[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3430 Reported in Senate (RS)]
<DOC>
Calendar No. 265
118th CONGRESS
1st Session
S. 3430
[Report No. 118-121]
To amend titles XVIII and XIX of the Social Security Act to expand the
mental health care workforce and services, reduce prescription drug
costs, and extend certain expiring provisions under Medicare and
Medicaid, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 7, 2023
Mr. Wyden, from the Committee on Finance, reported the following
original bill; which was read twice and placed on the calendar
_______________________________________________________________________
A BILL
To amend titles XVIII and XIX of the Social Security Act to expand the
mental health care workforce and services, reduce prescription drug
costs, and extend certain expiring provisions under Medicare and
Medicaid, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Better Mental
Health Care, Lower-Cost Drugs, and Extenders Act of 2023''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--EXPANDING MENTAL HEALTH CARE WORKFORCE AND SERVICES UNDER
MEDICARE AND MEDICAID
Sec. 101. Expanding eligibility for incentives under the Medicare
health professional shortage area bonus
program to practitioners furnishing mental
health and substance use disorder services.
Sec. 102. Improved access to mental health services under the Medicare
program.
Sec. 103. Clarifying coverage of occupational therapy under the
Medicare program.
Sec. 104. Medicare incentives for behavioral health integration with
primary care.
Sec. 105. Establishment of Medicare incident to modifier for mental
health services furnished through
telehealth.
Sec. 106. Guidance on furnishing behavioral health services via
telehealth to individuals with limited
English proficiency under Medicare program.
Sec. 107. Ensuring timely communication regarding telehealth and
interstate licensure requirements.
Sec. 108. Facilitating accessibility for behavioral health services
furnished through telehealth.
Sec. 109. Requiring Enhanced & Accurate Lists of (REAL) Health
Providers Act.
Sec. 110. Guidance to States on strategies under Medicaid and CHIP to
increase mental health and substance use
disorder care provider capacity.
Sec. 111. Guidance to States on supporting mental health services and
substance use disorder care for children
and youth.
Sec. 112. Recurring analysis and publication of Medicaid health care
data related to mental health services.
Sec. 113. Guidance to States on supporting mental health services or
substance use disorder care integration
with primary care in Medicaid and CHIP.
Sec. 114. Medicaid State option relating to inmates with a substance
use disorder pending disposition of
charges.
Sec. 115. Definition of Certified Community Behavioral Health Clinic
Services under Medicaid.
TITLE II--REDUCING PRESCRIPTION DRUG COSTS UNDER MEDICARE AND MEDICAID
Sec. 201. Assuring pharmacy access and choice for Medicare
beneficiaries.
Sec. 202. Ensuring accurate payments to pharmacies under Medicaid.
Sec. 203. Protecting seniors from excessive cost-sharing for certain
medicines.
TITLE III--MEDICAID EXPIRING PROVISIONS
Sec. 301. Delaying certain disproportionate share hospital payment
reductions under the Medicaid program.
Sec. 302. Extension of State option to provide medical assistance for
certain individuals who are patients in
certain institutions for mental diseases.
TITLE IV--MEDICARE EXPIRING PROVISIONS AND PROVIDER PAYMENT CHANGES
Sec. 401. Extension of funding for quality measure endorsement, input,
and selection.
Sec. 402. Extension of funding outreach and assistance for low-income
programs.
Sec. 403. Extension of the work geographic index floor under the
Medicare program.
Sec. 404. Extending incentive payments for participation in eligible
alternative payment models.
Sec. 405. Payment rates for durable medical equipment under the
Medicare Program.
Sec. 406. Extending the independence at home medical practice
demonstration program under the Medicare
program.
Sec. 407. Increase in support for physicians and other professionals in
adjusting to Medicare payment changes.
Sec. 408. Revised phase-in of Medicare clinical laboratory test payment
changes.
Sec. 409. Extension of adjustment to calculation of hospice cap amount
under Medicare.
TITLE V--OFFSETS
Sec. 501. Medicaid Improvement Fund.
Sec. 502. Medicare Improvement Fund.
TITLE I--EXPANDING MENTAL HEALTH CARE WORKFORCE AND SERVICES UNDER
MEDICARE AND MEDICAID
SEC. 101. EXPANDING ELIGIBILITY FOR INCENTIVES UNDER THE MEDICARE
HEALTH PROFESSIONAL SHORTAGE AREA BONUS PROGRAM TO
PRACTITIONERS FURNISHING MENTAL HEALTH AND SUBSTANCE USE
DISORDER SERVICES.
Section 1833(m) of the Social Security Act (42 U.S.C. 1395l(m)) is
amended--
(1) by striking paragraph (1) and inserting the following
new paragraph:
``(1) In the case of--
``(A) physicians' services (other than specified health
services that are eligible for the additional payment under
subparagraph (B)) furnished in a year to an individual, who is
covered under the insurance program established by this part
and who incurs expenses for such services, in an area that is
designated (under section 332(a)(1)(A) of the Public Health
Service Act) as a health professional shortage area as
identified by the Secretary prior to the beginning of such
year, in addition to the amount otherwise paid under this part,
there also shall be paid to the physician (or to an employer or
facility in the cases described in clause (A) of section
1842(b)(6)) (on a monthly or quarterly basis) from the Federal
Supplementary Medical Insurance Trust Fund an amount equal to
10 percent of the payment amount for the service under this
part; and
``(B) specified health services (as defined in paragraph
(5)) furnished in a year to an individual, who is covered under
the insurance program established by this part and who incurs
expenses for such services, in an area that is designated
(under such section 332(a)(1)(A)) as a mental health
professional shortage area as identified by the Secretary prior
to the beginning of such year, in addition to the amount
otherwise paid under this part, there also shall be paid to the
physician or applicable practitioner (as defined in paragraph
(6)) (or to an employer or facility in the cases described in
clause (A) of section 1842(b)(6)) (on a monthly or quarterly
basis) from such Trust Fund an amount equal to 15 percent of
the payment amount for the service under this part.'';
(2) in paragraph (2)--
(A) by striking ``in paragraph (1)'' and inserting
``in subparagraph (A) or (B) of paragraph (1)'';
(B) by inserting ``or, in the case of specified
health services, the physician or applicable
practitioner'' after ``physician'';
(3) in paragraph (3), by striking ``in paragraph (1)'' and
inserting ``in subparagraph (A) or (B) of paragraph (1)'';
(4) in paragraph (4)--
(A) in subparagraph (B), by inserting ``or
applicable practitioner'' after ``physician''; and
(B) in subparagraph (C), by inserting ``or
applicable practitioner'' after ``physician''; and
(5) by adding at the end the following new paragraphs:
``(5) In this subsection, the term `specified health services'
means services otherwise covered under this part that are furnished on
or after January 1, 2026, by a physician or an applicable practitioner
to an individual--
``(A) for purposes of diagnosis, evaluation, or treatment
of a mental health disorder, as determined by the Secretary; or
``(B) with a substance use disorder diagnosis for purposes
of treatment of such disorder or co-occurring mental health
disorder, as determined by the Secretary.
``(6) In this subsection, the term `applicable practitioner' means
the following:
``(A) A physician assistant, nurse practitioner, or
clinical nurse specialist (as defined in section 1861(aa)(5)).
``(B) A clinical social worker (as defined in section
1861(hh)(1)).
``(C) A clinical psychologist (as defined by the Secretary
for purposes of section 1861(ii)).
``(D) A marriage and family therapist (as defined in
section 1861(lll)(2)).
``(E) A mental health counselor (as defined in section
1861(lll)(4)).''.
SEC. 102. IMPROVED ACCESS TO MENTAL HEALTH SERVICES UNDER THE MEDICARE
PROGRAM.
(a) Access to Clinical Social Worker Services Provided to Residents
of Skilled Nursing Facilities.--
(1) Exclusion of clinical social worker services from the
skilled nursing facility prospective payment system.--Section
1888(e)(2)(A)(iii) of the Social Security Act (42 U.S.C.
1395yy(e)(2)(A)(iii)) is amended by adding at the end the
following new subclause:
``(VII) Clinical social worker
services (as defined in section
1861(hh)(2)).''.
(2) Conforming amendment.--Section 1861(hh)(2) of the
Social Security Act (42 U.S.C. 1395x(hh)(2)) is amended by
striking ``and other than services furnished to an inpatient of
a skilled nursing facility which the facility is required to
provide as a requirement for participation''.
(b) Access to the Complete Scope of Clinical Social Worker
Services.--Section 1861(hh)(2) of the Social Security Act (42 U.S.C.
1395x(hh)(2)), as amended by subsection (a)(2), is amended by striking
``for the diagnosis and treatment of mental illnesses (other than
services furnished to an inpatient of a hospital)'' and inserting ``,
including services for the diagnosis and treatment of mental illnesses
or services for health behavior assessment and intervention (identified
as of January 1, 2023, by HCPCS codes 96160 and 96161 (and any
succeeding codes)), but not including services furnished to an
inpatient of a hospital,''.
(c) Effective Date.--The amendments made by this section shall
apply to items and services furnished on or after January 1, 2026.
SEC. 103. CLARIFYING COVERAGE OF OCCUPATIONAL THERAPY UNDER THE
MEDICARE PROGRAM.
Not later than 1 year after the date of enactment of this Act, the
Secretary of Health and Human Services shall use existing communication
mechanisms to provide education and outreach to stakeholders about the
Medicare Benefit Policy Manual with respect to occupational therapy
services furnished to individuals under the Medicare program for the
treatment of a substance use or mental health disorder diagnosis using
applicable Healthcare Common Procedure Coding System (HCPCS) codes.
SEC. 104. MEDICARE INCENTIVES FOR BEHAVIORAL HEALTH INTEGRATION WITH
PRIMARY CARE.
(a) Incentives.--
(1) In general.--Section 1848(b) of the Social Security Act
(42 U.S.C. 1395w-4(b)) is amended by adding at the end the
following new paragraph:
``(13) Incentives for behavioral health integration.--
``(A) In general.--For services described in
subparagraph (B) that are furnished during 2026, 2027,
or 2028, instead of the payment amount that would
otherwise be determined under this section for such
year, the payment amount shall be equal to the
applicable percent (as defined in subparagraph (C)) of
such payment amount for such year.
``(B) Services described.--The services described
in this subparagraph are services identified, as of
January 1, 2023, by HCPCS codes 99484, 99492, 99493,
99494, and G2214 (and any successor or similar codes as
determined appropriate by the Secretary).
``(C) Applicable percent.--In this paragraph, the
term `applicable percent' means, with respect to a
service described in subparagraph (A), the following:
``(i) For services furnished during 2026 ,
175 percent.
``(ii) For services furnished during 2027,
150 percent.
``(iii) For services furnished during 2028,
125 percent.''.
(2) Waiver of budget neutrality.--Section 1848(c)(2)(B)(iv)
of such Act (42 U.S.C. 1395w-4(c)(2)(B)(iv)) is amended--
(A) in subclause (V), by striking ``and'' at the
end;
(B) in subclause (VI), by striking the period at
the end and inserting ``; and'' and
(C) by adding at the end the following new
subclause:
``(VII) the increase in payment
amounts as a result of the application
of subsection (b)(13) shall not be
taken into account in applying clause
(ii)(II) for 2026, 2027, or 2028.''.
