or
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;
who—
military service relocation State) by reason of such service;
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
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
who—
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.
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.
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).
in paragraph (87), by striking and
at the end;
in paragraph (88), by striking the period at the end and inserting ; and
; and
by inserting after paragraph (88) the following new paragraph:
by redesignating subparagraphs (H) through (U) as subparagraphs (I) through (V), respectively; and
by inserting after subparagraph (G) the following new subparagraph:
Section 1932 of the Social Security Act (42 U.S.C. 1396u–2) is amended by adding at the end the following new subsection:
Section 1902(kk)(1) of the Social Security Act (42 U.S.C. 1396a(kk)(1)) is amended—
by striking The State
and inserting:
by adding at the end the following new subparagraph:
Section 1902 of the Social Security Act (42 U.S.C. 1396a), as previously amended by this title, is amended—
in subsection (a)—
in paragraph (88), by striking ; and
and inserting a semicolon;
in paragraph (89), by striking the period at the end and inserting ; and
; and
by adding at the end the following new subsection:
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);
disenroll such individual from the State plan (or waiver of such plan); and
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).
Section 5121(d) of subtitle C of title V of division FF of the Consolidated Appropriations Act, 2023 (Public Law 117–328) is amended—
The amendments made by this sectionand inserting the following:
Subject to paragraph (2), the amendments made by this section
by adding at the end the following new paragraph:
an individual who is an eligible juvenileand 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.
Section 5122(a) of subtitle C of title V of division FF of the Consolidated Appropriations Act, 2023 (Public Law 117–328) is amended—
paragraph (31)each place it appears and inserting
the last numbered paragraph; and
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
.
a targeted low-income child whoand inserting
a targeted low income child (other than a child who is in Federal custody, including as an inmate in a Federal prison) who.
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
.
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.
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
).
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:
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.
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.
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.
The amounts applicable hospitals are paid for maternity, labor, and delivery services, by geographic location and hospital size, under—
A comparative payment rate analysis—
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
analyzing different payment methods for such services, such as the use of bundled payments, quality incentives, and low-volume adjustments.
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.
For purposes of this subsection, the term applicable hospital means any hospital located in a State that meets either of the following criteria:
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.
The hospital—
provides labor and delivery services.
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.
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).
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.
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.
2025and inserting
2026 and for the 1st quarter of fiscal year 2027;
fiscal year 2025and inserting
fiscal year 2026; and
by inserting , and the DSH allotment for Tennessee for the 1st quarter of fiscal year 2027, shall be $13,275,000
before the period.
Section 1923(f) of the Social Security Act (42 U.S.C. 1396r–4(f)) is amended—
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
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
in paragraph (8), by striking 2027
and inserting 2028
.
in paragraph (1)—
in subparagraph (A)—
in the matter preceding clause (i), by striking (other than a hospital described in paragraph (2)(B))
;
in clause (i), by inserting with respect to such hospital and year
after described in subparagraph (B)
; and
in clause (ii)—
in subclause (I), by striking and
at the end;
in subclause (II), by striking the period and inserting ; and
; and
by adding at the end the following new subclause:
in subparagraph (B)—
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
by adding at the end the following new clause:
by striking paragraph (2);
by redesignating paragraph (3) as paragraph (2); and
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)
.
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.
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.
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.
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)).
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)).
Section 1927(f) of the Social Security Act (42 U.S.C. 1396r–8(f)) is amended—
in paragraph (1)(A)—
andafter the semicolon at the end of clause (i) and all that precedes it through
(1)and inserting the following:
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:
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;
with respect to applicable non-retail pharmacies—
in subparagraph (B) of paragraph (1), by striking subparagraph (A)(ii)
and inserting subparagraph (A)(iii)
;
The vendor must update the Secretary no less often than monthly on the survey prices for covered outpatient drugs.
Bipartisan Health Care Act
.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:
The monthly response rate to the survey including a list of pharmacies not in compliance with subparagraph (F).
The sampling methodology and number of pharmacies sampled monthly.
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.
otherwise fails to comply with the requirements established under this paragraph.
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.
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.
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.
in paragraph (2)—
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
in subparagraph (B), by inserting and the basis for such dispensing fees
before the semicolon;
by redesignating paragraph (4) as paragraph (5);
, and $9,000,000 for fiscal year 2025 and each fiscal year thereafter,after
2010; and
by inserting Funds appropriated under this paragraph for fiscal year 2025 and any subsequent fiscal year shall remain available until expended.
after the period.
In the sectionand inserting
In this section; and
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.
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.
Implementation of the amendments made by this section shall be exempt from the requirements of section 553 of title 5, United States Code.
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.
Section 1927 of the Social Security Act (42 U.S.C. 1396r–8) is amended—
in subsection (e), by adding at the end the following new paragraph:
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—
any payment made by the entity or the PBM (as applicable) for such a drug—
is limited to—
ingredient cost; and
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;
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
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—
such drug was subject to an agreement under section 340B of the Public Health Service Act;
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
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;
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;
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
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.
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:
Covered entities described in subparagraph (A) of section 340B(a)(4) of the Public Health Service Act.
Covered entities described in subparagraphs (B) through (K) of such section.
Covered entities described in subparagraph (L) of such section.
Covered entities described in subparagraph (M) of such section.
Covered entities described in subparagraph (N) of such section.
Covered entities described in subparagraph (O) of such section.
in subsection (k), as previously amended by this title, by adding at the end the following new paragraph:
Section 1903(m) of such Act (42 U.S.C. 1396b(m)) is amended—
in paragraph (2)(A)(xiii)—
by striking and (III)
and inserting (III)
;
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
by moving the margin 2 ems to the left; and
by adding at the end the following new paragraph:
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).
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.
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.
Implementation of the amendments made by this section shall be exempt from the requirements of section 553 of title 5, United States Code.
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.
fiscal year 2025 beginning on April 1, 2025, and ending on September 30, 2025, and in fiscal year 2026and inserting
fiscal year 2026 beginning on January 1, 2026, and ending on September 30, 2026, and in fiscal year 2027;
in subparagraph (C)(i)—
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
;
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
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
in subparagraph (D)—
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
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
.
in clause (i), by striking April 1, 2025
and inserting January 1, 2026
; and
in clause (ii)(II), by striking April 1, 2025
and inserting January 1, 2026
.
Section 1886(b)(3)(D) of the Social Security Act (42 U.S.C. 1395ww(b)(3)(D)) is amended—
in the matter preceding clause (i), by striking April 1, 2025
and inserting January 1, 2026
; and
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
.
through fiscal year 2024, or the portion of fiscal year 2025 beginning on October 1, 2024, and ending on March 31, 2025and inserting
through fiscal year 2025, or the portion of fiscal year 2026 beginning on October 1, 2025, and ending on December 31, 2025.
Section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)) is amended—
in paragraph (12)(A), by striking April 1, 2025
and inserting January 1, 2027
; and
in paragraph (13), by striking April 1, 2025
each place it appears and inserting January 1, 2027
in each such place.
Section 1833(z) of the Social Security Act (42 U.S.C. 1395l(z)) is amended—
in paragraph (1)(A)—
by striking with 2026
and inserting with 2027
; and
by inserting , or, with respect to 2027, 3.53 percent
after 1.88 percent
;
in paragraph (2)—
in subparagraph (B)—
in the heading, by striking 2026
and inserting 2027
; and
in the matter preceding clause (i), by striking 2026
and inserting 2027
;
in subparagraph (C)—
in the heading, by striking 2027
and inserting 2028
; and
in the matter preceding clause (i), by striking 2027
and inserting 2028
; and
in subparagraph (D), by striking and 2026
and inserting 2026, and 2027
; and
in paragraph (4)(B), by inserting or, with respect to 2027, 3.53 percent
after 1.88 percent
.
in subclause (II), by striking 2026
and inserting 2027
; and
in subclause (III), by striking 2027
and inserting 2028
.
in subparagraph (D), by striking and
at the end;
in subparagraph (E), by striking the period at the end and inserting ; and
; and
by adding at the end the following new subparagraph:
or 2024and inserting
2024, or 2025.
Section 1890(d)(2) of the Social Security Act (42 U.S.C. 1395aaa(d)(2)) is amended—
in the first sentence—
by striking $11,030,000
and inserting $14,000,000
; and
by striking March 31, 2025
and inserting December 31, 2025
; and
March 31, 2025and inserting
December 31, 2025.
in clause (xiii), by striking and
at the end;
in clause (xiv), by striking the period and inserting ; and
; and
by inserting after clause (xiv) the following new clause:
in clause (xiii), by striking and
at the end;
in clause (xiv), by striking the period and inserting ; and
; and
by inserting after clause (xiv) the following new clause:
in clause (xiii), by striking and
at the end;
in clause (xiv), by striking the period and inserting ; and
; and
by inserting after clause (xiv) the following new clause:
in clause (xiii), by striking and
at the end;
in clause (xiv), by striking the period and inserting ; and
; and
by inserting after clause (xiv) the following new clause:
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
.
in paragraph (2)(B)(iii), by striking ending March 31, 2025
and inserting ending December 31, 2026
; and
in paragraph (4)(C)(iii), by striking ending on March 31, 2025
and inserting ending on December 31, 2026
.
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
.
Section 1834(m)(8) of the Social Security Act (42 U.S.C. 1395m(m)(8)) is amended—
in subparagraph (A), by striking ending on March 31, 2025
and inserting ending on December 31, 2026
;
in the subparagraph heading, by inserting before April 1, 2025
after rule
;
in clause (i), by striking during the periods for which subparagraph (A) applies
and inserting before April 1, 2025
; and
in clause (ii), by inserting furnished to an eligible telehealth individual before April 1, 2025
after telehealth services
; and
by adding at the end the following new subparagraph:
April 1, 2025and inserting
January 1, 2027.
April 1, 2025and inserting
January 1, 2027.
April 1, 2025and inserting
January 1, 2027.
ending on March 31, 2025and inserting
ending on December 31, 2026.
by striking ending on March 31, 2025
and inserting ending on December 31, 2026
; and
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.
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:
by a physician or practitioner that contracts with an entity that owns such virtual platform; or
for which a physician or practitioner has a payment arrangement with an entity for use of such virtual platform; and
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
.
