(1)

Section 1902(a)(77) of the Social Security Act (42 U.S.C. 1396a(a)(77)) is amended by inserting enrollment, after screening,.

(2)

The subsection heading for section 1902(kk) of such Act (42 U.S.C. 1396a(kk)) is amended by inserting enrollment, after screening,.

(3)

Section 2107(e)(1)(G) of such Act (42 U.S.C. 1397gg(e)(1)(G)) is amended by inserting enrollment, after screening,.

(1) In general

Section 1915(c) of the Social Security Act (42 U.S.C. 1396n(c)) is amended—

(2) Conforming amendments

Section 1915 of the Social Security Act (42 U.S.C. 1396n) is amended—

(1)

in paragraph (2)(E), by inserting , and the information specified in paragraph (12)(C)(v), when applicable after paragraph (11); and

(2)

by adding at the end the following new paragraph:

(12) Demonstration program to expand coverage for home or community-based services

(A) In general

(i) Approval

Not later than 24 months after the date on which the planning grants under subparagraph (B) are awarded, notwithstanding paragraph (1), the Secretary may approve a waiver that is standalone from any other waiver approved under this subsection for not more than 5 States, selected in accordance with clause (ii), to include as medical assistance under the State plan of such State, for the 3-year period beginning on the date of such approval, payment for part or all of the cost of home or community-based services (other than room and board (as described in paragraph (1))) approved by the Secretary which are provided pursuant to a written plan of care to individuals described in subparagraph (C)(iii).

(ii) Selection criteria

In selecting States for purposes of clause (i), the Secretary shall—

(I)

only select States that received a planning grant under subparagraph (B);

(II)

only select States that meet the requirements specified in subparagraph (C) and such other requirements as the Secretary may determine appropriate;

(III)

select States in a manner that ensures geographic diversity;

(IV)

give preference to States with a higher percentage (relative to other States that apply to be selected for purposes of clause (i)) of the total State population residing in rural areas (as determined by the Secretary);

(V)

give preference to States that have demonstrated more progress in rebalancing long-term services and supports systems under this title, as determined based on the relative share of individuals who use home or community-based services (as defined by the Secretary) under this title as a percentage of total individuals who use long-term services and supports (as defined by the Secretary) under this title (in the most recent year for which such data is available); and

(VI)

give preference to States that pursue a waiver under this paragraph that incorporates the provision of mental health services for adults with serious mental illness, children with serious emotional disturbances, or individuals with substance use disorder.

(B) Planning grants

(i) In general

(I) Approval

Not later than 18 months after the date of the enactment of this paragraph, the Secretary shall award planning grants of not more than $5,000,000 each to not more than 10 States for purposes of preparing to submit a request for a waiver under this subsection (including for costs to implement the waiver or other activities to expand the provision of home or community-based services under this section) to provide home or community-based services to individuals described in subparagraph (C)(iii).

(II) Selection criteria

In awarding planning grants under subclause (I), the Secretary shall use the selection criteria specified in subclauses (III) through (VI) of subparagraph (A)(ii).

(ii) Consultation

A State that is awarded a planning grant under clause (i) shall, in preparing to submit a request for a waiver described in such clause, consult with—

(I)

individuals in need of (and not receiving) home or community-based services, individuals receiving home or community-based services, and the caregivers of such individuals;

(II)

providers furnishing home or community-based services; and

(III)

such other stakeholders, as the Secretary may specify.

(C) State requirements

In addition to the requirements specified under this subsection (except for the requirements described in subparagraphs (C) and (D) of paragraph (2) and any other requirement the Secretary determines to be inapplicable in the context of a waiver relation to individuals who do not require the level of care described in paragraph (1)), the requirements specified in this paragraph are, with respect to a State, the following:

(i)

As of the date that such State requests a waiver under this subsection to provide home or community-based services to individuals described in clause (iii), all other waivers (if any) granted under this subsection to such State meet the requirements of this subsection.

(ii)

The State demonstrates to the Secretary that approval of a waiver under this subsection with respect to individuals described in clause (iii) will not result in a material increase of the average amount of time that individuals with respect to whom a determination described in paragraph (1) has been made will need to wait to receive home or community-based services under any waiver granted under this subsection, as determined by the Secretary.

(iii)

The State establishes needs-based criteria, subject to the approval of the Secretary, to identify individuals for whom a determination described in paragraph (1) is not applicable, who will be eligible for home or community-based services under a waiver approved under this paragraph, and specifies the home or community-based services such individuals so eligible will receive.

(iv)

The State established needs-based criteria for determining whether an individual described in clause (iii) requires the level of care provided in a hospital, nursing facility, or an intermediate care facility for individuals with developmental disabilities under the State plan or under any waiver of such plan that are more stringent than the needs-based criteria established under clause (iii) for determining eligibility for home or community-based services.

(v)

The State attests that the State's average per capita expenditure for medical assistance under the State plan (or waiver of such plan) provided with respect to such individuals enrolled in a waiver under this paragraph will not exceed the State's average per capita expenditures for medical assistance for individuals receiving institutional care under the State plan (or waiver of such plan) for the duration that the waiver under this paragraph is in effect.

(vi)

The State provides to the Secretary data (in such form and manner as the Secretary may specify) regarding the number of individuals described in clause (i) with respect to a State seeking approval of a waiver under this subsection, to whom the State will make such services available under such waiver.

(vii)

The State agrees to provide to the Secretary, not less frequently than annually, data for purposes of paragraph (2)(E) (in such form and manner as the Secretary may specify) regarding, with respect to each preceding year in which a waiver under this subsection to provide home and community-based services to individuals described in clause (iii) was in effect—

(I)

the cost (as such term is defined by the Secretary) of such services furnished to individuals described in clause (iii), broken down by type of service;

(II)

with respect to each type of home and community-based service provided under the waiver, the length of time that such individuals have received such service;

(III)

a comparison between the data described in subclause (I) and any comparable data available with respect to individuals with respect to whom a determination described in paragraph (1) has been made and with respect to individuals receiving institutional care under this title; and

(IV)

the number of individuals who have received home and community-based services under the waiver during the preceding year.

(1) In general

There are appropriated, out of any funds in the Treasury not otherwise obligated, $71,000,000 for fiscal year 2025, to remain available until expended, to the Secretary of Health and Human Services for purposes of carrying out subsection (d) and the amendments made by subsection (b).

(2) Reservation for planning grants

Of the amount appropriated under paragraph (1), the Secretary of Health and Human Services shall reserve $50,000,000 of such amount to award planning grants under the demonstration program established by the amendments made by subsection (b).

(1) In general

Section 1902(a)(10)(A)(ii)(XV) of the Social Security Act (42 U.S.C. 1396a(a)(10)(A)(ii)(XV)) is amended by striking but less than 65,.

(2) Definition modification

Section 1905(v)(1)(A) of the Social Security Act (42 U.S.C. 1396d(v)(1)(A)) is amended by striking , but less than 65,.

(1)

in subsection (a)—

(2)

by adding at the end the following new subsection:

(uu) Active duty relocated individual; home and community-Based services waiting list

For purposes of subsection (a)(88) and this subsection:

(1) Active duty relocated individual

The term active duty relocated individual means an individual—

(A)

who—

(i)

is enrolled under the State plan (or waiver of such plan); or

(ii)

with respect to an individual described in subparagraph (C)(ii), would be so enrolled pursuant to subsection (a)(10)(A)(ii)(VI) if such individual began receiving home and community-based services;

(B)

who—

(i)

is a member of the Armed Forces engaged in active duty service and is relocated to another State (in this subsection referred to as the military service relocation State) by reason of such service;

(ii)

would be described in clause (i) except that the individual stopped being engaged in active duty service (including by reason of retirement from such service) and the last day on which the individual was engaged in active duty service occurred not more than 12 months ago; or

(iii)

is a dependent (as defined by the Secretary) of a member described in clause (i) or (ii) who relocates to the military service relocation State with such member; and

(C)

who—

(i)

was receiving home and community-based services (as defined in section 9817(a)(2)(B) of the American Rescue Plan Act of 2021) at the time of such relocation; or

(ii)

if the State maintains a home and community-based services waiting list, was on such home and community-based services waiting list at the time of such relocation.

(2) Home and community-based services waiting list

The term home and community-based services waiting list means, in the case of a State that has a limit on the number of individuals who may receive home and community-based services under section 1115(a), section 1915(c), or section 1915(j), a list maintained by such State of individuals who are requesting to receive such services under 1 or more such sections but for whom the State has not yet completed an assessment and rendered a decision with respect to the eligibility of such individuals to receive the relevant home and community-based services at the time a slot for such services becomes available due to such limit.

(1)

in paragraph (87), by striking and at the end;

(2)

in paragraph (88), by striking the period at the end and inserting ; and; and

(3)

by inserting after paragraph (88) the following new paragraph:

(89)

beginning January 1, 2026, provide for a process to regularly obtain address information for individuals enrolled under such plan (or a waiver of such plan) from reliable data sources (as described in section 435.919(f)(1)(iii) of title 42, Code of Federal Regulations (or a successor regulation)) and act on any changes to such an address based on such information in accordance with such section (or successor regulation), except that this paragraph shall only apply in the case of the 50 States and the District of Columbia.

(1)

by redesignating subparagraphs (H) through (U) as subparagraphs (I) through (V), respectively; and

(2)

by inserting after subparagraph (G) the following new subparagraph:

(H)

Section 1902(a)(89) (relating to regularly obtaining address information for enrollees).

(A)

in paragraph (88), by striking ; and and inserting a semicolon;

(B)

in paragraph (89), by striking the period at the end and inserting ; and; and

(C)

by inserting after paragraph (89) the following new paragraph:

(90)

provide that the State shall comply with the eligibility verification requirements under subsection (vv), except that this paragraph shall apply only in the case of the 50 States and the District of Columbia.; and

(1)

by striking The amendments made by this section and inserting the following:

(1) In general

Subject to paragraph (2), the amendments made by this section; and

(2)

by adding at the end the following new paragraph:

(2) Delay of date by which States must comply with certain juvenile justice-related requirements

A State shall not be regarded as failing to comply with the requirements of section 1902(a)(84)(D) or 2102(d)(2) of the Social Security Act (42 U.S.C. 1396a(a)(84)(D), 1397bb(d)(2)) before January 1, 2026.

(1) Medicaid

(2) CHIP

(3) Effective date

The amendments made by this subsection shall take effect as if enacted on December 29, 2022.

(1) In general

Not later than 24 months after the date of enactment of this Act, and every 5 years thereafter, each State (as such term is defined in section 1101(a)(1) of the Social Security Act (42 U.S.C. 1301(a)(1)) for purposes of titles XIX and XXI of such Act) shall conduct a study on the costs of providing maternity, labor, and delivery services in applicable hospitals (as defined in paragraph (3)) and submit the results of such study to the Secretary of Health and Human Services (referred to in this section as the Secretary).