(b) Technical Assistance for the Adoption of Behavioral Health
Integration.--
(1) In general.--Not later than January 1, 2025, the
Secretary of Health and Human Services (in this subsection
referred to as the ``Secretary'') shall enter into contracts or
agreements with appropriate entities to offer technical
assistance to primary care practices that are seeking to adopt
behavioral health integration models in such practices.
(2) Behavioral health integration models.--For purposes of
paragraph (1), behavioral health integration models include the
Collaborative Care Model (with services identified as of
January 1, 2023, by HCPCS codes 99492, 99493, 99494, and G2214
(and any successor codes)), the Primary Care Behavioral Health
model (with services identified as of January 1, 2023, by HCPCS
code 99484 (and any successor code)), and other models
identified by the Secretary.
(3) Implementation.--Notwithstanding any other provision of
law, the Secretary may implement the provisions of this
subsection by program instruction or otherwise.
(4) Funding.--In addition to amounts otherwise available,
there is appropriated to the Secretary for fiscal year 2024,
out of any money in the Treasury not otherwise appropriated,
$5,000,000, to remain available until expended, for purposes of
carrying out this subsection.
SEC. 105. ESTABLISHMENT OF MEDICARE INCIDENT TO MODIFIER FOR MENTAL
HEALTH SERVICES FURNISHED THROUGH TELEHEALTH.
Section 1834(m)(7) of the Social Security Act (42 U.S.C.
1395m(m)(7)) is amended by adding at the end the following new
subparagraph:
``(C) Establishment of incident to modifier for
mental health services furnished through telehealth.--
Not later than 2 years after the date of the enactment
of this subparagraph, the Secretary shall establish
requirements to include a code or modifier, as
determined appropriate by the Secretary, on claims for
mental health services furnished through telehealth
under this paragraph that are furnished by auxiliary
personnel (as defined in section 410.26(a)(1) of title
42, Code of Federal Regulations, or any successor
regulation) and billed incident to a physician or
practitioner's professional services.''.
SEC. 106. GUIDANCE ON FURNISHING BEHAVIORAL HEALTH SERVICES VIA
TELEHEALTH TO INDIVIDUALS WITH LIMITED ENGLISH
PROFICIENCY UNDER MEDICARE PROGRAM.
Not later than 1 year after the date of the enactment of this
section, the Secretary of Health and Human Services shall issue and
disseminate, or update and revise as applicable, guidance on the
following:
(1) Best practices for providers to work with interpreters
to furnish behavioral health services via video-based and
audio-only telehealth, when video-based telehealth is not an
option.
(2) Best practices on integrating the use of video
platforms that enable multi-person video calls into behavioral
health services furnished via telehealth.
(3) Best practices on teaching patients, especially those
with limited English proficiency, to use video-based telehealth
platforms.
(4) Best practices for providing patient materials,
communications, and instructions in multiple languages,
including text message appointment reminders and prescription
information.
SEC. 107. ENSURING TIMELY COMMUNICATION REGARDING TELEHEALTH AND
INTERSTATE LICENSURE REQUIREMENTS.
The Secretary of Health and Human Services shall provide
information--
(1) on licensure requirements for furnishing telehealth
services under titles XVIII and XIX of the Social Security Act
(42 U.S.C. 1395 et seq.; 1396 et seq.); and
(2) clarifying the extent to which licenses through an
interstate license compact pathway can qualify as valid and
full licenses for the purposes of meeting Federal licensure
requirements under such titles.
SEC. 108. FACILITATING ACCESSIBILITY FOR BEHAVIORAL HEALTH SERVICES
FURNISHED THROUGH TELEHEALTH.
The Secretary of Health and Human Services shall provide regular
updates to guidance to facilitate the accessibility of behavioral
health services furnished through telehealth for the visually and
hearing impaired.
SEC. 109. REQUIRING ENHANCED & ACCURATE LISTS OF (REAL) HEALTH
PROVIDERS ACT.
(a) In General.--Section 1852(c) of the Social Security Act (42
U.S.C. 1395w-22(c)) is amended--
(1) in paragraph (1)(C)--
(A) by striking ``plan, and any'' and inserting
``plan, any''; and
(B) by inserting the following before the period:
``, and, in the case of a network-based plan (as
defined in paragraph (3)(C)), for plan year 2026 and
subsequent plan years, the information described in
paragraph (3)(B)''; and
(2) by adding at the end the following new paragraph:
``(3) Provider directory accuracy.--
``(A) In general.--For plan year 2026 and
subsequent plan years, each MA organization offering a
network-based plan (as defined in subparagraph (C))
shall, for each network-based 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;
``(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; and
``(v) meet such other requirements as the
Secretary may specify.
``(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) Network-based plan.--In this paragraph, the
term `network-based plan' has the meaning given that
term in subsection (d)(5)(C), except such term includes
a Medicare Advantage private fee-for-service plan, as
determined appropriate by the Secretary.''.
(b) Accountability for Provider Directory Accuracy.--
(1) Cost sharing for services furnished based on reliance
on incorrect provider directory information.--Section 1852(d)
of the Social Security Act (42 U.S.C. 1395w-22(d)) is amended--
(A) in paragraph (1)(C)--
(i) in clause (ii), by striking ``or'' at
the end;
(ii) in clause (iii), by striking the
semicolon at the end and inserting ``, or'';
and
(iii) by adding at the end the following
new clause:
``(iv) the services are furnished by a
provider that is not participating in the
network of a network-based plan (as defined in
subsection (c)(3)(C)) but is listed in the
provider directory of such plan on the date on
which the appointment is made, as described in
paragraph (7)(A);''; and
(B) by adding at the end the following new
paragraph:
``(7) Cost sharing for services furnished based on reliance
on incorrect provider directory information.--
``(A) In general.--For plan year 2026 and
subsequent plan years, if an enrollee is furnished an
item or service by a provider that is not participating
in the network of a network-based plan (as defined in
subsection (c)(3)(C)) but is listed in the provider
directory of such plan (as required to be provided to
an enrollee pursuant to subsection (c)(1)(C)) on the
date on which the appointment is made, and if such item
or service would otherwise be covered under such plan
if furnished by a provider that is participating in the
network of such plan, the MA organization offering such
plan shall ensure that the enrollee is only responsible
for the amount of cost sharing that would apply if such
provider had been participating in the network of such
plan.
``(B) Notification requirement.--For plan year 2026
and subsequent plan years, each MA organization that
offers a network-based plan shall--
``(i) notify enrollees of their cost-
sharing protections under this paragraph and
make such notifications, to the extent
practicable, by not later than the first day of
an annual, coordinated election period under
section 1851(e)(3) with respect to a year;
``(ii) include information regarding such
cost-sharing protections in the provider
directory of each network-based plan offered by
the MA organization.; and
``(iii) notify enrollees of their cost-
sharing protections under this paragraph in an
explanation of benefits.''.
(2) Required provider directory accuracy analysis and
reports.--
(A) In general.--Section 1857(e) of the Social
Security Act (42 U.S.C. 1395w-27(e)) is amended by
adding at the end the following new paragraph:
``(6) Provider directory accuracy analysis and reports.--
``(A) In general.--Beginning with plan years
beginning on or after January 1, 2026, subject to
subparagraph (C), a contract under this section with an
MA organization shall require the organization, for
each network-based plan (as defined in section
1852(c)(3)(C)) offered by the organization, to
annually--
``(i) conduct an analysis estimating the
accuracy of the provider directory of such plan
using a sample of providers included in such
provider directory (including provider
specialties with high inaccuracy rates of
provider directory information, such as
providers specializing in mental health or
substance use disorder treatment, as determined
by the Secretary); and
``(ii) submit a report to the Secretary
containing the results of such analysis,
including an accuracy score for such provider
directory (as determined using a methodology
specified by the Secretary under subparagraph
(B)(i)), and other information required by the
Secretary.
``(B) Determination of accuracy score.--
``(i) In general.--The Secretary shall
specify methodologies for MA plans to use in
estimating the accuracy of the provider
directory information of such plans and
determining the accuracy score for the plan's
provider directory.
``(ii) Considerations.--In carrying out
clause (i), the Secretary shall take into
consideration--
``(I) data sources maintained by MA
organizations;
``(II) publicly available data
sets;
``(III) the administrative burden
on plans and providers; and
``(IV) the relative importance of
certain provider directory information
on enrollee ability to access care.
``(C) Exception.--The Secretary may waive the
requirements of this paragraph in the case of a
network-based plan with low enrollment (as defined by
the Secretary).
``(D) Transparency.--Beginning with plan years
beginning on or after January 1, 2027, the Secretary
shall post accuracy scores (as reported under
subparagraph (A)(ii)), in a machine readable file, on
the internet website of the Centers for Medicare &
Medicaid Services.
``(E) Implementation.--The Secretary shall
implement this paragraph through notice and comment
rulemaking.''.
(B) Provision of information to beneficiaries.--
Section 1851(d)(4) of the Social Security Act (42
U.S.C. 1395w-21(d)(4)) is amended by adding at the end
the following new subparagraph:
``(F) Provider directory.--Beginning with plan
years beginning on or after January 1, 2027, the
accuracy score of the plan's provider directory (as
reported under section 1857(e)(6)(A)(ii)) on the plan's
provider directory.''.
(C) Funding.--In addition to amounts otherwise
available, there is appropriated to the Centers for
Medicare & Medicaid Services Program Management
Account, out of any money in the Treasury not otherwise
appropriated, $1,000,000 for fiscal year 2025, to
remain available until expended, to carry out the
amendments made by this paragraph.
(3) GAO study and report.--
(A) Analysis.--The Comptroller General of the
United States (in this paragraph referred to as the
``Comptroller General'') shall conduct study of the
implementation of the amendments made by paragraphs (1)
and (2). To the extent data are available and reliable,
such study shall include an analysis of--
(i) the use of protections required under
section 1852(d)(7) of the Social Security Act,
as added by paragraph (1);
(ii) the provider directory accuracy scores
trends under section 1857(e)(6)(A)(ii) of the
Social Security Act (as added by paragraph
(2)(A)), both overall and among providers
specializing in mental health or substance
disorder treatment;
(iii) provider response rates by plan
verification methods; and
(iv) other items determined appropriate by
the Comptroller General.
(B) Report.--Not later than January 15, 2031, the
Comptroller General shall submit to Congress a report
containing the results of the study conducted under
subparagraph (A), together with recommendations for
such legislation and administrative action as the
Comptroller General determines appropriate.
(c) Guidance on Maintaining Accurate Provider Directories.--
(1) Stakeholder meeting.--
(A) In general.--Not later than 3 months after the
date of enactment of this Act, the Secretary of Health
and Human Services (referred to in this subsection as
the ``Secretary'') shall hold a public stakeholder
meeting to receive input on approaches for maintaining
accurate provider directories for Medicare Advantage
plans under part C of title XVIII of the Social
Security Act (42 U.S.C. 1395w-21 et seq.), including
input on approaches for reducing administrative burden
such as data standardization and best practices to
maintain provider directory information.