Section 1866G of the Social Security Act (42 U.S.C. 1395cc–7) is amended—
in the section heading, by inserting the Thomas R. Carper, Tim Scott, Brad R. Wenstrup, D.P.M., and Earl Blumenauer
after Extension of
;
in subsection (a)—
in paragraph (1)—
March 31, 2025and inserting
December 31, 2029; and
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
)
of the Secretary; and
in paragraph (3)(E), by adding at the end the following new flush sentence:
in subsection (b)—
Studyand inserting
Initial study;
of the Secretary; and
in paragraph (3), by inserting or subsection (c)
before the period at the end;
by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; and
by inserting after subsection (b) the following new subsection:
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)—
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;
clinical conditions treated and diagnosis-related groups of discharges from inpatient settings relative to discharges from the Acute Hospital Care at Home initiative;
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;
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;
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
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.
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).
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.
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.
, 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 subsectionbefore the period at the end.
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;
with respect to a clinical diagnostic laboratory test identified under paragraph (1) as being at high risk of fraudulent claims—
the amount payable under such section 1834A with respect to such test;
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
the frequency with which a claim for payment under such section 1834A included the payment modifier identified by code 59 or 91; and
suggested strategies for reducing the number of fraudulent claims made with respect to tests so identified as being at high risk, including—
an analysis of whether the Centers for Medicare & Medicaid Services can detect aberrant billing patterns with respect to such tests in a timely manner;
any strategies for identifying and monitoring the providers who are outliers with respect to the number of such tests that such providers order; and
targeted education efforts to mitigate improper billing for such tests; and
such other information as the Inspector General determines appropriate.
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.
Best practices on improving access to digital patient portals for individuals with limited English proficiency.
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.
Best practices for providing patient materials, communications, and instructions in multiple languages, including text message appointment reminders and prescription information.
For purposes of subsection (a), an entity described in this subsection is an entity in 1 or more of the following categories:
electronic medical record companies;
remote patient monitoring companies; and
telehealth or mobile health vendors and companies.
Health care providers, including—
physicians; and
hospitals.
Health insurers.
Language service companies.
Interpreter or translator professional associations.
Health and language services quality certification organizations.
Patient and consumer advocates, including such advocates that work with individuals with limited English proficiency.
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
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
.
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.
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—
if an entity participates in the MDPP in the manner described in paragraph (1)—
the administrative location of such entity shall be the address of the entity on file under the Diabetes Prevention Recognition Program; and
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
no limit is applied on the number of times an individual may enroll in the MDPP.
In this section:
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).
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.
The term Secretary means the Secretary of Health and Human Services.
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.
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—
the potential for such devices to accurately prescribe treatments;
an examination of the benefits and challenges of artificial intelligence to augment such capabilities; and
policy options to enhance the benefits and mitigate potential challenges of developing or using such devices.
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
.
Section 1814(i)(2)(B) of the Social Security Act (42 U.S.C. 1395f(i)(2)(B)) is amended—
in clause (ii), by striking 2033
and inserting 2034
; and
in clause (iii), by striking 2033
and inserting 2034
.
Section 3904 of title 41, United States Code, is amended by adding at the end the following new subsections:
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).
Section 1860D–14(a) of the Social Security Act (42 U.S.C. 1395w–114(a)) is amended—
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—
for any other drug, $3 or, if less, the copayment amount applicable to an individual under clause (iii); and
for a generic drug, $0;
in paragraph (4)(A)(ii), by inserting (before 2027)
after a subsequent year
.
plan, and anyand inserting
plan, any; and
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
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—
maintain, on a publicly available internet website, an accurate provider directory that includes the information described in subparagraph (B);
in clause (ii), by striking or
at the end;
in clause (iii), by striking the semicolon at the end and inserting , or
; and
by adding at the end the following new clause:
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);
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—
the amount of cost sharing that would otherwise apply (without regard to this subparagraph).
For plan year 2027 and subsequent plan years, each MA organization that offers a specified MA plan shall—
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:
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:
For purposes of subclause (I), one type of specialty may be providers specializing in mental health or substance use disorder treatment.
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)).
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.
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.
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).
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.
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:
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.
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—
the use of cost-sharing protections required under section 1852(d)(7)(A) of the Social Security Act, as added by paragraph (1);
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;
other items determined appropriate by the Comptroller General.
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.
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.
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.
Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended—
in subsection (s)(2)—
by striking the semicolon at the end of subparagraph (JJ) and inserting ; and
; and
by adding at the end the following new subparagraph:
multi-cancer early detection screening tests (as defined in subsection (nnn));
by adding at the end the following new subsection:
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—
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;
is—
a genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids; or
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
reasonable and necessary for the prevention or early detection of an illness or disability; and
Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:
The payment amount for a multi-cancer early detection screening test (as defined in section 1861(nnn)) is—
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
the amount described in subparagraph (A); or
the payment amount determined for such test under section 1834A.
No payment may be made under this part for a multi-cancer early detection screening test furnished during a year to an individual if—
such individual—
is under 50 years of age; or
as of January 1 of such year, has attained the age specified in subparagraph (B) for such year; or
For purposes of subparagraph (A)(i)(II), the age specified in this subparagraph is—
for 2029, 65 years of age; and
for a succeeding year, the age specified in this subparagraph for the preceding year, increased by 1 year.
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.
Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended—
in subsection (a)—
in paragraph (1)(D)(i)(I), by striking section 1834(d)(1)
and inserting subsection (d)(1) or (aa) of section 1834
; and
in paragraph (2)(D)(i)(I), by striking section 1834(d)(1)
and inserting subsection (d)(1) or (aa) of section 1834
; and
section 1834(d)(1)and inserting
subsections (d)(1) and (aa) of section 1834.
Section 1862(a)(1)(A) of the Social Security Act (42 U.S.C. 1395y(a)(1)(A)) is amended—
by striking or additional preventive services
and inserting , additional preventive services
; and
by inserting , or multi-cancer early detection screening tests (as defined in section 1861(nnn))
after (as described in section 1861(ddd)(1))
.
Nothing in this section, including the amendments made by this section, shall be construed—
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
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.
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:
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.
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)).
The prescribing information described in paragraph (1) instructs that the drug should be infused at least 12 times per year—
intravenously or subcutaneously; or
at infusion rates that the Secretary determines would require the use of an external infusion pump.
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 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.
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).
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.
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:
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—
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;
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;
trends in the number of essential retail pharmacies, including variation in such trends by geographic region or other factors;
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;
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
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.
In this subsection, the term essential retail pharmacy means, with respect to a plan year, a retail pharmacy that—
is not a pharmacy that is an affiliate as defined in paragraph (4); and
is located in—
a medically underserved area (as designated pursuant to section 330(b)(3)(A) of the Public Health Service Act);
a rural area in which there is no other retail pharmacy within 10 miles, as determined by the Secretary;
a suburban area in which there is no other retail pharmacy within 2 miles, as determined by the Secretary; or
an urban area in which there is no other retail pharmacy within 1 mile, as determined by the Secretary.
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.
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.
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.
Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.
Chapter 35 of title 44, United States Code, shall not apply to the implementation of this paragraph.
In this subsection, the terms affiliate and pharmacy benefit manager have the meaning given those terms in section 1860D–12(h)(7).
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:
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.
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.
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.
A PDP sponsor subject to an allegation under this clause—
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
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.
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.
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.
Allegations submitted under this clause shall be exempt from disclosure under section 552 of title 5, United States Code.
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.
Consistent with applicable Federal or State law, a PDP sponsor shall not—
retaliate against a pharmacy for submitting any allegations under this clause; or
coerce, intimidate, threaten, or interfere with the ability of a pharmacy to submit any such allegations.
The Secretary shall investigate, as determined appropriate by the Secretary, allegations submitted pursuant to clause (i).
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.
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).
Section 1857(g)(1) of the Social Security Act (42 U.S.C. 1395w–27(g)(1)) is amended—
in subparagraph (J), by striking or
after the semicolon;
by redesignating subparagraph (K) as subparagraph (L);
by inserting after subparagraph (J), the following new subparagraph:
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
in subparagraph (L), as redesignated by subparagraph (B), by striking through (J)
and inserting through (K)
; and
in the flush matter following subparagraph (L), as so redesignated, by striking subparagraphs (A) through (K)
and inserting subparagraphs (A) through (L)
.
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:
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.
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:
For plan years beginning on or after January 1, 2028, section 1860D–12(b)(9).
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:
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).
A report under paragraph (1) shall not disclose—
identifiable information about individuals or entities unless such information is otherwise publicly available; or
trade secrets with respect to any entities.
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.
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:
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, and any affiliates of such pharmacy benefit manager, as applicable, agree to meet the following requirements:
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).
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.
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.
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.
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.
The pharmacy benefit manager shall—
The pharmacy benefit manager shall—
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—
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;
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;
specialty drug;
rebate; and
discount;
identify any drugs, claims, or price concessions excluded from any pricing guarantee or other cost performance measure in a clear and consistent manner; and
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.
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:
A list of all drugs covered by the plan that were dispensed including, with respect to each such drug—
the brand name, generic or non-proprietary name, and National Drug Code;
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;
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;
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);
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);
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;
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;
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;
the average pharmacy reimbursement amount paid by the plan for the drug in the aggregate and disaggregated by dispensing channel identified in item (cc);
the average National Average Drug Acquisition Cost (NADAC); and
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.
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:
The percentage of total prescriptions that were dispensed by pharmacies that are an affiliate of the pharmacy benefit manager for each drug.
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.
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.
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.
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.
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.
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:
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.
The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the listed drug.
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.
A written justification for providing more favorable coverage of the listed drug than the generic drugs described in item (aa).
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.
Where a reference product (as defined in section 351(i) of the Public Health Service Act) is covered by the plan, the following information:
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.
The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the reference product.
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.
A written justification for providing more favorable coverage of the reference product than the biosimilar biological product described in item (aa).
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.
Total gross spending on covered part D drugs by the plan, not net of rebates, fees, discounts, or other direct or indirect remuneration.
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.
The total spending on covered part D drugs net of rebates, fees, discounts, or other direct and indirect remuneration by the plan.
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.
The following information:
The amount of compensation provided by such pharmacy benefit manager or affiliate to each such broker, consultant, advisor, and auditor.
A list of all affiliates of the pharmacy benefit manager.