(2) Content of study

A State study required under paragraph (1) shall include the following information (to the extent practicable) with respect to maternity, labor, and delivery services furnished by applicable hospitals located in the State:

(3) Applicable hospital defined

For purposes of this subsection, the term applicable hospital means any hospital located in a State that meets either of the following criteria:

(4) Assistance to small hospitals in compiling cost information

There are appropriated to the Secretary for fiscal year 2025, $10,000,000 for the purpose of providing grants and technical assistance to a hospital described in paragraph (3)(B) to enable such hospital to compile detailed information for use in the State studies required under paragraph (1), to remain available until expended.

(5) HHS report on State studies

For each year in which a State is required to conduct a study under paragraph (1), the Secretary shall issue, not later than 12 months after the date on which the State submits to the Secretary the data described in such paragraph, a publicly available report that compiles and details the results of such study and includes the information described in paragraph (2).

(1)

in the heading, by striking 2025 and inserting 2026 and for the 1st quarter of fiscal year 2027;

(2)

by striking fiscal year 2025 and inserting fiscal year 2026; and

(3)

by inserting , and the DSH allotment for Tennessee for the 1st quarter of fiscal year 2027, shall be $13,275,000 before the period.

(1)

in paragraph (7)(A)—

(2)

in paragraph (8), by striking 2027 and inserting 2028.

(1)

in paragraph (1)—

(2)

by striking paragraph (2);

(3)

by redesignating paragraph (3) as paragraph (2); and

(4)

in paragraph (2), as so redesignated, by striking Notwithstanding paragraph (2) of this subsection (as in effect on October 1, 2021), paragraph (2) and inserting Paragraph (2).

(1) In general

Except as provided in paragraph (2), the amendments made by this section shall apply to payment adjustments made under section 1923 of the Social Security Act (42 U.S.C. 1396r–4) for Medicaid State plan rate years beginning on or after the date of enactment of this Act.

(2) State option to distribute unspent DSH allotments from prior years up to modified cap

(1)

in paragraph (1)(A)—

(2)

in subparagraph (B) of paragraph (1), by striking subparagraph (A)(ii) and inserting subparagraph (A)(iii);

(3)

in subparagraph (D) of paragraph (1), by striking clauses (ii) and (iii) and inserting the following:

(ii)

The vendor must update the Secretary no less often than monthly on the survey prices for covered outpatient drugs.

(iii)

The vendor must differentiate, in collecting and reporting survey data, for all cost information collected, whether a pharmacy is a retail community pharmacy or an applicable non-retail pharmacy, including whether such pharmacy is an affiliate (as defined in subsection (k)(14)), and, in the case of an applicable non-retail pharmacy, which type of applicable non-retail pharmacy it is using the relevant pharmacy type indicators included in the guidance required by subsection (d)(2) of section 112 of the Bipartisan Health Care Act.;

(4)

by adding at the end of paragraph (1) the following:

(F) Survey reporting

In order to meet the requirement of section 1902(a)(54), a State shall require that any retail community pharmacy or applicable non-retail pharmacy in the State that receives any payment, reimbursement, administrative fee, discount, rebate, or other price concession related to the dispensing of covered outpatient drugs to individuals receiving benefits under this title, regardless of whether such payment, reimbursement, administrative fee, discount, rebate, or other price concession is received from the State or a managed care entity or other specified entity (as such terms are defined in section 1903(m)(9)(D)) directly or from a pharmacy benefit manager or another entity that has a contract with the State or a managed care entity or other specified entity (as so defined), shall respond to surveys conducted under this paragraph.

(G) Survey information

Information on national drug acquisition prices obtained under this paragraph shall be made publicly available in a form and manner to be determined by the Secretary and shall include at least the following:

(i)

The monthly response rate to the survey including a list of pharmacies not in compliance with subparagraph (F).

(ii)

The sampling methodology and number of pharmacies sampled monthly.

(iii)

Information on price concessions to pharmacies, including discounts, rebates, and other price concessions, to the extent that such information may be publicly released and has been collected by the Secretary as part of the survey.

(H) Penalties

(i) In general

Subject to clauses (ii), (iii), and (iv), the Secretary shall enforce the provisions of this paragraph with respect to a pharmacy through the establishment of civil money penalties applicable to a retail community pharmacy or an applicable non-retail pharmacy.

(ii) Basis for penalties

The Secretary shall impose a civil money penalty established under this subparagraph on a retail community pharmacy or applicable non-retail pharmacy if—

(I)

the retail pharmacy or applicable non-retail pharmacy refuses or otherwise fails to respond to a request for information about prices in connection with a survey under this subsection;

(II)

knowingly provides false information in response to such a survey; or

(III)

otherwise fails to comply with the requirements established under this paragraph.

(iii) Parameters for penalties

(I) In general

A civil money penalty established under this subparagraph may be assessed with respect to each violation, and with respect to each non-compliant retail community pharmacy (including a pharmacy that is part of a chain) or non-compliant applicable non-retail pharmacy (including a pharmacy that is part of a chain), in an amount not to exceed $100,000 for each such violation.

(II) Considerations

In determining the amount of a civil money penalty imposed under this subparagraph, the Secretary may consider the size, business structure, and type of pharmacy involved, as well as the type of violation and other relevant factors, as determined appropriate by the Secretary.

(iv) Rule of application

The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a civil money penalty or proceeding under section 1128A(a).

(I) Limitation on use of applicable non-retail pharmacy pricing information

No State shall use pricing information reported by applicable non-retail pharmacies under subparagraph (A)(ii) to develop or inform payment methodologies for retail community pharmacies.;

(5)

in paragraph (2)—

(6)

by redesignating paragraph (4) as paragraph (5);

(7)

by inserting after paragraph (3) the following new paragraph:

(4) Oversight

(A) In general

The Inspector General of the Department of Health and Human Services shall conduct periodic studies of the survey data reported under this subsection, as appropriate, including with respect to substantial variations in acquisition costs or other applicable costs, as well as with respect to how internal transfer prices and related party transactions may influence the costs reported by pharmacies that are affiliates (as defined in subsection (k)(14)) or are owned by, controlled by, or related under a common ownership structure with a wholesaler, distributor, or other entity that acquires covered outpatient drugs relative to costs reported by pharmacies not affiliated with such entities. The Inspector General shall provide periodic updates to Congress on the results of such studies, as appropriate, in a manner that does not disclose trade secrets or other proprietary information.

(B) Appropriation

There is appropriated to the Inspector General of the Department of Health and Human Services, out of any money in the Treasury not otherwise appropriated, $5,000,000 for fiscal year 2025, to remain available until expended, to carry out this paragraph.; and

(8)

in paragraph (5), as so redesignated—

(1)

in the matter preceding paragraph (1), by striking In the section and inserting In this section; and

(2)

by adding at the end the following new paragraphs:

(12) Applicable non-retail pharmacy

The term applicable non-retail pharmacy means a pharmacy that is licensed as a pharmacy by the State and that is not a retail community pharmacy, including a pharmacy that dispenses prescription medications to patients primarily through mail and specialty pharmacies. Such term does not include nursing home pharmacies, long-term care facility pharmacies, hospital pharmacies, clinics, charitable or not-for-profit pharmacies, government pharmacies, or low dispensing pharmacies (as defined by the Secretary).

(13) Affiliate

The term affiliate means any entity that is owned by, controlled by, or related under a common ownership structure with a pharmacy benefit manager or a managed care entity or other specified entity (as such terms are defined in section 1903(m)(9)(D)).

(1) In general

Subject to paragraph (2), the amendments made by this section shall take effect on the first day of the first quarter that begins on or after the date that is 6 months after the date of enactment of this Act.

(2) Delayed application to applicable non-retail pharmacies

The pharmacy survey requirements established by the amendments to section 1927(f) of the Social Security Act (42 U.S.C. 1396r–8(f)) made by this section shall apply to retail community pharmacies beginning on the effective date described in paragraph (1), but shall not apply to applicable non-retail pharmacies until the first day of the first quarter that begins on or after the date that is 18 months after the date of enactment of this Act.

(1) In general

Not later than January 1, 2026, the Secretary of Health and Human Services shall, in consultation with stakeholders as appropriate, publish guidance specifying pharmacies that meet the definition of applicable non-retail pharmacies (as such term is defined in subsection (k)(12) of section 1927 of the Social Security Act (42 U.S.C. 1396r–8), as added by subsection (b)), and that will be subject to the survey requirements under subsection (f)(1) of such section, as amended by subsection (a).

(2) Inclusion of pharmacy type indicators

The guidance published under paragraph (1) shall include pharmacy type indicators to distinguish between different types of applicable non-retail pharmacies, such as pharmacies that dispense prescriptions primarily through the mail and pharmacies that dispense prescriptions that require special handling or distribution. An applicable non-retail pharmacy may be identified through multiple pharmacy type indicators.

(1) In general

Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.

(2) Nonapplication of Administrative Procedure Act

Implementation of the amendments made by this section shall be exempt from the requirements of section 553 of title 5, United States Code.