(B) Participants.--Participants of the meeting
under subparagraph (A) shall include representatives
from the Centers for Medicare & Medicaid Services and
the Office of the National Coordinator for Health
Information Technology, health care providers,
companies that specialize in relevant technologies,
health insurers, and patient advocates.
(2) Guidance to medicare advantage organizations.--Not
later than 12 months after the date of enactment of this Act,
the Secretary shall issue guidance to Medicare Advantage
organizations offering Medicare Advantage plans under part C of
title XVIII of the Social Security Act (42 U.S.C. 1395w-21 et
seq.) on maintaining accurate provider directories for such
plans, taking into consideration input received during the
stakeholder meeting under paragraph (1). Such guidance may
include the following, as determined appropriate by the
Secretary:
(A) Best practices for Medicare Advantage
organizations on how to work with providers to maintain
the accuracy of provider directories and reduce
provider and Medicare Advantage organization burden
with respect to maintaining the accuracy of provider
directories .
(B) Information on data sets and data sources with
information that could be used by Medicare Advantage
organizations to maintain accurate provider
directories.
(C) Approaches for utilizing data sources
maintained by Medicare Advantage organizations and
publicly available data sets to maintain accurate
provider directories.
(D) Information to be included in the provider
directory that may be useful for Medicare beneficiaries
to assess plan networks when selecting a plan and
accessing providers participating in plan networks
during the plan year.
(3) Guidance to part b providers.--Not later than 12 months
after the date of enactment of this Act, the Secretary shall
issue guidance to providers of services and suppliers who
furnish items or services for which benefits are available
under part B of title XVIII of the Social Security Act (42
U.S.C. 1395j et seq.) on when to update the National Plan and
Provider Enumeration System regarding any information changes.
SEC. 110. GUIDANCE TO STATES ON STRATEGIES UNDER MEDICAID AND CHIP TO
INCREASE MENTAL HEALTH AND SUBSTANCE USE DISORDER CARE
PROVIDER CAPACITY.
Not later than 12 months after the date of enactment of this Act,
the Secretary of Health and Human Services shall issue guidance to
States on strategies under Medicaid and the Children's Health Insurance
Program (CHIP) to increase access to mental health and substance use
disorder care providers that participate in Medicaid or CHIP, which may
include education, training, recruitment, and retention of such
providers, with a focus on improving the capacity of the mental health
and substance use disorder care workforce in rural and underserved
areas by increasing the number, type, and capacity of providers. Such
guidance shall include, but not be limited to--
(1) best practices from States that have used Medicaid or
CHIP waivers and authorities under titles XI, XIX, and XXI of
such Act (42 U.S.C. 1301 et seq., 1396 et seq., 1397aa et seq.)
for such purposes;
(2) best practices related to expanding the availability of
community-based mental health and substance use disorder
services under Medicaid and CHIP, including through the
participation of paraprofessionals with behavioral health
expertise, and review of State practices for leveraging
paraprofessionals within State scope of practice requirements
as well as State supervision requirements, such as peer support
specialists and clinicians with baccalaureate degrees; and
(3) best practices related to financing, supporting, and
expanding the education and training of providers of mental
health and substance use disorder services to increase the
workforce of such providers who participate in Medicaid and
CHIP, including by supporting on-site training in the clinical
setting and innovative public-private partnerships.
SEC. 111. GUIDANCE TO STATES ON SUPPORTING MENTAL HEALTH SERVICES AND
SUBSTANCE USE DISORDER CARE FOR CHILDREN AND YOUTH.
(a) Guidance on Increasing the Availability and Provision of Mental
Health Services and Substance Use Disorder Care Under Medicaid and
CHIP.--Not later than 12 months after the date of enactment of this
Act, the Secretary shall issue guidance to States regarding
opportunities to improve the availability and provision of mental
health services and substance use disorder care through Medicaid and
CHIP for children and youth. Such guidance shall address the following:
(1) The design and implementation of a continuum of
benefits for children and youth with significant mental health
conditions and substance use disorders covered by Medicaid and
CHIP, including the role of EPSDT, how EPSDT requires States to
make available a continuum of care across settings, and what is
required of States to ensure compliance with EPSDT.
(2) Strategies to facilitate access to mental health
services and substance use disorder care under Medicaid and
CHIP that are delivered in the home or in community-based
settings for children and youth. Such guidance shall outline
strategies employed by States to expand the availability of
such settings and include specific interventions and financing
arrangements that could be replicated.
(3) Strategies to facilitate access to mental health
services and substance use disorder care under Medicaid and
CHIP for children and youth who--
(A) are at risk for having a significant mental
health condition or substance use disorder;
(B) have a significant mental health condition or
substance use disorder; or
(C) have an intellectual or developmental
disability.
(4) Strategies to promote screening for mental health and
substance use disorder needs of children and youth, including
children and youth provided, or at risk for needing, child
welfare services, in coordination with providers, managed care
organizations (as defined by the Secretary), prepaid inpatient
health plans (as defined by the Secretary), prepaid ambulatory
health plans (as defined by the Secretary), and schools (as
defined by the Secretary).
(5) Strategies for supporting the provision of culturally
competent, developmentally appropriate, and trauma-informed
mental health services and substance use disorder care to
children and youth.
(6) Strategies for providing early prevention,
intervention, and screening services, including for children
and youth at higher risk for having mental health or substance
use disorder needs, children and youth who do not have a mental
health or substance use disorder diagnosis, children and youth
provided, or at risk for needing, child welfare services, and
children at risk of first episode psychosis.
(7) Best practices from State Medicaid and CHIP programs in
expanding access to mental health services and substance use
disorder care for children and youth, including children and
youth that are part of underserved communities and children and
youth with co-occurring intellectual disability or autism
spectrum disorder, and former foster youth.
(8) Strategies to coordinate services and funding provided
under parts B and E of title IV of the Social Security Act (42
U.S.C. 621 et seq., 670 et seq.), and other funding sources at
the discretion of the Secretary, with services for which
Federal financial participation is available under Medicaid or
CHIP, to support improved access to comprehensive mental health
services and substance use disorder care for children and youth
provided, or at risk for needing, child welfare services.
(b) Consultation.--The Secretary shall consult with the
Administrator of the Centers for Medicare & Medicaid Services, the
Assistant Secretary for the Administration for Children and Families,
the Assistant Secretary for Mental Health and Substance Use, and the
Director of the Office of National Drug Control Policy with respect to
the guidance issued under subsection (a).
(c) Definitions.--In this section:
(1) EPSDT.--The term ``EPSDT'' means early and periodic
screening, diagnostic, and treatment services under Medicaid in
accordance with sections 1902(a)(43), 1905(a)(4)(B), and
1905(r) of the Social Security Act (42 U.S.C. 1396a(a)(43),
1396d(a)(4)(B), 1396d(r)).
(2) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(3) State.--The term ``State'' has the meaning given that
term 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.
SEC. 112. RECURRING ANALYSIS AND PUBLICATION OF MEDICAID HEALTH CARE
DATA RELATED TO MENTAL HEALTH SERVICES.
(a) In General.--The Secretary, on a biennial basis, shall link,
analyze, and publish on a publicly available website Medicaid data
reported by States through the Transformed Medicaid Statistical
Information System (T-MSIS) (or a successor system) relating to mental
health services provided to individuals enrolled in Medicaid, including
an analysis by age. Such enrollee information shall be de-identified of
any personally identifying information, shall adhere to privacy
standards established by the Department of Health and Human Services,
and shall be aggregated to protect the privacy of enrollees, as
necessary. Each publication of such analysis shall include for each
State available data for the following measures:
(1) The number and percentage of individuals by age
enrolled in the State Medicaid plan or waiver of such plan in
each of the major enrollment categories (as defined in a
letter, to be made publicly available on the website of the
Medicaid and CHIP Payment and Access Commission, from the
Medicaid and CHIP Payment and Access Commission to the
Secretary) who have been diagnosed with a mental health
condition and whether such individuals are enrolled under the
State Medicaid plan or waiver of such plan, including the
specific waiver authority under which they are enrolled, to the
extent available.
(2) A list of the mental health treatment services,
including specifying adult and pediatric services, by each
major type of service, such as counseling, intensive home-based
services, intensive care coordination, crisis services tailored
to children and youth, youth peer support services, family-to-
family support, inpatient hospitalization, and other
appropriate services as identified by the Secretary, for which
beneficiaries in each State received at least 1 service under
the State Medicaid plan or a waiver of such plan.
(3) The number and percentage of individuals by age with a
substance use disorder diagnosis enrolled in the State Medicaid
plan or waiver of such plan who received services for a mental
health condition under such plan or waiver by each major type
of service specified under paragraph (2) within each major
setting type, such as outpatient, inpatient, residential, and
other home-based and community-based settings.
(4) The number of services provided under the State
Medicaid plan or waiver of such plan per individual with a
mental health diagnosis, including by age, enrolled in such
plan or waiver for each major type of service specified under
paragraph (2).
(5) The number and percentage of individuals by age
enrolled in the State Medicaid plan or waiver by major
enrollment category, who received mental health services
through--
(A) a Medicaid managed care entity (as defined in
section 1932(a)(1)(B) of the Social Security Act (42
U.S.C. 1396u-2(a)(1)(B))), including the number of such
individuals who received such assistance through a
prepaid inpatient health plan (as defined by the
Secretary) or a prepaid ambulatory health plan (as
defined by the Secretary);
(B) a fee-for-service payment model; or
(C) an alternative payment model, to the extent
available.
(6) The number and percentage of individuals by age with a
mental health diagnosis who received mental health services in
an outpatient or home-based and community-based setting after
receiving services in an inpatient or residential setting and
the number of services received by such individuals in the
outpatient or home-based and community-based setting.
(7) The number and percentage of inpatient admissions by
age in which services for a mental health condition were
provided to an individual enrolled in the State Medicaid plan
or a waiver of such plan that occurred within 30 days after
discharge from a hospital or inpatient facility in which
services for a mental health condition previously were provided
to such individual, disaggregated by type of facility, to the
extent such information is available.
(8) The number of emergency department visits by an
individual by age enrolled in the State Medicaid plan or a
waiver of such plan for treatment of a mental health condition
within 7 days of such individual being discharged from a
hospital inpatient facility in which services for a mental
health condition were provided, or from a mental health
facility, an independent psychiatric wing of acute care
hospital, or an intermediate care facility for individuals with
intellectual disabilities, disaggregated by type of facility,
to the extent such information is available.
(9) The number and percentage of individuals by age
enrolled in the State Medicaid plan or a waiver of such plan--
(A) who received an assessment to diagnose a mental
health condition; and
(B) the number of mental health services provided
to individuals described in subparagraph (A) in the 30
days post-assessment.
(10) Prescription National Drug Code codes, fill dates, and
number of days supply of any covered outpatient drug (as
defined in section 1927(k)(2) of the Social Security Act (42
U.S.C. 1396r-8(k)(2)) to treat a mental health condition that
were dispensed to an individual by age enrolled in the State
Medicaid plan or waiver with an episode described in paragraph
(7) or (8) during any period that occurs after the individual's
discharge date defined in paragraph (7) or (8) (as applicable),
and before the admission date applicable under paragraph (7) or
the date of the emergency department visit applicable under
paragraph (8).