A summary document submitted in a standardized template developed by the Secretary that includes such information described in subclauses (I) through (X).
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.
A written explanation under subclause (I) shall—
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
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.
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.
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).
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.
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.
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.
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.
disgorge to the Secretary any amounts disgorged to the PDP sponsor by a pharmacy benefit manager under paragraph (1)(A)(v);
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).
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).
Consistent with applicable Federal or State law, a PDP sponsor shall not—
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.
Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.
Nothing in this subsection shall be construed as—
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
modifying regulatory requirements or sub-regulatory program instruction or guidance related to pharmacy payment, reimbursement, or dispensing fees.
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).
Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.
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:
As the Secretary determines necessary to carry out this part.
To permit the Comptroller General to review the information provided.
To permit the Director of the Congressional Budget Office to review the information provided.
To permit the Executive Director of the Medicare Payment Advisory Commission to review the information provided.
To the Attorney General for the purposes of conducting oversight and enforcement under this title.
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.
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—
For purposes of this subsection:
The term affiliate means, with respect to any pharmacy benefit manager or PDP sponsor, any entity that, directly or indirectly—
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—
drug price, such as wholesale acquisition cost or drug benchmark price (such as average wholesale price);
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);
coverage or formulary placement decisions or the volume or value of any referrals or business generated between the parties to the arrangement; or
any other amounts or methodologies prohibited by the Secretary.
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
.
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:
For plan years beginning on or after January 1, 2028, section 1860D–12(h).
Chapter 35 of title 44, United States Code, shall not apply to the implementation of this subsection.
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.
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.
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:
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—
pharmacy benefit managers;
PDP sponsors offering prescription drug plans and Medicare Advantage organizations offering MA–PD plans;
drug wholesalers;
pharmacies;
manufacturers;
pharmacy services administrative organizations;
brokers, auditors, consultants, and other entities that—
advise PDP sponsors offering prescription drug plans and Medicare Advantage organizations offering MA–PD plans regarding pharmacy benefits; or
review PDP sponsor and Medicare Advantage organization contracts with pharmacy benefit managers; and
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).
The primary business models and compensation structures for each category of intermediary described in subparagraph (A).
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.
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.
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.).
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.
Other issues determined to be relevant and appropriate by the Comptroller General.
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.
The Medicare Payment Advisory Commission shall submit to Congress the following reports:
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—
a description of trends and patterns, including relevant averages, totals, and other figures for the types of information submitted;
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
any recommendations the Commission determines appropriate.
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.
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.
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;
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
after such provider has submitted an attestation under clause (ii), such provider has submitted a subsequent attestation within the timeframe specified by the Secretary.
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
recommendations based on such analysis, as the Inspector General determines appropriate.
Section 251A(6) of the Balanced Budget and Emergency Deficit Control Act of 1985 (2 U.S.C. 901a(6)) is amended—
in subparagraph (D), by striking such that,
and all that follows and inserting such that the payment reduction shall be 2.0 percent.
; and
by adding at the end the following:
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
with respect to the last 10 months in which such order is effective for such fiscal year, the payment reduction shall be 0 percent.
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
.
Section 510 of the Social Security Act (42 U.S.C. 710) is amended—
in subsection (a)—
in paragraph (1)—
by striking and for the period
and inserting for the period
;
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
by striking for fiscal year 2024 or 2025
and inserting for fiscal year 2024, 2025, or 2026
; and
in paragraph (2), by striking or 2025
each place it appears and inserting , 2025, or 2026
; and
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
Section 513 of the Social Security Act (42 U.S.C. 713) is amended—
in subsection (a)(1)—
by striking and for the period
and inserting for the period
; and
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
by striking and for the period
and inserting for the period
; and
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;
fiscal year 2024 or 2025and inserting
fiscal year 2024, 2025, or 2026; and
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 2024and 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.
Section 501(c)(1)(A)(viii) of the Social Security Act (42 U.S.C. 701(c)(1)(A)(viii)) is amended—
by striking $3,000,000
and inserting $7,500,000
; and
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
.
in subparagraph (H), by striking and
at the end;
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
by adding at the end the following:
in subparagraph (I), by striking and
at the end;
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
by adding at the end the following:
in subparagraph (D), by striking ; and
and inserting a semicolon;
in subparagraph (E), by striking the period and inserting a semicolon; and
by adding at the end the following:
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.).
and section 3101(d) of the Health Extensions and Other Matters Act, 2025and inserting
section 3101(d) of the Health Extensions and Other Matters Act, 2025, and section 401(d) of the.Bipartisan Health Care Act
Section 330B(b)(2) of the Public Health Service Act (42 U.S.C. 254c–2(b)(2)) is amended—
in subparagraph (E), by striking and
at the end;
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
by adding at the end the following:
Section 330C(c)(2) of the Public Health Service Act (42 U.S.C. 254c–3(c)(2)) is amended—
in subparagraph (E), by striking and
at the end;
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
in clause (x), by striking ; and
and inserting a semicolon;
by redesignating clause (xi) as clause (xii); and
by inserting after clause (x), the following:
for each of fiscal years 2026 through 2040—
the amount determined under this subparagraph for the previous fiscal year multiplied by 1.05; multiplied by
the ratio of—
the total number of individuals enrolled in the WTC Program on July 1 of such previous fiscal year; to
the total number of individuals so enrolled on July 1 of the fiscal year prior to such previous fiscal year; and
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—
the Speaker and minority leader of the House of Representatives;
the majority and minority leaders of the Senate;
the Committee on Health, Education, Labor, and Pensions and the Committee on the Budget of the Senate; and
the Committee on Energy and Commerce and the Committee on the Budget of the House of Representatives.
The report required under paragraph (1) shall include—
a projection of Program budgetary needs on a per-fiscal year basis through fiscal year 2090;
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;
an assessment of the projected budget authority and expenditures of the Program through fiscal year 2090 by comparing—
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
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
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.
Title XXXIII of the Public Health Service Act (42 U.S.C. 300mm et seq.) is amended—
Any amountsand inserting
Any unobligated amounts;
in section 3353(d) (42 U.S.C. 300mm–63(d)), by striking Any amounts
and inserting Any unobligated amounts
; and
in section 3354(d) (42 U.S.C. 300mm–64(d)), by striking Any amounts
and inserting Any unobligated amounts
.
This title may be cited as the SUPPORT for Patients and Communities Reauthorization Act of 2025
.
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
.
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
.
Section 392A of the Public Health Service Act (42 U.S.C. 280b–1) is amended—
in subparagraph (C), by inserting and associated risks
before the period at the end; and
in subparagraph (D), by striking opioids
and inserting substances causing overdose
; and
, and associated risk factors,after
such overdoses;
codingand inserting
monitoring and identifying;
public health laboratories; and
and other emerging substances relatedafter
analogues; and
and associated risk factorsafter
overdoses.
Section 392A(a)(3) of the Public Health Service Act (42 U.S.C. 280b–1(a)(3)) is amended—
in the matter preceding subparagraph (A), by striking and Indian Tribes—
and inserting and Indian Tribes for the following purposes:
;
by amending subparagraph (A) to read as follows:
in subparagraph (B), by striking for any
and inserting For any
.
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
.
FASD) education, prevention, identification, intervention, and services delivery program, which may include—
an education and public awareness program to support, conduct, and evaluate the effectiveness of—
strategies to educate school-age children, including pregnant and high-risk youth, concerning FASD;
public and community awareness programs concerning FASD; and
develop appropriate medical diagnostic methods for identifying FASD; and
utilizing and adapting existing Federal, State, or Tribal programs to include FASD identification and FASD-informed support;
developing and expanding screening and diagnostic capacity for FASD;
developing, implementing, and evaluating targeted FASD-informed intervention programs for FASD;
providing training with respect to FASD for professionals across relevant sectors; and
disseminating information about FASD and support services to affected individuals and their families; and
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.
The Secretary may award grants, cooperative agreements and contracts and provide technical assistance to eligible entities to carry out subsection (a).
be a State, Indian Tribe or Tribal organization, local government, scientific or academic institution, or nonprofit organization; and
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.
The Secretary may require that an eligible entity include in the application submitted under paragraph (2)(B)—
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
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.
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).
An entity receiving an award under subsection (a) may use such award for the following purposes:
Developing and supporting public education and outreach activities to raise public awareness of the risks associated with alcohol consumption during pregnancy.
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.
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.
Providing technical assistance to recipients of grants, cooperative agreements, or contracts under section 399H, as appropriate.
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.
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:
Resource development and dissemination.
Intervention services.
Training and technical assistance.
There are authorized to be appropriated to carry out this part $12,500,000 for each of fiscal years 2025 through 2029.
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—
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
);
a description of—
the activities carried out pursuant to such sections 399H and 399I to identify, prevent, and treat FASD; and
methods used to evaluate the outcomes of such activities; and
an assessment of activities carried out pursuant to such sections 399H and 399I to support individuals with FASD.
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:
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.
Section 546 of the Public Health Service Act (42 U.S.C. 290ee–1) is amended—
in subsection (a), by striking tribes and tribal
and inserting Tribes and Tribal
;
in subsections (a), (c), and (d)—
by striking approved or cleared
each place it appears and inserting approved, cleared, or otherwise legally marketed
; and
by striking opioid
each place it appears;
in subsection (f)—
by striking approved or cleared
each place it appears and inserting approved, cleared, or otherwise legally marketed
;
in paragraph (1), by striking opioid
;
in paragraph (2)—
by striking opioid and heroin
and inserting opioid, heroin, and other drug
; and
by striking opioid overdose
and inserting overdose
; and
in paragraph (3), by striking opioid and heroin
; and
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
.
by redesignating such part as part J; and
by redesignating sections 581 through 584 as sections 596 through 596C, respectively.
in the section heading, by striking VIOLENCE RELATED STRESS
and inserting TRAUMATIC EVENTS
;
in subsection (a)—
in the matter preceding paragraph (1), by striking tribes and tribal
and inserting Tribes and Tribal
; and
in paragraph (2), by inserting and dissemination
after the development
;
in subsection (b), by inserting and dissemination
after the development
;
in subsection (d)—
by striking The NCTSI
and inserting the following:
The NCTSI
by adding at the end the following:
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.
in subsection (e)—
by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and adjusting the margins accordingly;
in subparagraph (A), as so redesignated, by inserting and implementation
after the dissemination
;
by striking The NCTSI
and inserting the following:
The NCTSI
by adding at the end the following:
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).
by amending subsection (h) to read as follows:
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—
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
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.
by amending subsection (j) to read as follows:
$95,000,000 for fiscal year 2026;
$97,000,000 for fiscal year 2027;
$100,000,000 for fiscal year 2028; and
$100,000,000 for fiscal year 2029.