(1)

in subsection (e), by adding at the end the following new paragraph:

(6) Transparent prescription drug pass-through pricing required

(A) In general

A contract between the State and a pharmacy benefit manager (referred to in this paragraph as a PBM), or a contract between the State and a managed care entity or other specified entity (as such terms are defined in section 1903(m)(9)(D) and collectively referred to in this paragraph as the entity) that includes provisions making the entity responsible for coverage of covered outpatient drugs dispensed to individuals enrolled with the entity, shall require that payment for such drugs and related administrative services (as applicable), including payments made by a PBM on behalf of the State or entity, is based on a transparent prescription drug pass-through pricing model under which—

(i)

any payment made by the entity or the PBM (as applicable) for such a drug—

(I)

is limited to—

(aa)

ingredient cost; and

(bb)

a professional dispensing fee that is not less than the professional dispensing fee that the State would pay if the State were making the payment directly in accordance with the State plan;

(II)

is passed through in its entirety (except as reduced under Federal or State laws and regulations in response to instances of waste, fraud, or abuse) by the entity or PBM to the pharmacy or provider that dispenses the drug; and

(III)

is made in a manner that is consistent with sections 447.502, 447.512, 447.514, and 447.518 of title 42, Code of Federal Regulations (or any successor regulation) as if such requirements applied directly to the entity or the PBM, except that any payment by the entity or the PBM for the ingredient cost of such drug purchased by a covered entity (as defined in subsection (a)(5)(B)) may exceed the actual acquisition cost (as defined in 447.502 of title 42, Code of Federal Regulations, or any successor regulation) for such drug if—

(aa)

such drug was subject to an agreement under section 340B of the Public Health Service Act;

(bb)

such payment for the ingredient cost of such drug does not exceed the maximum payment that would have been made by the entity or the PBM for the ingredient cost of such drug if such drug had not been purchased by such covered entity; and

(cc)

such covered entity reports to the Secretary (in a form and manner specified by the Secretary), on an annual basis and with respect to payments for the ingredient costs of such drugs so purchased by such covered entity that are in excess of the actual acquisition costs for such drugs, the aggregate amount of such excess;

(ii)

payment to the entity or the PBM (as applicable) for administrative services performed by the entity or PBM is limited to an administrative fee that reflects the fair market value (as defined by the Secretary) of such services;

(iii)

the entity or the PBM (as applicable) makes available to the State, and the Secretary upon request in a form and manner specified by the Secretary, all costs and payments related to covered outpatient drugs and accompanying administrative services (as described in clause (ii)) incurred, received, or made by the entity or the PBM, broken down (as specified by the Secretary), to the extent such costs and payments are attributable to an individual covered outpatient drug, by each such drug, including any ingredient costs, professional dispensing fees, administrative fees (as described in clause (ii)), post-sale and post-invoice fees, discounts, or related adjustments such as direct and indirect remuneration fees, and any and all other remuneration, as defined by the Secretary; and

(iv)

any form of spread pricing whereby any amount charged or claimed by the entity or the PBM (as applicable) that exceeds the amount paid to the pharmacies or providers on behalf of the State or entity, including any post-sale or post-invoice fees, discounts, or related adjustments such as direct and indirect remuneration fees or assessments, as defined by the Secretary, (after allowing for an administrative fee as described in clause (ii)) is not allowable for purposes of claiming Federal matching payments under this title.

(B) Publication of information

The Secretary shall publish, not less frequently than on an annual basis and in a manner that does not disclose the identity of a particular covered entity or organization, information received by the Secretary pursuant to subparagraph (A)(iii)(III) that is broken out by State and by each of the following categories of covered entity within each such State:

(i)

Covered entities described in subparagraph (A) of section 340B(a)(4) of the Public Health Service Act.

(ii)

Covered entities described in subparagraphs (B) through (K) of such section.

(iii)

Covered entities described in subparagraph (L) of such section.

(iv)

Covered entities described in subparagraph (M) of such section.

(v)

Covered entities described in subparagraph (N) of such section.

(vi)

Covered entities described in subparagraph (O) of such section.; and

(2)

in subsection (k), as previously amended by this title, by adding at the end the following new paragraph:

(14) Pharmacy benefit manager

The term pharmacy benefit manager means any person or entity that, either directly or through an intermediary, acts as a price negotiator or group purchaser on behalf of a State, managed care entity (as defined in section 1903(m)(9)(D)), or other specified entity (as so defined), or manages the prescription drug benefits provided by a State, managed care entity, or other specified entity, including the processing and payment of claims for prescription drugs, the performance of drug utilization review, the processing of drug prior authorization requests, the managing of appeals or grievances related to the prescription drug benefits, contracting with pharmacies, controlling the cost of covered outpatient drugs, or the provision of services related thereto. Such term includes any person or entity that acts as a price negotiator (with regard to payment amounts to pharmacies and providers for a covered outpatient drug or the net cost of the drug) or group purchaser on behalf of a State, managed care entity, or other specified entity or that carries out 1 or more of the other activities described in the preceding sentence, irrespective of whether such person or entity calls itself a pharmacy benefit manager.

(1)

in paragraph (2)(A)(xiii)—

(2)

by adding at the end the following new paragraph:

(10)

No payment shall be made under this title to a State with respect to expenditures incurred by the State for payment for services provided by an other specified entity (as defined in paragraph (9)(D)(iii)) unless such services are provided in accordance with a contract between the State and such entity which satisfies the requirements of paragraph (2)(A)(xiii).

(1) In general

Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.

(2) Nonapplication of administrative procedure act

Implementation of the amendments made by this section shall be exempt from the requirements of section 553 of title 5, United States Code.

(1)

in subparagraph (B), in the matter preceding clause (i), by striking fiscal year 2025 beginning on April 1, 2025, and ending on September 30, 2025, and in fiscal year 2026 and inserting fiscal year 2026 beginning on January 1, 2026, and ending on September 30, 2026, and in fiscal year 2027;

(2)

in subparagraph (C)(i)—

(3)

in subparagraph (D)—

(1)

in clause (i), by striking April 1, 2025 and inserting January 1, 2026; and

(2)

in clause (ii)(II), by striking April 1, 2025 and inserting January 1, 2026.

(1) In general

Section 1886(b)(3)(D) of the Social Security Act (42 U.S.C. 1395ww(b)(3)(D)) is amended—

(2) Permitting hospitals to decline reclassification

Section 13501(e)(2) of the Omnibus Budget Reconciliation Act of 1993 (42 U.S.C. 1395ww note) is amended by striking through fiscal year 2024, or the portion of fiscal year 2025 beginning on October 1, 2024, and ending on March 31, 2025 and inserting through fiscal year 2025, or the portion of fiscal year 2026 beginning on October 1, 2025, and ending on December 31, 2025.

(1)

in paragraph (1)(A)—

(2)

in paragraph (2)—

(3)

in paragraph (4)(B), by inserting or, with respect to 2027, 3.53 percent after 1.88 percent.

(1)

in subclause (II), by striking 2026 and inserting 2027; and

(2)

in subclause (III), by striking 2027 and inserting 2028.

(1)

in subparagraph (D), by striking and at the end;

(2)

in subparagraph (E), by striking the period at the end and inserting ; and; and

(3)

by adding at the end the following new subparagraph:

(F)

such services furnished on or after March 15, 2025, and before January 1, 2026, by 3.5375 percent.

(A)

by striking $11,030,000 and inserting $14,000,000; and

(B)

by striking March 31, 2025 and inserting December 31, 2025; and

(1)

in clause (xiii), by striking and at the end;

(2)

in clause (xiv), by striking the period and inserting ; and; and

(3)

by inserting after clause (xiv) the following new clause:

(xv)

for the period beginning on April 1, 2025, and ending on December 31, 2026, $26,250,000.

(1)

in clause (xiii), by striking and at the end;

(2)

in clause (xiv), by striking the period and inserting ; and; and

(3)

by inserting after clause (xiv) the following new clause:

(xv)

for the period beginning on April 1, 2025, and ending on December 31, 2026, $26,250,000.

(1)

in clause (xiii), by striking and at the end;

(2)

in clause (xiv), by striking the period and inserting ; and; and

(3)

by inserting after clause (xiv) the following new clause:

(xv)

for the period beginning on April 1, 2025, and ending on December 31, 2026, $7,750,000.

(1)

in clause (xiii), by striking and at the end;

(2)

in clause (xiv), by striking the period and inserting ; and; and

(3)

by inserting after clause (xiv) the following new clause:

(xv)

for the period beginning on April 1, 2025, and ending on December 31, 2026, $26,250,000.

(1)

in paragraph (2)(B)(iii), by striking ending March 31, 2025 and inserting ending December 31, 2026; and

(2)

in paragraph (4)(C)(iii), by striking ending on March 31, 2025 and inserting ending on December 31, 2026.

(1)

in subparagraph (A), by striking ending on March 31, 2025 and inserting ending on December 31, 2026;

(2)

in subparagraph (B)—

(3)

by adding at the end the following new subparagraph:

(C) Payment rule for portion of 2025 and 2026

(i) In general

A telehealth service furnished to an eligible telehealth individual by a Federally qualified health center or rural health clinic on or after April 1, 2025, and before January 1, 2027, shall be paid as a Federally qualified health center service or rural health clinic service (as applicable) under the prospective payment system established under section 1834(o) or the methodology for all-inclusive rates established under section 1833(a)(3), respectively.

(ii) Treatment of costs

Costs associated with the furnishing of telehealth services by a Federally qualified health center or rural health clinic on or after April 1, 2025, and before January 1, 2027, shall be considered allowable costs for purposes of the prospective payment system established under section 1834(o) and the methodology for all-inclusive rates established under section 1833(a)(3), as applicable.

(iii) Requiring modifiers

Not later than July 1, 2025, the Secretary shall establish requirements to include 1 or more codes or modifiers, as determined appropriate by the Secretary, in the case of claims for telehealth services furnished to an eligible telehealth individual by a Federally qualified health center or rural health clinic.

(1) Delay in requirements for mental health services furnished through telehealth

Section 1834(m)(7)(B)(i) of the Social Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is amended, in the matter preceding subclause (I), by striking April 1, 2025 and inserting January 1, 2027.

(2) Mental health visits furnished by rural health clinics

Section 1834(y)(2) of the Social Security Act (42 U.S.C. 1395m(y)(2)) is amended by striking April 1, 2025 and inserting January 1, 2027.

(3) Mental health visits furnished by Federally qualified health centers

Section 1834(o)(4)(B) of the Social Security Act (42 U.S.C. 1395m(o)(4)(B)) is amended by striking April 1, 2025 and inserting January 1, 2027.

(1)

by striking ending on March 31, 2025 and inserting ending on December 31, 2026; and

(2)

by inserting , except that this subclause shall not apply in the case of such an encounter with an individual occurring on or after April 1, 2025, if such individual is located in an area that is subject to a moratorium on the enrollment of hospice programs under this title pursuant to section 1866(j)(7), if such individual is receiving hospice care from a provider that is subject to enhanced oversight under this title pursuant to section 1866(j)(3), or if such encounter is performed by a hospice physician or nurse practitioner who is not enrolled under section 1866(j) and is not an opt-out physician or practitioner (as defined in section 1802(b)(6)(D)) before the semicolon.

(A)

in paragraph (1)—

(B)

in paragraph (2), by striking of the Secretary; and

(C)

in paragraph (3)(E), by adding at the end the following new flush sentence:

The Secretary may require that such data and information be submitted through a hospital’s cost report, through such survey instruments as the Secretary may develop, through medical record information, or through such other means as the Secretary determines appropriate.;

(A)

in the subsection heading, by striking Study and inserting Initial study;

(B)

in paragraph (1)(A), by striking of the Secretary; and

(C)

in paragraph (3), by inserting or subsection (c) before the period at the end;

(1) In general

Section 1834(a) of the Social Security Act (42 U.S.C. 1395m(a)) is amended by adding at the end the following new paragraph:

(23) Master List inclusion and claim review for certain items

(A) Master List inclusion

Beginning January 1, 2028, for purposes of the Master List described in section 414.234(b) of title 42, Code of Federal Regulations (or any successor regulation), an item for which payment may be made under this subsection shall be treated as having aberrant billing patterns (as such term is used for purposes of such section) if the Secretary determines that, without explanatory contributing factors (such as furnishing emergent care services), a substantial number of claims for such items under this subsection are for such items ordered by a physician or practitioner who has not previously (during a period of not less than 24 months, as established by the Secretary) furnished to the individual involved any item or service for which payment may be made under this title.