(b) Publication.--
(1) In general.--Not later than 18 months after the date of
enactment of this Act, the Secretary shall make publicly
available the first analysis required by subsection (a).
(2) Use of t-msis data.--The report required under
paragraph (1) and updates required under paragraph (3) shall--
(A) use data and definitions from the Transformed
Medicaid Statistical Information System (``T-MSIS'')
(or a successor system) data set that is no more than
12 months old on the date that the report or update is
published; and
(B) as appropriate, include a description with
respect to each State of the quality and completeness
of the data and caveats describing the limitations of
the data reported to the Secretary by the State that is
sufficient to communicate the appropriate uses for the
information.
(3) Revised publication.--Not later than 3 years after the
date of enactment of this Act, the Secretary shall publish a
revised publication of the analysis required by subsection (a)
that allows for a research-ready and publicly accessible
interface of the publication that is developed after
consultation with stakeholders on the usability of the data
contained in the publication.
(c) Making Permanent the Requirement to Annually Update the SUD
Data Book.--Section 1015 of the SUPPORT for Patients and Communities
Act (Public Law 115-271) is amended--
(1) in subsection (a)(3), by striking ``through 2024''; and
(2) in subsection (b), by adding at the end the following
new paragraph:
``(4) Publication of data.--
``(A) In general.--The Secretary shall publish in
the Federal Register a system of records notice that
modifies the system of records notice required under
paragraph (1) to provide that--
``(i) the data specified in paragraph (2)
shall be published on a publicly available
website; and
``(ii) such data shall be de-identified of
any personally identifying information, shall
adhere to privacy standards established by the
Department of Health and Human Services, and
shall be aggregated to protect the privacy of
enrollees, as necessary.
``(B) Initiation of modified data-sharing
activities.--Not later than January 1, 2025, the
Secretary shall initiate the data sharing activities
outlined in the notice required under paragraph (1), as
modified pursuant to this paragraph.''.
(d) Definitions.--In this section:
(1) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(2) State.--The term ``State'' has the meaning given that
term in section 1101(a)(1) of the Social Security Act (42
U.S.C. 1301(a)(1)) for purposes of title XIX of such Act.
SEC. 113. GUIDANCE TO STATES ON SUPPORTING MENTAL HEALTH SERVICES OR
SUBSTANCE USE DISORDER CARE INTEGRATION WITH PRIMARY CARE
IN MEDICAID AND CHIP.
(a) Analysis Regarding Care Integration.--Not later than 18 months
after the date of enactment of this Act, the Secretary shall conduct an
analysis of Medicaid and CHIP regarding clinical outcomes among
different models of integration of mental health services or substance
use disorder care within the primary care setting. Such analysis
shall--
(1) consider different models for how mental health
services or substance use disorder care is delivered and
integrated within the primary care setting, including when
providers operating in an integrated model are physically
located in the same practice or building, when at least 1
provider in an integrated care model is available via
telehealth, and when primary care, mental health, or substance
use disorder care providers seek education and consultation
from other providers through electronic modalities; and
(2) evaluate--
(A) the use of different payment methodologies,
such as bundled payments and value-based payment
arrangements; and
(B) the use and quality of services to coordinate
care, including but not limited to case management,
care coordination, enhanced care coordination, and
enhanced care management, for mental health services
and for substance use disorder care.
(b) Guidance.--Not later than 12 months after the Secretary
completes the analysis required under subsection (a), the Secretary
shall issue guidance to States on supporting integration of mental
health services or substance use disorder care with primary care under
Medicaid and CHIP. Such guidance shall be informed by the analysis
required under subsection (a) and, at minimum, shall do the following:
(1) Provide an overview of State options for adopting and
expanding value-based payment arrangements and alternative
payment models, including accountable care organizations and
other shared savings programs, that integrate mental health
services or substance use disorder care with primary care.
(2) Describe opportunities for States to use and align
existing authorities and resources to finance integration of
mental health services or substance use disorder care with
primary care, including with respect to the use of electronic
health records in mental health care settings and in substance
use disorder care settings.
(3) Describe strategies to support integration of mental
health services or substance use disorder care with primary
care through the use of non-clinical professionals and
paraprofessionals, including trained peer support specialists.
(4) Provide examples of specific strategies and models
designed to support integration of mental health services or
substance use disorder care with primary care for differing age
groups, including children and youth, and individuals over the
age of 65.
(5) Describe options for assessing the clinical outcomes of
differing models and strategies for integration of mental
health services or substance use disorder care with primary
care.
(c) Integration of Mental Health Services or Substance Use Disorder
Care With Primary Care.--For purposes of subsections (a) and (b),
integration of mental health services or substance use disorder care
with primary care may include (and shall not be limited to, including
when furnished via telehealth, when appropriate)--
(1) adherence to the collaborative care model or primary
care behavioral health model for behavioral health integration;
(2) use of behavioral health integration models primarily
intended for pediatric populations with non-severe mental
health needs that are focused on prevention and early detection
and intervention methods through a multidisciplinary
collaborative behavioral health team approach co-managed with
primary care, to include same-day access to family-focused
mental health treatment services;
(3) having mental health providers or substance use
disorder providers physically co-located in a primary care
setting with same-day visit availability;
(4) implementing or maintaining enhanced care coordination
or targeted case management which includes regular interactions
between and within care teams;
(5) providing mental health or substance use disorder
screening and follow-up assessments, interventions, or services
within the same practice or facility as a primary care or
physical service setting;
(6) the use of assertive community treatment that is
integrated with or facilitated by a primary care practice; and
(7) delivery of integrated primary care and mental health
services or substance use disorder care in the home or in
community-based settings for individuals who choose and are
able to receive care in such settings, as authorized under
subsections (b), (c), (i), (j), and (k) of section 1915 of the
Social Security Act (42 U.S.C. 1396n), under a waiver under
section 1115 of such Act (42 U.S.C. 1315), or under section
1937, 1945, or 1945A of such Act (42 U.S.C. 1396u-7, 1396w-4,
1396w-4a).
(d) Definitions.--In this section:
(1) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(2) State.--The term ``State'' has the meaning given that
term 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.
SEC. 114. MEDICAID STATE OPTION RELATING TO INMATES WITH A SUBSTANCE
USE DISORDER PENDING DISPOSITION OF CHARGES.
(a) State Option.--
(1) In general.--Section 1905 of the Social Security Act
(42 U.S.C. 1396d) is amended--
(A) in the subdivision (A) following the last
numbered paragraph of subsection (a), by inserting
``subject to subsection (jj),'' before ``any such
payments''; and
(B) by adding at the end the following new
subsection:
``(jj) State Option to Provide Medical Assistance to Certain
Inmates With a Substance Use Disorder Pending Disposition of Charges.--
``(1) In general.--Subject to paragraph (2), a State may
elect to provide, and, notwithstanding the subdivision (A)
following the last numbered paragraph of subsection (a),
receive Federal financial participation for, medical assistance
for an individual who--
``(A) is an inmate of a public institution (as
defined in section 1902(nn)(3)) pending disposition of
charges; and
``(B) has been diagnosed with a substance use
disorder.
``(2) Limitation; conditions.--
``(A) Limitation.--A State may only receive Federal
financial participation for medical assistance provided
to an individual described in paragraph (1) during the
7-day period that begins on the first day that the
individual is an inmate of a public institution.
``(B) Conditions.--A State may only receive Federal
financial participation for medical assistance provided
to an individual described in paragraph (1) if--
``(i) the State has elected to not
terminate eligibility for medical assistance
under the State plan for individuals on the
basis that they are inmates of public
institutions (but may suspend coverage during
the period an individual is such an inmate);
and
``(ii) the diagnosis that the covered
individual has a substance use disorder is made
while the individual is an inmate of the public
institution by a licensed medical professional
using a standardized screening and assessment
model approved by the Secretary.''.
(2) Effective date.--The amendments made by this subsection
shall take effect on January 1, 2026.
(b) Technical Correction and Conforming Amendments.--
(1) Technical correction.--Section 5122(a)(1) of the
Consolidated Appropriations Act, 2023 (Public Law 117-328) is
amended by striking ``after'' and all that follows through the
period at the end and inserting ``after `or in the case of an
eligible juvenile described in section 1902(a)(84)(D) with
respect to the screenings, diagnostic services, referrals, and
targeted case management services required under such
section'.''.
(2) Other conforming amendments.--
(A) Section 1902(nn)(3) of the Social Security Act
(42 U.S.C. 1396a(nn)(3)), is amended by striking
``following'' and all that follows through ``section
1905(a)'' and inserting ``following the last numbered
paragraph of section 1905(a)''.
(B) The fifth sentence of section 1905(a) of the
Social Security Act (42 U.S.C. 1396d(a)) is amended by
striking ``paragraph (30)'' and inserting ``the last
numbered paragraph''.
SEC. 115. DEFINITION OF CERTIFIED COMMUNITY BEHAVIORAL HEALTH CLINIC
SERVICES UNDER MEDICAID.
(a) Definition of Medical Assistance.--Section 1905 of the Social
Security Act (42 U.S.C. 1396d) is amended--
(1) in subsection (a)--
(A) in paragraph (30), by striking ``; and'' and
inserting a semicolon;
(B) by redesignating paragraph (31) as paragraph
(32); and
(C) by inserting after paragraph (30) the following
new paragraph:
``(31) certified community behavioral health clinic
services, as defined in subsection (jj); and''; and
(2) by adding at the end the following new subsection:
``(jj) Certified Community Behavioral Health Clinic Services.--
``(1) In general.--The term `certified community behavioral
health services' means any of the following when furnished to
an individual as a patient of a certified community behavioral
health clinic (as defined in paragraph (2)), in a manner
reflecting person-centered care and which, if not available
directly through a certified community behavioral health
clinic, may be provided or referred through formal
relationships with other providers:
``(A) Crisis mental health services, including 24-
hour mobile crisis teams, emergency crisis intervention
services, and crisis stabilization.
``(B) Screening, assessment, and diagnosis,
including risk assessment.
``(C) Patient-centered treatment planning or
similar processes, including risk assessment and crisis
planning.
``(D) Outpatient mental health and substance use
services.
``(E) Outpatient clinic primary care screening and
monitoring of key health indicators and health risk.
``(F) Intensive case management.
``(G) Psychiatric rehabilitation services.
``(H) Peer support and counselor services and
family supports.
``(I) Intensive, community-based mental health care
for members of the armed forces and veterans,
particularly those members and veterans located in
rural areas, provided the care is consistent with
minimum clinical mental health guidelines promulgated
by the Veterans Health Administration, including
clinical guidelines contained in the Uniform Mental
Health Services Handbook of such Administration.
``(2) Certified community behavioral health clinic.--The
term `certified community behavioral health clinic' means an
organization that--
``(A) is engaged in furnishing to patients all of
the services described in paragraph (1);
``(B) is legally authorized to furnish such
services under State law;
``(C) agrees, as a condition of the certification
described in subparagraph (D), to furnish to the State
or Secretary any data required as part of ongoing
monitoring of the organization's provision of services,
including encounter data, clinical outcomes data,
quality data, and such other data as the State or
Secretary may require; and
``(D) has been certified by a State as meeting the
criteria established by the Secretary pursuant to
subsection (a) of section 223 of the Protecting Access
to Medicare Act as of January 1, 2024, and any
subsequent updates to such criteria, regardless of
whether the State is carrying out a demonstration
program under this title under subsection (d) of such
section.''.