Section 520E–3(b) of the Public Health Service Act (42 U.S.C. 290bb–36c(b)) is amended—
in paragraph (4), by striking and
at the end;
in paragraph (5), by striking the period at the end and inserting ; and
; and
by adding at the end the following:
taking such steps as may be necessary to ensure the suicide prevention hotline is protected from cybersecurity incidents and eliminates known cybersecurity vulnerabilities.
Section 520E–3 of the Public Health Service Act (42 U.S.C. 290bb–36c) is amended—
by redesignating subsection (f) as subsection (g); and
by inserting after subsection (e) the following:
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—
any identified cybersecurity vulnerabilities to the program within a reasonable amount of time after identification of such a vulnerability; and
any identified cybersecurity incidents to the program within a reasonable amount of time after identification of such incident.
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—
any identified cybersecurity vulnerabilities to the program within a reasonable amount of time after identification of such vulnerability; and
any identified cybersecurity incidents to the program within a reasonable amount of time after identification of such incident.
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.
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.
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.
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
.Not later than 180 days after the date of the enactment of this Act, the Comptroller General of the United States shall—
conduct and complete a study that evaluates cybersecurity risks and vulnerabilities associated with the 9–8–8 National Suicide Prevention Lifeline; and
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.
Section 7102(c) of the SUPPORT for Patients and Communities Act (42 U.S.C. 290bb–7a(c)) is amended—
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
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.
Section 7022 of the SUPPORT for Patients and Communities Act (42 U.S.C. 290aa note) is amended—
by striking subsection (g) and inserting the following:
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.
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.
The Work Group shall consult with relevant stakeholders and subject matter experts, including—
State, Tribal, and local subject matter experts in reducing, preventing, and responding to drug overdose caused by fentanyl-contamination of illicit drugs; and
family members of both adults and youth who have overdosed by fentanyl-contaminated illicit drugs.
The Work Group shall—
examine Federal efforts to reduce and prevent drug overdose by fentanyl-contaminated illicit drugs;
identify strategies to improve State, Tribal, and local responses to overdose by fentanyl-contaminated illicit drugs;
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;
make recommendations to Congress for improving Federal programs, including with respect to the coordination of efforts across such programs; and
make recommendations for educating youth on the potency and dangers of drugs contaminated by fentanyl.
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.
by striking subsection (i) and inserting the following:
The Committee shall terminate on September 30, 2029.
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.
The guidance under subsection (a) shall include—
recommended standards for effective at-home drug disposal systems to meet applicable requirements enforced by the Food and Drug Administration;
recommended information to include as instructions for use to disseminate with at-home drug disposal systems;
best practices and educational tools to support the use of an at-home drug disposal system, as appropriate; and
recommended use of licensed health providers for the dissemination of education, instruction, and at-home drug disposal systems, as appropriate.
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—
an update on the actions taken by the FDA to consider the effectiveness, safety, benefit-risk profile, and use of approved opioid analgesic drugs;
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;
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
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).
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.
Section 508 of the Public Health Service Act (42 U.S.C. 290bb–1) is amended—
in subsection (d)(11)(C), by striking providing health services
and inserting providing health care services
;
in subsection (g)—
by inserting a plan describing
after will provide
; and
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
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
.
Section 597 of the Public Health Service Act (42 U.S.C. 290ll) is amended—
in subsection (a)(1), by inserting diagnosis,
after related to
; and
in subsection (b), by inserting addiction medicine,
after psychiatry,
.
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
.
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
.
Section 7053 of the SUPPORT for Patients and Communities Act (42 U.S.C. 290dd–2 note) is amended by striking subsection (e).
Section 7132 of the SUPPORT for Patients and Communities Act (Public Law 115–271; 132 Stat. 4046) is amended—
in subsection (b)(1)—
by redesignating subparagraph (CC) as subparagraph (DD); and
by inserting after subparagraph (BB) the following:
The Administration for Community Living.
in subsection (d)(1), in the matter preceding subparagraph (A), by inserting , developmental disability service providers
before , individuals who are
; and
in subsection (i), by striking 2023
and inserting 2029
.
Section 3203 of the SUPPORT for Patients and Communities Act (21 U.S.C. 823 note) is amended—
by striking subsection (b); and
by striking (a) In general.—The Secretary
and inserting the following: The Secretary
.
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:
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.
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.
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—
the findings of the review under subsection (a); and
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.
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.
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)—
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
if appropriate, request that the Attorney General initiate rulemaking proceedings to revise the schedules accordingly with respect to such products.
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).
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
.
Section 547A of the Public Health Service Act (42 U.S.C. 290ee–2a) is amended—
in subsection (b)(4), by striking building; and
and inserting the following:
building, such as—
professional development of peer support specialists; and
making recovery support services available in nonclinical settings; and
by redesignating subsections (d) and (e) as subsections (e) and (f), respectively;
by inserting after subsection (c) the following:
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.
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 description of the distinct roles and responsibilities of the Regional Center and the Center;
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;
a description of any gaps or areas of duplication relating to the activities of the Regional Center and the Center within such region; and
recommendations relating to the modification, expansion, or termination of the Regional Center under this subsection.
This subsection shall terminate on September 30, 2029.
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
.
Section 552 of the Public Health Service Act (42 U.S.C. 290ee–7) is amended—
in subsection (d)(2)—
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
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
;
in subsection (h)—
by redesignating paragraphs (1) through (4) as subparagraphs (A) through (D), respectively, and adjusting the margins accordingly;
by striking With respect to
and inserting the following:
With respect to
by adding at the end the following:
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.
in subsection (j), by striking 2019 through 2023
and inserting 2025 through 2029
.
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—
in paragraph (2)—
in subparagraph (A)—
in clause (i)—
by inserting , or a consortium of local educational agencies,
after a local educational agency
; and
by striking high schools
and inserting secondary schools
; and
in clause (vi), by striking tribe, or tribal
and inserting Tribe, or Tribal
;
by amending subparagraph (E) to read as follows:
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).
by redesignating subparagraph (K) as subparagraph (L); and
by inserting after subparagraph (J) the following:
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).
in paragraph (3)(A), in the matter preceding clause (i)—
by striking and abuse
; and
by inserting at increased risk for substance misuse
after specific populations
;
in paragraph (4)—
in the matter preceding subparagraph (A), by striking Indian tribes
and inserting Indian Tribes
;
in subparagraph (A), by striking and abuse
; and
in subparagraph (B), by striking peer mentoring
and inserting peer-to-peer support
;
in paragraph (5), by striking tribal
and inserting Tribal
;
in paragraph (6)(A)—
in clause (iv), by striking ; and
and inserting a semicolon; and
by adding at the end the following:
a plan to sustain the activities carried out under the grant program, after the grant program has ended; and
in paragraph (8), by striking 2022
and inserting 2027
; and
by amending paragraph (9) to read as follows:
To carry out this subsection, there are authorized to be appropriated—
$12,000,000 for fiscal year 2026;
$13,000,000 for fiscal year 2027;
$14,000,000 for fiscal year 2028; and
$15,000,000 for fiscal year 2029.
Section 7183 of the SUPPORT for Patients and Communities Act (42 U.S.C. 290ee–8) is amended—
in the section heading, by inserting ; TREATMENT, RECOVERY, AND WORKFORCE SUPPORT GRANTS
after CAREER ACT
;
in subsection (b), by inserting each
before for a period
;
in subsection (c)—
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
by amending paragraph (2) to read as follows:
The rates described in this paragraph are the following:
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.
The highest average rates of unemployment for calendar years 2018 through 2022 based on data provided by the Bureau of Labor Statistics.
The lowest average labor force participation rates for calendar years 2018 through 2022 based on data provided by the Bureau of Labor Statistics.
in subsection (g)—
in each of paragraphs (1) and (3), by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;
by redesignating paragraphs (1) through (3) as subparagraphs (A) through (C), respectively, and adjusting the margins accordingly;
in the matter preceding subparagraph (A) (as so redesignated), by striking An entity
and inserting the following:
An entity
by adding at the end the following:
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.
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.
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)
;
in subsection (j)—
in paragraph (1), by inserting SUPPORT for Patients and Communities Reauthorization Act of 2025for grants awarded prior to the date of enactment of the
after grant period under this section
; and
in paragraph (2)—
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
in subparagraph (A), by striking (g)(3)
and inserting (g)(1)(C)
; and
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
.
Section 8071 of the SUPPORT for Patients and Communities Act (42 U.S.C. 5301 note; Public Law 115–271) is amended—
by striking the section heading and inserting CAREER Act; Recovery Housing Pilot Program
;
through 2023and inserting
through 2029;
in subsection (b)—
not later than 60 days after the date of enactment of this Actand inserting
not later than 60 days after the date of enactment of the; andSUPPORT for Patients and Communities Reauthorization Act of 2025
in paragraph (2)(B)(i)—
for calendar years 2013 through 2017; and
for calendar years 2018 through 2022after
rates of unemployment;
in subclause (II)—
for calendar years 2013 through 2017; and
for calendar years 2018 through 2022after
participation rates; and
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.
in subsection (f), by striking For the 2-year period following the date of enactment of this Act, the
and inserting The
.
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
.
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—
by striking the item relating to section 7183 and inserting the following:
by striking the item relating to subtitle F of title VIII and inserting the following:
by striking the item relating to section 8071 and inserting the following:
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
.
Section 309A(a) of the Controlled Substances Act (21 U.S.C. 829a(a)) is amended by striking paragraph (2) and inserting the following:
the controlled substance is a drug in schedule III, IV, or V to be administered—
by injection or implantation for the purpose of maintenance or detoxification treatment; or
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.