(B) Claim review

With respect to items furnished on or after January 1, 2028, that are included on the Master List pursuant to subparagraph (A), if such an item is not subject to a determination of coverage in advance pursuant to paragraph (15)(C), the Secretary may conduct prepayment review of claims for payment for such item.

(2) Conforming amendment for prosthetic devices, orthotics, and prosthetics

Section 1834(h)(3) of the Social Security Act (42 U.S.C. 1395m(h)(3)) is amended by inserting , and paragraph (23) of subsection (a) shall apply to prosthetic devices, orthotics, and prosthetics in the same manner as such provision applies to items for which payment may be made under such subsection before the period at the end.

(1)

which, if any, clinical diagnostic laboratory tests are identified as being at high risk of fraudulent claims, and an analysis of the factors that contribute to such risk;

(2)

with respect to a clinical diagnostic laboratory test identified under paragraph (1) as being at high risk of fraudulent claims—

(3)

suggested strategies for reducing the number of fraudulent claims made with respect to tests so identified as being at high risk, including—

(4)

such other information as the Inspector General determines appropriate.

(1)

Best practices on facilitating and integrating use of interpreters during a telemedicine appointment.

(2)

Best practices on providing accessible instructions on how to access telecommunications systems (as such term is used for purposes of section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) for individuals with limited English proficiency.

(3)

Best practices on improving access to digital patient portals for individuals with limited English proficiency.

(4)

Best practices on integrating the use of video platforms that enable multi-person video calls furnished via a telecommunications system for purposes of providing interpretation during a telemedicine appointment for an individual with limited English proficiency.

(5)

Best practices for providing patient materials, communications, and instructions in multiple languages, including text message appointment reminders and prescription information.

(1)

Health information technology service providers, including—

(2)

Health care providers, including—

(3)

Health insurers.

(4)

Language service companies.

(5)

Interpreter or translator professional associations.

(6)

Health and language services quality certification organizations.

(7)

Patient and consumer advocates, including such advocates that work with individuals with limited English proficiency.

(1)

in subparagraph (A)(ii), by inserting (including, with respect to items and services furnished through audio and video real-time communications technology (excluding audio-only) on or after April 1, 2025, and before January 1, 2027, in the home of an individual who is an outpatient of the hospital) after outpatient basis; and

(2)

in subparagraph (B), by inserting (including, with respect to items and services furnished through audio and video real-time communications technology on or after April 1, 2025, and before January 1, 2027, the virtual presence of such physician, physician assistant, nurse practitioner, or clinical nurse specialist) after under the program.

(1)

an entity may participate in the MDPP by offering only online MDPP services via synchronous or asynchronous technology or telecommunications if such entity meets the conditions for enrollment as an MDPP supplier (as specified in section 424.205(b) of title 42, Code of Federal Regulations (or a successor regulation));

(2)

if an entity participates in the MDPP in the manner described in paragraph (1)—

(3)

no limit is applied on the number of times an individual may enroll in the MDPP.

(1) MDPP

The term MDPP means the Medicare Diabetes Prevention Program conducted under section 1115A of the Social Security Act (42 U.S.C. 1315a), as described in the final rule published in the Federal Register entitled Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program (88 Fed. Reg. 78818 (November 16, 2023)) (or a successor regulation).

(2) Regulatory terms

The terms Diabetes Prevention Recognition Program, full CDC DPRP recognition, MDPP beneficiary, MDPP services, and MDPP supplier have the meanings given each such term in section 410.79(b) of title 42, Code of Federal Regulations.

(3) Secretary

The term Secretary means the Secretary of Health and Human Services.

(1)

in paragraph (1)(C)—

(2)

by adding at the end the following new paragraph:

(3) Provider directory accuracy

(A) In general

For plan year 2027 and subsequent plan years, each MA organization offering a specified MA plan (as defined in subparagraph (C)) shall, for each such plan offered by the organization—

(i)

maintain, on a publicly available internet website, an accurate provider directory that includes the information described in subparagraph (B);

(ii)

not less frequently than once every 90 days (or, in the case of a hospital or any other facility determined appropriate by the Secretary, at a lesser frequency specified by the Secretary but in no case less frequently than once every 12 months), verify the provider directory information of each provider listed in such directory and, if applicable, update such provider directory information;

(iii)

if the organization is unable to verify such information with respect to a provider, include in such directory an indication that the information of such provider may not be up-to-date; and

(iv)

remove a provider from such directory within 5 business days if the organization determines that the provider is no longer a provider participating in the network of such plan.

(B) Provider directory information

The information described in this subparagraph is information enrollees may need to access covered benefits from a provider with which such organization offering such plan has an agreement for furnishing items and services covered under such plan such as name, specialty, contact information, primary office or facility address, whether the provider is accepting new patients, accommodations for people with disabilities, cultural and linguistic capabilities, and telehealth capabilities.

(C) Specified MA plan

In this paragraph, the term specified MA plan means—

(i)

a network-based plan (as defined in subsection (d)(5)(C)); or

(ii)

a Medicare Advantage private fee-for-service plan (as defined in section 1859(b)(2)) that meets the access standards under subsection (d)(4), in whole or in part, through entering into contracts or agreements as provided for under subparagraph (B) of such subsection.

(1) Cost Sharing for Services Furnished Based on Reliance on Incorrect Provider directory Information

Section 1852(d) of the Social Security Act (42 U.S.C. 1395w–22(d)) is amended—

(2) Required provider directory accuracy analysis and reports

(3) GAO study and report

(1) Stakeholder meeting

(2) Guidance to Medicare Advantage organizations

Not later than 12 months after the date of enactment of this Act, the Secretary shall issue guidance to Medicare Advantage organizations offering Medicare Advantage plans under part C of title XVIII of the Social Security Act (42 U.S.C. 1395w–21 et seq.) on maintaining accurate provider directories for such plans, taking into consideration input received during the stakeholder meeting under paragraph (1). Such guidance may include the following, as determined appropriate by the Secretary:

(3) Guidance to part B providers

Not later than 12 months after the date of enactment of this Act, the Secretary shall issue guidance to providers of services and suppliers who furnish items or services for which benefits are available under part B of title XVIII of the Social Security Act (42 U.S.C. 1395j et seq.) on when to update the National Plan and Provider Enumeration System for information changes.

(1)

in subsection (s)(2)—

(2)

by adding at the end the following new subsection:

(nnn) Multi-Cancer early detection screening tests

(1) In general

The term multi-cancer early detection screening test means a test furnished to an individual for the concurrent detection of multiple cancer types across multiple organ sites on or after January 1, 2029, that—

(A)

is cleared under section 510(k), classified under section 513(f)(2), or approved under section 515 of the Federal Food, Drug, and Cosmetic Act;

(B)

is—

(i)

a genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids; or

(ii)

a test based on samples of biological material that provide results comparable to those obtained with a test described in clause (i), as determined by the Secretary; and

(C)

the Secretary determines is—

(i)

reasonable and necessary for the prevention or early detection of an illness or disability; and

(ii)

appropriate for individuals entitled to benefits under part A or enrolled under part B.

(2) NCD process

In making determinations under paragraph (1)(C) regarding the coverage of a new test, the Secretary shall use the process for making national coverage determinations (as defined in section 1869(f)(1)(B)) under this title.

(1) In general

Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

(aa) Payment and standards for multi-Cancer early detection screening tests

(1) Payment amount

The payment amount for a multi-cancer early detection screening test (as defined in section 1861(nnn)) is—

(A)

with respect to such a test furnished before January 1, 2031, equal to the payment amount in effect on the date of the enactment of this subsection for a multi-target stool screening DNA test covered pursuant to section 1861(pp)(1)(D); and

(B)

with respect to such a test furnished on or after January 1, 2031, equal to the lesser of—

(i)

the amount described in subparagraph (A); or

(ii)

the payment amount determined for such test under section 1834A.

(2) Limitations

(A) In general

No payment may be made under this part for a multi-cancer early detection screening test furnished during a year to an individual if—

(i)

such individual—

(I)

is under 50 years of age; or

(II)

as of January 1 of such year, has attained the age specified in subparagraph (B) for such year; or

(ii)

such a test was furnished to the individual during the previous 11 months.

(B) Age specified

For purposes of subparagraph (A)(i)(II), the age specified in this subparagraph is—

(i)

for 2029, 65 years of age; and

(ii)

for a succeeding year, the age specified in this subparagraph for the preceding year, increased by 1 year.

(C) Standards following USPSTF rating of A or B

In the case of a multi-cancer early detection screening test that is recommended with a grade of A or B by the United States Preventive Services Task Force, beginning on the date on which coverage for such test is provided pursuant to section 1861(ddd)(1), the preceding provisions of this paragraph shall not apply.

(2) Conforming amendments

(1)

in the case of an individual who undergoes a multi-cancer early detection screening test, to affect coverage under part B of title XVIII of the Social Security Act for other cancer screening tests covered under such title, such as screening tests for breast, cervical, colorectal, lung, or prostate cancer; or

(2)

in the case of an individual who undergoes another cancer screening test, to affect coverage under such part for a multi-cancer early detection screening test or the use of such a test as a diagnostic or confirmatory test for a result of the other cancer screening test.

(1) In general

Section 1860D–4(b)(1) of the Social Security Act (42 U.S.C. 1395w–104(b)(1)) is amended by adding at the end the following new subparagraph:

(F) Enforcement of standards for reasonable and relevant contract terms and conditions

(i) Allegation submission process

(I) In general

Not later than January 1, 2028, the Secretary shall establish a process through which a pharmacy may submit to the Secretary an allegation of a violation by a PDP sponsor offering a prescription drug plan of the standards for reasonable and relevant contract terms and conditions under subparagraph (A)(ii), or of subclause (VIII) of this clause.

(II) Frequency of submission

(aa) In general

Except as provided in item (bb), the allegation submission process under this clause shall allow pharmacies to submit any allegations of violations described in subclause (I) not more frequently than once per plan year per contract between a pharmacy and a PDP sponsor.

(bb) Allegations relating to contract modifications

In the case where a contract between a pharmacy and a PDP sponsor is modified following the submission of allegations by a pharmacy with respect to such contract and plan year, the allegation submission process under this clause shall allow such pharmacy to submit an additional allegation related to those modifications with respect to such contract and plan year.