(b) Effective Date.--The amendments made by this section shall
apply with respect to medical assistance furnished on or after January
1, 2024.
TITLE II--REDUCING PRESCRIPTION DRUG COSTS UNDER MEDICARE AND MEDICAID
SEC. 201. ASSURING PHARMACY ACCESS AND CHOICE FOR MEDICARE
BENEFICIARIES.
(a) In General.--Section 1860D-4(b)(1) of the Social Security Act
(42 U.S.C. 1395w-104(b)(1)) is amended by striking subparagraph (A) and
inserting the following:
``(A) In general.--
``(i) Participation of any willing
pharmacy.--A PDP sponsor offering a
prescription drug plan shall permit any
pharmacy that meets the standard contract terms
and conditions under such plan to participate
as a network pharmacy of such plan.
``(ii) Contract terms and conditions.--
``(I) In general.--For plan years
beginning on or after January 1, 2028,
in accordance with clause (i), contract
terms and conditions offered by such
PDP sponsor shall be reasonable and
relevant according to standards
established by the Secretary under
subclause (II).
``(II) Standards.--Not later than
the first Monday in April of 2027, the
Secretary shall establish standards for
reasonable and relevant contract terms
and conditions for purposes of this
clause.
``(III) Request for information.--
Not later than January 1, 2025, for
purposes of establishing the standards
under subclause (II), the Secretary
shall issue a request for information
to seek input on trends in prescription
drug plan and network pharmacy contract
terms and conditions, current
prescription drug plan and network
pharmacy contracting practices, whether
pharmacy reimbursement and dispensing
fees under this part cover pharmacy
ingredient and operational costs, areas
in current regulations or program
guidance related to contracting between
prescription drug plans and network
pharmacies requiring clarification or
additional specificity, factors for
consideration in determining the
reasonableness and relevance of
contract terms and conditions between
prescription drug plans and network
pharmacies, and other issues determined
appropriate by the Secretary.''.
(b) Treatment of Essential Retail Pharmacies.--Section 1860D-
4(b)(1)(C) of the Social Security Act (42 U.S.C. 1395w-104(b)(1)(C)) is
amended by adding at the end the following new clause:
``(v) Essential retail pharmacies.--
``(I) In general.--For plan years
beginning on or after January 1, 2028,
a PDP sponsor of a prescription drug
plan that has preferred pharmacies in
its network shall contract with, as
preferred pharmacies in such plan's
network, at least--
``(aa) 80 percent of
essential retail pharmacies (as
defined in subclause (III)) in
such plan's service area that
are independent community
pharmacies (as defined in
subclause (V)(bb)); and
``(bb) 50 percent of
essential retail pharmacies in
such plan's service area not
described in item (aa).
``(II) Total reimbursement for
essential retail pharmacies that are
independent community pharmacies.--For
plan years beginning on or after
January 1, 2028, total reimbursement
(as defined in subclause (V)(dd)) paid
by a PDP sponsor to an essential retail
pharmacy that is an independent
community pharmacy for a covered part D
drug shall not be lower than--
``(aa) in the case where
National Average Drug
Acquisition Cost information
for such drug for retail
community pharmacies or
applicable non-retail community
pharmacies has been available
under section 1927(f) for at
least one full plan year--
``(AA) if such
information is
available for such drug
for retail community
pharmacies, the average
National Average Drug
Acquisition Cost for
such drug for retail
community pharmacies
for the most recent
plan year for which
such information is
available;
``(BB) in the case
where such information
for retail community
pharmacies is not
available, the average
National Average Drug
Acquisition Cost for
such drug for
applicable non-retail
pharmacies for the most
recent plan year for
which such information
is available;
``(bb) in the case where
National Average Drug
Acquisition Cost information
for such drug under section
1927(f) is not available for
retail community pharmacies or
applicable non-retail
pharmacies, the wholesale
acquisition cost (as defined in
section 1847A(c)(6)(B)) for
such drug; and
``(cc) in the case where
National Average Drug
Acquisition Cost information
under section 1927(f) is
available for such drug and
ending on the date such survey
information has been available
for such drug but has not been
available for a full plan
year--
``(AA) the most
recent National Average
Drug Acquisition Cost
for such drug for
retail community
pharmacies, if
available; or
``(BB) if the
information specified
in subitem (AA) is not
available, the most
recent National Average
Drug Acquisition Cost
for such drug for
applicable non-retail
pharmacies.
``(III) Definition of essential
retail pharmacy.--In this clause, the
term `essential retail pharmacy' means,
with respect to a plan year, a retail
pharmacy that--
``(aa) is not an affiliate
of a pharmacy benefit manager
or PDP sponsor;
``(bb) is located in a
medically underserved area (as
designated pursuant to section
330(b)(3)(A) of the Public
Health Service Act); and
``(cc) is designated as an
essential retail pharmacy by
the Secretary for such plan
year under subclause (IV).
``(IV) Designation of essential
retail pharmacies.--
``(aa) In general.--For
each plan year (beginning with
plan year 2028), the Secretary
shall designate pharmacies that
meet the requirements specified
in items (aa) and (bb) of
subclause (III) as essential
retail pharmacies, in
accordance with this subclause.
``(bb) Required submissions
from pdp sponsors.--For each
plan year beginning with plan
year 2028, each PDP sponsor
offering a prescription drug
plan shall submit to the
Secretary, for the purposes of
determining retail pharmacies
that do not meet the
requirement specified in item
(aa) of subclause (III), a list
of any retail pharmacy that is
an affiliate of such sponsor,
subject to time, manner, and
form requirements established
by the Secretary.
``(cc) Publication.--Not
later than one month prior to
the start of each plan year
(beginning with plan year
2028), the Secretary shall
list, on a publicly available
website of the Centers for
Medicare & Medicaid Services,
all pharmacies designated as
essential retail pharmacies for
such plan year.
``(dd) Revocation of
designation.--In the case
where, during a plan year, the
Secretary determines that a
pharmacy no longer meets the
requirements for designation as
an essential retail pharmacy,
the Secretary may revoke such
designation for such pharmacy,
as determined appropriate by
the Secretary.
``(V) Other definitions.--In this
clause:
``(aa) 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 PDP
sponsor or that acts as a
contractor or agent to such
pharmacy benefit manager or PDP
sponsor, if such contractor or
agent performs any of the
functions described in item
(cc).
``(bb) Independent
community pharmacy.--The term
`independent community
pharmacy' means a retail
pharmacy, including a pharmacy
that is associated with a
franchise or a pharmacy
services administrative
organization, that has fewer
than 4 locations and is not
affiliated with any person or
entity other than its owners.
``(cc) 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 identifies
itself as a `pharmacy benefit
manager'.
``(dd) Total
reimbursement.--The term `total
reimbursement' means, with
respect to a covered part D
drug, the negotiated price (as
defined in section 1860D-
2(d)(1)(B)) plus any incentive
payments paid by the PDP
sponsor to such essential
retail pharmacy that is an
independent community pharmacy
net of any fees, pharmacy price
concessions, discounts, or any
other forms of remuneration
paid by such pharmacy and
furnished by such PDP sponsor
under section 1860D-2(f)(4).''.
(c) Enforcement.--
(1) In general.--Section 1860D-4(b)(1) of the Social
Security Act (42 U.S.C. 1395w-104(b)(1)) is amended by adding
at the end the following new subparagraph:
``(F) Enforcement of standards for reasonable and
relevant contract terms and conditions and essential
retail pharmacy protections.--
``(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 an allegation of a
violation by a PDP sponsor offering a
prescription drug plan of--
``(aa) the standards for
reasonable and relevant
contract terms and conditions
under subparagraph (A)(ii); or
``(bb) the requirements for
total reimbursement for
essential retail pharmacies
that are independent community
pharmacies under subparagraph
(C)(v)(II).
``(II) Frequency of submission.--
``(aa) Violations of
reasonable and relevant
contract terms and
conditions.--
``(AA) In
general.--Except as
provided in subitem
(BB), the allegation
submission process
under this clause shall
allow pharmacies to
submit any allegations
of violations described
in item (aa) of
subclause (I) not more
frequently than once
per plan year per
contract between a
pharmacy and a PDP
sponsor.
``(BB) Allegations
relating to contract
changes.--In the case
where a contract is
amended or otherwise
updated 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
changes with respect to
such contract and plan
year.
``(CC)
Submissions.--Submission
s of any allegations
under this item shall
be separate from any
submissions under item
(bb) and may include
multiple allegations of
such violations.
``(bb) Violations of
essential retail pharmacy
protections.--
``(AA) In
general.--The
allegation submission
process under this
clause shall allow
essential retail
pharmacies that are
independent community
pharmacies to submit
any allegations of
violations described in
item (bb) of subclause
(I) once per calendar
quarter.
``(BB)
Submissions.--Submission
s of any allegations
under this item shall
be separate from any
submissions under item
(aa) and may include
multiple allegations of
such violations.
``(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 separate
standardized templates for pharmacies
to use for the submission of
allegations described in items (aa) and
(bb) of subclause (I). Each 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.
``(ii) Investigation.--The Secretary shall
investigate, as determined appropriate by the
Secretary, allegations submitted pursuant to
clause (i).
``(iii) Enforcement.--
``(I) Reasonable and relevant
contract terms and conditions.--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
shall use existing authorities under
sections 1857(g) and 1860D-12(b)(3)(E)
to impose civil monetary penalties or
take other enforcement actions.
``(II) Essential retail pharmacy
protections.--In the case where the
Secretary determines that a PDP sponsor
offering a prescription drug plan has
violated the requirements for total
reimbursement for essential retail
pharmacies that are independent
community pharmacies under subparagraph
(C)(v)(II), the Secretary shall--
``(aa) if the amount of
total reimbursement paid by the
sponsor to an essential retail
pharmacy that is an independent
community pharmacy for a
covered part D drug was less
than the amount of total
reimbursement required to be
paid to the pharmacy under
subparagraph (C)(v)(II) for
such drug, require the PDP
sponsor to pay to the pharmacy
an amount equal to the
difference between such
amounts; and
``(bb) use existing
authorities under section
1857(g) and 1860D-12(b)(3)(E)
to impose civil monetary
penalties or take other
enforcement actions.
``(III) 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).
``(iv) Definitions.--In this subparagraph,
the terms `essential retail pharmacy',
`independent community pharmacy', and `total
reimbursement' have the meaning given those
terms in subparagraph (C)(v).''.
(2) Conforming amendment.--Section 1857(g)(1) of the Social
Security Act (42 U.S.C. 1395w-27(g)(1)) is amended--
(A) in subparagraph (J), by striking ``or'' after
the semicolon;
(B) by redesignating subparagraph (K) as
subparagraph (L);
(C) by inserting after subparagraph (J), the
following new subparagraph:
``(K) fails to comply with--
``(i) the standards for reasonable and
relevant contract terms and conditions under
subparagraph (A)(ii) of section 1860D-4(b)(1);
or
``(ii) the requirements for total
reimbursement for essential retail pharmacies
that are independent community pharmacies under
subparagraph (C)(v)(II) of such section; or'';
(D) in subparagraph (L), as redesignated by
subparagraph (B), by striking ``through (J)'' and
inserting ``through (K)''; and
(E) in the flush matter following subparagraph (L),
as so redesignated, by striking ``subparagraphs (A)
through (K)'' and inserting ``subparagraphs (A) through
(L)''.