Effective as if included in the enactment of Public Law 117–328—
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)
;
section 1262 of division FF of Public Law 117–328 (136 Stat. 5681) is amended—
in subsection (a)—
in the matter preceding paragraph (1), by striking 303(g)
and inserting 303(h)
;
in the matter being stricken by subsection (a)(2), by striking (g)(1)
and inserting (h)(1)
; and
in the matter being inserted by subsection (a)(2), by striking (g) Practitioners
and inserting (h) Practitioners
; and
in subsection (b)—
in the matter being stricken by paragraph (1), by striking 303(g)(1)
and inserting 303(h)(1)
;
in the matter being inserted by paragraph (1), by striking 303(g)
and inserting 303(h)
;
in the matter being stricken by paragraph (2)(A), by striking 303(g)(2)
and inserting 303(h)(2)
;
in the matter being stricken by paragraph (3), by striking 303(g)(2)(B)
and inserting 303(h)(2)(B)
;
in the matter being stricken by paragraph (5), by striking 303(g)
and inserting 303(h)
; and
in the matter being stricken by paragraph (6), by striking 303(g)
and inserting 303(h)
; and
section 1263(b) of division FF of Public Law 117–328 (136 Stat. 5685) is amended—
by striking 303(g)(2)
and inserting 303(h)(2)
; and
by striking (21 U.S.C. 823(g)(2))
and inserting (21 U.S.C. 823(h)(2))
.
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended—
by redesignating the second subsection designated as subsection (l) as subsection (m); and
in subsection (m)(1), as so redesignated—
in subparagraph (A)—
in clause (iv)—
in subclause (I)—
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
;
by striking or the Commission
and inserting the Commission
; and
by inserting , or the Council on Podiatric Medical Education
before the semicolon at the end; and
in subclause (III), by inserting or the American Academy of Family Physicians
after Association
; and
in clause (v), in the matter preceding subclause (I)—
by striking osteopathic medicine, dental surgery
and inserting osteopathic medicine, podiatric medicine, dental surgery
; and
by striking or dental medicine curriculum
and inserting or dental or podiatric medicine curriculum
; and
in subparagraph (B)—
in clause (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
by inserting , the American Academy of Family Physicians,
before or the Accreditation Council
; and
in clause (ii)—
by striking or accredited school
and inserting , an accredited school
; and
by inserting , or an accredited school of pharmacy
before in the United States
.
The amendment made by subsection (a) shall take effect as if enacted on December 29, 2022.
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
.
This title may be cited as the Pandemic and All-Hazards Preparedness and Response Act
.
Section 319(e) of the Public Health Service Act (42 U.S.C. 247d(e)) is amended—
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
;
in paragraph (2)(B)—
in the matter preceding clause (i), by striking tribal organization
and inserting Tribal organization, or the State or Tribal health official
; and
in clause (v), by striking tribal organization
and inserting Tribal organization or State or Tribal health official
;
in paragraph (6)—
in the matter preceding subparagraph (A)—
Reauthorization Act of 2013and inserting
and Response Act; and
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
in subparagraph (A), by inserting , including requests from State or Tribal health officials
before the semicolon;
in paragraph (7)(A), by striking tribal organization
and inserting Tribal organization
; and
in paragraph (8), by striking March 31, 2025
and inserting December 31, 2026
.
Section 319C–1 of the Public Health Service Act (42 U.S.C. 247d–3a) is amended—
in subsection (b)(2)—
in subparagraph (A)(ii), by striking influenza
and inserting response planning
; and
in subparagraph (H), by inserting , such as community-based organizations, including faith-based organizations, and other public and private entities
after stakeholders
;
in subsection (g)—
and the ability of each entity receiving an award under subsection (a) to respond to all-hazards threatsbefore the period at the end of the first sentence;
in paragraph (2)—
in the paragraph heading, by striking influenza
and inserting response
; and
in subparagraph (A)—
by striking to pandemic influenza
and inserting to a pathogen causing a pandemic, including pandemic influenza
; and
by striking such pandemic influenza
and inserting such pandemic response
;
in paragraph (5)—
in the paragraph heading, by striking influenza
and inserting pandemic response
;
2019and inserting
2026;
in subparagraph (A), by striking 2018
and inserting 2025
; and
in subparagraph (B), by striking pandemic influenza
and inserting a pathogen causing a pandemic
; and
in paragraph (6)—
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
in subparagraph (B), by inserting with respect to the requirements of this section or section 319C–2
after paragraph (5)
; and
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
.
Section 319C–2 of the Public Health Service Act (42 U.S.C. 247d–3b) is amended—
in subsection (b)(1)(A)—
; andand inserting a semicolon; and
one or more emergency medical service organizations; and
to the extent practicable, one or more emergency management organizations; and
in subsection (g)(1)—
by striking (1) Local response capabilities
and inserting:
extent practicable, ensureand inserting the following: “extent practicable—
by striking the period and inserting ; and
; and
by adding at the end the following:
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.
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)
.
in subsection (b)(2)—
in subparagraph (A), by striking and
at the end;
in subparagraph (B), by striking the period and inserting ; and
; and
by inserting at the end the following:
designate a lead entity to administer such award and support coordination between entities described in this subsection.
in subsection (g)(1), as amended by subsection (a)(1)(B), by adding at the end the following:
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.
in subsection (j)(1)—
for each of fiscal years 2019 through 2023and inserting
for each of fiscal years 2025 and 2026, to remain available through December 31, 2026; and
in subparagraph (B)(iii), by striking September 30, 2023
and inserting December 31, 2026
.
Section 319D(h) of the Public Health Service Act (42 U.S.C. 247d–4(h)) is amended—
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
in paragraph (2), by striking 2022 and 2023
and inserting 2025 and 2026, to remain available through December 31, 2026
.
in paragraph (2)(B)(i)—
in subclause (I), by striking and 2024
and inserting through 2025
; and
in subclause (II), by striking 2025
and inserting 2026
;
in paragraph (4)—
in subparagraph (G), by striking ; and
at the end and inserting a semicolon;
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
in subparagraph (I), as so redesignated, by striking State efforts
and inserting State or regional efforts
;
by redesignating paragraphs (5) through (9) as paragraphs (6) through (10), respectively;
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.
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
.
Section 2409(b) of the PREVENT Pandemics Act (Public Law 117–328) is amended—
; andand inserting a semicolon;
in paragraph (3), by striking the period and inserting ; and
; and
by adding at the end the following:
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).
To be eligible to receive an award under this section, an entity shall—
a description of activities proposed to be carried out pursuant to an award under subsection (a);
factors such entity proposes to use to select wastewater sampling sites;
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;
a plan to sustain such wastewater surveillance activities described in such application following the conclusion of the award period; and
any additional information the Secretary may require.
In making awards under subsection (a), the Secretary may give priority to eligible entities that have submitted an application that—
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
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.
establish or enhance existing capacity and capabilities to conduct wastewater sampling, testing, and related analysis;
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
implement projects that use evidence-based or innovative practices to conduct wastewater surveillance activities.
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.
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).
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.
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—
research to improve the efficiency and effectiveness of wastewater sample collection and analysis and increase the sensitivity and specificity of wastewater testing methods; and
implementation and development of evidence-based practices to facilitate the estimation of the incidence and prevalence of infectious disease within a community.
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.
Section 317S of the Public Health Service Act (42 U.S.C. 247b–21) is amended—
in subsection (a)(3)(A), by striking subsection (b)(3)
and inserting subsection (b)(4)
;
by redesignating paragraphs (3) through (6) as paragraphs (4) through (7), respectively; and
by inserting after paragraph (2) the following:
The Secretary may consider the use of innovative and novel technology for mosquito prevention and control in making grants under paragraph (1).
by amending subsection (d) to read as follows:
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.
in subsection (f)(1), by striking 2019 through 2023
and inserting 2025 and 2026, to remain available through December 31, 2026
.
Section 2811 of the Public Health Service Act (42 U.S.C. 300hh–10) is amended—
in subsection (b)—
in paragraph (3)—
by striking Oversee advanced research, development, and procurement
and inserting the following:
Oversee advanced research, development, procurement, and replenishment
by adding at the end the following:
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.
in paragraph (4)—
in subparagraph (F)—
in the matter preceding clause (i), by striking and in consultation with the Secretary of Homeland Security,
; and
in clause (i), by inserting enhance
after capabilities and
;
in subparagraph (G)—
in the matter preceding clause (i), by inserting the Office of Pandemic Preparedness and Response Policy,
after Veterans Affairs,
;
based onand inserting
based on—;
; andat the end and inserting a semicolon;
in clause (iii), by striking the period and inserting ; and
; and
by adding at the end the following:
that include, as appropriate, participation by relevant industry, academia, professional societies, and other stakeholders.
in subparagraph (H)—
by inserting and the Director of the Office of Pandemic Preparedness and Response Policy
after Security Affairs
; and
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;
the Director of the Office of Pandemic Preparedness and Response Policy,after
Security Affairs,; and
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
in paragraph (7)—
in the matter preceding subparagraph (A), by inserting and the requirements developed pursuant to paragraph (3)(B)
after subsection (d)
;
by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and
by inserting after subparagraph (D) the following:
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;
in subsection (d)—
by amending paragraph (1) to read as follows:
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.
in paragraph (2), in the matter preceding subparagraph (A), by inserting strategy and
before plan
; and
in subsection (f)—
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
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
.
Section 2802 of the Public Health Service Act (42 U.S.C. 300hh–1) is amended—
in subsection (a)(3)—
by striking In 2022, the
and inserting The
; and
by inserting , maintaining, and sustaining
after establishing
; and
in subsection (b)—
in paragraph (2)—
in subparagraph (A), by inserting that support interagency coordination and availability of information, as appropriate
before the period;
in subparagraph (B), by inserting rapid testing,
after and supplies,
;
in paragraph (3)—
in the matter preceding subparagraph (A), by inserting and blood banks
after dental health facilities
;
and current capacity of facilities within such systems, as applicablebefore the period; and
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;
in paragraph (5), by inserting applicable federally funded activities and
after (including
;
in paragraph (8)—
in subparagraph (A), by inserting public health and medical
before activities
; and
in subparagraph (B), by striking familiarity with
and inserting understanding of, and coordination between,
;
by redesignating paragraphs (9) and (10) as paragraphs (10) and (12), respectively;
by inserting after paragraph (8) the following:
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.
by inserting after subparagraph (10), as so redesignated, the following:
Assessing current and potential health security threats from natural disasters with respect to public health and medical preparedness and response.
by inserting after paragraph (12), as so redesignated, the following:
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.
by striking tribal
each place it appears and inserting Tribal
.