(III) Access to relevant documents and materials

A PDP sponsor subject to an allegation under this clause—

(aa)

shall provide documents or materials, as specified by the Secretary, including contract offers made by such sponsor to such pharmacy or correspondence related to such offers, to the Secretary at a time, and in a form and manner, specified by the Secretary; and

(bb)

shall not prohibit or otherwise limit the ability of a pharmacy to submit such documents or materials to the Secretary for the purpose of submitting an allegation or providing evidence for such an allegation under this clause.

(IV) Standardized template

The Secretary shall establish a standardized template for pharmacies to use for the submission of allegations described in subclause (I). Such template shall require that the submission include a certification by the pharmacy that the information included is accurate, complete, and true to the best of the knowledge, information, and belief of such pharmacy.

(V) Preventing frivolous allegations

In the case where the Secretary determines that a pharmacy has submitted frivolous allegations under this clause on a routine basis, the Secretary may temporarily prohibit such pharmacy from using the allegation submission process under this clause, as determined appropriate by the Secretary.

(VI) Exemption from freedom of information act

Allegations submitted under this clause shall be exempt from disclosure under section 552 of title 5, United States Code.

(VII) Rule of construction

Nothing in this clause shall be construed as limiting the ability of a pharmacy to pursue other legal actions or remedies, consistent with applicable Federal or State law, with respect to a potential violation of a requirement described in this subparagraph.

(VIII) Anti-retaliation and anti-coercion

Consistent with applicable Federal or State law, a PDP sponsor shall not—

(aa)

retaliate against a pharmacy for submitting any allegations under this clause; or

(bb)

coerce, intimidate, threaten, or interfere with the ability of a pharmacy to submit any such allegations.

(ii) Investigation

The Secretary shall investigate, as determined appropriate by the Secretary, allegations submitted pursuant to clause (i).

(iii) Enforcement

(I) In general

In the case where the Secretary determines that a PDP sponsor offering a prescription drug plan has violated the standards for reasonable and relevant contract terms and conditions under subparagraph (A)(ii), the Secretary may use authorities under sections 1857(g) and 1860D–12(b)(3)(E) to impose civil monetary penalties or other intermediate sanctions.

(II) Application of civil monetary penalties

The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this clause in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).

(2) Conforming amendment

Section 1857(g)(1) of the Social Security Act (42 U.S.C. 1395w–27(g)(1)) is amended—

(1) In general

Section 1860D–12(b) of the Social Security Act (42 U.S.C. 1395w–112) is amended by adding at the end the following new paragraph:

(9) Accountability of pharmacy benefit managers for violations of reasonable and relevant contract terms and conditions

For plan years beginning on or after January 1, 2028, each contract entered into with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that any pharmacy benefit manager acting on behalf of such sponsor has a written agreement with the PDP sponsor under which the pharmacy benefit manager agrees to reimburse the PDP sponsor for any amounts paid by such sponsor under section 1860D–4(b)(1)(F)(iii)(I) to the Secretary as a result of a violation described in such section if such violation is related to a responsibility delegated to the pharmacy benefit manager by such PDP sponsor.

(2) MA–PD plans

Section 1857(f)(3) of the Social Security Act (42 U.S.C. 1395w–27(f)(3)) is amended by adding at the end the following new subparagraph:

(F) Accountability of pharmacy benefit managers for violations of reasonable and relevant contract terms

For plan years beginning on or after January 1, 2028, section 1860D–12(b)(9).

(1) Prescription drug plans

Section 1860D–12 of the Social Security Act (42 U.S.C. 1395w–112) is amended by adding at the end the following new subsection:

(h) Requirements relating to pharmacy benefit managers

For plan years beginning on or after January 1, 2028:

(1) Agreements with pharmacy benefit managers

Each contract entered into with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that any pharmacy benefit manager acting on behalf of such sponsor has a written agreement with the PDP sponsor under which the pharmacy benefit manager, and any affiliates of such pharmacy benefit manager, as applicable, agree to meet the following requirements:

(A) No income other than bona fide service fees

(i) In general

The pharmacy benefit manager and any affiliate of such pharmacy benefit manager shall not derive any remuneration with respect to any services provided on behalf of any entity or individual, in connection with the utilization of covered part D drugs, from any such entity or individual other than bona fide service fees, subject to clauses (ii) and (iii).

(ii) Incentive payments

For the purposes of this subsection, an incentive payment (as determined by the Secretary) paid by a PDP sponsor to a pharmacy benefit manager that is performing services on behalf of such sponsor shall be deemed a bona fide service fee (even if such payment does not otherwise meet the definition of such term under paragraph (7)(B)) if such payment is a flat dollar amount, is consistent with fair market value (as specified by the Secretary), is related to services actually performed by the pharmacy benefit manager or affiliate of such pharmacy benefit manager, on behalf of the PDP sponsor making such payment, in connection with the utilization of covered part D drugs, and meets additional requirements, if any, as determined appropriate by the Secretary.

(iii) Clarification on rebates and discounts used to lower costs for covered part d drugs

Rebates, discounts, and other price concessions received by a pharmacy benefit manager or an affiliate of a pharmacy benefit manager from manufacturers, even if such price concessions are calculated as a percentage of a drug’s price, shall not be considered a violation of the requirements of clause (i) if they are fully passed through to a PDP sponsor and are compliant with all regulatory and subregulatory requirements related to direct and indirect remuneration for manufacturer rebates under this part, including in cases where a PDP sponsor is acting as a pharmacy benefit manager on behalf of a prescription drug plan offered by such PDP sponsor.

(iv) Evaluation of remuneration arrangements

Components of subsets of remuneration arrangements (such as fees or other forms of compensation paid to or retained by the pharmacy benefit manager or affiliate of such pharmacy benefit manager), as determined appropriate by the Secretary, between pharmacy benefit managers or affiliates of such pharmacy benefit managers, as applicable, and other entities involved in the dispensing or utilization of covered part D drugs (including PDP sponsors, manufacturers, pharmacies, and other entities as determined appropriate by the Secretary) shall be subject to review by the Secretary, in consultation with the Office of the Inspector General of the Department of Health and Human Services, as determined appropriate by the Secretary. The Secretary, in consultation with the Office of the Inspector General, shall review whether remuneration under such arrangements is consistent with fair market value (as specified by the Secretary) through reviews and assessments of such remuneration, as determined appropriate.

(v) Disgorgement

The pharmacy benefit manager shall disgorge any remuneration paid to such pharmacy benefit manager or an affiliate of such pharmacy benefit manager in violation of this subparagraph to the PDP sponsor.

(vi) Additional requirements

The pharmacy benefit manager shall—

(I)

enter into a written agreement with any affiliate of such pharmacy benefit manager, under which the affiliate shall identify and disgorge any remuneration described in clause (v) to the pharmacy benefit manager; and

(II)

attest, subject to any requirements determined appropriate by the Secretary, that the pharmacy benefit manager has entered into a written agreement described in subclause (I) with any relevant affiliate of the pharmacy benefit manager.

(B) Transparency regarding guarantees and cost performance evaluations

The pharmacy benefit manager shall—

(i)

define, interpret, and apply, in a fully transparent and consistent manner for purposes of calculating or otherwise evaluating pharmacy benefit manager performance against pricing guarantees or similar cost performance measurements related to rebates, discounts, price concessions, or net costs, terms such as—

(I)

generic drug, in a manner consistent with the definition of the term under section 423.4 of title 42, Code of Federal Regulations, or a successor regulation;

(II)

brand name drug, in a manner consistent with the definition of the term under section 423.4 of title 42, Code of Federal Regulations, or a successor regulation;

(III)

specialty drug;

(IV)

rebate; and

(V)

discount;

(ii)

identify any drugs, claims, or price concessions excluded from any pricing guarantee or other cost performance measure in a clear and consistent manner; and

(iii)

where a pricing guarantee or other cost performance measure is based on a pricing benchmark other than the wholesale acquisition cost (as defined in section 1847A(c)(6)(B)) of a drug, calculate and provide a wholesale acquisition cost-based equivalent to the pricing guarantee or other cost performance measure.

(C) Provision of information

(i) In general

Not later than July 1 of each year, beginning in 2028, the pharmacy benefit manager shall submit to the PDP sponsor, and to the Secretary, a report, in accordance with this subparagraph, and shall make such report available to such sponsor at no cost to such sponsor in a format specified by the Secretary under paragraph (5). Each such report shall include, with respect to such PDP sponsor and each plan offered by such sponsor, the following information with respect to the previous plan year:

(I)

A list of all drugs covered by the plan that were dispensed including, with respect to each such drug—

(aa)

the brand name, generic or non-proprietary name, and National Drug Code;

(bb)

the number of plan enrollees for whom the drug was dispensed, the total number of prescription claims for the drug (including original prescriptions and refills, counted as separate claims), and the total number of dosage units of the drug dispensed;

(cc)

the number of prescription claims described in item (bb) by each type of dispensing channel through which the drug was dispensed, including retail, mail order, specialty pharmacy, long term care pharmacy, home infusion pharmacy, or other types of pharmacies or providers;

(dd)

the average wholesale acquisition cost, listed as cost per day’s supply, cost per dosage unit, and cost per typical course of treatment (as applicable);

(ee)

the average wholesale price for the drug, listed as price per day’s supply, price per dosage unit, and price per typical course of treatment (as applicable);

(ff)

the total out-of-pocket spending by plan enrollees on such drug after application of any benefits under the plan, including plan enrollee spending through copayments, coinsurance, and deductibles;

(gg)

total rebates paid by the manufacturer on the drug as reported under the Detailed DIR Report (or any successor report) submitted by such sponsor to the Centers for Medicare & Medicaid Services;

(hh)

all other direct or indirect remuneration on the drug as reported under the Detailed DIR Report (or any successor report) submitted by such sponsor to the Centers for Medicare & Medicaid Services;

(ii)

the average pharmacy reimbursement amount paid by the plan for the drug in the aggregate and disaggregated by dispensing channel identified in item (cc);

(jj)

the average National Average Drug Acquisition Cost (NADAC); and

(kk)

total manufacturer-derived revenue, inclusive of bona fide service fees, attributable to the drug and retained by the pharmacy benefit manager and any affiliate of such pharmacy benefit manager.

(II)

In the case of a pharmacy benefit manager that has an affiliate that is a retail, mail order, or specialty pharmacy, with respect to drugs covered by such plan that were dispensed, the following information:

(aa)

The percentage of total prescriptions that were dispensed by pharmacies that are an affiliate of the pharmacy benefit manager for each drug.

(bb)

The interquartile range of the total combined costs paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply for each drug dispensed by pharmacies that are not an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan.

(cc)

The interquartile range of the total combined costs paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply for each drug dispensed by pharmacies that are an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan.

(dd)

The lowest total combined cost paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply, for each drug that is available from any pharmacy included in the pharmacy network of such plan.