(d) Accountability of Pharmacy Benefit Managers for Violations of
Reasonable and Relevant Contract Terms and Conditions and Essential
Retail Pharmacy Protections.--
(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 and essential retail pharmacy protections.--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 subclause
(I) or (II) of section 1860D-4(b)(1)(F)(iii) as a result of a
violation described in such subclause (I) or (II) 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 and conditions and essential retail pharmacy
protections.--For plan years beginning on or after
January 1, 2028, section 1860D-12(b)(9).''.
(e) Section 1860D-42 of the Social Security Act (42 U.S.C. 1395w-
152) is amended by adding at the end the following new subsection:
``(e) Briefing and Reporting Requirements Related to Pharmacy Price
Concessions Under This Part.--
``(1) Briefing requirements.--The Secretary shall provide
periodic briefings to the Committee on Finance of the Senate,
the Committee on Ways and Means of the House of
Representatives, and the Committee on Energy and Commerce of
the House of Representatives, beginning not later than 90 days
after the date of enactment of this subsection, on
implementation, oversight, data collection, and enforcement
activities related to the administration of the `Pharmacy Price
Concessions to Drug Prices at the Point of Sale' provisions
codified under sections 423.100 and 423.2305 of title 42, Code
of Federal Regulations (or any successor regulations), as
published in the Federal Register on May 9, 2022, in the final
rule entitled `Medicare Program; Contract Year 2023 Policy and
Technical Changes to the Medicare Advantage and Medicare
Prescription Drug Benefit Programs; Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency;
Additional Policy and Regulatory Revisions in Response to the
COVID-19 Public Health Emergency'.
``(2) Reporting requirements.--Beginning not later than 90
days after the date of enactment of this subsection, and at
least once every plan year beginning thereafter (through plan
year 2027), the Secretary shall develop and submit to Congress
reports on the activities specified in paragraph (1).
``(3) Contents for briefings and reports.--The briefings
required under paragraph (1) and reports required under
paragraph (2) shall include information on--
``(A) implementation, oversight, data collection,
and enforcement activities related to contract terms
and conditions among PDP sponsors, MA organizations,
and pharmacies for the purpose of establishing or
maintaining pharmacy network participation or preferred
pharmacy network participation;
``(B) patterns and trends in such terms and
conditions, to the extent applicable;
``(C) implementation, oversight, and enforcement
activities and developments related to assuring
pharmacy access under section 1860D-4(b)(1), along with
applicable regulations and program instruction or
guidance;
``(D) plans, strategies, initiatives, or
programmatic changes undertaken by the Secretary to
prevent, mitigate, or otherwise address stakeholder
feedback and concerns related to convenient pharmacy
access for beneficiaries under this part; and
``(E) other issues determined appropriate by the
Secretary.''.
(f) Funding.--In addition to amounts otherwise available, there is
appropriated to the Centers for Medicare & Medicaid Services Program
Management Account, out of any money in the Treasury not otherwise
appropriated, $250,000,000 for fiscal year 2024, to remain available
until expended, to carry out the amendment made by this section.
SEC. 202. ENSURING ACCURATE PAYMENTS TO PHARMACIES UNDER MEDICAID.
(a) In General.--Section 1927(f) of the Social Security Act (42
U.S.C. 1396r-8(f)) is amended--
(1) in paragraph (1)(A)--
(A) by redesignating clause (ii) as clause (iii);
and
(B) by striking ``and'' after the semicolon at the
end of clause (i) and all that precedes it through
``(1)'' and inserting the following:
``(1) Determining pharmacy actual acquisition costs.--The
Secretary shall conduct a survey of retail community pharmacy
drug prices and applicable non-retail pharmacy drug prices to
determine national average drug acquisition cost benchmarks as
follows:
``(A) Use of vendor.--The Secretary may contract
services for--
``(i) with respect to retail community
pharmacies, the determination of retail survey
prices of the national average drug acquisition
cost for covered outpatient drugs that
represent a nationwide average of consumer
purchase prices for such drugs, net of all
discounts and rebates (to the extent any
information with respect to such discounts and
rebates is available) based on a monthly survey
of such pharmacies;
``(ii) with respect to applicable non-
retail pharmacies--
``(I) the determination of survey
prices, separate from the survey prices
described in clause (i), of the non-
retail national average drug
acquisition cost for covered outpatient
drugs that represent a nationwide
average of consumer purchase prices for
such drugs, net of all discounts and
rebates (to the extent any information
with respect to such discounts and
rebates is available) based on a
monthly survey of such pharmacies; and
``(II) at the discretion of the
Secretary, for each type of applicable
non-retail pharmacy (as identified
pursuant to the type indicators
established by the Secretary under
subsection (k)(12)(B)(ii)), the
determination of survey prices,
separate from the survey prices
described in clause (i) or subclause
(I) of this clause, of the national
average drug acquisition cost for such
type of pharmacy for covered outpatient
drugs that represent a nationwide
average of consumer purchase prices for
such drugs, net of all discounts and
rebates (to the extent any information
with respect to such discounts and
rebates is available) based on a
monthly survey of such pharmacies;
and'';
(2) 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, the
relevant pharmacy type indicator for all cost
information collected, including whether a
pharmacy is owned by, operated by, or otherwise
affiliated with a pharmacy benefit manager and
whether a pharmacy is a retail community
pharmacy or an applicable non-retail pharmacy,
and, in the case of an applicable non-retail
pharmacy, which type of applicable non-retail
pharmacy (as identified pursuant to the type
indicators established by the Secretary under
subsection (k)(12)(B)(ii)) it is.'';
(3) 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, or rebate related to the dispensing of
covered outpatient drugs to individuals receiving
benefits under this title, regardless of whether such
payment, reimbursement, administrative fee, discount,
or rebate 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 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 frame and number of
pharmacies sampled monthly.
``(iii) Information on price concessions to
the pharmacy, 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.--The Secretary, in consultation
with the Office of the Inspector General of the
Department of Health and Human Services, shall enforce
the provisions of this paragraph with respect to a
pharmacy through the establishment of appropriate civil
monetary penalties, which may be assessed with respect
to each violation or survey non-response, and with
respect to each non-compliant pharmacy (including a
pharmacy that is part of a chain), until compliance
with this paragraph has been completed. The provisions
of section 1128A (other than subsections (a) and (b))
shall apply to a civil money penalty under the
preceding sentence 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 paragraph (1)(A)(ii) to develop or
inform reimbursement rates for retail community
pharmacies.'';
(4) in paragraph (2)--
(A) in subparagraph (A), by inserting ``, including
payment rates under managed care entities or other
specified entities (as such terms are defined in
section 1903(m)(9)(D)),'' after ``under this title'';
and
(B) in subparagraph (B), by inserting ``and the
basis for such dispensing fees'' before the semicolon;
(5) by redesignating paragraph (4) as paragraph (5);
(6) 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
affiliated with pharmacy benefit managers, wholesalers,
distributors, and other entities that acquire 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
2024, to remain available until expended, to carry out
this paragraph.''; and
(7) in paragraph (5), as so redesignated, by inserting ``,
and $9,000,000 for fiscal year 2024 and each fiscal year
thereafter,'' after ``2010''.
(b) Definitions.--Section 1927(k) of the Social Security Act (42
U.S.C. 1396r-8(k)) is amended by adding the following--
``(12) Applicable non-retail pharmacy.--
``(A) In general.--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).
``(B) Identification of applicable non-retail
pharmacies.--
``(i) In general.--For purposes of
subsection (f), the Secretary shall, not later
than January 1, 2025, in consultation with
stakeholders as appropriate, issue guidance
specifying pharmacies that meet the definition
of applicable non-retail pharmacies and that
will be subject to the survey requirements
under subsection (f)(1).
``(ii) Inclusion of pharmacy type
indicators.--The guidance promulgated under
clause (i) 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.
``(13) 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 or
other specified entity (as such terms are defined in section
1903(m)(9)(D)), or manages the prescription drug benefits
provided by such 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
carries out 1 or more of the activities described in the
preceding sentence, irrespective of whether such person or
entity calls itself a `pharmacy benefit manager'.''.
(c) Effective Date.--The amendments made by this section take
effect on 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.
SEC. 203. PROTECTING SENIORS FROM EXCESSIVE COST-SHARING FOR CERTAIN
MEDICINES.
Section 1860D-2 of the Social Security Act (42 U.S.C. 1395w-102) is
amended--
(1) in subsection (b)--
(A) in paragraph (2)(A), in the matter preceding
clause (i), by striking ``and (9)'' and inserting ``,
(9), (10), and (11)''; and
(B) by adding at the end the following new
paragraphs:
``(10) Tying cost-sharing to net price for certain
medications.--
``(A) In general.--For plan years beginning on or
after January 1, 2028, for costs above the annual
deductible specified in paragraph (1) and below the
annual out-of-pocket threshold specified in paragraph
(4), any coinsurance amount for a discount-eligible
drug that is included on the plan's formulary and
subject to coinsurance rather than a copayment shall be
calculated based on the net price of such discount-
eligible drug.
``(B) Reporting to the secretary.--For plan years
beginning on or after January 1, 2028, a PDP sponsor of
a prescription drug plan and an MA organization
offering an MA-PD plan shall annually submit to the
Secretary, in a form and manner determined appropriate
by the Secretary--
``(i) approximate price concessions and net
prices for each discount-eligible drug; and
``(ii) a written explanation of the
methodology used to calculate such approximate
price concessions and net prices.
``(C) Requirements for approximate price
concessions.--
``(i) In general.--Approximate price
concessions submitted under subparagraph (B)
shall comply with--
``(I) the drug-specific threshold
under clause (ii) for the applicable
plan year; and
``(II) the aggregate threshold
under clause (iii) for the applicable
plan year.
``(ii) Thresholds.--
``(I) Plan years 2028 through
2032.--For plan years 2028 through
2032--
``(aa) the drug-specific
threshold is 20 percent; and
``(bb) the aggregate
threshold is 15 percent.
``(II) Subsequent plan years.--
``(aa) In general.--For
plan years beginning with 2033,
the Secretary may, as
determined appropriate by the
Secretary, adjust the drug-
specific and aggregate
thresholds under this clause.
``(bb) Considerations.--In
making any such adjustments,
the Secretary may consider
historical variations in
expected and actual
manufacturer price concessions
for covered part D drugs,
factors that may result in
manufacturer price concession
uncertainty or variation in a
given plan year, PDP sponsor
and MA organization behavioral
responses, effects of precise
manufacturer price concession
disclosures, beneficiary out-
of-pocket costs, expenditures
under this part, and other
factors determined appropriate
by the Secretary.