Section 319B of the Public Health Service Act (42 U.S.C. 247d–2) is amended to read as follows:
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.
The purpose of the plan under subsection (a) shall be to—
facilitate the development and utilization of diagnostic tests;
describe the processes for the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, and for rapid scaling of testing capacity; and
facilitate coordination and collaboration among public and private entities to improve the rapid development and utilization of diagnostic testing during a public health emergency.
The plan under subsection (a) shall take into consideration—
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;
novel technologies and platforms that—
may be used to improve testing capabilities, including—
high-throughput laboratory diagnostics;
point-of-care diagnostics; and
rapid at-home diagnostics;
improve the accessibility of diagnostic tests; and
facilitate the development and manufacture of diagnostic tests;
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);
strategies for the rapid and efficient distribution of tests locally, regionally, or nationwide and appropriate scaling of laboratory testing capacity; and
assessment of such strategies through drills and operational exercises carried out under section 2811(b)(4)(G), as appropriate.
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.
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.
in subsection (a)—
in paragraph (1), by inserting and activities
after Federal programs
;
in paragraph (2)—
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
by inserting , pursuant to paragraph (4),
after comprehensive plan
;
by amending paragraph (3) to read as follows:
The task force described in paragraph (1) shall consider factors the Secretary considers appropriate, including factors to—
slow the emergence of resistant bacteria and fungi and prevent the spread of resistant infections;
strengthen activities to combat resistance with respect to zoonotic diseases;
advance development and use of rapid and innovative capabilities, including diagnostic tests, for identification and characterization of resistant bacteria and fungi;
accelerate basic and applied research and development for new antibiotics, antifungals, and other related therapeutics and vaccines; and
support international collaboration and capacities for antimicrobial-resistance prevention, detection, and control.
by redesignating paragraph (4) as paragraph (5);
by inserting after paragraph (3) the following:
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—
by redesignating subsections (b) through (o) as subsections (c) through (p), respectively;
by inserting after subsection (a) the following:
The Secretary may continue the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, referred to in this subsection as the Advisory Council
.
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.
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).
The Advisory Council shall, to the greatest extent practicable, coordinate activities carried out by the Council with the task force established under subsection (a).
Chapter 10 of title 5, United States Code, shall apply to the activities and duties of the Advisory Council.
The Advisory Council under this subsection shall terminate on December 31, 2026.
in subsection (n), as so redesignated, by striking (f) through (j)
and inserting (g) through (k)
.
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
Section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) is amended—
in subsection (a)—
in paragraph (2)—
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
the emergency health security threat or threats such countermeasure procurement is intended to address, including—
whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats; and
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;
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
;
in subparagraph (I), by inserting , through a standard operating procedure,
after ensure
;
by inserting after subparagraph (G) the following:
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;
in subparagraph (K), as so redesignated, by striking ; and
at the end and inserting a semicolon;
in subparagraph (L), as so redesignated, by striking the period and inserting ; and
; and
by adding at the end the following:
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.
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
in paragraph (6)(A)—
by inserting after clause (vii) the following:
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—
in subsection (c)(2)(C), by striking promptly
and inserting , not later than 60 days after each such determination,
;
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
in subsection (g)(1), by striking 2019 through 2028
and inserting 2025 through 2034
.
Section 319L of the Public Health Service Act (42 U.S.C. 247d–7e) is amended—
; andand inserting a semicolon; and
by redesignating clause (iii) as clause (iv); and
by inserting after clause (ii) the following:
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
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
in paragraph (5), by adding at the end the following:
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.
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
in subsection (e)(1), by amending subparagraph (D) to read as follows:
This paragraph shall cease to have force or effect after December 31, 2026.
Section 2811–1 of the Public Health Service Act (42 U.S.C. 300hh–10a) is amended—
in subsection (b)—
by inserting after paragraph (10) the following:
The Director of the Biomedical Advanced Research and Development Authority.
The Director of the Strategic National Stockpile.
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
by inserting after subparagraph (C) the following:
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.
relevant stakeholders, including industry,after
consider input from; and
by adding at the end the following:
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.
Section 317G of the Public Health Service Act (42 U.S.C. 247b–8) is amended—
by striking The Secretary,
and inserting the following:
The Secretary,
by adding at the end the following:
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.
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—
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—
improving the quality and consistency of applicable procedures and practices within laboratories funded pursuant to subsection (a); and
ensuring coordination, as appropriate, of federally funded activities carried out at such laboratories.
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).
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).
the activities and accomplishments of the regional biocontainment laboratories;
any published or disseminated research findings based on research conducted in such laboratories in the applicable year;
oversight activities carried out by the Secretary pursuant to subsection (b);
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;
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
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.
Section 2315(c) of the PREVENT Pandemics Act (42 U.S.C. 6627) is amended to read as follows:
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).
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).
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—
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
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.
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).
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.
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.
The limitation under this subsection shall expire on December 31, 2026.
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.
If a special master determines that—
the special master shall, not later than 30 days after such determination, notify the petitioner of such determination.
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).
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.
in subsection (b)(4)—
by striking Except as provided
and inserting the following:
Except as provided
by adding at the end the following:
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.
in subsection (d)(3)—
by striking This section
and inserting the following:
This section
by adding at the end the following:
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).
Title XXI of the Public Health Service Act (42 U.S.C. 300aa–1 et seq.) is amended—
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
;
in section 2112(d) (42 U.S.C. 300aa–12(d))—
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
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)
;
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.
in section 2116 (42 U.S.C. 300aa–16), by adding at the end the following:
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.
Section 2111(a)(2)(A)(i) of the Public Health Service Act (42 U.S.C. 300aa–11(a)(2)(A)(i)) is amended—
in subclause (I), by striking , and
and inserting a semicolon;
in subclause (II)—
by moving the margin 2 ems to the right; and
by striking , or
and inserting ; and
; and
by adding at the end the following:
the judgment described in subclause (I) does not result from a petitioner's motion to dismiss the case; or
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).
.
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:
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.
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).
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).
The technical assistance described in paragraph (1) shall include—
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
assisting applicable entities, through contracts or cooperative agreements, as appropriate, in the implementation of such evidence-based strategies.
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).
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.).
Subsection (g) of section 2811A of the Public Health Service Act (42 U.S.C. 300hh–10b) is amended to read as follows:
The Advisory Committee shall terminate on December 31, 2026.
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).
Section 2811B of the Public Health Service Act (42 U.S.C. 300hh–10c) is amended—
in subsection (d)—
and departmentsafter
agencies; and
17 membersand inserting
25 members; and
in paragraph (2)—
by striking subparagraphs (J) and (K);
by redesignating subparagraphs (A) through (I) and (L) as clauses (i) through (x), respectively, and adjusting the margins accordingly;
by inserting before clause (i), as so redesignated, the following:
The Federal members shall include the following:
by inserting before subparagraph (B), as so designated, the following:
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:
by amending subsection (g) to read as follows:
The Advisory Committee shall terminate on December 31, 2026.
Section 2811C of the Public Health Service Act (42 U.S.C. 300hh–10d) is amended—
by inserting after subsection (b) the following:
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.
in paragraph (1), by striking 17 members
and inserting 25 members
;
in paragraph (2)—
by striking subparagraphs (K) through (M);
by inserting before clause (i), as so redesignated, the following:
The Federal members shall include the following:
by adding at the end of subparagraph (B), as so designated, the following:
Representatives of such other Federal agencies as the Secretary determines necessary to fulfill the duties of the Advisory Committee.
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:
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.
Other members as the Secretary determines appropriate, of whom—
at least one such member shall represent a local, State, or national organization with expertise in individuals with disabilities;
at least one such member shall be an individual with a disability; and
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.
by adding at the end the following:
In appointing members, including the Chair, to the Committee under this subsection, the Secretary may give consideration to disability status.
by amending subsection (h), as so redesignated, to read as follows:
The Advisory Committee shall terminate on December 31, 2026.
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—
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;
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;
the relative effectiveness and efficiency of such alternative models in stimulating innovation, compared to the status quo that includes patents and regulatory exclusivities;
strategies to implement such alternative models described in paragraph (1), including a phased transition; and
the anticipated economic and societal impacts of such alternative models, including an assessment of impact on—
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;
the rate at which new drugs would be developed, approved, and marketed in the United States;
access to medication;
average lifespan and disease burden in the United States;
the number of manufacturers that would be seeking approval for a drug or bringing a drug to market for the first time;
Federal discretionary and mandatory spending; and
public and private insurance markets.
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.
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).
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
.
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
.
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
.
Section 319C–3 of the Public Health Service Act (42 U.S.C. 247d–3c) is amended—
in subsection (b)(3), by striking under the
and all that follows through such Act)
and inserting under law
; and
in subsection (e)(2), by striking September 30, 2023
and inserting December 31, 2026
.
Section 319I of the Public Health Service Act (42 U.S.C. 247d–7b) is amended—
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
in subsection (k), by striking 2019 through 2023
and inserting 2025 and 2026, to remain available through December 31, 2026
.
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
.
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
.
Section 2812 of the Public Health Service Act (42 U.S.C. 300hh–11) is amended—
in subsection (c)(4)(B), by striking March 31, 2025
and inserting December 31, 2026
; and
$57,400,000 for each of fiscal years 2019 through 2023and inserting
$65,900,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026.
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
.
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
.
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
.
fiscal years 2019 through 2023and inserting
fiscal years 2025 through 2029.
Section 2and inserting
Section 3.
Section 5(a) of the PREEMIE Reauthorization Act of 2018 (Public Law 115–328) is amended by striking Bipartisan Health Care ActThe 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
.
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
upon completion of the study under subparagraph (A)—
approve by consensus a report on the results of such study;
an assessment of each of the topics listed in paragraph (2);
the analysis required by paragraph (3); and
the raw data used to develop such report; and
the Secretary of Health and Human Services;
the Committee on Energy and Commerce of the House of Representatives; and
the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate.
an analysis of stays in neonatal intensive care units and the cost of such stays;
long-term costs of stays in such units to society and the family involved post-discharge; and
health care costs for families post-discharge from such units (such as medications, therapeutic services, co-payments for visits, and specialty equipment).
opportunities to improve maternal and infant health; and
opportunities for public health programs to provide support and resources for parents in-hospital, in non-hospital settings, and post-discharge.