(ee)

The difference between the average acquisition cost of the affiliate, such as a pharmacy or other entity that acquires prescription drugs, that initially acquires the drug and the amount reported under subclause (I)(jj) for each drug.

(ff)

A list inclusive of the brand name, generic or non-proprietary name, and National Drug Code of covered part D drugs subject to an agreement with a covered entity under section 340B of the Public Health Service Act for which the pharmacy benefit manager or an affiliate of the pharmacy benefit manager had a contract or other arrangement with such a covered entity in the service area of such plan.

(III)

Where a drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (referred to in this subclause as the listed drug) is covered by the plan, the following information:

(aa)

A list of currently marketed generic drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act pursuant to an application that references such listed drug that are not covered by the plan, are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the listed drug, or are subject to utilization management that the listed drug is not subject to.

(bb)

The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the listed drug.

(cc)

Where a generic drug listed under item (aa) is on a formulary tier typically associated with higher cost-sharing than the listed drug, the estimated average cost-sharing that a beneficiary would have paid for a 30-day supply of each of the generic drugs described in item (aa), had the plan provided coverage for such drugs on the same formulary tier as the listed drug.

(dd)

A written justification for providing more favorable coverage of the listed drug than the generic drugs described in item (aa).

(ee)

The number of currently marketed generic drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act pursuant to an application that references such listed drug.

(IV)

Where a reference product (as defined in section 351(i) of the Public Health Service Act) is covered by the plan, the following information:

(aa)

A list of currently marketed biosimilar biological products licensed under section 351(k) of the Public Health Service Act pursuant to an application that refers to such reference product that are not covered by the plan, are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the reference product, or are subject to utilization management that the reference product is not subject to.

(bb)

The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the reference product.

(cc)

Where a biosimilar biological product listed under item (aa) is on a formulary tier typically associated with higher cost-sharing than the reference product, the estimated average cost-sharing that a beneficiary would have paid for a 30-day supply of each of the biosimilar biological products described in item (aa), had the plan provided coverage for such products on the same formulary tier as the reference product.

(dd)

A written justification for providing more favorable coverage of the reference product than the biosimilar biological product described in item (aa).

(ee)

The number of currently marketed biosimilar biological products licensed under section 351(k) of the Public Health Service Act, pursuant to an application that refers to such reference product.

(V)

Total gross spending on covered part D drugs by the plan, not net of rebates, fees, discounts, or other direct or indirect remuneration.

(VI)

The total amount retained by the pharmacy benefit manager or an affiliate of such pharmacy benefit manager in revenue related to utilization of covered part D drugs under that plan, inclusive of bona fide service fees.

(VII)

The total spending on covered part D drugs net of rebates, fees, discounts, or other direct and indirect remuneration by the plan.

(VIII)

An explanation of any benefit design parameters under such plan that encourage plan enrollees to fill prescriptions at pharmacies that are an affiliate of such pharmacy benefit manager, such as mail and specialty home delivery programs, and retail and mail auto-refill programs.

(IX)

The following information:

(aa)

A list of all brokers, consultants, advisors, and auditors that receive compensation from the pharmacy benefit manager or an affiliate of such pharmacy benefit manager for referrals, consulting, auditing, or other services offered to PDP sponsors related to pharmacy benefit management services.

(bb)

The amount of compensation provided by such pharmacy benefit manager or affiliate to each such broker, consultant, advisor, and auditor.

(cc)

The methodology for calculating the amount of compensation provided by such pharmacy benefit manager or affiliate, for each such broker, consultant, advisor, and auditor.

(X)

A list of all affiliates of the pharmacy benefit manager.

(XI)

A summary document submitted in a standardized template developed by the Secretary that includes such information described in subclauses (I) through (X).

(ii) Written explanation of contracts or agreements with drug manufacturers

(I) In general

The pharmacy benefit manager shall, not later than 30 days after the finalization of any contract or agreement between such pharmacy benefit manager or an affiliate of such pharmacy benefit manager and a drug manufacturer (or subsidiary, agent, or entity affiliated with such drug manufacturer) that makes rebates, discounts, payments, or other financial incentives related to one or more covered part D drugs or other prescription drugs, as applicable, of the manufacturer directly or indirectly contingent upon coverage, formulary placement, or utilization management conditions on any other covered part D drugs or other prescription drugs, as applicable, submit to the PDP sponsor a written explanation of such contract or agreement.

(II) Requirements

A written explanation under subclause (I) shall—

(aa)

include the manufacturer subject to the contract or agreement, all covered part D drugs and other prescription drugs, as applicable, subject to the contract or agreement and the manufacturers of such drugs, and a high-level description of the terms of such contract or agreement and how such terms apply to such drugs; and

(bb)

be certified by the Chief Executive Officer, Chief Financial Officer, or General Counsel of such pharmacy benefit manager, or affiliate of such pharmacy benefit manager, as applicable, or an individual delegated with the authority to sign on behalf of one of these officers, who reports directly to the officer.

(III) Definition of other prescription drugs

For purposes of this clause, the term other prescription drugs means prescription drugs covered as supplemental benefits under this part or prescription drugs paid outside of this part.

(D) Audit rights

(i) In general

Not less than once a year, at the request of the PDP sponsor, the pharmacy benefit manager shall allow for an audit of the pharmacy benefit manager to ensure compliance with all terms and conditions under the written agreement described in this paragraph and the accuracy of information reported under subparagraph (C).

(ii) Auditor

The PDP sponsor shall have the right to select an auditor. The pharmacy benefit manager shall not impose any limitations on the selection of such auditor.

(iii) Provision of information

The pharmacy benefit manager shall make available to such auditor all records, data, contracts, and other information necessary to confirm the accuracy of information provided under subparagraph (C), subject to reasonable restrictions on how such information must be reported to prevent redisclosure of such information.

(iv) Timing

The pharmacy benefit manager must provide information under clause (iii) and other information, data, and records relevant to the audit to such auditor within 6 months of the initiation of the audit and respond to requests for additional information from such auditor within 30 days after the request for additional information.

(v) Information from affiliates

The pharmacy benefit manager shall be responsible for providing to such auditor information required to be reported under subparagraph (C) or under clause (iii) of this subparagraph that is owned or held by an affiliate of such pharmacy benefit manager.

(2) Enforcement

(A) In general

Each PDP sponsor shall—

(i)

disgorge to the Secretary any amounts disgorged to the PDP sponsor by a pharmacy benefit manager under paragraph (1)(A)(v);

(ii)

require, in a written agreement with any pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager, that such pharmacy benefit manager or affiliate reimburse the PDP sponsor for any civil money penalty imposed on the PDP sponsor as a result of the failure of the pharmacy benefit manager or affiliate to meet the requirements of paragraph (1) that are applicable to the pharmacy benefit manager or affiliate under the agreement; and

(iii)

require, in a written agreement with any such pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager, that such pharmacy benefit manager or affiliate be subject to punitive remedies for breach of contract for failure to comply with the requirements applicable under paragraph (1).

(B) Reporting of alleged violations

The Secretary shall make available and maintain a mechanism for manufacturers, PDP sponsors, pharmacies, and other entities that have contractual relationships with pharmacy benefit managers or affiliates of such pharmacy benefit managers to report, on a confidential basis, alleged violations of paragraph (1)(A) or subparagraph (C).

(C) Anti-retaliation and anti-coercion

Consistent with applicable Federal or State law, a PDP sponsor shall not—

(i)

retaliate against an individual or entity for reporting an alleged violation under subparagraph (B); or

(ii)

coerce, intimidate, threaten, or interfere with the ability of an individual or entity to report any such alleged violations.

(3) Certification of compliance

(A) In general

Each PDP sponsor shall furnish to the Secretary (at a time and in a manner specified by the Secretary) an annual certification of compliance with this subsection, as well as such information as the Secretary determines necessary to carry out this subsection.

(B) Implementation

Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.

(4) Rule of construction

Nothing in this subsection shall be construed as—

(A)

prohibiting flat dispensing fees or reimbursement or payment for ingredient costs (including customary, industry-standard discounts directly related to drug acquisition that are retained by pharmacies or wholesalers) to entities that acquire or dispense prescription drugs; or

(B)

modifying regulatory requirements or sub-regulatory program instruction or guidance related to pharmacy payment, reimbursement, or dispensing fees.

(5) Standard formats

(A) In general

Not later than June 1, 2027, the Secretary shall specify standard, machine-readable formats for pharmacy benefit managers to submit annual reports required under paragraph (1)(C)(i).

(B) Implementation

Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.

(6) Confidentiality

(A) In general

Information disclosed by a pharmacy benefit manager, an affiliate of a pharmacy benefit manager, a PDP sponsor, or a pharmacy under this subsection that is not otherwise publicly available or available for purchase shall not be disclosed by the Secretary or a PDP sponsor receiving the information, except that the Secretary may disclose the information for the following purposes:

(i)

As the Secretary determines necessary to carry out this part.

(ii)

To permit the Comptroller General to review the information provided.

(iii)

To permit the Director of the Congressional Budget Office to review the information provided.

(iv)

To permit the Executive Director of the Medicare Payment Advisory Commission to review the information provided.

(v)

To the Attorney General for the purposes of conducting oversight and enforcement under this title.

(vi)

To the Inspector General of the Department of Health and Human Services in accordance with its authorities under the Inspector General Act of 1978 (section 406 of title 5, United States Code), and other applicable statutes.

(B) Restriction on use of information

The Secretary, the Comptroller General, the Director of the Congressional Budget Office, and the Executive Director of the Medicare Payment Advisory Commission shall not report on or disclose information disclosed pursuant to subparagraph (A) to the public in a manner that would identify—

(i)

a specific pharmacy benefit manager, affiliate, pharmacy, manufacturer, wholesaler, PDP sponsor, or plan; or

(ii)

contract prices, rebates, discounts, or other remuneration for specific drugs in a manner that may allow the identification of specific contracting parties or of such specific drugs.

(7) Definitions

For purposes of this subsection:

(A) Affiliate

The term affiliate means, with respect to any pharmacy benefit manager or PDP sponsor, any entity that, directly or indirectly—

(i)

owns or is owned by, controls or is controlled by, or is otherwise related in any ownership structure to such pharmacy benefit manager or PDP sponsor; or

(ii)

acts as a contractor, principal, or agent to such pharmacy benefit manager or PDP sponsor, insofar as such contractor, principal, or agent performs any of the functions described under subparagraph (C).