``(cc) Requirements.--In
making any such adjustments,
the Secretary shall ensure that
the aggregate threshold for an
applicable plan year is lower
than the drug-specific
threshold for such applicable
plan year.
``(dd) Publication.--The
Secretary shall publish any
adjustments to the drug-
specific and aggregate
thresholds under this clause no
later than the first Monday of
April of the year before the
start of the plan year for
which such adjusted thresholds
are applicable.
``(D) Publication of discount-eligible drugs.--Not
later than 15 months before the start of each plan year
(beginning with plan year 2028), the Secretary shall
publish on a publicly available website a list of the
discount-eligible drugs that apply with respect to such
plan year (as determined by the Secretary under
subparagraph (F)(iv)).
``(E) Enforcement.--
``(i) Monitoring compliance.--The
Secretary, in consultation with the Office of
the Inspector General, shall conduct periodic
audits of prescription drug plans and MA-PD
plans to monitor compliance with the
requirements under this paragraph. All
information reported by a PDP sponsor or MA
organization under this paragraph may be
subject to audit by the Secretary and the
Office of the Inspector General.
``(ii) Penalties.--
``(I) In general.--A PDP sponsor or
an MA organization that violates the
requirements under this paragraph may
be subject to civil monetary penalties,
consistent with sections 1857(g) and
1860D-12(b)(3)(E), as determined
appropriate by the Secretary.
``(II) Application.--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).
``(F) Definitions.--In this paragraph:
``(i) Actual price concessions.--The term
`actual price concessions' means, with respect
to a covered part D drug, the amount of
manufacturer price concessions that the PDP
sponsor or MA organization reports for such
drug in the Detailed DIR Report (or successor
report) for the applicable plan year.
``(ii) Aggregate threshold.--The term
`aggregate threshold' means the maximum
percentage by which the total approximate price
concessions for all discount-eligible drugs may
vary from the total actual manufacturer price
concessions for all such discount-eligible
drugs as reported in the Detailed DIR Report
(or successor report) for the applicable plan
year.
``(iii) Approximate price concessions.--The
term `approximate price concessions' means,
with respect to a covered part D drug, the
amount of price concessions from manufacturers
that the PDP sponsor or MA organization
estimates it will receive with respect to an
applicable plan year, subject to the thresholds
established under subparagraph (C)(ii), and
reflected in the net price.
``(iv) Discount-eligible drug.--
``(I) In general.--The term
`discount-eligible drug' means a
covered part D drug (other than a
covered part D drug described in
paragraph (8) or (9))--
``(aa) that is in an
applicable category or class
described in subclause (II);
and
``(bb) for which the
aggregate manufacturer price
concessions received by PDP
sponsors and MA organizations
(or pharmacy benefit managers
acting on behalf of such
sponsors or organizations) for
such drug are equal to or
exceed 50 percent of aggregate
gross covered prescription drug
costs for such drug in the most
recent plan year for which data
is available, as determined by
the Secretary based on previous
submissions of Detailed DIR
Reports (or successor reports)
or other relevant reporting
from PDP sponsors or MA
organizations.
``(II) Applicable category or
class.--The applicable categories and
classes described in this subclause are
the following, as specified by the
United States Pharmacopeia:
``(aa) Anti-inflammatories
(Inhaled Corticosteroids).
``(bb) Bronchodilators,
Anticholinergic.
``(cc) Bronchodilators,
Sympathomimetic.
``(dd) Respiratory tract
agents.
``(ee) Anticoagulants.
``(ff) Cardiovascular
agents.
``(v) Drug-specific threshold.--The term
`drug-specific threshold' means the maximum
percentage by which approximate price
concessions with respect to a discount-eligible
drug may vary from the actual manufacturer
price concessions for such drug, as reported in
the Detailed DIR Report (or successor report)
for the applicable plan year.
``(vi) Net price.--The term `net price'
means, with respect to a covered part D drug,
the negotiated price of such drug, net of all
approximate price concessions (estimated on an
average per-unit basis, as needed) not already
reflected in the negotiated price for the
applicable plan year.
``(vii) Manufacturer price concessions.--
The term `manufacturer price concessions'
means, with respect to a covered part D drug,
rebates that the PDP sponsor or MA organization
receives from manufacturers.
``(G) Nonapplication of paperwork reduction act.--
Chapter 35 of title 44, United States Code, shall not
apply to any data collection undertaken by the
Secretary under this paragraph.
``(11) Limiting cost-sharing to net price.--
``(A) In general.--For plan years beginning on or
after January 1, 2028, the cost-sharing (for costs
above the annual deductible specified in paragraph (1))
for a covered part D drug (other than a covered part D
drug described in paragraph (8) or (9)) shall not
exceed the negotiated price for such covered part D
drug net of all price concessions (as defined in
paragraph (10)(F)(v)), as reported in the Detailed DIR
Report (or successor report) for the applicable plan
year.
``(B) Enforcement.--
``(i) Monitoring compliance.--The Secretary
shall monitor compliance with the requirements
under subparagraph (A) on an ongoing basis,
including through periodic audits.
``(ii) Retroactive penalties.--
``(I) In general.--A PDP sponsor or
an MA organization that violates the
requirements under subparagraph (A) may
be subject to civil monetary penalties,
consistent with sections 1857(g) and
1860D-12(b)(3)(E), as determined
appropriate by the Secretary. The
Secretary may impose such penalties
retroactively upon review of the
Detailed DIR Report (or any successor
report) with respect to a given plan
year.
``(II) Application.--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).
``(12) GAO study and report on implementation and effects
of cost-sharing relief provisions.--
``(A) Study.--The Comptroller General of the United
States (in this paragraph referred to as the
`Comptroller General') shall conduct a study on certain
effects of the implementation of the requirements
specified under the provisions of paragraphs (10) and
(11).
``(B) Report.--Once the data and information needed
to conduct the study described in subparagraph (A) has
become available and the Comptroller General has had
sufficient opportunity to review and analyze such data
and information, the Comptroller General shall develop
and publish a report on the findings of such study,
including with respect to the following:
``(i) Effects on enrollee cost-sharing,
utilization and adherence, formulary coverage
and placement, and utilization management with
respect to affected covered part D drugs
(discount-eligible drugs and covered part D
drugs for which, prior to implementation of
such provisions, cost-sharing exceeded net
price for some beneficiaries).
``(ii) Changes to pharmacy reimbursement
methodologies and levels, if any, with respect
to discount-eligible drugs.
``(iii) Changes in manufacturer rebating
levels (relative to gross costs) for discount-
eligible drugs.
``(iv) Other behavioral responses by PDP
sponsors, enrollees, manufacturers, pharmacies,
or other entities related to the implementation
of such provisions.
``(v) Effects of such provisions on
enrollee premiums and Federal outlays.
``(vi) Other issues determined appropriate
by the Comptroller General.
``(C) Subsequent reports.--The Comptroller General
may, as determined appropriate, conduct subsequent
studies and produce subsequent reports with respect to
the ongoing implementation and effects of the
provisions of paragraphs (10) and (11).''; and
(2) in subsection (c), by adding at the end the following
new paragraphs:
``(7) Tying cost-sharing to net price for certain drugs.--
The coverage is provided in accordance with subsection (b)(10).
``(8) Limiting cost-sharing to net price.--The coverage is
provided in accordance with subsection (b)(11).''.
TITLE III--MEDICAID EXPIRING PROVISIONS
SEC. 301. DELAYING CERTAIN DISPROPORTIONATE SHARE HOSPITAL PAYMENT
REDUCTIONS UNDER THE MEDICAID PROGRAM.
Section 1923(f)(7)(A) of the Social Security Act (42 U.S.C. 1396r-
4(f)(7)(A)), as amended by section 2341 of title III of division B of
the Continuing Appropriations Act, 2024 and Other Extensions Act
(Public Law 118-15), is further amended--
(1) in clause (i)--
(A) in the matter preceding subclause (I), by
striking ``For the period beginning'' and all that
follows through ``2027'' and inserting ``For each of
fiscal years 2026 and 2027''; and
(B) in subclauses (I) and (II), by striking ``or
period'' each place it appears; and
(2) in clause (ii), by striking ``for the period
beginning'' and all that follows through ``2027'' and inserting
``for each of fiscal years 2026 and 2027''.
SEC. 302. EXTENSION OF STATE OPTION TO PROVIDE MEDICAL ASSISTANCE FOR
CERTAIN INDIVIDUALS WHO ARE PATIENTS IN CERTAIN
INSTITUTIONS FOR MENTAL DISEASES.
(a) Making Permanent State Plan Amendment Option To Provide Medical
Assistance for Certain Individuals Who Are Patients in Certain
Institutions for Mental Diseases.--Section 1915(l)(1) of the Social
Security Act (42 U.S.C. 1396n(l)(1)) is amended by striking ``With
respect to calendar quarters beginning during the period beginning
October 1, 2019, and ending September 30, 2023,'' and inserting ``With
respect to calendar quarters beginning on or after October 1, 2019,''.
(b) Maintenance of Effort Revision.--Section 1915(l)(3) of the
Social Security Act (42 U.S.C. 1396n(l)(3)) is amended--
(1) in subparagraph (A)--
(A) in the matter preceding clause (i), by striking
``other than under this title''; and
(B) in clause (i), by striking ``or, if higher,''
and all that follows through ``in accordance with this
subsection''; and
(2) by adding at the end the following new subparagraph:
``(D) Application of maintenance of effort
requirements to certain states.--In the case of a State
with a State plan amendment in effect as of September
30, 2023, for the 1-year period beginning on the date
of enactment of this subparagraph, the provisions of
subparagraph (A) shall be applied as if the amendments
to that subparagraph made by the Better Mental Health
Care, Lower-Cost Drugs, and Extenders Act of 2023 had
never been made.''.
(c) Additional Requirements.--
(1) In general.--Section 1915(l)(4) of the Social Security
Act (42 U.S.C. 1396n(l)(4)) is amended--
(A) in subparagraph (A), by striking ``through
(D)'' and inserting ``through (F)'';
(B) in subparagraph (D), by adding at and below
clause (ii)(II), the following flush sentence:
``With respect to calendar quarters beginning on or
after October 1, 2025, the State shall have in place
evidence-based, substance use disorder-specific
individual placement criteria and utilization
management approaches to ensure placement of an
eligible individual in an appropriate level of care
and, prior to the approval of a State plan amendment
for which approval is sought on or after such date,
shall notify the Secretary of how the State will ensure
that the requirements of clauses (i) and (ii) will be
met.''; and
(C) by adding at the end the following new
subparagraph:
``(E) Review process.--With respect to calendar
quarters beginning on or after October 1, 2025, the
State shall have in place a process to review the
compliance of eligible institutions for mental diseases
with nationally recognized, evidence-based, substance
use disorder-specific program standards specified by
the State.''.
(2) One-time assessment.--Section 1915(l)(4) of the Social
Security Act (42 U.S.C. 1396n(l)(4)), as amended by paragraph
(1), is further amended by adding at the end the following new
subparagraph:
``(F) Assessment.--
``(i) In general.--The State shall, not
later than 12 months after the approval of a
State plan amendment described in this
subsection (or, in the case such State has such
an amendment approved as of September 30, 2023,
not later than 12 months after the date of
enactment of this subparagraph), commence an
assessment of--
``(I) the availability for
individuals enrolled under a State plan
under this title (or waiver of such
plan) of treatment in--
``(aa) each level of care
described in clause (i) of
subparagraph (C); and
``(bb) each level of care
described in clause (ii) of
subparagraph (C) at which the
State provides medical
assistance; and
``(II) the availability of
medication-assisted treatment and
medically supervised withdrawal
management services for such
individuals.