State and other programs’ best practices with respect to reducing premature birth rates; and
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.
(including obstetricians and gynecologists)after
clinical specialties; and
as applicableand inserting
if available; and
, as appropriateand 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.
$58,000,000 for each of fiscal years 2019 through 2023and inserting
$100,000,000 for each of fiscal years 2025 through 2029.
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
;
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
;
in paragraph (3)—
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
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
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
.
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.
in subsection (a), by inserting and prevalence
after incidence
;
in subsection (b)—
in paragraph (1), by inserting and reduction of associated injuries and fatalities
before the semicolon;
in paragraph (2), by inserting and related risk factors
before the semicolon; and
in paragraph (3)—
in the matter preceding subparagraph (A), by striking 2020
each place it appears and inserting 2030
; and
in subparagraph (A)—
in clause (i), by striking ; and
and inserting a semicolon;
by redesignating clause (ii) as clause (iv);
by inserting after clause (i) the following:
populations at higher risk of traumatic brain injury, including populations whose increased risk is due to occupational or circumstantial factors;
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
in subsection (c), by inserting , and other relevant Federal departments and agencies
before the period at the end.
by amending the section heading to read as follows: The Bill Pascrell, Jr., national program for traumatic brain injury surveillance and registries
;
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,
;
, including the occupation of the individual, when relevant to the circumstances surrounding the injurybefore the semicolon; and
in paragraph (4), by inserting short- and long-term
before outcomes
;
by striking subsection (b);
by redesignating subsection (c) as subsection (b);
in subsection (b), as so redesignated, by inserting and evidence-based practices to identify and address concussion
before the period at the end; and
by adding at the end the following:
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.
Section 394A of the Public Health Service Act (42 U.S.C. 280b–3) is amended—
in subsection (a), by striking 1994, and
and inserting 1994,
; and
in subsection (b), by striking 2020 through 2024
and inserting 2025 through 2029
.
in subsection (b)(2)—
by inserting , taking into consideration populations that may be at higher risk for traumatic brain injuries
after outreach programs
; and
by inserting Tribal,
after State,
;
in subsection (c), by adding at the end the following:
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.
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.
(such as third party payers, State agencies, community-based providers, schools, and educators); and
by inserting (such as third party payers, State agencies, community-based providers, schools, and educators)
after professionals
;
in subsection (h), by striking paragraphs (1) and (2) and inserting the following:
The terms American Indian consortium and State have the meanings given such terms in section 1253.
does not include brain dysfunction caused by congenital or degenerative disorders, or birth trauma.
in subsection (i), by striking 2020 through 2024
and inserting 2025 through 2029
.
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
.
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—
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—
examine the incidence and prevalence of long-term or chronic symptoms or conditions in individuals who have experienced a traumatic brain injury;
examine the evidence base of research related to the chronic effects of traumatic brain injury across the lifespan;
examine any correlations between traumatic brain injury and increased risk of other conditions, such as dementia and mental health conditions;
assess existing services available for individuals with such long-term or chronic symptoms or conditions; and
identify any gaps in research related to such long-term or chronic symptoms or conditions of individuals who have experienced a traumatic brain injury.
Not later than 2 years after the date of enactment of this Act, the Secretary shall—
submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report detailing the findings, conclusions, and recommendations of the study described in paragraph (1); and
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
.
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
.
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
.
Section 3 of the Dr. Lorna Breen Health Care Provider Protection Act (Public Law 117–105) is amended—
in subsection (b), by inserting and annually thereafter,
after of this Act,
; and
in subsection (c), by striking 2022 through 2024
and inserting 2025 through 2029
.
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—
by redesignating such section 764 as section 764A;
in subsection (a)(3)—
to eligible entities inand inserting “to eligible entities that—
are in
by striking the period and inserting ; or
; and
by adding at the end the following:
have a focus on the reduction of administrative burden on health care workers.
not less thanafter
period of; and
in subsection (f), by striking 2022 through 2024
and inserting 2025 through 2029
.
Title XV of the Public Health Service Act (42 U.S.C. 300k et seq.) is amended—
in section 1501 (42 U.S.C. 300k)—
in subsection (a)—
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
;
in paragraph (3), by striking programs for the detection and control
and inserting for the prevention, detection, and control
;
in paragraph (4), by striking the detection and control
and inserting the prevention, detection, and control
;
in paragraph (5)—
by striking monitor
and inserting ensure
; and
by striking ; and
and inserting a semicolon;
by redesignating paragraph (6) as paragraph (9);
by inserting after paragraph (5) the following:
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;
to reduce disparities in breast and cervical cancer incidence, morbidity, and mortality, including in populations with higher than average rates;
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
in paragraph (9), as so redesignated, by striking through (5)
and inserting through (8)
; and
by striking subsection (d);
in section 1503 (42 U.S.C. 300m)—
in subsection (a)—
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
;
by striking paragraphs (2) and (4);
by redesignating paragraph (3) as paragraph (2); and
in paragraph (2), as so redesignated, by striking ; and
and inserting a period; and
by striking subsection (d);
in section 1508(b) (42 U.S.C. 300n–4(b))—
by striking Bipartisan Health Care Act1 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
;
by striking Labor and Human Resources
and inserting Health, Education, Labor, and Pensions
; and
by striking Bipartisan Health Care Actpreceding fiscal year
and inserting preceding 2 fiscal years in the case of the first report after the date of enactment of the
; and
in section 1510(a) (42 U.S.C. 300n–5(a))—
2011, andand inserting
2011,; and
, and $235,500,000 for each of fiscal years 2025 through 2029before the period at the end before the period at the end.
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—
an estimate of the number of individuals eligible for services provided under such program;
a summary of trends in the number of individuals served through such program; and
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.
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:
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
.
The program under subsection (a) shall include—
high-risk, high reward research on the effects of trisomy 21 on human development and health;
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;
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;
research on the biological mechanisms in individuals with Down syndrome pertaining to structural, functional, and behavioral anomalies and dysfunction as well as stunted growth;
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;
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
The Director of NIH shall ensure that—
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
such institutes and centers, prioritize, as appropriate, Down syndrome research that does not duplicate existing research activities of the National Institutes of Health.
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.
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.
Each report under paragraph (1) shall include—
identification of the institute or center involved;
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
identification of any resulting real-world evidence that is or may be used for clinical research and medical care for patients with Down syndrome.
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:
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
).
The Initiative shall—
advance research to—
reduce preventable causes of maternal mortality and severe maternal morbidity;
reduce health disparities related to maternal health outcomes, including such disparities associated with medically underserved populations; and
improve health for pregnant and postpartum women before, during, and after pregnancy;
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
target health disparities associated with maternal mortality and severe maternal morbidity by—
implementing and evaluating community-based interventions for disproportionately affected women; and
identifying risk factors and the underlying biological mechanisms associated with leading causes of maternal mortality and severe maternal morbidity in the United States.
The authority under this section shall expire on September 30, 2029.
Section 372 of the Public Health Service Act (42 U.S.C. 274) is amended—
in subsection (b)(2)—
by moving the margins of subparagraphs (M) through (O) 2 ems to the left;
in subparagraph (A)—
in clause (i), by striking , and
and inserting ; and
; and
in clause (ii), by striking the comma at the end and inserting a semicolon;
in subparagraph (C), by striking twenty-four-hour telephone service
and inserting 24-hour telephone or information technology service
;
in each of subparagraphs (B) through (M), by striking the comma at the end and inserting a semicolon;
in subparagraph (N), by striking transportation, and
and inserting transportation;
;
in subparagraph (O), by striking the period and inserting a semicolon; and
by adding at the end the following:
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
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.
by adding at the end the following:
The Secretary may collect the registration fees under paragraph (1) directly or through awards made under subsection (b)(1)(A).
Any amounts collected under this subsection shall—
be credited to the currently applicable appropriation, account, or fund of the Department of Health and Human Services as discretionary offsetting collections; and
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).
The Secretary shall—
promptly post on the website of the Organ Procurement and Transplantation Network—
the amount of registration fees collected under this subsection from each member of the Organ Procurement and Transplantation Network; and
a list of activities such fees are used to support; and
update the information posted pursuant to subparagraph (A), as applicable for each calendar quarter for which fees are collected under paragraph (1).
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—
conduct a review concerning the activities under this subsection; and
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.
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
.Section 377 of the Public Health Service Act (42 U.S.C. 274f) is amended—
by redesignating subsections (c) through (f) as subsections (d) through (g), respectively;
by inserting after subsection (b) the following:
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.
in subsection (f), as so redesignated—
in paragraph (1), by striking subsection (c)(1)
and inserting subsection (d)(1)
; and
in paragraph (2), by striking subsection (c)(2)
and inserting subsection (d)(2)
.
Section 377(e) of the Public Health Service Act (42 U.S.C. 274f(e)), as redesignated by subsection (a)(1), is amended—
in paragraph (1), by adding or
at the end;
in paragraph (2), by striking ; or
and inserting a period; and
by striking paragraph (3).
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:
Not later than December 31 of each year, beginning in fiscal year 2026, the Secretary shall—
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
include in each such report—
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
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.
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.
.
Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(3)) is amended—
by redesignating subparagraphs (B) and (C) as subparagraphs (C) and (D), respectively; and
by striking subparagraph (A) and inserting the following:
For purposes of paragraph (1)(B), the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation of—
the drug or biological product for which the application referred to in such paragraph is submitted; or
such drug or biological product used in combination with—
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
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
that is directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.
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—
a single new active ingredient; or
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.
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.
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.
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)..
Section 505B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended—
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
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)
.
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
not later than 12 months after closing the comment period on such draft guidance, finalize such guidance.
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.
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).
Section 505B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)) is amended—
in paragraph (1), by striking Beginning 270
and inserting Noncompliance letter.—Beginning 270
;
in paragraph (2)—
by striking The drug or
and inserting Effect of noncompliance.—The drug or
; and
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
by adding at the end the following:
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.
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:
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—
issue a noncompliance letter pursuant to paragraph (1);
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
after reviewing such written response, determine whether the person demonstrated a lack of due diligence in satisfying such requirement.