(B) Bona fide service fee

The term bona fide service fee means a fee that is reflective of the fair market value (as specified by the Secretary, through notice and comment rulemaking) for a bona fide, itemized service actually performed on behalf of an entity, that the entity would otherwise perform (or contract for) in the absence of the service arrangement and that is not passed on in whole or in part to a client or customer, whether or not the entity takes title to the drug. Such fee must be a flat dollar amount and shall not be directly or indirectly based on, or contingent upon—

(i)

drug price, such as wholesale acquisition cost or drug benchmark price (such as average wholesale price);

(ii)

the amount of discounts, rebates, fees, or other direct or indirect remuneration with respect to covered part D drugs dispensed to enrollees in a prescription drug plan, except as permitted pursuant to paragraph (1)(A)(ii);

(iii)

coverage or formulary placement decisions or the volume or value of any referrals or business generated between the parties to the arrangement; or

(iv)

any other amounts or methodologies prohibited by the Secretary.

(C) Pharmacy benefit manager

The term pharmacy benefit manager means any person or entity that, either directly or through an intermediary, acts as a price negotiator or group purchaser on behalf of a PDP sponsor or prescription drug plan, or manages the prescription drug benefits provided by such sponsor or plan, including the processing and payment of claims for prescription drugs, the performance of drug utilization review, the processing of drug prior authorization requests, the adjudication of appeals or grievances related to the prescription drug benefit, contracting with network pharmacies, controlling the cost of covered part D drugs, or the provision of related services. Such term includes any person or entity that carries out one or more of the activities described in the preceding sentence, irrespective of whether such person or entity calls itself a pharmacy benefit manager.

(2) MA–PD plans

Section 1857(f)(3) of the Social Security Act (42 U.S.C. 1395w–27(f)(3)), as amended by section 226(d)(2), is amended by adding at the end the following new subparagraph:

(G) Requirements relating to pharmacy benefit managers

For plan years beginning on or after January 1, 2028, section 1860D–12(h).

(3) Nonapplication of Paperwork Reduction Act

Chapter 35 of title 44, United States Code, shall not apply to the implementation of this subsection.

(4) Funding

(1) Study

The Comptroller General of the United States (in this subsection referred to as the Comptroller General) shall conduct a study describing the use of compensation and payment structures related to a prescription drug’s price within the retail prescription drug supply chain in part D of title XVIII of the Social Security Act (42 U.S.C. 1395w–101 et seq.). Such study shall summarize information from Federal agencies and industry experts, to the extent available, with respect to the following:

(2) Report

Not later than 2 years after the date of enactment of this section, the Comptroller General shall submit to Congress a report containing the results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

(1) In general

The Medicare Payment Advisory Commission shall submit to Congress the following reports:

(2) Funding

In addition to amounts otherwise available, there is appropriated to the Medicare Payment Advisory Commission, out of any money in the Treasury not otherwise appropriated, $1,000,000 for fiscal year 2025, to remain available until expended, to carry out this subsection.

(1)

an analysis of the process established by the Secretary of Health and Human Services to conduct the reviews and determinations described in section 1833(t)(23)(B) of the Social Security Act, as added by subsection (a) of this section; and

(2)

recommendations based on such analysis, as the Inspector General determines appropriate.

(A)

in paragraph (1)—

(B)

in paragraph (2), by striking or 2025 each place it appears and inserting , 2025, or 2026; and

(A)

in subparagraph (A), in the matter preceding clause (i)—

(B)

in subparagraph (B)(i)—

(a) Extension for community health centers

Section 10503(b)(1) of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2(b)(1)) is amended—

(b) Extension for the National Health Service Corps

Section 10503(b)(2) of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2(b)(2)) is amended—

(c) Teaching health centers that operate graduate medical education programs

Section 340H(g)(1) of the Public Health Service Act (42 U.S.C. 256h(g)(1)) is amended—

(d) Application of provisions

Amounts appropriated pursuant to the amendments made by this section shall be subject to the requirements contained in Public Law 118–47 for funds for programs authorized under sections 330 through 340 of the Public Health Service Act (42 U.S.C. 254b et seq.).

(e) Conforming amendments

Section 3014(h)(4) of title 18, United States Code, is amended by striking and section 3101(d) of the Health Extensions and Other Matters Act, 2025 and inserting section 3101(d) of the Health Extensions and Other Matters Act, 2025, and section 401(d) of the Bipartisan Health Care Act.

(a) Extension of special diabetes programs for type I diabetes

Section 330B(b)(2) of the Public Health Service Act (42 U.S.C. 254c–2(b)(2)) is amended—

(b) Extending funding for special diabetes programs for Indians

Section 330C(c)(2) of the Public Health Service Act (42 U.S.C. 254c–3(c)(2)) is amended—

(a) In general

Section 3351(a)(2)(A) of the Public Health Service Act (42 U.S.C. 300mm–61(a)(2)(A)) is amended—

(b) Report to Congress

(c) Technical amendments

Title XXXIII of the Public Health Service Act (42 U.S.C. 300mm et seq.) is amended—

(a) In general

Section 392A of the Public Health Service Act (42 U.S.C. 280b–1) is amended—

(b) Additional grants

Section 392A(a)(3) of the Public Health Service Act (42 U.S.C. 280b–1(a)(3)) is amended—

(c) Authorization of appropriations

Section 392A(e) of the Public Health Service Act (42 U.S.C. 280b–1(e)) is amended by striking $496,000,000 for each of fiscal years 2019 through 2023 and inserting $505,579,000 for each of fiscal years 2025 through 2029.

(a) In general

Part O of title III of the Public Health Service Act (42 U.S.C. 280f et seq.) is amended to read as follows:

O Fetal alcohol syndrome prevention and services program

399H. Fetal alcohol spectrum disorders prevention, intervention, and services delivery program

(a) In general

The Secretary shall establish or continue activities to support a comprehensive fetal alcohol spectrum disorders (referred to in this section as FASD) education, prevention, identification, intervention, and services delivery program, which may include—

(1)

an education and public awareness program to support, conduct, and evaluate the effectiveness of—

(A)

educational programs targeting health professions schools, social and other supportive services, educators and counselors and other service providers in all phases of childhood development, and other relevant service providers, concerning the prevention, identification, and provision of services for infants, children, adolescents and adults with FASD;

(B)

strategies to educate school-age children, including pregnant and high-risk youth, concerning FASD;

(C)

public and community awareness programs concerning FASD; and

(D)

strategies to coordinate information and services across affected community agencies, including agencies providing social services such as foster care, adoption, and social work, agencies providing health services, and agencies involved in education, vocational training and civil and criminal justice;

(2)

supporting and conducting research on FASD, as appropriate, including to—

(A)

develop appropriate medical diagnostic methods for identifying FASD; and

(B)

develop effective culturally and linguistically appropriate evidence-based or evidence-informed interventions and appropriate supports for preventing prenatal alcohol exposure, which may co-occur with exposure to other substances;

(3)

building State and Tribal capacity for the identification, treatment, and support of individuals with FASD and their families, which may include—

(A)

utilizing and adapting existing Federal, State, or Tribal programs to include FASD identification and FASD-informed support;

(B)

developing and expanding screening and diagnostic capacity for FASD;

(C)

developing, implementing, and evaluating targeted FASD-informed intervention programs for FASD;

(D)

providing training with respect to FASD for professionals across relevant sectors; and

(E)

disseminating information about FASD and support services to affected individuals and their families; and

(4)

an applied research program concerning intervention and prevention to support and conduct service demonstration projects, clinical studies and other research models providing advocacy, educational and vocational training, counseling, medical and mental health, and other supportive services, as well as models that integrate and coordinate such services, that are aimed at the unique challenges facing individuals with Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families.

(b) Grants and Technical Assistance

(1) In general

The Secretary may award grants, cooperative agreements and contracts and provide technical assistance to eligible entities to carry out subsection (a).

(2) Eligible entities

To be eligible to receive a grant, or enter into a cooperative agreement or contract, under this section, an entity shall—

(A)

be a State, Indian Tribe or Tribal organization, local government, scientific or academic institution, or nonprofit organization; and

(B)

prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a description of the activities that the entity intends to carry out using amounts received under this section.

(3) Additional application contents

The Secretary may require that an eligible entity include in the application submitted under paragraph (2)(B)—

(A)

a designation of an individual to serve as a FASD State or Tribal coordinator of activities such eligible entity proposes to carry out through a grant, cooperative agreement, or contract under this section; and

(B)

a description of an advisory committee the entity will establish to provide guidance for the entity on developing and implementing a statewide or Tribal strategic plan to prevent FASD and provide for the identification, treatment, and support of individuals with FASD and their families.

(c) Definition of FASD-Informed

For purposes of this section, the term FASD-informed, with respect to support or an intervention program, means that such support or intervention program uses culturally and linguistically informed evidence-based or practice-based interventions and appropriate resources to support an improved quality of life for an individual with FASD and the family of such individual.

399I. Strengthening capacity and education for fetal alcohol spectrum disorders

(a) In general

The Secretary shall award grants, contracts, or cooperative agreements, as the Secretary determines appropriate, to public or nonprofit private entities with demonstrated expertise in the field of fetal alcohol spectrum disorders (referred to in this section as FASD). Such awards shall be for the purposes of building local, Tribal, State, and nationwide capacities to prevent the occurrence of FASD by carrying out the programs described in subsection (b).

(b) Programs

An entity receiving an award under subsection (a) may use such award for the following purposes:

(1)

Developing and supporting public education and outreach activities to raise public awareness of the risks associated with alcohol consumption during pregnancy.

(2)

Acting as a clearinghouse for evidence-based resources on FASD prevention, identification, and culturally and linguistically appropriate best practices to help inform systems of care for individuals with FASD across their lifespan.

(3)

Increasing awareness and understanding of efficacious, evidence-based screening tools and culturally and linguistically appropriate evidence-based intervention services and best practices, which may include improving the capacity for State, Tribal, and local affiliates.

(4)

Providing technical assistance to recipients of grants, cooperative agreements, or contracts under section 399H, as appropriate.

(c) Application

To be eligible for a grant, contract, or cooperative agreement under this section, an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.

(d) Subcontracting

A public or private nonprofit entity may carry out the following activities required under this section through contracts or cooperative agreements with other public and private nonprofit entities with demonstrated expertise in FASD:

(1)

Resource development and dissemination.

(2)

Intervention services.

(3)

Training and technical assistance.

399J. Authorization of appropriations

There are authorized to be appropriated to carry out this part $12,500,000 for each of fiscal years 2025 through 2029.

(b) Report

Not later than 4 years after the date of enactment of this Act, and every year thereafter, the Secretary of Health and Human Services shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing—

(1)

in subsection (a), by striking tribes and tribal and inserting Tribes and Tribal;

(2)

in subsections (a), (c), and (d)—

(3)

in subsection (f)—

(4)

in subsection (h), by striking $36,000,000 for each of fiscal years 2019 through 2023 and inserting $56,000,000 for each of fiscal years 2025 through 2029.