``(ii) Required completion.--The State
shall complete the assessment described in
clause (i) not later than 12 months after the
date the State commences such assessment.''.
(3) Clarification of levels of care.--Section 1915(l)(7)(A)
of the Social Security Act (42 U.S.C. 1396n(l)(7)(A)) is
amended by inserting ``(or any successor publication)'' before
the period.
TITLE IV--MEDICARE EXPIRING PROVISIONS AND PROVIDER PAYMENT CHANGES
SEC. 401. EXTENSION OF FUNDING FOR QUALITY MEASURE ENDORSEMENT, INPUT,
AND SELECTION.
Section 1890(d)(2) of the Social Security Act (42 U.S.C.
1395aaa(d)(2)) is amended--
(1) in the first sentence--
(A) by striking ``and $20,000,000'' and inserting
``$20,000,000''; and
(B) by inserting the following before the period at
the end: ``, and $20,000,000 for fiscal year 2024'';
and
(2) in the third sentence, by striking ``and 2023'' and
inserting ``2023, and 2024''.
SEC. 402. EXTENSION OF FUNDING OUTREACH AND ASSISTANCE FOR LOW-INCOME
PROGRAMS.
(a) State Health Insurance Assistance Programs.--Subsection
(a)(1)(B) of section 119 of the Medicare Improvements for Patients and
Providers Act of 2008 (42 U.S.C. 1395b-3 note), as amended by section
3306 of the Patient Protection and Affordable Care Act (Public Law 111-
148), section 610 of the American Taxpayer Relief Act of 2012 (Public
Law 112-240), section 1110 of the Pathway for SGR Reform Act of 2013
(Public Law 113-67), section 110 of the Protecting Access to Medicare
Act of 2014 (Public Law 113-93), section 208 of the Medicare Access and
CHIP Reauthorization Act of 2015 (Public Law 114-10), section 50207 of
division E of the Bipartisan Budget Act of 2018 (Public Law 115-123),
section 1402 of division B of the Continuing Appropriations Act, 2020,
and Health Extenders Act of 2019 (Public Law 116-59), section 1402 of
division B of the Further Continuing Appropriations Act, 2020, and
Further Health Extenders Act of 2019 (Public Law 116-69), section 103
of division N of the Further Consolidated Appropriations Act, 2020
(Public Law 116-94), section 3803 of the CARES Act (Public Law 116-
136), section 2203 of the Continuing Appropriations Act, 2021 and Other
Extensions Act (Public Law 116-159), section 1102 of the Further
Continuing Appropriations Act, 2021, and Other Extensions Act (Public
Law 116-215), and section 103 of division CC of the Consolidated
Appropriations Act, 2021 (Public Law 116-260), is amended--
(1) in the matter preceding clause (i), by striking
``Centers for Medicare & Medicaid Services Program Management
Account'' and inserting ``Administration for Community
Living'';
(2) in clause (xii), by striking ``and'' at the end;
(3) in clause (xiii), by striking the period at the end and
inserting ``; and''; and
(4) by inserting after clause (xiii) the following new
clause:
``(xiv) for fiscal year 2024,
$15,000,000.''.
(b) Area Agencies on Aging.--Subsection (b)(1)(B) of such section
119, as so amended, is amended--
(1) in clause (xii), by striking ``and'' at the end;
(2) in clause (xiii), by striking the period at the end and
inserting ``; and''; and
(3) by inserting after clause (xiii) the following new
clause:
``(xiv) for fiscal year 2024,
$15,000,000.''.
(c) Aging and Disability Resource Centers.--Subsection (c)(1)(B) of
such section 119, as so amended, is amended--
(1) in clause (xii), by striking ``and'' at the end;
(2) in clause (xiii), by striking the comma at the end and
inserting ``; and''; and
(3) by inserting after clause (xiii) the following new
clause:
``(xiv) for fiscal year 2024,
$5,000,000.''.
(d) Coordination of Efforts to Inform Older Americans About
Benefits Available Under Federal and State Programs.--Subsection (d)(2)
of such section 119, as so amended, is amended--
(1) in clause (xii), by striking ``and'' at the end;
(2) in clause (xiii), by striking the period at the end and
inserting ``; and''; and
(3) by inserting after clause (xiii) the following new
clause:
``(xiv) for fiscal year 2024,
$15,000,000.''.
SEC. 403. EXTENSION OF THE WORK GEOGRAPHIC INDEX FLOOR UNDER THE
MEDICARE PROGRAM.
Section 1848(e)(1)(E) of the Social Security Act (42 U.S.C. 1395w-
4(e)(1)(E)) is amended by striking ``January 1, 2024'' and inserting
``January 1, 2025''.
SEC. 404. EXTENDING INCENTIVE PAYMENTS FOR PARTICIPATION IN ELIGIBLE
ALTERNATIVE PAYMENT MODELS.
(a) In General.--Section 1833(z) of the Social Security Act (42
U.S.C. 1395l(z)) is amended--
(1) in paragraph (1)(A)--
(A) by striking ``with 2025'' and inserting ``with
2026''; and
(B) by inserting ``, or, with respect to 2026, 1.75
percent'' after ``3.5 percent''.
(2) in paragraph (2)--
(A) in subparagraph (B)--
(i) in the header, by striking ``2025'' and
inserting ``2026''; and
(ii) in the matter preceding clause (i), by
striking ``2025'' and inserting ``2026'';
(B) in subparagraph (C)--
(i) in the header, by striking ``2026'' and
inserting ``2027''; and
(ii) in the matter preceding clause (i), by
striking ``2026'' and inserting ``2027''; and
(C) in subparagraph (D), by striking ``and 2025''
and inserting ``2025, and 2026''; and
(3) in paragraph (4)(B), by inserting ``, or, with respect
to 2026, 1.75 percent'' after ``3.5 percent''.
(b) Conforming Amendments.--Section 1848(q)(1)(C)(iii) of the
Social Security Act (42 U.S.C. 1395w-4(q)(1)(C)(iii)) is amended--
(1) in subclause (II), by striking ``2025'' and inserting
``2026''; and
(2) in subclause (III), by striking ``2026'' and inserting
``2027''.
SEC. 405. PAYMENT RATES FOR DURABLE MEDICAL EQUIPMENT UNDER THE
MEDICARE PROGRAM.
(a) Areas Other Than Rural and Noncontiguous Areas.--The Secretary
shall implement section 414.210(g)(9)(v) of title 42, Code of Federal
Regulations (or any successor regulation), to apply the transition rule
described in the first sentence of such section to all applicable items
and services furnished in areas other than rural or noncontiguous areas
(as such terms are defined for purposes of such section) through
December 31, 2024.
(b) All Areas.--The Secretary shall not implement section
414.210(g)(9)(vi) of title 42, Code of Federal Regulations (or any
successor regulation) until January 1, 2025.
(c) Implementation.--Notwithstanding any other provision of law,
the Secretary may implement the provisions of this section by program
instruction or otherwise.
SEC. 406. EXTENDING THE INDEPENDENCE AT HOME MEDICAL PRACTICE
DEMONSTRATION PROGRAM UNDER THE MEDICARE PROGRAM.
(a) In General.--Section 1866E of the Social Security Act (42
U.S.C. 1395cc-5) is amended--
(1) in subsection (e)--
(A) in paragraph (1), by striking ``10-year'' and
inserting ``12-year''; and
(B) in paragraph (5)--
(i) in the second sentence, by striking
``tenth'' and inserting ``twelfth''; and
(ii) in the third sentence, by striking
``tenth'' and inserting ``twelfth''; and
(2) in subsection (h), by striking ``and $9,000,000 for
fiscal year 2021'' and inserting ``, $9,000,000 for fiscal year
2021, and $3,000,000 for fiscal year 2024''.
(b) Effective Date.--The amendments made by subsection (a) shall
take effect as if included in the enactment of Public Law 111-148.
SEC. 407. INCREASE IN SUPPORT FOR PHYSICIANS AND OTHER PROFESSIONALS IN
ADJUSTING TO MEDICARE PAYMENT CHANGES.
Section 1848(t)(1)(D) of the Social Security Act (42 U.S.C. 1395w-
4(t)(1)(D)) is amended by striking ``1.25 percent'' and inserting ``2.5
percent''.
SEC. 408. REVISED PHASE-IN OF MEDICARE CLINICAL LABORATORY TEST PAYMENT
CHANGES.
(a) Revised Phase-in of Reductions From Private Payor Rate
Implementation.--Section 1834A(b)(3) of the Social Security Act (42
U.S.C. 1395m-1(b)(3)) is amended--
(1) in subparagraph (A), by striking ``through 2026'' and
inserting ``through 2027''; and
(2) in subparagraph (B)--
(A) in clause (ii), by striking ``through 2023''
and inserting ``through 2024''; and
(B) in clause (iii), by striking ``2024 through
2026'' and inserting ``2025 through 2027''.
(b) Revised Reporting Period for Reporting of Private Sector
Payment Rates for Establishment of Medicare Payment Rates.--Section
1834A(a)(1)(B) of the Social Security Act (42 U.S.C. 1395m-1(a)(1)(B))
is amended--
(1) in clause (i), by striking ``December 31, 2023'' and
inserting ``December 31, 2024''; and
(2) in clause (ii)--
(A) by striking ``January 1, 2024'' and inserting
``January 1, 2025''; and
(B) by striking ``March 31, 2024'' and inserting
``March 31, 2025''.
SEC. 409. EXTENSION OF ADJUSTMENT TO CALCULATION OF HOSPICE CAP AMOUNT
UNDER MEDICARE.
Section 1814(i)(2)(B) of the Social Security Act (42 U.S.C.
1395f(i)(2)(B)) is amended--
(1) in clause (ii), by striking ``2032'' and inserting
``2033''; and
(2) in clause (iii), by striking ``2032'' and inserting
``2033''.
TITLE V--OFFSETS
SEC. 501. MEDICAID IMPROVEMENT FUND.
Section 1941(b)(3)(A) of the Social Security Act (42 U.S.C. 1396w-
1(b)(3)(A)), as amended by section 2342 of the Continuing
Appropriations Act, 2024 and Other Extensions Act (Public Law 118-15),
is amended by striking ``$6,357,117,810'' and inserting
``$561,000,000''.
SEC. 502. MEDICARE IMPROVEMENT FUND.
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended by striking ``$180,000,000'' and inserting
``756,000,000''.
Calendar No. 265
118th CONGRESS
1st Session
S. 3430
[Report No. 118-121]
_______________________________________________________________________
A BILL
To amend titles XVIII and XIX of the Social Security Act to expand the
mental health care workforce and services, reduce prescription drug
costs, and extend certain expiring provisions under Medicare and
Medicaid, and for other purposes.
_______________________________________________________________________
December 7, 2023
Read twice and placed on the calendar