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
.
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.
Section 508(b) of the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 355c–1(b)) is amended—
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;
;
in paragraph (15), by striking and
at the end;
in paragraph (16), by striking the period at the end and inserting ; and
; and
by adding at the end the following:
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
December 20, 2024, unlessand all that follows through the period at the end and inserting
September 30, 2029..
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:
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.
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
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).
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.
The value of such priority review voucher if transferred.
Identification of each drug for which a priority review voucher awarded under such section 529 was used.
The size of the company using each priority review voucher awarded under such section 529.
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.
The impact of such priority review vouchers on the workload, review process, and public health prioritization efforts of the Food and Drug Administration.
Any other incentives in Federal law that exist for companies developing drugs or biological products described in clause (i).
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
;
in subsection (b)—
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
in paragraph (1), by inserting , relating to the approved use or indication,
after the needs
;
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
by adding at the end the following:
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.
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).
select the location of the Abraham Accords Office in an Abraham Accords country; and
establish such office; and
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.
In this section, the term Abraham Accords country means a country identified by the Department of State as having signed the Abraham Accords Declaration.
Nothing in this section shall be construed to require any action inconsistent with a national security recommendation provided by the Federal Government.
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—
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 XXVII of the Public Health Service Act (42 U.S.C. 300gg et seq.) is amended—
in part D (42 U.S.C. 300gg–111 et seq.), by adding at the end the following new section:
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—
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
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).
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).
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—
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—
a list of drugs for which a claim was filed and, with respect to each such drug on such list—
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;
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);
for each such claim, the difference between the amount paid under subclause (I) and the amount paid under subclause (II);
the proprietary name, established name or proper name, and the National Drug Code;
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;
with respect to each drug dispensed, for each type of dispensing channel (including retail, mail order, or specialty pharmacy)—
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
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
the total number of—
prescription claims (including original prescriptions and refills);
participants and beneficiaries for whom a claim for such drug was filed through the applicable dispensing channel;
dosage units and dosage units per fill of such drug; and
days supply of such drug per fill;
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;
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;
the total net spending on the drug;
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;
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—
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;
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—
the total gross spending on drugs in such class before rebates, price concessions, alternative discounts, or other remuneration from applicable entities;
the net spending in such class after such rebates, price concessions, alternative discounts, or other remuneration from applicable entities;
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—
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;
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;
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
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;
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—
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—
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;
the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan or coverage; and
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—
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;
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;
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
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
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—
with respect to drugs covered by such plan or coverage during such reporting period—
the total net spending by the plan or coverage for all such drugs;
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
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;
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—
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;
consideration of the entity providing pharmacy benefit management services by the group health plan or health insurance issuer; or
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
total gross spending on all drugs under the plan or coverage during the reporting period.
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).
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.
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).
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.
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.
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—
prevent disclosure for the purposes of subsection (c), or any other public disclosure requirement under this section.
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.
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).
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.
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—
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.
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.
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.
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.
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.
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.
In this section:
The term applicable entity means—
an applicable group purchasing organization, drug manufacturer, distributor, wholesaler, rebate aggregator (or other purchasing entity designed to aggregate rebates), or associated third party;
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
such other entity as the Secretary may specify through rulemaking.
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.
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.
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.
The term plan sponsor has the meaning given such term in section 3(16)(B) of the Employee Retirement Income Security Act of 1974.
The term remuneration has the meaning given such term by the Secretary through rulemaking, which shall be reevaluated by the Secretary every 5 years.
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.
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.
The term wholesale acquisition cost has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act.
in section 2723 (42 U.S.C. 300gg–22)—
in subsection (a)—
in paragraph (1), by inserting (other than section 2799A–11)
after part D
; and
in paragraph (2), by inserting (other than section 2799A–11)
after part D
; and
in subsection (b)—
in paragraph (1), by inserting (other than section 2799A–11)
after part D
;
in paragraph (2)(A), by inserting (other than section 2799A–11)
after part D
; and
in paragraph (2)(C)(ii), by inserting (other than section 2799A–11)
after part D
.
Subtitle B of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1021 et seq.) is amended—
in subpart B of part 7 (29 U.S.C. 1185 et seq.), by adding at the end the following:
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—
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
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).
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).
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—
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—
a list of drugs for which a claim was filed and, with respect to each such drug on such list—
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;
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);
for each such claim, the difference between the amount paid under subclause (I) and the amount paid under subclause (II);
the proprietary name, established name or proper name, and the National Drug Code;
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;
with respect to each drug dispensed, for each type of dispensing channel (including retail, mail order, or specialty pharmacy)—
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
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
the total number of—
prescription claims (including original prescriptions and refills);
participants and beneficiaries for whom a claim for such drug was filed through the applicable dispensing channel;
dosage units and dosage units per fill of such drug; and
days supply of such drug per fill;
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;
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;
the total net spending on the drug;
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;
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—
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;
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—
the total gross spending on drugs in such class before rebates, price concessions, alternative discounts, or other remuneration from applicable entities;
the net spending in such class after such rebates, price concessions, alternative discounts, or other remuneration from applicable entities;
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—
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;
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;
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
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;
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—
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—
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;
the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan or coverage; and
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—
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;
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;
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
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
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—
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;
with respect to drugs covered by such plan or coverage during such reporting period—
the total net spending by the plan or coverage for all such drugs;
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
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;
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—
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;
consideration of the entity providing pharmacy benefit management services by the group health plan or health insurance issuer; or
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
total gross spending on all drugs under the plan or coverage during the reporting period.
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).
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.
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).
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.
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.
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—
prevent disclosure for the purposes of subsection (c), or any other public disclosure requirement under this section.
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.
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).
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.
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—
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.
In this section:
The term applicable entity means—
an applicable group purchasing organization, drug manufacturer, distributor, wholesaler, rebate aggregator (or other purchasing entity designed to aggregate rebates), or associated third party;
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
such other entity as the Secretary may specify through rulemaking.
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.
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.
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.
The term plan sponsor has the meaning given such term in section 3(16)(B).
The term remuneration has the meaning given such term by the Secretary through rulemaking, which shall be reevaluated by the Secretary every 5 years.
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.
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.
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)).
in section 502 (29 U.S.C. 1132)—
in subsection (a)(6), by striking or (9)
and inserting (9), or (13)
;
under subsection (c)(9)and inserting
under paragraphs (9) and (13) of subsection (c); and
in subsection (c), by adding at the end the following:
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.
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.
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.
in section 732(a) (29 U.S.C. 1191a(a)), by striking section 711
and inserting sections 711 and 726
.
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:
Chapter 100 of the Internal Revenue Code of 1986 is amended—
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—
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
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).
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).
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—
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—
a list of drugs for which a claim was filed and, with respect to each such drug on such list—
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;
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);
for each such claim, the difference between the amount paid under subclause (I) and the amount paid under subclause (II);
the proprietary name, established name or proper name, and the National Drug Code;
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;
with respect to each drug dispensed, for each type of dispensing channel (including retail, mail order, or specialty pharmacy)—
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
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
the total number of—
prescription claims (including original prescriptions and refills);
participants and beneficiaries for whom a claim for such drug was filed through the applicable dispensing channel;
dosage units and dosage units per fill of such drug; and
days supply of such drug per fill;
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;
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;
the total net spending on the drug;
the total amount received, or expected to be received, by the plan from any applicable entity in rebates, fees, alternative discounts, or other remuneration;
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—
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;
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—
the total gross spending on drugs in such class before rebates, price concessions, alternative discounts, or other remuneration from applicable entities;
the net spending in such class after such rebates, price concessions, alternative discounts, or other remuneration from applicable entities;
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—
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;
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;
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
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;
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—
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—
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;
the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan; and
a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan, and, with respect to each drug dispensed—
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;
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;
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
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
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—
with respect to drugs covered by such plan during such reporting period—
the total net spending by the plan for all such drugs;
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
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;
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—
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;
consideration of the entity providing pharmacy benefit management services by the group health plan; or
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
total gross spending on all drugs under the plan during the reporting period.
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).
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.
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).
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.
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.
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—
prevent disclosure for the purposes of subsection (c), or any other public disclosure requirement under this section.
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.
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).
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.
A group health plan, upon request of a participant or beneficiary, shall provide to such participant or beneficiary—
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.
In this section:
The term applicable entity means—
an applicable group purchasing organization, drug manufacturer, distributor, wholesaler, rebate aggregator (or other purchasing entity designed to aggregate rebates), or associated third party;
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
such other entity as the Secretary may specify through rulemaking.
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.
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.
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.
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)).
The term remuneration has the meaning given such term by the Secretary, through rulemaking, which shall be reevaluated by the Secretary every 5 years.
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.
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.
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)).
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
.
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..
by redesignating subclauses (II) through (IV) as subclauses (III) through (V), respectively;
in subclause (I)—
subclause (II)and inserting
subclause (III); and
by striking subclauses (II) and (III)
and inserting subclauses (III) and (IV)
; and
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:
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—
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.
For purposes of this subparagraph—
the terms applicable entity and applicable group purchasing organization have the meanings given such terms in section 726(e);
the terms covered plan, covered service provider, and responsible plan fiduciary have the meanings given such terms in subparagraph (B); and
the terms group health insurance coverage, health insurance coverage, and health insurance issuer have the meanings given such terms in section 733.
Brokerage services,and inserting
Services (including brokerage services),; and
in subitem (BB)—
by striking Consulting,
and inserting Other services,
; and
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.
.
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.
by striking requirements of this clause
and inserting requirements of this subparagraph
; and
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.
.
and the terms health insurance coverage and health insurance issuer have the meanings given such terms in section 733(b).
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
.
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.
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—
the ingredient or ingredients that cause such drug not to be qualitatively or quantitatively the same as the listed drug; and
for any ingredient for which there is an identified quantitative deviation, the amount of such deviation.
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
the Secretary makes a written determination that the prior determination must be changed because an error has been identified.
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.
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.
publish draft guidance;
provide a period of at least 60 days for comment on the draft guidance; and
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.
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.
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
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.
Section 223(c)(2)(E)(ii) of the Internal Revenue Code of 1986 is amended to read as follows:
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.
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.
For purposes of this clause, the term eligible plan year means plan years beginning—
after December 31, 2024, and before January 1, 2027.