(a) Technical amendment

The second part G of title V of the Public Health Service Act (42 U.S.C. 290kk et seq.), as added by section 144 of the Community Renewal Tax Relief Act (Public Law 106–554), is amended—

(b) In general

Section 582 of the Public Health Service Act (42 U.S.C. 290hh–1) is amended—

(a) National suicide prevention lifeline program

Section 520E–3(b) of the Public Health Service Act (42 U.S.C. 290bb–36c(b)) is amended—

(b) Reporting

Section 520E–3 of the Public Health Service Act (42 U.S.C. 290bb–36c) is amended—

(c) Study

Not later than 180 days after the date of the enactment of this Act, the Comptroller General of the United States shall—

(a) Youth prevention and recovery

Section 7102(c) of the SUPPORT for Patients and Communities Act (42 U.S.C. 290bb–7a(c)) is amended—

(b) Interdepartmental substance use disorders coordinating committee

Section 7022 of the SUPPORT for Patients and Communities Act (42 U.S.C. 290aa note) is amended—

(a) In general

Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, shall publish guidance to facilitate the use of at-home safe disposal systems for applicable drugs.

(b) Contents

The guidance under subsection (a) shall include—

(a) In general

Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall publish on the website of the Food and Drug Administration (referred to in this section as the FDA) a report that outlines a plan for assessing opioid analgesic drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) that addresses the public health effects of such opioid analgesic drugs as part of the benefit-risk assessment and the activities of the FDA that relate to facilitating the development of nonaddictive medical products intended to treat pain or addiction. Such report shall include—

(b) Public input

In carrying out subsection (a), the Secretary shall provide an opportunity for public input concerning the regulation by the FDA of opioid analgesic drugs, including scientific evidence that relates to conditions of use, safety, or benefit-risk assessment (including consideration of the public health effects) of such opioid analgesic drugs.

(1)

in subsection (d)(11)(C), by striking providing health services and inserting providing health care services;

(2)

in subsection (g)—

(3)

in subsection (s), by striking $29,931,000 for each of fiscal years 2019 through 2023 and inserting $38,931,000 for each of fiscal years 2025 through 2029.

(1)

in subsection (a)(1), by inserting diagnosis, after related to; and

(2)

in subsection (b), by inserting addiction medicine, after psychiatry,.

(1)

in subsection (b)(1)—

(2)

in subsection (d)(1), in the matter preceding subparagraph (A), by inserting , developmental disability service providers before , individuals who are; and

(3)

in subsection (i), by striking 2023 and inserting 2029.

(1)

by striking subsection (b); and

(2)

by striking (a) In general.—The Secretary and inserting the following: The Secretary.

(a) Review of use of certain funding

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary), acting through the Assistant Secretary for Mental Health and Substance Use, shall conduct a review of State use of funds made available under the Community Mental Health Services Block Grant program under subpart I of part B of title XIX of the Public Health Service Act (42 U.S.C. 300x et seq.) (referred to in this section as the block grant program) for first episode psychosis activities. Such review shall consider the following:

(b) Report and guidance

(a) Secretary of HHS

The Secretary of Health and Human Services shall, consistent with the requirements and procedures set forth in sections 201 and 202 of the Controlled Substances Act (21 U.S.C. 811, 812)—

(b) Attorney general

The Attorney General shall review any request made by the Secretary of Health and Human Services under subsection (a)(2) and determine whether to initiate proceedings to revise the schedules in accordance with the criteria set forth in sections 201 and 202 of the Controlled Substances Act (21 U.S.C. 811, 812).

(1)

in subsection (b)(4), by striking building; and and inserting the following:

building, such as—

(A)

professional development of peer support specialists; and

(B)

making recovery support services available in nonclinical settings; and;

(2)

by redesignating subsections (d) and (e) as subsections (e) and (f), respectively;

(3)

by inserting after subsection (c) the following:

(d) Regional centers

(1) In general

The Secretary may establish one regional technical assistance center (referred to in this subsection as the Regional Center), with existing resources, to assist the Center in carrying out activities described in subsection (b) within the geographic region of such Regional Center in a manner that is tailored to the needs of such region.

(2) Evaluation

Not later than 4 years after the date of enactment of the SUPPORT for Patients and Communities Reauthorization Act of 2025, the Secretary shall evaluate the activities of the Regional Center and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the findings of such evaluation, including—

(A)

a description of the distinct roles and responsibilities of the Regional Center and the Center;

(B)

available information relating to the outcomes of the Regional Center under this subsection, such as any impact on the operations and efficiency of the Center relating to requests for technical assistance and support within the region of such Regional Center;

(C)

a description of any gaps or areas of duplication relating to the activities of the Regional Center and the Center within such region; and

(D)

recommendations relating to the modification, expansion, or termination of the Regional Center under this subsection.

(3) Termination

This subsection shall terminate on September 30, 2029.; and

(4)

in subsection (f), as so redesignated, by striking $1,000,000 for each of fiscal years 2019 through 2023 and inserting $2,000,000 for each of fiscal years 2025 through 2029.

(1)

in subsection (d)(2)—

(2)

in subsection (h)—

(3)

in subsection (j), by striking 2019 through 2023 and inserting 2025 through 2029.

(1)

in paragraph (2)—

(2)

in paragraph (3)(A), in the matter preceding clause (i)—

(3)

in paragraph (4)—

(4)

in paragraph (5), by striking tribal and inserting Tribal;

(5)

in paragraph (6)(A)—

(6)

in paragraph (8), by striking 2022 and inserting 2027; and

(7)

by amending paragraph (9) to read as follows:

(9) Authorization of appropriations

To carry out this subsection, there are authorized to be appropriated—

(A)

$10,000,000 for fiscal year 2025;

(B)

$12,000,000 for fiscal year 2026;

(C)

$13,000,000 for fiscal year 2027;

(D)

$14,000,000 for fiscal year 2028; and

(E)

$15,000,000 for fiscal year 2029.

(a) In general

Section 7183 of the SUPPORT for Patients and Communities Act (42 U.S.C. 290ee–8) is amended—

(b) Reauthorization of the CAREER Act; Recovery Housing Pilot Program

(c) Clerical amendments

The table of contents in section 1(b) of the SUPPORT for Patients and Communities Act (Public Law 115–271; 132 Stat. 3894) is amended—

(1)

section 1252(a) of division FF of Public Law 117–328 (136 Stat. 5681) is amended, in the matter being inserted into section 302(e) of the Controlled Substances Act, by striking 303(g) and inserting 303(h);

(2)

section 1262 of division FF of Public Law 117–328 (136 Stat. 5681) is amended—

(3)

section 1263(b) of division FF of Public Law 117–328 (136 Stat. 5685) is amended—

(a) In general

Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended—

(b) Effective date

The amendment made by subsection (a) shall take effect as if enacted on December 29, 2022.

(1)

in paragraph (1), by striking tribal organization or such Governor or tribal organization's designee and inserting Tribal organization or the designee of the Governor or Tribal organization, or the State or Tribal health official;

(2)

in paragraph (2)(B)—

(3)

in paragraph (6)—

(4)

in paragraph (7)(A), by striking tribal organization and inserting Tribal organization; and

(5)

in paragraph (8), by striking March 31, 2025 and inserting December 31, 2026.

(1)

in subsection (b)(2)—

(2)

in subsection (g)—

(3)

in subsection (h)(1)(A), by striking $685,000,000 for each of fiscal years 2019 through 2023 and inserting $735,000,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026.

(a) Increasing participation by EMS in the hospital preparedness program

(b) Improving medical readiness and response capabilities

Section 319C–2 of the Public Health Service Act (42 U.S.C. 247d–3b) is amended—

(1)

in paragraph (1), by striking $25,000,000 for each of fiscal years 2022 and 2023 and inserting $40,000,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026; and

(2)

in paragraph (2), by striking 2022 and 2023 and inserting 2025 and 2026, to remain available through December 31, 2026.

(a) In general

Section 319F–2(i) of the Public Health Service Act (42 U.S.C. 247d–6b(i)) is amended—

(b) GAO report

Section 2409(b) of the PREVENT Pandemics Act (Public Law 117–328) is amended—

(a) In general

Title III of the Public Health Service Act is amended by inserting after section 317V (42 U.S.C. 247b–24) the following:

317W. Wastewater surveillance for pathogen detection

(a) Wastewater surveillance system

The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other Federal departments and agencies, shall award grants, contracts, or cooperative agreements to eligible entities to establish, maintain, or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes.

(b) Eligible entities

To be eligible to receive an award under this section, an entity shall—

(1)

be a State, Tribal, or local health department, or a partnership between such a health department and other public and private entities; and

(2)

submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require, which shall include—

(A)

a description of activities proposed to be carried out pursuant to an award under subsection (a);

(B)

factors such entity proposes to use to select wastewater sampling sites;

(C)

factors such entity proposes to use to determine whether a response to findings from such wastewater sampling may be warranted, and a plan for responding, as appropriate, consistent with applicable plans developed by such entity pursuant to section 319C–1;

(D)

a plan to sustain such wastewater surveillance activities described in such application following the conclusion of the award period; and

(E)

any additional information the Secretary may require.

(c) Consideration

In making awards under subsection (a), the Secretary may give priority to eligible entities that have submitted an application that—

(1)

details plans to provide public access to deidentified data generated through such wastewater surveillance activities in a manner that allows for comparison to such data generated by other recipients of an award under subsection (a); and

(2)

provides an assessment of community needs related to ongoing infectious disease monitoring, including estimates of the incidence and prevalence of infectious diseases that can be detected in wastewater and availability, at the time of the application, of other forms of infectious disease detection in the jurisdiction.

(d) Use of funds

An eligible entity shall, as appropriate, use amounts awarded under this section to—

(1)

establish or enhance existing capacity and capabilities to conduct wastewater sampling, testing, and related analysis;

(2)

conduct wastewater surveillance, as appropriate, in areas or facilities with increased risk of infectious disease outbreaks and limited ability to utilize other forms of infectious disease detection, such as at individual facilities, institutions, and locations in rural areas or areas in which wastewater is not treated through the relevant local utility of the jurisdiction; and

(3)

implement projects that use evidence-based or innovative practices to conduct wastewater surveillance activities.

(e) Partnerships

In carrying out activities under this section, eligible entities shall identify opportunities to partner with other public or private entities to leverage relevant capabilities maintained by such entities, as appropriate and consistent with this section.

(f) Technical assistance

The Secretary, in consultation with the heads of other applicable Federal agencies and departments, as appropriate, shall provide technical assistance to recipients of awards under this section to facilitate the planning, development, and implementation of activities described in subsection (d).

(g) Authorization of appropriations

To carry out this section, there is authorized to be appropriated $20,000,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026.